Syndax Pharmaceuticals (SNDX) investor relations material

Commercial performance and market leadership

• Achieved over $200 million annualized revenue in the second year of launch, with 85%+ market share in both NPM1 and KMT2A AML categories, supported by strong physician adoption and real-world data.

• Six consecutive quarters of double-digit growth, with expectations for continued expansion as new patient starts and therapy duration increase.

• Post-transplant maintenance is a key growth driver, targeting 70–80% of patients returning to therapy after transplant, with current transplant rates at about 50%.

• Average therapy duration in relapse/refractory AML is tracking at 6–12 months, with some patients exceeding nine months post-transplant.

Pipeline development and clinical strategy

• Two pivotal phase III frontline AML studies (EVOLVE-2 and REVEAL) are enrolling globally, targeting both fit and unfit patients, with dual primary endpoints including overall survival and response rates.

• Additional innovative studies include RAVEN (alternative transplant approach) and MenTain (first randomized maintenance study), aiming to differentiate and expand clinical utility.

• NUP98 AML subset is being targeted, with promising early data and plans for guideline submission.

Expansion into new indications and modalities

• Axatilimab is advancing in idiopathic pulmonary fibrosis (IPF) with the MAXPIRe proof-of-concept study, designed for robust statistical rigor and expected to read out in Q4.

• Axatilimab is also being evaluated in chronic GVHD, including a phase II Jakafi combination study and a pivotal phase III with dexamethasone, with data expected by year-end.

• Subcutaneous formulation of axatilimab is in development to enhance patient convenience and franchise value.