SAN DIEGO and SUZHOU, China, April 07, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. ("Adagene") (NASDAQ:ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced that Adagene's Chairman, Chief Executive Officer and President of R&D, Peter Luo, Ph.D., will participate in one-on-one investor meetings and provide a corporate update at Stifel's 2025 Virtual Targeted Oncology Forum, taking place April 8-9. Stifel's 2025 Virtual Targeted Oncology Forum Presentation Da ...

SAN DIEGO and SUZHOU, China, April 07, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced that Adagene’s Chairman, Chief Executive Officer and President of R&D, Peter Luo, Ph.D., will participate in one-on-one investor meetings and provide a corporate update at Stifel’s 2025 Virtual Targeted Oncology Forum, taking place April 8-9. Stifel’s 2025 Virtual Targeted Oncology Forum Presentation D ...

Currency Exchange and Economic Conditions - The Renminbi depreciated approximately by 9% against the U.S. dollar in 2022, appreciated approximately by 3% in 2023, and depreciated approximately by 1% in 2024[1085]. - The Renminbi's value is influenced by China's political and economic conditions, and future changes to the exchange rate system may occur[1085]. - The company has not experienced significant direct foreign exchange risk, but the value of investments in ADSs may be affected by exchange rate fluctuations[1084]. Inflation and Consumer Price Index - Year-over-year percent changes in the consumer price index in China were an increase of 2.0% in December 2022, a decrease of 0.3% in 2023, and an increase of 0.1% in 2024[1087]. - The company anticipates that inflation in China has not materially impacted its operations since inception, but future inflation rates may pose risks[1087]. Interest Rate and Financial Instruments - The company has not been exposed to material risks due to changes in interest rates, but future interest income may be lower than expected due to market fluctuations[1083]. - The company has not used any derivative financial instruments to manage interest rate or foreign exchange risk exposure[1084]. - The company has not used any derivative financial instruments to hedge foreign exchange risk exposure[1084]. ADR Program and Fees - The company has not received reimbursement from the depositary for expenses incurred in respect of the ADR program as of the date of the annual report[1103]. - The depositary may charge fees for various transactions related to ADSs, including a fee of $5.00 for each 100 ADSs issued or surrendered[1092].

Exhibit 99.1 Adagene Reports Full Year 2024 Financial Results and Provides Corporate Update Muzastotug Phase 2 dose expansion in MSS CRC with a 20 mg/kg loading dose regimen shows 33% overall response rate with four confirmed partial responses SAFEbody technology utilized to create masked T cell engagers for potentially superior safety profile with enhanced therapeutic index Cash balance of $85.2 million provides runway into late 2026 SAN DIEGO, Calif. and SUZHOU, China, March 24, 2025 – Adagene Inc. ("Adag ...

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]

Core Insights - Adagene Inc. reported a 33% overall response rate in its Phase 2 dose expansion study for muzastotug (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 combination with existing treatments like pembrolizumab [2][25] Clinical Development - The clinical data generated in 2024 with ADG126 supports the expansion of studies to include earlier lines of therapy and patients with liver metastases, who have historically benefited little from checkpoint inhibitors [2] - ADG126 is currently in Phase 1b/2 clinical studies in combination with pembrolizumab, showing good tolerability and a low discontinuation rate of 6% in the MSS CRC expansion cohort [4][26] - The company plans to initiate an investigator-initiated Phase 2 trial of ADG126 in neoadjuvant colorectal cancer in April 2025 [4] 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 the ADG126 program [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, which include milestone payments and the development of novel antibody-drug conjugates and SAFEbody candidates [6][7][8] - The collaboration with Exelixis has resulted in over $18 million in total payments to date [6] Pipeline Highlights - ADG138, another SAFEbody engineered T cell engager targeting HER2, is IND-ready and has shown a wide therapeutic window in preclinical models [3] - ADG152, targeting CD20, is in the IND-enabling phase and is designed to minimize cytokine release syndrome [5]

Core Insights - Adagene Inc. is set to present at the 11th Annual Immuno-Oncology 360⁰ Summit in Boston on March 26, 2025, focusing on advancements in antibody-based cancer therapies [1][2]. Company Overview - Adagene Inc. is a clinical-stage biotechnology company specializing in the discovery and development of novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence [4]. - The company has established strategic collaborations with global partners to enhance its SAFEbody precision masking technology, which is at the forefront of immuno-oncology [4]. Technology and Pipeline - Adagene's proprietary Dynamic Precision Library (DPL) platform includes NEObody™, SAFEbody, and POWERbody™ technologies, aimed at addressing safety and tolerability challenges in antibody therapeutics [5]. - The SAFEbody technology allows for tumor-specific targeting of antibodies while minimizing toxicity to healthy tissues by activating in the tumor microenvironment [5]. - The lead clinical program, ADG126 (muzastotug), is a masked anti-CTLA-4 SAFEbody currently in phase 1b/2 studies, particularly targeting Metastatic Microsatellite-stable Colorectal Cancer [6]. Event Details - The presentation titled "ADG126 SAFEbody: Targeting CTLA-4+ Tregs to Overcome MSS CRC Resistance" is scheduled for March 26, 2025, from 11:30 AM to 11:50 AM Eastern Time at the Sheraton Boston Hotel [9].

Core Insights - Adagene Inc. is participating in Leerink's Global Healthcare Conference 2025, where the CEO will provide a corporate update and engage in one-on-one investor meetings [1][2] Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence [3] - The company has established strategic collaborations with global partners to leverage its SAFEbody® precision masking technology [3] Technology and Pipeline - Adagene's proprietary Dynamic Precision Library (DPL) platform includes NEObody™, SAFEbody, and POWERbody™ technologies, which are designed to enhance the safety and efficacy of antibody therapeutics [4] - The SAFEbody technology specifically addresses safety challenges by masking the binding domain of biologic therapies, allowing for targeted action in the tumor microenvironment while reducing toxicity to healthy tissues [4] Clinical Programs - The lead clinical program, ADG126 (muzastotug), is a masked anti-CTLA-4 SAFEbody targeting regulatory T cells in the tumor microenvironment, currently in phase 1b/2 studies in combination with anti-PD-1 therapy for Metastatic Microsatellite-stable Colorectal Cancer [5] - The SAFEbody platform is validated for various antibody-based therapeutic modalities, including Fc empowered antibodies and antibody-drug conjugates [5]

Core Insights - Adagene Inc. announced a Phase 2 neoadjuvant trial of ADG126 for stage II or III colorectal cancer, with patient enrollment expected to begin in April 2025 and primary completion anticipated by mid-2027 [1][2] Group 1: Trial Details - The trial, led by Dr. Yong Wei Peng, will evaluate the efficacy of ADG126 in combination with KEYTRUDA, focusing on the rate of Major Pathologic Response (MPR) as the primary endpoint [2][3] - Secondary endpoints include complete pathological response, disease-free survival, and safety/tolerability, with the study also exploring pharmacodynamic effects on the tumor microenvironment [2][3] Group 2: Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence [4][5] - The company has established strategic collaborations leveraging its SAFEbody precision masking technology to address unmet patient needs in cancer treatment [4][5] Group 3: Technology and Pipeline - Adagene's lead clinical program, ADG126, is a masked anti-CTLA-4 SAFEbody targeting regulatory T cells in the tumor microenvironment, currently in phase 1b/2 studies for Metastatic Microsatellite-stable Colorectal Cancer [6] - The SAFEbody platform aims to enhance safety and tolerability of antibody therapeutics by enabling tumor-specific targeting while minimizing off-tumor toxicity [5][6]

Core Insights - Adagene Inc. announced updated clinical data for ADG126, an anti-CTLA-4 SAFEbody, showing a 33% overall response rate in microsatellite stable colorectal cancer when combined with pembrolizumab [1][2][4] Group 1: Clinical Data and Efficacy - The Phase 1b/2 trial demonstrated four confirmed partial responses out of twelve patients with a 20 mg/kg loading dose followed by 10 mg/kg every three weeks (Q3W) in combination with pembrolizumab [1][3] - The previous data at a 10 mg/kg Q3W dose showed an overall response rate of 23%, indicating an improvement in efficacy with the new dosing regimen [3] - All responders remain on treatment at a maintenance dose of either 10 mg/kg Q3W or 10 mg/kg every six weeks (Q6W) in combination with pembrolizumab [3] Group 2: Safety Profile - No Grade 4 or 5 treatment-related adverse events were observed, with pruritus being the most common treatment-related adverse event at 25% [4] - Higher Grade 2/3 treatment-related adverse events were managed through dose modifications, resulting in no treatment discontinuations to date [4] Group 3: Technology and Innovation - ADG126 utilizes a masking technology that enhances intra-tumoral accumulation and maintains optimal plasma concentration, positioning it as a potential best-in-class CTLA-4 inhibitor [3][6] - The SAFEbody technology aims to address safety and tolerability challenges associated with antibody therapeutics by enabling tumor-specific targeting while minimizing off-tumor toxicity [6][7] Group 4: Future Plans - Due to the enhanced therapeutic index of ADG126, the company plans to evaluate a broader patient population, including those with liver metastases, in the dose expansion cohort [3]