ADAG · Adagene Inc.

Adagene reported significant clinical and financial progress for the full year 2025. The company's lead asset, muzastotug (ADG126), demonstrated potent efficacy in combination with pembrolizumab, achieving a 29% confirmed overall response rate (ORR) in the 20 mg/kg dose cohorts among patients with microsatellite stable colorectal cancer (MSS CRC). The 10 mg/kg cohorts showed a median overall survival (mOS) of 19.4 months, comparing favorably to historical benchmarks. Management emphasized the improved tolerability profile, noting a low 4% discontinuation rate and no Grade 4 or 5 treatment-related adverse events across 67 patients, which supports the therapeutic index of their SAFEbody technology. Financially, the company reduced its GAAP net loss to $17.6 million from $33.4 million in the prior year. This improvement was driven by a 23% decrease in R&D expenses to $22.0 million, reflecting clinical prioritization, and a sharp increase in net revenue to $7.7 million from $0.1 million, primarily attributed to the recognition of revenue from collaboration agreements with Sanofi, ConjugateBio, and Third Arc Bio. With $74.5 million in cash and cash equivalents as of December 31, 2025, supplemented by ATM proceeds, the company anticipates funding operations into early 2028. Operationally, the randomized Phase 2 trial is enrolling ahead of plan, with results expected in the first half of 2027, positioning the company for a potential registration trial upon dose optimization.