5/10/2023

speaker
Operator
Conference Operator

to Cirrus Pharmaceuticals' first quarter 2023 financial results conference call. 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 Hunity, Director of Investor Relations and Corporate Communications at Cirrus.

speaker
Karen Hunity
Director of Investor Relations and Corporate Communications

Thank you. This morning, we issued a press release announcing our first quarter 2023 financial results and business updates. The full release is available on the investor and media sections 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. Kristen Stevens, our Chief Development Officer, Dr. Eric Olson, our Chief Scientific Officer, and Kylie 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 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, and our quarterly report on Form 10-Q 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. I would now like to turn the call over to Nancy.

speaker
Dr. Nancy Simonian
Chief Executive Officer

Thank you, Karen. Good morning, everyone, and thank you for joining us today. 2023 is off to a strong start as we focus on clinical execution and move closer to our goal of delivering new standards of care for the frontline treatment of hematologic malignancies. Today, we will be sharing progress with you across our programs in MDS, AML, and APL. We are excited about our continued progress on enrollment in our Select MDS-1 trial, and we remain on track to complete enrollment of the 190 patients in the fourth quarter of this year and to announce pivotal complete response data from Select MDS-1 trial in the third quarter of 2024. We recently amended the protocol for the Select MDS-1 trial to include overall survival as a key secondary endpoint. The primary endpoint of the trial remains complete response in 190 patients. By including overall survival as a key secondary endpoint, we have the potential to convert an accelerated approval based on CR to a full approval based on OS, if warranted, using an efficient one trial design. Importantly, this amendment does not impact the timing of our pivotal CR data from select MDS1. David will provide additional details on the amended protocol shortly. Turning to our efforts in AML, following promising data from the safety lead-in, we initiated the randomized portion of the Phase 2 trial last quarter. We continue to expect initial data from this trial in the fourth quarter of this year, followed by additional data in 2024. We also remain on track to provide an update on the dose confirmation study of 2101 in APL as well as the next steps on a registration pathway in the second half of this year. Taken together, these upcoming milestones lay the groundwork for multiple catalysts over the upcoming 12 to 18 months in which we will progress in turnover cards on each of our lead programs and move closer to our ultimate goal of delivering effective, well tolerated, and convenient therapies to targeted patient populations in need of better options. We believe MDS, AML, and APL each represent significant market opportunities in the frontline setting, which we are well positioned to address through our own commercial efforts in the United States. With that, I'd like to turn the call over to David to provide a more detailed update on our ongoing clinical programs.

Disclaimer

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