On August 14, 2025 Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, reported financial and operating results for the second quarter ended June 30, 2025, and provided a corporate update (Press release, Chemomab, AUG 14, 2025, View Source [SID1234655299]).
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"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.