Mezzion Secures $20 Million in Strategic Funding to Advance Global Phase 3 Clinical Development of Udenafil for Fontan Patients

SEOUL, South Korea, June 11, 2025 /PRNewswire/ — Mezzion Pharma Co., Ltd. (Mezzion) announced a major milestone in their clinical development program, having secured approximately $20 million USD in strategic funding to support the ongoing global Phase 3 FUEL-2 trial of udenafil for patients with Fontan circulation.

The financing was led by Midas-Meritz New Technology Finance Association and KDBC-Korea Investment & Securities New Technology Investment Association, representing a strong vote of confidence from top-tier institutional investors in Mezzion’s late-stage pipeline and long-term growth strategy.

“We are pleased to partner with Midas Private Equity (Midas PE) and KDBC as we enter a critical phase in the development of udenafil for the Fontan population, a community with significant unmet medical need,” said Dean Park, Chairman and CEO of Mezzion. “This investment affirms the strength of our data, the quality of our science, and the potential impact of our work on patients worldwide.”

Midas PE, the lead investor, is a prominent private equity firm with over $230 million in assets under management. CEO Lim Chun-soo expressed strong confidence in Mezzion’s direction:

“After a detailed review of Mezzion’s FUEL-1 results and the ongoing FUEL-2 protocol, we believe udenafil is well positioned for successful global Phase 3 completion and regulatory approval. We are proud to support Mezzion as it expands internationally and continues its leadership in rare disease innovation.”

This financing follows growing clinical and regulatory momentum for Mezzion. The introduction of dedicated ICD-10 codes for Fontan-associated conditions marks a major step forward in recognizing and addressing the needs of this long-overlooked population. It enhances care, improves coverage, and underscores Mezzion’s leadership and long-term commitment to advancing treatment for rare congenital heart disease.

Chairman Park added, “With accelerating enrollment and growing engagement across clinical sites, we believe time and data are now working in our favor. We have initially secured $20 million, and we will continue our efforts to receive valuable investments in the future.”

About Mezzion Pharma Co., Ltd.
Mezzion Pharma Co., Ltd., based in South Korea and listed on the KOSDAQ (140410), develops treatments for rare and underserved diseases. Its U.S. subsidiary, Mezzion Pharmaceuticals, Inc., headquartered in New Jersey, leads global clinical development and commercialization.  The company is currently advancing udenafil, a first-in-class therapy for patients with Fontan physiology, a rare congenital heart condition, now in global phase 3 trials.

For more information, visit www.mezzion.com and www.FUEL2Study.com.

Media Contacts:
John Presser, CBO, john.presser@mezzion.com
Mr. Sung-Il Noh, CFO,  sung-il.noh@mezzion.com

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SOURCE Mezzion Pharmaceuticals, Inc