On August 3, 2022 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the second quarter of 2022 and recent corporate updates (Press release, Mirati, AUG 3, 2022, View Source [SID1234617383]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Mirati continues to advance the development of a broad portfolio of targeted oncology medicines," said David Meek, chief executive officer, Mirati Therapeutics, Inc. "We are progressing toward the potential launch of adagrasib for patients with previously treated non-small cell lung cancer harboring a KRASG12C mutation in the U.S. this year. In addition, we have submitted a Marketing Authorization Application to the European Medicines Agency, bringing us one step closer to expanding the potential availability of adagrasib in the European Union. We continue to progress our sitravatinib and MRTX0902 clinical programs, which strengthen our targeted oncology portfolio. Our financial position remains strong, enabling continued investment and advancement of our extensive oncology pipeline."

Pipeline Updates

Adagrasib (Potent and selective KRASG12C inhibitor)

Presented full results from the registration-enabling Phase 2 cohort of the KRYSTAL-1 study evaluating adagrasib in patients with previously treated non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. These results were published concurrently in the New England Journal of Medicine. (View Release)
Presented late-breaking data on adagrasib in patients with KRASG12C-mutated NSCLC with active and untreated central nervous system (CNS) metastases at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. (View Release)
Submitted a Marketing Authorization Application to the European Medicines Agency for adagrasib for the treatment of patients with previously treated NSCLC harboring a KRASG12C mutation. (View Release)
Sitravatinib (Potent TAM receptor inhibitor)

Anticipated to achieve the number of events needed to trigger an interim analysis of overall survival in the global, registrational Phase 3 SAPPHIRE study evaluating sitravatinib plus nivolumab (OPDIVO)1 in second or third line non-squamous NSCLC in the fourth quarter of 2022.
MRTX0902 (Potent SOS1 inhibitor)

Submitted an Investigational New Drug (IND) application to the U.S. FDA to evaluate MRTX0902, a selective SOS1 inhibitor, which shifts KRAS into its inactivated state resulting in significantly increased activity of adagrasib and other KRAS inhibitors in preclinical models and may improve clinical efficacy of adagrasib in patients with KRAS G12C mutations. The Company expects to initiate a Phase 1/2 clinical study by year-end 2022.
Recent Corporate Updates

Announced the appointment of Laurie Stelzer as Chief Financial Officer. (View Release)
Second Quarter 2022 Financial Results

Cash, cash equivalents, and short-term investments of approximately $1.2 billion as of June 30, 2022
Research and development expenses for the second quarter 2022 were $128.3 million, compared to $134.6 million for the same period in 2021. The decrease was primarily related to a decrease in manufacturing costs that occurred after our 2021 NDA filing for the adagrasib program, offset by increases in headcount-related costs, including share-based compensation, due to increased headcount associated with the growth of our portfolio. Research and development expenses for the six months ended June 30, 2022 were $259.3 million, compared to $238.6 million for the same period in 2021. The increase was primarily related to increases in headcount-related costs, including share-based compensation, due to increased headcount associated with the growth of our portfolio, offset by a decrease in manufacturing costs that occurred after our 2021 NDA filing for the adagrasib program. The Company recognized research and development-related share-based compensation expenses of $22.8 million during the second quarter of 2022, compared to $16.5 million for the same period in 2021, and $49.1 million during the six months ended June 30, 2022, compared to $31.0 million for the same period in 2021.
General and administrative expenses for the second quarter of 2022 were $54.2 million, compared to $29.6 million for the same period in 2021. General and administrative expenses for the six months ended June 30, 2022 were $108.2 million, compared to $58.0 million for the same period in 2021. The increases were primarily due to an increase in commercial readiness costs, including increases in headcount-related costs, as we prepare for a potential product launch. The Company recognized general and administrative-related share-based compensation expenses of $15.9 million in the second quarter of 2022, compared to $11.5 million for the same period in 2021, and $32.5 million during the six months ended June 30, 2022, compared to $21.7 million for the same period in 2021.
Net loss for the second quarter of 2022 was $176.4 million, or $3.18 per share basic and diluted, compared to a net loss of $166.4 million, or $3.23 per share basic and diluted for the same period in 2021. Net loss for the six months ended June 30, 2022 was $364.8 million, or $6.57 per share basic and diluted, compared to a net loss of $302.1 million, or $5.91 per share basic and diluted for the same period in 2021.
Conference Call Information

There will be a conference call on August 3, 2022 at 4:30 p.m. ET / 1:30 p.m. PT during which company executives will review financial information for the second quarter of 2022 and provide corporate updates.

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 +1 877-502-9276, confirmation code: 1791105.

A replay of the call will be available approximately 2 hours after the event has ended at the same website.