UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On February 23, 2023, Kura Oncology, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the fourth quarter and year ended December 31, 2022 and providing a corporate update. A copy of this press release is furnished herewith as Exhibit 99.1.
The information contained in this Current Report on Form 8-K under Item 2.02 and Exhibit 99.1 hereto are being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section and will not be incorporated by reference into any registration statement filed by the Company, under the Securities Act of 1933, as amended, unless specifically identified as being incorporated therein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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Description |
99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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KURA ONCOLOGY, INC. |
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Date: February 23, 2023 |
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By: |
/s/ Teresa Bair |
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Teresa Bair |
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Chief Legal Officer |
Exhibit 99.1
Kura Oncology Reports Fourth Quarter and Full Year 2022 Financial Results
– Phase 1 data for ziftomenib highlighted by 30% CR rate among 20 patients with NPM1-mutant AML treated at recommended Phase 2 dose –
– Multiple patients dosed in registration-directed trial of ziftomenib in NPM1-mutant AML –
– First combination study of ziftomenib in NPM1-mutant and KMT2A-rearranged AML on track to initiate in first half of 2023 –
– IND for KO-2806, a next-generation farnesyl transferase inhibitor, cleared by FDA –
– $25 million strategic equity investment from Bristol Myers Squibb –
– $438 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, Feb. 23, 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 fourth quarter and full year 2022 financial results and provided a corporate update.
“We continue to have strong conviction in ziftomenib and its potential to be the best-in-class menin inhibitor,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “The speed with which we have begun enrolling patients with NPM1-mutant acute myeloid leukemia (AML) in our registration-directed trial speaks to our impressive Phase 1 data in this population as well as the significant interest in ziftomenib among investigators. In addition, we believe ziftomenib is well positioned for future combination strategies, with no evidence of drug-induced QTc prolongation, no predicted adverse drug-drug interactions and oral daily dosing that should enable convenient administration with standards of care. We continue to prioritize investment in the program and look forward to sharing further updates as the year progresses, including the presentation of a more mature dataset from our Phase 1 trial of ziftomenib in NPM1-mutant AML patients at a medical meeting in mid-2023.”
“Meanwhile, clearance of the IND for KO-2806 marks an important next step for our next-generation farnesyl transferase inhibitor (FTI) program,” Dr. Wilson continued. “Our preclinical data is supportive of FTIs in combination with a growing number of targeted therapies, including EGFR inhibitors and PI3 kinase alpha inhibitors as well as tyrosine
kinase inhibitors in renal cell carcinoma and KRAS G12C inhibitors in lung cancer, and we look forward to starting our first-in-human trial of KO-2806 in the coming months.”
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, February 23, 2023, to discuss the financial results for the fourth quarter and full year 2022 and to provide a corporate update. The live call may be accessed by dialing (877) 407-4018 for domestic callers and (201) 689-8471 for international callers and entering the conference ID: 13735896. 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. Ziftomenib is currently enrolling patients in a Phase 2 registration-directed trial (KOMET-001) 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. |
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Statements of Operations Data |
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(unaudited) |
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(in thousands, except per share data) |
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Three Months Ended |
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Year Ended |
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December 31, |
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December 31, |
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2022 |
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2021 |
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2022 |
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2021 |
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Operating Expenses: |
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Research and development |
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$ |
22,668 |
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$ |
20,956 |
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$ |
92,812 |
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$ |
84,721 |
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General and administrative |
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12,488 |
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12,082 |
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47,053 |
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46,537 |
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Total operating expenses |
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35,156 |
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33,038 |
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139,865 |
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131,258 |
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Other income, net |
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2,042 |
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295 |
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4,025 |
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792 |
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Net loss |
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$ |
(33,114 |
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$ |
(32,743 |
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$ |
(135,840 |
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$ |
(130,466 |
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Net loss per share, basic and diluted |
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$ |
(0.49 |
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$ |
(0.49 |
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$ |
(2.03 |
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$ |
(1.97 |
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Weighted average number of |
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67,781 |
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66,550 |
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66,990 |
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66,352 |
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KURA ONCOLOGY, INC. |
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Balance Sheet Data |
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(unaudited) |
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(in thousands) |
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December 31, |
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December 31, |
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2022 |
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2021 |
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Cash, cash equivalents and short-term investments |
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$ |
437,985 |
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$ |
517,960 |
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Working capital |
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422,369 |
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499,834 |
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Total assets |
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456,306 |
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534,051 |
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Long-term liabilities |
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11,971 |
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4,987 |
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Accumulated deficit |
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(568,808 |
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(432,968 |
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Stockholders’ equity |
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420,278 |
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506,609 |
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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