Mezzion Secures Strategic Financing to Support Advancement of Global Phase 3 FUEL-2 Trial in Fontan Patients

Institutional financing supports continued execution of late-stage program evaluating JURVIGO® (udenafil) in patients living with Fontan circulation

FORT LEE, N.J., May 14, 2026 /PRNewswire/ -- Mezzion Pharmaceuticals, Inc., a late-stage rare disease biopharmaceutical company focused on therapies for patients with single ventricle congenital heart disease and Fontan circulation, today announced the successful completion of strategic financing from institutional investors.

The financing is expected to support continued advancement of Mezzion's ongoing global confirmatory Phase 3 FUEL-2 clinical trial evaluating udenafil in adolescents and young adults living with Fontan circulation, a serious and life-limiting form of congenital heart disease for which there are currently no approved therapies specifically indicated for Fontan patients.

"This financing represents an important step in supporting the continued advancement of FUEL-2 and our commitment to the Fontan community," said Dr. Ridwan Shabsigh, President and COO of Mezzion Pharmaceuticals. "We remain focused on executing the study with the goal of potentially bringing the first approved therapy specifically indicated for individuals with Fontan physiology."

The financing follows the continued enrollment momentum and operational progress in the global FUEL-2 program, which is being conducted across leading pediatric congenital heart centers internationally.

"Despite a challenging biotech financing environment, we are grateful for the support and confidence of the institutional investors participating in this financing," said Dean Park, Chairman and CEO of Mezzion Pharmaceuticals. "We believe this support reflects the significant unmet medical need in patients with Fontan physiology and the potential for udenafil to meaningfully impact this underserved community."

About Mezzion Pharmaceuticals
Mezzion Pharmaceuticals, Inc., a U.S.-based subsidiary of Mezzion Pharma Co., Ltd. (KOSDAQ: 140410), is a late-stage biopharmaceutical company advancing therapies for rare and underserved diseases. Mezzion is developing JURVIGO® (udenafil) as a potential first-in-class therapy for patients with single ventricle congenital heart disease and Fontan physiology. Udenafil is investigational and has not been approved by any regulatory authority. For more information, visit www.mezzion.com and www.FUEL2Study.com.

Trademarks
JURVIGO® is a registered trademark of Mezzion Pharma Co., Ltd.

Media Contacts:
John Presser, EVP, CBO: [email protected]
Mr. Sung-Il Noh, CFO: [email protected]

SOURCE Mezzion Pharmaceuticals, Inc