3/15/2022

speaker
Operator
Conference Operator

Good morning, and welcome to Ciros Pharmaceuticals' fourth quarter and full year 2021 financial results conference call. At this time, all participants are in listen-only mode. This call is being webcast live on the Investors and Media section of Ciros' website at www.ciros.com. Please be advised that today's call is being recorded. At this time, I would like to turn the call over to Courtney Solberg, Manager of Corporate Communications and Investor Relations at Ciros.

speaker
Courtney Solberg
Manager, Corporate Communications and Investor Relations

Thank you. This morning we issued a press release with our fourth quarter and full year 2021 financial results, along with anticipated future milestones and recent accomplishments. The release is available on the Investors and Media section of Cirrus' website at www.cirrus.com. We will begin the call with prepared remarks by Dr. Nancy Simonian, our Chief Executive Officer, Dr. David Roth, our Chief Medical Officer, and Jason Haas, our Chief Financial Officer. We will then open the call for questions. Dr. Eric Olson, our Chief Scientific Officer, Kristen Stevens, our Chief Development Officer, and Conley Chee, our Chief Commercial Officer, are also on the call and will be available for Q&A. Before we begin, I would like to remind everyone that statements we make on this call will include forward-looking statements. Actual events or results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties, and other factors, including those set forth in the risk factors section of our annual report on Form 10-K that we filed this morning, and any other filings that we may make with the SEC in the future. In particular, the extent to which the COVID-19 pandemic continues to impact our operations and those of the third parties on which we rely will depend on future developments, which are highly uncertain and cannot be predicted with confidence. Any forward-looking statements made on this call represent our views as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. I would now like to return the call over to Nancy.

speaker
Dr. Nancy Simonian
Chief Executive Officer

Thank you, Courtney. Good morning, everyone, and thank you for joining us today to review our fourth quarter and full year financial results and recent updates. 2021 was a pivotal year for Cirrus, driven by the expertise, commitment, and capabilities of our team at Cirrus. Last year, we initiated three clinical trials and one expansion cohort across our targeted hematology and CDK inhibitor portfolios. including the Select MDS-1 Phase III Trial, our first pivotal study of Tamibaratine in RARA-positive patients with higher-risk MDS, the Select AML-1 Phase II Study of Tamibaratine in RARA-positive patients with AML, a dose confirmation study of SY-2101 in APL patients, and finally, an expansion cohort of SY-5609 in combination with chemotherapy in pancreatic cancer patients. These initiations highlight our advancement towards becoming a fully integrated biopharmaceutical company with a diversified pipeline with the potential to make a profound difference for patients. Additionally, in September, we reported promising clinical data from our phase one dose escalation trial of 5609. our highly selective and potent oral CDK7 inhibitor. Based on the results, as well as mechanistic rationale and preclinical data, we are now planning to evaluate 5609 in three distinct opportunities, pancreatic cancer, BRAF mutant colorectal cancer, and hematologic malignancies. To support the continued progress, as well as advance serous to the next phase of our growth, we appointed two new key leadership team members. In September, we named Conley Chee as our first chief commercial officer, who has been hard at work laying the groundwork to set us up for commercial success. And Jason Haas, appointed as our CFO in October, has been spearheading our financing efforts. Cirrus is looking forward to an exciting year in 2022. with three anticipated data readouts across our clinical portfolio. First, we will be sharing PK and safety data from our dose confirmation trial of 2101 in APL mid-year. Then in the second half of this year, we plan to report clinical activity data from the safety lead-in portions of the select AML1 phase two trial of Tamivirutine and the expansion cohort of 5609 in pancreatic cancer. and these results may unlock important insights into the potential of each of our programs and inform our development strategy moving forward. Additionally, we are looking forward to presenting an e-poster at the AACR meeting in April that shows our oral selective CDK12 inhibitor has potent single-agent activity in vitro and in vivo in multiple cancer models, as well as enhanced anti-tumor effect in combination with DNA damaging agents. These data support our decision to nominate our next development candidate from our CDK12 program, which we expect to do in the second half of this year. This program, as well as our other preclinical oncology programs, CDK11 and WRN, reflect the productivity of our gene control discovery engine. a key driver of our long-term goal to discover and develop highly potent and selective small molecules that target gene regulatory systems. I would now like to turn the call over to David, who will review our ongoing clinical programs. David?

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