AI Earnings Predictions for Syndax Pharmaceuticals Inc. (SNDX)

EX-99.1

2 sndx-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Syndax Reports Second Quarter 2026 Financial Results and Provides Business Update

• Total revenue of $73 million in 2Q26, a 92% year-over-year increase –

• Revuforj® (revumenib) net revenue of $54.7 million in 2Q26, a 91% year-over-year increase – –

• Niktimvo™ (axatilimab-csfr) net revenue of $60.3 million in 2Q26, a 67% year-over-year increase, resulting in Syndax collaboration revenue of $18.1 million –

• Expanded pipeline with a novel, mutant-selective, allosteric EGFR inhibitor for NSCLC and an internally developed next-generation menin inhibitor for myelofibrosis–

• Topline data expected in 4Q26 from Phase 2 trials of axatilimab in IPF and frontline cGVHD –

• Company to host a conference call today at 4:30 p.m. ET –

NEW YORK, NY, August 4, 2026 (GLOBE NEWSWIRE) – Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today reported its financial results for the second quarter ended June 30, 2026, and provided a business update.

“We delivered another quarter of strong commercial results, with both our medicines now annualizing at well over $200 million each and positioned for further growth,” said Michael A. Metzger, Chief Executive Officer. “Notably, we achieved $55 million in Revuforj net revenue and the sixth consecutive quarter of double-digit net revenue and prescription growth, highlighting our leadership in menin inhibition, robust demand in both NPM1 and KMT2A, and an increasing average treatment duration. Niktimvo net revenue grew to $60 million this quarter, underscoring the benefits of its unique mechanism of action in cGVHD and the substantial commercial opportunity.”

Mr. Metzger continued, “We’ve made excellent progress advancing our growing pipeline targeting multiple blockbuster opportunities, including two recently announced assets with first- and best-in-class potential in EGFR-mutated NSCLC and myelofibrosis. We are positioned to be first to frontline AML with Revuforj, driven by strong global site initiation and patient enrollment in our pivotal trials. We also have multiple near-term catalysts with Niktimvo Phase 2 data in IPF and frontline cGVHD expected in the fourth quarter, plus additional practice-informing and

potentially guideline-enabling Revuforj data in acute leukemia.”

Recent Business Highlights and Anticipated Milestones

Revuforj® (revumenib)

• Achieved $54.7 million in Revuforj net revenue in the second quarter of 2026, a 91% increase over the second quarter of 2025 and a 12% increase over the first quarter of 2026. Total prescriptions were approximately 1,500 in the second quarter of 2026, an approximate 121% increase over the second quarter of 2025 and a 15% increase over the first quarter of 2026. The net revenue and prescription growth reflects an increasing average treatment duration, primarily driven by a growing pool of patients receiving Revuforj for an extended period in the post-transplant setting.

• Advanced the Company’s scientific leadership in menin inhibition with the presentation of 16 revumenib abstracts at the 2026 American Society of Clinical Oncology (ASCO) and the European Hematology Association (EHA) annual meetings in June 2026. The data presented span multiple acute leukemia subtypes and settings, including frontline and post-transplant maintenance.

• Published data from the Phase 1/2 SAVE trial of an all-oral combination of revumenib, decitabine/cedazuridine, and venetoclax in relapsed/refractory (R/R) NPM1-mutated (NPM1m), KMT2A-rearranged (KMT2Ar), and NUP98-rearranged (NUP98r) acute myeloid leukemia (AML) in the Journal of Clinical Oncology in June 2026. The results showed deep and durable remissions in a heavily pretreated patient population. The ORR was 88% (37/42), CRc was 71% (30/42), and CR/CRh was 60% (25/42). 80% of evaluable CRc responders were measurable residual disease (MRD) negative. 45% (19/42) of patients proceeded to a transplant and 63% (12/19) resumed revumenib post-transplant.

• Published preclinical revumenib data showing that menin is a novel dependency in proliferative megakaryocytes, major drivers of myelofibrosis (MF), in Cancer Cell in July 2026. These data provide the basis for the Company’s plans to develop SNDX-62122, an internally developed, next-generation menin inhibitor, for MF.

• The Company expects to have a major presence at upcoming medical meetings in the second half of 2026 with the presentation of new/updated revumenib data including:

• Real-world evidence from multiple centers

• Post-transplant maintenance data

• Frontline data from the BEAT AML trial of revumenib in combination with venetoclax/azacitidine in NPM1m and KMT2Ar AML

• 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

• Frontline data from the Phase 1 trial of revumenib in combination with

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8-K

0001395937false00013959372026-02-262026-02-26

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. ☐

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)

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