Adagene expects $8M Sanofi closing, subject to conditions
Enrollment is complete in the 60-patient randomized study, with initial results expected in the first half of 2027.
Sentiment and the balance of points
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Rhea-AI Filing Summary
Adagene Inc. expects the second closing of Sanofi’s strategic investment to occur on or around November 20, 2026, subject to the satisfaction of other customary closing conditions. The closing is for US$8.0 million; Adagene expects to issue Sanofi 378,788 Series A non-voting convertible preferred shares, each initially convertible into ten ordinary shares. Once completed, Sanofi’s total investment under the agreement would be US$25.0 million. The first closing, for US$17.0 million, occurred on July 2, 2025.
Adagene also completed enrollment of 60 patients in its randomized Phase 2 dose-optimization trial of muzastotug with pembrolizumab for late-line microsatellite stable colorectal cancer without liver metastases. Patients were randomized 1:1 between two dose regimens. The primary endpoint is overall response rate; secondary endpoints are duration of response, progression-free survival and overall survival. Initial results are expected in the first half of 2027 to inform the Phase 3 dose regimen. Adagene retains worldwide commercial rights to muzastotug.
Filing Explained
Adagene reports that the Full Phase 2 Enrollment milestone was achieved on November 9, satisfying that trigger for Sanofi’s second investment closing; customary closing conditions remain, so the anticipated proceeds and additional preferred shares have not yet been received or issued.
Key Figures
Key Terms
overall response rate (ORR) medical
progression-free survival (PFS) medical
SAFEbody® technical
FAQ
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of November 2026
Commission file number: 001-39997
Adagene Inc.
(Exact Name of Registrant as Specified in Its Charter)
4F, Building C14, No. 218
Xinghu Street, Suzhou Industrial Park
Suzhou, Jiangsu Province, 215123
People’s Republic of China
(Address of Principal Executive Offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F x Form 40-F ¨
Adagene Inc. (“Adagene” or the “Company”) (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today announced the expected completion of the second closing of the previously announced strategic investment by Sanofi (Euronext Paris: SAN; Nasdaq: SNY).
As previously disclosed in the Company's Current Report on Form 6-K dated July 1, 2025, under the terms of the securities purchase agreement dated June 30, 2025 (the “Securities Purchase Agreement”), Sanofi Foreign Participations B.V.(“Sanofi”) agreed to purchase the Company’s Series A non-voting convertible preferred shares (the “Series A Preferred Shares”), each share of which is initially convertible into ten ordinary shares of the Company (the “Ordinary Shares”) in two closings, each subject to certain conditions. The first closing for US$17.0 million occurred on July 2, 2025, at which the Company issued 1,062,500 Series A Preferred Shares to Sanofi.
Following the Company’s announcement on November 9, 2026 that it had achieved Full Phase 2 Enrollment (as defined in the Securities Purchase Agreement), the second closing for US$8.0 million is expected to occur on or around November 20, 2026, subject to the satisfaction of other customary closing conditions. In connection with the second closing, the Company expects to issue an additional 378,788 Series A Preferred Shares to Sanofi, bringing Sanofi's total investment under the Securities Purchase Agreement to US$25.0 million.
The foregoing description of the Securities Purchase Agreement and the Series A Preferred Shares issued under the Securities Purchase Agreement does not purport to be complete and is qualified in its entirety by references to the full text of the form of Certificate of Designations and the Securities Purchase Agreement, which are filed as Exhibits 4.1 and Exhibit 10.1 to the Current Report on Form 6-K filed on July 1, 2025, respectively, and are incorporated by reference herein.
INCORPORATION BY REFERENCE
This report on Form 6-K is hereby incorporated by reference in the registration statements of Adagene on Form F-3 (No. 333-287161 and No.333-291196) to the extent not superseded by documents or reports subsequently filed.
FORWARD LOOKING Statement
The Company cautions you that statements contained in this report regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding management’s beliefs regarding the anticipated initial closing date of the private placement and the Company’s achievement of the milestone condition for the second closing of the Sanofi investment and the receipt of proceeds therefrom. The inclusion of forward-looking statements should not be regarded as a representation by the Company that any of its plans will be achieved. Actual results may differ from those set forth in this report due to the risks and uncertainties inherent in the Company’s business, including, without limitation, market risks and other market conditions; the risk that the conditions to each of the closings under the Securities Purchase Agreement are not satisfied; potential delays in the commencement, enrollment and completion of clinical trials; Adagene’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Adagene’s drug candidates; Adagene’s ability to achieve commercial success for its drug candidates, if approved; Adagene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene’s reliance on third parties to conduct drug development, manufacturing and other services; Adagene’s limited operating history and Adagene’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; Adagene’s ability to enter into additional collaboration agreements beyond its existing strategic partnerships or collaborations, as well as those risks more fully discussed in the “Risk Factors” section in Adagene’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Adagene, and Adagene undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | Press Release titled “Adagene Announces Completion of Enrollment in Randomized Dose Optimization Phase 2 Trial of Muzastotug in Combination with KEYTRUDA® (pembrolizumab) in Microsatellite Stable Colorectal Cancer.” |
Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| ADAGENE, INC. | ||||
| Date: | November 9, 2026 | By: | /s/ Peter (Peizhi) Luo | |
| Name: Peter (Peizhi) Luo | ||||
| Title: Chief Executive Officer | ||||
Exhibit 99.1
Adagene Announces Completion of Enrollment in Randomized Dose Optimization Phase 2 Trial of Muzastotug in Combination with KEYTRUDA® (pembrolizumab) in Microsatellite Stable Colorectal Cancer
- Enrollment of 60 patients complete; initial results expected in 1H 2027 to inform dose regimen for the Phase 3 trial
- Adagene continues to own worldwide commercial rights to muzastotug
SAN DIEGO and SUZHOU, China, November 9, 2026 (GLOBE NEWSWIRE) -- Adagene Inc. (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today announced completion of enrollment in its randomized Phase 2 dose-optimization trial of muzastotug (ADG126), a masked, anti-CTLA-4 SAFEbody®, in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with late-line microsatellite stable colorectal cancer (MSS CRC) without liver metastases.
“Completing enrollment in this randomized trial is an important step toward identifying the dose regimen of muzastotug for the Phase 3 registration trial,” said Peter Luo, Ph.D., Chairman and President of R&D at Adagene. “We acknowledge Sanofi’s additional equity investment associated with this trial, which supports continued development of muzastotug in solid tumors, including MSS CRC, where dose-limiting challenges have restricted the use of anti-CTLA-4 therapies. As we look ahead to initial results in the first half of 2027, we hope new data will validate muzastotug’s broad applicability and combinability, further enhanced by its induction and maintenance dosing regimens. This could position muzastotug as a transformative next-generation backbone for combination therapies across multiple indications, in both early- and late-line treatment settings. It could also unlock value in indications where legacy CTLA-4/PD-1 based combinations are already FDA-approved, as well as in historically refractory tumors like MSS CRC.”
About the Phase 2 Trial
The randomized Phase 2 trial (NCT05405595) was incorporated into the existing protocol for the Phase 1b/2 study following a 2025 meeting with the U.S. Food and Drug Administration (FDA). The primary endpoint of the Phase 2 trial is overall response rate (ORR), and secondary endpoints include duration of response (DOR), progression-free survival (PFS), and overall survival (OS).
The study enrolled 60 patients, randomized 1:1 into one of two treatment arms evaluating different dose regimens of muzastotug in combination with pembrolizumab. Both arms use induction to rapidly establish activated muzastotug exposure in tumors, followed by maintenance to sustain exposure and potentially improve ORR and OS:
| · | Arm A: Muzastotug 10 mg/kg every three weeks (Q3W) for four doses, followed by 10 mg/kg every six weeks (Q6W) maintenance |
| · | Arm B: Muzastotug 20 mg/kg Q6W for two doses, followed by 15 mg/kg Q6W maintenance |
As previously announced in July 2025, the following elements of the Phase 3 trial design were also confirmed following a meeting with the FDA:
| · | Patient Population: Trials will enroll late-line patients with MSS CRC without liver metastases, including those with peritoneal metastasis/involvement. |
| · | Phase 3 Trial Design: The FDA agreed with Adagene’s proposed standard-of-care (SOC) control arm for the Phase 3 clinical trial and confirmed that a muzastotug monotherapy arm was not required. |
| · | Phase 3 Endpoints: The primary endpoint of the Phase 3 trial will be OS. Secondary endpoints will include PFS, DOR and ORR. |
About Adagene
Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biotechnology company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address globally unmet patient needs. The company has forged strategic collaborations with reputable global partners that leverage its SAFEbody® precision masking technology in multiple approaches at the vanguard of science.
Powered by its proprietary Dynamic Precision Library (DPL) platform, composed of NEObody™, SAFEbody, and POWERbody™ technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. The company’s SAFEbody technology is designed to address safety and tolerability challenges associated with many antibody therapeutics by using precision masking technology to shield the binding domain of the biologic therapy. Through activation in the tumor microenvironment, this allows for tumor-specific targeting of antibodies, while minimizing on-target off-tumor toxicity in healthy tissues.
Adagene’s lead clinical program, muzastotug (ADG126), is a masked, anti-CTLA-4 SAFEbody with FDA Fast Track designation that targets a unique epitope of CTLA-4 in regulatory T cells (Tregs) in the tumor microenvironment. Muzastotug is currently in Phase 1b/2 and Phase 2 clinical studies in combination with anti-PD-1 therapy, particularly focused on microsatellite stable (MSS) metastatic colorectal cancer (CRC). Validated by ongoing clinical research, the SAFEbody platform can be applied to a wide variety of antibody-based therapeutic modalities, including Fc empowered antibodies, antibody-drug conjugates, and bi/multi-specific T-cell engagers.
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SAFEbody® is a registered trademark in the United States, China, Australia, Japan, Singapore, and the European Union.
Safe Harbor Statement
This press release contains forward-looking statements, including statements regarding the potential implications of clinical data for patients and Adagene’s advancement of, and anticipated preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Adagene’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Adagene’s drug candidates; Adagene’s ability to achieve commercial success for its drug candidates, if approved; Adagene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene’s reliance on third parties to conduct drug development, manufacturing and other services; Adagene’s limited operating history and Adagene’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; Adagene’s ability to enter into additional collaboration agreements beyond its existing strategic partnerships or collaborations, as well as those risks more fully discussed in the “Risk Factors” section in Adagene’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Adagene, and Adagene undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
Investor Contacts:
Raymond Tam
Raymond_tam@adagene.com
Corey Davis
LifeSci Advisors
cdavis@lifesciadvisors.com
Media Contact:
Michael Fitzhugh
LifeSci Communications
mfitzhugh@lifescicomms.com