Latest News by Industry
– Abstract reporting updated data from KOMET-001 accepted for oral presentation at ASH –
– First demonstration of durable clinical response with tipifarnib plus alpelisib in HNSCC –
– AIM-HN trial of tipifarnib in HRAS mutant HNSCC closed to further enrollment –
– $25 million equity investment from Bristol Myers Squibb and $125 million term loan facility from Hercules Capital –
– $428 million in cash plus equity investment and term loan facility, if fully drawn, provide runway into 2026 –
– Management to host webcast and conference call today at 8:00 a.m. ET –
SAN DIEGO, Nov. 03, 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 third quarter 2022 financial results and provided a corporate update.
“We are very proud to announce that our abstract reporting updated data from the KOMET-001 trial of ziftomenib has been accepted for oral presentation at the upcoming American Society of Hematology (ASH) Annual Meeting in December,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “We continue to have strong conviction in ziftomenib and its potential to be a best-in-class menin inhibitor. Our confidence is supported by a growing body of clinical data, and we look forward to sharing a comprehensive update on the program at ASH.”
“Earlier this morning, we also announced a $25 million equity investment from Bristol Myers Squibb and a $125 million term loan facility from Hercules Capital,” Dr. Wilson continued. “If the term loan facility is fully drawn, proceeds from these two transactions, together with our existing cash, are expected to fund our current operating plan into 2026, enabling us to advance ziftomenib as well as our farnesyl transferase inhibitor programs through important, clinical-stage inflection points that we believe will create meaningful value for patients and shareholders.”
Recent Highlights
Financial Results
Forecasted Milestones
Conference Call and Webcast
Kura’s management will host a webcast and conference call at 8:00 a.m. ET / 5:00 a.m. PT today, November 3, 2022, to discuss the financial results for the third quarter 2022 and to provide a corporate update. The live call may be accessed by dialing (888) 394-8218 for domestic callers and (323) 994-2093 for international callers and entering the conference ID: 2251807. 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 FTI, has received Breakthrough Therapy Designation for the treatment of patients with HRAS mutant HNSCC. Kura is conducting a Phase 1/2 trial (KURRENT-HN) 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 has also initiated a Phase 1 trial (KURRENT-LUNG) of tipifarnib in combination with osimertinib in treatment-naïve locally advanced/metastatic EGFR mutant NSCLC. Kura intends to perform initial clinical evaluation with tipifarnib while in parallel advancing KO-2806, the Company’s next-generation FTI, through IND-enabling studies. For additional information, please visit Kura’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 sufficiency of cash, cash equivalents and short-term investments, plus cash from the term loan facility from Hercules, if fully drawn, to fund its current operating plan into 2026. 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, including the Company’s quarterly report on Form 10-Q for the quarter ended September 30, 2022, 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, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | $ | 24,973 | $ | 22,367 | $ | 70,144 | $ | 63,765 | ||||||||
| General and administrative | 11,621 | 11,310 | 34,565 | 34,455 | ||||||||||||
| Total operating expenses | 36,594 | 33,677 | 104,709 | 98,220 | ||||||||||||
| Other income (expense), net | 1,090 | 311 | 1,983 | 497 | ||||||||||||
| Net loss | $ | (35,504 | ) | $ | (33,366 | ) | $ | (102,726 | ) | $ | (97,723 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.53 | ) | $ | (0.50 | ) | $ | (1.54 | ) | $ | (1.47 | ) | ||||
| Weighted average number of shares used in computing net loss per share, basic and diluted | 66,889 | 66,353 | 66,723 | 66,285 | ||||||||||||
| KURA ONCOLOGY, INC. | ||||||||
| Balance Sheet Data | ||||||||
| (unaudited) | ||||||||
| (in thousands) | ||||||||
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Cash, cash equivalents and short-term investments | $ | 427,775 | $ | 517,960 | ||||
| Working capital | 411,646 | 499,834 | ||||||
| Total assets | 447,988 | 534,051 | ||||||
| Long-term liabilities | 3,622 | 4,987 | ||||||
| Accumulated deficit | (535,694 | ) | (432,968 | ) | ||||
| Stockholders’ equity | 419,621 | 506,609 | ||||||
Contacts
Company:
Pete De Spain
Senior Vice President, Investor Relations &
Corporate Communications
(858) 500-8803
pete@kuraoncology.com
Investors:
Robert H. Uhl
Managing Director
ICR Westwicke
(858) 356-5932
robert.uhl@westwicke.com
Media:
Jason Spark
Managing Director
Evoke Canale
(619) 849-6005
jason.spark@evokegroup.com