Chemomab Therapeutics Ltd Stock Price, News & Analysis

Chemomab Therapeutics (NASDAQ: CMMB) has received positive feedback from two FDA meetings regarding the advancement of nebokitug to Phase 3 trials for Primary Sclerosing Cholangitis (PSC). The FDA agreed with Chemomab's Chemistry, Manufacturing, and Controls (CMC) strategy for late-stage development and commercialization. Additionally, in a Type C meeting, the FDA permitted non-clinical fetal and embryo developmental toxicology studies to be conducted parallel to Phase 3 trials, with results to be submitted as part of the Biologics Licensing Application (BLA). These regulatory milestones follow previous positive discussions about the Phase 3 pivotal trial design in December, as the company continues discussions with potential strategic partners.

Chemomab Therapeutics (NASDAQ: CMMB) has secured new patent protections in China and Russia for its lead product nebokitug (formerly CM-101), extending coverage up to 2041. The Chinese patent (No. ZL 2018 8 0018207.8) covers nebokitug's use in hepatic diseases, including primary sclerosing cholangitis (PSC), through 2038. The Russian patent (RU Patent 2022125176) protects various formulations and doses through 2041. These additions strengthen Chemomab's intellectual property portfolio for nebokitug, which has shown promising Phase 2 SPRING trial results in PSC treatment. The company has received FDA alignment on a regulatory approval pathway for PSC, a debilitating disease currently lacking effective treatments. Chemomab is pursuing potential partnerships to support a Phase 3 registrational trial in PSC.

Chemomab Therapeutics (NASDAQ: CMMB) reported significant progress in Q1 2025 with its lead drug candidate nebokitug for Primary Sclerosing Cholangitis (PSC). The company announced positive 48-week data from the SPRING trial, showing continued improvements in liver injury, inflammation, and fibrosis biomarkers. Notably, Chemomab aligned with FDA on a pathway to potential regulatory approval through a single, clinical-events-driven Phase 3 trial, positioning nebokitug to potentially become the first FDA-approved PSC treatment. Financial highlights include cash position of $10.6 million as of March 31, 2025, with runway extended to Q2 2026. R&D expenses decreased to $2.5 million from $3.1 million YoY, while net loss improved to $3.3 million from $3.9 million. The company is actively pursuing strategic partnerships to advance the Phase 3 program.

Chemomab Therapeutics (NASDAQ: CMMB) presented positive Phase 2 SPRING trial data for nebokitug (CM-101) in treating Primary Sclerosing Cholangitis (PSC) at DDW 2025. The trial demonstrated that nebokitug was well-tolerated for up to 48 weeks of treatment and showed significant improvements in multiple fibrotic and inflammatory biomarkers. In the double-blind, placebo-controlled 15-week treatment period, the drug exhibited dose-dependent anti-inflammatory, anti-fibrotic, and anti-cholestatic effects. Notably, patients with moderate to advanced disease receiving the 20 mg/kg dose showed sustained improvement in fibrosis markers, reduction in ELF scores, and stabilization of liver stiffness. These positive results support advancing nebokitug to Phase 3 clinical trials as a potential first-in-class treatment for PSC, a devastating progressive disease with no FDA-approved therapies.

Chemomab Therapeutics (Nasdaq: CMMB) has presented new positive clinical data at EASL 2025 supporting nebokitug's potential as a first-in-class treatment for Primary Sclerosing Cholangitis (PSC) and related fibro-inflammatory diseases.

The Phase 2 SPRING trial analysis revealed that nebokitug treatment resulted in dose-dependent improvements in multiple inflammatory and fibrotic biomarkers. A comprehensive proteomic analysis of 3,000 circulating proteins showed significant changes in proteins related to fibrosis, immune cell recruitment, and inflammation. The treatment led to downregulation of biological processes including cell-cell adhesion, extracellular matrix organization, and pathways involved in leukocyte migration.

Pharmacokinetic analyses demonstrated dose-proportional increases in nebokitug concentration, with steady-state levels achieved after the fourth dose. Linear regression analyses indicated trends between increasing patient exposure to nebokitug and decreasing levels of PSC disease biomarkers, including liver enzyme and transient elastography scores.

Chemomab Therapeutics (Nasdaq: CMMB) has announced upcoming presentations of clinical data for nebokitug (CM-101) in treating primary sclerosing cholangitis (PSC) at three major scientific conferences.

The presentations will take place at:

• DDW25 (May 3-6, 2025, San Diego) featuring an oral presentation by Dr. Paul Pockros on safety, tolerability, and biomarker improvements
• EASL 2025 (May 7-10, 2025, Amsterdam) with two poster presentations by CEO Adi Mor on pharmacokinetics, pharmacodynamics, and proteomic profile changes
• BSG LIVE'25 (June 23-26, 2025, Glasgow) featuring an oral presentation by Prof. Douglas Thorburn on the SPRING Study results

The presentations will focus on CM-101's impact on inflammation, fibrosis, and cholestasis in PSC patients.

Chemomab Therapeutics (Nasdaq: CMMB) has announced key leadership changes in its medical and clinical teams. David M. Weiner, MD, has been appointed as Interim Chief Medical Officer, returning to a role he previously held in 2021-2022. Additionally, Jack Lawler has been promoted to Chief Development Officer.

Dr. Weiner brings over 25 years of experience in therapeutic discovery and clinical development, replacing Matt Frankel, MD. Lawler, who joined Chemomab in 2022, has been credited with leading the successful Phase 2 SPRING trial for nebokitug in primary sclerosing cholangitis (PSC).

The appointments come at a important time following the company's successful completion of the Phase 2 PSC program. Nebokitug has shown potential to become the first FDA-approved drug for PSC with disease-modifying activity. The company is currently planning its next steps following these positive clinical results.

Chemomab Therapeutics (Nasdaq: CMMB) has reported positive results from the Open Label Extension (OLE) portion of its Phase 2 SPRING trial for nebokitug in primary sclerosing cholangitis (PSC) patients. The trial showed continued improvements across key liver biomarkers after 48 weeks of treatment.

Key findings include:

• Over 90% of eligible SPRING trial patients participated in the OLE
• Patients with moderate/advanced disease showed significantly lower clinical events (4.8%) compared to historical controls (25.8%)
• Treatment demonstrated improvements in liver injury, inflammation, and fibrosis markers
• The drug was well-tolerated at both 10 mg/kg and 20 mg/kg doses administered every three weeks

The results support nebokitug's potential to become the first approved drug with disease-modifying activity for PSC, a deadly disorder currently lacking effective treatments. The 20 mg/kg dose showed particularly strong results and will be used in the upcoming Phase 3 trial.

Chemomab Therapeutics (Nasdaq: CMMB) presented new data at CORA 2025 supporting the potential of nebokitug (CM-101) as a treatment for systemic sclerosis (SSc). The presentation, scheduled for March 8, 2025, in Venice, Italy, showcases nebokitug as a first-in-class monoclonal antibody targeting CCL24, a key driver in fibro-inflammatory conditions.

The new study, conducted with Dr. Alexandra Balbir-Gurman, analyzed skin and serum samples from SSc patients and demonstrated CCL24's role in induced fibrosis and SSc pathogenesis. A 2024 peer-reviewed study of over 200 SSc patients showed that higher CCL24 levels correlated with severe SSc forms and predicted pulmonary function deterioration and higher 10-year mortality.

Recent positive results from the Phase 2 SPRING trial in PSC patients demonstrated nebokitug's effectiveness in reducing fibro-inflammatory biomarkers, including ELF score, PRO-C3, IL-6, and TGF-β, which are also indicators of SSc activity.