Expanded Global Rights for Tenax Therapeutics on Levosimendan

Tenax Therapeutics, a pharmaceutical company in the final phase of development, has broadened its scope by amending an existing agreement with Orion Corporation. This adjustment has extended Tenax’s rights from covering North America to encompassing the entire globe. This move is expected to open doors for potential partnerships with pharmaceutical entities worldwide and enhance the company's net sales royalty rate structure, which now varies from the higher end of single digits to the lower end of the teens. Additionally, the cost of goods has been decreased.

The amended terms also include changes to milestone provisions, with an added payment for regulatory approval in Japan, underscoring the significant global potential of the PH-HFpEF market, which is valued in the billions. However, Tenax’s right to negotiate first for new applications of levosimendan developed by Orion for neurological indications has been excluded.

The company, formerly known as Oxygen Biotherapeutics, Inc., is focused on addressing significant unmet needs in cardiovascular and pulmonary diseases. The recent agreement has granted Tenax global development, commercial, and intellectual property rights for oral and subcutaneous levosimendan, which is intended for the treatment of pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF).

Chris Giordano, President and CEO of Tenax Therapeutics, expressed enthusiasm about the expanded rights, stating that it aligns with the company's corporate goals and positions them to capitalize on the value of levosimendan through potential global alliances. Tenax is also working in collaboration with Orion to secure additional intellectual property protection in key countries where they now hold commercial rights.

The effects of the amendment include a tiered royalty rate payable to Orion and milestone payments based on sales targets and regulatory approvals, including an additional payment upon approval in Japan. The terms regarding the transfer price and cost of goods have also been improved.

Tenax Therapeutics is gearing up for Phase 3 testing of levosimendan, with the goal of creating substantial shareholder value. The company is currently conducting the LEVEL Study, a double-blind, randomized, placebo-controlled trial involving approximately 152 subjects with PH-HFpEF. The primary outcome measure is the six-minute walk distance, and all participants have the option to enter a 92-week open-label extension after the initial 12-week study.

Levosimendan, discovered and initially developed by Orion, is a unique compound that influences the heart and vascular system through multiple mechanisms. It is approved in 60 countries for use in patients with acute heart failure and has shown promise in improving exercise capacity in PH-HFpEF patients, a condition with a significant unmet need and no current treatment options.

Tenax Therapeutics, which also holds rights to develop and commercialize various formulations of levosimendan and is working on an oral formulation of imatinib, is listed on The Nasdaq Stock Market under the symbol "TENX". The company is dedicated to advancing innovative solutions for serious medical conditions.