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– Updated data from Phase 2 trial of tipifarnib in HRAS mutant HNSCC support enrichment strategy in ongoing registration-directed trial –
– Data from Phase 2 trial of tipifarnib in AITL accepted for oral presentation at ASH 2019 –
– Initiation of first-in-class menin-MLL inhibitor KO-539 gives Company three wholly owned, clinical-stage oncology assets –
– $250 million in cash, cash equivalents and investments provide runway into second half of 2021 –
– Management to host webcast and conference call today at 4:30 p.m. ET –
SAN DIEGO, Nov. 05, 2019 (GLOBE NEWSWIRE) -- 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 third quarter 2019 financial results and provided a corporate update.
“We continue to be very encouraged by our growing body of data that support the potential of tipifarnib, highlighted recently by impressive results from our ongoing Phase 2 trial in HRAS mutant head and neck squamous cell carcinomas (HNSCC),” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “These data underscore the activity of tipifarnib in this difficult-to-treat patient population, and we believe they increase the probability of success of our registrational strategy in HRAS mutant HNSCC. We continue to execute on our AIM-HN registration-directed trial, which, if positive, will establish tipifarnib as a first-in-class farnesyl transferase inhibitor for patients with cancer. In addition, we look forward to additional data later this year from our ongoing Phase 2 trial in angioimmunoblastic T-cell lymphoma (AITL), an indication for which we are seeking regulatory feedback regarding next steps.”
“Meanwhile, we continue to make steady and encouraging progress with our emerging pipeline programs,” Dr. Wilson continued, “including continued dose escalation of our ERK inhibitor, KO-947, and the initiation of a Phase 1 trial of our first-in-class menin-MLL inhibitor, KO-539, in patients with relapsed or refractory acute myeloid leukemia (AML). We believe both of our early-stage drug candidates represent differentiated approaches that could potentially address large indications with high unmet need, and we look forward to sharing updates on all of our progress in the months 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, November 5, 2019, to discuss the financial results for the third quarter 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: 5159117. 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 a replay will be available shortly after the live event.
About Kura Oncology
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 in recurrent or metastatic patients with HRAS mutant head and neck squamous cell carcinoma. 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 dose-escalation trials. For additional information about Kura, please visit the Company’s website at www.kuraoncology.com.
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 potential expansion of tipifarnib to additional indications, 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 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 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|
|(in thousands, except per share data)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development||$||12,540||$||11,661||$||34,362||$||34,703|
|General and administrative||5,134||4,321||14,154||11,546|
|Total operating expenses||17,674||15,982||48,516||46,249|
|Other income, net||1,282||975||3,241||1,899|
|Net loss per share, basic and diluted||$||(0.36||)||$||(0.40||)||$||(1.11||)||$||(1.30||)|
|Weighted average number of shares used in computing net loss per share, basic and diluted||45,241||37,789||40,805||34,218|
|KURA ONCOLOGY, INC.|
|Balance Sheet Data|
|September 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||250,126||$||178,985|
Pete De Spain
Vice President, Investor Relations &
Robert H. Uhl