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 $(PSC.AU)$ 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$(R)$ (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(R) 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. 

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