On May 12, 2022 Chemomab Therapeutics, Ltd. (Nasdaq: CMMB), a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported financial and operating results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, Chemomab, MAY 12, 2022, View Source [SID1234614374]).

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"During the quarter we continued to make good progress in refining and implementing revisions to our CM-101 clinical program aimed at decreasing overall development risk, maximizing the clinical data obtained to facilitate clinical decision-making, and generating critical data to support advancement to registration trials," said Dale Pfost, PhD, Chief Executive Officer of Chemomab. "We are expanding our efforts in primary sclerosing cholangitis (PSC) with an enlarged clinical trial that is recruiting patients from new sites in the U.S. and Europe, while adding an important dose finding component and an open-label extension. We will be performing an interim analysis of the currently enrolling dose cohort in the PSC study to assess safety and to confirm the planned sample sizes for the CM-101 dose cohorts. This planned interim read-out is expected late this year."

Dr. Pfost added, "In systemic sclerosis (SSc), we expect the revised Phase 2 trial design to enable an expedited path to proof-of-concept data, and, importantly, to provide additional information on CM-101’s activity in modifying the skin, lung and vascular pathophysiology seen in SSc patients. We are designing this trial with the assistance of key SSc opinion leaders and are on track to launch the trial by the end of the year. I am also pleased to report that we have now completed enrollment in our Phase 2 safety, pharmacokinetic and biomarker liver fibrosis study, with final readouts expected near year’s end. We continue to use our capital efficiently and look forward to providing further details on our progress with the PSC and SSc Phase 2 trials this summer."

Recent Highlights:

Named Jack Lawler Vice President of Global Clinical Development Operations. Mr. Lawler, who is based in the U.S., brings the company more than 20 years of diverse global clinical drug development experience.
Chief Scientific Officer Dr. Adi Mor presented "Blocking CCL24, a novel target regulating inflammation fibrosis and endothelial damage, shows promising potential as treatment for Systemic Sclerosis" at the biennial International Rheumatology Conference in Israel. Study data from experimental models and patient samples demonstrated that CCL24, the target for CM-101, is overexpressed in skin and serum samples of diffuse SSc patients compared to healthy individuals. CCL24 levels also correlated with fibrotic biomarkers and disease progression. In an experimental mouse model of SSc, CM-101 profoundly reduced skin and lung fibrosis.
Professor Francesco Del Galdo of the University of Leeds presented "CCL24 as a Marker of Worse Prognosis in diffuse cutaneous SSc: a Promising Novel Biological Target" at the 7th Systemic Sclerosis World Congress. Professor Del Galdo’s findings support the role of CCL24 as a potential therapeutic target, demonstrating elevated serum levels of CCL24 in diffuse cutaneous SSc patients. High CCL24 serum levels were correlated with disease activity and worse prognosis as reflected by high fibrotic activity and deterioration of lung function over time in a longitudinal patient cohort.
Participated in the 32nd Annual Oppenheimer Healthcare Conference
At the Cantor Fitzgerald Rare Orphan Disease Summit, Dr. Adi Mor described how Chemomab’s CM-101 "pipeline in a product" strategy offers important synergies and efficiencies in the drug development process.
First Quarter 2022 Financial Highlights

Cash Position: Cash and cash equivalents were $57.5 million as of March 31, 2022, compared to $61.2 million as of December 31, 2021.
Research and Development (R&D) Expenses: R&D expenses were $2.7 million for the first quarter ended March 31, 2022, compared to $1.2 million for the same quarter in 2021.
General and Administrative (G&A) Expenses: G&A expenses were $2.6 million for the first quarter ended March 31, 2022, compared to $0.5 million for the same quarter in 2021. The current quarter figure includes a $0.9 million non-cash stock-based compensation payment.
Net Loss: Net loss was $5.1 million, or a net loss of $0.02 per basic and diluted share, for the first quarter ended March 31, 2022, compared to $1.7 million, or a net loss of $0.01 per basic and diluted share, for the quarter ended March 31, 2021. The weighted average number of Ordinary Shares outstanding, basic and diluted were 228,090,300 (equal to 11,404,515 American Depository Shares) and 156,751,771 (equal to 7,837,589 American Depository Shares) for the quarters ended March 31, 2022, and March 31, 2021, respectively.
For further details on the company’s financial results for the quarter ended March 31, 2022, refer to the Form 10-Q, which will be filed with the SEC today, May 12, 2022.

Conference Call
Chemomab management will host a conference call for investors today, Thursday, May 12, 2022, beginning at 8:00 a.m. Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by clicking this Webcast link to access the live webcast or replay, or by dialing 877-407-9208 (in the U.S.) or 201-493-6784 (outside the U.S. and in Israel) and entering passcode 13728593. Ask for the Chemomab conference call. The call also will be webcast live on the company’s website at View Source

A replay of the call will be available on the company website for 90 days at www.chemomab.com.