Corbus Pharmaceuticals Holdings, Inc. · NASDAQ:CRBP
Corbus Pharmaceuticals — Investor Presentation (February 2015)
27 slides from Corbus Pharmaceuticals's investor presentation, Feb 9, 2015
Slide 1: Developing Breakthrough Therapies for Rare Inflammatory Diseases
Exhibit 99.1 OTCQB: CRBP www.CorbusPharma.com Developing Breakthrough Therapies for Rare Inflammatory Diseases
Slide 2: Forward-Looking Statements
2 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 strategie
Slide 3: Overview
3 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
Slide 4: Our Target Indications: Current & Future
4 Our Target Indications: Current & Future Patient numbers Estimated Current therapies Drawbacks to current Indication (USA) Market size for inflammation therapies Current lead indications: Cystic Fibrosis 30,000 >$3B Steroids, ibuprofen Considerable side effects Diffuse Systemic Steroids, Sclerosis
Slide 5: CB2 Receptor: Turns inflammation "off"
5 3 CB2 Receptor: Turns inflammation “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 in
Slide 6: Mechanisms of Disease: leukotrienes and lipoxins
Mechanisms of Disease: leukotrienes and lipoxins in scleroderma lung disease—insights and potential therapeutic implications (Otylia Kowal Biebecka *, Keryaztof Kowal. Oliver Disther and Steffen Gay INTRODUCTION. inert ng dene SLD) and the beading cane of Prehdcoeepdes sertapyys neocon elle od aaven
Slide 7: Resunab
7 4 Resunab • 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
Slide 8: Resunab: Only CB2-Agonist Targeting Inflammation
8 Resunab: Only CB2-Agonist Targeting Inflammation Company Indication Brain penetration Status Affects CNS Entering Corbus Pharma Inflammation Minimal No Phase 2 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 Phas
Slide 9: Cystic Fibrosis
9 Cystic Fibrosis Targeting inflammation at the core of the disease
Slide 10: Overview: Cystic Fibrosis
5 10 Overview: Cystic Fibrosis • 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 du
Slide 11: Resunab targets key CF inflammatory players
11 Resunab targets key CF inflammatory players TGF- Lipoxin-A4 • Genetically linked to disease • Absent in CF lungs • Associated with worsening symptoms • Replacement therapy effective in animal models LXA4 LXA4 LXA4 Resunab Dose (µM) Resunab Dose (µM) Human Synovial Mouse Peritonitis Model Human PB
Slide 12: Corbus is uniquely positioned to treat inflammation in CF
7 12 Corbus is uniquely positioned to treat inflammation in CF Underlying Infection Fibrosis CFTR defect Inflammation Corbus Corbus Potentiators/ Antibiotics: Correctors: Novartis Vertex Gilead Pfizer Insmed Novartis Savara Galapagos Flatley Labs mRNA: ProQR Shire Other: N30 PTC
Slide 13: Resunab Reduces Pulmonary Fibrosis In Animal Models
13 Resunab Reduces Pulmonary Fibrosis In Animal Models Alveoli -air sacs Fibrosis-inducing agent (Bleomycin) administered to lungs day 1 followed by daily oral Resunab for 21 days Control 350 P<.004 300 250 200 Bleomycin 150 100 50 0 Bleomycin+ Resunab Control Bleomycin Bleomycin therapy + Resunab (
Slide 14: Resunab Planned Cystic Fibrosis Phase 2 Trial
14 Resunab Planned Cystic Fibrosis Phase 2 Trial 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 prof
Slide 15: Diffuse Systemic Sclerosis ("Scleroderma")
15 Diffuse Systemic Sclerosis (“Scleroderma”) Relief for a disease with no effective long-term therapy
Slide 16: Overview: Diffuse Cutaneous Systemic Sclerosis (Scleroderma)
16 Overview: Diffuse Cutaneous Systemic Sclerosis (Scleroderma) • 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% mortalit
Slide 17: Resunab Inhibits Key Factors in SSc
17 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 Health
Slide 18: Resunab Inhibits Skin Thickening In Mouse SSc Model
18 Resunab Inhibits Skin Thickening In Mouse SSc Model Healthy skin Thick skin induced by Near normal skin after oral Bleomycin Resunab taken once daily for four weeks 500 400 300 200 100 0 Control Bleomycin Bleomycin - + Resunab Gonzales et.al., Annals of Rheumatic Diseases, April 4, 2012
Slide 19: Resunab: Planned SSc Phase 2 Clinical Trial
19 Resunab: Planned SSc Phase 2 Clinical Trial • 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 + q
Slide 20: Management Team
20 Management Team Yuval Cohen, Ph.D. - Chief Executive Officer • Co-founder and former President of Celsus Therapeutics (CLTX) • Expertise in developing anti-inflammatory drugs including for CF Mark Tepper, Ph.D. - President & Chief Scientific Officer • Former VP USA Research & Operations, EMD Sero
Slide 21: Board of Directors
21 Board of Directors Yuval Cohen, Ph.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 i
Slide 22: World Class Scientific Advisors
22 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. – Case Western Reserve Medical School P
Slide 23: Financial Profile
23 Financial Profile 22 OTCQB: CRBP 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
Slide 24: Corbus Poised for Significant Upside
24 Corbus Poised for Significant Upside Recent Deals in CF and Fibrosis $8,300 $10,000 $1,000 $405 $444 $450 $100 Galapagos Galecto Amira Intermune (License -AbbVie) (M&A -BMS) (M&A -BMS) (M&A -Roche) Pre-Clinical Phase 1 Phase 3 Recent Deals Date Company Partner Type Drug Indication Stage Up-Front
Slide 25: Peer Valuation in Fibrosis Field
25 Peer Valuation in Fibrosis Field Company Indication Clinical Phase Share Price* Market Cap* Cystic Fibrosis / Systemic Corbus (CRBP) Phase 2 $2.15 $56m Sclerosis ProQR(PRQR) Cystic Fibrosis Pre-Clinical $16.47 $384m Insmed (INSM) Cystic Fibrosis Phase 3 $15.48 $769m PTC (PTCT) Cystic Fibrosis Pha
Slide 26: Conclusions
26 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-clinic
Slide 27: 100 River Ridge Drive Norwood, MA 02062 www.CorbusPharma.com
26 100 River Ridge Drive Norwood, MA 02062 www.CorbusPharma.com
Corbus Pharmaceuticals Holdings — Investor Presentation (February 2015) on 6ix