New Analyses of PSC Data from Phase 2 SPRING Trial Show that Treatment with Nebokitug Is Associated with Dose-Dependent and Significant Improvements in Multiple Inflammatory and Fibrotic Biomarkers Further Confirms the Clinical Potential of Nebokitug As a First-in-Class Novel Treatment for PSC and Other Fibro-Inflammatory Conditions Second EASL 2025 Poster Reports that Pharmacokinetic and Pharmacodynamic Data from the Phase 2 Spring Trial Demonstrates Effective and Dose-Dependent Antibody-Target Engagement TEL AVIV, Israel, April 28, 2025 (GLOBE NEWSWIRE) -- Chemomab Therapeutics, Ltd., (Nasdaq: CMMB), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today reported data from two study abstracts that will be presented as posters at EASL 2025, the Annual Congress of the European Association for the Study of the Liver, that will be held May 7–10, 2025, in Amsterdam, the Netherlands. Adi Mor, PhD, co-founder and Chief Executive Officer of Chemomab, commented, “This new clinical data further confirms the potential of nebokitug (CM-101) as a first-in-class treatment for primary sclerosing cholangitis (PSC) and other fibro-inflammatory diseases. The comprehensive proteomic analyses we are presenting at EASL 2025 indicate that treatment with nebokitug resulted in additional improvements in a wide variety of biomarkers that are broadly related to fibro-inflammatory disease pathways including in PSC, inflammatory bowel disease, and inflammation and fibrosis in general.” Comprehensive proteomic analyses of 3,000 circulating proteins in patient samples from the Phase 2 SPRING trial in patients with PSC showed that nebokitug-treated patients exhibited significant and dose-dependent changes in multiple proteins, including those playing a key role in fibrosis, immune cell recruitment and inflammation.1 The analysis provided new insights into PSC disease-related pathways and additional biological evidence of the clinical activity of nebokitug. Nebokitug-treated patients showed downregulation of biological processes related to fibrosis and inflammation, such as cell-cell adhesion and extracellular matrix organization, as well as to molecular functions including binding of growth factors and integrins. Treatment with nebokitug was also linked to the downregulation of disease-related proteins and pathways involved with leukocyte migration, cytokine activity, chemokine activity and collagen binding. The authors highlight how nebokitug’s ability to neutralize its CCL24 target exerts a wide impact, as demonstrated by the reductions in a broad array of inflammatory and fibrotic biomarkers in treated patients. The second abstract presents an analysis of the pharmacodynamics and pharmacokinetics (PK) of nebokitug and CCL24 using patient data from the Phase 2 SPRING trial in patients with PSC.2 PK analyses indicated dose-proportional increases in the concentration of nebokitug with steady-state levels achieved after the fourth dose. These increased levels of nebokitug corresponded with increased levels of nebokitug’s CCL24 target, reflecting effective antibody-target engagement that was dose-dependent between the two treatment groups. Importantly, linear regression analyses found trends between increasing patient exposure to nebokitug and decreasing levels of relevant PSC disease biomarkers, including liver enzyme and transient elastography scores. Copies of the EASL 2025 posters will be available at the R&D pages of the Chemomab website starting on the date they are presented. 1 CCL24 blockade alters the proteomic profile of patients with primary sclerosing cholangitis and down-regulates central disease processes, T Snir, R Greenman, R Aricha, I Vaknin, M Frankel, J Lawler, A Mor, EASL 2025 Abstract #1243, May 9, 2025 2 CM-101 impacts disease biomarkers in primary sclerosing cholangitis: assessment of the SPRING study pharmacokinetics and pharmacodynamics, M Frankel, J Lawler, I Vaknin, A Mor, EASL 2025 Abstract #1255, May 8, 2025 Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future financial condition, results of operations, business strategy and plans, and objectives of management for future operations, as well as statements regarding industry trends, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “estimate,” “intend,” “may,” “plan,” “potentially,” “will” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: the risk that certain acknowledgements from the End-of-Phase 2 (EOP2) meeting with the FDA in connection with PSC regulatory approval will not materialize into a pathway for regulatory approval; that certain conclusions and assumptions drawn from the EOP2 meeting with the FDA discussed in the press release will prove incorrect and adversely affect the ability for nebokitug to become an FDA fully approved therapy; the risk that the full data set from the nebokitug study or data generated in further clinical trials of nebokitug will not be consistent with the topline results of the nebokitug Phase 2 PSC trial; failure to obtain, or delays in obtaining, regulatory approvals for nebokitug in the U.S., Europe or other territories; failure to successfully commercialize nebokitug, if approved by applicable regulatory authorities, in the U.S., Europe or other territories, or to maintain U.S., European or other territory regulatory approval for nebokitug if approved; uncertainties in the degree of market acceptance of nebokitug by physicians, patients, third-party payors and others in the healthcare community; nebokitug development of unexpected safety or efficacy concerns related to nebokitug; failure to successfully conduct future clinical trials for nebokitug, including due to the Company's potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; risks that the Company's clinical studies will be delayed or that serious side effects will be identified during drug development; failure of third parties on which the Company is dependent to manufacture sufficient quantities of nebokitug for commercial or clinical needs, to conduct the Company's clinical trials; changes in laws and regulations applicable to the Company's business and failure to comply with such laws and regulations; business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises; and uncertainties with respect to the Company's need and ability to access future capital; and the intensity and duration of the current war in Israel, and its impact on our operations in Israel. These risks are not exhaustive. You should carefully consider the risks and uncertainties described in the “Risk Factors” sections of our 20-F for the year ended December 31, 2024. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this press release. Before you invest, you should read the documents we have filed and will file with the SEC for more complete information about us. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities law of any such state or jurisdiction. About Chemomab Therapeutics Ltd.Chemomab is a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need. Based on the unique role of the soluble protein CCL24 in promoting fibrosis and inflammation, Chemomab developed nebokitug (CM-101), a first-in-class dual activity monoclonal antibody that neutralizes CCL24 and has demonstrated disease-modifying potential. In clinical and preclinical studies, nebokitug has been shown to have a favorable safety profile and has been generally well-tolerated, with the potential to treat multiple severe and life-threatening fibro-inflammatory diseases. Chemomab has reported positive results from four clinical trials of nebokitug in patients. Based on positive data from its Phase 2 SPRING trial in primary sclerosing cholangitis (PSC), the company is preparing for potential initiation of a nebokitug PSC Phase 3 trial. The design of Phase 3 calls for a single pivotal trial based on a clinical event primary endpoint that provides a clear and streamlined pathway to potential full regulatory approval. Nebokitug has received FDA and EMA Orphan Drug and FDA Fast Track designations for the treatment of PSC. Chemomab’s nebokitug program for the treatment of systemic sclerosis has an open U.S. IND. For more information, visit: chemomab.com. Contact: Media and Investors:Barbara LindheimConsulting Vice President, Investor & Public Relations, Strategic CommunicationsPhone: +1 917-355-9234barbara.lindheim@chemomab.comIR@chemomab.com
