Pioneering the Next Generation of Targeted Psychoactive Medications TSXV: PSYB Safe Harbor Statement
The information contained in this presentation has been prepared by PsyBio Therapeutics Corp. and its affiliates (“PsyBio” or the “Company”) and contains confidential information pertaining to the business and operations of the Company. The information contained in this presentation: (a) is provided as at the date hereof, is subject to change without notice, and is based on publicly available information, internally developed data as well as third party information from other sources; (b) does not purport to contain all the information that may be necessary or desirable to fully and accurately evaluate an investment in the Company; (c) is not to be considered as a recommendation by the Company that any person make an investment in the Company; and (d) is for information purposes only and shall not constitute an offer to buy, sell, issue or subscribe for, or the solicitation of an offer to buy, sell or issue, or subscribe for any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Where any opinion or belief is expressed in this presentation, it is based on certain assumptions and limitations and is an expression of present opinion or belief only. The third party information has not been independently verified. While the Company may not have verified the third party information, it believes that it obtained the information from reliable sources and has no reason to believe it is not accurate in all material respects. No warranties or representations can be made as to the origin, validity, accuracy, completeness, currency or reliability of the information. PsyBio disclaims and excludes all liability (to the extent permitted by law), for losses, claims, damages, demands, costs and expenses of whatever nature arising in any way out of or in connection with the information in this presentation, its accuracy, completeness or by reason of reliance by any person on any of it. This presentation should not be construed as legal, financial or tax advice to any individual, as each individual’s circumstances are different. Readers should consult with their own professional advisors regarding their particular circumstances. In making an investment decision, investors should not rely solely on the information contained in this presentation.
This presentation does not contain all of the information that would normally appear in a prospectus under applicable Canadian securities laws. Neither the delivery of this presentation, at any time, nor any sale made pursuant to or in connection with this presentation, will imply that the information contained in the presentation is correct as of any time subsequent to the date set forth on the cover page of the presentation or the date at which such information is expressed to be stated, as applicable.
No securities commission, exchange or similar regulatory authority in Canada has reviewed or in any way passed upon the merits of this presentation, and any representation to the contrary is an offence.
CAUTIONARY NOTE TO UNITED STATES INVESTORS
The securities of the Company have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered and sold in the United States except pursuant to an exemption from the registration requirements of the U.S. Securities Act.
IN MAKING AN INVESTMENT DECISION, INVESTORS MUST RELY ON THEIR OWN EXAMINATION OF THE COMPANY AND THE TERMS OF THE OFFERING, INCLUDING THE MERITS AND RISKS INVOLVED. THE SECURITIES OF THE COMPANY HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND EXCHANGE COMMISSION OR BY ANY STATE SECURITIES COMMISSION OR REGULATORY AUTHORITY, NOR HAVE ANY OF THE FOREGOING AUTHORITIES PASSED ON THE ACCURACY OR ADEQUACY OF THIS PRESENTATION. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
Any securities of the Company sold in the United States will be “restricted securities” within the meaning of Rule 144 under the U.S. Securities Act. Such securities may be resold, pledged or otherwise transferred only pursuant to an effective registration statement under the U.S. Securities Act or pursuant to an applicable exemption from the registration requirements of the U.S. Securities Act.
Readers should be aware that the acquisition, holding or disposition of the securities described herein may have tax consequences both in Canada and the United States. The tax consequences of the acquisition, holding or disposition of such securities for investors who are resident in, or citizens of, the United States are not described herein. Consequently, any prospective investor is advised to consult their own tax advisors regarding the application of federal income tax laws to their particular circumstances, as well as any state, provincial, local, foreign and other tax consequences of investing in the securities described herein and acquiring, holding or disposing of such securities. Investing in the securities described herein involves risks. An investment in the securities is suitable only for investors who fully understand, and are capable of bearing, the risks of such investment. Prospective investors should review and consider carefully the information disclosed in the this presentation, including the “Risk Factors” described herein.
FORWARD LOOKING INFORMATION
Certain information set forth in this presentation, together with any supplements and any other information that may be furnished to prospective investors by the Company in connection therewith, contains “forward-looking statements” and “forward-looking information” within the meaning of applicable Canadian securities legislation (referred to herein as forward-looking statements). Except for statements of historical fact, certain information contained herein constitutes forward-looking statements which include but are not limited to statements related to activities, events or developments that PsyBio expects or anticipates will or may occur in the future, statements related to the Company’s business strategy objectives and goals, and management’s assessment of future plans and operations which are based on current internal expectations, estimates, projections, assumptions and beliefs, which may prove to be incorrect. Forward-looking statements can often be identified by the use of words such as “may”, “will”, “could”, “would”, “anticipate”, ‘believe”, expect”, “intend”, “potential”, “estimate”, “budget”, “scheduled”, “plans”, “planned”, “forecasts”, “goals” and similar expressions or the negatives thereof. Forward-looking statements are neither historical facts nor assurances of future performance. Forward-looking statements are based on a number of factors and assumptions made by management and considered reasonable at the time such information is provided, and forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements
Risk Factors that could cause actual results, performance or achievement to differ materially from those indicated in the forward-looking statements include, but are not limited to the following: the timing and unpredictability of regulatory actions; regulatory, legislative, legal or other developments with respect to its operations or business; limited marketing and sales capabilities; early stage of the industry and product development; limited products; reliance on third parties for clinical development activities; unfavourable publicity or consumer perception; general economic conditions and financial markets; the impact of increasing competition; the loss of key management personnel; capital requirements and liquidity; access to capital; the timing and amount of capital expenditures; the impact of the COVID-19 pandemic; the demand for the Company’s products and the size of the market; patent law reform; patent litigation and intellectual property; conflicts of interest; uninsurable risks; and litigation and other factors beyond the Company’s control. 2 2 Metabolic Engineering to Advance the Standard of Care
Evan M. Levine Dr. J. Andrew Jones Chairman and CEO Faculty Miami University and Inventor
Adams AM, Kaplan NA, Wei Z, Brinton JD, Monnier CS, “In vivo production of psilocybin in E. coli.” Enacopol AL, Ramelot TA, and Jones JA. Metabolic Engineering 56 (2019): 111-119
Adams AM, Kaplan NA, Wei Z, Brinton JD, Monnier CS, Enacopol AL, Ramelot TA, and Jones JA. "In vivo production of psilocybin in E. coli.“ Metabolic Engineering 56 (2019): 111-119 3 Globally-Acclaimed Discovery
Dr. Jones (Inventor, Chairman of SAB) has been recognized as one of AIChE’s 35-Under-35 in 2020
4 Paradigm Shift for Treating Mental Illness and Neurological Disorders Preliminary results of psycholytic therapies are indisputable, and psilocybin research is leading the industry
Platform Technology Utilizing Metabolic Engineering and Optimization Techniques: Discovered an efficient, patent-pending bacterial 1 biosynthesis process for tryptamine production
Developing a portfolio of tryptamine derived, 2 inspired by psychedelically compounds
Demonstrated the entourage effect of certain 3 tryptamines in a laboratory-controlled environment
5 Cheaper. Faster. Greener. Proprietary.
6 Key Investment Highlights
• Building a portfolio of natural, • Patent-pending • Multiple shots on goal non-natural and combinations compositions and through optimization for therapeutic benefit methods to produce techniques
• Protected cost advantage • Pending IP in bacterial biosynthesis: • Clinical Trials targeted for in a resurging area of research 5 provisional patents & 1 full patent filed 2022 with psilocybin plus
• Highly experienced team • Well capitalized • Public on TSX-V with extensive discovery in an oversubscribed with dual listing and development raise plans experience
Cheaper. Faster. Greener. Proprietary.
7 PsyBio Focuses on Strong Pending IP in Bacterial Biosynthetics
Process Development Drug and Development Manufacturing Clinical Trials
8 Advantages Over Published Methods
PsyBio Bacterial Chemical Yeast Natural Production Synthesis Synthesis Synthesis
Space GMP Facility GMP Facility GMP Facility Farming Requirements
Environmental Toxic Catalysts, Solvents, Friendly Friendly Friendly Considerations and Reagents
Product Pharmaceutical Pharmaceutical Pharmaceutical 10-Fold Batch-to-Batch Consistency Grade Grade Grade Variation
High Rate of Product High Product Stability Multiple Unstable Reaction Prone to Degradation Degradation during Stability at Room Temperature Intermediates ‘bluing reaction’ Fermentation
Speed & 2 - 4 days 4 – 10 days Weeks to Months 5 – 15 days Simplicity 1 Pot Autocatalytic 1 Pot Autocatalytic Sensitive to Environmental Long Reaction Scheme of Production Process Process Conditions
9 Building a Portfolio of Therapeutics Candidates and Combinations
NMT DMT Undisclosed Natural Psilocybin TMT & Norbaeocystin Non-Natural Baeocystin Tryptamine Aeruginascin Derivatives
10 Pre-Clinical Trial: High Level Results of the “Entourage Effect”
Early Efficacy Indicators: Significant enhancement Targeted Treatment: Variation in hallucinogenic efficacy of head twitch response following receipt of both of Psilocybe mushrooms is likely due to variation in the psilocybin and norbaeocystin vs. psilocybin alone relative concentration of these compounds
Norbaeocystin Psilocybin Combined Preclinical Indicative Alone Alone Dose Efficacy
# Sig. diff. from 0.1 † Sig. diff. from 0.2 § Sig. diff. from 2 Symbol Legend Sig. diff. from Ctrl # Sig. diff. from Nor † Sig. diff. from Psil Symbol Legend Sig. diff. from 0 11 PsyBio’s Development Overview
Candidate Evaluation
Anxiolytic Efficacy Testing (SPS Paradigm)
Antidepressant Process Efficacy Testing Development Head Twitch and Tech New Drug Response Transfer Discovery (HTR) Testing
12 Intellectual Property
U.S. Provisional Patent Application 63/135,054 “Psychopharmacological Interactions Between U.S. PCT (Non-Provisional) Patent Application Tryptamines Present in Psilocybe Mushrooms” PCT/US2020/51543 “Methods for the Production of Psilocybin and Intermediates or Side Products” U.S. Provisional Patent Application (Claims priority to U.S. Provisional Patent Application 62/990,633 and U.S. Provisional Patent Application 62/926,875) 63/135,054 U.S. Provisional Patent Application 62/926,875 “Systems and Methods for Pharmaceutical Psilocybin and Norbaeocystin Production” “Methods for the Production of Psilocybin” U.S. Provisional Patent Application 62/990,633 U.S. Provisional Patent Application “Methods for the Production of Psilocybin and Intermediates Thereof” 63/144,044 “Pharmacological Interactions Between Tryptamines and Tryptamine Derivatives”
13 Clinical Development Plan
Q1 2021 Q2 2021 Q3 2021 Q4 2021 Q1 2022 Q2 2022
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun
IND SUBMISSION Pre-IND Meeting
IND Development
Pharmacology / Toxicology
PK / PD Studies
Tech Transfer
Prepare Non-Clinical Strain CMC Bank 1 2 3 4 5 Clinical Analytical Methods Regulatory
Baseline Fermentation Psilocybin Isolation Pilot-scale Fermentation Psilocybin Isolation 1 Fermentations 2 Optimization 3 Process Development 4 & Primary Recovery 5 & Purification Process Development
Abbreviations: TLF (Top line Tables, Listings, & Figures); I/A (Interim Analysis); OLE (Open Label Extension); EFD (embryo-fetal development); FPI (First Patient In); LPI (Last Patient In); 14 PoC (Proof of Concept); DR (Dose Ranging); NHV (Normal Healthy Volunteer); TQT (Thorough QT); DDI (Drug-Drug Interaction); FE (Food Effect); Pbo (Placebo); PK (Pharmacokinetics); Corporate Finance Accomplishments and Roadmap
Closed C$14.5 million equity financing in Q4 /2020 led by Eight Capital and Canaccord Genuity with significant institutional participation.
Listed February 25, 2021 on the Toronto Venture Exchange TSXV: PSYB
Current Cash: Shares Outstanding: ~ C$13,000,000 ~ 113 Million TSXV: PSYB Warrants and Options Outstanding: Insider Ownership: ~ 11 Million ~ 42%
15 Drug Development Team
Undisclosed Pharmacology and Toxicology
Managing Partner – Investor DeckInvestor Undisclosed FDA Advisor
Evan Levine —
Dr. J. Andrew Jones Dr. Matthew McMurray Dr. Joan Robbins Confidential Co-Founder, CEO Inventor and Chairman, Neuropsychopharmacology Translational Research Charity Abelardo and Director Scientific Advisory Board Regulatory Affairs Managing Partner – • Managing Partner at • PhD Chemical and Biological ▪ Assistant Professor – • President – Calypharma Essential Regulatory Brown Simpson Asset Engineering —RPI Miami University Consulting Solutions Management • Assistant Professor — ▪ PhD Psychology and • Chief Scientific Officer — • CEO of Adventrx Miami University Behavioral Neuroscience Adventrx Pharmaceuticals Pharmaceuticals Lisa Hulle Regulatory Affairs Managing Partner – Essential Regulatory Solutions
16 Industry Comparables
Industry players are developing a broad range of participation
Company Name Symbol Market Cap / Est. Valuation
ATAI Life Sciences n/a not disclosed DeckInvestor
COMPASS Pathways NASDAQ:CMPS $1.7B
— Confidential MindMed NEO:MMED $1.8B
Cybin Corp NEO:CYBN $218M
Numinis Wellness TSX-V:NUMI $287M
FieldTrip CSE:FTRPF $251M
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Investor DeckInvestor
— Confidential
Contact Evan Levine — CEO PsyBio Therapeutics Inc.
(513) 449-9585
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