On May 11, 2016 Kura Oncology, Inc., (NASDAQ:KURA) a clinical stage biopharmaceutical company, reported financial results for the first quarter ended March 31, 2016 (Press release, Kura Oncology, MAY 11, 2016, View Source;p=RssLanding&cat=news&id=2167626 [SID:1234512296]).
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"Kura has made important progress in advancing its pipeline of precision oncology drug candidates over the past quarter," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "We continue to enroll patients in our on-going Phase 2 clinical trials of tipifarnib in patients with HRAS mutant solid tumors and in relapsed or refractory peripheral T-cell lymphoma, and earlier in May 2016, we initiated our Phase 2 trial of tipifarnib in lower risk myelodysplastic syndromes (MDS)."
Dr. Wilson added: "In the second half or 2016, we are also planning to initiate a Phase 2 clinical trial with tipifarnib in patients with chronic myelomonocytic leukemia (CMML), a population for which prognosis is very poor, with a three-year survival rate estimated at less than 30 percent. Objective responses, including complete responses, have been previously observed with tipifarnib in CMML. Moreover, as part of the study, we plan to test a biomarker hypothesis, which may allow us to identify those patients most likely to experience durable responses. We believe our ongoing Phase 2 clinical trials and our additional planned trial in CMML provide us with multiple potential opportunities to position tipifarnib for registration-enabling Phase 3 studies in late 2017 or early 2018."
Upcoming Clinical and Preclinical Milestones for Kura Oncology Programs
IND submission for ERK inhibitor, KO-947, is anticipated in the second quarter of 2016 followed by initiation of a Phase 1 clinical trial, which is anticipated in the second half of 2016
Receipt of topline data from the Phase 2 clinical trial for tipifarnib in HRAS mutant solid tumors is anticipated in the second half of 2016
Initiation of a Phase 2 clinical trial for tipifarnib in patients with CMML is anticipated in the second half of 2016
Nomination of a development candidate for the menin-MLL program is anticipated in the second half of 2016
Financial Results for the First Quarter 2016
Cash, cash equivalents and short-term investments totaled $78.5 million as of March 31, 2016, compared with $85.7 million as of December 31, 2015. Management expects that existing cash, cash equivalents and short-term investments will be sufficient to fund current operations into 2018.
Research and development expenses for the first quarter of 2016 were $4.6 million, compared to $3.6 million for the first quarter of 2015.
General and administrative expenses for the first quarter of 2016 were $2.4 million, compared to $1.1 million for the first quarter of 2015.
Net loss for the first quarter of 2016 was $6.6 million, or $0.36 per share, compared to a net loss of $4.5 million, or $1.41 per share, for the first quarter of 2015.
Subsequent to the first quarter of 2016, Kura Oncology put in place a $20.0 million long-term debt financing agreement, of which $7.5 million has been drawn down. Use of proceeds is for development programs and general corporate purposes.