Summary of Adagene (ADAG) Conference Call Company Overview - Adagene is focused on developing bio-better molecules, with its lead program being ADG-126, a masked anti-CTLA-4 therapy targeting microsatellite stable (MSS) colorectal cancer without liver metastasis [3][4] Key Data and Efficacy - At the ASCO conference, Adagene presented updated data showing a confirmed overall response rate (ORR) of 29% for ADG-126 at a dose of 20 mg/kg, with all responses ongoing [9] - The safety profile is reported as manageable, with no patients discontinuing due to adverse events, and less than 20% experiencing grade 3 adverse events [9][10] - In comparison, standard therapies for MSS colorectal cancer show a mid-single-digit response rate and a median overall survival (OS) of around 12 months [5][11] - Competitors like Agenus reported an ORR of 19% and a median OS of approximately 20 months, but with a 34% discontinuation rate due to adverse events [6][9] Safety Profile - The grade 3 adverse events reported were transient and involved immune-related adverse events, with only two cases out of twelve patients in the cohort [20][21] - The cohort also included patients with peritoneal involvement, which was previously excluded [23] Regulatory and Future Plans - Adagene plans to provide an update on regulatory interactions by Q3 2025 and is optimistic about the potential for a safe regimen with a high response rate [18][29] - The company is currently enrolling patients for a combination therapy involving ADG-126, pembrolizumab, and standard care, including patients with liver metastasis [25][26] Market Opportunities - The estimated incidence of MSS colorectal cancer without liver metastasis in the US is around 10,000 patients, while the neoadjuvant setting for stage II and III patients exceeds 100,000 [27] - Adagene is exploring the potential of ADG-126 in other tumor types, leveraging the efficacy of CTLA-4 in various indications [31][32] Pipeline and Future Catalysts - Adagene has preclinical assets, including a HER2 CD3 engager, which is IND ready and could enter clinical trials soon [34] - Upcoming catalysts include updates from the 20 mg/kg cohort, regulatory feedback, and preliminary data from a phase two trial in neoadjuvant colorectal cancer [36][37] Conclusion - Adagene is positioned to make significant advancements in the treatment of MSS colorectal cancer with its innovative therapies and is actively pursuing regulatory approvals and market expansion opportunities [38]

Core Insights - Adagene Inc. is participating in the Jefferies Global Healthcare Conference 2025, highlighting its commitment to investor engagement and communication [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 enhance its SAFEbody precision masking technology, which is at the forefront of scientific innovation [3]. Technology and Pipeline - Adagene's proprietary Dynamic Precision Library (DPL) platform includes NEObody™, SAFEbody, and POWERbody™ technologies, which are designed to improve the safety and tolerability 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 versatile and can be applied to various antibody-based therapeutic modalities, including Fc empowered antibodies and antibody-drug conjugates [5].

Core Insights - Adagene Inc. announced updated data from its Phase 1b/2 study of ADG126 in advanced microsatellite stable colorectal cancer (MSS CRC) with promising efficacy and safety results [1][2][3] Efficacy - ADG126 in combination with pembrolizumab achieved a 29% confirmed overall response rate (ORR) in the 20 mg/kg cohorts, while the 10 mg/kg cohorts had an ORR of 17% [1][3] - The median overall survival (OS) for the 10 mg/kg cohorts was reported at 19.4 months, with the median OS for the 20 mg/kg cohorts not yet reached [3][4] - All six responders in the 20 mg/kg cohorts remain on treatment, with four patients on study for over forty weeks [1] Safety - The 20 mg/kg Q6W dosing regimen demonstrated fewer than 20% Grade 3 adverse events, with no treatment discontinuations [2][4] - The study indicated a significant reduction in treatment-related toxicities while maintaining a near 30% ORR [2] Study Design - A total of 67 MSS CRC patients with no liver metastases were treated with ADG126 at either 10 mg/kg or 20 mg/kg, in combination with pembrolizumab [2] - The dosing regimens included a loading dose of 20 mg/kg followed by either 10 mg/kg every three weeks or 20 mg/kg every six weeks [2] Future Plans - As data continue to mature, the company plans to discuss the dosing regimen with regulatory bodies for the next phase of clinical development [4]

Core Insights - Adagene Inc. has appointed Dr. John Maraganore as Executive Advisor to provide strategic guidance and mentorship to the company's leadership team [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 [4] - The company has established strategic collaborations with global partners to leverage its SAFEbody precision masking technology [4] Technology and Innovation - 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 on-target off-tumor toxicity in healthy tissues [5] Clinical Development - Adagene's lead clinical program, ADG126 (muzastotug), is a masked anti-CTLA-4 SAFEbody currently in phase 1b/2 clinical studies, particularly targeting Metastatic Microsatellite-stable Colorectal Cancer [6] - The SAFEbody platform is validated for application across various antibody-based therapeutic modalities, including Fc empowered antibodies and antibody-drug conjugates [6] Leadership and Expertise - Dr. John Maraganore previously served as CEO of Alnylam, where he led the company through the approval and commercialization of four RNA interference therapeutic medicines, creating over $25 billion in market capitalization [2][3] - He has extensive experience advising and mentoring life sciences CEOs and sits on the boards of public and private companies [3]

Core Insights - Adagene Inc. is set to present a poster at ASCO 2025, showcasing its advancements in antibody-based therapies [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 enhance its SAFEbody precision masking technology [3] Technology and Pipeline - Adagene's proprietary Dynamic Precision Library (DPL) platform includes NEObody™, SAFEbody, and POWERbody™ technologies, aimed at addressing safety and tolerability issues in antibody therapeutics [4] - The SAFEbody technology allows for tumor-specific targeting of antibodies while minimizing toxicity to healthy tissues [4] Clinical Programs - The lead clinical program, ADG126 (muzastotug), is an anti-CTLA-4 SAFEbody currently in phase 1b/2 studies, focusing on Metastatic Microsatellite-stable Colorectal Cancer [5] - ADG126 targets a unique epitope of CTLA-4 in regulatory T cells within the tumor microenvironment and is being studied in combination with anti-PD-1 therapy [5] Upcoming Presentation Details - The poster presentation titled "Safety and Efficacy of ADG126 (an Anti-CTLA-4 Masking Antibody) in Combination with Pembrolizumab" will take place on May 31, 2025, at ASCO 2025 [7]

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]