Adagene Inc. Sponsored ADR (ADAG) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the s ...

Core Insights - Adagene Inc. announced an amendment to its collaboration and license agreement with Exelixis, allowing Exelixis to utilize Adagene's SAFEbody technology platform for developing an antibody-drug conjugate (ADC) targeting a solid tumor [1][2] Company Overview - Adagene is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, leveraging computational biology and artificial intelligence [5] - The company has established strategic collaborations with global partners to utilize its SAFEbody precision masking technology [5] Technology and Innovation - The SAFEbody technology enables antibodies or ADCs to remain "invisible" until they reach the tumor microenvironment, which enhances therapeutic index and minimizes toxicity to healthy cells [3][6] - Adagene's lead SAFEbody candidate, ADG126, is currently in a Phase 1b/2 study for metastatic microsatellite-stable colorectal cancer, with a Phase 2 trial expected to start before the end of 2025 [4][7] Clinical Development - 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 [7] - The SAFEbody platform is validated for various antibody-based therapeutic modalities, including Fc empowered antibodies and bi/multispecific T-cell engagers [7]

Summary of Adagene Inc. Conference Call Company Overview - **Company**: Adagene Inc. - **Industry**: Biotechnology, specifically focused on antibody generation and protein engineering Key Points and Arguments SAFEbody® Platform and ADG126 - Adagene utilizes AI for protein engineering and antibody generation, leading to the development of novel antibodies, including ADG126, a masked anti-CTLA-4 antibody [2][3] - ADG126 binds to a different epitope than first-generation anti-CTLA-4 antibodies (ipilimumab and tremelimumab), resulting in up to 10 times stronger antibody-dependent cellular cytotoxicity (ADCC) [2] - The proprietary masking technology of ADG126 allows for a significantly expanded therapeutic window, addressing the high dose-dependency and toxicity issues associated with anti-CTLA-4 therapies [3][4] Target Indication: Microsatellite Stable Colorectal Cancer (MSS-CRC) - MSS-CRC accounts for 95% of all colorectal cancer cases, presenting a significant unmet medical need as current immunotherapies have not been effective in this subgroup [5][6] - Adagene is focusing on patients without liver metastasis, which represent roughly one-third of MSS-CRC patients, equating to over 10,000 patients in the U.S. [26] - The combination of ADG126 with Keytruda (pembrolizumab) has shown a confirmed response rate of 29% in phase 1B trials, with a median overall survival of 19 months, outperforming standard care options [10][12][32] Clinical Development and Regulatory Path - A randomized phase 2 trial is set to begin before the end of 2023, testing two dose levels of ADG126 in combination with Keytruda [22][18] - The primary endpoint for the phase 2 trial will be the response rate, which will inform the pivotal phase 3 trial [18][19] - The FDA has indicated that a control arm may not be necessary for the phase 2 trial, recognizing the ineffectiveness of PD-1 and CTLA-4 monotherapies in the targeted setting [41][42] Financial Position and Collaborations - Adagene had approximately $63 million in cash at the end of June 2025, with a runway extending into 2027 due to a recent equity investment from SNOWPEA [27][28] - SNOWPEA has committed to invest up to $25 million, with the first tranche of $17 million already received, supporting the phase 2 trial [28] - The collaboration with SNOWPEA includes a phase 1/2 trial evaluating a novel combination involving ADG126, potentially expanding its addressable market [29] Competitive Landscape and Future Outlook - Adagene is well-positioned within the global biotech landscape, leveraging its Chinese heritage and global clinical trial capabilities [37][38] - The company is utilizing AI to enhance antibody design and decision-making processes, positioning itself as a disruptor in the biotech space [39] - Future data readouts and updates on clinical trials are anticipated, with a focus on durability and response rates from ongoing studies [30][32] Additional Important Points - The incidence of grade 3 adverse events in the high-dose cohort of ADG126 is less than 20%, with no grade 4 or 5 events reported, indicating a favorable safety profile [11][33] - The collaboration with SNOWPEA not only validates Adagene's technology but also enhances its clinical development capabilities [34]

Summary of Adagene Inc. Conference Call Company Overview - **Company**: Adagene Inc. - **Industry**: Biopharmaceuticals, specifically focused on antibody therapies for cancer treatment - **Key Technologies**: NEObody™, SAFEbody®, POWERbody™ Current Pipeline - **Lead Program**: ADG126, a novel masked anti-CTLA-4 antibody - **Mechanism**: Enhanced antibody-dependent cellular cytotoxicity (ADCC) and improved therapeutic index due to proprietary masking technology - **Dosing**: Currently dosing patients at 20 mg/kg every six weeks, up from an initial 10 mg/kg every six weeks [3][8] SAFEbody® Technology - **Mechanism**: Protease-sensitive masking technology that activates in the tumor microenvironment, requiring high levels of specific proteases and target expression [4][8] Collaboration with Sanofi - **Investment**: Sanofi made an equity investment of up to $25 million, with $17 million received at signing [5][6] - **Collaboration**: Expanded partnership includes a trial collaboration for a phase 1B/2 study evaluating a bispecific antibody in combination with ADG126 in solid tumors, targeting over 100 patients [6] Clinical Data and Safety - **Safety Profile**: Low discontinuation rate due to toxicity, allowing patients to receive multiple treatment cycles [9][10] - **Response Rates**: - 20 mg/kg cohort shows a response rate in the high 20% range - Median overall survival of 19 months compared to standard care's 10-12 months [12][10] - Confirmed overall response rate (ORR) at 29% for the 20 mg/kg cohort [12] Future Data Expectations - **Next Data Update**: Expected in early 2026 for phase 1B data set in combination with Keytruda [11] FDA Alignment - **Phase 2 Trial Design**: Randomized trial with two dosing levels (10 mg/kg and 20 mg/kg) to identify optimal dose for future phase 3 trials [13][15] Treatment Landscape - **Potential Impact**: If ADG126 shows a response rate above 20%, it could be clinically differentiated from current standard care, which has a median overall survival of 10-12 months [17][18] Pipeline Beyond ADG126 - **Other Programs**: ADG138, a double masker HER2/CD3 engager, is IND-ready and shows strong preclinical activity [22][24] Major Catalysts - **Upcoming Data**: More mature data from phase 1B expected in early 2026, including potential triplet combination data [26] - **Business Development**: Ongoing discussions for additional trial collaborations following positive data presentations [26] Financial Position - **Cash Position**: $63 million at the end of June, increased by $17 million from Sanofi investment, funding operations into 2027 [27]

Core Insights - Adagene Inc. announced that its lead product ADG126 will be featured in two oral presentations at the CSCO Meeting in Jinan, China, from September 10-14, 2025 [1] Group 1: Clinical Developments - ADG126, a masked anti-CTLA-4 SAFEbody, is currently in Phase 1b/2 clinical studies in combination with pembrolizumab for treating advanced microsatellite-stable colorectal cancer (MSS CRC) [6][7] - The combination therapy has shown an objective response rate (ORR) of approximately 30% and over 80% disease control in refractory/resistant MSS CRC patients without liver metastasis, with a median overall survival (OS) of 19.4 months in the 10 mg/kg cohort [3] Group 2: Presentations at CSCO Meeting - Dr. Xu Ruihua will present updated results of the ADG126-P001 study on September 11, 2025, focusing on the efficacy of ADG126 combined with pembrolizumab in advanced MSS CRC [2] - Dr. Heinz-Josef Lenz will discuss the role of anti-CTLA-4 therapy in metastatic CRC, emphasizing the potential of ADG126 in treating cold tumors like MSS CRC [3] Group 3: Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies using its proprietary SAFEbody technology [4][5] - The company employs computational biology and artificial intelligence to design antibodies that meet unmet patient needs, and it has established strategic collaborations to enhance its research capabilities [4]

Core Insights - Adagene Inc. has appointed Dr. Axel Hoos as Executive Advisor, enhancing its leadership in immuno-oncology [1][2] - The company is advancing innovative antibody therapies targeting CTLA-4, aiming to improve efficacy and reduce toxicity in cancer treatment [2][6] - Dr. Hoos brings extensive experience in immuno-oncology, having previously led the development of YERVOY, the first FDA-approved immune checkpoint inhibitor [2][3][4] Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies using computational biology and artificial intelligence [5] - The company utilizes its SAFEbody precision masking technology to address safety and tolerability challenges in antibody therapeutics [6] Pipeline and Technology - Adagene's lead clinical program, ADG126, is a masked anti-CTLA-4 SAFEbody currently in phase 1b/2 studies, particularly targeting Metastatic Microsatellite-stable Colorectal Cancer [7] - The SAFEbody platform allows for tumor-specific targeting while minimizing off-tumor toxicity, enhancing the therapeutic window for antibody treatments [6][7]

Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence to address unmet patient needs [3][4] - 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 targets the tumor microenvironment, allowing for tumor-specific antibody targeting while minimizing toxicity to healthy tissues [4] Clinical Programs - The lead clinical program, ADG126 (muzastotug), is a masked anti-CTLA-4 SAFEbody currently in phase 1b/2 clinical studies, focusing on Metastatic Microsatellite-stable (MSS) Colorectal Cancer in combination with anti-PD-1 therapy [5] - The SAFEbody platform is validated for use across various antibody-based therapeutic modalities, including Fc empowered antibodies and antibody-drug conjugates [5] Investor Engagement - Adagene's Chief Strategy Officer will participate in one-on-one investor meetings and a fireside chat at two upcoming investor conferences in New York in September [1][2] - Webcasts of the presentations will be available on the company's website for at least 30 days [2]

Core Viewpoint - Tianyan Pharmaceutical (ADAG) is a biopharmaceutical company focused on developing innovative cancer immunotherapies based on original antibodies, utilizing a powerful platform that combines computational biology and artificial intelligence [1]. Financial Performance - As of December 31, 2024, Tianyan Pharmaceutical reported total revenue of $103,200, a year-over-year decrease of 99.43% [1]. - The company recorded a net profit attributable to shareholders of -$33.4241 million, reflecting a year-over-year decline of 76.41% [1]. Company Overview - Tianyan Pharmaceutical is a platform-driven company engaged in the clinical product development stage, dedicated to discovering and developing new cancer immunotherapies [1]. - The company’s antibody discovery engine, known as the "Dynamic Precision Library," is advancing the development of its product pipeline, aiming to create potentially innovative or best-in-class products globally [1].

Core Insights - Tianyan Pharmaceutical (ADAG) experienced a 10.09% increase in stock price, reaching $2.51 per share, with a total market capitalization of $118 million as of August 22 [1] - The company's total revenue for the year ending December 31, 2024, is projected to be $103,200, a significant decrease of 99.43% year-over-year [1] - The net profit attributable to the parent company is expected to be -$33.4241 million, reflecting a year-over-year decline of 76.41% [1] Company Overview - Tianyan Pharmaceutical is a platform-driven biopharmaceutical company focused on the development of clinical products, particularly in cancer immunotherapy [1] - The company utilizes a combination of computational biology and artificial intelligence to create novel antibodies with high safety and efficacy [1] - The "Dynamic Precision Library" serves as the company's antibody discovery engine, driving the development of its product pipeline aimed at creating globally innovative or best-in-class products [1]

Core Viewpoint - Tianyan Pharmaceutical (ADAG) is a biopharmaceutical company focused on developing innovative cancer immunotherapies based on original antibodies, utilizing a powerful platform that combines computational biology and artificial intelligence [1]. Financial Performance - As of December 31, 2024, Tianyan Pharmaceutical reported total revenue of $103,200, a year-over-year decrease of 99.43% [1]. - The company recorded a net profit attributable to shareholders of -$33.4241 million, representing a year-over-year decline of 76.41% [1]. Company Overview - Tianyan Pharmaceutical is a platform-driven company engaged in the clinical product development phase, dedicated to discovering and developing new cancer immunotherapies [1]. - The company’s antibody discovery engine, known as the "Dynamic Precision Library," is advancing the development of its product pipeline, aiming to create potentially innovative or best-in-class products globally [1].