Chemomab Therapeutics Ltd.

Greetings and welcome to Chemomab Therapeutics first quarter 2023 earnings call and corporate update. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Barbara Leenheim. Consulting Vice President of Strategic Communications. Thank you. You may begin.

Welcome to the ChemoMap Therapeutics 2023 First Quarter Conference Call. Thank you for attending. I am Barbara Lindheim, Consulting Vice President of Strategic Communications at ChemoMap. With me today are Dale Post, our Chairman and CEO, Don Marvin, CFO, Chief Operating Officer, and Executive Vice President, Dr. Adi Moore, our co-founder and chief scientific officer, and Dr. Matt Frankel, our chief medical officer. Before turning the call over to Dale, please take note of our forward-looking statement. Today's call may contain forward-looking statements which may be identified by words such as may, could, will, expect, intend, plan, and other similar words and expressions. All forward-looking statements made today are based on management's current expectations, assumptions, and beliefs about our business and the environment in which we operate. These statements are subject to risks and uncertainties that could cause our actual results to materially differ from those expressed or implied on today's call. Listeners should not place undue reliance on forward-looking statements and are encouraged to review our earnings press release that we issued this morning together with our SEC filings for more complete discussion of factors that could cause our actual results to differ materially from those expressed or implied in forward-looking statements. You can read a comprehensive list of those factors under the heading risk factors contained in our annual report on Form 10-K together with factors under similar headings in the other reports and materials we file with the SEC. Except as required by federal security laws, ChemoMap does not undertake to publicly update or revise any forward-looking statements subsequent to the date made as a result of new information, future events, changing circumstances, or for any other reason. Let me now turn the call over to Dale.

Welcome to the CUMINVAP conference call covering updates through the first quarter of 2023. I am pleased to report that we have continued to make good progress on multiple fronts since our last investor call. Today, we will review financial results for the first quarter. Please see the press release we issued this morning for details. We will also discuss advances we achieved during the first quarter and note several significant developments that occurred late last year. In January, we reported encouraging top-line results from our CM-101 Phase II liver fibrosis trial in patients with NASH. In this study, CM-101 appeared safe and demonstrated improvement across multiple disease-related fibrotic and inflammatory biomarkers. We believe that the data have been well-received by opinion leaders working in NASH and other fibrotic diseases, as well as by pharma firms with whom we are in ongoing dialogue. Hadee will discuss the liver fibrosis NASH trial results shortly. Importantly, these results are consistent with the encouraging biomarker changes that were observed in two earlier CM-101 clinical trials. These results from these clinical trials and multiple non-clinical studies showing groups of fibroinflammatory markers moving in the same right direction, along with physiological measures too, increase our optimism about the potential for CM-101 as a treatment for fibroinflammatory diseases. Although we don't have immediate plans to pursue additional studies in NASH, we believe that CM101 may have therapeutic potential in NASH as a solo therapy or in combination regimen, and we will continue to assess partnership opportunities in NASH and other indications. Additionally, we believe that these results support the therapeutic potential of CM101 across multiple organs and inflammatory fibrotic diseases. and are especially encouraging in support of the prospects for our two main indications of primary sclerosis and cholangitis, or PSC, and systemic sclerosis, or SSC, two rare diseases that share some of the same fibroinflammatory features as NASH. We're making good progress in advancing our CM101 Phase II clinical program in PSC. We are pleased with the good productivity we have achieved by adding clinical sites and enhancing our patient outreach activities in line with our plans to report top line data from this trial in the second half of next year. We were also pleased late last year when the Independent Drug Monitoring Committee conducted a review of CM1 safety data and cleared us to add the planned 20 milligrams per kilogram dose arm to the PSE trial. We are now enrolling patients in this higher dose cohort. Turning to SSE, earlier this year, we reported that our IND for our Phase 2 trial was cleared by the FDA. We've been working diligently to prepare for the start of this trial, which will be conducted at sites in the U.S., Europe, and Israel. We're on track to open our initial U.S. sites around mid-year. We expect to report data from this trial in the latter part of 2024. We're also supporting our clinical programs with an active schedule of scientific presentations at major medical meetings in the US and Europe. And we anticipate several scientific publications in respective journals in the coming months. These activities aim to build knowledge about and interest in our unique approach to fibro-inflammatory diseases among researchers and opinion leaders. Finally, since our last investor call, we've added two exceptional senior executives. our Chief Medical Officer, Dr. Matt Frankel, and our Vice President of Corporate Development and Strategy, Dr. Mitch Jones. Matt brings us a wealth of global pharma and biotech industry experience across all aspects of clinical development and medical affairs, along with his outstanding track record in helping to bring numerous drugs to market in both rare and chronic diseases. Mitch, who is an MD PhD, has a rich combination of science and business skills, that make him well-qualified to lead the corporate development function at ChemoMed. His academic background in medicine and biomedical research is complemented by an extensive hands-on industry experience as a biotech entrepreneur, strategist, clinical researcher, and dealmaker. Matt and Mitch have already proven to be major contributors to ChemoMed, and we are delighted to have them on board. Let me now turn the call over to Dr. Adee Moore, our co-founder and CSO. Adee?