Adagene Inc.'s SEC filings document its foreign-private-issuer reporting for a clinical-stage biotechnology company developing antibody-based cancer immunotherapies. Form 6-K reports furnish clinical-data releases for muzastotug, regulatory updates for MSS colorectal cancer development, full-year financial results, business updates and notices of scientific presentations.
The filings also cover capital-structure and financing matters, including ADS offerings, underwriting agreements and the ADS-to-ordinary-share relationship. Other disclosures include licensing and collaboration agreements using SAFEbody technology, share-based compensation and equity accounts, governance updates, clinical development risks and exhibits furnished under Exchange Act reporting rules.
Adagene Inc. ownership disclosure: Janus Henderson Group plc reports beneficial ownership of 6,666,666 American Depository Receipts, representing 10.1% of the class as of 04/30/2026. The Asset Managers exercise shared voting and dispositive power over those ADRs on behalf of managed portfolios.
The filing states the Asset Managers generally exercise investment and voting discretion for client accounts and that only the Janus Henderson Biotech Innovation Master Fund Ltd. holds more than 5% of the ADRs among the managed portfolios. Signature dated 05/07/2026.
Adagene Inc. furnished a Form 6-K highlighting new clinical data for its lead anti-CTLA-4 SAFEbody, muzastotug (ADG126), from two ongoing Phase 1b/2 triplet combination studies presented at AACR 2026.
In first-line hepatocellular carcinoma, adding muzastotug to atezolizumab and bevacizumab showed a 66.7% overall response rate versus 32.5% for the atezolizumab plus bevacizumab control arm, with median progression-free survival of 8.2 months and overall survival beyond 22 months at data cut, while maintaining a comparable safety profile. In microsatellite stable colorectal cancer without liver metastases, muzastotug with pembrolizumab and fruquintinib produced dose-dependent responses with 25% and 40% overall response rates at 10 mg/kg and 15 mg/kg, respectively, and no dose-limiting toxicities or Grade 4–5 treatment-related adverse events.
The company emphasizes these results as further evidence that its SAFEbody masking technology may allow higher dosing of CTLA-4 blockade within the tumor microenvironment with reduced peripheral toxicity, supporting muzastotug’s potential role as a backbone combination therapy for difficult-to-treat solid tumors.
Adagene Inc. is offering 18,666,000 ADSs, representing 23,332,500 ordinary shares. The prospectus supplement states an initial public offering price of $3.75 per ADS, for a total offering amount of $69,997,500. Net proceeds are estimated at approximately $65.3 million to fund R&D (including ADG126 and ADG138) and general corporate purposes. The supplement highlights program updates for lead candidate ADG126 (muzastotug), ongoing randomized phase 2 MSS CRC study, interim clinical data, PRC regulatory and cybersecurity risks, HFCAA/PCAOB inspection considerations, and required post-offering CSRC filings.
Adagene Inc. is offering 18,666,000 ADSs, representing 23,332,500 ordinary shares. The prospectus supplement states an initial public offering price of $3.75 per ADS, for a total offering amount of $69,997,500. Net proceeds are estimated at approximately $65.3 million to fund R&D (including ADG126 and ADG138) and general corporate purposes. The supplement highlights program updates for lead candidate ADG126 (muzastotug), ongoing randomized phase 2 MSS CRC study, interim clinical data, PRC regulatory and cybersecurity risks, HFCAA/PCAOB inspection considerations, and required post-offering CSRC filings.
Adagene Inc. is offering 18,666,000 ADSs, representing 23,332,500 ordinary shares. The prospectus supplement states an initial public offering price of $3.75 per ADS, for a total offering amount of $69,997,500. Net proceeds are estimated at approximately $65.3 million to fund R&D (including ADG126 and ADG138) and general corporate purposes. The supplement highlights program updates for lead candidate ADG126 (muzastotug), ongoing randomized phase 2 MSS CRC study, interim clinical data, PRC regulatory and cybersecurity risks, HFCAA/PCAOB inspection considerations, and required post-offering CSRC filings.
Adagene Inc. has priced an underwritten public offering of 18,666,000 American Depositary Shares (ADSs) at US$3.75 per ADS, for expected gross proceeds of about US$70.0 million. Each ADS represents 1.25 ordinary shares. All ADSs are being sold by the company, with closing expected on April 6, 2026, subject to customary conditions.
Leerink Partners and LifeSci Capital are acting as joint book-running managers, and Lucid Capital Markets is co‑manager. Company officers and directors agreed to a 60‑day lock‑up restricting additional share sales. The transaction is being conducted under Adagene’s effective shelf registration statement on Form F‑3 and a related prospectus supplement.
Adagene Inc. has priced an underwritten public offering of 18,666,000 American Depositary Shares (ADSs) at US$3.75 per ADS, for expected gross proceeds of about US$70.0 million. Each ADS represents 1.25 ordinary shares. All ADSs are being sold by the company, with closing expected on April 6, 2026, subject to customary conditions.
Leerink Partners and LifeSci Capital are acting as joint book-running managers, and Lucid Capital Markets is co‑manager. Company officers and directors agreed to a 60‑day lock‑up restricting additional share sales. The transaction is being conducted under Adagene’s effective shelf registration statement on Form F‑3 and a related prospectus supplement.
Adagene Inc. has priced an underwritten public offering of 18,666,000 American Depositary Shares (ADSs) at US$3.75 per ADS, for expected gross proceeds of about US$70.0 million. Each ADS represents 1.25 ordinary shares. All ADSs are being sold by the company, with closing expected on April 6, 2026, subject to customary conditions.
Leerink Partners and LifeSci Capital are acting as joint book-running managers, and Lucid Capital Markets is co‑manager. Company officers and directors agreed to a 60‑day lock‑up restricting additional share sales. The transaction is being conducted under Adagene’s effective shelf registration statement on Form F‑3 and a related prospectus supplement.
Adagene Inc. proposes an offering of American Depositary Shares (ADSs), each representing 1.25 ordinary shares, to raise proceeds to fund research and development and for general corporate purposes. The company intends to apply net proceeds primarily to R&D on pipeline programs including ADG126 and other candidates.
The prospectus supplement highlights clinical updates for muzastotug (ADG126), ongoing randomized phase 2 dosing comparisons, Fast Track designation for ADG126 plus pembrolizumab in metastatic MSS colorectal cancer without active liver metastases, and interim efficacy/safety data from multiple combination studies. The supplement also emphasizes structural and regulatory risks tied to Adagene’s Cayman holding company structure and substantive PRC operations, including cybersecurity, CSRC filing requirements and HFCAA/PCAOB inspection uncertainty.
Adagene Inc. proposes an offering of American Depositary Shares (ADSs), each representing 1.25 ordinary shares, to raise proceeds to fund research and development and for general corporate purposes. The company intends to apply net proceeds primarily to R&D on pipeline programs including ADG126 and other candidates.
The prospectus supplement highlights clinical updates for muzastotug (ADG126), ongoing randomized phase 2 dosing comparisons, Fast Track designation for ADG126 plus pembrolizumab in metastatic MSS colorectal cancer without active liver metastases, and interim efficacy/safety data from multiple combination studies. The supplement also emphasizes structural and regulatory risks tied to Adagene’s Cayman holding company structure and substantive PRC operations, including cybersecurity, CSRC filing requirements and HFCAA/PCAOB inspection uncertainty.
Adagene Inc. proposes an offering of American Depositary Shares (ADSs), each representing 1.25 ordinary shares, to raise proceeds to fund research and development and for general corporate purposes. The company intends to apply net proceeds primarily to R&D on pipeline programs including ADG126 and other candidates.
The prospectus supplement highlights clinical updates for muzastotug (ADG126), ongoing randomized phase 2 dosing comparisons, Fast Track designation for ADG126 plus pembrolizumab in metastatic MSS colorectal cancer without active liver metastases, and interim efficacy/safety data from multiple combination studies. The supplement also emphasizes structural and regulatory risks tied to Adagene’s Cayman holding company structure and substantive PRC operations, including cybersecurity, CSRC filing requirements and HFCAA/PCAOB inspection uncertainty.
Adagene Inc. reported updated Phase 1b/2 data for its lead CTLA-4 SAFEbody, muzastotug, in advanced microsatellite stable colorectal cancer without liver metastases, given with pembrolizumab. The combined 20 mg/kg cohorts achieved a confirmed overall response rate of 31% (8/26), versus 13% (5/39) at 10 mg/kg, and median progression-free survival of 6.7 months versus 4.8 months. Median overall survival for the 10 mg/kg cohorts was 19.8 months with 48% of patients alive at two years, while one-year survival at 20 mg/kg reached 80.8%. Safety remained manageable across 67 patients, with a 4% discontinuation rate, no dose-limiting toxicities, and no treatment-related Grade 4 or 5 events, despite higher Grade 3 TRAEs at 20 mg/kg. FDA has granted Fast Track designation for the muzastotug plus pembrolizumab combination, an ongoing randomized Phase 2 trial is enrolling with results expected in the first half of 2027, and a potential registrational study is being planned.
Adagene Inc. reported updated Phase 1b/2 data for its lead CTLA-4 SAFEbody, muzastotug, in advanced microsatellite stable colorectal cancer without liver metastases, given with pembrolizumab. The combined 20 mg/kg cohorts achieved a confirmed overall response rate of 31% (8/26), versus 13% (5/39) at 10 mg/kg, and median progression-free survival of 6.7 months versus 4.8 months. Median overall survival for the 10 mg/kg cohorts was 19.8 months with 48% of patients alive at two years, while one-year survival at 20 mg/kg reached 80.8%. Safety remained manageable across 67 patients, with a 4% discontinuation rate, no dose-limiting toxicities, and no treatment-related Grade 4 or 5 events, despite higher Grade 3 TRAEs at 20 mg/kg. FDA has granted Fast Track designation for the muzastotug plus pembrolizumab combination, an ongoing randomized Phase 2 trial is enrolling with results expected in the first half of 2027, and a potential registrational study is being planned.
Adagene Inc. reported updated Phase 1b/2 data for its lead CTLA-4 SAFEbody, muzastotug, in advanced microsatellite stable colorectal cancer without liver metastases, given with pembrolizumab. The combined 20 mg/kg cohorts achieved a confirmed overall response rate of 31% (8/26), versus 13% (5/39) at 10 mg/kg, and median progression-free survival of 6.7 months versus 4.8 months. Median overall survival for the 10 mg/kg cohorts was 19.8 months with 48% of patients alive at two years, while one-year survival at 20 mg/kg reached 80.8%. Safety remained manageable across 67 patients, with a 4% discontinuation rate, no dose-limiting toxicities, and no treatment-related Grade 4 or 5 events, despite higher Grade 3 TRAEs at 20 mg/kg. FDA has granted Fast Track designation for the muzastotug plus pembrolizumab combination, an ongoing randomized Phase 2 trial is enrolling with results expected in the first half of 2027, and a potential registrational study is being planned.
Adagene Inc. reported full-year 2025 results showing a sharp improvement in both operations and clinical progress. Net revenue rose to US$7.7 million from US$0.1 million, mainly from collaboration and licensing performance obligations. Research and development expenses fell 23% to US$22.0 million, reflecting prioritization of lead SAFEbody candidate muzastotug (ADG126).
Net loss attributable to shareholders narrowed to US$17.6 million from US$33.4 million, while non-GAAP net loss improved to US$13.9 million. Cash and cash equivalents were US$74.5 million as of December 31, 2025, and together with 2026 ATM proceeds, are expected to fund operations into early 2028. Clinically, muzastotug plus pembrolizumab showed a 29% confirmed overall response rate in 21 MSS colorectal cancer patients at 20 mg/kg, with a favorable tolerability profile and maturing survival tail at 10 mg/kg, supporting ongoing randomized Phase 2 and future registrational planning.
Adagene Inc., a Cayman Islands holding company with substantive operations in China and the U.S., files its annual report and reports 59,231,993 ordinary shares outstanding as of December 31, 2025. Investors hold equity in the Cayman parent, not directly in its PRC or U.S. subsidiaries.
The report emphasizes extensive PRC-related risks, including government authority to influence or restrict operations, evolving rules on offshore offerings, cybersecurity and data security, and possible limits on cross-border transfers of scientific and personal data. It also details historical PCAOB inspection limits and the risk of potential HFCAA-driven delisting if future inspections lapse.
Adagene highlights complex tax, foreign exchange and corporate law exposure in China, including potential PRC resident enterprise classification, withholding taxes on dividends and share transfers, M&A and foreign investment reviews, and SAFE registration requirements for offshore structures and employee equity plans. The company notes that changes in U.S.–China trade and investment policies could further affect funding, collaborations and its industry supply chain.
Adagene Inc. Schedule 13G filing reports that Jorey Chernett beneficially owned 2,389,060 Ordinary shares as of the close of business on March 17, 2026, representing 5.1% of the class based on 58,914,087 Ordinary Shares outstanding as of June 30, 2025, per the issuer's prospectus.
The cover disclosure notes the CUSIP 005329107 is assigned to the issuer's ADSs quoted on NASDAQ under the symbol ADAG, and that each ADS represents one and one quarter Ordinary Share. The filing is a beneficial ownership report by the reporting person, signed on March 18, 2026.
Adagene Inc. Chief Strategy Officer Chane-Du Mickael Yannick filed an initial ownership report showing a mix of ordinary shares and equity awards. He holds 279,506 Adagene ordinary shares directly and 188,019 shares indirectly through OT Healthcare Fund I, LLC.
The filing also lists incentive stock options for 400,000 ordinary shares at an exercise price of 1.3760 per share expiring on May 13, 2035, and 400,000 performance-based options at 2.0320 per share expiring on February 5, 2036. In addition, he has indirect warrants for 250,000 shares expiring on July 3, 2028 and 250,000 shares expiring on September 2, 2028 through OT Bio Advisory, LLC.