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- Registration-directed trial of tipifarnib in HRAS mutant HNSCC ongoing –
– Positive Phase 2 trial of tipifarnib in AITL and CXCL12-driven PTCL support potential paths to registration –
– Additional Phase 2 data in HRAS mutant HNSCC, other SCCs and AITL anticipated in fourth quarter of 2019 –
– Strengthened balance sheet with $261.4 million in cash, cash equivalents and investments –
– Management to host webcast and conference call today at 4:30 p.m. ET –
SAN DIEGO, Aug. 01, 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 second quarter 2019 financial results and provided a corporate update.
“The past quarter was highlighted by impressive data from our ongoing Phase 2 trial of tipifarnib in peripheral T-cell lymphoma (PTCL),” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “These data support the potential to register tipifarnib in both the angioimmunoblastic T-cell lymphoma (AITL) and PTCL not otherwise specified (PTCL-NOS) populations. In addition, we took further steps toward broadening the potential of farnesyl transferase inhibition to treat other CXCL12-driven indications of high unmet need, including diffuse large B-cell lymphoma (DLBCL), cutaneous T-cell lymphoma (CTCL), acute myeloid leukemia (AML) and pancreatic cancer. These advancements, along with the continued execution of our registration-directed study in HRAS mutant head and squamous cell carcinomas (HNSCC), are important steps toward establishing tipifarnib as a first-in-class farnesyl transferase inhibitor for patients with certain genetically defined cancers.”
“As we look toward the second half of this year and early next year, we anticipate a number of milestones across our pipeline programs,” continued Dr. Wilson, “including an update from our ongoing Phase 2 trial of tipifarnib in HRAS mutant HNSCC and other squamous cell carcinomas (SCCs), additional Phase 2 data in AITL, completion of the dose-escalation portion of the Phase 1 trial of our ERK inhibitor, KO-947, and initiation of the Phase 1 trial of our menin-MLL inhibitor, KO-539. With our successful public offering in June, we have greater resources and flexibility to continue to create value across our pipeline.”
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, August 1, 2019, to discuss the financial results for the second 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: 5261899. 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. Kura’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 Kura has initiated a registration-directed trial 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 has been cleared to begin a Phase 1 clinical trial. 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||Six Months Ended|
|June 30,||June 30,|
|Research and development||$||11,440||$||11,476||$||21,822||$||23,042|
|General and administrative||4,451||3,800||9,020||7,225|
|Total operating expenses||15,891||15,276||30,842||30,267|
|Other income, net||948||537||1,959||924|
|Net loss per share, basic and diluted||$||(0.38||)||$||(0.45||)||$||(0.75||)||$||(0.91||)|
|Weighted average number of shares used in computing net loss per share, basic and diluted||38,928||32,971||38,550||32,403|
|KURA ONCOLOGY, INC.|
|Balance Sheet Data|
|June 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||261,413||$||178,985|
Pete De Spain
Vice President, Investor Relations &
Robert H. Uhl
Westwicke Partners, LLC