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Syndax Pharmaceuticals Inc

For the period ended Jun 30, 2025. Filed Aug 4, 2025.

View on SEC.gov

About 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.

Jun 30, 2025 · Filed Aug 4, 2025

SNDX$9.54+1.8%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-03-31; filed 2025-05-05.

0000950170-25-063518

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current 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 Operations

The 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 143 previous paragraphs and 144 current paragraphs.

80 unchanged; 44 reworded; 19 added; 16 removed; 3 previous and 1 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 (19)

Current report

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current 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.

Current 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.

Current 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.

Current 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.

Current 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).

Current 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.

Current 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.

Current 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.

Current report

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 report

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 report

An increase in commercial-related costs driven by ongoing commercialization activities for Revuforj and Niktimvo.
Removed paragraphs (16)

Previous report

As of the end of March 2025, 44% of the Company’s high priority, Tier 1 and Tier 2, accounts have ordered, up from one-third of accounts as of the end of February 2025. These accounts are the centers of excellence and the medium to large academic institutions which represent two-thirds of the patient opportunity. Among all the accounts that have ordered, two-thirds have ordered multiple times.

Previous report

Formulary coverage for Revuforj continues to build. As of the end of March 2025, formal coverage policies were in place for approximately 72% of all managed care lives, which includes commercially covered plus Medicare and Medicaid lives, up from 53% at the end of February 2025.

Previous report

Completed the submission of a supplemental New Drug Application (sNDA) to the U.S. FDA in April 2025, seeking Priority Review for the approval of Revuforj for the treatment of R/R mutant NPM1 (mNPM1) AML. The sNDA was submitted under the FDA’s Real-Time Oncology Review (RTOR) program, which allows for a more efficient review and close engagement between the sponsor and FDA throughout the submission process. The sNDA is supported by the previously reported positive pivotal data from the AUGMENT-101 trial.

Previous report

Submitted the pivotal R/R mNPM1 AML data from the AUGMENT-101 trial for publication. The manuscript has been accepted and the publication is expected imminently.

Previous report

More than 1,250 infusions of Niktimvo have been administered year-to-date and approximately 95% of top accounts and more than 70% of all bone marrow transplant centers have ordered as of the end of March 2025. A permanent J-code was assigned by CMS effective April 1, 2025.

Previous report

Presented a post-hoc analysis evaluating the effects of prior lines of therapy on clinical outcomes for patients with chronic GVHD in the AGAVE-201 trial of axatilimab. The data show that overall response rates were consistent with axatilimab regardless of the number of prior lines of therapy and that organ-specific responses were noted regardless of the last prior therapy. The data were presented at the 2025 Tandem Meetings of the American Society for Transplantation and Cellular Therapy and the Center for International Blood and Marrow Transplantation Research.

Previous report

Increase in commercial-related costs compared to the prior period, primarily due to the commercialization of Revuforj and Niktimvo
Reworded paragraphs (44)

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 designed to unlock their full potential. Revuforj is our first-in-class menin inhibitor that was approved by the 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. 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 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.

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 three months ended March 31, 2025 and 2024, we reported a net loss of $84.8 million and $72.4 million, respectively. As of March 31, 2025, we had an accumulated deficit of $1.3 billion. As of March 31, 2025, we had cash, cash equivalents and short- and long-term investments of $602.1 million.

Current 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.

Previous wording

Achieved $20.0 million in Revuforj net revenue in the first quarter of 2025, the first full quarter of the U.S. launch. Revuforj was launched in the U.S. in late November 2024 for the treatment of relapsed or refractory (R/R) acute leukemia with a KMT2A translocation in adult and pediatric patients one year and older.

Current wording

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 wording

Opened enrollment in the EVOLVE-2 trial, a pivotal, randomized, double-blind, placebo-controlled trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed mNPM1 or KMT2A-rearranged (KMT2Ar) AML patients who are unfit for intensive chemotherapy in the first quarter of 2025. The trial is being conducted in collaboration with the

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 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.

Previous wording

BEAT AML: A Phase 1 trial evaluating the combination of revumenib with venetoclax and azacitidine in newly diagnosed mNPM1 or KMT2Ar AML patients. The trial is being conducted as part of the Leukemia & Lymphoma Society's Beat AML® Master Clinical Trial. Updated data that showed an overall response rate (ORR) of 100% (37/37) and a composite complete remission (CRc) rate of 95% (35/37) were reported at the Company’s investor event at the 66 th ASH Annual Meeting. The Company anticipates that an update on the trial will be available at a medical meeting in the second quarter of 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 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.

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 66 th 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 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.

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.

Current 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.

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 66 th 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. 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.

Previous wording

The Company plans to initiate multiple trials of revumenib in combination with standard of care regimens in newly diagnosed acute leukemia patients who are fit to receive intensive chemotherapy, starting in the second half 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 mNPM1 or KMT2A-rearranged AML who are fit to receive intensive chemotherapy, with trial initiation expected in the fourth quarter of 2025.

Previous wording

The Company is evaluating revumenib in patients with R/R metastatic microsatellite stable (MSS) colorectal cancer (CRC). The Phase 1b portion of this proof-of-concept trial is ongoing.

Current 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.

Previous wording

Niktimvo achieved $13.6 million in net revenue in the first quarter of 2025, the first partial quarter of the U.S. launch. Niktimvo was launched in the U.S. in late January for the treatment of chronic graft-versus-host disease (GVHD) 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 co-commercialize Niktimvo, and Syndax records 50% of the Niktimvo net profit/loss, defined as net product revenue minus the cost of sales and commercial expenses.

Current 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.

Previous wording

Two trials evaluating axatilimab in combination with standard of care therapies in newly diagnosed chronic GVHD patients are ongoing, including:

Current wording

Two trials evaluating axatilimab in combination with standard of care therapies in newly diagnosed cGVHD patients are ongoing, including:

Previous wording

A Phase 2, open-label, randomized, multicenter trial of axatilimab in combination with ruxolitinib in patients ≥ 12 years of age with newly diagnosed chronic GVHD.

Current wording

A Phase 2, open-label, randomized, multicenter trial of axatilimab in combination with ruxolitinib in patients ≥ 12 years of age with newly diagnosed cGVHD.

Previous wording

A pivotal Phase 3, randomized, double-blind, placebo-controlled, multi-center trial of axatilimab in combination with corticosteriods in patients ≥ 12 years of age with newly diagnosed chronic GVHD.

Current wording

A pivotal Phase 3, randomized, double-blind, placebo-controlled, multi-center trial of axatilimab in combination with corticosteroids in patients ≥ 12 years of age with newly diagnosed cGVHD.

Previous wording

Enrollment is ongoing in the MAXPIRe trial, 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 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 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.

Previous wording

We generated no product revenue during the three months ended March 31, 2024.

Current wording

We generated no product revenue during the three and six months ended June 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 products will be presented as “Collaboration revenue” and its share of net losses will be presented as “Collaboration loss” within operating 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. 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 sales in the United States.

Current wording

Our cost of product sales includes the cost of goods sold and royalties associated with Revuforj and Niktimvo sales in the United States.

Previous wording

Comparison of the three months ended March 31, 2025 and 2024:

Current wording

Comparison of the three and six months ended June 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 $20.0 million for the three months ended March 31, 2025.

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 $28.6 million and $48.6 million for the three and six months ended June 30, 2025, respectively.

Previous wording

The following table summarizes the research and development expenses for the three months ended March 31, 2025 and 2024:

Current wording

The following table summarizes the research and development expenses for the three and six months ended June 30, 2025 and 2024:

Previous wording

For the three months ended March 31, 2025, our total research and development expenses increased $5.1 million from the comparable prior year period. The increase was primarily due to:

Current 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:

Previous wording

A decrease in revumenib-related costs, primarily driven by an $8.0 million milestone expense in the 2024 period paid to AbbVie and a reduction in CMC expense due to the capitalization of inventory for commercial use, offset by trial expenses to expand revumenib use across the mNPM1 and KMT2a acute leukemia landscape and medical affairs activities supporting the launch of Revuforj.

Current wording

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 wording

An increase in axatilimab-related costs, primarily driven by the IPF trial, the frontline chronic GVHD trial with ruxolitinib being conducted in partnership with Incyte, and a $10.0 million milestone payment to UCB as a result of the first patient dosed in a Phase III study with the compound in combination with another agent for any indication

Current wording

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 wording

An increase in personnel costs and other expenses, and stock-based compensation, which includes salaries, overhead and related expenses compared to the prior period, have increased to support on-going clinical trials, sNDA activities and medical affairs in support of commercialization

Current 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.

Previous wording

The following tables summarizes the selling, general and administrative expenses for the three months ended March 31, 2025 and 2024:

Current wording

The following tables summarizes the selling, general and administrative expenses for the three and six months ended June 30, 2025 and 2024:

Previous wording

For the three months ended March 31, 2025, our total selling, general and administrative expenses increased $18.0 million, from the comparable prior year period. The increase primarily is due to:

Current 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:

Previous wording

An increase in personnel cost and other expenses, and stock-based compensation, which includes salaries, overhead and related expenses, compared to the prior period, was primarily due to increased headcount to support the commercialization of Revuforj and Niktimvo

Current wording

An increase in personnel costs and stock-based compensation to support the commercialization of Revuforj and Niktimvo, primarily related to an increase in headcount.

Previous wording

For the three months ended March 31, 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 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.

Previous wording

For the three months ended March 31, 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 six months ended June 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 months ended March 31, 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 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.

Previous wording

For the three months ended March 31, 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 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.

Previous wording

Net cash used in operating activities increased from $83.5 million for the three months ended March 31, 2024 to $95.2 million for the three months ended March 31, 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 $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.

Previous wording

Net cash provided by investing activities for the three months ended March 31, 2025, was $94.1 million and was related to $104.7 million from the maturities of available-for-sale securities, offset by the purchase of $10.5 million of available-for-sale securities.

Current 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.

Previous wording

Net cash used in investing activities for the three months ended March 31, 2024, was $99.4 million and was related to $68.0 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 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.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2025, decreased by $1.2 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 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.

Previous wording

We believe that the combination of our available cash, cash equivalents, short-term and long-term investments as well as our Revuforj gross contribution and Niktimvo collaboration revenue is sufficient to fund existing and planned cash requirements. Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, third-party clinical research and development services, clinical costs, commercialization costs, legal and other regulatory expenses and general overhead costs. We have based our estimates on assumptions that may prove to be incorrect, and we could use our capital resources sooner than we currently expect.

Current wording

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 existing and planned cash requirements. Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, third-party clinical research and development services, clinical costs, commercialization costs, legal and other regulatory expenses and general overhead costs. We have based our estimates on assumptions that may prove to be incorrect, and we could use our capital resources sooner than we currently expect.

Previous wording

the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more trials than we currently expect;

Current wording

the outcome, timing and cost of seeking and obtaining additional regulatory approvals from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more trials than we currently expect;

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 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

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.

Previous wording

Our material contractual obligations and commitments as of March 31, 2025, primarily relate to our maturities of operating leases for office space and equipment and capital leases for office equipment. As of March 31, 2025, we have $0.9 million payable within 12 months.

Current 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.

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Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

Net Cash Provided by (Used in) Investing Activities
Rearranged previous paragraphs (3)

Previous report — wording carried elsewhere

HOVON network, a leading cooperative clinical trial group with extensive experience studying novel therapies for hematologic malignancies.

Previous report — wording carried elsewhere

In February 2025, we began to generate sales of Niktimvo in the United States in collaboration with our partner Incyte. Our share of net profits in connection with commercialization of Niktimvo will be presented as “Collaboration revenue” and its 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.

Previous report — wording carried elsewhere

Net Cash Provided by Investing Activities