쿠라 온콜로지(KURA) 2026년 2분기 실적 발표: 콤지프티 매출 910만 달러 달성

핵심 요약

• KOMZIFTI는 상업화 두 번째 분기인 2026년 2분기에 약 115명의 신규 환자 처방 개시와 250건 이상의 총 처방 건수를 기록하며 910만 달러의 제품 매출 순액을 달성했습니다.
• 쿠라 온콜로지(Kura Oncology)는 KOMZIFTI가 재발성/난치성 NPM1 변이 급성골수성백혈병(AML) 메닌 억제제 시장에서 신규 환자 처방 개시의 과반을 점유했다고 밝혔습니다. 신규 환자 처방 개시는 전분기 대비 약 35% 증가했고, 총 처방 건수는 약 60% 증가했습니다.
• 신규 환자 처방 개시의 약 40%는 의사 재량에 따른 베네토클락스 및 아자시티딘 또는 FLT3 억제제와의 병용 투여였습니다. 쿠라는 승인된 단독요법 적응증에 대해서만 KOMZIFTI를 판촉하고 있습니다.
• 2분기 공동연구 매출은 1,180만 달러를 기록했습니다. 순손실은 전년 동기의 6,610만 달러에서 6,830만 달러로 확대됐으나, 2026년 6월 30일 기준 현금, 현금성자산 및 단기투자자산은 총 5억 1,900만 달러였습니다.
• 경영진은 2026년 공동연구 매출 가이던스를 4,500만~5,500만 달러로 유지했습니다. 현재의 유동성과 향후 수령할 쿄와기린(Kyowa Kirin) 수령 예상액 1억 8,000만 달러를 합치면 2028년으로 예정된 첫 KOMET-017 임상 3상 톱라인 결과 발표 시점까지 지프토메닙 AML 프로그램 자금을 조달할 수 있을 것으로 예상됩니다.
• 쿠라는 신세포암 및 KRAS G12C 변이 고형암에서의 병용 임상 데이터를 바탕으로 달리파닙을 두 번째 핵심 전략 자산으로 지정했습니다.

주요 재무 데이터

사업 및 운영 성과

KOMZIFTI 상업화 출시

KOMZIFTI는 이번 분기 동안 약 115명의 신규 환자 처방 개시와 250건 이상의 총 처방 건수를 기록했습니다. 경영진은 이러한 출시 모멘텀의 요인으로 효능, 관리 가능한 수준의 안전성, 투여의 용이성, 타 약제와의 병용 적합성 및 상업적 실행력을 꼽았습니다.

대학병원 및 지역 치료 센터 전반으로 처방 도입이 확대되었습니다. 쿠라는 최우선순위 AML 거래처의 90% 이상과 협력 관계를 유지했습니다. 또한 적응증 제한 없이 보험 적용 대상자의 95% 이상에 대해 처방 보장이 이루어지고 있으며, 이 중 약 1,600만 명은 선호(preferred) 지위를 확보했다고 밝혔습니다.

경영진은 분기 성장이 시장 확대와 점유율 상승을 모두 반영한 것이라고 말했습니다. 아울러 재고 축적이나 기타 일회성 이벤트가 이번 분기 실적에 실질적으로 기여한 바는 없다고 밝혔습니다.

지프토메닙 임상 프로그램

재발성/난치성 환자를 대상으로 지프토메닙과 베네토클락스 및 아자시티딘을 병용한 KOMET-007 연구에서, 베네토클락스 투여 이력이 없는 환자군은 87%의 전체 반응률(ORR)과 70%의 복합 완전관해율을 달성했습니다. 약 11개월의 추적 관찰 기간 동안 전체 생존기간 중앙값에는 도달하지 않았습니다.

유럽혈액학회(EHA)에서 쿠라는 NPM1 변이 및/또는 KMT2A 재배열 AML로 새로 진단된 환자 99명을 대상으로 지프토메닙과 7+3 요법을 병용한 KOMET-007 장기 데이터를 발표했습니다. 경영진은 12개월 시점의 전체 생존율이 94%였으며, 중앙값 17.6개월의 추적 관찰 후에도 전체 생존기간 중앙값에는 도달하지 않았다고 보고했습니다. 회사는 지프토메닙이 집중 화학요법에 유의미한 골수억제 부작용을 가중시키지 않는 것으로 보인다고 밝혔습니다.

임상 3상 KOMET-017 프로그램은 미국, 유럽, 아시아 전역에서 환자 등록을 계속 진행하고 있습니다. 쿠라는 기관 활성화가 완료되면 200개 이상의 사이트가 확보될 것으로 예상하고 있으며, 집중 화학요법 연구의 첫 톱라인 결과를 2028년에 발표할 것이라는 기존 전망을 유지했습니다.

2026년에는 재발성/난치성 NPM1 및 FLT3 변이 AML에서의 지프토메닙과 길테리티닙 병용요법, 1차 치료에서의 7+3 및 퀴자티닙 병용요법에 대한 추가 업데이트가 예정되어 있습니다. 쿠라는 또한 베네토클락스/아자시티딘 장기 데이터 및 NPM1 및 KMT2A 변이 외의 추가적인 메닌 의존성 AML 아형에 대한 탐색적 연구 관련 업데이트도 계획하고 있습니다.

달리파닙 플랫폼

카보잔티닙 투여 이력이 있는 신세포암 환자에서 달리파닙과 카보잔티닙 병용요법은 44%의 객관적 반응률과 94%의 질병조절률을 나타냈습니다. 카보잔티닙 투여 이력이 없는 진행성 투명세포 신세포암 환자 34명에서는 용량군별로 33%~50%의 객관적 반응률을 보였으며, 무진행 생존기간 중앙값은 13개월이었습니다.

FIT-001의 무작위 배정 임상 1b상 부분에서는 달리파닙과 카보잔티닙 병용요법을 카보잔티닙 단독요법과 비교 평가하고 있습니다. 환자 등록은 2027년 상반기에 완료될 것으로 예상되며, 초기 데이터는 하반기에 공개될 예정입니다.

달리파닙과 아다가라십 병용요법은 반응 평가가 가능한 KRAS G12C 변이 암 환자의 77%에서 종양 축소를 이끌어냈습니다. 쿠라는 2027년 상반기에 2차 이상 KRAS 변이 췌장암 환자를 대상으로 달리파닙과 다락소나십 병용요법에 대한 플랫폼 연구를 개시할 계획입니다.

경영진 실적 전망(가이던스)

경영진은 이번 가이던스가 쿄와기린과의 공동연구 계약에 따른 수행 의무의 비현금성 회계 인식을 반영한 것임을 강조했습니다.

쿠라는 6월 30일 기준 유동성과 향후 수령할 쿄와기린 수령 예상액 1억 8,000만 달러를 통해 2028년으로 예정된 첫 KOMET-017 임상 3상 톱라인 결과 발표 시점까지 지프토메닙 AML 프로그램 자금을 조달할 수 있을 것으로 예상하고 있습니다.

리스크 및 주시 사항

• KOMZIFTI의 치료 지속 기간 데이터는 아직 미성숙한 상태이며, 환자들이 치료를 지속하고 재처방이 발생함에 따라 이를 평가하는 데 추가적인 시간이 걸릴 것입니다.
• 신규 환자 처방 개시의 약 40%는 의사 재량에 따른 병용요법이었으나, 쿠라는 승인된 단독요법 적응증에 대해서만 KOMZIFTI를 판촉하고 있습니다.
• 향후 발표될 FLT3 병용요법 데이터는 초기 단계입니다. 경영진은 안전성, 내약성, 그리고 기존 치료제와 지프토메닙을 병용할 수 있는 능력이 핵심 평가 요인이 될 것이라고 밝혔습니다.
• KOMET-017 결과 발표는 2028년에야 이뤄질 것으로 예상되며, 계획된 200개 이상의 기관 네트워크 구축을 위한 사이트 활성화 작업이 여전히 진행 중입니다.
• 달리파닙은 여전히 개발 초기 단계에 있습니다. 경영진은 허가용 임상 연구에 대규모 자본을 투입하기 전에 용량 선정과 임상적 입증을 우선시하고 있습니다.
• 순손실은 전년 동기 대비 증가한 반면, 현금 및 투자자산은 2025년 말 6억 6,720만 달러에서 2026년 6월 30일 기준 5억 1,900만 달러로 감소했습니다.

애널리스트 Q&A 하이라이트

시장 점유율 및 처방 성장: 경영진은 청구 데이터에 따르면 KOMZIFTI가 특히 재발성/난치성 NPM1 변이 AML 분야에서 신규 환자 처방 개시의 과반을 점유한 것으로 나타났다고 밝혔습니다. 쿠라는 이 시장을 경쟁 메닌 억제제들이 진입해 있는 더 작은 규모의 KMT2A 재배열 AML 세그먼트와 구분했습니다.

병용 투여: 약 40%의 병용 투여 비율은 전분기와 유사한 수준을 유지했습니다. 투여는 베네토클락스/아자시티딘 병용과 FLT3 억제제 병용으로 나뉘었으며, 새로 진단된 환자보다는 주로 재발성/난치성 환자에게 사용되었습니다.

보험 커버리지: 쿠라는 보험 적용 대상자의 95% 이상에서 커버리지를 확보했으며, 약 1,600만 명에 대해 선호(preferred) 지위를 확보했다고 보고했습니다. 경영진은 사전 승인 절차가 실질적인 약물 접근성 장애를 일으키지 않았다고 설명했습니다.

KOMET-017 환자 등록: 경영진은 환자 등록 진척의 요인으로 하나의 운영 체계 아래 집중 및 비집중 화학요법 연구를 함께 수행하는 임상 구조와 이전 KOMET-007 데이터에 대한 의료진의 관심을 꼽았습니다.

더 넓은 AML 치료 기회: 쿠라는 NPM1 및 KMT2A 변이 외의 메닌 의존성 AML 아형에서 지프토메닙을 평가하고 있습니다. 경영진은 MEIS1 발현을 생물학적 근거로 제시하며, 뒷받침하는 임상 데이터가 확보될 경우 공략 가능한 환자군을 확장할 가능성이 있다고 밝혔습니다.

달리파닙 자금 조달 및 파트너십: 경영진은 초기 달리파닙 플랫폼 연구를 위한 자금이 할당되어 있지만 전략적 제휴를 확정한 것은 아니라고 밝혔습니다. 쿠라는 더 큰 규모의 투자나 파트너십 결정을 내리기 전에 차별화된 허가 임상 경로를 구축할 계획입니다.

실적 발표 콘퍼런스 콜 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

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. [Operator Instructions]

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

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

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 2 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. But the monotherapy launch is only the beginning. Our objective is to establish ziftomenib as a foundational therapy across AML by combining 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 1 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

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 continue 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.

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 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 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, 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.

Mollie Leoni

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 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 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% 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 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. We continue to expect to report top line results for our intensive chemo ziftomenib trial in 2028, and our clinical data and operational execution gives 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 plus 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 darlifarnib, 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, darlifarnib plus cabo demonstrated a 44% objective response rate and a 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 was 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 Ib portion of FIT-001, which is comparing darlifarnib 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 darlifarnib 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 darlifarnib's proposed mechanism of enhancing a targeted therapy backbone via a tolerable method of MAP kinase pathway inhibition.

We plan to initiate our darlifarnib platform study evaluating darlifarnib plus daraxonasib 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 2 differentiated precision oncology franchises.

I'll now turn the call over to Tom to discuss our second quarter financial results.

Thomas Doyle

Thank you, Mollie. I'm happy to provide a brief overview of our financial results for the second quarter of 2026. Our net product revenue from KOMZIFTI sales was $9.1 million compared to none for the second quarter of 2025. Collaboration revenue from our Kyowa Kirin partnership was $11.8 million compared to $15.3 million for the same period in 2025.

Research and development expenses were $61.9 million compared to $62.8 million for the second quarter of 2025. Selling, general and administrative expenses were $31.8 million compared to $25.2 million for the second quarter of 2025. Net loss for the second quarter of 2026 was $68.3 million compared to a net loss of $66.1 million for the second quarter of 2025. This includes noncash share-based compensation expense of $8.2 million compared to $6.9 million for the same period in 2025.

As of June 30, 2026, Kura had cash, cash equivalents and short-term investments of $519 million compared to $667.2 million as of December 31, 2025. We are maintaining our previously communicated guidance for collaboration revenue. We expect this to be $45 million to $55 million in 2026, $90 million to $110 million in 2027 and $90 million to $110 million in 2028. This revenue reflects noncash-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 30, 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 III results from KOMET-017 anticipated in 2028.

With that, I'll turn the call back over to Troy.

Troy Wilson

Thank you, Tom. The second quarter demonstrates Kura is converting product differentiation into commercial leadership. KOMZIFTI is winning new patient starts in adult relapsed and refractory NPM1-mutant AML, while our clinical programs continue to expand ziftomenib towards the much larger frontline opportunity.

At the same time, darlifarnib is emerging as 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, Lenius, we're ready to take questions.

Operator

[Operator Instructions] Your first question comes from the line of Jason Zemansky with Bank of America.

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Jason Zemansky

Congratulations on the great quarter. Two quick from me. Regarding the 115 new patient starts, can you help us separate how much of the sequential increase reflected growth in overall menin class penetration versus share gains from your competitor? And then secondarily, can you help us understand the emerging relationship among starts, refills and recognized revenue, including any inventory or gross to net effects in the quarter?

Troy Wilson

Thanks, Jason. Yes, I'll ask Brian to take each of those questions in turn.

Brian Powl

Sure. Thanks, Jason, for the question. So yes, so as we've said, we're very pleased with that sequential growth over -- quarter-over-quarter. And I think what that represents, as we said, is continued execution on the team to penetrate into new accounts and extend for new patients. We -- our goal is to become the majority share -- the majority market leader in this space and this indication of new patient starts leading in only the second quarter summarizes that. I think what that shows is we're both taking share from competitors, but also having the opportunity to grow the market.

To your second question around kind of refills and dynamic kind of going that forward. I mean I think what you can see is in the results that we've shared, we've got a -- going from first quarter -- our first full quarter of launch into the second quarter, we demonstrated quarter-on-quarter growth of the new patient starts of about 35% and the TRx growth is actually about 60% growth quarter-over-quarter. So we're seeing repeat prescriptions. We're seeing new prescriptions. And I think we're able to see continued good growth. And there hasn't really been any inventory or stocking onetime events that really have contributed to that. But the story is really growth here.

Operator

Your next question comes from the line of Li Watsek with Cantor Fitzgerald.

Li Wang Watsek

Just curious, how do you expect KOMZIFTI's market leadership to evolve over time? And how much of that do you think is driven by combo use?

Troy Wilson

Brian, want to take this?

Brian Powl

Sure. Thanks for that, Li. I think that we -- as we've said when we first launched, we said that we have a differentiated product profile that we think will be preferential for physicians. And we expected that we would deliver quarter-on-quarter growth throughout the year as well as becoming the market leader in the menin space in the NPM1-mutant population. We've achieved that market leadership, as we've shared here based on new patient starts already in the second quarter, with the growth in TRx, the growth in revenue, what we think is all kind of signs or kind of arrows are green. They're turning in the direction of growth here, and we think momentum is on our side to continue to evolve that.

We -- I know we've been asked questions around duration. Duration is something that will come over time, and that's something we'll be seeing over -- as we continue to grow. But the focus is getting all the new -- every new patient have the opportunity to get them on KOMZIFTI, and that's what we've achieved so far. And we continue to execute on that will enable us to get to that overall market leadership.

Troy Wilson

What about combination use?

Brian Powl

Yes. And for combination use, yes, your question there. As we shared in the remarks, we have approximately 40% use in combination. That's consistent with where we were last quarter where we had obviously lower volume. So we're seeing that usage in combination growing. Obviously, the team is focused on promoting on label. But physicians see the choice and are looking to find ways to combine. We think that's a real growth opportunity for KOMZIFTI in the relapsed/refractory space because of the data that Mollie mentioned at the publication in Blood.

We'll be presenting new data in combination with FLT3 inhibitors, which, as you know, is approximately half of the NPM1-mutated market is co-mutated. So we'll be able to continue to develop that. We are seeing, as we said, kind of a split of both ven/aza combinations as well as FLT3 currently. But we think we're well positioned to continue that -- the data generation that will support physicians' choices to use KOMZIFTI.

Operator

Your next question comes from the line of Asthika Goonewardene with Leerink Partners.

Asthika Goonewardene

My congrats for the growth this quarter. Just got a couple of quick hits on the inter-quarter dynamics here. Could you just maybe tell us a little bit about what your Tier 2 or preferred coverage was with KOMZIFTI? I'm sorry, can you hear me okay?

Brian Powl

Yes.

Troy Wilson

Go ahead, Asthika.

Asthika Goonewardene

Yes. Sorry. So the question was, can you tell us about your Tier 2 or your preferred coverage of KOMZIFTI? And for patients requiring a prior authorization, what proportion of those prior authorizations were converted? And then I have a quick follow-up.

Troy Wilson

Sure. Thanks, Asthika, for the question. So yes, so I didn't go into too much detail about our market access coverage, but I think it represents the continued success of the story. We have over 95% of lives now covered, and we have approximately 16 million lives are actually covered with a preferred status where patients have to step through KOMZIFTI before receiving other menin inhibitors. And I think what that translates into is the growth that we're seeing.

Prior authorizations have been -- it's a standard, I think, mechanism in oncology. And I think what's been very important for us is we have not seen any challenges for physicians to be able to access the KOMZIFTI for their patients. And I think that's reflected in the growth we've seen quarter-over-quarter.

Asthika Goonewardene

And then the...

Troy Wilson

Yes, go ahead. You said, you got a quick follow-up.

Asthika Goonewardene

Yes. Just on KOMET-017. So it looks like on ClinicalTrials.gov that you have all the sites active. So can you tell us when you expect to complete enrollment in the intensive chemo arm?

Troy Wilson

Mollie, would you like to take Asthika's question about 017?

Mollie Leoni

Sure. Just to be clear, we'll have over 200 sites when all sites are active. So we're still in the process of activating them. But really, things have been going extremely well. So our guidance towards first data update and readout in 2028 remains fully on track.

Operator

Your next question comes from the line of Roger Song with Jefferies.

Nabeel Nissar

Congrats on the launch progress so far. This is Nabeel on for Roger. One from us. So on KOMET-017, you've mentioned the enrollment is running ahead of plan. Curious what's driving that? And how are you thinking about the value of being first to build that frontline data set in this class?

Troy Wilson

Mollie?

Mollie Leoni

Well, ultimately, there's a few different factors. But 017 is successful because the design is actually so incredibly convenient for sites to use and for prescribers to put their patients on. Having both studies for intensive and non-intensive chemotherapy within the same trial so that you do one round of bureaucratic start-up activities and operational activities really does make a difference, and it makes it easy for any patient with a menin inhibitor dependent disease to have a place to go as soon as they walk into their physician's office.

And beyond that, the 007 data, the Phase I data that we continue to present at various conferences really just bolsters everyone's excitement. These patients are doing very well. The addition of menin inhibitor seems to not add any toxicity and probably is adding a good deal of benefit. So I think it's all-around excitement over the data we're showing and the structure of the trial that these patients are able to enroll in.

Operator

Your next question comes from the line of Charles Zhu with LifeSci Capital.

Peter Green

This is Peter Green on for Charles. Just actually a quick question on FTIs. It sounds like early or first half of 2027, launching a platform trial combining darlifarnib with daraxonasib you've committed to in PDAC. Wondering if your thinking has changed on potential other combinations. For example, we had talked about colorectal cancer with EGFR and G12D. And we're also seeing other combinations with RAS such as TRMT5 gaining in the competitive landscape. So just curious what your thoughts are there.

Troy Wilson

Yes. Thanks, Peter. Mollie, do you want to comment?

Mollie Leoni

Sure. That's a very, very good question. So obviously, daraxonasib will be our first in the platform design. But the reason we did the platform design is so that we can explore all of these other combinations that make a lot of sense for patients and scientifically in parallel. So daraxonasib will be the first, but absolutely be looking for additional combinations in other indications and with other drugs.

Troy Wilson

Yes. And Peter, just to add to Mollie's comments, we see an opportunity to combine with daraxonasib in second-line PDAC. A lot of companies look to be steering into the frontline, perhaps trying to get there before a potential approval or maybe not to have to go head-to-head to be able to go against chemo. In our view, if we can replicate with daraxonasib, what we've seen with adagrasib, we think we can add clinical value to those second-line plus patients and hats off to the Revolution Medicines team for what they brought to patients. But I think it now gives us a platform on which to build through combinations, and you've mentioned some of them.

We're really looking, as Mollie said, to be selective. We're not -- we can't do everything, right? But we have a number of combinations under consideration that some of which require cooperative groups with other parties. And we'll provide more detail as it's appropriate.

Peter Green

And just a quick follow-up. Are there funds currently earmarked for this trial? And what are the expected costs?

Troy Wilson

Yes, there are funds, Peter. We haven't broken out the specific expense. I mean, at this point, we would plan for the Phase Ia. You want to confirm that you can -- that you have adequate safety and tolerability. If that looks good, then we'll reassess. We are at a point, you can probably hear it in the call where we have a wealth of opportunities that we could invest in. We're going to be -- we're going to continue to be very focused in our capital allocation. We think we now have awful leadership at least in new patient starts. We think soon in the other metrics with zifto, we want to [ position ] darli similarly. So all good things in time. We're fortunate with darli that this is still early development. So we're not talking about huge dollars relative to, for example, registration-enabling studies.

Operator

Your next question will come from the line of Salim Syed with Mizuho.

Salim Syed

Congrats on the quarter, guys. I'll try to keep you back and get you back on track with a single question rule here. Appreciate it. So Troy, you guys are saying in the press release here, a majority share of new patient starts for relapsed/refractory NPM1. Syndax is also saying 60% or 2/3 of the business -- 2/3 of the NPM1 business is what they're seeing on their side. Obviously, both of these can't be true. So I'm just wondering where is it in the data that there's this confusion that both parties can claim majority share of new patient starts here?

Troy Wilson

Yes, Salim. So thanks for the question. And actually, as the operator indicated, we are allowing people to ask one follow-up. So feel free to ask a follow-up. But let me dispel the confusion. We've said we have 115 new patient starts. We're reading the competitor, both us and the competitor off of claims data. They had 250 new patient starts for the quarter and said approximately 40% of them were NPM1. So by my math, that's 100 and a 25% decline in new patient starts quarter-over-quarter, whereas we're growing 35% quarter-over-quarter.

They do have the KMT2A business. And I think when they're talking about -- there's -- we want to be very clear. We're talking only about NPM1. We're only speaking to NPM1. NPM1, ultimately, as you well know, is the much larger opportunity that includes potentially FLT3 and as we go out to the frontline. Not to take anything away from the KMT2A market, but that's 5% of AML. So I think you have to be clear about what question are we asking exactly. And back to something Brian said, Salim, whether it's NPS, whether it's TRx, whether it's net revenue, they're all growing, they're all strongly growing. I think that's a good sign.

Operator

Your next question will come from the line of Phil Nadeau with TD Cowen.

Philip Nadeau

Now that you've had several quarters of commercial experience, I'm curious whether there's been any differences in the commercial experience with KOMZIFTI versus what we see in the clinical trials. Anything notable that physicians are pointing to? That's the first question. And then just a follow-up on the FLT3 combo data that we're going to see later this year. Can you give us some sense of what you're hoping to see from that data and what next steps could be?

Troy Wilson

Sure. Thanks, Phil, for the 2 questions. Brian, do you want to take the question on are we seeing things differently in the market versus maybe...

Brian Powl

What we've seen...

Troy Wilson

Yes, versus the clinical experience.

Brian Powl

Absolutely. Yes. Thanks for that question, Phil. And I'm happy to just kind of give a little bit of color there. But with the patients that have been kind of coming on to our studies, it's still a little bit early to see to kind of measure outcomes, as you know, but we've seen the uptake has been really supportive of the differentiation of KOMZIFTI as a new menin inhibitor in the market. The profile kind of the efficacy, safety, compatibility with other agents and the simplicity are what's leading to the increase in prescriptions, leading to the physician choice, and our team is executing clearly in order to get that.

I think as we continue to follow, we'll be tracking the duration story over time and getting an understanding of outcomes. But I think one indicator is that the combination use that we outlined shows you that physicians are very interested in using these therapies in combination. We were able to get the publication of the Blood -- Blood publication out quickly based on the feedback from physicians who really wanted to ensure they had the data available for them to make those decisions. So we'll continue to follow and we'll be, over time, be able to present that. But we're seeing consistency, I think, in the responses and the outline that we've gotten from the clinical data.

Troy Wilson

And speaking of combinations, Mollie, do you want to speak to the sort of what to expect from FLT3 and maybe thoughts around potential next steps?

Mollie Leoni

Absolutely. So with regards to the FLT3 data that we're going to show you, both the combination in the relapsed/refractory setting with gilteritinib as well as in the frontline setting, the quadruplet with quizartinib, the first, second and third things you should be looking for is safety and the ability to combine. So the fact that we're actually able to show you these data, show you safe combination, show you safe dose escalation should be really important because as we've always said, AML is a combination game. It requires these combinations in order to successfully treat patients.

So really, you should be looking to see the safety and tolerability. But obviously, we'll also be showing you the associated efficacy. Some is evolving at this time. The quizartinib trial is still rather new, but it's enrolling so quickly. We want to share data with you as soon as we could. And we'll continue to update as everything evolves for next steps. I think that, that will be a topic that will be covered actually when we present the data.

Operator

[Operator Instructions] Your next question comes from the line of Etzer Darout with Barclays.

Etzer Darout

Can you guys hear me okay?

Troy Wilson

Yes, Etzer, we can hear you.

Etzer Darout

Great. Just a question, I guess, a little bit of a follow-up related question to the earlier questions around real world versus clinical use. Wondering more around the combination use that you've noted, the 40%. How much of that is in that relapsed/refractory NMP1 (sic) [ NPM1 ] patient, basically the on-label indication versus maybe even earlier line use or uses just in patient populations beyond what's currently on the label? Anything there would be helpful.

Brian Powl

Yes. Thanks, Etzer, for that. The data that we reported is primarily in this relapsed/refractory population. It's not our indication, but in that population. Our goal is because we have KOMET-017 enrolling, I think we want to get any of those newly diagnosed patients to be put on those trials. But a lot of the dynamic that we've seen is that patients who are immediately refractory to frontline therapy may be preferentially treated in combination, and that's what I think physicians are using. So there's not really a big story in terms of dynamic outside of the population that we're treating.

Operator

Your next question comes from the line of Reni Benjamin with Citizens.

Reni Benjamin

Congrats on the quarter. I guess, Troy, I'd love to understand a little bit more about the rationale behind the evaluation of zifto in these MEIS1 AML patients that are not NPM1 or KMT2A. How important is this in terms of market potential? Or is this just a nice to have? And as a follow-up, kind of on the heels of the [ TCRs ] and ASCO data and Tom's comments about the cash on hand to fund the zifto readouts. Can you talk about what might be the best strategy to fund the darlifarnib franchise? And what might be the best sort of collaboration structures that you'd be looking at?

Troy Wilson

Yes. Thanks, Ren. Two very different questions. Let me ask Mollie -- just a reminder for everyone, back when we were doing dose escalation, we did see activity, including a CR in a SETD2/RUNX1 patient. And that was kind of an important marker. But Mollie, maybe you can speak a little bit to the rationale for that study. Obviously, we can't go under the abstract. But Mollie, maybe you can speak to Ren's first question, and I'll take the second.

Mollie Leoni

Yes. What you said is extraordinarily important. When we did the Phase Ia dose escalation, we saw activity outside of the places where you'd expect "to see it." And then from what we know from data that has been generated previously, up to 50% of AML probably has at least some form of MEIS1 expression high, meaning that it would probably be responsive to menin inhibition. So this is huge. If we can show you additional patient populations besides the NPM1 and the KMT2A, we really do think that we would be able to help up to 50% of AML patients, and we'll show you the data as to why we believe that.

Troy Wilson

And Ren, to your second question, just very quickly. At this point, our goal is to establish a registrational path in solid tumors for darlifarnib that provides meaningful clinical value and is differentiated from the competition. We think there's an opportunity in advanced renal cell carcinoma. Mollie spoke to that on her -- with her prepared comments. We think there's an opportunity on top of daraxonasib. Anything else, I think we have to be very thoughtful. We could make darlifarnib available to others. That would be an easy way to sort of expand the playing field.

Importantly, as we think about this, what you're picking up on now strategically is these 2 programs work together. So as we're moving toward initial top line results for ziftomenib in frontline AML in '28, that jives very nicely with the timing when you'd be making investment decisions for darlifarnib to be able to move it into a registrational setting. That's important in terms of building value for patients and shareholders. It's also interesting from a strategic perspective because now you have 2 potential blockbusters, one of which has hopefully a positive frontline data set, one or more and then a second one that's coming up behind it.

And as we indicated, the opportunity in renal cell and PDAC, either of those is on the same order as all of AML, right? So we really are -- I think we're really in a good position to have now 2 programs that are relatively close in time. And you see we're being very, very disciplined with our spend. Our R&D expense actually ticked down just slightly from last year. So we're going to continue to be very responsible stewards of capital and look to create value for shareholders.

Reni Benjamin

Got it. So the funds on hand can get you to those registrational studies and then the timing will work out right with the zifto readout and moving this on to registrational studies.

Troy Wilson

Yes. I think -- we -- let me put it this way, Ren. Let me say it slightly differently. We look at all the options all the time. Personally, I don't know that doing a strategic collaboration on darli would necessarily be the right thing to do at this stage. There's a lot of value there, particularly if folks remember, we have what we believe will be the market-leading menin inhibitor throughout the AML treatment continuum.

And we've cited the $7 billion TAM. Look at our frontline data, like that's not -- that's a very reasonable TAM. We have -- we are the senior party in that collaboration. We book all U.S. sales. We control global development. We control U.S. commercial. Now Ren, you have a second asset sort of sliding in behind it. That's a pretty nice setup in terms of building value. So that's the way we think about it.

Operator

Your next question comes from the line of David Dai with UBS.

Xiaochuan Dai

I also want to congrats on this great quarter. Just a quick question from me on the zifto and FLT3 combo. I'm just wondering how large do you believe this FLT3 and NPM1 co-mutated population could ultimately become within the broader zifto franchise? So I think you mentioned that there's 50% of AML patients have the FLT3/NPM1 co-mutation. But could you help us understand how big the market is in dollar amount?

Troy Wilson

Yes. Maybe I can take that, David. So just maybe take half a step back, just so everybody is clear, half of your NPM1 incident population has a co-mutation in FLT3. So if you really want to drive the greatest clinical benefit for patients, just as Mollie said, you're going to want to go to combinations. We know that's the future. Then there's another equally sized population. So FLT3 is 30% of AML. Half of that or 15% is overlapping with NPM1. The other half, David, are either with NPM1 wild-type or have other mutations.

To Mollie's point, I think it's reasonable to believe that a menin inhibitor certainly would be active in the co-mutated population. It may even be active in the wild-type -- the NPM1 wild-type, sort of let's stay tuned. We have said consistently, we see an opportunity to treat 50%, maybe more of AML patients throughout the treatment continuum. So when we go to that frontline setting, David, of right now, we've put a $7 billion TAM on it, $3 billion projected peak sales for us, all approvals, FLT3 is a portion of that. The big ones right now are KMT2A, NPM1 and let's see the FLT3 data, as Mollie said, a little later this year. Hopefully, that clarifies -- is the answer you're looking for.

Operator

[Operator Instructions] Our next question comes from the line of Daniel Brims at Lake Street.

Daniel Brims

Great quarter, guys. Just a quick question about what you're seeing as far as some kind of switching dynamic between the menin inhibitors. Obviously, it sounds like you guys can combine much more easily than your competitor. So just wondering if you're seeing patients starting there and then switching over to zifto as docs want to have better safety profile or be able to combine it with other things.

Troy Wilson

Yes. Thanks, Daniel. Brian, do you want to take Daniel's question?

Brian Powl

Sure. Thanks, Daniel, for that. Yes, there is certainly a dynamic of switching. I think there are some physicians who see an opportunity to shift to KOMZIFTI. Our goal is to obviously optimize benefit for every patient. We're looking to both grow the market and take share from other products in the space. And I think what we're showing you is that we're doing both. By getting to the -- this majority share of the new patient starts within our second full quarter shows that we're able to get patients not just who may have been on another therapy, but we're bringing in new patients. And as the new patient flow comes forward, we're very happy to see the physicians are choosing KOMZIFTI based on all the things that I've outlined, our profile, their choice and the opportunity for things like combinations as well. So I think it's going to be a dynamic that will continue to evolve in this space. Thank you for that question.

Operator

Your final question today comes from the line of Peter Green at LifeSci Capital.

Peter Green

Just wondering if you could contrast the sales force experience at sites familiar with ziftomenib, perhaps they have had trials or investigators there versus sites that are unfamiliar with ziftomenib? And if there's -- what proportion of prescriptions are coming from trial investigators?

Troy Wilson

Yes. Peter, thanks actually for getting back in the queue and asking an additional question. I'm going to turn it over to Brian for just a second, but let me just comment. There isn't any one thing, right? The good news is like every -- the team is executing like everything is going in the right direction. And we're -- we were hopeful this was what we would see. I have to give great credit to Brian and his team. The physician engagement, the preferences we're seeing, the commercial execution is really top notch. But Brian, do you want to speak to any differences between people who haven't worked with it and those who have.

Brian Powl

Of course. And thanks, Peter. Thanks, Troy, for the accolades to a great team. The team, as you said, has been executing even better than we could have expected. They're very experienced. They know a lot of these accounts because of their experience in hematology. And I would say that we're very pleased with where we're going, but we also haven't said that we penetrated every account. There's opportunity for growth, and we'll continue to see that opportunity. There are, of course, some sites that are more early adopters, those who've had experience, others are, as I've said, coming from experience with other menin inhibitors on other clinical trials, but then also those who haven't really had experience with menin inhibitors.

And I think the discussion with each of those groups may be slightly different than each other. So we have a great team that's able to engage and experience that. We're seeing growth everywhere. And I think that's what's been encouraging for us, and we're encouraged to see that momentum continue.

Operator

Thank you. There are no more questions at this time. I'd now like to turn the call over to Troy Wilson for closing remarks.

Troy Wilson

Thank you, Lenius. I want to thank you all once again. And in particular, I want to call out not only my team, everybody at Kura, but also the physicians and the care teams. At the end of the day, what we're trying to do is help patients. And I think the team is -- I couldn't be more proud. The team is making just tremendous progress. You hear it from the commercial setting, relapsed/refractory to the frontline execution to the data that you'll see later this year.

It's really just everybody working together on behalf of patients. We appreciate your interest. We appreciate your questions. We're going to be attending multiple conferences in September, and we look forward to seeing many of you there. In the meantime, if you have questions, you know how to find us, please reach out to Greg or me. Thank you all, and have a good evening.