Kura Oncology, Inc. (KURA)

Kura Oncology, Inc. (NASDAQ:KURA ) Q2 2025 Earnings Conference Call August 7, 2025 4:30 PM ET Company Participants Brian T. Powl - Chief Commercial Officer Greg Mann - Corporate Participant Mollie Leoni - Chief Medical Officer Thomas Doyle - Senior Vice President of Finance & Accounting Troy Edward Wilson - Chairman, CEO & President Conference Call Participants Ellen Horste - TD Cowen, Research Division Eric Tatenda Musonza - UBS Investment Bank, Research Division Jason Eron Zemansky - BofA Securities, Research Division Li Wang Watsek - Cantor Fitzgerald & Co., Research Division Peter Green - Unidentified Company Peter Richard Lawson - Barclays Bank PLC, Research Division Roger Song - Jefferies LLC, Research Division Suranjit Mukherjee - BTIG, LLC, Research Division Wei Ji Chang - Leerink Partners LLC, Research Division Operator Hello, and welcome, everyone, joining today's Second Quarter 2025 Kura Oncology, Inc. Financial Results Conference Call.

Kura Oncology (KURA) came out with a quarterly loss of $0.75 per share versus the Zacks Consensus Estimate of $0.15. This compares to a loss of $0.59 per share a year ago.

Kura (KURA) Revenue Drops 61%

– FDA Priority Review of New Drug Application (NDA) for ziftomenib in adults with R/R NPM1-m AML with Prescription Drug User Fee Act (PDUFA) target action date set for November 30, 2025 – – Fully engaged in commercial readiness activities in alignment with regulatory review timeline – – KOMET-017-IC (intensive chemotherapy) and NIC (non-intensive chemotherapy) phase 3 studies in newly diagnosed AML on track to start in 2H 2025 – – Three clinical abstracts from Kura's farnesyl transferase inhibitors (FTI) development program accepted for presentation at the 2025 ESMO Congress – – $630.7 million in pro forma cash, together with anticipated collaboration agreement payments, expected 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, Aug. 07, 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 second quarter 2025 financial results and provided a corporate update.

SAN DIEGO, Aug. 04, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (the “Company”) (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that on August 1, 2025, the Compensation Committee of the Company's Board of Directors (the “Compensation Committee”) granted inducement awards consisting of nonstatutory stock options to purchase 646,700 shares of common stock to thirty-five (35) new employees under the Company's 2023 Inducement Option Plan, as amended. The Compensation Committee approved the stock options as an inducement material to such employees' employment in accordance with Nasdaq Listing Rule 5635(c)(4).

SAN DIEGO, July 31, 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 it will report second quarter 2025 financial results after the close of U.S. financial markets on Thursday, August 7, 2025. Kura's management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT to discuss the financial results and provide a corporate update.

SAN DIEGO, July 03, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (the “Company”) (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that on July 1, 2025, the Compensation Committee of the Company's Board of Directors (the “Compensation Committee”) granted inducement awards consisting of nonstatutory stock options to purchase 141,750 shares of common stock to eight (8) new employees under the Company's 2023 Inducement Option Plan, as amended. The Compensation Committee approved the stock options as an inducement material to such employees' employment in accordance with Nasdaq Listing Rule 5635(c)(4).

Kura Oncology is a Strong Buy due to ziftomenib's positive Phase 2 data in newly diagnosed AML mutant patients and upcoming FDA Priority Review for relapsed/refractory NPM1-m/KMT2A-r AML. The pipeline is expanding beyond monotherapy, with promising results in combination regimens for newly diagnosed AML patients. Strong financials, including $703M in cash and a supportive partnership with Kyowa Kirin, minimize dilution risk and support operations through commercialization for 1st-line setting.

Investors need to pay close attention to KURA stock based on the movements in the options market lately.

– Encouraging clinical activity with deep responses demonstrated in the KOMET-007 trial with the combination of 600 mg ziftomenib with 7+3 in newly diagnosed patients with NPM1-m and KMT2A-r AML –

Kura Oncology shares rise this week after the FDA accepts its NDA for ziftomenib, a potential first-in-class treatment for NPM1-mutant AML.

SAN DIEGO, June 06, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (the “Company”) (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that on June 2, 2025, the Compensation Committee of the Company's Board of Directors (the “Compensation Committee”) granted inducement awards consisting of nonstatutory stock options to purchase 79,200 shares of common stock to five (5) new employees under the Company's 2023 Inducement Option Plan, as amended. The Compensation Committee approved the stock options as an inducement material to such employees' employment in accordance with Nasdaq Listing Rule 5635(c)(4).

– CR/CRh rate of 23% in pivotal Ph 2 cohort of R/R NPM1-m AML patients – – Consistent efficacy with comparable CR/CRh rates and clinically meaningful MRD-negative responses across pre-specified subgroups, regardless of prior HSCT, prior venetoclax, or FLT3/IDH co-mutations – – Favorable safety and tolerability profile in heavily pre-treated patients: limited myelosuppression; no clinically meaningful QTc prolongation; 3% of patients discontinued due to treatment-related adverse events – – Potential first approval of a once-daily, oral menin inhibitor for treatment of adult patients with relapsed or refractory NPM1-mutated AML with Priority Review and a PDUFA target action date of November 30, 2025 – – Kura Oncology to host virtual investor event today at 7:30pm ET / 4:30pm PT – SAN DIEGO and TOKYO, June 02, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) announced the presentation of positive pivotal results from the KOMET-001 Phase 2 registration-directed trial of ziftomenib, a once-daily, oral investigational menin inhibitor, in patients with relapsed/refractory (R/R) NPM1-mutant (NPM1-m) acute myeloid leukemia (AML) in an oral session today at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, IL from May 30 - June 3, 2025.

– New Drug Application based on positive results from the Phase 2 KOMET-001 trial – – FDA assigns a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2025 – – Potential first approval of a menin inhibitor for the treatment of adult patients with relapsed or refractory AML with an NPM1 mutation – SAN DIEGO and TOKYO, June 01, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced the U.S. Food and Drug Administration (FDA) has accepted Kura's New Drug Application (NDA) seeking full approval for ziftomenib as a treatment for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) mutation.

– Results from KOMET-001 registration-directed trial of ziftomenib in R/R NPM1-m AML patients selected for oral presentation on Monday, June 2nd –

SAN DIEGO, May 20, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (the “Company”) (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that management is scheduled to participate in three upcoming investor conferences: