management team rare autoimmune / inflammatory / ??market cap*: ... $5 million awarded in 2015 for...

Download Management Team Rare Autoimmune / Inflammatory /  ??Market Cap*: ... $5 million awarded in 2015 for first Phase 2 study, ... Rare Autoimmune / Inflammatory / Fibrotic Diseases Expected Development Milestones

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  • Indication PatientPopulation

    Phase of Development

    Orphan Designation

    Fast Track Status

    Open-Label Extension



    Genetic /Inflammatory Cystic Fibrosis (CF)

    75,000(worldwide) Phase 2b

    $30MM Awarded from CFF2

    Patient dosing expected to commence

    Q1 2018


    Systemic Sclerosis (SSc)


    Phase 3RESOLVE-1

    Commenced patient dosing Q1 2018

    Dermatomyositis (DM)


    Positive Phase 2 NIH Funded1

    Next clinical study expected to commence

    H2 2018

    Systemic Lupus Erythematosus


    500,000(US+EU) Phase 2

    NIH Funded1

    Commenced patient dosing Q1 2018

    Management TeamYuval Cohen, Ph.D.

    Chief Executive Officer, Director

    Mark Tepper, Ph.D.President, Chief Scientific Officer

    Barbara White, M.D. Chief Medical Officer

    Sean Moran, M.B.A., C.P.A.Chief Financial Officer

    Board of Directors

    Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) is a Phase 3 clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare, chronic, and serious inflammatory and fibrotic diseases. The Companys lead product candidate, lenabasum, is a novel, synthetic oral endocannabinoid-mimetic drug designed to resolve chronic inflammation and fibrotic processes. Lenabasum is currently being evaluated in systemic sclerosis, cystic fibrosis, dermatomyositis and systemic lupus erythematosus.

    NASDAQ: CRBPShare Price*: $7.10Market Cap*: $405MShares Outstanding: 57.1MAverage daily trading volume 955K shares*As of March 9, 2018

    Amb. Alan Holmer - Chairman Former Chief Executive Officer of PhRMA and Chair of Cystic Fibrosis Foundation

    Chapter, Washington, DC

    Yuval Cohen, Ph.D. Chief Executive Officer, Director

    Mr. David Hochman - Director Orchestra Ventures

    Dr. Renu Gupta - Director Former Chief Medical Officer of Insmed

    Avery W. Catlin - Director Retired Chief Financial Officer, Celldex

    Paris Panayiotopoulos - Director Former President and Chief Executive Officer

    and a member of the Board of Directors of ARIAD Pharmaceuticals, Inc

    Developing Breakthrough Therapies for Rare Inammatory and Fibrotic Diseases


    Institutional Investor Inquiries:Corbus Pharmaceuticals, Inc.Ted Jenkins, Senior Director,

    Investor Relations and CommunicationsPhone: 617.415.7745


    All Other Investor Inquiries:Jenene Thomas Communications

    Jenene ThomasPhone: 908.938.1475 Email:

    1: NIH grants fund Phase 2 trials of lenabasum in dermatomyositis and systemic lupus erythematosus; Corbus retains all rights to the product and owns the IND data; 2: $5 million awarded in 2015 for first Phase 2 study, project completed; up to additional $25 million development awarded in 2018 towards Phase 2b study

    Lenabasum Pipeline: Multiple Opportunities in Rare Autoimmune / Inflammatory / Fibrotic Diseases

    Expected Development Milestones

    700,000people living with these

    4 conditions in the 7 Major Markets


    from CFF2

    SSc:Dose first patient in Phase

    3 RESOLVE-1 study Report data from OLE

    CF:Commence Phase 2b study Dose first patient in Phase

    2b study

    DM: Launch next study Report data from OLE

    SLE:Dose first patient in

    Phase 2 study

    SSc: Complete dosing in

    Phase 3 RESOLVE-1 study

    CF: Complete enrollment and

    patient dosing in Phase 2b study

    DM: Complete enrollment in

    next study

    SLE: Complete dosing in

    Phase 2 study

    SSc: Report data from Phase 3

    RESOLVE-1 study Prepare NDA filing

    CF: Report topline results

    from Phase 2b study

    SSc: Expected approval Commercial launch

    2018 2019 2020 2021

  • Developing Breakthrough Therapies for Rare Inammatory and Fibrotic Diseases


    80% Female Patients

    90,000Patients in the US & EU No SSc-Specific

    Drugs Currently Approved

    Chronic inflammatory autoimmune disease causing fibrosis of skin and internal organs

    Chronic autoimmune disease in which the immune system attacks the body, leading to widespread inflammation and tissue damage

    Patients in the US & EU75,000

    No Drugcurrently approvedtargeting inflammation and fibrosis

    PExPulmonary Exacerbations (PEx)

    main driver of morbidity and mortality

    Serious systemic autoimmune condition characterized by distinct skin lesions that can be accompanied by erosions, photosensitivity, itch, ulcers, calcinosis and hair loss as well as muscle inflammation and wasting

    Currently treated with immunosuppressive therapies, but with significant toxicities

    70,000Patients in the US & EU 10 Year Survival Rate

    Patients in the US & EU500,000 Only One Drug

    currently approved for use 1 Occurs More Often in Women of ChildBearing Age

    Systemic Sclerosis

    Cystic Fibrosis


    Systemic Lupus Erythematosus

    40%-60% Mortality

    in 10 years


    Life-threatening, genetic disease that primarily affects the lungs and digestive system, characterized by chronic lung inflammation that leads to lung damage and fibrosis

    Target Indication Overview

    Systemic Sclerosis Ongoing Phase 3 RESOLVE-1 Study

    Double-blind20mg BID5mg BID placebo





    52 week studyrandomized, placebo-controlled

    Primary Endpoint: Change from baseline in mRSS Secondary Endpoints: Change from baseline in HAQ-DI; ACR CRISS; Change from baseline in FVC % predicted Primary Endpoint:

    Event rate of pulmonary exacerbations 20mg BID vs. placebo - Physician decision to treat with oral, intravenous or inhaled antibiotic(s) in the presence of at least 4/12 Fuchs criteria

    Cystic Fibrosis Ongoing Phase 2b Study

    Secondary Endpoints: Other measures of pulmonary exacerbations; CFQ-R Respiratory Domain Score; FEV1 % predicted

    Inclusion Criteria: 12 years of age and older; Enrichment for exacerbations; Any mutation, infecting organism, antibiotics and other background medications, including Orkambi and Kalydeco

    ~354 Subjectsoverall ratio of lenabasum:placebo1:1:1

    ~415 Subjectsoverall ratio of lenabasum:placebo3:2

    clinical sites across North America, Europe, Israel and Australia ~100

    Double-blind28 week study

    randomized, placebo-controlled

    clinical sites across North America, Europe, Israel, Japan, South Korea and Australia

    *Up to $25 million development award from CFF, announced in January 2018


    20mg BID

    5mg BID placebo





    Supported by $25 Million Development Award from Cystic Fibrosis Foundation*Topline Data Expected 2020

    80% Female Patients


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