Adagene Reports Six Months 2025 Financial Results and Provides Corporate Updates

Core Insights - Adagene's ADG126 shows promising results in Phase 1b/2 trials for microsatellite stable colorectal cancer (MSS CRC), with a median overall survival (mOS) of 19.4 months for the 10 mg/kg dose cohort, outperforming historical benchmarks [1][4] - The company has aligned with the FDA on the design elements for Phase 2 and Phase 3 trials, with patient enrollment expected to begin in the second half of 2025 [1][5] - Sanofi has made a strategic investment of up to US$25 million in Adagene, extending the company's cash runway into 2027 [1][6] Pipeline Highlights - ADG126 demonstrated a 29% confirmed overall response rate (ORR) in MSS CRC patients, with less than 20% of patients experiencing Grade 3 treatment-related adverse events [4][5] - The 20 mg/kg cohort's mOS has not yet been reached, indicating ongoing potential for further positive outcomes [1][4] - Adagene plans to evaluate ADG126 in combination with Merck's KEYTRUDA in a Phase 1b/2 trial involving over 100 patients [6][7] Corporate Updates - Adagene has strengthened its leadership team with key appointments, including John Maraganore as Executive Advisor and Mickael Chane-Du as Chief Strategy Officer [10] - The company has entered into a partnership with ConjugateBio to develop novel antibody-drug conjugates [9] Financial Highlights - As of June 30, 2025, Adagene reported cash and cash equivalents of US$62.8 million, down from US$85.2 million at the end of 2024 [11] - Research and development expenses decreased by approximately 18% to US$12.0 million for the first half of 2025 compared to US$14.7 million in the same period of 2024 [12] - The net loss attributable to shareholders was US$13.5 million for the first half of 2025, an improvement from US$17.0 million in the same period of 2024 [14]