Corporate Presentation – February 2015 Contact Information: Fabio Chianelli, CEO Office: 905-605-5535 ext. 10 E-mail: [email protected] Forward-Looking Statements Certain statements contained in this presenta0on cons0tute forward-‐looking informa0on within the meaning of securi0es laws. Forward-‐looking informa0on may relate to our future outlook and an0cipated events or results and may include statements regarding our future financial posi0on, business strategy, budgets, li0ga0on, projected costs, capital expenditures, financial results, taxes and plans and objec0ves. In some cases, forward-‐looking informa0on can be iden0fied by terms such as “may”, “will”, “should”, “expect”, “plan”, “an0cipate”, “believe”, “intend”, “es0mate”, “predict”, “poten0al”, “con0nue” or other similar expressions concerning maDers that are not historical facts. These statements are based on certain factors and assump0ons regarding, among other things, expected growth, results of opera0ons, performance, and business prospects and opportuni0es. While we consider these assump0ons to be reasonable based on informa0on currently available to us, they may prove to be incorrect. Forward looking-‐informa0on is also subject to certain factors, including risks and uncertain0es 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 0mely comple0on of clinical studies, and the ability to take advantage of business opportuni0es, the gran0ng of necessary approvals by regulatory authori0es, and general economic, market and business condi0ons. For more exhaus0ve informa0on on these risks and uncertain0es you should refer to our most recently filed Annual Informa0on Form which is available at www.sedar.com. Forward-‐looking informa0on contained in this presenta0on is based on our current es0mates, expecta0ons and projec0ons, which we believe are reasonable as of the current date. You should not place undue importance on forward-‐looking informa0on and should not rely upon this informa0on as of any other date. While we may elect to, we are under no obliga0on and do not undertake to update this informa0on at any par0cular 0me. 2 Company Highlights • Clinical-stage programs in Gout and Orphan drug indications • Focus on higher value / lower risk drug repurposing strategy • Lead drug in Gout: Initiated Phase II clinical study in the U.S. - +8 Million patients in U.S.; Established safety; IP protection to 2033 • Advancements in Cystinuria, Wilson Disease and Rett syndrome - Orphan drug designation opportunities; proceeding to Phase II stage • Secured Pharma development partner - Reducing development risk, cost, and time-to-market • Clear clinical and commercial path with significant near-term catalysts - Driven by phase II clinical data and partnerships 3 About Revive • Clinical-stage company founded in 2012 • Listed on TSX Venture (RVV) in January 2014 • Drug repurposing with faster-to-market potential – Lower development risk, lower cost, known safety & manufacturing – Notable examples: Viagra® (Pfizer) and Thalomid® (Celgene) • Focus on drugs with no commercial presence in the U.S. and/or EU • Developments in Gout and Orphan drug indications • Validate assets in Phase II and seek Pharma deal 4 Team Overview Management • Fabio Chianelli, CEO, Director – Titan Medical (TSXV: TMD) – Generex Biotechnology Corp. • Carmelo Marrelli, CA, CFO – Principal of Marrelli Support Services Inc. • Dr. Bev Incledon, PhD, VP of R&D – Eli Lilly Canada, Director of R&D • Dr. Robert Terkeltaub, MD, Clinical Advisor – UCSD Rheumatology Professor – Experienced PI in Gout Clinical Trials Board of Directors • Craig Leon, Chairman - Titan Medical (TSXV: TMD), Chair/CEO • William Jackson, Director - Atwill Medical Solutions, CEO - Covalon (TSXV:COV), CFO/COO/Dir - Titan Medical (TSXV: TMD), Director • Carlo Sansalone, Director - Sanscon Construction, President • Fabio Chianelli, CEO, Director - Titan Medical (TSXV: TMD) - Generex Biotechnology Corp. 5 Product Pipeline De-risked | Large Commercial Potential | Market Exclusivity Product Indication REV-002 Gout REV-003 Cystinura REV-004 Wilson Disease REV-005 Rett Syndrome (Acute flares–treat/prevent) Preclinical Phase I Phase II-A Phase II/III (Kidney stones) (Copper Build-up) Orphan Drug Indications (Cognitive, seizures, breathing) 6 Japanese Pharma Relationship • Exclusive relationship for bucillamine – Indications: Gout, Cystinuria and Wilson disease – Territories: Worldwide rights except Japan, Korea and Taiwan • Access to proprietary information and clinical drug supply – Non-clinical, clinical, post-marketing and manufacturing • Rapidly paves way for commercialization • Market exclusivity in major markets (U.S. / EU) – IP for Gout, orphan drug designations for Cysinturia / Wilson’s • Validation of market potential and intellectual property 7 Near-term Catalysts Start Gout Phase II-A Study Expansion of Orphan Indications Gout Phase II-A Interim Results Gout Phase II-A Final Results Start Gout Phase II-B Q1-2016 Q3-2015 Q2-2015 Q1-2015 Q4-2014 FDA Orphan Drug Designations Q3/4-2015 8 Gout Over production of uric acid Hyperuricemia High serum uric acid (sUA) Monosodium Urate (MSU) crystals deposited Inflammatory response: NF-kB signaling, IL-1, IL-6, chemokines Painful acute gout flares Chronic Arthritis / Joint damage Under excretion of uric acid Needle-like crystals in joints and/or soft tissues Leads to acute attacks of severe pain (flares) due to inflammation Drug Options: NSAIDs Glucocorticosteroids Colchicine (Colcrys®) 9 Gout Opportunity • Over 8 million adults (~3.9%) in the U.S. and 15 million globally • 40-60% do not reach uric acid target thus experience acute flares • Gout patients have high prevalence to other diseases (may have > 1) – Hypertension (~70-80%), Diabetes Type II (~25-40%), Chronic Kidney Disease (~30-50%), Coronary Artery Disease (~30-40%) • Current anti-inflammatory drugs are often contraindicated – Patients harbor moderate-to-strong contraindications to multiple gout drugs • Colchicine (Colcrys®) for acute flares ($688m US) with ~40% response rate • Drug limitations increase healthcare costs, non-adherence, discontinuations • Significant needs for drugs to treat and control gout flares 10 Revive’s Opportunity “REV-002” Indication: Gout The Drug: Bucillamine - Arthritis drug marketed since 1980s in Japan and South Korea - Promising efficacy in animal models: lowered inflammation / serum uric acid Patent Protected: PCT/CA2013/050882, until 2033 Market Potential: $1 billion + global sales for new gout drug Clinical Progress: - Initiated Phase II-A clinical study in the U.S. in January 2015 - Phase II-A Design: Open-label, multicenter parallel group trial to compare the safety and efficacy of bucillamine and colchicine treatment in acute gout flares - Primary end point: ≥50% reduction target joint pain score from baseline at 72 hrs - Interim results expected in Q2/FY15; Final results expected in Q3/FY15 11 Bucillamine vs Gout flare drugs More Adverse Events and Drug Interactions In: Hypertension Diabetes Type II CKD CAD/ HL CHF GI Tract Disease Bucillamine NO NO Y/N NO NO NO Colchicine YES NO YES YES NO YES Steroids YES YES NO YES YES YES NSAIDs YES NO YES YES YES YES • Bucillamine benefits from over 20 years of safety and contraindication data. • Bucillamine has a novel anti-inflammatory mechanism of action and distinct adverse event and drug interaction profile for therapeutic positioning in acute gouty arthritis. CDK: Chronic Kidney Disease, CAD: Coronary Artery Disease, HL: High Lipids, CHF: Congestive Heart Failure, GI: gastrointestinal12 Clinical and Commercial Path Pivotal / Partner Enabling study FDA acceptance / U.S. study underway Validation Development relationship Phase II-A Human Safety Manufacturing Animal Efficacy Non-clinical Tox Phase II-B Partnership Opportunity $1.28 Billion (2012) AstraZeneca acquired ARDEA (Gout drug @ Phase 3) Lowered development risk, cost, and time 2014 Phase III $800 Million (2012) Takeda acquired URL Pharma (Colcrys®) 2015 2016 2017 13 Cystinuria The Disease: Affecting ~12,000 U.S.; WW prevalence 1 in 7,000 - Rare autosomic recessive genetic disorder causing high levels of cysteine in the urine enabling the formation of kidney stones - Treatments tiopronin (Thiola®) and D-penicillamine for prevention of stone formation The Drug: Bucillamine - Arthritis drug marketed since 1980s in Japan and South Korea - Encouraging human efficacy: Effective agent in non-clinical and clinical studies; potential new therapeutic agent in place of tiopronin (Thiola®) and D-penicillamine (Source: T. Yoshioka et al, A new therapeutic agent for cystinuria, Urolithiasis 2: 571-574, (1994)). Market Exclusivity: Orphan drug designation allows 7 years in the U.S. and 10 years in EU - Current treatments off-patent, no orphan drug designation Market Potential: ~ $200-$300 million (2,000-3,000 patients at $100,000 annual cost) Clinical Progress: - Seek to file IND with FDA - Seek to apply for Orphan Drug Designation 14 Wilson Disease The Disease: Prevalence is about one in 30,000. - Rare autosomal recessive disorder that prevents the body from removing extra copper - May lead to significant build-up of copper in the liver, brain, kidneys and other tissues resulting in organ damage, organ dysfunction and death - Treatments are zinc salts chelating agents (D-penicillamine, trientine), liver transplants The Drug: Bucillamine - Arthritis drug marketed since 1980s in Japan and South Korea - Encouraging invivo efficacy: Effective chelating agent in comparison to other chelating agents that treat Wilson disease such as D-penicillamine (Source: Protective effects of chelating agents against renal toxicity of gold sodium thiomalate in rats, Arch Toxicol (1991) 65:532-536) Market Exclusivity: Orphan drug designation allows 7 years in the U.S. and 10 years in EU - Current treatments off-patent, no orphan drug designation Clinical Progress: - Seek to file IND with FDA - Seek to apply for Orphan Drug Designation 15 Rett Syndrome The Disease: Orphan disease designation; affects 16,000 U.S. & 20,000 EU - Affects mostly girls; Experience loss of motor skills, seizures, respiratory dysfunction - No cure; Current therapies focus on symptoms management The Drug: Tianeptine - Anti-depressant; Marketed since 1980s in Europe, Asia and South America - Encouraging results: Enhanced breathing; cognition, anti-seizure, motor skills potential Patent Protected: PCT/GB2013/051213, until 2033 Market Potential: $180-$360 million on unserved market - Low of 3,000 / max of 6,000 patients at $60,000 annual cost Clinical Progress: - Research collaboration with RettSyndrome.org who will fund and manage - Orphan Drug Designation in 2H/FY15 - Based on collaboration results, human clinical studies by Q4/FY2015 16 Key Financial Information Ticker Symbol RVV (TSX Venture) Share Price $0.55 (January 30, 2015) Capital Structure 23,936,437 common shares 4,996,500 Warrants @ $0.85 and 349,755 Broker Warrants 1,553,151 stock options (925,000 @ $0.60, 590,000 @ $0.66, 38,151 @ $0.30) Market Value ~ $13,000,000 Insider Ownership ~40% Cash and cash equivalents $3,213,033 (December 31, 2014) Monthly Cash burn ~ $200,000 Analyst Coverage Beacon Securities Limited – Doug Cooper, MBA 17
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