Apogee Therapeutics (APGE) investor relations material

Key data and clinical progress

• Phase II part B data for zumilokibart in atopic dermatitis showed robust efficacy with fewer dosing days compared to standard of care, including over 40% EASI-100 clear skin at 52 weeks.

• Maintenance data demonstrated continued improvement through 52 weeks, supporting IL-13 as a master cytokine in AD.

• Dose optimization in part B confirmed efficacy at mid and high doses, setting up phase III trials to start in the second half of the year.

• Phase III will include two replicate trials of 400 patients each and a third trial with TCS, aiming to replicate phase II success.

• EoE phase II trial starts in the second half of the year, with a registrational phase II-B planned for 2027.

Pipeline expansion and strategic plans

• Pipeline-in-a-product strategy targets asthma and EoE, leveraging overlap with AD and unmet needs in dosing frequency.

• Asthma phase II-B trial will enroll 500 patients, testing three, six, and 12-month dosing, with potential for registrational filing.

• IL-13/TSLP combination (273) aims for broader patient reach and higher efficacy, with trial plans to be announced in the second half.

• IL-13/OX40 (279) head-to-head with DUPIXENT data expected this year; advancement depends on surpassing efficacy benchmarks.

• Strategic partnerships and M&A remain options if they accelerate patient access or reduce capital costs.

Financial and commercial positioning

• $1.3 billion in cash plus Blackstone royalty and debt financing supports commercialization through 2029 and potential profitability.

• Blackstone deal provides up to $1.3 billion, with flexible, non-dilutive terms and low single-digit royalty buy-down in case of acquisition.

• Market access strategy focuses on early frontline access, leveraging differentiated dosing and efficacy to secure formulary placement.

• Biosimilar entry for DUPIXENT expected to have minimal impact on branded agent access or economics.

• Optionality for three- and six-month dosing expected to drive deeper biologic penetration and meet physician/patient preferences.