PBM

‍

Psyence Group's NASDAQ-Listed Associate, Psyence Biomed Issues Shareholder Update Recapping Recent Progress and Previewing Key Upcoming Data Milestones

READ THE INVESTOR PRESENTATION HERE

*****BREAKING NEWS THIS MORNING

Psyence Biomed Enters into Agreement to Acquire Stake in PsyLabs

PUBLISHED

SEP 19, 2024 7:30AM EDT

PsyLabs develops and produces certified pharmaceutical-grade natural psychedelics for applications in mental health and well-being

NEW YORK, Sept. 19, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd.(Nasdaq: PBM) ("Psyence Biomed" or the "Company") today announced that it has entered into a conditional share sale agreement with Psyence Group (CSE: PSYG) (as seller) for the acquisition of an 11.13% stake in privately-held PsyLabs, a company focused on the production of psychedelic active pharmaceutical ingredients (APIs) and extracts for use in research, clinical trials and drug development ("Proposed Acquisition"). Per the terms of the Proposed Acquisition, Psyence Biomed will issue to Psyence Group shares of its common stock valued at $1.1 million dollars, at a price of $0.55 per share, in exchange for Psyence Group’s 11.13% stake in PsyLabs.

Psyence Biomed previously announced a worldwide, exclusive, royalty-bearing IP licensing agreement with PsyLabs to supply pharmaceutical-grade, EU GMP nature-derived (non-synthetic) psilocybin to be evaluated in future clinical trials as a potential treatment for Alcohol Use Disorder (AUD) and other Substance Use Disorders (SUDs) and for commercialization of the licensed product. Psyence Biomed plans to lead with a clinical trial in AUD, Psyence Biomed’s second development indication. The licensed product will require further development work by PsyLabs, which will be conducted during the remainder of 2024 and into 2025. PsyLabs is also commercially licensed for the production and export of additional pharmaceutical grade psychoactive compounds, including ibogaine and mescaline.

"We are very pleased to strengthen our relationship with PsyLabs through this acquisition, which gives us access to state-of-the-art cultivation and production capabilities that support our goal of becoming a leading, vertically integrated developer of psychedelic-based therapeutics," said Dr. Neil Maresky, Chief Executive Officer of Psyence Biomed. “As we expand our pipeline into additional high-value mental health conditions beyond our current Adjustment Disorder program, including Alcohol Use Disorder and other Substance Use Disorders, we will look to PsyLabs for consistent supply of high-purity, nature-derived psilocybin that will best position us for long-term success.”

Tony Budden, Chief Executive Officer of PsyLabs, said, "As health regulatory agencies tighten the standards for psychoactive compounds, especially for Phase III trials and commercial production, purity is becoming a key factor for success in psychedelic drug development. At PsyLabs, we’ve developed a proprietary process — with patents already filed — that we believe produces the highest purity, naturally derived psilocybin on the market. Psyence Biomed's investment is a strong validation of our work, and we're excited to collaborate as they push their development into treatments for AUD, SUD’s, and beyond."

Additional information on PsyLabs may be found at www.psylabs.life and an informative video about the company and its capabilities may be found at this link:

The completion of the Proposed Acquisition is subject to the fulfilment, or waiver, of certain conditions, including board approvals, regulatory approvals, a satisfactory due diligence process, and the achievement of a pre-defined product development milestone by PsyLabs by no later than October 31, 2024.

‍

________________________

‍Hello Everyone,

Our profile from today was up double digits and close in the green.

Another urgent situation was just brought our attention this morning.

This one is sitting right in that same price range as our profile from today.

Pull up PBM immediately.

This is an extremely unique situation.

We have seen this one fall from around .50 over the last 3 weeks to where it is currently sitting just .14.

The significant event that took place today was PBM finally reversed on the back of an update from the company.

It closed up 11% on interest towards the higher side of their recent average.

Psyence Group is a life science biotechnology company listed on the Canadian Securities Exchange (CSE: PSYG), with a focus on natural psychedelics. Psyence Biomed is the world’s first life science biotechnology company traded on the Nasdaq (NASDAQ: PBM) that is focused on the development of botanical (nature derived, or non-synthetic) psilocybin-based psychedelic medicines, and works with natural psilocybin products for the healing of psychological trauma and its mental health consequences in the context of palliative care. Our name "Psyence" combines the words psychedelic and science to affirm our commitment to producing psychedelic medicines developed through evidence-based research.

Informed by nature and guided by science, Psyence Group works to develop advanced natural psilocybin products for clinical research and development.

‍

‍

Check out the news from today:

‍

Psyence Group's NASDAQ-Listed Associate, Psyence Biomed Issues Shareholder Update Recapping Recent Progress and Previewing Key Upcoming Data Milestones

PUBLISHED

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

Two Phase II data readouts anticipated in 2025

NEW YORK, Sept. 18, 2024 (GLOBE NEWSWIRE) -- Psyence Group Inc("Psyence Group") (CSE: PSYG), a life science biotechnology company pioneering the use of nature-derived psilocybin in mental health and wellbeing, is pleased to announce that its NASDAQ-listed associate, Psyence Biomedical Ltd. (Nasdaq: PBM) ("Psyence Biomed" or "PBM"), has issued a corporate update to its shareholders on September 16, 2024. According to the news release issued by Psyence Biomed, the company has achieved critical milestones with respect to its Phase IIb clinical trial which seeks to evaluate nature-derived psilocybin in conjunction with psychotherapy as a potential treatment for Adjustment Disorder in Palliative Care (being initiated in Australia), has strengthen and expanded on its clinical trial strategy, and has strengthen its financial position.

According to the news release, following the initiation of patient screening, Psyence Biomed seeks to enroll its Phase IIb study as efficiently as possible, and projects topline data availability towards the end of next year that, if positive, will support the initiation of a pivotal Phase III trial as soon as practicable thereafter. To better support this program, Psyence Biomed has partnered with Optimi Health as an exclusive supplier of GMP nature-derived psilocybin extract for future Phase III trials as well as subsequent commercialization, should negotiations between the parties be successful. The update further announces Psyence Biomed's planned second development indication, which will evaluate GMP nature-derived psilocybin as a potential treatment for Substance Use Disorders (SUDs), including Alcohol Use Disorder (AUD), and states that it has entered into an agreement with a third party, private company, Psylabs, to be the exclusive supplier of highly purified psilocybin extract exclusively for these indications.

The news release goes on to state that Psyence Biomed has signed a conditional, binding term sheet for the proposed acquisition of psilocybin-based drug developer, Clairvoyant Therapeutics, which, if implemented, introduces a synthetic psilocybin-based therapeutic candidate that nicely complements Psyence Biomed's ongoing nature-derived psilocybin development programs, expands the clinical pipeline into AUD, and (if successful) will transition Psyence Biomed to a commercial-stage, revenue-generating company. Finally, Psyence Biomed reports that it has entered into agreements to secure critical funding required to advance these initiates and that it expects to obtain sufficient capital to execute its strategy.

"Once again, the management team of Psyence Biomed has demonstrated that it is executing on its lead clinical program, advancing its clinical trial endeavors into a second indication and securing the resources required to execute on its overall strategy. We are pleased with the progress being made by Psyence Biomed and look forward to future updates," said Jody Aufrichtig, Executive Chairman of the Psyence Group.

For more on the Psyence Biomed corporate and shareholder updates, please refer to the primary news release available at https://psyencebiomed.com/psyence-biomed-issues-shareholder-update-recapping-recent-progress-and-previewing-key-upcoming-data-milestones/.

‍

dence Biomedical, Announces Initiation of First Trial Site in Australia for its Phase IIb Study of Nature Derived Psilocybin as a Potential Treatment for Adjustment Disorder in Palliative Care

NEW YORK, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Psyence Group Inc("Psyence Group") (CSE: PSYG), a life science biotechnology company pioneering the use of nature-derived psilocybin in mental health and wellbeing, is pleased to announce that its NASDAQ-listed associate, Psyence Biomedical Ltd (NASDAQ: PBM) ("PBM" or "Psyence Biomed"), has successfully completed the first site initiation visit at the first Australian clinical trial site for PBM’s Phase IIb study of nature derived (non-synthetic) psilocybin as a potential treatment for Adjustment Disorder in the Palliative Care context.

According to a news release issued by Psyence Biomed on Monday, September 9, 2024, it has 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 as reported in July as well as the successful export of the drug product, PEX010, to Australia, which marked a crucial step in preparation for initiation of the study. The affiliated trial site will soon commence screening patients, and the first subject is expected to be randomized into the study in October.

According to Veronika Simic, iNGENū's Senior Clinical Project Manager, “As a leading global contract research organization that has notable experience in the execution of psychedelic clinical trials, we believe psilocybin holds great promise as a treatment for a broad range of mental health conditions with unmet needs.” “We are pleased to partner with Psyence Biomedical as they work to introduce a novel, psilocybin-based treatment to patients suffering from Adjustment Disorder following a life limiting cancer diagnosis in Palliative Care, and we are prepared to advance this rigorously designed study as efficiently as possible.”

"We are very pleased that Psyence Biomed has achieved this significant milestone in their Phase IIb study, and look forward to further updates on patient enrollment and first patient dosing," said Jody Aufrichtig, Executive Chairman of the board of Psyence Group.

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 87 patients in conjunction with psychotherapy.

Psyence Group currently holds 5,000,000 common shares in Psyence Biomed.

More information on Psyence Biomed's upcoming Phase IIb clinical trial can be found at: 12624000449538p.

‍

‍

‍

‍

‍

Psyence Group's NASDAQ-Listed Associate, Psyence Biomedical, Announces Initiation of First Trial Site in Australia for its Phase IIb Study of Nature Derived Psilocybin as a Potential Treatment for Adjustment Disorder in Palliative Care

NEW YORK, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Psyence Group Inc("Psyence Group") (CSE: PSYG), a life science biotechnology company pioneering the use of nature-derived psilocybin in mental health and wellbeing, is pleased to announce that its NASDAQ-listed associate, Psyence Biomedical Ltd (NASDAQ: PBM) ("PBM" or "Psyence Biomed"), has successfully completed the first site initiation visit at the first Australian clinical trial site for PBM’s Phase IIb study of nature derived (non-synthetic) psilocybin as a potential treatment for Adjustment Disorder in the Palliative Care context.

According to a news release issued by Psyence Biomed on Monday, September 9, 2024, it has 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 as reported in July as well as the successful export of the drug product, PEX010, to Australia, which marked a crucial step in preparation for initiation of the study. The affiliated trial site will soon commence screening patients, and the first subject is expected to be randomized into the study in October.

According to Veronika Simic, iNGENū's Senior Clinical Project Manager, “As a leading global contract research organization that has notable experience in the execution of psychedelic clinical trials, we believe psilocybin holds great promise as a treatment for a broad range of mental health conditions with unmet needs.” “We are pleased to partner with Psyence Biomedical as they work to introduce a novel, psilocybin-based treatment to patients suffering from Adjustment Disorder following a life limiting cancer diagnosis in Palliative Care, and we are prepared to advance this rigorously designed study as efficiently as possible.”

"We are very pleased that Psyence Biomed has achieved this significant milestone in their Phase IIb study, and look forward to further updates on patient enrollment and first patient dosing," said Jody Aufrichtig, Executive Chairman of the board of Psyence Group.

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 87 patients in conjunction with psychotherapy.

Psyence Group currently holds 5,000,000 common shares in Psyence Biomed.

More information on Psyence Biomed's upcoming Phase IIb clinical trial can be found at: 12624000449538p.

NEWS

  • Psyence Group's NASDAQ-Listed Associate, Psyence Biomed Issues Shareholder Update Recapping Recent Progress and Previewing Key Upcoming Data Milestones
  • 4 hours ago
  • Psyence Group's NASDAQ-Listed Associate, Psyence Biomedical, Announces Initiation of First Trial Site in Australia for its Phase IIb Study of Nature Derived Psilocybin as a Potential Treatment for Adjustment Disorder in Palliative Care
  • 2 days ago
  • Psyence Biomed Issues Shareholder Update Recapping Recent Progress and Previewing Key Upcoming Data Milestones
  • 2 days ago
  • Psyence Biomedical Ltd. Announces Receipt of Staff Delisting Determination from Nasdaq
  • 5 days ago
  • Psyence Biomed Announces Initiation of First Trial Site in Australia for its Phase IIb Study of Nature Derived Psilocybin as a Potential Treatment for Adjustment Disorder in Palliative Care
  • Sep 9, 2024
  • Psyence Biomed Announces the Signing of a Conditional Binding Term Sheet for the Acquisition of Psilocybin-Based Drug Developer Clairvoyant
  • Sep 6, 2024
  • Psyence Biomed Announces Worldwide Exclusive Licensing Agreement with PsyLabs to Supply Nature-Derived Psilocybin to be Evaluated as a Potential Treatment for Alcohol Use Disorder (AUD) and Other Substance Use Disorders (SUDs)
  • Sep 4, 2024
  • Psyence Biomed Announces Registration Statement on Form F-1 for Up to $25 Million Equity Line of Credit with White Lion Capital, LLC, Declared Effective by SEC
  • Aug 30, 2024
  • Psyence Biomed to Present at the H.C. Wainwright 26th Annual Global Investment Conference, September 9th-11th, 2024
  • Aug 27, 2024
  • Optimi Health and Psyence Biomedical Sign Non-Binding Letter of Intent to Advance Global Psilocybin Drug Development

    • Aug 13, 2024

    ‍

    MANAGEMENT TEAM

    ‍

    ‍Sincerely,

    ‍

    DISCLAIMER

    THIS WEBSITE/NEWSLETTER IS A PUBLICATION OF ONE22 MEDIA, LLC, HEREIN REFERRED TO AS O22. O22’S REPORTS/RELEASES ARE A COMMERCIAL ADVERTISEMENT AND ARE FOR GENERAL INFORMATIONAL PURPOSES ONLY.O22 IS ENGAGED IN THE BUSINESS OF MARKETING AND ADVERTISING COMPANIES FOR MONETARY COMPENSATION.
    O22 HAS BEEN COMPENSATED A FEE OF SEVEN THOUSAND FIVE HUNDRED USD BY A THIRD PARTY, SHORE THING MEDIA, LLC FOR A ONE DAY PBM PROFILE.
    BY SUBSCRIBING TO OR OTHERWISE USING THIS WEBSITE/NEWSLETTER, YOU AGREE TO HOLD O22 AND ITS OPERATORS, OWNERS, AND EMPLOYEES HARMLESS AND TO COMPLETELY RELEASE THEM FROM ANY AND ALL LIABILITY DUE TO ANY AND ALL LOSS, DAMAGE, OR INJURY THAT YOU MAY INCUR, MONETARY OR OTHERWISE.
    INVESTING IN MICRO-CAP AND GROWTH SECURITIES IS HIGHLY SPECULATIVE AND CARRIES AN EXTREMELY HIGH DEGREE OF RISK. NEVER INVEST IN ANY STOCK FEATURED ON O22’S SITE OR NEWSLETTER UNLESS YOU CAN AFFORD TO LOSE YOUR ENTIRE INVESTMENT. THE DISCLAIMER IS TO BE READ AND FULLY UNDERSTOOD BEFORE USING O22’S SERVICES, JOINING O22’S SITE OR EMAIL/BLOG LIST, OR FOLLOWING ANY SOCIAL NETWORKING PLATFORMS O22 MAY USE.
    PLEASE NOTE WELL: O22 IS NOT A REGISTERED INVESTMENT ADVISOR, BROKER DEALER OR A MEMBER OF ANY ASSOCIATION FOR OTHER RESEARCH PROVIDERS IN ANY JURISDICTION WHATSOEVER. O22 IS NOT AFFILIATED WITH ANY EXCHANGE, ELECTRONIC QUOTATION SYSTEM, THE SECURITIES AND EXCHANGE COMMISSION, OR FINRA. NONE OF THE MATERIALS OR ADVERTISEMENTS HEREIN CONSTITUTE OFFERS OR SOLICITATIONS TO PURCHASE OR SELL SECURITIES OF THE COMPANIES PROFILED.
    THE INFORMATION CONTAINED HEREIN IS BASED ON INFORMATION SUPPLIED BY THE COMPANIES PROFILED, PUBLICLY AVAILABLE INFORMATION, PRESS RELEASES, AND OTHER SOURCES WHICH O22 BELIEVES TO BE RELIABLE, BUT IS NOT GUARANTEED BY O22 AS BEING ACCURATE AND DOES NOT PURPORT TO BE A COMPLETE STATEMENT OR SUMMARY OF THE AVAILABLE DATA. O22 IS NOT RESPONSIBLE FOR ANY CLAIMS MADE BY THE COMPANIES PROFILED. INVESTORS SHOULD NOT RELY ON THE INFORMATION CONTAINED IN THIS WEBSITE/NEWSLETTER IN DECIDING TO INVEST OR MAKE OTHER FINANCIAL DECISIONS. RATHER, INVESTORS SHOULD USE THE INFORMATION CONTAINED IN THIS WEBSITE/NEWSLETTER AS A STARTING POINT FOR DOING ADDITIONAL INDEPENDENT RESEARCH ON THE FEATURED COMPANIES. O22 STRONGLY ENCOURAGES READERS AND INVESTORS TO CONDUCT A COMPLETE AND INDEPENDENT INVESTIGATION OF THE RESPECTIVE COMPANIES, INCLUDING BY REVIEWING SEC FILINGS (FORMS 10-Q, 10-K, 8-K, 3, 4, 5, SCHEDULE 13D) AND BY CONSULTING YOUR OWN TAX, BUSINESS, FINANCIAL, AND INVESTMENT ADVISORS.
    THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 PROVIDES A SAFE HARBOR IN REGARD TO FORWARD-LOOKING STATEMENTS. ANY STATEMENTS THAT EXPRESS OR INVOLVE DISCUSSIONS WITH RESPECT TO PREDICTIONS, EXPECTATIONS, BELIEFS, PLANS, PROJECTIONS, OBJECTIVES, GOALS, ASSUMPTIONS OR FUTURE EVENTS OR PERFORMANCE ARE NOT STATEMENTS OF HISTORICAL FACT, AND MAY BE FORWARD-LOOKING STATEMENTS. FORWARD-LOOKING STATEMENTS ARE BASED ON EXPECTATIONS, ESTIMATES, AND PROJECTIONS AT THE TIME THE STATEMENTS ARE MADE THAT INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES WHICH COULD CAUSE ACTUAL RESULTS OR EVENTS TO DIFFER MATERIALLY FROM THOSE PRESENTLY ANTICIPATED. FORWARD-LOOKING STATEMENTS MAY BE IDENTIFIED THROUGH USE OF WORDS SUCH AS PROJECTS, FORESEES, EXPECTS, ANTICIPATES, ESTIMATES, BELIEVES, UNDERSTANDS, MAY, COULD, OR MIGHT. THERE IS NO GUARANTEE THAT PAST PERFORMANCE WILL BE INDICATIVE OF FUTURE RESULTS.

    ‍

    ‍

    ‍