Exhibit 99.1
Kura Oncology Reports First Quarter 2023
Financial Results
– Evolving data from Phase 1 trial of ziftomenib in NPM1-mutant AML to be presented at EHA –
– Site activation and enrollment in Phase 2 registration-directed trial of ziftomenib in NPM1-mutant AML outperforming projections –
– First combination study of ziftomenib in NPM1-mutant and KMT2A-rearranged AML to dose first patients in the second quarter of 2023 –
– Preclinical data highlighting potential use of FTIs in combination with multiple targeted therapies presented at AACR –
– IND for KO-2806, a next-generation FTI, cleared by FDA –
– $406 million in cash, equivalents and investments provide runway into fourth quarter of 2025 –
– Management to host webcast and conference call today at 4:30 p.m. ET –
SAN DIEGO, May 10, 2023– 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 first quarter 2023 financial results and provided a corporate update.
“Our conviction in ziftomenib and its potential to be the best-in-class menin inhibitor continues to increase,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “This confidence is supported by one of the highest complete response rates reported for a targeted therapy in the setting of relapsed/refractory leukemia and is reinforced by the rapid pace of enrollment in our ongoing registration-directed trial in NPM1-mutant acute myeloid leukemia (AML). We are also encouraged by the durable remissions in our Phase 1 trial, driven primarily by the single-agent activity of ziftomenib, and we look forward to presenting an update at the European Hematology Association (EHA) Congress next month. In parallel, we aim to broaden the opportunity for ziftomenib through a series of combination studies and remain on track to initiate the first of these studies, KOMET-007, later this quarter.”
Recent Highlights
Financial Results
Forecasted 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, May 10, 2023, to discuss the financial results for the first quarter 2023 and to provide a corporate update. The live call may be accessed by dialing (888) 886-7786 for domestic callers and (416) 764-8658 for international callers and entering the conference ID: 52214288. 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 is a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction for the treatment of genetically defined AML patients with high unmet need. The Company is currently enrolling patients in a Phase 2 registration-directed trial (KOMET-001) of ziftomenib in NPM1-mutant relapsed or refractory AML. Kura is preparing to initiate multiple Phase 1 trials to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations, including NPM1-mutant and KMT2A-rearranged AML. Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial (KURRENT-HN) in combination with alpelisib for patients with PIK3CA-dependent HNSCC. Kura intends to evaluate KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial (FIT-001) as a monotherapy and in combination with other targeted therapies in adult patients with advanced solid tumors. 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 to fund its current operating plan into fourth quarter of 2025. 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 |
| |||||
|
| March 31, |
| |||||
|
| 2023 |
|
| 2022 |
| ||
Operating Expenses: |
|
|
|
|
|
| ||
Research and development |
| $ | 25,192 |
|
| $ | 20,913 |
|
General and administrative |
|
| 11,374 |
|
|
| 11,869 |
|
Total operating expenses |
|
| 36,566 |
|
|
| 32,782 |
|
Other income, net |
|
| 2,497 |
|
|
| 329 |
|
Net loss |
| $ | (34,069 | ) |
| $ | (32,453 | ) |
Net loss per share, basic and diluted |
| $ | (0.50 | ) |
| $ | (0.49 | ) |
Weighted average number of shares used in |
|
| 68,403 |
|
|
| 66,607 |
|
|
|
|
|
|
|
|
KURA ONCOLOGY, INC. |
| |||||||
Balance Sheet Data |
| |||||||
(unaudited) |
| |||||||
(in thousands) |
| |||||||
|
|
|
|
|
|
| ||
|
| March 31, |
|
| December 31, |
| ||
|
| 2023 |
|
| 2022 |
| ||
Cash, cash equivalents and short-term investments |
| $ | 405,900 |
|
| $ | 437,985 |
|
Working capital |
|
| 397,217 |
|
|
| 422,369 |
|
Total assets |
|
| 425,975 |
|
|
| 456,306 |
|
Long-term liabilities |
|
| 11,559 |
|
|
| 11,971 |
|
Accumulated deficit |
|
| (602,877 | ) |
|
| (568,808 | ) |
Stockholders’ equity |
|
| 395,183 |
|
|
| 420,278 |
|
Contacts
Investors:
Pete De Spain
Senior Vice President, Investor Relations &
Corporate Communications
(858) 500-8803
pete@kuraoncology.com
Media:
Alexandra Weingarten
Senior Manager, Corporate Communications
(858) 500-8822
alexandra@kuraoncology.com