Psyence Group

Shareholder update from Psyence Biomedical Ltd, one of the world's few vertically integrated biopharmas with a focus on psychedelic-based pharmaceutical therapeutics, and the first life science biotechnology company developing nature-derived (non-synthetic) psilocybin-based psychedelic medicine to be listed on Nasdaq •Phase IIb clinical trial progressing as planned; patient screening has commenced •Independent valuation of PsyLabs values Psyence Biomed’s stake at approximately $2 million, doubling in value •Strengthened balance sheet, with substantially reduced debt, heading into 2025 "We anticipate that Psyence Biomed will enter 2025 with a substantially debt-free balance sheet, offering greater financial flexibility and stability. This improved financial position allows the Company to focus its resources on advancing its clinical programs, including the ongoing Phase IIb trial in Adjustment Disorder and the planned Phase II trial in Alcohol Use Disorder (AUD), while positioning itself for long-term growth and operational efficiency," says Psyence Biomedical Ltd CEO Dr. Neil Maresky who adds, "In closing, I believe the progress that we have made this year – clinical, financial and operational – position us well to achieve multiple value-creating milestones in 2025 and beyond. "

Report from Benzinga's Juan Agustín Spinelli shares happy landmark reached in Psyence Biomedical Ltd's trajectory as the first life science biotechnology company developing nature-derived (non-synthetic) psilocybin mushroom-based psychedelic medicine to be listed on the NASDAQ. https://lnkd.in/ephrFpVq

Follow the #Psyence

It's impossible to manufacture "natural" psilocybin, that's why at PsyLabs, we grow it instead.

Double-down: Psyence Biomedical Ltd hits another milestone in developing a safe and effective, regulatory approved approach to nature-derived psilocybin for Palliative Care patients, long in need of new therapeutic options. https://lnkd.in/e7pPPwCN

Why is Psyence Biomedical Ltd the pioneer in working to develop safe, responsible, FDA-approved nature-derived (non-synthetic) psilocybin pharmaceutical candidates? Because we Follow the #Psyence. "Evidence-based and independent finding affirms Psyence Biomedical Ltd's commitment to nature-derived psilocybin" says CEO Dr. Neil Maresky who welcomed this study in the Journal of Molecular Psychiatry from the research team guided by Professor Bernard Lerer, MD, at Hadassah BrainLabs at The Hebrew University of Jerusalem. Said Professor Bernard Lerer: "Notably, psychedelic [psilocybin] mushroom extract was more effective than chemical psilocybin. . . " Neither Psyence Biomedical Ltd nor any of its investors or affiliates funded or in any way sponsored the study. Psyence Biomedical Ltd stands alone as the only Nasdaq-listed biopharmaceutical company to research a nature-derived psilocybin candidate to treat Adjustment Disorder in the context of Palliative Care.

Psyence Biomedical Ltd honors World Palliative Care Day by celebrating the 10 year anniversary of this World Health Organization (WHO) resolution declaring "palliative care is an ethical responsibility of health systems, and that it is the ethical duty of health care professionals to alleviate pain and suffering, whether physical, psychosocial or spiritual." As the world's first life science biotechnology company focussed development of nature-derived (non-synthetic) psychedelic listed on the Nasdaq, our company's first focus is on treating a diagnosis in the context of Palliative Care. In working to provide more safe FDA-approved pharma solutions for clinicians treating psychosocial and spiritual distress, we honor the legacy of our field's palliative care pioneers. Which is why we support Dr. eduardo bruera of MD Anderson Cancer Center as he sends respect to the many clinicians who work in Palliative Medicine with few resources and we salute Dr. Ira Byock whose teaching at Dartmouth Hitchcock Medical Center and Clinics and books, especially his Palliative Medicine classic, "The Best Care Possible" have shown so many of us at Psyence Biomedical Ltd the way forward.

"Mushroom drug psilocybin ‘more effective than antidepressant’"reports Rhys Blakely, science correspondent for The Times of London. Psyence Biomedical Ltd, recognized as pioneers of the world's first life science biotechnology developing mushroom-derived (non-synthetic) psilocybin-based psychedelic medicine to be listed on Nasdaq, welcomes this interview with Tommaso Barba of Imperial College London. Dr. Barba shares that while "Prozac, Paxil and Zoloft . . .the main types of drugs used to treat depression. . .work well, but not for everyone. They are also associated with some side-effects." In contrast, his study suggests "psilocybin generally seems to offer a real alternative, and perhaps additional benefits," a finding that affirms Psyence Biomedical Ltd's commitment to an evidence-based approach to innovation as it works to develop safe and effective, FDA-approved, nature-derived psychedelic therapeutics. Another reason we Follow the #Psyence

The Crain Communications psychedelic industry flagship Green Market Report shares that Psyence Biomedical Ltd is "poised to hit several psilocybin-related 'milestones,' according to reportage from its Senior Reporter John Schroyer who notes: "Psyence inks several deals to expand psilocbin research, footprint"

Doubledown. Psyence Biomedical Ltd accelerates its journey as a vertically integrated life science biotech company. TWO phase IIb data readouts now anticipated in 2025. Also sharing news of the Psyence Biomedical Ltd expanded pipeline, the acquisition of Clairvoyant Therapeutics, subject to due diligence and customary closing conditions. Our Phase IIb trial evaluating nature-derived psilocybin with psychotherapy as a potential treatment for Adjustment Disorder in a Palliative Care context in on track with iNGENū CRO, the FDA-centric Australian CRO, a partnership which grants us the economic benefits, including significant R&D tax credits. At a time of increased regulatory scrutiny, we are happy to deepen our collaboration with Fluence a global leader in providing comprehensive, evidence-based psychedelic training to healthcare professionals and to achieving a therapeutic alliance that we hope will set a gold standard of excellence. Together with our partners, Fluence and iNGENū CRO 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 for an indication --Adjustment Disorder-- which WHO deems 7th most diagnosed psychiatric condition in the world. We have strengthened our Clinical Supply of Natural Psilocybin by partnering with Optimi 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. With Optimi's collaboration, we look to bring transformative treatments for mental health conditions, achieve pioneering advancements in psychedelic-based mental health therapies and enable Psyence Biomedical Ltd to help patients in Palliative Care context.         Second Indication: We also announced our second indication, and will evaluate GMP nature-derived psilocybin as a potential treatment for Substance Use Disorders (SUDs), including Alcohol Use Disorder (AUD). Our agreement with PsyLabs secures highly purified nature-derived psilocybin extract exclusively for these indications. Acquisition of Second Phase IIb Asset Deepening our commitment to helping relieve the human misery of AUD to diversify our drug development pipeline, we signed conditional agreement to acquire of psilocybin-based drug developer Clairvoyant Therapeutics. Clairvoyant is currently executing a Phase IIb clinical trial in AUD, with topline data expected in early 2025. "We are pleased to join forces. . .with our 'speed to market' strategy for psilocybin in AUD'" said Damian Kettlewell Clairvoyant CEO. Finally, to ensure that we have the critical funding required to advance these initiatives, we entered into agreements that are expected to provide us with sufficient capital to execute our strategy.     Proud to share more details in a letter from our CEO Dr. Neil Maresky, please see below.