Psyence Biomedical Ltd. Stock Price, News & Analysis

Psyence Biomedical (Nasdaq: PBM) has issued a shareholder update highlighting recent progress and upcoming milestones. The company has:

• Initiated a Phase IIb study of nature-derived psilocybin for Adjustment Disorder in Palliative Care
• Expanded its pipeline to include Alcohol Use Disorder (AUD) and Substance Use Disorders (SUDs)
• Announced the acquisition of Clairvoyant, a synthetic psilocybin-based drug developer
• Secured exclusive supply agreements for GMP nature-derived psilocybin

Two Phase II data readouts are anticipated in 2025: Clairvoyant's AUD trial in early 2025 and Psyence's Adjustment Disorder trial in the second half of 2025. The company has also strengthened its financial position to support these initiatives.

Psyence Biomedical (Nasdaq: PBM) has received a staff determination letter from Nasdaq on September 12, 2024, indicating the company's failure to regain compliance with two listing requirements by the September 9, 2024 deadline. The requirements in question are the Market Value of Listed Securities (MVLS) of $50 million and the Market Value of Publicly Held Shares (MVPHS) of $15 million for continued listing on The Nasdaq Global Market.

The company was initially notified of these deficiencies on March 11, 2024, and given 180 calendar days to comply. Facing potential suspension or delisting, Psyence Biomedical intends to request a hearing before the Nasdaq Hearings Panel, which will automatically stay any delisting action pending the hearing and any additional extension period granted by the Panel.

Psyence Biomedical (Nasdaq: PBM) has announced the successful completion of the first site initiation visit for its Phase IIb study of nature-derived psilocybin as a potential treatment for Adjustment Disorder in Palliative Care. The study will be conducted at an Australian clinical trial site, with patient screening set to begin soon and the first subject expected to be randomized in October 2024.

The randomized, double-blind, placebo-controlled study will evaluate two therapeutic doses of psilocybin (10mg, 25mg) against an active low-dose comparator (1mg) in 87 patients, in conjunction with psychotherapy. Psyence has partnered with Fluence and iNGENū CRO Pty to support the study. The company anticipates topline data in the second half of 2025, which could potentially lead to the initiation of a Phase III clinical program.

Psyence Biomedical (Nasdaq: PBM) has entered into a conditional binding term sheet to acquire Clairvoyant Therapeutics Inc, a Canadian clinical-stage developer of psilocybin-based therapeutics. The acquisition involves issuing US$500,000 in PBM common shares upon closing, with potential additional payments of up to US$500,000 based on milestones. PBM will also advance up to US$1,800,000 to settle Clairvoyant's liabilities.

Clairvoyant is currently conducting a Phase IIb clinical trial evaluating a synthetic psilocybin candidate for Alcohol Use Disorder (AUD). The trial has enrolled and treated 154 randomized double-blinded subjects, with topline results expected in early 2025. This acquisition could expand PBM's pipeline into AUD treatment and potentially transition the company to a commercial-stage, revenue-generating entity.

Psyence Biomedical (Nasdaq: PBM) has entered into a worldwide, exclusive royalty-bearing IP licensing agreement with PsyLabs to supply pharmaceutical-grade, EU GMP nature-derived psilocybin for potential treatment of Alcohol Use Disorder (AUD) and other Substance Use Disorders (SUDs). Psyence Biomed plans to focus on AUD as its second development indication, following its first indication of Adjustment Disorder in advanced cancer patients. The licensed product requires further development by PsyLabs throughout 2024 and into 2025.

In 2021, 44.4 million adults in the U.S. had substance or alcohol use disorders, highlighting the significant need for new treatment options. Previous academic studies have shown promise for psilocybin combined with psychotherapy in treating AUD and SUDs.

Psyence Biomedical (Nasdaq: PBM) announced that the SEC has declared effective its registration statement for a $25 million equity line of credit (ELOC) with White Lion Capital, This 24-month arrangement allows Psyence Biomed to sell up to $25 million in shares to White Lion, subject to certain conditions.

Dr. Neil Maresky, CEO of Psyence Biomed, stated that this funding source will support the company's preparation for a Phase IIb clinical trial of nature-derived, non-synthetic psilocybin as a potential treatment for Adjustment Disorder in Palliative Care. The company also plans to advance other long-term growth initiatives.

Psyence Biomedical (Nasdaq: PBM), a developer of nature-derived psilocybin-based therapeutics, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9th-11th, 2024 at the Lotte New York Palace Hotel in New York City.

Key points:

• Psyence Biomed will present virtually and engage in one-on-one investor meetings
• The company's corporate presentation will be available on-demand from September 9th at 7:00 am (ET)
• Interested parties can schedule meetings with management by emailing ir@psyencebiomed.com

This participation provides an opportunity for Psyence Biomed to showcase its developments in psilocybin-based therapeutics to a global investment audience.

Optimi Health Corp. (CSE: OPTI) and Psyence Biomedical (NASDAQ: PBM) have signed a non-binding Letter of Intent (LOI) for a strategic partnership. Under this arrangement, Optimi would become the exclusive supplier of GMP nature-derived psilocybin extract for Psyence's global drug development initiatives, focusing on FDA-approved use in Palliative Care.

Key points of the LOI include:

• Optimi to provide comprehensive CMC support for regulatory submissions and future IND applications
• Psyence to obtain exclusive rights to Optimi's drug candidate for Palliative Care treatment
• Collaboration aims to advance psilocybin-based therapies and quality science
• Focus on Adjustment Disorder in the context of Palliative Care

Both companies' CEOs expressed enthusiasm for the potential partnership, highlighting its strategic importance in advancing psychedelic-based mental health therapies.

Psyence Biomedical (Nasdaq: PBM) has entered into a $25 million common stock purchase agreement with White Lion Capital, This 24-month agreement allows Psyence Biomed to sell up to $25 million in shares to White Lion, subject to certain conditions. The purchase price will be 90% of the lowest VWAP for Fixed Purchase Notices and the lowest traded price for Rapid Purchase Notices. White Lion has agreed not to engage in short selling Psyence Biomed's shares. The agreement can be terminated by Psyence Biomed at any time without penalty.

This funding will support Psyence Biomed's upcoming Phase IIb clinical trial of nature-derived, non-synthetic psilocybin for Adjustment Disorder in Palliative Care, as well as earlier-stage programs in other indications.