─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 Regulatory Approval

for the Treatment of PSC with No Liver Biopsies or Confirmatory Studies Needed; Nebokitug

Positioned to Potentially Become the First FDA-Approved Treatment for PSC─

─On Track for Releasing Clinical Data from SPRING Trial Open Label Extension in First Quarter 2025-

-Discussions with Potential Strategic Partners Ongoing─

TEL AVIV, Israel, March 3, 2025 -- 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, 2024, and provided a corporate update.

“The past year has been a transformative period for both Chemomab and the PSC field,” said Adi Mor, PhD, co-founder and Chief Executive Officer of Chemomab. “Following rapid enrollment in our nebokitug (CM-101) Phase 2 SPRING trial in patients with PSC, we were able to report topline results in July, approximately six months ahead of schedule. We and our PSC expert advisers view these Phase 2 data as the strongest in PSC to date. Nebokitug achieved the SPRING trial primary endpoint, demonstrating a favorable safety profile. Additionally, patients treated with nebokitug who had moderate/advanced disease showed improvements in multiple secondary efficacy endpoints encompassing the fibrotic, inflammatory and cholestatic aspects of PSC. This is the first time that an investigational drug for PSC has shown improvements across such a wide range of highly relevant disease markers. These promising results set the stage for our FDA End-of-Phase 2 meeting. We recently reported the positive results of that meeting and outlined the design for a single pivotal Phase 3 trial for nebokitug in PSC, which provides us with a clear and streamlined pathway to potential regulatory approval.”

Dr. Mor continued, “We were very pleased by FDA’s positive and collaborative spirit at the meeting and their stated commitment to facilitating the advancement of effective new therapies for PSC. 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 additional confirmatory studies will be needed. The design is similar to the approach used in oncology trials and is both feasible and efficient. Importantly, use of a clinical event-driven endpoint helps derisk the Phase 3 trial, since key publications have linked the type of improvements in PSC biomarkers seen in nebokitug-treated patients in the SPRING trial with decreases in clinical events.”

Dr. Mor added, “We continue to assess a variety of potential strategic paths forward. The recent positive developments have been of keen interest to potential strategic partners and active discussions are advancing following FDA’s regulatory guidance. At the same time, we are laying the foundation for beginning the Phase 3 trial, leveraging the strong relationships our clinical team developed with global PSC centers during the SPRING study. We believe that nebokitug could become the first FDA-approved therapy for PSC, addressing the tremendous unmet need in this devastating, often lethal disease. We look forward to reporting data from the SPRING trial Open Label Extension later this quarter.”

2024 and Recent Highlights:

•

On November 19, 2024, Chemomab reported that data from its Phase 2 SPRING trial in patients with PSC was presented at the American Association for the Study of Liver Disease (AASLD) The Liver Meeting® 2024. In an oral, late-breaking presentation, Professor Christopher Bowlus, MD, a SPRING trial investigator and  Professor and Chief of the Division of Gastroenterology and Hepatology at the University of California Davis School of Medicine, discussed data from the double-blinded, placebo-controlled portion of the Phase 2 trial.

Full Year and Fourth Quarter 2024 Financial Highlights:

 

 

 

The weighted average number of Ordinary Shares outstanding, basic and diluted was 324,649,751 (equal to 16,232,489 ADSs) for the year ended December 31, 2024, and 234,998,859 (equal to 11,749,943 ADSs) for the year ended December 31, 2023, respectively.

For further details on the company’s financial results for the year ended December 31, 2024, please refer to the company’s annual report on Form 20-F, which will be filed with the SEC in March, 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 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, 2023. 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 recent positive data from its Phase 2 SPRING trial in primary sclerosing cholangitis (PSC), the company is preparing for potential initiation of a PSC nebokitug Phase 3 trial. The design calls for a single pivotal study based on a clinical event primary endpoint that provides a clear and streamlined pathway to potential regulatory approval. Data from the SPRING trial open label extension will be reported in the first quarter of 2025. 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 Lindheim

Consulting Vice President, Investor & Public Relations, Strategic Communications

Phone: +1 917-355-9234

 

		December 31,				December 31,
		2024				2023
Assets
Current assets
Cash and cash equivalents			6,071				9,292
Short-term bank deposit			8,195				10,492
Restricted cash			76				76
Other receivables and prepaid expenses			1,698				1,037
Total current assets			16,040				20,897
Non-current assets
Long-term prepaid expenses			385				559
Property and equipment, net			250				303
Operating lease right-of-use assets			289				392
Total non-current assets			924				1,254
Total assets			16,964				22,151
Current liabilities
Trade payables			666				516
Accrued expenses			1,563				3,423
Employee and related expenses			874				823
Operating lease liabilities			115				76
Total current liabilities			3,218				4,838
Non-current liabilities
Non-current operating lease liabilities			209				316
Total non-current liabilities			209				316
Commitments and contingent liabilities
Total liabilities			3,427				5,154
Shareholders' equity
Ordinary Shares no par value - Authorized: 4,650,000,000 and 650,000,000 Ordinary shares as of December 31, 2024, and  December 31, 2023 , respectively
Issued and outstanding: 377,132,220, and 284,094,700 Ordinary shares as of  December 31, 2024 and 2023, respectively			-				-
Additional paid-in capital			116,160				105,675
Accumulated deficit			(102,623	)			(88,678	)
Total shareholders’ equity			13,537				16,997
Total liabilities and shareholders’ equity			16,964				22,151

		Three months				Three months				Year Ended				Year Ended
		Ended				Ended				December				December
		December 31				December 31				31,				31,
		2024				2023				2024				2023
		Unaudited				Unaudited				Unaudited				Audited
Operating expenses
Research and development			2,411				3,097				11,327				18,381
General and administrative			802				751				3,412				7,078
Total operating expenses			3,213				3,848				14,739				25,459
Financing income, net			(250	)			(431	)			(794	)			(1,238	)
`
Net loss for the year			2,963				3,417				13,945				24,221

---