Kura Oncology Reports Fourth Quarter and Full Year 2024 Financial Results

Rhea-AI Summary

Kura Oncology (KURA) reported positive Q4 and full year 2024 results, highlighting the success of its KOMET-001 registrational trial in R/R NPM1-mutant AML, which achieved its primary endpoint. The company plans to submit a New Drug Application in Q2 2025.

Key financial highlights include collaboration revenue of $53.9M, R&D expenses of $170.0M for 2024 (up from $115.2M in 2023), and G&A expenses of $77.1M (up from $50.6M). The company reported a net loss of $174.0M for 2024. Cash position stands at $727.4M, including a $330.0M upfront payment from Kyowa Kirin partnership.

Strategic developments include alignment with FDA and EMA on KOMET-017 protocol, with anticipated topline MRD-negative CR results in 2028. The company's partnership with Kyowa Kirin supports ziftomenib commercialization through frontline AML combination setting.

Positive

• KOMET-001 trial met primary endpoint with 20-30% CR/CRh rate
• Strong cash position of $727.4M including $330M Kyowa Kirin payment
• 91% CR rate in KOMET-007 trial combination therapy
• FDA/EMA alignment on Phase 3 trial protocols
• Strategic partnership with Kyowa Kirin secured

Negative

• Net loss increased to $174.0M in 2024 from $152.6M in 2023
• R&D expenses increased 47.6% to $170.0M
• G&A expenses rose 52.4% to $77.1M
• Long timeline for Phase 3 results (2028)

Insights

Financial Analyst

Kura Oncology's Q4 and full year 2024 results highlight a transformative period marked by clinical success and financial reinforcement through strategic partnership. The achievement of the primary endpoint in the KOMET-001 registrational trial for ziftomenib in R/R NPM1-mutant AML positions the company for a potential NDA submission in Q2 2025, establishing a clear path to market.

The $330 million upfront payment from the Kyowa Kirin collaboration has dramatically strengthened Kura's balance sheet, with cash reserves now at $727.4 million, extending runway into 2027. This partnership strategically de-risks the ziftomenib commercialization pathway while preserving Kura's strategic control in the U.S. market. The collaboration revenue of $53.9 million significantly improved Q4 financial metrics, reducing net loss to $19.2 million compared to $42.8 million in Q4 2023.

The 70% year-over-year increase in R&D expenses to $170 million for full-year 2024 reflects the company's aggressive expansion of clinical programs and preparation for commercialization. Similarly, the 52% increase in G&A expenses signals infrastructure building ahead of potential product launches.

Regulatory alignment with both FDA and EMA on the KOMET-017 protocol design, particularly the acceptance of MRD-negative CR as a primary endpoint for potential accelerated approval, creates a clearer regulatory pathway. However, investors should note that topline results from the Phase 3 trial aren't expected until 2028, indicating a significant period before potential approval in frontline settings.

The expansion into GIST with the KOMET-015 trial represents a strategic diversification beyond hematological malignancies, potentially addressing a market where 60% of patients develop resistance to first-line treatment within two years. This indication expansion could significantly increase ziftomenib's addressable market beyond AML.

While clinical progress is encouraging, Kura faces execution risks in completing registration trials and navigating regulatory reviews. The substantial cash position provides important operational flexibility, but investors should monitor quarterly burn rates as multiple Phase 3 programs advance simultaneously.

Oncology Expert

Ziftomenib's achievement of its primary endpoint in the KOMET-001 trial represents a significant advancement for patients with NPM1-mutant AML, a genetic subtype that accounts for approximately 30% of AML cases. The reported CR/CRh rate of 20-30% in the relapsed/refractory setting is clinically meaningful, especially considering the effective options for these patients after failure of initial therapy.

The FDA's acceptance of MRD-negative CR as a primary endpoint for potential accelerated approval is particularly noteworthy. MRD negativity has emerged as a powerful predictor of long-term outcomes in AML, with patients achieving MRD-negative status showing significantly reduced relapse rates and improved survival compared to those with persistent MRD. This regulatory flexibility acknowledges the evolving understanding of response assessment in AML beyond traditional morphologic remission.

The 91% CR rate observed in the 7+3 combination cohort is remarkably high compared to historical standards of 60-70% CR rates with intensive chemotherapy alone in favorable-risk AML. The 100% CR rate in NPM1-mutant patients suggests potential for ziftomenib to convert this intermediate-risk group to outcomes more similar to favorable-risk patients. For KMT2A-rearranged patients, who typically have dismal outcomes with standard therapy, the 83% CR rate represents a substantial improvement over historical results.

Mechanistically, ziftomenib's targeting of the menin-KMT2A interaction disrupts aberrant gene expression programs driving leukemogenesis in these molecular subtypes. This approach differs from conventional cytotoxic therapies by specifically addressing the underlying disease biology, potentially improving efficacy while reducing off-target toxicities.

The expansion into GIST represents an intriguing application of menin inhibition beyond hematologic malignancies. Preclinical data showing enhanced activity with imatinib suggests ziftomenib may help overcome adaptive resistance mechanisms in GIST by targeting complementary signaling pathways.

While the development timeline extending to 2028 for frontline approval seems lengthy, it reflects the reality of conducting definitive Phase 3 trials in AML, where survival endpoints typically require extended follow-up. The strategic collaboration with Kyowa Kirin provides necessary financial sustainability through this development period while maintaining Kura's commercial rights in the U.S. market.

– KOMET-001 registrational trial in R/R NPM1-mutant AML achieved primary endpoint –

– Alignment reached with FDA and EMA on key aspects of the KOMET-017 protocol including use of MRD-negative CR endpoint for potential U.S. accelerated approval pathway in frontline intensive chemotherapy trial –

– Topline MRD-negative CR results from KOMET-017-IC Phase 3 trial anticipated in 2028 –

– Multiple data presentations for ziftomenib and pipeline programs expected throughout 2025 –

– $727.4 million in cash, together with anticipated collaboration agreement payments, to support ziftomenib commercialization through the frontline AML combination setting –

– Management to host webcast and conference call today at 4:30 p.m. ET –

SAN DIEGO, Feb. 26, 2025 (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 2024 financial results and provided a corporate update.

“We are very pleased the KOMET-001 registrational trial achieved its primary endpoint. We look forward to sharing topline data at an upcoming medical conference and expect to submit a New Drug Application (NDA) in relapsed/refractory (R/R) NPM1-mutant acute myeloid leukemia (AML) next quarter,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “In parallel, we are advancing ziftomenib into registrational studies in the frontline (1L) setting. Approximately half of patients with newly diagnosed NPM1-mutated (NPM1-m) AML and 80% of patients with KMT2A-rearranged (KMT2A-r) AML will die from the disease within five years.   Given this unmet need, we are pleased to have reached alignment with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on key aspects of our Phase 3 trials, including the use of minimum residual disease (MRD)-negative complete response (CR) as a primary endpoint for potential accelerated approval in the U.S., with topline results anticipated in 2028. Our KOMET-017 trial is breaking new ground, and we and our partners at Kyowa Kirin are working as rapidly as possible to bring ziftomenib to AML patients worldwide.”

Recent Highlights

• Positive topline results from registration-directed trial of ziftomenib in R/R NPM1-m AML – Kura and Kyowa Kirin announced positive topline results from KOMET-001, the Phase 2 registration-directed trial of ziftomenib in patients with R/R NPM1-m AML. The KOMET-001 trial achieved its primary endpoint, consistent with the targeted 20-30% CR/CR with partial hematological recovery (CRh) rate, and data have been submitted for presentation at ASCO. The benefit-risk profile for ziftomenib is highly encouraging, and safety and tolerability were consistent with previous reports. Facilitated by the Breakthrough Therapy Designation status of ziftomenib in R/R NPM1-m AML, the Company completed its pre-NDA meeting with FDA and anticipates submitting an NDA in the second quarter of 2025.
  
  
• Positive feedback from FDA for 1L combination trial designs – Earlier this month, Kura and Kyowa Kirin announced alignment with FDA on the KOMET-017 global trial protocol evaluating ziftomenib in combination with both intensive and non-intensive combination regimens in patients with newly diagnosed NPM1-m and/or KMT2A-r AML. This includes alignment on potential pathways for accelerated approval in the U.S. in both the KOMET-017-IC (intensive chemotherapy) and KOMET-017-NIC (non-intensive chemotherapy) trials by allowing the trials to use MRD-negative CR and CR, as primary endpoints, respectively. The companies also gained alignment with the EMA on the KOMET-017 protocol, and expect to initiate the KOMET-017 Phase 3 trials in the second half of 2025.
  
  
• Positive clinical data for Phase 1 trial of ziftomenib in combination with standards of care – In December 2024, Kura Oncology and Kyowa Kirin announced encouraging clinical data from KOMET-007, a Phase 1 trial of ziftomenib in combination with standards of care, including cytarabine/daunorubicin (7+3) and venetoclax/azacitidine in patients with NPM1-m and KMT2A-r AML. Among response-evaluable patients enrolled in the 7+3 combination cohort for patients with 1L NPM1-m or KMT2A-r adverse risk AML, 91% achieved a CR (100% for NPM1-m, 83% for KMT2A-r patients). Ziftomenib was generally well tolerated in combination at all dose levels evaluated across all cohorts in the Phase 1a dose-escalation portion of the trial. The positive results from KOMET-007 reported at ASH reinforce the companies’ commitment to evaluating ziftomenib across the continuum of 1L AML treatment options.
  
  
• Global strategic collaboration with Kyowa Kirin to develop and commercialize ziftomenib in acute leukemias – In November 2024, Kura Oncology and Kyowa Kirin announced they entered into a global strategic collaboration to develop and commercialize ziftomenib (Kyowa Agreement), funding the expansive AML development program through U.S. commercialization in 1L combinations. Under the partnership, Kura retains leadership and key strategic rights to ziftomenib in the U.S. and preserves strategic flexibility, while enabling development and commercialization of ziftomenib across the continuum of care in acute leukemias, including both fit and unfit 1L indications, post-transplant maintenance setting and combinations with targeted therapies.
  
  
• Preclinical data supporting opportunity for ziftomenib in treatment of gastrointestinal stromal tumors (GIST) – In October 2024, Kura reported preclinical data presented at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, supporting the potential for ziftomenib in combination with KIT inhibitors for GIST patients. The combination of ziftomenib and imatinib demonstrated robust and durable antitumor activity in imatinib-sensitive (1L) and imatinib-resistant (2L/3L) GIST patient-derived xenograft models. Sixty percent of patients develop resistance to imatinib within two years and ziftomenib has the potential to delay the onset of resistance to, or overcome resistance in patients pre-treated with, imatinib. In August 2024, Kura announced clearance by the FDA of an IND application and the Company remains on track to initiate the KOMET-015 trial evaluating ziftomenib plus imatinib in patients with advanced GIST, in the first half of 2025.
  
  
• Clinical and preclinical data support combinations of farnesyl transferase inhibitors with targeted therapies – Despite multiple advances, innate and adaptive resistance remain a challenge for many classes of targeted therapies in cancer. A growing body of clinical and preclinical data demonstrates the potential of farnesyl transferase inhibitors as companion therapeutic agents to augment the antitumor activities of various targeted therapies and overcome resistance in combination. Enrollment in the FIT-001 trial evaluating our next-generation farnesyl transferase inhibitor KO-2806 continues to progress and the dose-escalation portion of the KURRENT-HN trial with tipifarnib is now complete. Kura expects to present the first clinical data for KO-2806 as a monotherapy and in combination, as well as clinical data from the KURRENT-HN trial, in the second half of 2025.
  

Financial Results

• Collaboration revenue from our Kyowa Kirin partnership for the fourth quarter and full year 2024 was $53.9 million, compared to no revenue in 2023.
  
  
• Research and development (R&D) expenses for the fourth quarter of 2024 were $52.3 million, compared to $32.5 million for the fourth quarter of 2023. R&D expenses for the full year 2024 were $170.0 million, compared to $115.2 million for the prior year.
  
  
• General and administrative (G&A) expenses for the fourth quarter of 2024 were $24.1 million, compared to $14.2 million for the fourth quarter of 2023. G&A expenses for the full year 2024 were $77.1 million, compared to $50.6 million for the prior year.
  
  
• Net loss for the fourth quarter of 2024 was $19.2 million, compared to a net loss of $42.8 million for the fourth quarter of 2023. Net loss for the full year 2024 was $174.0 million, compared to a net loss of $152.6 million for the prior year.
  
  
• Net loss for the fourth quarter and full year 2024 included non-cash, share-based compensation expense of $8.6 million and $33.9 million, respectively. This compares to $7.2 million and $28.1 million for the same periods in 2023.
  
  
• As of December 31, 2024, Kura had cash, cash equivalents and short-term investments of $727.4 million, including the upfront payment of $330.0 million from Kyowa Kirin, compared to $424.0 million as of December 31, 2023.
  
  
• Based on our current plans, we believe our cash, cash equivalents and short-term investments as of December 31, 2024 will be sufficient to enable us to fund our current operating expenses into 2027, and combined with anticipated collaboration funding under the Kyowa Agreement, should support our ziftomenib AML program through commercialization in the 1L combination setting.
  

Forecasted Milestones

• Submit an NDA for ziftomenib in R/R NPM1-m AML in the second quarter of 2025.
  
  
• Present topline data from KOMET-001 Phase 2 registration-directed trial in R/R NPM1-m AML in the second quarter of 2025.
  
  
• Present preliminary clinical data from the KOMET-007 Phase 1b expansion cohort evaluating ziftomenib with intensive chemotherapy (7+3) at a medical meeting in the second quarter of 2025.
  
  
• Initiate the KOMET-015 trial evaluating ziftomenib and imatinib in patients with advanced GIST in the first half of 2025.
  
  
• Initiate two independent Phase 3 registration-enabling trials in 1L intensive (KOMET-017-IC) and non-intensive (KOMET-017-NIC) AML in the second half of 2025.
  
  
• Present preliminary clinical data from the KOMET-007 Phase 1b expansion cohort evaluating ziftomenib with venetoclax and azacitidine at a medical meeting in the second half of 2025.
  
  
• Nominate a development candidate for next-generation menin inhibitor program in diabetes in mid-2025.
  
  
• Initiate one or more expansion cohorts of KO-2806 and cabozantinib in patients with advanced renal cell carcinoma in the first half of 2025.
  
  
• Present data from the Phase 1 monotherapy dose escalation of KO-2806 in patients with RAS mutations in the second half of 2025.
  
  
• Present data from the Phase 1 trial evaluating KO-2806 and cabozantinib in patients with renal cell carcinoma in the second half of 2025.
  
  
• Present data from the dose escalation portion of KURRENT-HN trial evaluating tipifarnib and alpelisib in PIK3CA-dependent head and neck squamous cell carcinoma (HNSCC) in the second half of 2025.
  

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 26, 2025, to discuss the financial results for the fourth quarter and full year 2024 and to provide a corporate update. The live call may be accessed by dialing (800) 579-2543 for domestic callers and (785) 424-1789 for international callers and entering the conference ID: KURAQ4. A live webcast and archived replay of the event will be available here or 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 targeting cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the FDA for the treatment of R/R NPM1-m AML. In November 2024, Kura Oncology entered a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-m AML has been completed, and the companies anticipate submission of an NDA to the FDA in the second quarter of 2025. Kura Oncology and Kyowa Kirin are also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-m and KMT2A-r AML. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent HNSCC. For additional information, please visit Kura’s website at www.kuraoncology.com and follow us on X and LinkedIn.

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; plans, trial designs and expected timing of clinical trials; the expected timing and presentation of results and data from clinical trials; the anticipated timing of submission of an NDA for ziftomenib; the potential for U.S. accelerated approval and full approval of product candidates; and the success and impact of interactions with the FDA; the potential for menin inhibitors to shift the treatment paradigm for GIST; the strength of Kura’s balance sheet and the sufficiency of cash, cash equivalents and short-term investments to fund its current operating plan to 2027, and combined with anticipated collaboration funding under the Kyowa Agreement, to support Kura’s ziftomenib AML program through commercialization in the 1L combination setting. 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,
	2024				2023						2024								2023
Collaboration revenue	$	53,883			$	—					$	53,883							$	—
Operating expenses
Research and development		52,267				32,533						169,967								115,235
General and administrative		24,071				14,229						77,111								50,569
Total operating expenses		76,338				46,762						247,078								165,804
Other income, net		5,256				3,976						21,230								13,173
Income tax expense		(2,018	)			—						(2,018					)			—
Net loss	$	(19,217	)		$	(42,786			)		$	(173,983					)		$	(152,631	)
Net loss per share, basic and diluted	$	(0.22	)		$	(0.55			)		$	(2.02					)		$	(2.08	)
Weighted average number of shares used in computing net loss per share, basic and diluted		87,136				77,337						86,161								73,229

KURA ONCOLOGY, INC. Balance Sheet Data (unaudited) (in thousands)
	December 31,				December 31,
	2024				2023
Cash, cash equivalents and short-term investments	$	727,395			$	423,957
Working capital	666,117				397,218
Total assets	760,159				448,935
Long-term liabilities	267,807				16,399
Accumulated deficit	(895,422		)		(721,439		)
Stockholders’ equity	413,640				397,273

Investors:
Patti Bank
Managing Director
(415) 513-1284
patti.bank@icrhealthcare.com

Media:
Alexandra Weingarten
Associate Director, Corporate Communications
(858) 500-8822
alexandra@kuraoncology.com

FAQ

What were the key results of KURA's KOMET-001 trial in 2024?

KOMET-001 achieved its primary endpoint with 20-30% CR/CRh rate in R/R NPM1-mutant AML patients, with encouraging benefit-risk profile.

When will KURA submit the New Drug Application (NDA) for ziftomenib?

Kura plans to submit the NDA for ziftomenib in R/R NPM1-mutant AML in Q2 2025.

What is KURA's current cash position and financial outlook?

KURA has $727.4M in cash as of December 31, 2024, sufficient to fund operations into 2027.

What were the response rates in KURA's KOMET-007 trial?

91% of evaluable patients achieved CR in the 7+3 combination cohort, with 100% CR for NPM1-m and 83% for KMT2A-r patients.

When are KURA's Phase 3 KOMET-017 trial results expected?

Topline MRD-negative CR results from KOMET-017-IC Phase 3 trial are anticipated in 2028.