Kura Oncology Q2 2026 Earnings Call Transcript

On Wednesday, Kura Oncology (NASDAQ: KURA ) discussed second-quarter financial results during its earnings call. The full transcript is provided below. APIs provide real-time access to earnings call transcripts and financial data. Visit to learn more.

1 million in net product revenue for Comzifti in its second full quarter, capturing a majority of new patient starts in the relapsed refractory NPM1 mutant AML menin inhibitor market. The company aims to establish xifdomnib as a foundational therapy across AML by combining it with multiple standards of care, supported by new clinical data showing promising long-term outcomes. Darla Farnab is positioned as a second strategic asset, with clinical evidence supporting its potential to enhance targeted therapies in renal cell carcinoma and KRAS G12C mutated solid tumors.

3 million, with cash, cash equivalents, and short-term investments totaling $519 million, expected to fund the ziftomenib AML program through 2028. Future outlook includes multiple clinical updates in the second half of 2026, focusing on monotherapy, combination therapy, and treatment settings, with ongoing strategic collaborations and disciplined capital deployment. Full Transcript OPERATOR Good day everyone. My name is Lenius and I will be your conference operator today.

At this time I would like to welcome you to the Kura Oncology Second Quarter 2026 Financial Results Earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time and if you've joined via the webinar, please use the raise hand icon which can be found at the bottom of your webinar application.

To allow everyone the opportunity to participate, we ask that you please limit yourself to one question and one follow up question if time permits. At the end of the Q and A session, we invite you to rejoin the queue for additional questions. At this time I would like to turn the call over to Greg Mann, Senior Vice President of Investor Relations and Corporate Affairs of Kura Oncology. Please go ahead.

Greg Mann, Senior Vice President, Investor Relations & Corporate Affairs Thank you, Lenius. Good afternoon and welcome to Kura Oncology's 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. Troy Wilson, President, Chief Executive Officer and Chairman of the Board Thank you, Greg, and good afternoon everyone. The second quarter marked another step forward in Kura's evolution as a commercial-stage oncology company. Comzifti 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 Comzifti. 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 Comzifti's rapid adoption reflects the strength of that differentiated profile in the largest currently FDA-approved menin inhibitor opportunity. But the monotherapy launch is only the beginning.

Our objective is to establish xifdomnib 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 xiftamentib combines cleanly with standard therapy, deepens responses and supports more durable outcomes. With nearly 100 patients and extended follow up, comment 007 meaningfully increases our confidence in our frontline strategy. Molly 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 Darla Farnab, 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 KRASG12C mutated solid tumors, we've generated clinical evidence that Darle Farnab 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 Darla Farnab 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. Brian Powl, Chief Commercial Officer Thanks, Troy.

1 million in net product revenue with approximately 115 new patient starts and more than 250 total prescriptions. Based on current prescription data, Comzifte 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 continue to initiate menin inhibitor therapy with Comzifti. Physician-initiated combination use with venetoclax and nasalcitidine and with FLT3 inhibitors in commutated patients represented approximately 40% of new patient starts, and 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 Comzifti 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 priority AML prescribers nationwide.

We maintained 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, Comsifty 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 Comzifti, and exceptional commercial execution.

Although we promote Comzifty 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 if diminutive 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 Comzifti's leadership into earlier lines and additional patient populations. Ultimately, positioning ziftimentiv is 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 Conzifty 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 Molly. Mollie Leoni, Chief Medical Officer 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 darlafarnib, 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 CRc 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 + 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. 6 months. These results compare favorably with historical 12-month overall survival of 70% to 80% in younger fit patients and 45% to 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 data set reported for any menin inhibitor, making it a key indicator of the potential for the Phase 3 KOMET-017 program, continuing to enhance that data pool. , Europe and Asia. We continue to expect to report top-line results from our intensive chemo + ziftomenib trial in 2028, and our clinical data and operational execution give us the confidence that we are well positioned to lead in frontline AML. Our FLT3 combination program is also advancing.

We expect preliminary clinical data later this year from ziftomenib plus gilteritinib in relapsed or refractory NPM1- and FLT3-mutated patients. In the second half of 2026, we also expect to provide combination data with 7+3/quizartinib. Additionally, there will be other updates, including long-term ven-aza data and an exploratory analysis evaluating ziftomenib activity in additional non-NPM1, non-KMT2A-rearranged, menin-dependent AML subtypes. Taken together, these studies aim to demonstrate ziftomenib’s potential to combine effectively across multiple treatment approaches while maintaining the safety profile needed for long-term use in both relapsed and frontline AML.

Turning to darlafarnib, our second major strategic asset. Starting with renal cell carcinoma, we have reported powerful data in both cabozantinib-exposed and cabozantinib-naive patients. In the cabozantinib-exposed setting, darlafarnib plus cabo demonstrated a 44% objective response rate and 94% disease control rate. Expected response rates in this patient population would be approximately 17% to 22%.

The ability to generate responses when cabo had previously failed provides compelling clinical proof of mechanism. The data in cabozantinib-naive patients were even more encouraging. In 34 patients with advanced clear cell renal cell carcinoma, objective response rates ranged from 33% to 50% across dose levels, with a median progression-free survival of 13 months. For context, historical response rates in this setting range from 18% to 40%, with median progression-free survival of approximately 6 to 11 months.

The safety profile of the combination was manageable across doses tested. These data informed the dose combinations being evaluated in the randomized Phase 1b portion of FIT-001, which is comparing darlafarnib plus cabo with cabo alone in cabo-naive clear cell renal cell carcinoma. The study is designed to select a recommended dose and inform a potential registrational strategy. We expect enrollment to complete in the first half of 2027 with initial data in the second half of the year.

In addition, at ASCO, first-in-human data with darlafarnib plus adagrasib demonstrated tumor shrinkage in 77% of response-evaluable patients with KRAS G12C-mutated cancers. Activity was observed across tumor types and dose levels, resulting in an approximate doubling of the response rate expected with monotherapy adagrasib. This combination was also well tolerated. These results in both cabo and adagrasib combinations consistently and independently tell the story of darlafarnib’s proposed mechanism of enhancing a targeted therapy backbone via a tolerable method of MAP kinase pathway inhibition.

We plan to initiate our darlafarnib platform study evaluating darlafarnib plus daraxanrecib in second-line or later KRAS-mutant pancreatic cancer in the first half of 2027. Our priorities remain clear: execute our registrational studies, generate high-quality, practice-informing clinical data and continue building two differentiated precision oncology franchises. I'll now turn the call over to Tom to discuss our second quarter financial results. Thomas Doyle, Senior Vice President, Finance and Accounting & Principal Accounting Officer Thank you, Mollie.

I'm happy to provide a brief overview of our financial results for the second quarter of 2026. 1 million, compared to none for the second quarter of 2025. 3 million for the same period in 2025. 8 million for the second quarter of 2025.

2 million for the second quarter of 2025. 1 million for the second quarter of 2025. 9 million for the same period in 2025. 2 million as of December 31, 2025.

We are maintaining our previously communicated guidance for collaboration revenue. We expect this to be $45 to $55 million in 2026, $90 to $110 million in 2027 and $90 to $110 million in 2028. This revenue reflects non-cash-based accounting recognition of performance obligations under our collaboration agreement with Kyowa Kirin. Our current cash, cash equivalents and short-term investments as of June 30th, together with anticipated payments of $180 million under our collaboration agreement with Kyowa Kirin, are expected to fund our ziftomenib AML program through the first top-line Phase 3 results from KOMET-017 anticipated in 2028.

With that, I'll turn the call back over to Troy. Troy Wilson, President, Chief Executive Officer and Chairman of the Board Thank you, Tom. The second quarter demonstrates Kura Oncology is converting product differentiation into commercial leadership. Comzyfti is winning new patient starts in adult relapsed and refractory NPM1-mutant AML while our clinical programs continue to expand ziftomenib toward the much larger frontline opportunity.

At the same time, darlafarnib is emerging as a potentially differentiated precision combination platform with broad applicability across solid tumors. Together, these programs give us multiple independent drivers of long-term value creation backed by the capital and execution to realize those opportunities. With that, Linneus, we're ready to take questions. OPERATOR Thank you.