—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:
Second Quarter 2025 Financial Highlights
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
barbara.lindheim@chemomab.com
Chemomab Therapeutics Ltd.
and its subsidiaries
Interim Condensed Consolidated Balance Sheets (Unaudited) | ||||||
In USD thousands (except for share amounts) | June 30, | December 31, | ||||
2025 | 2024 | |||||
Assets | ||||||
Current assets | ||||||
Cash and cash equivalents | 5,448 | 6,071 | ||||
Short term bank deposits | 3,917 | 8,195 | ||||
Restricted cash | 148 | 76 | ||||
Other receivables and prepaid expenses | 1,101 | 1,698 | ||||
Total current assets | 10,614 | 16,040 | ||||
Non-current assets | ||||||
Long term prepaid expenses | 298 | 385 | ||||
Property and equipment, net | 217 | 250 | ||||
Operating lease right-of-use assets | - | 289 | ||||
Total non-current assets | 515 | 924 | ||||
Total assets | 11,129 | 16,964 | ||||
Current liabilities | ||||||
Trade payables | 378 | 666 | ||||
Accrued expenses | 666 | 1,563 | ||||
Employee and related expenses | 386 | 874 | ||||
Operating lease liabilities | - | 115 | ||||
Total current liabilities | 1,430 | 3,218 | ||||
Non-current liabilities | ||||||
Operating lease liabilities - long term | - | 209 | ||||
Total non-current liabilities | - | 209 | ||||
Commitments and contingent liabilities | ||||||
Total liabilities | 1,430 | 3,427 | ||||
Shareholders' equity (*) | ||||||
Ordinary shares no par value - Authorized: 4,650,000,000 shares as of June 30, 2025, and as of December 31, 2024; | - | - | ||||
Issued and outstanding: 413,851,140 Ordinary shares as of June 30, 2025 and 377,132,220 as of December 31, 2024; | - | - | ||||
Additional paid in capital | 117,702 | 116,160 | ||||
Accumulated deficit | (108,003 | ) | (102,623 | ) | ||
Total shareholders’ equity | 9,699 | 13,537 | ||||
Total liabilities and shareholders’ equity | 11,129 | 16,964 |
(*) 1 American Depositary Share (ADS) represents 20 Ordinary Shares
Chemomab Therapeutics Ltd.
and its subsidiaries
Interim Condensed Consolidated Statements of Operations (Unaudited) | ||||||||
In USD thousands (except for share and per share amounts) | ||||||||
Three months | Three months | Six months | Six months | |||||
Ended | Ended | Ended | Ended | |||||
June 30, | June 30, | June 30, | June 30, | |||||
2025 | 2024 | 2025 | 2024 | |||||
Operating expenses | ||||||||
Research and development | 1,287 | 2,928 | 3,780 | 6,080 | ||||
General and administrative | 975 | 840 | 1,969 | 1,736 | ||||
Total operating expenses | 2,262 | 3,768 | 5,749 | 7,816 | ||||
Financing income, net | 205 | 137 | 369 | 317 | ||||
Loss before taxes | 2,057 | 3,631 | 5,380 | 7,499 | ||||
Taxes on Income | - | - | - | - | ||||
Net loss for the period | 2,057 | 3,631 | 5,380 | 7,499 |
Basic and diluted loss per Ordinary Share (*) | 0.004 | 0.013 | 0.012 | 0.026 | |||
Weighted average number of Ordinary Shares outstanding, basic, and diluted (*) | 463,508,519 | 286,080,133 | 459,829,621 | 285,111,876 |
(*) 1 American Depositary Share (ADS) represents 20 Ordinary Shares
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