PIONEERING TRANSFORMATIVE MEDICINES THAT TARGET
THE ENDOCANNABINOID SYSTEM
NASDAQ: CRBP | corbuspharma.com | @corbuspharma
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, business strategies, potential growth opportunities and other statements that are predictive in nature. Additional written and oral forward-looking statements may be made by the Company from time to time in filings with the Securities and Exchange Commission (SEC) or otherwise. The Private Securities Litigation Reform Act of 1995 provides a safe-harbor for forward-looking statements. These statements may be identified by the use of forward- looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the SEC. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this presentation. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise
FORWARD-
LOOKING STATEMENTS
2
Corbus at a glance
Targeting the endocannabinoid system
Focus on inflammatory and fibrotic diseases
Key catalysts expected in 2020 (4 clinical program readouts)
Large markets with significant unmet needs
VITAL STATS
Ticker
C R B P
Founded in
2 0 1 4
125+
Employees
Based in
Norwood, MA
$ 2 1 4 M
Capital raised to date
~ $ 4 5 M
Additional awards and grants from NIH and CFF
$ 2 7 M
Upfront payment from Kaken Pharmaceuticals collaboration
3
Corbus pipeline: early and late stage programs
LENABASUM
CRB-4001
PRECLINICAL
LIBRARY*
PRECLINICAL | PHASE 1 | PHASE 2 | PHASE 3 | APPROVAL | |||
Systemic sclerosis | |||||||
I M M U N E | Dermatomyositis | ||||||
A U T O | Systemic lupus erythematosus | ||||||
GENETIC | Cystic fibrosis | ||||||
NASH | |||||||
Goal: 1-2 new Phase 1 programs | |||||||
each year starting in 2021 | *>700 drug candidates |
Lenabasum is not approved for the treatment of systemic sclerosis, dermatomyositis, cystic fibrosis or systemic lupus erythematosus; CRB-4001 is not approved for the treatment of NASH
4
2020: THE YEAR OF DATA
5
LENABASUM
- Phase 3 data in systemic sclerosis in summer 2020
- Phase 2b data in cystic fibrosis in summer 2020
- Phase 2a data in lupus (SLE)
CRB-4001
- Key inflection point: Phase 1 data
What is the
Endocannabinoid
System (ECS)?
2 r e l a t e d G P C R s
CB1 and CB2
2 e n d o g e n o u s a g o n i s t s
Anandamide & 2-AG
M e t a b o l i c e n z y m e s
FAAH and MAGL
6
CB1
C A N N A B I N O I D
R E C E P T O R T Y P E 1
Mostly in CNS.
Also found in liver,
kidney and lung where it
is pro-inflammatory.
CB2
C A N N A B I N O I D
R E C E P T O R T Y P E 2
Expressed on activated
immune cells and fibroblasts.
Plays a role in immune response.
Growing recognition of therapeutic potential of targeting the ECS
COMPANY | DRUG CANDIDATE | PHASE | TARGET | TYPE OF COMPOUND |
Lenabasum | Phase 3 in SSc & DM | SSc, DM, CF & SLE | Small molecule (NCE) | |
(CB2 agonist) | Phase 2 in CF & SLE | |||
CRB-4001 | Phase 1 safety data expected | NASH | Small molecule (NCE) | |
(CB1 inverse agonist) | in 2020 | |||
RO6871304 | Preclinical | Uveitis | Small molecule (NCE) | |
(CB2 agonist) | ||||
GFB-024 | Preclinical | Diabetic kidney disease | Monoclonal antibody | |
(CB1 antagonist) | (Phase 1 planned 2H 2020) | (mAb) | ||
Nimacimab | Phase 1 completed | NAFLD & diabetes or pre-diabetes | Monoclonal antibody | |
(CB1 antagonist) | (mAb) | |||
JNJ-42165279 | Phase 2 | Autism Spectrum Disorder & Social Anxiety Disorders | Small molecule (NCE) | |
(FAAH inhib) | ||||
JNJ-42226314 | Preclinical | Potential therapeutic application in several CNS disorders, neuropathic and | Small molecule (NCE) | |
(MAGL inhib) | inflammatory pain | |||
ABX-1431 | Phase 2, Acquired by | Tourette's syndrome | Small molecule (NCE) | |
(MGLL inhib) | H. Lundbeck A/S | |||
Cesamet (nabilone) | Commercial | Nausea & Vomiting Associated with Cancer | Phytocannabinoid | |
(THC) | Chemotherapy | |||
Marinol® | Commercial | Anorexia Associated with Weight Loss in Patients with AIDS, Nausea & | Phytocannabinoid | |
(THC) | Vomiting Associated with Cancer Chemotherapy | |||
Epidiolex® | Commercial | Seizures Associated with Lennox-Gastaut Syndrome or Dravet Syndrome | Phytocannabinoid | |
(CBD) | ||||
Sativex® | Commercial in EU | Symptomatic Relief of Spasticity in MS | Phytocannabinoid | |
7 | (CBD & THC) | |||
Target indications across major markets provide commercialization opportunities
~PATIENT POPULATION1
NORTH
AMERICA1
SSc: 80K
DM: 40K
SLE: 280K
CF: 30K
EUROPE1
SSc: 80K
DM: 30K
SLE: 240K
CF: 40K
CHINA2
SSc:140K
DM: 70K
SLE: 420K
JAPAN1
SSc: 28K
DM: 9K
SLE: 50K
KOREA1
SSc:9K
DM: 3K
SLE: 16K
J A P A N P A R T N E R S H I P Kaken Pharmaceuticals
- Exclusive licensing agreement for SSc and DM lenabasum indications in Japan
- Up-front$27M payment and up to $173M of potential milestone payments
- Double-digitroyalty payments
1: Health Advances, LLC, Lenabasum Commercial Market Assessment, North America Includes Canada and Mexico; 2: Rheumatology, Ru Li, Jian Sun, et al. (2012)
8
LENABASUM
9
Lenabasum MOA: CB2 receptor agonist targeting innate immune response
- Oral NCE
- Resolves inflammation
- Limits fibrosis
- Non-immunosuppressive
- Phase 3 data summer 2020
- IP until 2034
IN SILICO BINDING OF
LENABASUM (PURPLE)
TO CB2 RECEPTOR
10
Lenabasum Fact Sheet
- MW 400 Da
- Ki = 54 nM for CB2 vs. 680 nM for CB1
- 30% blood-brain barrier penetration further reduces potential CB1-mediated CNS AEs
- Oral administration, Tmax 2.5 - 4 hours, T½ 3-5 hours, longer biologic half-life
- Metabolized mainly in liver, ~2/3 fecal and ~1/3 renal excretion
- MTD: 180 mg total daily dose
- DLT: 240 mg: multiple mild or moderate AEs including dizziness, fatigue, nausea, vomiting, and unusual feelings
AUC0-IFN, ng.hr/ml
45000
40000
35000
30000
25000
20000
15000
10000
5000
0
0
y = 153.04x + 805.21
R2 = 0.8764
50 | 100 | 150 | 200 | 250 | 300 |
Total Daily Dose, mg
Closed circles = single doses, fasted; open circles, single doses fed; squares = multiple doses; open square = multiple doses in subjects ≥ 65 years of age
11
- The majority of adverse reactions observed in clinical studies conducted to date are mild or moderate
- Most common adverse events thought to be related to lenabasum are dizziness, dry mouth, and fatigue, which are consistent with expected class effects
- Minimal changes from baseline in vital signs and laboratory safety tests and changes similar to those seen with placebo
- Safety data in blinded clinical studies are consistent with that observed in unblinded studies (n > 800)
LENABASUM SAFETY OVERVIEW
12
Lenabasum PD: Human E.coli Blister Model
U.V. killed E. coli | Laser Doppler | Blister |
intradermal injection | imaging | induction |
Blister fluid aspiration
Placebo | Lenabasum 20 mg BID | |
Lenabasum 5 mg BID | Prednisone 15 mg | |
Motwani et al. Clin Pharmacol Ther. 2017 Dec 14. doi: 10.1002
13
SYSTEMIC
SCLEROSIS
14
Systemic sclerosis (SSc) at a glance:
- Rare and life-threatening autoimmune disease characterized by tissue inflammation & fibrosis
- Most lethal of the systemic autoimmune diseases1
- Standard of care: immunosuppressive therapies with potential for significant toxicity
Images provided by the Scleroderma Foundation | 1: Elhai M, Meune C, Avouac J, Kahan A, Allanore Y.
Rheumatology 2012;51(6):1017e26,
15
Clinical trial design: Pioneering the use of the ACR-CRISS endpoint
PHASE 2
DOUBLE-BLIND,PLACEBO-CONTROLLED
Primary endpoint: | 42 |
ACR-CRISS | subjects |
16 weeks | 9 sites in U.S |
PHASE 2
OPEN-LABEL EXTENSION
Primary endpoint: | 29 |
ACR-CRISS | subjects* |
Ongoing | 8 sites in U.S |
(> 36 months) |
*At Month 25
PHASE 3
DOUBLE-BLIND,PLACEBO-CONTROLLED
Baseline characteristics of subjects are similar to those in the Phase 2 study
Primary endpoint: | 365 |
ACR-CRISS | subjects |
52 weeks | 76 sites in |
1:1:1 dosing 20 mg BID | 5 mg BID | Placebo |
SECONDARY ENDPOINTS
- Change from baseline in mRSS
- Change from baseline in HAQ-DI
- Change from baseline in FVC % predicted
Orphan Drug Designation from FDA, EMA and PMDA Fast Track status from FDA
16
The dynamics of the ACR CRISS score
Step 1: Assign score "0" if significant new organ
damage related to SSc occurs
Step 2: Otherwise, calculate score using change from baseline in mRSS, PtGA, MDGA, HAQ-DI and FVC % predicted
- Exponential, weighted score (median)
- Measures probability of improvement from baseline
- Scored as 0.000-1.000 or 0.0%-100.0%
- Both improvement and worsening in core items are incorporated into score
- The more core items improve and the greater the improvement → the greater the ACR CRISS score
- Change in mRSS has greatest weight
Example: Improvement in Multiple Core Items Increase
ACR CRISS Score Generated by a -5 Point Improvement in mRSS
1.00 | ||
0.90 | ||
0.80 | ||
0.70 | 70% | |
Score | 61% | |
0.60 | ||
CRISS | mRSS alone | |
0.50 | 50% | |
ACR | mRSS + -0.250 Improvement in HAQ-DI | |
0.40 | ||
35% | ||
0.30 | mRSS + -0.250 improvement in HAQ-DI + 3% improvement in FVC % predicted | |
0.20 | 18% | mRSS + -0.250 improvement in HAQ + 3% improvement in FVC % predicted, and -1 |
improvement in MDGA" | ||
0.10 | mRSS + -0.250 improvement in HAQ-DI, 3% improvement in FVC % predicted, -1 | |
improvement in MDGA, and -1 improvement in PtGA | ||
0.00 |
0 -1-2-3-4-5-6-7-8-9-10-11-12-13-14
Change from Baseline in mRSS
17
Phase 2 | Improvement in ACR CRISS score
D B P C | O P E N - LABEL EXTENSION | |||||||||||||||||||||||
1.0 | 0.95 0.95 | 0.96 | 0.96 | 0.98 | ||||||||||||||||||||
0.9 | ||||||||||||||||||||||||
score | 0.8 | Placebo DBPC | 0.77 | |||||||||||||||||||||
0.7 | Lenabasum DBPC | 0.70 | ||||||||||||||||||||||
Lenabasum OLE | ||||||||||||||||||||||||
median | 0.63 | |||||||||||||||||||||||
0.6 | ||||||||||||||||||||||||
0.58 | ||||||||||||||||||||||||
Score, | ||||||||||||||||||||||||
0.5 | ||||||||||||||||||||||||
CRISS | n=42 | |||||||||||||||||||||||
0.4 | ||||||||||||||||||||||||
0.33 | ||||||||||||||||||||||||
ACR | 0.3 | 0.28 | ||||||||||||||||||||||
0.2 | 0.19 | 0.21 | 0.26 | 0.25 | Placebo in Tocilizumab Ph 3 study | |||||||||||||||||||
0.1 | mean | |||||||||||||||||||||||
0.03 | ||||||||||||||||||||||||
0.01 | 0.01 | 20.2 wk | Placebo in Abatacept Ph 2 study | |||||||||||||||||||||
0.0 | ||||||||||||||||||||||||
0.0 | 0.01 | 0.01 | ||||||||||||||||||||||
0.0 | ||||||||||||||||||||||||
0 | 4 | 8 | 12 | 16 | 0 | 4 | 12 | 20 | 28 | 36 | 44 | 52 | 60 | 68 | 76 | 84 | 92 100 108 | |||||||
Weeks |
Subjects on stable standard-of-care drugs,
including immunosuppressive drugs
American College of Rheumatology Combined Response Index in diffuse cutaneous systemic sclerosis (ACR CRISS) score provides a composite measure of probability of improvement from baseline. Calculated using change from baseline in modified Rodnan Skin Score (mRSS), Physician Global Assessment, Patient Global Assessment, Health Assessment Questionnaire - Disability Index and forced vital capacity (FVC) percent predicted.
29/36 (80%) of subjects enrolled in the OLE were still enrolled after 2 years
OTHER RECENTLY COMPLETED TRIALS IN SSc
Time | ACR CRISS | |||
Drug | N | score | ||
(wks) | ||||
Active | PBO | |||
Cyclophosphamide1 | 84 | 52 | 0.24 | 0.01 |
Tocilizumab2, Ph 2 | 693 | 24 | 0.23 | 0.01 |
623 | 48 | 0.31 | 0.0 | |
Tocilizumab3 + rescue | ||||
immunosuppressive drugs after | 210 | 48 | 0.89 | 0.25 |
16 weeks if needed, Ph 3 |
Abatacept4 + rescue
immunosuppressive drugs695 52 0.68 0.01 after 26 weeks if needed, Ph 2
- Khanna et al. ACR abstract 726, 2017; Khanna et al. Arthritis Rheumatol. 2016; 68:299-311; 2: Khanna et al. EULAR abstract SAT0373, 2017; 3: Completers only, Initial N = 87.3; 4: Khanna et al. ACR abstract 898, 2018k; 5: Khanna et al. ACR abstract 900, 2018 69 completers
18
Phase 2 | Improvement in mRSS
D B P C | O P E N - LABEL EXTENSION |
0 0.0
-0.01-0.01
-1.3 | -2.0 | -1.7 | Placebo Cyclophosphamide | ||
-2.6 | -2.6 | ||||
-3.8 | -3.50 | -4.4 | Placebo Tocilizumab Ph 3 | ||
-4.6 | -4.5 | Placebo Abatacept Ph 2 | |||
-5 | |||||
-5.25 | |||||
mean | |||||
-6.61 | -6.94 | ||||
mRSS, | -7.32 | ||||
Placebo DBPC | -8.41 | -9.28 | |||
Lenabasum DBPC | -8.94 | -9.17 | |||
-10 |
Lenabasum OLE | -9.83 |
-10.28 | |
-10.67 |
mean 20.2 wk
-15
0 | 4 | 8 | 12 | 16 | 0 | 4 | 12 | 20 | 28 | 36 | 44 | 52 | 60 | 68 | 76 | 84 | 92 100108 |
Week
Subjects on stable standard-of-care drugs,
including immunosuppressive drugs
Baseline mRSS mean mRSS (SD) = 23.6 (10.4) for lenabasum arm and 26.2 (11.1) for placebo arm in Part A and 20.4 (11.0) for all subjects at start of open-label dosing; 1: Khanna et al, Ann Rheum Dis 2006; 65:1325
Reduction of 4 to 5 points is generally considered minimal clinically important difference (MCID)1
OTHER RECENTLY COMPLETED TRIALS IN SSc
mRSS, mean | ||||
Drug | N | Time | (SD) change | |
from baseline | ||||
(wks) | ||||
Active | PBO | |||
Six drug trials1 | 492 | ~26 | -2.9 | |
Cyclophosphamide2 | 84 | 52 | -5.3 | -1.7 |
Tocilizumab3, Ph 2 | 67 | 24 | -4.2 | -2.1 |
58 | 48 | -5.9 | -3.2 | |
Tocilizumab4 + rescue | ||||
immunosuppressive drugs | 212 | 48 | -6.1 | -4.4 |
after 16 weeks if needed, Ph 3 |
Abatacept5 + rescue
immunosuppressive drugs886 52 -6.2-4.5 after 26 weeks if needed , Ph 2
- α interferon, d-penicillamine, relaxin Ph 2 and 3, minocycline, methotrexate, anti-TGFβ, Merkel et al, Arthritis Rheum 2012;64:3420; 2: Khanna et al, ACR abstract 2016; 3: Le et al, Ann Rheum Dis 2011; 70: 1104; 4: Khanna et al. EULAR abstract SAT0373, 2017; 5: Khanna et al. ACR abstract 898, 2018; 6: Khanna et al. ACR abstract 900, 2018 6 69 completers
19
Phase 2 | Improvement in all five domains of ACR CRISS score
mRSS
0
Placebo DBPC
Lenabasum DBPC
Lenabasum OLE
-5 meanmRSS,
-10
mean 20.2 wk
-15 | |||||||||||||||||
0 | 4 | 8 | 12 | 16 | 0 | 4 | 12 | 20 | 28 | 36 | 44 | 52 | 60 | 68 | 76 | 84 | 92 100108 |
Week |
FVC % predicted, mean
FVC% Predicted
2 | |||||||||||||||||
1 | |||||||||||||||||
0 | Placebo DBPC | ||||||||||||||||
Lenabasum DBPC | |||||||||||||||||
Lenabasum OLE | |||||||||||||||||
-1 | |||||||||||||||||
-2 | |||||||||||||||||
-3 | |||||||||||||||||
-4 | |||||||||||||||||
mean 20.2 wk | |||||||||||||||||
-5 | |||||||||||||||||
0 | 4 | 8 | 12 | 16 | 0 | 4 | 12 | 20 | 28 | 36 | 44 | 52 | 60 | 68 | 76 | 84 | 92 100108 |
Week |
HAQ-DI
0.2 | ||||||||||||||||||
0.1 | ||||||||||||||||||
Placebo DBPC | ||||||||||||||||||
Lenabasum DBPC | ||||||||||||||||||
meanHAQDI,- | 0.0 | Lenabasum OLE | ||||||||||||||||
-0.1 | ||||||||||||||||||
-0.2 | ||||||||||||||||||
mean 20.2 wk | ||||||||||||||||||
-0.3 | ||||||||||||||||||
0 | 4 | 8 | 12 | 16 | 0 | 4 | 12 | 20 | 28 | 36 | 44 | 52 | 60 | 68 | 76 | 84 | 92 100108 |
Week
Patient Global Assessment
1.0 | ||||||||||||||||||
0.5 | ||||||||||||||||||
Placebo DBPC | ||||||||||||||||||
Lenabasum DBPC | ||||||||||||||||||
meanPtGA, | 0.0 | Lenabasum OLE | ||||||||||||||||
-0.5 | ||||||||||||||||||
-1.0 | ||||||||||||||||||
mean 20.2 wk | ||||||||||||||||||
-1.5 | ||||||||||||||||||
0 | 4 | 8 | 12 | 16 | 0 | 4 | 12 | 20 | 28 | 36 | 44 | 52 | 60 | 68 | 76 | 84 | 92 100108 | |
Week |
Physician Global Assessment
0.0
Placebo DBPC
Lenabasum DBPC
Lenabasum OLE
-0.5 meanMDGA,
-1.0
mean 20.2 wk
-1.5 | |||||||||||||||||
0 | 4 | 8 | 12 | 16 | 0 | 4 | 12 | 20 | 28 | 36 | 44 | 52 | 60 | 68 | 76 | 84 | 92 100 108 |
Week |
20
Phase 2 | Improvement in patient-reported skin symptoms
0 | |
-10 | |
mean | |
SSPRO, | -20 |
-30 | |
-40 |
Skin Symptoms (SSPRO)
-14.0 | Placebo DBPC | ||||||||||||||||
Lenabasum DBPC | |||||||||||||||||
-18.2 | Lenabasum OLE | ||||||||||||||||
-23.8 | |||||||||||||||||
-25.9 | -25.8 | -26.7 | |||||||||||||||
-27.0 | -26.2 | -26.3 | -29.3 | -30.3 | |||||||||||||
-31.7 | |||||||||||||||||
mean 20.2 wk | |||||||||||||||||
0 | 4 | 8 | 12 | 16 | 0 | 4 | 12 | 20 | 28 | 36 | 44 | 52 | 60 | 68 | 76 | 84 | 92 100108 |
Week |
5D-Itch, mean
1
0
-1
-2
-3
-4
5D-Itch
-0.60 | Placebo DBPC | ||||||||||||||||
Lenabasum DBPC | |||||||||||||||||
-0.71 | Lenabasum OLE | ||||||||||||||||
-1.34 | -1.35 | ||||||||||||||||
-1.48 | -2.00 | ||||||||||||||||
-2.16 | |||||||||||||||||
-2.28 | -2.25 | ||||||||||||||||
-2.16 | |||||||||||||||||
-2.60 | |||||||||||||||||
mean 20.2 wk | -3.43 | ||||||||||||||||
0 | 4 | 8 | 12 | 16 | 0 | 4 | 12 | 20 | 28 | 36 | 44 | 52 | 60 | 68 | 76 | 84 | 92 100108 |
Week |
21
Lenabasum treatment improves/stabilizes histological findings of inflammation and fibrosis in skin biopsies compared to placebo
Phase 2 | Improvement in biomarkers
Inflammation | Fibrosis | ||||||||||
Biopsies | 100% | ||||||||||
15% | 15% | ||||||||||
80% | |||||||||||
of Skin | 15% | 43% | Improved | 38% | 48% | ||||||
% | 60% | ||||||||||
Baseline, | 40% | 69% | Stable | ||||||||
from | 43% | 39% | |||||||||
Change | 46% | ||||||||||
20% | Worsened | ||||||||||
0% | 13% | 13% | |||||||||
Placebo | Lenabasum | Placebo | Lenabasum | ||||||||
Data from Phase 2 trial JBT101-SSc-001, study evaluated the safety, tolerability, pharmacokinetics and efficacy of Llenabasum in adult subjects with diffuse cutaneous systemic sclerosis.
22
Greatest unmet need is in patients with early or active diffuse systemic sclerosis (SSc)
ESTIMATED U.S. PREVALENCE
60-75K SSc Patients1
20-30K
Diffuse SSc Patients2
~10-15K
Early Diffuse SSc
(<6 years) or
Active Disease3
EU SSc PATIENT POPULATION ESTIMATED
TO BE SLIGHTLY HIGHER THAN U.S. (~80-90K)4
- Furst. J Rheumatol. 2012; Robinson Jr. Curr Med Res Opin. 2008; Mayes. Arthritis Rheum. 2003; Maricq. Arthritis Rheum. 1989; 2: Estimated 33-40%: Mayes. Arthritis Rheum. 2003; Peoples. J Scleroderma Relat Discord. 2016; Young. J Clin Rheumatol. 2016; 3: Estimated @ 50% of Diffuse SSc; 4: Health Advances, LLC Corbus Assessment &
23 Aurore Bergamasco et al., Clin Epidemiol, 2019.
LIMITED SYSTEMIC SCLEROSIS
- Skin manifestations are limited to hands, face, feet and forearms
- Lower risk of internal organ involvement exists
DIFFUSE SYSTEMIC SCLEROSIS
- Skin manifestations may extend to torso
- Early onset of organ involvement and rapid disease progression
- Treated more aggressively with immunosuppressants
Systemic sclerosis is a multi-system, heterogenous disease without an approved treatment for overall disease
Symptom onset | Diagnosis |
Treatment | Ongoing systemic sclerosis | |
initiation | management | |
MAINTAIN ORGAN #1 | MAINTAIN ORGAN |
Lungs | GI tract |
Shortness of | Diarrhea, |
breath, fatigue | dysphagia |
Chronic pain | Hand & fingers |
Joint & | Discoloration |
muscle pain | & swelling |
Mentioned
More common Less common
PCP RHEUM
ORTHO | DERM |
PULMCARD
GASTRO
Patients often see other healthcare professionals for symptoms prior to diagnosis by Rheumatologist
INITIATE ORGAN #1 THERAPY | ASSESS RESPONSE | THERAPY | #1 THERAPY | |||||
Symptoms | Treatments | INITIATE ORGAN #2 THERAPY | ||||||
Skin thickening, | Mycophenolate mofetil | |||||||
tightening, digital ulcers | Methotrexate | |||||||
PDE5 inhibitors | SWITCH / | PATIENTS | ||||||
Raynaud's | INADEQUATE | ADVERSE | ||||||
Calcium channel blockers | STOP | OFTEN RECEIVE | ||||||
RESPONSE | REACTION | |||||||
TREATMENT | POLY-PHARMACY | |||||||
Proton pump inhibitors | ||||||||
GI issues | Antacids | |||||||
Antibiotics | ||||||||
PDE5 inhibitors
Pulmonary hypertension Bosentan
Prostacyclin / lloprost
MMF
ILDNintedanib
Rituximab
SCT
Cardiac fibrosis, Renal crisis Ace inhibitors
Methotrexate
Chronic painPlaquenil
NSAIDs
Steroids
All insights and quotes derived from proprietary qualitative market research conducted in Q3 2019 [n=20 U.S. Rheumatologists treating at least 10 SSc patients; n=20 U.S. SSc diagnosed patients]
24
Corbus is the only company with a late-stage experimental drug in systemic sclerosis
"Treatment for scleroderma is the number one unmet need in rheumatology today."
Treatment Center Rheumatologist
"Physicians are just trying to use whatever immunosuppressive agents they can find today to treat SSc. We need efficacious therapies to treat SSc patients."
U.S. Payer
25
SYSTEMIC SCLEROSIS (SSc) IS A LIFE-THREATENING AND
DEBILITATING RARE DISEASE
- 11-22average years of life expectancy lost1
- 2 in 3 patients become unable to work and show symptoms of depression2,3
RHEUMATOLOGISTS MANAGE SYMPTOMS, BUT HAVE NO APPROVED TREATMENT TO ADDRESS THE TOTALITY OF DISEASE
- Experts are at scleroderma centers, but care also extends to community rheumatologists
- Current therapies address symptoms or specific organ complications
- Multiple therapies required, often immunosuppressive
LENABASUM TARGET PROFILE MET WITH INTEREST BY
PHYSICIANS, PAYERS AND PATIENTS
- Payers and physicians recognize the high unmet need in SSc
- Potential efficacy, safety and tolerability profile viewed favorably
- Oral dosing further strengthens product profile
- Hao Y, Hudson M, Baron M, et al; Arthritis Rheumatol. 2017;69(5):1067-1077. 2: Thombs BD, Taillefer SS, Hudson M, Baron M. Arthritis Rheum. 2007;57(6):1089-1097. 3: Sharif R, Mayes MD, Nicassio PM, et al; and GENISOS Study Group. Semin Arthritis Rheum. 2011;41(1):38-47. *All insights and quotes derived from proprietary qualitative market research conducted in H2 2019 [n=20 U.S. Rheumatologists treating at least 10 SSc patients; n=20 U.S. SSc diagnosed patients; n=10 U.S. Payers]
Corbus can efficiently serve patients and providers with a small field footprint and targeted multichannel initiatives
In addition to the 46 Scleroderma Centers primarily in
metropolitan areas, many community-based Rheumatologists also diagnose and treat
Washington DC
SCLERODERMA RESEARCH CENTERS (46)
Corbus study sites (28) | Non -study sites (18) |
Prescribers can be reached through
a small customer facing team
augmented through other channels
Experts &
High Treaters
~200 Rheums
Treaters
~1,500 Rheums
(Other Academic & community
based Rheums with 10+
systemic sclerosis patients)
Low SSc Patient Volume
(Remaining ~3,000 practicing Rheums and other specialists supporting Rheums in management of systemic sclerosis manifestations)
*Preliminary prescriber sizing estimates based on Komodo Serenity analysis.
26
Corbus recently launched a disease education campaign in systemic sclerosis
CURRENT MINDSET
Systemic sclerosis (SSc) is a terrible disease, and I am doing the best I can to manage my patients' skin and organ symptoms with what I have.
FUTURE MINDSET
With no available solutions that address both inflammation and fibrosis, advancements in SSc therapy should address the full burden of disease to allow for a more meaningful improvement in my patients lives. Targeting CB2 is a promising path forward.
OVERARCHING MESSAGE
A novel approach is needed to address the totality of systemic sclerosis
FOUR CORE MESSAGING PILLARS
- SSc is a rare and debilitating disease driven by inflammation and fibrosis
- There is significant unmet need in available treatment options that treat clinical manifestations, not the underlying mechanisms of the disease
- A multi-factorial approach is needed: both in patient care and development of therapy
- CB2 agonism shows promise as a novel approach to address the inflammation and fibrosis that drives SSc
27
TotalSSc.com Core Story Pillars
PILLAR 1 | PILLAR 2 | PILLAR 3 | PILLAR 4 |
Systemic Sclerosis | Current treatment | Emerging measure: | Future Hope: |
(SSc) complexity | limitations | ACR CRISS | New mechanism of action |
28
Lenabasum launch team leadership
Craig Millian, MBA | Brian Walsh, MBA | Kaizar Lehri, MBA |
Chief Commercial Officer | Head, Global Marketing | Head of Global Supply Chain |
25 years of experience leading commercial | More than 10 years of commercial | Accomplished executive with more than |
organizations for a range of pharmaceutical | leadership roles in healthcare | 25 years of supply chain management |
companies as well as a successful track | management, consulting and sales | and technology implementation |
record building pharmaceutical brands | experience |
Keith White, MBA | Quinn Dinh, MD | Lindsey Smith |
Head of Market Access | Vice President, Medical Affairs | Director, Investor Relations |
Proven commercial leader with more than | Experienced senior leader with more than 10 | and Corporate Communications |
20 years of professional experience at | years of medical affairs and R&D experience, | Strategic corporate communications |
leading commercial stage biotech companies | with a focus on rare and complex diseases | professional with patient advocacy, media |
relations and product launch experience |
29
DERMATOMYOSITIS
30
Dermatomyositis (DM) and systemic sclerosis are related rare systemic autoimmune diseases
• DM is a rare and life-threatening autoimmune disease characterized by skin and muscle inflammation
• 30% mortality in 5 years1
• Standard of care: immunosuppressive therapies with potential for significant toxicity
Images provided by Myositis Support and Understanding and The Myositis Association; 1: Schiopu et al, 2012
31
Ongoing Phase 3 DETERMINE study
- Baseline characteristics of subjects are similar to those in the Phase 2 study
- Anticipate enrollment complete in 2020
D O U B L E - B L I N D , R A N D O M I Z E D , P L A C E B O -
C O N T R O L L E D S T U D Y
5 2 - W E E K S T U D Y
M U L T I N A T I O N A L
1 5 0
S U B J E C T S
2 : 1 : 2
D O S I N G
20 mg BID
5 mg BID
Placebo
P R I M A R Y E N D P O I N T I N U . S . & E U :
- American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) 2016 Total Improvement Score (TIS) in Adult Dermatomyositis & Polymyositis
SECONDARY ENDPOINTS
- Mean MMT-8 Score
- CDASI activity score
- Investigator Global Assessment scale of skin activity
- Short Form-36 physical functioning domain score
- Corticosteroid dose
- FVC % predicted
Orphan Drug Designation from FDA and EMA
32
Phase 2 | Improvement in skin activity
DBPC | OPEN-LABEL EXTENSION | ||||||||||||||||||||||
0 | 0.0 | ||||||||||||||||||||||
-2.5 | |||||||||||||||||||||||
-3.4 | -3.7 | -3.7 | |||||||||||||||||||||
-4.6 | -4.3 | ||||||||||||||||||||||
-5 | |||||||||||||||||||||||
(Mean) | -5.0 | -5.5 | Placebo DBPC | ||||||||||||||||||||
-7.8 | |||||||||||||||||||||||
-7.6 | |||||||||||||||||||||||
-8.0 | Lenabasum DBPC | ||||||||||||||||||||||
Score | -9.4 | Lenabasum OLE | |||||||||||||||||||||
-10 | -9.3 | ||||||||||||||||||||||
Activity | n=22 | -15.1 | -14.8 | ||||||||||||||||||||
-12.7 | -13.8 | ||||||||||||||||||||||
CDASI | -15 | ||||||||||||||||||||||
-16.0 | -15.6 | ||||||||||||||||||||||
-16.8 | |||||||||||||||||||||||
-20 | -20.2 | -20.1 | -20.9 | ||||||||||||||||||||
-20.8 | |||||||||||||||||||||||
-21.1 | |||||||||||||||||||||||
-21.9 | |||||||||||||||||||||||
mean 31 wk | |||||||||||||||||||||||
-25 | |||||||||||||||||||||||
0 | 2 | 4 | 6 | 8 | 12 | 16 | 0 | 4 | 12 | 20 | 28 | 36 | 44 | 52 | 60 | 68 | 76 | 84 | 92 | 100 |
Weeks
- Subjects had moderate to severe skin disease refractory to immunosuppressive treatment
- CDASI activity score measures active disease in the skin
-
Favorable safety profile persists in
OLE - Durable efficacy in OLE
- 90% persistence in OLE at 2 years
- Reduction of 4 points at 12 months is associated with improvement in skin-related quality of life outcomes, itch and pain1
1 Week 0 DBPC CDASI activity score mean (SD) = 33.3 (9.74) for lenabasum and 35.8 (7.77) for placebo. P* = 0.09, p = 0.05, p = 0.28, p = 0.04, for lenabasum vs. placebo at Weeks 4, 8, 12, and 16, respectively, of DBPC Part A of study, MMRM, 2-sided; 1: Robinson et al. Br J Dermatol. 2015;172:169
33
Distribution of CDASI scores at 23 months in open-label extension study
Individual CDASI Scores
- 72% achieved low skin disease activity
(CDASI ≤ 14) by week 100
CDASI Activity score
Each Bar Represents an Individual Subject, Month 23
34
Phase 2 | Patient-reported improvement in skin and overall disease activity
Patient Skin Activity 10-cm VAS (Mean)
1
0
-1
-2
-3
-4
Skin Activity
Placebo DBPC | ||||||||||
-0.9 | Lenabasum DBPC | |||||||||
Lenabasum OLE | ||||||||||
-1.1 | ||||||||||
-1.5 | ||||||||||
-1.5 | -1.9 | |||||||||
-2.3 | -2.2 | -2.4 | ||||||||
-2.7 | -3.0 | -2.9 | ||||||||
-3.0 | -3.4 | |||||||||
mean 31 wk | -3.6 | |||||||||
0 | 4 | 8 | 12 16 | 0 | 4 | 12 20 28 36 44 52 60 68 76 84 92100 | ||||
Weeks |
Patient Disease Activty 10-cm VAS (Mean)
1
0
-1
-2
-3
-4
Disease Activity
Placebo DBPC | ||||||||
-0.9 | Lenabasum DBPC | |||||||
Lenabasum OLE | ||||||||
-1.0 | ||||||||
-1.2 | ||||||||
-1.3 | ||||||||
-1.9 | ||||||||
-2.1 | -2.2 | |||||||
-2.2 | ||||||||
-2.7 | -2.8 | |||||||
-2.9-2.9 | -3.3 | |||||||
-3.3 | ||||||||
mean 31 wk | ||||||||
0 | 4 | 8 | 12 16 | 0 | 4 | 12 20 28 36 44 52 60 68 76 84 92100 |
Weeks
35
Phase 2 | Patient-reported improvement in function and other symptoms
(Mean) | 0 | ||
Functioning | -5 | ||
SkinDex | -10 | ||
-15 | |||
Pain29-PROMIS (Mean)FunctionPhysical | 4 | ||
2 | |||
0 | |||
-2 | |||
-4 | |||
-6 |
Placebo DBPC
Lenabasum DBPC
Lenabasum OLE
mean 31 wk | ||||||
0 | 4 | 8 | 12 16 | 0 | 4 | 12 20 28 36 44 52 60 68 76 84 92100 |
Weeks |
Placebo DBPC | ||||
Lenabasum DBPC | ||||
Lenabasum OLE | ||||
mean 31 wk | ||||
0 | 4 | 8 12 16 | 0 | 4 12 20 28 36 44 52 60 68 76 84 92100 |
Weeks |
(Mean) | 0 | |||||||
Placebo DBPC | ||||||||
Lenabasum DBPC | ||||||||
10 | Lenabasum OLE | |||||||
Symptoms | ||||||||
20 | ||||||||
SkinDex | 30 | mean 31 wk | ||||||
40 | ||||||||
0 | 4 | 8 | 12 16 | 0 | 4 | 12 20 28 36 44 52 60 68 76 84 92100 | ||
Weeks | ||||||||
0 | Placebo DBPC | |||||||
Lenabasum DBPC | ||||||||
(Mean) | -1 | Lenabasum OLE | ||||||
-2 | ||||||||
VAS | -3 | |||||||
Itch | ||||||||
-4 | ||||||||
mean 31 wk | ||||||||
-5 | ||||||||
0 | 4 | 8 | 12 16 | 0 | 4 | 12 20 28 36 44 52 60 68 76 84 92100 |
Weeks
4
Pain (Mean) | 2 | ||
PROMIS-29 Interference | 0 | ||
2 | |||
4 | |||
-6 | |||
(Mean) | 0 | ||
-5 | |||
Emotions | 5 | ||
0 | |||
SkinDex | 0 | ||
-25 |
Placebo DBPC
Lenabasum DBPC
Lenabasum OLE
mean 31 wk | ||||||
0 | 4 | 8 | 12 16 | 0 | 4 | 12 20 28 36 44 52 60 68 76 84 92100 |
Weeks |
Placebo DBPC
Lenabasum DBPC
Lenabasum OLE
mean 31 wk
0 | 4 | 8 | 12 16 | 0 | 4 | 12 20 28 36 44 52 60 68 76 84 92100 |
Weeks
36
Phase 2 | Improvement in biomarkers
Lenabasum treatment was associated with reduction in T cell infiltration in skin biopsies in DM
LenabasumPlacebo
K E E W | K E E W | |
0 | 0 | |
K E E W | K E E W | |
2 1 | 2 1 | |
Associated with Improvement in CD4+ Cells in Skin Biopsies
Chen et al. EULAR poster FRI0307
37
CYSTIC
FIBROSIS
38
Despite advances in CF treatment, a large percentage of CF patients experience pulmonary exacerbations (PEx)
- Vast majority of treatment occurs in one of 130 CF Care Centers, including 33 Corbus sites
- Decline in percentage of patients experiencing PEx-IV has been modest despite introduction of CFTR modulators
- On average, patients spend nearly 18 days hospitalized for PEx per year
- Even with latest approval, 10% of CF patients remain ineligible for a CFTR modulator
U.S. CF PREVALENCE (AGE 12+)
21,500 U.S. CF 12+
8,600 (~40%)
1 or more PEx-IV per year
4,000 (~18%)
2 or more
PEx-IV per year
*Prevalence & PEx-IV rates estimated from 2018 CFF Patient Registry Annual Report
39
Ongoing CF
Phase 2b study
- Enrollment complete
- Topline data expected summer of 2020
- Up to $30M in funding from CFF
D O U B L E - B L I N D , R A N D O M I Z E D , P L A C E B O -
C O N T R O L L E D S T U D Y
2 8 - W E E K S T U D Y
M U L T I N A T I O N A L
4 2 6
S U B J E C T S
2 : 1 : 2
D O S I N G
20 mg BID
5 mg BID
Placebo
P R I M A R Y E N D P O I N T
- Event Rate of PEx
Open to people with CF 12 years and older, regardless of mutation or current background medications, including Orkambi®, Kalydeco® and Symdeko®
SECONDARY ENDPOINTS
- Other measures of PEx
- Cystic Fibrosis Questionnaire- Revised Respiratory Domain Score
- FEV1 % predicted
Orphan Drug Designation from FDA and EMA
Fast Track status from FDA
40
Lenabasum treatment was associated with longer time to PEx in Phase 2 study (n = 85) and consistent
reduction in key inflammatory biomarkers in sputum
Phase 2
Kaplan-Meier Survival Time Without a PEx
1.0
+ Censored
0.9 | |||||||||||||||||
a PEx | 0.8 | ||||||||||||||||
0.7 | |||||||||||||||||
Without | |||||||||||||||||
0.6 | |||||||||||||||||
Survivalof | |||||||||||||||||
0.5 | |||||||||||||||||
Probability | 0.4 | ||||||||||||||||
0.3 | |||||||||||||||||
0.2 | |||||||||||||||||
0.1 | Lenabasum | ||||||||||||||||
Placebo | |||||||||||||||||
0.0 | |||||||||||||||||
61 | 59 | 55 | 52 | 51 | 50 | 50 | 48 | 47 | 42 | 38 | 37 | 22 | 1 | ||||
24 | 22 | 22 | 22 | 20 | 16 | 16 | 16 | 15 | 15 | 15 | 13 | 7 | 0 | ||||
0 | 10 | 20 | 30 | 40 | 50 | 60 | 70 | 80 | 90 | 100 |
p = 0.047 Days PEx Free
Reduction with Lenabasum 20mg BID
Compared to Placebo (Log10)
p = 0.20 | -0.7 | Neutrophils, | ||||
cells/ml | ||||||
0.7 | ||||||
p = 0.053 | -1.49 | Eosinophils, | ||||
cells/ml | ||||||
-1.49 | ||||||
p = 0.089 | -1.37 | Lymphocytes, | ||||
cells/ml | ||||||
-1.37 | ||||||
-0.61 | Macrophages, | |||||
cells/ml | ||||||
-0.61 | ||||||
Neutrophil | ||||||
p = 0.061 | -0.23 | elastase, | ||||
cells/ml | ||||||
p = 0.033 | -0.19 | IL-8, pg/ml | ||||
p = 0.037 | -0.19 | IgG, mg/dl | ||||
-2.5 | -2 | -1.5 | -1 | 0 |
41
Despite advances in CF treatment, pulmonologists project a sizable percentage of their CF patients will continue to exacerbate
"I'd start with patients who have PEx in the past, 2 per year. There will still be high PEx'ers no matter what [even with triple therapy]."
U.S., Pulmonologist
"Reducing PEx is an explicit treatment goal.
A lot of the loss in lung function is experienced during a PEx."
U.S., Pulmonologist
REDUCING PEx IS THE MOST IMPORTANT TREATMENT
GOAL FOR CF PATIENTS
- Pulmonologists describe PEx as a key mechanism of disease progression
- PEx have negative physical and emotional impacts on patients
- PEx are expensive to the healthcare system and reduce productivity
ADVANCEMENTS IN CFTR MODULATORS WILL LIKELY REDUCE EXACERBATIONS BUT UNMET NEED REMAINS
- Virtually all eligible patients will be considered for Trikafta
- Pulmonologists still expect many patients will continue to exacerbate
PULMONOLOGISTS VIEW LENABASUM AS APPROPRIATE FOR PATIENTS WHO NEED TO REDUCE THE FREQUENCY OF PEx,
REGARDLESS OF MUTATION
- Pulmonologists would consider lenabasum for patients on CFTR modulators if they continue to exacerbate
- Lenabasum offers potential treatment option for patients who are ineligible for modulators
All insights and quotes derived from proprietary qualitative market research conducted in H2 2019 [n=20 U.S. Pulmonologists that treat at least 20 CF patients over 12 years of age]
42
Ongoing systemic lupus erythematosus Phase 2 study funded and run by National Institutes of Health
- Topline data expected 2020
D O U B L E - B L I N D , R A N D O M I Z E D , P L A C E B O -
C O N T R O L L E D S T U D Y
1 6 - W E E K S T U D Y
1 5 S I T E S I N U . S .
~ 1 0 0
S U B J E C T S
1 : 1 : 1 : 1
D O S I N G
20 mg BID
20 mg BID
5 mg BID
Placebo
P R I M A R Y E N D P O I N T I N U . S . :
-
Change from baseline in the
7-Day Average of the Maximum Daily Numeric Rating Scale for Pain (NRS-Pain) Score
SECONDARY ENDPOINTS
- BILAG-2004
- SELENA-SLEDAIScore
- SELENA-SLEDAIFlare Index
- Patient Global Assessment
- PROMIS-29
- SLE Responder Index
- Swollen or Tender Joint Count
43
CRB-4001
44
2020: Targeting CB1 for metabolism was highly desirable
DRUG NAME | COMPANY | STAGE |
Rimonabant | Launched in EU |
Taranabant | Phase 3 |
Otenabant | Phase 3 |
Surinabant | Phase 2 |
Ibipinabant | Phase 2 |
Projected annual sales of rimonabant were $3bn1
1: 2007 Analyst Sales Estimates: WestLB, Sanford Bernstein, Raymond James, ING, Goldman Sachs
45
…But it ended poorly in 2008
CB1 binding in the brain led to
depression and suicidality
Rimonabant (Acomplia) withdrawn
Entire drug class terminated
46
2019: Focusing on CB1 without affecting the brain
COMPANY | COMPOUND | PHASE | MOA | TYPE OF COMPOUND |
CRB-4001 | Phase 1 safety data | CB1 inverse agonist | Oral small molecule |
expected in 2020 | |||
GFB-024 | Preclinical | CB1 antagonist | Injectable mAb |
(Phase 1 planned 2H 2020) | |||
Nimacimab | Phase 1 completed | CB1 antagonist | Injectable mAb |
(JNJ-2463) | |||
47
Risk factors for progression of NASH to cirrhosis
NAFLD | Noncirrhotic | NASH with | |
Normal liver | NASH | Cirrhosis | |
Fatty liver | |||
Fatty liver + inflammation | Fatty liver + inflammation | ||
and fibrosis | and severe fibrosis | ||
PROGRESSION TO NAFLD AND FURTHER | PROGRESSION TO | ||
PROGRESSION TO NONCIRRHOTIC NASH | NASH WITH CIRRHOSIS | ||
Obesity | Insulin resistance | Diabetes | Fibrosis | ||
Metabolic syndrome | Sedentary lifestyle | |||
Age | Genetic factors |
World Gastroenterology Organization Global Guidelines, 2012
48
CRB-4001 is an attractive candidate to treat NASH
- Strong preclinical data around CRB-4001
- Preferentially binds CB1b, predominant isoform in liver in obesity
- Limited CB1 occupancy in mouse brain
CRB-4001 Blocks Metabolic Abnormalities and Reduces Biomarkers
of Liver Damage Common In Nash In Animal Models
Stimulates Insulin Release1 | Reduces Body Fat2 | Reduces Liver Fat3 | ||||||||||||||
Insulin levels | Vehicle | 30 | Fat mass | Lean mass | Hepatic triglyceride (mg/g) | |||||||||||
8 | Ex4 = long-actingglucagon-like | |||||||||||||||
STD | HFD | |||||||||||||||
(ng/min/100islets) | peptide 1Receptor agonist (0.33nM) | 50 | ||||||||||||||
*,# | ||||||||||||||||
6 | CRB-4001 (0.1nM) | (g) | ||||||||||||||
Rimonabant (0.1nM) | 2 | 40 | ||||||||||||||
0 | * | 30 | ||||||||||||||
4 | ||||||||||||||||
20 | ||||||||||||||||
10 | * | |||||||||||||||
Insulin | 2 | 10 | ||||||||||||||
0 | ||||||||||||||||
0 | ||||||||||||||||
Veh | Veh | CRB-4001 | ||||||||||||||
10 | 15 | 20 | 25 | 30 | ||||||||||||
Perfusion time (min) | ||||||||||||||||
Reduces Pro-Inflammatory Mediators | Has Antifibrotic Effects on Fibroblasts | Reduces Liver Enzymes3 | ||||||||||||||
+ multiple effects on cells4 | effect | 0 | Fibroblasts | ALT (U/L) | ||||||||||||
IL-1 | 200 | STD | HFD | |||||||||||||
induced | ||||||||||||||||
4000 | -2 | 150 | ||||||||||||||
100 | ||||||||||||||||
2000 | of | |||||||||||||||
change | -4 | 50 | * | |||||||||||||
Veh | Veh | CRB-4001 | ||||||||||||||
0 | Fold | -6 | 0 | |||||||||||||
CRB-4001, µM
- Gonzalez-Mariscalet al. Sci. Rep. 2016; 6: 33302; Insulin release from isolated islet cells perfused with 7.5 nM glucose alone (blue line) and in combination with 0.33 nM Ex4 (red-line,half-max stimulation or with 0.1 nM CRB-4001 (green line) or 0.1 nM rimonabant (purple line), Treatment time point is indicated by arrow. Islet cells isolated from obese individual; 2: Tam et al. Cell Metabolism 2012; 16 167-179; N = 6/group. *p < 0.005 relative to STD, # p < 0.01 relative to high-fat diet (HFD) vehicle group; 3: Cell Metabolism 2012: 16 167-179; STD = standard diet, HFD = high fat diet. 6-7 DIO mice per group, Veh = vehicle. CRB-4001 at 3 mg/kg/day X 28 days. * = p < 0.01 vs HFD vehicle; 4: Data as concentration of cytokine, pg/mL
49
NEXT STEPS
SAFETY DATA
- Phase 1 safety data expected in 2020
KEY INFLECTION POINT
- Demonstrate differentiated brain CB1 binding as compared to rimonabant
50
CORBUS PLATFORM: NOVEL PRECLINICAL CANDIDATES
THAT TARGET THE ENDOCANNABINOID SYSTEM
51
First group of compounds generated from our proprietary platform in preclinical development
I P p r o t e c t i o n u n t i l
2039
F i r s t c l i n i c a l c a n d i d a t e w i l l b e s e l e c t e d i n
2020
CB1
C A N N A B I N O I D
R E C E P T O R T Y P E 1
Novel CB1 Inverse
Agonists
CRB-4614
CRB-4496
CB2
C A N N A B I N O I D
R E C E P T O R T Y P E 2
Novel CB2 Agonists
CRB-371
CRB-378
CRB-317
CRB-388
CRB-391
CRB-350
52
Management team with proven record of execution
Yuval Cohen, PhD | Sean Moran, CPA, MBA | Craig Millian, MBA |
Chief Executive Officer, Director | Chief Financial Officer | Chief Commercial Officer |
More than 13 years of executive | More than 20 years of senior financial | 25 years of experience leading |
leadership experience in inflammatory | experience with emerging biotechnology, | commercial organizations for a range of |
disease drug development | drug delivery and medical device | pharmaceutical companies as well as a |
companies | successful track record building | |
pharmaceutical brands |
Barbara White, MD | Robert Discordia, PhD | Ross Lobell |
Chief Medical Officer and Head of Research | Chief Operating Officer | VP, Regulatory Affairs |
Previous academician with more than 15 years | More than 25 years of biopharmaceutical | More than 35 years of regulatory affairs |
of industry clinical development and medical | industry experience in CMC development | experience with an extensive |
affairs experience in inflammatory and | and business operations | biopharmaceutical background in leading |
autoimmune diseases | preclinical, clinical and nonclinical | |
regulatory strategies |
53
Experienced and engaged board of directors
Amb. Alan Holmer Ret.
Chairman of the Board
More than two decades of public service in Washington, D.C. including Special Envoy to China; Former CEO of PhRMA
David Hochman
Director
More than 20 years of healthcare, entrepreneurial and venture capital experience; Chairman & CEO, Orchestra BioMed; Chairman, Motus GI Holdings, Inc. (NASDAQ: MOTS)
Avery W. (Chip) Catlin
Director
More than 25 years of senior financial leadership experience in life science companies; Former CFO and Secretary of Celldex Therapeutics
Rachelle Jacques
Director
More than 25-year professional career,
experience in U.S. and global biopharmaceutical commercial leadership, including multiple high- profile product launches in rare diseases; CEO of Enzyvant Therapeutics
Yuval Cohen, PhD | George Golumbeski, Ph.D. |
Chief Executive Officer, Director | Director |
More than 13 years of executive | Pharmaceutical / biotechnology leader with |
leadership experience in inflammatory | distinctive expertise in corporate development & |
disease drug development | corporate strategy. Formerly led corporate and |
business development at Celgene and Novartis |
John K. Jenkins, MD | Pete Salzmann, M.D., MBA |
Director | Director |
Distinguished 25-year career serving at | 20 years of industry experience and currently |
the U.S. FDA, including 15 years of | serves as Chief Executive Officer of Immunovant |
senior leadership in CDER and OND | (NASDAQ: IMVT), a biopharmaceutical |
company focused on developing therapies for | |
patients with autoimmune diseases |
54
Financial profile:
CRBP (NASDAQ)
$ 2 1 4 M
E Q U I T Y R A I S E D T O - D A T E
$ 4 5 M
N O N - D I L U T I V E F U N D I N G F R O M N I H A N D C F F O U N D A T I O N 1
- Includes development award from CFF announced in January 2018 which provides up to $25m in funding; 2: Based on July 7, 2020 closing price of $8.03 per share
7 2 . 5 M
C O M M O N S H A R E S O U T S T A N D I N G ( 8 6 . 6 M F U L L Y D I L U T E D )
$ 4 6 . 6 M
C A S H B A L A N C E A S O F 3 / 3 1 / 2 0 2 0
$ 5 8 2 M
M A R K E T C A P 2
55
PIONEERING TRANSFORMATIVE MEDICINES THAT TARGET
THE ENDOCANNABINOID SYSTEM
NASDAQ: CRBP | corbuspharma.com | @corbuspharma
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Corbus Pharmaceuticals Holdings Inc. published this content on 28 July 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 28 July 2020 18:50:05 UTC