Second Quarter 2019 Financial and Operational Review
Tenax Therapeutics, Inc. (NASDAQ:TENX) began activating sites for its Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF (HELP) trial in late 2018. After a thorough screening process, the first patient was enrolled in March 2019. As of early August six patients are enrolled. We anticipate a steady addition of subjects in the 36-patient, six medical center site study as 2019 progresses. As a reminder, the is a multi-center, double-blind, placebo-controlled study conducted in North America with a primary endpoint of reducing pulmonary pressure with exercise.
On August 14, Tenax filed its Form 10-Q with the SEC. No revenues were reported in the period and operating expenses totaled $1.8 million. Net loss per share was ($0.28). Research and development costs of $0.6 million doubled from the $0.3 million spent in the prior second quarter period as the HELP trial was launched, and screening and enrolling efforts took place. General and administrative expenses totaled $1.2 million, down 26%. The change was attributed to lower personnel costs and almost a $100,000 cut in legal & professional expenses that were partially offset by higher non-income taxes paid. Net loss for the period was ($1.8) million or ($0.28) per share.
Cash and securities balance was $8.9 million and cash burn totaled ($1.9) million for 2Q:19. The company continues with no debt. We anticipate an increase in expenses in coming quarters as the Phase II trial advances enrollment.
Last November Tenax announced the activation of the first clinical research site for the PH-HFpEF HELP trial at Stanford University School of Medicine. In March, the first of an expected 36 patients was enrolled in the trial and by August 23rd, eight patients had been added in 12 active sites. Three additional sites are expected to be activated in the next few weeks.
The process of developing the trial began in April 2018 when the FDA allowed Tenax to submit their Investigational New Drug (IND) application under the existing clinical protocol for levosimendan. The agency also addressed the company’s questions and provided guidance on the Phase II trial. Substantial safety work has been performed on levosimendan, eliminating the need for another Phase I. The FDA recognized that there are no approved drug therapies to treat PH-HFpEF patients and acknowledged this may eventually allow for a limited Phase III clinical program. Tenax will provide additional detail on the implications of a limited Phase III study at the End-of-Phase II Meeting for PH-HFpEF which we anticipate taking place in 1H:20.
View Exhibit I – PH WHO Groups1
After meeting with the FDA for the pre-IND meeting, Tenax refined its trial design to reflect the input provided by the agency. The study is anticipated to enroll 36 PH-HFpEF patients in twelve to thirteen sites with a trial duration of 14 to 18 months. Based on preliminary work, enrollees will have a pulmonary arterial pressure (PAP) equal to or greater than 35, a pulmonary capillary wedge pressure (PCWP) equal to or greater than 20, a cardiac index (CI) of less than or equal to 2.2, a left ventricular ejection fraction (LVEF) of over 40 and be NYHA Class IIb or III.
The primary endpoint of the study will be a change from baseline PCWP with bicycle exercise at Week 6. Expected secondary endpoints will relate to a change in resting PCWP under a variety of conditions, a change in resting & stressed CI, change in pulmonary vascular resistance (PVR) at rest & under stress, a global assessment at week six based on the Likert scale and length of exercise period, a physician’s assessment of functional class and clinical events, including death and hospitalizations.
View Exhibit II – Phase II Study Design2
In late June, we had a chance to speak with CEO Anthony DiTonno on the CEO Money show and as some questions about Levosimendan, its mechanism of action and what we should be looking for in the future from Tenax. The video can be accessed here.
‣ Activate First Sites – November 2018
‣ Raise Capital – December 2018
‣ Enroll First Patient – March 2019
‣ End of Phase II Meeting with FDA – 2020
‣ Raise capital – Mid 2020
‣ Launch Phase III - 2020
Administrative efforts at the sites have taken longer than we expected; however, now that many sites are active, we anticipate a few patients being added every week and enrollment to be completed by year end. Data should be available by 1Q:20. As of late August, eight patients have been enrolled and almost all sites are able to start responders for the five week chronic phase. Three additional sites will be activated in the near term. Based on the research and analysis included in our initiation, we believe PH-HFpEF patients will benefit from Levosimendan’s mechanism of action and clinical trials can be pursued with a reasonable cost and time commitment. The indication is also in an area with no other approved treatments. Market size is material and with no other approved therapy available, pricing should be strong and penetration high. We maintain our target price to $4.00.
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1. Exhibit from TENX Corporate Presentation, January 2019
2. Source: Tenax January 2019 Investor Presentation.