Psyence Biomed Issues Shareholder Update Recapping Recent Progress and Previewing Key Upcoming Data Milestones

Rhea-AI Summary

Psyence Biomedical (Nasdaq: PBM) has issued a shareholder update highlighting recent progress and upcoming milestones. The company has:

• Initiated a Phase IIb study of nature-derived psilocybin for Adjustment Disorder in Palliative Care
• Expanded its pipeline to include Alcohol Use Disorder (AUD) and Substance Use Disorders (SUDs)
• Announced the acquisition of Clairvoyant, a synthetic psilocybin-based drug developer
• Secured exclusive supply agreements for GMP nature-derived psilocybin

Two Phase II data readouts are anticipated in 2025: Clairvoyant's AUD trial in early 2025 and Psyence's Adjustment Disorder trial in the second half of 2025. The company has also strengthened its financial position to support these initiatives.

 

Initiated Phase IIb study of nature-derived psilocybin as a potential treatment for Adjustment Disorder in Palliative Care

Expanded pipeline into Alcohol Use Disorder (AUD) and Substance Use Disorders (SUDs) through exclusive IP licensing agreement with Psylabs for its botanical psilocybin product

Announced acquisition of synthetic psilocybin-based drug developer Clairvoyant, further bolstering AUD development program

Two Phase II data readouts anticipated in 2025

NEW YORK, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence Biomed” or the “Company”) today issued the following update to shareholders:

Dear shareholders:

It has been an eventful and productive few months since my last letter in March, and I wanted to take this opportunity to update you on our recent progress, as well as key milestones that we are focused on going forward.

Phase IIB Trial in Palliative Care Initiated in Australia

Beginning with our lead clinical program, which is evaluating nature-derived psilocybin in conjunction with psychotherapy as a potential treatment for Adjustment Disorder in Palliative Care, we recently announced the initiation of patient screening in our Phase IIb clinical trial that we are running in Australia. Together with our partners, Fluence and iNGENū, we will endeavor to enroll this study as efficiently as possible, and we look forward to topline data in the back half of next year that, if positive, will support the initiation of a pivotal Phase III trial as soon as practicable thereafter. We see this as a big value inflection point for our company.

Strengthened Clinical Supply of Natural Psilocybin

To better support this program, we have partnered with Optimi Health through a non-binding Letter of Intent (LOI) whereby Optimi will be our exclusive supplier of GMP nature-derived psilocybin extract for both our Phase III trial (assuming the Phase IIb study is successful) as well as subsequent commercialization. This LOI gives us confidence that we will have a reliable supply of high-quality GMP nature-derived psilocybin extract as we continue to advance our Adjustment Disorder clinical program.

Second Indication: Alcohol Use Disorder and other Substance Use Disorders

We also announced our second development indication, which will evaluate GMP nature-derived psilocybin as a potential treatment for Substance Use Disorders (SUDs), including Alcohol Use Disorder (AUD). We plan to focus initially on AUD, and, to that end, we signed an agreement with Psylabs to be the exclusive supplier of highly purified psilocybin extract exclusively for these indications. SUDs represent a significant burden to society, with as many as 44.4 million people aged 18 and over in the U.S. alone diagnosed with an AUD or SUD in 2021¹.

Numerous prior academic studies suggest that psilocybin, when combined with psychotherapy, can be a safe and effective treatment option for these individuals^2,3,4 – something that we aim to confirm in rigorously designed clinical studies.

Acquisition of Second Phase IIb Asset

Staying on the topic of AUD for a moment, to further bolster our development efforts, we signed a conditional binding term sheet for the acquisition of psilocybin-based drug developer Clairvoyant (the “Proposed Acquisition”). This acquisition, when completed, makes strategic sense for Psyence for several reasons. First, it introduces a synthetic psilocybin-based therapeutic candidate that nicely complements our ongoing nature-derived psilocybin development programs. Additionally, it efficiently expands our pipeline into AUD – a high-value indication – with a regulatory pathway that, if successful, will transition us to a commercial-stage, revenue-generating company. Clairvoyant is currently executing a Phase IIb clinical trial in AUD, with topline data expected in early 2025. Closing of this acquisition is contingent upon the completion of due diligence and customary closing conditions.

Together, these initiatives give us line-of-sight to two critical Phase IIb data readouts, in two separate indications, in the relative near-term: first, data from Clairvoyant’s ongoing trial in AUD in early 2025, followed by results from our trial in Adjustment Disorder in the second half of 2025.

Strengthened Financial Position

Finally, to ensure that we have the critical funding required to advance these initiates, we entered into agreements that are expected to provide us with sufficient capital to execute our strategy as outlined above.

In closing, by announcing our second indication and strengthening our pipeline and supply chain, we continue our journey to become a fully-fledged, vertically integrated life science biotech company. While conditions in the capital markets continue to be challenging, we believe that our many accomplishments over these past months position us to be a leader in the rapidly emerging field of psychedelic-based therapeutics development for mental health and related disorders.

I look forward to keeping you apprised of our continued progress. Thank you for your ongoing interest and support.

Sincerely,

Neil Maresky, MD
Dr. Neil Maresky
Chief Executive Officer

About Psyence Biomed

Psyence Biomedical Ltd. (Nasdaq: PBM) is the world’s first life science biotechnology company focused on the development of botanical (nature-derived and 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. Psyence 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: ir@psyencebiomed.com
Media Inquiries: media@psyencebiomed.com
General Information: info@psyencebiomed.com
Phone: +1 416-477-1708

Investor Contact:
Jeremy Feffer
Managing Director
LifeSci Advisors
jfeffer@lifesciadvisors.com

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 conclusion of a definitive agreement to the satisfaction of the parties, the fulfilment of the conditions to the closing of the Proposed Acquisition, access to the capital and liquidity required for Psyence Biomed to execute on the AUD strategy and Clairvoyant’s ability to successfully conduct its trial and deliver its intended drug product to patients. These forward-looking statements are based on a number of assumptions, including the assumptions that the parties will obtain all such regulatory, corporate, shareholder and other approvals as may be required to implement the Proposed Acquisition, the continuation of the clinical trial referred to in this news release on schedule, and the safety and effectiveness of psilocybin as a treatment option for AUD.

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) the inability to complete the Proposed Acquisition; (ii) the inability to recognize the anticipated benefits of the Proposed Acquisition (iii) the ability of CRO to execute its obligations in respect of the clinical trial; (iv) changes in applicable laws which may impact the clinical trial and/or the conducting thereof; (v) Clairvoyant’s ability to achieve successful clinical results; (vi) Psyence Biomed’s ability to obtain regulatory approval for the proposed product candidate, and any related restrictions or limitations of any approved products; (vii) the ability of Psyence Biomed to maintain the listing of its common shares and warrants on Nasdaq; and (viii) volatility in the price of the securities of Psyence Biomed due to a variety of factors, including 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 prospectus filed by the Company with the SEC on August 30, 2024 and other documents filed by the Company 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 information. 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, the Company does not intend to update these forward-looking statements.

The Company makes no medical, treatment or health benefit claims about the Company’s 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 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 proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company 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.

¹ Department of Health and Human Services (HHS), Substance Abuse and Mental Health Services Administration (SAMHSA), 2022 National Survey on Drug Use and Health (NSDUH), Table 5.1A
² https://jamanetwork.com/journals/jama/article-abstract/2796962#:~:text=Using%20psilocybin%20(a%20psychedelic,trial%20published%20in%20JAMA%20Psychiatry
³ https://pubmed.ncbi.nlm.nih.gov/36001306/
⁴ https://www.frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2023.1134454/full

FAQ

What are the key clinical trials Psyence Biomed (PBM) is currently conducting?

Psyence Biomed (PBM) is conducting a Phase IIb trial of nature-derived psilocybin for Adjustment Disorder in Palliative Care in Australia. Additionally, through the acquisition of Clairvoyant, they have a Phase IIb trial for Alcohol Use Disorder (AUD) underway.

When does Psyence Biomed (PBM) expect to release Phase II data for its clinical trials?

Psyence Biomed (PBM) anticipates two Phase II data readouts in 2025. The first is from Clairvoyant's AUD trial, expected in early 2025. The second is from their Adjustment Disorder trial, expected in the second half of 2025.

What new indications has Psyence Biomed (PBM) added to its pipeline?

Psyence Biomed (PBM) has expanded its pipeline to include Alcohol Use Disorder (AUD) and other Substance Use Disorders (SUDs). They plan to focus initially on AUD.

Who are Psyence Biomed's (PBM) key partners for psilocybin supply?

Psyence Biomed (PBM) has partnered with Optimi Health for GMP nature-derived psilocybin extract supply for their Adjustment Disorder program. They also signed an agreement with Psylabs for highly purified psilocybin extract for SUDs and AUD indications.