Core Insights - Chemomab Therapeutics has successfully aligned with the FDA on a single Phase 3 registration study for its lead product candidate, nebokitug, aimed at treating primary sclerosing cholangitis (PSC) [2][3] - The Phase 3 trial design provides regulatory clarity and eliminates the need for liver biopsies or additional confirmatory studies, focusing on clinically relevant endpoints associated with PSC disease progression [3][5] - Nebokitug is a first-in-class dual activity monoclonal antibody that neutralizes CCL24, showing promise in treating PSC and other fibro-inflammatory diseases [7][11] Group 1: Trial Design and Objectives - The Phase 3 trial is a randomized placebo-controlled study with a 2:1 active to placebo ratio, enrolling approximately 350 PSC patients [6] - The primary endpoint is the time-to-first clinical event, which includes various adverse events related to PSC progression, such as acute cholangitis and liver transplantation [6][4] - The trial aims to collect sufficient clinical events to demonstrate statistically significant changes between treatment and placebo arms, with an estimated two-year timeline for participants to experience a clinically meaningful event without intervention [6][4] Group 2: Regulatory and Strategic Developments - The FDA's agreement on the trial design marks a significant milestone, providing a streamlined path to potential full regulatory approval based on a single pivotal trial [3][5] - The company is actively engaging with potential strategic partners while preparing for the Phase 3 program, which could launch before the end of the year [3][5] - The trial's design is similar to oncology registration trials, focusing on disease progression-related events, which may allow for broader labeling compared to symptom-related endpoints [5][6] Group 3: Clinical Background and Need - PSC is a rare and debilitating liver disease with no FDA-approved therapies, affecting an estimated 30,000 patients in the U.S. and 80,000 worldwide [8] - The disease is characterized by inflammation and fibrosis of the bile ducts, leading to severe complications such as liver failure and increased cancer risk [8] - There is a high unmet medical need for effective treatments to address PSC symptoms and slow disease progression, highlighting the importance of nebokitug's development [8][11]

Core Insights - 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 will present at the virtual Oppenheimer 35 Annual Healthcare Life Sciences Conference on February 11, 2025, with a live webcast available for 90 days [1][2] Company Overview - Chemomab is developing CM-101, a first-in-class dual activity monoclonal antibody that neutralizes the soluble protein CCL24, which plays a role in fibrosis and inflammation [3] - CM-101 has shown a favorable safety profile and potential to treat multiple severe fibro-inflammatory diseases, with positive results reported from four clinical trials [3] - The company anticipates achieving a clear FDA registrational pathway for the planned Phase 3 pivotal trial of CM-101 in primary sclerosing cholangitis (PSC) and reporting data from the SPRING trial open label extension in early 2025 [3] - CM-101 has received FDA and EMA Orphan Drug and FDA Fast Track designations for PSC treatment [3] - The program for systemic sclerosis treatment is Phase 2-ready with an open U.S. IND [3]

Core Insights - Chemomab Therapeutics Ltd. announced positive results from its Phase 2 SPRING trial for CM-101 in patients with primary sclerosing cholangitis (PSC), demonstrating anti-fibrotic, anti-inflammatory, and anti-cholestatic activity [1][5][6] Study Details - The Phase 2 SPRING trial involved 76 PSC patients receiving two doses of CM-101 (10 mg/kg and 20 mg/kg) every three weeks for 15 weeks [3] - The trial included a double-blinded, placebo-controlled design, focusing on patients who completed all doses and the week 15 visit [2][3] Efficacy and Safety - CM-101 met its primary endpoint with a favorable safety profile, showing mild to moderate adverse events similar to the placebo group [4] - Significant improvements were observed in liver stiffness, ELF scores, PRO-C3 levels, liver biochemistries, total bilirubin levels, and pruritus scores in CM-101 treated patients compared to placebo [4][5] Future Development - Chemomab plans to advance CM-101 into a registrational trial and expects to meet with the FDA by the end of 2024 to discuss the trial design [6][7] - An open-label extension of the Phase 2 SPRING trial is ongoing, with results anticipated in the first quarter of 2025 [7] Company Background - Chemomab is a clinical-stage biotechnology company focused on developing therapeutics for fibroinflammatory diseases, with CM-101 being a first-in-class monoclonal antibody targeting CCL24 [9] - The company has received FDA and EMA Orphan Drug designations and FDA Fast Track status for CM-101 in PSC [9]

Group 1 - Chemomab Therapeutics reported earnings per share of -26 cents for the second quarter of 2024 [1] - The company did not report any revenue for the quarter [1]

Exhibit 99.1 Chemomab Therapeutics Ltd. and its subsidiaries Interim Condensed Consolidated Financial Statements As of June 30, 2024 (Unaudited) Chemomab Therapeutics Ltd. and its subsidiaries Page Interim Condensed Consolidated Financial Statements as of June 30, 2024 (Unaudited) Contents | --- | |------------------------------------------------------------------| | | | Interim Condensed Consolidated Balance Sheets | | Interim Condensed Consolidated Statements of Operations | | Interim Condensed Consolidat ...

──Reported Positive Phase 2 Results Demonstrating Safety and Anti-Fibrotic, Anti-Inflammatory and AntiCholestatic Activity across Multiple Components of Primary Sclerosing Cholangitis (PSC)── ──Establishes Clinical Proof-of-Concept for Disease-Modifying Potential of CM-101 and Provides Foundation for Advancing to PSC Phase 3 Pivotal Trial── ──Completed PIPE Financing Including Major New and Existing Investors that Extends Cash Runway Through Beginning of 2026── ──On Track to Achieve Key Clinical Milestones ...

TEL AVIV, Israel, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB) ("Chemomab" or the "Company"), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced the company will issue a press release reporting its second quarter 2024 financial results and providing a business update on August 21, 2024, at 7:00 am Eastern Time. Investors who would like to discuss the financial results or business updat ...

— HBM Healthcare Investments, OrbiMed and Sphera Biotech Master Fund LP Participated in the Financing that Extends Cash Runway Potentially to the Beginning of 2026— —Chemomab is Well-Positioned to Achieve Key Clinical Milestones in Q1 2025 While Continuing to Advance Its Discussions with Potential Partners Based on Positive Phase 2 Results— TEL AVIV, Israel, July 30, 2024 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB) ("Chemomab" or the "Company"), a clinical stage biotechnology company devel ...

On July 23, 2024, Nasdaq provided confirmation to the Company that for the 10 consecutive business days preceding receipt of the letter, from July 9, 2024 to July 22, 2024, the closing bid price of the ADSs was $1.00 or greater, that the Company has hence regained compliance with Listing Rule 5550(a)(2) and that the matter is now closed. About Chemomab Therapeutics Ltd. Chemomab had previously announced on November 6, 2023, that it was notified by Nasdaq that it was not in compliance with the minimum bid pr ...

The PIPE included participation from both new investors, including HBM Healthcare Investments and Sphera Biotech Master Fund LP, and existing investors. Chemomab expects that the net proceeds from the PIPE will extend its cash runway to fund its operations through the beginning of 2026, an extension of approximately one year from current projections, which should fund the Company for approximately one year after the completion of two major milestones expected in early 2025. The Company intends to use the ne ...