First Quarter 2019 Financial and Operational Review
Following the December 2018 activation of trial sites, Tenax Therapeutics, Inc. (NASDAQ:TENX) enrolled its first patient in 1Q:19. We anticipate a steady addition of patients in the 36-patient, six medical center site study as 2019 progresses. As a reminder, the Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF or HELP trial is a multi-center, double-blind, placebo-controlled study in North America. Enrollment is anticipated to continue throughout the year.
On May 15, Tenax filed its Form 10-Q with the SEC. No revenues were reported in the period and operating expenses were $1.7 million. Net loss per share was ($0.33). Research and development costs of $0.5 million increased dramatically from the $59,000 spent in the prior period as the HELP trial was launched and first patient enrolled. General and administrative expenses totaled $1.2 million, up 1%. Higher personnel costs were offset by lower legal and professional costs. Net loss for the period was ($1.6) million or ($0.33) per share.
Cash balance was $10.8 million and cash burn totaled ($2.1) million for 1Q:19. The company continues with no debt. We anticipate an acceleration 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 trial at Stanford University School of Medicine. In March, the first of an expected 36 patients was enrolled in the trial.
The process of developing the trial began last April 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 late 2019/early 2020.
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
‣ 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
2019 has begun with HELP sites activated and the first paitent enrolled. While the trial took longer than expected to launch, we are hopeful that it will enroll quickly and produce results by early 2020. 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