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Case Western Reserve Medical School Professor Medicine, National PI on largest ever anti inflammatory CF study Robert Spiera M.D. Hospital for Special Surgery NYC Professor of Medicine, Head of Scleroderma and Vasculitis Center Daniel Furst, M.D. UCLA School of Medicine Director of UCLA Scleroderma Program Robert Zurier, M.D. UMass Medical School Ex Chair of Rheumatology 22 Financial Profile OTCQB: CRBP 23 Stock Ticker: OTC.QB: CRBP $55,774,000 Market capitalization as of February 4, 2015 $10,300,000 Raise from successful private placement (Q2 2014) from institutional and retail base 25,941,000 Common shares outstanding as of February 4, 2015 41,500,000 Fully diluted shares outstanding (including warrants and stock options) $11,400,000 Available from exercise of warrants callable at $2.50 per share NASDAQ Up listing to NASDAQ planned by Q1 2015 2014 2016 2015 22 Oct 2014 Began trading on OTCQB Q1 2015 File IND with FDA Q1 2015 Plan to up list to NASDAQ Q2 2015 Launch clinical trials H2 2016 Data from clinical trials Corbus Poised for Significant Upside Recent Deals Date Company Partner Type Drug Indication Stage Up Front Deal Total 11/14 Galecto BMS Option to acquire TD139 Idiopathic pulmonary fibrosis Phase 1 NA $444M* 8/14 InterMune Roche Acquisition Esbriet Idiopathic pulmonary fibrosis Approved NA $8.3B* 9/2013 Galapagos AbbVie License GLPG1837 Mutations in CF patients, including F508del and G551D Pre clinical $45M* $405M* 7/2011 Amira BMS Acquisition AM152 Idiopathic pulmonary fibrosis and systemic sclerosis Phase 1 $325M* $475M* * Figures from company press releases Recent Deals in CF and Fibrosis $100 $1,000 $10,000 $405 $444 $450 $8,300 Galapagos (License AbbVie) Galecto (M A BMS) Amira (M A BMS) Intermune (M A Roche) Pre Clinical Phase 1 Phase 3 24 Peer Valuation in Fibrosis Field * As of February 5, 2015 Company Indication Clinical Phase Share Price* Market Cap* Corbus (CRBP) Cystic Fibrosis / Systemic Sclerosis Phase 2 $2.15 $56m ProQR(PRQR) Cystic Fibrosis Pre Clinical $16.47 $384m Insmed (INSM) Cystic Fibrosis Phase 3 $15.48 $769m PTC (PTCT) Cystic Fibrosis Phase 3 $49.06 $1.44bn Intercept (ICPT) Liver Fibrosis Phase 3 $194.77 $4.16bn Vertex (VRTX) Cystic Fibrosis Approved, $800m in sales $109.01 $26.35bn 25 Conclusions Lead Product Resunab is a novel, safe and promisingly potent clinical stage anti inflammatory/anti fibrotic drug which acts to resolve inflammation Targets multiple rare chronic inflammatory indications Proven safe in two Phase 1 trials Promising potency in multiple pre clinical inflammatory/fibrotic models Launch two Phase 2 trials in 2015 (Cystic Fibrosis and Scleroderma) Completion of studies in 2016 Strong patent portfolio until 2033+ 26 26 100 River Ridge Drive Norwood, MA 02062 www.CorbusPharma.com
(Chip ) Caitlin CFO Celldex Therapeutics (CLDX) since 2000 Raised over $415 MM financing 20 years experience in industry: Repligen (CFO) and Endogen (CFO) 21 World Class Scientific Advisors Sumner Burstein, Ph.D. UMass Medical School Professor of Biochemistry and Pharmacology; inventor of Resunab Michael Knowles, M.D., Ph.D. UNC Chapel Hill Professor of Pulmonary and Critical Care Medicine James Chmiel, M.D.
Chief Executive Officer Amb. Alan Holmer Chairman of the Board Former CEO of PhRMA (1996 2005) Over two decades of public service in Washington, D.C. including Special Envoy to China (2007 2009) Former board member Inspire Pharma (sold to Merck for $430m in 2011) Chairman of the Board of the Metropolitan Washington, D.C. Chapter of the Cystic Fibrosis Foundation David Hochmann Managing Partner of Orchestra Medical Ventures Over 17 years of venture capital and investment banking experience Former Managing Director of Spencer Trask Ventures, Inc. securing over $420 million in equity capital Renu Gupta, MD 25 years of development, regulatory and senior management experience in the biopharm industry Former CMO of Insmed, a specialty CF company and current advisor to the CEO Former Vice President and Head of US Clinical Research and Development at Novartis (2003 2006) Avery W.
Previously held positions in industry: SVP and Head, R D for Stiefel a GSK company, VP and Head of Inflammation Clinical Development at UCB and MedImmune/AstraZeneca, and Director, Medical Affairs, Amgen Expertise in CF and Pulmonary diseases. Former Director, Clinical Research Operations of Insmed and Clinical Program Scientist at PTC Therapeutics (PTCT) Board of Directors Yuval Cohen, Ph.D.
Investigator, Bristol Myers Squibb Key member of project teams which developed the following marketed drugs: Taxol (Ovarian Cancer, 2000 peak sales of $1.6B), Orencia (RA, 2013 sales of $1.4B), Rebif (MS, 2013 sales of $2.59B), Gonal F (Fertility, 2013 sales of $815MM) Former CFO: InVivo (NVIV), Celsion (CLSN), Transport Pharma, Echo Therapeutics (ECTE) Anika Therapeutics (ANIK) Board certified Rheumatologist and clinical immunologist.
Chief Executive Officer Mark Tepper, Ph.D. President Chief Scientific Officer Sean Moran, C.P.A. M.B.A. Chief Financial Officer Barbara White, M.D. Chief Medical Officer Scott Constantine, M.S. Director, Clinical Operations Co founder and former President of Celsus Therapeutics (CLTX) Expertise in developing anti inflammatory drugs including for CF Former VP USA Research Operations, EMD Serono; Sr.
Kalydeco by Vertex priced at $320,000/yr) TGF Lipoxin A4 Genetically linked to disease Absent in CF lungs Resunab Dose ( M) LXA 4 LXA 4 LXA 4 Resunab Dose ( M) Mouse Peritonitis Model Human PBMC (ex vivo) Human Synovial Fibroblasts (ex vivo) Zurier et al., Vol. 23 May 2009 The FASEB Journal 11 Resunab targets key CF inflammatory players Replacement therapy effective in animal models Associated with worsening symptoms 7 Antibiotics: Novartis Gilead Insmed Savara Potentiators/ Correctors: Vertex Pfizer Novartis Galapagos Flatley Labs mRNA: ProQR Shire Other: N30 PTC Corbus Corbus Corbus is uniquely positioned to treat inflammation in CF 12 CFTR defect Underlying Inflammation Infection Fibrosis Fibrosis inducing agent (Bleomycin) administered to lungs day 1 followed by daily oral Resunab for 21 days P .004 Bleomycin+ Resunab therapy Bleomycin Control Gonzales et.al., Annals of Rheumatic Diseases, 2012. 71:1545 51 * Measured by hydroxyproline Alveoli air sacs Resunab Reduces Pulmonary Fibrosis In Animal Models Control Bleomycin Bleomycin + Resunab (1mg/kg) 13 0 50 100 150 200 250 300 350 Resunab Planned Cystic Fibrosis Phase 2 Trial 14 Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016 Q2 2016 Q3 2016 Q4 2016 Protocol filed with FDA X Study launches X First patient dosed X Study duration X X X X X X Last patient dosed X Study data released X Double blind randomized placebo control study in the US and EU Primary endpoints: Safety/tolerability Secondary endpoints: Pharmacokinetics and efficacy (FEV1, Lung Clearance Index, CFQ R Respiratory Domain) Exploratory endpoints: Metabolipidomic profile for MOA, biomarkers of disease activity in blood and sputum, biomarkers of inflammation, and microbiota in the lungs Patient number: 70 adults with CF in ~ 20 sites US EU Treatment duration: 3 months + 1 month follow up Dose response: 1 mg/day, 5 mg/day, 20 mg/day and 2x20 mg/day Diffuse Systemic Sclerosis ( Scleroderma ) Relief for a disease with no effective long term therapy 15 Overview: Diffuse Cutaneous Systemic Sclerosis (Scleroderma) 16 Chronic inflammatory disease causing fibrosis of skin, joints and internal organs Orphan disease (50,000 patients in USA) 80% of patients are women mostly in their 40 s and 50 s Common cause of death: lung fibrosis (50% mortality in 10 years) Early stage of disease responds to steroids/methotrexate but with serious side effects No effective and safe long term therapy available Pipelines often target Idiopathic Pulmonary Fibrosis (IPF) in conjunction to SSc Resunab Inhibits Key Factors in SSc TGF beta plays key role in SSc progression (same in CF and IPF) Elevated TGF beta levels associated with disease progression Strong Resunab efficacy data in animal models Resunab reduces TGF beta and collagen in skin fibroblasts from SSc patients Concentration of Resunab ( M) Concentration of Resunab ( M) Healthy skin fibroblasts Scleroderma patients skin fibroblasts 17 TGF beta Collagen Resunab Inhibits Skin Thickening In Mouse SSc Model Gonzales et.al., Annals of Rheumatic Diseases, April 4, 2012 Control Bleomycin Bleomycin + Resunab Thick skin induced by Bleomycin Near normal skin after oral Resunab taken once daily for four weeks Healthy skin 0 100 200 300 400 500 18 Resunab : Planned SSc Phase 2 Clinical Trial 19 Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016 Q2 2016 Q3 2016 Q4 2016 Protocol filed with FDA X Study launches X First patient dosed X Study duration X X X X X X Last patient dosed X Study data released X Double blind placebo control randomized study in USA under IND from FDA Primary end points: Safety/tolerability + Change in clinical outcomes (CRISS) Secondary end points: Metabolipodomic profile + biomarkers of disease activity inflammation + quality of life (QOL) Patient number: 36 adults with SSc at 8 10 US sites Treatment duration: 3 months + 1 month follow up Dose response: 5mg/day, 20mg/day and 20mg/2Xday Management Team 20 Yuval Cohen, Ph.D.
Prospective investors are cautioned not to place undue reliance on such forward looking statements, which speak only as of the date of this presentation. The Company undertakes no obligation to publicly update any forward looking statement, whether as a result of new information, future events or otherwise. 2 Overview Corbus Pharma is focusing on rare, life threatening, chronic inflammatory diseases Lead drug Resunab : a first in class oral anti inflammatory/fibrosis small molecule Acts to trigger natural pathway of inflammatory resolution ( off switch for inflammation) Proven safe in Phase 1 + promising pre clinical potency in multiple animal models Entering Phase 2 clinical trials 2015 in: Successful $10.3m private financing round (May 2014) Obtained multiple NIH grants IP protection until 2033 and potentially longer Commenced trading on OTC.QB in October 2014 3 Cystic Fibrosis (CF) Systemic Sclerosis (SSc) also known as Scleroderma Our Target Indications: Current Future Indication Patient numbers (USA) Estimated Market size Current therapies for inflammation Drawbacks to current therapies Current lead indications: Cystic Fibrosis 30,000 $3B Steroids, ibuprofen Considerable side effects Diffuse Systemic Sclerosis (Scleroderma) 50,000 $2B Steroids, methotrexate Side effects, poor efficacy Potential future indications: Dermatomyositis 13,000 $1B Steroids, mAbs Side effects, poor efficacy Lupus (SLE) 500,000 1.5MM $3B Steroids, mAbs Side effects, poor efficacy Idiopathic Pulmonary Fibrosis (IPF) 70,000 $1B Pirfenidone Limited efficacy InterMune bought by Roche for $8.5B (2014) Other Chronic Inflammatory Diseases 10,000 100,000 $10B Steroids, NSAIDs mAbs Side effects, poor efficacy 4 3 Inflammation ON Pro inflammatory Mediators ( IL6, IL8, PGE2, LTB4) Immune cell TGF CB2 receptor Inflammation OFF Fibrosis ON Fibrosis OFF CB2 receptor is present on immune cells and activated by endogenous mediators Activation of CB2 turns inflammation off ( inflammatory resolution ) by stimulating the production of anti inflammatory Specialized Pro resolving Mediators (SPMs) Chronic inflammation caused by imbalance between pro inflammatory mediators and SPMs Resunab expected to be first CB2 binding anti inflammatory drug to reach market Upstream of other approaches: potential for better safety and potency CB2 Receptor: Turns inflammation off Immune cell 5 COX LOX LXA 4 Specialized Pro resolving Mediators (Lipoxins, Resolvins, etc) 4 Resunab 7 Resunab: synthetic oral small molecule CB2 agonist Designed to trigger the resolution of chronic inflammation with once or twice a day dosing Full manufacturing, drug supply, non clinical safety pharmacology package for Phase 2 programs Excellent clinical safety profile to date: two prior Phase 1 clinical trials (n=123) Preparing to launch two Phase 2 clinical studies in H1 2015 Resunab : Only CB2 Agonist Targeting Inflammation Company Indication Brain penetration Status Affects CNS Corbus Pharma Inflammation Minimal Entering Phase 2 No AbbVie Pain Full Phase 1 Yes Glenmark Pain Full Phase 1 Yes Eli Lilly Knee pain Full Phase 2 Yes AstraZeneca Post operative pain Full Phase 2 Yes Resunab is the only CB2 drug that can be used to treat inflammation because it does not target the brain 8 Cystic Fibrosis Targeting inflammation at the core of the disease 9 5 Antibiotics Kalydeco (for 6%) of patients Very limited treatment No treatment Overview: Cystic Fibrosis 10 Orphan disease (30,000 patients in USA, 75,000 WW) Average life expectancy of CF patients is approximately 40 years Inflammation at core of disease s morbidity and mortality (pulmonary fibrosis) Very high doses of steroids/ibuprofen effective but rarely used due to toxicity Need for safe, chronic anti inflammatory drug is unmet and universally recognized Pharmacoeconomics support premium pricing (e.g.
These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward looking statements. Such factors include those set forth in the Company s filings with the Securities and Exchange Commission.
Additional written and oral forward looking statements may be made by the Company from time to time in filings with the Securities and Exchange Commission (SEC) or otherwise. The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward looking statements. These statements may be identified by the use of forward looking expressions, including, but not limited to, expect, anticipate, intend, plan, believe, estimate, potential, predict, project, should, would and similar expressions and the negatives of those terms.
Developing Breakthrough Therapies for Rare Inflammatory Diseases www.CorbusPharma.com OTCQB: CRBP Exhibit 99.1 Forward Looking Statements This presentation contains certain forward looking statements, including those relating to the Company s product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature.