Chemomab Therapeutics Ltd. · NASDAQ:CMMB
Chemomab Therapeutics — Investor Presentation (February 2025)
39 slides from Chemomab Therapeutics's investor presentation, February 2025
Slide 1: Corporate Presentation: Nebokitug Advancing to Phase 3 Pivotal Trial
FEBRUARY 2025 CM-101 (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 & Additional Indications
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 Establish Phase 3 Sclerosing FDA End-of-Ph 2 meeting to discuss Phase 3 design Desig
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 De-risks Clinical Development
Nebokitug (CM-101): Broad & Diverse Preclinical Data De-risks Clinical Development CCL24 Target Validation Mechanism of Action Ex-vivo Patient Samples EXTENSIVE DATA Primary sclerosing cholangitis Systemic sclerosis SUPPORTING CM-101 effects on fibroblast activation CM-101 effects on immune cell mig
Slide 7: Safety & Anti-Fibrotic Mechanisms Demonstrated Across 5 Clinical Trials
Safety & Anti-Fibrotic Mechanisms Demonstrated Across 5 Clinical Trials NEBOKITUG APPEARED SAFE IN CLINICAL TRIALS IN NEBOKITUG IMPROVED MULTIPLE BIOMARKERS HEALTHY VOLUNTEERS & IN PATIENTS IN CLINICAL TRIALS IN PATIENTS • Safe & well-tolerated to date in 5 clinical trials • Reduced fibrosis-related
Slide 8: Nebokitug: Potential Treatment for Primary Sclerosing Cholangitis (PSC)
Nebokitug: Potential Treatment for Primary Sclerosing Cholangitis (PSC) 8
Slide 9: Developing Nebokitug for PSC - 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 10: Nebokitug's Activity Uniquely Demonstrates Disease-Modifying Potential
Nebokitug’s Activity Uniquely Demonstrates Disease-Modifying Potential CM-101 is the only therapeutic candidate targeting both inflammation and fibrosis Disease Modifying Company Candidate Mechanism Stage Potential Phase 2 Anti-CCL24; Dual activity inhibiting Achieved Phase 2 POC showing safety Chem
Slide 11: Preclinical Validation: CCL24 Levels Elevated in PSC Patients
Preclinical Validation: CCL24 Levels Are Elevated in PSC Patients & Associated with Protein Expression in Key Pathways CCL24 LEVELS IN HEALTHY VS PSC PATIENT LIVER TISSUE CCL24 LEVELS ARE ASSOCIATED WITH KEY PSC PATHWAYS Hepatic Hepatic Fibrosis Immune cell Healthy Liver PSC Livers Cholestasis / HSC
Slide 12: Nebokitug Reduces Liver Fibrosis by >80% Preclinically
Preclinical Validation: Nebokitug (CM-101) Reduces Liver Fibrosis by >80% Preclinically REDUCED LIVER COLLAGEN DEPOSITION RAT MODEL LIVERS SIRIUS RED (COLLAGEN) % FIBROSIS (SIRIUS RED STAINING) Healthy 100 Col1A1 Col3A1 Pro-fibrotic TIMP1 Genes 80 ACTA2 TGF-β 82% 60 reduction ALT TAA Liver AST Fibro
Slide 13: Nebokitug Reduces Liver Injury & Fibrosis in PSC Models
Preclinical Validation: Nebokitug (CM-101) Reduces Liver Injury & Fibrosis in PSC Models NEBOKITUG DEMONSTRATED SIZEABLE REDUCTIONS IN PSC-RELATED PATHOLOGY* REDUCED MACROPHAGES ATTENUATED LIVER ATTENUATED LIVER REDUCED BILE EPITHELIAL COLLAGEN DEPOSITION COLLAGEN DEPOSITION PROLIFERATION Mdr2 -/- M
Slide 14: Phase 2 PSC SPRING Trial Design and Endpoints
Phase 2 PSC SPRING Trial Design and Endpoints Randomized, Double-Blind, Placebo-Controlled--includes dose-finding & open label extension Nebokitug (CM-101) Primary Sclerosing Cholangitis SPRING Trial Key Enrollment Criteria PSC patients with large duct disease of >24 weeks duration • ALP > 1.5 ULN •
Slide 15: 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 do
Slide 16: SPRING Trial Patient Demographics (Safety Population)
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 17: SPRING Trial Baseline Characteristics (Safety Population)
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 18: SPRING Trial: Good Safety Profile & Generally Well-Tolerated
SPRING Trial: Nebokitug (CM-101) 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
Slide 19: SPRING Trial: Pharmacokinetics Profile Over 15 Weeks
SPRING Trial: Nebokitug (CM-101) Pharmacokinetics Profile Over 15 weeks Concentration (μg/mL, Ctrough) 200 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-depe
Slide 20: SPRING Trial: Liver Stiffness Improved in Treated Patients
SPRING Trial: Liver Stiffness Improved in Nebokitug (CM-101)-Treated Patients Significantly improved liver stiffness measures compared to placebo in Nebokitug-treated patients with moderate/advanced disease All patients Patients with baseline moderate/advanced p=0.12 disease* p=0.16 * p=0.01 2 6 * p
Slide 21: SPRING Trial: ELF Scores Improved in Moderate/Advanced Disease
SPRING Trial: ELF Scores Improved in Nebokitug (CM-101) Patients with Moderate/ Advanced Disease Treated with 20 mg/kg Dose Patients with baseline Fibrosis-Related ELF moderate/advanced disease* Components-Change from Baseline Over Time CM-101 20 mg/kg vs. Placebo through 15 weeks 40 TIMP1 All patie
Slide 22: SPRING Trial: Serum Inflammatory & Fibrotic Biomarkers Reduced
SPRING Trial: Serum Inflammatory & Fibrotic Biomarkers Reduced in Nebokitug (CM-101)-Treated Patients with Moderate/Advanced Disease* IL-6 PROC-3 TGF1 p=0.1 1.5 p=0.1 change from baseline at week 15 *p=0.021 0.6 change from baseline at week 15 *p= 0.02 change from baseline at week 15 8 1.0 6 0.4 (N
Slide 23: SPRING Trial: Anti-Cholestatic Effects
Phase 2 SPRING Trial: Nebokitug (CM-101) 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 Itch Scores improved in Nebokitug-treated patients Dose-dependent improveme
Slide 24: SPRING Trial: Liver Function Tests Improved
SPRING Trial: Liver Function Tests Improved in Nebokitug (CM-101)-Treated Patients 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 2.8
Slide 25: SPRING Trial: Positive Results De-Risk Nebokitug & Support Phase 3
SPRING Trial: Positive Results De-Risk Nebokitug & Support Advancing to Phase 3 • Established clinical proof-of concept for Nebokitug & validated role of CCL24 target as an important contributor to inflammatory/fibrosis cycle • Achieved primary safety endpoint—both doses of nebokitug demonstrated go
Slide 26: Key Takeaways from Nebokitug FDA EOP2 Meeting
Key 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-weighted events that
Slide 27: Planned Nebokitug Phase 3 Trial Design in PSC
Planned Nebokitug Phase 3 Trial Design in Primary Sclerosing Cholangitis Inclusion criteria • PSC patients with large duct disease of >24 Treatment until weeks duration First Clinical Event* • Enrichment based on ELF and LSM • Stable IBD allowed Placebo • Ascending cholangitis Randomization IV Q3W •
Slide 28: The Nebokitug Phase 3 Design Has Key Advantages
The Nebokitug Phase 3 Design Has Key Advantages • No liver biopsies • Clinical events are used in routine clinical practice and are the most reliable indicator of PSC disease progression • No costly and difficult-to-execute post-marketing confirmatory study needed • Will capture data on elastography
Slide 29: Publications Show Association Between Liver Stiffness Scores & Clinical Events
Multiple Publications Show Clear Association Between Liver Stiffness Scores & Clinical Events+ Decreased LSM scores in Phase 2 Nebokitug-treated patients suggest potential for improved clinical outcomes LSM progression is strongly linked with patients’ clinical Nebokitug significantly lowered LSM sc
Slide 30: Historical Studies Show Association between ELF Scores & Clinical Outcomes
Historical Clinical Studies Show Clear Association between ELF Scores & Clinical Outcomes ELF scores were maintained below a key 0.19 threshold in Phase 2 Nebokitug-treated patients+, supporting the potential for reductions in clinical events PSC patients with ELF score changes that remained below t
Slide 31: Upcoming Nebokitug PSC Milestones
Upcoming Nebokitug PSC Milestones • Phase 2 Open Label Extension data confirming safety & providing additional insight into nebokitug activity in PSC to be reported in Q1 2025 • Preparations underway to set stage for rapid Phase 3 trial initiation • Discussions with potential strategic partners cont
Slide 32: Nebokitug: Potential Treatment for Systemic Sclerosis (SSc)
Nebokitug: Potential Treatment for Systemic Sclerosis (SSc) Phase 2-Ready 32
Slide 33: 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 34: Phase 2 Data Expands Rationale for Nebokitug in Systemic Sclerosis
Phase 2 SPRING Trial Proof-of-Concept Data Expands Rationale for Advancing Nebokitug (CM-101) 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 • Hi
Slide 35: 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 36: 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 37: Experienced Management with Extensive Biopharma Experience
Experienced Management with Extensive Biopharma Experience Adi Mor, PhD Matthew Frankel, MD Co-founder, Chief Chief Medical Officer & Executive Officer & Chief Vice President, Drug Scientific Officer Development Ilan Vaknin, PhD Sigal Fattal, CPA Vice President, Chief Financial Officer Research & De
Slide 38: Potential Breakthrough in Fibro-Inflammatory Diseases Validated by Positive Phase 2 Data
Nebokitug: Potential Breakthrough in Fibro-Inflammatory Diseases Validated by Positive Phase 2 Data with FDA-Aligned Single Pivotal Trial Regulatory Pathway DUAL MECHANISM OF ACTION Disease-modifying potential with novel, unique target FOCUSED ON HIGH UNMET NEED, LARGE POTENTIAL RARE DISEASES With a
Slide 39: Thank you!
Nebokitug (CM-101): Novel Mechanism Drug for Fibro- Inflammatory Diseases Advancing to Phase 3 Pivotal Trial Thank you! www.Chemomab.com
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