—Preparations for the Nebokitug PSC Phase 3 Clinical Trial Advance as Discussions with Potential Strategic Partners Continue— —Achieves FDA Alignment on CMC and Non-Clinical Toxicology Regulatory Path for Nebokitug in PSC— FDA fully approved therapy; the risk that the full data set from the nebokitug study or data generated in further clinical trials of nebokitug may not be consistent with the results of the nebokitug Phase 2 PSC trial; failure to obtain, or delays in obtaining, regulatory approvals for neb ...

Core Viewpoint - Chemomab Therapeutics has secured new patent protections for its lead product nebokitug in China and Russia, enhancing its intellectual property portfolio and positioning for future commercialization in the treatment of primary sclerosing cholangitis (PSC) [1][2][3] Patent Protections - The State Intellectual Property Office of China issued Patent No. ZL 2018 8 0018207.8, which protects the use of nebokitug in hepatic diseases, including PSC, with coverage extending to 2038 [2] - The Federal Service for Intellectual Property of Russia granted RU Patent 2022125176, which covers various formulations and doses of nebokitug, providing protection until 2041 [3] Clinical Development and Regulatory Pathway - Positive data from the Phase 2 SPRING trial of nebokitug has established a promising clinical profile for treating PSC, which is a debilitating disease with no effective treatments [2] - The FDA has outlined a clear pathway for regulatory approval of nebokitug in PSC, which is significant for the company's future plans [2] - Chemomab is preparing for a potential Phase 3 registrational trial for nebokitug in PSC, following the positive results from earlier trials [6] Company Overview - Chemomab Therapeutics is a clinical-stage biotechnology company focused on developing innovative therapeutics for fibro-inflammatory diseases, with nebokitug being a first-in-class dual activity monoclonal antibody targeting CCL24 [6] - The company has reported positive results from four clinical trials of nebokitug, demonstrating a favorable safety profile and potential for treating severe fibro-inflammatory diseases [6]

Core Insights - Chemomab Therapeutics has achieved significant milestones in the development of nebokitug for the treatment of primary sclerosing cholangitis (PSC), including a clear regulatory pathway with the FDA for potential full approval and positive 48-week data from the Phase 2 SPRING trial [1][2][10] Company Developments - The company reported that nebokitug treatment in PSC patients with moderate/advanced disease resulted in continued improvements across key biomarkers of liver injury, inflammation, and fibrosis [1][2] - Chemomab has aligned with the FDA on a streamlined regulatory approval program for nebokitug, which will utilize a single pivotal Phase 3 trial based on clinical events associated with disease progression, eliminating the need for liver biopsies [2][10] - The positive results from the SPRING trial indicate that nebokitug-treated patients showed a significantly lower number of clinical events compared to historical controls, particularly in the 20 mg/kg dose group [2][4] Financial Highlights - As of March 31, 2025, Chemomab's cash position was $10.6 million, down from $14.3 million at the end of 2024, with a cash runway expected to last until the second quarter of 2026 [5][8] - The company reported a net loss of $3.3 million for the first quarter of 2025, compared to a net loss of $3.9 million in the same period of 2024 [8][14] Research and Development - R&D expenses for the first quarter of 2025 were $2.5 million, a decrease from $3.1 million in the first quarter of 2024, primarily due to the winding down of activities related to the Phase 2 SPRING trial [8][13] - The company is actively pursuing multiple partnering options to advance the nebokitug program and is in discussions with potential strategic partners [1][2] Clinical Trial Updates - Data from the Phase 2 SPRING trial was presented at major conferences, including Digestive Disease Week 2025 and EASL 2025, highlighting the drug's potential in treating PSC [3][4] - The Open Label Extension study confirmed that nebokitug was safe and well-tolerated over 12 months, with significant improvements in liver biomarkers and stabilization of cholestasis-related markers [6][10]

Core Insights - The new clinical data confirms the potential of nebokitug (CM-101) as a first-in-class treatment for primary sclerosing cholangitis (PSC) and other fibro-inflammatory diseases [2][8] - Comprehensive proteomic analyses indicate that treatment with nebokitug resulted in significant and dose-dependent improvements in various biomarkers related to fibro-inflammatory disease pathways [2][3] - The pharmacokinetic and pharmacodynamic data from the Phase 2 SPRING trial demonstrate effective and dose-dependent antibody-target engagement [4][8] Group 1: Clinical Data and Findings - Nebokitug-treated patients exhibited significant and dose-dependent changes in multiple proteins related to fibrosis, immune cell recruitment, and inflammation [2][3] - The treatment was linked to downregulation of disease-related proteins and pathways involved with leukocyte migration, cytokine activity, chemokine activity, and collagen binding [3] - The analysis provided new insights into PSC disease-related pathways and additional biological evidence of the clinical activity of nebokitug [2] Group 2: Pharmacokinetics and Pharmacodynamics - PK analyses indicated dose-proportional increases in the concentration of nebokitug, with steady-state levels achieved after the fourth dose [4] - Increased levels of nebokitug corresponded with increased levels of its CCL24 target, reflecting effective antibody-target engagement [4] - Linear regression analyses found trends between increasing patient exposure to nebokitug and decreasing levels of relevant PSC disease biomarkers, including liver enzyme and transient elastography scores [4] Group 3: Company Overview and Future Plans - Chemomab Therapeutics is a clinical stage biotechnology company focused on developing innovative therapeutics for fibro-inflammatory diseases with high unmet need [8] - The company has reported positive results from four clinical trials of nebokitug and is preparing for a potential Phase 3 trial based on positive data from the Phase 2 SPRING trial [8] - Nebokitug has received FDA and EMA Orphan Drug and FDA Fast Track designations for the treatment of PSC [8]

Core Points - Chemomab Therapeutics has appointed David M. Weiner, MD, as Interim Chief Medical Officer and Jack Lawler as Chief Development Officer, both bringing extensive experience in biotechnology and pharmaceutical R&D [1][2][4] - Dr. Weiner previously served as Interim CMO at Chemomab and has over 25 years of experience in drug development, while Mr. Lawler has 25 years of clinical drug development experience and has been with Chemomab since 2022 [1][5][8] - The company is preparing for the potential initiation of a Phase 3 trial for its drug nebokitug, which has shown promising results in the Phase 2 SPRING trial for primary sclerosing cholangitis (PSC) [10] Company Overview - Chemomab is a clinical stage biotechnology company focused on developing therapeutics for fibro-inflammatory diseases, with its lead product nebokitug being a first-in-class monoclonal antibody targeting CCL24 [10] - Nebokitug has received FDA and EMA Orphan Drug designations and FDA Fast Track designation for PSC treatment, indicating its potential for expedited regulatory review [10] - The company has reported positive results from four clinical trials of nebokitug, demonstrating a favorable safety profile and the potential to treat multiple severe fibro-inflammatory diseases [10]