TENAX THERAPEUTICS, INC.
For the period ended Mar 31, 2026. Filed May 12, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 12, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001193125-25-277793
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-12.
0001193125-26-219383
Item 2. 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 58 previous paragraphs and 58 current paragraphs.
33 unchanged; 21 reworded; 4 added; 4 removed; 0 previous and 0 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 (4)
Current report
Based on our current operating plan, we believe that our existing cash and cash equivalents as of March 31, 2026, along with cash received from warrant exercises subsequent to quarter end, will be sufficient to fund our planned operations through at least the first quarter of 2028.
Current report
Salary and benefits increased $0.3 million for the three months ended March 31, 2026, compared to the same period in 2025. The change was primarily attributable to increased head count and salaries, and related compensation.
Current report
Interest income decreased by $0.1 million for the three months ended March 31, 2026, as compared to the same period in the prior year primarily due to lower interest rates. The Company had an immaterial other expense for the three months ended March 31, 2026 and none for the comparable period in the prior year.
Current report
On March 24, 2026, we filed a universal shelf registration statement on Form S-3 with the SEC, which the SEC declared effective on April 1, 2026. Pursuant to this registration statement, we have the ability to sell up to $300.0 million of any combination of our equity or debt securities in one or more public offerings, at prices and on terms that we will determine at the time of offering.
Removed paragraphs (4)
Previous report
Given our resources on September 30, 2025, we believe we can continue our operations through 2027.
Previous report
Interest income increased $0.4 million and $2.0 million for the three and nine months ended September 30, 2025, respectively, as compared to the same periods in the prior year primarily related to higher interest income on increased cash deposits as a result of the August 2024 Offering and the March 2025 Offering, and increased interest rate. The Company had no interest expense for the three and nine months ended September 30, 2025 and an immaterial amount for the comparable periods in the prior year.
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). Net proceeds from the offering were $92.3 million, after deducting the placement agent fees and offering expenses payable by the Company.
Previous report
On February 8, 2024, we sold in 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. Net proceeds of the offering were $8.0 million, after deducting the placement agent fees and offering expenses payable by the Company.
Reworded paragraphs (21)
Previous wording
Tenax Therapeutics is a clinical-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 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 using clinical insights to develop novel cardiopulmonary therapies. We employ a clinician-driven 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 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 March 2025, we closed a private placement financing (the “March 2025 Offering”) raising gross proceeds of approximately $25.0 million. We intend to use the net proceeds from the March 2025 Offering to advance our Phase 3 oral levosimendan program, by completing our ongoing Phase 3 LEVEL study of TNX-103 in pulmonary hypertension resulting from heart failure with preserved ejection fraction (PH-HFpEF) and initiating a second 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.
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
Patient enrollment in our Phase 3 LEVEL study continues, with high rates of study and therapy continuation during the blinded and open-label extension stages. We expect to enroll 230 patients in the first half of 2026. LEVEL is being conducted in the United States and Canada. We remain on track to commence LEVEL-2 this year. The LEVEL-2 trial will have a global footprint.
Current wording
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.
Previous wording
Financial Overview – Three and Nine Months Ended September 30, 2025 (in thousands)
Current wording
Financial Overview – Three Months Ended March 31, 2026 (in thousands)
Previous 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 clinical studies; (ii) the cost of supplying clinical trial materials; (iii) payments to CROs and consultants; (iv) employee-related expenses, including salaries, non-cash stock compensation expense, and benefits; and (v) facilities, depreciation and other allocated expenses, including 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 three and nine months ended September 30, 2025 and 2024 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 CROs 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 three months ended March 31, 2026 and 2025 are as follows (in thousands):
Previous wording
Clinical and preclinical development costs increased $5.7 million and $10.0 million for the three and nine months ended September 30, 2025, respectively, as compared to the same periods in the prior year. Clinical and preclinical development costs for the three and nine months ended September 30, 2025 consists primarily of expenses associated with our ongoing Phase 3 LEVEL trial and our second global Phase 3 study, LEVEL-2, for which we are conducting start-up activities, compared with costs for the three and nine month periods ended September 30, 2024, associated with the planning of LEVEL and the initiation of the first LEVEL sites and enrollment of the first LEVEL patients.
Current wording
Clinical and preclinical development costs increased $5.8 million for the three months ended March 31, 2026, as compared to the same period in the prior year. Clinical and preclinical development costs for the three months ended March 31, 2026 consist 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, as compared to the three months ended March 31, 2025, which consisted primarily of costs associated with our Phase 3 LEVEL trial.
Previous wording
Salary and benefits costs increased for the three and nine months ended September 30, 2025 as compared to the same periods in the prior year primarily due to higher salaries and additional performance-based compensation expense as a result of an increase in the number of employees. Non-cash stock-based compensation expense increased by $1.1 million and $2.9 million for the three and nine months ended September 30, 2025, respectively, as compared to the same periods in 2024 primarily due to stock options granted in December 2024, for which the expense is being amortized over a one year vesting period, in addition to new option grants made in 2025 to new and existing employees that vest and are being expensed over four years.
Current wording
Salary and benefits costs increased by $0.5 million for the three months ended March 31, 2026 as compared to the same period in the prior year primarily due to higher salaries and additional performance-based compensation expense as a result of an increase in the number of employees. Non-cash stock-based compensation expense decreased by $0.3 million for the three months ended March 31, 2026, as compared to the same period in 2025 primarily due to stock options granted in December 2024, for which the expense was recognized over a one year vesting period and became fully vested in December 2025, partially offset by new option grants made in 2026 to employees that vest and are being expensed over four years.
Previous wording
Other costs increased for the three and nine months ended September 30, 2025 as compared to the same periods in the prior year, primarily due to increased regulatory consulting costs as we expanded our ongoing Phase 3 LEVEL trial.
Current wording
Other costs decreased for the three months ended March 31, 2026 as compared to the same period in the prior year, primarily due to increased regulatory consulting costs as we continued to expand our Phase 3 trials.
Previous 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 three and nine months ended September 30, 2025 and 2024 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 three months ended March 31, 2026 and 2025 are as follows (in thousands):
Previous wording
Non-cash stock-based compensation expense increased $4.5 million and $11.4 million for the three and nine months ended September 30, 2025, respectively, as compared to the same periods in 2024 primarily due to stock options granted in December 2024, for which the expense amortizes over a one-year vesting term, in addition to new option grants made in 2025.
Current wording
Non-cash stock-based compensation expense decreased $1.0 million for the three months ended March 31, 2026, as compared to the same period in 2025 primarily due to stock options granted in December 2024, for which the expense was amortized over a one-year vesting term, which was partially offset by new option grants made in 2026.
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 $0.2 million and $1.5 million for the three and nine month periods ended September 30, 2025, respectively, as compared to the same periods in the prior year primarily related to increased capital market expenses, consulting expenses, and accounting expenses.
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 $0.1 million for the three month period ended March 31, 2026, as compared to the same period in the prior year.
Previous wording
Other costs include expenses incurred for franchise and other taxes, travel, supplies, insurance, depreciation, and other miscellaneous charges. Other costs increased $0.2 million and $0.7 million for the three and nine months ended September 30, 2025, respectively, as compared to the same periods in the prior year primarily due to increased franchise and other taxes, travel, and insurance related to the growth of the Company.
Current wording
Other costs include expenses incurred for franchise and other taxes, travel, supplies, insurance, depreciation, and other miscellaneous charges.
Previous wording
Interest Income, Interest Expense, and Other Income (Expense), net
Current wording
Interest Income, Interest Expense, and Other Expense, net
Previous wording
We have incurred losses since our inception and, as of September 30, 2025, we had an accumulated deficit of $351.9 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 March 31, 2026, we had an accumulated deficit of $383.2 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.
Previous wording
The process of conducting preclinical studies and clinical trials necessary to obtain approval from the United States Food and Drug Administration is costly and time consuming. The probability of success for each product candidate and clinical trial may be affected by a variety of factors, including, among other things, the quality of the product candidate’s early clinical data, investment in the program, competition, manufacturing capabilities and commercial viability. As a result of the uncertainties discussed above, uncertainty associated with clinical trial enrollment and risks inherent in the development process, we are unable to determine the duration and completion costs of current or future clinical stages of our product candidates or when, or to what extent, we will generate revenues from the commercialization and sale of any of our product candidates. Development timelines, probability of success and development costs vary widely. We are currently focused on developing our two product candidates, levosimendan and imatinib, and have prioritized levosimendan; however, we will need substantial additional capital in the future in order to finalize the development of levosimendan, commence its commercialization, potentially develop imatinib, and to continue with the development of other potential product candidates.
Current wording
The process of conducting preclinical studies and clinical trials necessary to obtain approval from the FDA is costly and time consuming. The probability of success for each product candidate and clinical trial may be affected by a variety of factors, including, among other things, the quality of the product candidate’s early clinical data, investment in the program, competition, manufacturing capabilities and commercial viability. As a result of the uncertainties discussed above, uncertainty associated with clinical trial enrollment and risks inherent in the development process, we are unable to determine the duration and completion costs of current or future clinical stages of our product candidates or when, or to what extent, we will generate revenues from the commercialization and sale of any of our product candidates. Development timelines, probability of success and development costs vary widely. We are currently focused on developing our two product candidates, levosimendan and imatinib, and have prioritized levosimendan; however, we will need substantial additional capital in the future in order to finalize the development of levosimendan, commence its commercialization, potentially develop imatinib, and to continue with the development of other potential product candidates.
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 $102.8 million and $96.7 million and working capital of $96.2 million and $92.0 million as of September 30, 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.
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 $123.2 million and $104.2 million and working capital of $114.7 million and $97.1 million as of March 31, 2026 and December 31, 2025, 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 concluding in approximately the first half of 2026. Our ability to continue to pursue development of our products, including completion of the second global Phase 3 trial (LEVEL-2), 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. We commenced our LEVEL-2 trial in December 2025 and are currently enrolling patients. Our ability to continue to pursue development of our products beyond March of 2028, including completion of a second Phase 3 oral levosimendan trial, will depend on obtaining license income, income from warrants exercised by investors should they elect to do so, or other financial resources. There is no assurance that we will obtain any license agreement or other financing or that we will otherwise succeed in obtaining any necessary resources.
Previous wording
Net cash used in operating activities was $22.4 million for the nine months ended September 30, 2025, compared to $11.3 million for the nine months ended September 30, 2024. The increase in cash used in operating activities was primarily due to increased expenses as we expanded our clinical trials and increased payroll costs. The increase in payroll costs was primarily driven by the addition of new employees and targeted salary adjustments, reflecting a necessary investment to support our expanded clinical trial activity during the nine months ended September 30, 2025 as compared to the prior year.
Current wording
Net cash used in operating activities was $9.3 million for the three months ended March 31, 2026, compared to $7.0 million for the three months ended March 31, 2025. The increase in cash used in operating activities was primarily due to increased expenses as we expanded our clinical trials and increased payroll costs. The increase in payroll costs was primarily driven by the addition of new employees and targeted salary adjustments, reflecting a necessary investment to support our expanded clinical trial activity during the three months ended March 31, 2026 as compared to the prior year period.
Previous wording
There was no net cash provided or consumed by investing activities for the nine months ended September 30, 2025 or the nine months ended September 30, 2024.
Current wording
There was no net cash provided or consumed by investing activities for the three months ended March 31, 2026 or the three months ended March 31, 2025.
Previous wording
Net cash provided by financing activities was $26.9 million for the nine months ended September 30, 2025, compared to $99.8 million for the nine months ended September 30, 2024, a decrease of $72.9 million. During the nine months ended September 30, 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 $3.7 million from the exercise of warrants and pre-funded warrants. During the nine months ended September 30, 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 $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.
Current wording
Net cash provided by financing activities was $30.5 million for the three months ended March 31, 2026, compared to $23.6 million for the three months ended March 31, 2025, an increase of $6.9 million. During the three months ended March 31, 2026, the Company received proceeds of $30.5 million from the exercise of warrants and pre-funded warrants. During the three months ended March 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 $0.3 million from the exercise of warrants and pre-funded warrants.
Previous wording
Based on our working capital on September 30, 2025, we believe we have sufficient capital on hand to fund operations through 2027.
Current wording
Based on our working capital on March 31, 2026, and additional cash received subsequent to quarter end of $7.9 million, we believe we have sufficient capital on hand to fund operations through at least the first quarter of 2028.