ADDED
We are conducting two Phase 3 clinical trials, LEVEL and LEVEL-2 for oral levosimendan, which are expensive and time consuming, and the outcomes of the clinical trials are uncertain.
Similarly, discrete observations during clinical trials may not reflect the general response to the products that will be revealed at the conclusion of the clinical trials or in future, widespread use of the product once marketed.
Risks Related to Our Financial Position and Need for Additional Capital We will require substantial additional funding to further develop, file marketing authorization applications, and if approved, commercialize our product candidates, including to complete the open label extension stage of our ongoing Phase 3 LEVEL and LEVEL-2 trials of levosimendan; as well as to initiate or complete any future imatinib Phase 3 trial.
Risks Relating to Our Industry Intense competition might render our product candidates noncompetitive or obsolete.
Our Bylaws contain an exclusive forum provision for certain disputes, which could limit our stockholders ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees, or agents.
ITE M 1 BUSINESS Overview Tenax Therapeutics is a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies.
In March 2025, we closed a private placement financing (the March 2025 Offering ) raising gross proceeds of $25.0 million.
We intend to use the net proceeds from the March 2025 Offering, in addition to the approximately $100.0 million raised in August 2024, to advance our Phase 3 oral levosimendan program.
Specifically, we plan to complete our ongoing Phase 3 LEVEL study of TNX-103 in pulmonary hypertension in heart failure with preserved ejection fraction ( PH-HFpEF ).
We also plan to advance our second global Phase 3 study, LEVEL-2, which was initiated in December 2025.
REMOVED
We are required to conduct additional clinical trials, including the LEVEL and LEVEL-2 trials for oral levosimendan, which are expensive and time consuming, and the outcomes of the clinical trials are uncertain.
Risks Related to Our Financial Position and Need for Additional Capital We will require substantial additional funding to further develop our product candidates, including to complete the open label extension stage of our ongoing Phase 3 LEVEL trial of levosimendan and to complete a second planned global Phase 3 study, LEVEL-2, as well as to initiate or complete an imatinib Phase 3 trial.
Anti-takeover provisions in our corporate charter documents and under Delaware law could make an acquisition of us more difficult, which could discourage takeover attempts and lead to management entrenchment, and the market price of our common stock may be lower as a result.
ITE M 1 BUSINESS Overview Tenax Therapeutics is a clinical-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies.
In August 2024, we closed a private placement financing (the August 2024 Offering ) raising gross proceeds of approximately $100.0 million and in March 2025 we closed a private placement financing (the "March 2025 Offering ) raising gross proceeds of $25.0 million.
We intend to use the net proceeds from the August 2024 and March 2025 Offerings to advance our Phase 3 oral levosimendan program, by completing our ongoing Phase 3 LEVEL study and initiating a second planned global Phase 3 study, LEVEL-2.
We intend to submit marketing authorization applications following completion of the two Phase 3 trials of levosimendan and, when appropriate, a single Phase 3 trial of imatinib.
Efficiently conduct clinical development to establish clinical proof of principle in new indications, refine dosage levels and dosing strategies, conduct other required clinical and nonclinical testing as FDA and other regulators may require, and continue Phase 3 testing of oral levosimendan, as our prioritized product candidate.
Our focus is primarily on designing and executing formulation improvements, protecting these innovations with patents and other forms of exclusivity, and employing innovative clinical trial science to establish a robust foundation for subsequent development, product approval, and commercialization.
We intend to submit marketing authorization applications following two Phase 3 trials of levosimendan, as our prioritized drug candidate.