On August 6, 2020 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results and a corporate update for the second quarter ended June 30, 2020 (Press release, Mirati, AUG 6, 2020, View Source [SID1234563108]).
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"Mirati is working to design, develop and deliver novel oncology therapies for patients with significant unmet medical need. With MRTX849, our KRAS G12C selective inhibitor, we remain on track to complete enrollment of the registration-enabling monotherapy arm of the KRYSTAL Phase 1/2 clinical trial in patients with 2nd or 3rd line non-small cell lung cancer (NSCLC) in the third quarter. We look forward to presenting updated Phase 1/1b data at the 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics in October," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. "Today, we are also pleased to announce that we have selected MRTX1133, a potentially first-in-class KRAS G12D selective inhibitor to advance into IND-enabling GLP toxicology studies. We will share additional detail about MRTX1133 later this year and expect to file an IND in the first half of 2021."
RECENT CORPORATE UPDATES:
MRTX849 (KRAS G12C Selective Inhibitor)
Enrollment ongoing in the KRYSTAL Phase 1/2 clinical trial, including the following arms:
Single-agent Phase 2 registrational arm in 2nd or 3rd line therapy in NSCLC
Combination with a PD-1 (pembrolizumab) in 1st line NSCLC
Single-agent and in combination with an EGFR inhibitor (cetuximab) in 2nd line colorectal cancer (CRC)
Enrollment ongoing, under a separate clinical trial protocol, in the Phase 1/2 combination with TNO155, Novartis’ development-stage SHP2 inhibitor, in 2nd or 3rd line NSCLC and CRC
Initiated combination cohort of the KRYSTAL clinical trial with a pan-EGFR inhibitor (afatinib) in 2nd or 3rd line NSCLC
Plan to initiate the combination clinical trial with a CDK4/6 inhibitor (palbociclib) in patients with a CDK4 amplification in 2nd or 3rd line NSCLC later this year
MRTX1133 (KRAS G12D Selective Inhibitor)
Announced selection of a lead clinical candidate, MRTX1133
Completed dose-ranging toxicology studies and advancing into IND-enabling GLP toxicology studies
Sitravatinib
Enrollment ongoing in the Phase 3 SAPPHIRE trial in combination with nivolumab (OPDIVO) in patients with NSCLC
Operational Updates
On May 18th, 2020, announced the appointment of Joseph Leveque, M.D., as Chief Medical Officer
Ended the second quarter 2020 with $645.7 million in cash, cash equivalents, and short-term investments
Financial Results for the Second Quarter 2020
No license and collaboration revenues were earned for the three months ended June 30, 2020 and $0.3 million in license and collaboration revenues were earned for the six months ended June 30, 2020. License and collaboration revenues for the three and six months ended June 30, 2019 were $0.6 million and $1.8 million, respectively. License and collaboration revenues earned for these periods relate to a manufacturing supply services agreement with BeiGene.
Research and development expenses for the second quarter of 2020 were $65.1 million, compared to $38.3 million for the same period in 2019. Research and development expenses for the six months ended June 30, 2020 were $136.8 million, compared to $72.6 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 MRTX849, 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 $11.5 million during the second quarter of 2020, compared to $6.6 million for the same period in 2019, and $23.3 million during the six months ended June 30, 2020, compared to $11.8 million for the same period in 2019.
General and administrative expenses for the second quarter of 2020 were $19.8 million, compared to $9.9 million for the same period in 2019. General and administrative expenses for the six months ended June 30, 2020 were $37.8 million, compared to $19.7 million for the same period in 2019. The increase is due primarily to an increase in share-based compensation expense and, to a lesser extent, an increase in employee-related expenses and professional service expense. The Company recognized general and administrative-related share-based compensation expenses of $9.3 million during the second quarter of 2020, compared to $6.0 million for the same period in 2019, and $19.0 million during the six months ended June 30, 2020, compared to $12.0 million for the same period in 2019.
Net loss for the second quarter of 2020 was $82.9 million, or $1.89 per share basic and diluted, compared to net loss of $45.7 million, or $1.26 per share basic and diluted for the same period in 2019. Net loss for the six months ended June 30, 2020 was $169.5 million, or $3.91 per share basic and diluted, compared to net loss of $86.6 million, or $2.43 per share basic and diluted for the same period in 2019.
Cash, cash equivalents, and short-term investments were $645.7 million at June 30, 2020.
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 (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 and in the first quarter of 2020, enrollment began in the registration enabling cohort in monotherapy NSCLC, colorectal cancer and pancreatic cancer.
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. 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 combinations with a checkpoint inhibitor in non-small cell lung cancer (NSCLC). In addition, sitravatinib in combinations with checkpoint inhibitors are being evaluated in selected checkpoint inhibitor naïve patients.