CMMB Chemomab Therapeutics Ltd

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of November 2023

 

Commission File Number 001-38807

 

CHEMOMAB THERAPEUTICS LTD.
(Translation of registrant’s name into English)

 

Kiryat Atidim, Building 7, Tel-Aviv, Israel

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

 

Form 20-F ☒           Form 40-F ☐

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

Unaudited Condensed Consolidated Interim Financial Statements as of September 30, 2023

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Condensed Consolidated Balance Sheets

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Condensed Consolidated Interim Statements of Operations (Unaudited)

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Condensed Consolidated Interim Statements of Changes in Equity (Unaudited)

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Condensed Consolidated Interim Statements of Changes in Equity (Unaudited)

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Condensed Consolidated Interim Statements of Cash Flows (Unaudited)

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The Company currently has no products approved for sale. The Company’s operations are funded primarily by its shareholders. The Company has incurred operating losses in each year since its inception and does not expect to generate significant revenue unless and until it obtains marketing approval for its products. Continuation of the Company’s development programs depend on its future ability to raise sources of financing. The Company believes that its existing liquidity resources as of September 30, 2023, will enable it to fund its operations through December 31, 2024 with the ability to perform cost reductions in order to extend the operations even further, if required to do so.

At this time, the Company assesses, on the basis of the information it has on the date of approval of the financial statements, that the current events and the recent escalation of the conflict underway in Israel,  have no significant effect on the business results of the Company. Since this is an event that is not under the control of the Company and matters such as the fighting continuing or stopping may affect the Company's assessments, as of the reporting date, it is not possible to predict the duration or severity of the ongoing conflict or its effects on the Company's business activities. The Company is continuing to regularly follow developments on the matter and is examining the effect on its operations and financial condition.

In October 2023, the ITA rejected the company’s appeal on the assessment. The Company is planning to submit an appeal to the Israeli district court. Based on the consultancy of its tax advisors, the Company estimates that the amount of provision recorded in 2022 remains adequate.

In September 2023, the Company terminated the Cantor ATM Agreement. In October 2023, the Company entered into ATM agreement (the "Roth ATM Agreement") with Roth Capital Partners LLC ("Roth"). According to the Roth ATM Agreement, the Company may offer and sell, from time to time, its ADSs having an aggregate offering price of up to $2,864 thousand through Roth or the Roth ATM Agreement. On October 16, 2023, as amended on October 30, 2023, the Company filed a registration statement on Form F-3 (File No. 333-275002) with the SEC (the “Registration Statement”), which included a prospectus supplement for the issuance and sale of up to $2,864 thousand of its ADSs pursuant to the Roth ATM Agreement. The Registration Statement is a replacement registration statement with respect to securities that remain unsold under the registration statement on Form S-3 (File No. 333-255658) filed on April 30, 2021, and declared effective on May 17, 2021.

TEL AVIV, Israel ─ November 9, 2023 ─ Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company focused on the discovery and development of innovative therapeutics for fibro-inflammatory diseases with high unmet need, today reported financial and operating results for the third quarter ended September 30, 2023, and provided a corporate update.

“Chemomab made excellent progress during the third quarter,” said Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab. “Our focus on successfully completing our CM-101 Phase 2 trial in primary sclerosing cholangitis (PSC) is fueling rapid progress, as robust patient interest is enabling us to advance towards completion of the enrollment stage of the trial. We expect to provide more detail on projected trial completion and reporting timelines early in the new year.”

Dr. Mor added, “During the quarter we also participated in activities to raise awareness about PSC and the high unmet need for effective PSC therapies. We were an active participant in and supporter of the annual conference of the leading U.S. patient advocacy organization, which was complemented by our work with PSC advocates in Europe and Israel. We also continued to work closely with PSC key opinion leaders who are coordinating efforts to advance the evolving regulatory environment for PSC therapies, with the goal of incorporating new knowledge and improved technologies into regulatory decision-making. We expect that our ongoing collaborations with opinion leaders and patient groups will help us move expeditiously towards a Phase 3 registrational trial in PSC, if our current Phase 2 trial is successful.”

“We are also continuing our campaign to educate the scientific and medical communities about CCL24 and CM-101. We have an oral presentation and multiple posters at both the 2023 AASLD Liver Meeting^® in Boston and the 2023 ACR Convergence conference in San Diego next week. Our continued success in achieving oral and poster presentations at top medical conferences highlights the scientific relevance of our CM-101 programs.”

“We are continuing to manage our resources prudently and expect our quarterly cash burn to continue to decrease in 2024. We reiterate our prior guidance that we believe we have adequate financial resources to both achieve our significant Phase 2 PSC topline data milestone and take us through the end of next year. We view the upcoming PSC milestone as a major catalyst for Chemomab. If successful, we expect the trial results to provide us a range of options for advancing CM-101 in PSC and other indications.”

“Finally, I want to note that despite the major challenges confronting Israel, we do not expect an impact on our ongoing activities. Currently, our headquarters and R&D operations in Tel Aviv are fully operational and our clinical development and medical affairs teams based in the U.S. are functioning normally, as planned. We would like to thank our employees and our many colleagues around the globe who have offered us tremendous support during this difficult time for Israel.”

Third Quarter 2023 Corporate Updates

Scientific Studies Accepted for Oral and Poster Presentations at 2023 AASLD The Liver Meeting^® and at ACR Convergence 2023

Studies authored and co-authored by Chemomab scientists were accepted for presentation at two major U.S. medical conferences in November, including an oral presentation on PSC and a scientific poster at the AASLD The Liver Meeting^® in Boston, as well as a poster presentation on the role of Chemomab’s CCL24 target in systemic sclerosis at the American College of Rheumatology Convergence 2023 conference in San Diego. Further details of the presentations will be released later this month.

Participated in Investor Conferences

Chemomab management recently participated in several investor conferences, including the 2023 Roth MKM Health Opportunities Conference and the 2023 H.C. Wainwright 25^th Annual Global Investment Conference. During the quarter the Company was also proactive in reaching out to analysts and investors to educate them about Chemomab’s programs and our future plans.

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Third Quarter 2023 Financial Highlights

The weighted average number of Ordinary Shares outstanding, basic and diluted, for the quarter ended September 30, 2023, was 236,449,153 (equal to 11,822,458 American Depository Shares) compared to 228,773,418 Ordinary Shares (equal to 11,438,671 American Depository Shares) for the quarter ended September 30, 2022. 

For further details on Chemomab’s financial results for the quarter ended September 30, 2023, refer to the Report of Foreign Private Issuer on Form 6-K, which was filed with the SEC on November 9, 2023.

Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These forward-looking statements include, among other things, statements regarding the clinical development pathway for CM-101; the future operations of Chemomab and its ability to successfully initiate and complete clinical trials and achieve regulatory milestones; the nature, strategy and focus of Chemomab; the development and commercial potential and potential benefits of any product candidates of Chemomab; and that the product candidates have the potential to address high unmet needs of patients with serious fibrosis-related diseases and conditions. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based upon Chemomab's current expectations. Forward-looking statements involve risks and uncertainties. Because such statements deal with future events and are based on Chemomab's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Chemomab could differ materially from those described in or implied by the statements in this presentation, including those found under the caption "Risk Factors" and elsewhere in Chemomab's filings and reports with the SEC. Chemomab expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Chemomab's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based, except as required by law.

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 and pivotal role of CCL24 in promoting fibrosis and inflammation, Chemomab developed CM-101, a monoclonal antibody designed to neutralize CCL24 activity. In preclinical and clinical studies, CM-101 appears safe, with the potential to treat multiple severe and life-threatening fibro-inflammatory diseases. Chemomab has reported encouraging results from three clinical trials of CM-101 in patients, including a Phase 1b trial in NAFLD patients, a Phase 2a liver fibrosis trial in NASH patients and an investigator-initiated study in patients with severe lung injury. The CM-101 program for the treatment of systemic sclerosis is Phase 2-ready and a Phase 2 trial in primary sclerosing cholangitis patients is ongoing, with topline data expected in the second half of 2024. For more information about Chemomab, visit chemomab.com.

Contacts:

Media and Investors:

Barbara Lindheim

Consulting Vice President, Investor & Public Relations,

Strategic Communications

Phone: +1 917 355-9234

Chemomab Therapeutics Ltd.

and its subsidiaries

In USD thousands (except for share amounts)

		September 30,				December 31,
		2023				2022
		Unaudited				Audited
Assets
Current assets
Cash and cash equivalents			9,156				13,519
Short term bank deposits			12,216				26,374
Restricted cash			72				77
Other receivables and prepaid expenses			922				1,766
Total current assets			22,366				41,736
Non-current assets
Long term prepaid expenses			603				733
Property and equipment, net			319				367
Operating lease right-of-use assets			130				227
Total non-current assets			1,052				1,327
Total assets			23,418				43,063
Current liabilities
Trade payables			731				1,688
Accrued expenses			3,007				3,378
Employee and related expenses			1,527				1,560
Operating lease liabilities			105				123
Total current liabilities			5,370				6,749
Non-current liabilities
Operating lease liabilities - long term			5				91
Total non-current liabilities			5				91
Commitments and contingent liabilities
Total liabilities			5,375				6,840
Shareholders' equity (*)
Ordinary shares no par value - Authorized: 650,000,000 shares as of September 30, 2023 and December 31, 2022			-				-
Issued and outstanding: 248,094,700 Ordinary shares as of September 30, 2023 and 232,636,700 as of December 31, 2022			-				-
Treasury share at cost (11,640,460 Ordinary shares as of September 30, 2023 and December 31, 2022)			(1,218	)			(1,218	)
Additional paid in capital			103,884				101,260
Accumulated deficit			(84,623	)			(63,819	)
Total shareholders’ equity			18,043				36,223
Total liabilities and shareholders’ equity			23,418				43,063

 

(*) 1 American Depositary Share (ADS) represents 20 Ordinary Shares

Chemomab Therapeutics Ltd.

and its subsidiaries

In USD thousands (except for share and per share amounts)

(*) 1 American Depositary Share (ADS) represents 20 Ordinary Shares

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