Mirati Therapeutics, Inc.

Good afternoon and welcome to the Mirati Therapeutics fourth quarter 2021 earnings call. My name is Sarah 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 the star key followed by the digit two. It is my pleasure to introduce Ryan Acy, Vice President of Corporate Affairs at Meradi. Ryan, you may begin the call.

Thank you, Sarah. Welcome everyone to this afternoon's call. With me today are David Meek, Meradi's Chief Executive Officer, Dr. Jamie Christensen, Meradi's Chief Scientific Officer, Ben Hickey, Miradi's Chief Commercial Officer, and Vicki Reed, Miradi's Chief Accounting Officer. Unfortunately, due to a last-minute acute stomach flu, Dr. Chuck Baum, Miradi's President, Founder, and Head of Research and Development, will not be able to participate in this afternoon's 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 that is filed with the U.S. Securities and Exchange Commission. This afternoon, we released financial results for the quarter ended December 31, 2021, and recent corporate updates. This press release is available on the Investors section of our website at verati.com. With that, I'll turn the call over to David.

Thank you, Ryan. Good afternoon, everyone, and thank you for joining us. On this afternoon's call, I will provide some initial remarks before asking Jamie to share an update on our clinical development programs, Ben to comment on our commercial preparedness, and Vicki to summarize our financial results. I will then provide a few concluding remarks before taking your questions. 2021 was an important year of growth, progress, and strong execution for Merati. There are many achievements our team accomplished, and I'll highlight just a few of them here. We received breakthrough therapy designation for adagracib for the treatment of previously treated KRAS G12C mutated non-small cell lung cancer. We announced positive top-line monotherapy data from the registrational Phase II cohort of adagracib's CRYSTAL-1 study and completed the submission of the adagracib new drug application in patients with previously treated non-small cell lung cancer under the FDA's real-time oncology review pilot program. We presented highly encouraging colorectal cancer data for adagracib, both as a single agent and in combination with cetuximab in late-line patients. We also shared preliminary results from the combination of adagracib and pembrolizumab in first-line non-small-cell lung cancer, which provided strong support for our continued prioritization of this combination. We initiated several additional potentially registrational studies with adagracib, including as a single agent in certain subpopulations of first-line non-small-cell lung cancer, as well as in combination with cetuximab and second-line colorectal cancer. Beyond that aggressive, we continue to advance and expand our increasingly broad targeted oncology pipeline, including completing the submission of an investigational new drug application for MRTX1719, our NTA cooperative PRMT5 inhibitor. In November, we bolstered our capital position with a secondary public offering, which gives us increased financial strength and flexibility to continue to appropriately invest for success across our pipeline and in preparation for a potential U.S. commercial launch later this year. We continue to build our corporate capabilities. We're a company with strong end-to-end expertise from early discovery through drug development and commercial with strong foundational enabling functions. We're incredibly excited about the transformational year ahead of us. We are well prepared and have the resources to achieve our bold agenda. Important potential milestones in 2022 include gaining FDA approval for Atagracid and rapidly launching our first commercial product to patients with lung cancer in the U.S., which remains our top priority. Adagracib's profile has the potential to make a meaningful difference for patients with lung, colorectal, pancreatic, and other cancers. We remain confident that Adagracib has blockbuster potential. We expect to complete the submission of our European regulatory package for Adagracib based on our Phase II results. With Adagracib's blockbuster potential, we are advancing the broad development plan we have for Adagracib. including exploring earlier lines of therapy and into additional tumors. We are aggressively moving forward the other important value drivers in our broader portfolio. We now have three meaningful programs in clinical development, each with a large commercial opportunity and areas of high unmet need. We're on track to reach the number of events needed to trigger the interim readout of CitraVaccine's Phase III Sapphire Study in the second half of 2022. We initiated a phase one clinical study for MRTX1719, our MTA cooperative PRNT5 program, and expect to submit INDs for MRTX1133, our KRAS G12D inhibitor, and MRTX0902, our SOS1 inhibitor, in the second half of 2022. We have established ambitious goals for ourselves this year. We see significant enthusiasm across all areas of the company, as we continue to execute on these priorities and drive results with a sense of urgency and passion to transform the lives of patients with cancer. I'm excited about our momentum and proud of the company we are building. With that, I'll turn it over to Jamie.