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Kura Oncology Reports Fourth Quarter and Full Year 2019 Financial Results - Registration-directed trial of tipifarnib in HRAS mutant head and neck squamous cell carcinomas anticipated to complete enrollment in first quar

Key Takeaway: Kura Oncology Reports Fourth Quarter and Full Year 2019 Financial Results - Registration-directed trial of tipifarnib in HRAS mutant head and neck squamous cell carcinomas anticipated to complete enrollment in first quarter of 2021 - - Company preparing to initiate a registrati

Full Press Release Details

Kura Oncology Reports Fourth Quarter and Full Year 2019 Financial Results
- Registration-directed trial of tipifarnib in HRAS mutant head and neck squamous cell carcinomas anticipated to complete enrollment in first quarter of 2021 -
- Company preparing to initiate a registration-directed trial of tipifarnib in T-cell lymphomas following positive feedback from FDA -
- Recommended Phase 2 dose defined for ERK inhibitor KO-947-
- Phase 1/2 dose-escalation continues for menin-MLL inhibitor KO-539 -
- $236.9 million in cash, cash equivalents and investments provide runway into 2022 -
- Management to host webcast and conference call today at 4:30 p.m. ET -
SAN DIEGO, Feb. 25, 2020 - Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported fourth quarter and full year 2019 financial results and provided a corporate update.
"We entered the new year with three wholly owned, clinical-stage drug candidates and a focus on operational execution across our pipeline," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "The conduct of AIM-HN, our registrational-directed trial of tipifarnib in HRAS mutant head and neck squamous cell carcinoma (HNSCC), remains our highest priority. We have also taken a number of steps to better position the company for our next phase of growth, including an increasing investment in pre-commercial activities, expansion of our team of medical science liaisons and the appointment of a Chief Commercial Officer.
"Meanwhile, our growing body of clinical data in T-cell lymphomas, coupled with positive regulatory feedback and the high unmet need for these patients, support our efforts to expand the development of tipifarnib beyond our initial focus in HRAS mutant solid tumors," Dr. Wilson continued. "And we continue to make progress with our emerging drug candidates, KO-947 and KO-539, each with the potential to address genetically defined populations of cancer patients. We believe we are well positioned to advance each of our programs to meaningful inflection points, and we look forward to providing updates on our progress in the year ahead."
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, February 25, 2020, to discuss the financial results for the fourth quarter and full year 2019 and provide a corporate update. The live call may be accessed by dialing (877) 516-3514 for domestic callers and (281) 973-6129 for international callers and entering the conference code: 8077975. A live webcast of the call will be available from the Investors and Media section of the Company's 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's lead drug candidate is tipifarnib, a farnesyl transferase inhibitor, for which the Company is conducting a registration-directed trial of tipifarnib in recurrent or metastatic patients with HRAS
mutant HNSCC. In addition, tipifarnib is being evaluated in multiple other Phase 2 clinical trials in solid tumor and hematologic indications. Kura's pipeline also includes KO-947, an ERK inhibitor, and KO-539, a menin-MLL inhibitor, both of which are currently in Phase 1 clinical trials. For additional information about Kura, 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's product candidates, tipifarnib, KO-947 and KO-539, progress and expected timing of Kura's drug development programs and clinical trials 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'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 may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, applications and other interactions with regulatory bodies, 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 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 Year Ended
December 31, December 31,
2019 2018 2019 2018
Operating Expenses:
Research and development $ 13,464 $ 12,084 $ 47,826 $ 46,787
General and administrative 5,499 4,550 19,653 16,096
Total operating expenses 18,963 16,634 67,479 62,883
Other income, net 1,098 537 4,339 2,436
Net loss $ (17,865 ) $ (16,097 ) $ (63,140 ) $ (60,447 )
Net loss per share, basic and diluted $ (0.39 ) $ (0.42 ) $ (1.51 ) $ (1.72 )
Weighted average number of shares used in computing net loss per share, basic and diluted 45,333 38,079 41,946 35,191
KURA ONCOLOGY, INC.
Balance Sheet Data
(unaudited)
(in thousands)
December 31, December 31,
2019 2018
Cash, cash equivalents and short-term investments $ 236,891 $ 178,985
Working capital 224,039 167,582
Total assets 241,972 182,379
Long-term liabilities 7,627 7,779
Accumulated deficit (212,877 ) (149,737 )
Stockholders' equity 218,781 160,985
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Canale Communications
Last updated: Feb 25, 2020