On January 23, 2026 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, reported year-end unaudited cash and cash equivalents of $74.5 million and provided a business update.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
2025 Key Accomplishments:
· Phase 1b/2 trial results with muzastotug in MSS CRC at ASCO (Free ASCO Whitepaper): Shared updated data from 10 mg/kg and 20 mg/kg cohorts at ASCO (Free ASCO Whitepaper) 2025, demonstrating a favorable safety profile at 10-20x times higher dosing than first generation CTLA-4 inhibitors. Encouraging overall response rates and durable responses suggest potential for long-term survival benefit.
· FDA Fast Track designation for muzastotug in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), for adult patients with microsatellite stable metastatic colorectal cancer (MSS CRC) without current or active liver metastases.
· Regulatory alignment with FDA End-of-Phase 1 meeting, clarifying dose selection, trial design, patient population and endpoints for Phase 2 and Phase 3 with muzastotug.
· Initiated randomized Phase 2 dose-optimization study with muzastotug; first patient dosed in October 2025.
· Strategic Partnerships and Collaborations:
o Sanofi: Secured a strategic investment of 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 other anticancer therapies 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.
o Third Arc Bio: Partnered to develop two masked CD3 T cell engagers, expanding SAFEbody into next-generation T cell therapies.
o Exelixis: Advanced a third masked ADC against a solid tumor target, building on the 2021 collaboration.
o ConjugateBio: Collaborated on bispecific ADCs using Adagene-derived antibody, further demonstrating scalable platform potential.
As of December 31, 2025, the Company had unaudited cash and cash equivalents of $74.5 million, which is anticipated to provide sufficient runway until late 2027. Such amount of cash and cash equivalents is preliminary, unaudited and subject to finalization. This financial information should not be viewed as a substitute for the audited financial statements prepared in accordance with US GAAP and is not incorporated into any Adagene’s filings with the U.S. Securities and Exchange Commission.
2026 Objectives:
· Q1 2026: Data update from the ongoing Phase 1b/2 study of muzastotug + 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.
Peter Luo, Ph.D., CEO and President of R&D at Adagene said, "Our strategy for muzastotug is grounded in Nobel Prize-recognized advances in regulatory T cell biology, which have fundamentally reshaped our understanding of immune suppression in cancer. We have translated these foundational insights into a clinical action plan for intratumoral T reg modulation that integrates mechanistic innovation with emerging clinical evidence and regulatory momentum. In 2026, we hope new data will demonstrate muzastotug’s broad applicability, positioning it as a potentially transformative next-generation backbone therapy that can be used in combination across multiple indications."
(Press release, Adagene, JAN 23, 2026, View Source [SID1234662186])