Corbus Pharmaceuticals Holdings, Inc. · NASDAQ:CRBP

Corbus Pharmaceuticals — Technical Presentation (November 2020)

33 slides from Corbus Pharmaceuticals's technical presentation, Nov 10, 2020

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

    () R B US z 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 anon Cosie Phannaceitiraic Holdinae Inc OO Nov 090 |

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

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

  4. Slide 4: Organ involvement in SSc

    organ involvement in SSc fr: et of Raynaud’s phenome: Patients with SSc have four times (4x) greater risk of death than their healthy counterparts DLCO <80% Gl involvement Skin involvement Digital ulcers FVCEBO% Median 11 years of survival Restrictive lung disease Cumulative percentage PAPsys>40mmHg

  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 © 2020 Corbus Pharmaceuticals Holdings, Inc. 09 Nov 2020

  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 “of or. 1 . topoisomerase 1 antibodies) when their immune

  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 Lung fibrosis induced with bleomycin Lung fibrosis is induced with bleomycin (bleomycin versus control) Lenabasum, whether started prophylactically before bleomycin or therapeutically 1 week = ate after bleomycin, reduced lung inflamm

  10. Slide 10: Lenabasum improved inflammation and fibrosis in skin biopsies from SSc patients

    Phase 2 | Lenabasum improved inflammation and fibrosis in skin biopsies from SSc patients in a Phase 2 s = - ro) Inflammation Fibrosis P = 0.006 Fisher's exact probability test P = 0.05 Fisher's exact probability test ~ 100% — o 15% © 2 = Be 80% m improved More improvement or g (e) stability of hist

  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 — — - aoe Extracellular Matrix Organization Pathway de) | beer ela Lenabasum Placebo = associated with E 2 : ; 2.0 =0. 2.0 = oO inflammation and fibrosis pr0.0002 penseso os in paired skin

  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 Greater numerical 3 reduction in modified bs we 2 q 15 Rodnan skin score (mRSS), 2 gs a measure of skin fibrosis, 22 2 os and forced vital capacity 23 é 0 (FVC) percent predic

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

    RESOLVE-1 Phase 3 Study Design and Results © 2020 Corbus Pharmaceuticals Holdings, Inc. 09 Nov 2020

  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 ‘Screened N=429 I Randomized N=375 I Modified intent-to-treat isposi N=363 © Lower than anticipated — —— ——— ce abasum 20m sum 5m drop-out rate of 9.6% Nat N22 N=120 Completed Week 52 MITT Discontinued Com

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

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

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

    Phase 3 | Baseline disease characteristics in RESOLVE-1 were as expected Cc Placebo Lenabasum Lenabasum —— 5mg 20mg 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) (qo) Subjects pee moderate <= 3 years cea cos 6% faa

  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 Change Change Change i chiss in in in FVC, Efficacy was much raedisn eae ae Lo I higher than expected in - (op) All placebo subjects! 113 0.894 -8.0 ae 51 the placebo group Any

  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 very 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 VY”) ACR CRISS Step 1 = 0 score indicates subject developed new significant, heart, lung, or kidney involvement, using pre-specified criteria Placebo Lenabasum Lenabasum ¢ )) Ste

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

    Phase 3 | Subjects treated with lenabasum 20 mg BID added to established IST (> 2 years duration) had stable FVC % predicted Nominal P = 0.039 Week 52, 2-sample t-test stable FVC % predicted over 1 year so 2 o & Subjects treated with oo = 38 lenabasum 20 mg BID a5 added to established xa immunosuppr

  23. Slide 23: 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 had stable FVC % predicted over 1 year Change in FVC% predicted Change in mean FVC% predicted, > individual values, Week 52 Week 52 0% <) . 20% (qo) Subjects had more no . A% oO stable lung function aes _ (FVC, % predicted)

  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 Nominal P = 0.048 at Week 52, 2-sample t-test c & -275 + @Placebo oO 0 4 8 #12 16 20 24 28 32 36 40 44 48 52 Weeks > O x = © zi A oO 2 25 N=38 G— Subjects treated with a = tu lenabasum 20 mg BI

  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 % predicted over 1 year Change in FVC% predicted Change in mean FVC% predicted, individual values, Week 52 Week 52 ° : Subjects had more stable lung function (FVC, mL) over 1 year when lenabasum 20 mg BID, ra

  27. Slide 27: Subjects with ILD also 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 Interstitial lung disease (ILD) was defined as history of fibrosis on chest Xray > or computerized tomography of lungs or pattern of restrictive lung disease on oO spirometry incl

  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 m Lenabasum 20 mg BID, N = 32 m Placebo, N = 20 70% 9 63% Differences not significant 60% Numerically lower proportions of subjects 50% treated with lenabasu

  29. Slide 29: Subjects with ILD also 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 Not statistically significant, Week 52 ae Placebo _Lenabasum 5 mg. Lenshasum 20 mg N=20 N=28 N=32 > O O Su

  30. Slide 30: Lenabasum's safety profile remained favorable in RESOLVE-1

    Phase 3 | Lenabasum’s safety profile remained favorable in RESOLVE-1 Treatment-emergent Adverse Events Hacebe Henabasum Penabesun (TEAE) mg 20mg 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 (1

  31. Slide 31: 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

  32. Slide 32: Summary

    32 ummary © 2020 Corbus Pharmaceuticals Holdings, Inc. 09 Nov 2020

  33. Slide 33: 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

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