Mirati Therapeutics, Inc.

Good afternoon and welcome to the Merati Therapeutics second quarter 2022 earnings call. My name is Danielle and I'll 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 the pound key. It is now my pleasure to introduce Ryan Acy, Vice President of Corporate Affairs at Merati. Ryan, please go ahead.

Thank you, Danielle, and welcome everyone to this afternoon's call. Joining me on the call today are David Meek, Merati's Chief Executive Officer, Dr. Chuck Baum, Merati's President, Founder, and Head of Research and Development, and Lori Stelzer, Merati's Chief Financial Officer. Dr. Jamie Christensen, Merati's Chief Scientific Officer, and Ben Hickey, Merati's Chief Commercial Officer, are 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, factual 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 June 30, 2022, and recent corporate updates. This press release is available on the Investors section of our website at Mirati.com. With that, David, I'll turn the call over to you.

Thank you, Ryan, and good afternoon, everyone. On this Saturday's call, I'll provide an update on key developments since our last earnings call, including steps we are taking to prepare for a potential commercial launch of Adagraphsit this year. Chuck will share an update on our R&D programs, and Lori, our recently appointed CFO, will summarize our financial results. I'll then provide closing remarks before we open the line for questions. So let's get started. The second quarter was a very productive and important one for Mirati, and we have a lot to be excited about. We made significant progress towards achieving a number of important milestones and strategic priorities in the second quarter, including presenting our latest data on Adagrasive at ASCO and building out our commercial capabilities in advance of its launch. At ASCO, we shared several significant Adagrasive updates, and Chuck will touch on the specifics. I'd like to point out a few key takeaways that are worth noting, as we believe there was a lot to be excited about with the data released. At a high level, these results highlight important points of potential differentiation, including CNS penetration and combinability of Atagracid with concurrent Pembrolizumab, and position us very well for both near and long-term commercial success. Our results give us confidence in our ability to secure a U.S. approval and execute a strong commercial launch of Adagraciv in second line and beyond non-small cell lung cancer, which is a key priority for the company. We are very comfortable competing in the KRES G12C inhibitor market, especially in the tablet formulation. Our ongoing interactions with FDA are productive, and we continue to collaborate closely and effectively through the review of the Adagraciv new drug application. We recently had our mid-cycle review, and have added clarity that there will be no advisory committee and no REMS program. The FDA has voiced no major safety issues to date or expectations for new studies prior to approval. As such, we are preparing for the approval of the FDA with a tablet formulation and are finalizing our commercial readiness plans. As a reminder, our PDUFA date is December 14th, but we will be ready to go if approval comes before then. We recently hired the remainder of greater than 100% customer-facing U.S. field force, and believe we have the talent needed to drive a successful commercial launch. In addition, we built out our marketing, market access, patient support, and medical affairs capabilities, and now have in place all the components of a successful commercial organization necessary to execute our commercial strategies. Our commercial team will be fully trained and launch ready in the U.S. by the end of the third quarter, Some of you know I have considerable commercial experience in pharma and biotech, and I can say without hesitation, I'm very impressed with the quality and caliber of the team we have been able to assemble at Mirati. Our commercial strategy is built on several pillars that we believe will enable us to be successful. First, Adagrasib's differentiating molecular profile and 24-hour half-life have enabled us to generate meaningful clinical data, includingly the recently presented greater than 30% overall response rates in non-small cell lung cancer patients with active brain metastases, and the longest-needing overall survival data to date of greater than 14 months in our pooled analysis. Second, we've been able to attract top talent across biotech, pharma, and healthcare provider organizations, giving us a team with extensive lung cancer experience and demonstrated success in launching top oncology products. There are opportunities to increase both testing and identification of KRAS G12C eligible patients. In response, our field teams are working to assist in market development activities to improve both patient access and outcomes. Third, we have purpose-built our commercialization team with a singular focus on adagracive. We have built this team with an optimized design and focus on integration, digitization, and speed of execution across functions. Fourth, we have the capital necessary to invest for success, both in terms of executing on the initial launch as well as investing in the long-term value optimization of this differentiated program. In summary, we're very excited about the potential launch and the opportunity to deliver Adagracib and make a positive impact on patients living with cancer. Beyond the U.S., we completed a submission of Adagracib's marketing authorization application for the treatment of patients with non-small cell lung cancer harboring the KRAS G12C mutation who have received at least one prior systemic therapy to the European Medicines Agency. This submission is an important step in bringing us closer to possibly expanding the availability of Adagracid to patients in the European Union. From a management team perspective, we made an important addition to our leadership team in the second quarter. Laurie Stelter joined Marotti as our CFO. bringing with her an invaluable skill set acquired over her 25-year career in the biopharmaceutical industry, including a wealth of finance expertise and strategic insight. Lori has considerable experience navigating the needs of a company, transitioning from a research and development stage to a commercial stage, which will be beneficial as we prepare for the commercial launch of Adagraphs in the U.S. and finalize our strategy outside of the U.S., We are very fortunate to bring Lori on at this pivotal time in our history. And finally, we continue to be in a strong financial position, which enables us to execute on our strategy and provides us with the flexibility to prudently invest for success across our target oncology pipeline and prepare for a successful adagraphid launch pending FDA approval later this year. With that, I'll turn the call over to Chuck for a clinical update.