Kura Oncology (NASDAQ: KURA ) is a pharmaceutical company best known for being one of the pioneers in a novel form of targeted therapy that is currently causing a major stir among researchers inI have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and not get burned by the pitfalls of investing in this s ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-37620 KURA ONCOLOGY, INC. Securities registered pursuant to 12(g) of the Act: None Indicate by check mark if the registrant is a well ...

Kura Oncology, Inc. (NASDAQ:KURA) Q4 2024 Earnings Conference Call February 26, 2025 4:30 PM ET Company Participants Patti Bank - IR Troy Wilson - President and CEO Mollie Leoni - CMO Tom Doyle - SVP of Finance and Accounting Brian Powl - CCO Conference Call Participants Li Watsek - Cantor Fitzgerald Yen-Der Li - Leerink Partners Jason Zemansky - Bank of America Peter Lawson - Barclays Dara Azar - Stifel Charles Zhu - LifeSci Capital David Dai - UBS Justin Zelin - BTIG George Farmer - Scotiabank Operator Go ...

CORPORATE PRESENTATION Our goal is to develop transformative therapies to extend and improve the lives of patients with cancer February 2025 FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements. Such statements include, but are not limited to, statements regarding our research, preclinical and clinical development activities, plans and projected timelines for ziftomenib, KO-2806 and tipifarnib, plans regarding regulatory filings, our expectations regarding the relative benefits o ...

Kura Oncology (KURA) came out with a quarterly loss of $0.22 per share versus the Zacks Consensus Estimate of a loss of $0.63. This compares to loss of $0.55 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 65.08%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.64 per share when it actually produced a loss of $0.63, delivering a surprise of 1.56%.Over the last four quarters, the compa ...

Core Insights - Kura Oncology's KOMET-001 registrational trial for ziftomenib in relapsed/refractory NPM1-mutant acute myeloid leukemia (AML) achieved its primary endpoint, paving the way for a New Drug Application (NDA) submission in the upcoming quarter [2][3] - The company has reached alignment with the FDA and EMA on the KOMET-017 trial protocol, which includes the use of minimum residual disease (MRD)-negative complete response (CR) as a primary endpoint for potential accelerated approval in the U.S. [2][3] - Kura Oncology reported a cash position of $727.4 million, which, along with anticipated collaboration payments, is expected to support the commercialization of ziftomenib through frontline AML combination settings [1][7] Clinical Development - The KOMET-001 trial demonstrated a targeted complete response (CR) rate of 20-30%, with positive topline results submitted for presentation at ASCO [3] - The KOMET-017 trial is set to evaluate ziftomenib in combination with intensive and non-intensive chemotherapy regimens, with topline results anticipated in 2028 [1][2] - Positive clinical data from the Phase 1 trial (KOMET-007) showed that 91% of patients achieved a CR when ziftomenib was combined with standard treatments [3][4] Financial Performance - Collaboration revenue for the fourth quarter and full year 2024 was $53.9 million, compared to no revenue in 2023 [6] - Research and development (R&D) expenses for Q4 2024 were $52.3 million, up from $32.5 million in Q4 2023, while full-year R&D expenses reached $170.0 million compared to $115.2 million in the prior year [6] - The net loss for Q4 2024 was $19.2 million, a decrease from a net loss of $42.8 million in Q4 2023, with a full-year net loss of $174.0 million compared to $152.6 million in 2023 [6][14] Strategic Collaborations - Kura Oncology entered a global strategic collaboration with Kyowa Kirin to develop and commercialize ziftomenib, retaining leadership and strategic rights in the U.S. [6][10] - The collaboration aims to fund an expansive AML development program through U.S. commercialization in first-line combinations [6][10] Future Milestones - The company plans to submit an NDA for ziftomenib in R/R NPM1-mutant AML in Q2 2025 and present topline data from the KOMET-001 trial in the same timeframe [11] - Initiation of the KOMET-015 trial evaluating ziftomenib and imatinib in advanced gastrointestinal stromal tumors (GIST) is expected in the first half of 2025 [11] - Two independent Phase 3 trials for first-line intensive and non-intensive AML are anticipated to start in the second half of 2025 [11]

Core Insights - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment [2] - The company has an investigational therapy, ziftomenib, which has received Breakthrough Therapy Designation from the FDA for relapsed/refractory NPM1-mutant acute myeloid leukemia [2] - Kura Oncology has entered a global strategic collaboration with Kyowa Kirin to develop and commercialize ziftomenib for AML and other hematologic malignancies [2] Company Pipeline - Ziftomenib is the first and only menin inhibitor to receive Breakthrough Therapy Designation for R/R NPM1-mutant AML [2] - Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed [2] - KO-2806, a next-generation farnesyl transferase inhibitor, is currently in a Phase 1 dose-escalation trial [2] - Tipifarnib is in a Phase 1/2 trial in combination with alpelisib for PIK3CA-dependent head and neck squamous cell carcinoma [2] Upcoming Events - Troy Wilson, CEO, will participate in three investor conferences in March 2025 [3] - The events include the TD Cowen Health Care Conference, Barclays Global Healthcare Conference, and Leerink Partners Global Biopharma Conference [3] - Live audio webcasts will be available on Kura's website, with archived replays following the events [1][3]

Core Insights - Kura Oncology, Inc. will report its fourth quarter and full year 2024 financial results on February 26, 2025, after U.S. market close [1] - A conference call and webcast will be held at 4:30 p.m. ET / 1:30 p.m. PT to discuss the financial results and provide a corporate update [1] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment [3] - The company's pipeline includes small molecule drug candidates targeting cancer signaling pathways, with ziftomenib being a notable investigational therapy for relapsed/refractory NPM1-mutant acute myeloid leukemia [3] - Kura entered a global strategic collaboration with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies [3] - Enrollment in a Phase 2 registration-directed trial of ziftomenib for R/R NPM1-mutant AML has been completed [3] - Kura is also conducting clinical trials for ziftomenib in combination with current standards of care for newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML [3] - KO-2806, a next-generation farnesyl transferase inhibitor, is in a Phase 1 dose-escalation trial [3] - Tipifarnib, another farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for PIK3CA-dependent head and neck squamous cell carcinoma [3]

Core Insights - Kura Oncology and Kyowa Kirin announced positive topline results from the KOMET-001 trial for ziftomenib in R/R NPM1-mutant AML, achieving the primary endpoint of complete response (CR) plus CR with partial hematological recovery (CRh) [1][4][5] - The companies are on track to submit a New Drug Application (NDA) for ziftomenib to the FDA in the second quarter of 2025 [1][5] - Two Phase 3 trials, KOMET-017-IC and KOMET-017-NIC, are expected to initiate in the second half of 2025 to evaluate ziftomenib in combination with different chemotherapy regimens [2][8] Company Developments - Kura and Kyowa Kirin's collaboration aims to commercialize ziftomenib, with plans for two registrational Phase 3 trials to support potential accelerated approval [2][8] - The KOMET-001 trial is the only investigational therapy to receive Breakthrough Therapy Designation (BTD) from the FDA for R/R NPM1-mutant AML [5][16] - Kura's management expressed confidence in ziftomenib's potential to transform treatment for AML patients, particularly given the positive FDA interactions [3][11] Clinical Trial Insights - The KOMET-017-IC trial will assess ziftomenib combined with intensive chemotherapy, while the KOMET-017-NIC trial will evaluate ziftomenib with venetoclax and azacitidine for patients unfit for intensive chemotherapy [9][10] - Both trials will have dual-primary endpoints to support potential U.S. accelerated approval and full approval [7][10] - The focus on achieving minimum residual disease (MRD) negative CR as a primary endpoint is seen as innovative and may expedite therapy availability [12][13] Market Context - AML is a challenging blood cancer with a high relapse rate, affecting approximately 20,000 Americans annually, with significant unmet medical needs in the treatment landscape [15] - The 5-year survival rate for AML is reported at 31.9%, highlighting the urgency for effective therapies [11][15] - Ziftomenib is positioned to address a substantial portion of AML patients, particularly those with NPM1 mutations [3][11]

Executive Leadership Changes - Mollie Leoni, MD, promoted to Chief Medical Officer after serving as Executive Vice President of Clinical Development and clinical lead for the ziftomenib program since 2020 [1] - Francis Burrows, PhD, promoted to Chief Scientific Officer after leading translational research efforts for the past nine years [1] - Stephen Dale, MD, steps down as Chief Medical Officer and Head of R&D to prioritize personal health, effective January 2, 2025 [1] Leadership Contributions and Expertise - Stephen Dale played a key role in advancing ziftomenib through a first registration-enabling study and laying the foundation for KO-2806 as a combination partner across solid tumor indications [2] - Mollie Leoni has a robust background in oncology and orphan drug development, previously leading clinical efforts for mogamulizumab at Kyowa Kirin, which achieved international registration for cutaneous T-cell lymphoma [2] - Francis Burrows has over 20 years of experience in drug discovery and development, focusing on cancer biology and small molecule drugs, and founded two biotech startups, including Conforma Therapeutics, acquired by Biogen in 2006 [3] Company Overview and Pipeline - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with a pipeline of small molecule drug candidates targeting cancer signaling pathways [4] - Ziftomenib, a once-daily oral menin inhibitor, is the first investigational therapy to receive Breakthrough Therapy Designation from the FDA for relapsed/refractory NPM1-mutant AML [4] - Kura entered a global strategic collaboration with Kyowa Kirin in November 2024 to develop and commercialize ziftomenib for AML and other hematologic malignancies [4] - Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed, with a New Drug Application anticipated in 2025 [5] - KO-2806, a next-generation farnesyl transferase inhibitor, is in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies [5] - Tipifarnib, a selective FTI, is in a Phase 1/2 trial in combination with alpelisib for PIK3CA-dependent head and neck squamous cell carcinoma [5]