Arecor Therapeutics (AREC) investor relations material

Strategic focus and pipeline overview

• Developing ultra-concentrated, ultra-rapid acting insulin (AT278) for diabetes and cardiometabolic diseases, targeting unmet needs in automated insulin delivery (AID) systems.

• Proprietary pipeline leverages existing approved therapeutics, reducing clinical risk and focusing on enhancements for high-value markets.

• Selective partnerships with major pharma and med tech firms, including Eli Lilly, Ligand, and MiniMed, under a licensing model.

• R&D efforts include a technology platform for oral peptide delivery, initially targeting GLP-1s.

AT278 clinical development and market opportunity

• AT278 is five times more concentrated than current best-in-class insulins and demonstrates superior pharmacokinetic and pharmacodynamic profiles.

• Two phase I studies in Type 1 and Type 2 diabetics showed faster onset and greater insulin availability compared to NovoLog and Humulin R U-500.

• Addresses challenges in AID systems, enabling longer wear times (up to 7 days) and smaller pump form factors, especially for high daily dose patients.

• U.S. addressable market for AT278 in AID systems estimated at $3 billion initially, with potential to expand to $5 billion as more patients transition to AID.

• Partnership with Sequel Med Tech to integrate AT278 into their AID system, with phase II clinical study planned for the second half of this year.

Clinical data and regulatory pathway

• AT278 shows 5–24 minutes faster insulin absorption and 66% more insulin on board in the first hour versus comparators, supporting improved glucose control.

• Both Type 1 and Type 2 studies met all primary and secondary endpoints, with no safety signals detected.

• Phase II study will use Time-in-Range as the primary endpoint in a six-week crossover design, comparing AT278 to NovoLog in AID systems.

• Regulatory pathway leverages existing insulin safety/efficacy data, requiring targeted studies; phase III expected post-phase II, with no need for large repeat studies for each device.