On May 4, 2017 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage oncology biotechnology company, reported financial results for the first quarter 2017 and provided an update on its product development programs (Press release, Mirati, MAY 4, 2017, View Source [SID1234518877]). Schedule your 30 min Free 1stOncology Demo! "As anticipated, 2017 will be an important and defining year for Mirati. Our single agent precision medicine programs and immuno-oncology combination programs are advancing and we remain on track to report key data in the second half of the year," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. "We have made significant progress in our pre-clinical KRAS and LSD-1 programs and we are very encouraged by the data from these programs".
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Single Agent Programs
Glesatinib (MGCD265)
Mirati is enrolling patients in its registration-enabling Phase 2 NSCLC AMETHYST clinical trial, which is evaluating single agent glesatinib for the treatment of NSCLC patients with MET driver mutations. The Company expects to provide an update on efficacy data from the AMETHYST trial in the second half of 2017.
Sitravatinib (MGCD516)
The Phase 1b expansion clinical trial of sitravatinib is enrolling NSCLC patients with RET, CHR4q12 and CBL genetic alterations. The Company expects to provide an update on efficacy data in the third quarter of 2017.
Immuno-oncology Combination Programs
Sitravatinib plus nivolumab
The multicenter Phase 2 NSCLC clinical trial is evaluating sitravatinib in combination with nivolumab, a checkpoint inhibitor approved for the treatment of patients with a variety of solid tumors including NSCLC. The trial is enrolling patients who have relapsed after treatment with a checkpoint inhibitor. Sitravatinib is a potent inhibitor of the TAM (Tyro, Axl, Mer) and split (KDR, KIT) tyrosine kinase families which regulate multiple aspects of the immune system thought to enhance anti-tumor immunity. The Company expects to provide an initial update on this combination trial in the second half of 2017.
Mocetinostat (MGCD103) plus durvalumab
Mirati is collaborating with Medimmune/Astra Zeneca on a Phase 2 clinical trial combining mocetinostat, an orally administered spectrum-selective Class 1 HDAC inhibitor, and durvalumab, MedImmune’s monoclonal antibody inhibiting PD-L1. The combination trial is exploring the potential of mocetinostat to enhance the effectiveness of checkpoint inhibitors in NSCLC and the Company expects to provide an update in mid 2017.
Preclinical Programs
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KRAS Inhibitor Program: A mutant-selective (G12C) KRAS inhibitor program is advancing rapidly. Potent and selective inhibitors have been identified and have demonstrated marked tumor regression in KRAS mutant xenograft tumor models. An IND candidate selection is anticipated by second half of 2017.
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LSD1 Inhibitor Program: A highly-potent and potentially best-in-class LSD1 inhibitor has been identified with potential for rapid clinical proof-of-concept in small cell lung cancer or acute myeloid leukemia. An investigational new drug (IND) submission is planned for this compound in the fourth quarter 2017.
First Quarter 2017 Financial Results
In January 2017, we completed a public offering of our common stock and pre-funded common stock warrants that generated net proceeds of $66.8 million. Cash, cash equivalents, and short-term investments were $105.5 million at March 31, 2017, compared to $56.7 million at December 31, 2016. We continue to expect that our currently available cash, cash equivalents and short-term investments are sufficient to fund operations into late 2018.
Research and development expenses for the first quarter of 2017 were $14.4 million, compared to $18.0 million for the same period in 2016. The decrease in research and development expenses is primarily driven by a decrease in manufacturing expenses associated with glesatinib, offset by an increase in expenses associated with our ongoing Phase 1b clinical trial of sitravatinib.
General and administrative expenses for the first quarter of 2017 were $3.7 million, compared to $4.1 million for the same period in 2016. The decrease in general and administrative expense is largely the result of a decrease in non-cash share-based compensation expense, which is due to lower exercise prices for options granted during the last half of 2016 and first quarter of 2017.
Net loss for the first quarter of 2017 was $17.8 million, or $0.73 per share basic and diluted, compared to net loss of $21.9 million, or $1.13 per share basic and diluted for the same period in 2016.