Psyence Biomedical Ltd. · NASDAQ:PBM
Psyence Biomedical — Investor Presentation (November 2024)
33 slides from Psyence Biomedical's investor presentation, Nov 22, 2024
Slide 1: Investor Presentation November 2024
Investor Presentation Nasdaq: PBM November 2024
Slide 2: Disclaimer
2 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 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 r
Slide 3: Industry and Market Data; Forward Looking Statements
3 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 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 ar
Slide 4: Summary of risk factors
4 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 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 operat
Slide 5: Mission
5 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature MISSION To develop nature derived, psilocybin - based therapeutics to address the unmet mental health needs of palliative care and addiction
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 Near - term value - driving catalysts, including first patient randomized in Phase IIb trial in Australia (anticipated
Slide 7: Projected Upcoming Milestones
7 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature Projected Upcoming Milestones Phase III Phase II Phase I Pre - clinical First patient enrolled – Q4’24 Top line data – 2025 Adjustment Disorder Initiate Phase IIb pending additional funding Alcohol Use Disorder/ Subs
Slide 8: Psychedelics Research is Gaining Acceptance and Momentum
8 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature Psychedelics Research is Gaining Acceptance and Momentum
Slide 9: Accelerating Psychedelics M&A and Growing Institutional Investor Interest
9 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature Accelerating Psychedelics M&A and Growing Institutional Investor Interest
Slide 10: Differentiated FDA Pathway
10 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 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 Psilocybin vs. Synthetic Psilocybin
11 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 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.
Slide 12: Nature Derived Psilocybin May Be Demonstrably More Therapeutic than Synthetic
12 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature • 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: Palliative Care
13 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature *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
Slide 14: Adjustment Disorder
14 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature Adjustment Disorder
Slide 15: Adjustment Disorder (AjD)
15 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature *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/10.1080/15622975.20
Slide 16: Projected Global Palliative Care Market
16 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature *Source: https://www.globenewswire.com/news - release/2024/10/15/2963268/0/en/Palliative - Care - Market - Projected - to - Reach - USD - 23 - 34 - Billion - by - 2032 - Growing - at - a - 9 - 06 - CAGR - SNS - Insi
Slide 17: Worldwide, 56.8 Million People Require Palliative Care
17 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature Source: https://www.who.int/news - room/fact - sheets/detail/palliative - care 34% of patients requiring palliative care – 19.3 million people – have received a serious cancer diagnosis According to the WHO, “The gl
Slide 18: Psilocybin-Assisted Psychotherapy (PAP)
18 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature *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 : 10.338
Slide 19: Prior Proof-of-Concept Studies Provide Rationale for Phase IIb
19 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 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
Slide 20: Clinical Trial Program Overview
20 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 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 psyc
Slide 21: PEX010: Phase IIb Trial Design
21 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 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
Slide 22: Anticipated Developmental Pathway to Approval
22 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature FDA Pre - IND Feedback Received HREC approved Phase IIb study in Adjustment Disorder ( announced March 6 ) Two trial sites selected Last patient Last visit for primary endpoint Top Line Results Planned End of Phase
Slide 23: Alcohol Use Disorder (AUD) and Other Substance Use Disorders
23 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature Alcohol Use Disorder (AUD) and Other Substance Use Disorders (SUDs)
Slide 24: AUD and Other SUDs: A Significant Burden to Society
24 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature AUD and Other SUDs: A Significant Burden to Society (US) 1 44.4 million People in the U.S. aged 18 or older had an alcohol or substance use disorder in 2022 21.8 million Alcohol Use Disorder 15.6 million Drug Use Di
Slide 25: Alcohol is a Leading Risk Factor in Disease Burden
25 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature Alcohol is a Leading Risk Factor in the Overall Disease Burden Globally 1 339M 50M 3.4M 80% of adults drink alcohol 2 15% of adults in these countries are “at risk” of AUD 3,4 Only 1% of drinkers seek any form of dr
Slide 26: Prior Academic Studies Support Psilocybin for SUDs
26 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature Prior Academic Studies Provide Strong Scientific Rationale for Continued Development of Psilocybin for SUDs 2022 2022 2023
Slide 27: A Vertically Integrated Psychedelic Biopharma Company
27 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature A Vertically Integrated Psychedelic Biopharma Company Worldwide exclusive licensing agreement with PsyLabs creates consistent supply of nature - derived (non - synthetic) psilocybin for Psyence Biomed’s AUD clinical
Slide 28: Psyence's Intellectual Property within Drug Development
28 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 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 •
Slide 29: Psychedelics Peer Valuations
29 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature Source : S&P CapitalIQ , Company Filings 1. Market data valuations reflective as of the close on 11 / 1 / 2024 , the valuations listed on this slide reflect valuations of certain companies operating in a similar fie
Slide 30: Significant Unexplored White Space in Nature Derived Psilocybin
30 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature Synthetic Nature derived Psilocybin Other psychedelics Ayahuasca, Ibogaine Significant Unexplored White Space Exists in the Area of Nature Derived Psilocybin MDMA, Ketamine, LSD Psilocybin Psilocybin
Slide 31: Management Team
31 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 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 32: Board of Directors
32 Psyence Biomedical Ltd. / Healing Minds with Science . Changing Lives with Nature 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 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 Near - term value - driving catalysts, including first patient randomized in Phase IIb trial in Australia (anticipated
Psyence Biomedical — Investor Presentation (November 2024) on 6ix