Core Insights - Chemomab Therapeutics has successfully completed an FDA End-of-Phase 2 meeting, establishing a clear pathway for potential regulatory approval of nebokitug for the treatment of primary sclerosing cholangitis (PSC) without the need for liver biopsies or confirmatory studies [1][4][3] - The company is on track to release clinical data from the SPRING trial open label extension in the first quarter of 2025, and discussions with potential strategic partners are ongoing [1][5][3] Clinical Development - The Phase 2 SPRING trial for nebokitug demonstrated a favorable safety profile and met its primary endpoint, with significant improvements in multiple secondary efficacy endpoints for patients with moderate/advanced PSC [3][4][7] - The FDA has aligned with Chemomab on a single pivotal Phase 3 trial design that focuses on clinical event-driven endpoints, which is expected to streamline the regulatory approval process [3][4][5] Financial Performance - For the full year ended December 31, 2024, Chemomab reported a net loss of 24.2 million in 2023 [11][18] - Research and development expenses for 2024 were 18.4 million in 2023, reflecting reduced clinical costs as the Phase 2 trial neared completion [8][11] Cash Position - As of December 31, 2024, Chemomab had cash, cash equivalents, and short-term bank deposits totaling 19.9 million at the end of 2023, with a cash runway expected to last through the first quarter of 2026 [6][11] Strategic Outlook - The company is actively assessing various strategic paths forward and has received interest from potential partners following the positive FDA meeting [3][5] - Nebokitug has received FDA and EMA Orphan Drug and FDA Fast Track designations, positioning it as a promising candidate for addressing the unmet needs in PSC treatment [13]
Chemomab Therapeutics Announces Year End and Fourth Quarter 2024 Financial Results and Provides a Corporate Update