Adagene (ADAG) investor relations material

Program differentiation and clinical development

• Lead program ADG126 (Muza) is a next-generation masked CTLA-4 antagonist with a unique epitope and proprietary SAFEbody masking technology, enabling higher dosing and improved safety compared to competitors.

• Clinical data in late-line MSS CRC show confirmed response rates of 15%-29%, with higher doses correlating to higher response rates and improved durability.

• Safety profile is favorable, with low rates of grade 3/4 adverse events and treatment discontinuation below 10% in combination with pembrolizumab.

• Ongoing dose optimization includes induction/maintenance regimens and expansion of high-dose cohorts, with upcoming data expected to provide more mature durability and survival outcomes.

• Comparative analysis suggests superior efficacy and safety versus other IO regimens, such as zanzalintinib/atezolizumab, and plans are in place for both doublet and triplet combinations with standard-of-care agents.

Pipeline expansion and strategic collaborations

• ADG126 is being evaluated beyond CRC, including a randomized study in hepatocellular carcinoma with atezolizumab and bevacizumab, with long median follow-up and data release planned at a medical meeting.

• Additional indications and earlier lines of therapy are under consideration, leveraging the agent’s high dosing capability and therapeutic index.

• Collaborations include a $25M equity investment and expanded partnership with Sanofi, focusing on SAFEbody technology and a novel combination trial with Sanofi’s PD-1/IL-15 bispecific.

• Other partnerships involve Exelixis and Third Arc Bio, both utilizing SAFEbody for biologics and T-cell engagers.

• Internal pipeline features preclinical double-masked T-cell engagers targeting HER2 and CD20, with plans to advance these programs through partnerships.