On August 5, 2019 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the second quarter ended June 30, 2019 (Press release, Mirati, AUG 5, 2019, View Source [SID1234538149]).
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Second Quarter Highlights:
Initiated the Phase 3 randomized clinical trial, evaluating the combination of sitravatinib and nivolumab versus single-agent docetaxel, in second line patients with advanced non-squamous non-small cell lung cancer (NSCLC), following treatment with a first line, platinum-based regimen and a checkpoint inhibitor.
Completed a successful public offering of common stock in June that provided net cash proceeds of $219.9 million.
Appointed Dr. Julie Cherrington, Ph.D. to Mirati’s Board of Directors.
"The first half of 2019 continued to bring significant advancements across our pipeline. We strengthened our financial position following our successful public offering in June and are well positioned to expand clinical development of MRTX849 as both a single agent and in combination with other therapies. Additionally, the appointment of Dr. Julie Cherrington to our Board brings significant research and development expertise that will strengthen our programs," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. "We expect that the second half of 2019 will be an exciting time for Mirati as we expect to advance MRTX849 into the single-agent expansion cohorts and into combination studies. In addition, we continue to expand the development efforts of sitravatinib in multiple indications and through our collaboration with BeiGene."
Financial Results for the Second Quarter 2019
Cash, cash equivalents, and short-term investments were $485.5 million at June 30, 2019, compared to $222.8 million at December 31, 2018. In January 2019, we completed a public offering of common stock that provided net cash proceeds of $107.9 million. In June 2019, we completed a public offering of common stock that provided net cash proceeds of $219.9 million.
License and collaboration revenues relate to the Collaboration and License Agreement between the Company and BeiGene, Ltd. ("BeiGene"), dated January 7, 2018. License and collaboration revenues for the three and six months ended June 30, 2019 were $0.6 million and $1.8 million, respectively, compared to none and $9.5 million for the three and six months ended June 30, 2018, respectively. The 2019 revenues relate to revenues earned in connection with a manufacturing supply services agreement with BeiGene and the 2018 revenues relate to the license the Company granted to BeiGene under the Collaboration and License Agreement.
Research and development expenses for the second quarter of 2019 were $38.3 million, compared to $23.8 million for the same period in 2018. Research and development expenses for the six months ended June 30, 2019 were $72.6 million, compared to $43.5 million for the same period in 2018. The increase in research and development expenses is due to an increase in expense associated with sitravatinib and MRTX849, 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 MRTX849 expense relates to the Phase 1 clinical trial, which was initiated in the first quarter of 2019. The Company recognized research and development-related share-based compensation expense of $6.6 million during the second quarter of 2019, compared to $1.8 million for the same period in 2018, and $11.8 million during the six months ended June 30, 2019, compared to $3.3 million for the same period in 2018.
General and administrative expenses for the second quarter of 2019 were $9.9 million, compared to $4.8 million for the same period in 2018. General and administrative expenses for the six months ended June 30, 2019 were $19.7 million, compared to $10.0 million for the same period in 2018. The increase is primarily due to an increase in share-based compensation expense due to an increase in the fair value of stock options granted during the three and six months ended June 30, 2019 compared to the same periods in 2018. The Company recognized general and administrative-related share-based compensation expense of $6.0 million during the second of 2019, compared to $2.1 million for the same period in 2018, and $12.0 million during the six months ended June 30, 2019, compared to $4.3 million for the same period in 2018.
Net loss for the second quarter of 2019 was $45.7 million, or $1.26 per share basic and diluted, compared to net loss of $27.9 million, or $0.94 per share basic and diluted for the same period in 2018. Net loss for the six months ended June 30, 2019 was $86.6 million, or $2.43 per share basic and diluted, compared to net loss of $42.6 million, or $1.45 per share basic and diluted for the same period in 2018.
About Sitravatinib
Sitravatinib is an investigational 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 being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including the ongoing potentially registration-enabling Phase 3 trial of sitravatinib in combination with a checkpoint inhibitor in non-small cell lung cancer (NSCLC). In addition, sitravatinib combinations with checkpoint inhibitors are being evaluated in selected checkpoint inhibitor naïve patients.
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.
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 non-small cell lung cancer 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.