Syndax Pharmaceuticals Inc
For the period ended Sep 30, 2025. Filed Nov 3, 2025.
View on SEC.govAbout this filing
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, 2025 · Filed Nov 3, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-04.
0000950170-25-101985
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-03.
0001193125-25-262521
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 144 previous paragraphs and 140 current paragraphs.
91 unchanged; 39 reworded; 10 added; 13 removed; 1 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 (10)
Current report
Achieved $32.0 million in Revuforj net revenue in the third quarter of 2025, representing a 12% increase over the second quarter of 2025. Total Revuforj prescriptions in the third quarter of 2025 were approximately 850, a 25% increase over total prescriptions in the second quarter of 2025.
Current report
Received U.S. FDA approval for Revuforj on October 24, 2025, for the treatment of R/R AML with a susceptible NPM1 mutation in adult and pediatric patients one year and older who have no satisfactory alternative treatment options. Revuforj is now the first and only FDA-approved therapy for both R/R AML with an NPM1 mutation and R/R acute leukemia with a KMT2A translocation.
Current report
Announced the inclusion of revumenib in the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for AML as a category 2A recommended treatment option for R/R NPM1m AML on September 18, 2025. The guideline update was based on positive pivotal results from the AUGMENT-101 trial of revumenib which were published in the journal Blood in 2025.
Current report
Announced that data from 12 revumenib abstracts, including 3 oral presentations, will be highlighted at the 67th American Society of Hematology, or ASH, Annual Meeting. We believe the abstracts present compelling results with revumenib in multiple acute leukemia subtypes across the R/R, frontline, and post-stem cell transplant settings.
Current report
Announced that data from 11 axatilimab abstracts, including 3 oral presentations, will be showcased at the 2025 ASH Annual Meeting. The abstracts highlight the potential for axatilimab to provide long-term benefit in recurrent or refractory cGVHD and the tolerability of axatilimab with ruxolitinib in newly diagnosed cGVHD.
Current report
A decrease in revumenib-related costs due to completion of a relapse or refractory NPM1m AML registrational trial that was ongoing in 2024 and a reduction in CMC expenses due to capitalization of inventory for commercial use, offset by 2025 period expenses in planning for and initiation of frontline trials evaluating revumenib in NPM1m and KM2Ar acute leukemias.
Current report
The majority of the period-over-period decrease in expense was driven by an axatilimab-related $15.0 million milestone payment for Niktimvo's approval, incurred in the third quarter of 2024 and not incurred in the 2025 period. This decrease was partially offset by costs incurred in the 2025 period for the ongoing Phase 2 IPF trial as well as the frontline cGVHD combination trial with ruxolitinib.
Current report
For the nine months ended September 30, 2025, total research and development expenses increased $4.0 million from the comparable prior year period. The increase was primarily due to:
Current report
2025 period expenses in planning for and initiation of frontline trials evaluating revumenib in NPM1m and KM2Ar acute leukemias, offset by a decrease in revumenib-related costs due to completion of a relapse or refractory NPM1m AMLregistrational trial that was ongoing in 2024 and a reduction in CMC expenses due to capitalization of inventory for commercial use.
Current report
Higher costs incurred in the 2025 period for the ongoing Phase 2 IPF trial as well as the frontline cGVHD combination trial with ruxolitinib, offset by an axatilimab-related $15.0 million milestone payment for Niktimvo's approval incurred in the 2024 period and not incurred in the 2025 period.
Removed paragraphs (13)
Previous report
Revuforj achieved $28.6 million in net revenue in the second quarter of 2025, representing a 43% increase over the first quarter of 2025. Revuforj was launched in the U.S. in November 2024 for the treatment of R/R acute leukemia with a KMT2A translocation in adult and pediatric patients one year and older.
Previous report
Announced that the FDA granted Priority Review to the Company’s sNDA for Revuforj for the treatment of R/R mNPM1 AML. The sNDA is being reviewed under the FDA's Real-Time Oncology Review program and has been assigned a PDUFA target action date of October 25, 2025.
Previous report
Presented new Revuforj data in R/R mNPM1 AML and R/R NUP98-rearranged, or NUP98r, AML from the AUGMENT-101 trial at the European Hematology Association, or EHA, Annual Congress Meeting in June 2025.
Previous report
Additional results from all efficacy-evaluable R/R mNPM1 AML patients in the pivotal Phase 2 portion of the AUGMENT-101 trial of revumenib (n=77) show an overall response rate, or ORR of 48% (37/77). The complete remission, or CR, plus complete remission with partial hematologic recovery, or CRh, rate was 26% (20/77). Median duration of CR/CRh response was 4.7 months. Among patients with CR/CRh assessed for measurable residual disease, or MRD, 63% (12/19) were MRD negative. Subpopulation analysis showed that a median overall survival, or OS, of 23.3 months (95% CI: 8.4-NR) was observed among the 37 patients who achieved an overall response, based on a Kaplan-Meier estimate from this single-arm trial.
Previous report
Among patients with R/R NUP98r AML included in the Phase 1 portion of AUGMENT-101, the ORR was 60% (3/5). One patient who proceeded to transplant resumed revumenib post-transplant and was in maintenance cycle 10 as of the data cutoff date. The safety profile of revumenib in patients with R/R NUP98r AML was consistent with previous reports observed in KMT2Ar or mNPM1 AML.
Previous report
Published pivotal data from patients with R/R mNPM1 AML in the Phase 2 portion of the AUGMENT-101 trial in the journal Blood in May 2025. The results published from the primary efficacy analysis (n=64) are consistent with the data presented at the EHA Annual Congress Meeting in June 2025 from the larger efficacy-evaluable population (n=77).
Previous report
Presented data at the EHA Annual Congress Meeting in June 2025 highlighting the robust and rapid responses observed in different organs and subgroups of patients with cGVHD in the pivotal AGAVE-201 trial that supported the FDA approval of Niktimvo.
Previous report
Corporate Updates
Previous report
In May 2025, the Company announced the appointment of Dr. Nick Botwood as Head of Research and Development and Chief Medical Officer. Dr. Botwood brings 25 years of industry experience leading drug development, R&D strategy, and global commercialization of novel oncology therapeutics.
Previous report
In June 2025, the Company announced the resignation of William Meury from its Board of Directors after seven years of service due to his acceptance of the role of President and Chief Executive Officer and a member of the Board of Directors at Incyte, the Company’s collaboration partner for Niktimvo.
Previous report
An increase in revumenib-related costs, primarily driven by multiple trials evaluating revumenib in mNPM1 and KMT2Ar acute leukemia, ongoing medical affairs activities supporting Revuforj, and a $5.0 million milestone expense in the second quarter of 2025 recognized as a result of an sNDA submission; partially offset by a decrease in CMC expense due to the capitalization of inventory for commercial use.
Previous report
An increase in axatilimab-related costs driven by the ongoing IPF trial, the frontline cGVHD combination trial with ruxolitinib for the three and six months ended June 30, 2025. For the six months ended June 30, 2025, the increase was of also driven by a $10 million milestone expense in the first quarter of 2025, as a result of the first patient dosed in a Phase III study with the compound in combination with another agent for any indication.
Previous report
An increase in personnel costs and stock-based compensation to support the commercialization of Revuforj and Niktimvo, primarily related to an increase in headcount.
Reworded paragraphs (39)
Previous wording
We are a commercial-stage biopharmaceutical company advancing innovative cancer therapies. We currently have two commercially approved products, Revuforj® (revumenib) and Niktimvo™ (axatilimab-csfr), and a robust slate of clinical development programs. Revuforj is our first-in-class menin inhibitor that was approved by the U.S. Food and Drug Administration, or FDA, in November 2024 for the treatment of relapsed or refractory, or R/R, acute leukemia with a lysine methyltransferase 2A gene, or KMT2A, translocation in adult and pediatric patients one year old and older. In April 2025, we completed the submission of a supplemental New Drug Application, or sNDA, for revumenib as a treatment for R/R acute myeloid leukemia, or AML, with a nucleophosmin 1 mutation, or mNPM1, based on the positive pivotal data from our AUGMENT-101 trial. In June 2025, the FDA granted Priority Review to our sNDA and assigned a Prescription Drug User Fee Act, or PDUFA, target action date of October 25, 2025. We are also studying revumenib in combination with standard-of-care agents in mNPM1 AML or KMT2A-rearranged acute leukemia across the treatment landscape, including in newly diagnosed patients. Additionally, we are exploring the use of revumenib as a treatment in solid tumors, specifically its activity in metastatic colorectal cancer. Niktimvo is our first-in-class colony stimulating factor-1 receptor, or CSF-1R, blocking antibody that was approved by the FDA in August 2024 for the treatment of chronic graft-versus-host disease, or cGVHD, after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. Axatilimab is in development for the treatment of newly diagnosed cGVHD patients in combination with standard-of-care therapies, as well for the treatment of idiopathic pulmonary fibrosis, or IPF. We plan to continue to leverage the technical and business expertise of our management team and scientific collaborators to license, acquire and develop additional therapeutics to expand our pipeline.
Current wording
We are a commercial-stage biopharmaceutical company advancing innovative cancer therapies. We currently have two commercially approved products, Revuforj® (revumenib) and Niktimvo™ (axatilimab-csfr), and a robust slate of clinical development programs. Revuforj is our first-in-class menin inhibitor that was approved by the U.S. Food and Drug Administration, or FDA, in November 2024 for the treatment of relapsed or refractory, or R/R, acute leukemia with a lysine methyltransferase 2A gene, or KMT2A, translocation in adult and pediatric patients one year and older. In October 2025, Revuforj received a second approval from the FDA for the treatment of R/R acute myeloid leukemia, or AML, with a susceptible nucleophosmin 1 mutation, or NPM1m, in adult and pediatric patients one year and older who have no satisfactory alternative treatment option. We are also studying revumenib in combination with standard-of-care agents in NPM1m AML or KMT2A-rearranged acute leukemia across the treatment landscape, including in newly diagnosed patients. Additionally, we are exploring the use of revumenib as a treatment in solid tumors, specifically its activity in metastatic colorectal cancer. Niktimvo is our first-in-class colony stimulating factor-1 receptor, or CSF-1R, blocking antibody that was approved by the FDA in August 2024 for the treatment of chronic graft-versus-host disease, or cGVHD, after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. Axatilimab is in development for the treatment of newly diagnosed cGVHD patients in combination with standard-of-care therapies, as well for the treatment of idiopathic pulmonary fibrosis, or IPF. We plan to continue to leverage the technical and business expertise of our management team and scientific collaborators to license, acquire and develop additional therapeutics to expand our pipeline.
Previous wording
We have begun generating product revenue from sales of Revuforj and collaboration revenue from sales of Niktimvo and plan to continue to leverage the technical and business expertise of our management team and scientific collaborators to license, acquire and develop additional therapeutics to expand our pipeline. We continue to incur significant research and development and other expenses related to our ongoing operations. Except for 2021, we have not been profitable and have incurred losses in each period since our inception in 2005. For the six months ended June 30, 2025 and 2024, we reported a net loss of $71.8 million and $68.1 million, respectively. As of June 30, 2025, we had an accumulated deficit of $1.4 billion. As of June 30, 2025, we had cash, cash equivalents and short- and long-term investments of $517.9 million.
Current wording
We have begun generating product revenue from sales of Revuforj and collaboration revenue from sales of Niktimvo. We continue to incur significant research and development and other expenses related to our ongoing operations. Except for 2021, we have not been profitable and have incurred losses in each period since our inception in 2005. For the nine months ended September 30, 2025 and 2024, we reported a net loss of $217.4 million and $224.6 million, respectively. As of September 30, 2025, we had an accumulated deficit of $1.4 billion. As of September 30, 2025, we had cash, cash equivalents and short- and long-term investments of $456.1 million.
Previous wording
Multiple trials evaluating revumenib in mNPM1 and KMT2Ar acute leukemia across the treatment landscape are ongoing. These trials include:
Current wording
Multiple trials evaluating revumenib in NPM1m and KMT2Ar acute leukemia across the treatment landscape are ongoing. These trials include:
Previous wording
EVOLVE-2: A pivotal, Phase 3, randomized, double-blind, placebo-controlled trial evaluating revumenib in combination with venetoclax and azacitidine in newly diagnosed mNPM1 AML patients who are unfit for intensive chemotherapy. The trial is being conducted in collaboration with the HOVON network, a leading cooperative clinical trial group with extensive experience studying novel therapies for hematologic malignancies.
Current wording
EVOLVE-2: A pivotal, Phase 3, randomized, double-blind, placebo-controlled trial evaluating revumenib in combination with venetoclax and azacitidine in newly diagnosed NPM1m AML patients who are unfit for intensive chemotherapy. The trial is being conducted in collaboration with the HOVON network, a leading cooperative clinical trial group with extensive experience studying novel therapies for hematologic malignancies.
Previous wording
SAVE: A Phase 1/2 trial evaluating an all-oral combination of revumenib with venetoclax and decitabine/cedazuridine in pediatric and adult patients with R/R AML or mixed-lineage acute leukemia (MPAL) harboring either mNPM1, KMT2Ar, or NUP98r alterations. The trial is being conducted by investigators from MD Anderson Cancer Center. Updated data that showed an ORR of 82% (27/33) and a CR/CRh rate of 48% (16/33) were presented at the 66th ASH Annual Meeting. The trial is now enrolling a cohort of newly diagnosed patients.
Current wording
SAVE: A Phase 1/2 trial evaluating an all-oral combination of revumenib with venetoclax and decitabine/cedazuridine in pediatric and adult patients with newly diagnosed and R/R AML or mixed-lineage acute leukemia harboring either NPM1m, KMT2Ar, or NUP98r alterations. The trial is being conducted by investigators from MD Anderson Cancer Center. Data from the first cohort of newly diagnosed patients will be highlighted at the ASH 2025 Annual Meeting in an oral presentation.
Previous wording
Intensive chemotherapy: A Phase 1 trial evaluating the combination of revumenib with intensive chemotherapy (7+3) followed by revumenib maintenance treatment in newly diagnosed mNPM1 or KMT2Ar acute leukemia patients. The Company expects to report data in the fourth quarter of 2025 supporting pivotal dose selection.
Current wording
Intensive chemotherapy: Two ongoing Phase 1 trials evaluating the combination of revumenib with intensive chemotherapy (7+3) followed by revumenib maintenance treatment in newly diagnosed NPM1m or KMT2Ar acute leukemia patients. Preliminary data from both trials will be presented at the ASH 2025 Annual Meeting.
Previous wording
BEAT AML: A Phase 1 trial evaluating the combination of revumenib with venetoclax and azacitidine in newly diagnosed older adults (≥60 years) with mNPM1 or KMT2Ar AML. The trial is being conducted as part of the Leukemia & Lymphoma Society's Beat AML® Master Clinical Trial. Updated data that showed a 67% (29/43) CR rate and 100% (37/37) flow-MRD negativity rate among evaluable responders were published in the Journal of Clinical Oncology and simultaneously presented in an oral presentation at the EHA Annual Congress Meeting in June 2025.
Current wording
BEAT AML: A Phase 1 trial evaluating the combination of revumenib with venetoclax and azacitidine in newly diagnosed older adults (≥60 years) with NPM1m or KMT2Ar AML. The trial is being conducted as part of the Leukemia & Lymphoma Society's Beat AML® Master Clinical Trial.
Previous wording
INTERCEPT: A Phase 1 trial evaluating the use of novel therapies, including revumenib, to target MRD and early relapse in AML. The trial is being conducted by the Australasian Leukaemia and Lymphoma Group as part of the INTERCEPT AML master clinical trial. Data that showed 54% (6/11) of patients had MRD reduction at any time, including 36% (4/11) who achieved MRD negativity, were presented at the 66th ASH Annual Meeting.
Current wording
INTERCEPT: A Phase 1 trial evaluating the use of novel therapies, including revumenib, to target MRD and early relapse in AML. The trial is being conducted by the Australasian Leukaemia and Lymphoma Group as part of the INTERCEPT AML master clinical trial.
Previous wording
Start-up activities are underway for two trials, known as the REVEAL trials, that will evaluate revumenib in combination with standard of care regimens in newly diagnosed acute leukemia patients with mNPM1 or KMT2A-rearranged AML who are fit to receive intensive chemotherapy, with trial initiation expected in the fourth quarter of 2025.
Current wording
Start-up activities are underway for two trials, known as the REVEAL trials, that will evaluate revumenib in combination with standard of care regimens in newly diagnosed acute leukemia patients with NPM1m or KMT2A-rearranged AML who are fit to receive intensive chemotherapy, with trial initiation expected by the end of 2025.
Previous wording
The Company is evaluating revumenib in patients with R/R metastatic microsatellite stable (MSS) colorectal cancer (CRC). The Company expects to report data from the trial by the end of 2025.
Current wording
The Company is evaluating revumenib in patients with R/R metastatic microsatellite stable colorectal cancer. The Company expects to report data from the trial at a medical conference in the first quarter of 2026.
Previous wording
Niktimvo achieved $36.2 million in net revenue in the second quarter of 2025, the first full quarter of the U.S. launch, representing significant growth compared to the $13.6 million in net revenue in the first quarter of 2025. Niktimvo was launched in the U.S. in late January 2025 for the treatment of chronic graft-versus-host disease, or cGVHD, after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs). Syndax and Incyte are co-commercializing Niktimvo. Syndax records 50% of the Niktimvo net commercial profit/loss, defined as net product revenue minus the cost of sales and commercial expenses. For the second quarter of 2025, Syndax’s share of the Niktimvo product contribution, reported as Collaboration revenue, was $9.4 million.
Current wording
Achieved $45.8 million in Niktimvo net revenue in the third quarter of 2025, representing a 27% increase over the second quarter of 2025. We are co-commercializing Niktimvo with Incyte. We record 50% of the Niktimvo net commercial profit/loss, defined as net product revenue minus the cost of sales and commercial expenses. For the third quarter of 2025, our share of the Niktimvo product contribution, reported as collaboration revenue, was $13.9 million.
Previous wording
Two trials evaluating axatilimab in combination with standard of care therapies in newly diagnosed cGVHD patients are ongoing, including:
Current wording
Two trials evaluating axatilimab in combination with standard of care therapies in newly diagnosed chronic GVHD patients are ongoing, including:
Previous wording
Enrollment is ongoing in MAXPIRe, a Phase 2, 26-week randomized, double-blinded, placebo-controlled trial of axatilimab on top of standard of care in patients with idiopathic pulmonary fibrosis (IPF). The Company expects to complete enrollment in the trial in the fourth quarter of 2025 with topline data anticipated in the second half of 2026.
Current wording
Enrollment is ongoing in MAXPIRe, a Phase 2, 26-week randomized, double-blinded, placebo-controlled trial of axatilimab on top of standard of care in patients with IPF. The Company expects to complete enrollment in the trial by the end of 2025 with topline data anticipated in the second half of 2026.
Previous wording
We generated no product revenue during the three and six months ended June 30, 2024.
Current wording
We generated no product revenue during the three and nine months ended September 30, 2024.
Previous wording
In accordance with Topic ASC 808, Collaboration Arrangements, Incyte has been identified as the principal in product sales, therefore, we will recognize its 50% share of any profits or losses in the amount of net product sales less cost of goods sold and shared commercial and other expenses, in the period in which the underlying sales and costs are recognized. Our share of net profits in connection with commercialization of Niktimvo will be presented as “Collaboration revenue, net” and our share of net losses will be presented as “Collaboration loss” within operating expenses. Collaboration revenue or expense is made up of our share of the 50% profit with Incyte. We record collaboration revenue net of commercial expenses. We will continue to recognize the costs associated with ongoing development services in the R&D operating expense line, including any cost-sharing components with Incyte.
Current wording
In accordance with Topic ASC 808, Collaboration Arrangements, Incyte has been identified as the principal in product sales, therefore, we will recognize its 50% share of any profits or losses in the amount of net product sales less cost of goods sold and shared commercial and other expenses, in the period in which the underlying sales and costs are recognized. Our share of net profits in connection with commercialization of Niktimvo will be presented as “Collaboration revenue, net” and our share of net losses will be presented as “Collaboration loss” within operating expenses. Collaboration revenue or expense is made up of our share of the 50% profit with Incyte. We record collaboration revenue net of commercial expenses, including any royalties owed on license agreements. We will continue to recognize the costs associated with ongoing development services in the R&D operating expense line, including any cost-sharing components with Incyte.
Previous wording
Our cost of product sales includes the cost of goods sold and royalties associated with Revuforj and Niktimvo sales in the United States.
Current wording
Our cost of product sales includes the cost of goods sold and royalties associated with Revuforj sales in the United States.
Previous wording
Selling, general and administrative expenses consist primarily of commercialization costs as well as employee-related expenses, including salaries, benefits, non-cash stock-based compensation and travel expenses, for our employees in executive, finance, human resources, information technology, business development and support functions, as well as sales and marketing expenses to support the launch and commercialization of Revuforj and Niktimvo. Other selling, general and administrative expenses include facility-related costs not otherwise allocated to research and development expenses and accounting, tax, legal, information technology and consulting services. We anticipate that our selling, general and administrative expenses will further increase in the future as we continue to increase our headcount to support our continued research and development and anticipated commercialization of our products.
Current wording
Selling, general and administrative expenses consist primarily of commercialization costs as well as employee-related expenses, including salaries, benefits, non-cash stock-based compensation and travel expenses, for our employees in executive, finance, human resources, information technology, business development and support functions, as well as sales and marketing expenses to support the launch and commercialization of Revuforj and Niktimvo. Other selling, general and administrative expenses include facility-related costs not otherwise allocated to research and development expenses and accounting, tax, legal, information technology and consulting services. We anticipate that our selling, general and administrative expenses will remain stable in the next few years.
Previous wording
Comparison of the three and six months ended June 30, 2025 and 2024:
Current wording
Comparison of the three and nine months ended September 30, 2025 and 2024:
Previous wording
In November 2024, we began to generate product revenue from sales of Revuforj in the United States. We record product revenue net of estimated discounts, chargebacks, rebates, product returns, and other gross-to-net revenue deductions. Product revenue, net from sales of Revuforj was $28.6 million and $48.6 million for the three and six months ended June 30, 2025, respectively.
Current wording
In November 2024, we began to generate product revenue from sales of Revuforj in the United States. We record product revenue net of estimated discounts, chargebacks, rebates, product returns, and other gross-to-net revenue deductions. Product revenue, net from sales of Revuforj was $32.0 million and $80.6 million for the three and nine months ended September 30, 2025, respectively.
Previous wording
In February 2025, we began to generate sales of Niktimvo in the United States in collaboration with our partner, Incyte. Our Collaboration revenue, net was $9.4 million for the three months ended June 30, 2025. Our Collaboration revenue, net was $9.1 million for the six months ended June 30, 2025, as it includes the $0.2 million of Collaboration loss recognized in the first quarter.
Current wording
In February 2025, we began to generate sales of Niktimvo in the United States in collaboration with our partner, Incyte. Our Collaboration revenue, net was $13.9 million for the three months ended September 30, 2025. Our Collaboration revenue, net was $23.0 million for the nine months ended September 30, 2025, and includes the $0.2 million of Collaboration loss recognized in the first quarter.
Previous wording
Our cost of product sales were $1.3 million and $2.2 million for the three and six months ended June 30, 2025, respectively, resulting from increased sales of Revuforj and Niktimvo.
Current wording
Our cost of product sales were $2.1 million and $4.3 million for the three and nine months ended September 30, 2025, respectively, resulting from increased sales of Revuforj. Included in cost of product sales are royalties owed to AbbVie on Revuforj sales as part of the Vitae License Agreement.
Previous wording
The following table summarizes the research and development expenses for the three and six months ended June 30, 2025 and 2024:
Current wording
The following table summarizes the research and development expenses for the three and nine months ended September 30, 2025 and 2024:
Previous wording
For the three and six months ended June 30, 2025, our total research and development expenses increased $13.6 million and $18.7 million, respectively, from the comparable prior year period. The increases were primarily due to:
Current wording
For the three months ended September 30, 2025, our total research and development expenses decreased by $14.7 million from the comparable prior year period. The decrease was primarily due to:
Previous wording
An increase in personnel costs and stock-based compensation to support on-going clinical trials and, sNDA and medical affairs activities in support of commercialization.
Current wording
An increase in personnel costs to support on-going clinical trials, preparation of a supplemental New Drug Application, and medical affairs activities in support of commercialization of Revuforj and Niktimvo.
Previous wording
The following tables summarizes the selling, general and administrative expenses for the three and six months ended June 30, 2025 and 2024:
Current wording
The following tables summarizes the selling, general and administrative expenses for the three and nine months ended September 30, 2025 and 2024:
Previous wording
For the three and six months ended June 30, 2025, our total selling, general and administrative expenses increased $14.7 million and $32.8 million, respectively, from the comparable prior year period. The increases were primarily due to:
Current wording
For the three and nine months ended September 30, 2025, our total selling, general and administrative expenses increased $13.8 million and $46.6 million, respectively, from the comparable prior year period. The increases were primarily due to commercial-related costs, driven by ongoing activities in 2025 associated with the commercial launches for Revuforj and Niktimvo. The increases in personnel and stock-based compensation costs were primarily related to higher costs in headcount in 2025 to support the commercialization of Revuforj and Niktimvo.
Previous wording
For the three and six months ended June 30, 2025, royalty interest expense increased due to the interest expense recognized related to the Royalty Pharma Purchase and Sale Agreement signed in November 2024.
Current wording
For the three and nine months ended September 30, 2025, royalty interest expense increased due to the interest expense recognized related to the Royalty Pharma Purchase and Sale Agreement signed in November 2024.
Previous wording
For the three and six months ended June 30, 2025, other interest expense decreased from the comparable period due to less interest expense recognized related to capital leases.
Current wording
For the three and nine months ended September 30, 2025, other interest expense decreased from the comparable period due to less interest expense recognized related to capital leases.
Previous wording
For the three and six months ended June 30, 2025, interest income decreased from the comparable period. The decrease of interest income was primarily due to the fluctuation of interest rates and average balance of cash equivalents and short and long-term investments.
Current wording
For the three and nine months ended September 30, 2025, interest income decreased from the comparable period. The decrease of interest income was primarily due to the fluctuation of interest rates and the average balance of cash equivalents and short and long-term investments.
Previous wording
For the three and six months ended June 30, 2025, other expense increased from the comparable period primarily related to the current period amortization of debt issuance costs related to the Royalty Pharma Purchase and Sale Agreement.
Current wording
For the three and nine months ended September 30, 2025, other expense increased from the comparable period primarily related to the current period amortization of debt issuance costs related to the Royalty Pharma Purchase and Sale Agreement.
Previous wording
Net cash used in operating activities increased from $155.2 million for the six months ended June 30, 2024 to $183.0 million for the six months ended June 30, 2025, primarily due to an increase in operating net loss, accounts receivable, and inventory, and decreases in prepaid expenses, and collaboration payables.
Current wording
Net cash used in operating activities increased from $217.5 million for the nine months ended September 30, 2024 to $253.5 million for the nine months ended September 30, 2025, primarily due to an increase in accounts receivable, inventory, collaboration receivable, and short term deposits, and a decrease in collaboration payable.
Previous wording
Net Cash Provided by (Used in) Investing Activities
Current wording
Net Cash Provided by Investing Activities
Previous wording
Net cash provided by investing activities for the six months ended June 30, 2025, was $136.0 million and was related to $238.3 million from the maturities of available-for-sale securities, offset by the purchase of $102.3 million of available-for-sale securities.
Current wording
Net cash provided by investing activities for the nine months ended September 30, 2025, was $208.5 million and was related to $341.3 million from the maturities of available-for-sale securities, offset by the purchase of $132.7 million of available-for-sale securities.
Previous wording
Net cash used in investing activities for the six months ended June 30, 2024, was $37.6 million and was related to $129.7 million from the maturities of available-for-sale securities, offset by the purchase of $167.4 million of available-for-sale securities.
Current wording
Net cash provided by investing activities for the nine months ended September 30, 2024, was $49.2 million and was related to $229.9 million from the maturities of available-for-sale securities, offset by the purchase of $180.7 million of available-for-sale securities.
Previous wording
Net cash provided by financing activities for the six months ended June 30, 2025, decreased by $1.4 million from the comparable prior year period primarily due to a decrease in proceeds from the exercise of stock options in the current period.
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2025, increased by $1.8 million from the comparable prior year period primarily due to an increase in proceeds from the exercise of stock options in the current period.
Previous wording
Additionally, the process of testing product candidates in clinical trials is costly, and the timing of progress in these trials is uncertain. We cannot estimate the actual amounts necessary to successfully complete the development and commercialization of our product candidates or whether, or when, we may achieve profitability.
Current wording
Additionally, the process of testing product candidates in clinical trials is costly, and the timing, progress and outcomes in these trials is uncertain. We cannot estimate the actual amounts necessary to successfully complete the development and commercialization of our product candidates or whether, or when, we may achieve profitability.
Previous wording
Although we have two FDA-approved products available for commercial sale in the U.S., we have not generated substantial product revenue to date. We believe that the combination of our available cash, cash equivalents, short-term and long-term investments as well as our expected Revuforj gross contribution and Niktimvo collaboration revenue is sufficient to fund our near-term existing and planned cash requirements. Until we generate substantial product revenue, we expect to finance our future cash needs through a combination of equity offerings, debt financings and additional funding from license and collaboration arrangements. Except for any obligations of our collaborators to reimburse us for research and development expenses or to make milestone or royalty payments under our agreements with them, we will not have any committed external source of liquidity.
Current wording
We expect to continue to support our future cash needs through a combination of equity offerings, debt financings and additional funding from license and collaboration arrangements. Except for any obligations of our collaborators to reimburse us for research and development expenses or to make milestone or royalty payments under our agreements with them, we will not have any committed external source of liquidity.
Previous wording
Our material contractual obligations and commitments as of June 30, 2025, primarily relate to our maturities of operating leases for office space and equipment and capital leases for office equipment. As of June 30, 2025, we have $0.4 million payable within 12 months.
Current wording
Our material contractual obligations and commitments as of September 30, 2025, primarily relate to our maturities of operating leases for office space and equipment and capital leases for office equipment. As of September 30, 2025, we have $0.3 million payable within 12 months.
Previous wording
In May 2023, we entered into a sales agreement with Cowen and Company, LLC, or TD Cowen, under which we could, from time to time, issue and sell shares of our common stock having aggregate sales proceeds of up to $200.0 million, in a series of one or more at-the-market equity offerings, or the 2023 ATM Program. TD Cowen is not required to sell any specific share amounts but acts as the Company’s sales agent, using commercially reasonable efforts consistent with its normal trading and sales practices. Pursuant to the sales agreement, shares will be sold under the shelf registration statement on Form S-3ASR (Registration No. 333-277424), which became automatically effective upon filing on February 27, 2024. Our common stock will be sold at prevailing market prices at the time of the sale, and as a result, prices may vary. For the three and six months ended June 30, 2025, we did not sell any shares of common stock under the 2023 ATM Program. As of June 30, 2025, we had $157.9 million available under the 2023 ATM Program.
Current wording
In May 2023, we entered into a sales agreement with Cowen and Company, LLC, or TD Cowen, under which we could, from time to time, issue and sell shares of our common stock having aggregate sales proceeds of up to $200.0 million, in a series of one or more at-the-market equity offerings, or the 2023 ATM Program. TD Cowen is not required to sell any specific share amounts but acts as the Company’s sales agent, using commercially reasonable efforts consistent with its normal trading and sales practices. Pursuant to the sales agreement, shares will be sold under the shelf registration statement on Form S-3ASR (Registration No. 333-277424), which became automatically effective upon filing on February 27, 2024. Our common stock will be sold at prevailing market prices at the time of the sale, and as a result, prices may vary. For the three and nine months ended September 30, 2025, we did not sell any shares of common stock under the 2023 ATM Program. As of September 30, 2025, we had $157.9 million available under the 2023 ATM Program.
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Previous report — wording carried elsewhere
An increase in commercial-related costs driven by ongoing commercialization activities for Revuforj and Niktimvo.