Tenax Therapeutics Closes $100M Private Placement, to Speed Up Oral Levosimendan Phase 3

Tenax Therapeutics, Inc., a pharmaceutical company in the Phase 3 development stage, announced the successful closing of a private placement, raising approximately $100 million from institutional and accredited healthcare investors. The financing was led by BVF Partners LP, and included other significant new investors such as Venrock Healthcare Capital Partners, Vivo Capital, Janus Henderson Investors, Vestal Point Capital, Velan Capital, ADAR1 Capital Management, LLC, Stonepine Capital Management, and Sphera Biotech.

This substantial funding aims to support the advancement of Tenax's oral levosimendan (TNX-103) Phase 3 development program, particularly the ongoing LEVEL Study, which targets the treatment of Pulmonary Hypertension Due to Heart Failure with Preserved Ejection Fraction (PH-HFpEF). Additionally, the proceeds will be used to initiate a second Phase 3 study in 2025, potentially accelerating the timeline to New Drug Application (NDA) submission. The protocol for this forthcoming study is planned to be submitted to the FDA for feedback.

Chris Giordano, President and CEO of Tenax Therapeutics, emphasized that this financing represents a transformative commitment from top-tier biotech investors confident in levosimendan’s potential to treat PH-HFpEF. The funding ensures the completion of the ongoing Phase 3 LEVEL study, including its open-label extension, and will also facilitate the initiation and advancement of enrollment for a second global Phase 3 study. Giordano reiterated the Tenax team’s dedication to completing these studies, as oral levosimendan is the only therapy that has demonstrated beneficial hemodynamic changes and improved exercise tolerance in PH-HFpEF patients.

The LEVEL study is designed to evaluate the impact of daily oral levosimendan on exercise capacity, measured by the six-minute walk distance (6MWD) test over a 12-week period. PH-HFpEF is a debilitating disease that significantly affects patients' daily activities, and currently, there are no therapies approved by the U.S. Food and Drug Administration for this condition.

Stuart Rich, MD, Chief Medical Officer of Tenax Therapeutics, highlighted that participants in the HELP study showed approximately a 10% improvement, or 29 meters, in their six-minute walk distance over a six-week period. Levosimendan became the first drug to demonstrate an exercise improvement in HFpEF patients, both with and without PH. Further improvements in exercise capacity were observed in a subsequent open-label study when patients transitioned from weekly intravenous to daily oral therapy. This ongoing Phase 3 LEVEL study is currently testing these benefits.

The private placement involved the issuance of 1,450,661 shares of Tenax’s common stock and pre-funded warrants to purchase an additional 31,882,671 shares. These securities were offered at $3.00 per share, with accompanying warrants priced at $4.50. Pre-funded warrants were priced at $2.99, with an exercise price of $0.01, remaining exercisable indefinitely. Leerink Partners led the placement, with Guggenheim Securities and William Blair as joint placement agents, and ROTH Capital Partners acted as the financial advisor.

Tenax Therapeutics agreed to file a registration statement with the SEC, registering the resale of the common stock and shares issuable upon the exercise of the pre-funded and accompanying warrants.

Levosimendan, initially developed by Orion Corporation, is a potassium ATP channel activator and calcium sensitizer impacting heart and vascular systems through multiple mechanisms. Approved in 60 countries outside the U.S. for acutely decompensated heart failure, Tenax's Phase 2 HELP study results showed that IV levosimendan could significantly improve exercise capacity in patients with PH-HFpEF—a basis for the ongoing LEVEL Phase 3 study.

Tenax Therapeutics remains committed to developing and commercializing products for cardiovascular and pulmonary diseases with high unmet medical needs. The company's common stock is listed on the Nasdaq under the symbol "TENX".