On February 28, 2019 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the fourth quarter and full-year ended December 31, 2018 (Press release, Mirati, FEB 28, 2019, View Source [SID1234533854]).
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"Mirati made great progress in 2018 with significant advances in our sitravatinib and KRAS (MRTX849) programs. We remain focused on both programs as we anticipate enrolling second-line NSCLC patients in our Phase 3 randomized trial with sitravatinib in combination with nivolumab in the first half of 2019. We look forward to seeing data from our collaboration with BeiGene, with initial proof of concept data from the clinical trials studying sitravatinib in combination with tislelizumab, in certain tumor types, expected in the second half of 2019. We’re also excited to see MRTX849 advance in the Phase 1/2 trial toward initial clinical efficacy data this year," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. "We are well funded to execute our plans following a successful financing in January and look forward to a pivotal year for Mirati."
Financial Results for the Fourth Quarter and Full Year 2018
Cash, cash equivalents, and short-term investments were $222.8 million at December 31, 2018, compared to $150.8 million at December 31, 2017. In January 2019, we completed a public equity offering with net proceeds of $107.9 million.
License and collaboration revenues for the fourth quarter of 2018 were $3.5 million and for the year ended December 31, 2018 were $12.9 million. There were no license and collaboration revenues during the same periods of 2017. License and collaboration revenues relate to the Collaboration and License Agreement between the Company and BeiGene, Ltd., which became effective January 7, 2018.
Research and development expenses for the fourth quarter of 2018 were $26.8 million, compared to $15.2 million for the same period in 2017. Research and development expenses for the year ended December 31, 2018 were $93.9 million compared to $58.1 million for the same period in 2017. The increase in research and development expenses for both periods is due to an increase in expense associated with sitravatinib and our KRAS inhibitor program, as well as an increase in salaries and related expense, including an increase in share-based compensation expense. The increase in sitravatinib expense is due to increased costs to support the expansion of existing and new clinical trials and the increase in KRAS inhibitor program expense relates primarily to increased manufacturing expenses for our lead clinical compound, MRTX849. The Company recognized research and development-related share-based compensation expense of $2.1 million during the fourth quarter of 2018 as compared to $0.7 million for same period in 2017 and $7.2 million during the year ended December 31, 2018 as compared to $3.2 million for the same period in 2017.
General and administrative expenses for the fourth quarter of 2018 were $6.4 million, compared to $3.0 million for the same period in 2017. General and administrative expenses for the year ended December 31, 2018 were $21.7 million compared to $13.5 million for the same period of 2017. The increase is due primarily to an increase in share-based compensation expense, and to a lesser extent increases in salaries and related expense, professional and consulting fees and patent filing fees. The Company recognized general and administrative-related share-based compensation expense of $2.1 million during the fourth quarter of 2018 as compared to $0.6 million for same period in 2017 and of $8.6 million during the year ended December 31, 2018 as compared to $3.6 million for the same period in 2017.
Net loss for the fourth quarter of 2018 was $28.3 million, or $0.87 per share basic and diluted, compared to net loss of $17.9 million, or $0.67 per share basic and diluted for the same period in 2017. Net loss for the year ended December 31, 2018 was $98.4 million, or $3.19 per share, compared to $70.4 million, or $2.78 per share, for the same period of 2017.
About Sitravatinib
Sitravatinib is a spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients whose cancers have progressed despite treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation.
Sitravatinib is also being evaluated as a single agent in a Phase 1b expansion clinical trial emphasizing enrollment of patients whose tumors harbor specific mutations in the CBL protein. When CBL is inactivated by mutation, multiple RTKs, including TAM, VEGFR2 and KIT, are dysregulated and may act as oncogenic tumor drivers in NSCLC and melanoma. Sitravatinib potently inhibits these RTKs and is being investigated as a treatment option for cancer patients with CBL mutations.
About MRTX849
MRTX849 is an investigational, orally-available small molecule, that is designed to potently and selectively inhibit a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 14% of NSCLC adenocarcinoma patients, 4% of colorectal cancer patients, and subsets of other types of cancer. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. MRTX849 is being evaluated in a Phase 1/2 trial treating patients with molecularly-identified KRAS G12C-positive advanced solid tumors.