Syndax Pharmaceuticals — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for Q3 2026 was $83.3 million, an 82% year-over-year increase compared to $45.9 million in Q3 2025.
• Revuforj (revumenib) net revenue was $60.7 million, a 90% year-over-year increase from Q3 2025.
• Niktimvo (axatilimab-csfr) net revenue was $67.4 million, a 47% year-over-year increase, resulting in Syndax collaboration revenue of $22.6 million.
• Research and development expenses increased to $67.5 million in Q3 2026 from $56.3 million in Q3 2025.
• Selling, general and administrative expenses decreased to $43.7 million in Q3 2026 from $44.9 million in Q3 2025.
• Net loss attributable to common stockholders was $49.4 million ($0.55 per share) for Q3 2026, compared to $60.7 million ($0.70 per share) for Q3 2025.
• As of September 30, 2026, the company held $551.1 million in cash, cash equivalents, and short- and long-term investments.
• Total assets were $692.7 million as of September 30, 2026, compared to $529.7 million as of December 31, 2025.
• Total liabilities were $709.9 million as of September 30, 2026, compared to $465.1 million as of December 31, 2025.
• Stockholders' deficit was $17.2 million as of September 30, 2026, compared to equity of $64.6 million as of December 31, 2025.
• Royalty interest expense was $11.8 million for the three months ended September 30, 2026, compared to $8.3 million in the prior year period.

Guidance and Future Outlook:

• For the full year 2026, the company expects total research and development plus selling, general and administrative expenses to be approximately $400 million, excluding $50 million in estimated non-cash stock compensation expense.
• The company expects its cash, investments, anticipated product revenue, collaboration revenue, and interest income to enable it to reach profitability.
• New Revuforj data from clinical trials and real-world studies is expected in Q4 2026.
• The RAVEN trial is expected to initiate in Q4 2026.
• The MenTain Phase 2 trial is expected to initiate in Q1 2027.
• An IND application for SNDX-4321 is expected to be submitted by the end of 2026, with a Phase 1 trial to initiate in 2027.
• An IND and Phase 1 trial for SNDX-62122 in myelofibrosis are expected in Q4 2027.
• Topline data from the Phase 2 axatilimab and ruxolitinib trial is expected in Q1 2027.
• Topline data from the Phase 3 axatilimab and corticosteroids trial is expected in early 2028.

Business Segments and Product Lines:

• Revuforj net revenue grew 11% quarter-over-quarter in Q3 2026, driven by a 20% increase in new patients and a 13% increase in total prescriptions.
• Approximately 50% of relapsed or refractory (R/R) KMT2Ar patients proceed to hematopoietic stem cell transplant (HSCT) after Revuforj, with about 60% resuming therapy post-transplant.
• Approximately 40% of R/R NPM1m patients proceed to HSCT after Revuforj, with about 50% resuming therapy post-transplant.
• Revuforj received the Best Product for Rare/Orphan Diseases award from The Galien Foundation and was named one of TIME's Best Inventions of 2026.
• Niktimvo collaboration revenue represents Syndax's 50% share of net commercial profit (net product revenue minus cost of sales and commercial expenses).
• Data published in Blood Advances in October 2026 showed that reduced-frequency dosing of axatilimab (0.6 mg/kg every four weeks) was feasible and well tolerated, with a median therapy duration of 21 months and 84% of patients remaining on treatment.
• The MAXPIRe Phase 2 trial for axatilimab in idiopathic pulmonary fibrosis (IPF) did not meet its primary endpoint; the company will not advance axatilimab in this indication.
• SNDX-4321 is a mutant-selective, CNS-penetrant, allosteric EGFR inhibitor in development for non-small cell lung cancer (NSCLC).
• SNDX-62122 is a next-generation menin inhibitor selected for development in myelofibrosis (MF).

Market and Competitive Landscape:

• Syndax holds the dominant share of new patients starting a menin inhibitor across all age groups and accounts for the vast majority of revenue in the class.
• The company aims to be the first to deliver a menin inhibitor in the frontline setting, targeting a multi-billion-dollar opportunity.
• Revuforj is the first and only FDA-approved menin inhibitor for R/R AML with NPM1 mutations or R/R acute leukemia with KMT2A translocations.
• Niktimvo is a first-in-class CSF-1R-blocking antibody approved for chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of therapy.
• Revumenib is being evaluated in multiple ongoing pivotal and Phase 1/2 trials across the acute leukemia treatment continuum, including collaborations with the HOVON network and MD Anderson Cancer Center.

Risks and Challenges:

• The MAXPIRe trial results for axatilimab in IPF did not meet the primary endpoint, leading to the discontinuation of development in that indication.
• Forward-looking statements involve risks including unexpected safety or efficacy data, lower than expected clinical trial enrollment, changes in commercial availability, changes in competition, regulatory changes, and potential litigation.
• Actual results may differ materially from expectations regarding clinical trial progress, reporting of data, and the achievement of profitability.

Management Commentary and Tone:

• CEO Michael A. Metzger described the quarter as delivering "strong commercial results" and highlighted Revuforj's position as the market leader.
• Management expressed confidence that ongoing pivotal frontline trials could transform the treatment paradigm for newly diagnosed AML.
• The CEO noted that a growing number of patients are proceeding to stem cell transplant and resuming therapy, positioning the business for long-term growth.
• Management emphasized a robust pipeline, world-class R&D capabilities, and a strong balance sheet as drivers for long-term value.

Other Key Points:

• Keith Goldan retired as Chief Financial Officer on November 2, 2026, and Aaron A. Ondrey was appointed as the new CFO, effective November 9, 2026.
• Syndax recorded 90.0 million common shares outstanding as of September 30, 2026.
• The company hosts a conference call and live audio webcast on November 2, 2026, at 4:30 p.m. ET.
• Preclinical data published in July 2026 identified menin as a novel dependency in proliferative megakaryocytes, supporting the development of SNDX-62122 for myelofibrosis.
• Syndax and Incyte are co-commercializing Niktimvo, with Incyte reporting the net product revenue and Syndax recording its share of the commercial profit.