false000139593700013959372026-11-022026-11-02
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): November 02, 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 November 2, 2026, Syndax Pharmaceuticals, Inc. (the “Company”) issued a press release and presentation announcing its financial results for the quarter ended September 30, 2026. 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 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensation Arrangements of Certain Officers.
On November 2, 2026, the Company issued a press release announcing that Keith A. Goldan will retire as the Company’s Chief Financial Officer, principal accounting and financial officer and treasurer effective November 9, 2026, after which he will continue as an advisor for an interim period until his retirement. Prior to his retirement date, Mr. Goldan will assist with the transition of his responsibilities. Mr. Goldan’s compensation as an advisor will be materially consistent with his current compensation. The Company thanks Mr. Goldan for his dedicated service to the Company as its Chief Financial Officer. The Company also announced that Aaron A. Ondrey will join the Company as Chief Financial Officer, effective November 9, 2026. In connection with Mr. Ondrey’s appointment as Chief Financial Officer, the Company’s board of directors also appointed him principal accounting and financial officer and treasurer of the Company.
Prior to joining the Company, Mr. Ondrey served as Chief Financial Officer of Beren Therapeutics, a private company, since September 2025. Before joining Beren, Mr. Ondrey was Chief Financial Officer of Rocket Pharmaceuticals, a publicly traded company, from March 2024 until September 2025, and Chief Financial Officer of Mirati Therapeutics, a publicly traded company from September 2023 until January 2024, and Senior Vice President, FP&A, from July 2022 through August 2023. From January 2020 until July 2022, Mr. Ondrey served as Vice President, Finance, at Arena Pharmaceuticals, a publicly traded company. Mr. Ondrey also previously served in financial roles of increasing responsibility at Alexion Pharmaceuticals and Regeneron Pharmaceuticals, each publicly traded companies. Mr. Ondrey received a B.S. in Finance from Case Western Reserve University.
There are no arrangements or understandings with the Company pursuant to which Mr. Ondrey was appointed to serve as Chief Financial Officer. There are no family relationships between Mr. Ondrey and any director or executive officer of the Company and there are no related party transactions of the kind described in Item 404(a) of Regulation S-K in which Mr. Ondrey was a participant.
In connection with his appointment, the Company entered into an employment agreement with Mr. Ondrey, effective November 2, 2026 (the “Employment Agreement”), providing for the terms of his employment, including (i) an annual base salary of $543,000; (ii) an annual target bonus equal to 45% of his base salary; and (iii) a one-time grant of an option to purchase 270,000 shares of the Company’s common stock, exercisable at a price per share equal to the closing price of the Company’s common stock on the Nasdaq Global Select Market on November 9, 2026, the date of grant. Twenty-five percent (25%) of the shares subject to such option shall vest on the one-year anniversary of the vesting commencement date, and one forty-eighth (1/48th) of the shares of common stock subject to such option shall vest monthly thereafter over the following thirty-six (36) months until all of the shares subject to such option are fully vested, subject to continued service.
The Employment Agreement further provides that in the event Mr. Ondrey’s employment is terminated without “cause,” as defined in the Employment Agreement, or he terminates his employment for “good reason,” as defined in the Employment Agreement, he is entitled to (i) a lump sum severance payment equal to nine months base salary, (ii) payment on his behalf of up to nine months of health insurance benefits continuation and (iii) with respect to equity awards granted to Mr. Ondrey prior to the date of his termination, accelerated vesting and the lapse of any reacquisition or repurchase rights that the Company holds with respect to such equity awards for the portion of such equity awards that would have otherwise vested within the 12-month period following the date of Mr. Ondrey’s termination were he to remain employed with the Company during such 12-month period. If Mr. Ondrey’s employment is terminated without cause or he terminates his employment for good reason within three months prior to, or 12 months after, a “change in control” of the Company, as defined in the Employment Agreement, he is instead entitled to (a) a lump sum severance payment equal to the sum of 18 months base salary and 100% of the greater of (1) the average annual target performance bonus paid to him for the preceding three years or (2) his annual target performance bonus in effect as of the change in control, (b) payment on his behalf of up to 18 months of health insurance benefits continuation and (c) full accelerated vesting on all of his unvested options and the lapse of any reacquisition or repurchase rights that the Company holds with respect to any other equity award granted to him pursuant to any of the Company’s equity incentive plans. In order to receive his severance benefits, Mr. Ondrey must sign a general release of claims.
In connection with his appointment as Chief Financial Officer Mr. Ondrey entered into the Company’s standard form of Indemnification Agreement, a copy of which was filed as Exhibit 10.21 to the Registration Statement on Form S-1 (File No. 333-208861) filed with the SEC on January 4, 2016.
The foregoing description of the Employment Agreement is qualified in its entirety by reference to the complete text of such agreement, which is attached as Exhibit 10.1 to this Current Report on Form 8-K and incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
|
|
Exhibit No. |
Description |
|
|
10.1 |
Employment Agreement, dated November 2, 2026, by and between the Company and Aaron A. Ondrey |
99.1 |
Press Release, dated November 2, 2026 |
99.2 |
Corporate Presentation, dated November 2, 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: November 2, 2026

Syndax Reports Third Quarter 2026 Financial Results and Provides Business Update
•Total revenue of $83.3 million in 3Q26, an 82% year-over-year increase –
Revuforj® (revumenib) net revenue of $60.7 million in 3Q26, a 90% y/y increase, underscores leadership in R/R NPM1m and KMT2Ar acute leukemia; 20% q/q growth in new patients
•Niktimvo (axatilimab-csfr) net revenue of $67.4 million in 3Q26, a 47% y/y increase, resulting in Syndax collaboration revenue of $22.6 million –
•New revumenib data expected in 4Q26 from clinical trials and real-world studies spanning the acute leukemia treatment continuum and multiple genetic subtypes –
•Company to host a conference call today at 4:30 p.m. ET –
NEW YORK, NY, November 2, 2026 (GLOBE NEWSWIRE) – Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today reported its financial results for the third quarter ended September 30, 2026, and provided a business update.
“We delivered another quarter of strong commercial results, generating $83 million in total revenue to Syndax. Revuforj net revenue grew to $61 million, driven by a 20% increase in new patients and an increasing number of patients on therapy in the post-transplant setting. We continue to have the dominant share of new patients across all age groups starting a menin inhibitor and the vast majority of revenue for the class, underscoring our position as the market leader. Importantly, a growing number of both R/R KMT2Ar and NPM1m patients are proceeding to a stem cell transplant after receiving Revuforj and then resuming therapy afterward, a dynamic that positions the business for long-term growth as the average duration of therapy extends,” said Michael A. Metzger, Chief Executive Officer.
Mr. Metzger continued, “We look forward to sharing new Revuforj combination data in the fourth quarter that reinforce our confidence that our ongoing pivotal frontline trials could transform the treatment paradigm for newly diagnosed AML. We remain well positioned to be the first to deliver a menin inhibitor in the frontline, unlocking a multi-billion-dollar opportunity. With growing revenue from two medicines, a robust pipeline generating multiple blockbuster opportunities, world-class R&D capabilities, and a strong balance sheet, Syndax is poised to deliver long-term value.”
Recent Business Highlights and Anticipated Milestones
Revuforj® (revumenib)
•Achieved $60.7 million in Revuforj net revenue in the third quarter of 2026, a 90% increase over the third quarter of 2025 and an 11% increase over the second quarter of 2026. New patients and total prescriptions increased by approximately 20% and 13%, respectively, in the third quarter of 2026 compared to the second quarter of 2026. The double-digit growth in net revenue, new patients, and total prescriptions reflects robust uptake in both Revuforj indications and a growing number of relapsed or refractory (R/R) KMT2A-rearranged (KMT2Ar) and NPM1-mutated (NPM1m) patients proceeding to hematopoietic stem cell transplant (HSCT) and then resuming therapy in the post-transplant setting.
•Claims data indicate that approximately 50% of R/R KMT2Ar patients proceed to HSCT after receiving Revuforj, of which about 60% have resumed therapy post-transplant. Notably, the data also indicate that approximately 40% of R/R NPM1m patients proceed to HSCT after receiving Revuforj, of which about 50% have resumed therapy post-transplant.
•In October 2026, Revuforj received the Best Product for Rare/Orphan Diseases award from The Galien Foundation, one of the world’s most prestigious awards for biomedical research and innovation. Additionally, Revuforj was named as one of TIME’s Best Inventions of 2026 in the Medical and Healthcare category.
•The Company expects to have a major presence at upcoming medical meetings, with the presentation in the fourth quarter of 2026 of new/updated revumenib data including:
•Frontline data from the BEAT AML trial of revumenib in combination with venetoclax/azacitidine in NPM1m and KMT2Ar acute myeloid leukemia (AML)
•Frontline data from the SAVE trial of the all-oral combination of revumenib, decitabine/cedazuridine, and venetoclax in NPM1m, KMT2Ar, or NUP98-rearranged (NUP98r) AML
•Frontline data from a Phase 1 trial of revumenib in combination with intensive chemotherapy in NPM1m, KMT2Ar, or NUP98r AML
•Post-transplant maintenance data
•Real-world evidence from multiple centers
•Data from INTERCEPT, a Phase 1 trial evaluating revumenib as pre-emptive therapy for measurable residual disease (MRD) or early relapse among patients with NPM1m or KMT2Ar AML
•The Company expects to publish safety and efficacy data from R/R NUP98r acute leukemia patients treated with revumenib in the fourth quarter of 2026.
•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.
•Multiple clinical trials evaluating revumenib across the acute leukemia treatment continuum are ongoing, such as:
•EVOLVE-2: A pivotal, Phase 3, randomized, double-blind, placebo-controlled trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed NPM1m (primary efficacy analysis population) and KMT2Ar 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.
•REVEAL-ND: A pivotal, Phase 3, randomized, double-blind, placebo-controlled trial of revumenib in combination with intensive chemotherapy in newly diagnosed NPM1m AML patients.
•SAVE: A Phase 1/2 trial evaluating an all-oral combination of revumenib with venetoclax and decitabine/cedazuridine in pediatric and adult patients with newly diagnosed and R/R AML or mixed-lineage acute leukemia harboring either NPM1m, KMT2Ar, or NUP98r alterations. The trial is being conducted by investigators from MD Anderson Cancer Center.
•Intensive chemotherapy: Two ongoing Phase 1 trials evaluating the combination of revumenib with intensive chemotherapy (7+3) in newly diagnosed NPM1m or KMT2Ar acute leukemia patients.
•BEAT AML: A Phase 1b trial evaluating the combination of revumenib with venetoclax and azacitidine in newly diagnosed older adults (≥60 years) with NPM1m or KMT2Ar AML. The trial is being conducted as part of the Leukemia & Lymphoma Society's Beat AML® Master Clinical Trial.
•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.
•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.
•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.
•The Company expects the RAVEN trial to initiate in the fourth quarter of 2026. RAVEN is a Phase 2 collaborative trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed KMT2Ar patients who would be considered eligible, or fit, for intensive chemotherapy.
•The Company expects the MenTain Phase 2 trial to initiate in the first quarter of 2027. MenTain will be the first randomized, placebo-controlled trial specifically focused on evaluating revumenib as post-transplant maintenance.
Niktimvo (axatilimab-csfr)
•Achieved $67.4 million in Niktimvo net revenue in the third quarter of 2026, a 47% increase over the third quarter of 2025 and a 12% increase over the second 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 $22.6 million in the third quarter of 2026.
•In October 2026, data supporting the safety and feasibility of reduced-frequency dosing of axatilimab in patients with recurrent or refractory chronic graft-versus-host disease (GVHD) were published in Blood Advances. Data from the pivotal AGAVE-201 trial show that transition from axatilimab 0.3 mg/kg every two weeks to 0.6 mg/kg every four weeks was feasible and well tolerated. Patients had a prolonged duration of therapy after the switch (median of 21 months), and 84% remained on treatment as of the data cutoff, suggesting ongoing clinical benefit.
•Two trials evaluating axatilimab in patients with newly diagnosed chronic GVHD are ongoing, including a Phase 2 trial in combination with ruxolitinib and a Phase 3 trial in combination with corticosteroids.
•The Company expects topline data from the Phase 2 trial of axatilimab in combination with ruxolitinib to be presented at a medical meeting in the first quarter of 2027.
•The Company expects topline data from the Phase 3 trial of axatilimab in combination with corticosteroids in early 2028.
•In October 2026, the Company announced that the MAXPIRe Phase 2 trial of axatilimab in idiopathic pulmonary fibrosis (IPF) did not meet its primary endpoint. The safety and tolerability profile observed in MAXPIRe was consistent with previous clinical studies of axatilimab, with no new safety signals identified. Based on the results observed, Syndax does not plan to move forward with further development of axatilimab in IPF. The results from the MAXPIRe trial do not affect ongoing trials of axatilimab in other potential indications.
Pipeline Assets
SNDX-4321
•In July 2026, the Company announced the expansion of its pipeline with SNDX-4321, a mutant-selective, CNS-penetrant, allosteric EGFR inhibitor. SNDX-4321 is in development for non-small cell lung cancer (NSCLC) patient populations with significant unmet needs, such as those with L858R mutations, CNS metastases, atypical activating mutations, or acquired resistance to current therapies. In contrast to ATP-site directed third- and fourth-generation EGFR inhibitors, SNDX-4321 is a novel allosteric inhibitor which binds at a pocket adjacent to the ATP site that is only accessible in the presence of L858R and certain other EGFR mutations.
•The Company expects to submit an investigational new drug (IND) application for SNDX-4321 by the end of 2026 and to initiate a Phase 1 trial in EGFRm NSCLC in 2027.
SNDX-62122
•In July 2026, the Company announced the selection of SNDX-62122, a next-generation menin inhibitor, for development in MF. SNDX-62122 is the first candidate from a library of internally developed, wholly owned next-generation menin inhibitors that the Company intends to advance into new areas.
•The Company expects to submit an IND and initiate a Phase 1 trial of SNDX-62122 in MF in the fourth quarter of 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.
Corporate Updates
•On November 2, 2026, the Company announced Keith Goldan’s decision to retire from his role as Chief Financial Officer and the appointment of Aaron A. Ondrey as Chief Financial Officer, effective November 9, 2026. Mr. Ondrey brings to Syndax more than 25 years of financial and operational leadership experience across the biotechnology industry, with deep expertise in financial management, corporate strategy, commercialization, and mergers and acquisitions.
Third Quarter 2026 Financial Results
As of September 30, 2026, Syndax had cash, cash equivalents, and short- and long-term investments of $551.1 million and 90.0 million common shares outstanding.
Total revenue for the third quarter of 2026 was $83.3 million, which consisted of $60.7 million in Revuforj net revenue and $22.6 million in Niktimvo collaboration revenue. The Niktimvo collaboration revenue is derived from the $67.4 million in Niktimvo net revenue that was previously reported by the Company's partner Incyte for the third quarter 2026. Syndax records 50% of the Niktimvo net commercial profit, defined as net revenue (recorded by Incyte) minus the cost of sales and commercial expenses.
Third quarter 2026 research and development expenses increased to $67.5 million from $56.3 million for the comparable prior year period. The year-over-year change was primarily the result of increased expenses associated with frontline trials evaluating revumenib in combination with standard-of-care agents in the treatment of AML.
Third quarter 2026 selling, general and administrative expenses decreased to $43.7 million from $44.9 million for the comparable prior year period. The year-over-year change was primarily the result of lower commercial expenses due to launch costs incurred in 2025 for Revuforj and Niktimvo that were not incurred in the same period in 2026.
For the three months ended September 30, 2026, Syndax reported a net loss attributable to common stockholders of $49.4 million, or $0.55 per share, compared to a net loss attributable to common stockholders of $60.7 million, or $0.70 per share, for the comparable prior year period.
Financial Guidance
For the full year of 2026, the Company continues to expect total research and development plus selling, general and administrative expenses to be approximately $400 million, excluding the impact of $50 million in estimated non-cash stock compensation expense.
Syndax expects that its cash, cash equivalents and short- and long-term investments, combined with its anticipated product revenue, collaboration 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, November 2, 2026.
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: Syndax3Q26
Domestic Dial-in Number: 800-590-8290
International Dial-in Number: 240-690-8800
Live webcast: https://sndx-3q26.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® (revumenib)
Revuforj (revumenib) is the first and only menin inhibitor that is FDA approved for the treatment of adult and pediatric patients one year and older with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options or R/R acute leukemia with a KMT2A translocation as determined by an FDA-authorized test.
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 NPM1m or KMT2Ar AML.
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).
About Syndax
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company's pipeline include Revuforj® (revumenib), an FDA-approved menin inhibitor, and Niktimvo (axatilimab-csfr), an FDA-approved monoclonal 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, Syndax's expected full year total operating expenses, including its
estimated non-cash stock compensation expense, and Syndax’s expectation that its cash, cash equivalents and short-term investments, combined with its anticipated product revenue, collaboration revenue and interest income, will enable the Company to reach profitability. 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.
Niktimvo is a trademark of Incyte.
All other trademarks are the property of their respective owners.
Syndax Contact
Sharon Klahre
Syndax Pharmaceuticals, Inc.
sklahre@syndax.com
Tel 781.684.9827
SNDX-G
|
|
|
|
|
|
|
|
|
|
SYNDAX PHARMACEUTICALS, INC. |
|
(unaudited) |
|
CONDENSED CONSOLIDATED BALANCE SHEETS |
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
(In thousands) |
2026 |
|
|
2025 |
|
Cash, cash equivalents, short and long-term investments |
$ |
551,079 |
|
|
$ |
394,070 |
|
Total assets |
$ |
692,671 |
|
|
$ |
529,706 |
|
Total liabilities |
$ |
709,851 |
|
|
$ |
465,076 |
|
Total stockholders' (deficit) equity |
$ |
(17,180 |
) |
|
$ |
64,630 |
|
|
|
|
|
|
|
|
|
Common stock outstanding |
|
89,989,347 |
|
|
|
87,405,979 |
|
Common stock and common stock equivalents* |
|
116,512,240 |
|
|
|
103,437,561 |
|
|
|
|
|
|
|
|
|
*Common stock and common stock equivalents: |
|
|
|
|
|
|
Common stock |
|
89,989,347 |
|
|
|
87,405,979 |
|
|
Common stock warrants (pre-funded) |
|
- |
|
|
|
285,714 |
|
|
|
Common stock and pre-funded stock warrants |
|
89,989,347 |
|
|
|
87,691,693 |
|
|
Options to purchase common stock |
|
13,302,121 |
|
|
|
13,128,306 |
|
|
Restricted Stock Units |
|
3,123,422 |
|
|
|
2,617,562 |
|
|
Conversion of convertible notes |
|
10,097,350 |
|
|
|
- |
|
|
|
Total common stock and common stock equivalents |
|
116,512,240 |
|
|
|
103,437,561 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SYNDAX PHARMACEUTICALS, INC. |
|
(unaudited) |
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
(In thousands, except share and per share data) |
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
Revenue |
|
|
|
|
|
|
Product revenue, net |
$ |
60,743 |
|
|
|
32,007 |
|
|
$ |
164,366 |
|
|
|
80,649 |
|
|
Collaboration revenue, net |
|
22,555 |
|
|
|
13,864 |
|
|
|
56,584 |
|
|
|
22,975 |
|
Total revenues |
|
83,298 |
|
|
|
45,871 |
|
|
|
220,950 |
|
|
|
103,624 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales |
$ |
13,996 |
|
|
|
2,100 |
|
|
$ |
19,837 |
|
|
|
4,264 |
|
|
Research and development |
|
67,481 |
|
|
|
56,280 |
|
|
|
194,362 |
|
|
|
180,143 |
|
|
Selling, general and administrative |
|
43,716 |
|
|
|
44,917 |
|
|
|
122,843 |
|
|
|
129,753 |
|
Total operating expenses |
|
125,193 |
|
|
|
103,297 |
|
|
|
337,042 |
|
|
|
314,160 |
|
Loss from operations |
|
(41,895 |
) |
|
|
(57,426 |
) |
|
|
(116,092 |
) |
|
|
(210,536 |
) |
Other (expense) income, net: |
|
|
|
|
|
|
|
|
|
|
|
|
Royalty interest expense |
|
(11,812 |
) |
|
|
(8,283 |
) |
|
|
(35,777 |
) |
|
|
(24,186 |
) |
|
Convertible note interest expense |
|
(1,164 |
) |
|
|
- |
|
|
|
(1,719 |
) |
|
|
- |
|
|
Other interest expense |
|
(2 |
) |
|
|
- |
|
|
|
(4 |
) |
|
|
(6 |
) |
|
Interest income |
|
5,593 |
|
|
|
5,269 |
|
|
|
12,900 |
|
|
|
18,402 |
|
|
Other expense |
|
(153 |
) |
|
|
(275 |
) |
|
|
(777 |
) |
|
|
(1,082 |
) |
Total other (expense) income, net |
|
(7,538 |
) |
|
|
(3,289 |
) |
|
|
(25,377 |
) |
|
|
(6,872 |
) |
Net loss |
$ |
(49,433 |
) |
|
$ |
(60,715 |
) |
|
$ |
(141,469 |
) |
|
$ |
(217,408 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized (loss) gain on marketable securities |
|
(1,528 |
) |
|
|
240 |
|
|
|
(2,120 |
) |
|
|
362 |
|
Other comprehensive loss |
|
(50,961 |
) |
|
|
(60,475 |
) |
|
|
(143,589 |
) |
|
|
(217,046 |
) |
Net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share attributable to common stockholders |
$ |
(0.55 |
) |
|
$ |
(0.70 |
) |
|
$ |
(1.59 |
) |
|
$ |
(2.51 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares used in calculating: |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share attributable to common stockholders |
|
89,789,842 |
|
|
|
86,620,992 |
|
|
|
89,017,885 |
|
|
|
86,531,218 |
|

November 2, 2026 Third Quarter 2026 Financial Results and Business Update Exhibit 99.2

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.

Strong 3Q26 commercial growth and progress across our pipeline 3 1. Estimated peak annual U.S. net revenue potential is inclusive of anticipated frontline indications. Market share estimates based on prescription and claims data on file. y/y, year-over-year; q/q, quarter-over-quarter; Tx, treatment; HSCT, hematopoietic stem cell transplant Dominant share of new patients and revenue for the class 20% q/q increase in new patients and growing use post-HSCT $2B+ peak annual net revenue expected in the U.S. alone1 $61M 3Q26 net revenue (+90% y/y) $67M 3Q26 net revenue (+47% y/y) $23M in collaboration revenue to Syndax—a meaningful contribution to our bottom line Collaboration revenue currently annualizing at $90M+ Frontline (1L) trials of Revuforj and Niktimvo underway; positioned to be first to 1L AML with a menin inhibitor Major presence planned at ASH, including new revumenib data across the acute leukemia Tx continuum Two novel pipeline assets expected to enter the clinic in 2027 Poised to unlock significant value with two drugs with blockbuster potential and a differentiated pipeline Growing revenue from two medicines Advancing expansion opportunities

Double-digit q/q growth in Revuforj net revenue, new patients, and TRx TRx, total prescriptions; HSCT, hematopoietic stem cell transplant; Tx, treatment; q/q, quarter-over-quarter ~300 new patient starts 3Q26 results $60.7M net revenue ~1,700total prescriptions ~100% growth vs. 3Q25~13% growth vs. 2Q26 90% growth vs. 3Q2511% growth vs. 2Q26 Net revenue ($M) Approx. TRx Quarterly results ~20% q/q growth Growth reflects strong uptake in two indications and a growing number of patients on Tx post-HSCT Seven consecutive quarters of double-digit q/q net revenue and TRx growth Dominant share of new patient starts for the class

Revuforj’s strong growth potential supported by multiple evolving Tx dynamics Continued use early in the R/R Tx paradigm and in combination Robust transplant rates observed in both R/R KMT2A and NPM1 % proceeding to HSCT % resuming Tx post-HSCT KMT2A ~50% ~60% NPM1 ~40% ~50% Growing adoption in R/R NPM1m AML ~40% of use in combo ~75% of use in 2L/3L of new 3Q26 patients were NPM1 patients ~50% >35% of 3Q26 net revenuefrom NPM1 business Estimates based on claims, prescription, and lab data on file.

Syndax is well positioned to continue driving growth in both Revuforj indications All covered lives includes all commercially covered lives plus Medicare and Medicaid lives. Excellent payer coverage with no meaningful barriers to access of all covered lives with formulary coverage for both Revuforj indications 99% Broad and expanding prescriber base of Tier 1+2 accounts activated >90% total accounts(+8% q/q growth) >620 Growing adoption in centers of all sizes

Strong Niktimvo 3Q26 results driven by robust demand and solid persistency >300 3Q26 new patients ~6,350 3Q26 infusions administered Syndax records 50% of the Niktimvo net commercial profit, defined as net revenue (recorded by Incyte) minus the cost of sales and commercial expenses. $67.4M 3Q26 net revenuereported by INCY 47% growth vs. 3Q25 12% growth vs. 2Q26 $22.6M 3Q26 collaboration revenue to SNDX 63% growth vs. 3Q25 25% growth vs. 2Q26 Collaboration revenue currently annualizing at $90M+

Pioneering menin inhibition with an industry-leading integrated evidence generation plan Rev, revumenib; IC, intensive chemotherapy; 1L, frontline; R/R, relapsed or refractory; ven/aza, venetoclax and azacitidine; HMA, hypomethylating agent; HSCT, hematopoieticstem cell transplantation; gilt, gilteritinib Major presence planned for upcoming medical meetings New data expected in 4Q26 from: 1L combo trials BEAT AML SAVE 708 MRD relapse study INTERCEPT Pre- and post-transplant setting Real-world studies Revumenib (select acute leukemia 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 ● ● ● Borate study Rev + gilt in FLT3 co-mutated ● ● ● Post-HSCT Maintenance Ball study Rev mono ● ● MenTain Rev mono ● ● ● MRDclearance INTERCEPT Rev mono ● ● Break Through Cancer Rev + ven ● ● ● 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 ●

Advancing multiple programs and novel assets targeting high unmet needs NSCLC, non-small cell lung cancer; MF, myelofibrosis; 1L, frontline + Multiple ongoing trials across the acute leukemia Tx continuum; positioned to be first to 1L AML SNDX-4321 Mutant-selective allosteric EGFR inhibitor for NSCLC IND submission expected by YE26; demonstration of monotherapy activity anticipated early 2028 Ph 1 initiation expected 4Q27, building on planned proof-of-principle trial of revumenib in MF Two ongoing combination trials with ruxolitinib or corticosteroids targeting 1L chronic GVHD FOUR INNOVATIVE ASSETS EXPECTED IN THE CLINIC IN 2027 Next-generation menin inhibitor for MF SNDX-62122 Life-cycle management Pipeline assets

Strong financial position with growing revenue and a robust balance sheet Financial Summary ($ in millions) Three Months EndedSept 30 2026 2025 Product revenue, net 60.7 32.0 Collaboration revenue, net 22.6 13.9 Total revenues 83.3 45.9 Cost of product sales (14.0) (2.1) Research & development (R&D) (67.5) (56.3) Selling, general and administrative (SG&A) (43.7) (44.9) Total operating expenses (125.2) (103.3) Other (expense) income, net (7.5) (3.3) Net loss (49.4) (60.7) Totals may not sum due to rounding; 1. Includes short- and long-term investments. AS OF 30 SEPT 2026: $551.1M in cash and equivalents1 90.0Mshares outstanding 2026 R&D + SG&A EXPENSE GUIDANCE: $400M, excluding $50M in expected stock option expense On the road to profitability

Positioned to unlock blockbuster opportunities and build long-term value Proven ability to translate scientific discoveries into novel therapies, with three FDA approvals between two drugs and thousandsof patients treated Fully integrated biotech with deep expertise and strong partnerships with leading researchers Two drugs with compelling expansion opportunities + two differentiated pipeline assets; strong patent protection into at least late 2030s1 Driving towards profitability with growing revenues; fully funded to advance late-stage trials and pipeline assets SOLID FINANCIAL POSITION TRACK RECORD OF SUCCESS WORLD-CLASS R&D CAPABILITIES MULTIPLE SHOTSON GOAL 1. Patent protection into at least late 2030s for Revuforj and Niktimvo and at least 2040s for SNDX-4321 and SNDX-62122.

Acute Leukemia Advance global enrollment in pivotal 1L trials of revumenib New 1L, maintenance, real-world, and MRD relapse data in 4Q26 + beyond Publish R/R NUP98r data in 4Q26 and submit publication to clinical guidelines Myelofibrosis Initiate Ph 1/2 proof-of-principle trial of revumenib in 4Q26; initial data 2H27 Submit IND and initiate Ph 1 SNDX-62122 trial in 4Q27 Frontline Chronic GVHD Topline Ph 2 axatilimab + ruxolitinib data at a medical meeting in 1Q27 Topline Ph 3 axatilimab + corticosteroid data early 2028 EGFR-mutated NSCLC Submit IND by YE 2026 Initiate Ph 1 trial in 2027; initial data early 2028 Anticipated milestones Revuforj (revumenib)& SNDX-62122 SNDX-4321 Niktimvo(axatilimab-csfr) Multiple near-term catalysts and value-creating opportunities

Sarah, diagnosed with R/R acute leukemia FUELED BY A PASSION FOR PATIENTS
