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Kura Oncology Reports Third Quarter 2021 Financial Results - Continued enrollment in Phase 1b study of menin inhibitor KO-539 in NPM1-mutant and KMT2A-rearranged relapsed/refractory AML - - ASH presentation to highlight

Key Takeaway: Kura Oncology Reports Third Quarter 2021 - Continued enrollment in Phase 1b study of menin inhibitor KO-539 in NPM1-mutant and KMT2A-rearranged relapsed/refractory AML - - ASH presentation to highlight molecular mechanisms of activity for KO-539 and potential for synergistic ac

Full Press Release Details

Kura Oncology Reports Third Quarter 2021
- Continued enrollment in Phase 1b study of menin inhibitor KO-539 in NPM1-mutant and KMT2A-rearranged relapsed/refractory AML -
- ASH presentation to highlight molecular mechanisms of activity for KO-539 and potential for synergistic activity in combination with venetoclax -
- First clinical site activated in Phase 1/2 trial of tipifarnib plus alpelisib in HNSCC -
- $543.4 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, Nov. 4, 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 third quarter 2021 financial results and provided a corporate update.
"I am pleased by the progress our team has made over the past quarter, highlighted by accelerated enrollment in the Phase 1b expansion cohorts for KO-539," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "We continue to be encouraged by preliminary results from the Phase 1b study, with evidence of activity at both doses and a favorable safety and tolerability profile. Pending determination of a recommended Phase 2 dose, we are designing a development strategy that builds on the potential to register KO-539 as a monotherapy, while giving us the flexibility to get to larger opportunities in combination more quickly, including in earlier lines of therapy. We look forward to providing a more comprehensive update, including results from the Phase 1a and Phase 1b studies, at a future medical meeting."
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, November 4, 2021, to discuss the financial results for the third quarter 2021 and provide a corporate update. The live call may be accessed by dialing (866) 269-4260 for domestic callers and (323) 347-3277 for international callers and entering the
conference code: 9395801. 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 Nine Months Ended
September 30, September 30,
2021 2020 2021 2020
Operating Expenses:
Research and development $ 22,367 $ 16,601 $ 63,765 $ 42,873
General and administrative 11,310 7,593 34,455 22,694
Total operating expenses 33,677 24,194 98,220 65,567
Other income (expense), net 311 425 497 2,101
Net loss $ (33,366 ) $ (23,769 ) $ (97,723 ) $ (63,466 )
Net loss per share, basic and diluted $ (0.50 ) $ (0.42 ) $ (1.47 ) $ (1.24 )
Weighted average number of shares used in computing net loss per share, basic and diluted 66,353 56,405 66,285 51,169
KURA ONCOLOGY, INC.
Balance Sheet Data
(unaudited)
(in thousands)
September 30, December 31,
2021 2020
Cash, cash equivalents and short-term investments $ 543,445 $ 633,320
Working capital 526,979 611,268
Total assets 561,141 647,212
Long-term liabilities 5,459 10,283
Accumulated deficit (400,225 ) (302,502 )
Stockholders' equity 533,756 610,905
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Westwicke Partners, LLC
Canale Communications
Last updated: Nov 4, 2021