3/2/2023

speaker
Operator
Operator

Good morning and welcome to CIROS Pharmaceuticals' fourth quarter and full year 2022 Financial Sales Conference call. At this time, all participants are in this synonym mode. This call is being webcast live on the Investors and Media section of CIROS' website at www.ciros.com. Please advise that today's call is being recorded. At this time, I would like to turn the call over to Karen Hunery, Director of Investor Relations and Corporate Communications at CIROS.

speaker
Karen Hunery
Director of Investor Relations and Corporate Communications

Thank you. This morning, we issued a press release announcing our fourth quarter and full year 2022 financial results. The full release is available on the Investors and Media section of the CIROS website at www.ciros.com. We will begin the call with prepared remarks by Dr. Nancy Simonian, our Chief Executive Officer, Dr. David Ross, our Chief Medical Officer, and Jason Haas, our Chief Financial Officer. We will then open the call up for questions. Christian Stevens, our Chief Development Officer, Dr. Eric Olson, our Chief Scientific 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 the statements we make on this conference call will include forward-looking statements. Actual events or results may 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 filing 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. 2022 marked a meaningful year for Cirrus. in which we made important advances towards our pursuit to deliver new standards of care for the frontline treatment of hematologic malignancies. Today, we are focused on our late-stage programs in MDS, AML, and APL, three diseases in which there is significant need for more convenient and well-tolerated treatment options that improve clinical outcomes while still maintaining patients' quality of life. We believe that MDS, AML, and APL markets are attractive with business synergies that we plan to address through our own commercial efforts in the U.S. Over the past year, we reached important milestones in our heme programs. In December, we announced positive data from the safety lead-in portion of the Select AML-1 study, enabling us to move into the randomized portion of our Phase II study this quarter. In August, we announced promising preliminary data from our dose confirmation study of SY-2101, which, if additional data are supportive, we believe could enable an efficient go-to-market strategy. We continued progressing the ongoing Select MDS-1 pivotal trial And in recent months, we've seen momentum in site activation and enrollment across our global sites. And in January, we were delighted to receive FDA fast track designation for Tamiberitone for the treatment of higher risk MDS, underscoring the critical need for new treatment options for this patient population. I am also pleased to announce that in December we extended our collaboration with Global Blood Therapeutics for another year with the term now scheduled to end in December 2023. In addition, we strengthened our balance sheet and extended our cash runway into the second quarter of 2025 with a successful close of our September 2022 financing in which we secured approximately $190 million in capital. Importantly, we believe these proceeds are sufficient to fund our cash requirements past phase three data from the Select MDS-1 trial and data from the randomized portion of the Select AML-1 trial, while also allowing us to begin investing in pre-commercial activities important in bringing our therapies to market. Together, these accomplishments provide a tremendous foundation as we look ahead and prepare for multiple upcoming catalysts. Specifically, we expect to complete enrollment in the Select MDS-1 Phase III trial in the fourth quarter of 2023 and to announce pivotal data in the third quarter of 2024, share initial data from the randomized portion of the Select AML-1 trial in the fourth quarter of 2023, followed by additional data in 2024. and share an update on the dose confirmation study of 2101 and APL and next steps on a registration pathway in the second half of 2023. I would now like to turn the call over to David to provide a more detailed update on our ongoing clinical programs. David?

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