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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 26, 2026

 

 

SYNDAX PHARMACEUTICALS, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-37708	32-0162505
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
730 THIRD AVENUE FLOOR 9
NEW YORK, New York				10017
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (781) 419-1400

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock		SNDX		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

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Item 2.02. Results of Operations and Financial Condition.

 

On February 26, 2026, Syndax Pharmaceuticals, Inc. (the “Company”) issued a press release and presentation announcing its financial results for the quarter and year ended December 31, 2025. A copy of the press release and presentation are furnished as Exhibits 99.1 and 99.2 to this Current Report on Form 8-K and are incorporated herein by reference.

 

The information contained in this Item 2.02 and in Exhibits 99.1 and 99.2 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.	Description
99.1	Press Release, dated February 26, 2026
99.2	Corporate Presentation, dated February 26, 2026
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

	SYNDAX PHARMACEUTICALS, INC.
	By:	/s/ Michael A. Metzger
		Michael A. Metzger
		Chief Executive Officer

 

Dated: February 26, 2026

 

 

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Fourth Quarter and Full Year 2025 Financial Results February 26, 2026 Exhibit 99.2

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Forward-looking statements disclosure This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events, progress, timing or circumstances) are intended to identify forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding future operations, financial results and the financial condition of Syndax Pharmaceuticals, Inc. (“Syndax” or the “Company”), including financial position, strategy and plans, the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for Syndax’s product candidates, the progress of regulatory submissions and approvals and subsequent commercialization and the potential use of Syndax’s product candidates to treat various cancer indications and fibrotic diseases, and Syndax’s expectations for liquidity and future operations, are forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical studies or clinical trials, clinical site activation rates or clinical trial enrollment rates that are lower than expected; changes in expected or existing competition; the impact of macroeconomic conditions (the Russia-Ukraine war, inflation, among others) on Syndax’s business and that of the third parties on which Syndax depends, including delaying or otherwise disrupting Syndax’s clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity; failure of our collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Moreover, Syndax operates in a very competitive and rapidly changing environment. Other factors that may cause our actual results to differ from current expectations are discussed in Syndax’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein. New risks emerge from time to time. It is not possible for Syndax’s management to predict all risks, nor can Syndax assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this presentation may not occur and actual results could differ materially and adversely from those anticipated or implied. Except as required by law, neither Syndax nor any other person assumes responsibility for the accuracy and completeness of the forward- looking statements. Syndax undertakes no obligation to update publicly any forward-looking statements for any reason after the date of this presentation to conform these statements to actual results or to changes in Syndax’s expectations.

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Strong commercial and pipeline execution positions Syndax for continued growth in 2026 and beyond On the road to profitability with growing revenues, a robust balance sheet, and stable expense outlook 2025 Achieved 3rd FDA approval in ~1 year 1st to initiate a pivotal 1L menin trial, positioning Syndax to be 1st to the 1L 1st to deliver real-world evidencefor menin inhibition Completed enrollment in Ph 2 IPF trial of axatilimab Pipeline Progress Commercial Results $124.8M $151.6M $172.4M 4Q25 $44.2M +38% q/q $56.0M +22% q/q $68.7M +50% q/q Total revenue Net revenue Net revenue

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Excellent first year Revuforj results with strong growth in 4Q25 following label expansion 38% q/q growth ~20% q/q growth END OF 2025 ~3,350 cumulative since launch $44.2M 4Q25 $124.8M 2025 net revenue ~1,150 Net revenue New patientstarts ~1,050 cumulative since launch ~300 TRx ~35% q/q growth TRx, total prescriptions; q/q, quarter-over-quarter; HSCT, hematopoietic stem cell transplantation TRx growth driven by new NPM1 patients and building use in KMT2A post-HSCT 1st year results surpassAML launch benchmarks and solidify leadership position in menin inhibition Accelerating demand and expansion of prescriber base throughout 4Q25

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Evolving clinical practice driving continued Revuforj growth in 2026 1 2 Robust transplant rate in KMT2Ar and growing usage post-transplant Growing adoption in R/R NPM1m AML 3 patient population Tx durations ~33% of KMT2A patients have proceeded to HSCT and ~40-45% have resumed Tx post-HSCT Early indicators suggest ≥30% of new patient starts were NPM1 in 4Q25 R/R, relapsed/refractory; 2L, second line; 3L, third line; HSCT, hematopoietic stem cell transplantation; Tx, treatment Use in early lines oftreatment and growing combination use Tx durations ~70% of use in 2L/3L ~40% of use in combination

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Current Revuforj indications unlock $2B+ TAM inR/R acute leukemia With the largest addressable population and anticipated duration of therapy, Revuforj is poised to become the largest targeted AML therapy R/R acute leukemia with KMT2A translocation R/R AML with NPM1m 1L “Unfit” AML with KMT2Ar or NPM1m 1L “Fit” AML with KMT2Ar or NPM1m ~2,000 ~4,500 ~3,500 ~5,500 U.S. Market Opportunity ($ B) $5B+ TAM across R/R and 1L $2B+ TAM in R/R Addressable AML population Revuforj FLT3 inhibitors IDH inhibitors Comprehensive clinical development program underway to unlock $5B+ TAM across acute leukemia Tx continuum Est. annualincidence

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Remarkable first year results highlight the importance of Niktimvo to patients and Syndax FY 2025 ~13,500 $56.0M 22% q/q growth 4Q25 $151.6M ~5,000 Net revenue to INCY New patientstarts >1,400 >300 Infusions administered Collaboration revenue to SNDX $19.4M 40% q/q growth $42.4M Syndax records 50% of the Niktimvo net commercial profit, defined as net revenue (recorded by Incyte) minus the cost of salesand commercial expenses. q/q, quarter-over-quarter; 3L+, third line plus Contribution to Syndax expected to grow materially over time Results surpass launch benchmark in 3L+ cGVHD Strong demand underscores Niktimvo’s ability to address inflammation and fibrosis

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Multiple drivers supporting continued Niktimvo growth in 2026 1 Continued adoption in 4L and growing usage in 3L cGVHD 2 Potential for extended treatment durations to address chronic disease Robust prescriber base and strong commercial synergies 3 3L, third line; 4L, fourth line; BMT, bone marrow transplant centers ~20% share of 3L+ cGVHD market in first 11 months ~60-70% of pts who started Niktimvo in 1Q25 remained on therapy at month 10 Tx durations patient population ~90% of U.S. BMT centers have ordered utilization 3

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Initial Niktimvo indication represents a $2B U.S. market opportunity, with substantial opportunities for label and geographic expansion cGVHD, chronic graft-versus-host disease; 1. Internal data on file; 2. SmartImmunology Insights cGVHD report March 2020; 3. SmartImmunology Insights IPF report March 2020. * IPF trial will be conducted and funded by Syndax. ~17,000 U.S. cGVHD patients1 ~6,500 currently treated 3L+ U.S. cGVHD patients ~35,000 cGVHD patients W.W.2 Idiopathic pulmonary fibrosis (IPF) patients3 ~150,000 U.S. | ~280,000 W.W. $2B TAM with initial Niktimvo indication Ongoing combo trials could support future expansion into 1L cGVHD Ph 2 IPF trial underway, the firstof several potential areas for further pipeline expansion Ph 3 cGVHD trial underwayoutside the U.S. $5B+ TAM

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Revumenib (select trials) Ph 1 Ph 2 Ph 3 FDA Approved Setting Study Name Regimen NPM1m KMT2Ar NUP98r R/R AUGMENT-101 Rev mono ● ● AUGMENT-102 Rev + IC ● ● ● SAVE Rev + ven/oral HMA ● ● ● Post-HSCT Maintenance Ball study Rev mono ● ● 1L Unfitfor IC BEAT AML Rev + ven/aza ● ● SAVE Rev + ven/oral HMA ● ● ● EVOLVE-2 Rev + ven/aza ● ● Fitfor IC 708 and NCI Rev + IC ● ● ● REVEAL-ND Rev + IC ● RAVEN Rev + ven/aza ● Axatilimab (select trials) Ph 1 Ph 2 Ph 3 FDA Approved Setting Study Name Regimen R/R cGVHD AGAVE-201 Axa mono 1L cGVHD AXemplify-357* Axa + corticosteroids NCT06388564* Axa + ruxolitinib IPF MAXPIRe Axa on top of SOC Laser-focused on unlocking the full potential of menin and CSF-1R inhibition Rev, revumenib; Axa, axatilimab; IC, intensive chemotherapy; 1L, frontline; R/R, relapsed or refractory; ven/aza, venetoclax and azacitidine; HMA, hypomethylating agent; HSCT, hematopoieticstem cell transplantation. *Trials led by Incyte. List is not inclusive of ongoing ex-U.S. trials. Global enrollment underway in pivotal 1L trials with dual primary endpoints to support potential for accelerated and full approval 1L, maintenance, & real-world data anticipated throughout 2026 at major medical meetings Two ongoing 1L cGVHD trials; topline axa + rux data anticipated early 2027 and axa + steroids early 2028 Completed enrollment in MAXPIRe; topline data anticipated in 4Q26

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A promising new target in IPF: CSF-1R inhibition of monocytes and macrophages Monocyte-derived alveolar macrophages play a key role in lung fibrosis1 Colony stimulating factor-1 receptor (CSF-1R) signaling is a key regulator of monocytes and macrophages2 Blocking CSF-1R with axatilimab: Reduces levels of circulating profibrotic and proinflammatory monocytes and monocyte-derived macrophages Inhibits the activity of pathogenic macrophages in tissues 1. Misharin et al. J Exp Med 2017; 2. Oldham et al. ERJ Open Res 2023 11

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Multiple lines of evidence support the potential for axatilimab in IPF 1. Scott et al. Lancet Resp Med 2019 ; 2. Unpublished data generated using a mouse surrogate antibody of axatilimab (Ab535); 3. Wolff et al. N Engl J Med 2024; DeFilipp et al. A Comprehensive Analysis of Axatilimab in Patients With Chronic Graft-Versus-Host Disease and Related Bronchiolitis Obliterans Syndrome: Integrated Analysis From 2 Clinical Studies. Oral presentation at TANDEM 2026. Overall survival (%) No. at risk <0.95 K/µL ≥0.95 K/µL Time since diagnosis (years) Higher monocyte levels are associated with shorter OS in IPF1 Remarkable antifibrotic activity observed with axatilimab in cGVHD across all organs studied3 Bleomycin models show reduction in lung fibrosis with axatilimab surrogate2 Saline control Bleomycin Bleomycin + Ab535 Niktimvo 0.3 mg/kg Q2W Notable response rates in fibrosis-dominated organs, including lungs (47%) and skin (27%) Response rate (%)

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Topline data from MAXPIRe Phase 2 trial of axatilimab in IPF anticipatedin 4Q26 A randomized, double-blind, placebo-controlled, multi-center international trial Key eligibility criteria: ≥40 yrs of age HRCT confirming IPF diagnosis FVC ≥45% of predicted normal (PN) FEV1/FVC ≥0.7 DLCO ≥30% and ≤90% PN Stable background use of pirfenidone or nintedanib allowed (N≈135) Placebo Q2W(n≈45) ClinicalTrials.gov ID: NCT06132256; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; SGRQ, St. George's Respiratory Questionnaire; DLCO, diffusion capacity for carbon monoxide; HRCT, high-resolution computed tomography PRIMARY ENDPOINT: Annualized rate of decline in FVC over 26 weeks (ml) Axatilimab 0.3 mg/kg Q2W (n≈90) Randomized 2:1 to axatilimab or placebo; stratified by background antifibrotic therapy (pirfenidone, nintedanib, or none) SECONDARY ENDPOINTS: Disease progression, SGRQ (quality of life measures), change in FVC % predicted, DLCO 26-week treatment

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Strong financial position driven by growing revenue and stable expense outlook Financial Summary ($ in millions) Three Months EndedDec 31 Year Ended Dec 31 2025 2024 2025 2024 Product revenue, net 44.2 7.7 124.8 7.7 Collaboration revenue, net 19.4 — 42.4 — Milestone, license, and royalty revenue 5.1 — 5.1 16 Total revenues 68.7 7.7 172.4 23.7 Cost of product sales (2.7) (0.8) (7.0) (0.8) Research & development (R&D) (78.6) (65.5) (258.8) (241.6) Selling, general and administrative (SG&A) (49.9) (37.7) (179.7) (120.9) Total operating expenses (131.3) (104.0) (445.4) (363.4) Other (expense) income, net (5.5) 2.2 (12.3) 20.9 Net loss (68.0) (94.2) (285.4) (318.8) Totals may not sum due to rounding; 1. Includes short-term investments; 2. Includes pre-funded warrants to purchase 285,714 common shares (rounded). AS OF 31 DEC 2025: $394.1M in cash and equivalents1 87.7Mshares outstanding2 2026 R&D + SG&A EXPENSE GUIDANCE:  $400M, excluding $50M in expected stock option expense On the road to profitability

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Proven execution supports continued focus on revenue growth, pipeline progress, and data generation 2026 Anticipated Milestones 2025 Key Accomplishments Advance global enrollment in pivotal 1L trials of revumenib Publish & present industry leading clinical data, including 1L, maintenance, and real-world evidence for revumenib Report topline Ph 2 axatilimab data in IPF in 4Q26 Initiate RAVEN 1L trial of revumenib in fit KMT2Ar in 2H26 Initiate a program to generate proof-of-principle clinical data with revumenib in myelofibrosis Executed two strong product launches Expanded Revuforj into 2nd indication Initiated 1st pivotal 1L trial of a menin inhibitor Presented first RWE for a menin inhibitor Initiated managed access program, expanding access to Revuforj in certain OUS regions 1L, frontline; RWE, real-world evidence; OUS, outside the United States

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