On August 12, 2026 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, reported financial results for the six months ended June 30, 2026, and provided corporate updates.
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"The first half of 2026 was a period of meaningful advances for the company, as our lead program, muzastotug, a masked, anti-CTLA-4 SAFEbody, continues to demonstrate compelling efficacy and a favorable safety profile in MSS CRC and HCC," said Peter Luo, Ph.D., CEO and President of R&D at Adagene. "The strength of muzastotug as a potential backbone therapy continues to be recognized with recent collaborations and the clinical data to date demonstrates the enhanced safety of muzastotug relative to legacy CTLA-4 therapies, even at approximately ten times higher doses. This enhanced safety allows muzastotug to be used as a potential backbone therapy in combination with pembrolizumab and/or other standard of care therapies, such as fruquintinib. We remain encouraged by the durable benefit we are seeing."
"We also welcomed Peter Lebowitz to our Scientific and Strategic Advisory Board, further strengthening the clinical expertise guiding our programs;" continued Dr. Luo. "The equity offering in April brought in new investors and extended our cash runway into late 2028, allowing us to accelerate our pipeline and deliver on our mission to transform cancer immunotherapy for patients."
PIPELINE HIGHLIGHTS
Muzastotug (ADG126) Phase 1b/2 study in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with advanced microsatellite stable colorectal cancer (MSS CRC) with no liver metastases.
● Updated data announced in April 2026 highlighted clinical results from patients that have been treated with a muzastotug dose of either 10 mg/kg or 20 mg/kg, in combination with pembrolizumab.
o In the combined 10 mg/kg cohorts, muzastotug achieved an overall response rate (ORR) of 13%. The median progression-free survival (PFS) was 4.8 months, and median overall survival (OS) was 19.8 months.
◾ In patients dosed with 10 mg/kg of muzastotug every 6 weeks (Q6W), the ORR was 0% (0/10) and median PFS was 4.5 months.
◾ In patients dosed with 10 mg/kg of muzastotug every 3 weeks (Q3W), the ORR was 17% (5/29) and median PFS was 4.8 months.
o In the combined 20 mg/kg cohorts, muzastotug achieved a confirmed ORR of 31%. The median PFS was 6.7 months, and median OS was not yet reached.
◾ In patients dosed with 20 mg/kg of muzastotug every 6 weeks (Q6W), the ORR was 25% (3/12) and median PFS was 4.9 months.
◾ In the 20 mg/kg loading dose cohort (20 mg/kg, followed by 10 mg/kg Q3W), the ORR was 36% (5/14) and median PFS was 15.4 months.
● 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 38% in the 20 mg/kg cohorts, which were generally transient and manageable.
● Enrollment into the randomized Phase 2 trial is well on-track, and results are expected in 1H 2027. The Phase 2 trial is enrolling patients into two arms designed to allow dose regimen selection for the Phase 3 trial. Both arms include an induction phase to drive early efficacy and a maintenance phase to prolong overall survival.
o Arm A: Patients receive 10 mg/kg induction dose of muzastotug plus 200 mg pembrolizumab Q3W for 4 doses followed by one 200 mg dose of pembrolizumab; the maintenance phase doses 10 mg/kg muzastotug Q6W plus 400 mg of pembrolizumab Q6W.
o Arm B: Patients receive 20 mg/kg induction dose of muzastotug Q6W plus 400 mg pembrolizumab Q6W for 2 doses; the maintenance phase doses muzastotug at 15 mg/kg Q6W plus 400 mg pembrolizumab Q6W.
● A potential registration trial is expected to begin once the recommended dose regimen has been established, supported by the Fast Track Designation and FDA alignment under Project Optimus.
Triple combination Phase 1b/2 study of muzastotug, atezolizumab and bevacizumab, in patients with first-line HCC:
● Data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2026 included results from the study which is evaluating the triple combination of muzastotug, atezolizumab and bevacizumab compared to atezolizumab and bevacizumab as an active control arm. Interim results from six patients in the muzastotug arm (18.8 months median duration of follow-up) demonstrated a 66.7% ORR (4/6) using HCC-specified modified RECIST v1.1 criteria. ORR was 50.0% (3/6) using RECIST v1.1 criteria. The median PFS was 8.2 months (same for both RECIST criteria) and the median OS was not yet reached at the data cut but was greater than 22 months.
● These results compared favorably to the 40 patients in the active control arm (17.2 months median duration of follow-up) that demonstrated an ORR of 32.5% (13/40) using HCC-specified modified RECIST v1.1 criteria, median PFS of 5.5 months, and median OS of 17.5 months. Using RECIST v1.1 criteria, the ORR was 17.5% (7/40) and the median PFS was 4.3 months.
● The triplet regimen of muzastotug, atezolizumab and bevacizumab was well-tolerated with safety data comparable to the doublet active control arm of atezolizumab and bevacizumab. Grade 3 or greater TRAEs were 50% (3/6) in the muzastotug arm and 45% (18/40) in the active control arm, which supports the potential for continuous dosing with muzastotug. Ongoing muzastotug plus atezolizumab treatment after bevacizumab discontinuation suggests potential flexibility to modify individual agents during safety-related interruptions while preserving durable clinical benefit from the muzastotug and atezolizumab doublet for an extended period of time.
Triple combination Phase 1b/2 study of muzastotug, pembrolizumab and fruquintinib in patients with advanced or metastatic MSS CRC:
● In data presented at AACR (Free AACR Whitepaper), interim results from the study demonstrated a 25% confirmed ORR (1/4) among patients at a dose of 10 mg/kg every 6 weeks (Q6W) of muzastotug (6.7 months median follow-up), and a 40% ORR (2/5) among patients at a dose of 15 mg/kg Q6W of muzastotug (5.9 months median follow-up). The triplet regimen was well-tolerated with no new safety signals, relative to known CTLA-4, PD-1, and fruquintinib monotherapy and combination safety data. There were no dose-limiting toxicities, 25 – 60% Grade 3 TRAEs, and no Grade 4 or Grade 5 TRAEs.
Investigator-initiated Phase 2 trial of muzastotug in the neoadjuvant setting, in combination with pembrolizumab, for the treatment of MSS CRC:
● Patients in this study received muzastotug up to 20 mg/kg in combination with pembrolizumab prior to surgery. Using paired tumor biopsies collected before and after treatment, the study evaluates muzastotug’s pharmacokinetic profile in tumor tissue and its pharmacodynamic effects on the immune landscape of the tumor microenvironment. These analyses are designed to further elucidate muzastotug’s unique mechanism of action and its potential to deliver an enhanced therapeutic index.
● Additionally, the trial’s primary endpoint is the rate of Major Pathologic Response (MPR), defined as ≤10% residual viable tumor in the surgical specimen, and is being evaluated in up to 20 patients. Secondary endpoints include complete pathological response, disease-free survival, and safety/tolerability. Preliminary clinical data will inform future development of muzastotug in the neoadjuvant setting.
COLLABORATION UPDATES
● Sanofi: A global Phase 1/2 basket trial evaluating muzastotug in combination with a next-generation investigational IO agent in patients with advanced solid tumors is being sponsored and conducted by Sanofi as part of an external clinical collaboration.
● Incyte: Established clinical collaboration to evaluate muzastotug in combination with Incyte’s TGFβR2xPD-1 bispecific antibody (INCA33890), a leading PD-1-based bispecific program which has demonstrated promising clinical efficacy and safety data as a monotherapy in immune checkpoint sensitive and insensitive cancers, including MSS CRC with and without liver metastases. A Phase 1 combination study in 3L MSS CRC patients with and without liver metastases, sponsored and conducted by Incyte, is expected to begin later this year.
● Exelixis: Preclinical data was presented at AACR (Free AACR Whitepaper) 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. XB404 demonstrated dose-related tumor growth inhibition and improved survival in cell line models. Investigational New Drug (IND)-enabling studies are ongoing.
● ConjugateBio: The collaboration is ongoing with bispecific ADCs utilizing an Adagene-derived antibody, further demonstrating scalable platform potential.
CORPORATE UPDATES
● Added Peter Lebowitz, M.D., Ph.D., former Global Head of Oncology R&D for Johnson & Johnson, to the Scientific and Strategic Advisory Board (SAB), who is helping guide the clinical development of muzastotug, including strategies to advance the program into registration studies.
● Completed underwritten public offering of American depositary shares in April 2026 with approximately $70 million in gross proceeds.
FINANCIAL HIGHLIGHTS
Cash and Cash Equivalents:
Cash and cash equivalents were US$127.9 million as of June 30, 2026, compared to US$74.5 million as of December 31, 2025. Cash and cash equivalents included proceeds received from the ATM offering and underwritten public offering completed in April 2026. The company expects a cash runway extending into late 2028.
Total borrowings from commercial banks in China (denominated in RMB) decreased to US$5.7 million as of June 30, 2026 from US$6.1 million as of December 31, 2025. The associated loan proceeds were primarily used to pay for the company’s R&D activities in China.
Net Revenue:
Net revenue was US$1.6 million for the six months ended June 30, 2026, compared to nil for the same period in 2025. The increase reflects net revenue recognized upon fulfillment of certain performance obligations associated with the collaboration and technology licensing agreements with Sanofi and Exelixis, respectively.
Research and Development (R&D) Expenses:
R&D expenses were US$14.0 million for the six months ended June 30, 2026, compared to US$12.0 million for the same period in 2025. The increase of approximately 16.2% in R&D expenses reflects continued clinical focus and development of muzastotug, the company’s masked, anti-CTLA-4 SAFEbody ADG126.
Administrative Expenses:
Administrative expenses were US$4.2 million for the six months ended June 30, 2026, compared to US$3.7 million for the same period in 2025. The increase was mainly due to increase in both personnel and office-related expenses.
Net Loss:
Net loss attributable to Adagene Inc.’s shareholders was US$16.4 million for the six months ended June 30, 2026, compared to US$13.5 million for the same period in 2025.
Ordinary Shares Outstanding:
As of June 30, 2026, there were 83,929,180 ordinary shares issued and outstanding. Each American depositary share, or ADS, represents one and one quarter (1.25) ordinary shares of the company.
(Press release, Adagene, AUG 12, 2026, View Source [SID1234670000])