Nebokitug

─ 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 pro 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 the SEC for more complete information about us. You may get these documents for free by visiting EDGAR on the SEC website at . 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 pro 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 barbara.lindheim@chemomab.com IR@chemomab.com Chemomab Therapeutics Ltd. and its subsidiaries Consolidated Balance Sheets as of In USD thousands (except share and per share amounts) December 31, December 31, 2025 2024 Assets Current assets Cash and cash equivalents 7,564 6,071 Short-term bank deposit 2 ,802 8,195 Restricted cash - 76 Other receivables and prepaid expenses 3,059 1,698 Total current assets 13,425 16,040 Non-current assets Long-term prepaid expenses 211 385 Property and equipment, net 176 250 Operating lease right-of-use assets - 289 Total non-current assets 387 924 Total assets 13,812 16,964 Current liabilities Trade payables 485 633 Accrued expenses 337 1536 Employee and related expenses 656 934 Operating lease liabilities - 115 Total current liabilities 1,478 3,218 Non-current liabilities Non-current operating lease liabilities - 209 Total non-current liabilities - 209 Commitments and contingent liabilities Total liabilities 1,478 3,427 Shareholders' equity Ordinary Shares no par value - Authorized: 4,650,000,000 as of December 31, 2025, and December 31, 2024. Issued and outstanding: 575,381,320, and 377,132,220 Ordinary shares as of December 31, 2025 and 2024, respectively (*) - - Additional paid-in capital 123,952 116,160 Accumulated deficit (111,618 ) (102,623 ) Total shareholders’ equity 12,334 13,537 Total liabilities and shareholders’ equity 13,812 16,964 (*) 1 American Depositary Share (ADS) represents 80 Ordinary Shares Consolidated Statements of Operations In USD thousands (except share and per share amounts) Three months Three months Year Ended Year Ended Ended Ended December December December 31 December 31 31, 31, 2025 2024 2025 2024 Unaudited Unaudited Unaudited Audited Operating expenses Research and development 1,093 2,411 5,833 11,327 General and administrative 881 802 3,734 3,412 Total operating expenses 1,974 3,213 9,567 14,739 Financing income, net (101 ) (250 ) (572 ) (794 ) ` Net loss 1,873 2,963 8,995 13,945 Basic and diluted loss per Ordinary Share 0.003 0.008 0.018 0.039 Weighted average number of Ordinary Shares outstanding, basic, and diluted (*) 625,680,763 377,132,220 510,227,715 359,048,638 (*) 1 American Depositary Share (ADS) represents 80 Ordinary Shares

自身免疫性肝病 因发病机制不明，治疗难度大，若控制不佳易进展为肝硬化、肝衰竭，让患者陷入长期焦虑。 2025 年，自身免疫性肝病领域的研究取得一系列进展，从治疗理念、发病机制到治疗方案均实现革新，精准化、个体化治疗成为主流，为患者带来新希望。以下从核心进展、临床价值、实操建议三方面，为你清晰解读。 治疗新理念 从 “控制指标”  到 “追求再代偿” 长期以来，自身免疫性肝病的治疗目标仅聚焦于稳定肝功能指标，但 2025 年的研究提出了更积极的方向 ——“再代偿”，即让已出现肝硬化失代偿（如腹水、肝性脑病）的患者，通过治疗恢复稳定状态，重新摆脱失代偿症状。 原发性胆汁性胆管炎（PBC）： 首次明确了 “再代偿” 的临床判定标准，让这一概念从模糊共识变得可评估、可操作；淋巴细胞 - 单核细胞比值可作为预测患者能否实现 “再代偿” 的关键指标，帮助医生提前判断治疗效果。 自身免疫性肝炎（AIH）： 研究证实，实现 “再代偿” 的患者能获得明确临床获益，肝性脑病分级和终末期肝病模型联合钠（MELD-Na）评分的下降幅度，是影响 “再代偿” 能否成功的重要因素。 强化治疗理念： 针对 PBC 患者中对熊去氧胆酸应答不佳或无法耐受的人群，提出 “强化治疗” 方案，包括早期识别、以碱性磷酸酶复常为目标的联合用药、结合生物标志物和肝脏硬度的风险分层，让治疗更精准。 发病新机制 聚焦肝脏免疫微环境 找到精准干预靶点 对发病机制的深入研究，为开发靶向药物提供了基础，2025 年的研究聚焦肝脏局部的免疫失衡。 固有免疫与适应性免疫的 “对话” 异常： PBC 患者肝脏中的库普弗细胞（肝脏巨噬细胞）自噬活性异常，会激活 CD8+T 细胞，进而损伤胆管，这一发现为通过调节巨噬细胞功能干预疾病提供了新思路。 免疫细胞的异常招募与功能转换： 特定 B 细胞会招募组织驻留 T 细胞，加重肝脏炎症；原本负责抑制炎症的调节性 T 细胞，会转化为促炎细胞，形成 “自我强化” 的炎症环路，持续损伤肝脏。 肝细胞铁死亡失控： 肝细胞的铁死亡机制异常激活，会进一步加重肝脏炎症，成为疾病进展的重要推手。 治疗新选择 个体化方案更贴合患者需求 基于新的理念和机制，2025 年的治疗方案更具针对性，覆盖不同疾病类型和症状。 原发性胆汁性胆管炎（PBC）： 二线治疗明确：奥贝胆酸撤市后，苯扎贝特成为核心二线选择，长期真实世界数据证实，它在改善肝功能指标、缓解症状、保护肝脏组织甚至延长生存期方面均有优势。 新型药物登场：PPARδ 选择性激动剂 Seladelpar 治疗 2 年，能稳定改善肝功能和瘙痒症状，安全性良好。 新药研发-症状靶向治疗：回肠胆汁酸转运体抑制剂 Linerixibat 在 Ⅲ 期临床试验中证实有效，针对性解决困扰患者的瘙痒问题，让治疗从 “只护肝” 转向 “兼顾患者整体生活质量”。 自身免疫性肝炎（AIH）： 风险因素明确：肝硬化和生化应答不充分是影响患者生存期的主要因素； 激素方案优化：急性 AIH 患者采用激素缓慢减量方案，能延长生存期并减少不良反应； IgG4 相关疾病：伊奈利珠单抗可降低复发风险，提高 1 年内无复发完全缓解的概率，为靶向治疗提供新选择。 原发性硬化性胆管炎（PSC）： 多款靶向药进入临床试验：Nebokitug（靶向炎症招募）、Bexotegrast（抑制纤维化激活）、Elafibranor（调节胆汁酸代谢）等，均显示出改善肝功能或纤维化的潜力； 精准治疗时代 规范应对是关键 2025 年自身免疫性肝病领域的进展，标志着诊疗已迈入 “精准化、个体化” 时代。从 “控制指标” 到 “追求再代偿”，从 “广谱用药” 到 “靶向干预”，这些突破让患者不再被动承受疾病，而是有了更主动的治疗方向。 对患者而言，核心是做好 “规范治疗、定期复查、精准匹配” ： 不放弃现有治疗基础，主动关注新进展，与医生充分沟通自身病情（如是否有肝硬化、药物应答情况、症状困扰），制定适合自己的方案。 相信随着研究的深入，未来会有更多精准疗法落地，帮助患者更好地控制病情，拥有更高质量的生活。 文章改编自：尚玉龙, 韩英 . 2025 年自身免疫性肝病研究进展：迈向精准调控与个体化治疗[J]. 中华肝脏病杂志, 2026, 34(1):10-12. DOI: 10.3760/cma.j.cn501113-20251219-00541. ⬆ 点击上方名片 ⬆ 关注护肝百科 获取更多权威肝病诊疗内容 声明：本文仅作健康科普，不能替代医院的检查和治疗。如有相关疾病，请及时前往正规医疗机构就诊，并谨遵医嘱。