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3/1/2023
Good afternoon and welcome to the Merati Therapeutics fourth quarter 2022 earnings call. My name is Cynthia 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 followed by the number two on your telephone keypad. It is my pleasure to introduce Ryan Acy, Vice President of Corporate Affairs at Merati. Ryan, you may begin the call.
Thank you, Cynthia, and 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. Alan Sandler, our Chief Medical Officer, Dr. Jamie Christensen, our Chief Scientific Officer, Ben Hickey, our Chief Commercial Officer, Lori Stelzer, our Chief Financial Officer. Before we begin, I would 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 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 fourth quarter and full year ended December 31, 2022, and recent corporate updates This press release is available on the investor section of our website at maradi.com. With that, Dave, I'll turn the call over to you.
Thank you, Ryan, and thank you for joining us on the call today. 2022 was a transformational year for Maradi, and I'm pleased to report we received our first approval and launched our first commercial product, Kruzaki, and KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer. We deployed our highly experienced lung cancer commercial field force, and made significant progress advancing our differentiated pipeline of targeted oncology products. Our team launched Cresati in mid-December, and while it is still in the early weeks, we are encouraged with Cresati's initial reception and its broader commercial potential. The initial launch feedback from clinicians, patients, and payers reinforces our belief that Cresati is the best-in-class KRAS G12C inhibitor, addressing a multibillion-dollar market opportunity across multiple lines of therapy and tumor types, both as a monotherapy as well as in combinations. Additionally, our broad and differentiated clinical pipeline has the potential to address unmet medical need for hundreds of thousands of people living with cancer as we endeavor to develop differentiated products that will play an important role in their care. As I step back and look at our products, capabilities, and people, It's clear we are well-positioned to achieve near-term success and to drive long-term growth. Mirati is focused on creating best-in-class small molecules for the treatment of cancers, with a current focus on being a leader across KRAS-mutated cancers. Our highly productive innovation engine has enabled us to develop KRAS and KRAS-enabling therapies to treat a broad range of patients. We expect to dose our first patient with MRTX1133 our KRAS G12D inhibitor, in the first quarter. Moreover, our other earlier stage clinical programs, including our MCA cooperative PRMT5 inhibitor and our KRAS-enabling SOS1 inhibitor, show tremendous progress. Furthermore, we have a potentially transformational opportunity on the horizon with citravacidib and lung cancer in combination with PD-1. We believe this pipeline has vast potential to create significant value for our shareholders. Alongside the development of these programs, we have built a scalable and synergistic commercial organization, particularly in lung cancer. At present, our U.S. commercial team is exclusively focused on launching Cresati. Furthermore, Mirani remains disciplined in how we deploy and invest our capital. We continue to focus on the combination of clinical data analysis and the corresponding commercial opportunity to drive our investment decisions. Looking back, 2022 was a year of remarkable execution and major achievements for Mirati. Key clinical highlights include accelerator approval for Grisotti in the U.S. and second line and beyond KRAS G12C mutated non-small cell lung cancer. Best-in-class intracranial response rates without aggressive in patients with active and untreated CNS metastases. Differentiated clinical data demonstrating idegressive plus PD-1 combination is safe and tolerable with promising early signs of efficacy. Broader potential in third-line and beyond colorectal cancer indication for the combination of idegressive and cetuximab. An investigational new drug application for MRTX1133, our first-in-class oral KRES-G12D selective inhibitor. Advancement of MRTX1719, our MTA cooperative PRMT5 precision medicine for people with an MTAP-deleted tumor, and MRTX0902, our potential first-in-class SOS1 KRS signaling modifier program into clinical trials. Looking ahead, 2023 is a year with several important upcoming catalysts and ambitious goals, which we will detail on today's call. We'll start with an overview of the Corsati launch, which is off to a strong start. I'll now turn the call over to Ben, who will provide you with an update on our early commercial experience. Ben?
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