Slide 1: Investor Presentation
Investor Presentation Nasdaq: PBM September 2024
Slide 2: Disclaimer
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 2 This presentation (“Presentation”) is being issued by Psyence Biomedical Ltd. (the “Company” or “Psyence”) for information purposes only. The content of this Presentation has not been approved by any securities regul
Slide 3: Forward-looking statements and industry data
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 3 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 Form 20-F filed with
Slide 4: Summary of risk factors
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 4 We are a clinical-stage biotechnology company and have incurred significant losses since our inception. We anticipate that we will incur significant losses for the foreseeable future. Psyence has a limited operating
Slide 5: Mission
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 5 MISSION To develop nature derived, psilocybin-based therapeutics to address unmet needs in the chronically underserved Palliative Care market.
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 Near-term value-driving catalysts, including initiation of Phase IIb trial in Australia, followed
Slide 7: Development Programs
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 7 Pre-clinical Phase I Phase II Phase III Projected Upcoming Milestones Adjustment Disorder First patient enrolled – Q4’24 Top line data – 2025 Second Indication Initiate Phase IIb pending additional funding Undisclose
Slide 8: Psychedelics Research is Gaining Acceptance and Momentum
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 8 Psychedelics Research is Gaining Acceptance and Momentum
Slide 9: Accelerating Psychedelics M&A and Growing Institutional Investor Interest
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 9 Accelerating Psychedelics M&A and Growing Institutional Investor Interest
Slide 10: Differentiated FDA Pathway
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 10 Differentiated FDA Pathway Differentiated FDA Pathway with benefits as defined by the Botanical Drug Guidance (2016): Combination of multiple active compounds Secondary compounds are part of the API Contrast to conv
Slide 11: Nature-Derived vs. Synthetic Psilocybin
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 11 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-Deri
Slide 12: Nature Derived Psilocybin May Be Demonstrably More Therapeutic than Synthetic
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 12 • 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 psiloc
Slide 13: What Palliative Care Is
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 13 *Source: https://www.nia.nih.gov/health/hospice-and-palliative-care/what-are-palliative-care-and-hospice-care Palliative Care is*: • Specialized medical care for people living with a life limiting illness, such as c
Slide 14: Adjustment Disorder (AjD)
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 14 *Source: https://www.nia.nih.gov/health/hospice-and-palliative-care/what-are-palliative-care-and-hospice-care Adjustment Disorder (AjD) 1. https://www.tandfonline.com/doi/full/10.1080/15622975.2018.1449967?src=recsy
Slide 15: The Global Palliative Care Market is Large with a Robust Projected CAGR
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 15 *Source: Global Psychedelic Therapeutics Market, 2022 (insightaceanalytic.com) Projected Global Palliative Care Market $28.6B with 9.4% CAGR (2030)* The Global Palliative Care Market is Large with a Robust Projected
Slide 16: Worldwide, 56.8 Million People Require Palliative Care
Source: https://www.who.int/news-room/fact-sheets/detail/palliative-care Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 16 34% of patients requiring palliative care – 19.3 million people – have received a serious cancer diagnosis According to the WHO, “The global n
Slide 17: Psilocybin-Assisted Psychotherapy (PAP)
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 17 *Brennan W and Belser AB (2022), Models of Psychedelic-Assisted Psychotherapy: A Contemporary Assessment and an Introduction to EMBARK, a Transdiagnostic,Trans-Drug Model. Front. Psychol. 13:866018. doi: 10.3389/fps
Slide 18: Prior Proof-of-Concept Studies Provide Strong Rationale for Upcoming Phase IIb
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 18 Prior Proof-of-Concept Studies Provide Strong Rationale for Upcoming Phase IIb At the 6-month follow-up, these changes were sustained, with about 80% of participants continuing to show clinically significant decreas
Slide 19: Clinical Trial Program Overview
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 19 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 psychoth
Slide 20: PEX010: Phase IIb Trial Design
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 20 Study Design: A randomized, double-blind, low-dose comparator-controlled Phase IIb study to investigate the efficacy and safety of psilocybin-assisted psychotherapy (PAP) with 25mg, 10mg and 1mg (low-dose comparator
Slide 21: Anticipated Developmental Pathway to Approval
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 21 FDA Pre-IND Feedback Received HREC approved Phase IIb study in Adjustment Disorder (announced March 6) First patient Randomised (Q4) Last patient Last visit for primary endpoint (Q4) Top Line Results Planned End of
Slide 22: Regulatory Protection and Intellectual Property
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 22 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 •
Slide 23: Transformational Merger with Newcourt Acquisition Corp.
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 23 Transformational Merger with Newcourt Acquisition Corp. 01 On January 25, 2024, Psyence Biomed completed its merger with Newcourt Acquisition Corp. and on January 26, 2024, it commenced trading on the Nasdaq exchang
Slide 24: Peer Comparables
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 24 Source: S&P CapitalIQ, Company Filings 1. Market data reflective as of the close on 8/27/2024, the valuations listed on this slide reflect valuations of certain companies operating in a similar field as Psyence. Ple
Slide 25: Psychedelics: Market Map
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 25 Synthetic Nature derived Psilocybin Other psychedelics Ayahuasca, Ibogaine Significant unexplored white space exists in the area of nature derived psilocybin Psychedelics: Market Map MDMA, Ketamine, LSD Psilocybin P
Slide 26: Management Team
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 26 Dr. Neil Maresky CEO Trained MD in Emergency Medicine and Family Practice VP Scientific Affairs AstraZeneca Canada Inc, Previously at Wyeth, Bayer 25+ years of experience leading Research and Development for Big Pha
Slide 27: Leadership and Board
Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 27 Dr. Neil Maresky CEO Trained MD in Emergency Medicine and Family Practice VP Scientific Affairs AstraZeneca Canada Inc, Previously at Wyeth, Bayer 25+ years of experience leading Research and Development for Big Pha
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 Near-term value-driving catalysts, including initiation of Phase IIb trial in Australia, followed