On May 4, 2022 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the first quarter of 2022 and recent corporate updates (Press release, Mirati, MAY 4, 2022, View Source [SID1234613520]).
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"Mirati continues to make significant progress across our pipeline, as we focus on executing our ambitious goals," said David Meek, chief executive officer, Mirati Therapeutics, Inc. "This includes working toward our first potential commercial launch in the U.S. this year with adagrasib for the treatment of patients with previously-treated KRASG12C-mutated lung cancer and advancing the adagrasib program in earlier lines of therapy and across additional tumors. In addition, we completed enrollment of our Phase 3 trial evaluating sitravatinib in advanced lung cancer, continue to enroll patients in an ongoing Phase 1 study with our MTA cooperative PRMT5 inhibitor, MRTX1719, and continue to advance our novel preclinical programs. These milestones, combined with our strong financial position enable us to continue to invest in the advancement of our broad targeted oncology portfolio and prepare to become a successful commercial stage company."
Pipeline Updates
Adagrasib (Potent and selective KRASG12C inhibitor)
•Announced two oral presentations at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Presentations to include full results from the registration-enabling Phase 2 cohort of the KRYSTAL-1 study evaluating adagrasib in patients with pre-treated non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation and late-breaking data on adagrasib in patients with KRASG12C-mutated NSCLC with active and untreated central nervous system (CNS) metastases.
•Presented preclinical data describing the mechanism of adagrasib CNS penetration at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. These data were simultaneously published in the journal of Clinical Cancer Research, which also included preliminary clinical experience in patients with active, untreated CNS metastases.
Sitravatinib (Potent TAM receptor inhibitor)
•Completed enrollment in the global, registrational Phase 3 SAPPHIRE study evaluating sitravatinib plus nivolumab (OPDIVO)1 in second or third line non-squamous NSCLC. The Company expects to reach the number of events needed to trigger an interim analysis of overall survival in Q4 2022.
MRTX1719 (MTA Cooperative PRMT5 inhibitor)
•Enrolling patients in an ongoing Phase 1 dose escalation cohort of the Company’s investigational MTA-cooperative PRMT5 inhibitor, MRTX1719, with initial clinical data expected in 2023.
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MRTX1133 (Potent and selective KRASG12D inhibitor)
•Presented preclinical results on the pharmacogenomics of the Company’s investigational KRASG12D inhibitor, MRTX1133, at the 2022 AACR (Free AACR Whitepaper) Annual Meeting. The Company plans to file an IND application for this program in the second half of 2022.
MRTX0902 (Potent SOS-1 inhibitor)
•Presented preclinical results on the design and discovery of the Company’s investigational SOS1 inhibitor, MRTX0902, at the 2022 AACR (Free AACR Whitepaper) Annual Meeting. The Company expects to file an IND application for this program in the second half of 2022.
First Quarter 2022 Financial Results
•Ended the first quarter with approximately $1.3 billion in cash, cash equivalents, and short-term investments.
•Research and development expenses for the first quarter of 2022 were $131.0 million, compared to $104.1 million for the same period in 2021. The increase in research and development expenses is primarily due to an increase in salaries and other employee-related expense, which includes an increase in share-based compensation expense, an increase in expense associated with the development of adagrasib, sitravatinib and MRTX1719, an increase in preclinical and early discovery activities, as well as an increase in other research and development costs, offset by a decrease in expense for MRTX1133. The Company recognized research and development-related share-based compensation expenses of $26.3 million during the first quarter of 2022, compared to $14.5 million for the same period in 2021.
•General and administrative expenses for the first quarter of 2022 were $54.0 million, compared to $28.4 million for the same period in 2021. The increase is due to an increase in salaries and other employee-related expenses, which includes an increase in share-based compensation expense, an increase in professional services expense primarily associated with commercial scale up, an increase in insurance, rent and other facilities-related costs. The Company recognized general and administrative-related share-based compensation expenses of $16.6 million in the first quarter of 2022, compared to $10.2 million for the same period in 2021.
•Net loss for the first quarter of 2022 was $188.4 million, or $3.40 per share basic and diluted, compared to a net loss of $135.7 million, or $2.67 per share basic and diluted for the same period in 2021.
Conference Call Information
There will be a conference call on May 4, 2022 at 4:30 p.m. ET/ 1:30 p.m. PT during which company executives will review financial information for the first quarter of 2022 and provide a corporate update.
Investors and the general public are invited to listen to a live webcast of the call at the "Investors and Media" section on Mirati.com or by dialing the U.S. toll free +1 313-209-4906 or international +1 800-406-5356, confirmation code: 6391007.
A replay of the call will be available approximately 2 hours after the event has ended at the same website.