Psyence Biomedical Ltd 6-K, filed Apr 11, 2025
Psyence Biomedical Ltd. (PBM)
About this 6-K
Psyence Biomedical Ltd filed this 6-K on April 11, 2025.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO
RULE 13a-16 OR 15d-16 UNDER THESECURITIES
EXCHANGE ACT OF 1934
For the month of April 2025
Commission File Number: 001-41937
Psyence Biomedical Ltd.
(Translation of registrant’s name into English)
121 Richmond Street West
Penthouse Suite 1300
Toronto, Ontario M5H 2K1
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
☒ Form 20-F ☐ Form 40-F
Explanatory Note
On April 2, 2025, Psyence Australia Pty Ltd, a wholly-owned subsidiary of Psyence Biomedical Ltd. (the “Company” or “Psyence”), entered into a binding letter of intent (the “LOI”) with Southern Star Research Pty Ltd (“Southern Star Research”), a full-service Australian contract research organization (CRO), in connection with the Company’s Phase IIb clinical trial evaluating its botanical psilocybin drug candidate, PEX010, for the treatment of adjustment disorder in cancer patients (the “Trial”).
Pursuant to the LOI, Southern Star Research has agreed to provide Start Up Activities to facilitate the transition of CRO services from iNGENū CRO Pty Ltd (“iNGENū”), the Company’s former CRO. The Start Up Activities include clinical, regulatory, and operational handover support, and are subject to the terms, scope, and fee schedule set forth in a separate proposal dated April 1, 2025 (the “Start Up Proposal”). Southern Star Research’s full engagement as CRO is subject to the negotiation and execution of a definitive master services agreement (the “Definitive Contract”) on or before May 31, 2025.
Under the LOI, Southern Star Research has agreed to coordinate directly with iNGENū to ensure an orderly transition of all clinical trial deliverables, data, and documentation. The LOI also contains customary provisions relating to confidentiality, intellectual property ownership, indemnification, and limitations of liability.
The foregoing description of the LOI does not purport to be complete and is subject to, and qualified in its entirety by, the full text of the LOI, a copy of which is filed as Exhibit 99.1 to this Report on Form 6-K and incorporated herein by reference.
Termination of Prior CRO Engagement
On April 3, 2025, Psyence Australia Pty Ltd entered into an exit deed (the “Exit Deed”) with iNGENū to formally terminate the parties’ existing master services agreement dated March 21, 2023 and related study order. Under the Exit Deed, iNGENū has agreed to provide up to 45 business days of transition support at no cost to the Company, including knowledge transfer, site and regulatory handover, and data transfer services.
The Exit Deed includes mutual releases of all past and future claims between the parties related to the Trial and contains customary provisions regarding confidentiality, non-disparagement, intellectual property, and regulatory obligations.
The foregoing description of the Exit Deed does not purport to be complete and is subject to, and qualified in its entirety by, the full text of the Exit Deed, a copy of which is filed as Exhibit 99.2 to this Report on Form 6-K and incorporated herein by reference.
On April 8, 2025, the Company issued a press release announcing the entry into the LOI with Southern Star Research. A copy of the press release is furnished hereto as Exhibit 99.3.
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Cautionary Note on Forward-Looking Statements
This Report on Form 6-K contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, our plans, objectives, expectations, and intentions with respect to future operations, products and services; and other statements identified by words such as “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimated,” “believe,” “intend,” “plan,” “projection,” “outlook” or words of similar meaning.
Forward-looking statements in this communication include statements regarding the handover and progress of the Phase IIb clinical trial, and trial execution under the newly engaged CRO. These forward-looking statements are based on a number of assumptions, including the assumption that there will be no delays in the execution of the Phase IIb clinical trial implementation schedule, topline data from this trial will be positive, and that the demand for psychedelic-assisted therapy will continue to increase. There can be no assurance that the Company will continue to maintain compliance with Nasdaq’s continued listing requirements.
There are numerous risks and uncertainties that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements.
These risks and uncertainties include, among others: (i) delays in the execution of the Phase IIb trial; (ii) the ability of Psyence BioMed to maintain the listing of its common shares and warrants on Nasdaq; (iii) volatility in the price of the securities of Psyence BioMed due to a variety of factors, including the recent share consolidation, changes in the competitive and highly regulated industries in which Psyence BioMed operates, variations in performance across competitors, changes in laws and regulations affecting Psyence BioMed’s business and changes in Psyence BioMed’s capital structure. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of the Company’s final prospectus (File No. 333-284444) filed with the Securities and Exchange Commission (the “SEC”) on January 24, 2025 and other documents filed by Psyence BioMed from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Actual results and future events could differ materially from those anticipated in such statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Except as required by law, Psyence BioMed does not intend to update these forward-looking statements.
The Company does not make any medical, treatment or health benefit claims about its proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by authorized clinical research. There is no assurance that the use of psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not conducted clinical trials for the use of the proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company has verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.
Incorporation by Reference
The information contained in this Report on Form 6-K, including Exhibits 99.1 and 99.2, but excluding Exhibit 99.3 (Press Release), is hereby incorporated by reference into the Company’s Registration Statement on Form F-3 (File No. 333-285542), and any prospectuses or prospectus supplements filed pursuant thereto.
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EXHIBIT INDEX
| * | Certain confidential portions (indicated by brackets and asterisks) have been omitted from this exhibit. |
| ^ | Certain of the exhibits and schedules to this Exhibit have been omitted in accordance with Regulation S-K Item 601(a)(5). The Registrant agrees to furnish a copy of all omitted exhibits and schedules to the SEC upon its request. |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Dated: April 11, 2025
| Psyence Biomedical Ltd. | ||
| By: | /s/ Dr. Neil Maresky | |
| Name: | Dr. Neil Maresky | |
| Title: | Chief Executive Officer and Director | |
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Exhibit 99.1
| LEVEL 7, 330 COLLINS STREET, MELBOURNE VIC 3000 |
 |
PSYENCE AUSTRALIA info@psyencebiomed.com +1 416-477-1708 www.psyencebiomed.com |
SOUTHERN STAR RESEARCH PTY LTD (ACN 103 120 896)
1 Merriwa Street,
Gordon
NSW 2072 Australia
April 2, 2025
Dear David
RE: LETTER OF INTENT – APPOINTMENT AS CRO
We, Psyence Australia Pty Ltd (as the "Sponsor"), a wholly-owned subsidiary of Psyence Biomedical Ltd, wish to appoint you (as the "CRO") (collectively "the Parties") to provide services to rescue and conduct the active Ph IIb clinical trial evaluating the proprietary botanical drug candidate PEX010, licensed by Filament Health Corp. to us, for the treatment of Adjustment Disorder in terminal cancer patients (AD) (the "Trial"). Currently, the Parties are engaged in detailed discussions and negotiations regarding a final Work Order and definitive Master Services Agreement ("Definitive Contract") for the execution of the Trial and related services by you ("Master Services") as set out in the proposal issued by you dated March 28, 2025 ("Master Proposal"). The Parties intend to negotiate in good faith to execute the Definitive Contract prior to the expiration of this Letter of Intent ("LOI").
The terms set out in the Master Proposal represent the salient terms upon which the Definitive Contract shall be negotiated. Your appointment as CRO will be effective upon the conclusion of the Definitive Contract in accordance with its terms.
Save for the provisions contained herein, the Start Up Proposal (as defined below) and the non-disclosure agreement dated February 25, 2025 ("NDA"), which shall be binding on the Parties, no other enforceable legal agreement exists between the Parties until the Definitive Contract has been executed by the Parties.
| Hand Over of Trial |
It is recorded that the Trial was commenced with iNGENū CRO Pty Ltd ("iNGENū") as the initial CRO.
Subject to the conclusion of the Definitive Contract, we wish to appoint you as CRO in respect of the Trial, taking over the Trial execution from iNGENū. In preparation for such appointment and rescue, you agree that you will co-operate with us and iNGENū to facilitate the orderly handover of all works and deliverables, and ensure the full transfer of all data, intellectual property and other property from iNGENū in terms of the scope of works ("Start Up Activities"), payment terms and at the cost ("Start Up Cost") set out in the proposal date April 1, 2025 ("Start Up Proposal").
Save for the Start Up Activities, which shall be carried out at the Start Up Cost, you will not commence any work under the Master Proposal or incur any costs unless approved by us in writing or upon conclusion of the Definitive Contract. |
PSYENCE AUSTRALIA PTY LTD
ACN 665 259 727
| Costs and expenses | Save for the Start Up Costs which will be owing to you, each Party will be responsible for their own costs and charges incurred with respect to their duties under this LOI including, without limitation, all costs and charges incurred prior to the date of this LOI. |
| Intellectual Property |
Any and all discoveries, inventions, and data, whether or not protected by patent, copyright, trade secret, or otherwise resulting from the Trial or the Start Up Activities, or containing any confidential information of us resulting directly from the Trial or the Start Up Activities, or which is received by you from us or from iNGENū is our exclusive property.
This LOI shall in no way be construed as the granting of a license, or other interest to you in any of our intellectual property or proprietary or confidential information.
Provisions governing intellectual property and licensing between the Parties shall be dealt with in more detail in the Definitive Contract. |
| Definitive Contract & Termination |
This LOI shall terminate in the event that the Parties do not execute a Definitive Contract by May 31, 2025.
In the event of termination of this LOI the Parties shall each return to the other any confidential materials which they have received from the other hereunder, with the exception of one copy of such materials which each may maintain under the confidentiality provisions hereof, and in the same manner as they protect all of their other important legal documents, as is reasonably necessary for regulatory, insurance or other legitimate legal purposes.
Southern Star Research will not be obliged to provide any services beyond the termination date.
Psyence will remain obligated to make payments to Southern Star Research in respect of the Start Up Costs for all Start Up Activities performed and reasonable expenses duly incurred in terms of the Start Up Proposal up to the termination date. |
| Confidentiality | The Parties acknowledge that they have entered into the NDA and that the recipients of Confidential Information (as defined therein) shall maintain the confidentiality of the Confidential Information in accordance with the NDA. The provisions of the NDA shall apply to this LOI, mutatis mutandis. |
| Publication |
No rights are granted to any Party to make any publication or disclosure related to the Trial or the existence and content of this LOI to any third party. The foregoing shall not apply to the extent that any such publication or disclosure is required by applicable law or the rules of a securities exchange to which a Party or any of its affiliates are subject.
Notwithstanding the above, you agree that we may issue a press release at the conclusion of this LOI in a manner which is customary of publicly listed companies, provided that you will have 24 hours to review the press release and provide any comments thereon prior to publication. |
PSYENCE AUSTRALIA PTY LTD
ACN 665 259 727
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Upon execution of this LOI by both parties, Psyence hereby authorizes Southern Star Research to proceed with the Start Up Activities pursuant to the terms and conditions of this LOI, read with the Start Up Proposal. The Start Up Activities, Start Up Costs and associated fees and expenses are outlined in the Start Up Proposal.
Southern Star Research agrees to indemnify Psyence from any loss, damage, cost or expense (including reasonable attorneys’ fees) ("Loss") to the extent arising from any third party claim, demand, assessment, action, suit or proceeding ("Claim") directly occurring as a result of:
a) the negligence or willful misconduct of Southern Star Research; or
b) Southern Star Research’s breach of this LOI.
Psyence agrees to indemnify Southern Star Research from any Loss to the extent arising from any Claim occurring directly as a result of:
a) the negligence or willful misconduct of Psyence; or
b) Psyence’s breach of this LOI.
As soon as is reasonably possible on receipt of notice of any Claim which may give rise to a right of indemnity from the other Party hereto, the indemnified Party shall give written notice thereof to the indemnifying Party of such claim for indemnity. Such claim for indemnity shall indicate the nature of the claim and the basis therefore.
Neither Party shall be liable to the other for any punitive, consequential, incidental, indirect, or special damages (including lost profits or revenue), whether pled in contract, tort, or any other theory of law.
The liability of the indemnifying party will be reduced to the extent that the indemnified party contributed to and or caused the Loss.
All amounts paid under this LOI will be credited against any amounts due from Psyence, under the Definitive Contract (if any) agreed between the Parties covering the full scope of services. All amounts will be paid in AUD.
Southern Star Research will invoice in advance for 50% of all Start Up Costs ("Deposit Invoice"). Southern Star Research will then invoice the balance upon completion of the Start Up Activities, unless agreed otherwise in the Definitive Contract.
Southern Star Research acknowledges and agrees that the responsibility for the Start Up Activities are being transferred to Southern Star Research. Psyence shall retain responsibility for all other activities related to the Trial until such time as the Definitive Contract has been concluded and Master Services agreed, following which Southern Star Research acknowledges and agrees that the responsibility for the Master Services shall be transferred to Southern Star Research.
PSYENCE AUSTRALIA PTY LTD
ACN 665 259 727
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The Parties acknowledge and agree that under no circumstances will clinical trial subjects be screened or be enrolled in the Trial or dosed until the Definitive Contract and Work Order are fully executed by both Parties.
This LOI contains the entire understanding of the parties with respect to the subject matter contained herein and can only be modified in writing with the signature of both parties. It will be superseded in its entirety by the Definitive Contract. If the Definitive Contract between the parties is not executed, the obligations of both parties under this LOI regarding confidential information shall survive any termination or expiration of this LOI.
If you are in agreement with the points outlined above, please sign and return this LOI whereupon, it is agreed, this LOI will be effective as of the date of the last signature below.
| Sincerely, | |
| /s/ Neil Maresky | |
| Dr. Neil Maresky | |
| CEO | |
| Psyence Australia Pty Ltd |
| Agreed and Accepted: | |
| SOUTHERN STAR RESEARCH PTY LTD |
| Signature: | /s/David Lloyd | |
| Name: | David Lloyd, Managing Director | |
| Date: | ||
PSYENCE AUSTRALIA PTY LTD
ACN 665 259 727
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Exhibit 99.2
| Exit Deed | April 3, 2025 |
This Exit Deed is made and entered into by and between:
Psyence Australia Pty Ltd (“Sponsor”), (ACN 665 259 727); and
iNGENū CRO Pty Ltd (“CRO”) (ACN 656 400 056)
With reference to:
- Master Services Agreement dated 21 March 2023, and;
- Study Order dated 23 March 2023,
collectively, the "MSA".
1. Termination Acknowledgement
The Sponsor has elected to terminate the Study engagement in accordance with clause 19 of the MSA. No patients have been dosed; however, screening activities at Empax had commenced. The parties acknowledge and agree that termination is being affected prior to the Milestone payment due for First Patient In (FPI).
2. Withdrawal of Letter
The Sponsor hereby agrees to formally withdraw the letter dated March 11, 2025 address to the CRO, provided that the CRO agrees to perform its obligations under clauses 3, 5 and 6 below.
3. $0 Transition Support
CRO agrees to provide transition support at no charge by the CRO ($0 contract) for up to forty five (45) business days from the date of this Exit Deed. Support includes knowledge transfer, regulatory transition, site handover, database and data transfer, and general assistance as reasonably requested by Sponsor. Any third-party transfer and/or termination costs associated are to be covered by the Sponsor, and are further particularised in Clause 6 below.
4. Centralised Communication
All communications from the Sponsor to the CRO during the transition shall be directed solely to either the CRO's COO or CEO. The Sponsor will not liaise directly with other CRO personnel or third parties without prior written instruction. All CRO to Sponsor communication will be through the CEO or CFO.
5. Final Data & Document Transfer
The CRO agrees to deliver all screening logs, regulatory documents, site, database and data transfer, and vendor contracts, and essential TMF documentation in CRO’s possession within 5 calendar days of the date this Exit Deed. Upon request, other documents from sites, and/or third parties, .e.g. HREC will be gathered and shared within reasonable timeframes.
6. Vendor Management & Financial Settlement
The Sponsor agrees to pay [*] rate that is the equivalent of [*] invoices, which is a rate of [*]. CRO will raise an invoice [*] outlining in the description that this expenditure directly relates to partial payment of vendors associated with the clinical trial activities. This [*] invoice is to be paid by the Sponsor by no later than 5pm AEST on Monday 7th April 2025 thereof in settlement of all third party vendor invoices as detailed in Appendix 1 incurred as at the date of this Exit Deed.
The CRO agrees to pay the outstanding
invoices and liabilities with third-party vendors as detailed in Appendix 1 related to services rendered under the Study Order by no later
than 5pm AEST on Monday 7th April 2025.
The Parties confirm that all CRO invoices or payments due under the
MSA by the Sponsor have been settled in full and that no further payments are owing or shall be due by the Sponsor.
Upon execution of this Exit Deed, termination notices will be sent to all vendors. The Sponsor shall be entitled to reengage any of those
vendors or others as they determine. All vendor severance fees (if any) are to be borne by the Sponsor.
The CRO has no further financial obligation under the SO or MSA beyond payments already made or agreed at the time of this Exit Deed.
[*]
8. Intellectual Property & Confidentiality
All IP created during the engagement, including New Materials and Improvements, vests in the Sponsor as per MSA clause 15.2. CRO agrees to assign and transfer any remaining rights and execute documentation as needed. Confidentiality obligations in clause 16 of the MSA remain in full effect post-termination.
[*]
10. Mutual Release
Subject to fulfilment of the terms in this Exit Deed, each Party releases the other from any claims or liabilities under the MSA or SO, except unresolved obligations identified in this Deed.
11. Release from all claims
The Sponsor agrees upon signing this Exit Deed to release the CRO from all historic, current and future claims related to the MSA, Study Order and related contracts.
12. Execution and Legal Provisions
This Exit Deed will be governed by the laws of Victoria, Australia, per MSA clause 21.12.
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Signed by authorised representatives of each
party.
EXECUTION
Executed by iNGENu Pty Ltd (ACN 656 400 056) in accordance with section 126 of the Corporations Act 2001 (Cth), by its duly authorised agent:
| Signature of Director | Signature of Director | |
| Name of Director (Print) | Name of Director (Print) | |
| Date | Date |
Executed by Psyence Australia Pty Ltd (ACN 665 259 727) in accordance with section 126 of the Corporations Act 2001 (Cth), by its duly authorised agent:
| Signature of Director | Signature of Director | |
| Name of Director (Print) | Name of Director (Print) | |
| Date | Date |
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Appendix 1
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Exhibit 99.3
Psyence BioMed Signs LOI with Southern Star Research to Expand Phase IIb Clinical Trial in Australia
New partnership strengthens Psyence BioMed’s global clinical trial capabilities, accelerating the development of psilocybin-assisted therapy for adjustment disorder
NEW YORK, April 8, 2025 — Psyence BioMed (Nasdaq: PBM) (“Psyence BioMed” or the “Company”) today announced the signing of a Letter of Intent (LOI) with Southern Star Research Pty Ltd, a premier Australian contract research organization (CRO). This collaboration will accelerate Psyence BioMed’s ongoing Phase IIb psilocybin clinical trial in Australia, which focuses on adjustment disorder in patients diagnosed with cancer.
Adjustment disorder ranks as the seventh most frequently diagnosed psychiatric condition globally, affecting millions of people who currently have no FDA-approved pharmaceutical treatment.
The engagement of a new CRO represents a pivotal step in optimizing Psyence BioMed’s clinical trial, enabling collaboration with a broader national oncology and mental health network to accelerate the Phase II clinical trial timeline. Southern Star Research’s scale and capabilities will support the next phase of the Company’s clinical development plan. Psyence BioMed thanks iNGENū CRO for their contribution to the protocol design, ethics approval and site activation. To ensure continuity and operational efficiency, Psyence BioMed is coordinating a seamless handover of trial management responsibilities to Southern Star Research as it moves forward with its clinical programs.
“Southern Star Research’s state-of-the-art operations, with its advanced infrastructure, national network within Oncology and Mental health, as well as in-depth knowledge of the Australian clinical trial environment will enhance patient recruitment and support efficient trial execution,” said Dr. Neil Maresky, CEO of Psyence BioMed. “Their expertise and dedication to clinical excellence make them a strong partner in our mission to develop innovative therapies that address the urgent mental health needs of patients with adjustment disorder.”
Dr David Lloyd, Managing Director and Co-Founder of Southern Star Research, expressed enthusiasm for the collaboration, stating: “We are excited to collaborate with Psyence BioMed on the expansion of their Phase IIb clinical trial. This partnership represents a significant step in our long-term commitment to advancing novel psychedelic-assisted therapies for mental health conditions such as adjustment disorder, an area with an enormous unmet need. Our talented team is dedicated to supporting the development of pioneering treatments, and we look forward to contributing to the success of this important clinical trial and many more in the future.”
Psyence BioMed senior leadership will discuss the new agreement during the Company’s corporate webinar on Thursday, April 10, 2025, at 12:00 PM EST.
To register, please visit: https://psyencebiomed.com/corporate-webinar_april2025/
About Southern Star Research Pty Ltd
Southern Star Research Pty Ltd is an Australian full-service CRO specializing in providing clinical trial services for biotechnology and pharmaceutical companies. With a strong focus on quality and partnership. Southern Star Research is dedicated to advancing clinical research and helping bring innovative therapies to patients.
About Psyence BioMed:
Psyence Biomedical Ltd. (Nasdaq: PBM) is one of the few multi-asset, vertically integrated biopharmaceutical companies specializing in psychedelic-based therapeutics. It is the first life sciences biotechnology company focused on developing nature-derived (non-synthetic) psilocybin-based psychedelic medicine to be listed on Nasdaq. Psyence is dedicated to addressing unmet mental health needs, particularly in palliative care. The name ‘Psyence’ merges ‘psychedelics’ and ‘science,’ reflecting the company’s commitment to an evidence-based approach in developing safe, effective, and FDA-approved nature-derived psychedelic treatments for a broad range of mental health disorders.
Learn more at www.psyencebiomed.com and on LinkedIn.
Contact Information for Psyence Biomedical Ltd.
Email: ir@psyencebiomed.com
Media Inquiries: media@psyencebiomed.com
General Information: info@psyencebiomed.com
Phone: +1 416-477-1708
Investor Contact:
Michael Kydd
Investor Relations Advisor michael@psyencebiomed.com
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Forward Looking Statements
This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, our plans, objectives, expectations, and intentions with respect to future operations, products and services; and other statements identified by words such as “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimated,” “believe,” “intend,” “plan,” “projection,” “outlook” or words of similar meaning.
Forward-looking statements in this communication include statements regarding the handover and progress of the Phase IIb clinical trial, and trial execution under the newly engaged CRO. These forward-looking statements are based on a number of assumptions, including the assumption that there will be no delays in the execution of the Phase IIb clinical trial implementation schedule, topline data from this trial will be positive, and that the demand for psychedelic-assisted therapy will continue to increase. There can be no assurance that the Company will continue to maintain compliance with Nasdaq’s continued listing requirements.
There are numerous risks and uncertainties that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements.
These risks and uncertainties include, among others: (i) delays in the execution of the Phase IIb trial; (ii) the ability of Psyence BioMed to maintain the listing of its common shares and warrants on Nasdaq; (iii) volatility in the price of the securities of Psyence BioMed due to a variety of factors, including the recent share consolidation, changes in the competitive and highly regulated industries in which Psyence BioMed operates, variations in performance across competitors, changes in laws and regulations affecting Psyence BioMed’s business and changes in Psyence BioMed’s capital structure. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of the Company’s final prospectus (File No. 333-284444) filed with the Securities and Exchange Commission (the “SEC”) on January 24, 2025 and other documents filed by Psyence BioMed from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Actual results and future events could differ materially from those anticipated in such statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Except as required by law, Psyence BioMed does not intend to update these forward-looking statements.
The Company does not make any medical, treatment or health benefit claims about its proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by authorized clinical research. There is no assurance that the use of psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not conducted clinical trials for the use of the proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company has verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.
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