TENAX THERAPEUTICS, INC.

Previous 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.

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 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. Currently, we do not have any significant imatinib development activities ongoing. Importantly, both levosimendan and imatinib have already been approved in other indications and prescribed around the world starting more than 25 years ago, 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 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.

Current wording

In March 2025 and August 2024, we completed two private placement financings raising gross proceeds, in the aggregate, of approximately $125 million. We intend to use the net proceeds from these financings, together with proceeds received from the subsequent exercise of warrants and pre-funded warrants sold in the March 2025 and August 2024 offerings, to advance our Phase 3 oral levosimendan program. Specifically, we plan to complete our ongoing Phase 3 LEVEL clinical trial of TNX-103 in PH-HFpEF and make public before the end of 2026 the results of the 12-week randomized treatment period. The open-label stage of the trial will continue after this. We also plan to continue our second, global, Phase 3 clinical trial, LEVEL-2, which began in December 2025. Following completion of the two Phase 3 levosimendan trials, we intend to submit marketing authorization applications.

Previous 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.

Current wording

Our Phase 3 LEVEL clinical trial continues, with high rates of clinical trial and therapy continuation during the blinded and open-label extension stages. We completed randomization in the LEVEL clinical trial of more than 230 patients before the end of the first quarter of 2026, and we expect to report initial topline data in August of 2026. LEVEL is being conducted in the United States and Canada. Our second Phase 3 clinical trial, LEVEL-2, is ongoing globally, with enrollment completion anticipated by the end of 2027.

Previous wording

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 wording

Based on our current operating plan, we believe that our existing cash and cash equivalents as of June 30, 2026, along with cash received from warrant exercises subsequent to quarter end, will be sufficient to fund our planned operations through the second quarter of 2028.

Previous wording

Financial Overview – Three Months Ended March 31, 2026 (in thousands)

Current wording

Financial Overview – Three and Six Months Ended June 30, 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 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):

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 and six months ended June 30, 2026 and 2025 are as follows (in thousands):

Previous 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.

Current wording

Clinical and preclinical development costs increased $6.5 million and $12.2 million for the three and six months ended June 30, 2026, respectively, as compared to the same period in the prior year. Clinical and preclinical development costs for the three and six months ended June 30, 2026 consist primarily of expenses associated with our ongoing Phase 3 LEVEL trial and our second, larger, global, Phase 3 clinical trial, LEVEL-2, which began in December 2025, as compared to the three and six months ended June 30, 2025, which consisted primarily of costs associated with our Phase 3 LEVEL trial.

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 months ended March 31, 2026 and 2025 are as follows (in thousands):

Current wording

Selling, general and administrative expenses consist primarily of compensation for executive, commercial and administrative personnel, including non-cash stock-based compensation. Other selling, 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. Selling, general and administrative expenses and percentage changes for the three and six months ended June 30, 2026 and 2025 are as follows (in thousands):

Previous wording

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 wording

Salary and benefits increased $0.5 million and $0.8 million for the three and six months ended June 30, 2026, compared to the same period in 2025. The change was primarily attributable to increased personnel and their related compensation and benefits.

Previous 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.

Current wording

Non-cash stock-based compensation expense decreased $1.0 million and $1.9 million for the three and six months ended June 30, 2026, respectively, 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 $0.1 million for the three month period ended March 31, 2026, as compared to the same period in the prior year.

Current wording

Legal and professional fees consist of general legal costs, those related to our intellectual property, accounting fees, consulting fees and investor relations services, as well as fees paid to the members of our Board of Directors. Legal and professional fees increased $0.6 million and $0.7 million for the three and six months ended June 30, 2026, respectively, 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.

Current wording

Other costs include expenses incurred for franchise and other taxes, travel, supplies, insurance, depreciation, and other miscellaneous charges. As we advance the development of levosimendan, our selling, general and administrative expenses have been increasing. We recently began to incur commercial costs, and with levosimendan continuing through Phase 3 development and progressing closer to commercial availability, we expect our selling, general and administrative expenses to increase in future periods.

Previous wording

Interest Income, Interest Expense, and Other Expense, net

Current wording

Interest Income and Other Expense, net

Previous 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.

Current wording

We have incurred losses since our inception and, as of June 30, 2026, we had an accumulated deficit of $401.0 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, potentially, 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 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 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.

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. We will need substantial additional capital in the future in order to finalize the development of levosimendan, commence its commercialization, potentially reinitiate the development of 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 $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.

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 $121.7 million and $104.2 million and working capital of $113.6 million and $97.1 million as of June 30, 2026 and December 31, 2025, respectively. Warrant exercises resulted in approximately $13.4 million and $43.8 million of cash for the Company in the three and six months ended June 30, 2026, respectively. There is the potential to raise an additional $34 million if all outstanding warrants from the August 2024 Offering and February 2024 Offering as of June 30, 2026 are exercised. 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 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.

Current wording

We completed randomization in the LEVEL trial at the end of the first quarter of 2026 and expect to report topline data in August 2026. We began our LEVEL-2 trial in December 2025 and are currently enrolling patients, with enrollment completion anticipated by the end of 2027. Our ability to continue to pursue development of our products beyond the second quarter of 2028, including completion of this second Phase 3 oral levosimendan trial (LEVEL-2), 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

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 wording

On March 5, 2025, we sold 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 March 2025 Offering were $23.2 million, after deducting the placement agent fees and offering expenses payable by the Company.

Previous wording

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.

Current wording

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 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.

Previous 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.

Current wording

Net cash used in operating activities was $23.5 million for the six months ended June 30, 2026, compared to $13.2 million for the six months ended June 30, 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 six months ended June 30, 2026 as compared to the prior year period.

Previous 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.

Current wording

There was no net cash provided or consumed by investing activities for the six months ended June 30, 2026 or the six months ended June 30, 2025.

Previous 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.

Current wording

Net cash provided by financing activities was $43.9 million for the six months ended June 30, 2026, compared to $23.8 million for the six months ended June 30, 2025, an increase of $20.0 million. During the six months ended June 30, 2026, the Company received proceeds of $43.8 million from the exercise of warrants and pre-funded warrants. During the six months ended June 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 $0.6 million from the exercise of warrants and pre-funded warrants.

Previous wording

the initiation, design, footprint, progress, timing and completion of clinical trials for our product candidates and potential product candidates;

Current wording

the initiation, design, progress, timing and completion of clinical trials for our product candidates and potential product candidates;

Previous 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.

Current wording

Based on our working capital on June 30, 2026, and additional cash received subsequent to quarter end of $8.1 million, we believe we have sufficient capital on hand to fund operations through the second quarter of 2028.