Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
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.
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 |
| · | 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 |
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). |
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.
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.
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.
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
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$0.0001 per share; 640,000,000 shares authorized, and 58,886,944 shares issued and outstanding as of December
31, 2024; and 640,000,000 shares authorized, and 59,231,993 shares issued and outstanding as of December 31, 2025) | |
| 5,889 | | |
| 5,923 | |
| Additional
paid-in capital | |
| 362,220,445 | | |
| 366,043,455 | |
| Accumulated
other comprehensive loss | |
| (526,903 | ) | |
| (1,914,831 | ) |
| Accumulated
deficit | |
| (311,175,587 | ) | |
| (328,785,000 | ) |
| Total shareholders’
equity | |
| 50,523,844 | | |
| 35,349,547 | |
| TOTAL
LIABILITIES, MEZZANINE EQUITY AND SHAREHOLDERS’ EQUITY | |
| 89,268,425 | | |
| 78,263,297 | |
Unaudited
Consolidated Statements of Comprehensive Loss
| | |
For the Year
Ended | | |
For the Year
Ended | |
| | |
December
31, 2024 | | |
December
31, 2025 | |
| | |
US$ | | |
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 | ) |
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 | ) |