Full Press Release Details
Psyence Biomedical LTD Redefines Psychedelic
Medicine with a Multi-Asset Strategy, Advancing Clinical Trials and Scalable Manufacturing
Company executives will host a corporate webinar
for investors and stakeholders on
Thursday, April 10, 2025
Dear Shareholders and Future Investors:
At Psyence BioMed, we are truly grateful for the
ongoing support and trust of our shareholders. Your dedication to our vision drives our growth, and we're excited to share our latest
global achievements. We are committed to keeping you well-informed and engaged. As we embrace the exciting opportunities in the psychedelics
industry, we look forward to continuing this conversation together.
Creating a Multi-Asset Biotech Company:
Psyence BioMed is working toward becoming one
of the few vertically integrated biopharma companies focused on building a multi-asset biotech psychedelics platform that we believe enhances
our competitiveness and strengthens our position for future growth. With expertise in clinical research, scalable production, and global
supply, we are well-positioned to drive long-term value in the evolving psychedelics industry.
At the core of this strategy is our ongoing Phase
IIb clinical trial, which targets 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.
Conducted in Australia, this pioneering study
leverages the country's progressive regulatory framework, providing a swift and cost-effective setting for the development of psychedelic
therapies. Running our Phase IIb clinical trial in Australia gives us a significant advantage. The country's R&D Life Sciences
tax incentive provides a rebate of up to 43.5% on clinical trial costs, helping us reduce expenses, lower risk, and accelerate our path
to market. Australia's globally recognized research framework helps ensure our trial data is accepted by regulators such as the
FDA, streamlining U.S. commercialization. Additionally, with Australia having rescheduled psilocybin and MDMA two years ago, we're
positioned at the forefront of both clinical research and real-world evidence, as clinicians actively treat patients with these medicines.
Building on the advantages of our Phase IIb clinical
trial in Australia, we are further strengthening our position in the psychedelic therapeutics market through strategic partnerships.
Our exclusive royalty-bearing IP licensing agreement
with Psyence UK Group Ltd. ("PsyLabs"), an international psychedelic Active Pharmaceutical Ingredient (API) development company
with a facility that is federally licensed to cultivate and export psychedelic compounds to the legal medical and research markets, may
support long-term access to EU-GMP certified ingredients. This partnership strengthens our position in the growing psychedelic therapeutics
market by securing access to a federally licensed ISO accredited facility for the cultivation and export of psychedelic compounds
including psilocin, mescaline, ibogaine, and dimethyltryptamine (DMT). PsyLabs' long-term vision to become the leading supplier
of naturally derived pharmaceutical-grade ingredients, with a diverse development pipeline, aligns with our goal of meeting increasing
market demand for safe, regulated, and effective psychedelic-assisted therapies for patients across the world.
Investing in World-Class Scientific Leadership
A strong foundation of scientific expertise is
critical to our mission to revolutionize mental health care. With the establishment of a world-class Scientific Advisory Board (SAB),
our research, clinical development, and regulatory strategies are guided by some of the most respected minds in psychedelic medicine and
guides us along the path toward developing groundbreaking treatments for underserved conditions.
One of our most significant achievements is the
recent recruitment of Dr. Dan Stein, a recognized leader in the field of psychopharmacology. Dr. Stein joins a Scientific Advisory Board
led by chair Dr. Al Garcia-Romeu, a founder of the Johns Hopkins Center for Psychedelic and Consciousness Research - the world's
largest psychedelic science research center - which he serves as associate director and professor. Dr. Garcia-Romeu's internationally
recognized scientific rigor and credibility informs Psyence BioMed's evidence-based approach to psychedelic medicine.
Psyence BioMed's thought leadership in the
psychedelic medicine research sector contributes significantly to our work to advance our ongoing clinical research and regulatory approvals,
and ensures our pharmaceutical candidates meet the highest standards of safety, efficacy, and innovation.
Strategic Growth and Clinical Expansion
As we continue to strengthen our scientific leadership,
we are also making strategic moves to enhance our clinical trial capabilities.
We are in the process of assembling a steering
committee to launch our clinical trial in Alcohol Use Disorder (AUD) and other Substance Use Disorders (SUD), Psyence BioMed's second
development indication. AUD is responsible for around 2.6 million deaths globally each year, with 1.6 million attributed to noncommunicable
diseases, 700,000 to injuries, and 300,000 to communicable diseases. Men account for the majority of alcohol-related deaths, with 2 million
compared to 600,000 in women. Approximately 400 million people, or 7% of the global population aged 15 and older, live with alcohol use
disorders, with 209 million experiencing alcohol dependence (World Health Organization). This trial is a step toward helping address significant
unmet medical needs in this area. As we enter the early stages of this research, the steering committee will provide strategic guidance,
ensuring our study design aligns with regulatory requirements and industry best practices. At the same time, we are refining our broader
approach to maximize the impact of our psychedelic-based therapeutics.
Strengthening Financial Position to Maximize
With no debt, a strong cash position and two strategic,
low-cost financing mechanisms in place, we are well-positioned to execute our long-term vision while trading at an attractive valuation
relative to our assets. Our financial strength enables us to advance key initiatives, including our clinical trials, manufacturing capabilities,
and global expansion, without compromising stability.
We remain committed to building a resilient, multi-asset
biotech company with solid fundamentals designed to withstand market fluctuations. For investors with a disciplined, long-term outlook,
this presents a compelling opportunity to be part of a company positioned for future growth.
To maintain financial flexibility, we believe
we have structured our financing to ensure both stability and strategic adaptability. Our access to At-the-Market (ATM) financing and
an Equity Line of Credit (ELOC) allows us to raise capital efficiently, ensuring that our clinical and manufacturing initiatives progress
without undue financial strain. Additionally, we are carefully monitoring operational expenditure, ensuring that capital is allocated
effectively and sustainably to maximize shareholder value. By balancing growth investments with prudent financial management, we are positioned
to create sustainable long-term value while driving innovation in the psychedelic therapeutics market.
We believe that the recent Forbes report highlighting
the projected $3.3 billion growth of the psychedelic mushroom market by 2031 underscores the immense potential of the industry, and Psyence
BioMed is well-positioned to capitalize on this opportunity. Further, a November 2024 study from Emory University highlighted the national
need for therapies featuring psilocybin, indicating that psilocybin-assisted therapy could benefit over 5 million individuals in the U.S.
alone. Fueled by the rising demand for psychedelic-assisted therapy, evolving regulations, and increasing awareness of its therapeutic
benefits, we are expanding our clinical trial capabilities in Australia while reinforcing our financial foundation to address this growing
need. Through a focused approach on our assets and a clear strategic vision, we remain dedicated to delivering value to both patients
Our ongoing progress is a testament to the trust
and support of our shareholders, who are integral to our mission of transforming mental health care through psychedelic-assisted therapies.
As we continue to execute our strategic roadmap, we are excited to keep you updated on the positive impact we're making in this rapidly
As part of our commitment to strengthening engagement
with our shareholders, we are excited to announce a corporate webinar with our executive team on Thursday, April 10, 2025, at 12:00 PM
EST. This session will offer investors and stakeholders a unique opportunity to connect directly with Psyence BioMed's leadership,
ask questions, and gain valuable insights into our ongoing clinical research and future initiatives. Our executive team will also share
our broader vision for the future of psychedelic therapeutics. We encourage all investors and stakeholders to join us for this informative
and interactive discussion.
Please register at: https://psyencebiomed.com/corporate-webinar_april2025/
About Psyence BioMed:
Psyence Biomedical Ltd. (Nasdaq: PBM) is one of
the few 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 www.psyencebiomed.com and
Contact Information for Psyence Biomedical Ltd.