“This past period has been an exciting time of transformation for Chemomab. The positive results of the Phase 2 SPRING trial represent a major milestone for the company and clearly establish clinical proof-of-concept for CM-101 in primary sclerosing cholangitis and potentially other fibrotic diseases,” said Adi Mor, PhD, CEO. “CM-101 achieved the primary and key secondary endpoints in the trial and is the first therapy to demonstrate broad, clinically relevant effects on the three main components of PSC. This is also the first PSC trial to show, after just 15 weeks of treatment, a statistically significant reduction in liver stiffness, a widely used and well validated measure for assessing disease progression in PSC. We believe these results provide strong support for advancing CM-101 to a Phase 3 PSC trial, which we are in the process of planning and will be discussing with the FDA during the End-of-Phase 2 meeting targeted for later this year. We anticipate two milestones early in 2025 – additional data from the open label extension portion of the SPRING trial and finalization of the PSC Phase 3 design reflecting our discussions with the FDA. Based on recent developments in related indications, we are optimistic that an accelerated approval design incorporating surrogate biomarkers may be feasible for CM-101. We were pleased to welcome existing and major new investors, including OrbiMed, HBM Partners and Sphera, who participated in our successful $10 million PIPE financing. The proceeds generated by this financing will enable us to achieve our upcoming milestones in early 2025 and fund the operations of the company through the beginning of 2026. As a first-in-class molecule with a promising novel target relevant to multiple fibro-inflammatory diseases, CM-101 has long been of interest to potential biopharma partners. As expected, the positive data reported from the Phase 2 SPRING trial provides us opportunities to further advance the optimal path forward for CM-101, including potentially partnering to accelerate timelines for CM-101 development in PSC and other indications.”
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