Adagene (ADAG) Morgan Stanley 24th Annual Global Healthcare Conference summary

Technology and pipeline overview

• SAFEbody masking technology enables targeted activation of therapies in tumor microenvironments, requiring both high protease activity and target expression for activation.

• Lead compound ADG126, a masked CTLA-4 antibody, is being developed alongside a broad early-stage pipeline, including masked T-cell engagers targeting HER2 and CD3.

• AI has been integral in identifying novel antibodies and epitopes, improving R&D productivity and enabling differentiated mechanisms of action.

Clinical data and differentiation

• ADG126 combined with pembrolizumab in MSS colorectal cancer (CRC) without liver metastases has shown response rates of 15%-36%, significantly higher than historical controls.

• Safety profile is favorable, with discontinuation rates due to adverse events below 10% at doses up to 20 mg/kg, compared to 1-3 mg/kg for first-generation CTLA-4 therapies.

• No Grade 4 or 5 adverse events observed in over 60 patients, supporting a differentiated therapeutic index.

Market opportunity and strategy

• Initial addressable market for late-line, non-liver metastasis MSS CRC is over 10,000 patients in the U.S., with a global market exceeding $1 billion.

• Ongoing collaborations expand reach to broader late-line populations (>30,000 patients) and neoadjuvant CRC (>150,000 patients in the U.S.).

• First-line hepatocellular carcinoma (HCC) is highlighted as a significant market, with 15,000-20,000 patients in the U.S.