Apogee Therapeutics (APGE) investor relations material

Key clinical data and upcoming milestones

• Maintenance data for quarterly and semi-annual dosing in atopic dermatitis will be released this month, aiming to demonstrate improved adherence and reduced dosing burden compared to current standards like Dupixent and Ebglyss.

• Part B data, testing higher exposure levels for efficacy, is expected in Q2, with the goal of confirming or exceeding the strong results seen in Part A, including rapid itch relief and high EASI-75 rates.

• Phase 3 trials for the lead asset will launch by year-end, featuring two replicate studies versus placebo and a third with topical corticosteroids, targeting a 2029 launch.

• The company is fully funded through the second half of 2028, covering the phase 3 top-line data period.

• Head-to-head data versus Dupixent for APG279 is expected in the second half, aiming to establish superiority and position as the preferred second-line therapy.

Dosing strategy and market positioning

• Both quarterly and semi-annual dosing regimens will be advanced into phase 3, with flexibility to adjust doses based on maintenance data.

• Market research indicates quarterly dosing could transform the market, with semi-annual dosing adding further share and deepening biologic penetration.

• Physicians and patients value choice, and semi-annual dosing could add up to 10% additional market share.

• Quarterly dosing alone could drive up to 80% market share if efficacy matches current standards.

Safety and efficacy considerations

• Higher doses are not expected to introduce new safety concerns; conjunctivitis remains the main class-related adverse event, typically mild and transient.

• Placebo rates are being managed by expanding the European site footprint and increasing placebo arm size in Part B, aiming for more reliable efficacy comparisons.

• A minimum 5 percentage point separation on key efficacy endpoints is considered compelling for superiority claims.