Syros Pharmaceuticals, Inc.

Good morning and welcome to Cirrus Pharmaceuticals first quarter 2024 financial results conference call. At this time, all participants are in a listen only mode. This call is being webcast live on the investors and media section of Cirrus website at www.cirrus.com. Please be advised that today's call is being recorded. At this time, I would like to turn the call over to Karen Unity, Director of Investor Relations and Corporate Communications at Cirrus.

Thank you. This morning, we issued a press release announcing our first quarter 2024 financial results. The full release is available on the Investor and Media section of Cirrus' website at www.cirrus.com. We will begin the call with prepared remarks by Conley Chee, 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. Kristen Stevens, our Chief Development Officer, is also on the call and will be available for Q&A. Before we begin, I would like to remind everyone that the statements we make on this conference call will include forward-looking statements. Actual events or results could differ materially than 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 quarterly report on Form 10-Q that we filed this morning, our annual report on Form 10-K that we filed earlier in the year, and any other filings that we may make with the SEC in the future. Any forward-looking statements represent our views only 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 turn the call over to Conley. Conley?

Thanks, Karen. And thank you, everyone, for joining this morning. 2024 marks an important year for Xerox. We're acutely focused on execution across our clinical development programs and pre-commercial activities as we continue to advance tamiberitine, a potential new standard of care for the frontline treatment of hematologic malignancies. We are very encouraged by recent progress of our programs in higher risk MDS and unfit AML. As David will discuss shortly, our phase three select MDS one trial recently passed a pre-specified interim futility analysis. This is a meaningful milestone for our program. The interim futility analysis was designed to evaluate the primary endpoint of complete response. And as a reminder, we remain blinded to the data that was reviewed by the Independent Data Monitoring Committee. They recommended that our study continue without modification, and while that result was anticipated, this is an important step to pass as we look forward to reporting our pivotal data by mid-Q4 of this year. Also in April, the FDA granted fast-track designation for tamibericaine in combination with venetoclax and azacitidine for the treatment of newly diagnosed unfit AML with RARA overexpression. As you know, fast track designation is granted to compounds that are intended to treat serious conditions and for which non-clinical or clinical data demonstrated the potential to address unmet medical needs. We believe that this designation not only reflects the need for a new therapeutic option in AML, but speaks to the strength of our initial data from select AML1, which we reported at the end of last year. This is the second FDA fast track designation that we received for Tamiviratine. Previously, the FDA granted this designation to Tamiviratine in combination with azacitidine for the treatment of higher risk MDS with rama overexpression. Together, the progress that I described continues to reinforce our confidence and the potential for camiberitine to provide a safe and efficacious therapy for MDS and AML patients with raw, raw overexpression. We look forward to important data readouts ahead, including additional data from our Phase II Select AML-1 trial, expected in the third quarter of this year, and as I mentioned before, pivotal data from our Phase III Select MDS-1 trial, expected by mid-Q4. As we approach these readouts, I'm also really pleased by our progress in advancing our launch readiness activities so we can effectively deliver Tamivaritine to patients in the U.S. following approval. We look forward to sharing details of our launch preparations as we move closer to a potential NDA filing. With that, I'll now turn it over to David to review our programs and upcoming milestones in more detail. David?