Core Insights - Chemomab Therapeutics is advancing its Phase 3 program for nebokitug, a treatment for primary sclerosing cholangitis (PSC), and is actively seeking strategic partnerships to optimize development resources and accelerate the program [3][4][11] - The company has received positive feedback from the FDA regarding the Chemistry, Manufacturing, and Controls (CMC) strategy and the timeline for nonclinical toxicology testing, which supports the timely advancement of the Phase 3 program [7][11] - Chemomab plans to adjust the ratio of its American Depositary Shares (ADSs) from 1:20 to 1:80, effective August 26, 2025, which will serve as a reverse split for ADS holders [3][10] Company Developments - The Phase 2 SPRING trial data for nebokitug was presented at major scientific meetings, highlighting its anti-fibrotic, anti-inflammatory, and anti-cholestatic effects [2][4][5] - Chemomab has expanded its patent protections for nebokitug in China and Russia, extending coverage until 2041, which is crucial for future commercialization [7][9] - The company reported a net loss of $2.1 million for Q2 2025, a decrease from $3.6 million in Q2 2024, reflecting reduced R&D expenses due to the completion of the Phase 2 trial [6][15] Financial Highlights - As of June 30, 2025, Chemomab had cash and cash equivalents of $9.5 million, expected to fund operations through the second quarter of 2026 [6][10] - R&D expenses for Q2 2025 were $1.3 million, down from $2.9 million in Q2 2024, while G&A expenses increased to approximately $1.0 million from $0.8 million in the same period [6][15] - The total number of ordinary shares issued and outstanding increased to 413,851,140 as of June 30, 2025, compared to 377,132,220 as of December 31, 2024 [10][14]

Core Insights - Chemomab Therapeutics has achieved significant milestones with the FDA regarding the development of nebokitug for primary sclerosing cholangitis (PSC) [1][4] - The FDA has agreed on the Chemistry, Manufacturing, and Controls (CMC) strategy and the non-clinical toxicology testing pathway for nebokitug, allowing for parallel testing during the Phase 3 clinical trial [2][3] Company Overview - Chemomab Therapeutics is a clinical-stage biotechnology company focused on developing therapeutics for fibro-inflammatory diseases, particularly targeting the soluble protein CCL24 [8] - Nebokitug (CM-101) is a first-in-class dual activity monoclonal antibody that neutralizes CCL24, showing potential in treating severe fibro-inflammatory diseases [5][8] Clinical Development - The company is preparing for a Phase 3 clinical trial of nebokitug, building on positive results from the Phase 2 SPRING trial, which met its primary safety endpoint and showed improvements in secondary endpoints [5][8] - Nebokitug has received FDA and EMA Orphan Drug designations and FDA Fast Track status for PSC treatment, indicating its potential significance in addressing unmet medical needs [5][8]

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]

TEL AVIV, Israel, April 21, 2025 (GLOBE NEWSWIRE) -- Chemomab Therapeutics, Ltd., (Nasdaq: CMMB), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced that clinical data on nebokitug (CM-101) for the treatment of patients with primary sclerosing cholangitis (PSC) will be presented at major upcoming scientific conferences including DDW25, Digestive Disease Week 2025; EASL 2025, the Annual Congress of the European Assoc ...

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]