Kura Oncology, Inc.
For the period ended Sep 30, 2026. Filed Nov 10, 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.
Sep 30, 2026 · Filed Nov 10, 2026
KURA$7.570.0%Stored close · as of Nov 10, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious 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 OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-10.
0001193125-26-455455
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 164 previous paragraphs and 172 current paragraphs.
122 unchanged; 34 reworded; 16 added; 6 removed; 2 previous and 0 current paragraphs rearranged.
Tables are not compared: 4 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 (16)
Current report
Recent Developments
Current report
Management Update
Current report
Our board of directors appointed Jennifer Fulk as our Chief Financial Officer, principal financial officer and principal accounting officer, effective as of September 8, 2026.
Current report
In July 2026, we formed a wholly owned subsidiary, Caspian Therapeutics, Inc., or Caspian, to focus on the development of KO-7246 and other next-generation menin inhibitors for the treatment of diabetes and other cardiometabolic diseases. On September 8, 2026, Caspian completed the sale and issuance of $50.0 million of shares of its Series A preferred stock in a private financing, or the Series A Financing. We invested $4.3 million in the Series A Financing. As of immediately following the completion of the Series A Financing, our common stock and Series A preferred stock of Caspian comprised approximately 49.2% of the outstanding capital stock of Caspian. Proceeds from the Series A Financing are expected to fund advancement of KO-7246 through investigational new drug application, or IND, enabling development and initial clinical proof-of-concept in diabetes, as well as support the advancement of a second menin inhibitor development candidate for diabetes and cardiometabolic diseases.
Current report
In August 2026, we announced the publication of a manuscript in Blood detailing the discovery and preclinical development of ziftomenib. As reported in the publication, across KMT2A-rearranged, NPM1-mutated and NUP98-rearranged leukemia models, ziftomenib demonstrated potent on-target activity, including suppression of key KMT2A-regulated genes such as MEIS1 and HOXA9, induction of differentiation, and reduced leukemia cell viability. Ziftomenib also was shown to induce leukemia regression and extended survival in multiple xenograft and patient-derived xenograft models, including durable responses observed after treatment discontinuation in a patient-derived model. The research further evaluated ziftomenib against treatment-emergent MEN1 mutations associated with resistance to menin inhibition.
Current report
On September 29, 2026, we and Caspian announced comprehensive data generated by Kura prior to Caspian’s launch in preclinical studies of KO-7246 in diabetes at the 62 nd European Association for the Study of Diabetes Annual Meeting, or EASD. As presented at EASD, KO-7246 regenerated functional β-cell mass, demonstrated durable glycemic control, and increased endogenous insulin production in preclinical models of Type 1 and Type 2 diabetes. In human islets, KO-7246 selectively increasedβ-cell proliferation and improved glucose-responsive insulin secretion.
Current report
We continue our efforts to identify additional next-generation menin inhibitor development candidates in solid tumors and other indications.
Current report
Darlifarnib is our next-generation farnesyl transferase inhibitor, or FTI. Darlifarnib exhibits enhanced potency, pharmacokinetics, and physicochemical properties relative to earlier FTI candidates. In preclinical studies, darlifarnib demonstrated increased anti-tumor activity and bioavailability compared to earlier-generation FTIs, as well as a manageable tolerability profile when administered in combination with other targeted therapies. Darlifarnib’s pharmacokinetic properties support once-daily dosing in humans, compared with twice-daily dosing for earlier-generation FTIs, making for a more favorable combinability profile. We believe these characteristics support development of darlifarnib across multiple oncology indications. In addition, in contrast to earlier FTI candidates, darlifarnib is the subject of several patent families that we own, including two granted composition-of-matter patents and numerous worldwide pending applications.
Current report
Darlifarnib in Combination with Daraxonrasib in KRAS-Mutated Pancreatic Ductal Carcinoma
Current report
We plan to initiate a Phase 1 study of darlifarnib with daraxonrasib in second-line or later KRAS-mutated PDAC as part of FIT-001 in the first half of 2027, with preliminary data potentially available in the second half of 2027.
Current report
We reached alignment with the FDA on the design of a single-arm registrational study of darlifarnib in patients with HRAS-mutated salivary gland cancer. We expect to submit an IND for darlifarnib in this indication in the fourth quarter of 2026 and to initiate the registrational trial in the first half of 2027.
Current report
Comparison of the Nine Months Ended September 30, 2026 and 2025
Current report
On November 9, 2026, we entered into a loan and security agreement with the lenders party thereto, or the Lenders, and KRGD SA, LLC, an affiliate of Oberland Capital Management LLC, or Oberland, in its capacity as administrative agent and collateral agent for itself and the Lenders, or the Oberland Loan Agreement. At closing, we borrowed $50.0 million and used a portion of the proceeds to repay our outstanding obligations under the loan and security agreement with Hercules Capital, Inc. and several banks and other financial institutions, or the Hercules Loan Agreement, which we terminated at closing. We may borrow up to an additional $225.0 million, consisting of (i) a $50.0 million second tranche and a separate $25.0 million third tranche, each available through December 31, 2027, (ii) a $50.0 million fourth tranche available through December 31, 2028 following our announcement of positive clinical data from the KOMET-017 Phase 3 study of ziftomenib, or the Phase 3 Milestone, and (iii) up to $100.0 million available in minimum increments of $25.0 million through December 31, 2028, subject to mutual agreement. All advances are subject to applicable funding conditions. Draws under each of the second and third tranches are at our option, subject to applicable funding conditions. Following satisfaction of the Phase 3 Milestone and applicable funding conditions, we are required to draw the fourth tranche unless we already have drawn the second tranche, in which case the fourth-tranche draw is optional.
Current report
In connection with the Oberland Loan Agreement, we also entered into a royalty participation agreement, or the Royalty Participation Agreement, with Oberland, requiring quarterly payments based on U.S. net sales of ziftomenib and certain related products beginning October 1, 2028. The aggregate cap equals 20.0% of the aggregate principal amount funded under the Oberland Loan Agreement, including original issue discount but excluding capitalized payment-in-kind interest, or the Cap Amount. The royalty participation ends on the earliest of (i) November 9, 2036, (ii) the date upon which the Royalty Holders receive aggregate royalty participation payments equal to the Cap Amount, and (iii) payment in full of a repurchase price, or the Repurchase Price, equal to, as of any date of determination, the then-applicable Cap Amount less aggregate royalty participation payments previously received by the Royalty Holders. If the royalty participation period ends on November 9, 2036, we must pay the then-applicable Repurchase Price.
Current report
In connection with the Oberland Loan Agreement, on November 9, 2026, we also entered into a securities purchase agreement, or the Purchase Agreement, with TPC Investments III LP, or TPC, an affiliate of Oberland, which provides for up to $25.0 million of equity investment in our common stock, consisting of $5.0 million funded at the initial closing, an additional $5.0 million to be funded contemporaneously with the funding of the fourth tranche under the Oberland Loan Agreement, and an option for TPC to purchase up to an additional $15.0 million of our common stock during the term specified in the Purchase Agreement, in each case at prices per share determined in accordance with the Purchase Agreement. Pursuant to the Purchase Agreement, at the initial closing on November 9, 2026, TPC purchased an aggregate of 687,758 shares of our common stock, at a purchase price of $7.27 per share, for aggregate gross proceeds of approximately $5.0 million.
Current report
See Part II, Item 5, “Other Information” in this Quarterly Report for additional information regarding the Oberland Loan Agreement, the Royalty Participation Agreement and the Purchase Agreement.
Removed paragraphs (6)
Previous report
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 report
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 report
In November 2022, we entered into a loan and security agreement with several banks and other financial institutions or entities party thereto, or collectively the Lenders, and Hercules Capital, Inc., or Hercules, in its capacity as administrative agent and collateral agent for itself and the Lenders, which was amended in October 2023 and October 2025, or the Loan Agreement, providing for up to $125.0 million in a series of term loans, or Term Loans. Under the terms of the Loan Agreement, we borrowed $10.0 million of an initial $25.0 million tranche of Term Loans. The remaining tranches of Term Loans expired without us drawing down such additional loans. The Term Loans have a maturity date of November 2, 2027, or the Maturity Date. Repayment of the Term Loans is interest only until May 1, 2027. After the interest-only payment period, borrowings under the Loan Agreement are repayable in monthly payments of principal and accrued interest until the Maturity Date. The per annum interest rate for the Term Loans is the greater of (i) the prime rate as reported in The Wall Street Journal minus 6.25% plus 8.65% and (ii) 8.65%. As of June 30, 2026, the interest rate on the Term Loans was 9.15%.
Previous report
Comparison of the Six Months Ended June 30, 2026 and 2025
Previous report
In November 2022, we entered into the Loan Agreement with the Lenders and Hercules, in its capacity as administrative agent and collateral agent for itself and the Lenders, providing for up to $125.0 million in a series of Term Loans. Under the terms of the Loan Agreement, we borrowed $10.0 million of an initial $25.0 million tranche of Term Loans. The remaining tranches of Term Loans expired without us drawing down such additional loans. The Maturity Date for the Term Loans is November 2, 2027. Repayment of the Term Loans is interest only until May 1, 2027. After the interest-only payment period, borrowings under the Loan Agreement are repayable in monthly payments of principal and accrued interest until the Maturity Date. The per annum interest rate for the Term Loans is the greater of (i) the prime rate as reported in The Wall Street Journal minus 6.25% plus 8.65% and (ii) 8.65%. As of June 30, 2026, the interest rate on the Term Loans was 9.15%.
Previous report
At our option, we may prepay all or any portion of the outstanding Term Loans at any time. The Loan Agreement also contains an end of term fee in an amount equal to approximately $1.5 million (which is 6.05% of the maximum amount of the first tranche of loans), which is due and payable on the earliest to occur of (i) the Maturity Date, (ii) the date we prepay the outstanding loans in full, and (iii) the date that the secured obligations become due and payable. Our obligations under the Loan Agreement are secured by substantially all of our assets other than our intellectual property, but including proceeds from the sale, licensing or other disposition of our intellectual property. As part of the Loan Agreement, we are subject to certain negative covenants, which, among other things, prohibit us from selling, transferring, assigning, mortgaging, pledging, leasing, granting a security interest in or otherwise encumbering our intellectual property, subject to limited exceptions.
Reworded paragraphs (34)
Previous wording
References to “we,” “us” and “our” refer to Kura Oncology, Inc.
Current wording
References to “Kura,” “we,” “us” and “our” refer to Kura Oncology, Inc.
Previous wording
For the six months ended June 30, 2026, we achieved $14.9 million in KOMZIFTI net product revenue.
Current wording
For the nine months ended September 30, 2026, we achieved $28.8 million in KOMZIFTI net product revenue.
Previous wording
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
Discovery and Preclinical Development of Ziftomenib
Previous wording
We previously evaluated ziftomenib in combination with venetoclax and azacitidine in patients with newly diagnosed NPM1-mutated AML in the Phase 1 KOMET-007 trial, and we delivered an oral presentation of preliminary data from the Phase 1b expansion cohort evaluating this regimen at the 67th Annual Meeting of the American Society of Hematology, or ASH, in December 2025. As presented at ASH, 40 patients with newly diagnosed NPM1-mutated AML had been enrolled in the cohort as of the September 24, 2025 data cutoff date, 58% (23/40) of whom had an ECOG performance status of two and 37 of whom were response evaluable. High rates of durable morphologic complete responses (composite complete remission, or CRc, 86%; CR 73%) were observed, with 68% of CRc responders having achieved molecular measurable residual disease, or MRD, negativity by central next-generation sequencing.
Current wording
We previously evaluated ziftomenib in combination with venetoclax and azacitidine in patients with newly diagnosed NPM1-mutated AML in the Phase 1 KOMET-007 trial, and we delivered an oral presentation of preliminary data from the Phase 1b expansion cohort evaluating this regimen at the 67th Annual Meeting of the American Society of Hematology, or 2025 ASH Annual Meeting, in December 2025. As presented at the 2025 ASH Annual Meeting, 40 patients with newly diagnosed NPM1-mutated AML had been enrolled in the cohort as of the September 24, 2025 data cutoff date, 58% (23/40) of whom had an ECOG performance status of two and 37 of whom were response evaluable. High rates of durable morphologic complete responses (composite complete remission, or CRc, 86%; CR 73%) were observed, with 68% of CRc responders having achieved molecular measurable residual disease, or MRD, negativity by central next-generation sequencing.
Previous wording
As of the data cutoff for the ASH presentation, median duration of CR and median OS were not reached at median follow-up of 26.1 weeks (range 1.6–54.1). 68% of patients remained alive and on treatment or in long-term follow-up as of the data cutoff. The triplet combination was generally well tolerated, with a safety profile consistent with that reported for venetoclax and azacitidine alone. Rates of ziftomenib-related myelosuppression were low, and the median times to neutrophil and platelet recovery were also consistent with those expected for venetoclax and azacitidine alone. One case each of Grade 2 DS and Grade 3 investigator-assessed QTc prolongation were successfully managed without treatment discontinuation.
Current wording
As of the data cutoff for the 2025 ASH Annual Meeting presentation, median duration of CR and median OS were not reached at median follow-up of 26.1 weeks (range 1.6–54.1). 68% of patients remained alive and on treatment or in long-term follow-up as of the data cutoff. The triplet combination was generally well tolerated, with a safety profile consistent with that reported for venetoclax and azacitidine alone. Rates of ziftomenib-related myelosuppression were low, and the median times to neutrophil and platelet recovery were also consistent with those expected for venetoclax and azacitidine alone. One case each of Grade 2 DS and Grade 3 investigator-assessed QTc prolongation were successfully managed without treatment discontinuation.
Previous wording
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 wording
Updated long-term data from the KOMET-007 Phase 1b trial, including durability, survival, and MRD outcomes, have been accepted for presentation in a poster session on December 14, 2026 at the 68 th Annual Meeting of the American Society of Hematology, or 2026 ASH Annual Meeting.
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 and anticipate presenting preliminary data in the second half of 2026.
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. Preliminary data from this cohort have been accepted for presentation in an oral session on December 14, 2026 at the 2026 ASH Annual Meeting.
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. 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.
Current wording
We have completed enrollment of patients with relapsed or refractory NPM1-mutated or KMT2A-rearranged AML in the cohorts of our Phase 1 KOMET-007 trial 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 in patients with relapsed or refractory NPM1-mutated AML. 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
We are evaluating ziftomenib in combination with gilteritinib in patients with relapsed or refractory NPM1 and FLT3 co-mutated AML in our Phase 1 KOMET-008 trial. We have completed patient enrollment in the dose expansion portion of this cohort and anticipate presenting preliminary data in the second half of 2026.
Current wording
We are evaluating ziftomenib in combination with gilteritinib in patients with relapsed or refractory NPM1 and FLT3 co-mutated AML in our Phase 1 KOMET-008 trial. We have completed patient enrollment in the dose expansion portion of this cohort and preliminary data have been accepted for presentation in an oral session on December 12, 2026 at the 2026 ASH Annual Meeting.
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. 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.
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 under the KOMET-001 protocol. An exploratory analysis from our evaluation of ziftomenib monotherapy activity in molecularly defined, MEIS1-associated non-NPM1-mutated and non-KMT2A-rearranged AML has been accepted for presentation in a poster session on December 14, 2026 at the 2026 ASH Annual Meeting.
Previous wording
In December 2023, we announced a clinical collaboration with Blood Cancer United, or BCU, formerly known as The Leukemia & Lymphoma Society, to evaluate ziftomenib in combination with chemotherapy in pediatric patients with relapsed or refractory KMT2A-rearranged, NUP98-rearranged or NPM1-mutated acute leukemia. Under the terms of the collaboration agreement, BCU serves as the coordinating sponsor of a Phase 1 trial of ziftomenib in pediatric patients with acute leukemias in North America, the Princess Máxima Center for Pediatric Oncology in Utrecht, Netherlands serves as the coordinating sponsor of the trial in Europe, and we supply BCU and the Princess Máxima Center with ziftomenib for the trial.
Current wording
In December 2023, we announced a clinical collaboration with Blood Cancer United, or BCU, formerly known as The Leukemia & Lymphoma Society, to evaluate ziftomenib in combination with chemotherapy in pediatric patients with relapsed or refractory KMT2A-rearranged, NUP98-rearranged or NPM1-mutated acute leukemia. Under the terms of the collaboration agreement, BCU serves as the coordinating sponsor of a Phase 1 trial of ziftomenib in pediatric patients with acute leukemias in North America, the Princess Máxima Center for Pediatric Oncology in Utrecht, Netherlands serves as the coordinating sponsor of the trial in Europe, and we supply BCU and the Princess Máxima Center with ziftomenib for the trial. Preliminary results from the trial have been accepted for presentation in an oral session on December 13, 2026 at the 2026 ASH Annual Meeting.
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 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 have reached a range of dose levels with encouraging safety and tolerability in the dose escalation portion of the trial.
Previous 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.
Current wording
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
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 wording
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.
Previous wording
As of June 30, 2026, we had cash, cash equivalents and short-term investments of $519.0 million.
Current wording
As of September 30, 2026, we had cash, cash equivalents and short-term investments of $492.1 million.
Previous wording
In November 2025, we began to generate revenues from product sales. Since our inception and prior to such product revenues, we have funded our operations primarily through equity and debt financings and payments received under the Kyowa License Agreement. We anticipate that we will require significant additional financing in the future to continue to fund our operations as discussed more fully below under the heading “Liquidity and Capital Resources.”
Current wording
We have funded our operations primarily through equity and debt financings, payments received under the Kyowa License Agreement, and, since November 2025, product revenues. We anticipate that we will require significant additional financing in the future to continue to fund our operations as discussed more fully below under the heading “Liquidity and Capital Resources.”
Previous 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.
Current wording
Product Revenue, net. We recognized product revenue, net, of $13.9 million for the three months ended September 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 September 30, 2025.
Previous 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.
Current wording
Collaboration Revenue. For the three months ended September 30, 2026 and 2025, we recognized $8.9 million and $20.8 million, respectively, of collaboration revenue primarily 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 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.
Current wording
Selling, General and Administrative Expenses. The decrease in selling, general and administrative expenses for the three months ended September 30, 2026 compared to the same period in 2025 was primarily due to decreases in non-cash share-based compensation expense and sales and marketing 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
Other income, net. The decrease in other income, net for the three months ended June 30, 2026 compared to the same period in 2025 was primarily due to a decrease in interest income.
Current wording
Other income, net. The decrease in other income, net for the three months ended September 30, 2026 compared to the same period in 2025 was primarily due to a decrease in interest income. During the three months ended September 30, 2026, we also recognized a gain on deconsolidation of a subsidiary of approximately $30.6 million, which was offset by a loss on equity method investment of approximately $30.6 million.
Previous wording
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 wording
Product Revenue, net. We recognized product revenue, net, of $28.8 million for the nine months ended September 30, 2026 related to sales of KOMZIFTI in the United States, following FDA approval in November 2025. We generated no product revenue during the nine months ended September 30, 2025.
Previous wording
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 wording
Collaboration Revenue. For the nine months ended September 30, 2026 and 2025, we recognized $33.2 million and $50.1 million, respectively, of collaboration revenue primarily related to services performed under the Kyowa License Agreement.
Previous 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.
Current wording
The increase in ziftomenib-related research and development expenses for the nine months ended September 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 nine months ended September 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 nine months ended September 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
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 wording
Selling, General and Administrative Expenses. The increase in selling, general and administrative expenses for the nine months ended September 30, 2026 compared to the same period in 2025 was primarily due to increases in personnel costs and professional services expenses.
Previous wording
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.
Current wording
Other income, net. The decrease in other income, net for the nine months ended September 30, 2026 compared to the same period in 2025 was primarily due to a decrease in interest income. During the nine months ended September 30, 2026, we also recognized a gain on deconsolidation of a subsidiary of approximately $30.6 million, which was offset by a loss on equity method investment of approximately $30.6 million.
Previous wording
Since our inception, we have funded our operations primarily through equity and debt financings and payments received under the Kyowa License Agreement. We have devoted our resources to funding research and development programs, including discovery research, preclinical and clinical development activities and, more recently, to building out our commercial capabilities and infrastructure.
Current wording
Since our inception, we have funded our operations primarily through product revenues, equity and debt financings, and payments received under the Kyowa License Agreement. We have devoted our resources to funding research and development programs, including discovery research, preclinical and clinical development activities and, more recently, to building out our commercial capabilities and infrastructure.
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 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.
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 September 30, 2026, in exchange for the licenses and rights granted to Kyowa Kirin to participate in the development and commercialization of ziftomenib, we received $595.8 million.
Previous wording
In November 2023, we entered into a Sales Agreement with Leerink Partners LLC and Cantor Fitzgerald & Co., or the ATM Facility, under which we may offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $150.0 million. We have not sold any shares of our common stock under the ATM Facility.
Current wording
In November 2023, we entered into a sales agreement with Leerink Partners LLC and Cantor Fitzgerald & Co., or the Sales Agreement, under which we could offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $150.0 million, or the Original ATM Facility. During each of the three and nine months ended September 30, 2026, we sold 2,563,568 shares of our common stock under the Original ATM Facility, at an average sales price of $12.64 per share, for net proceeds of approximately $31.5 million, after deducting sales agent commissions and offering expenses. As of September 30, 2026, approximately $117.6 million remained available for future sales under the Original ATM Facility. On November 2, 2026, our November 2023 automatic shelf registration statement on Form S-3 and prospectus therein relating to the Original ATM Facility expired. On November 10, 2026, we entered into an Amendment No. 1 to Sales Agreement with Leerink Partners LLC and Cantor Fitzgerald & Co., or Amendment No. 1, to, among other things, remove the $150.0 million aggregate offering price limitation from the Sales Agreement. Promptly following the filing of this Quarterly Report, we plan to file with the SEC an automatic shelf registration statement on Form S-3 and related prospectus under which we may offer and sell, from time to time, at our sole discretion, shares of our common stock under the Sales Agreement, as amended by Amendment No. 1, having an aggregate offering price of up to an additional $150.0 million.
Previous 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.
Current wording
We have incurred operating losses and negative cash flows from operating activities since inception. As of September 30, 2026, we had an accumulated deficit of $1.4 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 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:
Current wording
As of September 30, 2026, we had cash, cash equivalents and short-term investments of $492.1 million. We believe that our cash, cash equivalents and short-term investments as of September 30, 2026 will be sufficient to fund our current operating plan into 2028. In addition, when combined with the anticipated $180.0 million in collaboration milestone payments under the Kyowa License Agreement and additional conditional financing capacity under the Oberland Loan Agreement, we expect to have sufficient financial resources to support our operations beyond the anticipated initial topline results from the pivotal Phase 3 KOMET-017 study in 2028. Our future capital requirements will depend on many factors, including:
Previous 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.
Current wording
Operating Activities. The increase of $21.5 million in net cash used in operating activities for the nine months ended September 30, 2026 compared to the same period in 2025 was primarily due to increases of $14.2 million in net loss and changes in operating assets and liabilities of $11.5 million, offset by a decrease of $4.8 million in amortization of premiums and accretion of discounts on short-term investments.
Previous 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.
Current wording
Investing Activities. The increase of $26.1 million in net cash provided by investing activities for the nine months ended September 30, 2026 compared to the same period in 2025 was primarily due to decreases of $217.4 million in purchases of short-term investments and $3.1 million in purchases of property and equipment, offset by a decrease of $190.1 million in maturities of short-term investments and an increase of $4.3 million in purchases of investment in equity securities in Caspian.
Previous 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.
Current wording
Financing Activities. Net cash provided by financing activities for the nine months ended September 30, 2026 was primarily related to an aggregate of approximately $31.5 million in net proceeds from the sale of common stock under the Original ATM Facility. Net cash provided by financing activities for the nine months ended September 30, 2025 related to proceeds from the issuance of shares of common stock under our equity plans.
Previous wording
We have borrowed $10.0 million of Term Loans under our Loan Agreement, which requires us to make principal and interest payments. The Term Loans are subject to variable changes in the per annum interest rate, which is the greater of (i) the prime rate as reported in The Wall Street Journal minus 6.25% plus 8.65% and (ii) 8.65%. As of June 30, 2026, the interest rate on the Term Loans was 9.15%. In addition, an end of term fee will be due in an amount equal to approximately $1.5 million (which is 6.05% of the maximum amount of the first tranche of loans), payable on the earliest of the Maturity Date, acceleration or prepayment of the Term Loans.
Current wording
We borrowed $10.0 million of term loans, or Hercules Term Loans, under our Hercules Loan Agreement, which required us to make principal and interest payments. The Hercules Term Loans were subject to variable changes in the per annum interest rate, which is the greater of (i) the prime rate as reported in The Wall Street Journal minus 6.25% plus 8.65% and (ii) 8.65%. As of September 30, 2026, the interest rate on the Hercules Term Loans was 9.40%. On November 9, 2026, we terminated the Hercules Loan Agreement and repaid the $10.0 million outstanding principal balance, accrued interest and fees. Also on November 9, 2026, we entered into the Oberland Loan Agreement, Royalty Participation Agreement and Purchase Agreement. See Part II, Item 5, “Other Information” in this Quarterly Report for additional information.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
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 report — wording carried elsewhere
In November 2023, we entered into the ATM Facility under which we may offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $150.0 million. We have not sold any shares of our common stock under the ATM Facility.