Syndax Pharmaceuticals Inc

Previous wording

We are a commercial-stage biopharmaceutical company advancing innovative cancer therapies. We currently have two commercially approved medicines, Revuforj® (revumenib) and Niktimvo™ (axatilimab-csfr), and a robust slate of clinical development programs.

Current wording

We are a commercial-stage biopharmaceutical company advancing innovative cancer therapies. We currently have two commercially approved medicines, Revuforj® (revumenib) and Niktimvo™ (axatilimab-csfr), and a robust pipeline of late- and early-stage development programs.

Previous wording

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 options. We are also studying revumenib in combination with standard-of-care agents in NPM1m AML or KMT2A-rearranged, or KMT2Ar, acute leukemia across the treatment landscape, including in newly diagnosed patients. Additionally, we are exploring the potential for menin inhibition in the treatment of myelofibrosis, or MF.

Current wording

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 options. We are also studying revumenib in combination with standard-of-care agents in NPM1m AML or KMT2A-rearranged, or KMT2Ar, acute leukemia across the treatment landscape, including in newly diagnosed patients.

Previous wording

We have incurred significant operating losses since our inception. While we generate product revenue from sales of Revuforj and collaboration as well as milestone 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 three months ended March 31, 2026 and 2025, we reported a net loss of $42.7 million and $84.8 million, respectively. As of March 31, 2026, we had an accumulated deficit of $1.5 billion. As of March 31, 2026, we had cash, cash equivalents and short-term investments of $352.1 million

Current wording

We have incurred significant operating losses since our inception. While we generate product revenue from sales of Revuforj and collaboration as well as milestone 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 six months ended June 30, 2026 and 2025, we reported a net loss of $92.0 million and $156.7 million, respectively. As of June 30, 2026, we had an accumulated deficit of $1.6 billion. As of June 30, 2026, we had cash, cash equivalents and short- and long-term investments of $575.1 million.

Previous wording

R/R data from the SAVE trial of revumenib in combination with venetoclax and decitabine/cedazuridine in NPM1m, KMT2Ar, and NUP98r acute leukemia.

Current wording

Frontline data from the Phase 1/2 SAVE trial of an all-oral combination of revumenib, decitabine/cedazuridine, and venetoclax in NPM1m, KMT2Ar, or NUP98r AML.

Previous wording

Post-transplant maintenance: A Phase 1 trial evaluating the safety and preliminary efficacy of revumenib as post-transplant maintenance after HSCT in patients with KMT2Ar or NPM1m acute leukemia. The trial is being conducted by investigators from the City of Hope Medical Center.

Current wording

Post-transplant maintenance: A Phase 1 trial evaluating the safety and preliminary efficacy of revumenib as post-transplant maintenance in patients with KMT2Ar or NPM1m acute leukemia. The trial is being conducted by investigators from the City of Hope Medical Center.

Previous wording

Break Through Cancer: A Phase 2 trial studying whether the combination of revumenib and venetoclax can eliminate measurable residual disease, or MRD, in patients with AML and extend progression-free survival. The trial is being conducted by Break Through Cancer, a collaboration between leading U.S. cancer research centers.

Current wording

Break Through Cancer: A Phase 2 trial studying whether the combination of revumenib and venetoclax can eliminate MRD in patients with AML and extend progression-free survival. The trial is being conducted by Break Through Cancer, a collaboration between leading U.S. cancer research centers.

Previous wording

Achieved $55.1 million in Niktimvo net revenue in the first quarter of 2026, representing significant growth compared to the $13.6 million in net revenue generated in the first quarter of 2025 from the first two months of the launch. Syndax records 50% of the Niktimvo net commercial profit, defined as net product revenue minus the cost of sales and commercial expenses. Syndax’s share of the Niktimvo product contribution, reported as collaboration revenue, was $15.9 million in the first quarter of 2026.

Current wording

Achieved $60.3 million in Niktimvo net revenue in the second quarter of 2026, a 67% increase over the second quarter of 2025 and a 9% increase over the first quarter of 2026. Syndax and Incyte are co-commercializing Niktimvo. Syndax records 50% of the Niktimvo net commercial profit, defined as net product revenue minus the cost of sales and commercial expenses. Syndax’s share of the Niktimvo product contribution, reported as collaboration revenue, was $18.1 million in the second quarter of 2026.

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. Topline data is now anticipated in the fourth quarter of 2026

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 chronic GVHD. We anticipate topline data in the fourth quarter of 2026.

Previous wording

A pivotal Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of axatilimab in combination with corticosteroids in patients ≥ 12 years of age with newly diagnosed chronic GVHD. Topline data is anticipated in early 2028.

Current wording

A pivotal Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of axatilimab in combination with corticosteroids in patients ≥ 12 years of age with newly diagnosed chronic GVHD. We anticipate topline data in early 2028.

Previous wording

Completed enrollment 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 in the first quarter of 2026. We expect to report topline data in the fourth quarter of 2026.

Current wording

We anticipate topline data from MAXPIRe, a Phase 2, 26-week randomized, double-blinded, placebo-controlled trial of axatilimab on top of standard of care in patients with IPF in the fourth quarter of 2026.

Previous wording

New/updated data expected in the second half of 2026:

Current wording

We expect to submit an IND and initiate a Phase 1 trial of SNDX-62122 in MF in 2027. The development of SNDX-62122 will be informed by a Phase 1/2 proof-of-principle trial of revumenib in MF that is expected to initiate in the fourth quarter of 2026 with initial clinical data expected in the second half of 2027.

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, 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.

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, net” 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

Since our inception, we have primarily focused on our clinical development programs. Research and development expenses consist primarily of costs incurred for the development of our product candidates and include:

Current wording

Since our inception, we have primarily focused on our clinical development programs. Research and development expenses consist primarily of costs incurred for the development of our products and product candidates and include:

Previous wording

Research and development activities are central to our business model. Product candidates in late stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of late-stage clinical trials. We plan to continue to spend a significant amount of our resources on research and development activities for the foreseeable future as we continue to advance the development of our product candidates. The amount of research and development expenses allocated to external spending will continue to grow, while we expect our internal spending to grow at a slower and more controlled pace.

Current wording

Research and development activities are central to our business model. Product candidates in late stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of late-stage clinical trials. We plan to continue to spend a significant amount of our resources on research and development activities for the foreseeable future as we continue to advance the development of our products and product candidates. The amount of research and development expenses allocated to external spending will continue to grow, while we expect our internal spending to grow at a slower and more controlled pace.

Previous wording

In addition, the probability of success for each drug candidate will depend on numerous factors, including competition, manufacturing capability and commercial viability. The successful development of our products and additional product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing or costs of the efforts that will be necessary to complete the remainder of the development of our products and additional product candidates for the period, if any, in which material net cash inflows from these potential product candidates may commence. Clinical development timelines, the probability of success and development costs can differ materially from expectations.

Current wording

In addition, the probability of success for each product candidate will depend on numerous factors, including competition, manufacturing capability and commercial viability. The successful development of our products and additional product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing or costs of the efforts that will be necessary to complete the remainder of the development of our products and additional product candidates for the period, if any, in which material net cash inflows from these potential product candidates may commence. Clinical development timelines, the probability of success and development costs can differ materially from expectations.

Previous wording

Comparison of the three months ended March 31, 2026 and 2025:

Current wording

Comparison of the three and six months ended June 30, 2026 and 2025:

Previous wording

In November 2024, we began to generate product revenue from sales of Revuforj in the United States. Product revenue, net from sales of Revuforj increased by $28.9 million from the comparable prior year period primarily due to increased sales volume as a result of second indication approval and increased brand awareness.

Current wording

In November 2024, we began to generate product revenue from sales of Revuforj in the United States. Product revenue, net from sales of Revuforj for the three and six months ended June 30, 2026, was $54.7 million and $103.6 million, respectively. The increase in product revenue from the comparable prior period end was due to increased sales volume as a result of increased brand awareness.

Previous wording

Collaboration revenue, net, representing our share of net profits in connection with commercialization of Niktimvo, for the three months ended March 31, 2026, was $15.9 million. We generated $0.2 million of collaboration loss for the three months ended March 31, 2025, as Niktimvo launched in January 2025, and was not yet in a net revenue position.

Current wording

Collaboration revenue, net, representing our share of net profits in connection with commercialization of Niktimvo, for the three and six months ended June 30, 2026, was $18.1 million and $34.0 million, respectively. The increase in collaboration revenue from the comparable prior period end was due to increased sales volume as a result of increased brand awareness.

Previous wording

Our cost of product sales increased by $1.7 million from the comparable prior year period due to increased product sales of Revuforj. Included in cost of product sales are royalties owed to AbbVie on Revuforj sales as part of the Vitae License Agreement.

Current wording

Our cost of product sales increased by $1.9 million from the comparable prior year period due to increased product 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 months ended March 31, 2026 and 2025:

Current wording

The following table summarizes the research and development expenses for the three and six months ended June 30, 2026 and 2025:

Previous wording

For the three months ended March 31, 2026, our total research and development expenses decreased by $2.8 million from the comparable prior year period. The change was primarily due to:

Current wording

For the three and six months ended June 30, 2026, our total research and development expenses increased by $5.8 million and $3.0 million from the comparable prior year periods, respectively. The changes were primarily due to:

Previous wording

Revumenib: An increase, due to the initiation of frontline trials evaluating revumenib in combination with standard-of-care agents in the treatment of AML;

Current wording

Revumenib: An increase in the three and six months ended June 30, 2026, from the comparable prior year period, due to frontline trials evaluating revumenib in combination with standard-of-care agents in the treatment of AML;

Previous wording

Axatilimab: A decrease, due to a non-recurring $10.0 million development milestone expense recognized in the first quarter of 2025;

Current wording

Axatilimab: A decrease in the three months ended June 30, 2026, from the comparable prior year period due to timing of trials and a decrease in the six months ended June 30, 2026, from the comparable prior year period due to a non-recurring $10.0 million development milestone expense recognized in the first quarter of 2025;

Previous wording

An increase in stock-based compensation, driven by a higher stock price.

Current wording

An increase in stock-based compensation from the comparable prior year period driven by a higher stock price.

Previous wording

The following tables summarizes the selling, general and administrative expenses for the three months ended March 31, 2026 and 2025:

Current wording

The following tables summarizes the selling, general and administrative expenses for the three and six months ended June 30, 2026 and 2025:

Previous wording

For the three months ended March 31, 2026, our total selling, general and administrative expenses decreased $3.4 million from the comparable prior year period. The change was primarily due to;

Current wording

For the three and six months ended June 30, 2026, our total selling, general and administrative expenses decreased by $2.3 million and $5.7 million, respectively, from the comparable prior year periods. The changes were primarily due to;

Previous wording

A decrease in commercial-related expenses due to launch costs incurred in the first quarter of 2025 for Revuforj and Niktimvo that were not incurred in the same period in 2026;

Current wording

A decrease in commercial-related expenses due to launch costs incurred in the first quarter of 2025 for Revuforj and Niktimvo that were not incurred in 2026;

Previous wording

For the three months ended March 31, 2026, 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, 2026, royalty interest expense increased from the comparable prior year period 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, 2026, 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.

Current wording

For the three and six months ended June 30, 2026, interest income decreased from the comparable prior year 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 months ended March 31, 2026, the total other (expense) income, net decreased from the comparable prior year period primarily due to the fluctuation in foreign currency losses on short- and long-term investments.

Current wording

For the three and six months ended June 30, 2026, the total other expense, net decreased from the comparable prior year period primarily due to the fluctuation in foreign currency losses on short- and long-term investments.

Previous wording

Net cash used in operating activities decreased from $95.2 million for the three months ended March 31, 2025 to $50.3 million for the three months ended March 31, 2026, primarily due to a decrease in operating net loss of $42.2 million.

Current wording

Net cash used in operating activities decreased from $183.0 million for the six months ended June 30, 2025 to $80.6 million for the six months ended June 30, 2026, primarily due to a decrease in operating net loss of $64.7 million, as well as decreases in accounts receivable, inventory, and prepaid expenses; offset by decreases in accounts payable and accrued expenses.

Previous wording

Net cash provided by investing activities for the three months ended March 31, 2026, was $38.4 million and was related to $77.8 million from the maturities of available-for-sale securities, offset by the purchase of $39.4 million of available-for-sale securities.

Current wording

Net cash provided by investing activities for the six months ended June 30, 2026, was $21.5 million and was related to $146.8 million from the maturities of available-for-sale securities, partially offset by the purchase of $125.3 million of available-for-sale securities.

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, partially offset by the purchase of $102.3 million of available-for-sale securities.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2026, increased by $7.0 million from the comparable prior year period primarily due to an increase 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, 2026, increased by $259.2 million from the comparable prior year period as a result of cash raised from the sale and issuance of convertible notes in June 2026, and proceeds from exercised stock options.

Previous wording

We believe that the combination of our available cash, cash equivalents, short-term investments, as well as our expected product revenues from sales of Revuforj 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- and long-term investments, as well as our expected product revenues from sales of Revuforj 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

We have incurred losses and cumulative negative cash flows from operations since our inception, excluding the year ended December 31, 2021. As of March 31, 2026, we had an accumulated deficit of $1.5 billion. We anticipate that we will likely continue to incur significant losses for at least the next couple years. To the extent that we raise additional capital through the future sale of equity or debt, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. If we raise additional funds through collaboration arrangements in the future, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Current wording

We have incurred losses and cumulative negative cash flows from operations since our inception, excluding the year ended December 31, 2021. As of June 30, 2026, we had an accumulated deficit of $1.6 billion. We anticipate that we will likely continue to incur significant losses for at least the next couple years. To the extent that we raise additional capital through the future sale of equity or debt, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. If we raise additional funds through collaboration arrangements in the future, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

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 months ended March 31, 2026, we did not sell any shares of common stock under the 2023 ATM Program. As of March 31, 2026, 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 six months ended June 30, 2026, we did not sell any shares of common stock under the 2023 ATM Program. As of June 30, 2026, we had $157.9 million available under the 2023 ATM Program.