Adagene Reports Full Year 2024 Financial Results and Provides Corporate Update

Core Insights - Adagene Inc. reported a 33% overall response rate in its Phase 2 dose expansion study for ADG126 in microsatellite stable colorectal cancer (MSS CRC) with a 20 mg/kg loading dose regimen, including four confirmed partial responses [1][4] - The company has a cash balance of $85.2 million, which is expected to fund operations into late 2026 [1][9] - Adagene's SAFEbody technology is designed to enhance the safety profile and therapeutic index of antibody-based therapies, particularly in the context of immunotherapy [1][25] Clinical Development - ADG126, a masked anti-CTLA-4 SAFEbody, is currently in Phase 1b/2 clinical studies in combination with pembrolizumab for MSS CRC [26] - The company plans to expand its study to include earlier lines of therapy and patients with liver metastases, who have historically benefited little from checkpoint inhibitors [2][4] - The combination of ADG126 with T cell engagers (TCEs) is expected to enhance therapeutic responses by depleting regulatory T cells [2] Financial Performance - For the year ended December 31, 2024, Adagene reported a net revenue of $0.1 million, a significant decrease from $18.1 million in 2023 [14] - Research and development expenses decreased by approximately 21% to $28.8 million in 2024, reflecting a focus on ADG126 [15] - The net loss attributable to shareholders was $33.4 million for 2024, compared to $18.9 million in 2023 [18] Collaborations and Partnerships - Adagene has ongoing collaborations with Exelixis, Sanofi, and Roche, focusing on the development of SAFEbody technology and other therapeutic candidates [6][7][8] - The collaboration with Exelixis has resulted in milestone payments totaling over $18 million to date [6] - The partnership with Sanofi includes potential milestone payments of up to $2.5 billion and tiered royalties [7] Future Milestones - The company expects to conduct an End-of-Phase 1 meeting with the FDA by Q3 2025 to discuss proposed dosing regimens and trial designs [12] - Initial clinical data from an investigator-initiated Phase 2 trial for neoadjuvant ADG126 in colorectal cancer is anticipated [12] - Adagene aims to establish additional collaboration and licensing agreements in the near future [12]