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MIRATI THERAPEUTICS REPORTS FOURTH QUARTER AND FULL YEAR 2015 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
Clinical Updates and Milestones Expected Across All Three Lead Programs During 2016
SAN DIEGO March 9, 2016 Mirati Therapeutics, Inc. (NASDAQ: MRTX) today reported financial results for the fourth quarter and full year ended December 31, 2015 and provided an update on its drug development programs.
We made significant progress across our entire pipeline in 2015, setting up a potentially transformative year for the Company in 2016, said Charles M. Baum, M.D., Ph.D., president and CEO of Mirati. After reporting initial results in our Phase 1b dose expansion clinical trial for glesatinib last fall, which included two confirmed responses in non-small cell lung cancer patients, we have quickly moved into a Phase 2 clinical trial utilizing our diagnostic collaborations with Guardant Health and Foundation Medicine to help us identify which NSCLC patients we believe are most likely to respond.
We expect to see updated data from both of those trials later this year, as well as data from our Phase 1b dose expansion clinical trial for sitravatinib, and we are looking forward to starting our Phase 2 combination trial in immuno-oncology for mocetinostat in the second quarter. Following our successful financing last September, we are now poised to capitalize on the significant potential of our targeted cancer therapies for patients in need of better treatment options.
2015 Operational Highlights
Glesatinib (MGCD265): Molecularly targeted kinase inhibitor
· In September 2015, presented data at the World Conference on Lung Cancer 2015 demonstrating the favorable tolerability and clinical efficacy of MGCD265 in a Phase 1b dose expansion clinical trial
· In December 2015, initiated a single arm, open-label Phase 2 clinical trial in NSCLC patients with driver alterations in MET which occur in up to 7% of NSCLC patients
· In December 2015, announced a collaboration with Guardant Health to use the Guardant360 diagnostic tool in the Phase 2 clinical trial to screen NSCLC patients for certain genetic alterations to the MET pathway in order to identify those patients we believe are most likely to respond to MGCD265
· In December 2015, announced a separate collaboration with Foundation Medicine for the development of a companion diagnostic test for MGCD265 in NSCLC
Sitravatinib (MGCD516): Molecularly targeted kinase inhibitor
· In September 2015, presented interim clinical data from the ongoing Phase 1 dose escalation clinical trial of MGCD516 in patients with advanced solid tumors at the European Cancer Congress (ECC) 2015:
· Demonstrated that MGCD516 is well tolerated with a favorable pharmacokinetic profile
· Established recommended Phase 2 dose of 150 mg QD
The following information was filed by Mirati Therapeutics, Inc. (MRTX) on Wednesday, March 9, 2016 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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