Kura Oncology, Inc.
For the period ended Jun 30, 2026. Filed Aug 12, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 12, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-12.
0001193125-26-219481
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-12.
0001193125-26-346884
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 154 previous paragraphs and 164 current paragraphs.
115 unchanged; 30 reworded; 12 added; 9 removed; 0 previous and 7 current paragraphs rearranged.
Tables are not compared: 3 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (12)
Current report
KOMZIFTI® (ziftomenib)
Current report
For the six months ended June 30, 2026, we achieved $14.9 million in KOMZIFTI net product revenue.
Current report
We anticipate presenting updated long-term data from the KOMET-007 Phase 1b trial, including durability, survival, and MRD outcomes, in the second half of 2026.
Current report
In venetoclax-naïve patients treated with the recommended once-daily dose of 600 mg of ziftomenib in combination with venetoclax and azacitidine, the ORR was 87% and the CRc rate was 70%, with 75% central MRD negativity. The median duration of CRc response was 9.2 months (95% CI, 5.8-NE). Median OS was not reached after median follow-up of 10.7 months in this population.
Current report
In venetoclax-experienced patients treated with a once-daily dose of 600 mg of ziftomenib in combination with venetoclax and azacitidine, the ORR was 48% and the CRc rate was 24%, with 50% central MRD negativity. The median duration of CRc response was 8.6 months (95% CI, 1.6-NE). After median follow-up of 9.9 months, this population experienced median OS of 7.4 months.
Current report
The triplet combination was well tolerated, with a safety profile consistent with that reported for the venetoclax and azacitidine combination alone. Two patients treated with the triplet experienced DS, and both events resolved with protocol-specified mitigation. One case of ziftomenib-related QTc prolongation was observed, and the event resolved without a change or interruption in dose.
Current report
Next-Generation Menin Inhibitors
Current report
We expect to complete enrollment in the FIT-001 Phase 1b study evaluating darlifarnib plus cabozantinib in cabozantinib-naïve ccRCC in the first half of 2027 and to report initial clinical data in the second half of 2027.
Current report
Preclinical studies of darlifarnib have shown enhanced anti-tumor activity across multiple classes of RAS inhibitors, including mutant-selective and multi-selective RAS(ON) inhibitors, as well as pan-KRAS and pan-RAS approaches, and demonstrated tumor regressions in models previously exposed to KRAS inhibitor therapy. These data support darlifarnib’s broad applicability across the evolving RAS inhibitor landscape, including mutant-selective, pan-KRAS and RAS(ON) multiselective inhibitors.
Current report
Darlifarnib Combination Platform Study
Current report
On June 3, 2026, we announced a new platform study designed to evaluate darlifarnib across multiple targeted therapy combinations and disease settings. The flexible design is intended to allow combinations with both approved and investigational targeted therapies in multiple tumor types, add new arms over time, and advance successful combinations into dedicated registrational studies. We anticipate initiation of a Phase 1a study in the first planned platform combination — darlifarnib with daraxonrasib in KRAS-mutant pancreatic cancer — in the first half of 2027.
Current report
Comparison of the Six Months Ended June 30, 2026 and 2025
Removed paragraphs (9)
Previous report
KOMZIFTITM (ziftomenib)
Previous report
We have begun generating product revenue from sales of KOMZIFTI. In the first quarter of 2026 – the first full quarter of commercialization – we achieved $5.8 million in KOMZIFTI net product revenue.
Previous report
We previously evaluated ziftomenib in combination with 7+3 in patients with newly diagnosed NPM1-mutated or KMT2A-rearranged adverse risk AML in the KOMET-007 trial. In June 2025, we presented positive data at the European Hematology Association Congress from the KOMET-007 Phase 1b cohort evaluating this regimen. Ziftomenib dosed once daily at 600 mg in combination with 7+3 demonstrated robust and evolving clinical activity in patients with newly diagnosed AML. Among 71 response-evaluable patients, 93% of patients with NPM1-mutated AML and 89% of patients with KMT2A-rearranged AML achieved a CRc at the time of data cutoff. A rate of CR-MRD negativity of 71% for patients with NPM1-mutated AML with a median time to MRD negativity of 4.7 weeks and a rate of CR-MRD negativity of 88% for patients with
Previous report
KMT2A-rearranged AML with a median time to MRD negativity of 4.4 weeks were observed. 96% of patients with NPM1-mutated AML and 88% of patients with KMT2A-rearranged AML remained alive and on study as of the data cutoff.
Previous report
Among the 51 patients with relapsed or refractory NPM1-mutated AML, the objective response rate, or ORR, was 65% and the CRc rate was 48%, with CRc median duration of 39.9 weeks. In venetoclax-naïve patients, the ORR was 83% and the CRc rate was 70%, compared with 48% and 28%, respectively, in venetoclax-exposed patients. Median OS was 54.9 weeks (95% CI 32.0–NE). 14 patients received hematopoietic stem cell transplantation, or HSCT, five proceeded to ziftomenib maintenance therapy, and five were pending maintenance at time of data cutoff.
Previous report
Among the 32 patients with relapsed or refractory KMT2A-rearranged AML, the ORR was 41% and the CRc rate was 28%, with CRc median duration of 12.4 weeks. In venetoclax-naïve patients, the ORR was 70% and the CRc rate was 60%. Median OS was 21.1 weeks (95% CI 12.4–64.9). Two patients received HSCT and both proceeded to ziftomenib maintenance therapy.
Previous report
The combination was generally well tolerated in both relapsed or refractory NPM1-mutated and relapsed or refractory KMT2A-rearranged AML. Rates of ziftomenib-related myelosuppression were low, with neutrophil and platelet recovery consistent with expectations for venetoclax and azacitidine alone. No ziftomenib-related QTc prolongation was reported. One Grade 3 DS case (in a patient with an NPM1 mutation) was successfully resolved with protocol-specified measures, and the patient resumed treatment with ziftomenib.
Previous report
Menin Inhibition in Diabetes
Previous report
We plan to explore opportunities to evaluate additional indications and combination partners, such as novel PI3 kinase alpha, or PI3K alpha, and RAS inhibitors, for darlifarnib in 2026.
Reworded paragraphs (30)
Previous wording
We have made significant progress in securing insurance coverage and reimbursement for KOMZIFTI in the United States. We have secured parity coverage for more than 93% of covered lives in the United States, without restrictions beyond KOMZIFTI’s approved label. Among private payors, several published policies require patients with relapsed or refractory NPM1-mutated AML to step through KOMZIFTI first before receiving other available menin inhibitors.
Current wording
We have made significant progress in securing insurance coverage and reimbursement for KOMZIFTI in the United States. We have secured parity coverage for more than 95% of covered lives in the United States. Among private payors, several published policies require patients with relapsed or refractory NPM1-mutated AML to step through KOMZIFTI first before receiving other available menin inhibitors.
Previous wording
Updated data from our evaluation of ziftomenib with 7+3 in newly diagnosed NPM1-mutated or KMT2A-rearranged AML from the KOMET-007 trial have been accepted for an oral presentation at the European Hematology Association Congress on June 14, 2026. The presentation will feature results from the 99 patients treated with ziftomenib in combination with 7+3 as of the abstract data cutoff of January 16, 2026. Among all 99 response-evaluable patients, CRc rates were 96% (47/49) and 90% (45/50), with MRD negativity of 83% (39/47) and 82% (32/39), in patients with NPM1 mutations and KMT2A rearrangements, respectively. Median follow-up was 14.9 months for patients with NPM1-mutated AML and 9.3 months for patients with KMT2A‑rearranged AML. At data cutoff, median CRc duration had not been reached for NPM1-mutated AML and was 11.2 months for KMT2A-rearranged AML. Treatment-emergent adverse events were similar between the two patient subgroups, and low rates of additive myelosuppression were observed.
Current wording
On June 14, 2026, we shared long-term results from our evaluation of ziftomenib with 7+3 in newly diagnosed NPM1-mutated or KMT2A-rearranged AML from the KOMET-007 trial in an oral presentation at the European Hematology Association Congress. The presentation featured results from 99 patients treated with ziftomenib in combination with 7+3 as of the data cutoff of April 10, 2026. Among all 99 response-evaluable patients, CRc rates were 96% (47/49) and 90% (45/50), with local CRc MRD-negativity rates of 85% (40/47) and 82% (32/39), in patients with NPM1 mutations and KMT2A rearrangements, respectively. Median OS was not reached, with median follow-up of 17.6 months for patients with NPM1-mutated AML and 11.0 months for patients with KMT2A-rearranged AML. At 12 months, OS rates were 94% for NPM1-mutated AML and 71% for KMT2A-rearranged AML. At data cutoff, median CR duration had not been reached for NPM1-mutated AML and was 12.0 months for KMT2A-rearranged AML. Treatment-emergent adverse events were similar between the two patient subgroups, and low rates of additive myelosuppression were observed. No Grade 4 DS or QTc prolongation events were reported. Four patients (4%) experienced Grade 3 DS; all cases successfully resolved with protocol-specified mitigation and three continued on ziftomenib treatment. Three patients (3%) experienced Grade 3 investigator-assessed QTc prolongation (all three on azole antifungals, fluoroquinolones, or other medications at time of assessment; one with ongoing hypokalemia and hypomagnesemia); none were assessed as ziftomenib-related and all QTc events successfully resolved with all patients continuing on ziftomenib treatment.
Previous wording
In October 2025, we and Kyowa Kirin announced dosing of the first patient in a cohort of the KOMET-007 trial evaluating the safety, tolerability and activity of ziftomenib in combination with 7+3 plus quizartinib in patients with newly diagnosed NPM1/FLT3-ITD co-mutated AML. We continue to advance the enrollment of patients in this cohort.
Current wording
In October 2025, we and Kyowa Kirin announced dosing of the first patient in a cohort of the KOMET-007 trial evaluating the safety, tolerability and activity of ziftomenib in combination with 7+3 plus quizartinib in patients with newly diagnosed NPM1/FLT3-ITD co-mutated AML. We continue to advance the enrollment of patients in this cohort and anticipate presenting preliminary data in the second half of 2026.
Previous wording
We are evaluating ziftomenib in combination with venetoclax and azacitidine in patients with relapsed or refractory NPM1-mutated or KMT2A-rearranged AML in our Phase 1 KOMET-007 trial. At ASH in December 2025, we delivered an oral presentation of safety and clinical activity results from Phases 1a and 1b of this ongoing study. Of the 83 patients included in the dataset as of the September 24, 2025 data cutoff date, 80 were response evaluable and 58% (48/83) had received prior venetoclax.
Current wording
We are evaluating ziftomenib in combination with venetoclax and azacitidine in patients with relapsed or refractory NPM1-mutated or KMT2A-rearranged AML in our Phase 1 KOMET-007 trial.
Previous wording
We have completed enrollment of patients with relapsed or refractory NPM1-mutated AML in the dose expansion cohort evaluating the combination of ziftomenib with venetoclax and azacitidine. We expect to publish updated data from our evaluation of this combination in patients with relapsed or refractory NPM1-mutated AML in the first half of 2026.
Current wording
We have completed enrollment of patients with relapsed or refractory NPM1-mutated AML in the dose expansion cohort evaluating the combination of ziftomenib with venetoclax and azacitidine. On June 2, 2026, we announced the publication in Bloodof updated results from our evaluation of this combination. The publication reports data from 64 response-evaluable patients, 27 of whom were treated in Phase 1a dose escalation and 37 of whom were treated in Phase 1b expansion, as of the January 16, 2026 data cutoff date. Patients had received 1 to 8 prior lines of therapy (median of 1), and 37 patients (55%) had prior venetoclax exposure. Robust clinical activity was observed in patients with relapsed or refractory NPM1-mutated AML across all ziftomenib dose levels, with nearly two-thirds of all patients experiencing clinically meaningful, deep, and durable responses. In addition, rapid responses were observed, with a median time to CRc of 3.9 weeks.
Previous wording
While the FDA approval of KOMZIFTI marked the completion of our clinical evaluation of ziftomenib as a monotherapy for adult patients with relapsed or refractory NPM1-mutated AML in the United States, we continue to evaluate ziftomenib as a monotherapy in patients with non-NPM1-mutated and non-KMT2A-rearranged AML and in patients with KMT2A-rearranged acute lymphoblastic leukemia under the KOMET-001 protocol.
Current wording
While the FDA approval of KOMZIFTI marked the completion of our clinical evaluation of ziftomenib as a monotherapy for adult patients with relapsed or refractory NPM1-mutated AML in the United States, we continue to evaluate ziftomenib as a monotherapy in patients with non-NPM1-mutated and non-KMT2A-rearranged AML and in patients with KMT2A-rearranged acute lymphoblastic leukemia under the KOMET-001 protocol. We anticipate presenting an exploratory analysis from our evaluation of ziftomenib monotherapy activity in molecularly defined, MEIS1-associated non-NPM1-mutated and non-KMT2A-rearranged AML in the second half of 2026.
Previous wording
In April 2025, we dosed the first patients in a Phase 1 trial evaluating ziftomenib in combination with imatinib in patients with advanced gastrointestinal stromal tumors, or GIST, after imatinib failure, which we refer to as the KOMET-015 trial. We are advancing the combination in dose escalation and have reached a range of dose levels with encouraging safety and tolerability.
Current wording
In April 2025, we dosed the first patients in a Phase 1 trial evaluating ziftomenib in combination with imatinib in patients with advanced gastrointestinal stromal tumors after imatinib failure, which we refer to as the KOMET-015 trial. We are advancing the combination in dose escalation and have reached a range of dose levels with encouraging safety and tolerability.
Previous wording
We continue to make progress toward multiple next-generation menin inhibitor drug candidates. We have nominated our first next-generation menin inhibitor, KO-7246, which we expect to advance into investigational new drug application, or IND, -enabling studies in diabetes and cardiometabolic diseases in 2026 with external investment or through a collaboration. We anticipate the presentation of preclinical data on the use of menin inhibitors in diabetes in 2026. We also expect to advance preclinical development of an additional next-generation menin inhibitor development candidate for use in combination therapy for solid tumors in 2026.
Current wording
We continue to make progress toward multiple next-generation menin inhibitor drug candidates. We have nominated our first next-generation menin inhibitor, KO-7246, which we expect to advance into investigational new drug application, or IND, -enabling studies in diabetes and cardiometabolic diseases in 2026 with external investment or through a collaboration. We anticipate the presentation of preclinical data on the use of menin inhibitors in diabetes in 2026.
Previous wording
We are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of darlifarnib, our next-generation farnesyl transferase inhibitor, or FTI, in a Phase 1 first-in-human trial, which we call the FIT-001 trial. The FIT-001 trial includes multiple cohorts to evaluate darlifarnib in combination with other targeted therapies in large solid tumor indications.
Current wording
Darlifarnib is our next-generation farnesyl transferase inhibitor. Darlifarnib inhibits farnesylation of the RHEB protein, resulting in selective mTORC1 inhibition while sparing mTORC2. This mechanism has potential to enhance the activity of multiple targeted therapies where complementary inhibition of oncogenic pathways may improve clinical outcomes. We are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of darlifarnib in a Phase 1 first-in-human trial, which we call the FIT-001 trial. The FIT-001 trial includes multiple cohorts to evaluate darlifarnib in combination with other targeted therapies in large solid tumor indications.
Previous wording
As part of our FIT-001 trial, we are evaluating darlifarnib in combination with cabozantinib in patients with clear cell renal cell carcinoma, or ccRCC, and patients with non-clear cell renal cell carcinoma, or RCC. At the European Society for Medical Oncology, or ESMO, Congress in October 2025, we presented preliminary Phase 1a dose-escalation data demonstrating the combination’s manageable safety profile across multiple doses, including at the full label dose of cabozantinib. Antitumor activity was observed across all doses, including in patients with prior exposure to cabozantinib. As of the August 15, 2025 data cutoff date, the ORR was 33-50% in ccRCC, and 17-50% in patients with prior cabozantinib exposure, and the disease control rate was 80-100% in ccRCC. In February 2026, we initiated the Phase 1b dose expansion cohorts to assess an optimal biologically active dose for the combination of darlifarnib and cabozantinib in patients with advanced RCC.
Current wording
As part of our FIT-001 trial, we are evaluating darlifarnib in combination with cabozantinib in patients with clear cell renal cell carcinoma, or ccRCC, and patients with non-clear cell renal cell carcinoma, or RCC. In February 2026, we initiated a global, randomized Phase 1b dose expansion study evaluating darlifarnib plus cabozantinib against cabozantinib alone to establish the recommended Phase 3 dose for the combination in cabozantinib-naïve patients with advanced or metastatic ccRCC.
Previous wording
On April 17, 2026, we announced new preliminary data from a subset analysis of FIT-001 patients with ccRCC who were previously treated with cabozantinib, a population that typically derives limited benefit from subsequent therapy. Results were presented at the 2026 International Kidney Cancer Symposium (IKCS): Europe in Paris, France. In patients with ccRCC who had previously received cabozantinib, the ORR was 44% and the disease control rate was 94%. Tumor shrinkage was observed in 75% of patients, with reductions ranging from 32% to 47% among responders. A manageable safety profile was demonstrated across all RCC patients at multiple dose levels, including the full FDA-approved dose of cabozantinib.
Current wording
On April 17, 2026, we announced new preliminary data from a subset analysis of FIT-001 patients with ccRCC who were previously treated with cabozantinib, a population that typically derives limited benefit from subsequent therapy. Results were presented at the 2026 International Kidney Cancer Symposium (IKCS): Europe in Paris, France. In 16 patients with ccRCC who had previously received cabozantinib, the ORR was 44% and the disease control rate was 94%. Tumor shrinkage was observed in 75% of patients, with reductions ranging from 32% to 47% among responders. A manageable safety profile was demonstrated across all RCC patients at multiple dose levels, including the full FDA-approved dose of cabozantinib.
Previous wording
We expect to present updated Phase 1a dose-escalation data from the combination of darlifarnib and cabozantinib in the second half of 2026.
Current wording
On July 24, 2026, we shared updated Phase 1a dose-escalation data from the combination of darlifarnib and cabozantinib in an oral presentation at the 2026 Kidney Cancer Research Summit, or KCRS. The presentation highlighted long-term follow-up results in heavily pretreated cabozantinib-naïve patients with advanced ccRCC. Across the dose levels evaluated, the ORR ranged from 33% to 50% and median progression-free survival was 13 months. Median duration of response was not estimable at most dose levels assessed because multiple responses remained ongoing at the time of data cutoff. Durable clinical benefit was observed across all evaluated dose levels, with more than half of the 34 cabozantinib-naïve patients remaining on treatment at data cutoff. As reported at KCRS, the safety and tolerability profile of the combination was manageable and generally consistent with reported safety profiles of the individual agents.
Previous wording
Darlifarnib in Combination with Adagrasib in NSCLC, CRC and PDAC
Current wording
Darlifarnib in Combination with Adagrasib in KRAS-Mutant Cancers
Previous wording
We are evaluating darlifarnib in combination with adagrasib in patients with KRAS G12C-mutated non-small cell lung cancer, or NSCLC, colorectal cancer, or CRC, and pancreatic ductal adenocarcinoma, or PDAC, as part of our FIT-001 trial. Under the terms of a clinical collaboration agreement with Mirati Therapeutics, Inc., or Mirati, a wholly owned subsidiary of Bristol Myers Squibb, we sponsor the trial and Mirati supplies us with adagrasib, a KRAS G12C inhibitor, for use in the trial. An abstract containing preliminary clinical data from the dose escalation portion of the FIT-001 trial evaluating the combination of darlifarnib and adagrasib has been accepted for a poster presentation at the 2026 American Society of Clinical Oncology Annual Meeting on May 30, 2026.
Current wording
We are evaluating darlifarnib in combination with adagrasib in patients with KRAS G12C-mutated non-small cell lung cancer, or NSCLC, colorectal cancer, or CRC, and pancreatic ductal adenocarcinoma, or PDAC, as part of our FIT-001 trial. Under the terms of a clinical collaboration agreement with Mirati Therapeutics, Inc., or Mirati, a wholly owned subsidiary of Bristol Myers Squibb, we sponsor the trial and Mirati supplies us with adagrasib, a KRAS G12C inhibitor, for use in the trial. On May 30, 2026, we presented preliminary clinical data from the dose escalation portion of the FIT-001 trial evaluating the combination of darlifarnib and adagrasib at the 2026 American Society of Clinical Oncology Annual Meeting, or ASCO. Among 26 response-evaluable patients, tumor shrinkage was observed in 77% of patients overall and in 94% of KRAS inhibitor-naïve patients. Confirmed objective response rates included 67% in PDAC, 50% in NSCLC, and 29% in KRAS inhibitor-naïve CRC. Clinical activity was also observed in patients previously treated with KRAS inhibitors. The combination of darlifarnib with adagrasib demonstrated a manageable safety profile, with observed adverse events consistent with expected on-target effects.
Previous wording
Preliminary data from the FIT-001 trial evaluating darlifarnib as a monotherapy in RAS-altered advanced solid tumors were presented at ESMO in October 2025. The data presented at ESMO indicate that darlifarnib has a manageable safety and tolerability profile when administered at doses from 3 to 10 mg per day. Encouraging antitumor activity was observed in advanced HRAS-mutated solid tumors across multiple dose levels, demonstrating on-target activity and a broad therapeutic window.
Current wording
Preliminary data from the FIT-001 trial evaluating darlifarnib as a monotherapy in RAS-altered advanced solid tumors were presented at the European Society for Medical Oncology, or ESMO, in October 2025. The data presented at ESMO indicate that darlifarnib has a manageable safety and tolerability profile when administered at doses from 3 to 10 mg per day. Encouraging antitumor activity was observed in advanced HRAS-mutated solid tumors across multiple dose levels, demonstrating on-target activity and a broad therapeutic window.
Previous wording
As of March 31, 2026, we had cash, cash equivalents and short-term investments of $580.8 million.
Current wording
As of June 30, 2026, we had cash, cash equivalents and short-term investments of $519.0 million.
Previous wording
In November 2024, we entered into the Kyowa License Agreement to develop and commercialize globally ziftomenib for the treatment of patients with AML and other hematologic malignancies, which may be expanded into other oncology indications at the option of Kyowa Kirin, subject to certain conditions. As of March 31, 2026, we have received or expected to receive $595.7 million under the Kyowa License Agreement, consisting of $570.0 million in upfront and milestone payments and $25.7 million in profit and loss sharing payments.
Current wording
In November 2024, we entered into the Kyowa License Agreement to develop and commercialize globally ziftomenib for the treatment of patients with AML and other hematologic malignancies, which may be expanded into other oncology indications at the option of Kyowa Kirin, subject to certain conditions. As of June 30, 2026, we have received or expected to receive $597.1 million under the Kyowa License Agreement, consisting of $570.0 million in upfront and milestone payments and $27.1 million in profit and loss and expense sharing.
Previous wording
Cost of product sales consists primarily of direct and indirect costs related to the manufacture of KOMZIFTI for commercial sale, including internal manufacturing related staff costs, third-party manufacturing and packaging costs, raw material and component costs, freight-in and storage costs. Prior to the FDA approval of KOMZIFTI in November 2025, costs incurred for the manufacture of KOMZIFTI were recorded as research and development expenses, which resulted in zero-cost inventory. As a result, the cost of product sales related to KOMZIFTI will initially reflect a lower average per unit cost of materials, as previously expensed zero-cost inventory is utilized for commercial production and sold to customers. We expect the cost of product sales for KOMZIFTI to increase in relation to product revenues as we deplete these inventories.
Current wording
Cost of product sales consists primarily of direct and indirect costs related to the manufacture of KOMZIFTI for commercial sale, including internal manufacturing related staff costs, third-party manufacturing and packaging costs, raw material and component costs, freight-in, storage costs and royalties on product sales. Prior to the FDA approval of KOMZIFTI in November 2025, costs incurred for the manufacture of KOMZIFTI were recorded as research and development expenses, which resulted in zero-cost inventory. As a result, the cost of product sales related to KOMZIFTI will initially reflect a lower average per unit cost of materials, as previously expensed zero-cost inventory is utilized for commercial production and sold to customers. We expect the cost of product sales for KOMZIFTI to increase in relation to product revenues as we deplete these inventories.
Previous wording
Product Revenue, net. We recognized product revenue, net, of $5.8 million for the three months ended March 31, 2026 related to sales of KOMZIFTI in the United States, following FDA approval in November 2025. We generated no product revenue during the three months ended March 31, 2025.
Current wording
Product Revenue, net. We recognized product revenue, net, of $9.1 million for the three months ended June 30, 2026 related to sales of KOMZIFTI in the United States, following FDA approval in November 2025. We generated no product revenue during the three months ended June 30, 2025.
Previous wording
Collaboration Revenue. For the three months ended March 31, 2026 and 2025, we recognized $12.5 million and $14.1 million, respectively, of collaboration revenue related to services performed under the Kyowa License Agreement.
Current wording
Collaboration Revenue. For the three months ended June 30, 2026 and 2025, we recognized $11.8 million and $15.3 million, respectively, of collaboration revenue related to services performed under the Kyowa License Agreement.
Previous wording
Selling, General and Administrative Expenses. The increase in selling, general and administrative expenses for the three months ended March 31, 2026 compared to the same period in 2025 was primarily due to increases in personnel costs, sales and marketing expenses, and non-cash share-based compensation expense. We expect our selling, general and administrative expenses to increase in future periods to support our planned increases in research and development and commercialization activities.
Current wording
Selling, General and Administrative Expenses. The increase in selling, general and administrative expenses for the three months ended June 30, 2026 compared to the same period in 2025 was primarily due to increases in personnel costs and professional services expenses. We expect our selling, general and administrative expenses to increase in future periods to support our planned increases in research and development and commercialization activities.
Previous wording
The increase in ziftomenib-related research and development expenses for the three months ended March 31, 2026 compared to the same period in 2025 was primarily due to increases in costs related to ziftomenib combination trials, including our registration-directed frontline clinical trials. The increase in darlifarnib-related research and development expenses for the three months ended March 31, 2026 compared to the same period in 2025 was primarily due to increased costs related to our Phase 1 clinical trial. The increase in personnel costs and other expenses for the three months ended March 31, 2026 compared to the same period in 2025 was primarily due to increases in headcount costs to support our ongoing clinical trials. We expect our research and development expenses to increase in future periods as we continue clinical development activities for our ziftomenib and darlifarnib programs.
Current wording
The increase in ziftomenib-related research and development expenses for the six months ended June 30, 2026 compared to the same period in 2025 was primarily due to increases in costs related to ziftomenib combination trials, including our registration-directed frontline clinical trials. The increase in darlifarnib-related research and development expenses for the six months ended June 30, 2026 compared to the same period in 2025 was primarily due to increased costs related to our Phase 1 clinical trial. The increase in personnel costs and other expenses for the six months ended June 30, 2026 compared to the same period in 2025 was primarily due to increases in headcount costs to support our ongoing clinical trials.
Previous wording
In November 2024, we entered into the Kyowa License Agreement to develop and commercialize globally ziftomenib for the treatment of patients with AML and other hematologic malignancies, which may be expanded into other oncology indications at the option of Kyowa Kirin, subject to certain conditions. As of March 31, 2026, in exchange for the licenses and rights granted to Kyowa Kirin to participate in the development and commercialization of ziftomenib, we received or expected to receive $595.7 million.
Current wording
In November 2024, we entered into the Kyowa License Agreement to develop and commercialize globally ziftomenib for the treatment of patients with AML and other hematologic malignancies, which may be expanded into other oncology indications at the option of Kyowa Kirin, subject to certain conditions. As of June 30, 2026, in exchange for the licenses and rights granted to Kyowa Kirin to participate in the development and commercialization of ziftomenib, we received or expected to receive $597.1 million.
Previous wording
We have incurred operating losses and negative cash flows from operating activities since inception. As of March 31, 2026, we had an accumulated deficit of $1.2 billion. Although we have recorded product revenue related to KOMZIFTI, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution of KOMZIFTI and, following regulatory approval, other products containing ziftomenib, to the extent that such sales, marketing, manufacturing and distribution are not the responsibility of collaborators or potential collaborators. In addition, we expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of, continue and initiate clinical trials of, and seek marketing approval for, our product candidates. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or commercialization efforts.
Current wording
We have incurred operating losses and negative cash flows from operating activities since inception. As of June 30, 2026, we had an accumulated deficit of $1.3 billion. Although we have recorded product revenue related to KOMZIFTI, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution of KOMZIFTI and, following regulatory approval, other products, to the extent that such sales, marketing, manufacturing and distribution are not the responsibility of collaborators or potential collaborators. In addition, we expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of, continue and initiate clinical trials of, and seek marketing approval for, our product candidates. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or commercialization efforts.
Previous wording
As of March 31, 2026, we had cash, cash equivalents and short-term investments of $580.8 million. We believe that our cash, cash equivalents and short-term investments as of March 31, 2026 will be sufficient to fund our current operating plan into the fourth quarter of 2027. In addition, when combined with the anticipated $180.0 million in payments under the Kyowa License Agreement, we expect to have sufficient capital to advance our ziftomenib AML program through the first topline results from KOMET-017, anticipated in 2028. Our future capital requirements will depend on many factors, including:
Current wording
As of June 30, 2026, we had cash, cash equivalents and short-term investments of $519.0 million. We believe that our cash, cash equivalents and short-term investments as of June 30, 2026 will be sufficient to fund our current operating plan into the fourth quarter of 2027. In addition, when combined with the anticipated $180.0 million in payments under the Kyowa License Agreement, we expect to have sufficient capital to advance our ziftomenib AML program through the first topline results from KOMET-017, anticipated in 2028. Our future capital requirements will depend on many factors, including:
Previous wording
We are subject to all of the risks incident in the development and commercialization of new therapeutic products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We may need substantial additional funding in connection with our continuing operations.
Current wording
We are subject to all of the risks incident to the development and commercialization of new therapeutic products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We may need substantial additional funding in connection with our continuing operations.
Previous wording
Operating Activities. The increase of $13.9 million in net cash used in operating activities for the three months ended March 31, 2026 compared to the same period in 2025 was primarily due to increases of $15.9 million in net loss and changes in operating assets and liabilities of $0.4 million, offset by increases of $1.8 million in accretion of discount on short-term investments and $0.6 million in non-cash share-based compensation.
Current wording
Operating Activities. The increase of $47.7 million in net cash used in operating activities for the six months ended June 30, 2026 compared to the same period in 2025 was primarily due to increases of $18.1 million in net loss and changes in operating assets and liabilities of $35.2 million, offset by increases of $3.5 million in amortization of premiums and accretion of discounts on short-term investments and $1.8 million in non-cash share-based compensation.
Previous wording
Investing Activities. The decrease of $77.2 million in net cash used in investing activities for the three months ended March 31, 2026 compared to the same period in 2025 was primarily due to decreases of $97.1 million in purchases of short-term investments and $0.2 million in purchases of property and equipment, offset by a decrease of $20.1 million in maturities of short-term investments.
Current wording
Investing Activities. The increase of $110.5 million in net cash provided by investing activities for the six months ended June 30, 2026 compared to the same period in 2025 was primarily due to decreases of $192.1 million in purchases of short-term investments and $1.0 million in purchases of property and equipment, offset by a decrease of $82.6 million in maturities of short-term investments.
Previous wording
Financing Activities. Net cash provided by financing activities for both the three months ended March 31, 2026 and 2025 related to proceeds from the issuance of shares of common stock under our equity plans.
Current wording
Financing Activities. Net cash provided by financing activities for both the six months ended June 30, 2026 and 2025 related to proceeds from the issuance of shares of common stock under our equity plans.
Previous wording
Pursuant to our in-license agreements, we have milestone and contractual payment obligations contingent upon the achievement of certain milestones or events. We may be required to pay up to approximately $76.9 million in milestone payments, plus additional sales royalties and sublicense fees, in the event that regulatory and commercial milestones under the in-license agreements are achieved. Our in-license agreements are cancelable by us with written notice within 180 days or less.
Current wording
Pursuant to our in-license agreements, we have milestone and contractual payment obligations contingent upon the achievement of certain milestones or events. We may be required to pay up to approximately $76.8 million in milestone payments, plus additional sales royalties and sublicense fees, in the event that regulatory and commercial milestones under the in-license agreements are achieved. Our in-license agreements are cancelable by us with written notice within 180 days or less.
Rearranged current paragraphs (7)
Current report — wording carried from elsewhere
We also expect to advance preclinical development of an additional next-generation menin inhibitor development candidate for use in combination therapy for solid tumors in 2026.
Current report — wording carried from elsewhere
The decrease in ziftomenib-related research and development expenses for the three months ended June 30, 2026 compared to the same period in 2025 was primarily due to the timing of clinical development activities. The increase in personnel costs and other expenses for the three months ended June 30, 2026 compared to the same period in 2025 was primarily due to increases in headcount costs to support our ongoing clinical trials. We expect our research and development expenses to increase in future periods as we continue clinical development activities for our ziftomenib and darlifarnib programs.
Current report — wording carried from elsewhere
Product Revenue, net. We recognized product revenue, net, of $14.9 million for the six months ended June 30, 2026 related to sales of KOMZIFTI in the United States, following FDA approval in November 2025. We generated no product revenue during the six months ended June 30, 2025.
Current report — wording carried from elsewhere
Collaboration Revenue. For the six months ended June 30, 2026 and 2025, we recognized $24.3 million and $29.4 million, respectively, of collaboration revenue related to services performed under the Kyowa License Agreement.
Current report — wording carried from elsewhere
Research and Development Expenses. The following table illustrates the components of our research and development expenses for the periods presented, in thousands:
Current report — wording carried from elsewhere
Selling, General and Administrative Expenses. The increase in selling, general and administrative expenses for the six months ended June 30, 2026 compared to the same period in 2025 was primarily due to increases in personnel costs, professional services expenses, travel expenses and non-cash share-based compensation expense.
Current report — wording carried from elsewhere
Other income, net. The decrease in other income, net for the six months ended June 30, 2026 compared to the same period in 2025 was primarily due to a decrease in interest income.