Full Press Release Details
Kura Oncology Reports Second Quarter 2021
- First patients dosed in Phase 1b expansion cohorts with menin inhibitor KO-539 -
- Clinical collaboration with Novartis to evaluate tipifarnib in combination with the PI3K inhibitor alpelisib in HNSCC -
- KO-2806 nominated as lead development candidate in next-generation farnesyl transferase inhibitor program -
- $567.5 million in cash, cash equivalents and investments provide runway into 2024 -
- Management to host webcast and conference call today at 4:30 p.m. ET -
SAN DIEGO, August 5, 2021 - 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 2021 financial results and provided a corporate update.
"I am extremely proud of the progress our team has made over the past several months, underscoring our focus on operational execution," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "We continue to have strong conviction in KO-539 and its potential to be both a first-in-class and a best-in-class menin inhibitor. This confidence is supported by clinical data from KOMET-001, our Phase 1/2 trial of KO-539 in patients with relapsed or refractory acute myeloid leukemia (AML). Given the wide therapeutic window KO-539 demonstrated in the Phase 1a dose escalation portion of the trial, we have now advanced into the Phase 1b expansion cohorts in patients with NPM1-mutant and KMT2A-rearranged relapsed/refractory AML. The Phase 1b enables us to refine the selection of a recommended Phase 2 dose while maintaining an aggressive development timeline for the program."
"Although it is early and the results are still preliminary," continued Dr. Wilson, "we are encouraged by observations of early signs of clinical activity in the Phase 1b expansion cohorts. We are also encouraged by the rate of patient screening and enrollment, an indication of the enthusiasm of the investigators as well as the strong execution of our clinical operations team. We intend to provide an update on both the Phase 1a and the Phase 1b at a future medical meeting, pending determination of the recommended
Phase 2 dose. In the meantime, we look forward to providing qualitative updates on the progress of the Phase 1b in the months ahead."
Financial Results and Guidance
Conference Call and Webcast
Kura's management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, August 5, 2021, to discuss the financial results for the second quarter 2021 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: 3171857. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.kuraoncology.com.
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. KO-539, a potent and selective menin inhibitor, is currently in a Phase 1/2 clinical trial (KOMET-001) and targeting patients with relapsed/refractory AML, including patients with NPM1 mutations or KMT2A rearrangements. Tipifarnib, a potent, selective and orally bioavailable farnesyl transferase inhibitor, has received Breakthrough Therapy Designation for the treatment of patients with HRAS mutant HNSCC and is currently in a registration-directed study (AIM-HN) in patients with this devastating disease. In addition, Kura is pursuing the use of tipifarnib in combination with other oncology therapeutics to address larger genetic subsets of patients, including those who have HRAS- and/or PIK3CA-dependent HNSCC. The Company is also developing a next-generation farnesyl transferase inhibitor, which is intended to target innovative biology and larger oncology indications through rational combinations. 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-539 and KO-2806, 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, applications and other interactions with regulatory bodies, 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 | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | $ | 21,074 | $ | 13,697 | $ | 41,398 | $ | 26,272 | ||||||||
| General and administrative | 12,573 | 7,476 | 23,145 | 15,101 | ||||||||||||
| Total operating expenses | 33,647 | 21,173 | 64,543 | 41,373 | ||||||||||||
| Other income (expense), net | (16 | ) | 686 | 186 | 1,676 | |||||||||||
| Net loss | $ | (33,663 | ) | $ | (20,487 | ) | $ | (64,357 | ) | $ | (39,697 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.51 | ) | $ | (0.40 | ) | $ | (0.97 | ) | $ | (0.82 | ) | ||||
| Weighted average number of shares used in computing net loss per share, basic and diluted | 66,282 | 51,633 | 66,250 | 48,522 |
| KURA ONCOLOGY, INC. | ||||||||
| Balance Sheet Data | ||||||||
| (unaudited) | ||||||||
| (in thousands) | ||||||||
| June 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Cash, cash equivalents and short-term investments | $ | 567,494 | $ | 633,320 | ||||
| Working capital | 552,342 | 611,268 | ||||||
| Total assets | 584,891 | 647,212 | ||||||
| Long-term liabilities | 5,050 | 10,283 | ||||||
| Accumulated deficit | (366,859 | ) | (302,502 | ) | ||||
| Stockholders' equity | 558,551 | 610,905 |
Vice President, Investor Relations &
Corporate Communications
Westwicke Partners, LLC
Canale Communications