TENX Tenax Therapeutics Inc

Tenax Therapeutics, Inc. (Nasdaq: TENX), a Phase 3, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced Dr. Sanjiv Shah, Stone Endowed Professor of Medicine, Director of Research for the Bluhm Cardiovascular Institute, and Director of the HFpEF Program at Northwestern University Feinberg School of Medicine, will present data and review the scientific basis for the use of levosimendan in PH-HFpEF. Dr Shah’s presentation will occur during a scientific session focused on the treatment of pulmonary hypertension in patients with heart failure at the upcoming Cardiovascular Research Foundation’s Technology and Heart Failure Therapeutics (THT) Conference in Boston.

Details of the presentation:

Date:		Wednesday, March 6, 2024
Time:		9:39 – 9:51 am EDT
Lecturer:		Sanjiv J. Shah, M.D.
Presentation Title:		“PH-HFpEF: Levosimendan”
Session:		Pulmonary Hypertension – Concurrent Session 2 (9:15 – 10:47 am EDT)
Conference:		THT 2024, Westin Boston Seaport, Boston, MA, 04-06 March

“THT 2024 is an ideal forum for raising awareness about the unique properties of levosimendan and its potential to improve the hemodynamic abnormalities underlying PH-HFpEF,” said Chris Giordano, President & Chief Executive Officer of Tenax Therapeutics. “Our Phase 3 LEVEL study is on the cutting edge of PH-HFpEF drug development, and Tenax is privileged Dr. Shah has chosen to review the scientific rationale for levosimendan use in these patients with the many international heart failure experts attending THT 2024.”

About CRF’s Technology and Heart Failure (THT) Conference

CRF, the Cardiovascular Research Foundation, sponsors the Technology and Heart Failure Therapeutics conference, an immersive experience in the latest treatment innovations, focusing on device- and tech-based treatments within the context of drug therapies. THT 2024 is an in-person only conference designed for a multidisciplinary audience that includes anyone interested in heart failure management and a comprehensive overview of existing and investigational interventions.1 Source: https://tht2024.crfconnect.com/about-tht

About the Phase 3 LEVEL Study (NCT05983250)

The LEVEL Study is a Phase 3, double-blind, randomized, placebo-controlled study of levosimendan in patients with PH-HFpEF. Approximately 152 subjects will be randomized in a 1:1 ratio to receive an oral dose of levosimendan or placebo 2 mg/day for Weeks 1 to 4 and 3 mg/day for Weeks 5 to 12. The primary outcome measure for the study is six-minute walk distance from Baseline to Week 12. All randomized subjects will have the option to enter the 92-week OLE following the completion of all study events at Week 12.

About Levosimendan (TNX-101, TNX-102, TNX-103)

Levosimendan is a unique, potassium ATP channel activator and calcium sensitizer that affects the heart and vascular system through multiple mechanisms of action. Initially discovered and developed by Orion Corporation in Finland, intravenous levosimendan is approved in 60 countries outside the United States for use in hospitalized patients with acutely decompensated heart failure. Results of Tenax Therapeutics’ Phase 2 HELP study of levosimendan in patients with pulmonary hypertension (PH) with heart failure with preserved ejection fraction (HFpEF) demonstrated that I.V. levosimendan produces potent dilation of the central and pulmonary venous circulations which translates into an improvement in exercise capacity, a discovery that is the basis of LEVEL, the Phase 3 investigation of Tenax Therapeutics’ potential groundbreaking therapy. To date, no other drug therapy has improved exercise tolerance in patients with PH associated with HFpEF, “a growing epidemic with high morbidity and mortality and no treatment. The clear unmet need and lethal nature of PH-HFpEF must be met with novel solutions at all levels of therapeutic development” (AHA Scientific Advisory, “A Call to Action,” 2022).

About Tenax Therapeutics

Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company owns global rights to develop and commercialize I.V., subcutaneous, and oral formulations of levosimendan. Tenax also is developing a unique oral formulation of imatinib.  For more information, visit www.tenaxthera.com. Tenax’s common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”.

Caution Regarding Forward-Looking Statements

Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. These forward-looking statements may include information concerning possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: risks related to our business strategy, including the prioritization and development of product candidates;   risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, initiation, enrollment, and results of such trials; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; our estimates regarding the potential market opportunity for our product candidates; the potential advantages of our product candidates; and other risks and uncertainties set forth from time to time in our SEC filings. Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law.

Contacts

Investor Contact:John FrauncesManaging DirectorLifeSci Advisors, LLCC: 917-355-2395, or

Brian MullenLifeSci Advisors, LLCC: 203-461-1175