Chemomab Therapeutics Ltd. · NASDAQ:CMMB
Chemomab Therapeutics — Investor Presentation (May 2025)
49 slides from Chemomab Therapeutics's investor presentation, May 28, 2025
Slide 1: Nebokitug: Novel Mechanism Drug Advancing to Phase 3 Pivotal Trial
May 2025 Nebokitug : Novel Mechanism Drug for Fibro-Inflammatory Diseases Advancing to Phase 3 Pivotal Trial Corporate Presentation NASDAQ: CMMB
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements other than statements of historical facts conta
Slide 3: Nebokitug Positioned to be First Approved Treatment for PSC
Nebokitug (CM-101)* Positioned to be First Approved Treatment for Primary Sclerosing Cholangitis (PSC) k Novel Mechanism with Unique target central to biology of inflammation & fibrosis potentially Disease-Modifying Potential applicable to wide range of fibro-inflammatory diseases Targeting Diseases
Slide 4: Nebokitug Phase 2 Data Provides Proof-of-Concept for Phase 3
Nebokitug Phase 2 Data Provides Proof-of-Concept for Phase 3 & Additional Indications Global Agent Indication Preclinical Phase 1 Phase 2 Phase 3 Milestones Rights Preparing for Phase 3 Trial Start Nebokitug Primary Finalize Phase 3 Sclerosing Phase 3 enabling activities underway Design in H1 2025 A
Slide 5: Nebokitug Reduces Both Inflammation and Fibrosis by Neutralizing CCL24
Nebokitug Reduces Both Inflammation and Fibrosis by Neutralizing CCL24 CCL24 Product Candidate The Target THE POWER Nebokitug OF CCL24 CCR3 Dual Role in Promoting Fibrosis The Receptor & Inflammation • Directly activates fibroblasts • Enhances local immune cell recruitment • Drives self-reinforcing
Slide 6: Broad & Diverse Preclinical Data Derisks Clinical Development
Nebokitug: Broad & Diverse Preclinical Data Derisks Clinical Development CCL24 Target Validation Mechanism of Action Ex-vivo Patient Samples EXTENSIVE DATA Primary sclerosing cholangitis Systemic sclerosis SUPPORTING Nebokitug effects on fibroblast activation Nebokitug effects on immune cell migrati
Slide 7: Nebokitug: Potential Treatment for Primary Sclerosing Cholangitis (PSC)
Nebokitug: Potential Treatment for Primary Sclerosing Cholangitis (PSC) 8
Slide 8: PSC: Devastating Rare Liver Disease With High Unmet Need
Chemomab is Developing Nebokitug for Primary Sclerosing Cholangitis - Devastating Rare Liver Disease With High Unmeet Need Orphan disorder with no FDA-approved therapies • Primarily affects mid-life men; ~70% also have IBD • Inflammation & fibrosis of bile ducts obstructs bile flow, leading to: – Lo
Slide 9: Nebokitug's Activity Uniquely Demonstrates Disease-Modifying Potential
Nebokitug’s Activity Uniquely Demonstrates Disease-Modifying Potential Nebokitug is the only therapeutic candidate targeting both inflammation and fibrosis Disease Modifying Company Candidate Mechanism Stage Potential Phase 2 Anti-CCL24; Dual activity inhibiting Phase 2 POC at 15 & 48-weeks Chemomab
Slide 10: Phase 2 PSC SPRING Trial Design and Endpoints
Phase 2 PSC SPRING Trial Design and Endpoints Randomized, Double-Blind, Placebo-Controlled--included dose-finding & open label extension Key Enrollment Criteria PSC patients with large duct disease of >24 weeks Nebokitug Primary Sclerosing Cholangitis SPRING Trial duration • ALP > 1.5 ULN • Stable I
Slide 11: SPRING Trial Patient Disposition
SPRING Trial Patient Disposition Randomized and Treated N=76 Placebo Nebokitug (CM-101) (10 mg/kg & 20 mg/kg) Safety Population Safety Population n=20 n= 56 Double Blind Completers* Double Blind Completers n=161 n=502 1-Excludes 4 patients for: withdrawal of consent (1), adverse event (1), not all d
Slide 12: SPRING Trial Patient Demographics
SPRING Trial Patient Demographics (Safety Population) Characteristic Placebo Nebokitug Nebokitug Nebokitug 10 mg/kg 20 mg/kg (All) n=20 n=25 n=31 n=56 Age (year), mean, (range) 40.5 (23–75) 48.6 (23–74) 45.6 (23–67) 46.9 (23–74) Male Gender, n, (%) 13 (65%) 16 (64%) 17 (55%) 33 (59%) Race, n, (%) Wh
Slide 13: SPRING Trial Baseline Characteristics
SPRING Trial Baseline Characteristics (Safety Population) Serum Liver Function Tests Placebo Nebokitug Nebokitug Nebokitug (All) mean, (SD) n=20 10 mg/kg 20 mg/kg n=56 n=25 n=31 Alkaline Phosphatase (U/L) 355 (203) 333 (189) 325 (167) 329 (176) Alanine Aminotransferase (U/L) 121 (83) 91 (63) 83 (51)
Slide 14: Good Safety Profile and Generally Well-Tolerated in PSC Patients
SPRING Trial: Nebokitug Demonstrated a Good Safety Profile & Was Generally Well-Tolerated in PSC Patients Fatigue 6 (30%) 5 (20%) 11 (36%) 16 (29%) Treatment Emergent Adverse Placebo CM-101 CM-101 CM-101 Events N, (%) n=20 10mg/kg 20mg/kg (All) Headache 4 (20%) 2 (8%) 7 (23%) 9 (16%) n=25 n=31 n=56
Slide 15: Nebokitug Pharmacokinetics Profile Over 15 Weeks
SPRING Trial: Nebokitug Pharmacokinetics (PK) Profile Over 15 weeks 200 Concentration (μg/mL, Ctrough) Mean (±SEM) CM-101 150 100 50 0 0 3 6 9 12 15 Week Placebo; n=19 10 mg/kg; n=23 20 mg/kg; n=27 Nebokitug data shows favorable & dose-dependent pharmacokinetics in patients with PSC ka Dose-dependen
Slide 16: Liver Stiffness Improved in Nebokitug-Treated Patients
SPRING Trial: Liver Stiffness Improved in Nebokitug-Treated Patients Significantly improved liver stiffness measures at 15 weeks compared to placebo in nebokitug-treated patients with moderate/advanced disease All patients Patients with baseline moderate/advanced disease* p=0.12 p=0.16 * p=0.01 2 6
Slide 17: ELF Scores Improved in Patients with Moderate/Advanced Disease
SPRING Trial: ELF Scores Improved in Patients with Moderate/Advanced Disease Treated with 20 mg/kg of Nebokitug All patients Patients with moderate/advanced disease* 0.8 Placebo (n=16) 0.8 Placebo (n=7) 10 mg/kg (n=22) 10 mg/kg (n=14) 0.6 20 mg/kg (n=27) 0.6 20 mg/kg (n=14) change from baseline chan
Slide 18: ELF Score Components Improved with 20 mg/kg
SPRING Trial: Fibrosis-Related ELF Score Components Improved in Patients with Moderate/Advanced Disease* Treated with 20 mg/kg of Nebokitug TIMP1 PIIINP 40 Placebo (n=7) 4 Placebo (n=7) 10 mg/kg (n=14) change from baseline at week 15 10 mg/kg (n=14) 20 20 mg/kg (n=14) 20 mg/kg (n=14) change from bas
Slide 19: Inflammatory Biomarkers Reduced in Patients with Moderate/Advanced Disease
SPRING Trial: Inflammatory Biomarkers Known to be Elevated in Patients with PSC are Reduced in Patients with Moderate/Advanced Disease Treated with Nebokitug 20
Slide 20: Fibrotic & Inflammatory Biomarkers Were Reduced
SPRING Trial: Fibrotic & Inflammatory Biomarkers Were Reduced in Nebokitug-Treated Patients with Moderate/Advanced Disease PROC-3 TGF1 p=0.1 p=0.1 0.6 change from baseline at week 15 *p= 0.02 change from baseline at week 15 8 6 0.4 (NPX units; log2 scale) 4 mean (SE) LS mean (SE) 2 0.2 (ng/ml) 0 -2
Slide 21: Nebokitug Shows Anti-Cholestatic Effects
SPRING Trial: Nebokitug Shows Anti-Cholestatic Effects Improvements in Itch scores and bilirubin levels after 15 weeks signal possible improvement in the cholestatic status of patients treated with nebokitug Pruritus Total Bilirubin Dose-dependent improvement in bilirubin supports Itch Scores improv
Slide 22: Liver Function Tests Improved at 15 Weeks
SPRING Trial: Liver Function Tests Improved in Nebokitug-Treated Patients at 15 Weeks All patients Patients with baseline moderate/advanced disease 39.2 40 20 16.5 Median % change from baseline at week 15 Median % change from baseline at week 15 10.4 10 19.3 20 5.0 13.8 2.9 10.4 0.3 0 3.5 3.6 4.9 2.
Slide 23: Positive Results at 15 Weeks Support Advancing to Phase 3
SPRING Trial: Positive Results at 15 Weeks Derisk Nebokitug & Support Advancing to Phase 3 • Established clinical proof-of-concept and validated role of CCL24 target as an important contributor to inflammatory/fibrosis cycle • Achieved primary safety endpoint—both doses of nebokitug demonstrated goo
Slide 24: SPRING Trial Open Label Extension 48-Week Results
Nebokitug: SPRING Trial Open Label Extension 48-Week Results 25
Slide 25: 48-Week Design and Endpoints
Nebokitug Phase 2 PSC SPRING Trial 48-Week Design and Endpoints 93% of eligible patients elected to continue to Open Label Extension (OLE) Nebokitug SPRING Trial • Data from 48-weeks of nebokitug treatment were used to evaluate: – Long term safety Nebokitug 10 mg/kg IV Q3W – Durability of effects Pa
Slide 26: SPRING Trial OLE Patient Disposition
SPRING Trial OLE Patient Disposition Open Label* N=50 Placebo to Nebokitug Placebo to Nebokitug Nebokitug Nebokitug (10mg/kg) (20mg/kg) (10 mg/kg) (20 mg/kg) Safety Population Safety Population Safety Population Safety Population n=1 n=11 n=11 n=27 Study Completers Study Completers Study Completers
Slide 27: OLE Patient Demographics & Baseline Characteristics
SPRING Trial OLE Patient Demographics & Baseline Characteristics (Safety Population) Baseline values between the groups were similar 28
Slide 28: OLE Safety and Tolerability Profile
SPRING Trial OLE Safety and Tolerability Profile The two serious TEAEs that were possibly drug-related were acute cholangitis and gallstone pancreatitis 29
Slide 29: Nebokitug Reduces Risk of Disease Progression by ELF Score
48-Week Results: Nebokitug Reduces Risk of Disease Progression as Indicated by ELF Score ELF improvement seen in patients with moderate/advanced disease All patients Moderate/advanced patients * 10 mg/kg n=4 10 mg/kg (n=8) 20 mg/kg n=10 20 mg/kg (n=21) change from baseline Mean (SE) ELF score 0.5 ch
Slide 30: Nebokitug Reduced Key Fibrotic Biomarkers
48-Week Results: Nebokitug 20 mg/kg Reduced Key Fibrotic Biomarkers PRO-C3 and PIIINP & TIMP—the 2 ELF components linked to fibrosis—were reduced over time PIIINP TIMP1 Pro-C3 10 mg/kg (n=8) 10 mg/kg n=8 2 100 10 mg/kg (n=8) 20 mg/kg (n=21) 10 20 mg/kg n=20 20 mg/kg (n=21) change from baseline chang
Slide 31: Slowed Progression of Liver Stiffness vs Historical Controls
48-Week Results: Nebokitug Slowed Progression of Liver Stiffness Compared to Historical Controls All patients Moderate/ advanced patients* change from baseline [kPa/year] change from baseline [kPa/year] 3 3 Mean (SE) LSM Mean (SE) LSM 2 2 1 1 0 0 10mg/kg 20mg/kg Historical 10mg/kg 20mg/kg Historical
Slide 32: Treatment Stabilizes Liver Biochemistries
48-Week Results: Treatment with Nebokitug Stabilizes Liver Biochemistries 20 Median % change from 10mg/kg 10.5 n=8 10 5.8 20 mg/kg baseline 3.7 2.4 n=22 0 0 -10 -8.1 -8.0 -15.1 -20 AST ALT ALP Bilirubin All patients AST-aspartate aminotransferase; ALT-alanine aminotransferase, ALP-alkaline phosphata
Slide 33: Slowed Liver Stiffness Progression Associated with Fewer Clinical Events
48-Week Results: Nebokitug-Slowed Progression of Liver Stiffness is Associated with Fewer Clinical Events Nebokitug-reduced progression supports Publications show that LSM progression is fewer clinical events strongly predictive of clinical outcomes1 Moderate/ advanced patients* change from baseline
Slide 34: Nebokitug 20mg/kg Reduced Total Serum Bile Acids
48-Week Results: Nebokitug 20mg/kg Reduced Total Serum Bile Acids * Reduction in total serum bile acids reflects cholestasis improvement Total serum bile acids include UDCA and conjugates * Moderate/advanced patients: Defined as ELF>9.8 at baseline
Slide 35: Treatment Appears to Reduce PSC-related Clinical Events
48-Week Results: Treatment with Nebokitug Appears to Reduce PSC-related Clinical Events* Lower Number of Clinical Events after Nebokitug Treatment Compared to Matching Historical Data Historical Data1 % of patients experiencing PSC-related clinical event 30 25.8 % % of patients 20 10 4.8 % 1-Muir et
Slide 36: Key Findings After 48 Weeks of Treatment
Nebokitug SPRING Trial: Key Findings After 48 Weeks of Treatment • Reduces biomarkers associated with disease progression • Shows continued improvement in markers of fibrosis – Improves ELF score, ELF fibrosis-related components and PRO-C3 in patients with moderate/advanced disease receiving 20mg/kg
Slide 37: FDA End-of-Phase 2 Meeting & Phase 3 Trial Design
Nebokitug FDA End-of-Phase 2 Meeting & Phase 3 Trial Design 38
Slide 38: Key Phase 3 Design Takeaways from FDA EOP2 Meeting
Key Phase 3 Design Takeaways from Nebokitug FDA EOP2 Meeting FDA offered Nebokitug a clear and efficient pathway to full approval in PSC • A single event-driven pivotal trial • Primary Endpoint: Composite of Clinical Events designed to demonstrate efficacy based on any one of multiple, equally-weigh
Slide 39: LSM & ELF Changes Support Potential for Reduced Clinical Events
Nebokitug-treated Patients Showed Changes in LSM & ELF Scores that Support the Potential for Reductions in Clinical Events Multiple Publications Show Clear Association Between Changes in ELF & Liver Stiffness Scores & Subsequent PSC Clinical Events+ LSM progression is strongly linked with patients’
Slide 40: Planned Nebokitug PSC Phase 3 Trial Design
Planned Nebokitug PSC Phase 3 Trial Design Inclusion Criteria • PSC patients with large duct disease of >24 Treatment until First weeks duration Clinical Event* • ELF≥9.8 and LSM≤15Kpa • Ascending cholangitis • Stable IBD allowed Placebo • Strictures requiring Stratification Factors Patients with IV
Slide 41: Planned Phase 3 Design Has Major Advantages
Nebokitug Planned Phase 3 Design Has Major Advantages • Clear and efficient Phase 3 design can be completed in a timely manner • No liver biopsies • Derisked: Major publications show association between decreases in clinical events and improvements in biomarkers such as elastography and ELF scores •
Slide 42: Nebokitug: Potential Treatment for Systemic Sclerosis (SSc)
Nebokitug: Potential Treatment for Systemic Sclerosis (SSc) Phase 2-Ready 43
Slide 43: Systemic Sclerosis: Most Lethal Systemic Rheumatic Disease
Systemic Sclerosis (SSc): Most Lethal Systemic Rheumatic Disease DEVASTATING ORPHAN DISEASE CAUSED BY RARE AUTOIMMUNE RHEUMATIC DISEASE Rare progressive cholestatic liver disorder which Debilitating disease characterized by INFLAMMATION, FIBROSIS & VASCULOPATHY NO DISEASE MODIFYING THERAPY currently
Slide 44: Phase 2 Data Expands Rationale for Nebokitug in Systemic Sclerosis
Phase 2 SPRING Trial Proof-of-Concept Data Expands Rationale for Advancing Nebokitug in Systemic Sclerosis Reinforces extensive evidence of therapeutic potential in SSc: CCL24 Involvement in SSc Pathology • Multiple SSc preclinical studies support CCL24 blockade as therapeutic strategy • High CCL24
Slide 45: CCL24: A Critical Target in Systemic Sclerosis
CCL24: A Critical Target in Systemic Sclerosis PATIENT SAMPLES CCL24 Elevated in SSc Skin High CCL24 Correlate to High CCL24 in SSc Serum SSc Skin FVC reduction Predicts Mortality Healthy Skin Correlation between serum CCL24 High CCL24 serum levels predict and relative change in FVC over the 10-year
Slide 46: CCL24 Blockade or Knockout Ameliorates SSc in Mouse Model
CCL24 Blockade or Knockout Ameliorates SSc in Mouse Model CCL24 BLOCKADE REDUCES SSc-LIKE INFLAMMATION & FIBROSIS IN LUNG & SKIN CCL24 knockout mice Nebokitug (CM-101)-treated mice Immune Cell Lung Infiltration Dermal Thickness++ BLEOMYCIN (IT)-INDUCED LUNG FIBROSIS 5000 4000 * # Cells 3000 Infiltra
Slide 47: Experienced Management with Extensive Biopharma Experience
Experienced Management with Extensive Biopharma Experience Adi Mor, PhD Sigal Fattal, CPA Co-founder, Chief Chief Financial Officer Executive Officer & Chief Scientific Officer David Weiner, MD Jack Lawler Interim Chief Medical Chief Development Officer Officer Revital Aricha, PhD Vice President, Tr
Slide 48: Potential Breakthrough Now Derisked by Successful 48-Week Phase 2 Data
Nebokitug: Potential Breakthrough in Fibro-Inflammatory Diseases Now Derisked by Successful 48-Week Phase 2 Data DUAL MECHANISM OF ACTION Disease-modifying potential with novel, unique target FOCUSED ON HIGH UNMET NEED, LARGE POTENTIAL RARE DISEASES With active engagement with potential strategic pa
Slide 49: Thank you!
Nebokitug: Novel Mechanism Drug for Fibro-Inflammatory Diseases Advancing to Phase 3 Pivotal Trial Thank you! w w w.C h e m o m a b . c om
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