11/8/2022

speaker
Jenny
Operator

Good afternoon and welcome to the Mirati Therapeutics third quarter 2022 earnings call. My name is Jenny and I will be the operator for today's call. All lines have been placed on mute to prevent any background noise. After the conclusion of the speaker's prepared remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. We ask that you please limit yourself to one question and one related follow-up. If you'd like to withdraw your question, please press star followed by the number two key. It is my pleasure to introduce Ryan Assi, Vice President of Corporate Affairs at Merati. Ryan, you may begin the call.

speaker
Ryan Assi
Vice President of Corporate Affairs

Thank you, Jenny. Welcome, everyone, to this afternoon's call. Joining me on the call today are David Meek, our Chief Executive Officer, Dr. Chuck Baum, our President, Founder, and Head of Research and Development, Dr. Jamie Christensen, our Chief Scientific Officer, Ben Hickey, our Chief Commercial Officer, and Laurie Stelzer, our Chief Financial Officer. We're also joined by our recently appointed Chief Medical Officer, Dr. Alan Sandler. Before we begin, I'd like to inform you that certain statements we make during this call will be forward-looking. Because such statements deal with future events and are subject to many risks and uncertainties, actual results may differ maturely from those in the forward-looking statements. For a full discussion of these risks and uncertainties, please review our annual report on Form 10-K and our quarterly reports on Form 10-Q that are filed with the U.S. Securities and Exchange Commission. This afternoon, we released financial results for the quarter ended September 30th, 2022, and recent corporate updates. This press release is available on the investor section of our website at marati.com. With that, David, I'll turn the call over to you.

speaker
David Meek
Chief Executive Officer

Thanks, Ryan, and thank you for joining us on the call today. The third quarter was another productive one for Marati. as a team made important progress advancing our strategic initiatives. As a result, we are on the brink of realizing what could be transformative catalysts over the next several months. First, our PDUFA date for Adagracib is December 14th, and we're excited by the prospect that people living with non-small cell lung cancer could soon have the opportunity to receive Adagracib. We believe we've made a thorough and compelling application for U.S. approval and our interactions with the agency continue to be very constructive. Second, in first-line non-small-cell lung cancer, we expect to share updates and direction across our multi-pronged development approach this quarter. This will include more data on the concurrent dosing of adagracib at 400 milligrams twice daily with full-dose pembrolizumab, which is our most advanced adagracib combination approach in the first-line setting. Third, We're on track to top-line the interim readout of the Citruvacidib Phase III Sapphire Study by the end of the year. Fourth, we've made significant progress advancing MRTX1133, our KRAS G12D inhibitor, and plan to file an IND later this quarter. Jamie will say more about the 1133 program in his commentary. With that, I'll turn the call over to Ben to provide an update on our launch readiness and commercial organization.

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