Psyence Biomed Provides Update on Previously Announced Acquisition of Clairvoyant
Psyence Biomedical (Nasdaq: PBM) has decided not to proceed with the previously announced acquisition of Clairvoyant Therapeutics, Inc. following due diligence. The company continues to advance its Phase IIb clinical trial of nature-derived psilocybin for Adjustment Disorder in Palliative Care, with the first patient expected to be randomized this quarter and topline data anticipated in H2 2025.
Psyence Biomed is also progressing its program for Substance Use Disorders (SUDs), focusing on Alcohol Use Disorder (AUD). The company recently announced an exclusive IP licensing agreement with PsyLabs and plans to acquire an 11.13% stake in the company. Psyence Biomed remains committed to developing nature-derived psilocybin-based therapeutics for mental health and addiction-related conditions.
Psyence Biomedical (Nasdaq: PBM) ha deciso di non procedere con l'acquisizione precedentemente annunciata di Clairvoyant Therapeutics, Inc. a seguito della due diligence. L'azienda continua a portare avanti il suo trial clinico di Fase IIb di psilocibina derivata dalla natura per il Disturbo da Adattamento nella Cura Palliativa, con il primo paziente previsto per essere randomizzato in questo trimestre e dati preliminari attesi nel secondo semestre del 2025.
Psyence Biomed sta anche avanzando il suo programma per i Disturbi da Uso di Sostanze (SUD), concentrandosi sul Disturbo da Uso di Alcol (AUD). L'azienda ha recentemente annunciato un accordo esclusivo di licenza IP con PsyLabs e prevede di acquisire una partecipazione dell'11,13% nella società. Psyence Biomed rimane impegnata nello sviluppo di terapie a base di psilocibina derivata dalla natura per la salute mentale e le condizioni legate alla dipendenza.
Psyence Biomedical (Nasdaq: PBM) ha decidido no proceder con la adquisición previamente anunciada de Clairvoyant Therapeutics, Inc. tras la debida diligencia. La empresa sigue avanzando en su ensayo clínico de Fase IIb sobre psilocibina derivada de la naturaleza para el Trastorno de Adaptación en Cuidados Paliativos, con el primer paciente previsto para ser randomizado este trimestre y los datos preliminares anticipados para el segundo semestre de 2025.
Psyence Biomed también está desarrollando su programa para los Trastornos por Uso de Sustancias (SUD), centrándose en el Trastorno por Consumo de Alcohol (AUD). La empresa anunció recientemente un acuerdo exclusivo de licencia de propiedad intelectual con PsyLabs y planea adquirir una participación del 11,13% en la compañía. Psyence Biomed sigue comprometida con el desarrollo de terapias basadas en psilocibina derivada de la naturaleza para la salud mental y condiciones relacionadas con la adicción.
Psyence Biomedical (Nasdaq: PBM)은 진행하지 않기로 결정했습니다 Clairvoyant Therapeutics, Inc. 인수에 대한 이전 발표를 통해 철저한 실사를 거쳤습니다. 이 회사는 현재 조정 장애를 위한 자연 유래 사이로시빈의 IIb상 임상 시험을 앞으로 진행 중이며, 첫 번째 환자가 이번 분기에 무작위 배정될 것으로 예상되며, 주요 데이터는 2025년 하반기에 예상됩니다.
Psyence Biomed는 또한 알코올 사용 장애 (AUD)에 중점을 두고 물질 사용 장애 (SUD) 프로그램을 진행 중입니다. 이 회사는 최근 PsyLabs와 독점적인 지식 재산권 라이센스 계약을 발표했으며, 회사의 11.13% 지분을 인수할 계획입니다. Psyence Biomed는 정신 건강 및 중독 관련 질환을 위한 자연 유래 사이로시빈 기반 치료제를 개발하는 데 헌신하고 있습니다.
Psyence Biomedical (Nasdaq: PBM) a décidé de ne pas poursuivre l'acquisition précédemment annoncée de Clairvoyant Therapeutics, Inc. à la suite de la due diligence. L'entreprise continue de faire progresser son essai clinique de Phase IIb sur la psilocybine dérivée de la nature pour le trouble d'adaptation en soins palliatifs, le premier patient devant être randomisé ce trimestre et des données préliminaires attendues au second semestre 2025.
Psyence Biomed progresse également dans son programme pour les troubles liés à l'utilisation de substances (SUD), en se concentrant sur le trouble lié à l'usage d'alcool (AUD). L'entreprise a récemment annoncé un accord exclusif de licence de propriété intellectuelle avec PsyLabs et prévoit d'acquérir une participation de 11,13 % dans la société. Psyence Biomed reste engagée à développer des thérapies à base de psilocybine dérivée de la nature pour la santé mentale et les conditions liées à la dépendance.
Psyence Biomedical (Nasdaq: PBM) hat beschlossen, nicht fortzufahren mit der zuvor angekündigten Übernahme von Clairvoyant Therapeutics, Inc. nach eingehender Prüfung. Das Unternehmen verfolgt weiterhin seine klinische Phase IIb-Studie zu aus der Natur gewonnenem Psilocybin bei Anpassungsstörungen in der Palliativmedizin, wobei der erste Patient in diesem Quartal randomisiert werden soll und topline Daten für die zweite Hälfte 2025 erwartet werden.
Psyence Biomed arbeitet auch weiter an seinem Programm für Substanzgebrauchsstörungen (SUD), mit Schwerpunkt auf Alkoholgebrauchsstörungen (AUD). Das Unternehmen gab kürzlich eine exklusive IP-Lizenzvereinbarung mit PsyLabs bekannt und plant, eine Beteiligung von 11,13 % an dem Unternehmen zu erwerben. Psyence Biomed bleibt entschlossen, therapeutische Lösungen auf Basis von natürlichem Psilocybin für psychische Gesundheit und suchtrelevante Erkrankungen zu entwickeln.
- Advancing Phase IIb clinical trial for Adjustment Disorder in Palliative Care
- Progressing development program for Substance Use Disorders, focusing on Alcohol Use Disorder
- Secured exclusive, worldwide IP licensing agreement with PsyLabs
- Plans to acquire 11.13% stake in PsyLabs, enhancing vertical integration
- Decision not to proceed with the acquisition of Clairvoyant Therapeutics
Insights
The decision not to proceed with the Clairvoyant acquisition is a significant development for Psyence Biomed. While it may initially appear negative, it demonstrates the company's disciplined approach to M&A and capital allocation. The focus on their core programs in Adjustment Disorder and Alcohol Use Disorder (AUD) shows a strategic prioritization of internal pipeline development.
The ongoing Phase IIb trial for Adjustment Disorder and the progression of the AUD program are key value drivers. The expected patient randomization this quarter and anticipated topline data in H2 2025 provide near-term catalysts for investors to monitor. The exclusive licensing agreement with PsyLabs and potential 11.13% stake acquisition indicate a move towards vertical integration, which could enhance Psyence's competitive position in the psychedelic therapeutics space.
Financially, while specific figures aren't provided, the company's decision-making suggests a prudent approach to cash management and resource allocation. Investors should closely watch for updates on the PsyLabs acquisition and any impact on the company's cash position and burn rate.
Psyence Biomed's focus on nature-derived psilocybin therapeutics positions them in a promising niche within the broader psychedelic medicine field. The Phase IIb trial for Adjustment Disorder in palliative care patients is particularly noteworthy, as it addresses an underserved patient population with significant unmet needs.
The expansion into Substance Use Disorders, starting with Alcohol Use Disorder, demonstrates a strategic approach to building a diverse pipeline. This is important in the nascent psychedelic therapeutics industry, where having multiple shots on goal can mitigate risk.
The partnership with PsyLabs for highly purified psychedelic APIs is a significant advantage, potentially ensuring a stable supply of high-quality compounds for clinical development. This vertical integration could provide Psyence with a competitive edge in terms of cost control and quality assurance.
From a clinical perspective, the expected milestones - patient randomization this quarter and topline data in H2 2025 - will be critical in validating the company's therapeutic approach and informing future development strategies.
NEW YORK, Oct. 04, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) ("Psyence Biomed" or the "Company"), a developer of psilocybin-based therapeutics, today provided an update on its previously announced proposed acquisition of Clairvoyant Therapeutics, Inc. Following the completion of necessary due diligence and other pre-closing activities specified in the conditional binding term sheet that was announced on September 9, 2024, Psyence Biomed has decided not to proceed with the acquisition at this time.
Psyence Biomed continues to advance its recently initiated Phase IIb clinical trial of nature derived psilocybin in conjunction with psychotherapy as a potential treatment for Adjustment Disorder following a life-limiting cancer diagnosis in Palliative Care. The first patient is expected to be randomized into the study this quarter, and topline data from the study is anticipated in the second half of 2025.
Additionally, the Company is progressing its second development program, which will evaluate nature derived psilocybin in conjunction with psychotherapy as a potential treatment for Substance Use Disorders (SUDs), leading with Alcohol Use Disorder (AUD). To support its AUD program, Psyence Biomed recently announced a worldwide, exclusive royalty-bearing IP licensing agreement with PsyLabs, a private company focused on the production of highly purified psychedelic active pharmaceutical ingredients and extracts. Psyence Biomed also subsequently agreed to acquire an
"After completing the specified due diligence process, we unfortunately were not able to close the acquisition of Clairvoyant," stated Dr. Neil Maresky, M.D., Chief Executive Officer of Psyence Biomed. "We continue to remain focused on being a leader in the development of nature derived psilocybin-based therapeutics that have the potential to treat a broad range of mental health and addiction related conditions. We are very enthusiastic about our own development programs in Adjustment Disorder and AUD, which continue to advance without interruption, and we look forward to the achievement of multiple potentially value creating milestones in the months ahead. We will also remain opportunistic in exploring other assets that may fit within our core clinical strategy."
About Psyence Biomed
Psyence Biomedical Ltd. (Nasdaq: PBM) is one of the world’s few biopharmas with a focus on psychedelic-based pharmaceutical therapeutics. As the first life science biotechnology company developing nature-derived (non-synthetic) psilocybin-based psychedelic medicine to be listed on Nasdaq, Psyence is initially working to address the unmet needs of patients who suffer from mental health disorders in the context of Palliative Care. 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, FDA-approved, nature-derived psychedelic therapeutics to treat a broad range of mental health disorders. 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 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 PsyLabs' ability to successfully deliver its intended drug product. 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 PsyLabs' product development strategy as 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 PsyLabs to execute its obligations in respect of its product development objectives; (iv) changes in applicable laws which may impact drug development, clinical trials and/or the conducting thereof; (v) Psyence Biomed’s ability to obtain regulatory approval for the proposed product candidate, and any related restrictions or limitations of any approved products; (vi) the ability of Psyence Biomed to maintain the listing of its common shares and warrants on Nasdaq; and (vii) 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 final prospectus (File No. 333 276973) filed with the Securities and Exchange Commission 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.
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