Full Press Release Details
Kura Oncology Reports Fourth Quarter and Full Year 2018 Financial Results
- Registration-directed trial of tipifarnib in HRAS mutant HNSCC underway -
- Data from three ongoing Phase 2 trials of tipifarnib anticipated this year -
- Third drug candidate menin-MLL inhibitor KO-539 poised to enter clinic next quarter -
- $179 million in cash, cash equivalents and investments provide runway into 2021 -
- Management to host webcast and conference call today at 4:30 p.m. ET -
SAN DIEGO, March 5, 2019 - 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 2018 financial results and provided a corporate update.
"I am very pleased with the progress we have made over the past year, highlighted by the initiation of our registration-directed trial of tipifarnib in HRAS mutant head and neck squamous cell carcinoma (HNSCC)," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "In addition, we have made considerable strides toward broadening the clinical utility of tipifarnib, showing proof-of-concept in angioimmunoblastic T-cell lymphoma (AITL), validating CXCL12 as a therapeutic target in peripheral T-cell lymphoma (PTCL) and identifying a potential association between CXCL12 expression and clinical benefit in pancreatic cancer. Together, these efforts are helping us to expand the opportunity for tipifarnib beyond HRAS mutant solid tumors and into additional indications of high unmet need."
"As we begin 2019, we believe Kura is well positioned, with additional data from three ongoing Phase 2 trials of tipifarnib expected throughout the year and an emerging pipeline that includes KO-947, an ERK inhibitor with Phase 1 data expected later this year, and KO-539, a menin-MLL inhibitor that is anticipated to enter the clinic next quarter. We look forward to providing updates on each of our programs during the year as we continue to execute on our initial registration-directed trial."
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 5, 2019, to discuss the financial results for the fourth quarter and full year 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 entering the conference code: 8996475. 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 has initiated 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, currently in a Phase 1 dose-escalation trial, and KO-539, a menin-MLL inhibitor, which is anticipated to enter into a Phase 1 clinical trial in the second quarter of 2019. 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 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 | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| (in thousands, except per share data) | ||||||||||||||||
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | $ | 12,084 | $ | 8,119 | $ | 46,787 | $ | 26,426 | ||||||||
| General and administrative | 4,550 | 2,876 | 16,096 | 9,651 | ||||||||||||
| Total operating expenses | 16,634 | 10,995 | 62,883 | 36,077 | ||||||||||||
| Other income, net | 537 | 247 | 2,436 | 643 | ||||||||||||
| Net loss | $ | (16,097 | ) | $ | (10,748 | ) | $ | (60,447 | ) | $ | (35,434 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.42 | ) | $ | (0.37 | ) | $ | (1.72 | ) | $ | (1.52 | ) | ||||
| Weighted average number of shares used in computing net loss per share, basic and diluted | 38,079 | 29,234 | 35,191 | 23,237 |
| KURA ONCOLOGY, INC. | ||||||||
| Balance Sheet Data | ||||||||
| (unaudited) | ||||||||
| (in thousands) | ||||||||
| December 31, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Cash, cash equivalents and short-term investments | $ | 178,985 | $ | 93,145 | ||||
| Working capital | 167,582 | 84,610 | ||||||
| Total assets | 182,379 | 95,851 | ||||||
| Long-term liabilities | 7,779 | 5,955 | ||||||
| Accumulated deficit | (149,737 | ) | (89,290 | ) | ||||
| Stockholders' equity | 160,985 | 79,865 |
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Westwicke Partners, LLC
Canale Communications