Chemomab Therapeutics Ltd. (NASDAQ:CMMB) is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet needs. The company's lead product candidate, CM-101, is a first-in-class monoclonal antibody that targets the soluble protein CCL24, a key regulator of inflammation and fibrosis.

Business Overview

Chemomab has pioneered the therapeutic targeting of CCL24, a chemokine that promotes various cellular processes regulating inflammatory and fibrotic activities through the CCR3 receptor. CCL24 is expressed in different cell types, including immune cells, endothelial cells, and epithelial cells. The company has developed CM-101, a novel CCL24-inhibiting product candidate with dual anti-fibrotic and anti-inflammatory properties that modulates the complex interplay of these mechanisms, which drive abnormal states of fibrosis and clinical fibrotic diseases.

Chemomab is actively advancing CM-101 in Phase 2 clinical studies for two distinct indications: primary sclerosing cholangitis (PSC), a rare obstructive and cholestatic liver disease, and systemic sclerosis (SSc), a rare autoimmune rheumatic disease characterized by fibrosis in the skin, lungs, and other organs. The company estimates that there are approximately 77,000 patients suffering from PSC and 170,000 patients suffering from SSc in the U.S., EU, and Japan, representing a combined market opportunity of over $2.5 billion.

Financial Performance

For the full year 2022, Chemomab reported an annual net loss of $24.16 million, with no revenue generated. The company's annual operating cash flow was -$23.55 million, and its annual free cash flow was -$23.55 million.

In the first quarter of 2023, Chemomab's research and development expenses increased by 151% to $6.89 million, compared to $2.75 million in the same period of 2022. This increase was primarily due to increased clinical and preclinical activities. General and administrative expenses decreased by 16% to $2.16 million, down from $2.58 million in the first quarter of 2022, mainly due to a decrease in non-cash share-based expenses and insurance expenses.

As of March 31, 2023, Chemomab had $20.77 million in cash and cash equivalents, $11.94 million in short-term bank deposits, and $77,000 in restricted cash, totaling $32.79 million in available liquidity. The company believes that its existing cash resources will enable it to fund its operations through June 30, 2024.

Recent Developments

In February 2023, Chemomab reported that the U.S. Food and Drug Administration (FDA) cleared the company's Investigational New Drug (IND) application to evaluate CM-101 in a Phase 2 trial in adults with systemic sclerosis (SSc). The Phase 2 ABATE trial is expected to enroll 45 patients with clinically active dermatologic, vascular, or pulmonary SSc and is designed to assess the safety, tolerability, and activity of CM-101 in this patient population.

In January 2023, Chemomab reported positive topline results from its Phase 2a liver fibrosis biomarker trial of CM-101 in non-alcoholic steatohepatitis (NASH) patients. The trial met its primary endpoint of safety and tolerability, and CM-101 demonstrated encouraging activity in secondary endpoints that included a range of liver fibrosis biomarkers and physiologic assessments.

Risks and Challenges

Chemomab faces several risks and challenges common to clinical-stage biotechnology companies, including the inherent uncertainty of drug development, the need for significant additional funding to advance its pipeline, and the competitive landscape in the fibrotic and inflammatory disease treatment space. The company's ability to successfully develop and commercialize its product candidates will be crucial to its long-term success.

Outlook and Conclusion

Chemomab is making significant progress in the development of its lead product candidate, CM-101, for the treatment of rare and debilitating fibrotic and inflammatory diseases. The company's recent IND clearance for a Phase 2 trial in SSc and the positive results from its NASH trial demonstrate the potential of CM-101 to address unmet medical needs in this therapeutic area.

As Chemomab continues to advance its pipeline and navigate the challenges of drug development, investors will be closely watching the company's ability to execute on its clinical and operational objectives. With a strong cash position and a promising lead candidate, Chemomab appears well-positioned to continue its progress in the years ahead.