Chemomab Therapeutics reports Q3 EPS (1c) vs (2c) last year

“These are exciting and transformational times for Chemomab,” said Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab. “In the third quarter we reported the results of our CM-101 Phase 2 SPRING trial in patients with primary sclerosing cholangitis. The positive data from this trial represents a major clinical proof-of-concept for CM-101 as a potential disease-modifying treatment for PSC and other fibro-inflammatory diseases.bWe are on track to complete two important milestones in the first quarter of 2025-first, agreement with the FDA on the design of a PSC pivotal trial for CM-101 and second, reporting new clinical data from the open label portion of the Phase 2 SPRING trial. We will be meeting with the FDA before the end of this year to discuss the design of a CM-101 registrational trial in patients with PSC. Based on recent developments, we are optimistic that our proposed design, which incorporates surrogate biomarkers as primary endpoints in a single pivotal study, will be accepted. This would be a significant development for Chemomab and for the PSC field. Importantly, in the Phase 2 SPRING trial, CM-101 demonstrated positive results across the surrogate biomarker endpoints under consideration, which may represent a significant de-risking as CM-101 advances into Phase 3. We look forward to sharing the outcome of these discussions with the FDA and the data from the open label portion of the SPRING trial in the first quarter of 2025. We currently are laying the groundwork for the PSC registrational trial, which we anticipate launching later in 2025. We continue to have active discussions with potential strategic partners, whose long-time interest in Chemomab and CM-101 has significantly ramped up since the release of our positive Phase 2 data. Our focus is on assessing options that would help accelerate the PSC clinical program, as well as our programs in systemic sclerosis and potentially other fibro-inflammatory diseases. Our goal is to maximize the value of our novel and unique asset for all our stakeholders and ensure that CM-101 is available to patients in need. We are excited that our Phase 2 SPRING trial data is the subject of a high profile late breaking oral presentation at the upcoming 2024 AASLD conference. Chemomab will be well-represented at this major scientific meeting, and we also will be available for meetings during the JP Morgan Healthcare Conference in San Francisco in January.”