Psyence Biomedical Ltd 20-F for FY2026
Psyence Biomedical Ltd. (PBM)
About this 20-F
Psyence Biomedical Ltd filed this 20-F on June 22, 2026, covering the fiscal year ended March 31, 2026 (FY2026).
Headline figures
Fiscal year ended March 31, 2026, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Net loss
- $6.94M
- compared with net income of $1.01M a year earlier
- Diluted EPS
- -$12.56
- compared with $32.76 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(Mark One)
OR
For the fiscal year ended
OR
OR
Date of event requiring this shell company report:
Commission File Number:
(Exact name of Registrant as specified in its charter)
| Not applicable | ||
| (Translation of Registrant’s name into English) | (Jurisdiction of incorporation or organization) |
+1 (416) 477-1708
(Address of principal executive offices)
Copy to:
(Name, Telephone, Email and/or Facsimile number and Address of Company Contact Person)
Securities registered or to be registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| The | ||||
purchase one Common Share at an exercise price of $42,963.28 per share | The |
Securities registered or to be registered pursuant to Section 12(g) of the Act: None
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None
The number of the issuer’s outstanding common shares as of March 31,
2026 was
Indicate by check mark if the registrant is a well-known seasoned issuer,
as defined in Rule 405 of the Securities Act. Yes ☐
If this report is an annual or transition report, indicate by check
mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. Yes ☐
Indicate by check mark whether the registrant: (1) has filed all
reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically
every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during
the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer, or an emerging growth company. See definition of “accelerated filer,” “large accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):
| Large accelerated filer | ☐ | Accelerated filer | ☐ | ☒ | |
| Emerging growth company |
If an emerging growth company that prepares its financial statements
in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant has filed a report on
and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of
the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.
If securities are registered pursuant to Section 12(b) of
the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an
error to previously issued financial statements.
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
| U.S. GAAP ☐ | ☒ | Other ☐ |
If “Other” has been checked in response to the previous question indicate by check mark which financial statement item the registrant has elected to follow. Item 17 ☐ Item 18 ☐
If this is an annual report, indicate by check
mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
TABLE OF CONTENTS
Except as otherwise indicated or required by context, references in this Annual Report on Form 20-F (the “Report”) to “we,” “us,” “our,” “Psyence Biomedical,” “Psyence,” “PBM” or the “Company” refer to Psyence Biomedical Ltd., a corporation organized under the laws of Ontario, Canada.
i
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 20-F (this “Report”) and the documents incorporated by reference herein include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). As used in this Report, “the Company,” “Psyence Biomedical,” “we,” “us” and “our” refer to Psyence Biomedical Ltd. and its subsidiaries, unless the context otherwise requires. Forward-looking statements relate to, among others, our plans, objectives and expectations for our business, operations and financial performance and condition, and can be identified by terminology such as “may,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar expressions that do not relate solely to historical matters. Forward-looking statements are based on management’s belief and assumptions and on information currently available to management. Although we believe that the expectations reflected in forward-looking statements are reasonable, such statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by forward-looking statements.
Forward-looking statements in this Report and in any document incorporated by reference in this Report may include, but are not limited to, statements about:
| ● | the ability of Psyence Biomedical to maintain the listing of the Common Shares or the Warrants on Nasdaq, including in light of the Company’s recent history of, and ongoing efforts to maintain compliance with, the continued listing requirements of the Nasdaq Capital Market; |
| ● | volatility in the price of the securities of Psyence Biomedical due to a variety of factors, including the recent share consolidation and reverse stock split, changes in the competitive and highly regulated industries in which Psyence Biomedical operates, variations in performance across competitors, changes in laws and regulations affecting Psyence Biomedical’s business and changes in Psyence Biomedical’s capital structure; |
| ● | Psyence Biomedical’s success in retaining or recruiting, or changes required in, its officers, key employees or directors; |
| ● | factors relating to the business, operations and financial performance of the Company, including, but not limited to: |
| o | the Company’s ability to achieve successful clinical results, including in its Phase IIb clinical trial, on which the Company is substantially dependent; |
| o | the Company currently has no products approved for commercial sale; |
| o | the regulatory status of, and evolving and uncertain laws and regulations applicable to, psilocybin, ibogaine and other psychedelic substances, which remain controlled substances in many jurisdictions; |
| o | the Company’s ability to obtain regulatory approval for its product candidates, and any related restrictions or limitations of any approved products; |
| o | the Company’s ability to obtain licensing of third-party intellectual property rights for future discovery and development of the Company’s product candidates; |
| o | the Company’s ability to commercialize product candidates and achieve market acceptance of such product candidates; |
| o | the Company’s success is dependent on product candidates which it licenses from third parties; |
| o | the Company’s success is dependent on the supply of materials necessary to perform its clinical trials; |
| o | the Company’s ability to continue as a going concern and its need for substantial additional capital to fund its operations; |
| o | dilution to existing shareholders resulting from the issuance of additional securities, including under the Company’s at-the-market offering program and equity line of credit; and |
| o | the ability to respond to general economic conditions. |
Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors discussed under the “Risk Factors” section below and in the Company’s other filings with the SEC. Accordingly, you should not rely on these forward-looking statements, which speak only as of the date of this Report. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this Report or to reflect the occurrence of unanticipated events. You should, however, review the factors and risks described in the reports we will file from time to time with the SEC after the date of this Report.
Although we believe the expectations reflected in the forward-looking statements were reasonable at the time made, we cannot guarantee future results, level of activity, performance or achievements. Moreover, neither we nor any other person assume responsibility for the accuracy or completeness of any of these forward-looking statements. You should carefully consider the cautionary statements contained or referred to in this section in connection with the forward-looking statements contained in this Report and any subsequent written or oral forward-looking statements that may be issued by the Company or persons acting on its behalf.
ii
PART I
ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
Not Applicable.
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE
Not applicable.
ITEM 3. KEY INFORMATION
A. [Reserved.]
B. Capitalization and Indebtedness
Not applicable.
C. Reasons for the Offer and Use of Proceeds
Not applicable.
D. Risk Factors
Investing in our securities involves a high degree of risk. You should carefully consider the following information about these risks, together with the other information appearing elsewhere in this Report, including our financial statements, the notes thereto and the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” before deciding to invest in our securities. The occurrence of any of the following risks could have a material adverse effect on our business, reputation, financial condition, results of operations and future growth prospects, as well as our ability to accomplish our strategic objectives. As a result, the trading price of our securities could decline and you could lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business operations and the market price of our securities.
Risks Related to Our Business and Industry
We are a clinical-stage biotechnology company and have incurred significant losses since our inception. We anticipate that we will incur significant losses for the foreseeable future.
Investment in biotechnology product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate effectiveness or an acceptable safety profile, gain regulatory approval and become commercially viable. All of Psyence’s product candidates will require substantial additional capital expenditures and development time, including extensive clinical research and resources, before it would be able to apply for and then receive marketing authorization and begin generating revenue from product sales.
Since its inception, Psyence has invested most of its resources in establishing strategic partnerships, securing intellectual property licensing rights, advancing its clinical trial program, raising capital, building its management team and providing general and administrative support for these operations. Psyence has incurred losses since its inception and expects to incur significant losses for the foreseeable future. Psyence’s net profit/(loss) for the years ended March 31, 2026, March 31, 2025 and March 31, 2024 was ($6.89 million), $1 million and ($50.96 million), respectively. The March 31, 2025 net profit was driven by the fair value gains on conversion of debt into equity and warrant liability fair value remeasurement. To date, no products have been approved for commercial sale and Psyence has not generated any revenue. Psyence has financed operations solely through the sale of equity securities and convertible debt financings. Psyence continues to incur significant research and development and other expenses related to ongoing operations and expects to incur losses for the foreseeable future.
Due to the numerous risks and uncertainties associated with the development of its product candidates, Psyence is unable to predict the timing or amount of its expenses, or when it will be able to generate any meaningful revenue or achieve or maintain profitability, if ever. In addition, its expenses could increase beyond current expectations if Psyence is required by the Therapeutic Goods Administration in Australia (“TGA”), the U.S. Food and Drug Administration (“FDA”), the European Medicines Agency (“EMA”), Medicines and Healthcare products Regulatory Agency in the UK (“MHRA”), or other comparable foreign regulatory authorities, to perform preclinical studies or clinical trials in addition to those that Psyence currently anticipates, or if there are any delays in any of Psyence’s or its future collaborators’ clinical trials or the development of the existing product candidates and any other product candidates that Psyence may identify. Even if Psyence’s existing product candidates or any future product candidates that Psyence may identify are approved for commercial sale, Psyence anticipates incurring significant costs associated with commercializing any approved product and ongoing compliance efforts.
1
Psyence has a limited operating history and expects a number of factors to cause its operating results to fluctuate on an annual basis, which may make it difficult to predict the future performance of Psyence.
Psyence is a clinical stage biotechnology development company with a limited operating history. Consequently, any predictions made about Psyence’s future success or viability may not be as accurate as they could be if Psyence had a longer operating history and additional definitive partnership agreements in place. Psyence’s operating results are expected to significantly fluctuate from quarter-to-quarter or year-to-year due to a variety of factors, many of which are beyond its control. Factors relating to Psyence’s business that may contribute to these fluctuations include, but are not limited to:
| ● | any delays or issues in finding, and establishing successful business arrangements with, pharmaceutical and product development partners to assist in moving its product candidates through the development and commercialization processes; |
| ● | delays in the commencement, enrolment and timing of clinical trials; |
| ● | the success of its preclinical trials; |
| ● | potential side effects of its product candidates that could delay or prevent approval or license-out agreements or cause an approved product candidate to be eliminated; |
| ● | supply chain interruptions, which could delay Psyence in the process of developing its product candidates; |
| ● | its ability to obtain additional funding to develop its product candidates; |
| ● | its ability to attract and retain talented and experienced personnel to manage its business effectively; |
| ● | competition from existing psychedelic analogs companies or new psychedelic analogs companies that continue to emerge; |
| ● | assuming market authorization has been obtained for our product candidates, the ability of patients or healthcare providers to obtain coverage or sufficient reimbursement for such products; |
| ● | its ability to adhere to clinical study requirements directly or with third parties such as clinical research organizations (“CROs”); |
| ● | its dependency on third-party manufacturers to manufacture products and key ingredients; |
| ● | its ability to establish or maintain collaborations, licensing or other transactions; |
| ● | its ability to defend against any challenges to its intellectual property, including claims of patent infringement; |
| ● | its ability to enforce its intellectual property rights against potential competitors; |
| ● | its ability to secure additional intellectual property protection for its product candidates and associated manufacturing methods currently under development; |
| ● | a biological or chemical effect that Psyence does not predict; |
| ● | adverse economic circumstances; and |
| ● | potential liability claims. |
Accordingly, the results of any historical financial periods should not be relied upon as indications of future operating performance.
2
Psyence has never generated revenue and may never be profitable.
Psyence may never be able to develop or commercialize marketable products or achieve profitability. Revenue from the sale of any product candidate for which regulatory approval is obtained will be dependent, in part, upon the size of the markets in the territories for which Psyence gains regulatory approval, the accepted price for the product, the acceptance of the product by physicians and patients, the ability to obtain reimbursement at any price and whether Psyence owns the commercial rights for that territory. Psyence’s growth strategy depends on its ability to generate revenue. In addition, if the number of addressable patients is not as anticipated, the indication or intended use approved by regulatory authorities is narrower than expected, or the reasonably accepted population for treatment is narrowed by competition, physician choice or treatment guidelines, Psyence may not generate significant revenue from sales of such products, even if approved. Even if Psyence is able to generate revenue from the sale of any approved products, Psyence may not become profitable and may need to obtain additional funding to continue operations. Even if Psyence were to achieve profitability in the future, it may not be able to sustain profitability in subsequent periods.
Psyence’s failure to achieve sustained profitability would depress the value of the Company and could impair its ability to raise capital, expand the business, diversify its research and development pipeline, market its product candidates, if approved, and pursue or continue operations. Psyence’s prior losses, combined with expected future losses, have had and will continue to have an adverse effect on shareholders’ equity and working capital.
The Company will require substantial additional funding to achieve its business goals, and if it is unable to obtain this funding when needed and on acceptable terms, it could be forced to delay, limit or terminate its product development efforts.
Psyence’s clinical trial and product development pipeline currently consists of an approved Phase IIb Study in Australia. We have also obtained approval from the MHRA to conduct a Phase IIa study in the UK, which was not initiated due to certain cost-effective incentives provided by Australia. Once the Phase IIb Study in Australia is completed, a Phase III pivotal study program will begin, of which the size and number of trials will depend on the results of the Phase IIb Study, the advice given to Psyence from the regulatory authorities and whether the FDA will assess the program as being fast-tracked or eligible as a breakthrough therapy. If the assessment is the latter, the Phase III program could be smaller than anticipated and less than the usual required two pivotal studies to support market authorization.
Conducting clinical trials and developing biopharmaceutical products is expensive and time consuming, and we expect to require substantial additional capital to conduct research, preclinical studies and clinical trials for the current and future trials, seek regulatory approvals for our product candidates and launch and commercialize any products for which Psyence may receive regulatory approval, including building our own commercial sales, marketing and distribution organization. Our management and strategic decision makers have not made decisions regarding the future allocation of certain resources among Psyence’s pipeline of trials, but continue to evaluate the needs and opportunities with respect to each of these trials routinely and on a case-by-case basis. Because the outcome of any preclinical or clinical development and regulatory approval process is highly uncertain (including the size and quantum of the Phase III registrational program), Psyence cannot reasonably estimate the actual amounts necessary to successfully complete the development, regulatory approval process and potential commercialization of its product candidates and any future product candidates it may identify.
3
Psyence expects that the existing available cash will be sufficient to fund operations beyond 12 months from the date of this filing. As of March 31, 2026, we had USD$7,491,954 in cash and cash equivalents and restricted cash. However, Psyence’s operating plan may change as a result of many factors currently unknown, and Psyence may need to seek additional funds sooner than planned, through public or private equity or debt financings, sales of assets or programs, other sources, such as strategic collaborations or license and development agreements, or a combination of these approaches. Even if Psyence believes that its funds are sufficient for its current or future operating plans, it may, subject to obtaining the necessary contractual consents, opportunistically seek additional capital if market conditions are favorable or for specific strategic considerations. Psyence’s spending will vary based on new and ongoing product development and business development activities. Any such additional fundraising efforts for Psyence may divert management from their day-to-day activities, which may adversely affect Psyence’s ability to develop and commercialize product candidates that Psyence may identify and pursue. Moreover, such financing may result in dilution to shareholders, imposition of debt covenants and repayment obligations, or other restrictions that may affect Psyence’s business. Changing circumstances, some of which may be beyond Psyence’s control, could cause Psyence to consume capital significantly faster than currently anticipated, and Psyence may need to seek additional funds sooner than planned. Psyence’s future funding requirements, both short-term and long-term, will depend on many factors, including, but not limited:
| ● | the time and cost necessary to complete ongoing and planned clinical trials; |
| ● | the outcome, timing and cost of meeting regulatory requirements established by the TGA, FDA, the EMA, the MHRA and other comparable foreign regulatory authorities; |
| ● | the progress, timing, scope and costs of preclinical studies, clinical trials and other related activities for ongoing and planned clinical trials, and potential future clinical trials; |
| ● | the costs of obtaining clinical and commercial supplies of raw materials and drug products for Psyence’s product candidates, as applicable, and any other product candidates Psyence may identify and develop; |
| ● | Psyence’s ability to successfully identify and negotiate acceptable terms for third-party supply and contract manufacturing agreements with contract manufacturing organizations (“CMOs”); |
| ● | the costs of commercialization activities for any of Psyence’s product candidates that receive marketing approval, including the costs and timing of establishing product sales, marketing, distribution and manufacturing capabilities, or entering into strategic collaborations with third parties to leverage or access these capabilities; |
| ● | the amount and timing of sales and other revenues from Psyence’s product candidates, if approved, including the sales price and the availability of coverage and adequate third-party reimbursement; |
| ● | the cash requirements of developing Psyence’s programs and Psyence’s ability and willingness to finance their continued development; |
| ● | the cash requirements of any future acquisitions or discovery of product candidates; |
| ● | the time and cost necessary to respond to technological and market developments, including other products that may compete with one or more of Psyence’s product candidates; |
| ● | supply chain interruptions, which could delay Psyence in the process of developing its product candidates; |
| ● | the costs of acquiring, licensing or investing in intellectual property rights, products, product candidates and businesses; |
| ● | the costs of maintaining, expanding and protecting Psyence’s intellectual property portfolio; |
| ● | its ability to attract, hire and retain qualified personnel as Psyence expands research and development and establishes a commercial infrastructure; and |
| ● | the costs of operating as a public company in the United States and maintaining a listing on Nasdaq. |
Psyence cannot be certain that additional funding will be available on acceptable terms, or at all. Market volatility resulting from the introduction of significant instability and uncertainty into global supply chains, pricing structures, and international trade relationships due to the geopolitical and trade policy uncertainty, including U.S. tariff measures and escalations in the Middle East, could adversely affect global economic conditions and our business. Other factors could also adversely impact the ability to access funds as and when needed. If adequate funds are not available to Psyence on a timely basis, Psyence may be required to delay, limit or terminate one or more research or development programs or trials or the potential commercialization of any approved products or be unable to expand operations or otherwise capitalize on business opportunities, as desired, which could materially affect Psyence’s business, prospects, financial condition and results of operations.
4
Recent U.S. federal actions to accelerate the development of psychedelic therapies may benefit competitors more than us, or may not benefit us at all.
On April 18, 2026, a federal executive order directed agencies to expedite the research, regulatory review and access pathways for psychedelic therapies for serious mental illness, and on April 24, 2026, the FDA announced corresponding regulatory actions, including the issuance of Commissioner’s National Priority Vouchers to companies developing psilocybin- and methylone-based product candidates and the clearance of the first U.S. clinical study of an ibogaine derivative. While these developments may signal a more favorable federal posture toward the class of products in which Psyence operates, they do not change the statutory standards for FDA approval and do not approve any product candidate. These developments may disproportionately benefit competitors that are further advanced in clinical development, are better capitalized, or have been selected for expedited-review designations that Psyence has not received and may never receive. The acceleration of competing programs could intensify competition, compress the period within which Psyence must reach key development milestones to remain commercially relevant, and otherwise adversely affect Psyence’s business, prospects, financial condition and results of operations.
We depend on our current key personnel and our ability to attract and retain employees.
Our future growth and success depends on our ability to recruit, retain, manage and motivate our employees. We are highly dependent on our current management and scientific personnel, including Jody Aufrichtig (Executive Chairman and Chief Executive Officer), Warwick Corden-Lloyd (Chief Financial Officer), Dr. Neil Maresky (Global Head of Clinical Development) and Taryn Vos (General Counsel). The inability to hire or retain experienced management personnel could adversely affect our ability to execute our business plan and harm our operating results. Due to the specialized scientific and managerial nature of our business, we rely heavily on our ability to attract and retain qualified scientific, technical and managerial personnel. The competition for qualified personnel in the pharmaceutical field is intense and we may be unable to continue to attract and retain qualified personnel necessary for the development of our business or to recruit suitable replacement personnel.
Our historical financial results may not be representative of our results as a separate, stand-alone company.
Some of the historical financial information we have included in this Report has been derived from the financial statements and accounting records of PGI (as defined below) and does not necessarily reflect what our financial position, results of operations or cash flows would have been had we been a separate, stand-alone company during the periods presented. The historical information does not necessarily indicate what our results of operations, financial position cash flows or costs and expenses will be in the future.
The psychedelic therapy and biotechnology industries are intensely competitive and subject to rapid and significant technological change, and consolidation in the industries could harm our competitive position.
The psychedelic therapy and biotechnology industries are undergoing rapid growth and substantial change, which has resulted in an increase in competitors, consolidation and formation of strategic relationships. Acquisitions or other consolidating transactions could harm Psyence in a number of ways, including by losing strategic partners if they are acquired by or enter into relationships with a competitor, losing customers, revenue and market share, or forcing Psyence to expend greater resources to meet new or additional competitive threats, all of which could harm Psyence’s operating results.
The psychedelic therapy and biotechnology industries are intensely competitive and subject to rapid and significant technological change. Psyence has competitors in Canada, the United States, Europe and other jurisdictions, including major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical and generic drug companies and universities and other research institutions. Many of our competitors have greater financial and other resources, such as larger research and development staff and more experienced marketing and manufacturing organizations than we do. Large pharmaceutical companies, in particular, have extensive experience in, and substantial capital resources for, conducting research, molecular derivative development, obtaining regulatory approvals, obtaining intellectual property protection and establishing key relationships. These companies also have significantly greater sales and marketing capabilities and experience in completing collaborative transactions in Psyence’s target markets with leading companies and research institutions.
5
Psyence’s competitors may introduce new psychedelic analogs or develop technological advances that compete with Psyence. Psyence cannot predict the timing or impact of competitors introducing new psychedelic analogs or technological advances. Such competing psychedelic analogs may be safer, more effective, more effectively marketed, licensed or sold or have lower prices or superior performance features than Psyence’s psychedelic analogs, and this could negatively impact Psyence’s business and results of operations. Established pharmaceutical companies may also invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make the psychedelic analogs that Psyence develops obsolete. As a result of any of these factors, Psyence’s competitors may succeed in obtaining patent protection or discovering, developing and commercializing psychedelic analogs before Psyence does or may develop psychedelic analogs that are deemed to be more effective or gain greater market acceptance than those of Psyence.
Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative transactions with large, established companies. In addition, many universities and private and public research institutions may become active in the development of novel compounds. Psyence’s competitors may succeed in developing, acquiring or licensing on an exclusive basis, technologies and psychedelic analogs that are more effective or less costly than any of the psychedelic analogs that Psyence is currently developing or that it may develop, which could render its psychedelic analogs obsolete or non-competitive. If Psyence’s competitors’ market psychedelic analogs that are more effective, safer or less expensive or that reach the market sooner than Psyence’s psychedelic analogs, if any, Psyence may not achieve commercial success. In addition, because of its limited resources, it may be difficult for Psyence to stay abreast of the rapid changes in each technology. If Psyence fails to stay at the forefront of technological change, it may be unable to compete effectively. Technological advances or products developed by its competitors may render its technologies or psychedelic analogs obsolete, less competitive or not economical.
Current and future preclinical and clinical studies will be conducted outside the United States, and the FDA may not accept data from such studies to support any NDAs submitted after completing the applicable developmental and regulatory prerequisites (absent an IND).
Psyence is conducting a clinical study outside the United States. Psyence has received full approval of a study in the UK from the MHRA, which was not initiated due to certain cost-effective incentives provided by Australia. Psyence has received full approval from the Australian Human Research Ethics Committees (HRECs), the body responsible for the review of research proposals involving human participants to ensure that they are ethically acceptable. The protocol under review in Australia will be reviewed as part of a Pre-IND (Investigational New Drug) application by the FDA. To the extent Psyence does not conduct these clinical trials under an IND, the FDA may not accept data from such trials. Although the FDA may accept data from clinical trials conducted outside the United States that are not conducted under an IND, the FDA’s acceptance of these data is subject to certain conditions. For example, the clinical trial must be well designed and conducted and performed by qualified investigators in accordance with ethical principles and all applicable FDA regulations. The trial population must also adequately represent the intended U.S. population, and the data must be applicable to the U.S. population and U.S. medical practice in ways that the FDA deems clinically meaningful. There can be no guarantee that the FDA will accept data from trials conducted outside of the United States. If the FDA does not accept the data from such clinical trials, this would likely result in the need for additional trials and the completion of additional regulatory steps, which would be costly and time-consuming and could delay or permanently halt the development of Psyence’s product candidates.
There is a high rate of failure for product candidates proceeding through clinical trials.
Psyence has no registered products on the market, and its new potential psilocybin-based product candidates are currently either in the preclinical or clinical development phase. Psyence’s ability to achieve and sustain profitability with respect to its product candidates in which psilocybin is featured as the active pharmaceutical ingredient depends on obtaining regulatory approvals for and, if approved, successfully commercializing, its product candidates, either alone or with third parties. Before obtaining regulatory approval for the commercial distribution of its current or future product candidates, Psyence or an existing or future collaborator must conduct extensive preclinical tests and clinical trials to demonstrate the safety, purity and potency of its product candidates.
Generally, there is a high rate of failure for product candidates proceeding through clinical trials. Psyence may suffer significant setbacks in its clinical trials similar to the experience of a number of other companies in the pharmaceutical and biotechnology industries, even after receiving promising results in earlier trials. Further, even if Psyence views the results of a clinical trial to be positive, applicable international regulatory authorities may disagree with Psyence’s interpretation of the data. In the event that Psyence obtains negative results from clinical trials for product candidates or other problems related to potential chemistry, manufacturing and control issues or other hurdles occur and its current or future product candidates are not approved, Psyence may not be able to generate sufficient revenue or obtain financing to continue its operations, its ability to execute on its current business plan may be materially impaired and its reputation in the industry and in the investment community might be significantly damaged. In addition, Psyence’s inability to properly design, commence and complete clinical trials may negatively impact the timing and results of its clinical trials and ability to seek approvals for its product candidates.
6
The testing, marketing and manufacturing of any new drug product for use in the U.S. will require approval from the FDA. Psyence cannot predict with any certainty the amount of time necessary to obtain such FDA approval and whether any such approval will ultimately be granted. Preclinical and clinical trials may reveal that one or more product candidates are ineffective or unsafe, in which event further development of such product candidates could be seriously delayed or terminated. Moreover, obtaining approval for certain product candidates may require testing on human subjects of substances whose effects on humans are not fully understood or documented. Delays in obtaining FDA or any other necessary regulatory approvals of any proposed drug and failure to receive such approvals would have an adverse effect on the drug’s potential commercial success and on Psyence’s business, prospects, financial condition and results of operations. In addition, it is possible that a proposed drug may be found to be ineffective or unsafe due to conditions or facts that arise after development has been completed and regulatory approvals have been obtained. In this event, Psyence may be required to withdraw such proposed drug from the market. To the extent that its success will depend on any regulatory approvals from government authorities outside of the U.S. that perform roles similar to that of the FDA, uncertainties similar to those stated above will also exist.
Because the results of preclinical studies and earlier clinical trials are not necessarily predictive of future results, Psyence may not have favorable results in its planned and future clinical trials.
Successful development of therapeutic products is highly uncertain and is dependent on numerous factors, many of which are beyond Psyence’s control. Product candidates that appear promising in the early phases of development may fail to reach the market for several reasons, including, but not limited to:
| ● | preclinical or clinical study results that may show the product to be less effective than desired (e.g., the study failed to meet Psyence’s primary objectives) or to have harmful or problematic side effects; |
| ● | failure to receive the necessary regulatory approvals or a delay in receiving such approvals. Among other things, such delays may be caused by slow enrollment in clinical studies, length of time to achieve study endpoints, additional time requirements for data analysis or regulatory requests for additional preclinical or clinical data or unexpected safety or manufacturing issues; |
| ● | manufacturing costs, pricing, or reimbursement issues or other factors that make the product not economical; and |
| ● | the proprietary rights of others and their competing products and technologies that may prevent the product from being commercialized. |
Any positive results from preclinical testing of Psyence’s prospective product candidates may not necessarily be predictive of the results from planned or future clinical trials for such product candidates. Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical trials after achieving positive results in preclinical and early clinical development, and Psyence cannot be certain that it will not face similar setbacks. These setbacks have been caused by, among other things, preclinical findings while clinical trials were underway or safety or efficacy observations in clinical trials, including adverse events. If Psyence fails to produce positive results in its planned clinical trials for its product candidates as described in the section titled “Business”, or its future clinical trials, the development timeline and regulatory approval and commercialization prospects for such product candidates, and, correspondingly, Psyence’s business and financial prospects, would be materially adversely affected.
Negative results from clinical trials or studies of others and adverse safety events involving Psyence’s psychedelic analogs could have a material adverse effect on Psyence’s business.
From time to time, studies or clinical trials on medical-grade psilocybin mushroom products may be conducted or sponsored by academics, research institutions or others, including government agencies. The publication of negative results of studies or clinical trials related to Psyence’s proposed products or the therapeutic areas in which Psyence’s proposed products will compete could have a material adverse effect on Psyence’s business, prospects, financial condition and results of operations.
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Supply chain interruptions could delay Psyence in the process of developing its product candidates.
There are few licensed suppliers of input materials for the manufacture of Psyence’s product candidates. Any loss of stored materials or facilities through fire, theft or other causes could have an adverse effect on Psyence’s ability to procure the product candidate materials and continue product development activities. Furthermore, Psyence is largely dependent on Psyence Labs Ltd and its affiliates (“PsyLabs”), a British Virgin Islands-based company focused on the production of psychedelic active pharmaceutical ingredients, for the supply of NPX-5 (capsules containing 25mg naturally sourced psilocybin and product being used in Psyence’s Phase IIb Study), and any interruption in PsyLabs’ supply chain (or the supply chain of any other suppliers engaged by Psyence) will lead to delays in Psyence’s drug development timelines. Furthermore, PsyLabs, as well as any other suppliers engaged by Psyence, will be required to continue to meet regulatory requirements applicable to the NPX-5 product candidate and maintain GMP compliant standards which dictate the minimum requirements for the methods, facilities and controls used in manufacturing, processing and packing of a drug product. There can be no assurances that PsyLabs or any CMOs will be able to meet Psyence’s timetable and requirements or carry out their contractual obligations in accordance with the applicable regulations. In addition, the drug product supplied to Psyence may not meet its specifications and quality policies and procedures nor may they be able to supply the drug product in commercial quantities when the time comes. If Psyence is unable to arrange for alternative third-party supply sources on commercially reasonable terms or in a timely manner, it may delay the development of its product candidates and could have a material adverse effect on Psyence’s business operations and financial condition.
Further, the failure of CMOs to operate in compliance with GMP or other applicable quality related regulations could result in, among other things, certain product liability claims in the event such failure to comply results in defective products that caused injury or harm. In general, Psyence’s dependence upon third parties for the supply of Psyence’s drug product may adversely affect profit margins and Psyence’s ability to develop and deliver viable end products on a timely and competitive basis.
Psyence’s proprietary information, or that of its strategic business partners, may be lost or Psyence may suffer security breaches.
In the ordinary course of its business, Psyence collects and stores sensitive data, including valuable and commercially sensitive intellectual property, clinical trial data, proprietary business information and that of Psyence’s strategic business partners, as well as the personally identifiable information of clinical trial subjects, employees and patients, in and on Psyence’s networks. Despite security measures, information technology and infrastructure may be vulnerable to attacks by hackers or breached due to employee error, malfeasance or other disruptions. Any such breach could compromise Psyence’s networks and the information stored there could be accessed, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, regulatory penalties, disruption of operations, damage to Psyence’s reputation, and cause a loss of confidence in Psyence’s ability to conduct clinical trials, which could adversely affect Psyence’s business, prospects, financial condition and results of operations.
Costs associated with compliance with numerous laws and regulations could impact our financial results. In addition, we could become subject to increased enforcement and/or litigation risks associated with the psychedelic therapeutics industry.
The manufacture, labeling and distribution of products containing psilocybin or other psychedelic analogs is governed by various federal, state and local agencies. To the extent we are able to successfully commercialize any of our currently contemplated product candidates via the FDA’s NDA approval pathway, the presence of psychedelic analogs as active or inactive ingredients, as applicable, may give rise to heightened regulatory scrutiny and greater risk of consumer litigation, either of which could further restrict the permissible scope of our marketing claims about such products or our ability to sell them in the United States at all. The shifting compliance environment and the need to build and maintain robust systems to comply with different psychedelic-related regulations in jurisdictions may increase costs and/or the risk that we may violate one or more applicable regulatory requirements. If our operations, or any of our activities or prospective products, are found to be in violation of any such laws or any other governmental regulations that apply to the manufacture, distribution, or sale of prescription drug products, generally, and to products containing psychedelic analogs, we may be subject to penalties, including, without limitation, civil and criminal penalties, damages, fines, the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business or our financial results.
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Failure to comply with any applicable regulatory requirements, relating to psilocybin or otherwise, may result in, among other things, injunctions, product withdrawals, recalls, product seizures, fines and criminal prosecutions. Additionally, advertising and labeling laws are often enforced by governmental officials, and any action based on potentially misleading or deceptive advertising is often followed by costly class-action complaints under consumer-protection laws.
Psyence may acquire businesses or products, or form additional strategic alliances, in the future, and may not realize the benefits of such acquisitions.
Psyence may acquire additional businesses or products, form additional strategic alliances, or create joint ventures with third parties that it believes will complement or augment its existing business. Any of these relationships may require Psyence to incur non-recurring and other charges, increase Psyence’s near and long-term expenditures, issue securities that dilute Psyence’s existing shareholders or disrupt Psyence’s management and business. In addition, we face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex. If Psyence acquires businesses with promising markets or technologies, it may not be able to realize the benefit of acquiring such businesses if it is unable to successfully integrate them with its existing operations and company culture. Psyence may encounter numerous difficulties in developing, manufacturing, and marketing any new products resulting from a strategic alliance or acquisition that delay or prevent it from realizing their expected benefits or enhancing its business. There is no assurance that, following any such acquisition, Psyence will achieve the synergies expected in order to justify the transaction, which could result in a material adverse effect on its business and prospects.
We rely on third parties to conduct our clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of, or commercialize, our product candidates.
Psyence relies on Southern Star Research Pty Ltd (“Southern Star Research”), full-service Australian CRO, to conduct clinical development activities with Psyence’s product candidates, which activities involve trial design, regulatory submissions, clinical patient recruitment, clinical trial monitoring, clinical data management and analysis, safety monitoring and project management.
Additionally, we expect to utilize and depend upon independent investigators and collaborators, such as medical institutions, CROs, CDMOs and strategic partners to conduct our preclinical studies under agreements with us and in connection with our clinical trials. We expect to have to negotiate budgets and contracts with CROs, trial sites and CDMOs, which may result in delays to our development timelines and increase costs. We will rely heavily on these third parties over the course of our clinical trials, and we control only certain aspects of their activities. As a result, we have less direct control over the conduct, timing and completion of these clinical trials and the management of data developed through clinical trials than would be the case if we were relying entirely upon our own staff. Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with applicable protocol, legal and regulatory requirements and scientific standards and our reliance on third parties does not relieve us of our regulatory responsibilities. We and these third parties are required to comply with good clinical practices (“GCPs”), which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for product candidates in clinical development. Regulatory authorities enforce these GCPs through periodic inspections of trial sponsors, principal investigators and trial sites. If we or any of these third parties fail to comply with applicable GCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that, upon inspection, such regulatory authorities will determine that any of our clinical trials comply with the GCP regulations. Our failure or any failure by these third parties to comply with these regulations or to recruit a sufficient number of patients may require us to repeat clinical trials, which would delay the regulatory approval process. Moreover, our business may be implicated if any of these third parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.
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Any third parties conducting our clinical trials are not and will not be our employees and, except for remedies available to us under our agreements with such third parties, we cannot control whether or not they devote sufficient time and resources to our product candidates. These third parties may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other drug development activities, which could affect their performance on our behalf. If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to complete development of, obtain regulatory approval of or successfully commercialize our product candidates. As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed.
Switching or adding third parties to conduct our clinical trials involves substantial cost and requires extensive management time and focus. In addition, changes in manufacturers often involve changes in manufacturing procedures and processes, which could require that we conduct bridging studies between our prior clinical supply used in our clinical trials and that of any new manufacturer. We may be unsuccessful in demonstrating the comparability of clinical supplies which could require the conduct of additional clinical trials. Additionally, there is a natural transition period when a new third party commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines.
Psyence’s insurance coverage may be inadequate or expensive.
Psyence’s business is subject to a number of risks and hazards generally, including adverse clinical trial results, accidents, labor disputes and changes in the regulatory environment. Such occurrences could result in damage to assets, personal injury or death, environmental damage, delays in operations, monetary losses and possible legal liability.
Psyence’s insurance may not cover all the potential risks associated with its operations. Psyence may also be unable to maintain insurance to cover these risks at economically feasible premiums. Insurance coverage may not be available (or generally available on acceptable terms) or may not be adequate to cover any resulting liability. The successful assertion of one or more large claims against us that exceed available insurance coverage, or the occurrence of changes in our insurance policies, including premium increases or the imposition of large retention, or deductible, or co-insurance requirements, could have an adverse effect on our business, financial condition and results of operations.
Certain significant personnel may allocate their time to other businesses, which may cause conflicts of interest in their determination as to how much time to devote to our affairs and potentially competitive fiduciary and pecuniary interests that conflict with our interests.
Certain of Psyence’s directors and officers do not devote their full time to the affairs of Psyence and certain of Psyence’s directors and officers are also directors, officers and shareholders of other biotechnology and research and development companies or other public companies in general, and as a result they may find themselves in a position where their duty to another company conflicts with their duty to Psyence. Although Psyence has policies which address such potential conflicts and the Business Corporations Act (Ontario) has provisions governing directors in the event of such a conflict, there is no assurance that any such conflicts will be resolved in favor of Psyence. If any such conflicts are not resolved in favor of Psyence, Psyence may be adversely affected.
We have received research and development incentives from the Australian government. If we don’t qualify for future research and development incentives, we may encounter difficulties in funding research and development projects, which could harm our operating results.
We have previously received a research and development (R&D) cash rebate through the Australian Government’s Research and Development Tax Incentive program, which provides up to a 43.5% rebate on qualifying R&D expenses in Australia.
For Psyence Australia Pty Ltd.’s (“Psyence Australia”, the Company’s Australian subsidiary) fiscal years ended June 30, 2025 and June 30, 2023, it received a cash refund of AUD $441,732 and AUD $1,336,622 respectively. To receive this research and development cash rebate, we qualified for certain conditions under the R&D Tax Incentive legislation (Income Tax Assessment Act 1997 (Cth), Division 355) in Australia including, but not limited to, having a company incorporated under Australian law, all R&D activities being conducted solely within Australia, the Company’s aggregated group turnover not being equal to, or more than, AU$20M for relevant period; all R&D activities are conducted by, or will be conducted for, the Company, and all CRO expenditures have been physically undertaken in Australia.
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Entitlement to tax benefits under the Research and Development Tax Incentive for eligible R&D purposes is based on an annual application to the Australian Government. We believe that we continue to be eligible for the tax benefits. If these tax benefits are reduced, cancelled, or discontinued, or if we fail to meet certain conditions, we may encounter difficulties funding further funding R&D projects, which could harm our operating results.
Risks Related to Regulatory Matters
Psilocybin and ibogaine remain Schedule I controlled substances under U.S. federal law, and any rescheduling is uncertain in timing and outcome.
Psilocybin and ibogaine are currently classified as Schedule I controlled substances under the U.S. Controlled Substances Act, the most restrictive classification, which is reserved for substances determined to have a high potential for abuse and no currently accepted medical use. Although recent federal actions contemplate that certain psychedelics that complete late-stage research could be considered for rescheduling to a less restrictive schedule upon FDA approval, no such rescheduling has occurred for psilocybin or ibogaine, and there can be no assurance that any rescheduling will occur or that it will occur on a timeline useful to Psyence. Unless and until rescheduling occurs, Psyence’s ability to conduct clinical trials in the United States, to manufacture, import, export, store and handle product candidates, and ultimately to commercialize any approved product in the United States, will remain subject to significant federal restrictions, registration requirements and enforcement risk, any of which could materially and adversely affect Psyence’s business. In addition, the regulatory treatment of ibogaine differs from that of psilocybin and is subject to distinct safety considerations, including documented cardiotoxicity risks, which may result in heightened or different regulatory scrutiny of any ibogaine-related activities Psyence pursues, whether directly or through PsyLabs.
If we fail to comply with healthcare regulations, we could face substantial enforcement actions, including civil and criminal penalties and our business, operations and financial condition could be adversely affected.
The research and development, studying, manufacturing, packaging, labeling, advertising and distribution of Psyence’s planned product candidates are subject to regulation by one or more governmental authorities, and various agencies of the federal, provincial, state and localities in which Psyence intends to commercialize its products. These governmental authorities may attempt to regulate any of its products that fall within their jurisdiction. Such governmental authorities may not accept the evidence of safety for any ingredients that Psyence may want to market, may determine that a particular product or product ingredient presents an unacceptable health risk and may determine that a particular statement of nutritional support that Psyence wants to use is an unacceptable claim. Such a determination would prevent Psyence from marketing particular products or using certain statements of nutritional support on its products. Psyence also may be unable to disseminate third-party literature that supports its products if the third-party literature fails to satisfy certain requirements. In addition, governmental authorities could require Psyence to remove a particular product from the market. Any recall or removal would result in additional costs to Psyence, including lost revenues from any products that it is required to remove from the market, any of which could be material. Any such product recalls or removals could lead to liability, substantial costs and reduced growth prospects, all of which could be material.
Our prospective products will be subject to the various federal and state laws and regulations relating to health and safety and failure to comply with, or changes in, these laws or regulations could have an adverse impact on our business.
We are in the process of developing an investigational new drug for which we intend to pursue FDA approval via the New Drug Application (“NDA”) process.
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In connection with our development and future commercialization (if applicable) of the above-described prospective products, we and each contemplated product candidate are subject to the Federal Food Drug and Cosmetic Act (FDCA). The FDCA is intended to assure the consumer, in part, that drugs and devices are safe and effective for their intended uses and that all labeling and packaging is truthful, informative, and not deceptive. The FDCA and FDA regulations define the term “drug,” in part, by reference to its intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Therefore, almost any ingested or topical or injectable product that, through its label or labeling (including internet websites, promotional pamphlets, and other marketing material), that is claimed to be beneficial for such uses will be regulated by FDA as a drug. The definition also includes components of drugs, such as active pharmaceutical ingredients. Drugs must generally either receive premarket approval by FDA through the NDA process or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review. If the FDA does not award premarket approval for our product candidates through the NDA process, this could have a material adverse effect on our business, financial condition and results of operations.
The FDA will accept data from studies performed in other countries, as long as the study complies with GCP and ICH guidelines. FDA will review the Phase IIb protocol prior to the start of the study to provide advice on what and how aspects of the trial will be captured. Advice from a pre-IND meeting with the FDA was received in July 2023, which informed the Phase IIb Study design and may also inform the phase III program we plan to do.
Clinical trials are expensive, time-consuming, uncertain and susceptible to change, delay or termination. The results of clinical trials are open to differing interpretations.
Clinical testing is expensive, time consuming, and uncertain as to outcome and may be more costly than anticipated due various factors including, but not limited to, regulatory environment, legal compliance, supply and demand of services and inflationary costs. We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, or at all. Failures in connection with one or more clinical trials can occur at any stage of testing.
Regulatory agencies may analyze or interpret the results of clinical trials differently than Psyence. Even if the results of the clinical trials are favorable, the clinical trials for the product candidates are expected to continue for several years and may take significantly longer to complete. Events that may prevent successful or timely completion of clinical development include:
| ● | delays in reaching a consensus with regulatory authorities on trial design and other trial related matters; |
| ● | delays in reaching agreement on acceptable terms with prospective third party service providers assisting the CROs in the conduct of the trial; |
| ● | actual or perceived lack of effectiveness of the product candidate during clinical trials; |
| ● | discovery of serious or unexpected toxicities or side effects experienced by trial participants or other safety issues, such as drug interactions; |
| ● | slower than expected rates of subject recruitment and enrollment rates in clinical trials; |
| ● | difficulty in retaining subjects for the entire duration of applicable clinical studies (as study subjects may withdraw at any time due to adverse side effects from the therapy, insufficient efficacy, fatigue with the clinical trial process, death or for any other reason; |
| ● | delays or inability in manufacturing or obtaining sufficient quantities of materials for use in clinical trials due to regulatory and manufacturing constraints; |
| ● | inadequacy of or changes in manufacturing process or product candidate formulation; |
| ● | delays in obtaining and maintaining regulatory authorizations, including “clinical holds” or delays requiring suspension or termination of a trial by a regulatory agency, such as the TGA, before or after a trial is commenced; |
| ● | changes in applicable regulatory policies and regulation, including changes to requirements imposed on the extent, nature or timing of studies; |
| ● | uncertainty regarding proper dosing; |
| ● | delay or failure to supply product for use in clinical trials which conforms to regulatory specification; |
| ● | unfavorable results from ongoing pre-clinical studies and clinical trials; |
| ● | failure of the CRO, or other third-party contractors to comply with all contractual requirements or to perform their services in a timely or acceptable manner; |
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| ● | failure by Psyence, its employees, the CRO or its employees to comply with all applicable regulatory requirements relating to the conduct of clinical trials; |
| ● | scheduling conflicts with participating clinicians and clinical institutions; |
| ● | failure to design appropriate clinical trial protocols; |
| ● | regulatory concerns with administering a psychoactive product, generally, and the potential for abuse; |
| ● | insufficient data to support regulatory approval; and |
| ● | inability or unwillingness of medical investigators to follow our clinical protocols; or difficulty in maintaining contact with patients during or after treatment, which may result in incomplete data. |
Any of the foregoing could have a material adverse effect on our business, financial condition and results of operations.
Psyence may be subject to federal, state and foreign healthcare laws and regulations and implementation of or changes to such healthcare laws and regulations could adversely affect Psyence’s business and results of operations.
If Psyence successfully completes the requisite preclinical and clinical testing, makes the required regulatory submissions and obtains any corresponding authorizations or licenses (as applicable), fulfills all other applicable development-related regulatory obligations, and, eventually, obtains FDA approval to market one or more of its current or future product candidates in the United States, Psyence will be subject to certain healthcare laws and regulations. In Australia, the U.S. and certain foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the healthcare system in ways that could impact Psyence’s ability to commercialize Psyence’s product candidates. If Psyence were found to be in violation of any of these laws or any other federal, state or foreign regulations, Psyence may be subject to administrative, civil and/or criminal penalties, damages, fines, individual imprisonment, exclusion from federal health care programs and the restructuring of its operations. Any of these could have a material adverse effect on its business and financial results. Since many of these laws have not been fully interpreted by the courts, there is an increased risk that Psyence may be found in violation of one or more of their provisions. Any action against Psyence for violation of these laws, even if Psyence is ultimately successful in its defense, will cause Psyence to incur significant legal expenses and divert management’s attention away from the operation of the business. In addition, in many foreign countries, particularly the countries of the European Union, the pricing of prescription drugs is subject to government control.
Serious adverse events or other safety risks could require Psyence to abandon development and preclude, delay or limit approval of its current or future product candidates, limit the scope of any approved label or market acceptance, or cause the recall or loss of marketing approval of products that are already marketed.
If any of Psyence’s current or future product candidates, prior to or after any approval for commercial sale, cause serious or unexpected side effects, or are associated with other safety risks such as misuse, abuse or diversion, a number of potentially significant negative consequences could result, including:
| ● | regulatory authorities may interrupt, delay or halt clinical trials; |
| ● | regulatory authorities may deny regulatory approval of future product candidates; |
| ● | regulatory authorities may require certain labeling statements, such as warnings or contraindications or limitations on the indications for use, and/or impose restrictions on distribution; |
| ● | regulatory authorities may withdraw their approval, require more onerous labeling statements, or require Psyence may be required to change the way the product is administered or conduct additional clinical trials; |
| ● | Psyence’s relationships with its collaboration partners may suffer; |
| ● | Psyence could be sued and held liable for harm caused to patients; or |
| ● | Psyence’s reputation could suffer. |
Any of these events could prevent us from achieving or maintaining market acceptance of our product candidates, if approved, and could significantly harm our business, financial condition, results of operations and prospects.
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Psyence may voluntarily suspend or terminate a clinical trial if at any time its believes that any of its product candidates presents an unacceptable risk to participants, if preliminary data demonstrates that the product candidate is unlikely to receive regulatory approval or unlikely to be successfully commercialized, or if sufficient funds to proceed to the next phases of clinical trials are not raised.
After obtaining the requisite regulatory authorizations to commence or advance clinical trials, Psyence may voluntarily suspend or terminate any of its clinical trials for any number of reasons, including if it believes that a product candidate’s use, or a person’s exposure to such product candidate, may cause adverse health consequences or death. In addition, regulatory agencies may at any time recommend the temporary or permanent discontinuation of a clinical trial or request that Psyence cease using investigators in the clinical trials if the agency believes that a clinical trial is not being conducted in accordance with applicable regulatory requirements, or that it presents an unacceptable safety risk to participants. If Psyence elects or is forced to suspend or terminate a clinical trial of any of its product candidates, the commercial prospects for that product will be harmed and its ability to generate product revenue from such product candidate may be delayed or eliminated. Furthermore, any of these events may result in labeling statements such as warnings or contraindications. In addition, such events or labeling could prevent Psyence or its partners from achieving or maintaining market acceptance of the affected product candidate and could substantially increase the costs of commercializing its future product candidates and impair its ability to generate revenue from the commercialization of these product candidates either by Psyence or by its collaboration partners.
The clinical trial is divided into stages and progression of each stage is dependent on governmental approval to proceed to the next stage being furnished by Psyence. Accordingly, if Psyence believes that it does not have sufficient funds to progress with the next phases of the clinical trials, or for any other reason, Psyence is entitled to exercise this discretion in accordance with applicable laws and regulatory compliance and approvals, taking patient risk and safety into account.
The success of Psyence’s product candidates and future approved products, if any, is subject to a number of constantly-evolving state and federal laws, regulations, and enforcement policies pertaining to psilocybin containing products.
Local, state, federal, and international psilocybin laws and regulations remain highly restrictive and subject to evolving interpretations, which could require Psyence to incur substantial costs associated with compliance requirements. Psyence seeks independent local legal opinions confirming the lawfulness of Psyence’s existing and proposed activities as well as its compliance with legal, regulatory and governmental developments as they pertain to and affect Psyence’s operations. In addition, violations of these laws, or allegations of such violations, could disrupt Psyence’s business and result in a material adverse effect on Psyence’s operations. In addition, it is possible that regulations may be enacted in the future that will be directly applicable to Psyence’s proposed business regarding the administration of psilocybin or psilocybin-assisted psychotherapy. Psyence cannot predict the nature of any future laws, regulations, interpretations, or applications, nor can it determine what effect additional governmental regulations or administrative policies and procedures, when and if promulgated, could have on its activities in the psychedelics industry.
There can be no assurance that Psyence’s product candidates containing psilocybin (as the active pharmaceutical ingredient) will be approved for commercialization in Australia, the U.S. or any other target jurisdiction at any time in the near or distant future. Any regulations the FDA issues relating to the sale, marketing, and/or other activities involving administration of psilocybin or psilocybin-assisted psychotherapy could have a material adverse effect on Psyence’s business, financial condition and results of operations.
We may seek fast track and breakthrough therapy designations or priority review for one or more of our product candidates, but we might not receive such designation or priority review, and even if we do, such designation or priority review may not lead to a faster development or regulatory review or approval process, and does not assure FDA approval of our product candidates.
We may seek fast track, breakthrough therapy, and/or regenerative medicine advanced therapy designations or priority review for one or more of our product candidates.
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The FDA may issue a fast track designation to a product candidate if it is intended, whether alone or in combination with one or more other products, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition. Fast track designation applies to the combination of the product and the specific indication for which it is being studied. The sponsor of a new biologic may request that the FDA designate the biologic as a fast track product at any time during the clinical development of the product. For fast track products, sponsors may have greater interactions with the FDA during product development. A fast track product may also be eligible for rolling review, where the FDA may consider for review sections of the Biologic License Application (“BLA”) on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the BLA, the FDA agrees to accept sections of the BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the BLA. However, the FDA’s goal for reviewing a BLA fast track application under the Prescription Drug User Fee Act (“PDUFA”) does not begin until the last section of the application is submitted. Fast track designation may be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data emerging in the clinical trial process.
A breakthrough therapy is defined as a product candidate that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the product candidate may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For product candidates that have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens. Product candidates designated as breakthrough therapies by the FDA are also eligible for priority review if supported by clinical data at the time of the submission of the BLA.
Fast track designation, priority review, and breakthrough therapy designation are within the discretion of the FDA. Accordingly, even if we believe that one of our product candidates meets the criteria for any such designation, the FDA may disagree and instead determine not to make such designation. In any event, the receipt of such designation may expedite the development or approval process, but do not change the standards for approval. Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.
We may seek approval of our product candidates, where applicable, under the FDA’s accelerated approval pathway. This pathway may not lead to a faster development, regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval.
A product may be eligible for accelerated approval if it is designed to treat a serious or life-threatening disease or condition and generally provides a meaningful advantage over available therapies upon a determination that the product candidate has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality (“IMM”), that is reasonably likely to predict an effect on IMM or other clinical benefit. The FDA considers a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given disease, such as IMM. For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. An intermediate clinical endpoint is a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit. The accelerated approval pathway may be used in cases in which the advantage of a new drug over available therapy may not be a direct therapeutic advantage, but is a clinically important improvement from a patient and public health perspective. If granted, accelerated approval is usually contingent on the sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe the drug’s clinical benefit. Under the Food and Drug Omnibus Reform Act of 2022 (“FDORA”), the FDA is permitted to require, as appropriate, that a post-approval confirmatory study or studies be underway prior to approval or within a specified time period after the date of accelerated approval was granted. FDORA also requires sponsors to send updates to the FDA every 180 days on the status of such studies, including progress toward enrollment targets, and the FDA must promptly post this information publicly. FDORA also gives the FDA increased authority to withdraw approval of a drug or biologic granted accelerated approval on an expedited basis if the sponsor fails to conduct such studies in a timely manner, send the necessary updates to the FDA, or if such post-approval studies fail to verify the drug’s predicted clinical benefit. Under FDORA, the FDA is empowered to take action, such as issuing fines, against companies that fail to conduct with due diligence any post-approval confirmatory study or submit timely reports to the agency on their progress. In addition, the FDA currently requires, unless otherwise informed by the agency, pre-approval of promotional materials for products receiving accelerated approval, which could adversely impact the timing of the commercial launch of the product. Thus, even if we seek to utilize the accelerated approval pathway, we may not be able to obtain accelerated approval and, even if we do, we may not experience a faster development, regulatory review or approval process for that product. There can be no assurance that the FDA would allow any of the product candidates we may develop to proceed on an accelerated approval pathway, and even if the FDA did allow such pathway, there can be no assurance that such submission or application will be accepted or that any expedited development, review or approval will be granted on a timely basis, or at all. Moreover, even if we received accelerated approval, any post-approval studies required to confirm and verify clinical benefit may not show such benefit, which could lead to withdrawal of any approvals we have obtained. Receiving accelerated approval does not assure that the product’s accelerated approval will eventually be converted to a traditional approval.
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Risks Relating to the Psychedelic Therapy Market and Biotechnology Industry
Our business and prospects depend in part on continued favorable governmental policy toward psychedelic therapies, which is subject to political and administrative uncertainty and could change.
Recent improvements in the U.S. federal posture toward psychedelic therapies have been driven substantially by executive action and statements of current officials rather than by legislation. Public reporting has indicated differing views among senior federal health officials regarding the pace and appropriateness of accelerating this class of products. Governmental policy, agency leadership, enforcement priorities and the availability of expedited pathways may change, including as a result of changes in administration, and any reversal of, or failure to implement, the current favorable posture could adversely affect Psyence, the demand for and perception of psychedelic therapies generally, the trading price of Psyence’s securities, and Psyence’s ability to raise capital. Conversely, to the extent investor enthusiasm for the psychedelics sector is driven by these policy developments, any disappointment in their implementation could contribute to volatility in the price of Psyence’s securities that is unrelated to Psyence’s own clinical or operational progress.
The psychedelic therapy industry and market are relatively new, and this industry and market may not continue to exist or grow as anticipated.
Psyence operates its business in a relatively new industry and market. In addition to being subject to general business risks, Psyence must continue to build brand awareness in this industry and market through significant investments in its strategy, operational capacity, quality assurance and compliance with regulations. In addition, there is no assurance that the industry and market will continue to exist and grow as currently estimated or anticipated or function and evolve in a manner consistent with management’s expectations and assumptions. Any event or circumstance that adversely affects the psychedelic therapy industry and market could have a material adverse effect on Psyence’s business, financial conditions and results of operations.
Psilocybin is considered scientifically to be the safest of the psychedelics and/or drugs of abuse potential. In fact, psilocybin has been described as being anti-addictive and has been studied for the use in substance addictive disorders, such as alcohol use disorder, smoking cessation and opioid addiction. Notwithstanding the foregoing, the psychedelic therapy market will face specific marketing challenges given the products’ status as a controlled substance, which has resulted in past and current public perception that the products have negative health and lifestyle effects and have the potential to cause physical and social harm due to psychoactive and potentially addictive effects. Any marketing efforts by Psyence would need to overcome this perception to build consumer confidence, brand recognition and goodwill.
Negative public opinion and perception of the psychedelic industry could adversely impact Psyence’s ability to operate and Psyence’s growth strategy.
Consumer perception of Psyence’s products may be significantly influenced by scientific research or findings, regulatory investigations, litigation, media attention and other publicity regarding the consumption of naturally derived, medicinal-grade psilocybin mushroom products. There can be no assurance that future scientific research, findings, regulatory proceedings, litigation, media attention or other research findings or publicity will be favorable to the naturally derived medicinal-grade psilocybin mushroom market or any particular product, or consistent with earlier publicity. Future research reports, findings, regulatory proceedings, litigation, media attention or other publicity that are perceived as less favorable than, or that question, earlier research reports, findings or publicity could have a material adverse effect on the demand for Psyence’s envisaged products and Psyence’s business, results of operations, financial condition and cash flows. Psyence’s dependence upon consumer perception means that adverse scientific research reports, findings, regulatory proceedings, litigation, media attention or other publicity, whether or not accurate or with merit, could have a material adverse effect on Psyence, the demand for Psyence’s products, and Psyence’s business, results of operations, financial condition and cash flows. Further, adverse publicity reports or other media attention regarding the safety, efficacy and quality of naturally derived medicinal-grade psilocybin mushroom in general, or Psyence’s products specifically, or associating the consumption of naturally derived medicinal-grade psilocybin mushroom’s negative effects or events, could have such a material adverse effect. Such adverse publicity reports or other media attention could arise even if the adverse effects associated with such products resulted from consumers’ failure to consume such products appropriately or as directed.
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The expansion of the use of psychedelics in the medical industry may require new clinical research into effective medical therapies.
Research in the UK, Canada, Australia and internationally regarding the medical benefits, viability, safety, efficacy, addictiveness, dosing and social acceptance of psychedelic and psychoactive products remains in early stages. There have been relatively few clinical trials on the benefits of such products. Although Psyence believes that the articles, reports and studies support its beliefs regarding the medical benefits, viability, safety, efficacy, dosing and social acceptance of psychedelic and psychoactive products, future research and clinical trials may prove such statements to be incorrect, or could raise concerns regarding, and perceptions relating to, psychedelic and psychoactive products. Future research studies and clinical trials may draw opposing conclusions to those stated in this Report or reach negative conclusions regarding the medical benefits, viability, safety, efficacy, dosing, social acceptance or other facts and perceptions related to psychedelic and psychoactive products, which could have a material adverse effect on the demand for Psyence’s product candidate and psychedelic therapies and a material adverse effect on Psyence’s business, financial condition and results of operations.
The psychedelic therapy industry is difficult to quantify and investors will be reliant on their own estimates of the accuracy of market data.
Because the psychedelic therapy industry is in a nascent stage with uncertain boundaries, there is a lack of information about comparable companies available for potential investors to analyze in deciding whether to invest in Psyence and, few, if any, established companies whose business model Psyence can follow or upon whose success Psyence can build. Accordingly, investors will have to rely on their own estimates in deciding whether to invest in Psyence. There can be no assurance that Psyence’s estimates are accurate or that the market size is sufficiently large for its business to grow as projected, which may negatively impact its financial results.
Risks Related to Intellectual Property
Psyence may not be able to adequately protect or enforce its intellectual property rights, which could harm its competitive position.
Psyence relies upon a combination of patent, copyright, trademark and trade secret laws, as well as nondisclosure agreements, know-how of the scientific team, and other methods, to protect its proprietary technologies and processes. The strengths of patents in the pharmaceutical field involve complex legal and scientific questions and can be uncertain. Where appropriate, Psyence will seek patent protection for certain aspects of its products and technology. Filing, prosecuting and defending patents in a wide range of countries can be prohibitively expensive. If Psyence fails to adequately protect its intellectual property, it may face competition from companies who attempt to create a generic product to compete with its future product candidates. Psyence may also face competition from companies who develop a substantially similar product to its future product candidates that are not covered by any patents.
While Psyence will apply for a number of patents upon the discovery or creation of something novel, there can be no assurances that any patents will be issued. Specifically, naturally occurring substances arising from botanical sources, e.g Psilocybin, cannot be patented. As such, we will be required to rely on other processes such as extraction, purification, or formulation in order to establish patents and such processes are not guaranteed to receive issued patents. Even if patents are issued, the claims allowed may not be sufficiently broad to protect all of Psyence’s intellectual property. In addition, any future patents issued to Psyence may be challenged, invalidated or circumvented. As such, any rights granted under these patents may not provide Psyence with meaningful protection. If Psyence’s patents do not adequately protect its intellectual property, competitors may be able to offer products similar to Psyence’s products.
Psyence will be further dependent, to an extent, on PsyLabs to maintain and defend the intellectual property currently being licensed to Psyence under the PsyLabs IP Agreement, and which is relevant for use in Psyence’s Phase IIb Study. Any failure on the part of PsyLabs to adequately maintain or defend its intellectual property will have a direct effect on the viability of Psyence’s Australian palliative care clinical trial initiatives.
Psyence’s strategy is to patent technologies with commercial potential in jurisdictions with significant commercial opportunities. However, patent protection may not be available for some of the products or technologies Psyence is developing, such as in the areas of methods of treatment (which are not patentable in most jurisdictions).
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The patent positions of pharmaceutical products are complex and uncertain. The scope and extent of patent protection for future product candidates are particularly uncertain. Protection of Psyence’s future product candidates will be sought in respect of, among other things, composition-of-matter for specific formulations, methods of use, and delivery mechanisms, bearing in mind that patent protection is not available for naturally derived psilocybin alone. If any of Psyence’s products are approved and marketed for an indication for which it does not have an issued or licensed patent, Psyence’s ability to use a patent to prevent a competitor from commercializing a non-branded version of its commercial products for that non-patented indication could be significantly impaired or even eliminated.
Many companies have encountered significant problems in protecting, defending and enforcing intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property rights, particularly those relating to pharmaceuticals, which could make it difficult for Psyence to stop the infringement of patents or marketing of competing products in violation of its proprietary rights generally. Proceedings to enforce patent rights in foreign jurisdictions may not be successful, could result in substantial cost and divert Psyence’s efforts and attention from other aspects of its business.
We are dependent on licensed intellectual property. If we were to lose our rights to licensed intellectual property, we may not be able to continue developing or commercializing our product candidates, if approved.
We do not currently own any patents, and we are heavily reliant upon a number of license agreements under which we are granted rights to intellectual property that are important to our business and we may need or choose to enter into additional license agreements in the future.
Specifically, our business and active Phase IIb Study is highly dependent on the PsyLabs IP Agreement with PsyLabs for the rights to NPX-5, which expires when terminated by the parties in accordance with a provision of the agreement and covers the Phase IIb Study, as well as the Phase III and commercialization phases which will follow therefrom. Until we develop our own product candidates, the termination, non-renewal or hinderance of use of the license granted under the PsyLabs IP Agreement could have a material adverse effect on our ability to develop our product candidates. Furthermore, following the completion of the Phase IIb Study, we may be required to enter into a further agreement with PsyLabs with respect to the supply and licensing of alternative drug product for use in our pivotal Phase III studies in palliative care, and there can be no guarantees that such agreements will be finalized. The Company continues to evaluate its bridging program into Phase III in this regard, which bridging program will require regulatory agency approval, and there can be no guarantees that such approvals will be obtained.
Our existing license agreements impose, and we expect that future license agreements will impose on us, various development, regulatory and/or commercial diligence obligations, payment of milestones and/or royalties and other obligations. If we fail to comply with our obligations under these agreements, the licensor may have the right to terminate the license, in which event we would not be able to market products covered by the license. Our business could suffer, for example, if any current or future licenses terminate, if the licensors fail to abide by the terms of the license, if the licensed patents or other rights are found to be invalid or unenforceable, or if we are unable to enter into necessary licenses on acceptable terms.
Licensing of intellectual property is of critical importance to our business and involves complex legal, business and scientific issues. Disputes may arise between us and our licensors regarding intellectual property subject to a license agreement, including:
| ● | the scope of rights granted under the license agreement and other interpretation-related issues; |
| ● | whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; |
| ● | our right to sublicense patent and other rights to third parties; |
| ● | our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of our product candidates, and what activities satisfy those diligence obligations; |
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| ● | our obligation to pursue, or license others to pursue, development of indications we are not currently pursuing; |
| ● | the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; |
| ● | our right to transfer or assign the license; and |
| ● | the effects of termination. |
If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates.
We may enter into additional licenses to third-party intellectual property that are necessary or useful to our business. Our current licenses and any future licenses that we may enter into may impose various royalty payment, milestone, and other obligations on us. Under some license agreements, we may not control prosecution of the licensed intellectual property, or may not have the first right to enforce the intellectual property. In those cases, we may not be able to adequately influence patent prosecution or enforcement, or prevent inadvertent lapses of coverage due to failure to pay maintenance fees. If we fail to comply with any of our obligations under a current or future license agreement, the licensor may allege that we have breached our license agreement, and may accordingly seek to terminate our license. Termination of any of our current or future licenses could result in our loss of the right to use the licensed intellectual property, which could materially adversely affect our ability to develop and commercialize a product candidate or product, if approved, as well as harm our competitive business position and our business prospects. Under some license agreements, termination may also result in the transfer of or granting in rights under certain of our intellectual property and information related to the product candidate being developed under the license, such as regulatory information.
The agreements under which we license intellectual property or technology to or from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations and prospects. Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates.
In addition, if our licensors fail to abide by the terms of the license, if the licensors fail to prevent infringement by third parties, if the licensed patents or other rights are found to be invalid or unenforceable, or if we are unable to enter into necessary licenses on acceptable terms, our business could suffer. Moreover, our licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject to claims, regardless of their merit, that we are infringing, misappropriating or otherwise violating the licensor’s rights.
Similarly, if we are unable to successfully obtain rights to required third-party intellectual property rights or maintain the existing intellectual property rights we have, we may have to seek alternative options, such as developing new product candidates with design-around technologies, which may require more time and investment, or abandon development of the relevant research programs or product candidates and our business, financial condition, results of operations and prospects could suffer.
If third parties claim that intellectual property owned or used by Psyence infringes upon their intellectual property, Psyence’s operating profits could be adversely affected.
There is a substantial amount of litigation, both within and outside the U.S., involving patent and other intellectual property rights in the pharmaceutical industry. Psyence may, from time to time, be notified of claims that Psyence is infringing upon patents, trademarks, copyrights or other intellectual property rights owned by third parties, and Psyence cannot provide assurances that other companies will not, in the future, pursue such infringement claims against it, its commercial partners or any third-party proprietary technologies it has licensed. If Psyence were found to infringe upon a patent or other intellectual property right, or if Psyence failed to obtain or renew a license under a patent or other intellectual property right from a third party, or if a third party that Psyence were licensing technologies from was found to infringe upon a patent or other intellectual property rights of another third party, Psyence may be required to pay damages, suspend the manufacture of certain products or reengineer or rebrand its products, if feasible, or it may be unable to enter certain new product markets. Any such claims could also be expensive and time-consuming to defend and divert management’s attention and resources. Psyence’s competitive position could suffer as a result. In addition, if Psyence has declined or failed to enter into a valid non-disclosure or assignment agreement for any reason, Psyence may not own the intellectual property, and its products may not be adequately protected. Thus, Psyence cannot guarantee that any of its future product candidates, or its commercialization thereof, does not and will not infringe any third party’s intellectual property.
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We may infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from commercializing, or increase the costs of commercializing our product candidates.
Our success will depend in part on our ability to operate without infringing the proprietary rights of third parties. We are not aware of any third-party proprietary rights that our planned products will infringe or misappropriate, but we have not conducted any freedom to operate study as we are in the earliest stages of development. We thus cannot guarantee that our product candidates, or manufacture or use of our product candidates, will not infringe third-party patents. Furthermore, a third party may claim that we are using inventions covered by the third party’s patent rights and may go to court to stop us from engaging in our normal operations and activities, including making or selling our product candidates. These lawsuits are costly and could affect our results of operations and divert the attention of managerial and scientific personnel. Some of these third parties may be better capitalized and have more resources than us. There is a risk that a court would decide that we are infringing the third party’s patents and would order us to stop the activities covered by the patents. In that event, we may not have a viable way around the patent and may need to halt commercialization of our product candidates. In addition, there is a risk that a court will order us to pay the other party damages for having violated the other party’s patents. In addition, we may be obligated to indemnify our licensors and collaborators against certain intellectual property infringement claims brought by third parties, which could require us to expend additional resources. The pharmaceutical and biotechnology industries have produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform.
If we are sued for patent infringement, we would need to demonstrate that our product candidates or methods either do not infringe the patent claims of the relevant patent or that the patent claims are invalid, and we may not be able to do this. Proving invalidity is difficult. For example, in the U.S., proving invalidity requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents. Even if we are successful in these proceedings, we may incur substantial costs and diversion of management’s time and attention in pursuing these proceedings, which could have a material adverse effect on us. If we are unable to avoid infringing the patent rights of others, we may be required to seek a license, which may not be available, defend an infringement action or challenge the validity of the patents in court. Patent litigation is costly and time-consuming. We may not have sufficient resources to bring these actions to a successful conclusion. In addition, if we do not obtain a license, develop or obtain non-infringing technology, fail to defend an infringement action successfully or have infringed patents declared invalid, we may incur substantial monetary damages, encounter significant delays in bringing our product candidates to market and be precluded from manufacturing or selling our product candidates.
Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than us or the third parties from whom we license intellectual property because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations.
If Psyence is not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of its products could be significantly diminished.
Psyence relies, to an extent, on trade secrets to protect its proprietary licensed intellectual property, especially where it does not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. Psyence relies in part on confidentiality agreements and restraints of trade with its current and former employees, consultants, outside scientific collaborators, sponsored researchers, contract manufacturers, vendors and other advisors, as well as similar confidentiality protections benefiting its strategic partners and licensors to protect Psyence’s owned and licensed trade secrets and other proprietary information. These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, Psyence cannot guarantee that it, nor its strategic and business partners, have executed these agreements with each party that may have or have had access to owned and licensed trade secrets. Any party with whom Psyence or strategic and business partners have executed such an agreement may breach that agreement and disclose proprietary information, including owned and licensed trade secrets, and adequate remedies for such breaches may not be available.
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Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the U.S. are less willing or unwilling to protect trade secrets. If any of Psyence’s owned or licensed trade secrets were to be lawfully obtained or independently developed by a competitor, Psyence would have no right to prevent them, or those to whom they disclose such trade secrets, from using that technology or information to compete with it. If any of Psyence’s owned and licensed trade secrets were to be disclosed to or independently developed by a competitor or other third-party, Psyence’s competitive position would be harmed.
Risks Related to Ownership of Our Securities
Future sales of our securities by existing holders could cause our stock price to decline.
If we or our existing holders sell, or indicate an intent to sell, substantial amounts of our Common Shares or securities convertible into our Common Shares in the public market, or if the public perceives that such sales could occur, this could have an adverse impact on the market price of our Common Shares, even if there is no relationship between such sales and the performance of our business. We also intend to register all Common shares that we may issue under our Incentive Plan. Once we register these shares, they can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates.
If we fail to meet applicable continued listing requirements, Nasdaq may delist our Common Shares from trading, in which case the liquidity and market price of our Common Shares could decline.
We cannot assure you that we will be able to meet the continued listing standards of Nasdaq in the future. On March 11, 2024, we received two letters from the Nasdaq staff, one notifying the Company that for the last 30 consecutive business days, the Company’s Market Value of Listed Securities was below the minimum of $50 million required for continued listing on the Nasdaq Global Market pursuant to Nasdaq Listing Rule 5450(b)(2)(A), and the other notifying the Company that for the last 30 consecutive business days, the Company’s Market Value of Publicly Held Shares was below the minimum of $15 million required for continued listing on the Nasdaq Global Market pursuant to Nasdaq Listing Rule 5450(b)(2)(C). Additionally, on June 27, 2024, we received a notification letter from the Nasdaq staff notifying the Company that the Company’s closing bid price per share was below $1.00 for a period of 30 consecutive business days and that the Company did not meet the minimum bid price requirement set forth in Nasdaq Listing Rule 5450(a)(1). On November 20, 2024, we announced the favorable outcome of the Nasdaq Listing Qualifications Hearing that was held on October 31st, 2024. The Nasdaq Hearings Panel granted the Company an extension until December 31st, 2024, to demonstrate compliance with all Nasdaq continued listing rules. During the Company’s Nasdaq Listing Qualifications Hearing, we presented a comprehensive plan to regain and maintain compliance with Nasdaq’s continued listing requirements, including 5550(a)(2), the $1 minimum bid price requirement, 5550(a)(5), the $1.0 million minimum market value of publicly held shares requirement, and 5550(b)(1), the $2.5 million minimum stockholders’ equity requirement.
As part of its plan, we requested to be transferred from The Nasdaq Global Market to The Nasdaq Capital Market pursuant to a panel exception, effective November 15th, 2024. Furthermore, as previously announced, we obtained shareholder approval during the Annual Meeting held on November 12th, 2024, to effect a 75-for-1 share consolidation, which became effective on November 26, 2024, and we obtained stockholder approval during a Special Meeting held on April 16, 2025, to effect a 7.97-for-1 share consolidation, which became effective on May 5, 2025 and to effect a 6.25-for-1 share consolidation, which became effective on February 2, 2026, in each case to satisfy Nasdaq’s $1 minimum bid price requirement. There can be no assurance that any reverse share consolidation will produce a lasting increase in the trading price of the Common Shares; a reverse consolidation may be followed by further price declines and may reduce the liquidity and increase the volatility of the Common Shares.
On April 16, 2025, the Company received a notification letter from the Listings Qualifications Department (the “Staff”) of the Nasdaq Stock Market LLC (“Nasdaq”) indicating that the Company was not in compliance with the $1.00 Minimum Bid Price Rule. The Staff’s determination was based on the closing bid price of the Company’s common shares being below $1.00 for 30 consecutive business days from March 5, 2025 through April 15, 2025. On June 17, 2025, the Company announced it had received formal notification from the Nasdaq Hearings Panel confirming that the Company has regained compliance with all applicable Nasdaq continued listing requirements, following a successful compliance hearing held on May 29, 2025.
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If we fail to comply with the applicable listing standards and Nasdaq delists our Common Shares, we and our shareholders could face significant material adverse consequences, including:
| ● | a limited availability of market quotations for our Common Shares; |
| ● | reduced liquidity for our Common Shares; |
| ● | a determination that our Common Shares are “penny stock”, which would require brokers trading in our Common Shares to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our Common Shares; |
| ● | a limited amount of news about us and analyst coverage of us; and |
| ● | a decreased ability for us to issue additional equity securities or obtain additional equity or debt financing in the future. |
The National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the states from regulating the sale of certain securities, which are referred to as “covered securities.” Because our Common Shares and Public Warrants are listed on Nasdaq, such securities are covered securities. Although the states are preempted from regulating the sale of our securities, the federal statute does allow the states to investigate companies if there is a suspicion of fraud, and, if there is a finding of fraudulent activity, then the states can regulate or bar the sale of covered securities in a particular case. Further, if we were no longer listed on Nasdaq, our securities would not be covered securities and we would be subject to regulations in each state in which we offer our securities.
The market price and trading volume of the Common Shares may be volatile and could decline significantly.
The stock markets, including Nasdaq, on which the Company lists its securities, have from time to time experienced significant price and volume fluctuations. Even if an active, liquid and orderly trading market develops and is sustained for the Common Shares, the market prices of the Common Shares may be volatile and could decline significantly. In addition, the trading volumes in the Common Shares may fluctuate and cause significant price variations to occur. There can be no assurance that the market prices of the Common Shares will not fluctuate widely or decline significantly in the future in response to a number of factors, including, among others, the following:
| ● | the realization of any of the risk factors presented in this Report; |
| ● | actual or anticipated differences in our estimates, or in the estimates of analysts, for the Company’s revenues, results of operations, cash flows, liquidity or financial condition; |
| ● | announcements by the Company or its competitors of significant business developments; |
| ● | changes in customers; |
| ● | acquisitions or expansion plans; |
| ● | the Company’s involvement in litigation; |
| ● | sale of Common Shares or other securities in the future; |
| ● | market conditions in the Company’s industry; |
| ● | changes in key personnel; |
| ● | the trading volume of Common Shares; |
| ● | actual, potential or perceived control, accounting or reporting problems; |
| ● | changes in accounting principles, policies and guidelines; |
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| ● | other events or factors, including but not limited to those resulting from infectious diseases, health epidemics and pandemics (including but not limited to the COVID-19 pandemic), natural disasters, war, acts of terrorism or responses to these events; and |
| ● | general economic and market conditions. |
In addition, the stock markets have experienced extreme price and volume fluctuations. Broad market and industry factors may materially harm the market price of the Common Shares, regardless of our operating performance. In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been instituted against that company. If the Company were involved in any similar litigation it could incur substantial costs and our management’s attention and resources could be diverted.
Our Warrants are exercisable for Common Shares, which would increase the number of shares eligible for future resale in the public market and result in dilution to our shareholders.
An aggregate of 45,112 Common Shares are issuable upon exercise of warrants, including 3,169 Common Shares issuable upon exercise of Public Warrants, 153 Common shares issuable upon exercise of Private Warrants, 134 Common shares issuable upon exercise of Addendum Private Warrants, 20,075 Common Shares issuable upon exercise of Series A Warrants, 20,075 Common Shares issuable upon exercise of Series B Warrants, and 1,506 Common Shares Issuable upon exercise of the Placement Agent Warrants. These Public Warrants and Private Warrants are currently exercisable at an exercise price of $42,963.28 per share, the Addendum Private Warrants $1,867.97 per share, the Series A Warrants and Series B Warrants at $99.63 per Common Share, and the Placement Agent Warrants at $124.53 per Common Share and each contain 4.99% beneficial ownership limitations that may be waived at the option of each holder upon 61 days’ notice to the Company, but in no event may such beneficial ownership limitation exceed 19.99% of the number of outstanding Common Shares. To the extent such warrants are exercised, 45,112 additional Common Shares will be issued, representing approximately 1.18% of our current outstanding Common Shares and could result in dilution to the holders of Common Shares and increase the number of shares eligible for resale in the public market. Sales of substantial numbers of such shares in the public market or the fact that such Warrants may be exercised could adversely affect the market price of Common Shares. Notwithstanding the foregoing, because the Nasdaq official closing price of our Common Shares was $3.09 on June 17, 2026, the Private Warrants and Public Warrants are currently “out-of-the-money” and it is unlikely that any of the Warrants will be exercised by holders anytime in the near future.
If securities or industry analysts do not publish research, publish inaccurate or unfavorable research or cease publishing research about the Company, its share price and trading volume could decline significantly.
The trading market for Common Shares depends, in part, on the research and reports that securities or industry analysts publish about the Company or its business. The Company may be unable to sustain coverage by well-regarded securities and industry analysts. If either none or only a limited number of securities or industry analysts maintain coverage of the Company, or if these securities or industry analysts are not widely respected within the general investment community, the demand for Common Shares could decrease, which might cause its share price and trading volume to decline significantly. In the event that the Company obtains securities or industry analyst coverage or, if one or more of the analysts who cover the Company downgrade their assessment of the Company or publish inaccurate or unfavorable research about the Company’s business, the market price and liquidity for Common Shares could be negatively impacted.
The requirements of being a public company may strain the Company’s resources, divert the Company management’s attention and affect the Company’s ability to attract and retain qualified board members.
The Company has incurred and will continue to incur additional legal, accounting and other expenses since becoming a public company. The Company is subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Act, the Nasdaq listing requirements and other applicable securities rules and regulations. These expenses may increase even more if the Company no longer qualifies as an “emerging growth company,” as defined in Section 2(a) of the Securities Act. The Exchange Act requires that we file annual and other material reports with respect to our businesses, financial condition, and results of operations. In addition, we must establish the corporate infrastructure necessary for operating a public company, which may divert our management’s attention from implementing our growth strategy, which could delay or slow the implementation of our business strategies, and in turn negatively impact our financial condition and results of operations.
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Changing laws, regulations and standards relating to corporate governance and public disclosure are creating uncertainty for public companies, increasing legal and financial compliance costs and making some activities more time-consuming. These laws, regulations and standards are subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. The Company expects these laws and regulations to increase its legal and financial compliance costs and to render some activities more time-consuming and costly, although the Company is currently unable to estimate these costs with any degree of certainty.
The Company’s management team has limited experience managing a publicly traded company, interacting with public company investors and complying with the increasingly complex laws pertaining to public companies. The Company’s management team may not successfully or efficiently manage the transition to being a public company subject to significant regulatory oversight and reporting obligations under the federal securities laws and regulations and the continuous scrutiny of securities analysts and investors. The need to establish the corporate infrastructure demanded of a public company may divert the management’s attention from implementing its growth strategy, which could prevent the Company from improving its business, financial condition and results of operations. Furthermore, the Company expects these rules and regulations to make it more difficult and more expensive for the Company to maintain director and officer liability insurance, and consequently the Company may be required to incur substantial costs to obtain such coverage. These additional obligations could have a material adverse effect on its business, financial condition, results of operations and prospects. These factors could also make it more difficult for the Company to attract and retain qualified members of its Board, particularly to serve on the Company’s audit committee, compensation committee and nominating and corporate governance committee, and qualified executive officers.
As a result of disclosure of information in this Report and in filings required of a public company, the Company’s business and financial condition will become more visible, which may result in threatened or actual litigation, including by competitors and other third parties. If such claims are successful, the Company’s business and operating results could be adversely affected, and, even if the claims do not result in litigation or are resolved in the Company’s favor, these claims, and the time and resources necessary to resolve them, could have an adverse effect on its business, financial condition, results of operations and prospects.
The Company is an “emerging growth company,” and it cannot be certain if the reduced SEC reporting requirements applicable to emerging growth companies will make the Company’s Common Shares less attractive to investors, which could have a material and adverse effect on the Company, including its growth prospects.
The Company is an “emerging growth company” as defined in the JOBS Act. The Company will remain an “emerging growth company” until the earliest to occur of (i) the last day of the fiscal year (a) following the fifth anniversary of the date of the first sale of our common equity securities pursuant to an effective registration statement under the Securities Act, (b) in which the Company has total annual gross revenue of at least $1.235 billion or (c) in which the Company is deemed to be a large accelerated filer, which means the market value of Common Shares held by non-affiliates exceeds $700 million as of the last business day of the Company’s prior second fiscal quarter, and (ii) the date on which the Company issued more than $1.0 billion in non-convertible debt during the prior three-year period. The Company intends to take advantage of exemptions from various reporting requirements that are applicable to most other non “emerging growth companies” including, but not limited to, an exemption from the provisions of Section 404(b) of the Sarbanes-Oxley Act requiring that the Company’s independent registered public accounting firm provide an attestation report on the effectiveness of its internal control over financial reporting and reduced disclosure obligations regarding executive compensation, and exemptions from the requirements of holding a non-binding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.
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Furthermore, even after the Company no longer qualifies as an “emerging growth company,” as long as the Company continues to qualify as a foreign private issuer under the Exchange Act, the Company will be exempt from certain provisions of the Exchange Act that are applicable to U.S. domestic public companies, as described under “—The Company qualifies as a foreign private issuer …” below. As a result, the Company shareholders may not have access to certain information they deem important. The Company cannot predict if investors will find Common Shares less attractive because it relies on these exemptions. If some investors do find Common Shares less attractive as a result, there may be a less active trading market and share price for Common Shares may be more volatile.
The Company qualifies as a foreign private issuer within the meaning of the rules under the Exchange Act, and as such the Company is exempt from certain provisions applicable to United States domestic public companies.
Because the Company qualifies as a foreign private issuer under the Exchange Act, the Company is exempt from certain provisions of the securities rules and regulations in the United States that are applicable to U.S. domestic issuers, including, but not limited to: (i) the rules under the Exchange Act requiring the filing of quarterly reports on Form 10-Q and current reports on Form 8-K with the SEC; (ii) the sections of the Exchange Act regulating the solicitation of proxies, consents, or authorizations in respect of a security registered under the Exchange Act; (iii) the sections of the Exchange Act requiring insiders to file public reports of their share ownership and trading activities and liability for insiders who profit from trades made in a short period of time; and (iv) the selective disclosure rules by issuers of material nonpublic information under Regulation FD.
The Company is required to file an annual report on Form 20-F within four months of the end of each fiscal year. Press releases relating to financial results and material events will also be furnished to the SEC on Form 6-K. However, the information the Company is required to file with or furnish to the SEC will be less extensive and less timely compared to that required to be filed with the SEC by U.S. domestic issuers. Accordingly, if you continue to hold Common Shares, you may receive less or different information about the Company than you would receive about a U.S. domestic public company.
The Company may lose its foreign private issuer status which would then require it to comply with the domestic reporting regime of the Exchange Act and cause us to incur significant additional legal, accounting and other expenses.
As discussed above, the Company is a foreign private issuer and therefore is not required to comply with all of the periodic disclosure and current reporting requirements of the Exchange Act and may take advantage of certain exemptions to Nasdaq’s corporate governance rules. The determination of foreign private issuer status is made annually on the last business day of an issuer’s most recently completed second fiscal quarter, and, accordingly, the next determination will be made with respect to the Company on September 30, 2026. In the future, the Company would lose its foreign private issuer status if (1) more than 50% of its outstanding voting securities are owned by U.S. residents and (2) a majority of its directors or executive officers are U.S. citizens or residents, or it fails to meet additional requirements necessary to avoid loss of foreign private issuer status. If the Company loses its foreign private issuer status, it will be required to file with the SEC periodic reports and registration statements on U.S. domestic issuer forms, which are more detailed and extensive than the forms available to a foreign private issuer. The Company would also have to mandatorily comply with U.S. federal proxy requirements, and its officers, directors and principal shareholders will become subject to the short-swing profit disclosure and recovery provisions of Section 16 of the Exchange Act. In addition, it would lose its ability to rely upon exemptions from certain corporate governance requirements under the listing rules of Nasdaq. As a U.S. listed public company that is not a foreign private issuer, the Company could incur significant additional legal, accounting and other expenses that it will not incur as a foreign private issuer.
Psyence currently reports financial results under IFRS® Accounting Standards as issued by the International Accounting Standards Board, which differs in certain significant respects from U.S. GAAP.
Psyence currently reports financial results under IFRS. There are and there may in the future be certain significant material differences between IFRS and U.S. GAAP. As a result, financial information and reported earnings of Psyence for historical or future periods could be significantly different if they were prepared in accordance with U.S. GAAP. In addition, the Company does not intend to provide a reconciliation between IFRS and U.S. GAAP unless it is required under applicable law. As a result, you may not be able to meaningfully compare our financial statements under IFRS with those of companies that prepare financial statements under U.S. GAAP.
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If we are classified as a passive foreign investment company, United States taxpayers who own our Common Shares may have adverse United States federal income tax consequences.
A non-U.S. corporation such as ourselves will be classified as a passive foreign investment company, which is known as a PFIC, for any taxable year if, for such year, either
| ● | At least 75% of our gross income for the year is passive income; or |
| ● | The average percentage of our assets (determined at the end of each quarter) during the taxable year which produces passive income or which are held for the production of passive income is at least 50%. |
Passive income generally includes dividends, interest, rents, royalties (other than rents or royalties derived from the active conduct of a trade or business) and gains from the disposition of passive assets.
If we are determined to be a PFIC for any taxable year (or portion thereof) that is included in the holding period of a U.S. taxpayer who holds our Common Shares, the U.S. taxpayer may be subject to increased U.S. federal income tax liability and may be subject to additional reporting requirements.
Depending on the amount of our cash and other assets held for the production of passive income, it is possible that, for our current taxable year or for any subsequent year, more than 50% of our assets may be assets which produce passive income. We will make this determination following the end of any particular tax year. Although the law in this regard is unclear, we treat our consolidated affiliated entities as being owned by us for United States federal income tax purposes, not only because we exercise effective control over the operation of such entities but also because we are entitled to substantially all of their economic benefits, and, as a result, we consolidate their operating results in our consolidated financial statements. For purposes of the PFIC analysis, in general, a non-U.S. corporation is deemed to own its pro rata share of the gross income and assets of any entity in which it is considered to own, directly or indirectly, at least 25% of the equity by value. Our status as a PFIC is a fact-intensive determination made on an annual basis, and no opinion of counsel has or will be provided regarding our classification as a PFIC.
For a more detailed discussion of the application of the PFIC rules to us and the consequences to U.S. taxpayers who own our Common Shares if we were determined to be a PFIC, see “Material U.S. Federal Income Tax Considerations for U.S. Holders — Passive Foreign Investment Company Rules.”
You may face difficulties in protecting your interests, and your ability to protect your rights through U.S. courts may be limited, because the Company is incorporated under the laws of Canada, the Company conducts substantially all of its operations and a majority of its directors and executive officers reside outside of the United States.
The Company is a corporation incorporated under the laws of Canada, and conducts a majority of its operations through its subsidiaries outside the United States. Substantially all of the Company’s assets are located outside the United States. A majority of the Company’s officers and directors reside outside the United States and a substantial portion of the assets of those persons are located outside of the United States. As a result, it could be difficult or impossible for you to bring an action against the Company or against these individuals outside of the United States in the event that you believe that your rights have been infringed upon under the applicable securities laws or otherwise and it will be difficult to effect service of process within the United States upon the Company’s officers or directors, or enforce judgments obtained in United States courts against the Company’s officers or directors. Even if you are successful in bringing an action of this kind, the laws of Ontario could render you unable to enforce a judgment against the Company’s assets or the assets of the Company’s directors and officers.
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The Articles of Incorporation and certain Canadian legislation contain provisions that may have the effect of delaying or preventing a change in control.
Certain provisions of the Articles of Incorporation, together or separately, could discourage potential acquisition proposals, delay or prevent a change in control and limit the price that certain investors may be willing to pay for our common shares. For instance, our Articles of Incorporation contain provisions that establish certain advance notice procedures for nomination of candidates for election as directors at shareholders’ meetings.
In addition, a non-Canadian must file an application for review with the Minister responsible for the Investment Canada Act and obtain approval of the Minister prior to acquiring control of a “Canadian Business” within the meaning of the Investment Canada Act, where prescribed financial thresholds are exceeded. Finally, limitations on the ability to acquire and hold our common shares may be imposed by the Competition Act (Canada). The Competition Act (Canada) establishes a pre-merger notification regime for certain types of merger transactions that exceed certain statutory shareholding and financial thresholds. Transactions that are subject to notification cannot be closed until the required materials are filed and the applicable statutory waiting period has expired or been waived by the Commissioner. The Commissioner of Competition still retains the authority under the Competition Act (Canada) to review any acquisition or establishment, directly or indirectly, including through the acquisition of shares, of control over or of a significant interest in us, whether or not it is subject to mandatory notification. Otherwise, there are no limitations either under the laws of Canada or Ontario, or in our articles on the rights of non-Canadians to hold or vote our common shares. Any of these provisions may discourage a potential acquirer from proposing or completing a transaction that may have otherwise presented a premium to our shareholders. We cannot predict whether investors will find our company and our Common Shares less attractive because we are governed by foreign laws.
It is not expected that the Company will pay dividends in the foreseeable future.
It is expected that the Company will retain most, if not all, of its available funds and any future earnings to fund the development and growth of its business. In addition, the Company is a holding company and its subsidiaries are located abroad. Part of the Company’s primary internal sources of funds to meet its cash needs will be its share of the dividends, if any, paid by the Company’s subsidiaries. The distribution of dividends to the Company from the subsidiaries in certain markets where the Company operates is subject to restrictions imposed by the applicable laws and regulations in these markets. As a result, it is not expected that the Company will pay any cash dividends in the foreseeable future.
The Board has complete discretion as to whether to distribute dividends. Even if the Board decides to declare and pay dividends, the timing, amount and form of future dividends, if any, will depend on the future results of operations and cash flow, capital requirements and surplus, the amount of distributions, if any, received by the Company from subsidiaries, the Company’s financial condition, contractual restrictions and other factors deemed relevant by the Board. There is no guarantee that the Common Shares will appreciate in value or that the trading price of the Common Shares will not decline. Holders of the Common Shares should not rely on an investment in Common Shares as a source for any future dividend income.
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ITEM 4. INFORMATION ON THE COMPANY
The following terms, as used in this section shall have the following meanings:
| AjD | Adjustment Disorder | |
| API | Active Pharmaceutical Ingredient | |
| NPX-5 | Capsules containing 25mg naturally sourced psilocybin, being the product being used in Psyence’s Phase IIb Study | |
| PEX010 | Capsule containing 25mg naturally sourced psilocybin | |
| Phase IIb Field of Use | Anxiety and depression, including associated ailments, such as PTSD, stress, grief, and AjD within the context of palliative care |
A. Corporate History and Development
The Business Combination
On January 9, 2023 Psyence Group Inc. (“PGI” or “Psyence Group”) entered into a definitive business combination agreement, as amended (the “Business Combination Agreement” or “BCA”) with Newcourt Acquisition Corp. (NASDAQ: NCAC), a special purpose acquisition company (“SPAC”). The agreement aimed to create a public company leveraging natural psilocybin for palliative care treatment. PGI is a listed Canadian company that contributed its clinical trial activities to the Company as described below.
The transaction concluded on January 25, 2024, with PBM’s listing on NASDAQ. This transaction involved PBM acquiring the SPAC through a merger, thereby making the SPAC a wholly-owned subsidiary of PBM.
Transaction Overview:
On January 25, 2024 (the “Closing Date”), the Company, a corporation organized under the laws of Ontario, Canada, completed the previously announced business combination (the “RTO Transaction”) as per the BCA. The parties involved in the BCA included:
| - | PGI; |
| - | Newcourt Acquisition Corp., a Cayman Islands exempted company (“NCAC”); |
| - | Newcourt SPAC Sponsor LLC, a Delaware limited liability company (“NCAC Sponsor”); |
| - | Psyence (Cayman) Merger Sub, a Cayman Islands exempted company and a wholly owned subsidiary of Psyence Group (“Merger Sub”); |
| - | Psyence Biomed Corp., a corporation organized under the laws of British Columbia, Canada (“Original Target”); |
| - | Psyence Biomed II Corp., a corporation organized under the laws of Ontario, Canada (“Psyence Biomed II”); |
| - | Psyence Australia (Pty) Ltd (“Psyence Australia”) |
Key Transactions (collectively, the “Business Combination”):
Formation of Subsidiaries: Prior to the Closing Date, PGI formed three wholly owned subsidiaries: Psyence Biomed II, Psyence Australia and PBM.
Amalgamation: Prior to the Closing Date, PGI amalgamated with the Original Target. Consequently, PGI transferred shares of Psyence Australia and related business assets previously owned by the Original Target to Psyence Biomed II.
Share Exchange: PGI contributed Psyence Biomed II to PBM in a share-for-share exchange (the “Company Exchange”).
Merger: Following the Company Exchange, Psyence (Cayman) Merger Sub merged with Newcourt Acquisition Corp., with Newcourt Acquisition Corp. being the surviving entity. Each outstanding ordinary share of Newcourt Acquisition Corp. was converted into the right to receive one common share of PBM.
Warrant Conversion: Each outstanding warrant to purchase Newcourt Acquisition Corp. Class A ordinary shares was converted into warrants to acquire one common share of PBM on substantially the same terms as the original warrants.
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The Common Shares and the Public Warrants are traded on The Nasdaq Stock Market LLC (“Nasdaq”) under the symbols “PBM” and “PBMWW,” respectively.
Psyence Biomedical Ltd was incorporated as a corporation under the laws of Ontario, Canada on June 29, 2023.
Investment in Psyence Labs Ltd
During the year ended March 31, 2026, the Company made additional investment in PsyLabs to establish a multi-asset, vertically integrated biopharmaceutical platform focused on psychedelic-based therapeutics, with pharmaceutical-grade drug candidates manufactured through its investment in PsyLabs. During the fiscal year ended March 31, 2025, the Company acquired 1,000 shares of PsyLabs in exchange for 5,695 common shares of the Company, having an aggregate fair value of approximately $722,033, which was recorded as the cost of the investment. On April 15, 2025, the Company acquired an additional 250 PsyLabs shares for total cash consideration of $500,000, and on August 15, 2025, it acquired a further 1,750 PsyLabs shares for total cash consideration of $3,500,000, increasing its holding to 3,000 PsyLabs shares, or approximately 16.46% of PsyLabs’ outstanding shares. In February 2026, the Company exercised a put option and issued 1,146,159 of its common shares, having a fair value of approximately $2,934,167, to acquire an additional 2,900 PsyLabs shares, increasing its ownership to approximately 27.93%. As a result of acquiring significant influence, the Company has accounted for its investment in PsyLabs under the equity method as an investment in an associate from February 25, 2026. The carrying amount of the Company’s investment in PsyLabs as of March 31, 2026 was approximately $8,060,928. PsyLabs is a privately held company headquartered in the British Virgin Islands that focuses on the production of psychedelic active pharmaceutical ingredients and extracts, and is an affiliate of the Company.
Principal Capital Expenditures and Divestitures
The Company is a clinical-stage biopharmaceutical company and has not historically made material expenditures on property, plant and equipment. Since the beginning of the fiscal year ended March 31, 2024 through the date of this Report, the Company’s principal capital expenditures and divestitures have consisted principally of its acquisition of equity interests in, and licensing arrangements with, PsyLabs. and its affiliates, and the disposition of its prior licensing arrangement with Filament Health Corp. (“Filament”), as described below. The Company has not made any other individually material capital expenditures or divestitures, including any other material interests in other companies, during this period.
Disposition of Filament licensing arrangement.
In December 2022, the Company had entered into a royalty-bearing, binding term sheet with Filament for the worldwide right to commercialize Filament’s proprietary botanical drug candidate, PEX010, within the Company’s designated fields of use. On July 22, 2024, the parties entered into an addendum (the “Filament Addendum”), and the parties subsequently agreed to terminate the Filament term sheet and transition from PEX010 to PsyLabs’ NPX-5 as the product candidate used in the Company’s Phase IIb Study. The Company did not receive cash proceeds in connection with this disposition.
Capital Expenditures and Divestitures Currently in Progress; Geographic Distribution and Financing
As of the date of this Report, the Company’s principal capital expenditures currently in progress consist of the continued funding of its Phase IIb clinical trial in Australia, conducted through its Australian contract research organization, Southern Star Research Pty Ltd, and its Australian subsidiary, Psyence Australia (Pty) Ltd, together with its ongoing investment in and licensing arrangements with PsyLabs. These investments are located principally outside of Canada: the Company’s equity investment in PsyLabs relates to an entity domiciled in the British Virgin Islands, and the Company’s clinical-development expenditures are incurred principally in Australia. The Company has no material capital expenditures in progress within Canada, its country of incorporation.
The Company has financed these capital expenditures and investments through a combination of internal and external sources. The cash portions of the PsyLabs share acquisitions and the funding of the Company’s clinical-development activities have been financed from the Company’s available cash resources, which have been generated principally from sales of equity securities and convertible debt financings, while the February 2026 increase in the Company’s PsyLabs interest was financed through the issuance of the Company’s common shares rather than cash. The Company expects to finance its capital expenditures and investments currently in progress through its existing cash resources and, as needed, additional external financing. See “Item 3.D — Risk Factors” and “Item 5 — Operating and Financial Review and Prospects.”
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Other Information
Our registered address and principal executive office is 121 Richmond Street West, Penthouse Suite 1300, Toronto, Ontario M5H 2K1, and our telephone number is +1 (416) 477-1708.
Our U.S. transfer agent and registrar is Continental Stock Transfer & Trust Company, located at 1 State Street, 30th Floor, New York, NY 10004.
We file reports and other information with the SEC pursuant to the SEC’s rules and regulations that apply to foreign private issuers. The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. Our electronic filings are available for viewing on the SEC’s website at http:// www.sec.gov). The website address of the Company is www.psyencebiomed.com. The information contained on the website does not form a part of, and is not incorporated by reference into, this Report.
B. Business Overview
The Company is a multi-asset, vertically integrated biopharmaceutical company focused on psychedelic-based therapeutics, with pharmaceutical-grade drug candidates manufactured through its investment in PsyLabs. It is the first life sciences biotechnology company focused on developing nature-derived (non-synthetic) psilocybin and ibogaine-based psychedelic medicine to be listed on Nasdaq. We are dedicated to addressing unmet mental health needs and are committed to an evidence-based approach in developing safe, effective, and FDA-approved nature-derived psychedelic treatments for a broad range of mental health disorders. The Company is currently conducting research through clinical trials to evaluate the safety and effectiveness of natural psilocybin in treating adjustment disorder in patients with a cancer diagnosis in a palliative care context.
We strive to set the global standard for excellence and consistency in drug development using nature-based psilocybin products. Psyence’s priority is developing pharmaceutical grade psilocybin to help heal psychological trauma and the diagnosable disorders that can result therefrom, including AjD, alcohol use disorder (“AUD”), other substance use disorders (“SUDs”), anxiety, depression, post-traumatic stress disorder (“PTSD”), and grief and bereavement, especially in the context of palliative care. Our focus includes therapeutic protocols for medical and scientific research including observational studies.
NPX-5, capsules containing 25mg naturally sourced psilocybin, is being used in our Phase IIb Study, replacing PEX010 as the lead product candidate. Psyence has entered into the PsyLabs IP Agreement with PsyLabs, a psychedelic Active Pharmaceutical Ingredient (API) development company, federally licensed to cultivate, extract, and export psilocybin mushrooms and other psychedelic compounds including psilocin, mescaline, ibogaine, and dimethyltryptamine (DMT) to legal medical and research markets, and the proprietary owner of NPX-5, for the licensing of NPX-5 with respect to Psyence’s designated fields of use: anxiety and depression, including associated ailments, such as PTSD, stress, grief, and adjustment disorder within the context of palliative care. See “— Licensing of PEX010 – Palliative Care” and “— Licensing of NPX-5 – Palliative Care” below.
We have contracted Southern Star Research, a full-service Australian CRO, to conduct the Phase IIb Study, which is a double-blind, randomized, low-dose controlled clinical trial to assess the efficacy and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of AjD due to incurable cancer. Outsourcing the study to a CRO assists the company in operating in a more capital efficient manner without the overhead of handling in-house.
Psyence Biomedical conducts its operations through its subsidiaries based in Ontario and Australia and also owns a subsidiary in the Cayman Islands, as listed below:
| Name | Country of Incorporation and Place of Business | Proportion of Ordinary Shares Held by Psyence Biomedical |
||||
| Psyence Biomed II Corp | Ontario, Canada | 100 | % | |||
| Psyence Australia Pty Ltd. | Australia | Indirect 100 | % | |||
| Newcourt Acquisition Corp | Cayman Islands | 100 | % | |||
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The diagram below depicts a current version of Psyence Biomedical.
The Company is subject to certain of the informational filing requirements of the Exchange Act. Since the Company is a “foreign private issuer,” it is exempt from the rules and regulations under the Exchange Act prescribing the furnishing and content of proxy statements, and the officers, directors and principal shareholders of the Company are exempt from the reporting and “short-swing” profit recovery provisions contained in Section 16 of the Exchange Act with respect to their purchase and sale of Common Shares. In addition, the Company is not required to file reports and financial statements with the SEC as frequently or as promptly as U.S. public companies whose securities are registered under the Exchange Act. However, the Company is required to file with the SEC an Annual Report on Form 20-F containing financial statements audited by an independent accounting firm. The SEC also maintains a website at www.sec.gov that contains reports and other information that the Company files with or furnishes electronically to the SEC.
The website address of the Company is www. psyencebiomed.com. The information contained on the website does not form a part of, and is not incorporated by reference into, this Report.
Phase IIb Study - Palliative Care Clinical Trial
On January 9, 2023, Psyence and iNGENū CRO Pty Ltd (“iNGENū”) signed a letter of intent to further develop Psyence’s licensed natural psilocybin drug product, starting with a Phase IIb Study in order to lead a pre-IND meeting with the FDA. In May 2025, the Company transferred all clinical trial execution duties from iNGENū to Southern Star Research and entered into a Master Services Agreement (the “MSA”) with Southern Star Research. Under the MSA, Southern Star Research will provide comprehensive CRO services for the Phase IIb Study.
The product to be used in this Phase IIb Study will be the proprietary botanical drug candidate NPX-5 (25mg), which Psyence sources from PsyLabs. The planned randomized double-blind study will evaluate the use of psilocybin-assisted psychotherapy versus psychotherapy alone and will test 87 patients utilizing the HAM - A scale as the primary endpoint, which is an FDA validated endpoint, and safety data will be collected throughout the study.
For safety, there are no specific endpoints as all safety findings are captured as adverse events. The primary and secondary efficacy endpoints are all established in the protocol before it is reviewed and approved by the Ethics Committee before the study can start.
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The HAM-A is a rating scale developed to measure the severity of anxiety symptoms and is widely used in both clinical and research settings. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). During the Phase IIb Study, the HAM-A scale will be used to measure change in anxiety levels over time as the primary endpoint.
The 87-patient Phase IIb Study being conducted by the CRO, Southern Star Research, in Australia is the one that has been referred to in discussions with the FDA in the pre-IND process, which is in the late planning stage, and estimated to commence enrollment in the second half of 2025.
The estimated costs of this Phase IIb Study were initially $5,575,000 made on the basis of milestones completed. Included in this original estimate were costs for 75 participants; an end of Phase II meeting preparation and attendance after the completion of the Phase IIb Study with the FDA as well as psychotherapy training, psychotherapy sessions and therapist fees for participants. Subsequently, the Phase IIb Study was increased to 87 patients, and we anticipate the estimated cost of this study to be increased by approximately 5%.
On September 15, 2022, we received full approval of a study (the “UK Trial”) in the United Kingdom from the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) using natural psilocybin in the field of palliative care with oncology patients. For this study, we had partnered with Clerkenwell Clinics Limited (“Clerkenwell Health”), which would have been responsible for jointly designing and delivering the UK Trial. Following such approval, we opted to forego proceeding with the UK Trial in order to pursue the opportunity to conduct the Phase IIb Study in Australia, as Psyence could benefit from the Australian Federal Government’s Research & Development tax incentive program, which could provide up to a 43.5% rebate on Psyence’s R&D expenses in Australia, making it a more cost-effective endeavor. In addition, the Phase IIb Study adds a dose-finding arm, which allows us to accelerate our development strategy, seeking input from the FDA with our pre-IND application. On March 5, 2024, Psyence received full approval of the Phase IIb Study from to the Australian Human Research Ethics Committees (HRECs), the body responsible for the review of research proposals involving human participants to ensure that they are ethically acceptable. If the outcome of the Phase IIb Study is positive, we believe we may be able to proceed directly to a Phase III trial in the United States, subject to FDA review and the opening of an IND; however, there is no guarantee that the FDA will accept data from trials conducted outside of the United States.
Licensing of PEX010 - Palliative Care
In April 2022, Psyence entered into a research licensing agreement with Filament for the licensing of PEX010 and its associated intellectual property, as well as for the supply of PEX010 for the specific intention of the clinical development of the product for use in palliative care patients (“Filament Research IP Agreement”). Pursuant to the Filament Research IP Agreement, Filament granted Psyence an irrevocable, royalty free, worldwide license (with the right to sub-license, subject to certain restrictions) to use and distribute PEX010 and certain related intellectual property (such as delivery mechanism, preparation methods and know-how) solely for use in connection with pre-clinical and clinical studies and trials to be conducted in Canada, the UK and world-wide in the treatment of anxiety and depression, including associated ailments, such as PTSD, stress, grief, and adjustment disorder within the context of palliative care. This license is granted in respect of the clinical trial phase of Psyence’s activities, specifically phase II clinical trials which consisted of the Phase IIb Study. The license was granted on an exclusive basis solely within the territory of the UK with respect to the designated fields of use, and Psyence had a right of first refusal to extend its exclusive license beyond the territory of the UK. Psyence did not have any rights to use PEX010 for any profit-making or commercial purposes under the Filament Research IP Agreement. Any results of testing, research, conduct of and any information derived from the clinical studies and trials using PEX010 became the sole property of Psyence. Under the Filament Research IP Agreement, Filament was entitled to receive milestone payments of up to CAD$250,000 in aggregate based on four distinct phase II clinical trial milestones to be achieved by Psyence. If Psyence were to pursue a second or multiple indications, such aggregate milestone payments would have been increased accordingly. For the year ended March 31, 2024, Psyence incurred $167,306 costs under the Filament Research IP Agreement related to milestone payments, which was accounted for as research and development costs.
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In addition to the licensing rights described above, Filament undertook to support Psyence’s clinical trial efforts through the supply of the required quantities of PEX010 to Psyence, for no additional charge, based on Psyence’s good faith forecasts of its needs. Filament also committed to the creation and provision of such information, assistance and support for the execution of the dossiers, IMBP and other documents required to conduct Psyence’s clinical trials in accordance with the trial schedules. The license term was 5 years, expiring in April 2027. On July 22, 2024, the parties concluded an addendum to the Filament Research IP Agreement (“Filament Addendum”) whereby Filament undertook to provide a sufficient supply of PEX010 to Psyence in order to facilitate the substitution of an alternative drug candidate for use in Phase III trials and for commercialization purposes following the conclusion of the Phase IIb Study, however the parties later agreed to transition to NPX-5 as part of the Phase IIb Study.
In December 2022, Psyence entered into a royalty-bearing, binding term sheet for the commercial licensing of intellectual property (with the right to sub-license) from Filament, which was subject to the terms of a definitive license agreement, and which granted Psyence the worldwide right to commercialize PEX010 within the designated fields of use, being anxiety and depression, including associated ailments, such as PTSD, stress, grief, and adjustment disorder within the context of palliative care. The term sheet remained subject to further negotiations between the parties and the execution of a subsequent definitive agreement within a predefined time period. Following further discussions, Psyence and Filament mutually agreed to terminate the term sheet by way of the Filament Addendum, whereafter Psyence transitioned to an alternative supplier, PsyLabs for purposes of the ongoing Phase IIb Study.
Psyence has successfully negotiated and executed supply agreements and licensing agreements for the use of PsyLabs’ intellectual property within the Phase IIb Field of Use and indications of AUD and other SUDs respectively. See “— Licensing of NPX-5 – Palliative Care” and — Licensing of additional API for use in AUD and SUD”.
Psyence has not performed any pre-clinical or clinical trials on PEX010 or NPX-5. NPX-5 is manufactured by or on behalf of PsyLabs in accordance with applicable quality standards for the intended stage of development and proposed clinical or authorised patient-access use. PsyLabs has not yet completed pre-clinical or clinical trials on NPX-5. In December 2025, the Bellberry Human Research Ethics Committee (“HREC”) formally approved the use of PsyLabs’ NPX-5 in Psyence’s ongoing Phase IIb study evaluating psilocybin-assisted psychotherapy for Adjustment Disorder in patients with cancer.
Licensing of NPX-5 - Palliative Care
As stated above, Psyence has transitioned to NPX-5 as part of the ongoing Phase IIb Study. In December 2025, the Company entered into an exclusive (with respect to the territory of Australia), royalty-bearing IP licensing agreement with PsyLabs, in terms of which PsyLabs will supply the Company with pharmaceutical-grade, GMP-compliant, nature-derived (non-synthetic) psilocybin for use in the Phase IIb Study, future clinical trials, and eventual commercialization in the Phase IIb Field of Use (“PsyLabs IP Agreement”).
The license was granted on an exclusive basis solely within the territory of Australia with respect to the Phase IIb Field of Use, however Psyence has a right of first refusal to extend its exclusive license beyond the territory of Australia. Any results of testing, research, conduct of and any information derived from the clinical studies and trials using NPX-5 shall become the sole property of Psyence. Under the PsyLabs IP Agreement, PsyLabs is entitled to receive milestone payments of up to $95,000 in aggregate based on two distinct phase II clinical trial milestones, up to $876,000 in aggregate based on two distinct commercialization milestones in respect of the first marketing approval permitting commercial sales and up to $584,000 in aggregate based on two distinct commercialization milestones in respect of any other marketing approval permitting commercial sales thereafter, as achieved by Psyence. For the year ended March 31, 2026, Psyence incurred $75,000 costs under the PsyLabs IP Agreement related to milestone payments, which was accounted for as research and development costs.
Licensing of additional API for use in AUD and SUD
In September 2024, the Company entered into an exclusive, royalty-bearing IP licensing agreement with PsyLabs, following an initial investment whereby the Company acquired a minority stake in PsyLabs. Under the terms of this agreement, PsyLabs will supply the Company with pharmaceutical-grade, EU-GMP, nature-derived (non-synthetic) psilocybin for use in future clinical trials and eventual commercialization in SUD, including AUD.
In parallel with an additional financial commitment in PsyLabs in April 2025, the Company has secured an exclusive right of first refusal in respect of the worldwide supply of pharmaceutical-grade, nature-derived ibogaine. Under this agreement, PsyLabs will grant the Company the right of first refusal to acquire the exclusive rights to a dedicated supply of ibogaine for evaluation in the treatment of SUD, including AUD.
These exclusive partnerships further strengthens the Company’s integrated development strategy, ensuring access to high-quality psychedelic compounds to support its growing clinical pipeline and diversification into multiple therapeutic areas.
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Relationships with Third Parties
Psyence’s Australian-based research and development will be conducted by its CRO partner, Southern Star Research, in Australia. As stated above, PsyLabs’ NPX-5 will serve as the product candidate under investigation during the Phase IIb Study.
Psyence’s R&D capabilities
Psyence’s Global Head of Clinical Development (Dr. Neil Maresky) and Scientific Advisor (Dr. Clive Ward-Able) are both medically trained physicians with close to 60 years of experience between them within the pharmaceutical industry related to R&D and the commercialization of new products. This experience provides the foundations for an excellent understanding of the clinical development, regulatory and commercialization needs of various pharmaceutical markets to design the optimal development program.
Psyence plans on working with various CROs and consultancy agencies to prepare and operationalize their protocols for the various phases of the clinical development program.
Intellectual Property
Psyence engages a team of lawyers and advisors that helps strengthen the protection of its IP assets. As psilocybin is a naturally occurring substance, it cannot be patented. However, patents may be granted on formulations, methods of use, compositions of matter and formulation processes, provided that such items are novel, non-obvious and have significant improvements to existing inventions.
Psyence’s IP strategy is built around:
| ● | Establishing and maintaining a competitive advantage on formulation, dosage and administration of psilocybin, as well as psychedelic-assisted therapy modules for palliative care indications; and |
| ● | Ensuring business flexibility through directing its research in areas which maintain freedom to operate (relative to third party patent positions) and secures the most favorable commercial terms in agreements with other companies in collaborating on later research, and the commercialization of Psyence’s IP assets. |
Psyence has a specialist, experienced in-house team focused on delivery of this strategy, including internationally recognized patent professionals working directly with Psyence’s board on these issues.
Specific actions are being taken towards delivery of this strategy include:
| ● | Ongoing patent landscaping on the competitor patent landscape. Psyence has completed a patent landscaping review and has ongoing patent watching searches in place on the back of this to identify any new filings made in this space; |
| ● | Actively considering potential patent filings, with the intention to identify, file, prosecute and eventually maintain Psyence’s patent portfolio. This patent portfolio is intended to be built out incrementally across the proprietary formulation and treatment technologies that are under development by Psyence; |
| ● | Active management of key know-how and trade secrets (in order to supplement the patent portfolio); and |
| ● | Thoughtful negotiation of in-licensing arrangements of third-party IP rights that can enhance or accelerate the building of our business. |
Psyence does not currently hold any patents. Psyence will be dependent, to an extent, on PsyLabs to maintain and defend the intellectual property currently being licensed to Psyence under the PsyLabs IP Agreement, which is relevant for use in Psyence’s Phase IIb Study.
Competitive Environment
There are currently no pharmaceutical agents with FDA regulatory approval for the treatment of AjD within palliative care or any other arena. The current treatment of AjD is empirical, with either psychotherapy or off-label pharmacological agents, such as anti-depressants or anxiolytics, or a combination of both.
We believe that the competitive landscape analysis of other commercial psychedelic-assisted treatments in clinical trials strongly suggests that Psyence’s clinical asset has a first-mover advantage in both the palliative care and cancer-related AjD market upon approval. NPX-5 and its associated IP has been licensed to Psyence, giving it exclusivity for the Phase IIb Field of Use in Australia for R&D and commercialization purposes. Psyence plans to expand their targeted indication of cancer-related AjD to address different types of AjD and other secondary indications both in a palliative and non-palliative context.
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In 2019, the FDA designated psilocybin therapy as “breakthrough therapy” for the treatment of severe depressive disorder. This precedent provides the possibility that psilocybin-based drug candidates, such as NPX-5, may be eligible for a number of processes that could result in expedited marketing approval of such psilocybin-based drug candidates, such as Fast Track, Accelerated Approval, Priority Review and Breakthrough Status. Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.
A breakthrough therapy designation conveys all of the fast track program features (see below for more details on fast track designation), more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review.
Additionally, even if we are granted an accelerated approval pathway, that may or may not lead to a faster development or regulatory review or approval process and may or may not increase the likelihood that our other product candidate will receive marketing approval. The European Medicines Agency (EMA) PRIME program, similar to the Food and Drug Administration (FDA) breakthrough therapy designation program, was launched in March 2016 to enhance support for the development of medicines that target an unmet medical need. PRIME and the U.S. breakthrough therapy designation share the same objective (timely patient access to innovative medicines).
Business Objectives
Psyence intends to further expand the development of its product candidates for additional indications. While Psyence’s initial focus will be on the development of NPX-5 for the treatment of AjD in patients with a recent diagnosis of cancer in its Phase IIb Study, indication expansion will focus on other causes of AjD potentially leading to an increased opportunity within the indication. Further indications will be considered once the AjD program is ongoing in areas such as AUD and other SUDs and potentially with the use of other in-licensed candidates, however no such agreements have been reached at this stage.
Psyence’s Psilocybin Asset
In order to accelerate clinical development of a palliative care, psilocybin-based asset, Psyence had initially licensed Filament’s proprietary botanical drug candidate, PEX010, and its associated IP, however Psyence has now transitioned to NPX-5 as part of the Phase IIb Study. PsyLabs has developed innovative technology to extract and standardize stable doses of natural compounds from mushrooms. In December 2025 the HREC formally approved the use of PsyLabs’ NPX-5 in Psyence’s ongoing Phase IIb Study. Pursuant to the PsyLabs IP Agreement, Psyence will own all the data, results of testing, research, any information and any other IP derived or arising from any clinical trials, with the exclusion of IP related to the manufacture, processing or production of the PsyLabs input material, which will vest in PsyLabs.
NPX-5 is a pharmaceutical-grade, natural psilocybin drug candidate. It consists of five oral capsules containing 5mg of naturally derived psilocybin each (totaling 25mg of naturally derived psilocybin). NPX-5 will be used as an adjunct to psychotherapy for the treatment of AjD due to an incurable cancer diagnosis versus psychotherapy alone within a palliative care context.
Description of NPX-5
NPX-5 is extracted and purified from the psilocybes species of mushroom. Psilocybin is rapidly metabolized in the body to form psilocin, a psychoactive molecule. There has recently been a resurgence in the study of the use of psychedelics in a multitude of potential indications such as depression, anxiety disorders, PTSD, addictions and within palliative care, which is the focus area for Psyence’s development of NPX-5.
As part of the ongoing Phase IIb Study, NPX-5 is being tested in patients with a recent cancer diagnosis and who have developed AjD which can severely affect their quality of life as well as those closely related to them.
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Oral psilocybin has about a 50% bioavailability and psilocin is detectable in plasma within 15 minutes of administration of the parent compound.1, 2 The half-life of psilocin in blood is 2-3 hours. Onset of noticeable psychoactive effects for a 25 mg dose typically occur within one hour, peaks at two hours after a dose and finishes at six hours after the dose.
The investigational medicinal product, NPX-5, is an oral capsule containing a naturally derived Psilocybe cubensis mushroom extract standardized for psilocybin content. Psilocybin is chemically described as 4-phosphoryloxy-N,N-dimethyltryptamine (4-PO-DMT). Each NPX-5 capsule is formulated to contain 5 mg of psilocybin, together with appropriate excipients, in a hydroxypropyl methylcellulose capsule shell.
Indication and Treatments
Adjustment Disorder
Incurable cancer is predictably associated with challenges and burdens that may lead to symptoms of depression, demoralization, and fears of suffering, dependency, and mortality.3 Up to 50% of individuals with advanced cancer report symptoms that are sufficiently severe to reach clinical levels, exacerbating physical symptoms and impairing quality of life.4, 5 Multiple physical symptoms, dramatic alteration in support needs and personal relationships, difficulty navigating a complex health care system, and the threat of impending mortality all may constitute pathways to distress.6
AjD is defined in International Classification of Diseases 11th Revision (ICD-11) as a maladaptive reaction, which usually emerges within one month of a significant life-stressor, such as illness, family or partnership problems, job-related issues, or financial difficulties. 7 There are two core categories of symptoms that characterize AjD: a preoccupation with the stressor or its consequences, and failure to adapt. Preoccupation includes recurring distressing thoughts about the stressor, constant worry, and rumination. Failure to adapt describes a generalized stress-response (e.g., sleep disturbances or concentration problems) that results in significant impairment in social, interpersonal, occupational, educational, or other significant areas of functioning
AjD is also defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnostic criteria,8 and while there is great overlap with the definition and symptomatology compared to the ICD 11 classification, the DSM definition separates AjD into 6 different subtypes, Both the ICD and DSM have had substantial impact on global psychiatric practice and research. While the DSM has been used more often in research around the world,9 a study of nearly 5,000 psychiatrists in 44 countries demonstrated that the majority of psychiatrists outside the U.S. utilize ICD classifications in their daily clinical practice.10 The DSM-5 conceptualizes AjD as a stress-related syndrome in a separate chapter of “Trauma and Stress Related Disorders”,11 representing the most significant change from DSM-IV.12 However, the current diagnostic construct is crucially dependent on an exclusion criterion, so that a diagnosis of AjD is rarely applicable when another mental disorder is present.
| 1 | Brown RT, Nicholas CR, Cozzi NV, Gassman MC, Cooper KM, Muller D, et al. Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. Clin Pharmacokinet. 2017;56:1543–1554. |
| 2 | Hasler F, Bourquin D, Brenneisen R, Bär T, Vollenweider FX. Determination of psilocin and 4-hydroxyindole-3-acetic acid in plasma by HPLC-ECD and pharmacokinetic profiles of oral and intravenous psilocybin in man. Pharm Acta Helv. 1997;72:175 – 184. |
| 3 | Lo C, Zimmermann C, Rydall A, Walsh A, Jones JM, Moore MJ, et al. Longitudinal study of depressive symptoms in patients with metastatic gastrointestinal and lung cancer. J Clin Oncol. 2010;28:3084 – 3089. |
| 4 | Hopwood P, Stephens RJ. Depression in patients with lung cancer: prevalence and risk factors derived from quality-of-life data. J Clin Oncol. 2000;18:893 – 903. |
| 5 | Delgado-Guay M, Parsons HA, Li Z, Palmer JL, Bruera E. Symptom distress in advanced cancer patients with anxiety and depression in the palliative care setting. Support Care Cancer. 2009;17:573 – 579. |
| 6 | Rodin G, Lo C, Mikulincer M, Donner A, Gagliese L, Zimmermann C. Pathways to distress: the multiple determinants of depression, hopelessness, and the desire for hastened death in metastatic cancer patients. Soc Sci Med. 2009;68:562 – 569. |
| 7 | Maercker A, Brewin CR, Bryant RA, Cloitre M, van Ommeren M, Jones LM, et al. Diagnosis and classification of disorders specifically associated with stress: proposals for ICD-11. World Psychiatry. 2013;12:198 – 206. |
| 8 | Casey P, Doherty A. AjD: implications for ICD-11 and DSM-5. Br J Psychiatry. 2012;201:90 – 92. |
| 9 | Clark LA, Cuthbert B, Lewis-Fernández R, Narrow WE, Reed GM. Three Approaches to Understanding and Classifying Mental Disorder: ICD-11, DSM-5, and the National Institute of Mental Health’s Research Domain Criteria (RDoC). Psychol Sci Public Interest. 2017;18:72 – 145. |
| 10 | Reed GM, Mendonça Correia J, Esparza P, Saxena S, Maj M. The WPA-WHO Global Survey of psychiatrists’ attitudes towards mental disorders classification. World Psychiatry. 2011;10:118 – 131. |
| 11 | Kangas M. DSM-5 Trauma and Stress-Related Disorders: Implications for Screening for Cancer-Related Stress. Front Psychiatry. 2013;4:122. |
| 12 | Strain JJ, Friedman MJ. Considering AjDs as stress response syndromes for DSM-5. Depress Anxiety. 2011;28:818 – 823. |
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Treatment Plans
Traditional Treatments
Evidence suggests that addressing psychosocial, emotional, and physical symptoms early in the cancer trajectory, through such steps as palliative care or psychological interventions, may positively influence survival outcomes.13,14,15,16 Comorbid depression with cancer leads to worsened quality of life, increased sensitivity to pain, difficulties with treatment, communication difficulties, caregiver burnout, increased risk of suicide, longer periods of hospitalization, and a reduced expectation of survival.17,18,19,20,21 The National Institute for Clinical Excellence Palliative Cancer Care Guidelines22 recommend that if experiencing more severe types of psychological distress — which would include moderate to severe AjD — patients should be offered specialist psychological interventions such as psychotherapy, including cognitive behavioral therapy (“CBT”).
| 13 | Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, et al. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010;363:733 – 742. |
| 14 | Bakitas MA, Tosteson TD, Li Z, Lyons KD, Hull JG, Li Z, et al. Early Versus Delayed Initiation of Concurrent Palliative Oncology Care: Patient Outcomes in the ENABLE III Randomized Controlled Trial. J Clin Oncol. 2015;33:1438 – 1445. |
| 15 | Giese-Davis J, Collie K, Rancourt KMS, Neri E, Kraemer HC, Spiegel D. Decrease in depression symptoms is associated with longer survival in patients with metastatic breast cancer: a secondary analysis. J Clin Oncol. 2011;29:413 – 420. |
| 16 | Spiegel D, Giese-Davis J. Depression and cancer: mechanisms and disease progression. Biol Psychiatry. 2003;54:269 – 282. |
| 17 | Skarstein J, Aass N, Fosså SD, Skovlund E, Dahl AA. Anxiety and depression in cancer patients: relation between the Hospital Anxiety and Depression Scale and the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire. J Psychosom Res. 2000;49:27 – 34. |
| 18 | Depression as a predictor of disease progression and mortality in cancer patients: a meta-analysis. Centre for Reviews and Dissemination (UK); 2009. |
| 19 | Prieto JM, Blanch J, Atala J, Carreras E, Rovira M, Cirera E, et al. Psychiatric morbidity and impact on hospital length of stay among hematologic cancer patients receiving stem-cell transplantation. J Clin Oncol. 2002;20:1907 – 1917. |
| 20 | Misono S, Weiss NS, Fann JR, Redman M, Yueh B. Incidence of suicide in persons with cancer. J Clin Oncol. 2008;26:4731 – 4738. |
| 21 | Colleoni M, Mandala M, Peruzzotti G, Robertson C, Bredart A, Goldhirsch A. Depression and degree of acceptance of adjuvant cytotoxic drugs. Lancet. 2000;356:1326 – 1327. |
| 22 | Nice N. Improving supportive and palliative care for adults with cancer. London: NICE. 2004. 2004. |
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Psilocybin-assisted psychotherapy
CBT has been shown to improve anxiety in patients diagnosed with incurable cancer, but appears to be less effective at improving depressive symptoms.23 Several recently published trials have examined the efficacy of psilocybin, a classic serotonergic psychedelic drug that induces its acute subjective effects through the agonism of serotonin 2A (5-HT2A) receptors, to treat depression and anxiety in patients with life -threatening cancer, amongst other psychiatric conditions.24,25,26,27 Psilocybin-assisted psychotherapy is a course of therapy involving single or multiple sessions in which a dose of psilocybin is administered in conjunction with psychotherapy, delivered by a suitably trained therapist in a controlled setting. This intervention consists of three therapy stages: (1) preparation, (2) dosing session(s), and (3) integration, which allow for a more patient-centric approach compared to other therapy models. The pharmacological effects of psilocybin, in synergy with the psychotherapy, are considered to give rise to increased neuroplasticity, which facilitates rapid and deep psychological transformation that may accelerate and augment the effects of the psychotherapy process.27
PAP has been demonstrated in various academic studies to cause expeditious, substantial, and sustained improvements in cancer-related anxiety and depression, existential distress, quality of life, and orientation toward death.25,26 For example, in an academic study 15 of 29 patients with cancer-related depression and anxiety, at the 6.5-month follow up, psilocybin was associated with enduring anxiolytic and anti-depressant effects (approximately 60-80% of participants continued with clinically significant reductions in depression or anxiety respectively), sustained benefits in existential distress and quality of life, as well as improved attitudes towards death.28 In another study of 51 patients,25 similar results were reported. At 6-month follow-up, these changes were sustained, with about 80% of participants continuing to show clinically significant decreases in depressed mood and anxiety. Participants attributed improvements in attitudes about life/self, mood, relationships, and spirituality to the “high” experience resulting from the psilocybin, with over 80% endorsing moderately or greater increased well-being/life satisfaction.29,30,31,32,33,34,35
| 23 | Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006;44:1 – 25. |
| 24 | Carhart-Harris R, Giribaldi B, Watts R, Baker-Jones M, Murphy-Beiner A, Murphy R, et al. Trial of Psilocybin versus Escitalopram for Depression. N Engl J Med. 2021;384:1402 – 1411. |
| 25 | Grob CS, Danforth AL, Chopra GS, Hagerty M, McKay CR, Halberstadt AL, et al. Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer. Arch Gen Psychiatry. 2011;68:71 – 78. |
| 26 | Griffiths RR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, et al. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016;30:1181 – 1197. |
| 27 | Brouwer A, Carhart-Harris RL. Pivotal mental states. J Psychopharmacol. 2021;35:319 – 352. |
| 28 | Agin-Liebes GI, Malone T, Yalch MM, Mennenga SE, Ponté KL, Guss J, et al. Long-term follow-up of PAP for psychiatric and existential distress in patients with life-threatening cancer. J Psychopharmacol. 2020;34:155 – 166. |
| 29 | Carhart-Harris RL, Bolstridge M, Rucker J, Day CMJ, Erritzoe D, Kaelen M, et al. Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study. Lancet Psychiatry. 2016;3:619 – 627. |
| 30 | Carhart-Harris RL, Bolstridge M, Day CMJ, Rucker J, Watts R, Erritzoe DE, et al. Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Psychopharmacology. 2018;235:399 – 408. |
| 31 | Davis AK, Barrett FS, May DG, Cosimano MP, Sepeda ND, Johnson MW, et al. Effects of PAP on Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2021;78:481 – 489. |
| 32 | Bogenschutz MP, Forcehimes AA, Pommy JA, Wilcox CE, Barbosa PCR, Strassman RJ. Psilocybin- assisted treatment for alcohol dependence: a proof-of-concept study. J Psychopharmacol. 2015;29:289 – 299. |
| 33 | Johnson MW, Garcia-Romeu A, Cosimano MP, Griffiths RR. Pilot study of the 5-HT2AR agonist psilocybin in the treatment of tobacco addiction. J Psychopharmacol. 2014;28:983 – 992. |
| 34 | Moreno FA, Wiegand CB, Taitano EK, Delgado PL. Safety, tolerability, and efficacy of psilocybin in 9 patients with obsessive-compulsive disorder. J Clin Psychiatry. 2006;67:1735 – 1740. |
| 35 | Griffiths RR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, et al. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016;30:1181 – 1197. |
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A number of factors provide rationale for focusing on patients with AjD following a diagnosis of incurable cancer as the target population. The size of the cancer population, which generally makes up approximately 30% of target country palliative patients, provides justification for research, in regard to both the magnitude of needs and the access to participant recruitment. Additionally, previous clinical trials have demonstrated the feasibility and efficacy of PAP for people with depression and anxiety symptoms, both within and outside of the palliative care setting, highlighting the versatility and universality of this intervention. Moreover, the sustained reductions in anxiety and depression amongst palliative care patients suggest the longevity of positive outcomes mediated by PAP and the potential to dramatically improve patient quality of life, in what remains of their life.
Classic psychedelics, a term referring to naturally-derived psychedelics including mescaline, lysergic acid diethylamide and psilocybin, all share a common mechanism of action via the serotonergic pathways. Psilocybin is a prodrug that, when ingested, is metabolized into the psychoactive compound psilocin. Psilocin acts as a partial agonist at the serotonergic 5-HT2A receptor, and research has demonstrated that activation of the 5-HT2A receptor subtype is integral to the mechanism of action leading to subjective psychedelic experience.36,37,38,39,40
The pharmacological effects of psilocybin, in synergy with psychotherapy, are considered to give rise to increased neuroplasticity and create a ‘pivotal mental state,’ which facilitates rapid and deep psychological transformation that may accelerate and augment the effects of the psychotherapy process.27 This is thought to underlie the transdiagnostic efficacy of PAP for a wide range of difficult to treat psychiatric conditions, including treatment-resistant depression, PTSD, substance use disorders, psychological distress with a life-threatening illness and obsessive-compulsive disorder.
Clinical Studies
In recent palliative care clinical trials conducted at New York School of Medicine and Johns Hopkins University School of Medicine, in which participants received PAP at doses of 22 mg/70 kg, 30 mg/70 kg, and 0.3 mg/kg, no serious adverse events (“SAEs”) were reported. Adverse effects of PAP amongst participants had all been previously described for psilocybin and were mild and transient, and included physical discomfort, psychological discomfort, increased systolic and diastolic blood pressure without criteria for medical intervention, increased heart rate with a mild sympathomimetic effect, nausea and vomiting, transient anxiety and headaches or migraines. None of the participants experienced prolonged psychosis or hallucinogen persisting perception disorder (“HPPD”).
| 36 | Willins DL, Meltzer HY. Direct injection of 5-HT2A receptor agonists into the medial prefrontal cortex produces a head-twitch response in rats. J Pharmacol Exp Ther. 1997;282:699 – 706. |
| 37 | Glennon RA, Teitler M, Sanders-Bush E. Hallucinogens and serotonergic mechanisms. NIDA Res Monogr. 1992;119:131 – 135. |
| 38 | Vollenweider FX, Vollenweider-Scherpenhuyzen MF, Bäbler A, Vogel H, Hell D. Psilocybin induces schizophrenia-like psychosis in humans via a serotonin-2 agonist action. Neuroreport. 1998;9:3897 – 3902. |
| 39 | Ray TS. Psychedelics and the human receptorome. PLoS One. 2010;5:e9019. |
| 40 | González-Maeso J, Weisstaub NV, Zhou M, Chan P, Ivic L, Ang R, et al. Hallucinogens Recruit Specific Cortical 5-HT2A Receptor-Mediated Signaling Pathways to Affect Behavior. Neuron. 2007;53:439 – 452. |
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There are currently 16 registered studies in Clinical Trials.Gov in the investigating the efficacy of PAP to treat depression, anxiety and demoralization in patients with incurable illnesses:
| NCT Number | Study Title | Study Status | Conditions | Sponsor | ||||
| NCT06001749 | Psilocybin in Cancer Pain Study | RECRUITING | Opioid-Related Disorders|Pain Management|Pain Management and Care|Advanced Cancer|Advanced Cancers | Yvan Beaussant, MD, MSci | ||||
| NCT06430541 | Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence | RECRUITING | Breast Cancer|Ovarian Cancer | University of Colorado, Denver | ||||
| NCT04522804 | Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer | COMPLETED | Cancer | University of Utah | ||||
| NCT05220046 | Palliadelic Treatment to Reduce Psychological Distress in Persons With Advanced Gastrointestinal Cancers | RECRUITING | Pancreas Cancer|Biliary Tract Cancer|Psychological Distress|Gastrointestinal Cancer | University of Nebraska | ||||
| NCT05847686 | Psilocybin-Assisted Therapy for the Treatment of Cancer-Related Anxiety in Patients With Metastatic Cancer | COMPLETED | Hematopoietic and Lymphatic System Neoplasm|Metastatic Malignant Solid Neoplasm | University of Washington | ||||
| NCT06416085 | Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Patients With Advanced Cancer | RECRUITING | Advanced Cancer|Stage IV Solid Tumor Cancer|Stage IV Sarcoma of Bone|Stage IV Lymphoma|Stage IV Melanoma|Endocrine Cancer | University Health Network, Toronto | ||||
| NCT04593563 | The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder | UNKNOWN | Major Depressive Disorder | Maryland Oncology Hematology, PA | ||||
| NCT00465595 | Psychopharmacology of Psilocybin in Cancer Patients | COMPLETED | Depressive Symptoms|Anxiety|Cancer | Johns Hopkins University | ||||
| NCT00957359 | Psilocybin Cancer Anxiety Study | COMPLETED | Cancer | NYU Langone Health | ||||
| NCT06319378 | Cancer Related Major Depression Treated With a Single Dose of Psilocybin | RECRUITING | MDD | Section for Affective Disorders; Northern Stockholm Psychiatry | ||||
| NCT05947383 | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of up to Two Doses of Psilocybin for the Treatment of Major Depressive Disorder in Adults With Cancer | RECRUITING | Cancer|Major Depressive Disorder | Sunstone Medical | ||||
| NCT04950608 | Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care | ACTIVE_NOT_RECRUITING | Hospice|Psilocybin|Demoralization|Terminal Illness|Cancer-related Problem/Condition|Psychotherapy|Terminal Cancer|Cancer Terminal | Yvan Beaussant, MD, MSci | ||||
| NCT06200155 | Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy | RECRUITING | Depression, Anxiety|Psilocybin-Assisted Psychotherapy|Advanced Cancer | M.D. Anderson Cancer Center | ||||
| NCT06644170 | A Second Psilocybin Group Therapy for the Treatment of Cancer-Related Anxiety in Partial Responders With Metastatic Cancer | RECRUITING | Hematopoietic and Lymphatic System Neoplasm|Metastatic Malignant Solid Neoplasm | University of Washington | ||||
| NCT05506982 | Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain | ACTIVE_NOT_RECRUITING | Hematopoietic and Lymphoid Cell Neoplasm|Malignant Solid Neoplasm | Emory University | ||||
| NCT05398484 | Psilocybin Therapy in Advanced Cancer | RECRUITING | Advanced Cancer | NYU Langone Health |
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Known and Potential Risks of Psilocybin
Abuse Potential
To date, there have been no confirmed reports of an overdose of pharmaceutical psilocybin. Currently, psilocybin is placed in Schedule 1 in the UK Misuse of Drugs Regulations 2001, defined as having no medical use, possessing high abuse liability, and lack of accepted safety when used under medical supervision. However, in preclinical studies using non-human primates, psilocybin, mescaline and N,N-Dimethyltryptamine did not serve as positive reinforcers in 3,4-Methylenedioxy methamphetamine (MDMA) experienced rhesus monkeys. This suggests that non-human primates do not find the psychoactive effects of the 5-HT2A receptor agonists addictive.
Analysis of long-term follow-up data from eight pooled experimental trials with healthy volunteers indicated no subsequent drug abuse, no changes to overall drug consumption habits (including alcohol, nicotine, cannabis and MDMA) or functional impairment following exposure to psilocybin in the laboratory. Where changes in drug consumption habits were noted, most respondents described decreased consumption, particularly with reference to psilocybin use. Large-scale survey research indicates that hallucinogens are selected as a primary substance of abuse in only a fraction of responders.
In clinical studies with psilocybin, exposing individuals with either no history of hallucinogen use, or a history of minimal use (less than ten times in total and not within the previous five years) have not resulted in reported instances of subsequent illicit hallucinogen abuse. Additionally, studies have shown side effects that are potentially predictive of low abuse potential, such as elevations in fear and anxiety. Based on available literature, it is not expected that either psilocybin-naïve or experienced individuals will develop dependence after exposure.
Safety
Psilocybin has been found to be of very low toxicity in humans and research animals.
In recent palliative care clinical trials conducted at New York School of Medicine and Johns Hopkins University School of Medicine, in which participants received PAP at a dose of 22 mg/70 kg, 30 mg/70 kg, and 0.3 mg/kg, no serious adverse events (“SAEs”) were reported. Adverse effects of PAP amongst participants had all been previously described for psilocybin and were mild and transient, and included physical discomfort, psychological discomfort, increased systolic and diastolic blood pressure without criteria for medical intervention, increased heart rate with a mild sympathomimetic effect, nausea and vomiting, transient anxiety and headaches or migraines. None of the participants experienced prolonged psychosis or hallucinogen persisting perception disorder (“HPPD”).
The clinical safety of psilocybin has been extensively studied in open-label and double-blind, controlled trials, both as a single agent and as adjunctive treatment in a number of clinical and non-clinical adult populations. Dosing regimens used in previous clinical trials with psilocybin have ranged from 0.014 mg/kg to 0.6 mg/kg, administered orally as either a single dose, or multiple doses weeks apart. Thousands of participants have received psilocybin under controlled conditions in a clinical setting for various indications, with results published in peer-reviewed journals. Knowledge gained from previous clinical trials with psilocybin and discussions with researchers leading other randomized control trials in this area has directed the design of Psyence’s planned Phase IIb Study.
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Psilocybin (also known as ‘magic mushrooms’) is rated as one of the least harmful recreational drugs. Commonly cited risks include prolonged psychotic reactions, flashback phenomena/HPPD, and bad trips. Prolonged psychotic responses are extremely rare in clinical studies with psilocybin (<1%), even at very high doses, and none have been reported in modern studies or studies with patients. The risk of flashback phenomena is minimal (or even negligible), and no cases have been observed in other studies with psilocybin. Periods of psychological challenge (for example, increased anxiety) are more commonly reported, but may be predictive of positive clinical outcomes.
Psilocybin Related Adverse Events by Incidence (at 25 mg)
| Common > 20% |
Less common < 15% |
Rare < 2% | ||
| 1) | 1) | 1) | ||
| Increased anxiety, particularly at the onset of the drug effects | Paranoia or suspiciousness. | HPPD/flashbacks | ||
| 2) | 2) | 2) | ||
| Mild-moderate increase in heart rate | Nausea | Worsening of mental state after the drug experience | ||
| 3) | 3) | |||
| Visual hallucinations | Dizziness | |||
| 4) | 4) | |||
| Transient headaches, lasting for one to two days (maximum) post-dosing | A ‘bad trip’ i.e. negative thoughts and mood during the acute drug effects |
It is not uncommon for people to experience some negative psychological content during a psilocybin ‘trip’, particularly if they suffer from ongoing psychological distress, as is characteristic of depression. Typically, this is managed by ensuring good preparation before, support during, and integration after the experience. While challenging episodes have been relatively commonly reported in previous trials, some of these have contributed to a psychological ‘breakthrough’ on the part of the participant. Recent evidence indicates that challenging psychological experiences can produce therapeutic benefits, improving psychological well-being in the long-term.
Negative aftereffects of challenging psychological experiences under psychedelics are thought to be a consequence of inadequate ‘set and setting’ and post-session integration work — and they may also relate to the duration of the challenging period. In the Phase IIb Study and further studies, such risks will be reduced via thorough psychological preparation and integration, good patient-staff rapport and a positive, supportive environment. Challenging experiences/periods will be managed principally through psychological support, but oral and injectable lorazepam and olanzapine, as rescue medications, will be available. These would only be used in cases of severe panic that were unresponsive to psychological intervention, and where the patient’s behavior was putting themselves and/or staff in danger. Consent for such medication will be sought from the patient ahead of study participation.
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Before, during and after the dosing session, patients will receive psychological support from therapists who have been specifically trained to deliver PAP in the context of research studies, including clinical trials. An onsite psychiatrist will also be available to support where needed. Monitoring of participants’ vital signs, behavior and mood will be conducted prior to the psilocybin being administered, and prior to the participant being discharged. On the dosing day, patients will only be allowed to return home only once the study psychiatrist is confident they are fit to do so, and authorizes the patient’s release. 24-hour emergency contact numbers will be provided for a member of the study team, and localized support and crisis services will also be provided.
Due to the psychoactive nature of psilocybin, the safety of participants in clinical trials can be enhanced by testing psilocybin within a “set and setting” protocol. By addressing the set (the emotional, cognitive, behavioral states, mindset and expectations of study participants just prior to psilocybin exposure) and setting (the physical environment in which the exposure occurs) of the experience, the risk of the subject reporting an event which is distressing or injuring themselves can be reduced. This approach generally incorporates three components: (1) preparation, (2) drug session and (3) post -session meetings to integrate the classic psychedelic experience.
During the preparation phase, participants undergo pre-exposure sessions designed to build rapport with the therapist who will be present during the drug dosing session and to identify personal themes and struggles that might be especially likely to impact the session experience. The drug session itself is conducted by a trained therapist (the gender of which is selected by the participant) and an appropriately trained member of the study team, who are present throughout the session. Sessions are typically conducted in a room designed to be quiet, comfortable, and aesthetically pleasing, and participants are encouraged to wear eyeshades and listen to a program of music through headphones during the drug exposure to aid them in focusing their attention inwards. In the third phase, participants are engaged in a series of drug-free therapy sessions to discuss their dosing session experience thoroughly, with the goal of maximizing its therapeutic benefit.
Suicide
While most trials with psilocybin have demonstrated reduced suicidality following dosing, one recent large-scale study conducted by Compass Pathways with 233 participants on the efficacy of psilocybin in a treatment-resistant depression (TRD) population reported that suicidal ideation and intentional self-injury were seen in all treatment groups, as is common in TRD studies. Most cases occurred more than a week after the COMP360 psilocybin session. There was no mean worsening of suicidal ideation scores on the MADRS scale in any treatment group. Suicidal behaviors were reported at least one month after COMP360 administration for three non-responders in the 25mg arm.
It is important to note that subjects with AjD and patients with a cancer diagnosis are also at increased risk of suicide. As such, in the Psyence Phase IIb Study, the risk of suicide and other AE’s will be assessed by thorough and regular screening using the Sheehan-Suicide Tracking Scale (S-STS) at every study visit. Participants with suicidal tendencies and histories of suicide attempts will be excluded from the study. The study psychiatrist and psychotherapist contact details will be provided to patients in case of emergency, in addition to providing localized information for support services and crisis management. A standard operating procedure for dealing with both AEs and any unexpected suicide attempt has been prepared. As such, we believe that the risk of suicide and other AEs will be reduced by thoroughly screening participants for any suicidal tendencies, by excluding patients with histories of suicide attempts and by regular monitoring of suicidal ideation and behavior.
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Target Population and Market — Palliative Care Patients
Previous trials have demonstrated that PAP is well tolerated in samples of palliative care patients, with no SAEs. Recruitment of palliative care participants may require screening of large samples in order to achieve the intended sample size. In previous PAP trials with palliative care participants, 10%-27% of screened individuals were enrolled in the study. Recruitment for trials of psychiatric disorders is complex, as such conditions may affect motivation and adherence, relating to both the physical and mental health of participants with a cancer diagnosis. Moreover, there is an exogenous risk of participant death during the trial for clinical trials in the palliative care setting. Similarly, as cancer may metastasize further, diligence must be paid to exclude participants with metastatic cancer to the brain, considering the potential impact on cognitive function. Together, this indicates that the success of recruitment and screening relies on the selection of participants with appropriate life expectancy, extent of cancer, and post-diagnosis time for the inclusion/exclusion criteria in PAP trials with palliative care patients.
Business Model
Psilocybin-assisted psychotherapy, once approved, will have to be delivered to patients in a guided manner over a period of 6 – 8 weeks, including the intention setting meetings, the psychedelic event (dosing session) and the subsequent integration meetings. This implies having trained guides who will spend a long time with patients over the course of the PAP, suitable clinic settings and psychologists’ oversight.
The final business model for the provision of NPX-5 will depend on a number of aspects, including the final outcomes of the studies, the indication(s) that will be allowed by the regulatory agencies and the state of the environment and market to provide psychedelic therapy at the time of approval. It is expected that the number of clinics available to be able to provide PAP will increase dramatically once the first psychedelic is approved for any indication.
Our possible business models will take into consideration of whether to merely supply NPX-5 for clinics to administer, through including a premium price for the intellectual property of a proprietary PAP, to enter into partnerships with clinics to administer PAP, or even to own dedicated clinics for administration of PAP.
The target audience for the initial indication will be oncology sites, including their oncologists and other health care professionals to create awareness of the effectiveness of PAP for cancer patients who have AjD. The principal marketing message will be to offer patients a better quality of life for their remaining years with a single administration of NPX-5 within a PAP. It has been shown that patients in palliative care who are less anxious or depressed utilize fewer healthcare resources, which is an aspect that will help justify the costs of the PAP.
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Alcohol Use Disorder (AUD)
Psyence Biomed have intentions to study the use of psilocybin in the treatment of AUD and possibly Substance Use Disorder (SUD). There are a number of academic studies showing the efficacy of PAP in the treatment of both disorders although they have tended to be smaller studies. In the current planning phase, the creation of a steering committee for the AUD study has been initiated and preliminary market research is being conducted to identify the best patient to target in the study, to help identify the appropriate design, as well as to choose which endpoints should be used.
There is a big unmet medical need for an effective therapy to treat AUD despite the fact that there are a few products authorized regulatorily. However, those treatments have low long-term efficacy, and their indications are not particularly broad.
The deleterious societal and economic impact of AUD is enormous and to develop an effective, sustainable treatment for the disorder would be a great advance for patients, their families as well as the general public.
Legal and Regulatory Framework
Current Regulatory Landscape of Target Markets
Psyence will focus on the initial countries and regions to perform their clinical development and to commercialize the final product, being North America (US & Canada), EU, UK and Australia. Introductions into other regions will be contemplated at a later phase.
In the United States, foods, drugs and dietary supplements are subject to extensive regulation. The U.S. Food, Drug, and Cosmetic Act (the “FDCA”) and other federal and state statutes and regulations govern, among other things, the research, development, testing, manufacturing, storage, recordkeeping, approval, labelling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products. We must ensure that all promotion and marketing, distribution, and labeling of any pharmaceutical products comply with the U.S. regulations, including the FDCA and the U.S. Food and Drug Administration (the “FDA”).
Psilocybin and psilocin are strictly controlled under the U.S. Controlled Substances Act (“CSA”) as Schedule I substances. By definition, Schedule I substances have no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse. Schedule I and II drugs are subject to the strictest controls under the CSA, including manufacturing and procurement quotas, security requirements and criteria for importation. Anyone wishing to conduct research on substances listed in Schedule I under the CSA must register with the DEA and obtain DEA approval of the research proposal. A majority of state laws in the United States also classify psilocybin and psilocin as Schedule I controlled substances. For any product containing psilocybin or any Schedule I substance to be available for commercial marketing in the United States, such substance must be rescheduled, or the product itself must be scheduled, by the DEA to Schedule II, III, IV or V. Scheduling determinations by the DEA are dependent on FDA approval of a substance or a specific formulation of a substance.
Prescription drugs are classified and regulated under the federal Food and Drugs Act (Canada). Labeling, marketing and selling of any prescription drug must comply with Health Canada. The regulations in the European Union are similar to those in the U.S. and Canada.
Psyence will focus the phase IIb portion of its clinical development program in Australia. The TGA is Australia’s government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods, and the use of therapeutic goods supplied in clinical trials in Australia under the therapeutic goods legislation. Such legislation includes The Therapeutic Goods Act 1989 (“TG Act”), Regulations and Orders which set out the requirements for inclusion of therapeutic goods in the Australian Register of Therapeutic Goods (ARTG).
For a prescription medicine to be registered in the ARTG, a sponsor of the product (usually a pharmaceutical company such as Psyence) is required to submit a dossier of evidence on the clinical efficacy, safety and manufacturing quality for evaluation by the TGA. Clinical trials of medicines and biologicals regulated under the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) schemes are subject to the TGA’s Good Clinical Practice (GCP) Inspection Program. The TGA has issued a handbook which provides guidance on the legislative, regulatory and good clinical practice (GCP) requirements when conducting clinical trials in Australia using ‘unapproved’ therapeutic goods in order to assist trial sponsors, Human Research Ethics Committees (HRECs), investigators and approving authorities (institutions) in understanding their roles and responsibilities under the therapeutic goods legislation.
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Until recently, psilocybin was included in Schedule 9 (Prohibited Substances) of the Poisons Standard which, because of interaction with state and territory regulation, largely restricted the lawful supply of goods containing psilocybin to clinical trial settings only. However, effective as of July 1, 2023, the TGA made the decision to down schedule psilocybin to Schedule 8 in the Poisons Standard when used in respect of certain conditions, namely for the treatment of treatment-resistant depression.
To import products that contain a controlled substance (such as psilocybin), the importer requires both an exemption, approval or authority under the TG Act and a license and/or permit to import from the Office of Drug Control under the Customs (Prohibited Imports) Regulations 1956. Licenses and permits to import psilocybin are only granted by the Office of Drug Control where the use of the substance is permitted by the relevant state or territory under their respective medicines and poisons legislation and the use of the of psilocybin is to be prescribed by an Authorized Prescriber or for an authorized clinical trial.
Psyence will monitor the evolution of Australia’s regulations as they pertain to psilocybin and the conduct of clinical trials in Australia.
Regulatory Changes on the Horizon for Therapeutic Psychedelics
With the reintroduction of the Breakthrough Therapies Act in March 2023, there appears to be momentum to develop a legal-regulatory framework for therapeutic psychedelics. Congress also announced on November 17, 2022, the bipartisan Congressional Psychedelics Advancing Clinical Treatments Caucus (the PACT Caucus). The PACT Caucus will focus on exploring psychedelic research to alleviate the U.S. mental health crisis.
In April 2026, US President Donald Trump signed an executive order easing restrictions on mental health treatments, including ibogaine, to accelerate research and approval of psychedelic-based therapies for conditions such as PTSD, depression, and addiction. Signed on April 18, 2026, the order directs the FDA to issue Commissioner's National Priority Vouchers to psychedelic drugs that have received Breakthrough Therapy designation, aiming to expedite the FDA's review process for qualifying treatments. It also directs the FDA and DEA to establish a Right to Try pathway allowing eligible patients to access investigational psychedelic drugs, including ibogaine, that are under FDA review. Separately, the order allocates US$50 million in US Department of Health and Human Services funding to match state-level investments in psychedelic research, a provision widely seen as responding to Texas's state-funded ibogaine research program. Psychedelics such as ibogaine and psilocybin remain federally classified as Schedule I substances, and the order does not itself reschedule them or lower the evidentiary bar the FDA requires for approval.
C. Organizational Structure
The information set forth above in Item 4. A. is incorporated herein by reference.
D. Property, Plants and Equipment
Headquarters and Operational Office
Psyence’s headquarters address is 121 Richmond Street West, Penthouse Suite 1300, Toronto, Ontario, M5H 2K1, Canada. The Company has an operational office in South Africa at Building #4, Riverlands Mall, Podium Level, 51 Gogosoa St, Observatory, Cape Town, 7935.
ITEM 4A. UNRESOLVED STAFF COMMENTS
None.
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Unless the context otherwise requires, all references in this section to the “Company,” “we,” “us” or “our” refer to the business of Psyence Biomedical and its subsidiaries.
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our historical condensed consolidated audited financial statements for the years ended March 31, 2026, March 31, 2025 and March 31, 2024 and the related notes included elsewhere in this Report. This discussion contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under “Risk Factors” and elsewhere in this Report.
The numbers presented here are presented in USD.
Overview
Psyence Biomedical Ltd. (the “Company” or “PBM”) is a multi-asset, vertically integrated biopharmaceutical company focused on psychedelic-based therapeutics, with pharmaceutical-grade drug candidates manufactured through its investment in PsyLabs. It is the first life sciences biotechnology company focused on developing nature-derived (non-synthetic) psilocybin and ibogaine-based psychedelic medicine to be listed on Nasdaq. We are dedicated to addressing unmet mental health needs and are committed to an evidence-based approach in developing safe, effective, and FDA-approved nature-derived psychedelic treatments for a broad range of mental health disorders. The Company is currently conducting research through clinical trials to evaluate the safety and effectiveness of natural psilocybin in treating adjustment disorder in patients with a cancer diagnosis in a palliative care context.
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Operating Results
Sales and marketing costs
For the year ended March 31, 2026, the Company incurred sales and marketing expenses of $218,485 (2025 - $483,530; 2024 – $80,603). The decrease in the current year reflects a reduction in investor relations spend and marketing activities compared to the levels incurred during the year following the Company’s listing on the NASDAQ in January 2024.
Research and development expenses and cash rebate
For the year ended March 31, 2026, the Company incurred research and development expenses of $1,466,653, compared to $342,168 for the year ended March 31, 2025 and $954,593 for the year ended March 31, 2024. These costs consisted of $1,384,557 in the current year (March 31, 2025 - $237,168, March 31, 2024 - $954,593) incurred in relation to the clinical trial, $75,000 (March 31, 2025 - $105,000, March 31, 2024 - $167,306) in licensing fees, and $7,096 for general research (March 31, 2025 - $nil, March 31, 2024 - $1,567).
The significant year-over-year increase reflects accelerated activity in the Company’s clinical trial program for the treatment of adjustment disorder in palliative care patients, including expanded site costs, patient enrollment costs, and study management expenses under the new contract research organization (CRO).
For the year ended March 31, 2026, the Company received $292,247 as a R&D rebate, March 31, 2024, the Company received its first R&D rebate from the Australian Tax Office (ATO), amounting to $879,344, recognized as other income. This rebate represented 43.5% of the qualifying R&D expenditure incurred in Australia during the period. No R&D rebate was received for the year ended March 31, 2025, as clinical trial expenditure in Australia was lower compared to the prior year, resulting in reduced qualifying costs for the rebate. The Company anticipates R&D expenditure will continue to increase in future periods as the clinical trial advances toward its primary endpoints and additional trial sites are activated.
General and administration costs
For the year ended March 31, 2026, the Company incurred general and administrative expenses of $892,264, compared to $1,209,847 for the year ended March 31, 2025 and $557,904 for the year ended March 31, 2024.
The decrease in general and administrative expenses in the current year compared to the year ended March 31, 2025 is predominantly due to significant one-time costs in the prior year associated with establishing the infrastructure and compliance requirements of a newly U.S.-listed public company. Key drivers of the reduction include lower payroll and related costs, reduced regulatory and compliance fees, and the implementation of cost reduction measures across operational support functions. The Company expects general and administrative costs to stabilise at current levels as the corporate infrastructure established following the NASDAQ listing matures, though costs may increase in line with the growth of the Company’s operations.
Professional and consulting fees
For the year ended March 31, 2026, the Company incurred professional and consulting fees of $3,654,843, compared to $1,623,209 for the year ended March 31, 2025 and $1,158,484 for the year ended March 31, 2024.
The increase in professional and consulting fees during the current year was primarily driven by higher legal costs and consultant costs. Consulting fees amounted to $2,212,320 (2025 – $928,055; 2024 – $848,955), with the increase in the current year due to a one-off no-fault termination payment, share-based compensation, bonuses paid to key consultants and an employee moving to a consultancy contract. Legal fees increased significantly to $1,279,204 (2025 – $507,692; 2024 – $105,962), driven by the external legal work involved with the KAOS Group shareholder dispute, ongoing securities-related legal work, corporate governance matters, and transactional support. Accounting and audit fees totaled $163,319 (2025 – $187,462; 2024 – $203,567), a decrease reflecting reduced regulatory filings and efficiency in the audit process. The Company expects professional and consulting fees to normalize in future periods as one-off legal shareholder dispute and no-fault termination payment costs from the current year are not expected to recur.
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Other Gains and Losses
For the year ended March 31, 2026, the Company earned interest income of $263,370, compared to $95,787 and $2,134 for the years ended March 31, 2025 and 2024, respectively. The increase in interest income during the current year was driven by higher cash balances resulting from equity financings completed during the period.
The Company recorded a foreign exchange loss of $1,144 in 2026, compared to a loss of $7,317 in 2025 and a loss of $2,696 in 2024. Fluctuations in foreign exchange rates during the year impacted the translation of foreign currency denominated cash and liabilities.
During the year the Company entered into a settlement agreement with KAOS Capital Ltd. and Adam Arviv (the “KAOS Group”) to resolve a shareholder dispute arising from allegations made in January 2026. The Company, its Board of Directors, and officers denied all allegations and any associated liability. Under the terms of the settlement, the Company paid US$1,500,000 to the KAOS Group and facilitated the purchase of all 50,220 common shares held by the KAOS Group at US$5.00 per share (US$251,110) by a third party through a loan advanced to a third party. In exchange, the KAOS Group withdrew its allegations and provided a full mutual release of all claims, together with customary standstill and non-disparagement undertakings for a three-year period ending February 9, 2029. The total net settlement expense of $1,500,000 was recognized in the year ended March 31, 2026 and is presented as Other Expense in the consolidated statements of net income/(loss).
Investment in Psyence Labs
During the year ended March 31, 2026, the Company significantly expanded its investment in PsyLabs, a British Virgin Islands-based company focused on the production of psychedelic active pharmaceutical ingredients. The Company acquired additional shares for total cash consideration of $4,000,000 (250 shares in April 2025 for $500,000 and a further 1,750 shares in August 2025 for $3,500,000), bringing its total holding to 3,000 shares (16.46%). In February 2026, the Company exercised a put option and issued 1,146,159 common shares at a fair value of $2,934,167 to acquire a further 2,900 PsyLabs shares, increasing its ownership to 27.93%. This level of ownership conferred significant influence, and from February 25, 2026 the investment has been accounted for under the equity method as an investment in associate in accordance with IAS 28.
The carrying amount of the investment at March 31, 2026 was $8,060,928, reflecting the initial carrying amount of $8,106,167 less the Company’s share of PsyLabs’ net loss of $45,239 from the date of acquisition of significant influence. During the prior year the Company’s investment of 1,000 shares in PsyLabs was valued at $745,000 based on independent third-party transactions.
Fair value movements
Convertible note
During the prior year ended March 31, 2025, the Company recognized a total fair value gain of $5,052,708 related to its convertible note liability, compared to a fair value loss of $5,157,397 in the March 31, 2024 year ended. The gain reflects changes in the fair value of the liability as a result of market conditions, extinguishment terms, and conversion into common shares.
As part of the extinguishment of the convertible notes in the prior year, the Company entered into amendments and a termination agreement with the investor, resulting in the issuance of additional shares and warrants. The fair value of these instruments, totaling $1,695,080, was recorded as an expense in profit or loss. After accounting for this expense, the net fair value gain recognized in profit or loss was $3,357,628 for the prior year.
The full conversion and termination of the Company’s convertible note obligations occurred during the prior financial year.
Promissory Notes
During the prior year ended March 31, 2025, the Company fully extinguished its convertible promissory notes issued to Psyence Group Inc. and the NCAC Sponsor. These notes were originally issued in January 2024 for a combined principal of $3.2 million and classified as financial liabilities at fair value through profit or loss (FVTPL) due to variable conversion features. Both notes were converted into common shares during the prior year under debt-for-equity agreements, including additional shares issued under make-whole provisions.
As a result of these conversions in the prior year, the Company recognized a total fair value gain of $705,565 in profit or loss—$327,668 on the PGI note and $377,897 on the NCAC note. The fair value of the notes was reduced to nil at March 31, 2025 (2024 – $2,790,492), reflecting the full settlement of these liabilities.
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Liquidity and Capital Resources
Since incorporation, the Company has financed its operations through shareholder investments, a loan facility secured against its expected Australian Tax Office (ATO) R&D rebate, and the rebate itself. The Company’s primary uses of liquidity include funding scientific research, clinical studies, general and administrative costs including salaries and professional and consulting fees.
As of March 31, 2026, the Company had a cash balance of $7,491,954 and a positive working capital position of $8,487,385 compared to a cash balance of $6,171,130 and working capital of $5,965,908 as of March 31, 2025. In the Company’s opinion, the working capital is sufficient for the Company’s present requirements.
The Company’s ability to continue funding its operations and meet planned expenditures depends on various factors, including economic conditions, access to capital markets, regulatory developments, and other factors beyond its control.
The Company’s current obligations include funding commitments for its Phase IIb Study. These are expected to be met using existing cash and cash equivalents; however, the Company remains subject to risks, including the potential inability to raise additional funds through equity, debt, or other financing to meet its development plans, operating requirements, and liabilities as they become due.
The Company has incurred operating losses and cash outflows since inception and, given the nature of its business, will require ongoing financing to support its research and development activities. Its ability to access capital depends on factors such as market conditions, investor sentiment, and the trading price of its securities. There can be no assurance that additional financing will be available on acceptable terms, or at all.
The Company’s primary capital needs include funding research and development, clinical trials, staffing, professional and consulting fees, and general working capital. Access to future financing remains uncertain and may not be available on terms as favorable as those previously secured.
Research and Development
Expenditures on research activities, undertaken with the prospect of gaining new scientific or technical knowledge and understanding, are recognized in the statements of net loss and comprehensive loss as incurred.
Development expenditures are capitalized only if development costs can be measured reliably, the product or process is technically and commercially feasible, future economic benefits are probable, and the Company intends to complete development and has sufficient resources to complete development and to use or sell the asset. Other development expenditures are expensed as incurred. Research and development expenses include all direct and indirect operating expenses supporting the products in development. The costs incurred in establishing and maintaining patents are expensed as incurred.
D. Trend Information
The Company is a clinical-stage biopharmaceutical company. It has no approved products, has not generated any revenue from product sales, and does not maintain production, inventory or an order book. Accordingly, the requirement to describe material recent trends in production, sales, inventory, the state of the order book, and costs and selling prices is not applicable to the Company in the manner contemplated for a commercial-stage company. The following is a discussion of the known trends, uncertainties, demands, commitments and events that the Company’s management believes are reasonably likely to have a material effect on the Company’s results of operations, liquidity or capital resources, or that may cause the financial information reported in this Report not to be necessarily indicative of the Company’s future operating results or financial condition. This discussion should be read together with “—Operating Results,” “—Liquidity and Capital Resources” and “Item 3.D — Risk Factors.”
Continuing operating losses and dependence on external financing.
The Company has incurred operating losses and net cash outflows from operations since inception and expects to continue to do so for the foreseeable future as it advances its clinical-development program. The Company’s net loss for the year ended March 31, 2026 was approximately $6.89 million. Because the Company is pre-revenue, its ability to continue as a going concern and to fund its operations depends on its ability to raise additional capital, and there can be no assurance that financing will be available on acceptable terms, or at all. The Company expects this trend of operating losses and reliance on external financing to continue until such time, if ever, as one or more product candidates receive regulatory approval and are successfully commercialized.
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Increasing research and development expenditure.
Research and development expenses increased to approximately $1,466,653 for the year ended March 31, 2026 from approximately $342,168 for the year ended March 31, 2025, reflecting accelerated activity in the Company’s Phase IIb clinical trial, including expanded site costs, patient-enrollment costs and study-management expenses. The Company anticipates that research and development expenditure will continue to increase in future periods as the Phase IIb Study advances toward its primary endpoints, additional trial sites are activated, and the Company prepares for a potential Phase III program. As a result, the Company’s research and development expense for the year ended March 31, 2026 is not necessarily indicative of expected future research and development expense.
Non-recurring expenses in the current year.
The Company’s results for the year ended March 31, 2026 include certain expenses that management does not expect to recur at comparable levels, including a net settlement expense of $1,500,000 in connection with the settlement of the KAOS Group shareholder dispute, and elevated professional and consulting fees attributable to that dispute and to a one-off no-fault termination payment. The Company expects professional and consulting fees to normalize in future periods as these non-recurring items do not recur. Conversely, general and administrative expenses, which decreased in the current year following the maturation of the corporate infrastructure established after the Company’s NASDAQ listing, are expected to stabilize at approximately current levels, though they may increase in line with the growth of the Company’s operations. For these reasons, the Company’s reported expenses for the year ended March 31, 2026 may not be indicative of future results.
Variability of the Australian research and development rebate.
The Company received a research and development cash rebate of approximately $292,247 for the year ended March 31, 2026 under the Australian Government’s Research and Development Tax Incentive program, compared with no rebate for the year ended March 31, 2025 and approximately $879,344 for the year ended March 31, 2024. Because the rebate is a function of qualifying Australian research and development expenditure and is subject to an annual application and continued eligibility, the amount and timing of any future rebate is expected to vary from period to period and is not necessarily indicative of amounts that may be received in future periods.
Liquidity, the White Lion equity line of credit and dilution.
As of March 31, 2026, the Company had cash of approximately $7,491,954 and positive working capital of approximately $8,487,385. The Company’s principal near-term source of external liquidity is its equity line of credit with White Lion Capital, LLC, the aggregate commitment under which was increased to up to $100,000,000 by Amendment No. 2 in November 2025, and to which an intraday purchase mechanic was added by Amendment No. 3 in April 2026. The Company’s ability to draw on the equity line is subject to the conditions and limitations of the purchase agreement, including conditions tied to the trading price and trading volume of the Common Shares, and the Company’s use of the facility, together with sales under any at-the-market or other equity program, is expected to result in dilution to existing shareholders and may place downward pressure on the trading price of the Common Shares. The extent to which the Company relies on these equity financing sources, and the dilutive effect thereof, is expected to be a continuing trend for so long as the Company remains pre-revenue.
Equity-method investment in PsyLabs.
From February 25, 2026, the Company has accounted for its investment in PsyLabs under the equity method as an investment in an associate, and recognizes its proportionate share of PsyLabs’ net income or loss in the Company’s results of operations. Because PsyLabs is a development-stage enterprise, the Company expects to record its share of PsyLabs’ losses for the foreseeable future, and the carrying amount of the investment and the amounts recognized in the Company’s results of operations may fluctuate materially from period to period. The recognition of equity-method results commenced part-way through the year ended March 31, 2026 and is therefore not reflected for a full period in the current year’s results.
Evolving regulatory and policy environment for psychedelic therapies.
The regulatory and policy environment for psychedelic therapies in the United States has been evolving rapidly, including as a result of the April 2026 federal executive order and related actions by the U.S. Food and Drug Administration to accelerate the development of, and access to, psychedelic therapies. While these developments may, over time, affect the competitive landscape, the timing of regulatory pathways and investor sentiment toward the sector, they do not change the statutory standards for approval of the Company’s product candidates, and their ultimate effect on the Company is uncertain. See “Item 3.D — Risk Factors.”
Other than as described above and elsewhere in this Item 5 and in “Item 3.D — Risk Factors,” the Company is not aware of any trends, uncertainties, demands, commitments or events that are reasonably likely to have a material effect on the Company’s net sales or revenues, income from continuing operations, profitability, liquidity or capital resources, or that would cause the financial information reported in this Report not to be necessarily indicative of future operating results or financial condition.
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Critical Accounting Estimates
The preparation of financial statements in conformity with IFRS requires management to make certain estimates, judgments and assumptions concerning the future. Actual results may differ from these estimates. The Company’s management reviews these estimates, judgments, and assumptions on an ongoing basis, based on experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances. Revisions to estimates are adjusted prospectively in the period in which the estimates are revised. The following are deemed to be critical accounting policies as these require a high level of subjectivity and judgement and could have a material impact on the Company’s financial statements.
Fair value of Convertible Debt
Management exercised significant judgment in determining the fair value of the convertible promissory notes classified as financial liabilities measured at fair value through profit or loss (FVTPL) due to their conversion features. Fair value was assessed using valuation techniques incorporating observable and unobservable inputs, including share price volatility, risk-free interest rates, and conversion terms. Changes in these assumptions had a material impact on the profit or loss recognized during the year.
Quantitative and Qualitative Disclosures About Financial Instruments and Financial Risk Management
In the normal course of business, the Company is exposed to a variety of financial risks: credit risk, liquidity risk, foreign exchange risk and interest rate risk. These financial risks are subject to normal credit standards, financial controls, risk management, as well as monitoring. Our Board has overall responsibility for the establishment and oversight of the Company’s risk management framework.
Credit risk
Credit risk arises from cash and cash equivalents held with banks. The maximum exposure to credit risk is equal to the carrying value of the financial assets. The objective of managing counterparty credit risk is to prevent losses on financial assets. The Company minimizes the credit risk of cash and cash equivalents by depositing with only reputable financial institutions. The Company also assesses the credit quality of counterparties, taking into account their financial position, past experience and other factors.
Liquidity risk
Liquidity risk is the risk that the Company will not be able to meet its financial obligations as they fall due.
The Company manages liquidity risk through an ongoing review of future commitments and cash balances available. Historically, the Company’s main source of funding has been through investments from its parent. The Company’s access to financing is always uncertain and there can be no assurance of continued access to significant equity or debt funding on terms satisfactory to the Company, or at all.
Foreign exchange risk
Foreign currency risk is the risk that the fair values of future cash flows of a financial instrument will fluctuate because they are denominated in currencies that differ from the respective functional currency.
The Company operates internationally and is exposed to foreign exchange risk from the South African Rand, Great British Pound, Australian Dollar and United States Dollar. Foreign exchange risk arises from transactions as well as recognized financial assets and liabilities denominated in foreign currencies.
A 10% adverse change in exchange rate would have resulted in a loss of $86,443 as of March 31, 2026.
Management mitigates the risk of adverse exchange rate movements by holding funds in US dollars.
Interest rate risk
Interest rate risk is the risk that the fair value of future cash flows of a financial instrument will fluctuate because of changes in market interest rates. The Company has no significant interest-bearing assets or liabilities and therefore its income and operating cash flows are substantially independent of changes in market interest rates.
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Capital Management
The Company’s objectives when managing its capital are to safeguard its ability to continue as a going concern, to meet its capital expenditures for its continued operations, and to maintain a flexible capital structure which optimizes the cost of capital within a framework of acceptable risk. The Company manages its capital structure and adjusts it in light of changes in economic conditions and the risk characteristics of the underlying assets. To maintain or adjust its capital structure, the Company may issue new shares, issue debt, or acquire or dispose of assets. The Company is not subject to externally imposed capital requirements.
Management reviews its capital management approach on an ongoing basis. The Company considers its shareholders’ equity balance as capital.
Off-Balance Sheet Arrangements
We have no obligations, assets or liabilities, which would be considered off-balance sheet arrangements as of March 31, 2026. We do not participate in transactions that create relationships with entities or financial partnerships, often referred to as variable interest entities, which would have been established for the purpose of facilitating off-balance sheet arrangements. We have not entered into any off-balance sheet financing arrangements, established any special purpose entities, guaranteed any debt or commitments of other entities, or purchased any non-financial assets.
Contractual Obligations
We do not have any long-term debt, capital lease obligations, operating lease obligations or long-term liabilities.
JOBS Act
On April 5, 2012, the JOBS Act was signed into law. The JOBS Act contains provisions that, among other things, relax certain reporting requirements for qualifying public companies. We qualify as an “emerging growth company” and under the JOBS Act are allowed to comply with new or revised accounting pronouncements based on the effective date for private (not publicly traded) companies. We are electing to delay the adoption of new or revised accounting standards, and as a result, we may not comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for non- emerging growth companies. As such, our financial statements may not be comparable to companies that comply with public company effective dates.
Additionally, we are in the process of evaluating the benefits of relying on the other reduced reporting requirements provided by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, if, as an “emerging growth company,” we choose to rely on such exemptions we may not be required to, among other things, (i) provide an auditor’s attestation report on our system of internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act, (ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act, (iii) comply with any requirement that may be adopted by the PCAOB regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis) and (iv) disclose certain executive compensation related items such as the correlation between executive compensation and performance and comparisons of executive compensation to median employee compensation. These exemptions will apply for a period of five years following the completion of our IPO or until we are no longer an “emerging growth company,” whichever is earlier.
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
| A. | Directors and Senior Management |
The following sets forth certain information, as of the date of this Report, concerning the directors and executive officers of the Company. All executive officers are appointed by the Board to serve in their roles. Each executive officer is appointed for such term as may be prescribed by the Board or until a successor has been chosen and qualified or until such officer’s death, resignation or removal.
| Name | Age | Position(s) | ||
| Jody Aufrichtig | 53 | Chief Executive Officer and Chairman of the Board | ||
| Warwick Corden-Lloyd | 47 | Chief Financial Officer and Director | ||
| Marc Balkin | 52 | Director | ||
| Graham Patrick | 45 | Director | ||
| Sashank Pillay | 49 | Director |
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Executive Officers
Warwick Corden-Lloyd has served as the Chief Financial Officer of the Company since January 25, 2024. Mr. Corden-Lloyd has also served as Chief Financial Officer of PGI from May 21, 2020 until his resignation in January 2024. Mr. Corden-Lloyd is a Chartered Accountant and Certified Project Manager. He has over 23 years of financial and regulatory experience working in public accounting, consulting and listed financial services companies in the US, UK and South Africa. He has been a consultant of PsyLabs, a privately-held company specializing in the production of psychedelic active pharmaceutical ingredients and extracts for research, clinical trials, and drug development and an affiliate of the Company, since April 2024 and a board member of Novaspore Ltd., a wholly owned subsidiary of PsyLabs, since March 2022. From May 2020 to January 2021, Mr. Corden-Lloyd was the Corporate Finance Advisor and Chief Financial Officer of MindHealth Biomed Corp, the predecessor company prior to PGI. Mr. Corden-Lloyd was previously the Vice President of Operations and Finance at Canopy Growth Africa, (a wholly owned subsidiary of Canopy Growth Corporation (NYSE: CGC / TSX: WEED) from May 2019 to May 2020. Whilst at Canopy Growth, he oversaw the Finance, Legal, Supply Chain, Human Resources, Quality Assurance and Regulatory, Project Management and Country Manager divisions. Prior to that he was Head of Financial Accounting at Capitec Bank, South Africa’s largest customer retail bank, from February 2015 to May 2019 where he was responsible for managing the financial and regulatory reporting, budgeting and financial accounting for the bank. Before working at Capitec Bank, he worked for PricewaterhouseCoopers International Limited in the US, UK and South Africa and for The Bank of New York Mellon Corporation in the UK. Mr. Corden-Lloyd received a Bachelor of Accounting from the University of Stellenbosch, South Africa in 2002, a Bachelor of Accounting Honours from the University of Natal, South Africa in 2003 and registered with the South African Institute of Chartered Accountants in 2006.
Jody Aufrichtig has served as Chairman of the Board of the Company since January 25, 2024 and CEO of the Company since October 15, 2025. He has served as Board Chairman at PGI, and also served as a PGI director, since May 21, 2020. Mr. Aufrichtig is a chartered accountant and experienced entrepreneur with extensive experience in emerging markets. He has served as a consultant of PsyLabs, a privately-held company specializing in the production of psychedelic active pharmaceutical ingredients and extracts for research, clinical trials, and drug development and an affiliate of the Company, since April 2024. Mr. Aufrichtig is the founder of MindHealth Biomed Corp and has built multiple award-winning businesses and created substantial shareholder value in cannabis, commercial and residential property, private equity, tourism, leisure and other industries. Prior to founding MindHealth Biomed Corp, he was the Managing Director of Canopy Growth Africa (a wholly owned subsidiary of Canopy Growth Corporation (NYSE: CGC / TSX: WEED)) from May 2018 until he led a management buyout of the African operations in April 2020. Mr. Aufrichtig founded Daddy Cann Lesotho (Pty) Limited in July 2017 and was granted a license by the Ministry of Health (Lesotho) to cultivate, manufacture, supply, hold, import, export and transport cannabis. Daddy Cann Lesotho (Pty) Limited was subsequently acquired by Canopy Growth Corporation in May 2018. In 2000, Mr. Aufrichtig co-founded Indigo Properties, a business focused on commercial and residential property, tourism and leisure. Mr. Aufrichtig holds a Bachelor of Accounting and a Bachelor of Accounting Honours from the University of Cape Town, South Africa and is registered with the South African Institute of Chartered Accountants. He is well-qualified to serve as a director because of his extensive commercial and corporate experience in a broad variety of areas including finance and mergers and acquisitions and has served as a director and chairman of other publicly traded companies.
Marc Balkin has served as a director of the Company since January 25, 2024. He served as the Chief Executive Officer and served as a member of the board of directors of NCAC from March 2021 until January 25, 2024. Mr. Balkin is a founder of Balkin and Co, an advisory firm that has advised private equity firms and family offices on mergers, acquisitions and investments in Africa since 2015. Clients have included HP Bet (part of the family office of Dr. Hasso Plattner, a founder and current Chairman of SAP), Omidyar Network (part of the family office of Pierre Omidyar, the founder of eBay) and Rand Merchant Bank. Prior to founding Balkin and Co, Mr. Balkin was the Managing Partner of Hasso Plattner Ventures Africa, a Venture Fund in which Dr. Plattner was the key limited partner. Mr. Balkin also held responsibility for managing the Emerging Market portfolio of private equity and venture capital assets of Dr. Plattner’s family office. Mr. Balkin is currently a partner at DiGame, a growth fund focused on Africa and the Middle East in which the key investor is Abu Dhabi Investment Counsel (“ADIC”). Mr. Balkin represents DiGame on the board of direct-to-consumer asset manager 10X Investments. Since 2004, Mr. Balkin has served on and chaired a range of venture capital and private equity fund investment committees as the representative of the limited partners or investors. These include Enablis, First National Bank Vumela Fund, Telkom Future Makers and Alithea IDF. Between 2000 and 2007, Mr. Balkin was the founding partner of O2 Capital, a private equity fund manager for the Msele Nedventures Fund. The LPs in the fund included a range of development finance institutions such as Proparco (France), DEG (Germany) and IDC (South Africa) and the fund invested primarily in technology businesses in South Africa. Mr. Balkin obtained his BA in 1995 and his LLB in 1997 from University of Witwatersrand in Johannesburg. He is well-qualified to serve as a director because of his experience at board and committee level as well as his legal, finance and financial markets background.
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Graham Patrick has served as a director of the Company since December 1, 2025. Mr Patrick is a qualified attorney, conveyancer and notary with extensive experience in fiduciary oversight, good governance, management and cross-border transactions. He is a Partner at Stonehage Fleming, a global advisory business and adviser to many of the world’s leading families and wealth creators, and heads up their Mauritius office where he acts as chairperson and director for Stonehage Fleming (Mauritius) Limited and its subsidiaries. His career spans legal, financial, wealth and fiduciary industries. He currently holds board and other regulatory appointments for several companies across multiple areas of business and jurisdictions, including the British Virgin Islands, Mauritius, Seychelles and South Africa. Graham holds degrees in commerce and law, a postgraduate diploma in financial planning and is a member of the Fiduciary Institute of Southern Africa.
Sashank Pillay has served as a director of the Company since February 20, 2026. Following the Company’s sizable investment in PsyLabs, the Company appointed Mr. Pillay to the Board of Directors given his experience in cultivation and production project execution, design, construction, operations management and logistics, and knowledge of international controlled substance regulatory frameworks, quality management, logistics and supply chain management and customs and import/export facilitation. Prior to his appointment at PsyLabs, Mr Pillay served as the Country Manager (Lesotho) at Canopy Growth Africa, (a wholly owned subsidiary of Canopy Growth Corporation (NYSE: CGC / TSX: WEED), where he managed community and government relations liaison for governmentally licensed commercial cannabis and psilocybin cultivation and production facilities in Southern Africa. Whilst at Canopy Growth Africa, he also oversaw the Southern African production, cultivation, quality assurance, regulatory, project management, logistics and distribution divisions.
B. Compensation
The following tables and discussions relate to the compensation paid to or earned by our executive officers and directors who were serving during the financial year ended March 31, 2026.
Dr. Neil Maresky previously served as chief executive officer of the Company until October 15, 2025, following his resignation as chief executive officer of the PGI. Warwick Corden-Lloyd currently serves as chief financial officer of the Company following his resignation as chief financial officer of PGI. Jody Aufrichtig currently serves as Director, CEO and Executive Chairman of the Company. Dr. Maresky, Mr. Corden-Lloyd and Mr. Aufrichtig are referred to collectively in this information statement as our “named executive officers.”
Compensation arrangements for the Company’s executive officers have been determined based on the compensation policies, programs and procedures established by the Compensation Committee, which entailed: (i) for executive directors and officers (a) market related base annual salaries or fees, (b) annual cash bonuses based on a target percentage of such base annual salaries or fees based on the achievement of performance metrics approved by the Compensation Committee, (c) a sign-on award in the form of RSUs, which may be converted into Common Shares and which are subject to a trading lock-up period as well as a clawback policy and (d) long-term equity awards in the form of RSUs based on a multiple of such base annual salaries or fees, and (ii) for non-executive directors (y) a fixed monthly fee and (z) long-term equity awards in the form of RSUs based on a multiple of such fixed monthly fee.
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Summary Compensation Tables
The following table summarizes the compensation awarded to, earned by, or paid to our named executive officers for the fiscal year ended March 31, 2026.
| Name and principal position | Year | Salary (US$) | Bonus (US$) | Option awards (US$) | Stock Awards (US$)(1) | Nonequity incentive plan
compensation (US$) | All other compensation (US$) | Total (US$) | ||||||||||||||||||||||
| Neil Maresky (Chief Executive Officer until October 15, 2025, transitioned to Global Head, Clinical Development) | 2026 | 360,000 | - | - | 77,528 | (2) | - | 440,000 | (3) | 877,528 | ||||||||||||||||||||
| Jody Aufrichtig (Executive Chairman, and Chief Executive Officer from October 15, 2025) (Representing Aquacap Limited) | 2026 | 253,333 | 140,000 | - | 41,961 | (4) | - | - | 435,294 | |||||||||||||||||||||
Warwick Corden-Lloyd | 2026 | 208,000 | 85,000 | - | 24,238 | (5) | - | - | 317,238 | |||||||||||||||||||||
Other than as set forth in the foregoing table, the named executive officers have not received compensation pursuant to any standard arrangement for the compensation of directors for their services in their capacity as directors, including any additional amounts payable for committee participation or special assignments, any other arrangement, in addition to, or in lieu of, any standard arrangement, for the compensation of directors in their capacity as directors, or any arrangement for the compensation of directors for services as consultants or experts.
The following table summarizes the compensation awarded to, earned by, or paid to our directors for the fiscal year ended March 31, 2026.
| Name and principal position | Year | Fees (US$) | Stock Awards (US$)(1) | Total (US$) | ||||||||||
| Marc Balkin – Director (representing Balkin and Co Pty Ltd) | 2026 | 288,336 | 18,065 | (6) | 306,401 | |||||||||
| Christopher Bull – Director (Resigned December 1, 2025) | 2026 | 67,746 | 21,940 | (7) | 89,686 | |||||||||
| Graham Patrick – Director (Appointed December 1, 2025) | 2026 | 15,000 | - | 15,000 | ||||||||||
| Seth Feuerstein – Director (Resigned February 20, 2026) | 2026 | 25,000 | 6,450 | (8) | 31,450 | |||||||||
| Sashank Pillay – Director (Appointed February 20, 2026) | 2026 | 3,750 | - | 3,750 | ||||||||||
| (1) | The amounts reported in the “Stock awards” column represent the aggregate grant date fair value of the restricted stock units (RSUs) granted to the named executive officers during year ended March 31, 2026 computed in accordance with IFRS. The stock awards value was based on the share price on the date of grant of RSUs. Note that the amounts reported in these columns reflect the accounting cost for these RSUs and do not correspond to the actual economic value that may be received by the named executive officers from the stock RSUs. |
| (2) | This represents an aggregate of 3,922 RSUs granted during the year, with vesting dates as follows: 276 – April 17, 2025; 1,067 – April 1, 2026; 222 – April 17, 2026; 1,067 – October 1, 2026 and 1,290 - April 1, 2027. |
| (3) | In October 2025 Dr. Neil Maresky transitioned from his role as Chief Executive Officer and Director of the Company to serve as the Company’s Global Head, Clinical Development, where he leads the Phase IIb Study and clinical trial development programs. Pursuant to an consultancy agreement entered into on November 1, 2025 with the Company. The fees represented here include amounts agreed between Dr. Mareksy and the Company in lieu of no-fault termination payments which would otherwise have been payable to him under the terms of his employment contract. |
| (4) | This represents an aggregate of 2,179 RSUs granted during the year, with vesting dates as follows: 177 – April 17, 2025; 585 – April 1, 2026; 123 – April 17, 2026; 585 – October 1, 2026 and 709 - April 1, 2027. |
| (5) | This represents an aggregate of 1,225 RSUs granted during the year, with vesting dates as follows: 90 – April 17, 2025; 332 – April 1, 2026; 69 – April 17, 2026; 332 – October 1, 2026 and 402 - April 1, 2027. |
| (6) | This represents an aggregate of 915 RSUs granted during the year, with vesting dates as follows: 52 – April 17, 2025; 253 – April 1, 2026; 52 – April 17, 2026; 253 – October 1, 2026 and 402 - April 1, 2027. |
| (7) | This represents an aggregate of 1,110 RSUs granted during the year, with vesting dates as follows: 63 – April 17, 2025; 1,047 – December 1, 2025. |
| (8) | This represents an aggregate of 325 RSUs granted during the year, with 19 RSUs vesting before resignation and the remainder being cancelled upon resignation. |
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Employment, Consulting and Management Agreements
As of the date of this Report, the Company had the following employment, consulting and management agreements in place with its named executive officers:
Jody Aufrichtig – Chief Executive Officer & Board Chairman
The Company, its wholly-owned subsidiary, Biomed II, Jody Aufrichtig (as principal) and Aquacap Limited (as consultant) entered into a consulting agreement dated January 25, 2024 (the “Aquacap Agreement”), pursuant to which Mr. Aufrichtig performed the services of the Executive Chairman of the Board and Chief Development Officer. The Aquacap Agreement base fee was $200,000 per annum. Effective December 1, 2025, The Aquacap Agreement ’s base fee has been increased to $360,000 per annum for the services of Executive Chairman of the Board and Chief Executive Officer.
For each completed fiscal year of the Company, the Aquacap Agreement shall be eligible to receive an annual cash bonus based on a target bonus opportunity of 50% to 100% of the Aquacap Agreement ’s annual base fee, based on the achievement of performance metrics approved by the Compensation Committee.
Aquacap Limited or the Company may terminate the Aquacap Agreement at any time upon no less than sixty (60) days’ written notice to the other party. Additionally, the Company may terminate the Aquacap Agreement at any time without prior notice, for cause, subject to a ten business day cure period by Aquacap Limited.
The Company may terminate the Aquacap Agreement without cause, or in relation to a change of control at any time and Aquacap Limited may terminate the Aquacap Agreement for good reason (as defined in the agreement), and in each such case the Company shall pay Aquacap Limited severance pay (in lieu of notice) equal to 12 months of Aquacap Limited’s base fee (as at the date of notice of termination) plus an additional amount equal to the aggregate annual bonuses paid to Aquacap Limited over the preceding 12 months (from the date of notice of termination) plus a prorated payment on account of any annual bonus targets already met by Aquacap Limited as of the date of notice of termination for all active services rendered up to that date (calculated at target). Aquacap Limited shall be entitled to exercise any vested stock options until the earlier of 1) the option expiry date or 2) a date which is 12 months from the effective date of termination, and if so required, the Company shall extend the option expiry date accordingly.
In the event of termination by the Company for cause or by Aquacap Limited without good reason, Aquacap Limited shall not be entitled to any severance pay or any other payments, and none of the unvested equity incentives granted to Aquacap Limited shall vest.
Mr. Aufrichtig shall not be entitled to any minimum termination entitlements required by the Ontario Employment Standards Act, 2000 (“ESA”), and no minimum termination entitlements contemplated in the ESA shall apply to the Aquacap Agreement.
All equity incentives granted to Aquacap Limited will be subject to accelerated vesting upon a change of control, upon termination by the Company without cause, or death of Mr. Aufrichtig.
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Warwick Corden-Lloyd – Chief Financial Officer and Director
The Company, its wholly-owned subsidiary, Biomed II, Warwick Corden-Lloyd (as principal) and CordenLloyd Consulting (Pty) Ltd (as consultant, and an entity controlled by Mr. Corden-Lloyd) entered into a consulting agreement dated January 25, 2024 (the “CordenLloyd Agreement”), pursuant to which Mr. Corden-Lloyd shall perform the services of Chief Financial Officer of the Company. The CordenLloyd Agreement base fee was $180,000 per annum. Effective December 1, 2025, the CordenLloyd Agreement’s base fee has been increased to $264,000 per annum.
For each completed fiscal year of the Company, the CordenLloyd Agreement shall be eligible to receive an annual cash bonus based on a target bonus opportunity of 30% to 80% of the CordenLloyd Agreement ‘s annual base fee, based on the achievement of performance metrics approved by the Compensation Committee.
The Company may terminate the CordenLloyd Agreement without cause, or in relation to a change of control at any time and CordenLloyd Consulting (Pty) Ltd may terminate the CordenLloyd Agreement for good reason (as defined in the agreement), and in each such case the Company shall pay CordenLloyd Consulting (Pty) Ltd severance pay (in lieu of notice) equal to 12 months of CordenLloyd Agreement ’s base fee (as at the date of notice of termination) plus an additional amount equal to the aggregate annual bonuses paid to CordenLloyd Consulting (Pty) Ltd over the preceding 12 months (from the date of notice of termination) plus a prorated payment on account of any annual bonus targets already met by CordenLloyd Consulting (Pty) Ltd as of the date of notice of termination for all active services rendered up to that date (calculated at target). CordenLloyd Consulting (Pty) Ltd shall be entitled to exercise any vested stock options until the earlier of 1) the option expiry date or 2) a date which is 12 months from the effective date of termination, and if so required, the Company shall extend the option expiry date accordingly.
In the event of termination by the Company for cause or by CordenLloyd Consulting (Pty) Ltd without good reason, CordenLloyd Consulting (Pty) Ltd shall not be entitled to any severance pay or any other payments, and none of the unvested equity incentives granted to CordenLloyd Consulting (Pty) Ltd shall vest.
Mr. Corden-Lloyd shall not be entitled to any minimum termination entitlements required by the Ontario Employment Standards Act, 2000 (“ESA”), and no minimum termination entitlements contemplated in the ESA shall apply to the Corden-Lloyd Agreement.
All equity incentives granted to CordenLloyd Consulting (Pty) Ltd will be subject to accelerated vesting upon a change of control, upon termination by the Company without cause, or death of Mr. Corden - Lloyd.
Non-Executive Directors - Christopher Bull (resigned December 1, 2025), Marc Balkin, Dr Seth Feuerstein (resigned February 20, 2026), Graham Patrick and Sashank Pillay
Each of Christopher Bull, Marc Balkin, Dr Seth Feuerstein, Graham Patrick and Sashank Pillay have entered into letters of appointment on identical terms in their positions as non-executive directors (“NED”). Each of Christopher Bull’s, Marc Balkin’s and Dr Seth Feuerstein’s respective appointments under this letter is for an initial term commencing January 25, 2024 until the date of the following annual general meeting of the Company, unless terminated earlier by either party giving to the other one month’s prior written notice. Each of Graham Patrick’s and Sashank Pillay’s respective appointments under this letter is for an initial term commencing December 1, 2025 and February 20, 2026 respectively until the date of the following annual general meeting of the Company, unless terminated earlier by either party giving to the other one month’s prior written notice. Each NED’s appointment is further subject to the Company’s articles of association, and re-election to the board by the Company’s shareholders at the first annual general meeting of the Company.
Each NED is compensated for their services as a non-executive director in accordance with the compensation, annual bonus and long-term incentive policy adopted by the Board on February 2, 2024, as supplemented by the performance metrics to be approved by the Compensation Committee of the Company in accordance with the Company’s rules and policies governing performance and bonus schemes (still to be adopted). Each of Mr. Patrick, Mr. Pillay and Dr. Feuerstein earn US$2,500 per month / US$30,000 per annum, Mr. Bull earned £6,250 per month / £75,000 per annum. Mr Balkin earned US$2,500 per month / US$30,000 per annum until July 31, 2025 and then US$16,667per month / US$200,000 per annum from August 1, 2025 onward. Each NED shall be entitled to an allocation of RSUs for the 2026 fiscal years (as applicable) to be determined by the Compensation Committee, which shall vest in tranches.
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Cash and Equity Compensation
The Company’s Compensation Committee approved the named executive officers’ compensation at its first meeting. Following the Business Combination, compensation arrangements for the Company’s executive officers was determined based on the compensation policies, programs and procedures established by the Compensation Committee, which entailed: (i) for directors and executive officers (a) market related base annual salaries or fees, (b) annual cash bonuses based on a target percentage of such base annual salaries or fees based on the achievement of performance metrics approved by the Compensation Committee, (c) a sign-on award in the form of RSUs, which may be converted into Common Shares and which are subject to a trading lock-up period as well as a clawback policy and (d) long-term equity awards in the form of RSUs based on a multiple of such base annual salaries or fees, and (ii) for non-executive directors (y) a fixed monthly fee and (z) long-term equity awards in the form of RSUs based on a multiple of such fixed monthly fee.
For information regarding share options granted to Psyence’s directors and executive officers, see the section entitled “— Equity Incentive Plans” below.
Indemnification Agreements
The Company has entered into indemnification agreements with each of its officers and directors. Under these agreements, the Company may agree to indemnify its directors against certain liabilities and expenses incurred by such persons in connection with claims made by reason of their being a director of the Company.
Equity Incentive Plans
The 2023 Equity Incentive Plan
The Company has adopted the Psyence Biomedical Ltd. 2023 Equity Incentive Plan (as amended by the Board on June 28, 2024 and November 12, 2024, and rectified by the Board on June 17, 2025 and May 4, 2026), which is referred to herein as the “Incentive Plan.” The following is a summary of the material features of the Incentive Plan.
Purpose
The purpose of the Incentive Plan is to enhance the ability of the Company to attract, retain, and motivate persons who make (or are expected to make) important contributions to the Company by providing these individuals with equity ownership opportunities and/or equity-linked compensatory opportunities that are intended to motivate high levels of performance and align the interests of directors, employees, and consultants with those of the Company’s shareholders.
Eligibility
Persons eligible to participate in the Incentive Plan are employees, non-employee directors, and consultants of the Company and its subsidiaries as selected from time to time by the plan administrator in its discretion, including prospective employees, non-employee directors and consultants. Any awards granted to such a prospect before the individual’s start date may not become vested or exercisable, and no shares may be issued to such individual, before the date the individual first commences performance of services with the Company or its subsidiaries. As of the date of this report, approximately 11 individuals are eligible to participate in the Incentive Plan, which includes approximately 2 officers, 3 non-employee directors, and 6 consultants.
Administration
The Incentive Plan will be administered by the Board, the Compensation Committee of the Board, or such other similar committee pursuant to the terms of the Incentive Plan. The plan administrator, which initially will be the Compensation Committee of the Board, will have full power to select, from among the individuals eligible for awards, the individuals to whom awards will be granted, to make any combination of awards to participants, and to determine the specific terms and conditions of each award, subject to the provisions of the Incentive Plan. The plan administrator may delegate to one or more officers of the Company, the authority to grant awards to individuals who are not subject to the reporting and other provisions of Section 16 of the Exchange Act.
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Share Reserve
The number of the Common Shares that may be issued under the Incentive Plan is equal to 15% of the aggregate number of the Common Shares issued and outstanding immediately after the Closing (calculated on a fully-diluted basis), or 538 Common Shares. On November 12, 2024, shareholders approved the increase of the number of Common Shares reserved for issuance under the Plan to 2,182. All of the shares initially available under the Incentive Plan may be issued upon the exercise of equity incentives.
The number of shares available for issuance under the Incentive Plan also will include an automatic annual increase, or the evergreen feature, on the first day of each calendar year, beginning January 1, 2025 and continuing until (and including) January 1, 2034, to a number equal to 15% of the issued and outstanding number of shares of the Company calculated as of December 31st of the calendar year immediately preceding the date of such increase, or a lesser number of shares as determined by the Board. Shares issuable under the Incentive Plan may be authorized, but unissued, or reacquired the Common Shares. The total number of shares available currently under the plan is 153,318.
Shares underlying any awards under the Incentive Plan that are forfeited, cancelled, held back upon exercise of a share option or settlement of an award to cover the exercise price or tax withholding satisfied without the issuance of the Common Shares or otherwise terminated (other than by exercise) will be added back to the shares available for issuance under the Incentive Plan and, to the extent permitted under Section 422 of the Code and the Treasury Regulations promulgated thereunder, the shares that may be issued as incentive stock options.
Types of Awards
The Incentive Plan provides for the grant of share options, share appreciation rights, restricted shares, restricted share units, and other stock-based awards (collectively, “awards”). Unless otherwise set forth in an individual award agreement, each award shall vest over a three (3) year period, with one-third (1/3) of the award vesting on the first annual anniversary of the date of grant and the remaining portion of the award vesting annually thereafter.
Share Options. The Incentive Plan permits the granting of both options intended to qualify as incentive stock options under Section 422 of the Code and share options that do not so qualify. Share options granted under the Incentive Plan will be nonqualified options if they fail to qualify as incentive stock options or exceed the annual limit on incentive stock options. Incentive stock options may only be granted to employees of the Company and its subsidiaries. Nonqualified options may be granted to any persons eligible to receive awards under the Incentive Plan.
The exercise price of each share option will be determined by the plan administrator, but such exercise price may not be less than 100% of the fair market value of one the Common Share on the date of grant (which shall be the volume weighted average trading price during the thirty (30) preceding days) or, in the case of an incentive stock option granted to a 10% or greater shareholder, 110% of such share’s fair market value. The term of each share option will be fixed by the plan administrator and may not exceed ten (10) years from the date of grant (or five (5) years for an incentive stock option granted to a 10% or greater shareholder). The plan administrator will determine at what time or times each share option may be exercised, including the ability to accelerate the vesting of such share options.
Upon exercise of a share option, the exercise price must be paid in full either in cash, check or, surrender of other the Common Shares which meet the conditions established by the plan administrator to avoid adverse accounting consequences to the Company. Subject to applicable law and approval of the plan administrator, the exercise price may also be made by means of a broker-assisted cashless exercise. In addition, the plan administrator may permit nonqualified options to be exercised using a “net exercise” arrangement that reduces the number of shares issued to the optionee by the largest whole number of shares with fair market value that does not exceed the aggregate exercise price.
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Share Appreciation Rights. The plan administrator may award share appreciation rights subject to such conditions and restrictions as it may determine. Share appreciation rights entitle the recipient to the Common Shares or cash, equal to the value of the appreciation in the Company’s share price over the exercise price, as set by the plan administrator. The term of each share appreciation right will be fixed by the plan administrator and may not exceed ten years from the date of grant. The plan administrator will determine at what time or times each share appreciation right may be exercised, including the ability to accelerate the vesting of such share appreciation rights.
Restricted Shares. A restricted share award is an award of the Common Shares that vests in accordance with the terms and conditions established by the plan administrator. The plan administrator will determine the persons to whom grants of restricted share awards are made, the number of restricted shares to be awarded, the price (if any) to be paid for the restricted shares, the time or times within which restricted share awards may be subject to forfeiture, the vesting schedule and rights to acceleration thereof, and all other terms and conditions of restricted share awards. Unless otherwise provided in the applicable award agreement, a participant generally will have the rights and privileges of a shareholder as to such restricted shares, including without limitation the right to vote such restricted shares and the right to receive dividends, if applicable.
Restricted Share Units. Restricted share units are the right to receive the Common Shares at a future date in accordance with the terms of such grant upon the attainment of certain conditions specified by the plan administrator. Restrictions or conditions could include, but are not limited to, the attainment of performance goals, continuous service with the Company or its subsidiaries, the passage of time or other restrictions or conditions. The plan administrator determines the persons to whom grants of restricted share units are made, the number of restricted share units to be awarded, the time or times within which awards of restricted share units may be subject to forfeiture, the vesting schedule, and rights to acceleration thereof, and all other terms and conditions of the restricted share unit awards. The value of the restricted share units may be paid in Common Shares, cash, other securities, other property, or a combination of the foregoing, as determined by the plan administrator.
The holders of restricted share units will have no voting rights. Prior to settlement or forfeiture, restricted share units awarded under the Incentive Plan may, at the plan administrator’s discretion, provide for a right to dividend equivalents. Such right entitles the holder to be credited with an amount equal to all dividends paid on one Common Share while each restricted share unit is outstanding. Dividend equivalents may be converted into additional restricted share units. Settlement of dividend equivalents may be made in the form of cash, Common Shares, other securities, other property, or a combination of the foregoing. Prior to distribution, any dividend equivalents shall be subject to the same conditions and restrictions as the restricted share units to which they are payable.
Other Share-Based Awards. Other share-based awards may be granted either alone, in addition to, or in tandem with, other awards granted under the Incentive Plan and/or cash awards made outside of the Incentive Plan. The plan administrator shall have authority to determine the persons to whom and the time or times at which other share-based awards will be made, the amount of such other share-based awards, and all other conditions, including any dividend and/or voting rights.
Prohibition on Repricing
Except for an adjustment pursuant to the terms of the Incentive Plan or a repricing approved by shareholders, in no case may the plan administrator (i) amend an outstanding share option or share appreciation right to reduce the exercise price of the award, (ii) cancel, exchange, or surrender an outstanding share option or share appreciation right in exchange for cash or other awards for the purpose of repricing the award, or (iii) cancel, exchange, or surrender an outstanding share option or share appreciation right in exchange for a share option or share appreciation right with an exercise price that is less than the exercise price of the original award.
Tax Withholding
Participants in the Incentive Plan are responsible for the payment of any federal, state, or local taxes that the Company or its subsidiaries are required by law to withhold upon the exercise of share options or share appreciation rights or vesting of other awards. The plan administrator may cause any tax withholding obligation of the Company or its subsidiaries to be satisfied, in whole or in part, by the applicable entity withholding from the Common Shares to be issued pursuant to an award a number of shares with an aggregate fair market value that would satisfy the withholding amount due. The plan administrator may also require any tax withholding obligation of the Company or its subsidiaries to be satisfied, in whole or in part, by an arrangement whereby a certain number of the Common Shares issued pursuant to any award are immediately sold and proceeds from such sale are remitted to the Company or its subsidiaries in an amount that would satisfy the withholding amount due.
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Equitable Adjustments
In the event of a merger, consolidation, recapitalization, share split, reverse share split, reorganization, split-up, spin-off, combination, repurchase or other change in corporate structure affecting the Common Shares, the maximum number and kind of shares reserved for issuance or with respect to which awards may be granted under the Incentive Plan will be adjusted to reflect such event, and the plan administrator will make such adjustments as it deems appropriate and equitable in the number, kind, and exercise price of the Common Shares covered by outstanding awards made under the Incentive Plan.
Change in Control
In the event of any proposed change in control (as defined in the Incentive Plan), the plan administrator will take any action as it deems appropriate, which action may include, without limitation, the following: (i) the continuation of any award, if the Company is the surviving corporation; (ii) the assumption of any award by the surviving corporation or its parent or subsidiary; (iii) the substitution by the surviving corporation or its parent or subsidiary of equivalent awards; (iv) accelerated vesting of the award, with all performance objectives and other vesting criteria deemed achieved at targeted levels, and a limited period during which to exercise the award prior to closing of the change in control, or (v) settlement of any award for the change in control price (less, to the extent applicable, the per share exercise price). Unless determined otherwise by the plan administrator, in the event that the successor corporation refuses to assume or substitute for the award, a participant shall fully vest in and have the right to exercise the award as to all the Common Shares covered by the award, including those that would not otherwise be vested or exercisable, all applicable restrictions will lapse, and all performance objectives and other vesting criteria will be deemed achieved at targeted levels.
Transferability of Awards
Unless determined otherwise by the plan administrator, an award may not be sold, pledged, assigned, hypothecated, transferred, or disposed of in any manner, except to a participant’s estate or legal representative, and may be exercised, during the lifetime of the participant, only by the participant. If the plan administrator makes an award transferable, such award will contain such additional terms and conditions as the plan administrator deems appropriate.
Term
The Incentive Plan became effective when adopted by the Board, and, unless terminated earlier, the Incentive Plan will continue in effect for a term of ten (10) years.
Amendment and Termination
The Board may amend or terminate the Incentive Plan at any time. Any such termination will not affect outstanding awards. No amendment or termination of the Incentive Plan will materially impair the rights of any participant, unless mutually agreed otherwise between the participant and the Company. Approval of the shareholders shall be required for any amendment, where required by applicable law, as well as (i) to increase the number of shares available for issuance under the Incentive Plan and (ii) to change the persons or class of persons eligible to receive awards under the Incentive Plan. We have opted out of Nasdaq requirements to receive shareholder approval in connection with an amendment to the Incentive Plan.
Form S-8
On July 23, 2025, the Company filed with the SEC a registration statement on Form S-8 covering the Common Shares issuable under the Incentive Plan.
Material United States Federal Income Tax Considerations
The following is a general summary under current law of the material U.S. federal income tax considerations related to awards and certain transactions under the Incentive Plan, based upon the current provisions of the Code and Treasury Regulations promulgated thereunder. This summary deals with the general U.S. federal income tax principles that apply and is provided only for general information. It does not describe all U.S. federal tax consequences under the Incentive Plan, nor does it describe state, local, or foreign income tax consequences or employment tax consequences. The rules governing the tax treatment of such awards are quite technical, so the following discussion of tax consequences is necessarily general in nature and is not complete. In addition, statutory provisions are subject to change, as are their interpretations, and their application may vary in individual circumstances. This summary is not intended as tax advice to participants, who should consult their own tax advisors.
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The Incentive Plan is not qualified under the provisions of Section 401(a) of the Code and is not subject to any of the provisions of the U.S. Employee Retirement Income Security Act of 1974, as amended.
The ability of the Company or its subsidiaries to realize the benefit of any tax deductions described below depends on generation of taxable income as well as the requirement of reasonableness and the satisfaction of tax reporting obligations.
Incentive Stock Options. No taxable income is generally realized by the optionee upon the grant or exercise of an incentive stock option. If the Common Shares issued to an optionee pursuant to the exercise of an incentive stock option are sold or transferred after two years from the date of grant and after one year from the date of exercise, then generally (i) upon sale of such shares, any amount realized in excess of the option exercise price (the amount paid for the shares) will be taxed to the optionee as a long- term capital gain, and any loss sustained will be a long-term capital loss, and (ii) neither the Company nor its subsidiaries will be entitled to any deduction for U.S. federal income tax purposes; provided that such incentive stock option otherwise meets all of the technical requirements of an incentive stock option. The exercise of an incentive stock option will give rise to an item of tax preference that may result in alternative minimum tax liability for the optionee.
If the Common Shares acquired upon the exercise of an incentive stock option are disposed of prior to the expiration of the two-year and one-year holding periods described above (a “disqualifying disposition”), generally (i) the optionee will realize ordinary income in the year of disposition in an amount equal to the excess (if any) of the fair market value of the Common Shares at exercise (or, if less, the amount realized on a sale of such the Common Shares) over the option exercise price thereof, and (i) the Company or its subsidiaries will be entitled to deduct such amount. Special rules will apply where all or a portion of the exercise price of the incentive stock option is paid by tendering the Common Shares.
If an incentive stock option is exercised at a time when it no longer qualifies for the tax treatment described above, the share option is treated as a nonqualified option. Generally, an incentive stock option will not be eligible for the tax treatment described above if it is exercised more than three months following termination of employment (or one year, in the case of termination of employment by reason of disability). In the case of termination of employment by reason of death, the three-month rule does not apply.
Nonqualified Options. No income is generally realized by the optionee at the time a nonqualified option is granted. Generally, (i) at exercise, ordinary income is realized by the optionee in an amount equal to the difference between the option exercise price and the fair market value of the Common Shares issued on the date of exercise, and the Company or its subsidiaries receive a tax deduction for the same amount, and (ii) at disposition, appreciation or depreciation after the date of exercise is treated as either short-term or long- term capital gain or loss depending on how long the Common Shares have been held. Special rules will apply where all or a portion of the exercise price of the nonqualified option is paid by tendering the Common Shares. Upon exercise, the optionee will also be subject to Social Security taxes on the excess of the fair market value of the Common Shares over the exercise price of the share option.
Share Appreciation Rights, Restricted Shares, Restricted Share Units, and Other Share-Based Awards. The current U.S. federal income tax consequences of other awards authorized under the Incentive Plan generally follow certain basic patterns: (i) share appreciation rights are taxed and deductible in substantially the same manner as nonqualified options; (ii) nontransferable restricted shares subject to a substantial risk of forfeiture result in income recognition equal to the excess of the fair market value of the Common Shares over the price paid, if any, only at the time the restrictions lapse (unless the recipient elects to accelerate recognition as of the date of grant through a Code Section 83(b) election); and (iii) restricted share units, dividend equivalents, and other share or cash based awards are generally subject to tax at the time of payment. the Company or its subsidiaries generally should be entitled to a U.S. federal income tax deduction in an amount equal to the ordinary income recognized by the participant at the time the participant recognizes such income.
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The participant’s basis for the determination of gain or loss upon the subsequent disposition of the Common Shares acquired from a share appreciation right, restricted share award, restricted share unit, or other share-based award will be the amount paid for such shares plus any ordinary income recognized when the shares were originally delivered, and the participant’s capital gain holding period for those shares will begin on the day after they are transferred to the participant.
Parachute Payments. The vesting of any portion of an award that is accelerated due to the occurrence of a change in control (such as a sale event) may cause all or a portion of the payments with respect to such accelerated awards to be treated as “parachute payments” as defined in the Code. Any such parachute payments may be non-deductible to either the Company or its subsidiaries, in whole or in part, and may subject the recipient to a non-deductible 20% U.S. federal excise tax on all or a portion of such payment (in addition to other taxes ordinarily payable).
Section 409A. The foregoing description assumes that Section 409A of the Code does not apply to an award under the Incentive Plan. In general, share options and share appreciation rights are exempt from Section 409A if the exercise price per share is at least equal to the fair market value per share of the underlying share at the time the share option or share appreciation right was granted. Restricted share awards are not generally subject to Section 409A. Restricted share units are subject to Section 409A unless they are settled within two and one-half months after the end of the later of (1) the end of the Company’s fiscal year in which vesting occurs or (2) the end of the calendar year in which vesting occurs. If an award is subject to Section 409A and the provisions for the exercise or settlement of that award do not comply with Section 409A, then the participant would be required to recognize ordinary income whenever a portion of the award vested (regardless of whether it had been exercised or settled). This amount would also be subject to a 20% U.S. federal tax and premium interest in addition to the U.S. federal income tax at the participant’s usual marginal rate for ordinary income.
C. Board Practices
Corporate Governance
We have structured our corporate governance in a manner we believe will closely align our interests with those of our shareholders. Notable features of this corporate governance include:
| ● | we have a majority of independent directors on our Board, and our independent directors will meet regularly in executive sessions without the presence of our corporate officers or non-independent directors; |
| ● | we have an audit committee that consists of three independent directors, at least one of whom qualifies as an “audit committee financial expert” as defined by the SEC; and |
| ● | we have implemented a range of other corporate governance practices, including implementing a robust director education program. |
Number and Terms of Office of Officers and Directors
Our officers are appointed by the board of directors. Our board of directors is authorized to appoint officers as it deems appropriate. Our Board currently consists of 5 members, and pursuant to our Articles of Incorporation, may consist of a maximum of 10 members and a minimum of 3 members.
Independence of our Board of Directors
Three of our five directors are independent directors and our Board has an independent audit committee. The Board determines which members are “independent.” The Board has determined that each of Messrs. Balkin, Patrick and Pillay is “independent” as such term is defined under the Exchange Act and the rules of Nasdaq.
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Committees of the Board of Directors
The Board directs the management of our business and affairs and conducts its business through meetings of the Board and standing committees. The Company has audit, compensation and nominating and governance committees, each of which operates under a written charter.
In addition, from time to time, special committees may be established under the direction of the Board when the Board deems it necessary or advisable to address specific issues. Current copies of the Company’s committee charters will be posted on the Company’s website, as required by applicable SEC and Nasdaq rules. The information on or available through any of such website is not deemed incorporated in this Report and does not form part of this Report.
Audit Committee
Our audit committee (the “Audit Committee”) consists of Marc Balkin, Graham Patrick and Sashank Pillay. Mr. Balkin is an “audit committee financial expert” within the meaning of SEC regulations. Mr. Balkin serves as the chairperson of the Audit Committee. Each member of the Audit Committee can read and understand fundamental financial statements in accordance with applicable requirements. In arriving at these determinations, the Board will examine each Audit Committee member’s scope of experience and the nature of their employment.
The Company has adopted an audit committee charter, which details the principal functions of the Audit Committee, including:
| ● | evaluating the independence and performance of, and assesses the qualifications of, our independent auditor, and engages such independent auditor; |
| ● | approving the plan and fees for the annual audit, quarterly reviews, tax and other audit-related services, and approves in advance any non-audit service to be provided by the independent auditor; |
| ● | monitoring the independence of the independent auditor and the rotation of partners of the independent auditor on our engagement team as required by law; |
| ● | reviewing the financial statements to be included in our Annual Report on Form 20-F and Current Reports on Form 6-K and reviews with management and the independent auditors the results of the annual audit and reviews of our quarterly financial statements; |
| ● | overseeing all aspects of our systems of internal accounting control and corporate governance functions on behalf of the board; |
| ● | reviewing and approving in advance any proposed related-party transactions and report to the full Board on any approved transactions; and |
| ● | providing oversight assistance in connection with legal, ethical and risk management compliance programs established by management and our Board, including Sarbanes-Oxley Act implementation, and makes recommendations to our Board of directors regarding corporate governance issues and policy decisions. |
Compensation Committee
Our compensation committee (the “Compensation Committee”) consists of Marc Balkin, Graham Patrick and Sashank Pillay. The chair of the compensation committee is Graham Patrick.
The Compensation Committee is governed by a written charter approved by the Board. The charter of the Compensation Committee permits the Compensation Committee to engage outside consultants and to consult with human resources consultants when appropriate to assist in carrying out its responsibilities. Compensation consultants have not been engaged by the Company to recommend or assist in determining the amount or form of compensation for any current executive officers or directors of the Company. The Compensation Committee may also obtain advice and assistance from internal or external legal, accounting, or other advisers selected by the Compensation Committee. Our Compensation Committee is responsible for overseeing and making recommendations to our board of our directors regarding the salaries and other compensation of our executive officers and general employees and providing assistance and recommendations with respect to our compensation policies and practices.
Nominating and Corporate Governance Committee
Our nominating and corporate governance committee (the “Nominating and Corporate Governance Committee”) consists of Marc Balkin, Graham Patrick and Sashank Pillay. The chair of the Nominating and Corporate Governance Committee is Marc Balkin.
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The Nominating and Corporate Governance Committee is governed by a written charter approved by the Board. Our Nominating and Corporate Governance Committee is responsible for identifying and proposing new potential director nominees to the Board for consideration and reviewing our corporate governance policies.
Special Committee
Our special committee (the “Special Committee”) consists of Marc Balkin, Graham Patrick and Sashank Pillay. The chair of the Special Committee is Marc Balkin.
The Special Committee is governed by a written charter approved by the Board. Our Special Committee is responsible for addressing certain shareholder-related and governance matter tasked with reviewing, considering, and responding to any concerns expressed by shareholders of the Corporation, including concerns relating to the Corporation’s corporate governance practices, the re-election of directors of the Corporation, and the nomination or election of other persons as directors of the Corporation and reviewing and considering any transactions proposed by the Corporation with related parties of the Corporation. The Special Committee operates in an advisory and oversight capacity and would make recommendations to the full Board for consideration and determination, consistent with the Board’s fiduciary duties and applicable law.
Corporate Governance Practices and Foreign Private Issuer Status
The Company is a foreign private issuer within the meaning of the rules under the Exchange Act and, as such, the Company is permitted to follow the corporate governance practices of its home country in lieu of the corporate governance standards of Nasdaq applicable to U.S. domestic companies. For example, the Company is not required to file periodic reports and financial statements with the SEC as frequently or within the same time frames as U.S. companies with securities registered under the Exchange Act, although it may elect to file certain periodic reports and financial statements with the SEC on a voluntary basis on the forms used by U.S. domestic issuers. The Company is not required to comply with Regulation FD, which imposes restrictions on the selective disclosure of material information to shareholders. In addition, the Company’s officers, directors and principal shareholders are exempt from the reporting and short-swing profit recovery provisions of Section 16 of the Exchange Act and the rules under the Exchange Act with respect to their purchases and sales of the Company’s securities.
In addition, as a “foreign private issuer”, the Company is permitted to follow certain home-country corporate governance practices in lieu of certain Nasdaq requirements. A foreign private issuer must disclose in its annual reports filed with the SEC each Nasdaq requirement with which it does not comply followed by a description of its applicable home country practice. The Company currently intends to follow some, but not all, of the corporate governance requirements of Nasdaq. With respect to the corporate governance requirements of the Company that it does follow, the Company cannot give assurances that it will continue to follow such corporate governance requirements in the future, and may therefore in the future, rely on available Nasdaq exemptions that would allow the Company to follow its home country practice. Unlike the requirements of Nasdaq, the Company is not required, under the corporate governance practice and requirements in Ontario, to have its board consist of a majority of independent directors, nor is the Company required to have a compensation committee, a nominating or a corporate governance committee consisting entirely of independent directors, or to have regularly scheduled executive sessions with only independent directors each year. Such home country practices may afford less protection to holders of Common Shares.
The Company intends to rely on this “foreign private issuer exemption” with respect to the quorum requirement for shareholder meetings and with respect to Nasdaq shareholder approval rules. Whereas under the corporate governance rules of Nasdaq, a quorum requires the presence, in person or by proxy, of holders of at least 331∕3% of the total issued and outstanding voting power of our shares at each general meeting, pursuant to our bylaws, the quorum required for a general meeting will consist of at least two shareholders present in person or by proxy who hold or represent at least 25% of the total outstanding voting power of our shares.
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Limitation on Liability and Indemnification of Officers and Directors
Section 136 of the Business Corporations Act (Ontario) (the “OBCA”) governs the indemnification of directors and officers of a corporation and provides that a corporation may indemnify a director or officer of the corporation, a former director or officer of the corporation or another individual who acts or acted at the corporation’s request as a director or officer, or an individual acting in a similar capacity, of another entity, against all costs, charges and expenses, including an amount paid to settle an action or satisfy a judgment, reasonably incurred by the individual in respect of any civil, criminal, administrative, investigative or other proceeding in which the individual is involved because of that association with the corporation or other entity. A corporation shall not indemnify an individual unless the individual acted honestly and in good faith with a view to the best interests of the corporation or, as the case may be, to the best interests of the other entity for which the individual acted as a director or officer or in a similar capacity at the corporation’s request. If the matter is a criminal or administrative action or proceeding that is enforced by a monetary penalty, a corporation shall not indemnify an individual unless the individual had reasonable grounds for believing that the individual’s conduct was lawful.
The Company has entered into indemnification agreements with each director and officer of the Company in accordance with the provisions of the OBCA cited above, which are incorporated into such agreements. Under the indemnification agreements the termination of any proceedings by any judgment, order, settlement, conviction or the entering of a nolle prosequi does not, by itself, create a presumption that the individual did not act honestly and in good faith and with a view to the best interests of the corporation or that the individual had reasonable cause to believe that his or her conduct was unlawful. To the extent permissible by law, there shall be a presumption that the individual acted honestly and in good faith and with a view to the best interests of the corporation and that the individual had no reasonable cause to believe that his or her conduct was unlawful in the absence of fraud unless a question of law is involved.
D. Employees
As at March 31, 2026, we had 12 employees and consultants, of which 12 individuals provide services to the Company through consulting agreements. These employees and consultants are located in Canada, Australia, the US, South Africa and Mauritius.
E. Share Ownership
The following table sets forth information regarding the beneficial ownership of Common Shares on the date of this report:
| Number of Company | Number of Company | % of Company | ||||||||||
| Common | Unvested | Common | ||||||||||
| Name of Beneficial Owner(1) | Shares | RSUs | Shares | |||||||||
| Directors and Executive Officers | ||||||||||||
| Warwick Corden-Lloyd | 491 | 37,492 | * | |||||||||
| Jody Aufrichtig | 885 | 57,869 | * | |||||||||
| Marc Balkin | 357 | 14,713 | * | |||||||||
| Graham Patrick | - | - | - | |||||||||
| Sashank Pillay | - | - | - | |||||||||
| Neil Maresky (2) | 1,565 | 12,357 | * | |||||||||
| All Directors and Executive Officers as a group (six individuals) | 3,298 | 122,431 | * | |||||||||
Notes:
| (1) | Unless otherwise noted, the business address of each of those listed in the table above is 121 Richmond Street West, Penthouse Suite 1300, Toronto, Ontario M5H 2K1. |
| (2) | Resigned as CEO during October 2025 |
F. Disclosure of a Registrant’s Action to Recover Erroneously Awarded Compensation
Not applicable.
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ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
A. Major Shareholders
The following table sets forth information regarding the beneficial ownership of Common Shares on the date of this report, based on information obtained from the persons named below, by:
| ● | each person known by Psyence to be the beneficial owner of more than 5% of the outstanding Common Shares; |
Unless otherwise indicated, Psyence believes that all persons named in the tables below have sole voting and investment power with respect to all shares beneficially owned by them. Except as otherwise noted herein, the number and percentage of Common Shares beneficially owned is determined in accordance with Rule 13d-3 of the Exchange Act, and the information is not necessarily indicative of beneficial ownership for any other purpose. Under such rule, beneficial ownership includes any Common Shares as to which the holder has sole or shared voting power or investment power and also any Common Shares which the holder has the right to acquire within 60 days of the date of this report through the exercise of any option, warrant, convertible security or other right. As of June 17, 2026, there were 3,814,328 Common Shares issued and outstanding.
| Number of | ||||||||
| Company | % of Company | |||||||
| Common | Common | |||||||
| Name of Beneficial Owner | Shares | Shares | ||||||
| 5% Holders | ||||||||
| Psyence Labs Ltd | 1,146,159 | 30.05 | % | |||||
To the knowledge of the Company, we are not directly or indirectly owned or controlled by any other corporation, by any foreign government or by any other natural or legal person either severally or jointly. As far as is known to the Company, there are no arrangements regarding the operation of which may, at a subsequent date, result in a change in control of the Company.
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B. Related Party Transactions
PsyLabs Investment
During the prior year ended March 31, 2025, the Company acquired 1,000 shares in PsyLabs in exchange for shares in the Company. The total consideration was 5,695 Company shares. Based on the listed share price of PBM’s common shares at the respective dates of issuance, the total fair value of shares issued was $722,033, which was recorded as the cost of the investment in PsyLabs.
PsyLabs is a private company headquartered in the British Virgin Islands focused on the production of psychedelic active pharmaceutical ingredients and extracts.
As at March 31, 2025, the Company determined the fair value of its investment in PsyLabs to be $745,000, based on a recent arm’s length subscription transaction by a third-party investor at $745 per PsyLabs share.
On April 15, 2025, the Company acquired an additional 250 shares in PsyLabs for total consideration of $500,000 in cash. On August 15, 2025, the Company acquired a further 1,750 shares for total consideration of $3,500,000 in cash. Following these acquisitions, the Company held 3,000 PsyLabs shares, representing approximately 16.46% of PsyLabs’ outstanding shares. This level of ownership did not, at that time, confer significant influence over PsyLabs, and accordingly the investment was classified as a financial asset measured at fair value through profit or loss (“FVTPL”) in accordance with IFRS 9 – Financial Instruments.
The fair value of the investment, immediately prior to the events described under the Put Option Agreement below, was $5,172,000, based on a recent arm’s length subscription by a third-party investor at $1,724 (March 31, 2025 - $745) per PsyLabs share, representing a Level 2 input under IFRS 13 – Fair Value Measurement. An unrealized fair value gain of $427,000 (March 31, 2025 - $22,967) was recognized in the condensed consolidated statement of profit or loss and other comprehensive income for the year ended March 31, 2026.
Put Option Agreement and Transition to Associate
On July 3, 2025, the Company and PsyLabs entered into a put option agreement (the “Agreement”) pursuant to which PsyLabs was granted the right to require the Company to acquire up to 2,900 additional PsyLabs shares in exchange for newly issued common shares of the Company. The number of PBM shares to be issued was determined using the 30-day volume-weighted average price (“VWAP”) of PBM’s common shares as at close of business February 11, 2026, being $4.3624 per share, applied against a fixed consideration of $5,000,000, resulting in 1,146,159 PBM shares to be issued.
The transaction was consummated and 1,146,159 common shares of the Company were issued to PsyLabs on February 25, 2026 (the “Acquisition Date”), at which point all conditions under the Agreement were satisfied.
Acquisition Date and Significant Influence
The Acquisition Date is February 25, 2026, being the date on which PBM issued shares to PsyLabs and its ownership interest in PsyLabs increased from 16.46% to 27.93%. At this ownership level, the Company obtained significant influence over PsyLabs. Accordingly, from the Acquisition Date the investment is accounted for using the equity method in accordance with IAS 28 – Investments in Associates and Joint Ventures, and PsyLabs is classified as an associate of the Company.
Remeasurement of Previously Held Interest
Upon obtaining significant influence, the Company remeasured its previously held 3,000 PsyLabs shares to fair value as at the Acquisition Date. The fair value was determined at $1,724 per share, consistent with the most recent arm’s length subscription price, giving a remeasured carrying amount of $5,172,000. As this was equal to the FVTPL carrying amount immediately prior to the Acquisition Date, no additional fair value gain or loss was recognized on the previously held interest at the date of transition.
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Consideration Transferred for Additional Shares
The consideration for the 2,900 newly acquired PsyLabs shares was the fair value of the 1,146,159 PBM common shares issued on the Acquisition Date. The fair value was measured using PBM’s quoted closing share price on February 25, 2026 of $2.56 per share. Total consideration transferred was therefore $2,934,167.
Initial Carrying Amount of Investment in Associate
The initial carrying amount of the investment in associate is determined as follows:
| Initial Carrying Amount | ||||||
| Description | Shares | Amount | ||||
| Previously held interest – remeasured to fair value at Acquisition Date | 3,000 | $ | 5,172,000 | |||
| Consideration transferred for additional shares acquired | 2,900 | $ | 2,934,167 | |||
| Total – Investment in Associate at Acquisition Date | 5,900 | $ | 8,106,167 | |||
Equity Method – Post-Acquisition
From February 25, 2026, the Company recognizes its 27.93% proportionate share of PsyLabs’ post-acquisition profit or loss in the consolidated statement of profit or loss, with a corresponding adjustment to the carrying amount of the investment. For the period from the Acquisition Date to March 31, 2026, the Company recognized its share of PsyLabs’ net loss of $45,239, reducing the carrying amount of the investment accordingly.
| Carrying Amount | Amount | |||
| Investment in associate at Acquisition Date (February 25, 2026) | $ | 8,106,167 | ||
| Share of associate net loss – February 25 to March 31, 2026 | $ | (45,239 | ) | |
| Carrying amount at March 31, 2026 | $ | 8,060,928 | ||
Equity Incentive Plans
See “Management — Equity Incentive Plans.”
Employment Agreements and Indemnification Agreements
See “Executive Compensation — Employment, Consulting and Management Agreements” and “Management – Limitation on Liability and Indemnification of Officers and Directors.”
Related Party Transaction Policy
The Board has adopted a written related party transaction policy, which sets forth the policies and procedures for the review and approval or ratification or related person transactions.
A “Related Person Transaction” is a transaction, arrangement or relationship in which the Company or any of its subsidiaries was, is or will be a participant, the amount of which involved exceeds $120,000, and in which any related person had, has or will have a direct or indirect material interest.
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A “Related Person” means:
| ● | any person who is, or at any time during the applicable period was, one of the Company’s officers or one of the Company’s directors; |
| ● | any person who is known by the Company to be the beneficial owner of more than five percent (5%) of its voting stock; |
| ● | any immediate family member of any of the foregoing persons, which means any child, stepchild, parent, stepparent, spouse, sibling, mother-in-law, father-in-law, daughter-in-law, brother-in-law or sister-in-law of a director, officer or a beneficial owner of more than five percent (5%) of its voting stock, and any person (other than a tenant or employee) sharing the household of such director, officer or beneficial owner of more than five percent (5%) of its voting stock; and |
| ● | any firm, corporation or other entity in which any of the foregoing persons is a partner or principal or in a similar position or in which such person has a ten percent (10%) or greater beneficial ownership interest. |
The Company has policies and procedures designed to minimize potential conflicts of interest arising from any dealings it may have with its affiliates and to provide appropriate procedures for the disclosure of any real or potential conflicts of interest that may exist from time to time. Specifically, pursuant to its charter, the audit committee will have the responsibility to review related party transactions.
C. Interests of Experts and Counsel
Not applicable.
ITEM 8. FINANCIAL INFORMATION
A. Consolidated Statements and Other Financial Information
Financial Statements
Our consolidated financial statements begin on page F-1.
Dividend Policy
Psyence has not paid any cash dividends on its shares to date and does not intend to pay cash dividends in the foreseeable future. The payment of cash dividends in the future will be dependent upon the Company’s revenue and earnings, if any, capital requirements and general financial condition. The payment of any cash dividends is within the discretion of the Board. Further, our ability to declare dividends may be limited by the terms of financing or other agreements entered into by us or our subsidiaries from time to time.
B. Significant Changes
Except as disclosed elsewhere in this Report, no other significant changes to our financial condition have occurred since the date of the financial statements contained herein.
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ITEM 9. THE OFFER AND LISTING
A. Offer and Listing Details
Nasdaq Listing of Common Shares and Warrants
The Common Shares and the Warrants are listed on Nasdaq under the symbols “PBM” and “PBMWW,” respectively. As of June 17, 2026, the closing price of our Common Shares was $3.09 and our Warrants was $0.0307.
B. Plan of Distribution
Not applicable.
C. Markets
Refer to “Offer and Listing Details” in Item 9.A.
D. Selling Shareholders
Not applicable.
E. Dilution
Not applicable.
F. Expenses of the Issue
Not applicable.
ITEM 10. ADDITIONAL INFORMATION
A. Share Capital
Not applicable.
B. Articles of Association and By-Laws
The following description of the material terms of the securities of the Company includes a summary of specified provisions of the Articles of Incorporation and amended and restated by-laws (“bylaws”) of the Company. This description is qualified by reference to the Articles of Incorporation and by-laws, copies of which are attached as exhibits to this Report and incorporated in this Report by reference to Item 10.B of the Company’s Annual Report on Form 20-F for the fiscal year ended March 31, 2025. In this section, the terms “we,” “our” or “us” refer to the Company, and all capitalized terms used in this section are as defined in the Articles of Incorporation and bylaws, unless elsewhere defined herein.
We are a corporation organized under the laws of Ontario, Canada and our affairs are governed by our Articles of Incorporation, as registered on June 29, 2023 and the Business Corporations Act (Ontario).
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The following is a summary of the rights of our Common Shares as set forth in our Articles of Incorporation and bylaws and certain related sections of the OBCA. This summary does not purport to be complete and is qualified in its entirety by the full text of the Articles of Incorporation, which is filed as an exhibit to this Report.
Our authorized share capital consists of an unlimited number of Common Shares, each without par value. As of June 17, 2026, we have 3,814,328 issued and outstanding Common Shares.
The following description of our share capital and provisions of our Articles of Incorporation and bylaws are summaries of material terms and provisions and are qualified by reference to our Articles of Incorporation and bylaws, copies of which have been filed with the SEC as exhibits to this Report. The description of our Common Shares reflects amendments to our Articles of Incorporation and bylaws.
Common Shares
The holders of our Common Shares are entitled to one vote for each share held at any meeting of shareholders. The holders of our Common Shares are entitled to receive dividends as and when declared by our Board. In the event of our liquidation, dissolution or winding-up or other distribution of our assets among our shareholders, the holders of our Common Shares are entitled to share pro rata in the distribution of the balance of our assets. There are no preemptive, redemption, purchase or conversion rights attaching to our Common Shares. There are no sinking fund provisions applicable to our Common Shares. Our Common Shares are issued in fully registered form.
C. Material Contracts
Material Contracts Relating to the Company’s Operations
The information set forth in Item 4.B. “— Licensing of PEX010 – Palliative Care” and “— Licensing of NPX-5 – Palliative Care” and “—Licensing of additional API for use in AUD and SUD” is incorporated herein by reference.
Southern Star MSA
On May 21, 2025, Psyence Australia, a wholly-owned subsidiary of the Company, entered into a Master Services Agreement (the “MSA”) with Southern Star Research. Under the MSA, whereby Southern Star Research will serve as the Company’s CRO for its Phase IIb Study.
Pursuant to the MSA, Southern Star Research will provide comprehensive CRO services for the registrational Phase IIb Study, including:
| ● | Trial Management & Oversight: Clinical monitoring, site initiation, site management and close-out activities. |
| ● | Project Management: Development and maintenance of a detailed project plan, coordination of cross-functional teams and regular status reporting to Company senior management. |
| ● | Data Management & Biostatistics: Design, build and maintenance of the electronic data capture (EDC) system; data cleaning, database lock and generation of interim and final statistical reports. |
| ● | Regulatory & Ethics Support: Preparation of submissions to the Therapeutic Goods Administration (TGA) in Australia and local ethics committees; management of regulatory correspondence and amendments. |
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| ● | Pharmacovigilance & Safety Oversight: Collection, processing and reporting of adverse events, serious adverse events and safety follow-up as required under applicable regulations. |
| ● | Patient Recruitment & Retention: Assistance with site selection, patient screening strategy and patient retention programs to ensure timely enrollment of the target 87 participants in the double-blind, placebo-controlled study. |
| ● | Transitional Handover: Coordination with the Company’s prior CRO (iNGENū) to facilitate a seamless transition of all clinical deliverables, data, documentation and site-related activities. |
The Company will pay Southern Star Research aggregate fees in accordance with the MSA Exhibit A to the MSA. Fees are structured as follows:
| ● | Payments: Payment terms consist of an upfront deposit, being a percentage of the total project costs, as well as monthly invoices in accordance with services delivered per the work order. |
| ● | Expense Reimbursements: In addition to monthly invoices, Southern Star Research will be reimbursed for all reasonable out-of-pocket costs incurred in performing the services. |
The MSA includes mutual representations and warranties customary for CRO engagements.
Material Contracts Relating to the Company’s Financing
On July 25, 2024, the Company entered into a Common Shares Purchase Agreement (as amended, the “White Lion Purchase Agreement”) with White Lion Capital, LLC (“White Lion”) establishing an equity line of credit. Pursuant to the White Lion Purchase Agreement, the Company has the right, but not the obligation, to require White Lion to purchase, from time to time, up to $25,000,000 in aggregate gross purchase price of newly issued Common Shares, subject to certain limitations and conditions set forth in the White Lion Purchase Agreement.
Initially, the Company’s right to sell shares to White Lion commenced on the date of the execution of White Lion Purchase Agreement and extended until the earlier of (i) White Lion having purchased Common Shares equal to $25,000,000 and (ii) two years from the date of execution of the White Lion Purchase Agreement.
On November 4, 2025, the Company and White Lion entered into Amendment No. 2 to the White Lion Purchase Agreement. Amendment No. 2, among other things, increases the Company’s potential aggregate drawdown capacity, extends the commitment period, adds a volume-weighted average price (“VWAP”) purchase mechanic after certain funding thresholds are met (including a VWAP-based purchase price and per-notice caps tied to trading volume, subject to waiver), clarifies the timing of closings and funds flow, updates provisions relating to short sales, and makes other conforming changes. Amendment No. 2 also increased the Commitment Amount to up to one hundred million dollars ($100,000,000) of the Company’s Common Stock.
On April 19, 2026, the Company entered into Amendment No. 3 to the White Lion Purchase Agreement. Amendment No. 3 added a new purchase mechanism to the White Lion Purchase Agreement pursuant to which the Company may, during the commitment period, deliver an “Intraday Purchase Notice” (as defined therein) to White Lion, requiring White Lion to purchase a number of Common Shares not to exceed five percent (5%) of the VWAP.
D. Exchange Controls and Other Limitations Affecting Security Holders
Limitations on the ability to acquire and hold shares of the Company may be imposed by the Competition Act (Canada) (the “Competition Act”). This legislation permits the Commissioner of Competition to review any acquisition of a significant interest in us. This legislation grants the Commissioner jurisdiction, for up to three years, to challenge this type of acquisition before the Competition Tribunal if the Commissioner believes that it would, or would be likely to, result in a substantial lessening or prevention of competition in any market in Canada.
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E. Taxation
Material U.S. Federal Income Tax Considerations for U.S. Holders
The following discussion summarizes the anticipated U.S. federal income tax considerations generally applicable to a U.S. Holder (as defined below) of the ownership and disposition of the Common Shares. This discussion addresses only holders who acquire and hold Common Shares as “capital assets” (generally, assets held for investment purposes).
This summary is based on the Internal Revenue Code of 1986, as amended (the “Code”), U.S. Treasury regulations, administrative pronouncements and rulings of the United States Internal Revenue Service (the “IRS”), and the US Treaty, all as in effect on the date hereof, and all of which may be repealed, revoked or modified (possibly with retroactive effect) so as to result in U.S. federal income tax consequences different from those discussed below. This summary does not describe any state, local or foreign tax law considerations, or any aspect of U.S. federal tax law other than income taxation (e.g., alternative minimum tax, the 3.8% Medicare tax on certain net investment income, or estate or gift tax). Except as specifically set forth below, this summary does not discuss applicable income tax reporting requirements. U.S. Holders should consult their own tax advisers regarding such matters.
No ruling from the IRS has been requested, or will be obtained, regarding the U.S. federal income tax consequences of the ownership or disposition of the Common Shares. This summary is not binding on the IRS, and the IRS is not precluded from taking a position that is different from, and contrary to, the discussion set forth in this summary. In addition, because the authorities on which this summary is based are subject to various interpretations, the IRS and U.S. courts could disagree with one or more of the positions taken in this summary.
This summary does not purport to address all U.S. federal income tax consequences that may be relevant to a U.S. Holder as a result of the ownership and disposition of the Common Shares, nor does it take into account the specific circumstances of any particular holder, some of which may be subject to special tax rules, including, but not limited to, tax exempt organizations, partnerships and other pass-through entities and their owners, banks or other financial institutions, insurance companies, regulated investment companies, real estate investment trusts, qualified retirement plans, individual retirement accounts or other tax-deferred accounts, persons that hold the Common Shares as part of a straddle, hedging transaction, conversion transaction, constructive sale or other similar arrangements, persons that acquired the Common Shares in connection with the exercise of employee share options or otherwise as compensation for services, persons that are resident or ordinarily resident in or have permanent establishment in a jurisdiction outside the United States, dealers in securities or foreign currencies, traders in securities electing to mark to market, U.S. persons whose functional currency (as defined in the Code) is not the U.S. dollar, U.S. expatriates, or persons that own directly, indirectly or by application of the constructive ownership rules of the Code 10% or more of the Company’s shares by voting power or by value.
As used herein, a “U.S. Holder” is a beneficial owner of the Common Shares who, for U.S. federal income tax purposes, is: (1) an individual who is a citizen or resident of the United States; (2) a corporation (or other entity treated as a corporation for U.S. federal income tax purposes) that is created or organized in or under the laws of the United States, any state thereof, or the District of Columbia, (3) an estate whose income is subject to U.S. federal income tax regardless of its source, or (4) a trust (A) if a U.S. court is able to exercise primary supervision over the administration of the trust and one or more U.S. persons have the authority to control all substantial decisions of the trust, or (B) that has validly elected to be treated as a U.S. person for U.S. federal income tax purposes.
If a partnership (or other entity or arrangement treated as a partnership for U.S. federal income tax purposes) holds the Common Shares, the tax treatment of a partner in or owner of the partnership or other entity or arrangement will generally depend upon the status of the partner or owner and the activities of the entity. Prospective investors who are partners in partnerships (or other entities or arrangements treated as partnerships for U.S. federal income tax purposes) that are beneficial owners of the Common Shares are urged to consult their own tax advisors regarding the tax consequences of the ownership and disposition of the Common Shares.
This summary is of a general nature only and is not intended to be tax advice to any prospective investor, and no representation with respect to the tax consequences to any particular investor is made. Prospective investors are urged to consult their own tax advisors regarding the application of federal income tax laws to their particular circumstances, as well as any state, provincial, local, non-U.S. and other tax consequences of investing in the Common Shares and acquiring, holding or disposing of the Common Shares.
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Passive Foreign Investment Company Rules
A non-U.S. corporation is considered a PFIC for any taxable year if either:
| ● | at least 75% of its gross income for such taxable year is passive income; or |
| ● | at least 50% of the value of its assets (based on an average of the quarterly values of the assets during a taxable year) is attributable to assets that produce or are held for the production of passive income (the “asset test”). |
Passive income generally includes dividends, interest, rents and royalties (other than rents or royalties derived from the active conduct of a trade or business) and gains from the disposition of passive assets. We will be treated as owning our proportionate share of the assets and earning our proportionate share of the income of any other corporation in which we own, directly or indirectly, at least 25% (by value) of the shares. In determining the value and composition of our assets for purposes of the PFIC asset test, the value of our assets must be determined based on the market value of our Common Shares from time to time, which could cause the value of our non-passive assets to be less than 50% of the value of all of our assets on any particular quarterly testing date for purposes of the asset test.
We must make a separate determination each year as to whether we are a PFIC. Depending on the amount of our cash and other assets held for the production of passive income, it is possible that, for our current taxable year or for any subsequent taxable year, more than 50% of our assets may be assets held for the production of passive income. We will make this determination following the end of any particular tax year. Although the law in this regard is unclear, we treat our consolidated affiliated entities as being owned by us for United States federal income tax purposes, not only because we exercise effective control over the operation of such entities but also because we are entitled to substantially all of their economic benefits, and, as a result, we consolidate their operating results in our consolidated financial statements. In particular, because the value of our assets for purposes of the asset test will generally be determined based on the market price of our Common Shares and because cash is generally considered to be an asset held for the production of passive income, our PFIC status will depend in large part on the market price of our Common Shares and the amount of our cash and other assets held for the production of passive income. Accordingly, fluctuations in the market price of the Common Shares may cause us to become a PFIC. In addition, the application of the PFIC rules is subject to uncertainty in several respects. We are under no obligation to take steps to reduce the risk of our being classified as a PFIC. As stated above, the determination of the value of our assets will depend upon material facts (including the market price of our Common Shares from time to time) that may not be within our control, and no opinion of counsel has or will be provided regarding our classification as a PFIC. If we are a PFIC for any year during which you hold Common Shares, we will continue to be treated as a PFIC for all succeeding years during which you hold Common Shares. However, if we cease to be a PFIC and you did not previously make a timely “mark-to-market” election as described below, you may avoid some of the adverse effects of the PFIC regime by making a “purging election” (as described below) with respect to the Common Shares.
If we are a PFIC for your taxable year(s) during which you hold Common Shares, you will be subject to special tax rules with respect to any “excess distribution” that you receive and any gain you realize from a sale or other disposition (including a pledge) of the Common Shares, unless you make a “mark-to-market” election as discussed below. Distributions you receive in a taxable year that are greater than 125% of the average annual distributions you received during the shorter of the three preceding taxable years or your holding period for the Common Shares will be treated as an excess distribution. Under these special tax rules:
| ● | the excess distribution or gain will be allocated ratably over your holding period for the Common Shares; |
| ● | the amount allocated to your current taxable year, and any amount allocated to any of your taxable year(s) prior to the first taxable year in which we were a PFIC, will be treated as ordinary income, and |
| ● | the amount allocated to each of your other taxable year(s) will be subject to the highest tax rate in effect for that year and the interest charge generally applicable to underpayments of tax will be imposed on the resulting tax attributable to each such year. |
The tax liability for amounts allocated to years prior to the year of disposition or “excess distribution” cannot be offset by any net operating losses for such years, and gains (but not losses) realized on the sale of the Common Shares cannot be treated as capital, even if you hold the Common Shares as capital assets.
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A U.S. Holder of “marketable stock” (as defined below) in a PFIC may make a mark-to-market election for such stock to elect out of the tax treatment discussed above. If you make a mark-to-market election for the first taxable year during which you hold (or are deemed to hold) Common Shares and for which we are determined to be a PFIC, you will include in your income each year an amount equal to the excess, if any, of the fair market value of the Common Shares as of the close of such taxable year over your adjusted basis in such Common Shares, which excess will be treated as ordinary income and not capital gain. You are allowed an ordinary loss for the excess, if any, of the adjusted basis of the Common Shares over their fair market value as of the close of the taxable year. However, such ordinary loss is allowable only to the extent of any net mark-to-market gains on the Common Shares included in your income for prior taxable years. Amounts included in your income under a mark-to-market election, as well as gain on the actual sale or other disposition of the Common Shares, are treated as ordinary income. Ordinary loss treatment also applies to any loss realized on the actual sale or disposition of the Common Shares, to the extent that the amount of such loss does not exceed the net mark-to-market gains previously included for such Common Shares. Your basis in the Common Shares will be adjusted to reflect any such income or loss amounts. If you make a valid mark-to-market election, the tax rules that apply to distributions by corporations which are not PFICs would apply to distributions by us, except that the lower applicable capital gains rate for qualified dividend income discussed above under “— Taxation of Dividends and Other Distributions on our Common Shares” generally would not apply.
The mark-to-market election is available only for “marketable stock”, which is stock that is traded in other than de minimis quantities on at least 15 days during each calendar quarter (“regularly traded”) on a qualified exchange or other market (as defined in applicable U.S. Treasury regulations), including Nasdaq. U.S. holders should consult their own tax advisors regarding the availability and tax consequences of a mark-to-market election in respect to our Common Shares under their particular circumstances.
Alternatively, a U.S. Holder of stock in a PFIC may make a “qualified electing fund” election with respect to such PFIC to elect out of the tax treatment discussed above. A U.S. Holder who makes a valid qualified electing fund election with respect to a PFIC will generally include in gross income for a taxable year such holder’s pro rata share of the corporation’s earnings and profits for the taxable year. However, the qualified electing fund election is available only if such PFIC provides such U.S. Holder with certain information regarding its earnings and profits as required under applicable U.S. Treasury regulations. We do not currently intend to prepare or provide the information that would enable you to make a qualified electing fund election. If you hold Common Shares in any taxable year in which we are a PFIC, you will be required to file IRS Form 8621 in each such year and provide certain annual information regarding such Common Shares, including regarding distributions received on the Common Shares and any gain realized on the disposition of the Common Shares.
If you do not make a timely “mark-to-market” election (as described above), and if we were a PFIC at any time during the period you hold our Common Shares, then such Common Shares will continue to be treated as stock of a PFIC with respect to you even if we cease to be a PFIC in a future year, unless you make a “purging election” for the year we cease to be a PFIC. A “purging election” creates a deemed sale of such Common Shares at their fair market value on the last day of the last year in which we are treated as a PFIC. The gain recognized by the purging election will be subject to the special tax and interest charge rules treating the gain as an excess distribution, as described above. As a result of the purging election, you will have a new basis (equal to the fair market value of the Common Shares on the last day of the last year in which we are treated as a PFIC) and holding period (which new holding period will begin the day after such last day) in your Common Shares for tax purposes.
You are urged to consult your tax advisors regarding the application of the PFIC rules to your investment in our Common Shares and the elections discussed above.
Distributions on Common Shares
In general, subject to the PFIC rules discussed above, the gross amount of any distribution received by a U.S. Holder with respect to the Common Shares (including amounts withheld to pay Canadian withholding taxes) will be included in the gross income of the U.S. Holder as a dividend to the extent attributable to the Company’s current and accumulated earnings and profits, as determined under U.S. federal income tax principles. Because the Company does not expect to maintain calculations of the Company’s earnings and profits in accordance with U.S. federal income tax principles, U.S. Holders should expect that a distribution will generally be treated as a dividend for U.S. federal income tax purposes.
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The amount of any distributions paid in Canadian dollars will equal the U.S. dollar value of such distributions determined by reference to the exchange rate on the day they are received by the U.S. Holder (with the value of such distributions computed before any reduction for any Canadian withholding tax), regardless of whether the payment is in fact converted into U.S. dollars at that time. A U.S. Holder will have a tax basis in Canadian dollars equal to their U.S. dollar value on the date of receipt. If the Canadian dollars received are converted into U.S. dollars on the date of receipt, the U.S. Holder will generally not be required to recognize foreign currency gain or loss in respect of the distribution. If the Canadian dollars received are not converted into U.S. dollars on the date of receipt, a U.S. Holder may recognize foreign currency gain or loss on a subsequent conversion or other disposition of the Canadian dollars. Such gain or loss generally will be treated as U.S. source ordinary income or loss.
Subject to applicable limitations and provided the Company is eligible for the benefits of the US Treaty or the Common Shares are readily tradable on a United States securities market, dividends paid by the Company to non-corporate US Holders, including individuals, generally will be eligible for the preferential tax rates applicable to long-term capital gains for dividends, provided certain holding period and other conditions are satisfied, including that the Company is not classified as a PFIC in the tax year of distribution or in the preceding tax year. Any amount of distributions treated as dividends generally will not be eligible for the dividends received deduction available to certain corporate U.S. Holders in respect of dividends received from U.S. corporations.
Distributions to a U.S. Holder with respect to the Common Shares may be subject to Canadian non-resident withholding tax. Any Canadian withholding tax paid will not reduce the amount treated as received by the U.S. Holder for U.S. federal income tax purposes. However, subject to limitations imposed by U.S. law, a U.S. Holder may be eligible to receive a foreign tax credit for the Canadian withholding tax. The rules governing the foreign tax credit are complex. U.S. Holders are urged to consult their own tax advisors regarding the availability of the foreign tax credit under their particular circumstances, including the impact of, and any exception available to, the special income sourcing rule described in this paragraph. U.S. Holders who do not elect to claim a foreign tax credit may be able to claim an ordinary income tax deduction for Canadian income tax withheld, but only for a taxable year in which the U.S. Holder elects to do so with respect to all non-U.S. income taxes paid or accrued in such taxable year.
Sale, Exchange or Other Taxable Disposition of Common Shares
Subject to the PFIC rules discussed above, upon a sale, exchange or other taxable disposition of the Common Shares, a U.S. Holder will generally recognize a capital gain or loss equal to the difference between the amount realized on such sale, exchange or other taxable disposition and the adjusted tax basis of such Common Shares. If any foreign tax is imposed on the sale, exchange or other disposition of the Common Shares, a U.S. Holder’s amount realized will include the gross amount of the proceeds of the disposition before deduction of the tax. A U.S. Holder’s initial tax basis in the Common Shares generally will equal the cost of such Common Shares. Such gain or loss will be a long-term capital gain or loss if the Common Shares have been held for more than one year and will be short-term gain or loss if the holding period is equal to or less than one year. Such gain or loss generally will be considered U.S. source gain or loss for U.S. foreign tax credit purposes. Long-term capital gains of certain non-corporate U.S. Holders are eligible for reduced rates of taxation. For both corporate and non-corporate U.S. Holders, limitations apply to the deductibility of capital losses.
Information Reporting and Backup Withholding
In general, dividends paid to a U.S. Holder in respect of the Common Shares and the proceeds received by a U.S. Holder from the sale, exchange or other disposition of the Common Shares within the United States or through certain U.S.-related financial intermediaries will be subject to U.S. information reporting rules, unless a U.S. Holder is a corporation or other exempt recipient and properly establishes such exemption. Backup withholding may apply to such payments if a U.S. Holder does not establish an exemption from backup withholding and fails to provide a correct taxpayer identification number and make any other required certifications.
Backup withholding is not an additional tax. Any amounts withheld under the backup withholding rules will be allowed as a refund or credit against U.S. federal income tax liability, provided that the required information is timely furnished to the IRS.
In addition, U.S. Holders should be aware of reporting requirements with respect to the holding of certain foreign financial assets, including stock of foreign issuers which is not held in an account maintained by certain financial institutions, if the aggregate value of all of such assets exceeds U.S.$50,000. U.S. Holders must attach a complete IRS Form 8938, Statement of Specified Foreign Financial Assets, with their return for each year in which they hold the Common Shares. U.S. Holders should also be aware that if the Company were a PFIC, they would generally be required to file IRS Form 8621, Information Return by a Shareholder of a Passive Foreign Investment Company or Qualified Electing Fund, during any taxable year in which such U.S. Holder recognizes gain or receives an excess distribution or with respect to which the U.S. Holder has made certain elections. U.S. Holders are urged to consult their own tax advisors regarding the application of the information reporting rules to the Common Shares and their particular situations.
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Material Canadian Federal Income Tax Considerations
The following is a summary of the principal Canadian federal income tax considerations generally applicable to a person (a “Holder”) who acquires as a beneficial owner our Common Shares, and who, at all relevant times, for purposes of the application of the Income Tax Act (Canada) and the regulations adopted thereunder (collectively, the “Canada Tax Act”): (i) deals at arm’s length with the Company; (ii) is not affiliated with the Company; (iii) holds our Common Shares as capital property; and (iv) has not entered into, with respect to any of our Common Shares, a “derivative forward agreement” or a “dividend rental arrangement,” each as defined in the Canada Tax Act. Generally, our Common Shares will be capital property to a Holder provided the Holder does not acquire or hold such Common Shares in the course of carrying on a business or as part of an adventure or concern in the nature of trade.
This summary is based upon the current provisions of the Canada Tax Act, and an understanding of the current administrative practices published in writing by the Canada Revenue Agency prior to the date hereof. This summary takes into account all specific proposals to amend the Canada Tax Act publicly announced by, or on behalf of, the Minister of Finance (Canada) prior to the date hereof (the “Proposed Amendments”) and assumes that all Proposed Amendments will be enacted in the form proposed. This summary does not otherwise take into account or anticipate any changes in law or administrative policy, whether by legislative, governmental or judicial decision or action, and does not take into account or consider any provincial, territorial or foreign income tax considerations.
This summary is of a general nature only and is not exhaustive of all possible Canadian federal income tax considerations. It is not, is not intended to be, and should not be construed to be legal or tax advice to any particular Holder. Accordingly, Holders are urged to consult their own tax advisors having regard to their own particular circumstances.
Currency Conversion
Generally, for purposes of the Canada Tax Act, all amounts relating to the acquisition, holding or disposition of our Common Shares must be expressed into Canadian dollars. Amounts denominated in another currency must be converted into Canadian dollars based on exchange rates as determined in accordance with the Canada Tax Act.
Holders Not Resident in Canada
The following portion of the summary is generally applicable to a Holder who, at all relevant times, for purposes of the Canada Tax Act: (i) is not, and is not deemed to be, a resident of Canada, and (ii) does not use or hold, and is not deemed to use or hold, our Common Shares in a business carried on in Canada (a “Non-Resident Holder”). Special rules, which are not discussed in this summary, may apply to a Non-Resident Holder that is an insurer that carries on an insurance business in Canada and elsewhere.
Dividends
Dividends paid or credited, or deemed under the Canada Tax Act to be paid or credited, by the Company to a Non-Resident Holder on our Common Shares will generally be subject to Canadian withholding tax under the Canada Tax Act at the rate of 25% of the gross amount of the dividend, subject to any reduction in the rate of withholding to which the Non-Resident Holder is entitled under any applicable income tax convention.
Dispositions
A Non-Resident Holder for whom our Common Shares are not or are not deemed to be “taxable Canadian property” for purposes of the Canada Tax Act will generally not be subject to income tax under the Canada Tax Act on the disposition or deemed disposition of such shares.
Generally, provided that our Common Shares are listed on a “designated stock exchange” (which includes the Nasdaq), our Common Shares will not be taxable Canadian property to a Non-Resident Holder at a particular time unless at any time during the 60-month period that ends at that particular time, both of the following conditions were satisfied: (a) one or any combination of (i) the Non-Resident Holder, (ii) persons with whom the Non-Resident Holder did not deal at arm’s length (for purposes of the Canada Tax Act), and (iii) partnerships in which the Non-Resident Holder or a person with whom the Non-Resident Holder did not deal at arm’s length held a membership interest directly or indirectly through one or more partnerships, owned 25% or more of the issued shares of any class or series of a class of the capital stock of the Company, and at that time (b) more than 50% of the fair market value of our Common Shares was derived directly or indirectly from one or any combination of real or immovable property situated in Canada, “Canadian resource properties” (as defined in the Canada Tax Act), “timber resource properties” (as defined in the Canada Tax Act) or options in respect of, interests in, or for civil law rights in, any such property, whether or not such property exists. Notwithstanding the foregoing, our Common Shares may otherwise be deemed to be taxable Canadian property of a Non-Resident Holder in certain circumstances. The Non-Resident Holders for whom Common Shares may constitute taxable Canadian property should consult their own tax advisors.
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Holders Resident in Canada
The following portion of the summary is generally applicable to a Holder who, at all relevant times, for purposes of the Canada Tax Act, is or is deemed to be resident in Canada (a “Canadian Resident Holder”). Certain Canadian Resident Holders may be entitled to make, or may have already made, the irrevocable election permitted by subsection 39(4) of the Canada Tax Act the effect of which may be to deem to be capital property any of our Common Shares (and all other “Canadian securities”, as defined in the Canada Tax Act) owned by such Resident Holder in the taxation year in which the election is made and in all subsequent taxation years. Resident Holders whose Common Shares might not otherwise be considered to be capital property should consult their own tax advisors concerning this election.
This portion of the summary is not applicable to a Canadian Resident Holder (i) that is a “specified financial institution”, (ii) an interest in which is, or for whom the Securities would be, a “tax shelter investment”, (iii) that is a “financial institution” for purposes of the “mark-to-market” rules in the Canada Tax Act, (iv) that reports its “Canadian tax results” in a currency other than Canadian currency, or (v) that is a corporation resident in Canada that is, becomes, or does not deal at arm’s length for purposes of the Canada Tax Act with a corporation resident in Canada that is or becomes, as part of a transaction or event or series of transactions or events that includes the acquisition of our Common Shares, controlled by a non-resident person (or a group of such persons not dealing with each other at arm’s length) for purposes of the “foreign affiliate dumping” rules in section 212.3 of the Canada Tax Act.
Dividends
A Canadian Resident Holder will be required to include in computing its income for a taxation year any dividends received (or deemed to have been received) on our Common Shares. In the case of a Canadian Resident Holder that is an individual (other than certain trusts), such dividends will be subject to the gross-up and dividend tax credit rules applicable to taxable dividends received from “taxable Canadian corporations”, including the enhanced gross-up and dividend tax credit applicable to any dividends designated by the Company as an “eligible dividend” in accordance with the provisions of the Canada Tax Act. A dividend received (or deemed to have been received) by a Canadian Resident Holder that is a corporation will generally be deductible in computing the corporation’s taxable income. In certain circumstances, however, a taxable dividend received (or deemed to have been received) by a Canadian Resident Holder that is a corporation will be deemed to be either proceeds of disposition or a gain from the disposition of a capital property. Canadian Resident Holders that are corporations should consult their own tax advisors having regard to their own particular circumstances.
A Canadian Resident Holder that is a “private corporation”, as defined in the Canada Tax Act, or any other corporation controlled, whether because of a beneficial interest in one or more trusts or otherwise, by or for the benefit of an individual (other than a trust) or a related group of individuals (other than trusts), will generally be liable to pay a refundable tax under Part IV of the Canada Tax Act on dividends received (or deemed to have been received) on our Common Shares to the extent such dividends are deductible in computing the Canada Resident Holder’s taxable income for the taxation year.
Dividends received or deemed to be received by a Canadian Resident Holder who is an individual (other than certain trusts) may result in such Canadian Resident Holder being liable for alternative minimum tax under the Canada Tax Act.
Dispositions
Generally, a Canadian Resident Holder who disposes of, or is deemed for purposes of the Canada Tax Act to have disposed of our Common Shares will realize a capital gain (or a capital loss) in the taxation year of the disposition equal to the amount by which the proceeds of disposition of the Common Shares exceed (or are less than) the total of (1) the adjusted cost base to the Canadian Resident Holder of the Common Shares determined immediately before the disposition, and (2) any reasonable costs of disposition.
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Subject to the Capital Gains Proposal (as defined and discussed below), (i) one-half of any capital gain (a “taxable capital gain”) realized by a Canadian Resident Holder from a disposition of our Common Shares must be included in the Canadian Resident Holder’s income for the taxation year of disposition, and (ii) subject to and in accordance with the provisions of the Canada Tax Act, a Canadian Resident Holder will generally be required to deduct one-half of any capital loss (an “allowable capital loss”) realized in the taxation year of disposition against taxable capital gains realized in the same taxation year. Any unused allowable capital losses for the taxation year of disposition may generally reduce net taxable capital gains realized in any of the three prior taxation years or in any subsequent year in the circumstances and to the extent provided in the Canada Tax Act.
A Canadian Resident Holder that is an individual (other than certain trusts) that realizes a capital gain on the disposition or deemed disposition of our Common Shares may be liable for alternative minimum tax under the Canada Tax Act. Canadian Resident Holders that realize or could realize capital gains in connection with their Common Shares should consult their own tax advisors in this regard
If a Canadian Resident Holder is a corporation, any capital loss realized on a disposition or deemed disposition of our Common Shares may, in certain circumstances, be reduced by the amount of any dividends which have been received or which are deemed to have been received on such Common Shares. Similar rules may apply where a Canadian Resident Holder that is a corporation is a member of a partnership or a beneficiary of a trust that owns our Common Shares directly or indirectly through a partnership or a trust. Canadian Resident Holders to whom these rules may be relevant should consult their own tax advisors.
Additional Refundable Tax
A Canadian Resident Holder that is a “Canadian-controlled private corporation” (as defined in the Canada Tax Act) throughout the relevant taxation year or a “substantive CCPC” (as defined in the Canada Tax Act) at any time in the year, may be liable to pay an additional tax (refundable in certain circumstances) on its “aggregate investment income” (as defined in the Canada Tax Act) for the year, including taxable capital gains realized on the disposition of our Common Shares. Canadian Resident Holders that are “Canadian-controlled private corporations” or “substantive CCPCs” should consult their own tax advisors regarding their particular circumstances.
Eligibility for Investment
Provided that our Common Shares are listed on a “designated stock exchange” for the purposes of the Canada Tax Act (which currently includes the Nasdaq Global Market), our Common Shares will be, at such time, “qualified investments” under the Canada Tax Act for trusts governed by a registered retirement savings plan (“RRSP”), a registered retirement income fund (“RRIF”), a registered education savings plan (“RESP”), a deferred profit sharing plan, a registered disability savings plan (“RDSP”), a tax-free savings account (“TFSA”), or a first home savings account (“FHSA”), each as defined in the Canada Tax Act.
Notwithstanding the foregoing, if our Common Shares held by a TFSA, RRSP, RRIF, RDSP, FHSA, or RESP (a “Registered Plan”) are “prohibited investments” for purposes of the Canada Tax Act, the holder of the TFSA, FHSA or RDSP, the annuitant of the RRSP or RRIF, or the subscriber of a RESP (as the case may be) will be subject to a penalty tax as set out in the Canada Tax Act. Our Common Shares will generally be a “prohibited investment” if the holder of a TFSA, FHSA or RDSP, the annuitant of a RRSP or RRIF, or the subscriber of a RESP (as the case may be): (i) does not deal at arm’s length with the Company for purposes of the Canada Tax Act; or (ii) has a “significant interest” (within the meaning of the Canada Tax Act) in the Company. In addition, our Common Shares will not be a prohibited investment if such Common Shares are “excluded property”, as defined in the Canada Tax Act, for the Registered Plan. Holders who intend to hold our Common Shares in a Registered Plan should consult their own tax advisors in this regard.
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EACH PROSPECTIVE INVESTOR IS URGED TO CONSULT ITS OWN TAX ADVISOR ABOUT THE TAX CONSEQUENCES TO IT OF AN INVESTMENT IN COMMON SHARES IN LIGHT OF THE INVESTOR’S OWN CIRCUMSTANCES.
F. Dividends and Paying Agents
Not applicable.
G. Statement by Experts
Not applicable.
H. Documents on Display
We are subject to the informational requirements of the Exchange Act. Accordingly, we are required to file reports and other information with the SEC, including annual reports on Form 20-F and reports on Form 6-K. The SEC maintains an Internet site at www.sec.gov that contains reports, proxy and information statements and other information we have filed electronically with the SEC. As a foreign private issuer, we are exempt under the Exchange Act from, among other things, the rules prescribing the furnishing and content of proxy statements, and our executive officers, directors and principal shareholders are exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition, we are not required under the Exchange Act to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. companies whose securities are registered under the Exchange Act.
We also make available on our website, free of charge, our annual reports and the text of our reports on Form 6-K, including any amendments to these reports, as well as certain other SEC filings, as soon as reasonably practicable after they are electronically filed with or furnished to the SEC. Our website address is www.psyence.com. The reference to our website is an inactive textual reference only, and information contained therein or connected thereto is not incorporated into this Report.
I. Subsidiary Information
Not applicable.
J. Annual Report to Security Holders.
Not applicable.
ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS
The information set forth under Item 5 above is incorporated into herein by reference.
ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
A. Debt Securities
Not applicable.
B. Warrants and Rights
Not applicable.
C. Other Securities
Not Applicable.
D. American Depository Shares
Not Applicable.
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PART II
ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES
Not applicable.
ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS
Not applicable.
ITEM 15. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
At the end of the period covered by this Report, an evaluation of the effectiveness of the design and operation of the Company’s “disclosure controls and procedures” (as such term is defined in Rule 13a-15(e) and Rule 15d-15(e) under the Exchange Act) was carried out by the Company’s principal executive officer (the “CEO”) and principal financial officer (the “CFO”). There are inherent limitations to the effectiveness of any system of disclosure controls and procedures, including the possibility of human error and the circumvention or overriding of the controls and procedures. Accordingly, even effective disclosure controls and procedures can only provide reasonable assurance of achieving their control objectives. Based upon their evaluation, the Company’s CEO and CFO have concluded that, as of the end of the period covered by this Report, the design and operation of the Company’s disclosure controls and procedures were effective.
Management’s Annual Report on Internal Control over Financial Reporting.
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is a process designed under the supervision of our principal executive and principal financial officers to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with IFRS as issued by the IASB.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate due to changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Under the supervision and with the participation of our management, including our principal executive and principal financial officers, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of March 31, 2026. Based on this evaluation, our management concluded that our internal control over financial reporting was effective as of March 31, 2026.
Attestation Report of the Registered Public Accounting Firm.
This Report does not include an attestation report of the Company’s independent registered public accounting firm regarding internal control over financial reporting, as the Company is not required to obtain such an attestation pursuant to the rules of the Securities and Exchange Commission applicable to emerging growth companies and non-accelerated filers.
Changes in Internal Control over Financial Reporting
There has been no change in the Company’s internal control over financial reporting during the fiscal year ended March 31, 2026 that has materially affected, or is reasonably likely to materially affect, its internal control over financial reporting.
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ITEM 16. [RESERVED]
ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT
The Company’s Audit Committee consists of Marc Balkin, Graham Patrick and Sashank Pillay. Mr. Balkin is an “audit committee financial expert” within the meaning of SEC regulations. Mr. Balkin serves as the chairperson of the Audit Committee. Each member of the Audit Committee can read and understand fundamental financial statements in accordance with applicable requirements. In arriving at these determinations, the Board will examine each Audit Committee member’s scope of experience and the nature of their employment. For a description of the education and experience of each member of the Audit Committee, see “Item 6A. Directors, Senior Management and Employees.”
ITEM 16B. CODE OF ETHICS
We have adopted a code of ethics that applies to all of our executive officers, directors and employees in accordance with the rules of the Nasdaq and the SEC. The code of ethics codifies the business and ethical principles that govern all aspects of our business. You will be able to review these documents by accessing our public filings at the SEC’s website at www.sec.gov. The code of ethics is also available on the Company’s website at www.psyencebiomed.com.
ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The aggregate fees billed by the Company’s external auditors in each of the last two fiscal years are as follows.
| March 31, 2026 | March 31, 2025 | |||||||
| Audit fees | $ | 158,926 | $ | 152,253 | ||||
| Audit-related fees | $ | - | $ | — | ||||
| Tax fees | $ | - | $ | — | ||||
| All other fees | $ | - | $ | — | ||||
| Total | $ | 158,926 | $ | 152,253 | ||||
Notes:
The policy of the Company’s Audit Committee is to pre-approve all audit and non-audit services provided by MNP LLP, its current independent registered public accounting firm, including audit services, audit-related services, tax services, and other services as described above. Pursuant to this policy, the Audit Committee pre-approved all of the services provided to us by MNP during the year since the Closing.
ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES
Not applicable.
ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE COMPANY AND AFFILIATED PURCHASERS
Not applicable.
ITEM 16F. CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT
Not applicable.
ITEM 16G. CORPORATE GOVERNANCE
The information set forth in Item 6B above under the caption “Corporate Governance Practices and Foreign Private Issuer Status” is incorporated herein by reference.
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ITEM 16H. MINE SAFETY DISCLOSURE
Not applicable.
ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
ITEM 16J. INSIDER TRADING POLICIES
Our Board has
ITEM 16K. CYBERSECURITY
The Company has implemented cybersecurity
risk management measures intended to protect the confidentiality, integrity, and availability of its critical systems and information.
The cybersecurity risk management measures set
out the foundation of the process for assessing, identifying and managing material risks from cybersecurity threats and provide guidance
for response plan when facing cybersecurity threats. The Company has
There can be no assurance that the Company’s
cybersecurity risk management measures and processes, including its policies, controls or procedures, will be fully implemented, complied
with or effective in protecting the Company’s systems and information.
Cybersecurity Governance
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PART III
ITEM 17. FINANCIAL STATEMENTS
See Item 18.
ITEM 18. FINANCIAL STATEMENTS
Financial Statements Filed as Part of this Annual Report:
Audited consolidated financial statements for the years ended March 31, 2026, March 31, 2025 and March 31, 2024.
ITEM 19. EXHIBITS
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| # | The exhibits and schedules to this Exhibit have been omitted in accordance with Item 601(b)(2) of Regulation S-K. The Registrant agrees to furnish supplementally to the SEC a copy of all omitted exhibits and schedules upon its request. |
| † | Indicates a management contract or compensation plan. |
| * | Filed herewith. |
| ** | Furnished herewith |
| ^ | Certain confidential portions (indicated by brackets and asterisks) have been omitted from this exhibit. |
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SIGNATURE
The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this report on its behalf.
| Dated: June 22, 2026 | PSYENCE BIOMEDICAL LTD. | |
| By: | /s/ Jody Aufrichtig | |
| Name: | Jody Aufrichtig | |
| Title: | Chief Executive Officer | |
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INDEX TO FINANCIAL STATEMENTS
Consolidated Financial Statements for Psyence Biomedical Ltd. as of and for the Years ended March 31, 2026 and 2025
F-1
Psyence Biomedical Ltd.
Consolidated Financial Statements
For the years ended March 31, 2026, 2025 and 2024
Expressed in United States Dollars
(USD $)
F-2
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
Management’s Responsibility for Financial Reporting
The accompanying consolidated financial statements of the Company have been prepared by management in accordance with IFRS® Accounting Standards as issued by the International Accounting Standard Board. These consolidated financial statements contain estimates based on management’s judgment. Management maintains an appropriate system of internal controls to provide reasonable assurance that transactions are authorized, assets safeguarded, and proper records maintained.
The Audit Committee of the Board of Directors reviews the results of the annual audit and the consolidated financial statements prior to submitting the consolidated financial statements to the Board for approval.
The Company’s auditors, MNP LLP, are appointed by the audit committee to conduct an audit and their report follows.
| “Jody Aufrichtig” | |
| Chief Executive Officer |
Toronto, Canada
June 22, 2026
F-3
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
| REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM |  |
To the Board of Directors and Shareholders of Psyence Biomedical Ltd.
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated statements of financial position of Psyence Biomedical Ltd. (the “Company”) as at March 31, 2026 and 2025, and the related consolidated statements of net income/(loss) and comprehensive income/(loss), changes in shareholders’ equity/(deficit), and cash flows for the years in the three-year period ended March 31, 2026, and the related notes (collectively referred to as the “consolidated financial statements”).
In our opinion, the consolidated financial statements present fairly, in all material respects, the consolidated financial position of the Company as at March 31, 2026 and 2025, and the results of its consolidated operations and its consolidated cash flows for each of the years in the three-year period ended March 31, 2026, in conformity with IFRS® Accounting Standards as issued by the International Accounting Standards Board.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Chartered Professional Accountants
Licensed Public Accountants
June 22, 2026
We have served as the Company’s auditor since 2023.
| 1 Adelaide Street East, Suite 1900, Toronto ON, M5C 2V9 | 1.877.251.2922 T: 416.596.1711 F: 416.596.7894 |
F-4
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
Consolidated Statements of Financial Position
As at March 31, 2026 and March 31, 2025
| USD $ | Note | As at March 31, 2026 | As at March 31, 2025 | |||||||
| ASSETS | ||||||||||
| Current assets | ||||||||||
| Cash and cash equivalents | 6 | |||||||||
| Restricted cash | 6 | |||||||||
| Other receivables | ||||||||||
| Loan receivable | 8 | |||||||||
| Prepaid expense | 9 | |||||||||
| Total current assets | ||||||||||
| Non-current assets | ||||||||||
| Digital Assets | 7 | |||||||||
| Equipment | 10 | |||||||||
| Investment in Associate | 11 | |||||||||
| Investment in Psyence Labs Ltd | 11 | |||||||||
| TOTAL ASSETS | ||||||||||
| LIABILITIES | ||||||||||
| Current liabilities | ||||||||||
| Accounts payable and accrued liabilities | 12 | |||||||||
| Derivative warrant liabilities | 13 | |||||||||
| TOTAL LIABILITIES | ||||||||||
| SHAREHOLDERS’ EQUITY | ||||||||||
| Share Capital | 14 | |||||||||
| Warrants Reserve | 14 | |||||||||
| Options Reserve | 14 | |||||||||
| Accumulated Deficit | ( | ) | ( | ) | ||||||
| Reserves | ||||||||||
| TOTAL SHAREHOLDERS’ EQUITY | ||||||||||
| TOTAL LIABILITIES AND SHAREHOLDERS EQUITY | ||||||||||
Nature of operations (note 1)
Subsequent events (note 25)
Approved on behalf of Board of Directors
| “Jody Aufrichtig” | “Warwick Corden-Lloyd” | |
| Chief Executive Officer and Director | Chief Financial Officer and Director |
The accompanying notes are an integral part of the Consolidated Financial Statements
F-5
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
Consolidated Statements of Net Income/(Loss) and Comprehensive Income/(Loss)
For the years ended March 31, 2026, 2025 and 2024
| USD $ | Note | 2026 | 2025 | 2024 | ||||||||||
| Expenses | ||||||||||||||
| Sales and marketing | ||||||||||||||
| Research and development | ||||||||||||||
| General and administrative | ||||||||||||||
| Professional and consulting fees | ||||||||||||||
| Loss before other items | ( | ) | ( | ) | ( | ) | ||||||||
| Other items | ||||||||||||||
| Other income | 15 | |||||||||||||
| Other expense | 16 | ( | ) | |||||||||||
| Depreciation | 10 | ( | ) | ( | ) | ( | ) | |||||||
| Interest income | ||||||||||||||
| Interest expense | ( | ) | ( | ) | ( | ) | ||||||||
| Foreign exchange loss | ( | ) | ( | ) | ( | ) | ||||||||
| Listing expense | 5 | ( | ) | |||||||||||
| Transaction expense | 5 | ( | ) | |||||||||||
| Gain on debt settlement | 14 | |||||||||||||
| Fair value gain/(loss) on convertible note | 17 | ( | ) | |||||||||||
| Fair value gain/(loss) on warrant liability | 13 | ( | ) | ( | ) | |||||||||
| Fair value gain/(loss) on promissory notes | 18 | ( | ) | |||||||||||
| Fair value loss on warrant exchange | 13 | ( | ) | |||||||||||
| Fair value gain on investment in Psyence Labs Ltd | 11 | |||||||||||||
| Fair value loss on digital assets | 7 | ( | ) | |||||||||||
| Share of losses from Associate | 11 | ( | ) | |||||||||||
| NET INCOME/(LOSS) | ( | ) | ( | ) | ||||||||||
| Other comprehensive income/(loss) | ||||||||||||||
| Foreign exchange gain/(loss) on translation | ( | ) | ||||||||||||
| Other comprehensive income | ||||||||||||||
| TOTAL COMPREHENSIVE INCOME/(LOSS) | ( | ) | ( | ) | ||||||||||
| Income/(Loss) per share - basic and diluted | ( | ) | ( | ) | ||||||||||
| Weighted average number of outstanding shares - basic and diluted | ||||||||||||||
The accompanying notes are an integral part of the Consolidated Financial Statements
F-6
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
Consolidated Statements of Changes in Shareholders’ Equity/(Deficit)
For the years ended March 31, 2026, 2025 and 2024
| USD $ | Note | Number of shares | Share capital | Warrants Reserve | Reserves | Accumulated Deficit | Total shareholders’ equity (deficit) | |||||||||||||||||||
| Opening balance as at April 1, 2023 | 3 | ( | ) | ( | ) | |||||||||||||||||||||
| Issuance of shares to Psyence Group Inc | 14 | |||||||||||||||||||||||||
| Issuance of shares to NCAC shareholders | 5 | |||||||||||||||||||||||||
| Issuance of shares for debt settlement | 14 | |||||||||||||||||||||||||
| Issuance of shares to third party advisors | 14 | |||||||||||||||||||||||||
| Net loss for the year | - | ( | ) | ( | ) | |||||||||||||||||||||
| Other comprehensive income | - | |||||||||||||||||||||||||
| Balance, March 31, 2024 | ( | ) | ( | ) | ||||||||||||||||||||||
| Opening balance as at April 1, 2024 | ( | ) | ( | ) | ||||||||||||||||||||||
| Issuance of shares to third party advisors | 14 | |||||||||||||||||||||||||
| Issuance of shares for convertible note | 17 | |||||||||||||||||||||||||
| Issuance of warrants | 17 | - | ||||||||||||||||||||||||
| Issuance of shares for ELOC, net of issuance costs | 19 | |||||||||||||||||||||||||
| Issuance of shares for warrant exchange | 13 | |||||||||||||||||||||||||
| Issuance of shares for promissory notes | 18 | |||||||||||||||||||||||||
| Issuance of shares for Psyence Labs Ltd shares | 11 | |||||||||||||||||||||||||
| Issuance of units for PIPE financing, net of issuance costs | 20 | |||||||||||||||||||||||||
| Issuance of shares for warrant conversion | 17,20 | ( | ) | |||||||||||||||||||||||
| Net profit for the year | - | |||||||||||||||||||||||||
| Other comprehensive loss | - | ( | ) | ( | ) | |||||||||||||||||||||
| Balance, March 31, 2025 | ( | ) | ||||||||||||||||||||||||
F-7
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
| USD $ | Note | Number of shares | Share capital | Warrants Reserve | Options Reserve | Reserves | Accumulated Deficit | Total shareholders’ equity (deficit) | ||||||||||||||||||||||
| Opening balance as at April 1, 2025 | ( | ) | ||||||||||||||||||||||||||||
| Issuance of shares to third party advisors | 14 | |||||||||||||||||||||||||||||
| Issuance of shares for ELOC, net of issuance costs | 19 | |||||||||||||||||||||||||||||
| Issuance of shares for investment in Associate | 11 | |||||||||||||||||||||||||||||
| Share-based compensation | 14 | - | ||||||||||||||||||||||||||||
| Issuance of shares on exercise of RSUs | 14 | ( | ) | |||||||||||||||||||||||||||
| Net loss for the year | - | ( | ) | ( | ) | |||||||||||||||||||||||||
| Other comprehensive loss | - | |||||||||||||||||||||||||||||
| Balance, March 31, 2026 | ( | ) | ||||||||||||||||||||||||||||
The accompanying notes are an integral part of the Consolidated Financial Statements
F-8
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
Consolidated Statements of Cash Flows
For the years ended March 31, 2026, March 31, 2025 and March 31, 2024
| Note | 2026 | 2025 | 2024 | |||||||||||
| Net (loss)/profit | ( | ) | ( | ) | ||||||||||
| Non-cash adjustment: | ||||||||||||||
| Fair value (gain)/loss on convertible note | 17 | ( | ) | |||||||||||
| Fair value loss/(gain) on warrant liability | 13 | ( | ) | |||||||||||
| Fair value (gain)/loss on promissory notes | 18 | ( | ) | |||||||||||
| Fair value loss on warrant exchange | 13 | |||||||||||||
| Fair value gain on Psyence Labs Ltd | 11 | ( | ) | ( | ) | |||||||||
| Fair value loss on Digital Assets | 7 | |||||||||||||
| Share of losses from Associate | 11 | |||||||||||||
| Gain on debt settlement | 14 | ( | ) | |||||||||||
| Share-based compensation | 14 | |||||||||||||
| Third party advisors share issuance | 14 | |||||||||||||
| Depreciation | 10 | |||||||||||||
| Foreign exchange | ( | ) | ||||||||||||
| Listing expense | 5 | |||||||||||||
| Transaction expenses | 5 | |||||||||||||
| Changes in working capital: | ||||||||||||||
| Other receivables | ( | ) | ||||||||||||
| Loan receivable | 8 | ( | ) | |||||||||||
| Prepaids | 9 | ( | ) | ( | ) | |||||||||
| Accounts payable and accrued liabilities | 12 | ( | ) | ( | ) | |||||||||
| Cash used in operating activities | ( | ) | ( | ) | ( | ) | ||||||||
| Additions to equipment | 10 | ( | ) | ( | ) | ( | ) | |||||||
| Increase in restricted cash | 6 | ( | ) | ( | ) | |||||||||
| Investment in Digital Assets | 7 | ( | ) | |||||||||||
| Investment in Psyence Labs Ltd | 11 | ( | ) | |||||||||||
| Cash used for investing activities | ( | ) | ( | ) | ( | ) | ||||||||
| Proceeds received from convertible note | 17 | |||||||||||||
| Payment of promissory note | 18 | ( | ) | |||||||||||
| Net proceeds received from ELOC | 19 | |||||||||||||
| Net proceeds received for unit issuances | 20 | |||||||||||||
| Cash provided from financing activities | ||||||||||||||
| Change in cash and cash equivalents | ( | ) | ||||||||||||
| Cash and cash equivalents, beginning of year | ||||||||||||||
| Cash and cash equivalents, end of year | ||||||||||||||
The accompanying notes are an integral part of the Consolidated Financial Statements
F-9
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
Notes to the Consolidated Financial Statements
1. Nature of operations and going concern
Psyence Biomedical Ltd. (the “Company” or “PBM”), is a life science biotechnology company traded on the Nasdaq exchange (NASDAQ: PBM) that is focused on the development of botanical (nature derived, or non-synthetic) psilocybin-based psychedelic medicines. The Company is working towards developing psychedelic therapeutics to treat mental health disorders. The Company is currently conducting research through clinical trials to evaluate the safety and effectiveness of natural psilocybin in treating adjustment disorder in patients with a cancer diagnosis in a palliative care context (the “Clinical Trials”).
The Company’s registered office is at 121 Richmond Street West, PH Suite 1300, Toronto, Ontario M5H 2K1.
On November 26, 2024, the Company consolidated its common shares and warrants on the basis of 75:1.
On May 5, 2025, the Company consolidated its common shares and warrants on the basis of 7.97:1.
On February 2, 2026, the Company consolidated its common shares and warrants on the basis of 6.25:1.
All prior share capital information has been presented based on these ratios.
Business Combination Agreement and NASDAQ listing
On January 9, 2023 Psyence Group Inc. (“PGI” or “Psyence Group”) entered into a definitive business combination agreement, as amended (the “Business Combination Agreement” or “BCA”) with Newcourt Acquisition Corp. (NASDAQ: NCAC), a special purpose acquisition company (“SPAC”). The agreement aimed to create a public company leveraging natural psilocybin for palliative care treatment. PGI is a listed Canadian company that contributed its clinical trial activities to the Company as described below.
The transaction concluded on January 25, 2024, with PBM’s listing on NASDAQ. This transaction involved PBM acquiring the SPAC through a merger, thereby making the SPAC a wholly-owned subsidiary of PBM.
Transaction Overview:
On January 25, 2024 (the “Closing Date”), the Company, a corporation organized under the laws of Ontario, Canada, completed the previously announced business combination (the “RTO Transaction”) as per the BCA (Note 5). The parties involved in the BCA included:
| - | Psyence Group Inc. |
| - | Newcourt Acquisition Corp., a Cayman Islands exempted company (“NCAC”). |
| - | Newcourt SPAC Sponsor LLC, a Delaware limited liability company (“NCAC Sponsor”). |
| - | Psyence (Cayman) Merger Sub, a Cayman Islands exempted company and a wholly owned subsidiary of Psyence Group. |
| - | Psyence Biomed Corp., a corporation organized under the laws of British Columbia, Canada (“Original Target”). |
| - | Psyence Biomed II Corp., a corporation organized under the laws of Ontario, Canada (“Psyence Biomed II”). |
| - | Psyence Australia (Pty) Ltd (“Psyence Australia”) |
Key Transactions (collectively, the “Business Combination”):
Formation of Subsidiaries: Prior to the Closing Date, PGI formed three wholly owned subsidiaries: Psyence Biomed II, Psyence Australia and PBM.
Amalgamation: Prior to the Closing Date, PGI amalgamated with the Original Target. Consequently, PGI transferred shares of Psyence Australia and related business assets previously owned by the Original Target to Psyence Biomed II.
F-10
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
Share Exchange: PGI contributed Psyence Biomed II to PBM in a share-for-share exchange (the “Company Exchange”).
Merger: Following the Company Exchange, Psyence (Cayman) Merger Sub merged with Newcourt Acquisition Corp., with Newcourt Acquisition Corp. being the surviving entity. Each outstanding ordinary share of Newcourt Acquisition Corp. was converted into the right to receive one common share of PBM.
Warrant Conversion: Each outstanding warrant to purchase Newcourt Acquisition Corp. Class A ordinary shares was converted into warrants to acquire one common share of PBM on substantially the same terms as the original warrants.
These Consolidated Financial Statements provide historical financial information of PBM, reflecting PBM as if it had been historically operating the Clinical Trials conducted by PGI prior to the Closing Date. The Financial Statements are carve-out statements up to January 25, 2024, the date of listing of PBM.
2. Basis of presentation
Statement of compliance
The Consolidated Financial Statements, including comparatives, have been prepared in accordance with IFRS® Accounting Standards as issued by the International Accounting Standard Board (“IFRS”) on a going concern basis.
The Consolidated Financial Statements were authorized for issue on June 22, 2026 by the directors of the Company.
The Consolidated Financial Statements up until January 25, 2024 were presented on a carve out basis (“Carve-out Financial Statements”).
The Consolidated Financial Statements have been prepared on a carve-out basis from the PGI consolidated financial statements for the purpose of presenting the historical financial performance and cash flows of the Company on a stand-alone basis. The accounting policies applied in the Carve-out Financial Statements are, to the extent applicable, consistent with accounting policies applied in the PGI consolidated financial statements, and as a result, reflect the carrying amounts that are included in PGI’s consolidated financial statements.
In determining the perimeter of the Carve-out Financial Statements, the activities related to the Company’s clinical trials were considered to include the operations of Psyence Biomed Corp. and Psyence Australia (Pty) Ltd carried out through PGI directly as well as through legal entities of PGI as detailed above.
In the Carve-out Financial Statements, all intercompany balances and transactions have been eliminated. The transactions and balances with the remaining PGI operations that are not part of these Carve-out Financial Statements have not been eliminated.
The Carve-out Financial Statements present the expenses and cash flows attributable to the clinical trial activities from April 1, 2023 to the Closing Date, and include allocations of certain transactions and balances.
The Company believes the allocation assumptions applied in the Carve-out Financial Statements to be a reasonable reflection of the utilization of services provided by PGI. However, different allocation assumptions could have resulted in different outcomes. The allocations are therefore not necessarily representative of the financial performance or cash flows that would have been reported if the Company operated on its own or as an entity independent from PGI during the periods presented.
The Company believes the basis of preparation described above results in the Carve-out Financial Statements reflects costs associated with the functions that would be necessary to operate independently.
F-11
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
Basis of consolidation
These Consolidated Financial Statements incorporate the accounts of the Company and its subsidiaries performing Clinical Trials. A subsidiary is an entity controlled by PBM and its results are consolidated into the financial results of the Company from the effective date of control up to the effective date of loss of control.
Control exists when an investor is exposed, or has the rights, to variable returns from the involvement with the investee and has liability to affect those returns through its power over the investee.
The subsidiaries of the Company have been consolidated commencing the Closing Date and on March 31, 2026 for the purpose of these Consolidated Financial Statements are as follows:
| Name of entity | Place of incorporation | % ownership | Accounting method | |||||
| Psyence Australia Pty Ltd. | ||||||||
| Pysence Biomed II Corp. | ||||||||
| Newcourt Acquisition Corp. | ||||||||
Inter-company balances and transactions are eliminated upon consolidation.
The financial results of subsidiaries up to January 25, 2024 were presented on a carve out basis.
Basis of measurement
These Consolidated Financial Statements have been prepared on a historical cost basis, except for certain financial instruments, which are classified as fair value through profit or loss (“FVTPL”).
Functional and presentation currency
These Consolidated Financial Statements are presented in United States Dollars (“USD $”), which is also the Company’s functional currency. The Company’s functional currency before the Closing Date was Canadian Dollars.
This changed upon consummation of the BCA at which time the USD $ represents the currency of the Company’s funding and is the currency of the primary economic environment in which the Company operates in, except for the Company’s Australian subsidiary which has an Australian Dollar functional currency. The functional currency of Psyence Biomed II and NCAC is USD $.
See change in accounting policy in note 3 for further details on the change in the Company’s presentation currency.
3. Material accounting policies
Financial instruments
Financial assets and financial liabilities, including derivatives, are recognized on the consolidated statements of financial position when the Company becomes a party to the financial instrument or derivative contract.
Summary of the Company’s classification and measurements of financial assets and liabilities:
| Financial Assets and Liabilities | Classification | Measurement | ||
| Cash and cash equivalents | ||||
| Restricted cash | ||||
| Other receivables | ||||
| Loan receivable | ||||
| Investment in Psyence Labs Ltd | ||||
| Accounts payable and accrued liabilities | ||||
| Derivative warrant liabilities |
F-12
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
Classification
The Company classifies its financial assets in the following measurement categories: i) those to be measured subsequently at fair value through profit or loss (“FVTPL”); ii) those to be measured subsequently at fair value through other comprehensive income (“FVOCI”); and iii) those to be measured at amortized cost. The classification of financial assets depends on the business model for managing the financial assets and the contractual terms of the cash flows. Financial liabilities are classified as those to be measured at amortized cost unless they are designated as those to be measured subsequently at FVTPL (irrevocable election at the time of recognition). For assets and liabilities measured at fair value, gains and losses are either recorded in net loss or other comprehensive income/(loss).
The Company reclassifies financial assets only when its business model for managing those assets changes. Financial liabilities are not reclassified.
Amortized cost
This category includes financial assets that are held within a business model with the objective to hold the financial assets to collect contractual cash flows that meet the sole payments of principal and interest (“SPPI”) criterion. Financial assets and liabilities classified in this category are measured at amortized cost using the effective interest method.
Fair value through profit or loss
This category includes derivative instruments as well as quoted equity instruments which the Company has irrevocably elected, at initial recognition or transition, to classify at FVTPL. This category would also include debt instruments of which the cash flow characteristics fail the solely payments of principal and interest (“SPPI”) criterion or are not held within a business model whose objective is either to collect contractual cash flows, or to both collect contractual cash flows and sell. Financial assets and liabilities in this category are recorded at fair value with changes recognized in net loss. The Company records its financial liabilities including derivatives, convertible loans and promissory notes at FVTPL. Derivatives are mandatorily recorded at FVTPL, whereas the Company has elected to record convertible loans and promissory notes at FVTPL.
Financial assets at fair value through other comprehensive income
Equity instruments that are not held-for-trading can be irrevocably designated to have their change in fair value recognized through other comprehensive income/(loss) instead of through net loss. This election can be made on individual instruments and is not required to be made for the entire class of instruments. Attributable transaction costs are included in the carrying value of the instruments.
Financial assets at fair value through other comprehensive income/(loss) are initially measured at fair value and changes therein are recognized in other comprehensive income/(loss).
Compound financial instrument and derivative liability
The Company determined that the warrants, including public warrants and the private warrants are derivative instruments and should be classified as a financial liability and are measured at FVTPL. Derivative and financial liabilities designated at FVTPL are carried subsequently at fair value with gains or losses recognized in net loss.
Each embedded derivative is measured and presented separately unless the whole hybrid financial instrument is designated as at FVTPL.
F-13
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
Measurement
All financial instruments are required to be measured at fair value on initial recognition, plus, in the case of a financial asset or financial liability not at FVTPL, transaction costs that are directly attributable to the acquisition or issuance of the financial asset or financial liability. Transaction costs of financial assets and financial liabilities carried at FVTPL are expensed in net loss. Financial assets with embedded derivatives are considered in their entirety when determining whether their cash flows are solely payments of principal and interest.
Impairment of financial instruments
The Company recognizes a loss allowance for the expected credit losses associated with its financial assets, other than financial assets measured at fair value through profit or loss. Expected credit losses are measured to reflect a probability-weighted amount, the time value of money, and reasonable and supportable information regarding past events, current conditions and forecasts of future economic conditions. The Company applies the simplified approach for other receivables. Using the simplified approach, the Company records a loss allowance equal to the expected credit losses resulting from all possible default events over the assets’ contractual lifetime. The Company assesses whether there has been a significant increase in credit risk since initial recognition or a financial asset is credit-impaired at the reporting date. Regular indicators that a financial instrument is credit impaired include significant financial difficulties as evidenced through borrowing patterns or observed balances in other accounts and breaches of borrowing contracts such as default events or breaches of borrowing covenants. For financial assets with significant increase in credit risk since initial recognition and financial assets assessed as credit-impaired at the reporting date, the Company continues to recognize a loss allowance equal to lifetime expected credit losses. For financial assets measured at amortized cost, loss allowances for expected credit losses are presented in the statement of financial position as a deduction from the gross carrying amount of the financial asset. Financial assets are written off when the Company has no reasonable expectations of recovering all or any portion thereof.
Cash and cash equivalents
Cash and cash equivalents include cash on hand and, when applicable, short-term, highly liquid deposits which are either cashable or with original maturities of less than three months at the date of their acquisition.
Restricted cash
Restricted cash comprises a collateral agreement with a major chartered bank in Canada with regards to a credit card facility against which the Company deposited in a guaranteed investment certificate with the bank.
Digital Assets
The Company holds digital assets in the form of cryptocurrencies, which are accounted for as intangible assets in accordance with IAS 38 – Intangible Assets. Although IAS 38 does not specifically address cryptocurrencies, management has determined that cryptocurrencies meet the definition of an intangible asset as they are identifiable, non-monetary assets without physical substance that are held for investment purposes and from which the Company expects future economic benefits.
The Company applies the revaluation model under IAS 38, whereby digital assets are carried at fair value at the revaluation date less any subsequent accumulated impairment losses. Fair values are determined by reference to quoted prices on active cryptocurrency exchanges, representing Level 1 inputs under the fair value hierarchy in accordance with IFRS 13 – Fair Value Measurement. Revaluations are performed at each reporting date to ensure the carrying amount does not differ materially from fair value.
Under the revaluation model, increases in carrying amount arising from revaluation are recognized in other comprehensive income and accumulated in a revaluation surplus within equity, except to the extent that they reverse a revaluation decrease previously recognized in profit or loss, in which case the increase is recognized in profit or loss. Decreases in carrying amount are recognized in profit or loss, except to the extent that they reverse a previously recognized revaluation surplus in equity, in which case the decrease is recognized in other comprehensive income.
F-14
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
Related party transactions
Parties are considered to be related if one party has the ability, directly or indirectly, to control the other party in making financial and operating decisions. Parties are also considered to be related if they are subject to common control. Related parties may be individuals or entities. A transaction is considered to be a related party transaction when there is transfer of resources or obligations between related parties.
Change in accounting policy
Pursuant to completion of the Business Combination Agreement and NASDAQ listing as explained in Note 1, on January 25, 2024, the Company decided to change the presentation currency of its consolidated financial statements from Canadian Dollars to United States Dollars.
The Board of Directors believe that US Dollar financial reporting provides more relevant presentation of the Company’s financial position, funding and treasury functions, financial performance and cash flows.
A change in presentation currency represents a change in accounting policy in terms of IAS 8 – Accounting Policies, Changes in Accounting Estimates and Errors, requiring the restatement of comparative information.
In accordance with IAS 21 – The Effects of Changes in Foreign Exchange Rates, the methodology followed in restating historical financial information from CDN $ to USD $.
The average and closing rates used in translating the historical financial information from CDN $ to USD $ for the various periods were as follows:
The closing rate used as at March 31, 2024 was
$
The average rate used for the year ended March
31, 2024 was $
The change in presentation currency is a voluntary change which is accounted for retrospectively. For comparative reporting purposes, historical financial information has been translated to United States dollars which is disclosed in the tables below:
| Change in presentation currency | March 31, Reported | Foreign Currency Translation | March 31, Restated | |||||||||
| EQUITY | ||||||||||||
| Net equity | ( | ) | ( | ) | ||||||||
| NET DEFICIT | ( | ) | ( | ) | ||||||||
Research and development
Expenditures on research activities, undertaken with the prospect of gaining new scientific or technical knowledge and understanding, are recognized in the statements of net loss and comprehensive loss as incurred.
Development expenditures are capitalized only if development costs can be measured reliably, the product or process is technically and commercially feasible, future economic benefits are probable, and the Company intends to complete development and has sufficient resources to complete development and to use or sell the asset. Other development expenditures are expensed as incurred. Research and development expenses include all direct and indirect operating expenses supporting the products in development. The costs incurred in establishing and maintaining patents are expensed as incurred.
Provisions
Provisions are recognized when the Company has a present obligation, legal or constructive as a result of a previous event, if it is probable that the Company will be required to settle the obligation and a reliable estimate can be made of the obligation. The amount recognized is the best estimate of the expenditure required to settle the present obligation at the end of the reporting period, taking into account the risks and uncertainties surrounding the obligations. Provisions are reviewed at the end of each reporting period and adjusted to reflect the current best estimate of the expected future cash flows.
F-15
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
Foreign currency translation
The Consolidated Financial Statements are presented in USD $ which is the Company’s functional currency.
In each individual entity, a foreign currency transaction is initially recorded in the functional currency of the entity, by applying the exchange rate between the functional currency and the foreign currency at the date of the transaction.
At the end of the reporting period, monetary assets and liabilities of the Company which are denominated in foreign currencies are translated at the period-end exchange rate. Non-monetary assets and liabilities are translated at rates in effect at the date the assets were acquired, and liabilities incurred.
The resulting exchange gains or losses arising on the settlement of monetary items or on translating monetary items at rates different from those at which they were translated on initial recognition, are included in the consolidated statements of net income/(loss) and comprehensive income/(loss) in the year in which they arise.
For the purpose of presenting these Consolidated Financial Statements, the assets and liabilities of the subsidiary are translated into USD $ at the exchange rates prevailing at the end of the reporting period. Income and expenses are translated at the average rates for the period. The differences from translating subsidiaries are recorded in reserves.
Income/(loss) per share
The Company presents basic and diluted income/(loss) per share data for its common shares. Basic income/(loss) per share is calculated by dividing the profit or loss attributable to common shareholders of the Company by the weighted average number of common shares outstanding during the period. Diluted loss per share is determined by adjusting the income or loss attributable to common shareholders and the weighted average number of common shares outstanding, adjusted for the effects of all dilutive potential common shares, using treasury method for equity instruments and if-converted method for convertible debentures, warrants and share options issued.
Share-based compensation
The Company operates equity settled share-based remuneration plans for its eligible directors, officers, employees and consultants. All goods and services received in exchange for the grant of any share-based payments are measured at their fair value unless the fair value cannot be estimated reliably. If the Company cannot estimate reliably the fair value of the goods and services received, the Company shall measure their value indirectly by reference to the fair value of the equity instruments granted. For transactions with employees and others providing similar services, the Company measures the fair value of the services by reference to the fair value of the equity instruments granted. Equity settled share-based payments under share-based payment plans are ultimately recognized as an expense in profit or loss with a corresponding credit to contributed surplus, in equity. If vesting periods or other vesting conditions apply, the expense is allocated over the vesting period, based on the best available estimate of the number of share options expected to vest. Non-market vesting conditions are included in the assumptions about the number of options that are expected to become exercisable. Estimates are subsequently revised if there is any indication that the number of share options expected to vest differs from the previous estimate. Any cumulative adjustment prior to vesting is recognized in the current period. No adjustment is made to any expense recognized in prior period if share options ultimately exercised are different to that estimated on vesting. Market conditions are considered in the estimate of the fair value of share-based compensation on a grant date.
Government grants
Government grants are recognized when there is reasonable assurance that the grant will be received and that the Company will comply with all conditions attached to the grant.
The Company participates in the Australian Federal
Government’s Research and Development Tax Incentive Program, which provides a rebate of up to
F-16
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
Income taxes
Income tax comprises current and deferred tax. Income tax is recognized in profit or loss except to the extent that it relates to items recognized directly in shareholders’ equity, in which case the income tax is also recognized directly in equity or other comprehensive income.
Current tax is the expected tax payable on the taxable income for the year, using tax rates enacted at the end of the reporting period, and any adjustments to tax payable in respect of previous years. Current tax assets and current tax liabilities are only offset if a legally enforceable right exists to offset the amounts and the Company.
Deferred tax is recognized in respect of all qualifying temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in the Consolidated Financial Statements. Deferred income tax is determined on a non-discounted basis using the tax rates and laws that have been enacted or substantively enacted at the end of the reporting period and are expected to apply when the deferred tax asset or liability is settled. Deferred tax assets are offset when there is a legally enforceable right to offset tax assets and liabilities and when the deferred tax balances relate to the same taxation authority.
Deferred tax assets are recognized to the extent future recovery is probable. At each reporting period end, deferred tax assets are reduced to the extent that it is no longer probable that sufficient taxable earnings will be available to allow all or part of the asset to be recovered.
Investment in Associate
An associate is an entity over which the Company has significant influence. Significant influence is the power to participate in the financial and operating policy decisions of the investee, but is not control or joint control over those policies. The considerations made in determining significant influence or joint control are similar to those necessary to determine control over subsidiaries. The Company’s investment in its associate is accounted for using the equity method. Under the equity method, the investment in an associate is initially recognized at cost. The carrying amount of the investment is adjusted to recognize changes in the Company’s share of net assets of the associate or joint venture since the acquisition date. Goodwill relating to the associate or joint venture is included in the carrying amount of the investment and is not tested for impairment separately. The consolidated statement of net income/(loss) and comprehensive income/(loss) reflects the Company’s share of the results of operations of the associate. Any change in other comprehensive income of those investees is presented as part of the Company’s other comprehensive income. In addition, when there has been a change recognized directly in the equity of the associate, the Company recognizes its share of any changes, when applicable, in the consolidated statement of changes in shareholders’ equity. Unrealized gains and losses resulting from transactions between the Company and the associate are eliminated to the extent of the interest in the associate. The aggregate of the Company’s share of operating results of an associate is shown on the face of the consolidated statement of net income/(loss) and comprehensive income/(loss) and represents net income or loss after tax and non-controlling interests in the subsidiaries of the associate. The consolidated financial statements of the associate are prepared for the same reporting period as the Company. When necessary, adjustments are made to bring the accounting policies in line with those of the Company. The Company’s share of an associate’s losses that are in excess of its investment in the associate are recognized only to the extent that the Company has incurred legal or constructive obligations or made payments on behalf of the associate.
After application of the equity method, the Company determines whether it is necessary to recognize an impairment loss on its investment in its associate. At each reporting date, the Company determines whether there is objective evidence that the investment in the associate is impaired. If there is such evidence, the Company calculates the amount of impairment as the difference between the recoverable amount of the associate and its carrying value, and then recognizes the loss in the consolidated statement of operations and comprehensive loss.
Upon loss of significant influence over the associate, the Company measures and recognizes any retained investment at its fair value. Any difference between the carrying amount of the associate upon loss of significant influence and the fair value of the retained investment and proceeds from disposal is recognized in the consolidated statement of net income/(loss) and comprehensive income/(loss).
F-17
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
Investment in PsyLabs
As at March 31, 2025, the Investment in PsyLabs was accounted for as a financial instrument through FVTPL with changes in fair value recorded in the Consolidated Statement of Net Income/(Loss) and Comprehensive Income/(Loss).
Accounting Standards Effective January 1, 2024 and issued but not yet effective
IFRS 18 Presentation and Disclosure in Financial Statements
In April 2024, the IASB issued IFRS 18 – Presentation and Disclosure in Financial Statements which will replace IAS 1, Presentation of Financial Statements. The key new concepts introduced in IFRS 18 relate to the structure of the statement of earnings (loss), required disclosures in the financial statements for certain earnings or loss performance measures that are reported outside an entity’s financial statements and enhanced principles on aggregation and disaggregation which apply to the primary financial statements and notes in general. IFRS 18 will apply for reporting periods beginning on or after January 1, 2027, and also applies to comparative information. The Company is still in the process of assessing the impact of this standard on its consolidated financial statements.
Amendments to the Classification and Measurement of Financial Instruments (“Amendments to IFRS 9 and IFRS 7”)
In May 2024, the IASB issued Amendments to IFRS 9 and IFRS 7 which clarify the date of recognition and derecognition of some financial assets and liabilities with a new exception for some financial liabilities settled through an electronic cash transfer system, clarify and add further guidance for assessing whether a financial asset meets the solely payments of principal and interest criterion, add new disclosures for certain instruments with contractual terms that can change cash flows such as instruments with features linked to the achievement of environment, social and governance targets; and update the disclosures for equity instruments designated at FVOCI. Amendments to IFRS 9 and IFRS 7 is effective for periods beginning on or after January 1, 2026, with early adoption permitted. The Company is still in the process of assessing the impact of this standard on its consolidated financial statements.
4. Critical accounting estimates and judgements
The preparation of consolidated financial statements in conformity with IFRS requires management to make certain estimates, judgments and assumptions concerning the future. Actual results may differ from these estimates. The Company’s management reviews these estimates, judgments, and assumptions on an ongoing basis, based on experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances. Revisions to estimates are adjusted prospectively in the period in which the estimates are revised. The following are deemed to be critical accounting policies as these require a high level of subjectivity and judgement and could have a material impact on the Company’s consolidated financial statements.
Reverse takeover transaction
The determination of fair values of consideration paid and net assets acquired is subject to significant estimation. The Company treated the RTO Transaction as a capital transaction equivalent to the issue of shares of the Company in exchange for the net monetary assets of NCAC. The Company determined that the original shareholders of PGI became the single largest shareholder of the Company after the RTO Transaction, therefore the Company was the acquiror and NCAC was the acquiree.
The Company has determined the RTO Transaction
did not constitute a business combination as defined under IFRS 3, Business Combinations, as NCAC is a non-operating entity that did not
meet the definition of a business under IFRS 3. The excess of the consideration paid over the net liability acquired together with any
transaction costs incurred for the Transaction is expensed as a listing expense in accordance with IFRS 2 Share-Based Payments. The fair
value of the consideration paid was estimated by the closing trading price $
F-18
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
Investments
In the normal course of operations, the Company invests in equity interests of other entities. In such circumstances, management considers whether the facts and circumstances pertaining to each such investment result in the Company obtaining control, joint control or significant influence over the investee entity. In some cases, the determination of whether or not the Company controls, jointly controls or significantly influences the investee entities requires the application of significant management judgment to consider individually and collectively such factors as:
| ● | The purpose and design of the investee entity. |
| ● | The ability to exercise power, through substantive rights, over the activities of the investee entity that significantly impact its returns. |
| ● | The size of the Company’s equity ownership and voting rights, including potential voting rights. |
| ● | The size and dispersion of other voting interests, including the existence of voting blocks. |
| ● | Other investments in or relationships with the investee entity including, but not limited to, current or possible board representation, royalty and/or Stream investments, loans and other types of financial support, material transactions with the investee entity, interchange of managerial personnel or consulting positions. |
| ● | Other relevant and pertinent factors. |
If it is determined that the Company neither has control, joint control or significant influence over an investee entity, the Company accounts for the corresponding investment in equity interest at FVTPL.
Convertible instruments
The valuation of convertible debt instruments is subject to significant management estimation. Convertible notes are compound financial instruments which have been designated at FVTPL.
The identification of convertible debenture components is based on interpretations of the substance of the contractual arrangement and therefore requires judgment from management. The separation of the components affects the initial recognition of the convertible debenture at issuance and the subsequent remeasurement. As the Company has designated the entire convertible financial instrument as FVTPL given the embedded derivate liability that was contained by the convertible financial instrument, the debentures have not been separated into debt and derivative components. The fair values attributed to the different components of a financing transaction, and/or derivative financial instruments, are determined using valuation techniques. The Company uses judgement to select the methods used to make certain assumptions and in performing the fair value calculations in order to determine (a) the values attributed to each component of a transaction at the time of their issuance; (b) the fair value measurements for certain instruments that require subsequent measurement at fair value on a recurring basis; and (c) for disclosing the fair value of financial instruments subsequently carried at amortized cost. These valuation estimates could be significantly different because of the use of judgement and the inherent uncertainty in estimating the fair value of these instruments that are not quoted in an active market.
Contingencies
From time to time, the Company is named as a party to claims or involved in proceedings, including legal, regulatory and tax related, in the ordinary course of its business. While the outcome of these matters may not be estimable at the reporting date, the Company makes provisions, where possible, for the estimated outcome of such claims or proceedings. Should a loss result from the resolution of any claims or proceedings that differs from these estimates, the difference will be accounted for as a charge to profit or loss in that period. The actual results may vary and may cause significant adjustments.
The rebate over the tax claim is subject to inherent uncertainty and could be subject to being denied and clawed back by the Australian Tax office at a future date. The Company expects that a claw back of the rebate is highly unlikely.
F-19
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
Deferred taxes and Income taxes
Significant estimates are required in determining the Company’s income tax provision. Some estimates are based on interpretations of existing tax laws or regulations. Various internal and external factors may have favourable or unfavourable effects on the Company’s future effective tax rate. These include, but are not limited to, changes in tax laws, regulations and/or rates, changing interpretations of existing tax laws or regulations, and results of tax audits by tax authorities.
Provisions for taxes are made using the best estimate of the amount expected to be paid based on a qualitative assessment of all relevant factors. The Company reviews the adequacy of these provisions at the end of the reporting period. However, it is possible that at some future date an additional liability could result from audits by taxing authorities. Where the outcome of these tax-related matters is different from the amounts that were initially recorded, such differences will affect the tax provisions in the period in which such determination is made.
Share-based compensation
Valuation of share-based compensation requires management to make estimates regarding the inputs for option pricing models, such as the expected life of the option, the volatility of the Company’s stock price, the vesting period of the option and the risk-free interest rate are used. Actual results could differ from those estimates. The estimates are considered for each new grant of stock options.
Government grants
Government grants are recognized when there is reasonable assurance that the Company will comply with the conditions attached to them and the government grants will be received. Grants are recognized as income when they are received. The Company has recognized the government grant received during the period as research and development grants as other income in the consolidated statement of income/(loss) and comprehensive income/(loss).
Going concern
At the end of each reporting period, management exercises judgment in assessing the Company’s ability to continue as a going concern and operate in the normal course by reviewing the Company’s performance, resources and future obligations. The conclusion that the Company will be able to continue as a going concern is subject to critical judgments of management with respect to assumptions surrounding the short and long term operating budgets, expected profitability, investment and financing activities and management’s strategic planning. The assumptions used in management’s assessment are derived from actual operating results along with industry and market trends.
Impairment of investment in associate
There is judgment required to determine whether any indication of impairment exists at the end of each reporting period for investment in associate, including assessing whether there are observable indications that the asset’s value has declined during the period. Management uses judgment when assessing whether there are indicators of impairment. If such an indication exists, the recoverable amount of the interest is estimated in order to determine the extent of the impairment (if any). The recoverable amount is the higher of the fair value less costs of disposal and value in use. The calculation of the recoverable amount requires the use of estimates and assumptions.
F-20
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
5. Reverse takeover transaction with NCAC
On January 25, 2024 the Company completed the
RTO Transaction (See Note 1). As disclosed in Note 4, the RTO Transaction did not constitute a business combination as defined under IFRS
3, Business Combinations, as NCAC is a non-operating entity that does not meet the definition of a business under IFRS 3. The excess of
the consideration paid over the net liability acquired together with any transaction costs incurred for the Transaction is expensed as
a listing expense in accordance with IFRS 2 Share-Based Payments. The fair value of the consideration paid was determined by the closing
trading price $
Accordingly, upon consummation of the BCA the
Company issued
The calculation of listing expenses is as follows:
| Listing Expense | ||||
| Consideration paid: | ||||
| Shares issued to NCAC shareholders | ||||
| Total consideration shares issued | ||||
| Fair value of the common shares | $ | |||
| Deemed consideration amount for the common shares issued | $ | |||
| Net identifiable liabilities acquired: | ||||
| Cash and cash equivalent | $ | |||
| Accounts payable and accrued liabilities | $ | ( | ) | |
| NCAC promissory note (Note 18) | $ | ( | ) | |
| Derivative warrant liabilities (Note 13) | $ | ( | ) | |
| Net liabilities acquired | $ | |||
| Listing expense | $ | |||
The listing expense has been included in the consolidated statements of net loss and comprehensive loss.
Transaction expenses included in the consolidated
statements of net loss and comprehensive loss are others costs of $
6. Cash, restricted cash and cash equivalents
Cash and cash equivalents include the following amounts:
| March 31, 2026 | March 31, 2025 | |||||||
| Unrestricted cash held with chartered banks | ||||||||
| Restricted cash | ||||||||
| Total | ||||||||
| ● | unrestricted cash is held with chartered banks and |
| ● | the Company entered into a cash collateral agreement with a major chartered bank in Canada with regards
to a credit card facility against which the Company deposited Canadian Dollars $ |
F-21
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
7. Digital Assets
During the year ended March 31, 2026, the Company
deposited $
The following table summarizes the Company’s digital asset holdings as at March 31, 2026:
| Asset | Symbol | Quantity | Fair Value per Unit | Fair Value | Cost | Revaluation Decrease | ||||||||||||||||
| Bitcoin | BTC | $ | $ | $ | $ | ( | ) | |||||||||||||||
| Ethereum | ETH | $ | $ | $ | $ | ( | ) | |||||||||||||||
| Solana | SOL | $ | $ | $ | $ | ( | ) | |||||||||||||||
| Tether | USDT | $ | $ | $ | ||||||||||||||||||
| USD Coin | USDC | $ | $ | $ | ||||||||||||||||||
| Cash (USD) | $ | $ | $ | |||||||||||||||||||
| Total | $ | $ | $ | ( | ) | |||||||||||||||||
The revaluation decrease expense has been included in the consolidated statements of net loss and comprehensive loss.
8. Loan Receivable
On February 9, 2026, the Company entered into
a Loan Agreement with Curiosum Ltd., a private corporation (“Curiosum” or the “Borrower”), pursuant
to which the Company advanced a loan of $
The Loan arose directly from the settlement agreement
dated February 9, 2026 between the Company and KAOS Capital Ltd. (the “KAOS Settlement”). Under the KAOS Settlement,
the Borrower agreed to purchase
| Loan Terms | ||||
| Principal amount | $ | |||
| Maturity date (3 month term) | ||||
| Interest rate (RBC Prime Rate + 1% per annum) | % | |||
| Loan Carrying Amount | ||||
| Loan principal | $ | |||
| Accrued interest receivable | $ | |||
| Loan receivable | $ | |||
Subsequent to year end, the Loan was repaid in full.
F-22
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
9. Prepaid expenses
Prepaid expenses include the following amounts:
| March 31, 2026 | March 31, 2025 | |||||||
| Funds held in trust with attorneys | ||||||||
| Prepaid expenses | ||||||||
| Total | ||||||||
10. Equipment
| Computer equipment | ||||
| Cost | ||||
| At March 31, 2024 | ||||
| Additions | ||||
| At March 31, 2025 | ||||
| Additions | ||||
| At March 31, 2026 | ||||
| Accumulated Depreciation | ||||
| At March 31, 2024 | ( | ) | ||
| Charge for the year | ( | ) | ||
| At March 31, 2025 | ( | ) | ||
| Charge for the year | ( | ) | ||
| At March 31, 2026 | ( | ) | ||
| Carrying Value | ||||
| At March 31, 2025 | ||||
| At March 31, 2026 | ||||
11. Psyence Labs Ltd. Investment and Investment in Associate
During the prior year ended March 31, 2025, the
Company acquired
PsyLabs is a private company headquartered in the British Virgin Islands focused on the production of psychedelic active pharmaceutical ingredients and extracts.
As at March 31, 2025, the Company determined the
fair value of its investment in PsyLabs to be $
On April 15, 2025, the Company acquired an additional
F-23
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
The fair value of the investment, immediately
prior to the events described under the Put Option Agreement below, was $
Put Option Agreement and Transition to Associate
On July 3, 2025, the Company and PsyLabs entered
into a put option agreement (the “Agreement”) pursuant to which PsyLabs was granted the right to require the Company
to acquire up to
The transaction was consummated and
Acquisition Date and Significant Influence
The Acquisition Date is February 25, 2026, being
the date on which PBM issued shares to PsyLabs and its ownership interest in PsyLabs increased from
Remeasurement of Previously Held Interest
Upon obtaining significant influence, the Company
remeasured its previously held
Consideration Transferred for Additional Shares
The consideration for the
Initial Carrying Amount of Investment in Associate
The initial carrying amount of the investment in associate is determined as follows:
Initial Carrying Amount Description | Shares | Amount | ||||||
| Previously held interest – remeasured to fair value at Acquisition Date | $ | |||||||
| Consideration transferred for additional shares acquired | $ | |||||||
| Total – Investment in Associate at Acquisition Date | $ | |||||||
Equity Method – Post-Acquisition
From February 25, 2026, the Company recognizes
its
F-24
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
Carrying Amount
| Amount | ||||
| Investment in associate at Acquisition Date (February 25, 2026) | $ | |||
| Share of associate net loss – February 25 to March 31, 2026 | $ | ( | ) | |
| Carrying amount at March 31, 2026 | $ | |||
12. Accounts payable and accrued liabilities
Accounts payable and accrued liabilities include the following amounts:
| March 31, 2026 | March 31, 2025 | |||||||
| Trade payables | ||||||||
| Accrued liabilities | ||||||||
| Provisions | ||||||||
| Total | ||||||||
13. Derivative warrant liabilities
The Company has two classes of warrant liabilities
outstanding: Public Warrants and Private Warrants. As of March 31, 2026 and 2025, there were
During the prior year ended March 31, 2025, the
Company entered into the Warrant Exchange Agreement. Pursuant to the Warrant Exchange Agreement, the Company issued to the Holder
Public Warrants: The fair value of the Public Warrants is determined based on the observable market price, as they continue to be traded on the Nasdaq under the symbol “PBMWW.” Changes in fair value during the years ended March 31, 2026, March 31, 2025 and March 31, 2024, have been recognized in the consolidated statements of income/(loss) and comprehensive income/(loss).
Private Warrants:
| Warrant Inputs at March 31, 2026 | Warrant Inputs at March 31, 2025 | |||||||
| Share price | $ | $ | ||||||
| Expected dividend yield | ||||||||
| Exercise price | $ | $ | ||||||
| Risk-free interest rate | % | % | ||||||
| Expected life | ||||||||
| Expected volatility | % | % | ||||||
| Expiry date | ||||||||
F-25
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
At March 31, 2026 the fair value of the Public
and Private Warrants was $
The expected volatility was based on implied volatility of the Public Warrants.
As at March 31, 2026, the derivative warrant liability was reconciled as follows:
Derivative warrant liability – Public and Private Warrants
| Number | Amount ($) | |||||||
| At listing January 25, 2024 | ||||||||
| Fair value loss | ||||||||
| Opening balance April 1, 2024 | ||||||||
| Warrant exchange | ( | ) | ( | ) | ||||
| Fair value gain | ( | ) | ||||||
| Balance as at March 31, 2025 | ||||||||
| Fair value loss | ||||||||
| Balance as at March 31, 2026 | ||||||||
Warrant transactions and the number of warrants outstanding are summarized as follows:
| Public Warrants | Private Warrants | |||||||||||||||
| Number of Warrants | Weighted Average Exercise Price | Number of Warrants | Weighted Average Exercise Price | |||||||||||||
| Balance, March 31, 2024 | $ | $ | ||||||||||||||
| Warrant exchange | ( | ) | $ | $ | ||||||||||||
| Balance, March 31, 2025 | $ | $ | ||||||||||||||
| Balance, March 31, 2026 | $ | $ | ||||||||||||||
The following warrants were outstanding and exercisable at March 31, 2026:
| Issue Date | Expiry Date | Exercise Price | Number of Warrants Outstanding | Number of Warrants Exercisable | ||||||||||
| January 25, 2024 | $ | |||||||||||||
14. Share capital
a) Authorized
The Company is authorized to issue an unlimited number of Common Shares, each without par value.
b) Issued and outstanding
On November 26, 2024, the Company consolidated
its common shares on the basis of
On May 5, 2025, the Company consolidated its common
shares and warrants on the basis of
On February 2, 2026, the Company consolidated
its common shares and warrants on the basis of
F-26
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
As at March 31, 2026, there were
Common shares
| Note | Number | Amount ($) | ||||||||
| Opening balance April 1, 2023 | 3 | |||||||||
| Share issuance to PGI | ||||||||||
| Share issuance to NCAC shareholders | 5 | |||||||||
| Shares issued for debt settlement | ||||||||||
| Shares issued to third party advisors | ||||||||||
| Balance as at March 31, 2024 | ||||||||||
| Shares issued on conversion of convertible note | 17 | |||||||||
| Shares issued on conversion of convertible note warrants | 17 | |||||||||
| Shares issued for ELOC | 19 | |||||||||
| Commitment shares ELOC | 19 | |||||||||
| Share issuance costs for ELOC | 19 | ( | ) | |||||||
| Warrant exchange | 13 | |||||||||
| Shares issued to third party advisors | ||||||||||
| Shares issued on conversion of PGI promissory notes | 18 | |||||||||
| Shares issued on conversion of NCAC promissory notes | 18 | |||||||||
| Shares issued for PsyLabs share exchange | 11 | |||||||||
| Shares issued for PIPE financing | 20 | |||||||||
| Share issuance costs for PIPE financing | 20 | ( | ) | |||||||
| Shares issued for PIPE pre-funded warrants exercised | 20 | |||||||||
| Shares issuance costs for PIPE pre-funded warrants exercised | 20 | ( | ) | |||||||
| Balance as at March 31, 2025 | ||||||||||
| Shares issued to third party advisors | ||||||||||
| Shares issued for ELOC | 19 | |||||||||
| Share issuance costs for ELOC | 19 | ( | ) | |||||||
| Share issuance for Associate | 11 | |||||||||
| Exercise of RSUs | ||||||||||
| Balance as at March 31, 2026 | ||||||||||
On January 25, 2024, because of the completion
of the RTO Transaction, the Company issued
Payments to advisors of NCAC was settled in the
Company’s shares upon RTO Transaction at the closing price. Accounts payable of $
An amount of $
The opening balance of equity is the net parent investment which represents the net financings that the Company received from PGI to fund it’s operations through contributions to the clinical trials, cash extended to the Company’s subsidiaries and the net effect of cost allocations from transactions with PGI, all of which did not require repayments.
F-27
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
In the year ended March 31, 2026 a payment to
an advisor was settled in the Company’s shares upon delivery of services which was measured at the closing price at date of service.
c) Warrant Reserve
As at March 31, 2026, there were
| 2025 | ||||||||||
| Warrants | Note | Number | Amount ($) | |||||||
| Opening balance April 1, 2024 | ||||||||||
| Warrants issued for convertible note Addendum | 17 | |||||||||
| Warrants issued for convertible note Termination Agreement | 17 | |||||||||
| Convertible note Termination Agreement warrants exercised | 17 | ( | ) | ( | ) | |||||
| PIPE financing warrant issuance | 20 | |||||||||
| PIPE financing warrant issuance costs | 20 | |||||||||
| Issuance costs for PIPE financing warrants | 20 | ( | ) | |||||||
| PIPE pre-funded warrants exercised | 20 | ( | ) | ( | ) | |||||
| Issuance costs for PIPE pre-funded warrants exercised | 20 | |||||||||
| Balance as at March 31, 2025 and 2026 | ||||||||||
The following warrants were outstanding and exercisable at March 31, 2026:
| Issue Date | Expiry Date | Exercise Price | Number of Warrants Outstanding | Number of Warrants Exercisable | ||||||||||
| August 20, 2024 | $ | |||||||||||||
| December 24, 2024 | $ | |||||||||||||
| December 24, 2024 | $ | |||||||||||||
| December 24, 2024 | $ | |||||||||||||
d) Options Reserve
As at March 31, 2026, there were
RSUs
| Number | ||||
| Opening balance April 1, 2025 | ||||
| Issued during the year | ||||
| Exercised during the year | ( | ) | ||
| Cancelled during the year | ( | ) | ||
| Balance as at March 31, 2026 | ||||
F-28
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
RSU Issuances
On April 17, 2025 the Company issued
| ● |
| ● |
| ● |
The fair value of the RSUs was determined to be
$
On October 1, 2025 the Company issued
| ● |
| ● |
| ● |
The fair value of the RSUs was determined to be
$
The RSUs granted are accounted for as an equity instrument whereby share-based payments recognized in the consolidated statements of net loss and comprehensive loss are held in options reserve until exercised.
During the year ended March 31, 2026, $
During the year ended March 31, 2024, $
15. Other income
During the year ended, March 31, 2026, the Company
received a research and development rebate of AUD $
This rebate represents a government grant aimed at supporting research and development activities. Therefore, in accordance with IAS 20, Accounting for Governmental Grants and Disclosure of Government Assistance, the grant is recognized as income when there is a reasonable assurance that the grant will be received and that the Company will comply with the conditions attached to it. These conditions were satisfied when the Company received the rebates.
16. Other expense
On February 9, 2026, the Company entered into a settlement agreement with KAOS Capital Ltd. and Adam Arviv (the “KAOS Group”) to resolve a shareholder dispute arising from allegations made by the KAOS Group in January 2026. The Company, its Board of Directors, and officers denied the allegations and any associated liability.
Under the terms of the settlement, the Company
paid US$
The settlement has been funded from cash on hand.
The total net settlement expense recognised in the year ended March 31, 2026 is $
F-29
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
17. Convertible note liability
On January 15, 2024, in connection with the RTO
Transaction (Note 5), the Company and Psyence Biomed II entered into the Securities Purchase Agreement with the Investors and the NCAC
Sponsor, relating to up to four senior secured convertible notes obligations under which are guaranteed by certain assets of the Company
and Psyence Biomed II, issuable to the Investors at or after the Closing, as the case may be, for the aggregate principal amount of up
to $
The First Tranche Notes, for an aggregate of $
The Second Tranche Notes, for an aggregate of
$
The Company designated the entire instrument as FVTPL.
On August 20, 2024, the Company and the Investor entered into an addendum to the Securities Purchase Agreement (the “Addendum”). Under the provisions of the Addendum, the First and Second Trance Notes would be extinguished by the Company issuing common shares within the conversion limits detailed in the Securities Purchase Agreement.
As a consideration to the Investor entering into
the Addendum, the Company issued to the Investor
| Warrant Inputs at August 20, 2024 | ||||
| Share price | $ | |||
| Expected dividend yield | ||||
| Exercise price | $ | |||
| Risk-free interest rate | % | |||
| Expected life | ||||
| Expected volatility | % | |||
| Expiry date | ||||
The fair value of shares and warrants issued pursuant to the Addendum as detailed above, was recorded in the consolidated statements of income/(loss) and comprehensive income/(loss) as part of the fair value gain on convertible note.
On November 27, 2024, the Company and the Investor entered into the Termination Agreement pursuant to which all obligations, covenants and liabilities of the Company and the Investor under the Securities Purchase Agreement will be fully and finally terminated.
F-30
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
As a consideration to the Investor entering into
the Termination Agreement, the Company issued to the Investor
The fair value of shares and warrants issued pursuant to the Termination Agreement as detailed above, was recorded in the consolidated statements of income/(loss) and comprehensive income/(loss) as part of the fair value gain on convertible note.
Between May and September 2024, the Company converted
all outstanding balance of the First and Second Tranche Notes into common shares by issuing
The Company measured the fair value of the convertible
loan liability before each conversion using Monte Carlo valuation model with the following main assumptions: expected dividend yield
The change in fair value resulted in a fair value
gain of $ (2025 – gain of $
18. Promissory Notes
On January 25, 2024, the Company issued an unsecured
convertible promissory note to PGI (the “PGI Note”), in the principal amount of $
On January 25, 2024, the Company issued an unsecured
convertible promissory note to the NCAC Sponsor (the “NCAC Note”), in the principal amount of $
Both notes were designated at FVTPL due to the embedded conversion features, as the conversion prices were not fixed.
At inception on January 25, 2024 the fair value
of the PGI Note was $
PGI Note:
On September 30, 2024, the Company entered into
Debt for Equity Exchange Agreement with PGI pursuant to which the Company issued
On October 25, 2024, the Company entered into
Debt for Equity Exchange Agreement with PGI pursuant to which the Company issued
In accordance with the Debt for Equity Exchange
Agreements entered into on September 30, 2024 and October 25, 2024, as amended, the Company will need to issue additional shares to PGI
if the Company’s volume weighted average share price for the 10 days prior to November 26, 2024 is lower than $
In December 2024, the Company issued
The issuance of shares pursuant to the Debt for
Equity Exchange Agreements resulted in a fair value gain of $
F-31
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
NCAC Note:
On September 30, 2024, the Company entered into
Debt for Equity Exchange Agreement with NCAC Sponsor pursuant to which the Company issued
In accordance with the Debt for Equity Exchange
Agreements, as amended, the Company will need to issue additional shares to NCAC Sponsor if the Company’s volume weighted average
share price for the 10 days prior to November 26, 2024 is lower than $
In December 2024, the Company issued
The issuance of shares pursuant to the Debt for
Equity Exchange Agreements resulted in a fair value gain of $
The fair value of the notes was calculated using
a credit adjusted market borrowing rate. The fair value of both notes was $ as at March 31, 2026 (March 31, 2025 - $). A fair value
gain of $
19. ELOC
On August 28, 2024, the Company entered into a
$
As part of the consideration for entering into
the ELOC, the Company issued
During the year ended March 31, 2026, the Company
issued
20. PIPE Financing - Private Placement and Warrants
Private placement
On December 24, 2024, the Company completed a
private placement with HC Wainwright & Co., LLC, raising gross proceeds of $
| ● |
| ● |
| ● |
| o |
| o |
F-32
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
The proceeds were allocated between the common
shares and the warrants based on their relative fair values on the date of issuance.
Fair value allocation
| Component | Allocated Amount | |||
| Common shares | $ | |||
| Pre-funded warrants | $ | |||
| Warrants | $ | |||
| Total gross proceeds | $ | |||
Fair value allocation assumptions
The common shares were estimated using the share
price on date of issuance - $
The pre-funded warrants and the warrants were estimated using a Black Scholes valuation model using the following estimates:
| Pre-funded warrants | Warrants with 5 year expiry | Warrant with 2 year expiry | ||||||||||
| Share price | $ | $ | $ | |||||||||
| Expected dividend yield | ||||||||||||
| Exercise price | $ | $ | $ | |||||||||
| Risk-free interest rate | % | % | % | |||||||||
| Expected life | ||||||||||||
| Expected volatility | % | % | % | |||||||||
| Expiry date | ||||||||||||
Share Issuance Costs
The Company incurred $
Pre-funded Warrant Exercise
During the prior year ended March 31, 2025, all
All instruments issued in the private placement were classified as equity instruments, as they did not contain any contractual obligations to deliver cash or other financial assets and met the fixed-for-fixed condition.
21. Capital management
The Company’s objectives when managing capital are to safeguard the Company’s ability to continue as a going concern to pursue the development of natural health business, to maintain a flexible capital structure which optimizes the cost of capital at an acceptable risk level.
The Company manages its capital structure and adjusts it considering changes in economic conditions and the risk characteristics of the underlying assets. To maintain or adjust its capital structure, the Company may obtain additional funding from equity financing, issue new debt, acquire or dispose of assets or adjust the amount of cash and cash equivalents on hand. The Company defines capital as the aggregate of its capital stock and borrowings.
F-33
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
Total managed capital is as follows as at March 31, 2026 and 2025:
| 2026 | 2025 | |||||||
| Share capital | ||||||||
| Total | ||||||||
To facilitate the management of its capital requirements, the Company prepares annual budgets that are updated as necessary depending on various factors, including successful capital deployment and general industry conditions. The annual and updated budgets are approved by the Board of Directors.
Management considers its approach to capital management to be appropriate given the relative size of the Company. There were no changes in the Company’s approach to capital management during the period.
22. Transactions with related parties
All related party transactions are measured at the exchange amount, which is the amount of consideration established and agreed to by the related parties. All amounts either due from or due to related parties other than specifically disclosed are non-interest bearing, unsecured and have no fixed terms of repayments. The Company incurred the following transactions with related parties during the years ended March 31, 2026 and March 31, 2025:
Compensation to key management personnel
Key management personnel are those people who
have authority and responsibility for planning, directing and controlling the activities of the Company, directly or indirectly.
| Key Management Personnel | March 31, 2026 | March 31, 2025 | March 31, 2024 | |||||||||
| Short term benefits | ||||||||||||
| Share-based compensation | ||||||||||||
| Total | ||||||||||||
Short term benefits consist of consulting fees, director’s fees, payroll and other benefits paid to key management personnel. Share-based compensation is RSUs granted to key management personnel.
The March 31, 2024 share-based compensation was recognized for options and restricted stock units granted by Psyence Group under professional and consulting fees expenses and general and administrative expenses on the consolidated statements of net loss and comprehensive loss.
This share-based compensation relates only to the historic carve out pre-combination period and does not relate to options or RSUs in the Company.
F-34
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
23. Income tax note
The reconciliation of the combined Canadian federal
and provincial statutory income tax rate of
| 2026 | 2025 | 2024 | ||||||||||
| Net Income/(Loss) before recovery of income taxes | ( | ) | ( | ) | ||||||||
| Expected income tax (recovery)/expense | ( | ) | ( | ) | ||||||||
| Difference in foreign tax rates | ||||||||||||
| Listing expense | ||||||||||||
| Non-taxable fair value gain adjustment | ( | ) | ||||||||||
| Non-deductible R&D costs | ||||||||||||
| Non-deductible loss on loan settlement | ||||||||||||
| Share issue costs booked to equity | ( | ) | ( | ) | ||||||||
| Other permanent expenses | ( | ) | ||||||||||
| Change in tax benefits not recognized | ||||||||||||
| Income tax (recovery)/expense | ||||||||||||
The following table summarizes the components of deferred tax as at March 31, 2026 and 2025:
| 2026 | 2025 | |||||||
| Deferred tax asset | ||||||||
| Non-capital losses carried forward-Canada | ||||||||
| Deferred tax liability | ||||||||
| Investment in Associate | ( | ) | ||||||
Unrecognized deferred tax asset
Deferred taxes are provided as a result of temporary
differences that arise due to the differences between the income tax values and the carrying amounts of assets and liabilities.
| Unrecognized deductible temporary differences | 2026 | 2025 | ||||||
| Equipment | ||||||||
| Restricted interest and financing expenses – Canada | ||||||||
| Share issuance costs and others | ||||||||
| Investment in digital assets | ||||||||
| Non-capital losses carried forward-Canada | ||||||||
| Non-capital losses carried forward-Australia | ||||||||
Share issuance and financing costs will be fully amortized in 2030.
The Company’s non-capital loss carry forwards will expire as noted in the table below:
| Year of expiry | Canada | Australia | ||||||
| 2044 | ||||||||
| 2045 | ||||||||
| 2046 | ||||||||
| Indefinite | ||||||||
| Total | ||||||||
F-35
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
24. Financial instruments and financial risk management
a) Financial instrument classification and fair value measurement
Financial instruments that are recorded at fair value on the consolidated statements of financial position are classified using a fair value hierarchy that reflects the significance of the inputs used in making the measurements.
The fair value of hierarchy has the following levels:
| ● | Level 1 – quoted prices in active markets for identical financial instruments. |
| ● | Level 2 – quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in the markets that are not active; and model-derived valuations in which all significant inputs and significant value drivers are observable in active markets. |
| ● | Level 3 – valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable. |
The table below presents the carrying value of the Company’s financial instruments:
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| Digital Assets | ||||||||||||||||
| Derivative warrant liabilities – public warrants | ||||||||||||||||
| Balance, March 31, 2026 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| Investment in Psyence Labs Ltd | ||||||||||||||||
| Derivative warrant liabilities – public warrants | ||||||||||||||||
| Balance, March 31, 2025 | ||||||||||||||||
The face value of the other financial instruments approximates the fair value due to the short-term maturity nature of the financial instruments.
There were no transfers in and out of level 3 during the year.
b) Risk management
In the normal course of business, the Company is exposed to a variety of financial risks: credit risk, liquidity risk, foreign exchange risk and interest rate risk. These financial risks are subject to normal credit standards, financial controls, risk management as well as monitoring. The Company’s Board of Directors has overall responsibility for the establishment and oversight of the Company’s risk management framework.
Credit risk
Credit risk arises from cash, restricted cash and cash equivalents held with banks. The maximum exposure to credit risk is equal to the carrying value of the financial assets. The objective of managing counterparty credit risk is to prevent losses on financial assets. The Company minimizes the credit risk of cash and cash equivalents by depositing with only reputable financial institutions.
Liquidity risk
Liquidity risk is the risk that the Company will not be able to meet its financial obligations as they fall due.
The Company manages liquidity risk through an ongoing review of future commitments and cash balances available. Historically, the Company’s main source of funding has been through investments from its parent. The Company’s access to financing is uncertain. There can be no assurance of continued access to significant equity or debt funding.
F-36
PSYENCE BIOMEDICAL LTD.
Consolidated Financial Statements
The following table set forth the maturity of the contractual obligations as at March 31, 2026 and after:
| Carrying Amount | Contractual Cash Flows | Less than 1 year | Between 1 and 3 years | |||||||||||||
| Accounts payable & accrued liabilities | ||||||||||||||||
| Total contractual obligations | ||||||||||||||||
Interest rate risk
Interest rate risk is the risk that the fair value of future cash flows of a financial instrument will fluctuate because of changes in market interest rates. The Company has no significant interest-bearing assets or liabilities and therefore its income and operating cash flows are substantially independent of changes in market interest rates.
Foreign exchange risk
Foreign currency risk is the risk that the fair values of future cash flows of a financial instrument will fluctuate because they are denominated in currencies that differ from the respective functional currency.
As at March 31, 2026, a
25. Subsequent Events
On May 20, 2026, consultants and directors of
the Company exercised
On June 1, 2026 the Company granted
Subsequent to year end the Company issued
F-37
Exhibit 12.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO
EXCHANGE ACT RULE 13A-14(A)/15D-14(A)
AS ADOPTED PURSUANT TO SECTION 302
OF THE SARBANES-OXLEY ACT OF 2002
I, Jody Aufrichtig, certify that:
|
1. |
I have reviewed this Annual Report on Form 20-F of Psyence Biomedical Ltd.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: June 22, 2026 | /s/ Jody Aufrichtig |
| Jody Aufrichtig | |
| Chief Executive Officer | |
| (Principal Executive Officer) |
Exhibit 12.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO
EXCHANGE ACT RULE 13A-14(A)/15D-14(A)
AS ADOPTED PURSUANT TO SECTION 302
OF THE SARBANES-OXLEY ACT OF 2002
I, Warwick Corden-Lloyd, certify that:
|
1. |
I have reviewed this Annual Report on Form 20-F of Psyence Biomedical Ltd.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: June 22, 2026 | /s/ Warwick Corden-Lloyd |
| Warwick Corden-Lloyd | |
| Chief Financial Officer | |
| (Principal Financial Officer) |
Exhibit 13.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Annual Report of Psyence Biomedical Ltd. (the “Registrant”) on Form 20-F for the fiscal year ended March 31, 2026, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned certify pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
| 1. | The Report, fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended; and |
| 2. | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Registrant. |
Date: June 22, 2026
| /s/ Jody Aufrichtig | |
| Jody Aufrichtig | |
| Chief Executive Officer and Director | |
| (Principal Executive Officer) |
| /s/ Warwick Corden-Lloyd | |
| Warwick Corden-Lloyd | |
| Chief Financial Officer | |
| (Principal Financial Officer) |
Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the inclusion in the Annual Report on Form 20-F of our auditor’s report dated June 22, 2026 relating to the consolidated financial statements of Psyence Biomedical Ltd. (the “Company”) consisting of the consolidated statements of financial position as at March 31, 2026 and 2025 and the related consolidated statements of net income/(loss) and comprehensive income /(loss), changes in shareholders’ equity/(deficit) and cash flows for each of the years in the three year period ended March 31, 2026, as filed with the United States Securities and Exchange Commission.
Chartered Professional Accountants
Licensed Public Accountants
June 22, 2026
Toronto, Canada
| MNP LLP | |
| 1 Adelaide Street East, Suite 1900, Toronto ON, M5C 2V9 | 1.877.251.2922 T: 416.596.1711 F: 416.596.7894 |