Tenax Therapeutics (NASDAQ:TENX) announced on October 31st that it had enrolled 15 of 36 patients in its Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF (HELP) trial. The company also announced the average reduction in average pulmonary capillary wedge pressure (PCWP) for the successfully screened patients of 8 mmHg. As a reminder, the statistically defined threshold for inclusion during the open label screen for participation the randomization portion is 4.0 mmHg.
While it is impossible to determine the impact of the five additional administrations of Levosimendan, the strong initial response is surely a positive and suggests strong statistical significance if it holds for the duration of the study. Management currently believes that the trial will achieve full enrollment by the first quarter of 2020, followed by topline data a minimum of six weeks later. We anticipate another update on enrollees when Tenax files their third quarter 10-Q around November 14th.
Exhibit I – HELP Study Trial Design1,2
We continue to have a favorable view on Tenax given that there is no other approved treatment for PH-HFpEF. Furthermore, the Group II pulmonary hypertension group Tenax is targeting is much larger than the other groups, some of which have billion dollar plus treatments approved. The safety profile for Levosimendan is well understood and initial indications from the first administration of the drug are favorable. We also highlight the low valuation of the company compared to its potential. However, we note that the primary efficacy endpoints seek to demonstrate an improvement in the six minute walk test and improvement in quality of life among others and we will have to wait until 1Q:20 for a topline readout. We will update our valuation following the filing of the third quarter 10-Q.
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1. Source: September 2019 Tenax Therapeutics Corporate Presentation. https://s3.amazonaws.com/cdn.irdirect.net/PIR/942/3829/TENX%20Investor%20Presentation%20September%202019%20-%20HCW%20Conf%20-%20FINAL%20%20%208-29-2019.pdf
2. Following the initial administration of Levosimendan to determine whether or not the patient is a responder, responders are given five additional 24-hour infusions of Levosimendan over the subsequent five weeks.