Chemomab Therapeutics (CCMB) Oppenheimer 35th Annual Healthcare Life Sciences Conference 2025 summary

Key clinical developments and milestones

• CM-101 (Nebokitug) demonstrated positive Phase II results in primary sclerosing cholangitis (PSC), achieving clinical proof of concept and validating CCL24 as a target for fibrosis and inflammation.

• Two major milestones are expected in Q1 2025: FDA feedback on the regulatory path for PSC and additional data from the open-label extension of the PSC study.

• The open-label extension focuses on long-term safety and activity, with all patients receiving active drug and comparisons made to historical data.

• Phase III trial is planned as a global study, including the US, Europe, Israel, and potentially other regions.

• Current cash runway extends through early 2026, with ongoing evaluation of strategic funding opportunities for Phase III.

Scientific and clinical insights

• CM-101 targets CCL24, a cytokine central to both inflammation and fibrosis, and has shown efficacy in multiple preclinical and clinical models.

• The Phase II SPRING study in PSC showed significant improvements in liver stiffness, ELF score, and other biomarkers, especially in patients with moderate to advanced disease.

• The 20 mg/kg dose will be advanced to Phase III, as it showed the most consistent and broad effects.

• Safety profile was favorable, with no serious adverse events attributed to the drug and most adverse events being mild.

• The study allowed for concomitant use of UDCA, with no observed impact on drug efficacy.

Market potential and strategic positioning

• PSC affects about 80,000 patients in major markets, representing a commercial opportunity exceeding $1 billion.

• Systemic sclerosis, the second lead indication, has a market potential over $1.5 billion and no disease-modifying therapies.

• CM-101’s dual mechanism differentiates it from competitors and supports its potential as a pipeline-in-a-drug for multiple fibrotic diseases.

• Strong support from top-tier investors and interest from potential pharma partners position the program for accelerated development.

• Recruitment for future trials is expected to be robust due to high unmet need and established investigator relationships.