Adagene Provides Business Update and 2026 Objectives

Rhea-AI Summary

Adagene (Nasdaq: ADAG) reported unaudited cash and cash equivalents of $74.5 million as of December 31, 2025 and outlined 2026 objectives focused on clinical progress for muzastotug. Key 2025 milestones include updated Phase 1b/2 MSS CRC data presented at ASCO, FDA Fast Track designation for muzastotug+pembrolizumab in MSS metastatic colorectal cancer without active liver metastases, End-of-Phase 1 regulatory alignment, and initiation of a randomized Phase 2 dose-optimization study.

Strategic partnerships include a Sanofi investment of up to $25 million, collaborations with Third Arc Bio, Exelixis and ConjugateBio. Q1 2026 plans include a data update for muzastotug+pembrolizumab (41 patients at 10 mg/kg; 26 at 20 mg/kg) and additional trial readouts and collaborations.

Positive

• Unaudited cash of $74.5M providing runway into late 2027
• FDA Fast Track designation for muzastotug+pembrolizumab in MSS CRC
• Sanofi strategic investment of up to $25M supporting randomized Phase 2
• Randomized Phase 2 dose-optimization study initiated; first patient dosed Oct 2025

Negative

• Cash runway finite despite extension only into late 2027
• Reported cash is preliminary and unaudited, subject to finalization

Market Reaction

+4.43% $2.12

15m delay 2 alerts

+4.43% Since News

$2.12 Last Price

$2.00 $2.13 Day Range

+$4M Valuation Impact

$100M Market Cap

1.3x Rel. Volume

Following this news, ADAG has gained 4.43%, reflecting a moderate positive market reaction. Our momentum scanner has triggered 2 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $2.12. This price movement has added approximately $4M to the company's valuation.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Silver for real-time data.

Key Figures

Cash & equivalents: $74.5 million Sanofi investment: Up to $25 million Phase 1/2 patients: Over 100 patients +2 more

5 metrics

Cash & equivalents $74.5 million Unaudited, as of Dec 31, 2025; expected runway into late 2027

Sanofi investment Up to $25 million Strategic investment to support muzastotug randomized Phase 2 study

Phase 1/2 patients Over 100 patients Sanofi-sponsored Phase 1/2 trial in advanced solid tumors

10 mg/kg cohort size 41 patients Q1 2026 data update for Phase 1b/2 muzastotug + pembrolizumab in 3L+ MSS CRC

20 mg/kg cohort size 26 patients Q1 2026 data update for Phase 1b/2 muzastotug + pembrolizumab in 3L+ MSS CRC

Market Reality Check

Price: $2.03 Vol: Volume 599,500 is 8.43x t...

high vol

$2.03 Last Close

Volume Volume 599,500 is 8.43x the 20-day average of 71,151, indicating elevated interest pre-announcement. high

Technical Price $2.03 is trading above the 200-day MA at $1.87, reflecting strength before this update.

Peers on Argus

ADAG gained 20.12% with high volume, while peers like ZNTL, TCRX, ARMP, PYXS, an...

ADAG gained 20.12% with high volume, while peers like ZNTL, TCRX, ARMP, PYXS, and CRBP rose between 1.84% and 10.17%, suggesting a more stock-specific reaction than a broad biotech move.

Historical Context

5 past events · Latest: Dec 16 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 16	Regulatory designation	Positive	+13.8%	FDA granted Fast Track to muzastotug plus pembrolizumab in MSS metastatic CRC.
Nov 13	Licensing deal	Positive	+1.7%	Licensing agreement with Third Arc Bio for two masked CD3 T cell engagers.
Oct 31	Clinical trial start	Positive	-7.3%	First patient dosed in randomized Phase 2 dose-optimization muzastotug plus KEYTRUDA trial.
Sep 16	Collaboration expansion	Positive	+0.9%	Expanded SAFEbody collaboration with Exelixis to develop a third masked ADC.
Sep 05	Conference data	Positive	+2.8%	ADG126 data in MSS CRC highlighted in two oral presentations at CSCO 2025.

Pattern Detected

News and partnership/trial milestones have generally seen positive price alignment, with one notable divergence on a clinical trial start.

Recent Company History

Over the past months, Adagene has advanced muzastotug (ADG126) through clinical milestones and partnerships. Key updates included FDA Fast Track for MSS CRC on Dec 16, 2025 and initiation of a randomized Phase 2 dose-optimization study on Oct 31, 2025. The company also expanded SAFEbody collaborations with Exelixis and licensed masked CD3 T cell engagers to Third Arc Bio. Today’s broader business update and 2026 objectives build on this trajectory of clinical progress and partnering activity.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-10-31

An effective Form F-3 resale registration filed on Oct 31, 2025 covers up to 10,625,000 ordinary shares or 8,500,000 ADSs for a selling shareholder. Adagene is not selling securities under this prospectus and will receive no proceeds from these sales.

Market Pulse Summary

This announcement detailed Adagene’s year-end position and 2026 goals, including unaudited cash of $...

Analysis

This announcement detailed Adagene’s year-end position and 2026 goals, including unaudited cash of $74.5 million with expected runway into late 2027 and a Sanofi investment of up to $25 million. Multiple 2026 readouts are planned across Phase 1b/2 and randomized Phase 2 studies of muzastotug combinations in MSS colorectal cancer and hepatocellular carcinoma. Investors may watch execution on enrollment, upcoming data from cohorts of 41 and 26 patients, and partnering activity alongside the existing F-3 resale registration.

Key Terms

phase 1b/2, pembrolizumab, fast track designation, t cell engagers, +2 more

6 terms

phase 1b/2 medical

"Data update from the ongoing Phase 1b/2 study of muzastotug + pembrolizumab"

Phase 1b/2 is a combined early-stage human study that first checks a drug’s safety and side effects in a small group and then expands to test whether it shows signs of working in patients. Think of it as a product test that first confirms it’s safe to use, then looks for early evidence of benefit; positive results can significantly reduce clinical risk and increase a company’s value, while negative results raise the opposite.

pembrolizumab medical

"muzastotug + pembrolizumab in 3L+ MSS CRC patients remains on track"

A cancer immunotherapy drug that helps the body’s immune system recognize and attack tumor cells by blocking a molecular “brake” that tumors use to hide. Investors watch it because regulatory approvals, clinical trial results, dosing rules, and competition directly affect potential sales, profit forecasts, and the valuation of companies that sell or license the drug—think of trial outcomes as checkpoint signs that can open or close a revenue road.

fast track designation regulatory

"FDA Fast Track designation for muzastotug in combination with Merck’s ... KEYTRUDA"

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.

t cell engagers medical

"Partnered to develop two masked CD3 T cell engagers, expanding SAFEbody"

T cell engagers are engineered molecules that act like a matchmaker or bridge, linking a patient’s T cells (immune cells that kill infected or cancerous cells) directly to diseased cells so the immune system can destroy them. For investors, they matter because successful T cell engagers can become high-value therapies with steep clinical and regulatory milestones that drive a biotech company’s revenue potential and share price, while failures or safety issues can rapidly reduce valuation.

pharmacokinetics medical

"evaluate the safety, efficacy, pharmacokinetics and biomarker data in combination"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

project optimus regulatory

"dose-optimization study with muzastotug, which is being conducted in alignment with FDA Project Optimus"

Project Optimus is a regulatory initiative from the U.S. Food and Drug Administration aimed at changing how cancer drugs are dosed during development, encouraging careful testing to find the best effective dose rather than simply the highest tolerated one. For investors this matters because it can change clinical trial plans, add time or cost, affect safety and labeling outcomes, and ultimately influence a drug’s commercial success—like tuning volume to a clear level instead of always turning it up to the maximum.

AI-generated analysis. Not financial advice.

Data update from the ongoing Phase 1b/2 study of muzastotug + pembrolizumab in 3L+ MSS CRC patients remains on track for Q1 2026

Unaudited cash and cash equivalents of $74.5 million as of December 31, 2025 anticipated to provide sufficient runway into late 2027

SAN DIEGO and SUZHOU, China, Jan. 23, 2026 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced year-end unaudited cash and cash equivalents of $74.5 million and provided a business update.

2025 Key Accomplishments:

• Phase 1b/2 trial results with muzastotug in MSS CRC at ASCO: Shared updated data from 10 mg/kg and 20 mg/kg cohorts at ASCO 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:
  • 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.
  • 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.
    

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.”

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.

Investor Contacts:

Raymond Tam
raymond_tam@adagene.com

Corey Davis, Ph.D.
LifeSci Advisors
212-915-2577
cdavis@lifesciadvisors.com

Media Contact:

Lindsay Rocco
Elixir Health PR
862-596-1304
lrocco@elixirhealthpr.com

FAQ

What cash position did Adagene (ADAG) report at year-end 2025?

Adagene reported unaudited cash and cash equivalents of $74.5 million as of December 31, 2025.

When will Adagene (ADAG) provide the Q1 2026 muzastotug+pembrolizumab data update?

Adagene plans a Q1 2026 data update from the ongoing Phase 1b/2 study in 3L+ MSS CRC.

How many patients are in the 10 mg/kg and 20 mg/kg cohorts for muzastotug data Adagene (ADAG) will report?

The update will include 41 patients in the 10 mg/kg cohorts and 26 patients in the 20 mg/kg cohorts.

What regulatory progress has Adagene (ADAG) achieved for muzastotug?

Muzastotug received FDA Fast Track designation in combination with pembrolizumab for MSS metastatic colorectal cancer without active liver metastases and completed an End-of-Phase 1 meeting with FDA.

What partnerships support Adagene's muzastotug development?

Key partners include Sanofi (investment up to $25M and clinical supply), plus collaborations with Third Arc Bio, Exelixis and ConjugateBio.