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Kura Oncology Provides Regulatory Update on Tipifarnib and Reports Fourth Quarter and Full Year 2017 Financial Results - Company plans to initiate registration-directed trial of tipifarnib in second half of 2018 followin

Key Takeaway: Kura Oncology Provides Regulatory Update on Tipifarnib and Reports Fourth Quarter and Full Year 2017 Financial Results - Company plans to initiate registration-directed trial of tipifarnib in second half of 2018 following recent end of Phase 2 meeting with the FDA - - Single-ar

Full Press Release Details

Kura Oncology Provides Regulatory Update on Tipifarnib and Reports Fourth Quarter and Full Year 2017 Financial Results
- Company plans to initiate registration-directed trial of tipifarnib in second half of 2018 following recent end of Phase 2 meeting with the FDA -
- Single-arm trial to enroll at least 59 recurrent or metastatic HRAS mutant HNSCC patients with response rate as primary endpoint -
- Company expects cash, cash equivalents and short-term investments to be sufficient to fund current operations into first half of 2020 -
- Management to host webcast and conference call today at 4:30 p.m. ET -
SAN DIEGO, March 12, 2018 - Kura Oncology, Inc., (Nasdaq: KURA) a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, today provided a regulatory update for its lead product candidate, tipifarnib, and reported fourth quarter and full year 2017 financial results.
"Following a successful end of Phase 2 meeting with the FDA, we plan to initiate a single-arm, registration-directed trial of tipifarnib in at least 59 recurrent or metastatic patients with HRAS mutant squamous cell head and neck cancer (HNSCC) with objective response rate (ORR) as the primary endpoint," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "We expect to initiate this trial, which we are calling the AIM-HN trial, in the second half of 2018. We are encouraged by the feedback we received from the FDA regarding the development path for tipifarnib in HRAS mutant HNSCC, and we look forward to providing more specific information regarding the design and execution of the trial in the months ahead."
Recent Operational Highlights
Upcoming Potential Milestones and Expectations for Clinical Programs
Financial Results for the Fourth Quarter and the Full Year 2017
Conference Call and Webcast
Kura's management will host a webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT today, March 12, 2018, to discuss the regulatory update and financial results. 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 # 5196505. A live webcast of the call will be available from the Investors and Media section of the company website at www.kuraoncology.com, and will be archived there for 30 days.
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 lead product candidate, tipifarnib, progress and expected timing of Kura Oncology's drug development programs and clinical trials, including the timing of initiation of the AIM-HN trial, and submission of regulatory filings, the presentation of data from clinical trials, plans regarding regulatory filings and future clinical trials, the regulatory approval path for tipifarnib, 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 Years Ended
December 31, December 31,
2017 2016 2017 2016
Operating Expenses:
Research and development $ 8,119 $ 5,503 $ 26,426 $ 20,404
General and administrative 2,876 1,975 9,651 7,963
Total operating expenses 10,995 7,478 36,077 28,367
Other income, net 247 131 643 807
Net loss $ (10,748 ) $ (7,347 ) $ (35,434 ) $ (27,560 )
Net loss per share, basic and diluted $ (0.37 ) $ (0.38 ) $ (1.52 ) $ (1.47 )
Weighted average number of shares used in computing net loss per share, basic and diluted 29,234 19,153 23,237 18,701
KURA ONCOLOGY, INC.
Balance Sheet Data
(unaudited)
(in thousands)
December 31, December 31,
2017 2016
Cash, cash equivalents and short-term investments $ 93,145 $ 67,790
Working capital 84,610 63,359
Total assets 95,851 69,821
Long-term liabilities 5,955 7,494
Accumulated deficit (89,290 ) (53,856 )
Stockholders' equity 79,865 56,876
Contacts for Kura Oncology
Vice President, Investor Relations &
Corporate Communications
Westwicke Partners, LLC
Canale Communications
Last updated: Mar 12, 2018