Tenax Therapeutics, Inc. (NASDAQ:TENX) reported full year 2023 results on March 28, 2024 in a press release and the filing of its Form 10-K with the SEC. Over the last five months, the company has announced clearance of its investigational new drug (IND) application for clinically advancing oral levosimendan (TNX-103), enrolled the first patient in the LEVEL trial and presented data at a cardiovascular conference for PH-HFpEF. The company also made progress with patents, its license rights for levosimendan with Orion and expanded its scientific advisory board with a new member.
With the TNX-103 trial underway, Tenax is looking forward to a key opinion leader (KOL) event next week which will discuss the scientific rationale for levosimendan for treatment of pulmonary hypertension in patients with heart failure and preserved ejection fraction (PH-HFpEF). Below we summarize recent highlights and 2023 financial results.
Recent Highlights:
➢ IND cleared for start of oral levosimendan Phase III trial (LEVEL) in PH-HFpEF – November 2023
➢ Addition of Dr. Javed Butler to PH-HFpEF Scientific Advisory Board – November 2023
➢ 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
Tenax produced no revenues in 2023 and incurred operating expenses of $8.2 million resulting in a net loss of ($7.7) million, or ($31.04) per share.
For the year ending December 31, 2023 versus the same prior year period:
➢ General and administrative expenses fell 12% to $5.0 million primarily due to declines in personnel, legal and professional fees. Facilities costs were also down over the prior year which were partially offset by lower amounts for other items;
➢ Research and development expenses fell 40% to $3.2 million from $5.4 million as clinical and preclinical costs fell by $2.3 million. This reflects higher spending on the Phase II HELP trial in 2022, which was only partially replaced by resources allocated to ramping up the LEVEL trial in 2023. Decreases in clinical spending were counterbalanced by increases in higher personnel costs due to higher incentive compensation and other costs, related to regulatory spending;
➢ Net interest income was $0.5 million, rising due to greater cash balances and higher interest rates;
➢ Net loss was ($7.7) million versus ($11.1) million. For 2023, this was ($31.04) on a per share basis.
At the end of 2023, cash and equivalents totaled $9.8 million, compared to $2.1 million at the end of 2022. Tenax consumed ($5.9) million in cash for 2023. Financing cash flows were $13.6 million in 2023. Following the end of the year, a $9 million public offering was closed in February 2024. We estimate cash burn will increase in 2024 due to expansion of and patient accrual in the LEVEL trial. 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 attractive as an acquisition candidate.
KOL Event
Tenax will host a key opinion leader (KOL) event on April 18, 2024 at 10 am ET, moderated by Tenax’ Chief Medical Officer, Stuart Rich, MD. He will lead a panel featuring several experts in the field of heart failure and treating patients with pulmonary hypertension. The event will review emerging science, clinical experience with Tenax’ levosimendan (TNX-103) and the evolving heart failure landscape. Tenax will further provide an update on the LEVEL study followed by receiving questions by the audience. Panelists include:
➢ Sanjiv Shah, MD, Northwestern University
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
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. Three sites have been officially listed on the Clinical Trials website 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
$9 Million Public Offering
On February 8th, 2024 Tenax announced that it had priced $9 million in a public offering to access additional funds to support its Phase III LEVEL trial. The deal includes the issuance of 1.6 million shares and 3.2 million warrants at a purchase price of $5.65 per share. Warrants have a duration of five years with an exercise price of $5.65. Roth Capital Partners is serving as the placement agent. Net proceeds of $8.0 million will be used to advance the initiation of sites and the enrollment and treatment of patients in the LEVEL study, as well as for working capital, capital expenditures, and other general corporate purposes.
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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’ February 2024 Corporate Presentation
3. Tenax Therapeutics’ February 2024 Corporate Presentation
