Psyence Biomed Enters into Agreement to Acquire Stake in PsyLabs
Psyence Biomedical (Nasdaq: PBM) has entered into a conditional share sale agreement with Psyence Group to acquire an 11.13% stake in PsyLabs, a company specializing in psychedelic active pharmaceutical ingredients (APIs) and extracts. The deal, valued at $1.1 million, involves Psyence Biomed issuing common stock at $0.55 per share to Psyence Group. This acquisition follows a previously announced exclusive licensing agreement with PsyLabs for pharmaceutical-grade, nature-derived psilocybin to be used in clinical trials for Alcohol Use Disorder (AUD) and other Substance Use Disorders (SUDs). PsyLabs' proprietary process is claimed to produce the highest purity, naturally derived psilocybin on the market. The deal is subject to various conditions, including regulatory approvals and a product development milestone to be achieved by October 31, 2024.
Psyence Biomedical (Nasdaq: PBM) ha stipulato un accordo di vendita azionaria condizionale con Psyence Group per acquisire una partecipazione dell'11,13% in PsyLabs, un'azienda specializzata in principi attivi farmaceutici psichedelici (API) e estratti. L'accordo, valutato 1,1 milioni di dollari, prevede che Psyence Biomed emetta azioni ordinarie a 0,55 dollari per azione a Psyence Group. Questa acquisizione segue un precedente accordo di licenza esclusiva annunciato con PsyLabs per psilocibina di grado farmaceutico, derivata dalla natura da utilizzare negli studi clinici per disordini da uso di alcol (AUD) e altri disordini da uso di sostanze (SUD). Si afferma che il processo proprietario di PsyLabs produce la psilocibina naturalmente derivata con la massima purezza disponibile sul mercato. L'accordo è soggetto a diverse condizioni, comprese le approvazioni normative e un traguardo di sviluppo del prodotto che deve essere raggiunto entro il 31 ottobre 2024.
Psyence Biomedical (Nasdaq: PBM) ha firmado un acuerdo de venta de acciones condicionado con Psyence Group para adquirir una participación del 11,13% en PsyLabs, una empresa especializada en ingredientes farmacéuticos activos psicodélicos (APIs) y extractos. El acuerdo, valorado en 1,1 millones de dólares, implica que Psyence Biomed emita acciones comunes a 0,55 dólares por acción a Psyence Group. Esta adquisición sigue a un acuerdo de licencias exclusivo previamente anunciado con PsyLabs para psilocibina de grado farmacéutico, derivada de la naturaleza que será utilizada en ensayos clínicos para trastorno por uso de alcohol (AUD) y otros trastornos por uso de sustancias (SUD). Se afirma que el proceso propietario de PsyLabs produce la psilocibina derivada de la naturaleza con la mayor pureza del mercado. El acuerdo está sujeto a varias condiciones, incluidas las aprobaciones regulatorias y un hito de desarrollo de producto que debe alcanzarse antes del 31 de octubre de 2024.
Psyence Biomedical (Nasdaq: PBM)가 Psyence Group과 조건부 주식 매각 계약을 체결하여 PsyLabs의 11.13% 지분을 인수하게 되었습니다. 이 거래는 110만 달러로 평가되며, Psyence Biomed는 Psyence Group에 주당 0.55달러에 보통주를 발행하는 내용을 포함합니다. 이 인수는 임상 시험에서 사용할 자연 유래의 제약 등급 실로시빈에 대해 PsyLabs와 체결한 독점 라이선스 계약에 의해 진행됩니다. PsyLabs의 독점 공정은 시장에서 가장 높은 순도의 자연 유래 실로시빈을 생산한다고 주장됩니다. 이 거래는 여러 조건에 따라 다르며, 여기에는 규제 승인과 2024년 10월 31일까지 달성해야 하는 제품 개발 이정표가 포함됩니다.
Psyence Biomedical (Nasdaq: PBM) a conclu un accord de vente d'actions conditionnel avec Psyence Group pour acquérir un participation de 11,13% dans PsyLabs, une entreprise spécialisée dans les ingrédients pharmaceutiques actifs psychédéliques (API) et les extraits. L'accord, d'une valeur de 1,1 million de dollars, implique que Psyence Biomed émette des actions ordinaires à 0,55 dollar par action à Psyence Group. Cette acquisition fait suite à un précédent accord de licence exclusif annoncé avec PsyLabs pour de la psilocybine de grade pharmaceutique, dérivée de la nature à utiliser dans des essais cliniques pour les troubles liés à l'utilisation de l'alcool (AUD) et d'autres troubles liés à l'utilisation de substances (SUD). Le processus propriétaire de PsyLabs est censé produire la psilocybine dérivée de la nature avec la plus haute pureté sur le marché. L'accord est soumis à diverses conditions, y compris des approbations réglementaires et une étape de développement de produit à atteindre d'ici le 31 octobre 2024.
Psyence Biomedical (Nasdaq: PBM) hat eine bedingte Vereinbarung zum Aktienverkauf mit Psyence Group getroffen, um einen 11,13% Anteil an PsyLabs zu erwerben, einer Firma, die auf psychedelische aktive pharmazeutische Inhaltsstoffe (APIs) und Extrakte spezialisiert ist. Das Geschäft, das mit 1,1 Millionen Dollar bewertet wird, beinhaltet die Emission von Stammaktien zu 0,55 Dollar pro Aktie an die Psyence Group. Diese Akquisition folgt einem zuvor angekündigten exklusiven Lizenzvertrag mit PsyLabs für pharmazeutische, naturabgeleitete Psilocybin, das in klinischen Studien für Alkoholkonsumstörung (AUD) und andere Substanzgebrauchsstörungen (SUD) eingesetzt werden soll. Es wird behauptet, dass das eigene Verfahren von PsyLabs die reinste, naturabgeleitete Psilocybin auf dem Markt produziert. Der Deal steht unter dem Vorbehalt verschiedener Bedingungen, einschließlich behördlicher Genehmigungen und eines Produktentwicklungs-Meilensteins, der bis zum 31. Oktober 2024 erreicht werden muss.
- Acquisition of 11.13% stake in PsyLabs strengthens Psyence Biomed's position in psychedelic-based therapeutics
- Access to high-purity, nature-derived psilocybin for clinical trials in AUD and SUDs
- Expansion of pipeline into additional high-value mental health conditions
- Vertical integration in psychedelic drug development
- PsyLabs' proprietary process claims to produce highest purity naturally derived psilocybin
- Deal completion subject to multiple conditions, including regulatory approvals
- Product development milestone must be achieved by PsyLabs by October 31, 2024
- Issuance of new shares may lead to dilution for existing shareholders
Insights
This acquisition marks a strategic move for Psyence Biomed in the emerging psychedelic therapeutics sector. The 11.13% stake in PsyLabs for
The focus on nature-derived, non-synthetic psilocybin could be a key differentiator in the market, especially as regulatory standards tighten. PsyLabs' proprietary process for high-purity production may give Psyence a competitive edge in drug development for Alcohol Use Disorder (AUD) and other Substance Use Disorders (SUDs).
However, investors should note that the deal is conditional on several factors, including a product development milestone by October 31, 2024. This timeline adds an element of risk to the acquisition's completion.
Psyence Biomed's move to acquire a stake in PsyLabs is significant for its drug development pipeline. The company's focus on pharmaceutical-grade, EU GMP nature-derived psilocybin for AUD and SUDs represents a novel approach in a field dominated by synthetic compounds.
The emphasis on purity in psychoactive compounds, especially for Phase III trials and commercial production, aligns with increasing regulatory scrutiny. PsyLabs' claimed "highest purity" naturally derived psilocybin could be a game-changer if it translates to improved efficacy or reduced side effects in clinical trials.
Investors should monitor the progress of Psyence's AUD clinical trial and any updates on the licensed product's development work scheduled for 2024-2025. These milestones will be critical in assessing the long-term value of this strategic investment.
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
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:
| VIEW VIDEO OF PSYLABS |
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.
About Psyence Biomed
Psyence Biomedical Ltd. (Nasdaq: PBM) is one of the world’s few vertically integrated biopharmas with a focus on psychedelic-based pharmaceutical therapeutics. 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.
FAQ
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