SAN DIEGO, Nov. 3, 2016 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX) (“the Company” or “Mirati”) today reported financial results for the third quarter ended September 30, 2016 and provided an update on its product development programs.
“We are pleased by the continued progress in all three of our clinical development programs during the third quarter and are encouraged by enrollment rates, particularly in our Phase 2 trial for glesatinib,” said Charles M. Baum, M.D., Ph.D., President and CEO of Mirati. “We are focused on establishing the response rate in these patients, and will provide an efficacy update as we collect data on a meaningful number of patients.”
Current Programs
Glesatinib (MGCD265)
Patient enrollment continues in the glesatinib Phase 2 clinical trial in non-small cell lung cancer (NSCLC) patients with MET genetic alterations. Enrollment rates in the trial continue to increase, due in part to the Company’s diagnostic partnerships, which have enabled accelerated patient identification and enrollment. Patients in the Phase 2 clinical trial are demonstrating improved tolerability. An interim update will be provided once data is collected on at least 15 patients.
Sitravatinib (MGCD516)
The Phase 1b clinical trial of sitravatinib continues to enroll patients with RET, CHR4q12 and CBL genetic alterations in NSCLC and other solid tumors. Patient enrollment is on track, and updates will be provided on the status of this clinical trial as we receive more data.
We are also initiating a Phase 2 clinical trial to assess the potential for glesatinib or sitravatinib, each in combination with Nivolumab, to enhance the clinical efficacy of Nivolumab in patients with NSCLC.
Mocetinostat (MGCD103)
The Phase 2 clinical trial for mocetinostat in combination with durvalumab, MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, is progressing as planned. The clinical trial is exploring the potential of mocetinostat to enhance the effectiveness of checkpoint inhibitors in NSCLC and other solid tumors.
Third Quarter and Nine Month 2016 Financial Results
Cash, cash equivalents, and short-term investments were $73.0 million on September 30, 2016, as compared to $122.3 million on December 31, 2015.
Research and development expenses for the third quarter of 2016 were $16.1 million, compared to $14.6 million for the same period in 2015. Research and development expenses for the nine months ended September 30, 2016 were $52.5 million, compared to $34.0 million for the same period in 2015. The increase in research and development expenses for both the three and nine months ended September 30, 2016 compared to the same periods of 2015 relates to an increase in expenses associated with ongoing clinical trials for both glesatinib and sitravatinib, as well as an increase in other research and development expenses, which reflects higher compensation expense due to an increase in research and development employees during the three and nine months ended September 30, 2016. A one-time license fee of $2.5 million related to an early stage discovery project also contributed to the increase in expenses for the nine months ended September 30, 2016 compared to the same period in 2015.
General and administrative expenses for the third quarter of 2016 were $3.5 million, compared to $4.2 million for the same period in 2015. General and administrative expenses for the nine months ended September 30, 2016 were $11.4 million, compared to $12.2 million for the same period in 2015. The decrease in general and administrative expenses for the three and nine months ended September 30, 2016 compared to the same periods of 2015 is largely the result of a decrease in non-cash stock-based compensation expense.
Net loss for the third quarter of 2016 was $19.4 million, or $0.97 per share basic and diluted, compared to net loss of $18.7 million, or $1.11 per share basic and diluted for the same period in 2015. Net loss for the nine months ended September 30, 2016 was $63.4 million, or $3.21 per share basic and diluted, compared to net loss of $46.1 million, or $2.86 per share basic and diluted for the same period in 2015.
About Mirati Therapeutics
Mirati Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing a pipeline of targeted oncology products intended to treat specific genetic and epigenetic drivers of cancer in selected subsets of cancer patients with unmet needs. In addition, our product candidates will be evaluated in combination with checkpoint inhibitors (anti-PD-1 and PD-L1) to determine whether they will enhance the efficacy of those agents in patients with non-small cell lung cancer (“NSCLC”) and other solid tumors. Our clinical pipeline consists of three product candidates: glesatinib, sitravatinib and mocetinostat. Both glesatinib and sitravatinib are orally bio-available, spectrum-selective kinase inhibitors with distinct target profiles that are in development for the treatment of patients with NSCLC and other solid tumors. Glesatinib is in Phase 2 clinical development, and targets the MET and Axl receptor tyrosine kinase families. Sitravatinib is in Phase 1b clinical development and targets genetic alterations in RET rearrangements, CHR4q12 amplifications, and CBL mutations. Our third product candidate is mocetinostat, an orally bio-available, Class 1 selective histone deacetylase (“HDAC”) inhibitor.
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