• Funding supports advancement of oral levosimendan (TNX-103) Phase 3 development program, including completion of the ongoing LEVEL Study for the treatment of Pulmonary Hypertension Due to Heart Failure with Preserved Ejection Fraction (PH-HFpEF) • Proceeds also will fund the initiation of a second Phase 3 study planned for 2025, shortening timeline to NDA submission; the protocol for this study will be submitted to FDA for comment CHAPEL HILL, N.C., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. ("Tenax") (NASDAQ:TENX), a Phase 3, development-stage pharmaceutical company focused on developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, announced the closing of a private placement by certain institutional and accredited healthcare investors, raising gross proceeds of approximately $100 million. The oversubscribed private placement was led by new investor BVF Partners LP, with participation from other new investors, including Venrock Healthcare Capital Partners, Vivo Capital, Janus Henderson Investors, a large investment management firm, Vestal Point Capital, Velan Capital, ADAR1 Capital Management, LLC, Stonepine Capital Management, and Sphera Biotech. "This transformational financing is a significant commitment by top-tier biotech investors who believe in levosimendan's potential to impact the lives of patients suffering from PH-HFpEF," said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. "The proceeds position us to accelerate our ongoing Phase 3 development program and shorten the time to NDA submission. We are now funded through completion of the ongoing Phase 3 LEVEL study, including its open label extension. This funding should also enable us to initiate all sites and advance enrollment in a second, global Phase 3 study. The Tenax team looks forward to completing the Phase 3 studies of oral levosimendan in treatment of PH-HFpEF patients, the only therapy shown to produce favorable hemodynamic changes and improve exercise tolerance in these patients." The LEVEL study is designed to demonstrate the impact of daily oral levosimendan administration on exercise ability, as measured by the six-minute walk distance (6MWD) test, over a 12-week period. PH-HFpEF is a devastating disease that severely impacts patients' daily activity levels, and for which no therapies have been approved by the U.S. Food and Drug Administration. "Participants in the HELP study showed an approximate 10% improvement of 29 meters in their six-minute walk distance over a six-week period, making levosimendan the first drug to show exercise improvement in any patients with HFpEF, with or without PH. In a subsequent open-label study, patients showed further improvement in exercise capacity when transitioned from weekly IV to oral daily therapy," said Stuart Rich, MD, Chief Medical Officer of Tenax Therapeutics. Several other clinical assessments also demonstrated benefit following the transition to oral therapy, currently being tested in the Phase 3 LEVEL study. About the Private Placement The Company's private ...