Kura Oncology (NasdaqGS:KURA) FDA Announcement November 13, 2025 12:30 PM ET Speaker4At this time, I would like to welcome you to the Kura Oncology FDA Approval Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. If you would like to ask a question, please use the raise hand function at the bottom of your Zoom screen, which can be found at the bottom of your webinar application. To allow everybody the ...

– NPM1 mutations, one of the most common genetic drivers of AML, are now actionable for patients – – Acute unmet need in R/R NPM1-mutated AML defined by historically poor outcomes and low survival rates at relapse – – FDA grants full approval of KOMZIFTI ahead of PDUFA target action date – – Approval is based on the KOMET-001 trial, in which KOMZIFTI demonstrated deep responses, a potentially best-in-class safety profile, once-daily administration, and ease of co-administration with common supportive medica ...

Core Insights - The U.S. Food and Drug Administration (FDA) has approved Kura Oncology's drug for treating a rare form of blood cancer that has either returned or resisted initial therapy [1] Company Summary - Kura Oncology has received FDA approval for its drug, indicating a significant milestone in its product development and potential market entry [1] Industry Summary - The approval highlights ongoing advancements in the treatment of rare blood cancers, reflecting the industry's commitment to addressing unmet medical needs [1]

Financial Data and Key Metrics Changes - Collaboration revenue from the Kyowa Kirin partnership for Q3 2025 was $20.8 million compared to no revenue in Q3 2024 [16] - Research and development expenses for Q3 2025 were $67.9 million, up from $41.7 million in Q3 2024 [16] - General and administrative expenses for Q3 2025 were $32.8 million, compared to $18.2 million in the same period of 2024 [16] - Net loss for Q3 2025 was $74.1 million, compared to a net loss of $54.4 million in Q3 2024 [16] - Pro forma cash as of September 30, 2025, was $609.7 million, down from $727.4 million as of December 31, 2024 [17] Business Line Data and Key Metrics Changes - The company is advancing its clinical pipeline, particularly with Zifduminib, a menin inhibitor for acute myeloid leukemia (AML) [3][4] - Zifduminib's clinical data from the COMET-001 study showed a favorable benefit-risk profile, with high rates of complete remission and minimal residual disease negativity [5][6] - The company is targeting enrollment at over 150 global sites for its COMET-017 frontline phase 3 trials [7] Market Data and Key Metrics Changes - The company is preparing for the anticipated commercial launch of Zifduminib, with disease awareness campaigns exceeding targets [9] - The commercial organization is fully mobilized and ready to execute upon approval, with a focus on specialty hematologists and large academic institutions [23] Company Strategy and Development Direction - The company aims to position Zifduminib as the menin inhibitor of choice for eligible patients, with a focus on addressing unmet needs beyond the relapsed refractory setting [4] - The dual pipeline strategy includes both menin inhibition and farnesyl transferase inhibitors, which are seen as strategically important for growth [12] - The company plans to submit data for Zifduminib to the NCCN guidelines shortly after FDA approval [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a successful review outcome for Zifduminib, with a PDUFA target action date of November 30, 2025 [3][18] - The company remains in a strong financial position to support its pipeline and commercialization activities, expecting significant milestone payments in the near term [14][17] - Management highlighted the importance of safety and tolerability in differentiating Zifduminib from competitors, especially in the context of the recent black box warning for Torsades [28][30] Other Important Information - The company plans to host a virtual investor and analyst event to discuss ASH presentations on December 8, 2025 [6] - The company has received two $30 million milestone payments for the COMET-017 trials, bringing total milestones received this year to $105 million [14] Q&A Session Summary Question: What account types are being targeted for Zifduminib launch? - The focus is on specialty hematologists, with a mix of large academic institutions and community oncology practices [23][24] Question: What to expect from the ASH update? - The ASH presentations will include more evaluable patients, updated MRD negativity data, and longer follow-up information [25][26] Question: How does the new label impact the NPM1 launch? - The black box warning for Torsades is significant, especially for the NPM1 population, and differentiates Zifduminib based on its favorable safety profile [30][31] Question: What market share is expected relative to competitors? - While specific market share expectations were not provided, the company anticipates capturing a majority share based on Zifduminib's best-in-class profile [39] Question: What are the dynamics with FDA regulatory engagement? - The company has not noticed any changes in cadence with the FDA and remains on track for the November 30 PDUFA date [67]

Kura Oncology (KURA) came out with a quarterly loss of $0.85 per share versus the Zacks Consensus Estimate of a loss of $0.57. This compares to a loss of $0.63 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -49.12%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $0.15 per share when it actually produced a loss of $0.75, delivering a surprise of -600%.Over the last four quarters, the ...

Product Development - Kura Oncology's lead product candidate, ziftomenib, is being developed for genetically defined subsets of acute leukemias, including AML and ALL, with a collaboration agreement with Kyowa Kirin for global commercialization[81] - The KOMET-001 trial for ziftomenib in relapsed or refractory NPM1-mutated AML showed a complete remission rate of 22%, exceeding the historical benchmark of 12%[88] - The overall response rate in the KOMET-001 trial was 33%, with a median duration of overall response of 4.6 months[88] - Ziftomenib received Breakthrough Therapy Designation from the FDA in April 2024, and a new drug application was submitted on March 31, 2025, with a PDUFA target action date of November 30, 2025[87] - The KOMET-007 trial is evaluating ziftomenib in combination with standard therapies for newly diagnosed AML, with preliminary data expected to be presented at the American Society for Hematology Annual Meeting in December 2025[95] - The KOMET-017 trials are assessing ziftomenib in combination with intensive and non-intensive chemotherapy regimens for newly diagnosed NPM1-mutated AML, with topline results anticipated in 2028[98][99] - Kura Oncology is also exploring ziftomenib in combination with imatinib for gastrointestinal stromal tumors, with the KOMET-015 trial currently ongoing[102] - Darlifarnib, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 trial for safety and preliminary antitumor activity[104] - The combination of tipifarnib and alpelisib showed an ORR of 47% in heavily pretreated HNSCC patients[109] - The company anticipates presenting preliminary clinical data from the combination of darlifarnib and adagrasib in 2026[107] - The company expects to initiate Phase 1b expansion cohorts of darlifarnib and cabozantinib in advanced RCC in the first half of 2026[108] Financial Performance - Collaboration revenue for the three months ended September 30, 2025, was $20.8 million, with $20.3 million from the Kyowa License Agreement[129] - Research and development expenses increased by $26.2 million to $67.9 million for the three months ended September 30, 2025, compared to $41.7 million in the same period of 2024[128] - As of September 30, 2025, the company had cash, cash equivalents, and short-term investments totaling $549.7 million[111] - The company received an upfront payment of $330 million under the Kyowa License Agreement and achieved $75 million in development milestone payments as of September 30, 2025[112] - Collaboration revenue for the nine months ended September 30, 2025, was $50.1 million, with $49.6 million from the Kyowa License Agreement[135] - Research and development expenses for the nine months ended September 30, 2025, totaled $186.7 million, an increase of $69.0 million compared to $117.7 million in 2024[136] - Ziftomenib-related costs increased to $107.9 million for the nine months ended September 30, 2025, up from $52.3 million in 2024, reflecting a change of $55.5 million[136] - The accumulated deficit as of September 30, 2025, was $1.1 billion, indicating ongoing operating losses since inception[144] - Net cash used in operating activities for the nine months ended September 30, 2025, was $181.3 million, an increase of $46.5 million from $134.8 million in 2024[149] - The company has milestone payment obligations of up to approximately $78.8 million contingent upon achieving certain regulatory and commercial milestones under in-license agreements[155] Strategic Partnerships and Agreements - Kura Oncology plans to advance its product candidates through internal development and strategic partnerships while maintaining significant development and commercial rights[85] - The company received an upfront payment of $330.0 million under the Kyowa License Agreement and is eligible for up to $933.0 million in additional milestone payments[139] - Under the Kyowa License Agreement, the company will share equally (50/50) with Kyowa Kirin all development costs for activities planned to be conducted prior to the end of 2028[156] Cash and Investments - As of September 30, 2025, the company had cash, cash equivalents, and short-term investments of $549.7 million, expected to fund operations into 2027[145] - The company has borrowed $10.0 million under a loan agreement with a maturity date of November 2, 2027, with an end of term fee of approximately $1.5 million[142] - Net cash provided by investing activities for the nine months ended September 30, 2025, was $51.5 million, a significant increase from a net cash used of $6.6 million in 2024[150] Operational Risks and Considerations - The company has not generated any revenues from product sales and relies on equity and debt financings for operations[115] - The company expects general and administrative expenses to rise in future periods to support increased research and development and pre-commercial activities[133] - The company does not believe that a 10.0% change in interest rates would have a material effect on the fair value of its investment portfolio as of September 30, 2025[159] - The company is exposed to interest expense fluctuations through Term Loans, which bear interest at a rate that could be affected by changes in the prime rate[160] - Inflation has not had a material effect on the company's business, financial condition, or results of operations during the periods presented[161]

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Financial Performance - Kura Oncology reported collaboration revenue of $20.8 million for Q3 2025, compared to no revenue in Q3 2024[9] - Research and development expenses for Q3 2025 were $67.9 million, up from $41.7 million in Q3 2024, representing a 62.8% increase[9] - General and administrative expenses for Q3 2025 were $32.8 million, compared to $18.2 million in Q3 2024, reflecting an increase of 80.5%[9] - The net loss for Q3 2025 was $74.1 million, compared to a net loss of $54.4 million in Q3 2024, indicating a 36.3% increase in losses[9] Clinical Trials and Research - The company initiated the pivotal KOMET-017 Phase 3 trials for ziftomenib in frontline AML, which will evaluate its effectiveness in over 50% of AML patients[4] - Kura plans to present preliminary clinical data at the ASH Annual Meeting in December 2025, focusing on ziftomenib in combination with venetoclax/azacitidine[9] - The objective response rate (ORR) for darlifarnib in combination with cabozantinib was reported at 33-50% in ccRCC patients[5] Funding and Financial Outlook - Kura had pro forma cash, cash equivalents, and short-term investments of $609.7 million as of September 30, 2025, which is expected to support the ziftomenib AML program through topline results in KOMET-017[4] - Kura received two milestone payments of $30 million each from Kyowa Kirin in connection with the KOMET-017 trial[6] - The company anticipates sufficient funding to support operations into 2027, bolstered by collaboration agreements and current cash reserves[13]

Core Insights - Kura Oncology's ziftomenib is under FDA Priority Review for adults with relapsed/refractory NPM1-m acute myeloid leukemia (AML), with a target action date of November 30, 2025 [1] - The KOMET 017 Phase 3 trials for ziftomenib are accelerating, targeting over 50% of AML patients by evaluating its combination with intensive and non-intensive chemotherapy [1][5] - The company reported a net loss of $74.1 million for Q3 2025, an increase from a net loss of $54.4 million in Q3 2024, with significant increases in research and development expenses [7][16] Company Updates - Kura Oncology is advancing its ziftomenib program and broader precision oncology pipeline, supported by a strong balance sheet and collaboration with Kyowa Kirin [2] - The first patient was dosed in the KOMET-017 trial in September 2025, which includes two global, randomized, double-blind, placebo-controlled trials [5] - Preliminary clinical data from ziftomenib in combination with venetoclax/azacitidine will be presented at the 2025 ASH Annual Meeting [5][9] Financial Performance - Collaboration revenue for Q3 2025 was $20.8 million, compared to no revenue in Q3 2024 [7][16] - Research and development expenses rose to $67.9 million in Q3 2025 from $41.7 million in Q3 2024 [7][16] - As of September 30, 2025, the company had pro forma cash and equivalents of $609.7 million, expected to support operations into 2027 [7][18]

SAN DIEGO, Nov. 03, 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 announced receipt of a $30 million milestone payment under its collaboration agreement with Kyowa Kirin in connection with the dosing of the first patient in the second of two KOMET-017 Phase 3 registrational trials of ziftomenib, a once-daily, investigational oral menin inhibitor. Kura previou ...