CMMB
Chemomab TherapeuticsFDocument history
Earnings documents stored for CMMB.
Investor releaseQuarter not tagged2026-08-19Chemomab Therapeutics Announces Second Quarter 2026 Financial Results and Provides Corporate Update
GlobeNewswire
Chemomab Therapeutics Announces Second Quarter 2026 Financial Results and Provides Corporate Update
Proposed merger with Scipher Medicine to assess nebokitug in a Phase 2 precision medicine trial in rheumatoid arthritis (RA) continues to advance with closing expected by year-end RA is a $24 billion market with substantial unmet need—nebokitug could potentially be the first novel mechanism RA therapy approved in the U.S. since 2012 Scipher’s AI Network Medicine platform identified first-in-class CCL24-blocker nebokitug as the highest ranked clinical-stage candidate for RA, potentially providing additional therapeutic benefit to the two-thirds of RA patients who do not achieve low disease activity or remission with current therapies Nebokitug RA Phase 2 clinical trial expected to begin in H1 2027 and read out in H1 2028, providing a potential key inflection point Combined company is valued at $150 million before concurrent $30 million private placement at closing and is expected to have cash runway through the Phase 2 readout TEL AVIV, Israel, Aug. 19, 2026 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (“Chemomab”), a clinical stage biotechnology company developing innovative therapeutics for immune-fibrotic diseases with high unmet need, today announced financial and operating results for the second quarter ended June 30, 2026, and provided a corporate update. Adi Mor, PhD, co-founder and Chief Executive Officer of Chemomab, said, “The planned merger with Scipher Medicine continues to advance. As we have reported, Scipher’s validated AI network medicine platform, SPECTRA™, identified nebokitug as the leading candidate to address a major unmet need in rheumatoid arthritis (RA), a $24 billion market. We believe this merger provides our shareholders a compelling opportunity to potentially realize value through the clinical advancement of nebokitug in a large indication, as well as through Scipher’s revenue-generating precision medicine business and its biopharma partnerships. The opportunity also remains to secure a potential partner for a nebokitug Phase 3 trial in primary sclerosing cholangitis (PSC), an indication with no FDA-approved therapies. We look forward to working with our colleagues at Scipher to complete the proposed transaction and expedite the initiation of the Phase 2 trial in RA, marking an important new phase in the development of nebokitug and our anti-CCL24 platform.” Reg Seeto, MBBS, Chief Executive Officer of Scipher Me…Read full documentShow less
Proposed merger with Scipher Medicine to assess nebokitug in a Phase 2 precision medicine trial in rheumatoid arthritis (RA) continues to advance with closing expected by year-end RA is a $24 billion market with substantial unmet need—nebokitug could potentially be the first novel mechanism RA therapy approved in the U.S. since 2012 Scipher’s AI Network Medicine platform identified first-in-class CCL24-blocker nebokitug as the highest ranked clinical-stage candidate for RA, potentially providing additional therapeutic benefit to the two-thirds of RA patients who do not achieve low disease activity or remission with current therapies Nebokitug RA Phase 2 clinical trial expected to begin in H1 2027 and read out in H1 2028, providing a potential key inflection point Combined company is valued at $150 million before concurrent $30 million private placement at closing and is expected to have cash runway through the Phase 2 readout TEL AVIV, Israel, Aug. 19, 2026 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (“Chemomab”), a clinical stage biotechnology company developing innovative therapeutics for immune-fibrotic diseases with high unmet need, today announced financial and operating results for the second quarter ended June 30, 2026, and provided a corporate update. Adi Mor, PhD, co-founder and Chief Executive Officer of Chemomab, said, “The planned merger with Scipher Medicine continues to advance. As we have reported, Scipher’s validated AI network medicine platform, SPECTRA™, identified nebokitug as the leading candidate to address a major unmet need in rheumatoid arthritis (RA), a $24 billion market. We believe this merger provides our shareholders a compelling opportunity to potentially realize value through the clinical advancement of nebokitug in a large indication, as well as through Scipher’s revenue-generating precision medicine business and its biopharma partnerships. The opportunity also remains to secure a potential partner for a nebokitug Phase 3 trial in primary sclerosing cholangitis (PSC), an indication with no FDA-approved therapies. We look forward to working with our colleagues at Scipher to complete the proposed transaction and expedite the initiation of the Phase 2 trial in RA, marking an important new phase in the development of nebokitug and our anti-CCL24 platform.” Reg Seeto, MBBS, Chief Executive Officer of Scipher Medicine, said, “We believe the announced strategic merger with Chemomab is a unique opportunity to transform the treatment of immunology-based diseases with precision medicine. We plan to start with nebokitug in patients with rheumatoid arthritis, which like other immunology-based diseases is complex in origin. This complexity results in a heterogeneous patient population with unmet medical needs, since one-size-fits-all therapies do not work well for many patients. In RA, this approach has resulted in the majority of moderate-to-severe patients not achieving an enduring response, despite multiple available treatment options.” Dr. Seeto continued, “We reached out to Chemomab because SPECTRA™, our validated AI-enabled network medicine platform, had identified nebokitug’s novel mechanism as the highest ranked clinical program for potentially achieving efficacy in RA compared to both current and pipeline drugs in development. We intend to develop a nebokitug-specific molecular treatment-response signature (MTRS) using the technology that built the only MTRS approved by CMS in immunology. We believe this technology could increase the probability of clinical success, as we preferentially target the population that may benefit from nebokitug. Oncology has already demonstrated patient benefit with precision medicine by improving outcomes in a targeted population and has expanded the overall market with this approach of the right drug for the right patient. We see the field of immunology as the next frontier for precision medicine and we are already leading the way. Second Quarter 2026 and Recent Highlights: Entered into Definitive Merger Agreement with Scipher Medicine. On July 8, 2026, Chemomab announced that it had entered into a definitive merger agreement (the “Merger Agreement”) with Scipher Medicine Corporation pursuant to which the companies will combine in an all-stock transaction (the “Merger”). Under the terms of the Merger Agreement, Chemomab equity holders are expected to own approximately 32% of the combined company, with Scipher equity holders owning approximately 68%, subject to customary adjustments. The combined company is valued at $150 million prior to a concurrent $30 million private placement financing and is expected to have sufficient cash to fund operations through the readout of the nebokitug Phase 2 RA trial. The private placement is being led by a syndicate of current Scipher investors, including Northpond Ventures, with participation from Khosla Ventures, Blue Owl Healthcare Opportunities, funds managed by Neuberger, and other leading investors, and includes 100% warrant coverage, with the warrants having an exercise price based on a $75 million valuation. In addition, immediately following the closing, Chemomab shareholders will receive contingent value rights (CVRs), providing the opportunity to receive future cash payments of $10 million upon U.S. Food and Drug Administration approval of nebokitug for any indication and $40 million if Chemomab’s PSC program advances to a Phase 3 clinical trial or is partnered, in each case subject to the terms and conditions of the CVR agreement. Upon completion of the Merger, the combined company is expected to operate as Scipher Medicine Corporation and trade on the Nasdaq Capital Market under the ticker symbol “SCIP.” The combined company plans to initially focus on advancing nebokitug, a first-in-class clinical stage anti-CCL24 antibody, into a Phase 2 clinical trial for the treatment of rheumatoid arthritis, with topline results expected in the first half of 2028. Following the closing, Dr. Reginald Seeto will serve as Chief Executive Officer of the combined company, and Chemomab co-founder and Chief Executive Officer Dr. Adi Mor will join the combined company’s Board of Directors. Presented three abstracts on May 30, 2026 at EASL 2026, the Annual Congress of the European Association for the Study of the Liver in Barcelona, Spain. Presented new data from the company’s Phase 2 SPRING trial of nebokitug in PSC in an oral presentation at Digestive Disease Week® (DDW 2026)4. On May 4, 2026, a new proteomic study showed that treatment with nebokitug resulted in dose-dependent reductions in multiple inflammatory and tissue-remodeling signatures relevant to both PSC and IBD. The authors conclude that inhibition of nebokitug’s CCL24 target may provide meaningful benefit in PSC patients with concomitant IBD. 1 - AI-driven proteomic profiling differentiates composite improvement following treatment with nebokitug in PSC; T. Snir, R. Aricha, J. Lawler, C Cirillo, D. Weiner, and A. Mor; EASL 2026 Abstract No. 1839; Immune-mediated and cholestatic disease: Clinical aspects; May 30, 2026, 8:30 - 16:00 CEDT2 - Nebokitug down-regulates core fibrotic and immune pathways defined by single-cell liver profiling; R Aricha, T Snir, J Lawler, C Cirillo, D Weiner, A Mor; EASL 2026 Abstract No. 1852; Immune-mediated and cholestatic disease: Clinical aspects; May 30, 2026, 8:30 - 16:00 CEDT3 - Nebokitug modulates gut-liver inflammatory and tissue remodeling signatures in PSC patients with coexisting IBD; R Aricha, T Snir, J Lawler, C Cirillo, D Weiner, and A Mor; EASL 2026 Abstract No. 1859; Immune-mediated and cholestatic disease: Clinical aspects; May 30, 2026, 8:30 - 16:00 CEDT4 - Nebokitug modulates inflammatory and tissue-remodeling signatures in patients with PSC and coexisting IBD: Biomarker findings from SPRING Phase 2 trial; P. Mantry, T Snir, R Aricha, J Lawler, C Cirillo, D Weiner, A Mor; DDW 2026 Abstract No. 4484827, Advances in the Management of Primary Sclerosing Cholangitis; May 4, 2026, 2:00 - 3:30 PM CDT Second Quarter 2026 Financial Highlights: Cash Position: Cash, cash equivalents and short-term bank deposits were $6.7 million as of June 30, 2026, compared to $8.0 million as of March 31, 2026. Research and Development (R&D) Expenses: R&D expenses were $1.1 million for the second quarter of 2026, compared to $1.3 million for the second quarter of 2025. General and Administrative (G&A) Expenses: G&A expenses were $1.1 million for the second quarter of 2026, compared to $1.0 million for the second quarter of 2025. Net Loss: Net loss was $2.2 million, or a net loss of less than $0.01 per basic and diluted ordinary share, for the second quarter of 2026, compared to $2.1 million, or a net loss of less than $0.01 per basic and diluted ordinary share, for the second quarter of 2025. The weighted average number of ordinary shares outstanding, basic and diluted, was 640,243,933 (equal to approximately 8,003,049 ADSs) for the second quarter of 2026. Liquidity and Capital Resources: Chemomab believes its existing liquidity resources as of June 30, 2026 will enable it to fund its operations through the first quarter of 2027. Number of Issued and Outstanding Shares: As of June 30, 2026, the company had 579,648,600 issued and outstanding shares compared to 575,381,320 as of December 31, 2025. Merger UpdateChemomab has confidentially submitted a draft registration statement on Form S-4 to the U.S. Securities and Exchange Commission (SEC) in connection with its proposed Merger with Scipher Medicine. The confidential submission enables the SEC review process to begin while certain required financial information is being finalized, helping to support the transaction timeline. The registration statement is expected to be publicly filed following the SEC’s initial review process, in accordance with applicable SEC rules. The companies expect the Merger to close before the end of 2026, subject to SEC review, shareholder approvals and other customary closing conditions. For additional information, please refer to the company’s Form 6-K filed with the SEC today. Forward-Looking StatementsCertain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the structure, timing and completion of the proposed Merger; the parties’ ability to consummate the proposed transaction and the private placement financing; the combined company’s cash position after closing of the proposed Merger and expected cash runway of the combined company; the combined company’s expected listing on Nasdaq and ticker symbol after closing of the proposed Merger; expectations regarding the ownership structure of the combined company; the expected executive officers of the combined company; the future operations of the combined company; the expected issuance of the CVRs and the contingent payments contemplated by the CVRs; the nature, strategy and focus of the combined company; the development and commercial potential and potential benefits of any product candidates of the combined company; anticipated clinical drug development activities and related timelines, including the expected timing for trial initiation, data and other clinical results; and other statements that are not historical fact. Any forward-looking statements in this release are based on management’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. There can be no assurance that future developments affecting the combined company will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the combined company’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the conditions to the closing of the Merger are not satisfied, including the failure to timely obtain shareholder approval for the transaction, if at all; uncertainties as to the timing of the consummation of the Merger and the ability of each of Chemomab and Scipher to consummate the Merger; risks related to Chemomab’s ability to manage its operating expenses and its expenses associated with the Merger pending closing; risks related to the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the Merger; the risk that as a result of adjustments to the exchange ratio, Chemomab shareholders and Scipher stockholders could own more or less of the combined company than is currently anticipated; risks related to the market price of Chemomab’s common stock relative to the value suggested by the exchange ratio; unexpected costs, charges or expenses resulting from the transaction; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the Merger; the uncertainties associated with Chemomab’s and Scipher’s product candidates, as well as risks associated with the clinical development and regulatory approval of such product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; risks related to the inability of the combined company to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; risks associated with the possible failure to realize certain anticipated benefits of the Merger, including with respect to future financial and operating results; the risk that the related private placement financing is not consummated or is not consummated on the terms and in the amounts currently anticipated; the risk of potential adverse reactions or changes to relationships with employees, suppliers or other parties resulting from the announcement or completion of the proposed transaction; and those uncertainties and factors described under the heading “Risk Factors” in Chemomab’s Annual Report on Form 20-F for the year ended December 31, 2025 and Quarterly Report on Form 6-K for the quarter ended March 31, 2026, and Chemomab’s other filings from time to time with the SEC. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Chemomab and Scipher do not undertake or accept any duty to make any updates or revisions to any forward-looking statements. Additional Information and Where to Find ItIn connection with the proposed Merger, Chemomab has confidentially submitted to the SEC a draft registration statement on Form S-4 and intends to publicly file with the SEC a registration statement on Form S-4 that will include a proxy statement of Chemomab and a prospectus of the combined company, together with other relevant documents concerning the proposed transaction. This press release is not a substitute for the registration statement, proxy statement/prospectus or any other document that Chemomab may file with the SEC in connection with the proposed Merger. INVESTORS AND SECURITY HOLDERS OF CHEMOMAB ARE URGED TO READ THE REGISTRATION STATEMENT, PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT CHEMOMAB, SCIPHER, THE PROPOSED MERGER AND RELATED MATTERS. Investors and security holders will be able to obtain free copies of the registration statement and proxy statement/prospectus (when available), and other documents containing important information about Chemomab and Scipher, once such documents are filed with the SEC, through the website maintained by the SEC at www.sec.gov, or by contacting Chemomab’s Investor Relations department at the contact information provided in this press release. Participants in the SolicitationChemomab, Scipher and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from Chemomab’s shareholders in connection with the proposed Merger. Information regarding Chemomab’s directors and executive officers is available in Chemomab’s Annual Report on Form 20-F for the year ended December 31, 2025 and in its subsequent filings with the SEC, including its Quarterly Report on Form 6-K for the quarter ended March 31, 2026. Additional information regarding the interests of these participants and other persons who may be deemed participants in the solicitation, which may differ from those of Chemomab’s shareholders generally, will be included in the registration statement, proxy statement/prospectus and other relevant materials to be filed with the SEC in connection with the proposed Merger, when they become available. Investors and security holders should read the proxy statement/prospectus and other relevant materials carefully and in their entirety when they become available before making any voting or investment decisions. About Chemomab Therapeutics Ltd.Chemomab is a clinical stage biotechnology company developing innovative therapeutics for immune-fibrotic diseases with high unmet need. Based on the unique role of the soluble protein CCL24 in promoting fibrosis and inflammation, Chemomab developed nebokitug, 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 immune-fibrotic diseases. Chemomab has reported positive results from five clinical trials of nebokitug, including the Phase 2 SPRING trial in patients with primary sclerosing cholangitis. For more information, visit: chemomab.com. Contacts: Media & Investors:Chemomab TherapeuticsBarbara LindheimConsulting Vice PresidentInvestor & Public Relations, Strategic CommunicationsPhone: +1 [email protected] The accompanying notes are an integral part of the interim condensed consolidated financial information.(*) 1 American Depositary Share (ADS) represents 80 Ordinary Shares. (*) 1 American Depositary Share (ADS) represents 80 Ordinary Shares.
Investor releaseQuarter not tagged2026-05-14Chemomab Therapeutics Announces First Quarter 2026 Financial Results and Provides Corporate Update
GlobeNewswire
Chemomab Therapeutics Announces First Quarter 2026 Financial Results and Provides Corporate Update
—New Clinical and Translational Data Presented at Major Medical Meetings Further Confirms the Disease-Modifying Potential of Nebokitug in Primary Sclerosing Cholangitis and Suggests Possible Additional Benefit in PSC Patients with Co-Existing IBD— —Company Continues to Advance Multiple Partnering Options for Nebokitug— TEL AVIV, Israel, May 14, 2026 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical-stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced financial and operating results for the first quarter ended March 31, 2026, and provided a corporate update. “In the first quarter we continued to have productive discussions with potential strategic partners while releasing new data analyses that further extend our understanding of the therapeutic potential of nebokitug and its CCL24 target,” said Adi Mor, PhD, co-founder and Chief Executive Officer of Chemomab. “In an oral presentation earlier this month at Digestive Disease Week® 2026 and in three upcoming presentations at the 2026 EASL Congress, we unveiled new analyses based on patient data from the nebokitug Phase 2 SPRING trial. The studies further elucidate the disease pathways fueled by CCL24 and provide additional valuable information on how nebokitug interferes with multiple processes and pathways associated with disease progression in patients with primary sclerosing cholangitis (PSC). Most notably, new findings demonstrated that CCL24 and nebokitug-mediated CCL24 inhibition influence biological pathways linked to inflammatory bowel disease (IBD), a chronic and debilitating autoimmune inflammatory condition that affects an estimated 60-70% of PSC patients. We believe that nebokitug could become the first FDA-approved disease-modifying treatment for PSC, and, if these promising IBD-related findings are confirmed clinically, could offer a differentiated therapeutic benefit to the large population of patients living with both PSC and IBD.” First Quarter 2026 and Recent Highlights: On May 30, 2026, Chemomab will present data from three abstracts at EASL 2026, the Annual Congress of the European Association for the Study of the Liver in Barcelona, Spain. In one EASL 2026 study1, Olink-generated analyses of circulating proteins in patient samples from the SPRING trial were used to generate an…Read full documentShow less
—New Clinical and Translational Data Presented at Major Medical Meetings Further Confirms the Disease-Modifying Potential of Nebokitug in Primary Sclerosing Cholangitis and Suggests Possible Additional Benefit in PSC Patients with Co-Existing IBD— —Company Continues to Advance Multiple Partnering Options for Nebokitug— TEL AVIV, Israel, May 14, 2026 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical-stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced financial and operating results for the first quarter ended March 31, 2026, and provided a corporate update. “In the first quarter we continued to have productive discussions with potential strategic partners while releasing new data analyses that further extend our understanding of the therapeutic potential of nebokitug and its CCL24 target,” said Adi Mor, PhD, co-founder and Chief Executive Officer of Chemomab. “In an oral presentation earlier this month at Digestive Disease Week® 2026 and in three upcoming presentations at the 2026 EASL Congress, we unveiled new analyses based on patient data from the nebokitug Phase 2 SPRING trial. The studies further elucidate the disease pathways fueled by CCL24 and provide additional valuable information on how nebokitug interferes with multiple processes and pathways associated with disease progression in patients with primary sclerosing cholangitis (PSC). Most notably, new findings demonstrated that CCL24 and nebokitug-mediated CCL24 inhibition influence biological pathways linked to inflammatory bowel disease (IBD), a chronic and debilitating autoimmune inflammatory condition that affects an estimated 60-70% of PSC patients. We believe that nebokitug could become the first FDA-approved disease-modifying treatment for PSC, and, if these promising IBD-related findings are confirmed clinically, could offer a differentiated therapeutic benefit to the large population of patients living with both PSC and IBD.” First Quarter 2026 and Recent Highlights: On May 30, 2026, Chemomab will present data from three abstracts at EASL 2026, the Annual Congress of the European Association for the Study of the Liver in Barcelona, Spain. In one EASL 2026 study1, Olink-generated analyses of circulating proteins in patient samples from the SPRING trial were used to generate an AI/machine learning model to identify patients who showed a combined improvement in all three key fibrosis-related measures: ELF score, liver stiffness as measured by FibroScan© and PRO-C3. The model showed strong performance and reliability, accurately distinguishing patients who met the combined improvement definition from those who did not. The proteins driving this distinction were primarily related to liver biology, including metabolism, protein breakdown, and extracellular matrix and tissue remodeling. The authors conclude that AI-generated proteomic analysis was successful in distinguishing a composite efficacy improvement outcome in nebokitug-treated patients with PSC. Patients who met the criteria showed differential expressions of liver proteins, with functional liver related proteins as the main drivers of this change. This analysis highlights the breadth of treatment-associated improvements following CCL24-blocking therapy with nebokitug, as well as the important role of CCL24 blockade in PSC and other liver disease pathology. A second EASL 2026 study2 examined the impact of nebokitug treatment on four PSC-specific gene expression programs (GEPs) in patients with PSC. GEPs are the coordinated patterns of gene activity that determine which genes are turned on or off, when, and to what extent, ultimately controlling cellular functions and phenotypes in the individual. The four GEPs, which researchers had previously identified using single-cell analyses of human liver tissue, are upregulated in livers from patients with PSC compared to healthy controls or to patients with other liver disease. They include pathways associated with extracellular matrix remodeling, macrophage activation, fibrosis/myofibrosis, and immune activation. The new analysis assessed the effects of treatment with nebokitug on these GEPs by examining protein changes in patient serum samples from the nebokitug SPRING trial. Proteins corresponding to all four PSC-related GEPs, reflecting fibrosis-related collagens, fibrotic macrophage activity, myofibroblast pathways, and immune-activation signaling, were statistically significantly elevated in the SPRING trial patients with moderate-advanced disease compared to those with mild PSC. Treatment with nebokitug was associated with statistically significant and dose-dependent reductions in the signatures linked to these PSC-related fibrotic and immune proteins. These findings provide further support for nebokitug’s CCL24 blocking activity as a mechanism-based therapeutic approach targeting core molecular drivers of PSC pathogenesis. A third EASL 2026 study3 examined nebokitug and its CCL24 target in the context of the co-morbidity of PSC and inflammatory bowel disease (IBD). This co-morbidity, which affects about 60-70% of all PSC patients, is thought to reflect their intertwined gut–liver immune pathways. In the nebokitug SPRING trial, 62% of enrolled PSC patients had concomitant ulcerative colitis (UC) or Crohn’s disease (CD). This study evaluated whether CCL24 inhibition modulates inflammatory and tissue-remodeling signatures relevant to PSC-IBD pathogenesis. Serum proteins from SPRING trial patients were quantified using the Olink proteomic platform. Biomarker analyses focused on inflammatory cytokines, chemokines, monocyte/macrophage markers, epithelial injury markers, and tissue-remodeling proteins previously associated with UC and CD activity. Nebokitug treatment led to modulation of inflammatory pathways shared between PSC and IBD in patients with moderate-advanced PSC. Significant reductions were observed in multiple cytokines known to be strongly linked to IBD activation, mucosal immune recruitment and epithelial injury. Nebokitug also decreased multiple proteins associated with stromal and epithelial remodeling in IBD progression and demonstrated a significant elevation in MST-1, a negative regulator of inflammation that has been linked to genetic susceptibility and disease modulation in IBD, highlighting its potential relevance to intestinal inflammatory pathways. The authors conclude that treatment with nebokitug resulted in improvements across inflammatory and tissue-remodeling proteins relevant to PSC with coexisting intestinal inflammation from UC and CD. These findings suggest that CCL24 inhibition may beneficially impact shared gut–liver inflammatory circuits in patients with co-existing PSC and IBD. On May 4, 2026, new data from the company’s Phase 2 SPRING trial of nebokitug in PSC was presented at Digestive Disease Week® (DDW 2026) in Chicago, USA4. Dr. Parvez Mantry of Methodist Health System gave an oral presentation on a new proteomic study showing that treatment with nebokitug resulted in dose-dependent reductions in multiple inflammatory and tissue-remodeling signatures associated with intestinal and hepatic immune activation. These proteomic changes are relevant to both primary sclerosing cholangitis (PSC) and inflammatory bowel disease (IBD), a debilitating chronic condition that affects about 60-70% of all patients with PSC. In nebokitug-treated patients, especially those with moderate-advanced PSC, reductions in IBD-related inflammatory innate immune activation and epithelial remodeling biomarkers were observed. These proteomic changes indicate disease-relevant target engagement and are consistent with modulation of biological pathways relevant to both PSC and IBD. The authors conclude that inhibition of nebokitug’s CCL24 target may provide meaningful benefit in PSC patients with concomitant IBD. 1 - AI-driven proteomic profiling differentiates composite improvement following treatment with nebokitug in PSC; T. Snir, R. Aricha, J. Lawler, C Cirillo, D. Weiner, and A. Mor; EASL 2026 Abstract No. 1839; Immune-mediated and cholestatic disease: Clinical aspects; May 30, 2026, 8:30 - 16:00 CEDT 2 - Nebokitug down-regulates core fibrotic and immune pathways defined by single-cell liver profiling; R Aricha, T Snir, J Lawler, C Cirillo, D Weiner, A Mor; EASL 2026 Abstract No. 1852; Immune-mediated and cholestatic disease: Clinical aspects; May 30, 2026, 8:30 - 16:00 CEDT 3 - Nebokitug modulates gut-liver inflammatory and tissue remodeling signatures in PSC patients with coexisting IBD; R Aricha, T Snir, J Lawler, C Cirillo, D Weiner, and A Mor; EASL 2026 Abstract No. 1859; Immune-mediated and cholestatic disease: Clinical aspects; May 30, 2026, 8:30 - 16:00 CEDT 4 - Nebokitug modulates inflammatory and tissue-remodeling signatures in patients With PSC and coexisting IBD: Biomarker findings From the SPRING Phase 2 trial; Parvez Mantry, T Snir, R Aricha, J Lawler, C Cirillo, D Weiner, A Mor; DDW 2026 Abstract No. 4484827, Advances in the Management of Primary Sclerosing Cholangitis; May 4, 2026, 2:00 - 3:30 PM CDT First Quarter 2026 Financial Highlights Cash Position: Cash, cash equivalents and short-term bank deposits were $8.0 million as of March 31, 2026, compared to $10.4 million as of December 31, 2025. This cash runway is expected to fund the company through the end of the first quarter of 2027. Research and Development (R&D) Expenses: R&D expenses were $0.9 million for the first quarter of 2026, compared to $2.5 million for the first quarter of 2025. The decrease in R&D expenses in the first quarter of 2026 compared to the first quarter of 2025 primarily resulted from the continued winding down of activities related to the Phase 2 SPRING trial . General and Administrative (G&A) Expenses: G&A expenses were $0.9 million for the first quarter of 2026, compared to $1.0 million for the first quarter of 2025. Net Loss: Net loss in the first quarter of 2026 was $1.8 million, or a net loss of less than $0.01 per basic and diluted ordinary share, compared to $3.3 million, or a net loss of less than $0.01 per basic and diluted ordinary share, for the first quarter of 2025. The weighted average number of ordinary shares outstanding, basic and diluted, in the first quarter of 2026 was 638,293,363 (equal to approximately 7,978,667 ADSs). Liquidity and Capital Resources: Chemomab believes its existing liquidity resources as of March 31, 2026 will enable it to fund its operations through the end of the first quarter of 2027. Number of Issued and Outstanding Shares: As of March 31, 2026, the company had 576,030,200 Ordinary shares issued and outstanding (equal to approximately 7,200,377 ADSs), compared to 575,381,320 (equal to approximately 7,192,266 ADSs) as of December 31, 2025. Forward-Looking Statements This 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 Company’s press releases 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 obtain sufficient financing from investors or strategic partners, or 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 the Middle East, 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, 2025. 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, 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 five clinical trials of nebokitug. Based on positive data from its Phase 2 SPRING trial in primary sclerosing cholangitis (PSC), Chemomab and the FDA have aligned on the design of a nebokitug Phase 3 registration trial in patients with PSC. 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 received FDA and EMA Orphan Drug designations and has an open U.S. IND. For more information, visit: chemomab.com. Contacts: Media & Investors: Chemomab Therapeutics: Barbara Lindheim Consulting Vice President Investor & Public Relations, Strategic Communications Phone: +1 917-355-9234 [email protected] (*) 1 American Depositary Share (ADS) represents 80 Ordinary Shares. (*) 1 American Depositary Share (ADS) represents 80 Ordinary Shares
Investor releaseQuarter not tagged2026-03-19Chemomab Therapeutics Announces Year End and Fourth Quarter 2025 Financial Results and Provides a Corporate Update
GlobeNewswire
Chemomab Therapeutics Announces Year End and Fourth Quarter 2025 Financial Results and Provides a Corporate Update
─Completed Successful FDA End-of-Phase 2 Meeting Following Positive Nebokitug Phase 2 SPRING Trial Results in Primary Sclerosing Cholangitis (PSC)─ ─Achieved Alignment with FDA on Clear and Efficient Pathway to Potential Approval for the Treatment of PSC─ ─Multiple Scientific Presentations and Publications Raised Awareness of Nebokitug’s Potential to Become the First Disease-Modifying Treatment for PSC and Its Relevance to Other Fibro-Inflammatory Conditions─ ─Discussions with Strategic Partners Continue to Advance─ TEL AVIV, Israel, March 19, 2026 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced financial and operating results for the full year and fourth quarter ended December 31, 2025, and provided a corporate update. “2025 was a critical year for Chemomab and our nebokitug program,” said Adi Mor, PhD, co-founder and Chief Executive Officer of Chemomab. “Our Phase 2 SPRING trial data, viewed by many experts as the strongest to date in PSC, set the stage for our positive FDA End-of-Phase 2 meeting, which resulted in alignment on a clear pathway to potential regulatory approval based on a single Phase 3 trial. This pivotal trial will assess a primary composite endpoint comprised of well-characterized clinical events that are associated with disease progression in PSC. We believe that using a clinical event-driven endpoint helps de-risk the Phase 3 program, as key publications have linked the PSC-related biomarker improvements observed in nebokitug-treated patients in the SPRING trial with reductions in clinical events.” Dr. Mor added, “Our discussions with potential strategic partners continue to advance as we progress activities required for the timely initiation of the Phase 3 trial in PSC. In parallel, we are evaluating additional therapeutic indications where nebokitug has generated robust preclinical efficacy signals, providing a strong mechanistic and translational rationale for future clinical development.” 2025 and Recent Highlights: On December 2, 2025, Chemomab announced that the results of its Phase 2 SPRING trial were published in the American Journal of Gastroenterology. The study showed that nebokitug was generally safe and well tolerated and that patients treated with nebokitug had numer…Read full documentShow less
─Completed Successful FDA End-of-Phase 2 Meeting Following Positive Nebokitug Phase 2 SPRING Trial Results in Primary Sclerosing Cholangitis (PSC)─ ─Achieved Alignment with FDA on Clear and Efficient Pathway to Potential Approval for the Treatment of PSC─ ─Multiple Scientific Presentations and Publications Raised Awareness of Nebokitug’s Potential to Become the First Disease-Modifying Treatment for PSC and Its Relevance to Other Fibro-Inflammatory Conditions─ ─Discussions with Strategic Partners Continue to Advance─ TEL AVIV, Israel, March 19, 2026 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced financial and operating results for the full year and fourth quarter ended December 31, 2025, and provided a corporate update. “2025 was a critical year for Chemomab and our nebokitug program,” said Adi Mor, PhD, co-founder and Chief Executive Officer of Chemomab. “Our Phase 2 SPRING trial data, viewed by many experts as the strongest to date in PSC, set the stage for our positive FDA End-of-Phase 2 meeting, which resulted in alignment on a clear pathway to potential regulatory approval based on a single Phase 3 trial. This pivotal trial will assess a primary composite endpoint comprised of well-characterized clinical events that are associated with disease progression in PSC. We believe that using a clinical event-driven endpoint helps de-risk the Phase 3 program, as key publications have linked the PSC-related biomarker improvements observed in nebokitug-treated patients in the SPRING trial with reductions in clinical events.” Dr. Mor added, “Our discussions with potential strategic partners continue to advance as we progress activities required for the timely initiation of the Phase 3 trial in PSC. In parallel, we are evaluating additional therapeutic indications where nebokitug has generated robust preclinical efficacy signals, providing a strong mechanistic and translational rationale for future clinical development.” 2025 and Recent Highlights: On December 2, 2025, Chemomab announced that the results of its Phase 2 SPRING trial were published in the American Journal of Gastroenterology. The study showed that nebokitug was generally safe and well tolerated and that patients treated with nebokitug had numerical improvements in a range of biomarkers for inflammation and fibrosis, particularly at the 20 mg/kg dose and in the pre-specified subgroup of patients with moderate/advanced fibrosis. The authors concluded that these promising data support further evaluation of nebokitug for the treatment of PSC in a Phase 3 clinical trial. On November 6, 2025, Chemomab reported that data from the Phase 2 SPRING trial assessing nebokitug for the treatment of PSC was featured in three poster presentations at the American Association for the Study of Liver Disease (AASLD) The Liver Meeting® 2025. All three were designated by conference organizers as “posters of distinction.” Data presented from the SPRING trial open label extension showed the continued and consistent positive effects of nebokitug on key inflammatory and fibrotic biomarkers when administered to patients with PSC for up to 48 weeks, confirming its positive safety profile and further reinforcing its disease-modifying potential. Two other posters presented new clinical data that provided additional insights into the macrophage-related mechanism of action of nebokitug, a first-in-class antibody that inhibits the soluble protein CCL24, a key driver of disease processes in fibro-inflammatory diseases such as PSC. These results further confirm that nebokitug may halt or slow disease progression and improve clinical outcomes — the primary objectives of the proposed nebokitug Phase 3 PSC study. On August 14, 2025, Chemomab reported that it would change the ratio of its American Depositary Shares ("ADSs") to its ordinary shares (the "ADS Ratio"), from the then current ADS Ratio of one ADS to 20 ordinary shares to a new ADS Ratio of one ADS to 80 ordinary shares, effective on August 26, 2025. This ratio adjustment essentially served as a one-for-four reverse ADS split for Chemomab ADS holders. On June 30, 2025, Chemomab reported that results of the Phase 2 SPRING trial assessing nebokitug for the treatment of PSC were presented in an oral session at BSG Live’25, the annual scientific meeting of the British Society for Gastroenterology. The data were presented by Douglas Thorburn, MD, Professor of Hepatology within the Institute for Liver and Digestive Health at UCL and Principal Investigator of the trial. Post-conference, it was announced that Professor Thorburn’s talk on the SPRING trial results was awarded the prize for the Best Oral Presentation in its respective category. On June 11, 2025, Chemomab obtained confirmation from FDA on two development milestones for the nebokitug Phase 3 program. These included agreement with the FDA on the Chemistry, Manufacturing, and Controls (CMC) strategy proposed by Chemomab and its contract manufacturing partner and agreement that additional animal toxicology testing routinely required by FDA may be conducted in parallel with the nebokitug Phase 3 trial and submitted as part of the planned Biologics Licensing Application. This represents a favorable outcome for Chemomab and supports the timely advancement of the Phase 3 program. On June 3, 2025, Chemomab reported that two new patents covering the use of nebokitug for the treatment of liver diseases, including primary sclerosing cholangitis, were issued in China and Russia. These new patents further expand the protections provided by nebokitug’s composition of matter and methods and use patents issued in the U.S., Europe, Japan and additional key territories. On May 5, 2025, Chemomab announced that data from the company’s Phase 2 SPRING trial of nebokitug in PSC were presented in an oral Distinguished Abstract Plenary session at Digestive Disease Week® (DDW 2025). The DDW 2025 session presented data from the double-blind, placebo-controlled 15-week treatment period and the 48-week open label extension portion of the study. On April 28, 2025, Chemomab reported two posters were presented at EASL 2025, the Annual Congress of the European Association for the Study of the Liver. In one study, proteomic analyses of 3,000 circulating proteins in patient samples from the SPRING trial showed that nebokitug-treated patients exhibited significant and dose-dependent changes in proteins playing a key role in fibrosis, immune cell recruitment and inflammation. These data highlight the broad impact of nebokitug’s ability to neutralize CCL24, including reductions in a wide array of inflammatory and fibrotic biomarkers in treated patients. The second study analyzed the pharmacodynamics and pharmacokinetics of nebokitug and CCL24 using data from the SPRING trial. These analyses indicated effective antibody-target engagement and regression analyses revealed that increasing patient exposure to nebokitug was associated with decreasing levels of PSC disease biomarkers. On April 15, 2025, Chemomab announced new executive medical and clinical appointments. David M. Weiner, MD, rejoined Chemomab as Interim Chief Medical Officer, bringing extensive biotechnology and pharmaceutical industry R&D, drug development and strategic experience, and Jack Lawler, who oversaw the conduct of Chemomab’s successful Phase 2 SPRING Trial in PSC, was promoted to the position of Chief Development Officer. 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. 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 program. On January 13, 2025, a 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 function 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, such as PSC and systemic sclerosis. Full Year and Fourth Quarter 2025 Financial Highlights: Cash Position: Cash, cash equivalents and short-term bank deposits were $10.4 million as of December 31, 2025 compared to $14.3 million as of December 31, 2024. The current cash runway is expected to take the company through the end of the first quarter of 2027. Research and Development (R&D) Expenses: R&D expenses were $1.1 million for the fourth quarter and $5.8 million for the full year ended December 31, 2025, compared to $2.4 million and $11.3 million for the respective periods in 2024. The decrease in R&D expenses in the fourth quarter and full year of 2025 compared to the comparable periods in 2024 primarily resulted from decreased clinical costs as the company’s nebokitug Phase 2 PSC trial was completed. General and Administrative (G&A) Expenses: G&A expenses were $0.9 million for the fourth quarter and $3.7 million for the full year ended December 31, 2025, compared to $0.8 million and $3.4 million for the fourth quarter and full year in 2024. Net Loss: Net loss was $1.9 million, or a net loss of less than $0.01 per basic and diluted Ordinary Share, for the fourth quarter and $9.0 million, or a net loss of less than $0.02 per basic and diluted Ordinary Share, for the full year ended December 31, 2025, compared to a net loss of $3.0 million, or a net loss of less than $0.01 per basic and diluted Ordinary share, for the fourth quarter of 2024, 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. Number of Issued and Outstanding Shares: As of December 31, 2025, the company had 575,381,320 Ordinary shares issued and outstanding (equal to 7,192,267 ADSs), compared to 377,132,220 Ordinary shares issued and outstanding (equal to 4,714,153 ADSs) as of December 31, 2024. For further details on the company’s financial results for the year ended December 31, 2025, please refer to the company’s annual report on Form 20-F, which will be filed with the SEC on or around March 23, 2026. Forward-Looking Statements This 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 Company’s press releases 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 obtain sufficient financing from investors or strategic partners, or 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 the Middle East, 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, 2025. 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, 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 five clinical trials of nebokitug. Based on positive data from its Phase 2 SPRING trial in primary sclerosing cholangitis (PSC), Chemomab and the FDA have aligned on the design of a nebokitug Phase 3 registration trial in patients with PSC. 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 received FDA and EMA Orphan Drug designations and has an open U.S. IND. For more information, visit: chemomab.com. Contacts: Media and Investors: Barbara Lindheim Consulting Vice President, Investor & Public Relations, Strategic Communications Phone: +1 917-355-9234 [email protected] [email protected] (*) 1 American Depositary Share (ADS) represents 80 Ordinary Shares (*) 1 American Depositary Share (ADS) represents 80 Ordinary Shares
Investor releaseQuarter not tagged2025-12-02Chemomab Therapeutics Announces Nebokitug Phase 2 SPRING Trial Results in Primary Sclerosing Cholangitis Published in the American Journal of Gastroenterology
GlobeNewswire
Chemomab Therapeutics Announces Nebokitug Phase 2 SPRING Trial Results in Primary Sclerosing Cholangitis Published in the American Journal of Gastroenterology
—New Peer-Reviewed Publication Highlights Phase 2 SPRING Trial Data Supporting the Disease Modifying Potential of Nebokitug in PSC and Supports Advancement to a Phase 3 Registration Trial— TEL AVIV, Israel, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced that the results of its Phase 2 SPRING trial assessing nebokitug in patients with primary sclerosing cholangitis (PSC) were published in the current issue of the American Journal of Gastroenterology.1 The study showed that nebokitug was generally safe and well tolerated in patients with PSC for up to 48 weeks of treatment. Patients treated with nebokitug had numerical improvements in a range of biomarkers for inflammation and fibrosis, particularly at the 20 mg/kg dose and in the pre-specified subgroup of patients with moderate/advanced fibrosis. The authors conclude that these promising data support further evaluation of nebokitug for the treatment of PSC in a Phase 3 clinical trial. Christopher Bowlus, MD, the Lena Valente Professor and Chief of the Division of Gastroenterology and Hepatology at the University of California Davis School of Medicine, a SPRING trial investigator and one of the lead authors of the new publication, commented, “In the SPRING trial, nebokitug demonstrated that it has the potential to change the lives of patients with PSC by reducing fibrosis and inflammation, which should lead to improved outcomes. The promising clinical data reported in this publication and Chemomab’s plans to advance nebokitug into a Phase 3 registration trial are good news for patients with PSC, who are in desperate need of an effective therapy.” Publication Highlights Primary Sclerosing Cholangitis PSC is a rare, chronic, progressive liver disease that has no cure and lacks effective treatment except for liver transplantation in advanced cases. It is characterized by inflammation, fibrosis and destruction of the bile ducts, ultimately resulting in biliary cirrhosis, morbidity and potential early mortality. By targeting key aspects of PSC pathophysiology, new therapies with anti-inflammatory, anti-fibrotic, and anti-cholestatic effects may have beneficial effects and alter clinical outcomes in patients with PSC. CCL24 and Nebok…Read full documentShow less
—New Peer-Reviewed Publication Highlights Phase 2 SPRING Trial Data Supporting the Disease Modifying Potential of Nebokitug in PSC and Supports Advancement to a Phase 3 Registration Trial— TEL AVIV, Israel, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced that the results of its Phase 2 SPRING trial assessing nebokitug in patients with primary sclerosing cholangitis (PSC) were published in the current issue of the American Journal of Gastroenterology.1 The study showed that nebokitug was generally safe and well tolerated in patients with PSC for up to 48 weeks of treatment. Patients treated with nebokitug had numerical improvements in a range of biomarkers for inflammation and fibrosis, particularly at the 20 mg/kg dose and in the pre-specified subgroup of patients with moderate/advanced fibrosis. The authors conclude that these promising data support further evaluation of nebokitug for the treatment of PSC in a Phase 3 clinical trial. Christopher Bowlus, MD, the Lena Valente Professor and Chief of the Division of Gastroenterology and Hepatology at the University of California Davis School of Medicine, a SPRING trial investigator and one of the lead authors of the new publication, commented, “In the SPRING trial, nebokitug demonstrated that it has the potential to change the lives of patients with PSC by reducing fibrosis and inflammation, which should lead to improved outcomes. The promising clinical data reported in this publication and Chemomab’s plans to advance nebokitug into a Phase 3 registration trial are good news for patients with PSC, who are in desperate need of an effective therapy.” Publication Highlights Primary Sclerosing Cholangitis PSC is a rare, chronic, progressive liver disease that has no cure and lacks effective treatment except for liver transplantation in advanced cases. It is characterized by inflammation, fibrosis and destruction of the bile ducts, ultimately resulting in biliary cirrhosis, morbidity and potential early mortality. By targeting key aspects of PSC pathophysiology, new therapies with anti-inflammatory, anti-fibrotic, and anti-cholestatic effects may have beneficial effects and alter clinical outcomes in patients with PSC. CCL24 and Nebokitug Nebokitug is a humanized IgG1 anti-CCL24 monoclonal antibody. CCL24 promotes cellular processes that regulate inflammatory and fibrotic activities through the CCR3 receptor present on immune cells, fibroblasts and endothelial cells. Elevated CCL24 expression has been observed in liver biopsies from patients with PSC and in the periductal space, with CCL24 mainly expressed by inflammatory cells surrounding the bile ducts and cholangiocytes. Serum proteomic analysis of patients with PSC as compared to healthy subjects found CCL24 levels to be associated with PSC-related pathways and a CCL24-dependent signature observed in CCL24-treated hepatic stellate cells differentiated patients with PSC by disease severity. The therapeutic benefits of inhibiting CCL24 with nebokitug have been demonstrated in multiple experimental PSC models. SPRING Trial Design The SPRING trial was a double-blind, placebo-controlled Phase 2 study in which patients with PSC were randomized to receive either IV nebokitug 10 mg/kg, 20 mg/kg or placebo every 3 weeks for 15 weeks. The primary endpoint was safety and tolerability. Secondary endpoints included change from baseline to week 15 in liver blood tests, enhanced liver fibrosis (ELF) score, the fibrogenesis biomarker PRO-C3 and liver stiffness measurements (LSM), all of which have been shown to correlate with clinical outcomes in PSC. Biological activity was also assessed in a pre-specified subgroup with moderate/advanced fibrosis defined as patients with an LSM of greater than 8.7 kPa at baseline. Eligible patients who completed the 15-week double-blind period had the option to enter an open label extension (OLE) study to receive nebokitug for a total of up to 48 weeks. Seventy-six patients were enrolled at 33 sites in the US, UK, Germany, Spain and Israel. More than 90% of the 54 patients eligible to participate enrolled in the OLE. SPRING Trial Results Nebokitug was found to be safe and well tolerated compared to placebo at 15 weeks and no safety signal was observed for up to 48 weeks of treatment. The biological activities of nebokitug appeared to be dose dependent and more evident in patients with moderate/advanced fibrosis, who represented about half the study population and also comprise about half of all PSC patients. ELF score: ELF score predicts transplant-free survival in patients with PSC and a worsening of ELF score has been associated with increased risk of PSC-related complications and progression of liver fibrosis. Patients treated with 20 mg/kg of nebokitug and those with moderate/advanced fibrosis showed a numerical reduction of ELF after 15 weeks of treatment compared to an increase in ELF score in placebo-treated patients. A consistent and durable reduction was also observed in patients who continued nebokitug 20 mg/kg through 48 weeks of treatment. Notably, this was accompanied by sustained decreases through 48 weeks in the ELF score fibrotic components TIMP-1 and PIIINP, suggesting a durable antifibrotic effect of nebokitug over time. PRO-C3: Consistent with changes in ELF score, nebokitug treated patients showed numerical reductions in PRO-C3 after 15 weeks of treatment with nebokitug, which were sustained through 48 weeks, especially in patients with moderate/advanced fibrosis. Like the ELF score, PRO-C3 has been shown to be a predictor of transplant-free survival, and in a previous PSC clinical study it has been associated with fibrosis stages, fibrosis progression and PSC-related adverse events. Liver stiffness measurement: Liver stiffness is routinely assessed in clinical practice and has been shown to correlate with long‐term PSC patient outcomes. In the SPRING study, LSM improved in nebokitug-treated patients compared to placebo at 15 weeks and a statistically significant reduction in LSM compared to placebo at 15 weeks was observed in nebokitug-treated PSC patients with moderate/advanced fibrosis, indicating a potentially slower progression of disease. Multiple biomarkers: Improvements across multiple mechanistically-related biomarkers can strengthen the evidence for therapeutic effect in PSC. In the SPRING study, a greater proportion of nebokitug-treated patients with moderate/advanced fibrosis compared to placebo demonstrated numerical reductions in all three key biomarkers—ELF score, PRO-C3 and LSM. Half of nebokitug 20 mg/kg treated patients had improvements in all three biomarkers compared to none of the placebo patients. These consistent changes in multiple biomarkers within the same patients provide additional confidence in the potential anti-fibrotic and anti-inflammatory effects of nebokitug in PSC. 1 - Bowlus, Christopher L.; Thorburn, Douglas; Barclay, Stephen T.; Joshi, Deepak; Londoño, Maria-Carlota; Mantry, Parvez; Safadi, Rifaat; Aricha, Revita; Cirillo, Chris; Frankel, Matt; Lawler, John; Vaknin, Ilan; Mor, Adi; for the SPRING Study Group. Nebokitug, an anti-CCL24 monoclonal antibody, in patients with primary sclerosing cholangitis: A phase 2 study. The American Journal of Gastroenterology ():10.14309/ajg.0000000000003853, November 19, 2025. | DOI: 10.14309/ajg.0000000000003853 Forward-Looking Statements This 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, 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 five clinical trials of nebokitug. 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 Phase 3 trial in patients with PSC. 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. Contacts: Media & Investors: Chemomab Therapeutics Barbara Lindheim Consulting Vice President Investor & Public Relations, Strategic Communications Phone: +1 917-355-9234 [email protected]
Investor releaseQuarter not tagged2025-08-14Chemomab Therapeutics Announces Second Quarter 2025 Financial Results and Provides Corporate Update
GlobeNewswire
Chemomab Therapeutics Announces Second Quarter 2025 Financial Results and Provides Corporate Update
—Phase 3 Preparations Ongoing as Company Continues to Advance Multiple Partnering Options for Executing the Nebokitug Phase 3 Program— —Phase 2 SPRING Trial Data Highlighting Nebokitug’s Unique Anti-Fibrotic, Anti-Inflammatory and Anti-Cholestatic Effects in PSC Featured at Multiple Major Scientific Meetings— —FDA and Chemomab Align on CMC and Non-Clinical Toxicology Regulatory Path Forward for Nebokitug—` —Cash Runway through End of Second Quarter of 2026— —Announces Plans to Implement ADS Ratio Change Adjustment— TEL AVIV, Israel, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced financial and operating results for the second quarter ended June 30, 2025, and provided a corporate update. “In the second quarter of 2025 Chemomab continued to lay the groundwork for the nebokitug Phase 3 program in primary sclerosing cholangitis (PSC) and to progress discussions with potential strategic collaborators. Our goal is to secure the right partner to optimize development resources, accelerate the Phase 3 launch and maximize the commercial potential of nebokitug as the first approved disease-modifying therapy for this devastating disease with enormous unmet medical need,” said Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab. “During the quarter, we submitted our nebokitug Phase 3 protocol to the FDA and look forward to receiving their response soon. We are also engaging in a similar process with the European Medicines Agency, as we plan for a global Phase 3 trial that will include many sites in the E.U. and anticipate that the Phase 3 protocol agreed with the FDA would also support regulatory approvals in Europe. During the quarter we also aligned with the FDA on two additional requirements for the eventual regulatory approval of nebokitug—the CMC standards needed for manufacturing of drug supply for the “to be marketed” formulation as well as the timing of required nonclinical toxicology testing. We look forward to continuing to work closely with the FDA as we finalize the details of the Phase 3 development program.” Dr. Mor added, “As disclosed previously, we are planning to advance the nebokitug PSC Phase 3 program in collaboration with a strat…Read full documentShow less
—Phase 3 Preparations Ongoing as Company Continues to Advance Multiple Partnering Options for Executing the Nebokitug Phase 3 Program— —Phase 2 SPRING Trial Data Highlighting Nebokitug’s Unique Anti-Fibrotic, Anti-Inflammatory and Anti-Cholestatic Effects in PSC Featured at Multiple Major Scientific Meetings— —FDA and Chemomab Align on CMC and Non-Clinical Toxicology Regulatory Path Forward for Nebokitug—` —Cash Runway through End of Second Quarter of 2026— —Announces Plans to Implement ADS Ratio Change Adjustment— TEL AVIV, Israel, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced financial and operating results for the second quarter ended June 30, 2025, and provided a corporate update. “In the second quarter of 2025 Chemomab continued to lay the groundwork for the nebokitug Phase 3 program in primary sclerosing cholangitis (PSC) and to progress discussions with potential strategic collaborators. Our goal is to secure the right partner to optimize development resources, accelerate the Phase 3 launch and maximize the commercial potential of nebokitug as the first approved disease-modifying therapy for this devastating disease with enormous unmet medical need,” said Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab. “During the quarter, we submitted our nebokitug Phase 3 protocol to the FDA and look forward to receiving their response soon. We are also engaging in a similar process with the European Medicines Agency, as we plan for a global Phase 3 trial that will include many sites in the E.U. and anticipate that the Phase 3 protocol agreed with the FDA would also support regulatory approvals in Europe. During the quarter we also aligned with the FDA on two additional requirements for the eventual regulatory approval of nebokitug—the CMC standards needed for manufacturing of drug supply for the “to be marketed” formulation as well as the timing of required nonclinical toxicology testing. We look forward to continuing to work closely with the FDA as we finalize the details of the Phase 3 development program.” Dr. Mor added, “As disclosed previously, we are planning to advance the nebokitug PSC Phase 3 program in collaboration with a strategic partner and we continue in active discussions with a variety of potential partners on multiple possible paths forward. A number of developments during the quarter supported these discussions. Enlarging the scope of our patent protections is relevant for partnerships, and we were pleased to report adding to our existing large and comprehensive intellectual property portfolio with new nebokitug patents in China and Russia, two significant territories for future commercialization. We also presented SPRING trial data at a number of high profile scientific meetings, further raising awareness of nebokitug’s demonstrated potential as a groundbreaking treatment for PSC.” Dr. Mor concluded, “In parallel to the ongoing activities, we are assessing a number of near-term value-creating initiatives with the potential to accelerate the Phase 3 program and strengthen its probability of success. We anticipate sharing more information about these activities in the coming months.” Separately, Chemomab plans to change the ratio of its American Depositary Shares ("ADSs") to its ordinary shares (the "ADS Ratio"), from the current ADS Ratio of one ADS to 20 ordinary shares to a new ADS Ratio of one ADS to 80 ordinary shares, effective on August 26, 2025. Chemomab will continue to be traded on the Nasdaq Capital Market under the ticker "CMMB," with an updated CUSIP Number of 16385C104. This ratio adjustment will essentially serve as a one-for-four reverse split for ADS holders and requires no action on their part. The Bank of New York Mellon, the depositary bank for Chemomab’s ADS program, will arrange for the exchange on the effective date. There will be no issuance of new ADSs in connection with the adjustment. Second Quarter 2025 and Recent Highlights: On June 30, 2025, Chemomab reported that results of the Phase 2 SPRING trial assessing nebokitug for the treatment of PSC were presented in an oral session at BSG Live’25, the annual scientific meeting of the British Society for Gastroenterology. The SPRING trial data was presented by Douglas Thorburn, MD, Professor of Hepatology within the Institute for Liver and Digestive Health at UCL and Principal Investigator of the trial. Post-conference, it was announced that Professor Thorburn’s talk on the SPRING trial results was awarded the prize for the Best Oral Presentation in its respective category at BSG LIVE'25. On June 11, 2025, Chemomab obtained confirmation from the FDA on two development milestones for the nebokitug Phase 3 program. These included agreement with the FDA on the Chemistry, Manufacturing, and Controls (CMC) strategy proposed by Chemomab and its contract manufacturing partner and agreement that additional animal toxicology testing routinely required by the FDA may be conducted in parallel with the nebokitug Phase 3 clinical trial and submitted as part of the planned Biologics Licensing Application. This represents a favorable outcome for Chemomab and supports the timely advancement of the program. On June 3, 2025, Chemomab reported that two new patents covering the use of nebokitug for the treatment of liver diseases, including primary sclerosing cholangitis, were issued in China and Russia, providing coverage up to 2041. These new patents further expand the protections provided by nebokitug’s composition of matter and methods and use patents issued in the U.S., Europe, Japan and additional key territories. On May 5, 2025, Chemomab announced that data from the company’s Phase 2 SPRING trial of nebokitug in PSC was presented in an oral Distinguished Abstract Plenary session at Digestive Disease Week® (DDW 2025) in San Diego, California. The DDW 2025 session presented data from the double-blind, placebo-controlled 15-week treatment period and the 48-week open label extension portion of the study. On April 28, 2025, Chemomab reported data from two study abstracts that were presented as posters at EASL 2025, the Annual Congress of the European Association for the Study of the Liver. In one study, proteomic analyses of 3,000 circulating proteins in patient samples from the SPRING trial showed that nebokitug-treated patients exhibited significant and dose-dependent changes in proteins playing a key role in fibrosis, immune cell recruitment and inflammation. These data highlight how nebokitug’s ability to neutralize CCL24 exerts a wide impact, including reductions in a broad array of inflammatory and fibrotic biomarkers in treated patients. The second study analyzed the pharmacodynamics and pharmacokinetics (PK) of nebokitug and CCL24 using data from the SPRING trial. PK analyses indicated effective antibody-target engagement and linear regression analyses found trends between increasing patient exposure to nebokitug and decreasing levels of PSC disease biomarkers. On April 15, 2025, Chemomab announced new executive medical and clinical appointments. David M. Weiner, MD, rejoined Chemomab as Interim Chief Medical Officer, bringing extensive biotechnology and pharmaceutical industry R&D, drug development and strategic experience, and Jack Lawler, who oversaw the conduct of Chemomab’s successful Phase 2 SPRING Trial in PSC, was promoted to the position of Chief Development Officer. Second Quarter 2025 Financial Highlights Cash Position: Cash, cash equivalents and short-term bank deposits were $ 9.5 million as of June 30, 2025, compared to $10.6 million as of March 31, 2025. This cash is expected to fund the company through the second quarter of 2026. During the first half of 2025, the company issued 1,023,104 ADSs under its at-the-market (ATM) equity offering program, resulting in net proceeds of $1.3 million. Research and Development (R&D) Expenses: R&D expenses were $1.3 million for the second quarter of 2025, compared to $2.9 million for the second quarter of 2024. The decrease in R&D expenses in the second quarter of 2025 compared to the second quarter of 2024 primarily resulted from the end of activities related to the Phase 2 SPRING trial. General and Administrative (G&A) Expenses: G&A expenses were approximately $1.0 million for the second quarter of 2025, compared to $0.8 million for the second quarter of 2024. The increase in G&A expenses primarily reflects increases in noncash share-based expenses. Net Loss: Net loss was $2.1 million, or a net loss of less than $0.01 per basic and diluted ordinary share for the second quarter of 2025, compared to $3.6 million, or a net loss of $0.01 per basic and diluted ordinary share for the second quarter of 2024. The weighted average number of ordinary shares outstanding, basic and diluted, was 463,508,519 (equal to approximately 23.2 million ADSs) for the second quarter of 2025. Liquidity and Capital Resources: Chemomab believes its existing liquidity resources as of June 30th, 2025 will enable it to fund its operations through the second quarter of 2026. Number of Issued and Outstanding Shares: As of June 30, 2025, the company had 413,851,140 Ordinary shares issued and outstanding (equal to 20,692,557 ADSs), compared to 377,132,220 Ordinary shares issued and outstanding (equal to 18,856,611 ADSs) as of December 31, 2024. Forward-Looking Statements This 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. Contacts: Media & Investors: Chemomab Therapeutics Barbara Lindheim Consulting Vice President Investor & Public Relations, Strategic Communications Phone: +1 917-355-9234 [email protected] Chemomab Therapeutics Ltd. and its subsidiaries (*) 1 American Depositary Share (ADS) represents 20 Ordinary Shares Chemomab Therapeutics Ltd. and its subsidiaries (*) 1 American Depositary Share (ADS) represents 20 Ordinary Shares
Investor releaseQuarter not tagged2025-05-15Chemomab Therapeutics Announces First Quarter 2025 Financial Results and Provides Corporate Update
GlobeNewswire
Chemomab Therapeutics Announces First Quarter 2025 Financial Results and Provides Corporate Update
—Reported Positive 48-Week Data from SPRING Trial—Nebokitug Treatment in PSC Patients with Moderate/Advanced Disease Resulted in Continued Improvements across Key Biomarkers of Liver Injury, Inflammation and Fibrosis— —Aligned with FDA on Pathway to Potential Regulatory Approval for the Treatment of PSC with a Single, Clinical-Events-Driven Clinical Trial— —These Major Milestones Support the Advancement of Nebokitug to Phase 3 and Position It to Potentially Become the First FDA-Approved Treatment for PSC— —Cash Runway Extended to the Second Quarter of 2026— —Company Advancing Multiple Partnering Options for Executing the Nebokitug Program— TEL AVIV, Israel, May 15, 2025 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd.(Nasdaq:CMMB), (Chemomab), a clinical-stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced financial and operating results for the first quarter ended March 31, 2025, and provided a corporate update. “In the first quarter of 2025 Chemomab continued to successfully deliver on its commitments, achieving two major milestones with transformative potential for both the company and the global primary sclerosing cholangitis (PSC) community, ” said Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab. “The first was achieving, for the first time, a clear regulatory pathway with the FDA to advance nebokitug to a potential full regulatory approval in PSC. The second was release of our positive 48-week Open Label Extension (OLE) data from the nebokitug Phase 2 SPRING trial—data that confirmed and extended the positive results seen in the 15-week placebo-controlled portion of the study.” Dr. Mor continued, “Earlier this year we reported the results of our End-of-Phase 2 meeting with FDA. 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 confirmatory studies are needed. We believe the use of a clinical event-driven endpoint derisks the Phase 3 trial, since data from the SPRING study showed that PSC patients with moderate/advanced disease treated with nebokitug for 48 weeks showed a significantly lower number of clinical events compared to historical controls. The OLE data a…Read full documentShow less
—Reported Positive 48-Week Data from SPRING Trial—Nebokitug Treatment in PSC Patients with Moderate/Advanced Disease Resulted in Continued Improvements across Key Biomarkers of Liver Injury, Inflammation and Fibrosis— —Aligned with FDA on Pathway to Potential Regulatory Approval for the Treatment of PSC with a Single, Clinical-Events-Driven Clinical Trial— —These Major Milestones Support the Advancement of Nebokitug to Phase 3 and Position It to Potentially Become the First FDA-Approved Treatment for PSC— —Cash Runway Extended to the Second Quarter of 2026— —Company Advancing Multiple Partnering Options for Executing the Nebokitug Program— TEL AVIV, Israel, May 15, 2025 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd.(Nasdaq:CMMB), (Chemomab), a clinical-stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced financial and operating results for the first quarter ended March 31, 2025, and provided a corporate update. “In the first quarter of 2025 Chemomab continued to successfully deliver on its commitments, achieving two major milestones with transformative potential for both the company and the global primary sclerosing cholangitis (PSC) community, ” said Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab. “The first was achieving, for the first time, a clear regulatory pathway with the FDA to advance nebokitug to a potential full regulatory approval in PSC. The second was release of our positive 48-week Open Label Extension (OLE) data from the nebokitug Phase 2 SPRING trial—data that confirmed and extended the positive results seen in the 15-week placebo-controlled portion of the study.” Dr. Mor continued, “Earlier this year we reported the results of our End-of-Phase 2 meeting with FDA. 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 confirmatory studies are needed. We believe the use of a clinical event-driven endpoint derisks the Phase 3 trial, since data from the SPRING study showed that PSC patients with moderate/advanced disease treated with nebokitug for 48 weeks showed a significantly lower number of clinical events compared to historical controls. The OLE data also showed that nebokitug continued to be safe and well-tolerated over 12 months of treatment and resulted in broad and substantial improvements in all the key biomarkers associated with PSC. The results were especially strong in the 20 mg/kg dose that we intend to use in a Phase 3 trial, as well as in patients with moderate/advanced disease, a group that is most at risk for disease progression and that will be enrolled in Phase 3. Based on these developments—the strong 48-week SPRING trial data and the regulatory clarity achieved with the FDA—nebokitug is positioned to potentially become the first FDA-approved treatment for PSC, a devastating disease with no FDA-approved therapies.” Dr. Mor added, “We plan to advance the Phase 3 program by collaborating with a strategic partner. We are in active discussions with a variety of potential strategic partners on multiple possible paths forward and are actively considering a variety of value-creating options for advancing nebokitug toward registration. We expect to report more detail on our plans in the coming months. I want to thank our talented and committed employees and collaborators, and the many PSC community members who contributed to our success in achieving these major milestones. We look forward to continuing to work together to progress nebokitug towards becoming the first FDA-approved therapy for this devastating disease.” First Quarter 2025 and Recent Highlights: On May 5, 2025, Chemomab announced that data from the company’s Phase 2 SPRING trial of nebokitug in PSC was presented in an oral Distinguished Abstract Plenary session at Digestive Disease Week® (DDW 2025) in San Diego, California. The DDW 2025 session presented data from the double-blind, placebo-controlled 15-week treatment period and the 48-week open label extension portion of the study. On April 28, 2025 Chemomab reported data from two study abstracts that were presented as posters at EASL 2025, the Annual Congress of the European Association for the Study of the Liver. In one study, comprehensive proteomic analyses of 3,000 circulating proteins in patient samples from the Phase 2 SPRING trial showed that nebokitug-treated patients exhibited significant and dose-dependent changes in proteins playing a key role in fibrosis, immune cell recruitment and inflammation. Nebokitug-treated patients showed reductions in multiple proteins, including those involved in downregulation of biological processes related to fibrosis and inflammation. The authors highlighted how nebokitug’s ability to neutralize CCL24 exerts a wide impact, including reductions in a broad array of inflammatory and fibrotic biomarkers in treated patients. The second study analyzed the pharmacodynamics and pharmacokinetics (PK) of nebokitug and CCL24 using data from the SPRING trial. PK analyses indicated effective antibody-target engagement, and linear regression analyses found trends between increasing patient exposure to nebokitug and decreasing levels of PSC disease biomarkers. On April 15, 2025, Chemomab announced new medical and clinical appointments. David M. Weiner, MD, rejoined Chemomab as Interim Chief Medical Officer, binging extensive biotechnology and pharmaceutical industry R&D, drug development and strategic experience, and Jack Lawler, who oversaw the conduct of Chemomab’s successful Phase 2 SPRING Trial in PSC, was promoted to the position of Chief Development Officer. On March 27, 2025, Chemomab announced positive results from the Open Label Extension (OLE) portion of the Phase 2 SPRING trial of nebokitug in PSC. The OLE study confirmed that the drug was safe and well-tolerated in PSC patients for up to 48 weeks and resulted in positive effects, including continued improvements in key liver biomarkers such as the ELF score, the fibrosis-related components of ELF and the fibrosis biomarker PRO-C3. Liver stiffness scores as measured by FibroScan® were substantially lower in the nebokitug-treated patients with moderate/advanced disease compared to historical controls. Cholestasis-related markers stabilized over 48 weeks of treatment and total serum bile acids were reduced. Importantly, OLE patients with moderate/advanced disease treated with nebokitug for 48 weeks showed a significantly lower number of clinical events compared to historical controls. On March 6, 2025, Chemomab announced a new scientific presentation at the 8th International Congress on Controversies in Rheumatology and Autoimmunity (CORA 2025) that further confirmed the potential of nebokitug as a novel treatment for systemic sclerosis. The new data added to the extensive body of preclinical evidence that CCL24 is a key driver of the skin, lung and vascular manifestations of this disabling condition that lacks disease-modifying therapies. 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. 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 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 in diseases that involve excessive inflammation and fibrosis. First Quarter 2025 Financial Highlights Cash Position: Cash, cash equivalents and short-term bank deposits were $10.6 million as of March 31, 2025, compared to $14.3 million as of December 31, 2024. This cash runway is expected to fund the company through the second quarter of 2026. Research and Development (R&D) Expenses: R&D expenses were $2.5 million for the first quarter of 2025, compared to $3.1 million for the first quarter of 2024. The decrease in R&D expenses in the first quarter of 2025 compared to the first quarter of 2024 primarily resulted from the continued winding down of activities related to the Phase 2 SPRING trial . General and Administrative (G&A) Expenses: G&A expenses were $1.0 million for the first quarter of 2025, compared to $0.9 million for the first quarter of 2024. The increase in G&A expenses primarily reflects increases in share-based expenses. Net Loss: Net loss was $3.3 million, or a net loss of less than $0.01 per basic and diluted ordinary share for the first quarter of 2025, compared to $3.9 million, or a net loss of less than $0.01 per basic and diluted ordinary share for the first quarter of 2024. The weighted average number of ordinary shares outstanding, basic and diluted, was 456,149,916 (equal to approximately 22.8 million ADSs) for the first quarter of 2025. Liquidity and Capital Resources: Chemomab believes its existing liquidity resources as of March 31, 2025 will enable it to fund its operations through the second quarter of 2026. Number of Issued and Outstanding Shares: As of March 31, 2025, the company had 377,256,460 Ordinary shares issued and outstanding (equal to 18,862,823 ADSs), compared to 377,132,220 (equal to 18,856,611 ADSs) as of December 31, 2024. 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. Contacts: Media & Investors:Chemomab Therapeutics:Barbara LindheimConsulting Vice PresidentInvestor & Public Relations, Strategic CommunicationsPhone: +1 [email protected] Chemomab Therapeutics Ltd. and its subsidiaries The accompanying notes are an integral part of the interim condensed consolidated financial statements(*) 1 American Depositary Share (ADS) represents 20 Ordinary Shares Chemomab Therapeutics Ltd.and its subsidiaries The accompanying notes are an integral part of the interim condensed consolidated financial statements. (*) 1 American Depositary Share (ADS) represents 20 Ordinary Shares
Investor releaseQuarter not tagged2025-03-27Chemomab Reports Positive Results in Nebokitug Phase 2 PSC Open Label Extension Trial Showing Continued Broad and Substantial Improvements in Key Liver Biomarkers
GlobeNewswire
Chemomab Reports Positive Results in Nebokitug Phase 2 PSC Open Label Extension Trial Showing Continued Broad and Substantial Improvements in Key Liver Biomarkers
Reinforces potential of nebokitug to become the first approved drug with disease-modifying activity for PSC--a deadly disorder that currently has no effective treatments Treatment in PSC patients with moderate/advanced disease for 48 weeks resulted in continued improvements across key biomarkers of liver injury, inflammation and fibrosis, including ELF score, fibrosis-related ELF score components and PRO-C3 Patients treated with nebokitug for 48 weeks showed a significantly lower number of clinical events compared to matching historical controls and significantly reduced progression of liver stiffness vs historical controls, further derisking the planned PSC Phase 3 clinical trial design Treatment for up to 48 weeks was well-tolerated; Reinforces and expands positive results from 15-week double-blind Phase 2 SPRING trial TEL AVIV, Israel, March 27, 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 announced positive results from the Open Label Extension (OLE) portion of the Phase 2 SPRING trial assessing nebokitug as a treatment for patients with primary sclerosing cholangitis (PSC). More than 90% of SPRING trial patients eligible to participate in the OLE chose to continue. OLE participants who had been in the treatment arms of the 15-week double-blind portion of the SPRING trial received another 33 weeks of treatment with nebokitug, for a total of up to 48 weeks of treatment, and former placebo patients crossed over to receive 33 weeks of treatment with nebokitug. “We believe these positive results represent an important milestone for nebokitug, providing further clinical proof-of-concept in PSC and derisking our Phase 3 program. They are great news for Chemomab and for patients with PSC, a debilitating disorder that lacks any FDA-approved treatments and too often results in liver transplantation or death,” said Adi Mor, PhD, co-founder and Chief Executive Officer of Chemomab. “Since PSC is a chronic, slowly progressive disease, it was important to demonstrate that the positive results reported from the 15-week double-blind Phase 2 study were durable over a longer period of treatment. We are delighted that nebokitug continued to be safe and well-tolerated over 12 months of treatment and showed broad and s…Read full documentShow less
Reinforces potential of nebokitug to become the first approved drug with disease-modifying activity for PSC--a deadly disorder that currently has no effective treatments Treatment in PSC patients with moderate/advanced disease for 48 weeks resulted in continued improvements across key biomarkers of liver injury, inflammation and fibrosis, including ELF score, fibrosis-related ELF score components and PRO-C3 Patients treated with nebokitug for 48 weeks showed a significantly lower number of clinical events compared to matching historical controls and significantly reduced progression of liver stiffness vs historical controls, further derisking the planned PSC Phase 3 clinical trial design Treatment for up to 48 weeks was well-tolerated; Reinforces and expands positive results from 15-week double-blind Phase 2 SPRING trial TEL AVIV, Israel, March 27, 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 announced positive results from the Open Label Extension (OLE) portion of the Phase 2 SPRING trial assessing nebokitug as a treatment for patients with primary sclerosing cholangitis (PSC). More than 90% of SPRING trial patients eligible to participate in the OLE chose to continue. OLE participants who had been in the treatment arms of the 15-week double-blind portion of the SPRING trial received another 33 weeks of treatment with nebokitug, for a total of up to 48 weeks of treatment, and former placebo patients crossed over to receive 33 weeks of treatment with nebokitug. “We believe these positive results represent an important milestone for nebokitug, providing further clinical proof-of-concept in PSC and derisking our Phase 3 program. They are great news for Chemomab and for patients with PSC, a debilitating disorder that lacks any FDA-approved treatments and too often results in liver transplantation or death,” said Adi Mor, PhD, co-founder and Chief Executive Officer of Chemomab. “Since PSC is a chronic, slowly progressive disease, it was important to demonstrate that the positive results reported from the 15-week double-blind Phase 2 study were durable over a longer period of treatment. We are delighted that nebokitug continued to be safe and well-tolerated over 12 months of treatment and showed broad and substantial improvements in all the key biomarkers associated with PSC. The results were especially strong in the 20 mg/kg dose that we expect to use in the Phase 3 trial, as well as in patients with moderate/advanced disease, a group that is most at risk for disease progression and that will be the focus in Phase 3.” The OLE study confirmed that the drug was safe and well-tolerated in PSC patients receiving 10 mg/kg or 20 mg/kg of nebokitug administered once every three weeks for up to 48 weeks, and resulted in positive effects, including continued improvements in key liver biomarkers such as the ELF score, the fibrosis-related components of ELF and the fibrosis biomarker PRO-C3. Liver stiffness scores (transient elastography), as measured by FibroScan® were substantially lower in the nebokitug-treated patients with moderate/advanced disease compared to matching historical controls. Cholestasis-related markers stabilized over 48 weeks of treatment and total serum bile acids were reduced. OLE patients with moderate/advanced disease treated with nebokitug for 48 weeks showed a significantly lower number of clinical events (4.8%) compared to matching historical controls (25.8%)1. Results from the patients receiving placebo in the double-blind period who rolled over to receive 33 weeks of treatment during the OLE were consistent with the results in patients treated with nebokitug in the 15-week double-blind study, including stabilization of ELF scores and improvements in liver stiffness compared to baseline. Nebokitug Treatment for 48 Weeks Stabilizes Risk of Disease Progression as Determined by ELF Score All Patients-All OLE completers; Moderate/advanced by ELF (ELF>9.8 at baseline) Nebokitug Treatment for 48 Weeks Slowed Progression of Liver Stiffness Compared to Historical Controls Moderate/Advanced by LSM (F2-F3)- 8.7<TE (kPa) <14.4; Historical control-Corpechot et al 2014 Moderate/advanced (ELF>9.8 at baseline); PIINP-procollagen type III amino-terminal propeptide; TIMP1-tissue inhibitor of metalloproteinases 1; PRO-C3-fibrogenesis biomarker that detects the synthesis of type lll collagen Dr. Mor continued, “We view the broad and consistent stabilization and improvement in disease-related biomarkers seen with 48 weeks of nebokitug treatment, including reductions in the risk of disease progression as shown by the ELF score, as directly translatable and potentially derisking to our Phase 3 study. Additionally, the new data showed a significantly lower rate of clinical events in patients treated with nebokitug for 48 weeks compared to historical controls, further increasing our confidence in the Phase 3 trial design, where the primary endpoint is based on the number of clinical events. These findings reinforce nebokitug’s potential to alter the course of PSC, as well as the rationale for the planned Phase 3 trial that provides a clear pathway to potential full regulatory approval.” Douglas Thorburn, MD, Divisional Clinical Director for Liver and Digestive Health at the Royal Free London NHS Trust and Professor of Hepatology within the Institute for Liver and Digestive Health at UCL, and a coordinating investigator of the SPRING trial, said, “This new data reporting on patients who received up to 48 weeks of treatment with nebokitug reinforces the positive results that we saw in the initial 15-week double blinded trial. The fact that nebokitug continued to be generally well tolerated and to generate continued improvements across a broad range of disease-related biomarkers is very encouraging. Patients with PSC experience burdensome symptoms, unpredictable futures and lack effective treatments. I look forward to the continued clinical progress of nebokitug as a potential new therapy for PSC where there is so much unmet medical need.” Further details on the SPRING Trial Open Label Extension results can be viewed at https://investors.chemomab.com/presentations About the Nebokitug SPRING Trial Open Label Extension (OLE)The SPRING trial OLE was available to PSC patients who enrolled in the nebokitug Phase 2 SPRING trial (NCT04595825) after the OLE was added to the study design, and who completed the 15-week double-blind placebo-controlled portion of the trial. Of those 54 patients eligible to roll over, 93% elected to participate. Patients in the 10 mg/kg and 20 mg/kg dose arms continued on those doses, while placebo patients received either the 10 mg/kg or 20 mg/kg dose based on their initial double blind assignment. Nebokitug was administered by infusion once every three weeks. Treatment continued for an additional 33 weeks, with patients receiving a total of up to 48 weeks of treatment, along with a 12-week washout period. Patients with ELF scores greater than or equal to 9.8 and liver stiffness measurement scores (LSM) lower than 14.4 kPa were classified as having moderate/advanced disease. This definition is based on the patient enrichment criteria the FDA recommended that Chemomab use in the nebokitug Phase 3 trial. The OLE data was also analyzed using the definition for moderate/advanced status employed in the double-blind portion of the study (LSM≥8.7 kPa) and as expected, showed similar results, given the known overlap between high ELF scores and high LSM levels. In general, the OLE analysis assessed most of the same primary, secondary and exploratory endpoints that were measured in the double-blind portion of the trial. About Nebokitug (CM-101) Nebokitug is a first-in-class dual activity monoclonal antibody that neutralizes CCL24, a soluble protein that helps drive the inflammatory and fibrotic pathways central to primary sclerosing cholangitis (PSC) and other fibro-inflammatory diseases. By inhibiting CCL24, nebokitug blocks immune cell recruitment and fibroblast activation, thereby interrupting the self-reinforcing cycle that results in fibrosis. In clinical and preclinical studies, nebokitug has been shown to have a favorable safety profile, 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, including the Phase 2 SPRING trial in patients with PSC. This study achieved the primary safety endpoint and nebokitug-treated patients with moderate/advanced disease showed improvements on a wide range of disease-related secondary endpoint. The results of the Open Label Extension portion of the SPRING trial, where PSC patients received nebokitug for up to a total of 48 weeks, confirmed and extended the initial Phase 2 results. Nebokitug is also potentially being developed for systemic sclerosis (SSc). The SSc program has an open U.S. IND. Nebokitug has received FDA and EMA Orphan Drug designations for the treatment of PSC and SSc and FDA Fast Track status for the treatment of PSC in adults. About Primary Sclerosing CholangitisPSC is a rare, debilitating progressive liver disease characterized by inflammation and fibrosis (scarring) of the bile ducts that can lead to cirrhosis of the liver, liver failure and death. PSC also increases the risk of various cancers, which account for about half of PSC-related mortality. PSC affects an estimated 30,000 patients in the U.S. and about 80,000 worldwide. The underlying cause of PSC is unknown, but about 75% of patients also have inflammatory bowel disease. Liver transplantation is common in end stage disease cases, but even then, PSC re-occurs in about 20% of transplanted patients. With no approved therapies to date, there is a high unmet medical need for new drugs to address the symptoms of PSC and slow or stop the progression of this devastating illness. 1 - Muir et al, 2019 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 presentation 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. Contacts: Media and Investors:Barbara LindheimConsulting Vice President, Investor & Public Relations, Strategic CommunicationsPhone: +1 [email protected]@chemomab.com Photos accompanying this announcement are available at https://www.globenewswire.com/NewsRoom/AttachmentNg/1e169756-83fa-4933-b717-0b778ab8c3c2 https://www.globenewswire.com/NewsRoom/AttachmentNg/b03c0e26-84e7-4363-8d6e-4865acdb0678 https://www.globenewswire.com/NewsRoom/AttachmentNg/f1e1f110-80ee-4495-bb1c-c6fcdc1e234c

