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Kura Oncology Reports Second Quarter 2017 Financial Results and Provides Update on Tipifarnib Phase 2 Study Tipifarnib demonstrates high level of clinical activity and durable partial responses in ongoing Phase 2 trial i

Key Takeaway: Kura Oncology Reports Second Quarter 2017 Financial Results and Provides Update on Tipifarnib Phase 2 Study Tipifarnib demonstrates high level of clinical activity and durable partial responses in ongoing Phase 2 trial in HRAS mutant squamous cell head and neck cancers Managem

Full Press Release Details

Kura Oncology Reports Second Quarter 2017
Financial Results and Provides Update on Tipifarnib Phase 2 Study
Tipifarnib demonstrates high level of clinical activity and durable partial responses in ongoing Phase 2 trial in HRAS mutant squamous cell head and neck cancers
Management to host webcast and conference call today at 4:30 p.m. EDT
LA JOLLA, Calif., August 7, 2017 - Kura Oncology, Inc., (Nasdaq:KURA) a clinical stage biopharmaceutical company focused on the development of precision medicines for oncology, today reported second quarter 2017 financial results and provided a corporate update. In the company's ongoing Phase 2 trial of tipifarnib in patients with HRAS mutant squamous cell carcinomas of the head and neck (SCCHN), partial responses have been observed in three of five evaluable patients and two of the responses have demonstrated durability beyond one year.
"Although our data is preliminary, three responses out of the first five evaluable patients is very uncommon in the relapsed/refractory setting of SCCHN, and it underscores the potential of using small molecule drug candidates such as tipifarnib to target driver mutations such as HRAS in difficult-to-treat solid tumors," said Troy Wilson, Ph.D., J.D., President and CEO of Kura Oncology. "Furthermore, the durability of response - beyond one year in two patients - has been impressive, particularly when considering these patients received limited clinical benefit from prior therapy before enrolling in the study. Given response rates of 13-16% and median overall survival of up to 7.5 months with the currently approved treatments in the second line, including anti-PD1 antibodies, we are very encouraged both by the response rate and the durability of response we've observed thus far with tipifarnib."
"In addition to the clinical progress, we recently established a collaboration with Foundation Medicine to expand patient outreach," continued Dr. Wilson. "We also secured a U.S. patent directed to the use of tipifarnib in patients with HRAS mutant SCCHN that has an expiration date in August 2036. Together, these achievements are key elements of our strategy to advance tipifarnib to a first pivotal registrational trial in 2018, and we look forward to providing additional updates later this year."
Update on Phase 2 Clinical Trial in HRAS Mutant Solid Tumors
An update on the progress of the HRAS mutant SCCHN clinical trial as of July 27, 2017 is as follows:
Recent Operational Highlights
Upcoming Potential Milestones and Expectations for Clinical and Preclinical Programs
Financial Results for the Second Quarter 2017
Conference Call and Webcast
Kura's management will host a webcast and conference call regarding this announcement at 1:30 p.m. PDT/4:30 p.m. EDT today. The live call may be accessed by dialing (877) 516-3514 for domestic callers and (281) 973-6129 for international callers and using conference ID # 61058165. A live webcast of the call will be available from the investor relations section of the company website at www.kuraoncology.com, and will be archived there for 30 days. A telephone replay of the call will be available by dialing (855) 859-2056 for domestic callers, or (404) 537-3406 for international callers, and entering the conference ID # 61058165.
Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The company's pipeline consists of small molecule drug candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology's lead drug candidate is tipifarnib, a farnesyl transferase inhibitor, which is currently being studied in multiple Phase 2 clinical trials. Kura's pipeline also includes KO-947, an ERK inhibitor, currently in a Phase 1 trial, and KO-539, an inhibitor of the menin-MLL protein-protein interaction, currently in preclinical testing. For additional information about Kura Oncology, please visit the company's website at www.kuraoncology.com.
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, KO-947 and KO-539, 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. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura Oncology may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings and applications, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "promise, " "potential," "expects," "plans," "anticipates," "intends," "continues," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company's periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura Oncology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
KURA ONCOLOGY, INC.
Statements of Operations Data
(unaudited)
(in thousands, except per share data)
Three Months Ended Six Months Ended
June 30, June 30,
2017 2016 2017 2016
Operating Expenses:
Research and development $ 5,652 $ 4,936 $ 11,165 $ 9,585
General and administrative 2,278 1,855 4,418 4,246
Total operating expenses 7,930 6,791 15,583 13,831
Other income, net 110 130 230 544
Net loss $ (7,820 ) $ (6,661 ) $ (15,353 ) $ (13,287 )
Net loss per share, basic and diluted $ (0.40 ) $ (0.36 ) $ (0.78 ) $ (0.72 )
Weighted average number of shares used in computing net loss per share, basic and diluted 19,789 18,548 19,627 18,397
KURA ONCOLOGY, INC.
Balance Sheet Data
(unaudited)
(in thousands)
June 30, December 31,
2017 2016
Cash, cash equivalents and short-term investments $ 53,244 $ 67,790
Working capital 49,659 63,359
Total assets 55,847 69,821
Long-term liabilities 7,134 7,494
Accumulated deficit (69,209 ) (53,856 )
Stockholders' equity 43,637 56,876
Westwicke Partners, LLC
CORPORATE COMMUNICATIONS CONTACT:
Canale Communications
Last updated: Aug 7, 2017