– Patient enrollment continues in KOMET-001 Phase 1b study of ziftomenib (KO-539) in AML –
– Multiple milestones and data readouts from KOMET-001 expected in 2022 –
– First patients dosed in Phase 1/2 study of tipifarnib plus alpelisib in HNSCC –
– Abstract supporting next-generation FTI program accepted for presentation at AACR –
– $518 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, Feb. 24, 2022 (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 fourth quarter and full year 2021 financial results and provided a corporate update.
“We have made meaningful advancements across our programs during the past year, and we begin 2022 with significant momentum, resources and enthusiasm,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “By mid-2022, we expect to have three independent drug development programs with potential to create value in both solid and liquid tumor indications with high unmet need. We anticipate meaningful data catalysts for each of these programs in the next six to 24 months, beginning with top-line data from our KOMET-001 Phase 1b study. And we approach these catalysts from a position of strength, with an experienced team and more than $500 million in cash.”
Recent Highlights
Financial Results
2022 Milestones
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, February 24, 2022, to discuss the financial results for the fourth quarter and full year 2021 and to 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: 8645626. 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.
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. Ziftomenib (KO-539), a potent and selective menin inhibitor, is currently in a Phase 1b clinical trial (KOMET-001) for patients with relapsed/refractory AML, including patients with NPM1 mutations or KMT2A rearrangements. Tipifarnib, a potent, selective and orally bioavailable farnesyl transferase inhibitor (FTI), has received Breakthrough Therapy Designation for the treatment of patients with HRAS mutant HNSCC and is currently in a registration-directed trial (AIM-HN) in patients with this devastating disease. In addition, Kura is conducting a Phase 1/2 trial (KURRENT) of tipifarnib in combination with the PI3Kα inhibitor alpelisib to address larger genetic subsets of HNSCC patients, including those whose tumors are dependent on HRAS and/or PI3Kα pathways. The Company is also developing KO-2806, a next-generation FTI, 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, ziftomenib, tipifarnib 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 | Year Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Operating Expenses: | ||||||||||||||||
Research and development | $ | 20,956 | $ | 17,524 | $ | 84,721 | $ | 60,397 | ||||||||
General and administrative | 12,082 | 8,808 | 46,537 | 31,502 | ||||||||||||
Total operating expenses | 33,038 | 26,332 | 131,258 | 91,899 | ||||||||||||
Other income (expense), net | 295 | 173 | 792 | 2,274 | ||||||||||||
Net loss | $ | (32,743 | ) | $ | (26,159 | ) | $ | (130,466 | ) | $ | (89,625 | ) | ||||
Net loss per share, basic and diluted | $ | (0.49 | ) | $ | (0.45 | ) | $ | (1.97 | ) | $ | (1.69 | ) | ||||
Weighted average number of shares used in computing net loss per share, basic and diluted | 66,550 | 58,760 | 66,352 | 53,077 | ||||||||||||
KURA ONCOLOGY, INC. | ||||||||
Balance Sheet Data | ||||||||
(unaudited) | ||||||||
(in thousands) | ||||||||
December 31, | December 31, | |||||||
2021 | 2020 | |||||||
Cash, cash equivalents and short-term investments | $ | 517,960 | $ | 633,320 | ||||
Working capital | 499,834 | 611,268 | ||||||
Total assets | 534,051 | 647,212 | ||||||
Long-term liabilities | 4,987 | 10,283 | ||||||
Accumulated deficit | (432,968 | ) | (302,502 | ) | ||||
Stockholders’ equity | 506,609 | 610,905 |
Contacts
Company:
Pete De Spain
Senior Vice President, Investor Relations &
Corporate Communications
(858) 500-8803
[email protected]
Investors:
Robert H. Uhl
Managing Director
ICR Westwicke
(858) 356-5932
[email protected]
Media:
Jason Spark
Managing Director
Canale Communications
(619) 849-6005
[email protected]
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