Slide 1: Investor Presentation
Investor Presentation Nasdaq: PBM September 2024
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation (“Presentation”) is being issued by Psyence Biomedical Ltd. (the “Company” or “Psyence ”) for identified by words such as “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimated,” “believe,” information purposes only. The co
Slide 3: Forward Looking Statements
Forward Looking Statements The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other Industry and Market Data risks and uncertainties described in the “Risk Factors” section of the Company’s Form 20-F filed with the Securities and Exchange Com
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 we could face substantial enforcement actions, including civil and criminal penalties and our business, operations anticipate that we will incur sign
Slide 5: Mission
MISSION To develop nature derived, psilocybin-based therapeutics to address unmet needs in the chronically underserved Palliative Care market. Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 5
Slide 6: Company Highlights
Company Highlights Phase IIb-ready asset, 25mg psilocybin in conjunction with proprietary psychotherapy, to be evaluated for Adjustment Disorder in life-limiting illnesses in the Palliative Care context Leveraging benefits of nature-derived psilocybin, including potential synergistic effects of simi
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 Top line data – 2025 Initiate Phase IIb pending Second Indication additional funding Undisclosed Evaluation of pre-clinical CNS indication dat
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 methods of extraction and standardization that may preserve the benefits of nature derived psilocybin with consistent potency that is ideally suited for therapeutic uses. Nature Derived Synthetic Contain secondary al
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 (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 15: 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 $18.2B* Projected Global Palliative Care Market $28.6B with 9.4% CAGR (2030)* Cancer Cancer = 37% of Total PC Market $10.4B* *Source: Global Psychedelic Therapeutics Market, 2022 (insightaceanalytic.com) Psyence Bi
Slide 16: 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 17: 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 Psilocybin Assisted Psychotherapy (usually 6-8 weeks in total) Ongoing psychotherapy or Intention Integration r
Slide 18: 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 19: 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 20: 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 21: Anticipated Developmental Pathway to Approval
Anticipated Developmental Pathway to Approval1 3 5 7 First patient FDA Pre-IND Feedback Randomised Top Line FDA IND for PhIII Received (Q4) Results registrational trials Q2 2023 Q1 2024 H2 2024 H2 2025 H1 2026 HREC approved Phase IIb Last patient Last visit Planned End of Phase II/Type C study in Ad
Slide 22: Psyence's Intellectual Property within Drug development
Psyence’s Intellectual Property within Drug development Regulatory Protection Data and Marketing Exclusivity (upon approval, not yet received): • First indication with Investigational Product will be granted protection from any generic entry for periods up to 10 years • Upon approval, US FDA grants
Slide 23: Transformational Merger with Newcourt Acquisition Corp.
Transformational Merger with Newcourt Acquisition Corp. On January 25, 2024, Psyence Biomed completed its merger with 01 Newcourt Acquisition Corp. and on January 26, 2024, it commenced trading on the Nasdaq exchange, under the ticker “PBM.” In connection with the merger, Psyence Biomed entered into
Slide 24: Select Publicly-Traded Clinical Stage Psychedelic Comparable Company Descriptions
Select Publicly-Traded Clinical Stage Psychedelic Comparable Company Descriptions (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 R
Slide 25: Psychedelics: Market Map
Psychedelics: Market Map 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
Slide 26: 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 27: 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 28: Company Highlights
Company Highlights Phase IIb-ready asset, 25mg psilocybin in conjunction with proprietary psychotherapy, to be evaluated for Adjustment Disorder in life-limiting illnesses in the Palliative Care context Leveraging benefits of nature-derived psilocybin, including potential synergistic effects of simi