Core Insights - Chemomab Therapeutics has announced positive results from its Phase 2 SPRING trial for nebokitug, a treatment for primary sclerosing cholangitis (PSC), which supports advancing to a Phase 3 registration trial [1][3] Group 1: Trial Results - The Phase 2 SPRING trial demonstrated that nebokitug was generally safe and well tolerated for up to 48 weeks, with significant improvements in biomarkers for inflammation and fibrosis, particularly at the 20 mg/kg dose [2][7] - In patients with moderate/advanced fibrosis, nebokitug showed a dose-dependent biological activity, with about half of the study population falling into this category [7][10] - The trial included 76 patients across 33 sites in the US, UK, Germany, Spain, and Israel, with over 90% of eligible patients opting for an open-label extension study [6] Group 2: Mechanism of Action - Nebokitug is a humanized IgG1 anti-CCL24 monoclonal antibody that targets CCL24, which is associated with inflammatory and fibrotic processes in PSC [5][12] - Elevated CCL24 levels have been linked to disease severity in PSC, and inhibiting CCL24 with nebokitug has shown therapeutic benefits in experimental models [5][12] Group 3: Future Prospects - Based on the positive data from the SPRING trial, Chemomab is preparing to initiate a Phase 3 trial, which will focus on a clinical event primary endpoint to streamline the regulatory approval process [12] - Nebokitug has received Orphan Drug and Fast Track designations from the FDA, indicating its potential significance in treating PSC [12]

Core Insights - Chemomab Therapeutics Ltd. is a clinical stage biotechnology company focused on developing innovative therapeutics for fibro-inflammatory diseases with significant unmet medical needs [4] Group 1: Company Overview - Chemomab is developing nebokitug, a first-in-class dual activity monoclonal antibody targeting the soluble protein CCL24, which plays a role in fibrosis and inflammation [4] - Nebokitug has shown a favorable safety profile and has been well-tolerated in clinical and preclinical studies, with potential applications in multiple severe fibro-inflammatory diseases [4] - The company has reported positive results from five clinical trials of nebokitug, particularly from its Phase 2 SPRING trial in primary sclerosing cholangitis (PSC) [4] - Chemomab is preparing to initiate a Phase 3 trial for nebokitug in PSC, which is designed as a single pivotal trial with a clear pathway to regulatory approval [4] - Nebokitug has received Orphan Drug and Fast Track designations from the FDA and EMA for the treatment of PSC [4] Group 2: Upcoming Events - Co-founder and CEO Adi Mor will participate in Oppenheimer's Movers in Rare Disease Summit on December 11, 2025, in New York City [1][3] - Dr. Mor will present a corporate overview and will be available for one-on-one meetings with registered attendees during the summit [2][3]

Core Insights - Chemomab Therapeutics is advancing its preparations for the Phase 3 trial of nebokitug for primary sclerosing cholangitis (PSC), with positive feedback from both the FDA and EMA indicating that a single registration trial will suffice for approval [3][10] - The Phase 2 SPRING trial data presented at AASLD 2025 showed favorable safety and consistent improvements in key biomarkers for PSC patients treated with nebokitug for up to 48 weeks [4][10] - The company has multiple partnering options to support the Phase 3 program and expects its cash runway to last through the end of Q4 2026 [1][8] Regulatory Developments - The FDA and EMA have aligned on the trial design, allowing a composite of clinically relevant events as the study endpoint, which streamlines the pathway to potential regulatory approval [3][10] - The support from the PSC community at the AASLD 2025 conference indicates growing interest and recognition of nebokitug's potential as a disease-modifying therapy [3][4] Clinical Data - Data from the Phase 2 SPRING trial highlighted nebokitug's positive effects on inflammatory and fibrotic biomarkers, confirming its good safety profile and disease-modifying potential [4][10] - New insights into nebokitug's mechanism of action were presented, emphasizing its role in halting or slowing disease progression in PSC [4][10] Financial Performance - As of September 30, 2025, Chemomab reported cash and cash equivalents of $10.2 million, an increase from $9.5 million as of June 30, 2025, and $14.2 million as of December 31, 2024 [8] - Research and Development expenses decreased to approximately $1 million in Q3 2025 from $2.8 million in Q3 2024, primarily due to the conclusion of the Phase 2 SPRING trial activities [8][13] - The net loss for Q3 2025 was $1.7 million, a reduction from a net loss of $3.5 million in Q3 2024, reflecting improved financial management [8][13]

Core Insights - Chemomab Therapeutics announced new clinical data from the Phase 2 SPRING trial of nebokitug for primary sclerosing cholangitis (PSC), showing favorable safety and consistent improvements in key biomarkers over 48 weeks of treatment [1][2] Group 1: Clinical Trial Results - The open-label extension (OLE) of the SPRING trial demonstrated that nebokitug was well-tolerated and maintained its anti-inflammatory and anti-fibrotic effects for up to 48 weeks, with significant improvements in biomarkers such as ELF score and liver stiffness [2][3] - Out of 54 eligible patients who completed the initial 15-week double-blind portion, 50 chose to continue in the OLE, receiving up to 33 additional weeks of treatment [3] - The results support the evaluation of nebokitug at a dosage of 20 mg/kg in a Phase 3 trial for PSC patients [3] Group 2: Mechanism of Action - Nebokitug targets macrophage-mediated mechanisms in PSC, showing dose-dependent reductions in serum macrophage-related proteins, particularly in patients with moderate to advanced disease [4][5] - The treatment led to increased expression of macrophage stimulating protein 1 (MST1), which is functionally impaired in PSC patients due to a genetic variant [6] - Changes in MST1 levels were associated with improvements in liver stiffness measurements, indicating its potential as a biomarker for nebokitug's activity [6] Group 3: Future Directions - Chemomab is preparing for a Phase 3 trial based on positive data from the Phase 2 SPRING trial, with a focus on a clinical event primary endpoint to streamline regulatory approval [10] - Nebokitug has received FDA and EMA Orphan Drug designations and FDA Fast Track designation for PSC treatment, highlighting its potential in addressing unmet medical needs [10]

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]