Kura Oncology Reports Fourth Quarter and Full Year 2015 Operational and Financial Results
“Over the past year, we have made significant progress toward positioning
Development Program Updates and Company Highlights:
Tipifarnib in HRAS Mutant Solid Tumors
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May 2015 , Kura initiated a Phase 2 clinical trial of tipifarnib in patients with advanced tumors that carry HRAS mutations. The primary objective of the study is to investigate the antitumor activity, in terms of objective response rate, of tipifarnib in patients with locally advanced, unresectable or metastatic, relapsed and/or refractory tumors that carry HRAS mutations. Secondary objectives include evaluation of progression-free survival, duration of response, and safety. Top-line data from the trial is anticipated during the second half of 2016. - In
November 2015 , a Phase 2 clinical trial of tipifarnib was initiated in patients with advanced urothelial carcinoma tumors with HRAS mutations. The study is being conducted under the direction ofSe Hoon Park , M.D., Ph.D., in theDivision of Hematology-Oncology at theSamsung Medical Center inSeoul, South Korea . The primary objective of the study is objective response rate, and secondary objectives include evaluation of progression-free survival, duration of response, and safety.
Tipifarnib in Peripheral T-Cell Lymphoma
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September 2015 , Kura initiated a Phase 2 clinical trial of tipifarnib in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). PTCL consists of a group of rare and usually aggressive forms of non-Hodgkin's lymphoma that develop from mature T-cells. These patients generally have a poor prognosis with a low response rate to available treatment options and commonly experience repeated treatment failures. The primary objective of the study is to evaluate the efficacy of tipifarnib in terms of objective response rate. Secondary objectives include evaluation of progression-free survival, duration of response, and safety. Top-line data from the trial is anticipated in the second half of 2017.
Tipifarnib in Lower-Risk Myelodysplastic Syndromes
- Kura plans to initiate a Phase 2 clinical trial to investigate the anti-tumor activity of tipifarnib in patients with lower risk myelodysplastic syndromes (MDS) in the second quarter of 2016. MDS are a group of hematopoietic stem cell malignancies with significant morbidity and mortality. MDS is characterized by ineffective blood cell production, or hematopoiesis, leading to low blood cell counts, or cytopenias, and high risk of progression to acute myeloid leukemia. Kura’s interest in MDS arose from the results of a prior Phase 2 clinical trial sponsored by
Johnson & Johnson in patients with intermediate to high risk MDS and additional work by Kura to identify potential biomarkers that could be predictive of response to tipifarnib in MDS patients. Lower risk MDS has been prioritized because of the prevalence of this disease and the company’s belief that treatment of lower risk MDS remains a significant unmet need.
KO-947
- Kura plans to submit an investigational new drug application for KO-947, a small molecule inhibitor of extracellular receptor kinase (ERK1/2), in the second quarter of 2016. KO-947 demonstrates potent and selective inhibition of ERK kinase and has shown promising activity in patient-derived xenograft models. Kura is advancing KO-947 as a potential treatment for patients who have tumors with dysregulated activity of the MAPK pathway, including patients with lung, colorectal, pancreatic, melanoma and other cancers.
Menin-MLL
- Kura’s menin-MLL program is focused on the identification of product candidates with the potential to treat patients with MLL-rearranged as well as MLL-PTD leukemias, both of which have no current effective therapy. The company anticipates nominating a development candidate for the menin-MLL program during the second half of 2016.
Financial Highlights
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Public Offering and Listing on NASDAQ
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Upcoming Clinical and Preclinical Milestones for Kura Programs
- Initiation of a Phase 2 clinical trial for tipifarnib in lower-risk MDS, anticipated in the second quarter of 2016
- IND submission for ERK inhibitor, KO-947, anticipated in the second quarter of 2016
- Initiation of Phase 1 clinical trial for KO-947, anticipated in the second half of 2016
- Topline data from Phase 2 clinical trial for tipifarnib in HRAS mutant solid tumors, anticipated in the second half of 2016
- Nomination of development candidate for menin-MLL program, anticipated in the second half of 2016
Financial Results for the Fourth Quarter and the Full Year
Cash, cash equivalents and short-term investments totaled
Operating expenses for the fourth quarter of 2015 were
Research and development expenses for the fourth quarter of 2015 were
General and administrative expenses for the fourth quarter of 2015 were
Net loss for the fourth quarter of 2015 was
Financial Guidance
Kura expects that its current cash, cash equivalents and short-term investments of
Conference Call and Webcast
Kura’s management will host a webcast and conference call regarding this announcement at
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) | |||||||||||||||||
Period From | |||||||||||||||||
Twelve Months | August 22, 2014 | ||||||||||||||||
Three Months Ended | Ended | (Inception) to | |||||||||||||||
December 31, | December 31, | December 31, | |||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||||
Operating Expenses: | |||||||||||||||||
Research and development | $ | 5,113 | $ | 2,649 | $ | 17,777 | $ | 2,652 | |||||||||
General and administrative | 1,729 | 1,219 | 6,088 | 1,282 | |||||||||||||
Total operating expenses | 6,842 | 3,868 | 23,865 | 3,934 | |||||||||||||
Other income, net | 368 | 263 | 1,240 | 263 | |||||||||||||
Net loss | $ | (6,474 | ) | $ | (3,605 | ) | $ | (22,625 | ) | $ | (3,671 | ) | |||||
Net loss per share, basic and diluted | $ | (0.42 | ) | $ | (8.95 | ) | $ | (2.28 | ) | $ | (25.98 | ) | |||||
Shares used in computing net loss per share, basic and diluted | 15,262 | 403 | 9,933 | 141 |
KURA ONCOLOGY, INC. | |||||||
Balance Sheet Data | |||||||
(unaudited) | |||||||
(In thousands, except per share data) | |||||||
December 31, | |||||||
2015 | 2014 | ||||||
Cash, cash equivalents and short-term investments | $ | 85,746 | $ | 1,124 | |||
Working capital | 81,814 | (1,820 | ) | ||||
Total assets | 87,259 | 1,378 | |||||
Long-term liabilities | 101 | 1,795 | |||||
Accumulated deficit | (26,296 | ) | (3,671 | ) | |||
Stockholders' equity (deficit) | 82,103 | (3,433 | ) |
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