Psyence Biomed Executes Binding Agreements with Optimi Health Corp.
Psyence Biomed (Nasdaq: PBM) has executed binding agreements with Optimi Health Corp, advancing from their previous non-binding Letter of Intent. Under the agreements, Optimi becomes the exclusive worldwide supplier of GMP-certified, nature-derived psilocybin for Psyence's drug development and commercialization initiatives in Palliative Care.
Optimi will provide comprehensive Chemistry, Manufacturing, and Control (CMC) support for regulatory submissions related to Psyence's clinical trials and future Investigational New Drug applications. The company is currently advancing its Phase IIb clinical trial for Adjustment Disorder in Palliative Care, with plans for Phase III studies.
Psyence Biomed (Nasdaq: PBM) ha stipulato accordi vincolanti con Optimi Health Corp, passando dalla precedente Lettera di Intenti non vincolante. Sotto questi accordi, Optimi diventa il fornitore esclusivo a livello mondiale di psilocibina derivata dalla natura e certificata GMP per le iniziative di sviluppo e commercializzazione dei farmaci di Psyence in Cure Palliative.
Optimi fornirà supporto completo in Chimica, Produzione e Controllo (CMC) per le presentazioni regolatorie relative agli studi clinici di Psyence e alle future domande per Nuovi Farmaci Sperimentali. L'azienda sta attualmente avanzando con il suo studio clinico di Fase IIb per il Disturbo da Regolazione in Cure Palliative, con piani per studi di Fase III.
Psyence Biomed (Nasdaq: PBM) ha ejecutado acuerdos vinculantes con Optimi Health Corp, avanzando desde su anterior Carta de Intención no vinculante. Según los acuerdos, Optimi se convierte en el proveedor exclusivo a nivel mundial de psilocibina derivada de la naturaleza y certificada por GMP para las iniciativas de desarrollo y comercialización de medicamentos de Psyence en Cuidados Paliativos.
Optimi proporcionará soporte integral en Química, Fabricación y Control (CMC) para las presentaciones regulatorias relacionadas con los ensayos clínicos de Psyence y futuras solicitudes de Nuevo Medicamento en Investigación. La empresa está avanzando actualmente con su ensayo clínico de Fase IIb para el Trastorno de Ajuste en Cuidados Paliativos, con planes para estudios de Fase III.
사이언스 바이오메드 (Nasdaq: PBM)가 옵티미 헬스 코퍼레이션과 구속력 있는 계약을 체결하여 이전의 비구속적인 의향서에서 발전하였습니다. 이 계약에 따라 옵티미는 사이언스의 완화 치료를 위한 의약품 개발 및 상용화 활동에 대해 전 세계 독점 공급자가 되는 자연 유래의 GMP 인증 실로시빈을 제공합니다.
옵티미는 사이언스의 임상 시험 및 향후 신약 조사 신청과 관련된 규제 제출을 위한 종합적인 화학, 제조 및 품질 관리(CMC) 지원을 제공할 것입니다. 그 회사는 현재 완화 치료의 조정 장애에 대한 IIb 상임 임상 시험을 진행하고 있으며, III상 시험 계획이 있습니다.
Psyence Biomed (Nasdaq : PBM) a conclu des accords contraignants avec Optimi Health Corp, avançant depuis leur précédente lettre d'intention non contraignante. Selon ces accords, Optimi devient le fournisseur exclusif mondial de psilocybine dérivée de la nature et certifiée GMP pour les initiatives de développement et de commercialisation de médicaments de Psyence dans le domaine des soins palliatifs.
Optimi fournira un soutien complet en chimie, fabrication et contrôle (CMC) pour les soumissions réglementaires liées aux essais cliniques de Psyence et aux futures demandes de nouveaux médicaments d'enquête. L'entreprise progresse actuellement avec son essai clinique de Phase IIb sur le trouble de l'adaptation dans les soins palliatifs, avec des plans pour des études de Phase III.
Psyence Biomed (Nasdaq: PBM) hat verbindliche Vereinbarungen mit Optimi Health Corp getroffen und erweitert damit die zuvor unverbindliche Absichtserklärung. Gemäß den Vereinbarungen wird Optimi der exklusive weltweite Anbieter von GMP-zertifiziertem, naturbasiertem Psilocybin für Psyences Arzneimittelentwicklungs- und Kommerzialisierungsinitiativen im Bereich der Palliativversorgung.
Optimi wird umfassende Unterstützung in Chemie, Herstellung und Kontrolle (CMC) für die regulatorischen Einreichungen im Zusammenhang mit Psyences klinischen Studien und zukünftigen Anträgen auf neue Prüfpräparate bieten. Das Unternehmen geht derzeit mit seiner Phase-IIb-Studie zur Anpassungsstörung in der Palliativversorgung voran und plant Phase-III-Studien.
- Secured exclusive worldwide supply rights for GMP-certified psilocybin
- Obtained comprehensive CMC support for regulatory submissions
- Advancing Phase IIb clinical trial with pathway to Phase III studies
- None.
Insights
This binding supply agreement marks a significant milestone for Psyence Biomed's drug development program. The exclusive worldwide rights to Optimi's GMP-certified psilocybin strengthens PBM's position in the palliative care space, particularly for their Phase IIb clinical trial in Adjustment Disorder. The partnership includes important CMC support for regulatory submissions, which is essential for FDA approval processes.
The agreement secures a consistent supply chain for both the upcoming Phase III trials and potential commercial production, eliminating a major risk factor in drug development. Having a reliable source of GMP-certified, nature-derived psilocybin is particularly valuable as synthetic alternatives may have different therapeutic profiles. This positions PBM favorably for both their current palliative care focus and possible expansion into other mental health indications.
The execution of binding agreements with Optimi Health represents a strategic advancement in PBM's commercialization pathway. This deal de-risks the supply chain for PBM's clinical development program and potential commercial launch, which is important for investor confidence. The exclusive worldwide rights provide a competitive advantage and potential barrier to entry for competitors in the palliative care space.
The partnership's value extends beyond mere supply, as Optimi's CMC support will likely accelerate regulatory processes and reduce development costs. For a company with a
Psyence Biomed obtains exclusive worldwide supply rights to Optimi’s GMP-certified, nature-derived psilocybin for its drug development and commercialization initiatives in Palliative Care
NEW YORK, Dec. 10, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) ("Psyence Biomed" or the "Company") today announced that it has progressed beyond the previously-announced non-binding Letter of Intent (LOI) and executed binding agreements with Optimi Health Corp. Under the terms of the agreements, Optimi becomes the exclusive supplier of GMP-certified, nature-derived (non-synthetic) psilocybin extract for Psyence’s global drug development and commercialization initiatives for FDA-approved uses in the Palliative Care context.
Optimi will provide comprehensive Chemistry, Manufacturing, and Control (“CMC”) support for regulatory submissions related to Psyence’s clinical trials in Palliative Care and any future Investigational New Drug (“IND”) applications. Psyence will obtain exclusive rights to Optimi’s drug candidate for treatment use in the Palliative Care context.
Dane Stevens, Chief Executive Officer of Optimi Health, stated, “We are very excited to have the opportunity to support Psyence Biomed as it works toward the potential initiation of pivotal registrational Phase III studies in Adjustment Disorder. As psychedelic research and development activities gain traction globally, we strive to be the partner-of-choice for companies like Psyence Biomed who are on the leading edge of psilocybin-based drug development. We look forward to a mutually successful partnership.”
“As we continue to efficiently advance our Phase IIb clinical trial for Adjustment Disorder in Palliative Care, these binding agreements with Optimi ensure that we have a consistent supply of very high quality, nature derived psilocybin for pivotal registrational Phase III studies, commercial production if approved, and potential expansion into new indications,” said Dr. Neil Maresky, M.B.,B.Ch., Chief Executive Officer of Psyence Biomed. “We are pleased to have found a partner in Optimi that shares our commitment to the development of psilocybin-based therapeutics as potential treatments for a broad range of underserved mental health conditions.”
About Psyence Biomed
Psyence Biomedical Ltd. (Nasdaq: PBM) is the world’s first life science biotechnology company developing nature-derived (non-synthetic) psilocybin-based psychedelic medicines 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, regulatory-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 advancement of Psyence Biomed's Phase IIb clinical trial and planned Phase III studies, and the quality and consistency of its supply chain for nature derived psilocybin. These forward-looking statements are based on a number of assumptions, including the assumptions that the parties will obtain all such regulatory approvals as may be required to execute on the Phase IIb clinical trial and planned Phase III studies, there will not be any unforeseen delays in the implementation schedule of such clinical trial and studies, and that Optimi will be able to meet Psyence Biomed's supply needs.
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) delays in the implementation schedule of Psyence Biomed's Phase IIb clinical trials; (ii) the inability of Optimi to meet Psyence Biomed's supply needs to execute on its product development strategy (iii) the ability of Psyence Biomed 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. 333-282468) filed with the Securities and Exchange Commission on October 10, 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
What is the new supply agreement between Psyence Biomed (PBM) and Optimi Health Corp?
What stage is Psyence Biomed's (PBM) clinical trial for Adjustment Disorder in Palliative Care?
What regulatory support will Optimi provide to Psyence Biomed (PBM)?
