Tenax has licensed the calcium sensitizer/K-ATP activator levosimendan and is pursuing approval for an indication in Group 2 Pulmonary Hypertension in the US and Canada. The drug has been approved in over 60 countries with 35 published trials supporting its safety and efficacy and has over 1 million patient exposures. In January 2018 Tenax announced a new indication for Levo and met with the FDA to confirm trial design. This indication has a target population of nearly 2.0 million patients in the US with no exist ing treatment therapy. Tenax completed its Ph2 PH-HFpEF trial in 2020 and started the first of two Ph3 studies. In 2021, Tenax merged with PH Precision Med bringing Ph3-ready imatinib for PAH in house which is on hold. Levo has a 20+ year history of use in Europe with a substantial volume of literature supporting its safety and efficacy. Given the research support ing the use of Levo in heart failure, its inotropic and lusi tropic effects and the results from the HELP trial, there is sufficient evidence to support pivotal trials in PH-HFpEF. Additionally, PH-HFpEF represents a materially sized market with no effective therapy available, which provides substantial pricing and penetration opportunity.
