Adagene gets $2.0M Exelixis milestone payment

Q: How much milestone revenue does Adagene (ADAG) receive from the Exelixis collaboration?

Adagene receives a $2.0 million milestone payment from Exelixis tied to a preclinical milestone for XB404. The company also reports an additional payment triggered by candidate selection for another SAFEbody ADC program, though that additional amount is not specified.

Q: What future economics could Adagene (ADAG) receive from its Exelixis deal?

Adagene states it is eligible to receive additional development and commercialization milestones and royalties on net sales of products developed using its SAFEbody technology under the collaboration and license agreement with Exelixis.

Q: What is Adagene’s lead clinical program mentioned in the filing?

Adagene’s lead clinical program is muzastotug (ADG126), a masked, anti-CTLA-4 SAFEbody with FDA Fast Track designation. It is in Phase 1b/2 and Phase 2 studies in combination with anti-PD-1 therapy, focused on MSS metastatic colorectal cancer.

Adagene reports a collaboration milestone with Exelixis tied to XB404, generating a $2.0 million payment and additional program-related consideration.

Filing Impact

(Neutral)

Filing Sentiment

(Neutral)

Form Type

6-K

Rhea-AI Filing Summary

Adagene Inc. (ADAG) announced that it achieved a preclinical milestone under its collaboration and license agreement with Exelixis related to the SAFEbody-based antibody-drug conjugate candidate XB404. This milestone triggered a $2.0 million milestone payment from Exelixis to Adagene.

An additional payment was also triggered by the selection of candidates for another SAFEbody antibody-drug conjugate program. Under the collaboration, Exelixis may use Adagene’s SAFEbody technology to generate masked monoclonal antibodies, and Adagene remains eligible for further development and commercialization milestone payments and royalties on net sales of resulting products.

Positive

Collaboration with Exelixis progressed, triggering a $2.0 million milestone payment plus an additional program-related payment and eligibility for future milestones and royalties, reinforcing non-dilutive partnering value.

Negative

None.

Key Figures

Milestone payment from Exelixis: $2.0 million Fast Track designation: 1 program Clinical development stages: Phase 1b/2 and Phase 2

3 metrics

Milestone payment from Exelixis $2.0 million Preclinical milestone event for XB404 under the collaboration and license agreement

Fast Track designation 1 program Muzastotug (ADG126), Adagene’s lead clinical program, has FDA Fast Track designation

Clinical development stages Phase 1b/2 and Phase 2 Muzastotug (ADG126) is in Phase 1b/2 and Phase 2 combination studies

Key Terms

SAFEbody, antibody-drug conjugate, tumor microenvironment, Fast Track designation, +1 more

5 terms

SAFEbody medical

"Adagene’s SAFEbody technology is designed to address safety and tolerability challenges"

antibody-drug conjugate medical

"another SAFEbody antibody-drug conjugate (ADC) program"

An antibody-drug conjugate is a targeted medicine that combines an antibody, which can identify specific cells, with a powerful drug designed to destroy those cells. This approach allows for precise treatment, minimizing damage to healthy tissue. For investors, developments in this area can signal advances in cancer therapies and potential growth opportunities in the biotech sector.

tumor microenvironment medical

"Through activation in the tumor microenvironment, this allows for tumor-specific targeting"

The tumor microenvironment is the immediate area surrounding a cancer cell, made up of nearby cells, blood vessels, and support structures that influence how the cancer grows and spreads. It functions like a bustling neighborhood that can either help or hinder the tumor’s development. For investors, understanding changes in this environment can signal the effectiveness of treatments and potential shifts in a cancer-related market.

Fast Track designation regulatory

"a masked, anti-CTLA-4 SAFEbody with FDA Fast Track designation"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

microsatellite stable (MSS) medical

"particularly focused on microsatellite stable (MSS) metastatic colorectal cancer"

Microsatellite stable (MSS) describes a tumor whose short, repeating DNA sequences remain unchanged during cell division, meaning the cancer’s DNA repair system is functioning normally. For investors this matters because MSS status is a common biological test result used to predict how well certain therapies—especially some immunotherapies—will work, influence clinical trial design and enrollment, and affect regulatory decisions and commercial prospects for new cancer treatments.

FAQ

What did Adagene (ADAG) announce in its September 2026 Form 6-K?

Adagene announced achievement of a preclinical milestone under its collaboration and license agreement with Exelixis for the SAFEbody-based ADC candidate XB404, resulting in a $2.0 million milestone payment and an additional payment tied to another SAFEbody ADC program.

How much milestone revenue does Adagene (ADAG) receive from the Exelixis collaboration?

Adagene receives a $2.0 million milestone payment from Exelixis tied to a preclinical milestone for XB404. The company also reports an additional payment triggered by candidate selection for another SAFEbody ADC program, though that additional amount is not specified.

What is XB404 in Adagene’s collaboration with Exelixis?

XB404 is an antibody-drug conjugate candidate built with Adagene’s SAFEbody masking technology. It is designed to deliver a cytotoxic payload to ROR1/2-expressing tumors while aiming to minimize on-target, off-tumor side effects.

What future economics could Adagene (ADAG) receive from its Exelixis deal?

Adagene states it is eligible to receive additional development and commercialization milestones and royalties on net sales of products developed using its SAFEbody technology under the collaboration and license agreement with Exelixis.

What is Adagene’s lead clinical program mentioned in the filing?

Adagene’s lead clinical program is muzastotug (ADG126), a masked, anti-CTLA-4 SAFEbody with FDA Fast Track designation. It is in Phase 1b/2 and Phase 2 studies in combination with anti-PD-1 therapy, focused on MSS metastatic colorectal cancer.

How does Adagene (ADAG) describe its SAFEbody technology?

Adagene describes SAFEbody as a precision masking technology that shields the binding domain of antibody therapies, then activates them in the tumor microenvironment, aiming for tumor-specific targeting while minimizing on-target off-tumor toxicity in healthy tissues.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Available on EDGAR 09/09/2026 - 08:00 AM Accepted by SEC EDGAR 09/09/2026 - 08:00 AM

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-
16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the Month of September 2026

Commission File Number: 001-39997

Adagene Inc.

4F, Building C14, No. 218

Xinghu Street, Suzhou Industrial Park

Suzhou, Jiangsu Province, 215123

People’s Republic of China

+86-512-8777-3632

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F x Form 40-F ¨

SIGNATURES

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.

	By:	/s/ Peter Luo
	Name:	Peter Luo
	Title:	Chief Executive Officer

Date: September 9, 2026

EXHIBIT INDEX

Exhibit		Description

99.1		Press release titled “Adagene Achieves Milestone in Collaboration with Exelixis for Advancement of SAFEbody^® Antibody-Drug Conjugate Candidates”

Exhibit 99.1

Adagene Achieves Milestone in Collaboration with Exelixis for Advancement of SAFEbody^® Antibody-Drug Conjugate Candidates

SAN DIEGO and SUZHOU, China, September 9, 2026 – Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today announced the achievement of a milestone in its ongoing collaboration and license agreement with Exelixis, Inc. (“Exelixis”).

The milestone achievement is related to a preclinical milestone event for XB404 and resulted in a $2.0 million milestone payment from Exelixis. XB404, built with Adagene’s SAFEbody masking technology, is designed to deliver a cytotoxic payload to ROR1/2-expressing tumors while minimizing on-target, off-tumor side effects. An additional payment to Adagene was triggered by the selection of candidates for another SAFEbody^® antibody-drug conjugate (ADC) program. Exelixis has the right to utilize Adagene's SAFEbody technology platform to generate masked monoclonal antibodies for the development of masked ADC candidates.

Adagene is eligible to receive development and commercialization milestones and royalties on net sales of products developed.

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.

For more information, please visit: https://investor.adagene.com.

Follow Adagene on WeChat, LinkedIn and X.

NEObody® is a registered trademark in the United States, China, Australia, Japan, Singapore, Switzerland, Korea, United Kingdom and the European Union. SAFEbody® is a registered trademark in the United States, China, Australia, Japan, Singapore, and the European Union.

FORWARD LOOKING STATEMENTS

This press release contains forward-looking statements, including statements regarding expected clinical development plans. 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 the underlying 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 and other operations, 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:

Ian Stone

LifeSci Communications

istone@lifescicomms.com

Source: View Original Filing on SEC EDGAR

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EX-99.1 EXHIBIT 99.1 10.2 KB