TENX: IND Clears Way for Phase III
NASDAQ:TENX
READ THE FULL TENX RESEARCH REPORT
Third Quarter Financial and Operational Review
Tenax Therapeutics, Inc. (NASDAQ:TENX) reported 3Q:23 results on November 13, 2023 via its filing of Form 10-Q with the SEC. Since the filing of the second quarter 10-Q in mid-August, the company has finished compiling and submitting its investigational new drug (IND) application for clinically advancing oral levosimendan (TNX-103). The candidate is intended to treat pulmonary hypertension in patients with heart failure and preserved ejection fraction (PH-HFpEF); an indication which offers no other approved therapies. Concurrent with the third quarter report, Tenax announced that the FDA had cleared the IND for the oral levosimendan trial evaluating PH-HFpEF patients and that the related Phase III trial will start in 4Q:23. The advancement of the program has prompted the addition of a new member to the PH-HFpEF scientific advisory board which will guide levosimendan’s pathway towards FDA approval.
Now with a cleared IND and the confidence inspired by the recent patent issuance for oral and IV administration of levosimendan, Tenax will launch its Phase III levosimendan trial next month. We expect to hear further details regarding the trial and its administration as other study related milestones are achieved.
Recent Highlights:
➢ Reverse stock split executed - January 5, 2023
➢ $15.6 million public offering completed – February 2023
➢ IV levosimendan patent for PH-HFpEF issued – March - 2023
➢ Prioritization of TNX-103 (levosimendan for PH-HFpEF) in clinical trials – April 2023
➢ PH-HFpEF patent for oral levosimendan issued – July 2023
➢ IND cleared for start of oral levosimendan Phase III trial (LEVEL) in PH-HFpEF – November 2023
Tenax produced no revenues in 3Q:23 and incurred operating expenses of $2.1 million resulting in a net loss of ($2.0) million, or ($0.08) per share.
For the quarter ending September 30, 2023 versus the same prior year period:
➢ General and administrative expenses fell 24% to $1.1 million primarily due to declines in personnel, legal and professional fees. Decreased employment related costs from lower headcount as well as lower consulting, investor relations, capital market and Board of Director expenses also contributed to the change. These were partially offset by an increase in other costs arising from insurance and general office supplies;
➢ Research and development expenses fell 31% to $1.1 million from $1.5 million as higher prior-year costs from imatinib-related activities were only partially substituted by start-up costs related to the LEVEL trial. Personnel and other costs also fell;
➢ Net interest income was $145,000 due to greater cash balances and higher interest rates;
➢ Net loss was ($2.0) million versus ($2.9) million, or ($0.08) and ($2.22) per share, respectively.
At the end of 3Q:23, cash and equivalents totaled $11.1 million, compared to $2.1 million at the end of 2022. During the third quarter, cash burn was ($2.1) million. Financing cash flows were ($0.2) million related to the repayment of a short-term note. We estimate quarterly cash burn of around $3.6 million per quarter, which may vary depending upon the ebb and flow of LEVEL enrollment.
IND Clearance For Levosimendan (TNX-103) for PH-HFpEF
Tenax filed its investigational new drug (IND) application for PH-HFpEF during the third quarter and announced the program’s clearance in a November 13th press release. The FDA’s favorable nod will allow for the start of the LEVEL (LEVosimendan to Improve Exercise Limitation) trial. Activity to initiate the trial continued in the third quarter with site qualification and selection work taking place. Trial launch and site activity are expected to begin in the fourth quarter and subject enrollment is anticipated for early 2024. We expect that two Phase III trials will be conducted, each enrolling approximately 150 subjects.
As expected, the six-minute walk distance (6MWD) will be the primary endpoint for LEVEL. Secondary endpoints will include the Kansas City Cardiomyopathy Questionnaire (KCCQ)1 and potentially BNP/NT-proBNP (B-type natriuretic peptide and N-terminal pro-B-type natriuretic peptide). The latter elements are biomarkers used to help diagnose and monitor heart failure.
No long-term, cardiovascular outcomes trial will be required given the long-term data related to levosimendan use in patients. This allowance will reduce the cost and shorten the time to develop a new drug application (NDA) for TNX-103. Over two-thirds of the trial sites required for the study have been selected, which includes leading cardiovascular centers in the US and Canada. This includes sites that participated in the Phase II HELP study. Based on our conversation with management we anticipate that at least 50 sites will be engaged which will enroll subjects throughout 2024 and into 2025. Full enrollment should occur in 2025 and topline is expected in the first half of 2026.
Key LEVEL details:
➢ Launch in 4Q:23
➢ 6-minute walk distance is primary endpoint
➢ 6-month drug exposure required for 300 patients
➢ 12-month drug exposure required for 100 patients
➢ No cardiovascular outcomes trial required
➢ Oral administration
New PH-HFpEF Scientific Advisory Board Member
Professor Javed Butler, M.D., M.P.H., M.B.A. joins Tenax’ PH-HFpEF scientific advisory board (SAB) as announced in a November 17th press release. He is the President of the Baylor Scott and White Institute and Senior Vice President for Baylor Scott and White Health. Dr. Butler has distinguished himself in cardiovascular medicine with his position as professor and chair of the Department of Medicine at the University of Mississippi Medical Center and chair of Cardiovascular Research and author of more than 1,100 peer-reviewed publications. He has further served as a director of the Division of Cardiovascular Medicine and co-director of the Heart Institute at State University of New York (SUNY) Stony Brook University. Previously, he had functioned as the director for heart failure research at Emory University and director of the heart and heart-lung transplant programs at Vanderbilt University. He has also garnered several awards in heart failure and cardiology.
Dr. Butler joins other members of the SAB including Drs. Sanjiv Shah, Daniel Burkhoff and Barry Borlaug. The body was established in 2018 prior to the Phase II HELP study to support the development of TNX-103 in PH-HFpEF.
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1. The KCCQ is a disease-specific health status measure for patients with heart failure. It consists of 23 items grouped into symptom frequency, symptom burden, self-efficacy, social limitation, quality of life and physical limitation. Categories are scored, with higher values indicating better health status related to heart failure.
2. Tenax Therapeutics’ November 2023 Corporate Presentation
3. Tenax Therapeutics’ November 2023 Corporate Presentation
