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Chemomab Therapeutics Announces Year End and Fourth Quarter 2025 Financial Results and Provides a Corporate Update
Globenewswire· 2026-03-19 12:00
Core Insights - Chemomab Therapeutics has successfully completed an FDA End-of-Phase 2 meeting, achieving alignment on a clear pathway to potential approval for its treatment of primary sclerosing cholangitis (PSC) based on a single Phase 3 trial [1][3][12] - The Phase 2 SPRING trial results for nebokitug have been recognized as significant, with multiple scientific presentations raising awareness of its potential as a first disease-modifying treatment for PSC and other fibro-inflammatory conditions [1][4][12] - Ongoing discussions with strategic partners are aimed at advancing the necessary activities for the timely initiation of the Phase 3 trial [3][12] Company Developments - The Phase 2 SPRING trial data was published in the American Journal of Gastroenterology, indicating that nebokitug was generally safe and well-tolerated, with improvements in biomarkers for inflammation and fibrosis, particularly at the 20 mg/kg dose [4] - Data from the SPRING trial was featured in three poster presentations at the AASLD The Liver Meeting® 2025, all designated as "posters of distinction," confirming nebokitug's positive safety profile and disease-modifying potential [4] - Chemomab has received FDA and EMA Orphan Drug designations for nebokitug in PSC and systemic sclerosis, highlighting its therapeutic potential in severe fibro-inflammatory diseases [12] Financial Highlights - As of December 31, 2025, Chemomab reported cash, cash equivalents, and short-term bank deposits of $10.4 million, down from $14.3 million in 2024, with a cash runway expected to last until the end of Q1 2027 [10] - Research and Development (R&D) expenses for the fourth quarter were $1.1 million, and $5.8 million for the full year, a decrease from $2.4 million and $11.3 million in 2024, primarily due to the completion of the Phase 2 trial [10] - The net loss for the fourth quarter was $1.9 million, or less than $0.01 per share, and for the full year, it was $9.0 million, or less than $0.02 per share, compared to a net loss of $13.9 million in 2024 [10][17]
Chemomab Therapeutics (NasdaqCM:CMMB) FY Conference Transcript
2026-02-26 14:00
Summary of Chemomab Therapeutics FY Conference Call Company Overview - **Company**: Chemomab Therapeutics (NasdaqCM:CMMB) - **Industry**: Biotechnology, focusing on inflammatory and fibrotic diseases - **Lead Asset**: Nebokitug, a first-in-class monoclonal antibody targeting CCL24, involved in inflammation and fibrosis across multiple indications [2][3] Core Points and Arguments Clinical Development - **Primary Indications**: - Primary Sclerosing Cholangitis (PSC): A rare liver fibrotic disease with no FDA-approved drugs, approximately 70,000 patients in major markets [5][6] - Systemic Sclerosis (SSc): An inflammatory disease affecting primarily women, with a market potential exceeding $1.5 billion [20] - **Clinical Trials**: - Completed a successful Phase 2 study for PSC, showing significant anti-inflammatory and anti-fibrotic activity [3][4] - Nebokitug is now positioned as a Phase 3-ready program for PSC, with plans to start the trial with a partner [4][18] - The Phase 2 study included 76 patients, with a focus on moderate to advanced disease [7][10] Efficacy and Safety - **Phase 2 Study Results**: - Met primary and secondary endpoints, showing safety and tolerability [9][12] - Significant improvements in liver stiffness and ELF scores, particularly in patients with moderate to advanced disease [10][11][16] - 93% of eligible patients continued into an open-label extension, indicating high compliance [13] - Clinical events in treated patients were significantly lower (4.8%) compared to historical controls (26%) [17][18] Market Potential - **Revenue Projections**: Potential market for PSC could exceed $1 billion, based on conservative estimates focusing on moderate to advanced disease [6][28] - **Competitive Landscape**: Nebokitug is the only late-stage drug suggesting clear disease modification, unlike others focusing on symptom management [6][18] Future Directions - **Phase 3 Trial Design**: - Will focus on clinical events as primary endpoints, including various complications related to PSC [19] - Discussions with FDA have aligned on trial design for full approval [18] - **Expansion into Other Indications**: - Potential for nebokitug in systemic sclerosis and other fibrotic diseases, leveraging its dual anti-fibrotic and anti-inflammatory mechanism [23][24] Additional Important Information - **Financial Position**: Chemomab reported approximately $20.8 million in cash, sufficient to support activities through the end of 2026, including Phase 3 preparations [39] - **Partnership Strategy**: Seeking partners with financial commitment and expertise in commercialization to enhance trial efficiency and reduce costs [30][33] Conclusion Chemomab Therapeutics is advancing its lead asset, nebokitug, through clinical trials with promising results in treating PSC and potential applications in systemic sclerosis. The company is well-positioned for a Phase 3 trial, with significant market opportunities and a strong focus on disease modification.
Chemomab Therapeutics to Participate in Oppenheimer 36th Annual Healthcare Life Sciences Conference
Globenewswire· 2026-02-17 13:00
Company Overview - Chemomab Therapeutics Ltd. is a clinical stage biotechnology company focused on developing innovative therapeutics for fibro-inflammatory diseases with high unmet need [3] - The company has developed nebokitug, a first-in-class dual activity monoclonal antibody that neutralizes the soluble protein CCL24, which plays a role in promoting fibrosis and inflammation [3] - Nebokitug has shown disease-modifying potential and a favorable safety profile in clinical and preclinical studies, with positive results reported from five clinical trials [3] Clinical Development - Chemomab has aligned with the FDA on the design of a Phase 3 registration trial for nebokitug in patients with primary sclerosing cholangitis (PSC) based on positive data from its Phase 2 SPRING trial [3] - Nebokitug has received Orphan Drug designations from the FDA and EMA for the treatment of PSC, as well as Fast Track designation from the FDA [3] - The nebokitug program for systemic sclerosis has also received Orphan Drug designations and has an open U.S. IND [3] Upcoming Events - Chemomab's CEO Dr. Adi Mor and senior management will present at the virtual Oppenheimer 36 Annual Healthcare Life Sciences Conference on February 26, 2026 [1] - The corporate presentation will be webcast live and available for 90 days on the Chemomab investor relations website [1]
Chemomab Therapeutics Announces Nebokitug Phase 2 SPRING Trial Results in Primary Sclerosing Cholangitis Published in the American Journal of Gastroenterology
Globenewswire· 2025-12-02 13:00
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]
Chemomab to Participate in Oppenheimer’s Movers in Rare Disease Summit
Globenewswire· 2025-11-24 13:00
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]
Chemomab Therapeutics Announces Third Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-11-20 13:00
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]
Chemomab Announces Multiple Presentations at AASLD The Liver Meeting® 2025 Featuring Clinical Data from the Nebokitug Phase 2 Trial in Primary Sclerosing Cholangitis
Globenewswire· 2025-11-06 13:00
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]
Chemomab Announces New Patent Awards for Its First-in-Class Agent Nebokitug that is Positioned to Potentially Become the First Approved Drug for Primary Sclerosing Cholangitis
Globenewswire· 2025-06-03 12:00
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]