Full Press Release Details
Kura Oncology Reports Third Quarter 2018 Financial Results and Provides Corporate Update
- Registration-directed trial of tipifarnib in HRAS mutant HNSCC now underway -
- Encouraging preliminary clinical activity observed in HRAS mutant SCC cohort -
- Preliminary data from AITL and CXCL12+ cohorts in Phase 2 trial of tipifarnib in PTCL upcoming at ASH -
- $187.4 million in cash, cash equivalents and short-term investments -
- Management to host webcast and conference call today at 4:30 p.m. ET -
SAN DIEGO, November 5, 2018 - Kura Oncology, Inc., (Nasdaq: KURA) a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, today reported third quarter 2018 financial results and provided a corporate update.
"We are very encouraged by our growing body of data that support the potential of tipifarnib as a treatment for squamous cell carcinomas characterized by HRAS mutations," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "With our registration-directed trial of tipifarnib in HRAS mutant head and neck squamous cell carcinomas (HNSCC) now underway, we are focused on generating a data package to support an application for marketing approval in that indication, as we work to broaden the potential of tipifarnib in both HRAS mutant and non-HRAS mutant cancers. In that regard, we are encouraged by preliminary signals of clinical activity observed in patients with HRAS mutant SCCs as we believe this may represent a near-term opportunity to expand the use of tipifarnib into a broader set of HRAS mutant cancers."
"In addition," Dr. Wilson continued, "we believe the CXCL12 pathway also holds promise for identifying patients who will respond to tipifarnib, and we look forward to showing data next month at the American Society of Hematology (ASH) Annual Meeting from our ongoing Phase 2 clinical trial in patients with peripheral T-cell lymphoma (PTCL) in which we are evaluating, on a prospective basis, the role of the CXCL12 pathway and markers of bone marrow homing as potential biomarkers of clinical activity of tipifarnib."
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, November 5, 2018, to discuss the financial results for the third 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 entering the conference code: 6593979. 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 at least 59 recurrent or metastatic patients with HRAS mutant head and neck squamous cell carcinomas. 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, 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 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 | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | $ | 11,661 | $ | 7,142 | $ | 34,703 | $ | 18,307 | ||||||||
| General and administrative | 4,321 | 2,357 | 11,546 | 6,775 | ||||||||||||
| Total operating expenses | 15,982 | 9,499 | 46,249 | 25,082 | ||||||||||||
| Other income, net | 975 | 166 | 1,899 | 396 | ||||||||||||
| Net loss | $ | (15,007 | ) | $ | (9,333 | ) | $ | (44,350 | ) | $ | (24,686 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.40 | ) | $ | (0.38 | ) | $ | (1.30 | ) | $ | (1.16 | ) | ||||
| Weighted average number of shares used in computing net loss per share, basic and diluted | 37,789 | 24,344 | 34,218 | 21,217 |
| KURA ONCOLOGY, INC. | ||||||||
| Balance Sheet Data | ||||||||
| (unaudited) | ||||||||
| (in thousands) | ||||||||
| September 30, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Cash, cash equivalents and short-term investments | $ | 187,423 | $ | 93,145 | ||||
| Working capital | 177,487 | 84,610 | ||||||
| Total assets | 191,500 | 95,851 | ||||||
| Long-term liabilities | 3,988 | 5,955 | ||||||
| Accumulated deficit | (133,640 | ) | (89,290 | ) | ||||
| Stockholders' equity | 174,607 | 79,865 |
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Corporate Communications
Westwicke Partners, LLC
Canale Communications