Corbus Pharmaceuticals Holdings, Inc. · NASDAQ:CRBP
Corbus Pharmaceuticals — Investor Presentation (May 2017)
49 slides from Corbus Pharmaceuticals's investor presentation, May 9, 2017
Slide 1: Cystic Fibrosis: Focusing on Inflammation & Fibrosis
NASDAQ:CRBP | CORBUSPHARMA.COM
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS This presentation contains certain forward-looking statements, including those relating to the Company’s product development, clinical trials, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, bus
Slide 3: The Corbus Business Model
THE CORBUS BUSINESS MODEL A Market Small Expert Develop Sales Force Acquire Phase 2 > Focus Grow Pipeline Rare Inflammatory & Fibrotic Diseases * 7,000 known rare diseases * 95% have no approved drugs * >150 rare inflammatory diseases tray 3 1) globalgenes.org and NORD.org
Slide 4: Management Team
MANAGEMENT TEAM YUVAL COHEN PH.D. CHIEF EXECUTIVE OFFICER, DIRECTOR Co-founder and former President of Celsus Therapeutics (CLTX). Expertise in developing anti-inflammatory drugs including for CF SEAN MORAN C.P.A. M.B.A. CHIEF FINANCIAL OFFICER Former CFO: InVivo (NVIV), Celsion (CLSN), Transport Ph
Slide 5: Anabasum (fka JBT-101/Resunab)
ANABASUM (FKA JBT-101/RESUNAB) * Novel synthetic oral endocannabinoid-mimetic with unique MOA + First-in-class therapeutic: Positive Ph 2 data in SSc and CF * Pipeline in a product: opportunities in autoimmune, inflammatory & fibrotic diseases Anticipated + IP portfolio > 2033 Approval Syste! Sclero
Slide 6: Expected Near-Term Milestones
EXPECTED NEAR-TERM MILESTONES Q2 2017 Q3 2017 Q4 2017 met
Slide 7: Anabasum Restores Homeostasis During Pathologic Immune Responses
ANABASUM RESTORES HOMEOSTASIS DURING PATHOLOGIC IMMUNE RESPONSES INFLAMMATION CHRONIC INFLAMMATION ———» INFECTION 4 [ ANABASUM Ae 2 (Corbus) cB2 82 CcB2 SPECIALIZED HOMEOSTASIS TISSUE HEALING AND REMODELING FIBROSIS amy CB: | PRO-RESOLVING LIPID MEDIATORS PATHOGEN CLEARANCE CORBUSYY ‘Adapted from RE
Slide 8: Unique Targeting of CB2 Receptor
UNIQUE TARGETING OF CB2 RECEPTOR i) ne? © CB1 Receptors: analgesic receptors in brain CB2 Receptors: resolution receptors in immune system Only 30% BBB penetration Total daily clinical dose:
Slide 9: Diffuse Cutaneous Systemic Sclerosis
DIFFUSE CUTANEOUS SYSTEMIC SCLEROS pul? RELIEF SEA ; WITH NO OVER TARGETED THERAP PY ~ vy wy
Slide 10: Systemic Sclerosis
10 SYSTEMIC SCLEROSIS Chronic systemic autoimmune disease causing fibrosis of skin and internal organs Doin cs MRT 80%. $id 40-60 YEARS Average Age of Patients LUNG FIBROSIS My Common Cause of Death - 40%-60% Mortality in 10 Years KEY TAKE-AWAYS - Life-threatening, rare disease « No SSc-specific app
Slide 11: Upcoming Phase 3 Study of Anabasum in SSc
UPCOMING SINGLE PHASE 3 STUDY OF ANABASUM IN SSc Enrollment Commences Q4 2017 + Protocol submitted to FDA on March 31, 2017 based on guidance following successful end-of-Phase 2 meeting + Planned Study Design: + Single double-blind, randomized, placebo-controlled study + Primary endpoint: change fro
Slide 12: Phase 2 Study of Anabasum in SSc: Design
12 PHASE 2 STUDY OF ANABASUM IN SSc: DESIGN St + Double-blind, randomized, placebo-controlled, Phase 2 study (Part A) * 9 clinical sites in the U.S. + 43 adults ages 18 to 70 with diffuse cutaneous systemic sclerosis (SSc) * 2:1 overall ratio of anabasum:placebo + 16 week study, 12 weeks of active d
Slide 13: Treatment-Emergent Adverse Events in the Phase 2 Study of Anabasum in SSc
13 TREATMENT-EMERGENT ADVERSE EVENTS IN THE PHASE 2 STUDY OF ANABASUM IN SSc 2 serious treatment-emergent adverse events (TEAEs) occurred, both unrelated to study drug + Anabasum cohort: dehydration of moderate severity treated in hospital + Placebo cohort: abdominal pain and nausea of severe severi
Slide 14: Anabasum Demonstrated Improvements in ACR-CRISS Scores Compared to Placebo
ANABASUM DEMONSTRATED IMPROVEMENTS IN ACR-CRISS SCORES COMPARED TO PLACEBO Circle = subject Median = black bar P'=0.044 | Interquartile range = red bars | Anabasum (n = 26) Placebo (n = 15) 100% 100% e e e * Composite score of change from sox ° ee 30% e baseline in mRSS, HAQ-DI, FVC, and e se : ee P
Slide 15: Anabasum Demonstrated Increases in ACR-CRISS Scores Compared to Placebo
ANABASUM DEMONSTRATED INCREASES IN ACR-CRISS SCORES COMPARED TO PLACEBO Anabasum Trial Previous Comparator Trial, Post-hoc Analysis CRISS Score’, % CRISS Score, % Group Median (Interquartile Range or IQR)? Drug Median (IQR) Week 4 Week 8 Week 12 Week 16 Week 52 Anabasum, 3.0 19.0 27.5 33.0 Cyclophos
Slide 16: Skin Thickening Improved with Anabasum Treatment in Phase 2 Testing
SKIN THICKENING IMPROVED WITH ANABASUM TREATMENT IN PHASE 2 TESTING COMPARED TO PLACEBO + Improvement is a reduction in score + Minimal important improvement (MIl) in mRSS is > -3.2 to -5.2 points (Khanna et al, Ann Rheum Dis 2006;65:1325). mRSS Change from Baseline Previous Comparator Trials mRSS,
Slide 17: Skin Symptoms Improved with Anabasum Treatment in Phase 2 Testing
SKIN SYMPTOMS IMPROVED WITH ANABASUM TREATMENT IN PHASE 2 TESTING COMPARED TO PLACEBO Improvement is a reduction in score SSc Skin Symptoms Questionnaire’ 5-D Itch Questionnaire” Previous Comparator Trial 5-D Itch, mean change from baseline P3= 0.032 Drug Time Active | Placebo N=41 N=41 Tocilizumab*
Slide 18: Molecular Skin Score in Skin Biopsies from Phase 2
18 “MOLECULAR SKIN SCORE” IN SKIN BIOPSIES FROM PHASE 2 SHOWS IMPROVEMENT COMPARED TO PLACEBO This “molecular skin score” is a mathematical calculation of skin thickening in SSc based on gene expression in skin biopsies + Based on expression levels of specific genes from microarray data + Validated
Slide 19: All ACR-CRISS Core Efficacy Outcomes Favor Anabasum
ALL 5 ACR-CRISS CORE EFFICACY OUTCOMES FAVOR ANABASUM mRSS Change from Baseline FVC % Predicted, Change from Baseline? PtGA, Change from Baseline P¥=0.08 P=0.10 % a H & 3 7 2 $ E rr g $ H Z Efficacy population. # Least squares mean difference, 2 * Efficacy population, east squares mean difference, E
Slide 20: Ongoing Open-Label Extension of Phase 2 Study
ONGOING OPEN-LABEL EXTENSION OF PHASE 2 STUDY Data Scheduled for Presentation at ACR 2017 * Open-label extension of Phase 2 study to collect long-term safety and efficacy data 12 months duration, to be extended to 24 months All subjects receive anabasum Same safety and efficacy measures as in the bl
Slide 21: Summary on Anabasum Clinical Development in SSc
21 SUMMARY ON ANABASUM CLINICAL DEVELOPMENT IN SSc Safety and tolerability profiles of anabasum in SSc are acceptable Promising and consistent evidence of clinical benefit in multiple clinical outcomes in SSc Evidence of relevant biological activity in involved skin from patients in the Phase 2 stud
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Slide 23: Cystic Fibrosis
23 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 seeeetta 40 YEARS Average Life Expectancy of CF Patients KEY
Slide 24: Anabasum Is Uniquely Positioned in CF
ANABASUM IS UNIQUELY POSITIONED IN CF Potential to be First Therapy for Chronic Inflammation and Fibrosis in CF v First-in-class CB2 agonist in CF | | ¥ Targets inflammation and fibrosis “lon channel Dysfunction v¥ Not immunosuppressive | {| | | Y¥ Oral, daily dosing v Add-on to current therapy Anab
Slide 25: JBT101-CF-001 Phase 2 Trial Design
JBT101-CF-001 PHASE 2 TRIAL DESIGN Study Completed March 2017 * Double-blind, randomized, placebo-controlled, Primary Objective 16-week trial + Evaluate safety and tolerability * 21 clinical sites in the US, UK, Germany, Italy, + Pulmonary exacerbations are an event of and Poland special interest +
Slide 26: Primary Endpoint: Safety and Tolerability Outcomes
PRIMARY ENDPOINT: SAFETY AND TOLERABILITY OUTCOMES Safety + Primary safety outcome: Treatment-emergent adverse events Pre-Specified Events of Special Interest Include + Acute pulmonary exacerbations requiring IV antibiotics Tolerability + Discontinuation of study product because of treatment-emergen
Slide 27: Study Populations
STUDY POPULATIONS 89 Randomized 4 withdrew prior to dosing er >) + 3 withdrew consent + 1 pulmonary exacerbation Safety and Efficacy Populations N=85 23 Completed placebo treatment | 51 Completed anabasum treatment 27 14.1.1.1.ds
Slide 28: Baseline Demographics of Subjects
BASELINE DEMOGRAPHICS OF SUBJECTS Weeks 1-4 Weeks 5-16 Characteristic Anabasum Anabasum Placebo Anabasum Anabasum Placebo img QD 5 mg QD 20 mg QD 20 mg BID N=26 N=24 N=35 N=31 N=30 N=24 Male, % 65.4 50.0 48.6 51.6 50.0 62.5 Age, mean (range) 26.9 (19-52) | 28.8 (18-62) | 29.2 (18-59) | 28.5 (18-62)
Slide 29: Baseline Disease Characteristics of Subjects
BASELINE DISEASE CHARACTERISTICS OF SUBJECTS Weeks 1-4 Weeks 5-8 Characteristic JBT-101 JBT-101 Placebo JBT-101 JBT-101 Placebo imgQD 5mgQD 20 mg QD 20 mg BID N=26 N=24 N=35 N=31 N=30 N=24 : 13/9/4 14/7/3 21/10/4 14/12/5 20/773 14/7/83 F5080; 2 alleles/ 1 alleles/ O alleles 50%/35%/15% | 58%/29%/13%
Slide 30: Baseline Medications of Subjects
BASELINE MEDICATIONS OF SUBJECTS Subjects, n (%) Medication Anabasum Anabasum Placebo Anabasum Anabasum Placebo 1mg QD 5mgQD 20 mg QD 20 mg BID N=26 N=24 N=35 N=31 N=30 N=24 Azithromycin 8 (30.1) 16 (66.7) 21 (60.0) 14 (45.2) 13 (43.3) 14 (58.3) Prophylactic antibiotics eccluding atithinomyein 13 (5
Slide 31: Subjects with TEAEs by Dose
31 SUBJECTS WITH TEAEs BY DOSE Subjects, n (%) Treatment-Emergent Weeks 1-4 Weeks 5-12 Post Treatment Adverse Event (TEAE) Anabasum] Anabasum] Placebo | Anabasum] Anabasum] Placebo | Anabasum] Anabasum] Placebo 14mg 5mg 20mg | 20mg BID 20mg | 20mg BID N=26 N=24 N=35 N=34 N=30 N=24 N=31 N=30 N=24 Any
Slide 32: Pulmonary Exacerbation Requiring Treatment with Intravenous Antibiotics
PULMONARY EXACERBATION REQUIRING TREATMENT WITH INTRAVENOUS ANTIBIOTICS + Pre-specified event of special interest. Most severe category of pulmonary exacerbation in CF + Assignment to treatment arm is by time of onset of symptoms that required intravenous antibiotic treatment Treatment Group, N at r
Slide 33: First Acute Pulmonary Exacerbation Defined as Treatment with New Antibiotics
FIRST ACUTE PULMONARY EXACERBATION DEFINED AS TREATMENT WITH NEW ANTIBIOTICS A broader look at acute pulmonary exacerbations as defined by treatment with new antibiotics for respiratory system symptoms Treatment Group, N at risk for Subjects n/N at risk (%) 1st exacerbation Weeks 1-4 Weeks 5-12 Post
Slide 34: Anabasum Reduces Inflammatory Cells in CF Sputum (1)
ANABASUM REDUCES INFLAMMATORY CELLS IN CF SPUTUM (1) Least Squares (LS) mean difference from placebo, log49 (SE) 1mg 5mg 20 mg 20 mg BID 34 Total Cells Reduced Cell Numbers p=0.031 0.30 p=0.144 -0.82 ———— -0.64 1.75 -15 -1.25 -1 -0.75 -0.5 -0.25 0 LS Mean Difference from Placebo (SE) Neutrophils Red
Slide 35: Anabasum Reduces Inflammatory Cells in CF Sputum (2)
35 ANABASUM REDUCES INFLAMMATORY CELLS IN CF SPUTUM (2) Least Squares (LS) mean difference from placebo, logy, (SE) Lymphocytes Macrophages Reduced Cell Numbers Reduced Cell Numbers 1mg img img 5mg Smg | 5mg p=0.128 20 mg 20 mg ————| -0.74 20mg 20 mg BID 20 mg BID 7 7 —} -0.61 20 mg BID > 1505-125 -
Slide 36: Anabasum Reduces Inflammatory Mediators in CF Sputum
ANABASUM REDUCES INFLAMMATORY MEDIATORS IN CF SPUTUM Least Squares (LS) mean difference from placebo, 1og49 (SE) Interleukin-8 Neutrophil Elastase Immunoglobulin G 6 Reduced Mediators < Reduced Mediators Reduced Mediators 41mg -0.07 img 0.08 1mg 0.00 1mg 20 mg ——_—— -0.08 20 mg ——4 | 20 mg 20 mg p=
Slide 37: Effect of Anabasum on Inflammatory Mediators in Blood
EFFECT OF ANABASUM ON INFLAMMATORY MEDIATORS IN BLOOD Least Squares (LS) mean difference from placebo, 10g49 (SE) Interleukin-8 CRP. Immunoglobulin G < Reduced Mediators < Reduced Mediators < Reduced Mediators 1mg 042 img oof img Hox img 5 mg 5mg —pos 5mg o.00 5mg 20 mg p.01 20 mg [e0s| 20 mg 4 p=0.
Slide 38: Summary of Clinical Development of Anabasum in CF
38 SUMMARY OF CLINICAL DEVELOPMENT OF ANABASUM IN CF * Safety and tolerability profiles of anabasum in CF are acceptable * Promising evidence of clinical benefit in pulmonary exacerbations in CF * Evidence of relevant biological activity in sputum from patients in the Phase 2 study supports clinical
Slide 39: Next Steps in Clinical Development of Anabasum in CF
39 NEXT STEPS IN CLINICAL DEVELOPMENT OF ANABASUM IN CF * Submit Pediatric Investigational Plan to EMA * Obtain expert opinion in the design of Phase 2b study * Reach agreement on design on Phase 2b study with FDA (Type C meeting) and EMA (Protocol Assistance) * Phase 2b study planned to start in Q4
Slide 40: CFF Statement on Anabasum Phase 2 Results
CFF STATEMENT ON ANABASUM PHASE 2 RESULTS 40 “Corbus Pharmaceuticals reported promising results Thursday from an early stage clinical study of a potential anti- inflammatory drug for people with cystic fibrosis. Researchers believe that reducing excessive inflammation in people with CF will reduce l
Slide 41: Dermatomyositis & Lupus (SLE): Working with the NIH on Rare Autoimmune Diseases
DERMATOMYOSITIS & LUPUS (SLE): WORKING WITH THE NIH ON RARE AUTOIMMUNE DISEASES
Slide 42: Dermatomyositis
42 DERMATOMYOSITIS Chronic systemic autoimmune disease characterized by inflammation of skin and muscles 50,000 eee Patients in the U.S. + EU SKIN & MUSCLE Involvement Can Cause Significant Morbidity and Mortality from Interstitial Lung Disease NO FDA Approved Therapies for Overall Disease Activity
Slide 43: Anabasum: DM Phase 2 Clinical Study
ANABASUM: DM PHASE 2 CLINICAL STUDY Complete Patient Enrollment Expected Q2 2017 * Study funded by NIH award to University of Pennsylvania + Double blind placebo control randomized study in U.S. under IND from FDA + Primary endpoints: Safety/tolerability + change in skin activity and severity (CDASI
Slide 44: Anabasum: DM Open-Label Extension
44 ANABASUM: DM OPEN-LABEL EXTENSION * 12-month open-label extension study granted by U.S. FDA in November 2016 * Goal of the open-label extension is to collect long-term safety and efficacy data on anabasum * All subjects in the extension study are receiving anabasum * Same safety and efficacy endp
Slide 45: Systemic Lupus Erythematosus
45 SYSTEMIC LUPUS ERYTHEMATOSUS Chronic systemic autoimmune disease characterized by arthritis, skin rashes, kidney disease, and involvement of the nervous system and other organs 500,000 — 600,000 Patients in the U.S. + EU eee . 10-12:1 Women to Men PERRR Higher Incidence and More Severe in Blacks
Slide 46: Anabasum: SLE Phase 2 Clinical Study
ANABASUM: SLE PHASE 2 CLINICAL STUDY = Trial Expected to Start in H2 2017 Primary Endpoint: Secondary Endpoint: Safety and Tolerability Directional Trends in Efficacy + PK * Study funded by NIH award to Feinstein Institute for Medical Research + Double blind placebo control randomized study in U.S.
Slide 47: Scientific Advisors and Principal Investigators
SCIENTIFIC ADVISORS AND PRINCIPAL INVESTIGATORS Scientific Advisors Principal Investigators q i WY) Case WESTERN ESERVE Charles N. Serhan, PhD HARVARD James Chmiel, MD Bi caevysrenye ST 1836 US Pl for Cystic Fibrosis think beyond the possible : piinidal alent Robert Spiera, MD 27 HOSPITAL FOR Michae
Slide 48: Financial Profile: CRBP (NASDAQ)
FINANCIAL PROFILE: CRBP (NASDAQ) $78MM 50.2MM aised to-date $31 1 M M Common shares ® ae ae $49M M + Market cap* outstanding ‘ Cash balance** daily volume* (57.8MM fully diluted)** $20 M M y non-dilutive funding from N.I.H. and CF Foundation * Based on May 8, 2017 closing price of $6.20 per share 48
Slide 49: Contact Us
49 CONTACT US Corbus Pharmaceuticals Holdings, Inc. 617.963.0100 info@corbuspharn na.com www.corbuspharma.com 100 River Ridge Drive Norwood, MA 02062
Corbus Pharmaceuticals Holdings — Investor Presentation (May 2017) on 6ix