On March 3, 2025 Chemomab Therapeutics Ltd. (Nasdaq: CMMB), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, reported financial and operating results for the full year and fourth quarter ended December 31, 2024, and provided a corporate update (Press release, Chemomab, MAR 3, 2025, View Source [SID1234650827]).
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"The past year has been a transformative period for both Chemomab and the PSC field," said Adi Mor, PhD, co-founder and Chief Executive Officer of Chemomab. "Following rapid enrollment in our nebokitug (CM-101) Phase 2 SPRING trial in patients with PSC, we were able to report topline results in July, approximately six months ahead of schedule. We and our PSC expert advisers view these Phase 2 data as the strongest in PSC to date. Nebokitug achieved the SPRING trial primary endpoint, demonstrating a favorable safety profile. Additionally, patients treated with nebokitug who had moderate/advanced disease showed improvements in multiple secondary efficacy endpoints encompassing the fibrotic, inflammatory and cholestatic aspects of PSC. This is the first time that an investigational drug for PSC has shown improvements across such a wide range of highly relevant disease markers. These promising results set the stage for our FDA End-of-Phase 2 meeting. We recently reported the positive results of that meeting and outlined the design for a single pivotal Phase 3 trial for nebokitug in PSC, which provides us with a clear and streamlined pathway to potential regulatory approval."
Dr. Mor continued, "We were very pleased by FDA’s positive and collaborative spirit at the meeting and their stated commitment to facilitating the advancement of effective new therapies for PSC. We aligned on a full regulatory approval program for nebokitug using a single pivotal Phase 3 trial based on well-characterized clinical events that are associated with disease progression in PSC. Neither liver biopsies nor additional confirmatory studies will be needed. The design is similar to the approach used in oncology trials and is both feasible and efficient. Importantly, use of a clinical event-driven endpoint helps derisk the Phase 3 trial, since key publications have linked the type of improvements in PSC biomarkers seen in nebokitug-treated patients in the SPRING trial with decreases in clinical events."
Dr. Mor added, "We continue to assess a variety of potential strategic paths forward. The recent positive developments have been of keen interest to potential strategic partners and active discussions are advancing following FDA’s regulatory guidance. At the same time, we are laying the foundation for beginning the Phase 3 trial, leveraging the strong relationships our clinical team developed with global PSC centers during the SPRING study. We believe that nebokitug could become the first FDA-approved therapy for PSC, addressing the tremendous unmet need in this devastating, often lethal disease. We look forward to reporting data from the SPRING trial Open Label Extension later this quarter."
2024 and Recent Highlights:
On February 19, 2025, Chemomab reported that the International Nonproprietary Names (INN) program of the World Health Organization had assigned the INN designation nebokitug to the company’s lead product candidate CM-101.
On February 19, 2025, Chemomab announced the successful completion of its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) and alignment with FDA on the design of a Phase 3 registration study for nebokitug for the treatment of PSC. The design provides clarity on a streamlined path to full regulatory approval based on a single pivotal trial that does not require liver biopsies or confirmatory studies. The primary endpoint measures time-to-first clinical event and encompasses multiple clinical events associated with disease progression. Key publications have shown that the reductions in PSC biomarkers seen in the nebokitug Phase 2 SPRING trial are associated with reductions in clinical events, increasing confidence in the relevance of this approach for the nebokitug Phase 3 trial. The company is sharing the Phase 3 design in active discussions with potential strategic partners while laying the groundwork for initiating the Phase 3 program.
On January 13, 2025, a new peer-reviewed publication in the journal Cells further confirmed the key role of the soluble protein CCL24 in driving the fibro-inflammatory pathologies underlying PSC, systemic sclerosis and other fibrotic diseases. The review describes the pivotal role CCL24 plays in initiating and advancing fibrotic processes, highlighting its impact on fibrotic, immune and vascular pathways. It also presented preclinical and clinical evidence supporting the therapeutic potential of blocking CCL24 with agents like nebokitug in diseases that involve excessive inflammation and fibrosis.
On November 19, 2024, Chemomab reported that data from its Phase 2 SPRING trial in patients with PSC was presented at the American Association for the Study of Liver Disease (AASLD) The Liver Meeting 2024. In an oral, late-breaking presentation, Professor Christopher Bowlus, MD, a SPRING trial investigator and Professor and Chief of the Division of Gastroenterology and Hepatology at the University of California Davis School of Medicine, discussed data from the double-blind, placebo-controlled portion of the Phase 2 trial.
On July 30, 2024, Chemomab announced the closing of a private placement that resulted in gross proceeds of approximately $10 million to the company. Existing investors such as OrbiMed and new investors including HBM Partners and Sphera Biotech Master Fund participated in the financing.
On July 25, 2024, Chemomab reported positive topline results from the nebokitug Phase 2 SPRING trial in patients with PSC. Nebokitug met the primary study endpoint, demonstrating a favorable safety profile and nebokitug-treated patients with moderate/advanced disease showed improvements on a wide range of disease-related secondary endpoints, including liver stiffness, liver fibrosis biomarkers, such as the Enhanced Liver Fibrosis (ELF) score and PRO-C3 levels; total bilirubin and liver function tests; pruritus (itch) and markers of inflammation. Dose-dependent responses were observed for multiple disease-related biomarkers. A consistent pattern of greater improvement on the secondary endpoints was observed in the study arm receiving the 20mg/kg dose of nebokitug. This dose has been selected for the active treatment arm of the Phase 3 trial.
On June 18, 2024, Chemomab announced new scientific publications had been published in the peer-reviewed journals International Journal of Molecular Science and Drug Safety that reinforced the clinical potential of nebokitug in PSC.
On June 6, 2024, Chemomab presented new scientific and clinical data at EASL 2024 and at a Gordon Research Conference supporting the clinical potential of nebokitug as a novel treatment for PSC. The findings helped elucidate nebokitug’s mode of action in liver fibrosis and could help in characterizing its anti-fibrotic drug effects.
On April 18, 2024, Chemomab announced the publication of a new study in the journal Arthritis Care and Research that confirms the key role of CCL24 in systemic sclerosis. The longitudinal study of more than 200 SSc patients showed that elevated levels of serum CCL24 are associated with increased mortality and disease severity across the fibrotic and vascular manifestations of the disease.
On April 10, 2024, Chemomab hosted an expert PSC webinar featuring Christopher Bowlus, MD, of UC Davis Health; Ricky Safer, founder and CEO of PSC Partners Seeking a Cure and Massimo Pinzani, MD, PhD, of the UCL Institute for Liver and Digestive Health and UPMC ISMETT.
In March, 2024, Chemomab reported that the European Patent Office had granted a new patent for nebokitug, covering the use of nebokitug and sequence-related anti-CCL24 antibodies for the treatment of liver diseases, such as PSC. In February, new patents were granted in Brazil and Israel.
On January 30, 2024, Chemomab reported publication of new proteomics research in the peer-reviewed journal Cells. The proteomic analyses of human samples highlighted the unique role of CCL24 in activating key PSC-related disease mechanisms and further confirmed the potential of nebokitug as a promising treatment for PSC.
On January 3, 2024, Chemomab announced early completion of patient enrollment in the nebokitug Phase 2 PSC SPRING trial and moved up the expected topline data readout to midyear 2024.
Full Year and Fourth Quarter 2024 Financial Highlights:
Cash Position: Cash, cash equivalents and short-term bank deposits were $14.3 million as of December 31, 2024 compared to $19.9 million as of December 31, 2023. The current cash runway is expected to take the Company through the first quarter of 2026.
Research and Development (R&D) Expenses: R&D expenses were $2.4 million for the fourth quarter and $ 11.3 million for the full year ended December 31, 2024, compared to $3.1 million and $18.4 million for the respective periods in 2023. The decrease in R&D expenses in the fourth quarter of 2024 compared to the fourth quarter of 2023 primarily resulted from decreased clinical costs as the company’s nebokitug Phase 2 PSC trial was nearing completion.
General and Administrative (G&A) Expenses: G&A expenses were $0.8 million for the fourth quarter and $3.4 million for the full year ended December 31, 2024, compared to $0.8 million and $7.1 million for the fourth quarter and full year in 2023. The decrease in G&A expenses reflected selected reductions in headcount and reductions in share-based payments and recruitment costs.
Net Loss: Net loss was $3.0 million, or a net loss of less than $0.01 per basic and diluted Ordinary Share, for the fourth quarter and $13.9 million, or a net loss of $0.04 per basic and diluted Ordinary Share, for the full year ended December 31, 2024, compared to a net loss of $3.4 million, or a net loss of $0.01 per basic and diluted share, for the fourth quarter of 2023, and $24.2 million, or a net loss of $0.10 per basic and diluted Ordinary Share, for the full year ended December 31, 2023.
The weighted average number of Ordinary Shares outstanding, basic and diluted was 324,649,751 (equal to 16,232,489 ADSs) for the year ended December 31, 2024, and 234,998,859 (equal to 11,749,943 ADSs) for the year ended December 31, 2023, respectively.
For further details on the company’s financial results for the year ended December 31, 2024, please refer to the company’s annual report on Form 20-F, which will be filed with the SEC in March, 2025.