– Registration-directed trial of tipifarnib in HRAS mutant head and neck squamous cell carcinomas (HNSCC) on track to initiate in second half of 2018 –
– Data from multiple Phase 2 trials of tipifarnib in solid tumor and hematologic indications anticipated in second half of 2018 –
– Company expects cash, cash equivalents and short-term investments will be sufficient to fund current operations into the first half of 2020 –
– Management to host webcast and conference call today at 4:30 p.m. ET –
SAN DIEGO, May 08, 2018 (GLOBE NEWSWIRE) -- Kura Oncology, Inc., (Nasdaq:KURA) a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, today reported first quarter 2018 financial results and provided a corporate update.
“I am very pleased with the progress we made over the past quarter, highlighted by a successful end of Phase 2 meeting with the FDA,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “We are working diligently to initiate AIM-HN, our registration-directed trial of tipifarnib in HRAS mutant HNSCC, as well as SEQ-HN, our concurrent screening and outcomes study. We believe that tipifarnib has the potential to become an important treatment option for patients with HRAS mutant HNSCC, and we are committed to executing the clinical and regulatory strategy that best positions it for success.”
“We are also excited about the potential to expand the clinical utility of tipifarnib to other solid tumor and hematologic indications,” continued Dr. Wilson. “We are evaluating tipifarnib in multiple biomarker-guided Phase 2 clinical trials, and our goal is to generate proof-of-concept data in one or more of these additional indications by year end. We believe we have the cash runway to advance tipifarnib and our emerging pipeline of drug candidates through a series of upcoming potential data catalysts, and we look forward to providing further updates on our progress in the months ahead.”
Corporate Update
Upcoming Milestones
Financial Results
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, May 8, 2018, to discuss the financial results for the first quarter of 2018 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 using conference ID #7199738. 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.
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 Oncology’s lead drug candidate is tipifarnib, a farnesyl transferase inhibitor, which is currently being studied in multiple Phase 2 clinical trials in solid tumor and hematologic indications. The company plans to initiate the AIM-HN trial, a single-arm, registration-directed trial of tipifarnib in at least 59 recurrent or metastatic patients with HRAS mutant HNSCC in the second half of 2018. 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 development. 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, tipifarnib, KO-947 and KO-539, 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 | |||||||
March 31, | |||||||
2018 | 2017 | ||||||
Operating Expenses: | |||||||
Research and development | $ | 11,566 | $ | 5,513 | |||
General and administrative | 3,425 | 2,140 | |||||
Total operating expenses | 14,991 | 7,653 | |||||
Other income, net | 387 | 120 | |||||
Net loss | $ | (14,604 | ) | $ | (7,533 | ) | |
Net loss per share, basic and diluted | $ | (0.46 | ) | $ | (0.39 | ) | |
Weighted average number of shares used in computing net loss per share, basic and diluted | 31,829 | 19,464 | |||||
KURA ONCOLOGY, INC. | |||||||
Balance Sheet Data | |||||||
(unaudited) | |||||||
(in thousands) | |||||||
March 31, | December 31, | ||||||
2018 | 2017 | ||||||
Cash, cash equivalents and short-term investments | $ | 138,200 | $ | 93,145 | |||
Working capital | 129,010 | 84,610 | |||||
Total assets | 141,458 | 95,851 | |||||
Long-term liabilities | 5,307 | 5,955 | |||||
Accumulated deficit | (103,894 | ) | (89,290 | ) | |||
Stockholders’ equity | 124,800 | 79,865 | |||||
Contacts
Company:
Pete De Spain
Vice President, Investor Relations &
Corporate Communications
(858) 500-8803
[email protected]
Investors:
Robert H. Uhl
Managing Director
Westwicke Partners, LLC
(858) 356-5932
[email protected]
Media:
Jason Spark
Managing Director
Canale Communications
(619) 849-6005
[email protected]
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