Kura Oncology, Inc. 2026 Q2 Earnings Call

Please go ahead. Thank you, Lenius.

Good afternoon, and welcome to Kura Oncology second quarter 2026 conference call. Joining the call today are Dr. Troy Wilson, President and Chief Executive Officer, Brian Powl, Chief Commercial Officer, Dr. Mollie Leoni, Chief Medical Officer, and Tom Doyle, Senior Vice President, Finance and Accounting. We remind you that today's discussion will include forward-looking statements based on current expectations. Such statements represent management's judgment as of today and may involve risks and uncertainties that cause actual results to differ materially from expected results. Please refer to Kura's filings with the SEC, which are available from the SEC or on the Kura Oncology website for information concerning risk factors that could affect the company. With that, I'll turn the call over to Troy.

Thank you, Greg, and good afternoon, everyone. The second quarter marked another step forward in Kura's evolution as a commercial stage oncology company. KOMZIFTI moved into a leadership position in relapsed refractory NPM1 mutant AML menin inhibitor market, and new clinical data further strengthened our confidence in our strategy of building two differentiated growth franchises. I'll start with KOMZIFTI. In only our second full quarter on the market, KOMZIFTI generated $9.1 million in net product revenue, exceeding our expectations, and captured a majority of new patient starts in the relapsed refractory NPM1 mutant AML menin inhibitor market. At this stage of the launch, new patient starts are the clearest leading indicator of commercial performance. They measure which therapy physicians are choosing today, and they establish the base for future prescriptions and revenue.

Achieving majority share of new patient starts in only our second full commercial quarter, despite entering the market second, is clear evidence physicians are differentiating within the menin inhibitor class. In real-world AML practice, physicians choose therapies based on the total treatment profile, efficacy, predictable and manageable safety, dosing convenience, drug-drug interactions, and increasingly, the potential to combine with existing treatment approaches. We believe KOMZIFTI's rapid adoption reflects the strength of that differentiated profile in the largest currently FDA-approved menin inhibitor opportunity. The monotherapy launch is only the beginning. Our objective is to establish ziftomenib as a foundational therapy across AML by combining it with multiple standards of care. The long-term frontline data we reported at EHA demonstrated that ziftomenib combines cleanly with standard therapy, deepens responses, and supports more durable outcomes. With nearly 100 patients and extended follow-up, KOMET-007 meaningfully increases our confidence in our frontline strategy.

Mollie will discuss those data in more detail. Looking ahead, we expect multiple clinical updates in the second half of the year across monotherapy, combination therapy, and multiple treatment settings. Turning to darlifarnib, we now believe we have a second wholly owned strategic asset capable of creating significant value independent of our menin inhibitor franchise. Across cabozantinib exposed and cabozantinib-naive renal cell carcinoma, as well as in KRAS G12C mutated solid tumors, we've generated clinical evidence that darlifarnib has the potential to enhance the activity of targeted therapy backbones through a common biological mechanism while maintaining a manageable safety profile. Our strategy is straightforward. Pair darlifarnib with established and emerging targeted therapies, allowing us to advance the program efficiently while preserving opportunities for future strategic collaboration. Stepping back, Kura is substantially stronger than it was even just one quarter ago.

We have established commercial leadership in new patient starts in relapsed refractory NPM1 mutant AML. We have built one of the most mature and robust frontline menin inhibitor data sets in AML. We've advanced a wholly owned precision oncology platform beyond menin inhibition, and we've maintained the financial strength to execute through multiple value-creating milestones. Together, these assets position us to create value through commercial execution, pipeline expansion, and disciplined capital deployment. With that, I'll turn it over to Brian.

Thanks, Troy. In the second quarter, KOMZIFTI generated $9.1 million in net product revenue with approximately 115 new patient starts and more than 250 total prescriptions. Based on current prescription data, KOMZIFTI captured a majority share of new patient starts in the relapsed refractory NPM1 mutant AML menin inhibitor market in only its second full quarter of launch. That's the headline for the quarter. New patient starts are the clearest indicator of physician choice today and one of the strongest predictors of future commercial performance.

The quality of the launch is evidenced across multiple metrics. Repeat prescribing continued to increase, adoption expanded across both academic and community treatment centers, and new accounts continued to initiate menin inhibitor therapy with KOMZIFTI. Physician-initiated combination use with venetoclax and azacitidine and with FLT3 inhibitors in co-mutated patients represented approximately 40% of new patient starts. With more than 95% of covered lives and no label restrictions, physicians are confident to prescribe the therapy they believe is best for their patients. Physicians are increasingly choosing KOMZIFTI because of its differentiated profile, and we believe that profile is driving adoption. Our focus is simple: win every eligible patient. Every new patient creates the opportunity for repeat prescriptions and revenue. Our field force continues to execute at a high level, delivering consistent engagement with primary AML prescribers nationwide.

We maintain engagement with more than 90% of our top priority AML accounts during the quarter, while increasing the frequency of interactions with high-value treatment centers. Despite being second to market, KOMZIFTI achieved majority share of new patients in only its second full commercial quarter. This is uncommon in oncology. We believe it reflects meaningful product differentiation, growing physician adoption of KOMZIFTI, and exceptional commercial execution. Although we promote KOMZIFTI only for its approved monotherapy indication, physician-initiated combination use provides an early signal that clinicians see the product fitting naturally into future treatment paradigms. We view the prescribing behavior as evidence of practical fit, which is strategically important as ziftomenib advances into FLT3-mutated disease and newly diagnosed AML, where combination therapies will define the largest opportunities.

We believe the confidence physicians are showing today can extend KOMZIFTI's leadership into earlier lines and additional patient populations, ultimately positioning ziftomenib as a foundational therapy across AML. For the balance of the year, our priorities are clear. Maintain leadership within the relapsed/refractory NPM1-mutant AML menin inhibitor market. Continue to expand physician adoption by reinforcing the product attributes that physicians value most, and deliver consistent quarter-over-quarter growth in new patient starts, total prescriptions, and revenue. Our objective is straightforward. Establish KOMZIFTI as the leading menin inhibitor today while building physician, payer, and patient confidence to become a cornerstone therapy across AML tomorrow. With that, I'll turn the call over to Mollie.

Thank you, Brian. The second quarter strengthened both of our precision oncology franchises. For ziftomenib, new clinical data increased our confidence in its potential to become a foundational therapy across AML. For darlifarnib, the data continued to support its potential as a broad and differentiated combination platform in solid tumors. I'll begin with ziftomenib. Just before EHA, peer-reviewed results from the KOMET-007 relapsed/refractory ziftomenib plus venetoclax and azacitidine study were published in Blood. The regimen demonstrated meaningful activity in a heavily pretreated population, including patients previously treated with venetoclax. Impressively, among venetoclax-naive patients, the overall response rate was 87%, the CR/CRi rate was 70%, and median overall survival was not reached as of almost 11 months follow-up. Turning to EHA, we presented long-term results from KOMET-007, evaluating ziftomenib plus 7+3 in 99 patients with newly diagnosed NPM1 mutant and/or KMT2A rearranged AML.

Remission rates were high, responses were deep, with a 96% ORR in relapsed/refractory NPM1 mutant AML. At 12 months, overall survival was 94%, and median overall survival had not been reached after a median follow-up of 17.6 months. These results compare favorably with historical 12-month overall survival of 70%-80% in younger fit patients and 45%-55% in older adults who receive intensive chemotherapy alone. Importantly, ziftomenib did not appear to add any meaningful myelosuppression to intensive chemotherapy. To our knowledge, this remains the largest frontline intensive chemotherapy dataset reported for any menin inhibitor, making it a key indicator of the potential for the phase III KOMET-017 program. Continuing to enhance that data pool, the pivotal trial KOMET-017, our one-stop shop design continues to accrue across the U.S., Europe, and Asia.