# EDGAR Filing Document

**Accession Number:** 0001395937
**File Stem:** 0000950170-25-101974
**Filing Date:** 2025-8
**Character Count:** 43141
**Document Hash:** c5cb63fdce7d5229a3e66ce0b8c0bcc2
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000950170-25-101974.hdr.sgml**: 20250804

**ACCESSION NUMBER**: 0000950170-25-101974

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 28

**CONFORMED PERIOD OF REPORT**: 20250804

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250804

**DATE AS OF CHANGE**: 20250804

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Syndax Pharmaceuticals Inc
- **CENTRAL INDEX KEY:** 0001395937
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 320162505
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-37708
- **FILM NUMBER:** 251180127

**BUSINESS ADDRESS:**
- **STREET 1:** 730 THIRD AVENUE
- **STREET 2:** 9TH FLOOR
- **CITY:** NEW YORK
- **STATE:** NY
- **ZIP:** 10017
- **BUSINESS PHONE:** 781-419-1400

**MAIL ADDRESS:**
- **STREET 1:** 730 THIRD AVENUE
- **STREET 2:** 9TH FLOOR
- **CITY:** NEW YORK
- **STATE:** NY
- **ZIP:** 10017

?xml version='1.0' encoding='ASCII'? 8-K

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

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## **FORM** 8-K

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**CURRENT REPORT**

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

**Date of Report (Date of earliest event reported):** August 04, 2025<br>

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SYNDAX PHARMACEUTICALS, INC.

**(Exact name of Registrant as Specified in Its Charter)**

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

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**Registrant's Telephone Number, Including Area Code:** (781) 419-1400<br>

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

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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:**

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| | | |
|:---|:---|:---|
| **<br>Title of each class** | **Trading<br>Symbol(s)** | **<br>Name of each exchange on which registered** |
| Common Stock | SNDX | The Nasdaq Stock Market LLC |

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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 August 4, 2025, Syndax Pharmaceuticals, Inc. (the "***Company***") issued a press release and presentation announcing its financial results for the quarter and six months ended June 30, 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.

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| | |
|:---|:---|
| **Exhibit<br>No.**<br>| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**Description**<br>|
| &nbsp;&nbsp;99.1 | [<u>Press Release, dated August 4, 2025</u>](sndx-ex99_1.htm) |
| &nbsp;&nbsp;99.2 | [<u>Corporate Presentation, dated August 4, 2025</u>](sndx-ex99_2.htm) |
| &nbsp;&nbsp;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.

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

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Dated: August 4, 2025

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## Exhibit 99.1

Exhibit 99.1

![img199102934_0.jpg](img199102934_0.jpg)

**Syndax Reports Second Quarter 2025 Financial Results and Provides Business Update**

• *$28.6 million of Revuforj*<sup>®</sup> *(revumenib) net revenue, representing 43% growth over 1Q25 –*

• *$36.2 million of Niktimvo™ (axatilimab-csfr) net revenue reported by Incyte in first full quarter of launch;$9.4 million in collaboration revenue reported by Syndax –*

*– sNDA in R/R mNPM1 AML granted Priority Review; PDUFA action date of October 25, 2025 –*

• *$517.9 million in cash, cash equivalents and investments expected to fund the<br>company to profitability –*

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

NEW YORK, NY, August 04, 2025 (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, 2025, and provided a business update.

"Syndax reported another remarkable quarter. With strong Revuforj and Niktimvo sales momentum along with our expectation for stable expenses over the next few years and more than $500 million in cash, we are well on our way to becoming a profitable company with two blockbuster products," said Michael A. Metzger, Chief Executive Officer. "Notably, Revuforj net revenue increased 43% quarter-over-quarter, even with approximately a third of patients pausing treatment to receive a stem cell transplant. Revuforj is poised for continued growth as we further penetrate the KMT2A population and as patient recontinuations following stem cell transplantation build meaningfully. Importantly, we are nearing another major inflection point with the anticipated approval of Revuforj as the first therapy for R/R mNPM1 AML. Longer-term, our leadership in the menin space positions us to be first to the frontline and meaningfully expand the franchise."

Mr. Metzger continued, "Additionally, Niktimvo is off to a very fast start generating $50 million in net revenue in just the first five months of the launch. It is already profitable to Syndax and we expect increasing profitability margins as revenues continue to grow. The impressive results demonstrate the benefit of delivering a novel approach to treating chronic GVHD and the potential for Niktimvo to transform patient care and make a substantial financial impact for Syndax."

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**Recent Business Highlights and Anticipated Milestones**

**Revuforj**<sup>®</sup>**(revumenib)** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•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 relapsed or refractory (R/R) acute leukemia with a KMT2A translocation in adult and pediatric patients one year and older.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Announced that the U.S. FDA granted Priority Review to the Company's supplemental New Drug Application (sNDA) for Revuforj for the treatment of R/R mutant NPM1 (mNPM1) acute myeloid leukemia (AML). The sNDA is being reviewed under the FDA's Real-Time Oncology Review (RTOR) program and has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 25, 2025.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Presented new Revuforj data in R/R mNPM1 and NUP98-rearranged (NUP98r) AML from the AUGMENT-101 trial at the European Hematology Association (EHA) Annual Congress Meeting in June 2025.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•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 (ORR)1 of 48% (37/77). The complete remission (CR) plus complete remission with partial hematologic recovery (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 (MRD), 63% (12/19) were MRD negative. Subpopulation analysis showed that a median overall survival (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.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•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.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•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

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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).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Multiple trials evaluating revumenib in mNPM1 and KMT2Ar acute leukemia across the treatment landscape are ongoing. These trials include:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•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.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•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.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•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.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•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.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•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.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•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.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•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.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•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.

**Niktimvo™ (axatilimab-csfr)**

• 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 (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 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.

• 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 chronic GVHD in the pivotal AGAVE-201 trial that supported the FDA approval of Niktimvo.

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

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•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.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•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 chronic GVHD.

• 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.

**Corporate Updates**

• 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.

• 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.

**Second Quarter 2025 Financial Results**

As of June 30, 2025, Syndax had cash, cash equivalents, and short and long-term investments of $517.9 million and 86.3 million common shares and prefunded warrants outstanding.

Total revenue for the second quarter of 2025 was $38.0 million, which consisted of $28.6 million in Revuforj net product revenue and $9.4 million in Niktimvo collaboration revenue. The collaboration revenue is derived from the $36.2 million in Niktimvo net revenue that was previously reported by the Company's partner Incyte. Syndax records 50% of the Niktimvo net commercial profit/loss, defined as net product revenue (recorded by Incyte) minus the cost of sales and commercial expenses.

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Second quarter 2025 research and development expenses increased to $62.2 million from $48.7 million for the comparable prior year period. The increase was due to an increase in revumenib-related costs primarily driven by multiple trials evaluating revumenib in mNPM1 and KMT2Ar acute leukemia across the treatment landscape, milestone paid to AbbVie upon submission of the sNDA, and medical affairs activities supporting Revuforj as well as increased personnel costs to help support commercialization.

Second quarter 2025 selling, general and administrative expenses increased to $43.8 million from $29.1 million for the comparable prior year period. The increase was primarily due to increased employee-related expenses and professional fees to support increased sales and marketing-related expenses related to the U.S. commercial launch of Revuforj.

For the three months ended June 30, 2025, Syndax reported a net loss attributable to common stockholders of $71.8 million, or $0.83 per share, compared to a net loss attributable to common stockholders of $68.1 million, or $0.80 per share, for the comparable prior year period.

**Financial Guidance**

For the third quarter of 2025, the Company expects total research and development plus selling, general and administrative expenses to be $95 to $100 million, excluding non-cash stock compensation expense. For the full year of 2025, the Company expects total research and development plus selling, general and administrative expenses to be $370 to $390 million, excluding non-cash stock compensation expense. The full year 2025 guidance represents no change to prior guidance, which was $415 to $435 including $45 million in estimated non-cash stock compensation expense. The Company is not providing revenue guidance at this time.

Syndax expects that its operating expense base will remain stable over the next few years. As a result, Syndax expects that its cash, cash equivalents and short- and long-term investments, combined with its anticipated product revenue and interest income, will enable the company to reach profitability.

**Conference Call and Webcast**

In connection with the earnings release, Syndax's management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Monday, August 4, 2025.

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The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's website. Alternatively, the conference call may be accessed through the following:

Conference ID: Syndax2Q25<br>Domestic Dial-in Number: 800-590-8290<br>International Dial-in Number: 240-690-8800<br>Live webcast: https://sndx-2q25.open-exchange.net

For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company's website at www.syndax.com approximately 24 hours after the conference call and will be available for 90 days following the call.

**About Revuforj**<sup>®</sup> **(revumenib)**

Revuforj (revumenib) is an oral, first-in-class menin inhibitor that is FDA approved for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older.

The FDA has granted Priority Review to Syndax's supplemental New Drug Application (sNDA) seeking the approval of revumenib for the treatment of R/R mNPM1 AML. The sNDA is being reviewed 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. The sNDA is supported by positive pivotal data from the AUGMENT-101 trial of revumenib in patients with R/R mNPM1 AML. Results from this population were published in the journal Blood and presented at the 2025 European Hematology Association (EHA) Annual Congress Meeting.

Additionally, multiple trials of revumenib are ongoing or planned across the treatment landscape, including in combination with standard of care therapies in newly diagnosed patients with mNPM1 or KMT2Ar AML.

Revumenib was previously granted Orphan Drug Designation for the treatment of AML, ALL and acute leukemias of ambiguous lineage (ALAL) by the U.S. FDA and for the treatment of AML by the European Commission. The U.S. FDA also granted Fast Track designation to revumenib for the treatment of adult and pediatric patients with R/R acute leukemias harboring a KMT2A

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rearrangement or NPM1 mutation and Breakthrough Therapy Designation for the treatment of adult and pediatric patients with R/R acute leukemia harboring a KMT2A rearrangement.

**About Niktimvo™ (axatilimab-csfr)**

Niktimvo (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. 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).

In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications.

Axatilimab is being studied in frontline combination trials in chronic GVHD, including a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774). Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256).

**About the Real-Time Oncology Review Program (RTOR)**

RTOR provides a more efficient review process for oncology drugs to ensure that safe and effective treatments are available to patients as early as possible, while improving review quality and engaging in early iterative communication with the applicant. Specifically, it allows for close engagement between the sponsor and the FDA throughout the submission process and it enables the FDA to review individual sections of modules of a drug application rather than requiring the submission of complete modules or a complete application prior to initiating review. Additional information about RTOR can be found at: https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review.

**About Syndax** 

Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company's pipeline include Revuforj<sup>®</sup> (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal

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antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn.

**Forward-Looking Statements**

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipate," "believe," "could," "estimate," "expects," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" or the negative or plural of those terms, and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials, the reporting of clinical data for Syndax's product candidates, the acceptance of Syndax and its partners' products in the marketplace, sales, marketing, manufacturing and distribution requirements, the potential use of its product candidates to treat various cancer indications and fibrotic diseases, and Syndax's expected third quarter and full year research and development expenses, and expected third quarter and full year total operating expenses, including its estimated non-cash stock compensation expense. Many factors may cause differences between current expectations and actual results, including: unexpected safety or efficacy data observed during preclinical or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes to Revuforj's or Niktimvo's commercial availability; changes in expected or existing competition; changes in the regulatory environment; failure of Syndax's collaborators to support or advance collaborations or product candidates; and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Syndax assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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Niktimvo is a trademark of Incyte.<br>All other trademarks are the property of their respective owners.

**References**

1. Overall response rate (ORR) includes CR, CRh, CRp, CRi, MLFS, and PR; Composite complete remission (CRc) includes CR, CRh, CRp, and CRi.<br>CR = Complete remission<br>CRh = Complete remission with partial hematologic recovery<br>CRp = Complete remission with incomplete platelet recovery<br>CRi = Complete remission with incomplete count recovery<br>MLFS = Morphologic leukemia-free state<br>PR = Partial response

**Syndax Contact**

Sharon Klahre<br>Syndax Pharmaceuticals, Inc.<br> sklahre@syndax.com <br>Tel 781.684.9827<br>

SNDX-G

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

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| | | |
|:---|:---|:---|
| **SYNDAX PHARMACEUTICALS, INC.** | **SYNDAX PHARMACEUTICALS, INC.** | **SYNDAX PHARMACEUTICALS, INC.** |
| **(unaudited)** | **(unaudited)** | **(unaudited)** |
| **CONDENSED CONSOLIDATED BALANCE SHEETS** | **CONDENSED CONSOLIDATED BALANCE SHEETS** | **CONDENSED CONSOLIDATED BALANCE SHEETS** |
|  | **June 30,** | **December 31,** |
| **(In thousands)** | **2025** | **2024** |
| Cash, cash equivalents, short and long-term investments | $517860 | $692404 |
| Total assets | $596149 | $724816 |
| Total liabilities | $438725 | $436692 |
| Total stockholders' equity | $157424 | $288124 |
| Common stock outstanding | 86059077 | 85694443 |
| Common stock and common stock equivalents\* | 102855472 | 98972323 |
| \*Common stock and common stock equivalents: |  |  |
| Common stock | 86059077 | 85694443 |
| Common stock warrants (pre-funded) | 285714 | 285714 |
| Common stock and pre-funded stock warrants | 86344791 | 85980157 |
| Options to purchase common stock | 13933003 | 11688079 |
| Restricted Stock Units | 2577678 | 1304087 |
| Total common stock and common stock equivalents | 102855472 | 98972323 |

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| | | | | |
|:---|:---|:---|:---|:---|
| **SYNDAX PHARMACEUTICALS, INC.** | **SYNDAX PHARMACEUTICALS, INC.** | **SYNDAX PHARMACEUTICALS, INC.** | **SYNDAX PHARMACEUTICALS, INC.** | **SYNDAX PHARMACEUTICALS, INC.** |
| **(unaudited)** | **(unaudited)** | **(unaudited)** | **(unaudited)** | **(unaudited)** |
| **CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS** | **CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS** | **CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS** | **CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS** | **CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS** |
|  | **Three Months Ended June 30,** | **Three Months Ended June 30,** | **Six Months Ended June 30,** | **Six Months Ended June 30,** |
| **(In thousands, except share and per share data)** | **2025** | **2024** | **2025** | **2024** |
| Revenue |  |  |  |  |
| Product revenue, net | $28600 |  | $48642 |  |
| Collaboration revenue, net | 9358 |  | 9111 |  |
| Milestone and license revenue |  | 3500 |  | 3500 |
| Total revenue | 37958 | 3500 | 57753 | 3500 |
| Operating expenses: |  |  |  |  |
| Cost of product sales | $1279 |  | $2164 |  |
| Research and development | 62227 | 48655 | 123863 | 105147 |
| Selling, general and administrative | 43805 | 29061 | 84836 | 52083 |
| Total operating expenses | 107311 | 77716 | 210863 | 157230 |
| Loss from operations | (69353) | (74216) | (153110) | (153730) |
| Other income (expense), net | (2494) | 6153 | (3583) | 13267 |
| Net loss | $(71847) | $(68063) | $(156693) | $(140463) |
| Net loss attributable to common stockholders | $(71847) | $(68063) | $(156693) | $(140463) |
| Net loss per share: |  |  |  |  |
| Basic loss per share attributable to common stockholders | $(0.83) | $(0.80) | $(1.82) | $(1.65) |
| Diluted loss per share attributable to common stockholders | $(0.83) | $(0.80) | $(1.82) | $(1.65) |
| Weighted-average common shares used in calculating: |  |  |  |  |
| Basic loss per share attributable to common stockholders | 86337237 | 85274829 | 86255020 | 85244015 |
| Diluted loss per share attributable to common stockholders | 86337237 | 85274829 | 86225020 | 85244015 |

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## Exhibit 99.2

![Slide 1](sndx-ex99_2s1.jpg)

Second Quarter 2025 Financial Results Presentation / August 4, 2025

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![Slide 2](sndx-ex99_2s2.jpg)

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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![Slide 3](sndx-ex99_2s3.jpg)

Two exceptional product launches, with sales significantly exceeding expectations 3 Two first- & best-in-class medicines addressing major unmet needs Syndax is positioned to continue its rapid growth in 2025 and beyond, with $10B+ market opportunity across R/R and frontline indications On the road to profitability andmulti-billion-dollar franchises $5B+ TAM $5B+ TAM R/R, relapsed or refractory

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![Slide 4](sndx-ex99_2s4.jpg)

Robust KMT2A patient identification & uptake Strong Revuforj growth in 2Q25 with multiple drivers for continued momentum Concentrated use in early lines of Tx forR/R KMT2A acute leukemia Building transplant rate& usage post-transplant Near-term opportunityin R/R mNPM1 AML $28.6 M Revuforj net revenue in 2Q25(+43% q/q growth), with ~1/3 of KMT2A patients proceeding to stem cell transplant First- and best-in-class menin inhibitor Tx, treatment; q/q, quarter over quarter Drivers of continued momentum

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![Slide 5](sndx-ex99_2s5.jpg)

Exceptional Niktimvo results underscore the importance of this novel medicine to patients and Syndax First- and best-in-class anti-CSF-1R antibody $36.2 M Niktimvo net revenue reported by Incyte in 2Q25, the first full quarter of sales Substantial growth compared to $13.6 M net revenue in first 2 months of Q1 launch Profitable to Syndax in first full quarter ($9.4 M to Syndax in collaboration revenue) Proportion of net revenue retained by Syndax expected to materially grow over time

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![Slide 6](sndx-ex99_2s6.jpg)

Net revenue per quarter First 5 weeks of sales +43% $56 M in Revuforj net revenue since launch >1,300 Total prescriptions Patients have started treatment Of use in the 2L or 3L Of KMT2A patients estimated to have proceeded to HSCT following Revuforj treatment >500 ~70% KEY METRICS Estimates from launch through end of 2Q25 ~33% Robust Revuforj growth in 2Q25 2L, second line; 3L, third line; HSCT, hematopoietic stem cell transplantation

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![Slide 7](sndx-ex99_2s7.jpg)

Syndax is uniquely positioned for long-term growth and success in menin inhibition, a $5B+ market opportunity Source: Data on file; Redbook 2023 U.S. Market Opportunity ($ B) $5B+ TAM $2B+ TAM R/R Acute Leukemia withKMT2A translocation R/R Acute Leukemiawith mNPM1 1L "Unfit" Acute Leukemia with KMT2Ar or mNPM1 1L "Fit" Acute Leukemia with KMT2Ar or mNPM1 Est. annualincidence ~2,000 ~4,500 ~3,500 ~5,500

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![Slide 8](sndx-ex99_2s8.jpg)

Quarterly net revenue (reported by Incyte) $9.4 M in collaboration revenue reported by Syndax $50 M in Niktimvo net revenue since launch First two months of sales Exceptional Niktimvo uptake >4,000 ~700 >80% Infusions administered Patients have started treatment Of patients remain on therapy Of bone marrow transplant centers have ordered 80-90% KEY METRICS Estimates from launch through end of 2Q25

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![Slide 9](sndx-ex99_2s9.jpg)

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 couldsupport future expansioninto newly diagnosed cGVHD Ph 2 IPF trial underway; evaluating other potentialdisease areas Ph 3 cGHVD trial underwayoutside the U.S. $5B+ TAM

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![Slide 10](sndx-ex99_2s10.jpg)

Recent presentations/publications solidify revumenib's leading profile AUGMENT-101 data presented at EHA highlight robust activity acrossR/R mNPM1, KMT2Ar, and NUP98r acute leukemia Ph 2 R/R mNPM1 AML data: 26% (20/77) CR+CRh, 48% (37/77) ORR,and 23-month mOS observed among responders in a subgroup analysis Ph 1 R/R NUP98r AML data: 60% (3/5) ORR Pivotal R/R mNPM1 AML data published in Blood BEAT AML data presented at EHA and published in JCO support combinability of revumenib with ven/aza in 1L setting and potential for high rates of CR and MRD negativity First real-world revumenib evidence anticipated before year end ORR, overall response rate; CR, complete remission; CRh, complete remission with partial hematologic recovery; mOS, median overall survival; MRD, measurable residual disease; 1L, frontline

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![Slide 11](sndx-ex99_2s11.jpg)

Developing Revuforj and Niktimvo into industry-leading franchises Revumenib (select trials) Ph 1 or Ph 2 Ph 2 or Ph 3 Registration Approved mNPM1 KMT2Ar NUP98r R/R AUGMENT-101rev mono ✔ AUGMENT-101 rev mono ✔ AUGMENT-102rev + IC ✔ ✔ ✔ SAVE rev + ven/HMA ✔ ✔ ✔ 1L combo Unfit BEAT AML rev + ven/aza ✔ ✔ EVOLVE-2 rev + ven/aza ✔ ✔ 1L comboFit Rev + 7+3 ✔ ✔ REVEAL-ND NPM1 rev + I.C. ✔ REVEAL-ND KMT2Ar rev + I.C. ✔ ✔ Axatilimab (select trials) Ph 1 or Ph 2 Ph 2 or Ph 3 Registration Approved R/R cGVHD AGAVE-201 axa mono in ≥3L cGVHD Frontline cGVHD Axa + corticosteroids\* Axa + ruxolitinib\* Other MAXPIRe (axa in IPF) sNDA granted Priority Review; PDUFA target action date of October 25, 2025 IC, intensive chemotherapy; 1L, frontline; R/R, relapsed or refractory; ven/aza, venetoclax and azacitidine; sNDA, supplemental New Drug Application; EFS, event free survival; OS, overall survival \*Trials led by Incyte. List is not exclusive of ongoing ex-U.S. trials. Trial initiation anticipated in 4Q25 Dual primary endpoints: MRD negative CR & EFS to support potential for accelerated and full approval, respectively Topline MAXPIRe data anticipated in 2H26 Enrollment underway in EVOLVE-2 Dual primary endpoints: CR and OS in mNPM1 pts. to support potential for accelerated and full approval, respectively

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![Slide 12](sndx-ex99_2s12.jpg)

Strong financial position driven by growing Revuforj and Niktimvo contributions and stable expense outlook Key 2Q25 Financial Results (Unaudited) Three Months Ended June 30 (in millions) 2025 2024 Product revenue, net 28.6 - Collaboration revenue, net 9.4 - Milestone and license revenue - 3.5 Total revenues 38.0 3.5 Cost of product sales (1.3) - Research & development (62.2) (48.7) Selling, general and administrative (43.8) (29.1) Total operating expenses (107.3) (77.7) Total other income (expense) net (2.5) 6.2 Net loss (71.8) (68.1) Totals may not sum due to rounding; 1. Includes short- and long-term investments; 2. Includes pre-funded warrants to purchase 285,714 common shares (rounded) Strong balance sheet, increasing contributions from Revuforj & Niktimvo, and a stable expense outlook expected to drive path to profitability AS OF 30 JUNE 2025: $518 M in cash and equivalents1 86.3 Mshares outstanding2

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![Slide 13](sndx-ex99_2s13.jpg)

13 Two first- and best-in-class medicines addressing major unmet need Syndax is positioned to continue its rapid growth in 2025 and beyond, with $10B+ market opportunity across R/R and frontline indications Two exceptional product launches, with sales significantly exceeding expectations On the road to profitability andmulti-billion-dollar franchises $5B+ TAM $5B+ TAM

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![Slide 14](sndx-ex99_2s14.jpg)

Lilah, diagnosed with R/R AML FUELED BY A PASSION FOR PATIENTS

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![Slide 15](sndx-ex99_2s15.jpg)