6-K
Psyence Biomedical Ltd. (PBM)
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 THE
SECURITIES EXCHANGE ACT OF 1934
For the month of July 2024
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 x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
Modification and Termination of Material Agreements
As previously disclosed, Psyence Group Inc. (“PGI”) and Filament Health Corp. (“Filament”) are parties to (i) that certain License Agreement, dated as of April 18, 2022 (the “License Agreement”), relating to the supply and licensing of PEX010 by Filament to the Company in connection with the Company’s Phase II clinical trials evaluating nature-derived psilocybin as a potential treatment for Adjustment Disorder within the context of palliative care, and (ii) that certain binding Term Sheet for the Commercial Licensing of Intellectual Property, dated as of December 14, 2022 (the “Commercial Term Sheet”), relating to the commercial licensing of PEX010. The Commercial Term Sheet remained subject to the terms of a definitive agreement.
On July 22, 2024, Psyence Biomedical Ltd. (the “Company”), PGI and Filament entered into the First Addendum to the License Agreement and Commercial Term Sheet (the “Addendum”), pursuant to which, among other things, (1) PGI assigned to the Company all right, title and interest in and to the License Agreement and the license contemplated therein, (2) Filament agreed to provide a sufficient supply of products to the Company in order to facilitate the substitution of an alternative drug candidate for use in the Company’s Phase III trials and for commercialization purposes following the conclusion of the Phase IIb study, and (3) the parties agreed to mutually terminate the Commercial Term Sheet. Filament has agreed to continue to support the supply of PEX010 for the Company’s upcoming Phase IIb trial. The Company is evaluating two alternative suppliers of drug product for its pivotal Phase III studies as well as for future studies in other indications. The Company is in the final stages of negotiating supply agreements, as well as licensing agreements for the use of third-party intellectual property, with two licensed suppliers operating in the United Kingdom and North America. The Company intends to provide further updates on such agreements as they are executed. However, there can be no guarantees that such agreements will be finalized.
The foregoing descriptions of the License Agreement, the Commercial Term Sheet, and the Addendum do not purport to be complete and are subject to, and qualified in their entirety by reference to, the full texts of the License Agreement, the Commercial Term Sheet, and the Addendum, each of which are attached hereto as Exhibits 99.1, 99.2, and 99.3, respectively and incorporated herein by reference.
On July 24, 2024, the Company issued a press release announcing the terms of the Addendum and the export of PEX010 to Australia from Filament for use in the Company’s upcoming Phase IIb clinical trial. A copy of the press release is furnished hereto as Exhibit 99.4.
EXHIBIT INDEX
# Portions of this exhibit have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K.
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: July 24, 2024
| Psyence Biomedical Ltd. | |
|---|---|
| By: | /s/ Dr. Neil Maresky |
| Name: | Dr. Neil Maresky |
| Title: | Chief Executive Officer and Director |
Exhibit 99.3
FIRST ADDENDUM TO THE LICENSE AGREEMENT AND COMMERCIAL TERM SHEET Between
FILAMENT HEALTH CORP. a corporation incorporated in British Columbia Canada, with offices at #210-4475 Wayburne Drive, Burnaby BC (“Filament”)
and
PSYENCE GROUP INC, a corporation incorporated in Ontario, Canada, with offices at 121 Richmond Street West Penthouse Suite, 1300 Toronto, ON M5H2K1, Canada (an amalgamation between PSYENCE GROUP INC AND PSYENCE BIOMED CORP) (“PSYG”)
(collectively, the "Parties")
| 1 | RECITALS |
|---|
| 1.1 | The Parties entered into a License Agreement on April 18, 2022 (the “LicenseAgreement”) and a Term Sheet for the Commercial Licensing of Intellectual Property on December 14, 2022 (the “CommercialTerm Sheet”).. |
|---|---|
| 1.2 | Unless otherwise defined in this Addendum, defined words shall bear the same meanings<br>as defined in the Term Sheet or in the annexures thereto. |
| --- | --- |
| 1.3 | The Parties wish to make certain amendments to the License Agreement and include<br>additional clauses thereto. |
| --- | --- |
| 1.4 | The Parties wish to terminate the Commercial Term Sheet. |
| --- | --- |
| 1.5 | The Parties wish to record these amendments in writing. |
| --- | --- |
| 1.6 | This Addendum shall be effective upon the earlier of either the date which Psyence<br>(defined below) or its duly authorised agent, including Syntro Pty Ltd (Australia) takes possession of the Shipment (defined below) or<br>the date as per Section 2.2 below (the “Effective Date”). |
| --- | --- |
| 2 | SHIPMENT |
| --- | --- |
The Shipment consists of the following:
| ● | PEX010 5 mg Capsules: Lot PEX010(05)-EP-230222-1 > Expiry date: February 22, 2025 |
|---|---|
| ● | PEX010 25 mg Capsules: Lot PEX010(25)-EP-230914-1 > Expiry date: September 14, 2026 |
| --- | --- |
| ● | PEX010 1 mg Capsules: Lot PEX010(01)-EP-230321-1 > Expiry date: March 21, 2026 |
| --- | --- |
| ● | Placebo Capsules: Lot PCB2-EP-230206-1 > Expiry date: February 6, 2026 |
| --- | --- |
| 2.1 | Psyence represents and warrants that Psyence, or its duly authorised agent, will<br>take possession of the Shipment within 15 business days of notification by Filament that the Shipment is available for transfer. |
| --- | --- |
| 2.2 | In the event that Psyence, or its duly authorised agent, does not take possession<br>of the Shipment as per Section 2.1 above, this Addendum shall immediately become effective. |
| --- | --- |
| 3 | TERMINATION OF THE COMMERCIAL TERM SHEET |
| --- | --- |
The Term Sheet is hereby terminated with effect from the Effective Date.
| 3.1 | Filament represents and warrants that Filament will continue to provide stability<br>testing of the 5mg dosage of PEX010, which will enable the extension of the shelf-life of the 5mg dose to a shelf-life of 36 months, which<br>extension is to be confirmed by no later than June 30, 2025; and |
|---|---|
| 3.2 | In the event that the shelf-life extension in Section 3.1 above is unsuccessful,<br>Filament shall supply a suitable alternative 5mg product to be used in the Phase IIb study being conducted by Psyence in Australia. |
| --- | --- |
| 4 | AMENDMENTS AND ADDITIONS TO THE LICENSE AGREEMENT |
| --- | --- |
The License Agreement is hereby amended as follows:
| 4.1 | Pursuant to Section 13.7 of the License Agreement, PSYG hereby assigns to PSYENCEBIOMEDICAL LTD, a corporation incorporated in Ontario, Canada, with offices at 121 Richmond Street West Penthouse Suite, 1300 Toronto,<br>ON M5H2K1, Canada (“Psyence”) all right, title and interest in and to the License Agreement and the License contemplated therein<br>(the “Assignment”), which Assignment Psyence hereby accepts and to which Filament hereby consents. For the avoidance<br>of doubt, the License shall include the right of Psyence to sub-license the License to its wholly-owned subsidiaries without the consent<br>of Filament; |
|---|---|
| 4.2 | The inclusion of a new Section 2.3 as follows: |
| --- | --- |
2.3 Substitution:
| (a) | Filament will provide a sufficient supply of the Materials, End-Product and Placebos<br>and related materials as may be reasonably required by Psyence and/or any health regulatory authority having jurisdiction, to facilitate<br>the substitution of an alternative drug candidate for use in Phase III trials and for commercialization purposes (the "Substitution").<br>Filament shall use its commercially reasonable efforts to meet the Delivery Schedule and shall co-operate with Psyence and its Project<br>partners to ensure that the Project Schedule is adhered to. |
|---|---|
| (b) | Filament will provide, in such manner as reasonable determined by Filament, all<br>such other support as may be reasonably required by Psyence and/or the health regulatory authority having jurisdiction regulators to facilitate<br>the Substitution, including but not limited to the supplying of all such technical documentation and responses and as may be required. |
| --- | --- |
| (c) | In the event that the Substitution is successful and the alternative drug candidate<br>is approved by the health regulatory authority having jurisdiction for use in Phase III trials, Psyence shall be entitled to source the<br>alternative drug candidate from the supplier of its choice. |
| --- | --- |
| 4.3 | [Filament hereby waives the Milestone Payment referred to in Section 3.3(d).] |
| --- | --- |
| 5 | SAVINGS CLAUSE |
| --- | --- |
Save to the extent specifically or by necessary implication modified in or inconsistent with the provisions of this Addendum, all the terms and conditions of the License Agreement shall mutatis mutandis continue in full force and effect. If there is any discrepancy between this Addendum and the License Agreement, this Addendum shall prevail.
| 6 | COSTS |
|---|
Each Party will bear and pay its own legal costs and expenses of and incidental to the negotiation, drafting, preparation and implementation of this Addendum.
| 7 | SIGNATURE |
|---|
Signed on behalf of the parties, each signatory hereto warranting that he/she has due authority to do so.
IN WITNESS WHEREOF the parties have executed this Addendum as of the date first written above.
| PSYENCE GROUP INC | ||
|---|---|---|
| By: | /s/ Jody Aufrichtig | |
| Name: | Jody Aufrichtig | |
| Title: | Director | |
| I have authority to bind the<br> corporation. | ||
| PSYENCE BIOMEDICAL LTD | ||
| By: | /s/ Neil Maresky | |
| Name: | Neil Maresky | |
| Title: | Chief Executive Officer | |
| I have authority to bind the<br> corporation. | ||
| FILAMENT HEALTH CORP. | ||
| By: | /s/ Ben Lightburn | |
| Name: | Ben Lightburn | |
| Title: | Director | |
| I have authority to bind the<br> corporation. |
Exhibit 99.4
Psyence Biomed Announces Export of Nature-DerivedPsilocybin to Australia and Provides Update on Upcoming Phase IIb Trial
Trial projected to be initiated shortly followingreceipt of drug product by trial sites
NEW YORK, July 24, 2024 -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence Biomed” or the “Company”) today announced the export of nature-derived psilocybin to Australia and provided an update on its upcoming Phase IIb clinical trial evaluating nature-derived psilocybin as a potential treatment for Adjustment Disorder following an advanced cancer diagnosis in the Palliative Care context.
The Company previously announced that it had entered into partnerships with Fluence, a global leader in professional education and training for psychedelic therapy research, and iNGENū CRO Pty Ltd (“iNGENū”), an Australian clinical research organization (CRO), to support the study. Following a recent site visit by Psyence Biomed leadership to partners and trial sites in Australia, the Company is preparing to initiate the study shortly following the recent successful export of drug candidate, PEX010, from its current supplier, Filament Health.
“Over the past several months, we have made substantial progress preparing for our Phase IIb study, and following my recent site visit to Australia, I am pleased to report that all parties, including Psyence and our partners, Fluence and iNGENū, are poised to initiate the study imminently,” said Dr. Clive Ward-Able, Medical Director of Psyence Biomed. “With the successful export of PEX010, we now plan to focus on the efficient enrollment of patients into this important study.”
The randomized, double-blind, placebo-controlled Phase IIb study will evaluate two therapeutic doses of nature-derived psilocybin (10mg, 25mg) against an active low-dose comparator (1mg) in 84 patients in conjunction with psychotherapy. Psyence aims to execute an efficient yet rigorously designed study that, if successful, would best support advancement into future late-stage studies.
More information on the study can be found at: 12624000449538p.
Filament Health Commercial Licensing Agreement Update
Psyence Biomed’s commercial licensing agreement with Filament Health, which covered supply of PEX010 for pivotal Phase III studies in Adjustment Disorder and also granted Psyence Biomed the worldwide right to commercialize PEX010 (25 mg) within the context of Palliative Care, remained subject to further negotiations between the parties and the completion of a subsequent definitive agreement within a predefined time period.
Following further discussions, both parties have mutually agreed to terminate the commercial licensing agreement. Filament Health will continue to support the supply PEX010 for the upcoming Phase IIb trial, as previously announced. Psyence Biomed is evaluating two exclusive supply and license agreements with duly licensed suppliers operating in the United Kingdom and North America. The Company intends to provide further updates on such agreements as they are executed. However, there can be no guarantees that such agreements will be finalized.
“We have made significant progress identifying alternative suppliers of nature-derived, non-synthetic psilocybin for use in subsequent clinical studies, and we look forward to securing a partner that can support our needs over the long-term,” stated Dr. Neil Maresky, CEO of Psyence Biomed. “Importantly, this change should have minimal impact on our internal development timelines for our Phase IIb program, and we remain committed to introducing a novel therapy for Adjustment Disorder following an advanced cancer diagnosis in the Palliative Care context as efficiently as possible.”
AboutPsyence Biomed
Psyence Biomedical Ltd. (Nasdaq: PBM) is the world’s first life science biotechnology company focused on the development of botanical (nature-derived, or non-synthetic) psilocybin-based psychedelic medicine to be listed on Nasdaq. The name “Psyence” combines the words “psychedelics” and “science” to affirm Psyence Biomed’s commitment to an evidence-based approach to innovation as it works to develop safe and effective, nature-derived psychedelic therapeutics to treat a broad range of mental health disorders. The Company is initially focused on mental health disorders in the context of Palliative Care.
Learn more at www.psyencebiomed.com and on LinkedIn.
Contact Information
Email: [email protected]
Media Inquiries: [email protected]
General Information: [email protected]
Phone: +1 416-477-1708
Investor Contact:
Jeremy Feffer
Managing Director
LifeSci Advisors
Forward Looking Statements
This communication contains "forward-lookingstatements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limitedto, statements about future financial and operating results, our plans, objectives, expectations and intentions with respect to futureoperations, products and services; and other statements identified by words such as "will likely result," "are expectedto," "will continue," "is anticipated," "estimated," "believe," "intend," "plan," "projection," "outlook" or words of similar meaning.
Forward-looking statements in this communicationinclude statements regarding the commencement of the clinical trial referred to in this news release, the anticipated delivery of thedrug candidate, PEX010, in Australia, and the safety and effectiveness of psilocybin as a treatment option for adjustment disorder withinthe context of Palliative Care. These forward-looking statements are based on a number of assumptions, including the assumption that theanticipated shipment of the drug candidate, PEX010, will be successfully delivered to Australia, Psyence Australia Pty Ltd. (“PsyenceAustralia”), the Company’s Australian subsidiary, will receive all such regulatory and other approvals as may be requiredto implement the clinical trial, that patient recruitment will be successful in accordance with the expected timelines, and that contractnegotiations with alternative suppliers of drug product will be successful.
There are numerous risks and uncertaintiesthat 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) the ability of iNGENū to execute its obligations in respect of the clinicaltrial; (ii) changes in applicable laws which may impact the clinical trial and/or the conducting thereof; (iii) Psyence Australia’sability to achieve successful clinical results; (iv) Psyence Biomed’s ability to obtain regulatory approval for its product candidates,and any related restrictions or limitations of any approved products; (v) Psyence Biomed’s ability to obtain licensing of third-partyintellectual property rights and supply of raw materials for future discovery and development of its product candidates; (vi) the abilityof Psyence Biomed to maintain the listing of its common shares and warrants on Nasdaq; and (vii) volatility in the price of the securitiesof Psyence Biomed due to a variety of factors, including changes in the competitive and highly regulated industries in which Psyence Biomedoperates, variations in performance across competitors, changes in laws and regulations affecting Psyence Biomed’s business andchanges in Psyence Biomed’s capital structure. The foregoing list of factors is not exhaustive. You should carefully consider theforegoing factors and the other risks and uncertainties described in the "Risk Factors" section of the Registration Statementon Form F-1, initially filed by the Company with the SEC on February 9, 2024 and other documents filed by the Company from time to timewith the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results todiffer materially from those contained in the forward-looking statements. Actual results and future events could differ materially fromthose anticipated in such information. Nothing in this communication should be regarded as a representation by any person that the forward-lookingstatements 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 bylaw, the Company does not intend to update these forward-looking statements.
The Company makes no medical, treatment orhealth benefit claims about the Company’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similarregulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticalproducts. The efficacy of such products has not been confirmed by approved 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 its proposedproducts. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company verified suchin clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary tocommercialize its business, it may have a material adverse effect on the Company’s performance and operations.