Developing Breakthrough Therapies for Rare Inflammatory and Fibrotic Diseases NASDAQ:CRBP | CORBUSPHARMA.COM
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. 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. 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 SEC. 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
THE CORBUS BUSINESS MODEL Focus Rare inflammatory and fibrotic diseases • 7,000 known rare diseases 1 Acquire Develop • 95% have no approved drugs • >150 rare inflammatory diseases Phase 2 Grow pipeline Market Small expert sales force 1:globalgenes.org and NORD.org 3
MANAGEMENT TEAM YUVAL COHEN PH.D. MARK TEPPER PH.D. CHIEF EXECUTIVE OFFICER PRESIDENT & CHIEF SCIENTIFIC OFFICER Co-founder and former President of Celsus Former VP U.S. Research & Operations, EMD Serono; Therapeutics (CLTX). Expertise in developing anti- Sr. Investigator, Bristol-Myers Squibb inflammatory drugs including for CF BARBARA WHITE M.D. SEAN MORAN C.P.A. M.B.A. CHIEF MEDICAL OFFICER CHIEF FINANCIAL OFFICER Board-certified Rheumatologist and clinical Former CFO: InVivo (NVIV), Celsion (CLSN), immunologist. Previously SVP and Head, R&D Stiefel, Transport Pharma, Echo Therapeutics (ECTE) & VP and Head of Inflammation Clin. Dev. for UCB Anika Therapeutics (ANIK) & MedImmune, and Director, Medical Affairs, Amgen SCOTT CONSTANTINE M.S. DIRECTOR, CLINICAL OPERATIONS Expertise in CF and Pulmonary diseases trials. Former Director, Clinical Research & Operations of Insmed and Clinical Program Scientist at PTC Therapeutics (PTCT) 4
BOARD OF DIRECTORS YUVAL COHEN, PH.D. DAVID HOCHMAN Managing Partner of Orchestra Medical Ventures CHIEF EXECUTIVE OFFICER Over 17 years of venture capital and investment banking experience Former Managing Director of Spencer Trask Ventures, Inc. AMB. ALAN HOLMER securing over $420 million in equity capital CHAIRMAN OF THE BOARD Former CEO of PhRMA (1996-2005) Over two decades of public service in Washington, D.C. RENU GUPTA, M.D. including Special Envoy to China (2007-2009) Over 25 years of development, regulatory and senior Former board member Inspire Pharma management experience in the biopharm industry Chairman of the Board of the Metropolitan Washington, D.C. Former CMO of Insmed, a specialty CF company and current Chapter of the Cystic Fibrosis Foundation advisor to the CEO Former VP and Head of U.S. Clinical Research and Devp AVERY W. (CHIP) CAITLIN Novartis (2003-2006) CFO Celldex Therapeutics (CLDX) since 2000 Raised over $600MM financing Over 20 years experience in industry: Repligen (CFO) and Endogen (CFO) 5
RESUNAB: OUR FIRST ASSET • Novel synthetic oral endocannabinoid-mimetic with unique MOA • First-in-class therapeutic currently targeting four indications $5MM Award from CFF (1) • Cystic Fibrosis (“CF”) • Orphan Designation + Fast Track Status granted by FDA • Diffuse Cutaneous Systemic Sclerosis (“SSc or Scleroderma”) • Orphan Designation + Fast Track Status granted by FDA + Open Label Extension • Dermatomyositis (“DM”) • Systemic Lupus Erythematosus (“SLE”) 2x NIH Grants (2) • Acquired pharma asset with extensive Phase 1 safety data • IP portfolio 2033 6 1) As of 6/30/16, Corbus has received $2.5MM of the $5.MM CFF award. 2) NIH grants fund Ph. 2 trials of Resunab in dermatomyositis and systemic lupus erythematosus; Corbus retains all rights to the p roduct and owns the IND’data.
RESUNAB: CURRENT CLINICAL PIPELINE STATUS Number of Patients Anticipated in U.S. & EU Indication Phase 2 Anticipated Next Study NDA Data Readout # of patients Systemic Sclerosis SSc n = 36 Q4 2016 Q3 2017 2021 (SSc) 90,000 Cystic Fibrosis CF n = 70 Q1 2017 Q3 2017 2021 (CF) 75,000 Dermatomyositis DM n = 22 2H 2017 Q1 2018 2022 (DM) 50,000 Systemic Lupus SLE Erythematosus n = 100 Q4 2018 H2 2019 2023 500,000 (SLE) 7
EXPECTED UPCOMING MILESTONES Q2 2017 • Complete enrollment of Q1 DM study • 2017 Launch Phase 2 SLE study Q4 2016 Q3 • Top-line data from CF 2016 • Complete dosing in SSc • Top-line data from SSc Complete patient • Complete dosing in CF enrollment in CF • ODD for CF and SSc in EU • Commence open-label • Additional pre-clin data CF extension in SSc • NACF 2016 • ACR 2016 8
PATIENT POPULATIONS INCREASE WITH MORE INDICATIONS COMBINED TOTAL PATIENT POPULATIONS IN TARGETED INDICATIONS ASSUMING NDA START 2021 800,000 700,000 600,000 500,000 500,000 400,000 300,000 200,000 50,000 50,000 90,000 90,000 90,000 100,000 75,000 75,000 75,000 - 2021 2022 2023 CF SSc DM SLE 9
RESUNAB RESTORES HOMEOSTASIS DURING PATHOLOGIC IMMUNE REPONSES INFLAMMATION ± FIBROSIS INFECTION ACUTE LIPID MEDIATOR INFLAMMATION CLASS SWITCHING RESUNAB CB2 CB2 CB2 IMMUNE SYSTEM S PECIALIZED P RO-RESOLVING HOMEOSTASIS LIPID M EDIATORS TISSUE HEALING ± AND REMODELING PATHOGEN CLEARANCE Adapted from REIRE & VAN DYKE. Natural resolution of inflammation. Periodontology 2000, 2013;63:149– 164 10
RESUNAB: UNIQUE TARGETING OF CB2 RECEPTOR x12 x1 CB1 Receptors: CB2 Receptors: analgesic receptors in resolution receptors in brain immune system Only 30% Total daily BBB clinical dose penetration 1-40 mg 11
HUMAN MODEL OF INFLAMMATION RESOLUTION Chart progression of inflammation ACTIVATION followed by RESOLUTION for 72 hrs 2.5 days on Inject E.coli Induce 5mg or 20mg intradermally blister of Resunab Derrick Gilroy laboratory, University College London; Motwani BID et al, J Path Clin Res 2016:2:154-165 12
PROOF OF ACTIVITY: RESUNAB REDUCES BLOOD FLOW AT THE SITE OF THE BLISTER AS MEASURED BY DOPPLER LASER Placebo JBT-101 5 mg BID for 2.5 days prior @ 4 hrs • Reduction in blood flow was also seen at 72 hrs post E. coli injection Healthy human volunteers received placebo or JBT-101 at 5 mg twice a day for two days before and on the morning prior a subcutaneous injection of killed E. coli in each forearm. Vasodilation during the acute inflammatory response (4 hours) to E. coli was assessed by laser Doppler measurement of blood flow in the forearm over the site of E. coli injection. 13
PROOF OF ACTIVITY: RESUNAB REDUCES NEUTROPHILS IN THE SKIN DURING INFLAMMATION IN HUMANS PMNs/ml , 4hr 400000 300000 200000 100000 0 Placebo 5mg 20mg Activation phase Resolution phase Healthy human volunteers received placebo (n = 5), JBT-101 at 5 mg twice a day (n = 5), or JBT-101 20 mg twice a day (n = 5) for two days before and on the morning prior a subcutaneous injection of killed E. coli in each forearm. Suction blisters were raised over the site of E. coli injection in one forearm and blister fluid was collected. Neutrophils in the blister fluid at 4 and 10 hours were identified by cell surface markers of HLA-DR-CD16++ and counted. 14
RESUNAB REDUCES THE PRO-INFLAMMATORY MEDIATOR INTERLEUKIN-1 β IN HEALTHY HUMANS 120% • Three healthy adults received single doses of 3, 6, and 100% 10 mg Resunab Percent response • Five hours following each dose, peripheral blood 80% mononuclear cells were isolated and stimulated with LPS, then IL- 1β secretion was measured after 18 hours 60% incubation 40% • Percent of control response (prior to Resunab administration) was determined 20% 0% 0 mg 3 mg 6 mg 10 mg Resunab dose 15
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