Corbus Pharmaceuticals Holdings, Inc. · NASDAQ:CRBP
Corbus Pharmaceuticals — Investor Presentation (June 2016)
37 slides from Corbus Pharmaceuticals's investor presentation, Jun 16, 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 Develop Market Acquire Engaging the immune system to treat rare diseases Serious morbidity + life-threatening indications with clear unmet need Resunab currently in three Phase 2 studies & SLE Phase 2 study to commence Q1-17 Obtain support from patient organizations a
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: 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 6: Resunab: Our First Asset
RESUNAB: OUR FIRST ASSET As of 3/31/16, Corbus has received $2.5MM of the $5.MM CFF award. NIH grants fund Ph. 2 trials of Resunab in dermatomyositis and systemic lupus erythematosus; Corbus retains all rights to the product and owns the IND’data. Novel synthetic oral endocannabinoid-mimetic with un
Slide 7: Resunab: Current Clinical Pipeline Status
RESUNAB: CURRENT CLINICAL PIPELINE STATUS CF 75,000 SSc 90,000 DM 50,000 Cystic Fibrosis (CF) Systemic Sclerosis (SSc) Dermatomyositis (DM) Indication Number of Patients in U.S. & EU NDA Anticipated Next Study Phase 2 2021 2021 2022 Q3 2017 Q3 2017 Q1 2018 Anticipated Data Readout n = 70 n = 36 n =
Slide 8: Milestones: The Next Months
MILESTONES: THE NEXT 9 MONTHS Q2 2016 Q3 2016 Q4 2016 Q1 2017 FDA approval for 12-month open-label extension in SSc Phase 2 study European CF Conference 2016 Orphan designation for CF in EU Additional pre-clinical mechanistic studies in CF Orphan designation for SSc in EU Complete patient enrollment
Slide 9: Immune System Homeostasis
IMMUNE SYSTEM HOMEOSTASIS PRO-INFLAMMATORY MEDIATORS SPECIALIZED PRO-RESOLVING LIPID MEDIATORS LIPID MEDIATOR CLASS SWITCHING Adapted from REIRE & VAN DYKE. Natural resolution of inflammation. Periodontology 2000, 2013;63:149–164 RESUNAB RESTORES HOMEOSTASIS DURING PATHOLOGIC IMMUNE REPONSES INFLAMMA
Slide 10: Resunab: Unique Targeting of CB2 Receptor
RESUNAB: UNIQUE TARGETING OF CB2 RECEPTOR x1 CB1 Receptors: analgesic receptors in brain CB2 Receptors: resolution receptors in immune system Total daily clinical dose 1-40 mg x12 Only 30% BBB penetration
Slide 11: Resunab Reduces Interleukin-1β in Healthy Humans
RESUNAB REDUCES THE PRO-INFLAMMATORY MEDIATOR INTERLEUKIN-1β IN HEALTHY HUMANS Resunab dose 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-1β secr
Slide 12: Resunab: An Attractive Clinical Safety Profile
RESUNAB: AN ATTRACTIVE CLINICAL SAFETY PROFILE Treatment Emergent Adverse Event (TEAE) Most Common Treatment Emergent Adverse Events, by Severity of AE, n Subjects receiving ≥ 1 mg to ≤ 60 mg total daily dose, n = 52 (% all subjects at these doses) Subjects receiving ≥ 80 mg to ≤ 240 mg total daily
Slide 13: Cystic Fibrosis: Focusing on Inflammation & Fibrosis
CYSTIC FIBROSIS: FOCUSING ON INFLAMMATION & FIBROSIS
Slide 14: 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 U.S. 75,000 PATIENTS WORLDWIDE 40 YEARS AVERAGE LIFE EXPECTANCY OF CF PATIE
Slide 15: Resunab Is Uniquely Positioned in CF
RESUNAB IS UNIQUELY POSITIONED IN CF 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 current therapy CHANGE THE CF TREATMENT PARADIGM: DAILY FOUNDATIONAL TREATMENT FOR ALL CF PATIENTS CFTR De
Slide 16: Resunab Resolves Lung Inflammation in Infected CF Mouse Model
RESUNAB RESOLVES LUNG INFLAMMATION IN PSEUDOMONAS AERUGINOSA INFECTED CF MOUSE MODEL DESIGN WT CF Pseudomonas aeruginosa into lungs + Placebo for 10 days OR + Resunab for 10 days Analyze Total BAL Cell Recruitment Post-Resunab Absolute # of Cells (m/BAL; Mean±SEM) %MAC/ml BAL (Mean±SEM) Relative Num
Slide 17: 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 Bacterial CFU After 10 Days Resunab Number of CFUs x 1,000 (Mean±SEM) Mice WT WT CFTR-/- CFTR-/- Pseudomonas + + + + Resunab* - + - + Bonfield, Tracey; Tepper, Mark 2015 * - Treate
Slide 18: 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 WT + Pseudomonas, - Resunab WT + Pseudomonas + Resunab CF mice + Pseudomonas, - Resunab CF mice + Pseudomonas + Resunab Bonfield, Tracey; Tepper, Mark 2015 GROUP SURVIVAL RATE
Slide 19: Resunab: Cystic Fibrosis Phase 2 Trial
Double blind randomized placebo control study in the U.S. 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 MOA, biomarkers of disease activity an
Slide 20: Decision Making After Current Phase Trials: Defining Success
DECISION MAKING AFTER OUR CURRENT PHASE 2 TRIALS: DEFINING SUCCESS CB2 agonist activity in humans (metabolipidomic profile, biomarkers)? YES Safety and PK support next study? Additional Phase 2 study STOP Pivotal trials YES Directional improvements in clinical outcomes? YES Supportive discussions wi
Slide 21: Diffuse Cutaneous Systemic Sclerosis: No Approved Targeted Therapy
DIFFUSE CUTANEOUS SYSTEMIC SCLEROSIS: RELIEF FOR A DISEASE WITH NO APPROVED TARGETED THERAPY
Slide 22: Systemic Sclerosis
SYSTEMIC SCLEROSIS Chronic systemic autoimmune 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
Slide 23: Therapeutic Rationale for Resunab in Systemic Sclerosis
THERAPEUTIC RATIONALE FOR RESUNAB IN SYSTEMIC SCLEROSIS (SSc) Would be first approved drug in SSc Targets multiple disease pathways No immunosuppression Oral, daily dosing SET THE SSc TREATMENT PARADIGM: CONTROL ACTIVE DISEASE WITHOUT IMMUNOSUPPRESSION AUTOIMMUNE TRIGGER INFLAMMATION VASCULOPATHY FI
Slide 24: Resunab Inhibits Collagen Deposition in Bleomycin 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 25: Resunab Reduces Biomarkers in Fibroblasts from SSc Patients
RESUNAB REDUCES BIOMARKERS IN FIBROBLASTS FROM SSc PATIENTS Cultured human dermal fibroblasts from healthy volunteers or patients with diffuse cutaneous systemic sclerosis Resunab (μM) Resunab (μM) Healthy donor dermal fibroblasts Diffuse cutaneous systemic sclerosis dermal fibroblasts TGFβ *p < 0.0
Slide 26: Resunab: SSc Phase 2 Clinical Trial
Double blind placebo control randomized study in U.S. 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 profile, PK Patient number: 36 adul
Slide 27: Resunab: SSc Open-Label Extension
RESUNAB: SSc PHASE 2 CLINICAL TRIAL OPEN-LABEL EXTENSION 12-month open-label extension study of ongoing Phase 2 clinical trial of Resunab granted by U.S. FDA Goal of the open-label extension is to collect long term safety and efficacy data on Resunab All subjects from ongoing double-blind placebo-co
Slide 28: Dermatomyositis & Lupus: Working with the NIH
DERMATOMYOSITIS & LUPUS (SLE): WORKING WITH THE NIH ON RARE AUTOIMMUNE DISEASES
Slide 29: Dermatomyositis
DERMATOMYOSITIS Chronic systemic autoimmune disease characterized by inflammation of skin and muscles 50,000 PATIENTS IN THE U.S. + EU KEY TAKE-AWAYS Treated with steroids and immunosuppressive therapies but with significant toxicities Single center study underway at University of Pennsylvania NIH i
Slide 30: Systemic Lupus Erythematosus
SYSTEMIC LUPUS ERYTHEMATOSUS Chronic systemic autoimmune disease characterized by arthritis, skin rashes, kidney disease, and involvement of the nervous system and other organs KEY TAKE-AWAYS Treated with steroids and immunosuppressive therapies Multi-center study planned (n=100) NIH is funding the
Slide 31: Resunab Reduces Cytokine Production in Dermatomyositis PBMC
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 32: Resunab Reduces Cytokine Production by SLE PBMC
RESUNAB REDUCES PRO-INFLAMMATORY CYTOKINE PRODUCTION BY PBMC FROM INDIVIDUALS WITH SLE PBMC from a patient with SLE were stimulated ex vivo with CpG DNA and exposed to increasing concentrations of Resunab. IFNα gene expression was measured using RT-PCR. PBMC from five SLE patients stimulated with Cp
Slide 33: Resunab: DM Phase 2 Clinical Trial
Study funded by NIH award to University of Pennsylvania Double blind placebo control randomized study in U.S. under IND from FDA Primary end points: Safety/tolerability + change in skin activity and severity (CDASI) Secondary endpoints: Quality of life, biomarkers of inflammation and disease activit
Slide 34: Resunab: SLE Phase 2 Clinical Trial
Study funded by NIH award to Feinstein Institute for Medical Research Double blind placebo control randomized study in U.S. under IND from FDA Primary end points: Efficacy in inflammatory pain in subjects with active musculoskeletal disease Secondary endpoints: Efficacy in overall disease activity,
Slide 35: Scientific Advisors and Principal Investigators
JAMES CHMIEL, M.D. CASE WESTERN RESERVE MEDICAL SCHOOL Professor of Pediatrics, National PI on largest ever anti-inflammatory CF study U.S. PI for Cystic Fibrosis ROBERT SPIERA, M.D. HOSPITAL FOR SPECIAL SURGERY Director of the Vasculitis and Scleroderma Program U.S. PI for Scleroderma VICTORIA WERT
Slide 36: Financial Profile: CRBP (NASDAQ)
FINANCIAL PROFILE: CRBP (NASDAQ) $131MM Market cap* 43.7MM Common shares outstanding (51.1MM fully diluted)* $37MM Raised to-date + $5MM Award from CFF 194,619 90d average daily volume* $22.6MM Cash balance** (+$2.5MM from CFF award in 2016 ) * Based on June 14, 2016 closing price of $2.99 per share
Slide 37: Contact Us
CONTACT US Corbus Pharmaceuticals Holdings, Inc. 617.963.0100 info@corbuspharma.com www.corbuspharma.com 100 River Ridge Drive Norwood, MA 02062
Corbus Pharmaceuticals Holdings — Investor Presentation (June 2016) on 6ix