On February 25, 2021 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a late-stage targeted oncology company,reported financial results for the fourth quarter and full year of 2020, which reflect the company’s progress across its clinical and discovery pipeline and strength as it expands its operational structure and capabilities in preparation for potential commercialization in the United States (Press release, Mirati, FEB 25, 2021, View Source [SID1234575669]).

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"Our commitment to patients with cancer has enabled us to advance our two clinical programs, adagrasib and sitravatinib, as well as our preclinical pipeline. These preclinical programs include MRTX1133, a potentially first-in-class KRAS G12D selective inhibitor and a first-in-class synthetic lethal PRMT5 inhibitor," said Charles M. Baum, M.D., Ph.D., president and chief executive officer, Mirati Therapeutics, Inc. "We have added significant new talent and capabilities across the organization which combined with our financial resources will allow us to accelerate and expand development across our pipeline."

Corporate Updates:

Announced a strategic research and development collaboration with MD Anderson Cancer Center to expand the clinical and preclinical evaluation of Mirati’s two investigational small molecule, potent and selective KRAS inhibitors, adagrasib, a G12C inhibitor, and MRTX1133, a G12D inhibitor, each as monotherapy and in combination with other agents. (View Release)
Entered into McKesson’s MYLUNG consortium ("Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Consortium"), a collaborative research endeavor to deepen understanding of molecular testing barriers, improve care for patients with lung cancer, and expand the opportunity for patients to participate in clinical trials. (View Release)
Ended the fourth quarter with approximately $1.4 billion in cash, cash equivalents, and short-term investments.
Adagrasib:

Initiated KRYSTAL-7 (849-007), a Phase 2 clinical trial of adagrasib in combination with pembrolizumab (KEYTRUDA)1 in 1st line non-small cell lung cancer (NSCLC).
Initiated an additional Phase 2 cohort of the KRYSTAL-1 (849-001) in patients with KRAS G12C and the STK11 co-mutation in 1st line NSCLC.
Initiated KRYSTAL-12 (849-012), a Phase 3 clinical trial of monotherapy adagrasib versus docetaxel in 2nd line NSCLC.
Plan to initiate by Q2 2021 KRYSTAL-10 (849-010), a Phase 3 clinical trial of adagrasib in combination with cetuximab (ERBITUX)2 in 2nd line colorectal cancer.
1KEYTRUDA is a registered trademark of Merck
2ERBITUX is a registered trademark of Eli Lilly and Company in the U.S. and Merck KGaA outside the U.S.

Preclinical Updates:

Advanced a first-in-class PRMT5 inhibitor, leveraging a synthetic lethal strategy in MTAP-deleted cancers. This agent specifically inhibits the PRMT5 enzyme in the presence of methylthioadenosine (MTA), a nucleoside cofactor, which is uniquely elevated in cancers exhibiting the most commonly observed gene deletion event (MTAP/CDKN2A) across human cancers. Because PRMT5 is critical to the survival of normal human cells, the ability to specifically target the PRMT5/MTA complex in MTAP-deleted cancer cells while sparing normal human cells is expected to offer a wide therapeutic index compared with conventional first generation PRMT5 or MAT2A inhibitors.
Financial Results for the Fourth Quarter 2020

License and collaboration revenues for the three months ended December 31, 2020, were $1.7 million, and relate to the manufacturing supply services agreement with BeiGene. License and collaboration revenues for the twelve months ended December 31, 2020 were $13.4 million, of which $11.4 million related to a license agreement with ORIC Pharmaceuticals, Inc. and $2.0 million related to the manufacturing supply services agreement with BeiGene. License and collaboration revenues for the three and twelve months ended December 31, 2019 were $0.5 million and $3.3 million, respectively, and relate to the manufacturing supply services agreement with BeiGene.
Research and development expenses for the fourth quarter of 2020 were $82.7 million, compared to $62.9 million for the same period in 2019. Research and development expenses for the year ended December 31, 2020 were $299.3 million, compared to $182.9 million for the same period in 2019. The increase in research and development expenses is due to an increase in expense associated with the development of adagrasib, MRTX1133, and other preclinical and early discovery activities, as well as an increase in salaries and related expense, including an increase in share-based compensation expense. The Company recognized research and development-related share-based compensation expenses of $12.2 million during the fourth quarter of 2020, compared to $10.6 million for the same period in 2019, and $48.0 million during the year ended December 31, 2020, compared to $31.0 million for the same period in 2019.
General and administrative expenses for the fourth quarter of 2020 were $25.3 million, compared to $12.2 million for the same period in 2019. General and administrative expenses for the year ended December 31, 2020 were $83.4 million, compared to $42.6 million for the same period in 2019. The increase is due primarily to an increase in share-based compensation expense and an increase in employee-related expenses and professional service expense. The Company recognized general and administrative-related share-based compensation expenses of $9.6 million during the fourth quarter of 2020, compared to $6.1 million for the same period in 2019, and $37.8 million during the year ended December 31, 2020, compared to $24.5 million for the same period in 2019.
Net loss for the fourth quarter of 2020 was $101.1 million, or $2.08 per share basic and diluted, compared to net loss of $72.4 million, or $1.83 per share basic and diluted for the same period in 2019. Net loss for the year ended December 31, 2020 was $357.9 million, or $7.96 per share basic and diluted, compared to net loss of $213.3 million, or $5.69 per share basic and diluted for the same period in 2019.
Cash, cash equivalents, and short-term investments were $1.4 billion at December 31, 2020.