Company provides 2026 corporate outlook highlighting multiple clinical catalysts across first-in-class cardioendocrine pipeline

MAR002 Phase 1 Data: Robust, durable IGF-1 suppression supports potential for biweekly to monthly dosing; Phase 2/3 study initiation expected mid-2026

MAR001 Phase 2b TYDAL-TIMI 78 Study Enrollment Nearing Completion: multiple data readouts expected throughout 2026; advancing half-life-extended MAR001-HLE designed for infrequent, low-volume subcutaneous dosing toward Phase 3 readiness

Pipeline Expansion: Advancing next-generation siRNA portfolio with development candidate nomination(s) expected in 2026

Management to present at the 44^th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, at 10:30 a.m. PT

Marea Therapeutics, Inc., a clinical-stage biotechnology company harnessing the latest advances in human genetics to develop first-in-class, next-generation medicines for cardioendocrine diseases, today announced positive topline results from its first-in-human Phase 1 study of MAR002, a first-in-class allosteric monoclonal antibody targeting the growth hormone receptor (GHR) for the treatment of acromegaly. The company also highlighted key pipeline milestones expected in 2026 – including for its lead cardiometabolic program, MAR001, a first-in-class, subcutaneously delivered monoclonal antibody designed to block the activity of ANGPTL4, a genetically validated driver of remnant cholesterol and atherosclerotic cardiovascular disease (ASCVD) risk.

“The MAR002 data provide clear proof-of-mechanism and underscore our ability to translate human genetic insights into highly differentiated clinical candidates,” said Josh Lehrer, M.D., chief executive officer of Marea Therapeutics. “With MAR002 moving toward a registrational study, MAR001 nearing a major Phase 2b readout, and our siRNA platform expanding, Marea is uniquely positioned to redefine the treatment of cardioendocrine diseases. 2026 will be a catalyst-rich year as we execute across our entire portfolio.”

MAR002: Phase 1 Data Demonstrate Proof-of-Mechanism and Support Best-in-Disease Potential

• The first-in-human, randomized, blinded, parallel-group, placebo-controlled Phase 1 study enrolled healthy adult male volunteers and single ascending doses of MAR002 demonstrated a favorable safety and tolerability profile, with no drug-related safety signals observed.
• Treatment with MAR002 resulted in robust and durable dose-dependent reductions in circulating insulin-like growth factor-1 (IGF-1) with peak suppression of 52% (+/- 5.4%) occurring at the highest dose tested and greater than 45% suppression out to 43 days. This is compared to a maximum suppression of 48% (+/- 7%) and greater than 45% suppression lasting to only 5 days with the current commercially available GHR antagonist.
• Overall, these data confirm target engagement and proof-of-mechanism with pharmacokinetics (PK) supporting bi-weekly to monthly dosing.

“IGF-1 normalization is a validated biomarker and primary regulatory endpoint in acromegaly, and reductions observed in healthy volunteers have historically been highly predictive of clinical efficacy in patients,” said Rebecca Juliano, Ph.D., chief development officer of Marea Therapeutics. “Acromegaly affects more than 30,000 patients in the U.S., and fewer than 40% of patients achieve adequate disease control with current first-line somatostatin receptor ligands. MAR002 is designed to directly block growth hormone signaling at the receptor level and has the potential to achieve biochemical control in the vast majority of patients, positioning it as a potential best-in-disease therapy with convenient biweekly to monthly dosing. These Phase 1 data provide strong proof-of-mechanism for MAR002 and we look forward to initiating a Phase 2/3 clinical study of MAR002 in patients with acromegaly in mid-2026.”

MAR001: Multiple Data Readouts Expected in 2026 to Further Validate ANGPTL4 Inhibition for ASCVD

• Enrollment in the Phase 2b TYDAL-TIMI 78 study is expected to be completed by the end of January 2026. The study is designed to evaluate dose-response, safety, and pharmacodynamics in patients with elevated triglycerides and remnant cholesterol despite standard-of-care therapy.
• Topline 12-week data, including the primary endpoint of percent change in fasting triglycerides and remnant cholesterol, are expected in mid-2026, with 24-week data anticipated in the second half of 2026.
• In parallel, enrollment will also be completed in a Phase 2 mechanistic study by the end of January 2026, which is designed to further characterize MAR001’s effects on post-prandial lipid metabolism, triglyceride-rich lipoprotein handling, and fat distribution. Topline data from this study are expected in the second half of 2026.

MAR001-HLE: Next-Generation Program Advancing Toward Phase 3 Readiness

• Marea is also advancing a half-life-extended version of MAR001 (MAR001-HLE), incorporating Fc modifications designed to improve PK, enable monthly low-volume or better dosing, and significantly reduce cost of goods.
• Following a Type B meeting with the U.S. Food and Drug Administration (FDA) in November 2025, Marea has reached alignment on a streamlined Phase 1 PK bridging strategy to support the advancement of MAR001-HLE into Phase 3 development. A single-dose Phase 1 PK study in healthy volunteers is planned for 2026, with PK data expected by year-end. An investigational new drug (IND) filing for MAR001-HLE is anticipated in 2026, with a clinical bridging study planned for 2027.

Future Pipeline Expansion with siRNA

Beyond its two lead clinical programs, Marea continues to expand its pipeline of genetically validated cardioendocrine therapies:

• ANGPTL4 siRNA (adipose-targeted): A preclinical siRNA program targeting ANGPTL4 with a differentiated, tissue-focused approach; development candidate nomination is expected in 2026.

Presentation at the 44th Annual J.P. Morgan Healthcare Conference

Management will present at the 44th Annual J.P Morgan Healthcare Conference on Tuesday, January 13, at 10:30 a.m. PT.

About MAR001

MAR001 is a monoclonal antibody designed to block the activity of ANGPTL4. MAR001 binds with high affinity to the N-terminal coiled-coil domain of ANGPTL4. Given the enrichment in expression of ANGPTL4 in adipose tissue, MAR001 leads to augmented hydrolysis of triglyceride (TG) rich lipoproteins and optimal storage of TGs, and both nonclinical and clinical studies have demonstrated significant reductions in TG and remnant cholesterol (RC), the cholesterol carried on TG-rich lipoproteins. Substantial reductions in TG and RC are predicted to reduce atherosclerotic cardiovascular disease (ASCVD) risk.

About MAR002

MAR002 is a potent and selective half-life-extended, allosteric, human monoclonal growth hormone receptor antagonist (GHRA) antibody being developed for the treatment of acromegaly. The in vivo PK and PD properties of MAR002 are predictable and typical of a half-life extended human antibody, showing a long duration of action compatible with infrequent subcutaneous dose administration in humans. These characteristics support its potential to offer an effective and convenient treatment for patients with acromegaly.

About Marea Therapeutics

Marea Therapeutics is a clinical-stage biotechnology company harnessing the latest advances in human genetics to develop first-in-class, next-generation medicines for cardioendocrine diseases. The company’s lead therapy, MAR001, is in Phase 2 clinical development for adults with metabolic dysfunction and high risk for atherosclerotic cardiovascular disease. The company is also advancing MAR002 for the treatment of acromegaly. To learn more, please visit www.mareatx.com and follow us on LinkedIn and X.

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