3/27/2024

speaker
Operator
Conference Operator

quarter and full year 2023 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 Hunadi, Director of Investor Relations and Corporate Communications at Cirrus.

speaker
Karen Hunadi
Director of Investor Relations and Corporate Communications

Thank you. This morning, we issued a press release announcing our fourth quarter and full year 2023 financial results. The full release is available on the investor and media section of the Cirrus's 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 here 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 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. 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. With that, I would now like to turn the call over to Conley. Conley?

speaker
Conley Chee
Chief Executive Officer

Thank you, Karen. Good morning, everyone, and thank you for joining us. Late last year, we announced the initial data from our Select AML-1 trial, and since then, we've continued to make great progress in our effort to become a commercial-stage biotech company. Following our initial AML data, we completed an equity financing of approximately $45 million, reinforcing our cash position and providing us ample resources as we enter into 2024. This year will be a critical one in our evolution, with expected pivotal data from our Select MDS-1 trial, as well as additional randomized data from our Select AML-1 trial. And we're excited to share with you that we've completed enrollment of the 190 patients necessary for our primary endpoint analysis in our Select MDS-1 Phase 3 trial. And we remain on track to report pivotal CR data by the middle of Q4 this year. If successful, these data will allow us to file our first MDA and ultimately to deliver Tamiberitone to the approximately 50% of higher risk MDS patients with RARA overexpression in need of better options. Just as a reminder, our strategy is to launch Tamiberitone in the US with our own specialty sales force. And we continue to make great progress against our launch plan. We look forward to sharing more details on our commercial plan as we get closer to our pivotal data readout. As we've discussed previously, we believe Tamibaratine has the potential to bring about a transformational change for these patients by offering a unique and targeted new standard of care for the frontline treatment of hematologic malignancies. Our growing body of evidence indicates that Tamibaratine consistently produces impressive response rates with a rapid time to response, and it's generally well tolerated. We're excited to push forward with our program, and we'll be sure to keep you up to date as we progress throughout the year. With that, I now turn the call over to David to review our programs and upcoming milestones in more detail. David?

Disclaimer

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