Corbus Pharmaceuticals Holdings, Inc. · NASDAQ:CRBP

Corbus Pharmaceuticals — Technical Presentation (November 2020)

34 slides from Corbus Pharmaceuticals's technical presentation, Nov 16, 2020

  1. Slide 1: RESOLVE-1 Phase 3 Study of Lenabasum in Systemic Sclerosis

    RESOLVE-1 Phase 3 Study of Lenabasum in Systemic Sclerosis PHARMACEUTICALS Pioneering transformative medicines that target the endocannabinoid system © 2020 Corbus Pharmaceuticals Holdings, Inc.

  2. Slide 2: Systemic Sclerosis: The Unmet Need

    Systemic Sclerosis: The Unmet Need

  3. Slide 3: Systemic sclerosis is a rare, debilitating, life-threatening autoimmune disease

    Systemic sclerosis is a rare, debilitating and life-threatening autoimmune disease characterized by inflammation & fibrosis IMMUNE & FIBROBLAST — INFLAMMATION 4 3 ACTIVATION Va - 4 E / . y a \ PROGRESSIVE / \ VASCULAR DAMAGE TRECCERING: "| | Chronic & systemic S (EVENT 2 J "TISSUE ISCHEMIA \ & HYPOX

  4. Slide 4: Systemic sclerosis has among the highest mortality of systemic autoimmune diseases

    temic sclerosis has among the highest mortality of systemic autoimmune diseases, driven primarily by its deleterious effects on major organs an involvement in SSc f onset of Raynau enon Patients with SSc have four times (4x) greater risk of death than their healthy counterparts! DLCO <80% Gl involve

  5. Slide 5: Physicians are most concerned with lung involvement in SSc

    Physicians are most concerned with lung involvement in SSc Rheumatologists rank pulmonary disorders as the most strongly associated and highly concerning of SSc specific symptoms... ..they are also most familiar with, and find most important, forced vital capacity (FVC) as an SSc endpoint Strongly S

  6. Slide 6: Rationale for Lenabasum in Systemic Sclerosis

    Rationale for Lenabasum in Systemic Sclerosis

  7. Slide 7: Oral agonist of cannabinoid receptor type 2 (CB2)

    * Oral agonist of cannabinoid receptor type 2 (CB2), a GPCR that regulates inflammation and fibrosis * Designed as a disease-modifying alternative to immunosuppressive treatments for chronic inflammatory and fibrotic diseases « Has effects on immune cells and fibroblasts, both of which express CB2 w

  8. Slide 8: Animal model data provide link between CB2 and systemic sclerosis

    Animal model data provide link between CB2 and systemic sclerosis Excessive lung fibrosis develops in mice without CB2 — Mice without CB2 (CB2-/- knock-out mice) develop excessive lung and skin fibrosis and SSc-specific autoantibodies (anti-DNA “<i : : topoisomerase 1 antibodies) when their immune C

  9. Slide 9: Lenabasum reduced fibrosis in an animal model of SSc lung disease

    Lenabasum reduced fibrosis in an animal model of SSc lung disease Bleomycin Lung fibrosis induced with bleomycin Lung fibrosis is induced with bleomycin (bleomycin versus control) Lenabasum, whether started prophylactically before bleomycin or therapeutically 1 week after bleomycin, reduced lung inf

  10. Slide 10: Lenabasum improved inflammation and fibrosis in skin biopsies in Phase 2

    Phase 2 | Lenabasum improved inflammation and fibrosis in skin biopsies from SSc patients in a Phase 2 study Inflammation Fibrosis P = 0.006 Fisher's exact probability test P = 0.05 Fisher's exact probability -test 100% 0% Lenabasum Lenabasum = 8 © 2 S" ia9 = am 80% mlmproved More improvement or § (

  11. Slide 11: Lenabasum reduced expression of gene pathways involved in fibrosis

    Phase 2 | Lenabasum reduced expression of gene pathways involved in fibrosis in skin biopsies from SSc patients Extracellular Matrix Organization Pathway Lenabasum Placebo Greater reduction in gene ontology pathways associated with é ; : A 2.0 2.0 = inflammation and fibrosis pense in paired skin bio

  12. Slide 12: Lenabasum improved efficacy results in a 16-week Phase 2 study in SSc

    Phase 2 | Lenabasum improved efficacy results in a 16-week Phase 2 study in SSc Change in mRSS Change in FVC, % predicted 25 2 15 1 05 0 -0.5 Greater numerical reduction in modified Rodnan skin score (mRSS), a measure of skin fibrosis, and forced vital capacity (FVC) percent predicted, a measure of

  13. Slide 13: RESOLVE-1 Phase 3 Study Design and Results

    RESOLVE-1 Phase 3 Study Design and Results

  14. Slide 14: Eligibility criteria and efficacy endpoints in the RESOLVE-1 Phase 3 study

    Phase 3 | Eligibility criteria and efficacy endpoints in the RESOLVE-1 Phase 3 study were similar to those in Phase 2 Phase 3 Design * Double-blind, randomized, placebo- controlled, 52-week study of lenabasum in diffuse cutaneous SSc ACR CRISS at Week 52 was the primary efficacy endpoint Change in F

  15. Slide 15: 90% of the mITT population completed the RESOLVE-1 Phase 3 study

    Phase 3 | 90% of the modified intent-to-treat population completed the RESOLVE-1 Phase 3 study isposition Lower than anticipated drop-out rate of 9.6% Phase 3 D Screened N= 429 Randomized N= 375 Modified intent-to-treat N= 363 } Lenabasum 20 mg BID N= 120 Lenabasum 5 mg BID N=120 ~——, ‘Completed Wee

  16. Slide 16: Baseline demographics in RESOLVE-1 were as expected

    Phase 3 | Baseline demographics in RESOLVE-1 were as expected (= Placebo Lenabasum Lenabasum — 5mg 20 mg ro) N=123 N=120 N=120 ” Age, years, mean (SD) 51.9 (12.38) 49.7 (13.51) 49.7 (12.87) o + Many subjects were Female, % 74.0 73.3 80.0 middle-aged, white, Race, % faa) non-Hispanic females White 71

  17. Slide 17: Baseline disease characteristics in RESOLVE-1 were as expected

    Phase 3 | Baseline disease characteristics in RESOLVE-1 were as expected (= Placebo Lenabasum Lenabasum — Smg 20 mg ro) Characteristic (range) N=123 N=120 N=120 ” N (%) or mean (SD) - Disease duration, months 30.2(16.84) 32.2 (17.62) 32.7 (19.94) © Bees ie moderate <= 3 years 66% 59% 61% faa) a ne I

  18. Slide 18: Background Meds

    Phase 3 Background Meds Phase 3 | The majority of subjects in RESOLVE-1 were receiving background treatment with the immunosuppressant mycophenolate * 84% of RESOLVE-1 subjects were receiving stable doses of background immunosuppressive therapies (IST) Mycophenolate was the dominant IST Use of mycop

  19. Slide 19: Baseline immunosuppressant therapies appeared to influence efficacy outcomes

    Phase 3 | Baseline immunosuppressant therapies appeared to influence efficacy outcomes in RESOLVE-1 Placebo group, Week 52 ACR Change Change Change in in in FVC, “ N cRIss, : } Efficacy was much median MRSS, Fvc%, — mL, . . mean mean mean higher than expected in - Y All placebo subjects! 113 0.894 -

  20. Slide 20: No significant differences among treatment groups in primary efficacy outcome

    Phase 3 | There were no significant differences among treatment groups in primary efficacy outcome, ACR CRISS score, at Week 52 Lenabasum 20mg __Lenabasum 5 mg BID BID N=120 N=120 N= 123 « ACR CRISS score was much higher than Visit 11 (Week 52) expected in the n 100 113 115 placebo group Mean (SD) 0

  21. Slide 21: Few subjects had ACR CRISS Step 1 scores indicating bad outcomes

    Phase 3 | Few subjects in RESOLVE-1 had ACR CRISS Step 1 = 0 scores that indicate very bad heart, lung, or renal outcomes Tp) ACR CRISS Step 1 = 0 score indicates subject developed new significant, heart, lung, or kidney involvement, using pre-specified criteria o Placebo Lenabasum Lenabasum ( )) St

  22. Slide 22: Lenabasum added to established IST had stable FVC % predicted over 1 year

    Phase 3 | Subjects treated with lenabasum 20 mg BID added to established IST (> 2 years duration) had stable FVC % predicted stable FVC % predicted over 1 year > S s 2 iene eg mo] O 8 Ga fj Subjects treated with 3 =38 Qu lenabasum 20 mg BID 2 = LL added to established xa immunosuppressant Ss § =26 O

  23. Slide 23: Lenabasum added to established IST had stable FVC % predicted

    Phase 3 | Subjects treated with lenabasum 20 mg BID added to established IST had stable FVC % predicted over 1 year Change in FVC % predicted Change in mean FVC % predicted, individual values, Week 52 Week 52 “= si Subjects had more “ . 2 ag pani stable lung function wm (FVC, % predicted) over = 1m

  24. Slide 24: Less decline and more stability in FVC % predicted with established IST

    Phase 3 | Subjects treated with lenabasum 20 mg BID added to established IST had less decline and more stability in FVC % predicted @ Lenabasum 20 mg BID, N = 38 ™@ Placebo, N = 26 70% 64% A lower proportion of subjects treated with lenabasum 20 mg BID 50% added to established 60% Nominal P = 0.035

  25. Slide 25: Lenabasum added to established IST had stable FVC mL over 1 year

    Phase 3 | Subjects treated with lenabasum 20 mg BID added to established IST had stable FVC mL over 1 year “I vu Nominal P = 0.048 at Week 52, 2-sample t-test Nu ouo N u mean (SEM) a ee: Subjects treated with lenabasum 20 mg BID added to established I uw immunosuppressive N=26 therapies had stable F

  26. Slide 26: Lenabasum added to established IST had stable FVC mL over 1 year

    Phase 3 | Subjects treated with lenabasum 20 mg BID added to established IST had stable FVC mL over 1 year Change in FVC mL individual Change in mean FVC mL, Week 52 a values, Week 52 ° © a : : ™ oO Subjects had more = 7 = of stable lung function a) : _— 4 J Ga (FVC, mL) over 1 year g 2 = LLJ ff whe

  27. Slide 27: Subjects with ILD had stable FVC % predicted over 1 year

    Phase 3 | Subjects with ILD treated with lenabasum 20 mg BID added to established IST also had stable FVC % predicted over 1 year Interstitial lung disease (ILD) was defined as history of fibrosis on chest X-ray or computerized tomography of lungs or pattern of restrictive lung disease on spirometry

  28. Slide 28: Subjects with ILD had less worsening and more stability in FVC % predicted

    Phase 3 | Subjects with ILD treated with lenabasum 20 MG BID added to established IST had less worsening and more stability in FVC % predicted l Lenabasum 20 mg BID, N = 32 @ Placebo, N = 20 > 70% . Oo 63% Differences not significant 60% S Numerically lower <a. proportions of subjects 50% Ll treated

  29. Slide 29: Subjects with ILD had stable FVC mL over 1 year

    Phase 3 | Subjects with ILD treated with lenabasum 20 mg BID added to established IST also had stable FVC mL over 1 year Change in FVC mL individual values, Week 52 Change in FVC mL over 1 year Subjects with interstitial « > lung disease treated - 200 } . g +. ; with lenabasum 20mg . oa ae 4 BID add

  30. Slide 30: Efficacy Results at Week 52 in Subjects Receiving No Background Immunosuppressants

    Phase 3 | Efficacy Results in RESOLVE-1 at Week 52 in Subjects Receiving No Background Immunosuppressants Placebo Lenabasum * Greater improvement Result 20 mg BID seen in multiple N=15 N=10 Sie ue | ACR CRISS, median (IQR) 0.42 (0.895) | 0.81 (0.836) subjects receiving lenabasum 20 mg BID FUSS) -2.3

  31. Slide 31: Lenabasum's safety profile remained favorable in RESOLVE-1

    Phase 3 | Lenabasum’s safety profile remained favorable in RESOLVE-1 Placebo Lenabasum Lenabasum Treatment-emergent Adverse Events Smg 20 mg (TEAE) N=123,n(%) | N=120,n(%) N= 120,n(%) > Lenabasum’s safety Any TEAE 106 ( 86.2) 110 (90.2) 110 (91.7) <b) profile was favorable Any Serious TEAE 18 (14.6)

  32. Slide 32: Safety

    Phase 3 Safety Phase 3 | TEAEs occurring in at least 3% more of lenabasum 20 mg twice daily or placebo group, compared to the other group Likely class effects of dizziness, dry mouth and somnolence occurred more frequently in lenabasum groups than placebo No increase in neutropenia, opportunistic in

  33. Slide 33: Summary

    33 ummary © 2020 Corbus Pharmaceuticals Holdings, inc. 09 Nov 2020

  34. Slide 34: Summary of RESOLVE-1 Phase 3 study results

    Summary of RESOLVE-1 Phase 3 study results e There were no significant differences between lenabasum 20 mg BID and placebo in the primary and secondary endpoints at Week 52 e Unprecedented improvement was observed in subjects in the placebo group. Improvement in the placebo group was greatest in sub

Corbus Pharmaceuticals Holdings — Technical Presentation (November 2020) on 6ix