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Corporate PresentationMarch 2020
Revive Therapeutics Ltd. | Office: 905-605-5535 | E-mail: [email protected]
Psychedelic and Cannabis
Life Sciences Company
FORWARD LOOKING STATEMENTS
Certain statements contained in this presentation constitute forward-looking information within the meaning of securities laws. Forward-looking information may relate to our future outlook and anticipated events or results and may include statements regarding our future financial position, business strategy, budgets, litigation, projected costs, capital expenditures, financial results, taxes and plans and objectives. In some cases, forward-looking information can be identified by terms such as “may”, “will”, “should”, “expect”, “plan”, “anticipate”, “believe”, “intend”, “estimate”, “predict”, “potential”, “continue” or other similar expressions concerning matters that are not historical facts. These statements are based on certain factors and assumptions regarding, among other things, expected growth, results of operations, performance, and business prospects and opportunities. While we consider these assumptions to be reasonable based oninformation currently available to us, they may prove to be incorrect. Forward looking-information is also subject to certain factors, including risks and uncertainties that could cause actual results to differ materially from what we currently expect. These factors include, among other things, the availability of funds and resources to pursue development projects, the successful and timely completion of clinical studies, and the ability to take advantage of business opportunities, the granting of necessary approvals by regulatory authorities, and general economic, market and business conditions. For more exhaustive information on these risks and uncertainties you should refer to our most recently filed Annual Information Form which is available at www.sedar.com. Forward-looking information contained in this presentation is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time.
REVIVE THERAPEUTICS
§ Emerging cannabis and psychedelic life sciences company
§ Developing novel cannabis and psychedelic based therapies to treat liver, inflammatory, and rare diseases
§ Robust cannabis and psychedelic based product portfolio targeting multi-billion market opportunities
§ Significantly undervalued compared to its peers
§ Unique opportunity to invest in the next evolution of the cannabis and psychedelic market
R&D of Psychedelics and Cannabinoids
Targeting Inflammation and Rare Diseases
Novel Uses, Formulations, and
Delivery System
Targeting FDA Designations:Orphan, Fast track,
Breakthrough therapy and Rare pediatric diseases
PHARMACEUTICAL STRATEGY
PATENT PORTFOLIOPsychedelic and Cannabis Based Patent Portfolio
Title USPTO No. Status
Cannabinoid Delivery SystemUS 8642088US 9545423US 10104888
Issued on February 4, 2014Issued on January 17, 2017Issued on October 23, 2018
Use of Cannabidiol in the Treatment of Autoimmune Hepatitis US 8242178 Issued on August 14, 2012
Psilocybin effervescent and psilocybin tablet - Solid Oral Pharmaceutical Compositions 62/985,052 Provisional patent filed
Psilocybin hard-shell capsules - Pharmaceutical Capsule Compositions 62/985,070 Provisional patent filed
Psilocybin gum drops - Pharmaceutical Gumdrop Compositions 62/985,084 Provisional patent filed
Psilocybin oral strips and transmucosal - Thin-Film Pharmaceutical Delivery System and Formulations 62/985,098 Provisional patent filed
Psilocybin - Pharmaceutical Formulations and Methods for Sublingual and Buccal Administration 62/984,590 Provisional patent filed
Methods for the Extraction and Crystallization of Psilocybin 62/985,360 Provisional patent filed
DELIVERY TECHNOLOGY
§ Delivering naturally extracted and synthetic psilocybin and cannabinoids
§ CANNABINOIDS - Novel combination of composites allowing for multiple delivery formats, potential synergistic and therapeutic effects
§ Tannin (plant-based) - antibacterial, antifungal, antioxidant and wound healing properties
§ Chitosan (shrimp-based) - blood-clotting and antimicrobial properties
§ PSILOCYBIN - Novel precise dosed formulations in the form of capsules, sublingual spray, gel caps, effervescent tablets and oral/transmucosal strips
§ Releases (rapid, controlled, sustained), improved bioavailability, no first-pass metabolism
PRODUCT PIPELINE
Product Indication Stage of Development
Regulatory Status Market
CBD Autoimmune Hepatitis Filing IND Received FDA
Orphan Status
CBD Inflammatory Skin disorders
Pre-clinical To apply for FDA Orphan Status
$25B40mm US Pop
Psilocybin Undisclosed Pre-clinical Target FDA Orphan Status + $500M
PsilocybinUndisclosed
Multiple Indications
Pre-clinical Target FDA Orphan Status TBD
CBD IRI Solid Organ Transplants Pre-clinical Received FDA
Orphan Status
Psychedelic and Cannabis Based Rare Disease Focus
+ $100M50k US Pop
+ $100M20k US Pop
LIVER DISEASE OPPORTUNITY§ Potential $19.5Bn market by 2022; affecting +30mm people in U.S.
§ Focus on Autoimmune Hepatitis (AIH) and Nonalcoholic steatohepatitis (NASH)
§ AIH - rare disease (~ 76k patients in US) causing liver inflammation• Drawbacks of current therapies (steroids): Severe side effects in 13%,
relapse after drug withdrawal in 50%-86%*
§ NASH – fatty liver, most common liver disease (3-5% adults)• No approved therapeutic for NASH; Patients increased risk of cirrhosis,
expected to be leading cause of liver transplants
Source: World J Gastroenterol. 2010 Feb 28; 16(8): 934–947Global NASH Market July 2017 Acute Market Reports
Pharma deals in liver diseases:
§ Allergan/Tobira $1.7Bn acquisition§ Novartis/Conatus $650mm license§ Gilead/Nimbus $1.2Bn acquisition
INFLAMMATORY SKIN DISEASE OPPORTUNITY§ Inflammatory skin diseases from immune system reactions
§ Unmet medical need requiring new treatment options • Current treatments are inadequate, have unwanted side effects
profiles, and expensive
§ Dermatitis (Eczema) Market Opportunity• ~ 31mm patients in the U.S. and ~ $4Bn market size
§ Psoriasis Market Opportunity• ~ 7.5mm patients in the U.S. and ~ $20Bn market size
§ Acne Market Opportunity• ~$4.9Bn market size in 2016 and potential of ~$7.3Bn by 2025
Psoriasis
Dermatitis
Pharma deals in skin diseases:
§ Purdue/Exicure $790mm license§ Astra/Valeant $445mm license§ Allergan/Vitae $639mm deal
PSYCHEDELIC OPPORTUNITY§ Acquired Psilocin Pharma Corp.
§ PPC has novel methods of production of Psilocybin-based formulations
§ Developed six unique patent pending formulations for both natural and synthetically derived Psilocybin§ Capsules (PSY-0.1), Sublingual Spray (PSY-0.2), Gel Cap (PSY-0.3), Effervescent
Tablets (PSY-0.4/0.5), and Oral Strips (PSY-0.6).
§ Target markets§ Mental Health (Depression, PTSD & Anxiety) - 450mm population§ Eating Disorders (Anorexia, Bulimia & other classified EDs) – 70mm population§ Addiction (Alcohol, Drugs, Cigarettes) – 240mm population§ Rare diseases
FOUNDER – PSILOCIN PHARMA
§ Derrick Welsh§ 14 years of Health Care experience, with the past 5 years in the Cannabis
industry
§ Worked with several high profile publicly-traded Cannabis companies like Xanthic Bio Pharma and Green Growth Brands
§ Developed several patent pending formulations such as water Soluble THC and CBD products such as beverages, water enhancers and effervescent tablets
§ Developed a catalog of formulations, extraction and purification technology for the compound Psilocybin (6 products with different dosages) and can be titrated to suit clinical trials or public consumption in markets where Psilocybin is legal
STRATEGIC RELATIONSHIPS
Supply and collaboration of truffles
Acquired March 2020 Psychedelic pharma
Research collaboration for liver diseases
License of cannabidiol for treatment of Autoimmune
Hepatitis
Licensed Dealer ofmedical cannabis
(R&D, Testing)
License of cannabinoid delivery technology
VALUE DRIVING MILESTONES IN 2020Q2-2020 Submit IND for Phase 1/2a clinical study of Bucillamine in the treatment of Influenza / COVID-19
Q2-2020 Submit IND for Phase 1/2a clinical study for CBD in the treatment of Autoimmune Hepatitis
Q3-2020 Pre-IND meeting with FDA for Psilocybin in treatment of mental illness (indication undisclosed)
Q3-2020 Initiate Phase 1/2a clinical study for Bucillamine in the treatment of Influenza / COVID-19CBD
Q3-2020 Initiate Phase 1/2a clinical study for CBD in the treatment of Autoimmune Hepatitis
Q4-2020 Results from Phase 1/2a clinical study for Bucillamine in the treatment of of Influenza / COVID-19
Q4-2020 Results Phase 1/2a clinical study for CBD in the treatment of Autoimmune Hepatitis
Q4-2020 Initiate Phase 1/2a clinical study for Psilocybin in treatment of mental illness (indication undisclosed)
SIGNIFICANTLY UNDERVALUED
90 M105 M60 M
5 M
3.9 B
TEAM
Management
§ Michael FrankChairman and CEO
§ Carmelo MarrelliChief Financial Officer
Board of Directors§ Michael Frank
Chairman and CEO
§ William JacksonDirector
§ Joshua HermanDirector
§ Christian ScovennaDirector
§ Andrew LindzonDirector
STOCK INFORMATION
Ticker Symbols RVV (CSE)
Share Price CAD $0.06 (March 19, 2020)
52 week High/Low CAD $0.135 / $0.025
Capital Structure 163,946,282 common shares (233,040,291 fully-diluted)
Market Cap CAD ~ $10,000,000