Latest news with #PsyenceBioMed
Toronto Star
7 days ago
- Business
- Toronto Star
Corporate Update, August 2025
NEW YORK, Aug. 04, 2025 (GLOBE NEWSWIRE) — From Dr. Neil Maresky, CEO, Psyence BioMed (NASDAQ: PBM) Dear Shareholders, Thank you for your continued support as we advance our mission to develop safe, effective, and naturally derived psychedelic therapies for people living with serious mental health challenges. Over the past few months, Psyence BioMed (PBM) has made meaningful progress across several fronts: clinical development, strategic positioning, regulatory compliance, and manufacturing stability. These developments reflect not only a shift in our momentum but also a broader evolution of the company – one I'm excited to share with you. Clinical Progress & Trial Expansion Psyence BioMed continues to advance its clinical program with key developments that set the stage for expanded patient access and accelerated enrollment: ARTICLE CONTINUES BELOW Protocol Amendment & Screening Update: A critical protocol amendment that removes the cancer diagnosis requirement to be terminal was submitted and approved by the Human Ethics Review Board (HREC). This change is expected to significantly broaden our eligible patient pool, future patients and increase the trial's clinical relevance and impact. Site Activation: Three clinical sites have successfully completed qualification visits and all have been initiated (as of August 5th). We are pleased to be executing this trial in partnership with Southern Star Research, a leading contract research organization with deep expertise in both oncology and mental health. With the service agreement finalized, full operational rollout is now underway – positioning us to initiate patient enrollment in the near term. Our commitment to scientific leadership is anchored by our exceptional Scientific Advisory Board (SAB), which brings together globally recognized experts in neuroscience, psychiatry, and psychedelic medicine. The SAB plays a critical role in shaping our research agenda and guiding the clinical development of our psychedelic therapies. In the coming weeks, we will host a dedicated webinar featuring our SAB to share deeper insights into our evolving clinical vision for natural psychedelic therapies – including their potential applications in treating PTSD, substance use disorders, and other complex mental health conditions. Stay tuned for more information. Alcohol Use Disorder: PBM has established a Steering Committee (SC) to guide the development of its early-phase study investigating the use of naturally sourced psilocybin for the treatment of Alcohol Use Disorder (AUD). The study is planned to be conducted in South Africa and the SC comprises three experts in substance and alcohol use disorders, including Professor Dan Stein from the University of Cape Town, who also serves on the Psyence BioMed SAB. The SC will provide input on protocol design, advise on key endpoints, and help identify the most appropriate patient population – particularly in light of cultural nuances surrounding alcohol use. Ibogaine: Strengthening Our Strategic Alliance with PsyLabs Psyence BioMed's partnership with PsyLabs continues to evolve as a cornerstone of our Ibogaine program. Ibogaine is an incredibly exciting molecule, with powerful psychoactive properties that not only alters perception, mood, and affect, but also interrupts addictive behaviors. Together, we are advancing several key initiatives that reinforce our position as a global leader in the development of naturally derived psychedelic therapies. Last week we announced that PsyLabs has successfully produced a GMP-aligned Ibogaine Total Alkaloid extract – a milestone that reflects the impact of our ongoing investment and collaboration in this partnership. Our collaboration is focused on: Elevating Production Standards: Work is underway to achieve GMP-grade ibogaine manufacturing with exceptional purity – a rare and highly sought-after capability as the psychedelic sector moves toward increased regulatory rigor. Expanding Global Footprint: As the only publicly listed psychedelics company with a sustainable source of ibogaine in Africa, we are uniquely positioned to lead in ethical, scalable, and locally rooted production – offering a distinct competitive advantage in the global psychedelics market. Advancing Ethical Sourcing: Strategic relationships are being developed to support responsible, community-conscious harvesting of iboga, ensuring long-term supply chain integrity. This partnership is more than operational; it is foundational to our long-term strategy. Our licensing portfolio – including a Right of First Refusal (ROFR) agreement with PsyLabs for the licensing of ibogaine-based products and associated intellectual property – reinforces our ownership stake in this emerging therapeutic category and will be prominently featured in our upcoming investor communications. All of this work is happening in parallel with global momentum, including recent legislation in Texas, where the state has committed $50 million to ibogaine research to explore its potential in treating veterans with traumatic brain injury and PTSD. This is a powerful validation of the compound's promise. ARTICLE CONTINUES BELOW ARTICLE CONTINUES BELOW For additional insight, I encourage shareholders to read A New Frontier in Palliative Care in Insights Care Magazine, where PsyLabs CEO, Tony Budden, outlines a compelling case for nature-derived psychedelics in mainstream medicine. His perspective reflects the broader mission of our collaboration – one rooted in science, patient-centered care, and scalable infrastructure. Strong Financial Position & Nasdaq Compliance We are pleased to report that the Company has a strong cash balance of $11.4 million as at August 4, 2025, and is in a solid financial position with no outstanding debt. The Equity Line of Credit has enabled the Company to raise capital strategically and efficiently. This solid financial position enables us to pursue growth opportunities, accelerate our clinical programs, and navigate future market dynamics with confidence. Regaining compliance with Nasdaq listing requirements marked an important milestone in our continued growth and credibility as a public company. Psyence BioMed successfully regained full compliance with all applicable Nasdaq continued listing requirements in June 2025. As part of our compliance strategy, shareholders approved a share consolidation (reverse stock split) at a Special Meeting of Stockholders held on April 16, 2025. The proposal authorized a reverse split at a ratio of up to 1-for-50, or a lesser amount at the discretion of the Company's Board of Directors. The Board subsequently approved a final ratio of 1-for-7.97 to comply with Nasdaq's minimum bid price requirement under Listing Rule 5550(a)(2). Commitment to Long-Term Value At Psyence BioMed, our commitment to long-term value is grounded in a clear strategic vision: to build a resilient, multi-asset biotechnology company that leads in the development of nature-derived psychedelic therapies. We are focused on advancing clinically validated, scalable solutions for complex mental health conditions where current treatments fall short. Our leadership team brings a unique blend of global expertise in clinical research, pharmaceutical manufacturing, regulatory strategy, and commercialization. This operational strength positions us to efficiently advance drug candidates from early development through to clinical trials and, potentially, toward market access. ARTICLE CONTINUES BELOW ARTICLE CONTINUES BELOW We are a multi-asset company with an integrated platform that includes proprietary IP, advanced laboratory infrastructure, CMC expertise to enhance the efficiency and consistency of psychedelic compound extraction, and GMP-compliant manufacturing capabilities. This foundation positions us to pursue a range of opportunities across the psychedelics landscape. Each asset in our pipeline is strategically selected and developed with a clear focus on medical relevance, regulatory alignment, and long-term commercial potential. As the psychedelic sector moves toward greater scientific and regulatory maturity, investor attention is shifting to companies with well-defined therapeutic targets and disciplined execution. With forecasts projecting a $3.3 billion psychedelics market by 2031, Psyence BioMed is positioned to deliver differentiated clinical outcomes and enduring shareholder value. Our long-term value creation strategy is built on three pillars: scientific rigor, strategic focus, and operational excellence. We are building not just for momentum – but for meaningful, measurable impact in the years ahead. Warm regards, Dr. Neil Maresky Chief Executive Officer Psyence BioMed (NASDAQ: PBM) Psychedelic Medicine & Policy Updates Slowing aging: Psilocybin helps extend life span in human cells by over 50% Scientists have reported evidence psilocybin may help protect the body from age-related diseases, such as neurodegeneration, heart disease, and cancer through several health-protecting qualities, via a mouse model. Read here. Texas Will Invest $50 Million in Ibogaine Research, Testing the Psychedelic Drug's Medical Potential The state's new law marks one of the largest government investments into psychedelics to date, with advocates citing the drug's potential to help veterans with traumatic brain injury and PTSD. Read here. ARTICLE CONTINUES BELOW ARTICLE CONTINUES BELOW Drugs reduced anxiety and PTSD in Nova festival survivors, study finds Study finds survivors of the Nova music festival massacre who consumed classic psychedelics in the hours before the massacre reported significantly lower anxiety and PTSD symptoms, offering real-world insights into potential therapeutic applications. Listen here. Promising' psychedelic therapy aims to help cancer patients More than $5 million from the Canadian Cancer Society will go toward research on treating feelings of anxiety, depression and hopelessness in people with advanced cancer. Read more. Psychedelics may boost mental health by dampening inflammation Psychedelic drugs like MDMA and psilocybin may help treat depression, anxiety and other mental health conditions by reducing the number of inflammatory cells around the brain. Read more. Psychedelics Rewire Brain-Immune Circuits New research reveals that psychedelics like psilocybin do more than alter brain activity — they reshape how the brain and immune system communicate. Scientists identified a pathway where chronic stress disrupts amygdala signaling, triggering immune responses that increase fear and anxiety. Read more. Australia: Government Reimburses MDMA Therapy for Veterans Australia's Department of Veterans' Affairs (DVA) has begun reimbursing MDMA-assisted therapy for veterans with PTSD. This initiative utilizes MDMA capsules supplied by Optimi Health and administered through Mind Medicine Australia's Authorized Prescriber network. The move signifies a significant endorsement of psychedelic-assisted therapies at the governmental level. Read more. Psilocybin Shows Promise in Parkinson's Disease Treatment A pilot study conducted by the University of California, San Francisco, indicates that psilocybin may alleviate symptoms of Parkinson's disease. Participants reported improvements in mood, cognition, and motor function, with benefits lasting for weeks post-treatment. The study also suggests psilocybin may reduce brain inflammation and enhance neuroplasticity. Read more. ARTICLE CONTINUES BELOW ARTICLE CONTINUES BELOW Global Psilocybin Therapy Market Projected to Reach $3.3 Billion by 2031 According to a report by Forbes, the global market for psilocybin-assisted therapy is projected to grow from $1.5 billion in 2024 to $3.3 billion by 2031. This growth is driven by increasing acceptance of psychedelic therapies and the rising prevalence of mental health disorders. Read more. FDA Releases Draft Guidance on AI in Drug Development The U.S. Food and Drug Administration (FDA) has issued draft guidance outlining considerations for the use of artificial intelligence (AI) in drug and biological product development. The guidance proposes a risk-based framework to assess the credibility of AI models used in regulatory decision-making processes. Read more. U.S. Surgeon General Nominee Supports Psychedelic Therapy Dr. Casey Means, nominated for U.S. Surgeon General, has publicly endorsed the use of psychedelic therapies, including psilocybin-assisted treatment. Her stance reflects a growing interest in alternative mental health treatments at the highest levels of government. Read more. Republican Lawmaker Advocates for Psychedelic Therapy Congressman Morgan Luttrell (R-Texas), a former Navy SEAL, has become a vocal advocate for psychedelic therapy following his personal experience with ibogaine and DMT treatments for PTSD. His support highlights a bipartisan shift towards considering psychedelic-assisted therapies for mental health conditions, particularly among veterans. Read more. Learn more at and on LinkedIn. Contact Information for Psyence Biomedical Ltd. Email: ir@ Media Inquiries: media@ General Information: info@ Phone: +1 416-477-1708 Investor Contact: Michael Kydd Investor Relations Advisor michael@ 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, preparations for the Company's second development indication, the growth of the psychedelic mushroom market and the Company's growth potential. 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, topline data from this trial will be positive, there will be no obstacles to the launch of the Company's second indication, and that the demand for psychedelic-assisted therapy will continue to increase. There can be no assurance that the Company will continue to maintain compliance with Nasdaq's continued listing requirements. ARTICLE CONTINUES BELOW ARTICLE CONTINUES BELOW 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 IIb trial; (ii) the ability of Psyence BioMed to maintain the listing of its common shares and warrants on Nasdaq; (iii) 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 Company's final prospectus (File No. 333-284444) filed with the Securities and Exchange Commission (the 'SEC') on January 24, 2025 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 statements. 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 authorized clinical 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.
Yahoo
01-05-2025
- Business
- Yahoo
Psyence BioMed Announces Effective Date for 1-for-7.97 Reverse Stock Split
New York, New York--(Newsfile Corp. - May 1, 2025) - Psyence Biomedical Ltd. (NASDAQ: PBM) ("Psyence BioMed" or the "Company") today announced the effective date of its 1-for-7.97 share consolidation (reverse stock split) of the Company's issued and outstanding common shares. At a Special Meeting of Stockholders held on April 16, 2025, shareholders approved a share consolidation at a ratio of up to 1-for-50. Following this approval, the Company's Board of Directors authorized a 1-for-7.97 consolidation ratio, which will be implemented as the final share structure. The Company's common shares are expected to begin trading on a post-consolidated basis at the opening of the market on Monday, May 5, 2025. Following the consolidation, the Company's common shares will continue to trade under the symbol "PBM" on the Nasdaq Capital Market, with a new CUSIP number 74449F308. The consolidation is part of the Company's plan to regain compliance with the minimum bid price requirement of Nasdaq Listing Rule 5450(a)(1) (the "Nasdaq Rule 5450") for continued listing on The Nasdaq Capital Market. At the effective time of the consolidation, every 7.97 issued and outstanding shares of the Company will automatically be combined into one issued and outstanding common share. The number of shares and the exercise price of the Company's outstanding warrants and other equity instruments will also be adjusted proportionately in accordance with their respective terms. As of May 1, 2025, the Company had 4,648,610 common shares issued and outstanding. As a result of the consolidation, the Company will have 583,263 common shares issued and outstanding. No fractional shares will be issued in connection with the consolidation. Any fractional share resulting from the consolidation will be rounded down to the nearest whole share if the fraction is less than one-half of a share and rounded up to the nearest whole share if the fraction is at least one-half of a share. The consolidation affects all shareholders uniformly and will not alter any shareholder's percentage interest in the Company, except for minor adjustments resulting from the treatment of fractional shares. The share consolidation occurs at the registered shareholder level. Shareholders who hold their common shares through brokers, banks, or other nominees (i.e., in 'street name') are considered beneficial holders and may experience a delay in the reflection of the consolidation in their accounts, depending on the procedures of their broker, bank, or nominee. Continental Stock Transfer & Trust Company is acting as the exchange agent and transfer agent for the consolidation. Shareholders holding their shares in book-entry form or through brokerage accounts are not required to take any action. Beneficial holders are encouraged to contact their broker, bank, or custodian with any questions regarding the effect of the share consolidation. About Psyence BioMed: Psyence BioMed aims to be one of the few multi-asset, vertically integrated biopharmaceutical companies specializing in psychedelic-based therapeutics. It is the first life sciences biotechnology company focused on developing nature-derived (non-synthetic) psilocybin-based psychedelic medicine to be listed on Nasdaq. Psyence is dedicated to addressing unmet mental health needs, particularly in palliative care. The name 'Psyence' merges 'psychedelics' and 'science,' reflecting the company's commitment to an evidence-based approach in developing safe, effective, and FDA-approved nature-derived psychedelic treatments for a broad range of mental health disorders. Learn more at and on LinkedIn. Contact Information for Psyence Biomedical Ltd. Email: ir@ Inquiries: media@ Information: info@ +1 416-477-1708 Investor Contact:Michael KyddInvestor Relations Advisormichael@ Forward-Looking Statements This communication contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may relate to future financial and operating results, plans, objectives, expectations, and intentions regarding future operations, products, services, and other matters. Words such as "expects," "will," "intends," "believes," "plans," "anticipates," "projects," "targets," and similar expressions are intended to identify forward-looking statements. Forward-looking statements in this communication include statements regarding the timing and implementation of the share consolidation, the continued listing of the Company's securities on Nasdaq, and the anticipated impact of the consolidation. These statements are based on current assumptions and expectations, including that the share consolidation will be completed without delay, and that the Company will continue to meet Nasdaq's ongoing listing standards. There are numerous risks and uncertainties that may cause actual results or performance to differ materially from those expressed or implied in these forward-looking statements, including, but not limited to: (i) delays or challenges in completing the share consolidation; (ii) the Company's ability to maintain compliance with Nasdaq's continued listing standards; (iii) potential volatility in the Company's share price following the consolidation; (iv) changes in the regulatory, competitive, and economic landscape; and (v) risks associated with the Company's development plans and clinical trials. These and other important risks and uncertainties are described in the "Risk Factors" section of the Company's final prospectus (File No. 333-284444), filed with the U.S. Securities and Exchange Commission on January 24, 2025, and in other documents filed by the Company from time to time with the SEC. Actual results and future events could differ materially from those anticipated in such statements. Readers are cautioned not to 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 undertake any obligation to update or revise forward-looking statements. The Company does not make any medical, treatment, or health benefit claims regarding its proposed products. The U.S. Food and Drug Administration, Health Canada, or similar regulatory bodies have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic or nutraceutical products. The efficacy of such products has not been confirmed by authorized clinical research. There is no assurance that the use of such compounds can diagnose, treat, cure, or prevent any disease or condition. Clinical trials and regulatory approvals are required and, if not obtained, may have a material adverse impact on the Company's business. To view the source version of this press release, please visit Sign in to access your portfolio
Yahoo
17-04-2025
- Business
- Yahoo
Psyence BioMed Receives Nasdaq Notification Regarding Minimum Bid Price Deficiency
New York, New York--(Newsfile Corp. - April 17, 2025) - Psyence Biomedical Ltd. (NASDAQ: PBM) ("Psyence BioMed" or the "Company") announced today that it received a notification letter dated April 16, 2025, from the Listings Qualifications Department (the "Staff") of the Nasdaq Stock Market LLC ("Nasdaq") indicating that the Company is not in compliance with Nasdaq Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum bid price of $1.00 per share (the "Minimum Bid Price Rule"). The Staff's determination is based on the closing bid price of the Company's common shares being below $1.00 for 30 consecutive business days from March 5, 2025 through April 15, 2025. As previously disclosed, on December 20, 2024, a Nasdaq Hearings Panel granted the Company a one-year monitoring period pursuant to Nasdaq Listing Rule 5815(d)(4)(A) (the "Panel Monitor"). Under the terms of the Panel Monitor, any failure to meet continued listing requirements during the monitoring period results in a Staff Delisting Determination without the ability to submit a plan of compliance or receive an additional cure period under Rule 5810(c). Accordingly, the April 16, 2025 letter constitutes a Staff Delisting Determination. The Company intends to appeal this determination and request a hearing before a Nasdaq Hearings Panel. Under Nasdaq rules, this request will stay the suspension of trading and the delisting of the Company's securities pending the outcome of the hearing and any extension the Hearings Panel provides. To support efforts to regain compliance with the Minimum Bid Price Rule the Company's shareholders, at a Special Meeting of Stockholders held on April 16, 2025, authorized a share consolidation (reverse stock split) at a ratio of up to 1-for-50 or a lesser amount at the discretion of the Company's Board of Directors. The Company's Board of Directors subsequently approved the final share consolidation ratio of 1-for-7.97. The reverse stock split is intended to increase the per-share trading price of the Company's common shares to satisfy Nasdaq's listing requirements. The Nasdaq notification has no immediate impact as the shares will continue to trade uninterrupted on Nasdaq under the ticker symbol "PBM." However, there can be no assurance that the Company will be successful in its appeal or regain compliance with the Nasdaq Listing Rules. As required, the Company submitted this press release to Nasdaq's MarketWatch Department in advance of its public dissemination, in compliance with Nasdaq's disclosure requirements for material news announcements. About Psyence BioMed: Psyence BioMed is one of the few multi-asset, vertically integrated biopharmaceutical companies specializing in psychedelic-based therapeutics. It is the first life sciences biotechnology company focused on developing nature-derived (non-synthetic) psilocybin-based psychedelic medicine to be listed on Nasdaq. Psyence is dedicated to addressing unmet mental health needs, particularly in palliative care. The name 'Psyence' merges 'psychedelics' and 'science,' reflecting the company's commitment to an evidence-based approach in developing safe, effective, and FDA-approved nature-derived psychedelic treatments for a broad range of mental health disorders. Learn more at and on LinkedIn. Contact Information for Psyence Biomedical ir@ Media Inquiries: media@ General Information: info@ Phone: +1 416-477-1708 Investor Contact:Michael Kydd Investor Relations Advisormichael@ Forward-Looking Statements This communication contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may relate to future financial and operating results, plans, objectives, expectations, and intentions regarding future operations, products, services, and other matters. Words such as "expects," "will," "intends," "believes," "plans," "anticipates," "projects," "targets," and similar expressions are intended to identify forward-looking statements. Forward-looking statements in this communication include statements regarding the timing and implementation of the share consolidation, the continued listing of the Company's securities on Nasdaq, and the anticipated impact of the consolidation. These statements are based on current assumptions and expectations, including that the share consolidation will be completed without delay, our appeal to the Nasdaq Hearing Panel will be successful, the immediate impacts on our common shares, if any, and that the Company will continue to meet Nasdaq's ongoing listing standards. There are numerous risks and uncertainties that may cause actual results or performance to differ materially from those expressed or implied in these forward-looking statements, including, but not limited to: (i) delays or challenges in completing the share consolidation; (ii) the Company's ability to maintain compliance with Nasdaq's continued listing standards; (iii) potential volatility in the Company's share price following the consolidation; (iv) changes in the regulatory, competitive, and economic landscape; and (v) risks associated with the Company's development plans and clinical trials. These and other important risks and uncertainties are described in the "Risk Factors" section of the Company's final prospectus (File No. 333-284444), filed with the U.S. Securities and Exchange Commission on January 24, 2025, and in other documents filed by the Company from time to time with the SEC. Actual results and future events could differ materially from those anticipated in such statements. Readers are cautioned not to 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 undertake any obligation to update or revise forward-looking statements. The Company does not make any medical, treatment, or health benefit claims regarding its proposed products. The U.S. Food and Drug Administration, Health Canada, or similar regulatory bodies have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic or nutraceutical products. The efficacy of such products has not been confirmed by authorized clinical research. There is no assurance that the use of such compounds can diagnose, treat, cure, or prevent any disease or condition. Clinical trials and regulatory approvals are required and, if not obtained, may have a material adverse impact on the Company's business. To view the source version of this press release, please visit
Yahoo
15-04-2025
- Business
- Yahoo
Psyence BioMed Announces USD$500,000 Follow-On Investment in PsyLabs and Global Ibogaine Supply Agreement
New York, New York--(Newsfile Corp. - April 15, 2025) - Psyence Biomedical Ltd. (NASDAQ: PBM) ("Psyence BioMed" or the "Company") today announced a strategic follow-on investment of USD $500,000 into PsyLabs, a privately-held company specializing in the production of psychedelic active pharmaceutical ingredients (APIs) and extracts for research, clinical trials, and drug development. This follow-on investment underscores Psyence BioMed's commitment to building a vertically integrated, multi-asset psychedelics biotech platform with robust supply chain security and clinical development capabilities. This new capital investment builds on the exclusive, royalty-bearing IP licensing agreement formalized between the two companies in September 2024, following an initial investment where Psyence BioMed acquired an 11.13% equity stake in PsyLabs. Under the terms of that agreement, PsyLabs supplies Psyence BioMed with pharmaceutical-grade, EU-GMP, nature-derived (non-synthetic) psilocybin for use in future clinical trials and eventual commercialization in substance use disorders (SUD). In parallel with this financial commitment, Psyence BioMed has secured an exclusive right of first refusal in respect of the worldwide supply of pharmaceutical-grade, nature-derived Ibogaine. Under this agreement, PsyLabs will grant Psyence BioMed a right of first refusal to acquire the exclusive rights to a dedicated supply of Ibogaine for evaluation in the treatment of SUD, including Alcohol Use Disorder (AUD). This exclusive partnership further strengthens Psyence BioMed's integrated development strategy, ensuring access to high-quality psychedelic compounds to support its growing clinical pipeline and diversification into multiple therapeutic areas. Ibogaine, a naturally occurring psychoactive substance derived from the Tabernanthe iboga plant, has shown promise in early-stage research for its unique ability to interrupt SUDs, offering a novel approach to addiction treatment. Existing treatment options for SUDs and AUD remain limited in effectiveness, highlighting the urgent need for new solutions. "We are thrilled to strengthen our partnership with PsyLabs through both our financial investment and this opportunity to acquire exclusive Ibogaine supply rights," said Dr. Neil Maresky, CEO of Psyence BioMed. "Ibogaine holds significant potential as part of a new wave of therapeutics targeting some of the most challenging conditions in mental health. With this agreement, we are well positioned to accelerate our research efforts and bring much-needed innovation to patients worldwide." Tony Budden, Chief Executive Officer at PsyLabs, added: "This expanded collaboration with Psyence BioMed reflects our shared vision for advancing the science and development of nature-derived psychedelic medicines. By combining our manufacturing expertise with Psyence BioMed's clinical development capabilities, we are creating a powerful platform to explore the full potential of Ibogaine and psilocybin in addressing addiction and mental health disorders." Additional details about PsyLabs are available at An overview of the company's operations and manufacturing capabilities can be viewed in this video. These strategic initiatives and investments align with Psyence BioMed's vision to develop a diversified pipeline of psychedelic-based therapeutics supported by strong supply chain partnerships and proprietary intellectual property, as the Company advances toward becoming a leading, vertically integrated psychedelic biotech company. The follow-on investment shall be subject to the conclusion of a definitive right of first refusal agreement between the parties based on the salient terms already reduced to writing and other customary closing and suspensive conditions, including regulatory approvals (if any). About Psyence BioMed: Psyence BioMed is one of the few multi-asset, vertically integrated biopharmaceutical companies specializing in psychedelic-based therapeutics. It is the first life sciences biotechnology company focused on developing nature-derived (non-synthetic) psilocybin-based psychedelic medicine to be listed on Nasdaq. Psyence is dedicated to addressing unmet mental health needs, particularly in palliative care. The name 'Psyence' merges 'psychedelics' and 'science,' reflecting the company's commitment to an evidence-based approach in developing safe, effective, and FDA-approved nature-derived psychedelic treatments for a broad range of mental health disorders. Learn more at and on LinkedIn. About PsyLabs PsyLabs is a psychedelic Active Pharmaceutical Ingredient (API) development company, federally licensed to cultivate, extract, and export psilocybin mushrooms and other psychedelic compounds including psilocin, mescaline, ibogaine, and dimethyltryptamine (DMT) to legal medical and research markets. The company has successfully exported psilocybin products to Canada, the UK, Portugal, and Slovenia, and supplies purified extracts to its UK-based CMO partner. PsyLabs operates from an ISO 22000-certified facility audited by the British Standards Institution, ensuring the highest standards of safety and traceability. With a focus on natural compound purification, regulatory support, and global distribution, PsyLabs is expanding its product pipeline to include ibogaine and other next-generation Contact Information for Psyence Biomedical Ltd. Email: ir@ Media Inquiries: media@ General Information: info@ Phone: +1 416-477-1708 Investor Contact: Michael Kydd Investor Relations Advisor michael@ 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 acquisition of exclusive Ibogaine supply rights, the growing of Psyence BioMed's clinical pipeline, and the diversification of its therapeutic areas. These forward-looking statements are based on a number of assumptions, including the assumption that there will be no delays in the execution of a definition right of first refusal agreement, that Psyence BioMed shall exercise its exclusive Ibogaine supply acquisition rights, and that the demand for psychedelic-assisted therapy will include the use of Ibogaine. There can be no assurance that the Company will continue to maintain compliance with Nasdaq's continued listing requirements. 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 right of first refusal agreement; (ii) the ability of Psyence BioMed to maintain the listing of its common shares and warrants on Nasdaq; (iii) 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 Company's final prospectus (File No. 333-284444) filed with the Securities and Exchange Commission (the "SEC") on January 24, 2025 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 statements. 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 authorized clinical 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. To view the source version of this press release, please visit Sign in to access your portfolio
Yahoo
08-04-2025
- Business
- Yahoo
Psyence BioMed Signs LOI with Southern Star Research to Expand Phase IIb Clinical Trial in Australia
New partnership strengthens Psyence BioMed's global clinical trial capabilities, accelerating the development of psilocybin-assisted therapy for adjustment disorder New York, New York--(Newsfile Corp. - April 8, 2025) - Psyence BioMed (NASDAQ: PBM) ("Psyence BioMed" or the "Company") today announced the signing of a Letter of Intent (LOI) with Southern Star Research Pty Ltd, a premier Australian contract research organization (CRO). This collaboration will accelerate Psyence BioMed's ongoing Phase IIb psilocybin clinical trial in Australia, which focuses on adjustment disorder in patients diagnosed with cancer. Adjustment disorder ranks as the seventh most frequently diagnosed psychiatric condition globally, affecting millions of people who currently have no FDA-approved pharmaceutical treatment. The engagement of a new CRO represents a pivotal step in optimizing Psyence BioMed's clinical trial, enabling collaboration with a broader national oncology and mental health network to accelerate the Phase II clinical trial timeline. Southern Star Research's scale and capabilities will support the next phase of the Company's clinical development plan. Psyence BioMed thanks iNGENū CRO for their contribution to the protocol design, ethics approval and site activation. To ensure continuity and operational efficiency, Psyence BioMed is coordinating a seamless handover of trial management responsibilities to Southern Star Research as it moves forward with its clinical programs. "Southern Star Research's state-of-the-art operations, with its advanced infrastructure, national network within Oncology and Mental health, as well as in-depth knowledge of the Australian clinical trial environment will enhance patient recruitment and support efficient trial execution," said Dr. Neil Maresky, CEO of Psyence BioMed. "Their expertise and dedication to clinical excellence make them a strong partner in our mission to develop innovative therapies that address the urgent mental health needs of patients with adjustment disorder." Dr David Lloyd, Managing Director and Co-Founder of Southern Star Research, expressed enthusiasm for the collaboration, stating: "We are excited to collaborate with Psyence BioMed on the expansion of their Phase IIb clinical trial. This partnership represents a significant step in our long-term commitment to advancing novel psychedelic-assisted therapies for mental health conditions such as adjustment disorder, an area with an enormous unmet need. Our talented team is dedicated to supporting the development of pioneering treatments, and we look forward to contributing to the success of this important clinical trial and many more in the future." Psyence BioMed senior leadership will discuss the new agreement during the Company's corporate webinar on Thursday, April 10, 2025, at 12:00 PM EST. To register, please visit: About Southern Star Research Pty Ltd Southern Star Research Pty Ltd is an Australian full-service CRO specializing in providing clinical trial services for biotechnology and pharmaceutical companies. With a strong focus on quality and partnership. Southern Star Research is dedicated to advancing clinical research and helping bring innovative therapies to patients. About Psyence BioMed: Psyence Biomedical Ltd. (Nasdaq: PBM) is one of the few multi-asset, vertically integrated biopharmaceutical companies specializing in psychedelic-based therapeutics. It is the first life sciences biotechnology company focused on developing nature-derived (non-synthetic) psilocybin-based psychedelic medicine to be listed on Nasdaq. Psyence is dedicated to addressing unmet mental health needs, particularly in palliative care. The name 'Psyence' merges 'psychedelics' and 'science,' reflecting the company's commitment to an evidence-based approach in developing safe, effective, and FDA-approved nature-derived psychedelic treatments for a broad range of mental health disorders. Learn more at and on LinkedIn. Contact Information for Psyence Biomedical Ltd. Email: ir@ Media Inquiries: media@ General Information: info@ Phone: +1 416-477-1708 Investor Contact: Michael Kydd Investor Relations Advisor michael@ 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 handover and progress of the Phase IIb clinical trial, and trial execution under the newly engaged CRO. 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, topline data from this trial will be positive, and that the demand for psychedelic-assisted therapy will continue to increase. There can be no assurance that the Company will continue to maintain compliance with Nasdaq's continued listing requirements. 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 IIb trial; (ii) the ability of Psyence BioMed to maintain the listing of its common shares and warrants on Nasdaq; (iii) 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 Company's final prospectus (File No. 333-284444) filed with the Securities and Exchange Commission (the "SEC") on January 24, 2025 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 statements. 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 authorized clinical 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. To view the source version of this press release, please visit Sign in to access your portfolio
