Psyence Biomedical Ltd. · NASDAQ:PBM
Psyence Biomedical — Investor Presentation (November 2024)
33 slides from Psyence Biomedical's investor presentation, November 2024
Slide 1: Investor Presentation
Investor Presentation Nasdaq: PBM November 2024
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation (“Presentation”) is being issued by Psyence Biomedical Ltd. (the “Company” or “Psyence”) for patients. These forward-looking statements are based on a number of assumptions, including the assumptions that information purposes only. The content of this Pre
Slide 3: Forward Looking Statements: Industry and Market Data
Forward Looking Statements Industry and Market Data This Presentation has been prepared by Psyence and includes market data and other statistical information from third-party sources. Although Psyence believes these third-party sources are reliable as of their respective dates, neither Psyence, nor
Slide 4: Risk Factors Relating to Psyence’s Business
Risk Factors Relating to Psyence’s Business We are a clinical-stage biotechnology company and have incurred significant losses since our inception. We The results of clinical trials are open to differing interpretations. Psyence may be subject to federal, state and anticipate that we will incur sign
Slide 5: Mission
MISSION To develop nature derived, psilocybin-based therapeutics to address the unmet mental health needs of palliative care and addiction Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 5
Slide 6: Company Highlights
Company Highlights Phase IIb program, 25mg psilocybin in conjunction with proprietary psychotherapy, being evaluated for Adjustment Disorder in cancer in the Palliative Care context Leveraging benefits of nature-derived psilocybin, including potential synergistic effects of similar acting molecules
Slide 7: Psilocybin 25mg Development Programs
Psilocybin 25mg Development Programs Projected Upcoming Pre-clinical Phase I Phase II Phase III Milestones First patient enrolled – Q4’24 Adjustment Disorder Phase IIb Top line data – 2025 Alcohol Use Disorder/ Initiate Phase IIb pending Substance Use Protocol in Development additional funding Disor
Slide 8: Psychedelics Research is Gaining Acceptance and Momentum
Psychedelics Research is Gaining Acceptance and Momentum Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 8
Slide 9: Accelerating Psychedelics M&A and Growing Institutional Investor Interest
Accelerating Psychedelics M&A and Growing Institutional Investor Interest Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 9
Slide 10: Advantages of the Development of Botanical Drugs
Advantages of the Development of Botanical Drugs Differentiated FDA Intellectual Shorter Clinical Efficacy and Consumer Pathway property Development Preference Differentiated FDA Pathway Intellectual property Shorter track through Clinical Entourage effect of multiple active with benefits as defined
Slide 11: Nature-Derived Psilocybin vs. Synthetic Psilocybin
Nature-Derived Psilocybin vs. Synthetic Psilocybin Psyence has licensed proprietary, patent-protected methods of extraction and standardization that may preserve the benefits of nature derived psilocybin with consistent potency ideally suited for therapeutic uses. Nature Derived Synthetic Contain se
Slide 12: Nature Derived Psilocybin May Be Demonstrably More Therapeutic than Synthetic
Nature Derived Psilocybin May Be Demonstrably More Therapeutic than Synthetic • A recent paper published in Molecular Psychiatry details results of a preclinical study comparing the biological effects of nature derived psilocybin versus synthetic. • Findings suggest that nature derived psilocybin ha
Slide 13: Palliative Care is NOT End-of-Life (Hospice) Care
Palliative Care is*: Palliative Care is NOT • Specialized medical care for people living with a life limiting End-of-Life (Hospice) illness, such as cancer or heart failure. Care • Patients in Palliative Care may continue to receive treatment In Palliative Care, a person does as well as care intende
Slide 14: Adjustment Disorder
Adjustment Disorder Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 14
Slide 15: Adjustment Disorder (AjD)
Adjustment Disorder (AjD) A global survey of psychiatrists by the WHO revealed1: • AjD plays an enormous role in healthcare utilization • AjD ranked 7th among 44 psychiatric categories2 they managed at least once a week in their practice • A second global survey of clinical psychiatrists ranked AjD
Slide 16: The Global Palliative Care Market is Large with a Robust Projected CAGR
The Global Palliative Care Market is Large with a Robust Projected CAGR Other Disease $14.7B* Projected Global Palliative Care Market $23.3B with 9.1% CAGR (2032)* Cancer Cancer = ~37% of Total PC Market $8.6B* *Source: https://www.globenewswire.com/news-release/2024/10/15/2963268/0/en/Palliative-Ca
Slide 17: WHO Study: Worldwide, 56.8 Million People Require Palliative Care
WHO Study: Worldwide, 56.8 Million People Require Palliative Care Patients Requiring Palliative Care, Globally (millions) 34% of patients requiring palliative care – 19.3 million people – have received a serious 3.9 cancer diagnosis 2 3.2 According to the WHO, “The 5.9 21.9 global need for palliativ
Slide 18: Patient Safety and Efficacy Enhanced by Psilocybin-Assisted Psychotherapy (PAP)
Patient Safety and Efficacy Enhanced by Psilocybin-Assisted Psychotherapy (PAP) Introduction to Psychedelic session with Integration therapist and process therapist for 6-8 hours session 2 PsilocybinPsilocybin Assisted Psychotherapy (usually(usually Assisted Psychotherapy 6-8 weeks in total) 6-8 wee
Slide 19: Prior Proof-of-Concept Studies Provide Strong Rationale for Upcoming Phase IIb
Prior Proof-of-Concept Studies Provide Strong Rationale for Upcoming Phase IIb At the 6-month follow-up, these changes were At the 6.5-month follow-up, psilocybin was sustained, with about 80% of participants associated with enduring anxiolytic and continuing to show clinically significant antidepre
Slide 20: PEX010: Australia Clinical Trial Phase IIb
PEX010: Australia Clinical Trial Phase IIb Psyence’s clinical trial program is focused on assessing the safety and efficacy of psilocybin-assisted psychotherapy for the treatment of Adjustment Disorder* due to a life-limiting cancer diagnosis versus psychotherapy alone in the Palliative Care context
Slide 21: PEX010: Phase IIb Trial Design
PEX010: Phase IIb Trial Design Study Design: Cohort 1 Cohort 2 Cohort 3 A randomized, double-blind, low-dose comparator- 25mg PEX010 10mg PEX010 1mg PEX010 controlled Phase IIb study to investigate the efficacy and 29 subjects 29 subjects 29 subjects safety of psilocybin-assisted psychotherapy (PAP)
Slide 22: Anticipated Developmental Pathway to Approval
Anticipated Developmental Pathway to Approval1 5 7 FDA Pre-IND Feedback Two trial sites Last patient Last visit Planned End of Phase II/Type C Received selected for primary endpoint meeting with FDA Q2 2023 Q1 2024 Q3 2024 Q4 2024 H2 2025 H1 2026 HREC approved Phase IIb First patient Top Line FDA IN
Slide 23: Alcohol Use Disorder (AUD) and Other Substance Use Disorders (SUDs)
Alcohol Use Disorder (AUD) and Other Substance Use Disorders (SUDs) Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 23
Slide 24: AUD and Other SUDs: A Significant Burden to Society (US)
AUD and Other SUDs: A Significant Burden to Society (US)1 21.8 million Alcohol Use Disorder 15.6 million 44.4 million Drug Use Disorder People in the U.S. aged 18 or older had an alcohol or substance 7.0 million use disorder in 2022 Alcohol & Drug Use Disorders In 2022, there were over 17,000 substa
Slide 25: Alcohol abuse and dependence have the widest treatment gap
Alcohol is a Leading Risk Factor in the Overall Disease Burden Globally1 80% of adults drink Alcohol abuse and 339M alcohol2 dependence have the widest treatment gap 15% of adults in these among all mental countries are “at risk” health disorders 50M of AUD3,4 Drug treatment Only 1% of drinkers effi
Slide 26: Prior Academic Studies Provide Strong Scientific Rationale for Continued Development of Psilocybin for SUDs
Prior Academic Studies Provide Strong Scientific Rationale for Continued Development of Psilocybin for SUDs 2022 2022 2023 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 26
Slide 27: A Vertically Integrated Psychedelic Biopharma Company
A Vertically Integrated Psychedelic Biopharma Company Strategic investment in PsyLabs transformed Worldwide exclusive licensing agreement with Psyence Biomed into a vertically integrated PsyLabs creates consistent supply of nature- developer of psilocybin-based therapeutics derived (non-synthetic) p
Slide 28: Psyence’s Intellectual Property within Drug development
Psyence’s Intellectual Property within Drug development Our intellectual property strategy is built around the following objectives: Ensuring that we have freedom to operate (free of infringing third party patents) to pursue our commercial objectives in our key markets • We conduct ongoing patent fr
Slide 29: Psyence Biomed Represents a Value Driven Opportunity Versus Peer Companies
Psyence Biomed Represents a Value Driven Opportunity Versus Peer Companies (1) Company Ticker Market Cap Business Descriptions GH Research PLC, a clinical-stage biopharmaceutical company, engages in developing various therapies to treat psychiatric and neurological disorders. The company GH Research
Slide 30: Significant Unexplored White Space Exists in the Area of Nature Derived Psilocybin
Significant Unexplored White Space Exists in the Area of Nature Derived Psilocybin Nature derived Ayahuasca, Ibogaine Psilocybin Other Psilocybin psychedelics MDMA, Ketamine, LSD Psilocybin Synthetic Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 30
Slide 31: Psyence Biomedical Ltd Management Team
Psyence Biomedical Ltd Management Team Proven Track Record in Innovation with Extensive Pharma Development Experience Dr. Neil Maresky Jody Aufrichtig Warwick Corden-Lloyd CEO Executive Chairman Chief Financial Officer Trained MD in Emergency Medicine and Family Practice Chartered Accountant (ex EY)
Slide 32: Psyence Biomed Board of Directors
Psyence Biomed Board of Directors Proven Track Record in Innovation with Extensive Operating Experience Dr. Neil Maresky Jody Aufrichtig Marc Balkin CEO Executive Chairman Board Member Trained MD in Emergency Medicine and Family Practice Chartered Accountant (ex EY) with 25 years private equity expe
Slide 33: Company Highlights
Company Highlights Phase IIb program, 25mg psilocybin in conjunction with proprietary psychotherapy, being evaluated for Adjustment Disorder in cancer in the Palliative Care context Leveraging benefits of nature-derived psilocybin, including potential synergistic effects of similar acting molecules
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