Kura Oncology Reports First Quarter 2016 Financial Results
“Kura has made important progress in advancing its pipeline of precision oncology drug candidates over the past quarter,” said
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 ofMarch 31, 2016 , compared with$85.7 million as ofDecember 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.
About
Forward Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of Kura Oncology’s product candidates and compounds, progress and expected timing of Kura Oncology’s drug development programs and clinical trials, plans regarding regulatory filings and future research and clinical trials, expected timing of data from clinical trials of tipifarnib, the strength of Kura Oncology’s balance sheet and the adequacy of cash on hand. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. These forward-looking statements are based upon Kura Oncology’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that compounds that appeared promising in early studies or clinical trials do not demonstrate safety and/or efficacy in later studies or clinical trials, the risk that
KURA ONCOLOGY, INC. | |||||||
Statements of Operations Data | |||||||
(unaudited) | |||||||
(in thousands, except per share data) | |||||||
Three Months Ended | |||||||
March 31, | |||||||
2016 | 2015 | ||||||
Operating Expenses: | |||||||
Research and development | $ | 4,649 | $ | 3,628 | |||
General and administrative | 2,391 | 1,060 | |||||
Total operating expenses | 7,040 | 4,688 | |||||
Other income, net | 414 | 212 | |||||
Net loss | $ | (6,626 | ) | $ | (4,476 | ) | |
Net loss per share, basic and diluted | $ | (0.36 | ) | $ | (1.41 | ) | |
Weighted average number of shares used in computing net loss per share, basic and diluted |
18,245 | 3,184 |
KURA ONCOLOGY, INC. | |||||||
Balance Sheet Data | |||||||
(unaudited) | |||||||
(in thousands) | |||||||
March 31, | December 31, | ||||||
2016 | 2015 | ||||||
Cash, cash equivalents and short-term investments | $ | 78,466 | $ | 85,746 | |||
Working capital | 75,765 | 81,814 | |||||
Total assets | 80,382 | 87,259 | |||||
Long-term liabilities | 6 | 101 | |||||
Accumulated deficit | (32,922 | ) | (26,296 | ) | |||
Total stockholders’ equity | 76,066 | 82,103 | |||||
CONTACT INFORMATION INVESTOR CONTACT:Robert H. Uhl Managing DirectorWestwicke Partners, LLC (858) 356-5932 robert.uhl@westwicke.com CORPORATE COMMUNICATIONS CONTACT:Mark Corbae Vice PresidentCanale Communications (619) 849-5375 mark@canalecomm.com