This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
10/31/2024
Good morning and welcome to the Cirrus Pharmaceutical Third Quarter 2024 Financial Results Conference call. At this time, all participants are in a listen-only mode. Note that 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 Hannity, Director of Investor Relations and Corporate Communications at Cirrus. Please go ahead.
Thank you. This morning, we issued a press release announcing our third quarter 2024 financial results. The full 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 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 with us today 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 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. With that, I'd now like to turn the call over to Conley Chee. Conley?
Thank you, Karen. Good morning, everyone, and thank you for joining us. Throughout the third quarter and in recent weeks, we continue to advance our mission to develop and deliver Tamiberitone as a new standard of care for the frontline treatment of newly diagnosed higher risk MDS patients with RARA gene overexpression, which we believe represents approximately 50% of the higher risk population. These are exciting times at Cirrus as we are nearing the pivotal data readout from our ongoing select MDS1 phase three trial in mid-November. This is a significant milestone in our work and one we expect will be transformative for our company. As you know, there remains a tremendous unmet need for higher-risk MDS patients whose disease is often progressive and associated with a poor prognosis. There are very few frontline therapies in late-stage development, and no new treatments beyond hypomethylating agents have been approved in over a decade. The current standard of care, azacitidine, is an HMA that has only demonstrated a 17% complete response rate, leaving significant unmet need. Patients and physicians are seeking new treatment options that can enhance clinical outcomes without compromising safety and tolerability. We believe Tamiberitone has the potential to alter the current treatment paradigm and provide patients with a well-tolerated and convenient therapeutic option that can induce durable response and a better disease control. With approximately 9,000 higher risk MDS patients diagnosed in the U.S. each year, we believe there's a significant commercial opportunity for Tamiberitone. By 2029, with a total market opportunity for higher risk MDS therapeutics in the U.S. will be approximately $1.6 billion. and that the market opportunity for Tamibaratine in the U.S. for patients with RARA overexpression will be over $800 million. As we approach our pivotal data, we are working diligently to prepare for our first MDA filing and to launch Tamibaratine in the U.S. through our own commercial efforts. Once approved, our goal is to move quickly to deliver Tamibaratine to the thousands of higher-risk MDS patients with RARA overexpression awaiting better treatment options. We're really looking forward to announcing our data in the coming weeks. With that, I'll turn it over to David to review our MDS program and upcoming milestones in greater detail. David?
You're reading a preview of the SYRS Q3 2024 earnings call.
Free account.
