Corbus Pharmaceuticals Holdings, Inc. · NASDAQ:CRBP
Corbus Pharmaceuticals — Investor Presentation (January 2016)
33 slides from Corbus Pharmaceuticals's investor presentation, Jan 11, 2016
Slide 1: Targeting the Immune System in Rare Diseases
TARGETING THE IMMUNE SYSTEM IN RARE DISEASES NASDAQ:CRBP | CORBUSPHARMA.COM EXHIBIT 99.1
Slide 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 strategies, potential growth opportuni
Slide 3: The Corbus Business Model
THE CORBUS BUSINESS MODEL Focus Engaging the immune system to treat rare diseases Acquire Clinical stage pharma assets to build our pipeline Develop Rapidly translate lead candidates to clinical proof-of-concept & beyond Serious morbidity + life-threatening indications with clear unmet need Market W
Slide 4: 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 MANAGEMENT TEAM BARBARA WHITE M.D. CHIEF MEDICAL OFFICER Board-certified Rheumatologist and clinical immunologist. Previously SVP
Slide 5: Resunab: Our First Asset
Novel synthetic oral endocannabinoid-mimetic with unique MOA First-in-class therapeutic currently in three Phase 2 programs Acquired pharma asset with extensive Phase 1 safety data IP portfolio à 2033 RESUNAB™: OUR FIRST ASSET Cystic Fibrosis (CF) Orphan Designation + Fast Track Status granted by FD
Slide 6: Resunab: Current Clinical Pipeline Status
RESUNAB: CURRENT CLINICAL PIPELINE STATUS INDICATION CURRENT PHASE ANTICIPATED DATA READOUT ANTICIPATED NEXT STUDY NDA CYSTIC FIBROSIS (CF) PHASE 2 (n=70) Q4 2016 Q3 2017 2021 SYSTEMIC SCLEROSIS (SSc) PHASE 2 (n=36) Q4 2016 Q3 2017 2021 DERMATOMYOSITIS (DM) PHASE 2 (n=22) Q1 2017 Q1 2018 2022 CF 70,
Slide 7: Resunab Restores Homeostasis During Pathologic Immune Responses
ACUTE INFLAMMATION IMMUNE SYSTEM HOMEOSTASIS PRO-INFLAMMATORY MEDIATORS SPECIALIZED PRO-RESOLVING LIPID MEDIATORS TISSUE HEALING AND REMODELING LIPID MEDIATOR CLASS SWITCHING Adapted from REIRE & VAN DYKE. Natural resolution of inflammation. Periodontology 2000, 2013;63:149–164 RESUNAB RESTORES HOMEO
Slide 8: Resunab: Unique Targeting of CB2 Receptor
RESUNAB: UNIQUE TARGETING OF CB2 RECEPTOR x12 x1 Only 30% BBB penetration CB1 Receptors: analgesic receptors in brain CB2 Receptors: resolution receptors in immune system Total daily clinical dose 1-40 mg
Slide 9: Resunab Reduces Pro-Inflammatory Mediator Interleukin-1β in Healthy Humans
RESUNAB REDUCES THE PRO-INFLAMMATORY MEDIATOR INTERLEUKIN-1β IN HEALTHY HUMANS Resunab dose (mg) Percent response Three healthy adults received single doses of 3, 6, and 10 mg Resunab. Five hours following each dose, peripheral blood mononuclear cells were isolated and stimulated with LPS, then IL-1
Slide 10: Resunab: An Attractive Clinical Safety Profile
RESUNAB: AN ATTRACTIVE CLINICAL SAFETY PROFILE Treatment Emergent Adverse Event (TEAE) Treatment Emergent Adverse Events in ≥ Two Subjects for All Doses, by Severity of AE, n All subjects all doses, n = 123, (% all subjects all doses) Subjects receiving ≥ 1 mg to ≤ 60 mg total daily dose, n = 52 (%
Slide 11: Cystic Fibrosis: Focusing on Inflammation & Fibrosis
CYSTIC FIBROSIS: FOCUSING ON INFLAMMATION & FIBROSIS
Slide 12: Cystic Fibrosis
CYSTIC FIBROSIS CF is a life-threatening, genetic disease that primarily affects the lungs and digestive system. CF is characterized by chronic lung inflammation that leads to lung damage and fibrosis. 30,000 PATIENTS IN THE USA 75,000 PATIENTS WORLDWIDE 40 YEARS AVERAGE LIFE EXPECTANCY OF CF PATIEN
Slide 13: Resunab Is Uniquely Positioned in CF
RESUNAB IS UNIQUELY POSITIONED IN CF CFTR DEFECT INFLAMMATION INFECTION FIBROSIS POTENTIATORS/ CORRECTORS mRNA ANTIBIOTICS RESUNABTM (Corbus) First-in-class CB2 agonist in CF Targets inflammation and fibrosis Not immunosuppressive Agnostic of CFTR mutation or infection Oral, daily dosing Add-on to c
Slide 14: Resunab Resolves Lung Inflammation in Infected CF Mouse Model
RESUNAB RESOLVES LUNG INFLAMMATION IN PSEUDOMONAS AERUGINOSA INFECTED CF MOUSE MODEL DESIGN Bonfield, Tracey; Tepper, Mark 2015 Total BAL Cell Recruitment Post-Resunab Absolute # of Cells (m/BAL Mean ± SEM) %MAC/ml BAL (Mean ± SEM) Relative Number of Alveolar Macrophages Relative Number of Neutrophi
Slide 15: Resunab Enhances Resolution of Lung Infection in CF Mice
RESUNAB ENHANCES RESOLUTION OF LUNG INFECTION IN CF MICE INFECTED WITH PSEUDOMONAS - Associated with worsening symptoms Bonfield, Tracey; Tepper, Mark 2015 Bacterial CFU After 10 Days Resunab Number of CFUs x,1000 (Mean±SEM)
Slide 16: Resunab Reduces Weight Loss and Improves Survival in CF Mice
RESUNAB REDUCES WEIGHT LOSS AND IMPROVES SURVIVAL IN CF MICE INFECTED WITH PSEUDOMONAS - Associated with worsening symptoms Bonfield, Tracey; Tepper, Mark 2015 GROUP SURVIVAL RATE DAY 10 WT 5/5 (100%) WT + Resunab 5/5 (100%) CF 3/5 (60%) CF + Resunab 5/5 (100%)
Slide 17: Resunab: Cystic Fibrosis Phase 2 Trial
RESUNAB: CYSTIC FIBROSIS PHASE 2 TRIAL Double blind randomized placebo control study in the US and EU Primary endpoints: Safety/tolerability Secondary endpoints: Trends in efficacy (FEV1, Lung Clearance Index, CFQ-R Respiratory Symptom Score) + PK Exploratory endpoints: Metabolipidomic profile for M
Slide 18: Decision Making After Our Current Phase 2 Trials: Defining Success
DECISION MAKING AFTER OUR CURRENT PHASE 2 TRIALS: DEFINING SUCCESS CB2 agonist activity in humans (metabolipidomic profile, biomarkers)? YES Directional improvements in clinical outcomes? Safety and PK support next study? YES YES REVIEW Supportive discussions with regulatory authorities? Additional
Slide 19: Diffuse Cutaneous Systemic Sclerosis: Relief for a Disease with No Approved Targeted Therapy
DIFFUSE CUTANEOUS SYSTEMIC SCLEROSIS: RELIEF FOR A DISEASE WITH NO APPROVED TARGETED THERAPY
Slide 20: Systemic Sclerosis
SYSTEMIC SCLEROSIS Chronic inflammatory disease causing fibrosis of skin and internal organs 80% FEMALE PATIENTS 40-60 YEARS AVERAGE AGE OF PATIENTS KEY TAKE-AWAYS Life-threatening, rare disease No SSc-specific approved drugs Current therapy involves steroids and immunosuppressive agents with signif
Slide 21: Therapeutic Rationale for Resunab in Systemic Sclerosis
THERAPEUTIC RATIONALE FOR RESUNAB IN SYSTEMIC SCLEROSIS (SSc) AUTOIMMUNE TRIGGER INFLAMMATION VASCULOPATHY FIBROSIS RESUNAB RESUNAB Would be first approved drug in SSc Targets multiple disease pathways No immunosuppression Oral, daily dosing SET THE SSc TREATMENT PARADIGM: CONTROL ACTIVE DISEASE WIT
Slide 22: Resunab Inhibits Collagen Deposition in Bleomycin-Induced Lung Fibrosis
Bleomycin intratracheal injection, Day 1 Mice sacrificed after 21 days Resunab by gavage, Days 1-21 (prophylactic) or Days 8-21 (therapeutic) *p = 0.002, **p = 0.004, ***p = 0.001, ****p = 0.0001, bleomycin + Resunab treatment versus bleomycin PROPHYLACTIC AND THERAPEUTIC RESUNAB INHIBIT COLLAGEN DE
Slide 23: Resunab Reduces Biomarkers in Fibroblasts from SSc Patients
RESUNAB REDUCES BIOMARKERS IN FIBROBLASTS FROM SSc PATIENTS Resunab (μM) Resunab (μM) Healthy donor dermal fibroblasts Diffuse cutaneous systemic sclerosis dermal fibroblasts TGFβ *p < 0.0001 versus untreated fibroblasts * * #p < 0.001 versus healthy fibroblasts *p < 0.0001 versus untreated fibrobla
Slide 24: Resunab: SSc Phase 2 Clinical Trial
RESUNAB: SSc PHASE 2 CLINICAL TRIAL Double blind placebo control randomized study in US under IND from FDA Primary end points: Change in clinical outcomes (CRISS) + Safety/tolerability Secondary end points: Quality of life, biomarkers of inflammation and fibrosis in blood and skin, metabolipidomic p
Slide 25: Dermatomyositis: Critical Unmet Need in Rare Disease
DERMATOMYOSITIS: CRITICAL UNMET NEED IN RARE DISEASE
Slide 26: Dermatomyositis
DERMATOMYOSITIS is a connective tissue disease characterized by inflammation of skin and muscles 50,000 PATIENTS IN THE USA + EU KEY TAKE-AWAYS Treated with steroids and immunosuppressive therapies but with significant toxicities Single center study underway at University of Pennsylvania NIH is fund
Slide 27: Resunab Reduces Pro-Inflammatory Cytokine Production in PBMC from DM Patients
RESUNAB REDUCES PRO-INFLAMMATORY CYTOKINE PRODUCTION IN ISOLATED PBMC FROM DERMATOMYOSITIS PATIENTS Robinson et al, J Invest Dermatol 135:S10 (abstr #56), 2015. The LPS-stimulated PBMCs of DM patients The median quantity of IFN-α secreted from CPG-stimulated PBMCs of DM patients Resunab (µM) Resunab
Slide 28: Resunab: DM Phase 2 Clinical Trial
RESUNAB: DM PHASE 2 CLINICAL TRIAL Study funded by NIH award to University of Pennsylvania Double blind placebo control randomized study in USA under IND from FDA Primary end points: Safety/tolerability + change in skin activity and severity (CDASI) Secondary endpoints: Quality of life, biomarkers o
Slide 29: 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 Chairman of the Board of the Metropolitan Washingto
Slide 30: World-Class Scientific Advisors
DANIEL FURST, M.D. UCLA SCHOOL OF MEDICINE Director of UCLA Scleroderma Program ETHAN BURSTEIN, PH.D. ACADIA PHARMACEUTICALS INC. Senior Director of Biosciences SUMNER BURSTEIN, PH.D. UMASS MEDICAL SCHOOL Professor of Biochemistry and Pharmacology; inventor of Resunab ROBERT ZURIER, M.D. UMASS MEDIC
Slide 31: Financial Profile: CRBP (NASDAQ)
FINANCIAL PROFILE: CRBP (NASDAQ) $52.6MM Market cap* 37.6 MM Common shares outstanding (43MM fully diluted)* $22 MM Raised to-date + $5MM Award from CFF 158,168 90d average daily volume* * As of January 7, 2016
Slide 32: Milestones 2016
ANTICIPATED DATE MILESTONE Q1 Continue enrollment and dosing for our 3 phase 2 studies, add EU sites for CF Q2 Orphan designation for CF in EU Additional pre-clinical mechanistic studies in CF European CF Conference 2016 Q3 Orphan designation for SSc in EU Complete patient enrollment in CF and SSc s
Slide 33: Contact Us
CONTACT US Corbus Pharmaceuticals Holdings, Inc. 617.963.0100 info@corbuspharma.com www.corbuspharma.com 100 River Ridge Drive Norwood, MA 02062
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