Kura Oncology（KURA）2026年第2四半期決算説明会：KOMZIFTIの売上高は910万ドルに達する

主なポイント

• KOMZIFTIの2026年第2四半期の製品売上高（純額）は、商業化後2回目のフル四半期となり、910万ドルを計上しました。新規治療開始患者数は約115人、総処方数は250件を超えました。
• Kura Oncologyは、再発・難治性のNPM1変異急性骨髄性白血病（AML）メニン阻害剤市場において、KOMZIFTIが新規治療開始患者の過半数を獲得したと発表しました。新規治療開始患者数は前四半期比で約35%増加し、総処方数は約60%増加しました。
• 新規治療開始患者の約40%は、ベネトクラクスおよびアザシチジン、またはFLT3阻害剤との医師主導による併用療法でした。KuraはKOMZIFTIを承認された単剤療法の適応症についてのみプロモーションを行っています。
• 第2四半期の提携収入は1180万ドルでした。純損失は前年同期の6610万ドルから6830万ドルに拡大したものの、2026年6月30日時点の現金、現金同等物および短期投資の残高は計5億1900万ドルとなりました。
• 経営陣は、2026年の提携収入の見通し（ガイダンス）を4500万〜5500万ドルに据え置きました。現在の手元資金と協和キリンからの受領が見込まれる1億8000万ドルを合わせることで、2028年に予定されている最初のKOMET-017第III相試験のトップライン結果が得られるまで、ziftomenibのAMLプログラムに資金を供給できる見込みです。
• Kuraは、腎細胞がんおよびKRAS G12C変異固形がんにおける併用データを背景に、darlifarnibを第2の主要な戦略的資産と位置付けました。

主要財務データ

事業および業績の概要

KOMZIFTIの商業ローンチ

KOMZIFTIは当四半期中に約115人の新規治療開始患者と250件以上の総処方数を記録しました。経営陣は、ローンチの勢いについて、有効性、管理可能な安全性、投与の簡便性、他剤との併用適合性、および商業的実行力によるものとしています。

大学病院および地域の医療機関で導入が拡大しました。Kuraは最も優先度の高いAML顧客の90%以上とのエンゲージメントを維持しました。また、同社はラベル制限なしで被保険者人口の95%以上をカバーしており、そのうち約1600万人には優先的なステータスが適用されていると報告しました。

経営陣は、四半期ごとの成長が市場全体の拡大とシェア獲得の両方を反映していると述べました。また、流通在庫の積み増しやその他の一次的な要因は、当四半期の業績に大きく貢献していないと述べました。

Ziftomenib臨床プログラム

再発・難治性を対象としたziftomenibとベネトクラクスおよびアザシチジンの併用療法に関するKOMET-007試験において、ベネトクラクス未治療の患者で87%の全奏効率（ORR）と70%の複合完全寛解率を達成しました。約11ヶ月の追跡期間後も全生存期間（OS）の中央値には達していません。

欧州血液学会（EHA）において、Kuraは未治療のNPM1変異および/またはKMT2A遺伝子再構成を有するAML患者99人を対象とした、ziftomenibと7+3療法の併用に関するKOMET-007試験の長期データを発表しました。経営陣は12ヶ月時点の全生存率が94%であったと報告し、中央値17.6ヶ月の追跡期間後も全生存期間の中央値には達していません。また、同社はziftomenibが強力な化学療法に大きな骨髄抑制を追加することはなさそうだと述べました。

第III相KOMET-017プログラムは、米国、欧州、アジア全域で患者登録を継続しています。Kuraは治験施設の開設が完了すれば200施設を超えると見込んでおり、強力な化学療法試験からの最初のトップライン結果は2028年になると引き続き予想しています。

2026年には、再発・難治性のNPM1およびFLT3変異AMLにおけるziftomenibとギルテリチニブの併用、ならびに一次治療における7+3療法とキザルチニブの併用に関するさらなる最新情報が期待されています。Kuraはまた、ベネトクラクス/アザシチジン併用の長期データや、NPM1およびKMT2A変異以外のメニン依存性AMLサブタイプにおける探索的取り組みのアップデートも予定しています。

Darlifarnibプラットフォーム

カボザンチニブ既治療の腎細胞がんにおいて、darlifarnibとカボザンチニブの併用療法は44%の客観的奏効率と94%の病勢コントロール率を示しました。カボザンチニブ未治療の進行性淡明細胞型腎細胞がん患者34人において、客観的奏効率は用量レベルに応じて33%から50%の範囲であり、無増悪生存期間（PFS）の中央値は13ヶ月でした。

FIT-001試験のランダム化第Ib相パートでは、darlifarnibとカボザンチニブの併用療法をカボザンチニブ単独療法と比較しています。患者登録は2027年上半期に完了する見込みで、同下半期に初期データが示される予定です。

darlifarnibとアダグラシブの併用療法は、奏効評価可能なKRAS G12C変異がん患者の77%で腫瘍縮小を示しました。Kuraは、2027年上半期に2次治療以降のKRAS変異膵臓がんを対象としたdarlifarnibとdaraxonasibの併用に関するプラットフォーム試験を開始する計画です。

経営陣による業績見通し（ガイダンス）

経営陣は、このガイダンスが協和キリンとの提携契約に基づく履行義務の非現金性の会計上の収益認識を反映したものであることを強調しました。

Kuraは、6月30日時点の手元資金に協和キリンからの受領が見込まれる1億8000万ドルを併せることで、2028年に予定されている最初のKOMET-017第III相試験のトップライン結果が得られるまで、ziftomenibのAMLプログラムに資金を供給できると見込んでいます。

リスクおよび注視事項

• KOMZIFTIの治療期間プロファイルは未だ不十分であり、患者が治療を継続し継続処方が行われる中で、評価にはさらなる時間を要します。
• 新規治療開始患者の約40%は医師主導による併用療法でしたが、KuraはKOMZIFTIを承認された単剤療法の適応症についてのみプロモーションを行っています。
• 今後のFLT3併用データは初期段階のものです。経営陣は、安全性、耐容性、およびziftomenibと既存療法との併用可能性が評価の主な要因になると述べました。
• KOMET-017の結果公表は2028年まで予想されておらず、計画されている200以上の施設ネットワークに向けて施設開設が進行中です。
• Darlifarnibは依然として開発の初期段階にあります。経営陣は、承認申請につながる試験により多額の資本を投入する前に、用量設定と臨床的証拠（POC）の確立を優先しています。
• 純損失は前年同期比で増加し、現金および投資残高は2025年年末時点の6億6720万ドルから2026年6月30日時点には5億1900万ドルに減少しました。

アナリストQ&Aの要点

市場シェアと処方数の伸び：経営陣は、保険請求データからKOMZIFTIが特に再発・難治性のNPM1変異AMLにおいて新規治療開始患者の過半数を占めていることが示されていると述べました。Kuraは、競合するメニン阻害剤が対象とする規模のより小さなKMT2A遺伝子再構成AMLセグメントとこの市場を区別しました。

併用療法での使用：約40%の併用率は前四半期と同水準でした。使用割合はベネトクラクス/アザシチジン併用とFLT3阻害剤併用で二分されており、未治療患者ではなく主に再発・難治性患者を対象としていました。

支払者アクセス：Kuraは、被保険者人口の95%以上をカバーしており、約1600万人に優先的なステータスが適用されていると報告しました。経営陣は、事前承認手続きが重大なアクセス障害を引き起こすことはなかったと述べました。

KOMET-017の患者登録：経営陣は患者登録の進捗について、強力および非強力な化学療法試験を1つの運用枠組み内に含める治験構造と、過去のKOMET-007データに対する医師の関心によるものとしています。

より広範なAMLにおける機会：Kuraは、NPM1およびKMT2A変異以外のメニン依存性AMLサブタイプにおいてziftomenibを評価しています。経営陣は生物学的根拠としてMEIS1発現を挙げ、裏付けとなる臨床データ次第で、対応可能患者数を拡大できる可能性があると述べました。

Darlifarnibの資金調達および提携：経営陣は、初期のdarlifarnibプラットフォーム研究のための資金は割り当てられているものの、戦略的提携を確約したわけではないと述べました。Kuraは、より大規模な投資や提携の意思決定を行う前に、差別化された承認申請パスを確立する意向です。

決算説明会（トランスクリプト）全文

決算説明会の完全なトランスクリプト

経営陣による説明

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.

質疑応答

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.