TENAX THERAPEUTICS, INC.
For the period ended Dec 31, 2025. Filed Mar 10, 2026.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 10, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-03-25.
0000950170-25-044398
ITEM 7. —MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-10.
0001193125-26-099393
ITEM 7. —MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 62 previous paragraphs and 64 current paragraphs.
38 unchanged; 19 reworded; 6 added; 5 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 4 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (6)
Current report
Our Phase 3 LEVEL study continues, with high rates of study and therapy continuation during the blinded and open-label extension stages. We achieved our target enrollment of 230 patients in March of 2026. LEVEL is being conducted in the United States and Canada.
Current report
Based on our current operating plan, we believe that our existing cash and cash equivalents as of December 31, 2025 will be sufficient to fund our planned operations through at least the end of 2027.
Current report
Interest Income, Interest Expense, and Other Income (Expense), net
Current report
Interest income increased $1.9 million for the year ended December 31, 2025 as compared to the same period in the prior year primarily related to higher interest income on increased cash deposits as a result of the March 2025 Offering and warrant exercises during 2025, and increased interest rates. The Company had no interest expense for the year ended December 31, 2025 and an immaterial amount for the prior year. Other income (expense) was immaterial.
Current report
On March 5, 2025, we sold in the March 2025 Offering an aggregate of 378,346 shares of our common stock and pre-funded warrants to purchase an aggregate of 3,760,726 shares of our common stock at an offering price of $6.04 per share of common stock and $6.03 per pre-funded warrant, resulting in gross proceeds of $25.0 million. The pre-funded warrants do not expire and have an exercise price of $0.01. Net proceeds from the offering were $23.2 million, after deducting the placement agent fees and offering expenses payable by the Company.
Current report
Net cash provided by financing activities was $38.5 million for the year ended December 31, 2025, as compared to $99.9 million in the year ended December 31, 2024. During the year ended December 31, 2025, the Company received proceeds of $23.2 million net cash provided from the sale of common stock and pre-funded warrants in the March 2025 Offering and $15.3 million from the exercise of warrants and pre-funded warrants. During the year ended December 31, 2024 the Company received proceeds of a total of$98.5 million from the August 8, 2024 and February 8, 2024 sales of common stock, and pre-funded warrants and accompanying warrants, and $1.8 million from the exercise of warrants and pre-funded warrants, offset by the principal payment of $0.5 million related to a short-term note.
Removed paragraphs (5)
Previous report
Other Income and Expense, Net
Previous report
Other income and expenses include non-operating income and expense items. These items include but are not limited to interest income earned and fixed asset disposals. Other income increased $1.4 million for the year ended December 31, 2024 compared to the prior year due to higher interest income on increased cash deposits as a result of the August 2024 Offering.
Previous report
On August 8, 2024, we sold in the August 2024 Offering an aggregate of 1,450,661 shares of our common stock, and Pre-Funded Warrants to purchase 31,882,671 shares of our common stock, along with accompanying Warrants to purchase up to 16,666,666 shares of our common stock. The purchase price for each share and accompanying Warrant was $3.00, with the accompanying Warrant having an exercise price of $4.50 (provided, the purchase price for each Pre-Funded Warrant and accompanying Warrant was $2.99, with the Pre-Funded Warrants having an exercise price of $0.01). Gross proceeds from the August 2024 Offering were $99.7 million, before deducting the placement agent fees and estimated offering expenses payable by the Company. Net proceeds from the offering were $92.3 million, after deducting the placement agent fees and offering expenses payable by the Company.
Previous report
Net cash provided by financing activities was $99.9 million for the year ended December 31, 2024, compared to $13.6 million in the year ended December 31, 2023. The increase in cash provided by financing activities was due to higher net proceeds received from the August 2024 Offering and February 2024 Offering, compared to the February 2023 Offering.
Previous report
In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which is intended to provide enhanced segment disclosures. The standard will require disclosures about significant segment expenses and other segment items and identifying the Chief Operating Decision Maker ("CODM") and how they use the reported segment profitability measures to assess segment performance and allocate resources. These enhanced disclosures are required for all entities on an interim and annual basis, even if they have only a single reportable segment. The standard is effective for years beginning after December 15, 2023, and interim periods within annual periods beginning after December 15, 2024. Adopting this standard for the year ended December 31, 2024 resulted in enhanced disclosures but did not have a material impact on the Company's consolidated financial statements. The Company operates in one reportable segment, which is focused on identifying and developing therapeutics that address cardiovascular and pulmonary diseases with high unmet medical need. The determination of a single reportable segment is consistent with the consolidated financial information regularly provided to the Company’s CODM, which is its President and Chief Executive Officer, who reviews and evaluates consolidated net income (loss) for purposes of assessing performance, making operating decisions, allocating resources and planning and forecasting for future periods. The measure of segment assets is reported on the balance sheet as total assets.
Reworded paragraphs (19)
Previous wording
Tenax Therapeutics is a clinical-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies. We employ a clinician-focused drug development approach, led by key opinion leaders and heart failure experts and informed by their clinical insights to precisely target disease pathophysiology. We are currently actively conducting the LEVEL clinical trial to evaluate levosimendan as our prioritized product candidate, and have deprioritized a Phase 3 clinical trial of imatinib, two drugs supported by promising evidence that they may significantly improve the lives of patients with pulmonary hypertension. Importantly, both levosimendan and imatinib have already been approved in other indications and prescribed around the world for more than 20 years, and we believe their mechanisms of action are uniquely suitable to target and treat pulmonary hypertension. We believe this derisked approach of using already-approved drugs that provide well-established safety profiles from millions of patients, combined with a development path led by preeminent cardiology and pulmonary hypertension experts, puts us in a strong position to deliver breakthrough cardiopulmonary therapies designed to improve patients’ function and quality of life.
Current wording
Tenax Therapeutics is a Phase 3, development-stage pharmaceutical company leveraging clinical insights to develop novel cardiopulmonary therapies. We employ a clinician-driven drug development approach, led by key opinion leaders and advised by thought leaders who are pulmonary hypertension and heart failure experts and informed by their clinical insights to precisely target disease pathophysiology. We are currently actively conducting the LEVEL and LEVEL-2 clinical trials to evaluate levosimendan as our prioritized product candidate, and have deprioritized a Phase 3 clinical trial of imatinib, two drugs supported by promising evidence that they may significantly improve the lives of patients with pulmonary hypertension. Importantly, both levosimendan and imatinib have already been approved in other indications and prescribed around the world for more than 20 years, and we believe their mechanisms of action are uniquely suitable to target and treat pulmonary hypertension. We believe this derisked approach of using already-approved drugs that provide well-established safety profiles from millions of patients, combined with a development path led by preeminent cardiovascular and pulmonary hypertension experts, puts us in a strong position to deliver breakthrough cardiopulmonary therapies designed to improve patients’ functioning and quality of life.
Previous wording
In August 2024, we closed a private placement financing (the “August 2024 Offering”) raising gross proceeds of approximately $100 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. Given our resources on December 31, 2024 and gross proceeds of $25.0 million from our March 2025 offering, we believe we can continue our operations for at least the next 12 months.
Current wording
In March 2025, we closed a private placement financing raising gross proceeds of approximately $25.0 million. We intend to use the net proceeds from the March 2025 Offering, in addition to 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 PH-HFpEF. We also plan to advance our second global Phase 3 study, LEVEL-2, which commenced in December 2025. Following completion of the two Phase 3 levosimendan trials, we intend to submit marketing authorization applications. We also plan to submit an application for imatinib following completion of a single Phase 3 trial, when appropriate.
Previous wording
Research and development expenses were $12.7 million for the year ended December 31, 2024 as compared to $3.2 million for the same period in the prior year. Research and development expenses include, but are not limited to, (i) expenses incurred under agreements with CROs and investigative sites, which conduct a substantial portion of our pre-clinical and our clinical studies; (ii) the cost of supplying clinical trial materials; (iii) payments to contract service organizations as well as consultants; (iv) employee-related expenses, which include salaries and benefits; and (v) facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities and equipment, depreciation of leasehold improvements, equipment, and other supplies. All research and development expenses are expensed as incurred. Research and development expenses and percentage changes for the years ended December 31, 2024 and 2023, respectively, are as follows (in thousands):
Current wording
Research and development expenses include, but are not limited to, (i) expenses incurred under agreements with CROs and investigative sites, which conduct a substantial portion of our pre-clinical and our clinical studies; (ii) the cost of supplying clinical trial materials; (iii) payments to contract service organizations as well as consultants; (iv) employee-related expenses, which include salaries and benefits; and (v) facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities and equipment, depreciation of leasehold improvements, equipment, and other supplies. All research and development expenses are expensed as incurred. Research and development expenses and percentage changes for the years ended December 31, 2025 and 2024, respectively, are as follows (in thousands):
Previous wording
Clinical and preclinical development costs increased $8.8 million for the year ended December 31, 2024 as compared to the same period in the prior year. Clinical and preclinical development costs for 2024, consists of expenses associated with our Phase 3 LEVEL trial for oral levosimendan, compared with costs for 2023, associated primarily with our Phase 2 HELP Open Label Extension Study for levosimendan, and imatinib formulation development.
Current wording
Clinical and preclinical development costs increased $14.9 million for the year ended December 31, 2025 as compared to the same period in the prior year. Clinical and preclinical development costs for the year ended December 31, 2025 consists primarily of expenses associated with our ongoing Phase 3 LEVEL trial and our second global Phase 3 study, LEVEL-2, which commenced in December 2025, compared with costs for the year ended December 31, 2024, associated with the planning of LEVEL and the early progress initiating LEVEL sites and enrolling the first LEVEL patients.
Previous wording
Salary and benefits expense increased $271 thousand for the year ended December 31, 2024 compared to the same period in the prior year due primarily to higher salaries and bonuses. Stock-based compensation expense increased $648 thousand for the year ended December 31, 2024 due to stock option grants in 2024.
Current wording
Salary and benefits expense increased $1.1 million for the year ended December 31, 2025 as compared to the same period in the prior year primarily due the increased number of employees as we expanded our LEVEL trial and designed, planned, and commenced our LEVEL-2 trial. Stock-based compensation expense increased $3.6 million for the year ended December 31, 2025, as compared to the same period in the prior year due to stock option grants made late in 2024 and during 2025.
Previous wording
Other costs increased $161 thousand for the year ended December 31, 2024 as compared to the same period in the prior year, primarily due to higher regulatory costs over the prior year as we expanded our clinical trial during 2024.
Current wording
Other costs increased $0.3 million for the year ended December 31, 2025, as compared to the same period in the prior year, primarily due to higher regulatory costs over the prior year as we expanded our clinical trial during 2024.
Previous wording
General and administrative expenses were $6.8 million for the year ended December 31, 2024, compared to $5.0 million for the same period in 2023. General and administrative expenses consist primarily of compensation for executive, finance, legal and administrative personnel, including stock-based compensation. Other general and administrative expenses include facility costs not otherwise included in research and development expenses, legal and accounting services, and other professional and consulting services. General and administrative expenses and percentage changes for the years ended December 31, 2024 and 2023, respectively, are as follows (in thousands):
Current wording
General and administrative expenses consist primarily of compensation for executive, finance, legal and administrative personnel, including non-cash stock-based compensation. Other general and administrative expenses include facility costs not otherwise included in research and development expenses, legal and accounting services, and other professional and consulting services. General and administrative expenses and percentage changes for the years ended December 31, 2025 and 2024, respectively, are as follows (in thousands):
Previous wording
Salary and benefits expense increased $218 thousand for the year ended December 31, 2024 as compared to the same period in the prior year primarily due to higher salaries and bonuses in 2024. Stock-based compensation expense increased $286 thousand for the year ended December 31, 2024 due to stock option grants made in 2024.
Current wording
Salary and benefits expense remained relatively unchanged for the year ended December 31, 2025, as compared to the same period in the prior year due to lower bonuses offsetting salary increases and new employee salaries. Stock-based compensation expense increased $14.4 million for the year ended December 31, 2024 due to stock option grants in late 2024 and during 2025.
Previous wording
Legal fees consist of the cost of our legal counsel as well as legal costs related to our intellectual property. Professional fees consist of the costs incurred for accounting fees, capital market expenses, consulting fees and investor relations services, as well as fees paid to the members of our Board of Directors. Legal and professional fees increased $725 thousand for the year ended December 31, 2024 compared to the same period in the prior year primarily related to increased capital market expenses, consulting expenses, and accounting expenses, offset by a decrease in intellectual property related legal costs.
Current wording
Legal fees consist of the cost of our legal counsel as well as legal costs related to our intellectual property. Professional fees consist of the costs incurred for accounting fees, capital market expenses, consulting fees and investor relations services, as well as fees paid to the members of our Board of Directors. Legal and professional fees increased $1.7 million for the year ended December 31, 2025 compared to the same period in the prior year primarily related to increased capital market expenses, consulting expenses, and accounting expenses, offset by a decrease in intellectual property related legal costs.
Previous wording
Other costs increased $136 thousand for the year ended December 31, 2024 compared to the same period in the prior year. Other costs include expenses incurred for franchise and other taxes, travel, supplies, insurance, depreciation and other miscellaneous charges. The increase was primarily attributable to increased costs for franchise and other taxes.
Current wording
Other costs increased $0.7 million for the year ended December 31, 2025 compared to the same period in the prior year. Other costs include expenses incurred for franchise and other taxes, travel, supplies, insurance, depreciation and other miscellaneous charges. The increase was primarily attributable to increased costs for franchise and other taxes.
Previous wording
We have incurred losses since our inception and, as of December 31, 2024, we had an accumulated deficit of $314.9 million. We will continue to incur losses until we generate sufficient revenue to offset our expenses, and we anticipate that we will continue to incur net losses for at least the next several years. We expect to incur additional expenses related to our development and potential commercialization of levosimendan and, over the long term, imatinib for PAH, and other potential indications, as well as identifying and developing other potential product candidates, and as a result, we will need to generate significant net product sales, royalty and other revenues to achieve profitability.
Current wording
We have incurred losses since our inception and, as of December 31, 2025, we had an accumulated deficit of $367.5 million. We will continue to incur losses until we generate sufficient revenue to offset our expenses, and we anticipate that we will continue to incur net losses for at least the next several years. We expect to incur additional expenses related to our development and potential commercialization of levosimendan and, over the long term, imatinib for
Previous wording
We have financed our operations since September 1990 through the issuance of debt and equity securities and loans from stockholders. We had total current assets of $96.7 million and $11.7 million and working capital of $92.0 million and $8.1 million as of December 31, 2024 and December 31, 2023, respectively. Our practice is to invest excess cash, where available, in short-term money market investment instruments and high quality corporate and government bonds.
Current wording
We have financed our operations since September 1990 through the issuance of debt and equity securities and loans from stockholders. We had total current assets of $104.2 million and $96.7 million and working capital of $97.1 million and $92.0 million as of December 31, 2025 and December 31, 2024, respectively. Our practice is to invest excess cash, where available, in short-term money market investment instruments and high quality corporate and government bonds.
Previous wording
We are currently conducting the LEVEL trial and intend to recruit patients through approximately the end of 2025. Our ability to continue to pursue development of our products, including completion of a second Phase 3 oral levosimendan trial, beyond 2027, will depend on obtaining license income, income from warrants exercised by investors should they elect to do so, or outside financial resources. There is no assurance that we will obtain any license agreement or outside financing or that we will otherwise succeed in obtaining any necessary resources.
Current wording
We are currently conducting the LEVEL trial and intend to recruit patients into the first half of 2026 and we commenced our LEVEL-2 trial in December 2025 and are currently enrolling patients. Our ability to continue to pursue development of our products, including completion of a second Phase 3 oral levosimendan trial, beyond 2027, will depend on obtaining license income, income from warrants exercised by investors should they elect to do so, or outside financial resources. There is no assurance that we will obtain any license agreement or outside financing or that we will otherwise succeed in obtaining any necessary resources.
Previous wording
On February 3, 2023, we sold in a registered public offering (the "February 2023 Offering") (i) an aggregate of 86,994 shares of our common stock and pre-funded warrants to purchase an aggregate of 21,341 shares of our common stock and (ii) accompanying warrants to purchase up to an aggregate of 216,667 shares of our common stock at a combined offering price of $144.00 per share of common stock and accompanying warrant, or $143.92 per pre-funded warrant and accompanying warrant, resulting in gross proceeds to the Company of $15.6 million. Net proceeds of the offering were $14.1 million, after deducting the placement agent fees and offering expenses payable by the Company.
Current wording
On August 8, 2024, we sold in a private placement financing an aggregate of 1,450,661 shares of our common stock, and pre-funded warrants to purchase an aggregate of 31,882,671 shares of our common stock, and accompanying warrants to purchase up to an aggregate of 16,666,666 shares of our common stock with an exercise price of $4.50, at a combined offering price of $3.00 per share of common stock and accompanying warrant, or $2.99 per pre-funded warrant and accompanying warrant, resulting in gross proceeds of $99.7 million. Net proceeds from the offering were $92.3 million, after deducting the placement agent fees and offering expenses payable by the Company.
Previous wording
On February 8, 2024, we sold in a registered public offering (the “February 2024 Offering”) (i) an aggregate of 421,260 shares of our common stock and pre-funded warrants to purchase an aggregate of 1,178,740 shares of our common stock and (ii) accompanying warrants to purchase up to an aggregate of 3,200,000 shares of our common stock at a combined offering price of $5.65 per share of common stock and accompanying warrant, or $5.649 per pre-funded warrant and accompanying warrant, resulting in gross proceeds to the Company of $9.0 million. Net proceeds of the offering were $8.0 million, after deducting the placement agent fees and offering expenses payable by the Company.
Current wording
On February 8, 2024, we sold in a registered public offering (the “February 2024 Offering”) an aggregate of 421,260 shares of our common stock and pre-funded warrants to purchase an aggregate of 1,178,740 shares of our common stock and (ii) accompanying warrants to purchase up to an aggregate of 3,200,000 shares of our common stock with an exercise price of $5.65, at a combined offering price of $5.65 per share of common stock and accompanying warrant, or $5.649 per pre-funded warrant and accompanying warrant, resulting in gross proceeds to the Company of $9.0 million. Net proceeds of the offering were $8.0 million, after deducting the placement agent fees and offering expenses payable by the Company.
Previous wording
Net cash used in operating activities was $14.8 million for the year ended December 31, 2024 compared to $5.9 million for the year ended December 31, 2023. The increase in cash used for operating activities was primarily due to higher study expense activity in the year ended December 31, 2024 as compared to the prior year.
Current wording
Net cash used in operating activities was $35.8 million for the year ended December 31, 2025, compared to $14.8 million for the year ended December 31, 2024. The increase in cash used for operating activities was primarily due to higher study expense activity and increased employee hiring in the year ended December 31, 2025 as compared to the prior year.
Previous wording
There was no net cash provided or consumed by investing activities for the year ended December 31, 2024, compared to net cash provided by investing activities of $3 thousand in the year ended December 31, 2023 from the sale of office furniture when the Company relocated its' headquarters.
Current wording
There was no net cash provided or consumed by investing activities for the years ended December 31, 2025 and December 31, 2024.
Previous wording
Based on our working capital on December 31, 2024, we believe we have sufficient capital on hand to continue to fund operations through 2027.
Current wording
Based on our working capital on December 31, 2025, we believe we have sufficient capital on hand to continue to fund operations through the end of 2027.
Previous wording
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which is intended to provide enhancements to annual income tax disclosures. The standard will require more detailed information in the rate reconciliation table and for income taxes paid, among other enhancements. The standard is effective for years beginning after December 15, 2024 and early adoption is permitted. The Company is evaluating this standard to determine if adoption will have a material impact on the Company’s consolidated financial statements.
Current wording
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which is intended to provide enhancements to annual income tax disclosures. The standard will require more detailed information in the rate reconciliation table and for income taxes paid, among other enhancements. The standard is effective for years beginning after December 15, 2024. The Company adopted and applied the amendments of this ASU to its disclosures. The application of this ASU did not have a material impact on the Company's financial position, results of operations or cash flows.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
PAH, and other potential indications, as well as identifying and developing other potential product candidates, and as a result, we will need to generate significant net product sales, royalty and other revenues to achieve profitability.