Syndax Pharmaceuticals (SNDX) investor relations material

Business and Product Performance

• Revuforj and Niktimvo, both first-in-class oncology drugs, have launched successfully, targeting multi-billion-dollar markets and contributing to a sustainable growth engine.

• Revuforj generated $88 million in net revenue as of Q3, with 25% growth in total prescriptions and about 750 new patient starts over the previous quarter.

• Niktimvo reached $96 million in net sales since launch, with annualized sales nearing $200 million and profitability achieved in the first full quarter.

• Both products are marketed synergistically to the same physician audience, enhancing commercial efficiency.

• The company is on track for profitability in the next few years, supported by stable expenses and expanding product margins.

Clinical and Scientific Updates

• Revuforj is the first and only FDA-approved menin inhibitor for multiple acute leukemia subtypes, now indicated for both KMT2A and NPM1 mutations in adults and children ≥1 year.

• Niktimvo is the first and only CSF-1R blocking antibody FDA-approved for third-line chronic GVHD, showing rapid, durable responses and inclusion in NCCN Guidelines.

• Both drugs are supported by strong real-world and clinical trial data, showing high response rates, durable remissions, and favorable safety profiles.

• Extensive clinical development includes 23 presentations at ASH, with multiple oral and poster sessions for both products.

• Ongoing trials aim to expand indications for both drugs, including frontline settings and new disease areas such as IPF.

Key Clinical Trial Updates

• AGAVE-201 trial data for Niktimvo in R/R cGVHD show feasibility and tolerability of less frequent dosing, with 14% of patients on treatment for a median of 2.8 years.

• Phase 2 trial of axatilimab + ruxolitinib in 1L cGVHD demonstrates promising steroid-sparing potential and good tolerability.

• SAVE Phase 2 trial of revumenib + venetoclax and decitabine/cedazuridine in newly diagnosed AML shows high response and MRD negativity rates in older, ineligible patients.

• Phase 1 trial of revumenib with intensive chemotherapy in newly diagnosed AML shows deep responses and high MRD-negative rates, supporting further development.

• Real-world and clinical trial data show high response rates, MRD negativity, and promising maintenance strategies post-transplant.