TENAX THERAPEUTICS, INC.

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 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 March 31, 2025, we believe we can continue our operations through 2027.

Current 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.

Previous wording

Research and development expenses were approximately $5.7 million for the three months ended March 31, 2025, compared to $2.7 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 clinical studies; (ii) the cost of supplying clinical trial materials; (iii) payments to CROs and consultants; (iv) employee-related expenses, including salaries 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 months ended March 31, 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 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 six months ended June 30, 2025 and 2024 are as follows (in thousands):

Previous wording

Clinical and preclinical development costs increased $1.8 million for the three months ended March 31, 2025 as compared to the same period in the prior year. Clinical and preclinical development costs for the three months ended March 31, 2025 consists primarily of expenses associated with our ongoing Phase 3 LEVEL trial for oral levosimendan, compared with costs for the three months ended March 31, 2024, associated with the planning of LEVEL and the initiation of the first LEVEL sites and enrolment of the first LEVEL patients.

Current wording

Clinical and preclinical development costs increased $2.4 million and $4.3 million for the three and six months ended June 30, 2025, respectively, as compared to the same periods in the prior year. Clinical and preclinical development costs for the three and six months ended June 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 have begun preliminary work, compared with costs for the three and six month periods ended June 30, 2024, associated with the planning of LEVEL and the initiation of the first LEVEL sites and enrollment of the first LEVEL patients.

Previous wording

Salary and benefit costs increased $200 thousand for the three months ended March 31, 2025, compared to the same period in the prior year, which is primarily attributable to higher salaries and additional performance-based compensation expense. Stock-based compensation expense increased by $767 thousand for the three months ended March 31, 2025 compared to the same period in the prior year due to stock options granted in December 2024 and January 2025.

Current wording

Salary and benefits costs increased for the three and six months ended June 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 $1.0 million and $1.7 million for the three and six months ended June 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 January and May 2025 to new and existing employees that vest and are being expensed over four years.

Previous wording

Other costs increased $169 thousand for the three months ended March 31, 2025, compared to the same period in the prior year, primarily due to increased regulatory consulting costs.

Current wording

Other costs increased for the three and six months ended June 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.

Previous wording

General and administrative expenses were $5.7 million for the three months ended March 31, 2025, compared to $1.2 million for the same period in 2024. 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 three months ended March 31, 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 and six months ended June 30, 2025 and 2024 are as follows (in thousands):

Previous wording

Salary and benefits increased $19 thousand for the three months ended March 31, 2025, compared to the same period in 2024. The change was primarily attributable to higher salaries and related compensation. Stock-based compensation expense increased $3.3 million for the three months ended March 31, 2025 due to stock options granted in December 2024, for which the expense amortizes over a one year term.

Current wording

Salary and benefits increased for the three and six months ended June 30, 2025 as compared to the same periods in 2024 due to increased salaries and related compensation. Non-cash stock-based compensation expense increased $3.6 million and $6.9 million for the three and six months ended June 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 May 2025 that vest and are being expensed over four years.

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 $0.8 million for the three months ended March 31, 2025 compared to the same period 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 $0.4 million and $1.3 million for the three and six month periods ended June 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.

Previous wording

Other costs increased $324 thousand for the three months ended March 31, 2025, compared to the same period in 2024. Other costs include expenses incurred for franchise and other taxes, travel, supplies, insurance, depreciation, and other miscellaneous charges. The change was primarily attributable to decreases in insurance costs.

Current wording

Other costs include expenses incurred for franchise and other taxes, travel, supplies, insurance, depreciation, and other miscellaneous charges. Other costs increased $0.1 million and $0.5 million for the three and six months ended June 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.

Previous wording

Other income and expenses include non-operating income and expense items not otherwise recorded in our consolidated statement of comprehensive loss. These items include but are not limited to interest income earned and fixed asset disposals. Interest income increased $813 thousand primarily related to higher interest income on increased cash deposits as a result of the August 2024 Offering and the March 2025 Offering. The company had no interest expense for three months ended March 31, 2025 and $8 thousand for three months ended March 31,2024.

Current wording

Interest income increased $1.7 million primarily related to higher interest income on increased cash deposits as a result of the August 2024 Offering and the March 2025 Offering. The company had no interest expense for the six months ended June 30, 2025 and an immaterial amount for the six months ended June 30, 2024.

Previous wording

We have incurred losses since our inception and, as of March 31, 2025, we had an accumulated deficit of $325.3 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, 2025, we had an accumulated deficit of $336.1 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

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 $112.1 million and $96.7 million and working capital of $109.3 million and $92.0 million as of March 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.

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 $105.9 million and $96.7 million and working capital of $103.3 million and $92.0 million as of June 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.

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 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.

Previous wording

Net cash used in operating activities was $7.0 million for the three months ended March 31, 2025, compared to $5.2 million for the three months ended March 31, 2024. The increase in cash used in operating activities was primarily due to higher study expense activity as we expanded our clinical trials during the three months ended March 31, 2025 as compared to the prior year.

Current wording

Net cash used in operating activities was $13.2 million for the six months ended June 30, 2025, compared to $8.2 million for the six months ended June 30, 2024. The increase in cash used in operating activities was primarily due to increased study expense activity 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, 2025 as compared to the prior year.

Previous wording

There was no net cash provided or consumed by investing activities for the three months ended March 31, 2025 or the three months ended March 31, 2024.

Current wording

There was no net cash provided or consumed by investing activities for the six months ended June 30, 2025 or the six months ended June 30, 2024.

Previous wording

Net cash provided by financing activities was $23.6 million for the three months ended March 31, 2025, compared to $7.9 million for the three months ended March 31, 2024. The increase during the three months ended March 31, 2025 was due to the $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 as compared to $8.0 million net cash provided from the sale of common stock, pre-funded warrants and warrants in the February 2024 Offering, offset by the principal payment of $0.1 million related to a short-term note, during the three months ended March 31, 2024.

Current wording

Net cash provided by financing activities was $23.8 million for the six months ended June 30, 2025, compared to $7.8 million for the six months ended June 30, 2024. The increase during the six months ended June 30, 2025 was due to the $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 as compared to $8.0 million net cash provided from the sale of common stock, pre-funded warrants and warrants in the February 2024 Offering, offset by the principal payment of $0.2 million related to a short-term note, during the six months ended June 30, 2024.

Previous wording

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

Current wording

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