Chemomab Therapeutics Ltd.

Greetings. Welcome to ChemoMap fourth quarter and full year 2021 earnings call. At this time, all participants are in a listen-only mode. A 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. Please note this conference is being recorded. I will now turn the conference over to Barbara Lindholm, Vice President of Investor Relations. Thank you. You may begin.

Welcome to the Chemomab Therapeutics 2021 Fourth Quarter and Full Year Results Conference Call. Thank you for attending. I am Barbara Lindheim, Consulting Vice President of Communications at Chemomab. With me today are Dale Post, our Chairman and CEO, Don Marvin, CFO, Chief Operating Officer, and Executive Vice President, Dr. David Wiener, Chemomab Interim Chief Medical Officer, and Dr. Adi Moore, our co-founder and chief scientific officer. Before I turn the call over to Gail, 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 a 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, QMMAB 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. Dale.

Welcome to the first QMMAB quarterly conference call covering 2021 fourth quarter and full year. along with an update on our planned activities for 2022. I came on board as CEO this past September after a careful review of the company's science. I was impressed by the clinical and commercial potential of CM101, our pipeline and the product, focusing on indications of the confluence of inflammation and fibrogenesis, an area of great unmet medical need. Also, by the rigorous translational and preclinical science produced by our co-founder and CSO, Dr. Adee Moore and her team. Our lead clinical candidate, CM101, is a monoclonal antibody that neutralizes CCL24, a unique target that has been validated in 11 preclinical model systems. CM101 has demonstrated good safety in pharmacokinetics and pharmacodynamics in two phase one studies in both healthy volunteers and patients, which further supports our belief that CM101 has first-in-class potential in the two rare disease indications of primary sclerosing cholangitis, or PSC, and systemic sclerosis, SSC, as well as in additional clinical indications. I'm excited to be ChemoMab's CEO and now also chairman. I believe the company has a very bright future, and I look forward to sharing this progress with you. First, an overview of our progress in 2021, which was an eventful year for ChemoMab. Key accomplishments included In February, we announced positive results from a Phase 1b trial in patients with non-alcoholic fatty liver disease, reporting that CM-101 was observed to be safe and well-tolerated upon multiple administrations, with evidence for dose-dependent target engagement and positive changes in fibrotic biomarkers. In March, Chemumab completed a merger transaction, listed its ADRs on NASDAQ, and closed a $45.5 million pipe. As part of the merger and public listing, Chemomab expanded its board of directors, adding industry-savvy directors with business and clinical development expertise. In April, we dosed the first patient in our CM-101 Phase II liver fibrosis biomarker and subcutaneous formulation study. In June, the company expanded its partnership with AGC Biologics for final optimization and production of GMP manufacturing batches of CM-101, a partnership that continues to go well. In September, we announced a collaboration with researchers at Leeds University to further elucidate the role of CM101's target, CCL24, in the vascular damage associated with systemic sclerosis. In November, Don Marvin joined as Chief Financial Officer, Executive Vice President, and Chief Operating Officer. Don and I have worked together in the past, and I can attest to the tremendous strategic and operating expertise he brings to KimaMEM. In December, we received approval from the FDA for our first US IND aimed at expanding clinical activities in our PSC Phase II trial. We were also fortunate to have had Dr. David Wiener join us as interim CMO in December. Dave is an accomplished biotech senior executive who is exceedingly well versed in the design, implementation, and interpretation of large and small molecule clinical development programs. And at the start of the new year, he was joined by Jack Lawler, our VP of Global Clinical Development Operations, who also brings us a wealth of practical clinical development execution experience. We've recently undertaken a review of our CM101 clinical programs, bringing fresh perspectives to an assessment of the company's strategic aims and how best to achieve them. This review was based on several important developments, including the onboarding of our expanded senior management team, recent feedback from key global regulatory authorities, COVID's continuing impact on clinical trial recruitment and development timelines, and the challenging financial markets for newly public small-cap biotechnology companies. Our aim is to optimize the clinical development of CM101 by decreasing overall risk in the clinical program. maximizing the clinical information obtained to facilitate decision-making, generating critical data to support advancement to registrational trials, and optimizing the overall clinical development plan for CM-101 in systemic sclerosis and PSC, as well as potentially in additional indications where the scientific rationale is strong. In short, we want to achieve biological and pharmacological validation for CM-101 sooner and prepare to advance to registrational trials quickly and efficiently. I'm going to come back to these aims in a few minutes. The reviewers who included our research and clinical teams and our clinically knowledgeable QMMAB directors have recommended important modifications to the current clinical programs for CM101. We believe this is good news and we're excited to share it with you today. I'll first give a brief overview and then Dave will expand on a few major points. There are three keystone improvements. One, expanding our commitment to PSC with an enlarged clinical trial that adds an important dose finding component. Two, focusing on our systemic sclerosis clinical efforts on establishing earlier biological and clinical proof of concept for CM-101 in this indication. winding down enrollment in our safety PK and biomarker liver fibrosis study with final clinical readouts expected near the end of this year. One benefit of these revisions is that they will provide more clinical data readouts over the next 24 months. We anticipate three to four clinical readouts compared to the two previously planned. And importantly, they are designed to achieve the aims I outlined, more rapidly generating informative data It will help drive the next steps in clinical programs while decreasing our capital requirements, and we estimate extending our cash runway by about six months through the end of 2023. We intend to provide significant more detail about the revised clinical program in the next few months, likely around the first quarter 2022 earnings call in May. I will now turn the call over to Dr. David Weiner, who will provide more background on the clinical rationale for the changes. Dave?