Mirati Therapeutics, Inc.

Good afternoon and welcome to the Merati Therapeutic first quarter 2022 earnings call. My name is Kevin 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. If you would like to withdraw your question, press star followed by the number two. It is my pleasure to introduce Ryan AC, Vice President of Corporate Affairs at Merati. Ryan, you may begin the call.

Thank you, Kevin. Welcome everyone to this afternoon's call. Joining me on the call today from a couple of different locations are David Meek, Merati's Chief Executive Officer, Dr. Chuck Baum, Merati's President, Founder, and Head of Research and Development, Dr. Jamie Christensen, Merati's Chief Scientific Officer, and Vicki Reed, Merati's Chief Accounting Officer. Ben Hickey, Merati's Chief Commercial Officer, is also with us and will be available for the Q&A portion of the call. Please note that this conference call will include forward-looking statements. Because such statements deal with future events and are subject to many risks and uncertainties, actual results may differ materially 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 March 31, 2022, and recent corporate updates. This press release is available on the investor section of our website at Mirati.com. With that, David, I'll turn the call over to you. Thank you, Ryan.

Good afternoon, and thank you for joining us today. On this afternoon's call, I will provide initial remarks before turning to Chuck to share an update on our clinical development programs, to Jamie to comment on our preclinical portfolio, and Vicki to summarize our first quarter financial results. I will then provide a few concluding remarks before taking your questions. 2022 is a critical and transformational year for Mirati, and in the first quarter, we made significant progress on the ambitious goals we established for ourselves. We continue to execute well across our portfolio, and there continues to be significant enthusiasm across all areas of the company for the work we are doing. The progress we are making and the life-changing impact we are having on patients living with cancer. We are pleased that our first new drug application is under review with the FDA. The FDA is reviewing our NDA for Adagracib as a treatment for patients with previously treated non-small cell lung cancer who harbor a KRAS G12C mutation for accelerated approval under the FDA's real-time oncology review pilot program. We remain confident in the approvability of the NDA and will be fully launch ready in the third quarter. Securing a U.S. approval and executing a commercial launch of Adagracid in the second line non-small cell lung cancer setting is a key priority for the company. But it is also just the beginning of the full potential of where we believe this investigational product can help patients. With Adagracid, we're advancing a broad development plan beyond previously treated non-small cell lung cancer is both a single agent and in combination with other therapies including in earlier lines of therapy and across a number of solid tumors. This includes the work we are doing in first-line non-small cell lung cancer in combination with pembrolizumab and in a broad range of other tumors, such as colorectal and pancreatic cancers, where we have previously presented compelling early results. In addition to adagracin, we continue to advance and expand our broad target oncology pipeline. For citravacinib, We recently completed enrollment in the phase three SAFIRE registration trial and expect to reach the number of events needed to trigger an interim analysis for overall survival in the fourth quarter of 2022. If positive, citrinacin would be a highly synergistic commercial opportunity without aggressive. As a reminder, in the US and Europe, there are over 100,000 patients with second or third line non-small cell lung cancer who derived prior clinical benefit following treatment with a checkpoint inhibitor and approximately 70,000 of these patients are of the non-squamous histology. MRTX1719, our MTA cooperative PRMT5 program is enrolling patients in an ongoing phase one, two clinical trial with proof of concept clinical data expected next year. Our earlier stage target oncology pipeline, including MRTX1133, our KRESG12 inhibitor, and MRTX0902, our SOS1 inhibitor, continue to advance toward investigational new drug applications in the second half of 2022. We have a tremendously productive in-house discovery capability that continues to discover and advance novel mechanisms and put us in a position to have as many as five unique yet synergistic programs in terms of the clinical execution and future commercial call points in clinical development in the next 12 months. We continue to be in a strong financial position to execute on our strategy, which provides us with the flexibility to invest for success across our target oncology pipeline and in preparation for a successful and aggressive launch pending potential FDA approval later this year. As we grow and advance our pipeline, We are continuing to strengthen our capabilities to better enable us to achieve our objectives. With that, I'll turn the call over to Chuck.