Indication PatientPopulation
Phase of Development
Orphan Designation
Fast Track Status
Open-Label Extension
NondilutiveFunding
Highlights
Genetic /Inflammatory Cystic Fibrosis (CF) 75,000
(worldwide) Phase 2b ✓ ✓ $30MM Awarded from CFF2
Patient dosing expected to commence
Q1 2018
Autoimmune
Systemic Sclerosis (SSc)
90,000(US+EU)
Phase 3“RESOLVE-1” ✓ ✓ ✓ Commenced patient
dosing Q1 2018
Dermatomyositis (DM)
70,000(US)
Positive Phase 2 ✓ ✓
NIH Funded1
Next clinical study expected to commence
H2 2018
Systemic Lupus Erythematosus
(SLE)
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 Company’s 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 In�ammatory and Fibrotic Diseases
TM
Institutional Investor Inquiries:Corbus Pharmaceuticals, Inc.Ted Jenkins, Senior Director,
Investor Relations and CommunicationsPhone: 617.415.7745
Email: [email protected]
All Other Investor Inquiries:Jenene Thomas Communications
Jenene ThomasPhone: 908.938.1475 Email: [email protected]
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
$30MMAwarded
from CFF2
SSc:üDose first patient in Phase
3 RESOLVE-1 study• Report data from OLE
CF:üCommence Phase 2b study• Dose first patient in Phase
2b study
DM:• Launch next study• Report data from OLE
SLE:üDose 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 In�ammatory and Fibrotic Diseases
TM
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
Dermatomyositis
Systemic Lupus Erythematosus
40%-60% Mortality
in 10 years
57%
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 BID
5mg BID placebo
or
or
Dosing
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 Fuch’s 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
~70
20mg BID
5mg BID placebo
or
or
Dosing
Supported by $25 Million Development Award from Cystic Fibrosis Foundation*Topline Data Expected 2020
80% Female Patients
