Tenax Therapeutics, Inc. (NASDAQ:TENX) reported first quarter 2024 results on May 14th, 2024 in a press release and the filing of its Form 10-Q with the SEC. Since the beginning of the year, the company has enrolled the first patient in the oral levosimendan (TNX-103) LEVEL trial and presented data at a cardiovascular conference for PH-HFpEF. The company was also granted a new patent and expanded its license rights for levosimendan with Orion.
Stakeholders had a chance to interact with key opinion leaders (KOLs) in heart failure at an event which highlighted the LEVEL trial and the scientific rationale for treatment with levosimendan in patients with heart failure and preserved ejection fraction (PH-HFpEF). Below we summarize these recent highlights and 1Q:24 financial results.
Recent Highlights:
➢ First patient enrolled in LEVEL study – February 2024
➢ Expansion of levosimendan rights – February 2024
➢ Oral presentation at Technology and Heart Failure Therapeutics (THT) conference – March 2024
➢ USPTO patent grant for levosimendan in PH-HFpEF patent – April 2024
No revenues were reported in the first quarter and operating expenses were $3.9 million resulting in a net loss of ($3.8) million or ($3.12) per share.
For the quarter ending March 31, 2024 versus the same prior year period:
➢ General and administrative expenses fell 3% to $1.2 million primarily due to declines in facility and personnel costs partially offset by an increase in other cost including non-income taxes;
➢ Research and development expenses rose by more than a factor of 9x to $2.7 million from $266,000 as clinical and preclinical costs grew by $2.3 million. The increase reflects expenses related to the Phase II HELP open label extension and costs related to the Phase III LEVEL trial. Other costs were down slightly;
➢ Net interest expense was ($8,000) compared to ($7,000);
➢ Net loss was ($3.8) million versus ($1.4) million. 1Q:24 loss per share was ($3.12).
As of March 31, 2024, cash and equivalents totaled $12.5 million, compared to $9.8 million at the end of 2023. Tenax consumed ($5.2) million in cash in 1Q:24 with a decrease in accounts payable and accrued liabilities explaining the difference between net loss and cash burn. Financing cash flows were $7.9 million in 1Q:24 reflecting the February capital raise. Management estimates that Tenax has sufficient cash to continue to fund operations through 2024.
Expansion of Levosimendan Rights
On February 20th, Tenax reported that it had negotiated a favorable amendment to its global license agreement with Orion Corporation. The amendment broadens the geographic scope of the original license granting Tenax the exclusive right to develop and commercialize levosimendan products worldwide. Previously the license had only applied to the US and Canada. Compared with the previous agreement, the amendment reduces the royalty rates on sales but has increased some milestone payments as outlined in the company’s Form 8-K filing. Royalties are now in the high single digit to low-teen percentages. Furthermore, the agreement reduced the maximum capsule cost that will be negotiated in the future for oral levosimendan product. In return, Tenax relinquishes its right to negotiate for indications in the neurological space. Overall, the addition of Japan to future potential markets stands out as an attractive new opportunity. The broader suite of rights makes Tenax more appealing as an acquisition candidate and partner.
KOL Event
Tenax hosted a key opinion leader (KOL) event on April 18, 2024, moderated by Tenax’ Chief Medical Officer, Stuart Rich, MD. He led a panel featuring several experts in the field of heart failure and treating patients with pulmonary hypertension. The event reviewed emerging science, clinical experience with Tenax’ levosimendan (TNX-103) and the evolving heart failure landscape. Tenax further provided an update on the LEVEL study followed by audience questions. Panelists who are all members of Tenax’ scientific advisory board (SAB) include:
➢ Sanjiv Shah, MD, Northwestern University and chair of Tenax’ SAB
o Understanding the setting of PH-HFpEF
➢ Daniel Burkhoff, MD, PhD, CRF/Columbia University
o Mechanism of Action of Levosimendan
➢ Barry Borlaug, MD, Mayo Clinic
o Review of Phase II HELP study data
➢ Javed Butler, MD, MPH, MBA, Baylor Scott & White and recent addition to Tenax’ SAB
o Current treatment landscape in PH-HFpEF
Enrollment of First Patient in Phase III LEVEL Trial
A February 7th press release signaled the enrollment of the first patent in Tenax’ Phase 3 LEVEL Study (LEVosimendan to Improve Exercise Limitation in PH-HFpEF Patients). The study is listed under NCT05983250 in the National Library of Medicine’s Clinical Trials database. Over 40 sites have agreed to participate in the Group 2 pulmonary arterial hypertension (PAH) trial which is expected to generate topline results by 2H:25.
Tenax filed its investigational new drug (IND) application for the Phase III study in pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF) during 3Q:24 and announced the program’s clearance in a November 13th press release. Activity to initiate the trial began with site qualification and selection work taking place in Fall of 2023. Trial launch and site activity accelerated in the fourth quarter and enrollment has now started. We expect that two Phase III trials will be conducted, each enrolling approximately 150 subjects.
LEVEL’s primary endpoint is the six-minute walk distance (6MWD). Secondary endpoints will include the Kansas City Cardiomyopathy Questionnaire (KCCQ)1 and 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. Clinical worsening events and change in NYHA (New York Heart Association) functional class are other outcome measures that will be monitored.
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. Twenty-four sites have been initiated and others are in the process of being added at leading cardiovascular centers in the US and Canada. This includes sites that participated in the Phase II HELP study.
Key LEVEL details:
➢ Launched 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
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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.
