Psyence Biomedical Issues Shareholder Update Highlighting Recent Progress
Psyence Biomedical (Nasdaq: PBM) provided a shareholder update highlighting significant progress. The company's Phase IIb clinical trial for nature-derived psilocybin in Palliative Care patients with Adjustment Disorder is advancing, with patient screening commenced. Their stake in PsyLabs has doubled in value to approximately $2 million following an independent valuation. The company has strengthened its financial position through debt-for-equity swap agreements with Psyence Group and Newcourt SPAC Sponsor. PBM expects to enter 2025 substantially debt-free and is on track to regain compliance with Nasdaq listing requirements by year-end. Topline data from the Phase IIb trial is expected in H2 2025.
Psyence Biomedical (Nasdaq: PBM) ha fornito un aggiornamento agli azionisti evidenziando progressi significativi. Il trial clinico di Fase IIb per la psilocibina derivata dalla natura nei pazienti in cure palliative con Disturbo da aggiustamento è in fase di avanzamento, con l'inizio della selezione dei pazienti. La loro partecipazione in PsyLabs è raddoppiata di valore, raggiungendo circa 2 milioni di dollari dopo una valutazione indipendente. L'azienda ha rafforzato la propria posizione finanziaria attraverso accordi di scambio di debito in equity con Psyence Group e Newcourt SPAC Sponsor. PBM prevede di entrare nel 2025 sostanzialmente senza debiti ed è sulla buona strada per ristabilire la conformità ai requisiti di quotazione Nasdaq entro la fine dell'anno. I dati principali del trial di Fase IIb sono attesi nella seconda metà del 2025.
Psyence Biomedical (Nasdaq: PBM) proporcionó una actualización a los accionistas destacando un progreso significativo. El ensayo clínico de Fase IIb para la psilocibina derivada de la naturaleza en pacientes de Atención Paliativa con Trastorno de Ajuste está avanzando, habiéndose iniciado el proceso de selección de pacientes. Su participación en PsyLabs ha duplicado su valor, alcanzando aproximadamente 2 millones de dólares tras una valoración independiente. La empresa ha fortalecido su posición financiera mediante acuerdos de intercambio de deuda por acciones con Psyence Group y Newcourt SPAC Sponsor. PBM espera entrar en 2025 prácticamente libre de deudas y está en camino de recuperar la conformidad con los requisitos de listado de Nasdaq para fin de año. Se esperan datos iniciales del ensayo de Fase IIb en la segunda mitad de 2025.
Psyence Biomedical (Nasdaq: PBM)는 주주들에게 중요한 진전을 강조하는 업데이트를 제공했습니다. 조정 장애를 겪는 완화 치료 환자들을 위한 자연 유래 실로시빈에 대한 2b상 임상 시험이 진행 중이며, 환자 선별이 시작되었습니다. PsyLabs에 대한 그들의 지분 가치는 독립적인 평가 후 약 200만 달러로 두 배 증가했습니다. 이 회사는 Psyence Group 및 Newcourt SPAC 스폰서와의 채무-지분 스왑 계약을 통해 재정적 위치를 강화했습니다. PBM은 2025년에 거의 채무 없는 상태로 진입할 것으로 예상하며, 연말까지 Nasdaq 상장 요건에 대한 준수를 회복할 계획입니다. 2b상 시험의 주요 데이터는 2025년 하반기에 예상됩니다.
Psyence Biomedical (Nasdaq: PBM) a fourni une mise à jour aux actionnaires mettant en avant des avancées significatives. L'
Psyence Biomedical (Nasdaq: PBM) hat ein Update für die Aktionäre bereitgestellt, das erhebliche Fortschritte hervorhebt. Die Phase-IIb-Studie zur aus der Natur gewonnenen Psilocybin bei Palliativpatienten mit Anpassungsstörungen schreitet voran, wobei das Screening von Patienten begonnen hat. Ihr Anteil an PsyLabs hat sich nach einer unabhängigen Bewertung auf etwa 2 Millionen Dollar verdoppelt. Das Unternehmen hat seine finanzielle Position durch Schulden-gegen-Eigenkapital-Tauschverträge mit der Psyence Group und dem Newcourt SPAC-Sponsor gestärkt. PBM erwartet, 2025 praktisch schuldenfrei zu sein und ist auf dem Weg, bis Ende des Jahres die Nasdaq-Listing-Anforderungen wieder zu erfüllen. Die Hauptdaten der Phase-IIb-Studie werden für die zweite Jahreshälfte 2025 erwartet.
- PsyLabs stake value doubled to $2 million, representing 70% of current market cap
- Debt-for-equity swap agreements leading to substantially debt-free balance sheet for 2025
- Phase IIb clinical trial progressing with patient screening commenced
- Successfully transferred to Nasdaq Capital Market and implementing compliance plan
- Current market capitalization implies total company value of only ~$2.85 million
- Required to meet multiple Nasdaq listing requirements to maintain listing
- Implemented 1-for-75 share consolidation to meet minimum bid price requirement
Insights
This shareholder update reveals several positive financial developments. The
The company's progress toward Nasdaq compliance through strategic moves like the 1-for-75 share consolidation and transfer to Nasdaq Capital Market shows proactive management of listing requirements. With
The Phase IIb trial for Adjustment Disorder in palliative care patients represents a significant opportunity, targeting the seventh most diagnosed psychiatric condition globally. Patient screening has commenced at two active sites, with two more potential sites under consideration. The expected topline data in H2 2025 could be a major catalyst.
The vertical integration through PsyLabs ownership provides strategic control over pharmaceutical-grade psilocybin supply, particularly important for the planned Alcohol Use Disorder trials. The successful BSI re-audit and ISO 22000 certification validation of PsyLabs' extraction process demonstrates strong quality control and regulatory compliance, critical factors for clinical trial success.
Independent valuation of PsyLabs values Psyence Biomed’s stake at approximately
Debt-for-equity swap with Psyence Group and Newcourt SPAC Sponsor results in strengthened balance sheet, with substantially reduced debt, heading into 2025
Psyence Biomed believes it is on track to regain compliance with all applicable Nasdaq continued listing requirements by year-end
Phase IIb clinical trial progressing as planned; patient screening has commenced
NEW YORK, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence Biomed” or the “Company”) today issued the following update to shareholders:
Dear shareholders:
I wanted to take this opportunity to recap the significant progress that we have made since our last update, as we continue to progress our active Phase IIb clinical trial of nature-derived psilocybin in Palliative Care patients diagnosed with Adjustment Disorder, while also advancing plans for a clinical trial in our second development indication, Alcohol Use Disorder.
Psyence Biomed is working to develop the first-ever prescription medicine treatment option for the millions of patients who suffer from Adjustment Disorder, the seventh most-frequently diagnosed psychiatric condition in the world1.
Phase IIb Clinical Trial Progressing; First Patients to be Randomized Imminently
In September, we announced initiation of the first site participating in our Phase IIb clinical trial evaluating nature-derived psilocybin, in conjunction with psychotherapy, as potential treatment for Adjustment Disorder following a life-limiting cancer diagnosis in the Palliative Care context. A second trial site, Empax Center in Perth, Australia, was initiated in November. Two additional sites have expressed interest in participating and feasibility visits to the sites are being planned.
Patient screening has commenced, and we anticipate that the first patients will be randomized and treated soon thereafter. We remain on track for topline data from this trial in the second half of 2025 which, if positive, would be a significant achievement not only for our own development program, but an advancement for psychedelic-based therapeutics generally.
Favourable Result from Nasdaq Listing Qualification Hearing
As previously announced, during the Company’s Nasdaq Listing Qualifications Hearing, we presented a comprehensive plan to regain and maintain compliance with Nasdaq’s continued listing requirements. As part of this plan, we applied to transfer the listing of our shares to The Nasdaq Capital Market from The Nasdaq Global Market, and this transfer became effective November 15th. We also detailed a plan to regain compliance with Listing Rules 5550(a)(5), the
Finally, we implemented a 1-for-75 share consolidation, effective November 26th, that addressed Listing Rule 5550(a)(2), the
Having our shares traded on the Nasdaq exchange is critical to raising awareness of our company among healthcare-focused institutional investors, and once these listing requirements are fully satisfied, we can focus on advancing our pipeline.
Updated PsyLabs Holdings Valuation Implies
In October, Psyence Biomed became one of the world's few vertically integrated biopharmas with a focus on psychedelic-based pharmaceutical therapeutics with the acquisition of an
PsyLabs recently closed an oversubscribed seed round financing, raising
Notably, this independent analysis values our PsyLabs stake at approximately
Successful Re-Audit of PsyLabs by the British Standards Institution (BSI)
PsyLabs continues to optimize its cultivation and extraction processes to enhance efficiency, yield, and quality. Advanced cultivation techniques and innovative extraction methodologies ensure that PsyLabs’ psilocybin production remains both high-quality and cost-effective. These refinements position the company to scale effectively while adhering to sustainable practices.
PsyLabs recently announced the successful re-audit of its production facility by the British Standards Institution (BSI) for ISO 22000 certification. Conducted by an experienced audit firm that has audited the site for the past four years, this thorough review commended the maturity of PsyLabs’ quality management system and the team’s dedication to food safety and quality. Importantly, PsyLabs’ new extraction process has been incorporated into the scope of certification — a significant milestone that reflects the extensive compliance updates undertaken.
Our partnership with PsyLabs not only makes us vertically integrated with a supply chain, it demonstrates our commitment to advancing the highest quality psilocybin candidate into clinical development.
Strengthened Financial Position with Debt-For-Equity Swap Agreements and Strategic Acquisition of Shares of PsyLabs
Psyence Biomed entered into debt-for-equity swap agreements with Psyence Group and Newcourt SPAC Sponsor pursuant to which we agreed to issue PBM common shares in exchange for the discharging of the balance of the debt repayment obligations due under promissory notes dated January 25, 2024, issued by Psyence Biomed in connection with our listing on the Nasdaq in January 2024. In addition, the acquisition of shares of PsyLabs from Psyence Group was completed through the issuance of Psyence Biomed shares.
As a result of these strategic transactions, as well as the termination of outstanding senior secured convertible notes issued by PBM to a US based investment firm, 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.
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. I look forward to keeping you apprised of our continued progress.
Thank you for your continued interest and support.
Sincerely,
Neil Maresky
Dr. Neil Maresky, M.B.,B.Ch.
Chief Executive Officer, Psyence Biomed
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 for Psyence Biomedical Ltd.
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 progress of the Phase IIb clinical trial and the achievement of trial milestones, the regaining of compliance with all applicable Nasdaq Continued listing requirements, and the execution of binding agreements with Optimi. These forward-looking statements are based on a number of assumptions, including the assumption that there will be no delays in the execution of the Phase IIb clinical trial implementation schedule, that topline data from this trial will be positive, that the Company will effectively execute on its Nasdaq Continued listing compliance plan, and that agreement is reached with Optimi.
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 execution of the Phase 11B trial (ii) the ability of Psyence Biomed to maintain the listing of its common shares and warrants on Nasdaq; (iii) the ability to implement the Nasdaq compliance plan presented to the Panel; (iv) the success of negotiations with Optimi; and (v) volatility in the price of the securities of Psyence Biomed due to a variety of factors, including the recent share consolidation, 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 Psyence Biomed 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, Psyence Biomed does not intend to update these forward-looking statements.
The Company does not make any medical, treatment or health benefit claims about its 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 the proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company has 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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1 Evans SC, Reed GM, Roberts MC, Esparza P, Watts AD, Ritchie PLJ, Maj M, Saxena S. 2013. Psychologists’ perspectives on the diagnostic classification of mental disorders: results from the WHO-IUpsyS Global Survey. Int J Psychol. 48:177–193.
FAQ
What is the current value of Psyence Biomedical's stake in PsyLabs?
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