Adagene Reports Full Year 2023 Financial Results and Provides Corporate Update

Core Insights - Adagene Inc. reported significant advancements in its clinical pipeline, particularly with its lead candidate ADG126, a masked anti-CTLA-4 SAFEbody, demonstrating a best-in-class therapeutic index in metastatic microsatellite-stable colorectal cancer [1][2][26] - The company has initiated a phase 2 dose expansion study for ADG126, increasing patient enrollment to over 50, and introduced a new 20 mg/kg loading dose regimen, with data expected in 2024 [1][3][11] - Financially, Adagene ended 2023 with a cash balance of approximately US$110 million, which is projected to fund operations into 2026, alongside a notable increase in net revenue [1][13][14] Clinical Pipeline Highlights - ADG126 has shown a 30-fold improved therapeutic index and a mechanism for CTLA-4 mediated intratumoral Treg depletion, allowing for higher and more frequent dosing in combination with anti-PD-1 therapy [2][3] - In a phase 1b/2 trial, ADG126 demonstrated a differentiated safety profile with limited dose-dependent toxicities, achieving a 22% overall response rate in a subset of patients without liver metastases [3][4] - The ongoing clinical program for ADG126 includes a loading dose regimen and maintenance doses, with promising preliminary results in progression-free survival [4][11] Financial Performance - For the year ended December 31, 2023, Adagene reported net revenue of US$18.1 million, a 95% increase from US$9.3 million in 2022, primarily due to collaboration agreements [14] - Research and development expenses decreased by approximately 55% to US$36.6 million, reflecting a focused clinical strategy on ADG126 [15] - The net loss attributable to shareholders was US$18.9 million for 2023, significantly reduced from US$80.0 million in 2022, indicating improved financial health [18][20] Collaborations and Partnerships - Adagene has strategic collaborations with Exelixis and Sanofi, focusing on developing novel masked antibody-drug conjugates and bispecific antibodies, with potential milestone payments reaching up to US$2.5 billion [7][8] - The company is also collaborating with Roche on a phase 1b/2 trial evaluating ADG126 in combination with other therapies for hepatocellular carcinoma [8] Board of Directors Changes - Recent changes to the Board of Directors include the appointment of Dr. Ulf Grawunder as an independent director, enhancing the board's expertise in therapeutic antibody development [9][10]