Mirati Therapeutics, Inc.

Good afternoon, ladies and gentlemen. Welcome to the Merati Therapeutics Third Quarter 2021 Earnings Call. My name is Keith and I'll be your 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 the star key followed by the number one on your telephone keypad. If you'd like to withdraw your question from the queue, press the pound key. It is my pleasure to introduce Ryan A.C., Vice President of Corporate Affairs at Merati. Ryan, you may begin the call.

Thank you, Keith, and welcome everyone to this afternoon's call. With me today are David Meek, Mirati's Chief Executive Officer, Dr. Chuck Baum, Mirati's President, Founder, and Head of Research and Development, Dr. Jamie Christensen, Mirati's Chief Scientific Officer, and Vicki Reed, Mirati's Chief Accounting Officer. Please note that this conference call will include forward-looking statements. Because those 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 September 30th, 2021, and recent corporate updates. This press release is available on the Investors section of our website at maradi.com. With that, David, I'll turn the call over to you.

Thank you, Ryan. Good afternoon, everyone, and thank you for joining us. On this afternoon's call, I will provide some introductory remarks before asking Chuck to share an update on our clinical development programs, Jamie to comment on our preclinical programs, and Vicki to summarize our financial results. I will then provide an update on our operational plans before taking your questions. It has been a busy and rewarding two months since my announcement as Miradi's CEO. These first few weeks have confirmed my conviction about the near and long-term potential of this company. There is a relentless focus at Mirati on translating novel science into innovative therapies that bring hope to patients. Mirati is differentiated, and we are well on our way to creating a leading biotech company with one of the most exciting and tangible oncology portfolios in biopharma. We continue to make significant progress on advancing our clinical and preclinical stage portfolio and rapidly expanding our capabilities as we prepare for the expected U.S. commercial launch of Adagracib. We believe Adagracib's clinical profile is best in class. In addition to the breakthrough therapy designation we announced in June, we recently submitted the first Adagracib data package as part of the Real-Time Oncology Review Pilot Program, or RTOR, new drug application submission process to the FDA for previously treated non-small cell lung cancer. We are on track to finalize the NDA submission before the end of this year. Our U.S. launch preparation for Atagracid in patients with KRAS G12C mutated advanced non-small cell lung cancer has been well underway, and we look forward to sharing specifics about our launch planning for this potentially transformational therapy next year. To recognize its full potential, we are aggressively evaluating Adagracid in a broad development plan, including in proof of concept phase two trials for first line non-small cell lung cancer, a confirmatory phase three trial randomized to docetaxel in previously treated non-small cell lung cancer, and a registration enabling phase three trial in second line colorectal cancer. Beyond non-small cell lung cancer and colorectal cancer, We are very pleased with the preliminary results we reported in pancreatic cancer and are continuing to assess Adagracib in additional solid tumor settings to potentially help even more patients. To date, our capabilities have enabled us to execute across multiple programs, including Adagracib and Citravaxinib, on our own in key markets while partnering selectively in regions such as China. These capabilities have also enabled development of novel drug combinations. When combined with the strength of our internal research team and novel portfolio of targeted oncology programs, we believe this provides us with the potential for long-term growth and sustainability. The strength, capabilities, and innovative mindset of our employees fuel our success, and I'm grateful for our dedicated and passionate team. I would like to acknowledge and thank them for all they are accomplishing. With that, I'll turn it over to Chuck.