Kura Oncology, Inc. (KURA) Earnings

Management highlights

- Commercial Launch of ComSifty • In only its second full quarter on the market, ComSifty captured a majority share of new patient starts in the relapsed refractory NPM1 mutant AML menin inhibitor market, with 115 new patient starts and over 250 total prescriptions in Q2 2026. • 40% of new patient starts are physician-initiated off-label combination use with existing standard-of-care therapies including venetoclax, azacitidine, and FLT3 inhibitors, indicating early physician confidence in combination use that supports future expansion into earlier lines of therapy. • Over 95% of covered lives have access to ComSifty, with approximately 16 million lives covered under preferred formulary status, and no meaningful access barriers for prior authorization requests. • The sales force maintains consistent engagement with over 90% of top priority AML accounts, with increasing interaction frequency at high-volume treatment centers. - Clinical Development for Ziftomenib (ComSifty) • Peer-reviewed results from the Kama 007 trial of Ziftomenib plus venetoclax and azacitidine were published in Blood, demonstrating 87% overall response rate and 70% complete remission rate in venetoclax-naive relapsed/refractory patients, with median overall survival not reached at 11 months follow-up. • Long-term data from the Comet 007 trial of Ziftomenib plus intensive chemotherapy in newly diagnosed AML showed 96% ORR in relapsed refractory MPM1 mutant AML, 94% 12-month overall survival (compared to 70-80% historical for younger fit patients and 45-55% for older adults on chemotherapy alone), with no additional meaningful myelosuppression from Ziftomenib. • The pivotal Phase 3 Comodose 17 trial for frontline AML continues to accrue across North America, Europe, and Asia, with top-line results expected in 2028. Preliminary combination data with FLT3 inhibitors is expected later in 2026. - Clinical Development for Darlafarnib • Darlafarnib has demonstrated clinical activity as a combination partner with targeted therapies in renal cell carcinoma (RCC) and KRAS G12C mutated solid tumors, with a manageable safety profile that supports ongoing combination development. • In RCC, Darlafarnib plus cabozantinib achieved 44% ORR in cabozantinib-exposed patients (vs. 17-22% historical expected) and 33-50% ORR in cabozantinib-naive patients with 13 months median PFS (vs. 6-11 months historical expected). The randomized Phase 1b FIT001 trial is on track to complete enrollment in H1 2027 with initial data in H2 2027. • In KRAS G12C mutated cancers, Darlafarnib plus adagrasib achieved tumor shrinkage in 77% of response-evaluable patients, doubling the expected response rate of adagrasib monotherapy, with a manageable safety profile. • A new platform trial of Darlafarnib plus daroxanracib in second-line or later KRAS mutant pancreatic cancer is planned to initiate in H1 2027.

Guidance

- Collaboration revenue guidance for 2026 is maintained at $45 million to $55 million, with 2027 and 2028 collaboration revenue guidance maintained at $90 million to $110 million per year. - The pivotal Phase 3 Comodose 17 trial for frontline AML remains on track to deliver top-line results in 2028, consistent with prior guidance. - Preliminary clinical data for Ziftomenib combination regimens with FLT3 inhibitors is expected to be reported in the second half of 2026, consistent with prior plans. - The FIT001 trial for Darlafarnib in renal cell carcinoma is expected to complete enrollment in H1 2027 with initial data in H2 2027, in line with prior timelines. - Current cash, cash equivalents, short-term investments, and anticipated collaboration payments are expected to fully fund the Ziftomenib AML program through the 2028 Phase 3 top-line readout, as previously guided.

Segment performance

Cura Oncology has two primary business segments: the commercial ComSifty (Ziftomenib) menin inhibitor franchise and the clinical-stage Darlafarnib precision oncology platform. In Q2 2026, ComSifty generated $9.1 million in net product revenue, representing 43.5% of total company revenue for the quarter. Collaboration revenue from the Kiowa Care partnership was $11.8 million, representing 56.5% of total Q2 2026 revenue. Total company revenue for Q2 2026 was $20.9 million, compared to $15.3 million in total revenue in Q2 2025. Research and development expenses were $61.9 million in Q2 2026, down slightly from $62.8 million in Q2 2025. Selling, general, and administrative expenses were $31.8 million in Q2 2026, up from $25.2 million in Q2 2025.

Risks & headwinds

- All forward-looking statements regarding clinical trial results, commercial growth, and regulatory outcomes are subject to inherent risks and uncertainties that could cause actual results to differ materially from expectations, as detailed in Cura's SEC filings. - Commercial adoption and market share gains may not be sustained, and competitor performance could impact ComSifty's future market position. - Clinical trials may fail to meet primary or secondary endpoints, even with positive early data, and regulatory approval is not guaranteed for new indications or combinations. - Capital allocation decisions require prioritization of high-value opportunities, and delayed or negative clinical data could require changes to development plans or additional capital raising.

Analyst Q&A

• Q: The 115 new patient starts this quarter, how much of the sequential growth came from overall class market expansion versus share gains from competitors? Also, how do starts, refills and revenue align, and were there any one-time inventory impacts this quarter? /

  A: Cura achieved 35% quarter-over-quarter growth in new patient starts and 60% quarter-over-quarter growth in total prescriptions. Growth comes from both taking share from competitors and expanding the overall market for menin inhibitors. There were no one-time inventory or stocking events contributing to Q2 revenue; all growth reflects organic increases in new and repeat prescriptions.

• Q: Both Cura and competitor Syndex claim majority share of new NPM1 mutant AML patient starts. What explains this discrepancy? /

  A: Cura's majority share claim applies only to the NPM1 mutant AML segment, which is the far larger market opportunity. Syndex's claim includes KMT2A rearranged AML, which Cura is not including in its count. By Syndex's own reported numbers, they had ~100 new NPM1 patient starts this quarter (a 25% quarter-over-quarter decline) while Cura had 115 (35% growth), confirming Cura's majority share in NPM1.

• Q: How large is the market opportunity for Ziftomenib combinations in FLT3 co-mutated NPM1 AML? /

  A: Half of all incident NPM1 mutant AML patients have a co-mutated FLT3, and FLT3 mutations overall make up 30% of all AML cases, with 15% overlapping with NPM1. Cura estimates a $7 billion total addressable market for menin inhibitors across all AML treatment lines, with $3 billion projected peak sales for Ziftomenib if all indications are approved, and FLT3 combinations represent a meaningful portion of that opportunity. Additional data on this segment will be available later this year.

• Q: What is Cura's strategy for funding the Darlafarnib franchise, and when would a potential collaboration make sense? /

  A: Current cash resources are sufficient to advance Darlafarnib through early development to registrational planning, aligned with the 2028 Ziftomenib Phase 3 readout. Cura is prioritizing disciplined capital allocation and is currently not actively pursuing a collaboration for Darlafarnib, as the company has a strong strategic position with two potential blockbuster franchises and sees more value in advancing the program independently at this stage. Cura will continue evaluating all options to maximize shareholder value.