Syndax Pharmaceuticals (SNDX) investor relations material

Commercial portfolio and financial performance

• Two commercial assets, Revuforj and Niktimvo, are both in their second year of launch and annualizing over $200 million each.

• Revuforj is promoted for KMT2A-r acute leukemia and NPM1 mutated AML, covering both adults and pediatrics.

• Niktimvo is co-promoted with Incyte for third-line plus chronic cGVHD, with collaboration revenue reported.

• Both drugs have extensive life cycle management programs and near-term phase III readouts expected for axatilimab.

• Recurring revenue from post-transplant maintenance therapy is becoming the dominant growth driver for Revuforj.

Clinical insights and evolving treatment paradigms

• Real-world data show earlier use of Revuforj and increased combination therapy, improving response rates.

• Up to 80% of patients are treated in combination, and nearly 50% proceed to stem cell transplant, with 70% receiving Revuforj as post-transplant maintenance.

• Recurring maintenance therapy is now the main revenue contributor, expected to grow as more patients receive longer-term therapy.

• Ongoing real-world evidence and the MAINTAIN study aim to optimize post-transplant use and inform benefit-risk profiles.

• Data from leading centers and randomized studies will guide future clinical practice and dosing strategies.

Pipeline and upcoming catalysts

• Two preclinical assets, SNDX-4321 (allosteric EGFR inhibitor for NSCLC) and SNDX-62122 (menin inhibitor for MF), were unveiled, with clinical entry expected next year.

• SNDX-4321 targets a unique allosteric pocket, potentially overcoming resistance in EGFR-mutated lung cancer and showing strong CNS penetration.

• SNDX-62122 is optimized for myelofibrosis, with proof-of-principle studies using revumenib starting soon.

• The MAXPIRe phase II study in IPF is set to read out in Q4, with robust design and potential for rapid phase III transition if positive.

• Additional phase II readout for axatilimab in combination with ruxolitinib in frontline cGVHD is also expected in the near term.