Full Press Release Details
Reports Full Year 2025 Financial Results and Provides Corporate Update
2025, muzastotug showed 29% confirmed overall response rate (ORR) among 21 patients with MSS CRC in the 20 mg/kg dose cohorts
overall survival (OS) for the 10 mg/kg cohorts was 19.4 months, with a median follow-up of 17.8 months
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
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
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
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.
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.
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
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.
ADG126- Phase 1b/2 data:
AMERICAN ASSOCIATION FOR CANCER RESEARCH
The following abstracts have been selected
for presentation at AACR 2026:
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.
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.
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
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.
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)
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:
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 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:
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.
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:
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.
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.
"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.
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
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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