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“During the third quarter, we have continued to advance our tipifarnib development program,” said
“In addition, our trials in PTCL and lower-risk MDS are ongoing, and we recently initiated our planned Phase 2 trial for tipifarnib in patients with CMML,” stated Dr. Wilson. “We believe each of these Phase 2 studies has a strong scientific and clinical rationale, and they provide multiple potential opportunities for registration-enabling studies.”
Dr. Wilson continued, “We are preparing to advance our ERK inhibitor, KO-947, into clinical testing and are encouraged by the consistent and compelling activity we have observed in preclinical models of cancers with mutations or dysregulation of the MAPK pathway as well as by our identification of potential biomarkers to guide development. I am very pleased we are on track to submit an IND before year-end.”
Upcoming Clinical and Preclinical Activities for Kura Oncology Programs
- Submission of the investigational new drug (IND) for KO-947 is anticipated in the fourth quarter of 2016.
- Nomination of a development candidate for the menin-MLL program is anticipated in the fourth quarter of 2016.
- Presentation of preclinical data for KO-947 and menin-MLL program at EORTC in
Munichin November 2016.
- Initiation of a Phase 1 study for KO-947 is anticipated in the first half of 2017.
- Topline data from the Phase 2 study of tipifarnib in PTCL is anticipated in the first half of 2017.
- Additional data from the Phase 2 study of tipifarnib in HRAS mutant tumors is anticipated in the first half of 2017.
Financial Results for the Third Quarter 2016
- Cash, cash equivalents and short-term investments totaled
$74.6 millionas of September 30, 2016, compared with $85.7 millionas of December 31, 2015. Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into 2018.
- Research and development expenses for the third quarter of 2016 were
$5.3 million, compared to $4.6 millionfor the third quarter of 2015.
- General and administrative expenses for the third quarter of 2016 were
$1.7 million, compared to $1.8 millionfor the third quarter of 2015.
- Net loss for the third quarter of 2016 was
$6.9 million, or $0.37per share, compared to a net loss of $6.1 million, or $0.57per share, for the third quarter of 2015.
Webcast and Conference Call
Kura management will host a webcast and conference call regarding this announcement at
Forward Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of Kura Oncology’s product candidates and compounds, including tipifarnib, progress and expected timing of Kura Oncology’s drug development programs and clinical trials, plans regarding regulatory filings and future research and clinical trials, the strength of Kura Oncology’s balance sheet and the adequacy of cash on hand. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. These forward-looking statements are based upon Kura Oncology’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that compounds that appeared promising in early studies or clinical trials do not demonstrate safety and/or efficacy in later studies or clinical trials, the risk that
|KURA ONCOLOGY, INC.|
|Statements of Operations Data|
|(in thousands, except per share data)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development||$||5,316||$||4,635||$||14,901||$||12,664|
|General and administrative||1,742||1,793||5,988||4,359|
|Total operating expenses||7,058||6,428||20,889||17,023|
|Other income, net||132||338||676||872|
|Net loss per share, basic and diluted||$||(0.37||)||$||(0.57||)||$||(1.09||)||$||(1.98||)|
|Weighted average number of shares used in computing net loss per share, basic and diluted||18,850||10,723||18,549||8,136|
|KURA ONCOLOGY, INC.|
|Balance Sheet Data|
|September 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||74,568||$||85,746|
|Total stockholders’ equity||63,666||82,103|
CONTACT INFORMATION INVESTOR CONTACT:
Robert H. UhlManaging Director Westwicke Partners, LLC(858) 356-5932 firstname.lastname@example.org CORPORATE COMMUNICATIONS CONTACT: Mark CorbaeVice President Canale Communications(619) 849-5375 email@example.com