Kura Oncology FY Conference Summary Company Overview - Kura Oncology (NasdaqGS: KURA) is focused on developing targeted therapies for cancer treatment, particularly in acute leukemia and solid tumors [2][3] - The company has a strong cash position with $630.7 million as of the last quarter [2] Pipeline and Product Focus - The primary focus is on the Ziftomenib program for genetically defined acute leukemias, with additional efforts in gastrointestinal stromal tumors (GIST) and other cancers [2] - Kura is also exploring therapies for diabetes, indicating a diverse pipeline [2] Market Opportunity - The initial commercial opportunity for Ziftomenib in acute leukemia is estimated at $350 to $400 million, with a potential peak market opportunity of $7 to $10 billion for the class [3] - Kura anticipates capturing up to $3 billion of that market with Ziftomenib [3] Clinical Development - Ziftomenib has an NDA under review with the FDA, with a PDUFA action date set for November 30 [6] - The company is conducting multiple clinical trials, including a phase 1 study (007) and two phase 3 trials (017) for frontline treatment of acute leukemia [9][22] - The trials are designed to assess the efficacy of Ziftomenib in combination with standard therapies, with a focus on measurable residual disease (MRD) negativity as a key endpoint [23][24] Competitive Landscape - Kura believes Ziftomenib has a best-in-class profile due to its safety, tolerability, and lack of significant drug-drug interactions compared to competitors [12][13] - The company is preparing for a competitive market, with multiple menin inhibitors in development [29] Commercial Strategy - Kura has built a robust commercial team and is ready for a potential launch following FDA approval [15][17] - The partnership with Kyowa Kirin Co., Ltd. enhances Kura's commercial capabilities, with shared responsibilities in U.S. commercialization [18][20] Upcoming Milestones - Key upcoming milestones include the FDA decision on the NDA, data presentations at ASH and ESMO, and the initiation of phase 3 studies [45][46] - The company is also focused on advancing its FTI programs and exploring next-generation menin inhibitors for diabetes [33][39] Financial Outlook - Kura is confident in its cash position and has visibility on milestone payments from its partnership with Kyowa Kirin, which supports its development plans through 2029 [19][46] Conclusion - Kura Oncology is positioned for significant growth with its innovative therapies in oncology and diabetes, backed by a strong financial foundation and strategic partnerships [46]

Core Insights - Biotech stocks experienced significant gains in after-hours trading on September 9, 2025, driven by clinical updates, insider buying, and investor conference appearances across several small- and mid-cap companies [1] Company Summaries - **Immutep Ltd. (IMMP)**: Shares rose by 4.37% to $1.67 after-hours, following a decline of 6.98% during regular trading. The stock's rebound was fueled by the acceptance of data from its EFTISARC-NEO Phase II trial for oral presentation at CTOS 2025, focusing on a rare cancer with high unmet need [2][3] - **Nautilus Biotechnology Inc. (NAUT)**: Shares surged by 12.25% to $0.7521 after-hours, recovering from a 4.42% decline in regular trading. The increase was attributed to insider buying by CEO Sujal M. Patel, who purchased 83,500 shares, signaling confidence in the company [4][5] - **Pliant Therapeutics Inc. (PLRX)**: The stock ended regular trading at $1.75, up 1.16%, and jumped 16.00% to $2.03 after-hours. The upcoming third-quarter earnings report on November 6, 2025, is expected to provide updates on its lead candidate targeting idiopathic pulmonary fibrosis [6][7] - **Jin Medical International Ltd. (ZJYL)**: Shares closed at $0.6532, gaining 3.65% during regular trading and rising 7.15% to $0.6999 after-hours. The catalyst for this movement was the announcement of expanded production capabilities in China, aimed at enhancing global delivery of medical equipment [7][8] - **Phio Pharmaceuticals Corp. (PHIO)**: The stock rose 8.20% to $2.64 after-hours, building on a 13.49% increase during regular trading. The momentum was driven by participation in the H.C. Wainwright 27th Annual Global Investment Conference, where updates on its Phase 1b clinical trial for PH-762 will be presented [8][9] - **Kura Oncology Inc. (KURA)**: Shares increased by 6.12% to $8.50 after-hours, following a 1.60% decline in regular trading. The rally was linked to the company's presentation at the H.C. Wainwright conference, highlighting key developments and upcoming regulatory milestones for Ziftomenib [10][11][12]

Kura Oncology FY Conference Summary Company Overview - **Company**: Kura Oncology (NasdaqGS: KURA) - **Industry**: Biotechnology, specifically focused on oncology treatments Key Points and Arguments 1. **Commercial Readiness**: Kura is preparing for the PDUFA target action date of November 30 for Ziftomenib's approval in relapsed/refractory NPM1-mutant AML. The commercial organization is fully staffed and trained [2][5] 2. **Market Opportunity**: The potential market for menin inhibitors, particularly Ziftomenib, is estimated to exceed $7 billion annually, driven largely by frontline treatment opportunities [3][16] 3. **Pipeline Development**: Kura has a robust pipeline, including a Farnesyl transferase inhibitor program aimed at overcoming resistance mechanisms in targeted therapies [3][4] 4. **Patient Population**: The addressable market in the U.S. for Ziftomenib is projected to be over 200,000 patients annually, with specific focus on NPM1-mutant AML patients [4][16] 5. **Financial Position**: As of June 30, Kura had $630.7 million in cash, positioning the company well for upcoming milestones and commercialization efforts [4][5] 6. **Collaboration with Kyowa Kirin**: Kura has a partnership with Kyowa Kirin Co., Ltd., which includes significant milestone payments that will support Kura's cash position through the commercialization of Ziftomenib [5][17] 7. **Clinical Trials**: Kura is initiating two Phase 3 registration-enabling studies under the COMET-017 protocol to evaluate Ziftomenib in combination with standard therapies for AML [2][11] 8. **Efficacy and Safety**: Ziftomenib has shown strong safety and tolerability profiles, with promising clinical activity in heavily pretreated patients [9][10] 9. **Long-term Treatment Potential**: The company aims to keep patients on therapy for 12 to 24 months, which is unprecedented in AML treatment, potentially transforming it into a chronic therapy [16] 10. **Gastrointestinal Stromal Tumors (GIST)**: Kura is also evaluating Ziftomenib for GIST, targeting a market potential of $500 million to $1 billion in peak sales in the U.S. [18][19] 11. **Farnesyl Transferase Inhibitor Program**: Kura is developing KO-2806, a FTI program, which aims to address resistance in various cancers, with upcoming data expected from ongoing trials [20][24] Additional Important Content - **AML Statistics**: Approximately 70% of AML patients who achieve complete response relapse within three years, highlighting the need for effective treatments [6] - **Patient Demographics**: In the U.S., there are about 20,000 AML patients eligible for menin inhibitors, with a global estimate of 60,000 [7] - **Transplant Considerations**: Ziftomenib may allow patients to avoid or delay transplants, which carry significant risks and complications [13] - **Regulatory Pathway**: Kura is working closely with the FDA for accelerated approval pathways for its therapies [14] This summary encapsulates the critical insights from Kura Oncology's FY conference, emphasizing the company's strategic positioning, market potential, and ongoing clinical developments in the oncology space.

Kura Oncology Conference Call Summary Company Overview - **Company**: Kura Oncology - **Key Product**: Ziftomenib (also referred to as ZYPTOMENIB) - **Upcoming Milestones**: PDUFA for Ziftomenib, data updates at medical conferences, initiation of COMMOD-17 studies Core Industry Insights Ziftomenib Development and Market Position - **PDUFA Status**: Kura is optimistic about the NDA review process for Ziftomenib, receiving positive feedback from Key Opinion Leaders (KOLs) regarding its profile in relapsed/refractory settings [2][3] - **Efficacy and Safety**: The company emphasizes four pillars for Ziftomenib: efficacy, convenience, simplicity of administration, and safety [3] - **Commercial Readiness**: Kura's team is fully trained and prepared for market access and pre-approval information exchange [3] - **Combination Studies**: Data sharing is anticipated at the end of the year for the combination of Ziftomenib with venetoclax and azacitidine [3] Competitive Landscape - **Market Dynamics**: Kura expects to compete effectively against other menin inhibitors in the market, with a focus on strong efficacy and safety profiles [11][12] - **Physician Feedback**: Physicians have shown enthusiasm for Ziftomenib's once-daily oral administration and its potential for combination therapies [11][12] - **Patient Segmentation**: Initial patient starts are expected to be new patients rather than switches from existing therapies [14] Clinical Trials and Data Expectations - **Phase 3 Studies**: Kura is on track to initiate two parallel Phase 3 studies in Q4 [4] - **Combination Therapy Data**: The company aims to improve upon existing combination therapies' outcomes without increasing toxicity [28] - **Enrollment Strategy**: Kura's trial design allows for easier patient enrollment, which is expected to enhance participation rates [30][31] Financial Position - **Cash Reserves**: Kura reported $630.7 million in cash, with expectations of substantial milestone payments to maintain a strong financial position [6] Additional Opportunities Menin Inhibitors in Other Indications - **GIST and Diabetes**: Kura is exploring the use of menin inhibitors in GIST and has nominated a next-gen menin inhibitor for diabetes [45] - **Long-term Vision**: The company aims to lead the discovery and development of menin inhibitors across various oncology applications [45] Future Priorities - **Strategic Goals**: Key priorities include the approval and launch of Ziftomenib, additional combination data, and the start of the COMMOD-17 study [46] Important but Overlooked Aspects - **Collaboration with Kyowa Kirin**: Kura has a strong partnership with Kyowa Kirin for co-development and co-promotion, with Kura leading commercialization efforts in the US [25][26] - **Focus on Safety and Efficacy**: The emphasis on maintaining a favorable safety profile while improving efficacy in combination therapies is crucial for Kura's strategy [28][40] This summary encapsulates the key points discussed during the conference call, highlighting Kura Oncology's strategic direction, product development, and market positioning.

Core Insights - Kura Oncology, Inc. is hosting two virtual investor and analyst events to showcase its farnesyl transferase inhibitor (FTI) program, emphasizing its leadership in targeting cancer signaling pathways for solid tumors and hematologic malignancies [1][5] Event Summaries - The first event on September 16, 2025, will focus on the preclinical program of FTIs, discussing their synergistic combinations with targeted therapies such as tyrosine kinase inhibitors, RAS inhibitors, and PI3K alpha inhibitors, highlighting their potential to transform treatment for solid tumors [2] - The second event on October 18, 2025, will present clinical data from the 2025 ESMO Congress, including the first clinical insights from KO-2806, Kura's next-generation FTI, which aims to address resistance mechanisms in cancer [3] ESMO Congress Presentations - Kura will present preliminary results from the FIT-001 phase 1 trial of KO-2806 in combination with cabozantinib for renal cell carcinoma on October 18, 2025 [4] - A phase 1 study of KO-2806 as monotherapy in advanced solid tumors will be presented on October 19, 2025 [4] - Results from the KURRENT-HN trial involving tipifarnib and alpelisib in recurrent/metastatic head and neck squamous cell carcinoma will be shared on October 20, 2025 [4] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer, with a pipeline targeting cancer signaling pathways and addressing high-need hematologic malignancies and solid tumors [5] - The company is developing ziftomenib, a menin inhibitor for acute myeloid leukemias, and is advancing both menin and farnesyl transferase inhibition strategies to tackle resistance mechanisms in solid tumors [5][6]

Core Viewpoint - Kura Oncology reported a significant quarterly loss of $0.75 per share, which was much worse than the Zacks Consensus Estimate of $0.15, indicating a negative earnings surprise of -600.00% [1] Financial Performance - The company posted revenues of $15.29 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 89.23%, compared to zero revenues a year ago [2] - Kura Oncology has surpassed consensus EPS estimates two times over the last four quarters [2] Stock Performance - Kura Oncology shares have declined approximately 30.8% since the beginning of the year, while the S&P 500 has gained 7.9% [3] Future Outlook - The company's earnings outlook will be crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the next quarter is -$0.56 on revenues of $59.35 million, and for the current fiscal year, it is -$1.31 on revenues of $229.86 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Kura Oncology belongs, is currently ranked in the top 41% of over 250 Zacks industries, suggesting a favorable industry outlook [8]

Financial Data and Key Metrics Changes - Collaboration revenue from the Veracurin partnership for 2025 was $15.3 million compared to no revenue for 2024 [33] - Research and development expenses for 2025 were $62.8 million compared to $39.7 million for 2024, driven by spending on ZiftoMenib combination clinical trials [33] - General and administrative expenses for 2025 were $25.2 million compared to $16.7 million for 2024, primarily due to pre-commercial activities [33] - Net loss for 2025 was $66.1 million compared to a net loss of $50.8 million for 2024 [34] - As of June 30, 2025, the company had cash, cash equivalents, and short-term investments of $630.7 million compared to $727.4 million as of December 31, 2024 [34] Business Line Data and Key Metrics Changes - The company is focused on the development of ZiftoMenib for relapsed or refractory NPM1 mutant AML, with positive monotherapy data presented at ASCO [6][7] - The FDA accepted the NDA for ZiftoMenib, granting priority review with a PDUFA target action date of November 30, 2025 [7] - The company is preparing for potential approval by building commercial supply and quality systems and recruiting a sales force [9][30] Market Data and Key Metrics Changes - The total addressable market for NPM1 mutated relapsed refractory AML is estimated to be between $350 million to $400 million annually [30] - The company believes that menin inhibitors can reach fifty percent of newly diagnosed AML patients, representing a total addressable U.S. market potential of over $7 billion per year [32] Company Strategy and Development Direction - The company is committed to transforming outcomes for patients with AML and is accelerating the development of ZiftoMenib in frontline AML [6][8] - The strategic focus includes advancing menin inhibitors for diabetes and cardiometabolic diseases, as well as farnesyl transferase inhibitors for solid tumors [10][22] - The company aims to establish ZiftoMenib as a market leader in the relapsed refractory AML space and is preparing for a rapid launch upon FDA approval [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a successful review outcome by the PDUFA date and highlighted the collaborative interactions with the FDA [40][41] - The company anticipates robust enrollment in upcoming trials and believes the combination of ZiftoMenib with other therapies will address significant unmet needs in the AML patient population [55][56] Other Important Information - The company has $375 million in potential near-term milestones under the Kyowa Kirin collaboration, which includes significant milestones tied to the initiation of Phase three frontline trials [12] - The company is actively preparing for the ESMO Congress with three clinical abstracts accepted for presentation [11][36] Q&A Session Summary Question: Can you provide color on regulatory interactions for ZiftoMenib? - Management indicated that interactions have been collaborative and constructive, aligning with the timeline for priority review [40][41] Question: What is the scope of the farnesyl transferase inhibitor opportunity? - Management discussed ongoing evaluations in various tumor types and indicated that some areas may be better suited for partnerships [42][43] Question: Thoughts on the Menin class launch and KMT2A market opportunity? - Management expressed optimism about the competitive landscape and the potential for ZiftoMenib to be best in class [50][51] Question: What are the biggest potential risks to pivotal program timelines? - Management acknowledged that while unexpected events could push timelines, they are confident in their ability to meet the projected dates [80][81] Question: How is the FDA dialogue proceeding? - Management confirmed that interactions with the FDA have been consistent and productive, with no significant changes in frequency or quality [85][86] Question: What are the expectations regarding the evolution of NCCN guidelines? - Management plans to submit applications for ZiftoMenib to be included in the guidelines as soon as data is published and approval is obtained [75][76]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 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 Section 12(b) of the Act: | Title of each class | ...

Exhibit 99.1 Kura Oncology Reports Second Quarter 2025 Financial Results – 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 – – $630.7 million in pro forma cash, together with anticipated collaboration agreement payments, expected to support ziftomenib commercialization through ...

Core Viewpoint - Kura Oncology is set to report its second quarter 2025 financial results on August 7, 2025, and will provide a corporate update during a conference call [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 [3] Key Developments - Ziftomenib, an oral menin inhibitor, is the first investigational therapy to receive Breakthrough Therapy Designation from the FDA for relapsed or refractory NPM1-mutant acute myeloid leukemia [3] - A global strategic collaboration with Kyowa Kirin was established in November 2024 to develop and commercialize ziftomenib for AML and other hematologic malignancies [3] - Enrollment in the Phase 2 trial (KOMET-001) for ziftomenib in R/R NPM1-m AML has been completed, with the FDA accepting a New Drug Application and setting a target action date of November 30, 2025 [3] Ongoing Trials - Kura and Kyowa Kirin are conducting clinical trials for ziftomenib in combination with current standards of care for newly diagnosed and R/R NPM1-m and KMT2A-rearranged AML [3] - Ziftomenib is also being evaluated in a Phase 1 trial (KOMET-015) in combination with imatinib for advanced gastrointestinal stromal tumors [3] - KO-2806, a next-generation farnesyl transferase inhibitor, is in a Phase 1 trial (FIT-001) as monotherapy and in combination with targeted therapies for various solid tumors [3] - Tipifarnib is currently in a Phase 1/2 trial (KURRENT-HN) in combination with alpelisib for PIK3CA-dependent head and neck squamous cell carcinoma [3]