Glesatinib

SAN DIEGO, March 8, 2018 /PRNewswire/ --Mirati Therapeutics Inc. (NASDAQ: MRTX), a clinical stage oncology biotechnology company, today reported financial results for the fourth quarter and full-year ended December 31, 2017. "We made significant progress in our key programs in 2017," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. "Promising data from the sitravatinib and KRAS programs encouraged us to pursue a more aggressive approach to accelerate development, supported by the successful financing we completed in November. In early 2018, we initiated a strategic regional partnership with BeiGene Ltd. that we anticipate will rapidly expand the development of sitravatinib in multiple tumor types. We expect to report multiple key catalysts in 2018, including a mid-year clinical update for our sitravatinib program. Our KRAS inhibitor program, an important yet elusive target, is growing and we remain on track for an IND filing in the fourth quarter of 2018." Recent Corporate Highlights Sitravatinib clinical data presented at 2017 IASLC World Conference on Lung Cancer Combination of sitravatinib and nivolumab in non-small cell lung cancer (NSCLC) patients with documented progression following checkpoint inhibitor therapy demonstrated 3 confirmed Partial Responses in first 11 evaluable patients First evaluable NSCLC patient with CBL inactivating mutation treated with single agent sitravatinib demonstrated confirmed Partial Response with 77% tumor reduction KRAS G12C lead candidates selected and advanced into IND-enabling development activities Significant achievement in development of a direct inhibitor of KRAS, a well-known but previously undruggable cancer mutation A potentially transformational, first-in-class treatment for 14% of NSCLC and 5% of colorectal cancer patients Program is on track to advance to IND filing in the fourth quarter of 2018 Exclusive license agreement initiated with BeiGene Ltd. for the development, manufacture and commercialization of sitravatinib in Asia (excluding Japan), Australia and New Zealand Expected to accelerate development of sitravatinib in NSCLC as well as other key indications including bladder, renal and hepatocellular cancer $86.7M public offering completed in November 2017; $150.8M of cash, cash equivalents and short-term investments as of December 31, 2017 Fourth Quarter and Full Year Financial Results Cash, cash equivalents, and short-term investments were $150.8 million on December 31, 2017, as compared to $56.7 million on December 31, 2016. Research and development expenses for the fourth quarter of 2017 were $15.2 million, compared to $16.0 million for the same period in 2016. Research and development expenses for the year ended December 31, 2017 were $58.1 million, compared to $68.5 million for the same period in 2016. The decrease in research and development expenses for both periods is primarily due to a reduction in glesatinib expenses and a reduction in share-based compensation expense. These decreases are partially offset by increases in expenses associated with our ongoing sitravatinib clinical trials. General and administrative expenses for the fourth quarter of 2017 were $3.0 million, compared to $3.9 million for the same period in 2016. General and administrative expenses for the year ended December 31, 2017 were $13.5 million, compared to $15.3 million for the same period in 2016. The decrease in general and administrative expense for both periods is primarily due to a decrease in share-based compensation expense. Net loss for the fourth quarter of 2017 was $17.9 million, or $0.67 per share basic and diluted, compared to net loss of $19.7 million, or $0.99 per share basic and diluted for the same period in 2016. Net loss for the year ended December 31, 2017 was $70.4 million, or $2.78 per share basic and diluted, compared to net loss of $83.1 million, or $4.20 per share basic and diluted for the same period in 2016.

3 Biotechs That Got Huge Boosts From Spark’s FDA P Two months after positive preliminary data showed sitravatinib in combination with Opdivo demonstrated some efficacy in treating patients with NSCLC, Mirati said it will reprioritize its R&D to focus. Two months after positive preliminary data showed sitravatinib in combination with Opdivo demonstrated some efficacy in treating patients with non-small cell lung cancer (NSCLC), Mirati Therapeutics said it will reprioritize its R&D to focus on its immuno-oncology drug and its KRAS program – in favor of lead product glesatinib. Glesatinib has been in Phase II development for NSCLC and other solid tumors. Mirati said it is deprioritizing investment into this drug candidate. Additionally the company said it will pursue partnerships to develop the program. “Glesatinib has demonstrated clinical activity and acceptable tolerability in MET-altered NSCLC patients. However, in light of superior investment opportunities in its pipeline, the company will suspend further investment in glesatinib and will pursue opportunities to partner the program. The company intends to present glesatinib data at a future medical conference,” Mirati said in a statement. In addition to its change with glesatinib, Mirati said it has also suspended development of its preclinical LSD1 inhibitor program as part of its reprioritization. In light of superior investment opportunities in its pipeline, Mirati said it will seek a partner to continue development of the program. Funding that was initially allocated for the glesatinib will be used to advance Mirati’s other programming. The company said it has enough funds on hand to support development of sitravatinib and the KRAS programs through 2019. Mirati said it is reprioritizing in order to capitalize on encouraging data and development opportunities. “We are very encouraged by the early results from our sitravatinib immuno-oncology program. The combination of sitravatinib and nivolumab has demonstrated durable responses and prolonged stable disease in patients with non-small cell lung cancer that have documented progression on prior checkpoint therapy. This is a patient population with poor prognosis and limited treatment options. We are focusing on accelerating this promising opportunity with sitravatinib and advancing our potentially first-in-class KRAS program, both of which address large underserved patient populations with significant market potential,” Charles Baum , Mirati’s president and chief executive officer, said in a statement. Mirati expects Phase II data from the immuno-oncology combination of sitravatinib, a spectrum-selective kinase inhibitor, and Opdivo (nivolumab) in patients with checkpoint refractory non-small cell lung cancer (NSCLC) by mid-2018. Initial data from the ongoing Phase II included three confirmed Partial Responses in the first 11 evaluable patients. Eight of these patients exhibited tumor reduction, the company said. Sitravatinib is also being evaluated as a single agent in a Phase 1b expansion trial enrolling patients whose tumors harbor CBL, CHR4Q12 and RET genetic alterations in NSCLC and other tumor types. In its announcement, Mirati said it has selected a clinical lead and backup compounds in its KRAS program that potently target KRAS G12C mutations. The company said it intends to Investigational New Drug Application with the U.S. Food and Drug Administration by the fourth quarter of 2018. Investors were not happy with Mirati’s announcement. After news of Mirati’s reprioritization was announced late Monday, stockholders began dumping shares. Mirati stock fell from $15.60 per share to a low of $12.90. Share prices have rallied some back to $13.20.