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Adagene (NASDAQ: ADAG) revenue jumps in 2025 as losses narrow and cash runway extends

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(Neutral)
Filing Sentiment
(Neutral)
Form Type
6-K

Rhea-AI Filing Summary

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.

Positive

  • Revenue inflection and loss reduction: Net revenue increased to US$7.7 million from US$0.1 million, while GAAP net loss narrowed to US$17.6 million from US$33.4 million, showing materially improved financial performance.
  • Extended cash runway: Cash of US$74.5 million at December 31, 2025, plus 2026 ATM proceeds, is expected to provide funding into early 2028, reducing near-term financing pressure.
  • Encouraging clinical data for muzastotug: A 29% confirmed overall response rate in 21 MSS colorectal cancer patients at 20 mg/kg, with low severe toxicity and Fast Track Designation, supports advancement toward randomized Phase 2 and registrational planning.

Negative

  • Business remains loss-making: Despite improvements, Adagene reported a 2025 GAAP net loss of US$17.6 million and non-GAAP net loss of US$13.9 million, indicating ongoing dependence on external funding and partnering.
  • Balance sheet complexity increased: Introduction of US$16.55 million of Series A non-voting contingently redeemable convertible preferred shares classified as mezzanine equity adds another capital layer ahead of common shareholders.

Insights

Adagene pairs strong revenue growth with de-risking clinical data and extended cash runway.

Adagene delivered net revenue of US$7.7 million in 2025, up about 7,333%, driven by collaboration and technology licensing milestones. Combined with a 23% reduction in R&D spending to US$22.0 million, this materially narrows the company’s burn.

GAAP net loss fell to US$17.6 million, and non-GAAP net loss to US$13.9 million, indicating tighter cost control while advancing the pipeline. Cash of US$74.5 million at year-end, plus 2026 ATM proceeds, is expected to fund operations into early 2028, giving notable visibility.

On the clinical side, muzastotug plus pembrolizumab showed a 29% confirmed overall response rate in 21 MSS colorectal cancer patients at 20 mg/kg and a 4% discontinuation rate across 67 patients, with no Grade 4 or 5 treatment-related adverse events reported. These data, alongside FDA Fast Track Designation and planned randomized Phase 2 and registrational steps through 1H 2027, strengthen the asset’s potential while keeping safety and trial execution as key areas for future updates.

Net revenue 2025 US$7.7 million For the year ended December 31, 2025
Net revenue 2024 US$0.1 million For the year ended December 31, 2024
GAAP net loss 2025 US$17.6 million Net loss attributable to Adagene Inc.’s shareholders, 2025
Non-GAAP net loss 2025 US$13.9 million Excludes share-based compensation expenses, 2025
Cash and cash equivalents US$74.5 million As of December 31, 2025
R&D expenses 2025 US$22.0 million For the year ended December 31, 2025
Ordinary shares outstanding 59,231,993 shares As of December 31, 2025
Overall response rate 29% Confirmed ORR among 21 MSS CRC patients at 20 mg/kg dose
overall response rate (ORR) medical
"muzastotug showed 29% confirmed overall response rate (ORR) among 21 patients"
Overall response rate (ORR) is the percentage of trial participants whose disease measurably improves—typically tumor shrinkage or disappearance—according to predefined medical criteria. Investors watch ORR because it provides an early, concrete signal of a therapy’s effectiveness and commercial potential, similar to seeing what share of products in a test batch actually work before deciding to back wider production.
median overall survival (OS) medical
"Median overall survival (OS) for the 10 mg/kg cohorts was 19.4 months"
Median overall survival (OS) is the midpoint of how long patients live after a diagnosis or start of a treatment — half the patients lived longer and half lived shorter than that time. Investors use it as a headline measure of a therapy’s real-world benefit because longer median OS can drive regulatory approval, physician adoption, pricing and sales; think of it as the median performance metric that helps predict a drug’s commercial potential.
Fast Track Designation regulatory
"Supported by Fast Track Designation and FDA alignment under Project Optimus"
A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.
SAFEbody technical
"the company’s masked, anti-CTLA-4 SAFEbody ADG126"
non-GAAP net loss financial
"Non-GAAP net loss, which is defined as net loss attributable to ordinary shareholders"
mezzanine equity financial
"Total mezzanine equity ... 1,062,500 shares ... as of December 31, 2025"
Mezzanine equity is a layer of financing that sits between bank loans and full ownership, combining elements of borrowed money and equity. It often gives lenders higher potential returns in exchange for taking more risk, sometimes with the option to convert into ownership or receive extra payments; think of it as a middle seat that pays more because it’s less secure than front-row debt. Investors watch it because it affects a company’s debt risk, potential dilution of ownership, and expected returns.

 

 

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 April 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: April 1, 2026  

 

 

 

 

EXHIBIT INDEX

 

Exhibit   Description
     
99.1   Press release titled “Adagene Reports Full Year 2025 Financial Results and Provides Corporate Update”

 

 

 

 

Exhibit 99.1

 

 

 

Adagene Reports Full Year 2025 Financial Results and Provides Corporate Update

 

In 2025, muzastotug showed 29% confirmed overall response rate (ORR) among 21 patients with MSS CRC in the 20 mg/kg dose cohorts

 

Median overall survival (OS) for the 10 mg/kg cohorts was 19.4 months, with a median follow-up of 17.8 months

 

4% overall discontinuation rate, no dose limiting toxicities, and no Grade 4 or 5 treatment-related adverse events (TRAEs) across 67 patients in all dose cohorts supports improved tolerability profile of muzastotug

 

Randomized Phase 2 trial enrollment ahead of plan, with potential updates in 2026 and results expected in 1H 2027; registration trial expected to begin once optimal dose regimen has been established

 

Cash and cash equivalents of $74.5 million as of December 31, 2025, plus proceeds raised from the ATM Offering in 2026 year-to-date, anticipated to provide cash runway into early 2028

 

SAN DIEGO, Calif. and SUZHOU, China, April 1, 2026 – Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel anti-body-based therapies, today reported financial results for the full year 2025 and provided corporate updates.

 

“Our clinical data for muzastotug plus pembrolizumab consistently demonstrate potent, dose-dependent efficacy,” said Peter Luo, Ph.D., Chairman and President of R&D at Adagene. “The 10 mg/kg data reported at ASCO have now matured into the classic long survival tail of CTLA-4 inhibition. By significantly mitigating severe toxicities, patients remain on therapy longer, allowing CTLA-4-mediated intratumoral Treg depletion, alongside PD-1-mediated reinvigoration and CTLA-4-mediated priming of effector T cells, to drive durable disease control. Importantly, these data provide a clear, de-risked read-through to the 20 mg/kg dose, which already shows an encouraging 29% ORR with median duration of response not yet reached.

 

“Supported by Fast Track Designation and FDA alignment under Project Optimus, we are on track to finalize the optimal combination dose regimen for a potential MSS colorectal cancer registrational trial. The expanded therapeutic window also helps to establish muzastotug as a foundational combination backbone. At AACR, we will showcase this potential with data from triplet regimens—combining with fruquintinib in 3L+ MSS CRC, alongside results from the Morpheus Liver study evaluating a triplet of muzastotug, atezolizumab, and bevacizumab versus atezolizumab and bevacizumab alone in first-line HCC. These readouts underscore our ability to safely unlock deeper responses in hard-to-treat tumors.”

 

2026 OBJECTIVES & CASH RUNWAY INTO EARLY 2028

 

·Data update from the ongoing Phase 1b/2 study of muzastotug in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in 3L+ MSS CRC, including 41 patients in the 10 mg/kg cohorts and 26 patients in the 20 mg/kg cohorts

 

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·Complete enrollment of the ongoing randomized Phase 2 dose-optimization study with muzastotug, which is being conducted in alignment with FDA Project Optimus, and designed to allow dose regimen selection for Phase 3.

 

·Provide preliminary clinical data, including pathological responses, to inform future development from investigator-initiated Phase 2 trial for neoadjuvant muzastotug + pembrolizumab in colorectal cancer.

 

·Provide initial clinical data from a new cohort of patients in the ongoing Phase 1b/2 study of muzastotug + pembrolizumab in combination with standard of care (fruquintinib) in MSS CRC patients.

 

·Share results of the clinical trial collaboration with Roche, which evaluates muzastotug in triplet combination with atezolizumab and bevacizumab in first-line treatment of locally advanced or metastatic hepatocellular carcinoma (HCC; liver cancer).

 

·Establish additional collaboration/licensing agreements.

 

With cash and cash equivalents of $74.5 million as of December 31, 2025, plus proceeds raised from the ATM Offering in 2026 year-to-date, Company expects a cash runway extending into early 2028.

 

PIPELINE HIGHLIGHTS

 

ADG126- Phase 1b/2 data:

 

·As presented at ASCO 2025, muzastotug showed 29% (6/21) confirmed overall response rate (ORR) in the combined 20 mg/kg dose cohorts.

 

·Among 41 patients in the combined 10mg/kg dose cohorts, median overall survival (mOS) was 19.4 months with a 17.8-month median follow-up, which compares favorably to 11-12 month mOS from fruquintinib Phase 3 trials in the same population1

 

·Across 67 patients in all cohorts, a low 4% overall discontinuation rate, no dose limiting toxicities, and no Grade 4 or 5 treatment-related adverse events (TRAEs); Grade 3 TRAEs were 15% in the 10 mg/kg cohorts and 27% in the 20 mg/kg cohorts, which were generally transient and manageable.

 

·Updated data demonstrate the durability of response and further support the optimized therapeutic index profile of muzastotug, which overcomes well-known dose-limiting toxicities of other CTLA-4 inhibitors at 10-20-fold higher doses2, to provide potentially improved efficacy.

 

·Randomized Phase 2 trial enrollment ongoing, with results expected in 1H 2027; registration trial expected to begin once optimal dose regimen has been established

 

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AMERICAN ASSOCIATION FOR CANCER RESEARCH 2026 PRESENTATIONS

 

The following abstracts have been selected for presentation at AACR 2026:

 

1)Title: Ph1b evaluation of ADG126 (muzastotug, an anti-CTLA-4 masking antibody) pembrolizumab (Pembro) IO doublet in combination with fruquintinib (Fruq) in advanced and metastatic microsatellite stable colorectal cancer

 

This poster will provide initial clinical data from a new cohort of patients in the ongoing Phase 1b/2 study of muzastotug + pembrolizumab in combination with standard of care (fruquintinib) in MSS CRC patients.

 

2)Title: Results from the phase 1b/2 Morpheus Liver study in patients with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC): Muzastotug (ADG126: masked anti-CTLA-4 Ab) combination arm

 

This poster will share results of the clinical trial collaboration with Roche, which evaluates muzastotug in triplet combination with atezolizumab and bevacizumab in first-line treatment of liver cancer.

 

3)Title: Preclinical characterization of XB404, a masked anti-ROR1/2 antibody-drug conjugate

 

Partner Exelixis will present preclinical data from antibody-drug conjugate, XB404, built with Adagene’s SAFEbody masking technology and designed to deliver a cytotoxic payload to ROR1/2-expressing tumors while minimizing on-target, off-tumor side effects.

 

ONGOING COLLABORATIONS

 

·Sanofi: Invested up to $25 million to support muzastotug’s randomized Phase 2 study. Separately, Adagene will supply Sanofi with muzastotug to evaluate the safety, efficacy, pharmacokinetics and biomarker data in combination with Sanofi’s SAR445877 (PD-1 x IL-15 fusion protein) in over 100 patients in a Phase 1/2 clinical trial in advanced solid tumors. Sanofi also exercised its option for a third SAFEbody® discovery program.

 

·Third Arc Bio: Partnered to develop two masked CD3 T cell engagers, expanding SAFEbody® into next-generation T cell therapies.

 

·Exelixis: Advanced a third masked ADC against a solid tumor target, building on the 2021 collaboration.

 

·ConjugateBio: Collaborated on bispecific ADCs using Adagene-derived antibody, further demonstrating scalable platform potential.

 

·Roche: Roche is sponsoring and conducting a phase 1b/2 multi-national trial to evaluate ADG126 in a triple combination with atezolizumab and bevacizumab in first-line hepatocellular carcinoma (HCC).

 

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FINANCIAL HIGHLIGHTS

 

Cash and Cash Equivalents:

 

Cash and cash equivalents were US$74.5 million as of December 31, 2025, compared to US$85.2 million as of December 31, 2024. Total borrowings from commercial banks in China (denominated in RMB) decreased to US$6.1 million as of December 31, 2025 from US$ 18.2 million as of December 31, 2024. The associated loan proceeds were primarily used to pay for the company’s R&D activities in China.

 

Net Revenue:

 

Net revenue was US$7.7 million for the year ended December 31, 2025, compared to US$0.1 million in 2024. The increase of approximately 7,333% reflects net revenue recognized upon fulfillment of certain performance obligations associated with the collaboration and technology licensing agreements with Sanofi, ConjugateBio and Third Arc Bio, respectively.

 

Research and Development (R&D) Expenses:

 

R&D expenses were US$22.0 million for the year ended December 31, 2025, compared to US$28.8 million in 2024. The decrease of approximately 23% in R&D expenses reflects clinical focus on and prioritization of the company’s masked, anti-CTLA-4 SAFEbody ADG126.

 

Administrative Expenses:

 

Administrative expenses were US$7.1 million for the year ended December 31, 2025, compared to US$7.3 million in 2024. The decrease was mainly a result of cost-control measures.

 

Net Loss:

 

Net loss attributable to Adagene Inc.’s shareholders was US$17.6 million for the year ended December 31, 2025, compared to US$33.4 million in 2024.

 

Ordinary Shares Outstanding:

 

As of December 31, 2025, there were 59,231,993 ordinary shares issued and outstanding. Each American depository share, or ADS, represents one and one quarter (1.25) ordinary shares of the company.

 

Non-GAAP Net Loss:

 

Non-GAAP net loss, which is defined as net loss attributable to ordinary shareholders for the period after excluding share-based compensation expenses, was US$13.9 million for the year ended December 31, 2025, compared to US$28.5 million in 2024. Please refer to the section in this press release titled “Reconciliation of GAAP and Non-GAAP Results” for details.

 

Non-GAAP Financial Measures:

 

The company uses non-GAAP net loss and non-GAAP net loss per ordinary shares for the year, which are non-GAAP financial measures, in evaluating its operating results and for financial and operational decision-making purposes. The company believes that non-GAAP net loss and non-GAAP net loss per ordinary shares for the year help identify underlying trends in the company’s business that could otherwise be distorted by the effect of certain expenses that the company includes in its loss for the year. The company believes that non-GAAP net loss and non-GAAP net loss per ordinary shares for the year provide useful information about its results of operations, enhances the overall understanding of its past performance and future prospects and allows for greater visibility with respect to key metrics used by its management in its financial and operational decision-making.

 

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Non-GAAP net loss and non-GAAP net loss per ordinary shares for the year should not be considered in isolation or construed as an alternative to operating profit, loss for the year or any other measure of performance or as an indicator of its operating performance. Investors are encouraged to review non-GAAP net loss and non-GAAP net loss per ordinary shares for the year and the reconciliation to their most directly comparable GAAP measures. Non-GAAP net loss and non-GAAP net loss per ordinary shares for the year here may not be comparable to similarly titled measures presented by other companies. Other companies may calculate similarly titled measures differently, limiting their usefulness as comparative measures to the company’s data. The company encourages investors and others to review its financial information in its entirety and not rely on a single financial measure. Non-GAAP net loss and non-GAAP net loss per ordinary shares for the year represent net loss attributable to ordinary shareholders for the year excluding share- based compensation expenses. Share-based compensation expense is a non-cash expense arising from the grant of stock-based awards to employees. The company believes that the exclusion of share-based compensation expenses from the net loss in the Reconciliation of GAAP and Non-GAAP Results assists management and investors in making meaningful period-to-period comparisons in the company's operating performance or peer group comparisons because (i) the amount of share-based compensation expenses in any specific period may not directly correlate to the company’s underlying performance, (ii) such expenses can vary significantly between periods as a result of the timing of grants of new stock-based awards, and (iii) other companies may use different forms of employee compensation or different valuation methodologies for their share-based compensation.

 

Please see the “Reconciliation of GAAP and Non-GAAP Results” included in this press release for a full reconciliation of non-GAAP net loss and non-GAAP net loss per ordinary shares for the year to net loss attributable to ordinary shareholders for the year/period.

 

1.Qin S, Xu RH, Shen L, Et Al. Subgroup Analysis By Liver Metastasis In The FRESCO Trial Comparing Fruquintinib Versus Placebo Plus Best Supportive Care In Chinese Patients With Metastatic Colorectal Cancer. Onco Targets Ther. 2021;14:4439-; Garcia-Carbonero R, Dasari NA, Eng C, et al. 520P Efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer with and without liver metastasis: A subgroup analysis of the phase III FRESCO-2 trial. Ann Onc 2024;35:S439

 

2.(i) CheckMate 511 (Phase IIIb/IV): This study compared nivolumab 3 mg/kg plus ipilimumab 1 mg/kg Q3W × 4 versus the standard nivolumab 1 mg/kg plus ipilimumab 3 mg/kg Q3W × 4 in patients with advanced melanoma. The trial demonstrated similar efficacy with a significantly lower incidence of Grade 3–5 treatment-related adverse events (34% vs. 48%); and (ii) Lebbé C, et al. (2019). Evaluation of two dosing regimens for nivolumab in combination with ipilimumab in patients with advanced melanoma: Results from the Phase IIIb/IV CheckMate 511 trial. Journal of Clinical Oncology, 37(11):867–875.

 

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.

 

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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.

 

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

 

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA..

 

Safe Harbor Statement

 

This press release contains forward-looking statements, including statements regarding certain clinical results of ADG126, 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, and the impact of the COVID-19 pandemic on Adagene’s clinical development, commercial 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.

 

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Investor Contacts:

Raymond Tam

Raymond_tam@adagene.com

 

Corey Davis
LifeSci Advisors

cdavis@lifesciadvisors.com

 

Media:

Lindsay Rocco

Elixir Health Public Relations
1-862-596-1304
lrocco@elixirhealthpr.com

 

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Unaudited Consolidated Balance Sheets

 

   December 31,   December 31, 
   2024   2025 
    US$    US$ 
ASSETS          
Current assets:          
Cash and cash equivalents   85,194,502    74,523,782 
Amounts due from related parties   8,309    17,349 
Prepayments and other current assets   2,575,194    2,834,034 
Total current assets   87,778,005    77,375,165 
Property, equipment and software, net   1,125,389    717,374 
Operating lease right-of-use assets   283,645    145,535 
Other non-current assets   81,386    25,223 
TOTAL ASSETS   89,268,425    78,263,297 
LIABILITIES AND SHAREHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable   4,241,773    2,884,507 
Contract liabilities       3,462,683 
Amounts due to related parties   13,187,966    10,347,200 
Accruals and other current liabilities   2,816,038    2,790,794 
Income tax payable   5,265    410,198 
Warrant liabilities       205,146 
Short-term borrowings   4,868,956    4,268,154 
Current portion of long-term borrowings   12,923,599    711,359 
Current portion of operating lease liabilities   141,341    92,055 
Total current liabilities   38,184,938    25,172,096 
Long-term borrowings   417,339    1,138,174 
Operating lease liabilities   142,304    53,480 
TOTAL LIABILITIES   38,744,581    26,363,750 
Commitments and contingencies          
Mezzanine equity:          
Series A non-voting contingently redeemable convertible preferred shares (par value of US$0.0001 per share; nil authorized, issued and outstanding as of December 31, 2024; and 1,062,500 shares authorized, issued and outstanding as of December 31, 2025)       16,550,000 
Total mezzanine equity       16,550,000 
Shareholders’ equity:          
Ordinary shares (par value of US$0.0001 per share; 640,000,000 shares authorized, and 58,886,944 shares issued and outstanding as of December 31, 2024; and 640,000,000 shares authorized, and 59,231,993 shares issued and outstanding as of December 31, 2025)   5,889    5,923 
Additional paid-in capital   362,220,445    366,043,455 
Accumulated other comprehensive loss   (526,903)   (1,914,831)
Accumulated deficit   (311,175,587)   (328,785,000)
Total shareholders’ equity   50,523,844    35,349,547 
TOTAL LIABILITIES, MEZZANINE EQUITY AND SHAREHOLDERS’ EQUITY   89,268,425    78,263,297 

 

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Unaudited Consolidated Statements of Comprehensive Loss

 

   For the Year Ended   For the Year Ended 
   December 31, 2024   December 31, 2025 
   US$   US$ 
Revenues        
Licensing and collaboration revenue   103,204    7,670,902 
Operating expenses and income          
Research and development expenses   (28,781,412)   (22,033,573)
Including external related parties   (1,943,523)   (1,580,387)
Administrative expenses   (7,273,335)   (7,075,624)
Loss from operations   (35,951,543)   (21,438,295)
Interest and investment income   3,801,345    2,303,990 
Interest expense   (851,874)   (463,132)
Other income, net   466,620    323,988 
Foreign exchange gain (loss), net   (906,212)   1,318,235 
Change in fair value of warrant liabilities       47,941 
Loss before income tax   (33,441,664)   (17,907,273)
Income tax benefit   17,553    297,860 
Net loss attributable to Adagene Inc.’s shareholders   (33,424,111)   (17,609,413)
Other comprehensive income (loss)          
Foreign currency translation adjustments, net of nil tax   1,273,185    (1,387,928)
Total comprehensive loss attributable to Adagene Inc.’s shareholders   (32,150,926)   (18,997,341)
Net loss attributable to Adagene Inc.’s shareholders   (33,424,111)   (17,609,413)
Net loss attributable to ordinary shareholders   (33,424,111)   (17,609,413)
Weighted average number of ordinary shares used in per share calculation:          
—Basic   56,287,903    59,006,129 
—Diluted   56,287,903    59,006,129 
Net loss per ordinary share          
—Basic   (0.59)   (0.30)
—Diluted   (0.59)   (0.30)

 

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Reconciliation of GAAP and Non-GAAP Results

 

   For the Year Ended   For the Year Ended 
   December 31, 2024   December 31, 2025 
   US$   US$ 
GAAP net loss attributable to ordinary shareholders   (33,424,111)   (17,609,413)
Add back:          
Share-based compensation expenses   4,909,573    3,741,548 
Non-GAAP net loss   (28,514,538)   (13,867,865)
          
Weighted average number of ordinary shares used in per share calculation:          
—Basic   56,287,903    59,006,129 
—Diluted   56,287,903    59,006,129 
Non-GAAP net loss per ordinary share          
—Basic   (0.51)   (0.24)
—Diluted   (0.51)   (0.24)

 

10 

 

FAQ

How did Adagene (ADAG) perform financially in full-year 2025?

Adagene’s 2025 net revenue rose to US$7.7 million, up from US$0.1 million, mainly from collaboration and licensing milestones. GAAP net loss narrowed to US$17.6 million, and non-GAAP net loss improved to US$13.9 million, reflecting higher revenue and lower R&D spending.

What is Adagene’s cash position and runway after its 2025 results?

Adagene reported US$74.5 million in cash and cash equivalents as of December 31, 2025. Including additional proceeds from its 2026 ATM offering, the company expects this capital to fund operations into early 2028, providing several years of financing visibility for its pipeline.

What key clinical results did Adagene report for muzastotug in MSS colorectal cancer?

In 2025, muzastotug plus pembrolizumab achieved a 29% confirmed overall response rate among 21 MSS colorectal cancer patients at the 20 mg/kg dose. Median overall survival for 10 mg/kg cohorts reached 19.4 months, with maturing long-survival tail characteristics typical of CTLA-4 inhibition.

How favorable is the safety profile of Adagene’s lead candidate muzastotug?

Across 67 patients in all muzastotug dose cohorts, Adagene reported only a 4% overall discontinuation rate, no dose-limiting toxicities, and no Grade 4 or 5 treatment-related adverse events. This suggests an improved tolerability profile compared with traditional CTLA-4–targeting approaches.

What upcoming clinical milestones did Adagene outline for muzastotug?

Adagene plans randomized Phase 2 trial enrollment for muzastotug ahead of schedule, with updates expected in 2026 and results in 1H 2027. A registrational trial in MSS colorectal cancer is expected once the optimal combination dose regimen is finalized under FDA Project Optimus alignment.

How did Adagene’s operating expenses change in 2025?

Research and development expenses declined to US$22.0 million in 2025 from US$28.8 million, a reduction of about 23%, driven by focus on ADG126. Administrative expenses were stable at US$7.1 million, slightly down from US$7.3 million thanks to cost-control measures.

What is Adagene’s share count and ADS structure after 2025?

As of December 31, 2025, Adagene had 59,231,993 ordinary shares issued and outstanding. Each American depositary share (ADS) represents 1.25 ordinary shares, which investors should use when translating financial metrics to per-ADS terms.

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