Adagene (ADAG) investor relations material

Clinical program highlights

• Lead asset ADG126, a masked anti-CTLA-4 antibody, is being developed for late-line MSS-CRC without liver metastases, a setting with historically poor response rates and survival outcomes.

• Combination with KEYTRUDA has shown response rates of 15–30% and a discontinuation rate below 10%, with median overall survival reaching 19–20 months in early cohorts.

• Higher doses (20 mg/kg) are being safely administered, with no grade 4/5 adverse events and manageable grade 3 events, supporting a favorable safety profile.

• Efficacy trends indicate higher response rates and longer duration of response at increased doses, with a confirmed 29% response rate in high-dose cohorts.

• Upcoming data updates are expected soon, including expanded patient cohorts and landmark survival analyses.

Strategic partnerships and collaborations

• Sanofi invested up to $25 million, with $17 million already received, supporting ongoing randomized phase 2 trials and collaborative studies.

• Sanofi expanded its discovery collaboration, advancing a third SAFEbody candidate and validating the masking technology.

• No rights to ADG126 have been sold; Sanofi holds no right of first refusal, and all development rights remain with the company.

• Additional collaborations include a trial with Roche in first-line HCC and a phase 2 investigator-sponsored trial in Singapore for neoadjuvant CRC.

• The company aims to pursue further licensing deals and trial collaborations to expand market reach and evaluate novel regimens.

Market opportunity and differentiation

• MSS-CRC without liver metastases represents a significant market, with about 10,000 patients in the US and limited effective therapies.

• ADG126’s masking technology enables higher dosing and a broader therapeutic index compared to first-generation CTLA-4 inhibitors and competitors like BOT/BAL.

• The asset is positioned as a natural combination partner for various immuno-oncology agents, including PD-1, VEGF, TGF-β, and cytokine-based therapies.

• Strategic focus is on demonstrating efficacy in challenging indications to attract partners for broader development, including first/second-line CRC and other solid tumors.

• Differentiation is based on safety, ability to combine beyond PD-1, and potential for long-term survival benefits.