Investor Presentation February 6, 2015

Transcription

1 Investor Presentation February 6, 2015

2 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 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

3 Company Highlights Addressing large markets with unmet medical needs Gout and orphan drug indications Repurposing proven and marketed drugs De-risked later-stage clinical asset FDA Phase II study in gout Well-established safety (clinical and market use) Patent protection to 2030 s Secured Pharma development partner for gout Market validation and reduced development risk and cost Clear path to commercialization - Driven by phase II data and partnerships Significant near-term catalysts unlocking value 3

4 About Revive Clinical-stage company founded in 2012 Listed on TSX Venture in January 2013 Drug repurposing with faster-to-market potential Lower development risk, cost, known safety and manufacturing Example: Viagra (Pfizer) and Thalomid (Celgene) Focus on repurposing drugs with no commercial footprint in USA or Europe Advantages of a new drug (i.e. market exclusivity) Objective to validate assets in Phase II and seek Pharma deal 4

5 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

6 Product Pipeline De-risked assets, large markets, patent protection 2030 s Product Indication Preclinical Phase I Phase II-A Phase II/III REV-002 Gout REV-003 Rett Syndrome (Orphan drug indication) Orphan drug indications under consideration that would be slated to begin at Phase 2 clinical stage 6

7 Near-term Catalysts Orphan Drug Designations (Rett/Others) Gout Phase II-A Results Start Gout Phase II-B FDA Accept Gout Phase II-A Start Gout Phase II-A Q H-2015 Q Q Q

8 1. Gout Opportunity Over 8 million adults (~3.9%) in USA & 15 million globally Prevalence markedly increasing, especially in patients with limited therapy options 40%-60% do not reach uric acid lowering target, thus continue to experience acute flares and develop chronic arthritis Current anti-inflammatory drugs are often contraindicated Drug limitations increases healthcare costs, therapy restarts, nonadherence, discontinuations Significant needs for drugs to control inflammation & lower uric acid 8

9 Gout Over production of uric acid Hyperuricemia High serum uric acid (sua) Under excretion of uric acid Monosodium Urate (MSU) crystals deposited Needle-like crystals in joints and/or soft tissues Inflammatory response: NF-κB signaling, IL-1, IL-6, chemokines Painful acute gout flares Leads to acute attacks of severe pain (flares) due to inflammation Chronic Arthritis/Joint damage 9

10 Gout Management Objectives Diagnose, Treat and Prevent Acute Gout Flares Identify, Manage Comorbidities and Causes of Hyperuricemia Patient Education, Treatment Adherence Terkeltaub R. Nature Rev Rheumatology, 2010 Rees et al, ARD, 2012 Urate-lowering drugs: Treat to Target of Serum Urate <6 mg/dl At a Minimum 10

11 Pharmacologic Options to Treat Acute Gouty Inflammation First-line options 1-4 NSAIDs Glucocorticosteroids Colchicine (Colcrys ) Other options 1-4 Intra-articular glucocorticosteroids Synthetic ACTH 1,2,5 Off-label FDA, approved EMU Biologic IL-1 antagonism 1,3,4,6,7 1. *Terkeltaub RA. N Eng J Med. 2003;349: Schlesinger N, et al. Expert Opin Pharmacother. 2009;10: Terkeltaub R. Nat Rev Rheumatol. 2010;6: Terkeltaub RA, et al. Arthritis Rheum, 2010;62: ACTH = adrenocorticotropic hormone 1, 2, 5: Schlesinger N. Overview of the management of acute gout and the role of adrenocorticotropic hormone. Drugs. 2008;68(4): : So A, De Smedt T, Revaz S, Tschopp J. A pilot study of IL-1 inhibition by anakinra in acute gout. Arthritis Res Ther. 2007;9(2):R28. 7: Terkeltaub R, Sundy JS, Schumacher HR, Murphy F, Bookbinder S, Biedermann S, Wu R, Mellis S, Radin A. The interleukin 1 inhibitor rilonacept in treatment of chronic gouty arthritis: results of a placebo-controlled, monosequence crossover, non-randomised, single-blind pilot study. Ann Rheum Dis Oct;68(10):

12 Gout and Other Chronic Conditions Patients with gout have a high prevalence to show multiple other chronic conditions Hypertension (~70-80%) Diabetes Type II (~25-40%) Chronic Kidney Disease (~30-50%) Coronary Artery Disease (~30-40%) GI Tract Disease Congestive Heart Failure Majority of gout patients harbor moderate to strong contraindications to multiple first-line gout treatments Colchicine (Colcrys ), to prevent and treat acute flares, had US sales of $688 million in the U.S., but shown in studies to have treatment responder rate between 30% and 40% 12

13 Revive s New Opportunity REV-002 Indication: Gout The Drug: Bucillamine (being repurposed from RA to gout) Arthritis drug marketed since 1980s in Japan and South Korea Promising efficacy in mouse models: lowered inflammation and serum uric acid (Potential dual-acting treatment) Patent Protected: PCT/CA2013/050882, until 2033 Market Potential: $1 billion + global sales for new gout drug Clinical Update: FDA Investigational New Drug ( IND ) application accepted Initiated Phase II-A clinical study in the U.S. Phase II-A: Open-label, multicenter parallel group trial designed to compare the safety and efficacy of high and moderate bucillamine and low-dose colchicine treatment in acute gout flare End points: 50% reduction in target joint pain score from baseline at 72 hours Results expected in Q3/FY15 13

14 Bucillamine Anti-Inflammatory Mechanism: Unique versus Current Drugs Used to Treat Gouty Inflammation NSAIDs, Colchicine, Corticosteroids Nonselective Therapeutic effects Frequent and potentially serious adverse events, major organ toxicity, and drug interactions Bucillamine Dual thiol donor-based inhibitor of inflammation signal transduction (including NF-κB inhibition) Limits multiple cytokine responses central to gouty inflammation (including IL-1, IL-6, TNFalpha, synovial angiogenesis) 14

15 Rationale for Bucillamine in Gout # Bucillamine # *Putative Bucillamine Loci of Inhibitory Effects in Patients with Acute Gouty Arthritis Reactive Oxygen Species Urate Crystal Phagocytosis Bucillamine: Disease Modifying Anti- Rheumatic Drug With Unique Dual Sulfhydryl Thiol Donor Structure # Bucillamine Loci of Action in Gouty Inflammation Can Include: Thioredoxin-interacting Protein (TXNIP) in NLRP3 Inflammasome Activation NF-κB Signaling Release and Responses to IL-1β and Other Cytokines Including IL-6 and TNFα * Thioredoxin-interacting protein (TXNIP) * * NLRP3 Inflammasome Ac1va1on Release of IL-1beta and Other Inflammatory Cytokines NF-κB * Multiple Inflammatory Responses in Gout 15

16 Bucillamine vs. other Gout drugs Treatment Effect More Adverse Events and Drug Interactions In: Flares Lower Uric Acid Hypertension Diabetes Type II CKD CAD/ HL CHF GI Tract Disease Bucillamine YES YES* NO NO Y/N NO NO NO Colchicine YES NO YES NO YES YES NO YES Steroids Yes No YES YES NO YES YES YES NSAIDs YES NO YES NO YES YES YES YES Bucillamine benefits from 20 + years of safety and contraindication data Bucillamine belongs to a different class of drugs and has a different mechanism of action resulting in a potential unique dual-therapeutic action *based on gout animal studies. 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: gastrointestinal 16

17 Japanese Pharma Relationship Gout Partnership Potential Relationship with Japanese Pharma Rapidly paves way for commercialization Access to clinical, market, manufacturing info, drug supply In return, Pharma secured Japan, Korea and Taiwan rights Validation of market potential and intellectual property Unlocks advantages of a new drug Market exclusivity (i.e. USA and EU) 17

18 Commercialization Path Validation Partnership secured Human safety Manufacturing Animal Efficacy Non-clinical Tox Discovery Phase II-A Phase II-B Partnership Opportunity Phase III $1.28B - AstraZeneca acquired ARDEA (Lesinurad Phase 3) $800M - Takeda acquired URL Pharma (Colcrys )

19 2. Rett Syndrome Orphan Disease Designation Rare disease affecting 16,000 in U.S. and 20,000 in EU Experience loss of motor skills, seizures, respiratory dysfunction Girls are mostly affected No cure for Rett Syndrome Current therapies focus on symptoms management 19

20 Revive s New Opportunity REV-003 Indication: Rett Syndrome The Drug: Tianeptine (being repurposed from anti-depressant) Marketed since 1980s in Europe, Asia and South America Encouraging results: Enhanced breathing Potential for positive outcomes in behavior, cognition, anti-seizure 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 Update: Research collaboration with RettSyndrome.org (to fund and manage) Orphan Drug Designation in 1H/FY15 Based on collaboration results, human clinical studies in Q4/FY

21 Key Financial Information Ticker Symbol RVV (TSX Venture) Share Price $0.55 (January 30, 2015) Capital Structure 23,936,437 common shares 4,996,000 $ ,151 stock options $0.66 and $0.30) Market Value ~ $13,000,000 Insider Ownership ~40% Cash and cash equivalents $982,360 (September 30, 2014) Does not include $3,000,000 financing Dec 2014 Monthly Cash burn ~ $200,000 (Beginning Feb 2015) Analyst Coverage Beacon Securities Limited Doug Cooper, MBA 21