# Tenax Therapeutics, Inc.: Form 10-Q for the period ended Mar 31, 2025

- Company: [Tenax Therapeutics, Inc.](/companies/tenx.md) (CIK 34956)
- Form: 10-Q
- Filed: 2025-05-14
- Accepted by EDGAR: May 14, 2025, 16:12 ET
- Period: 2025-03-31
- Accession: 0000950170-25-071395
- Inline XBRL: yes
- Main document: https://www.sec.gov/Archives/edgar/data/34956/000095017025071395/tennx-20250331.htm
- All documents and exhibits: https://www.sec.gov/Archives/edgar/data/34956/000095017025071395/

## Figures reported in this filing

Standardized XBRL line items for the period ended 2025-03-31.

| Line item | Period | Value | XBRL concept |
| --- | --- | ---: | --- |
| Revenue | 3 months, 2025-01-01 to 2025-03-31 | $0 | us-gaap:RevenueFromContractWithCustomerExcludingAssessedTax |
| Research and development | 3 months, 2025-01-01 to 2025-03-31 | $5.7m | us-gaap:ResearchAndDevelopmentExpense |
| Operating income | 3 months, 2025-01-01 to 2025-03-31 | −$11.3m | us-gaap:OperatingIncomeLoss |
| Net income | 3 months, 2025-01-01 to 2025-03-31 | −$10.4m | us-gaap:NetIncomeLoss |
| Diluted EPS | 3 months, 2025-01-01 to 2025-03-31 | −$0.28 | us-gaap:EarningsPerShareDiluted |
| Basic EPS | 3 months, 2025-01-01 to 2025-03-31 | −$0.28 | us-gaap:EarningsPerShareBasic |
| Diluted shares (weighted) | 3 months, 2025-01-01 to 2025-03-31 | 36,584,920 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Operating cash flow | 3 months, 2025-01-01 to 2025-03-31 | −$7.0m | us-gaap:NetCashProvidedByUsedInOperatingActivities |
| Cash and equivalents | at 2025-03-31 | $111.4m | us-gaap:CashAndCashEquivalentsAtCarryingValue |
| Current assets | at 2025-03-31 | $112.1m | us-gaap:AssetsCurrent |
| Total assets | at 2025-03-31 | $112.1m | us-gaap:Assets |
| Current liabilities | at 2025-03-31 | $2.8m | us-gaap:LiabilitiesCurrent |
| Total liabilities | at 2025-03-31 | $2.8m | us-gaap:Liabilities |
| Shareholders' equity | at 2025-03-31 | $109.3m | us-gaap:StockholdersEquity |

## Management's discussion and analysis

As filed, 19,707 characters.

*The following discussion and analysis should be read in conjunction with the unaudited condensed consolidated financial statements and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q and with the audited condensed consolidated financial statements and related notes thereto included as part of our Annual Report on Form 10-K for the year ended December 31, 2024. All references in this Quarterly Report to “Tenax Therapeutics,” “we,” “our” and “us” means Tenax Therapeutics, Inc.*

### Cautionary Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are subject to the “safe harbor” created by those sections. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to them. In some cases, you can identify forward-looking statements by words such as “might,” “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential” and similar expressions intended to identify forward-looking statements. These statements reflect our current view with respect to future events and are subject to risks, uncertainties and assumptions related to various factors that could cause actual results and the timing of events to differ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section titled “Risk Factors” included in our most recent Annual Report on Form 10-K filed with the SEC. Furthermore, such forward-looking statements speak only as of this Quarterly Report on Form 10-Q. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.

### Overview

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.

### Recent Events

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.

### Financial Overview – Three Months Ended March 31, 2025

### Operating Expenses (in thousands)

| Operating expenses: | For the three months ended March 31, 2025 | 2024 | Increase/ (Decrease) | % Increase/ (Decrease) |
| --- | ---: | ---: | ---: | ---: |
| Research and development | $5,683 | $2,676 | 3,007 | 112% |
| General and administrative | 5,655 | 1,233 | 4,422 | 359% |
| Total operating expenses | $11,338 | $3,909 | 7,429 | 190% |

### Research and Development Expenses

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):

|  | For the three months ended March 31, 2025 | 2024 | Increase/ (Decrease) | % Increase/ (Decrease) |
| --- | ---: | ---: | ---: | ---: |
| Clinical and preclinical development | $4,273 | $2,402 | $1,871 | 78% |
| Salary and benefits | 371 | 171 | 200 | 117% |
| Stock-based compensation | 861 | 94 | 767 | 816% |
| Other costs | 178 | 9 | 169 | 1878% |

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.

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.

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.

### General and Administrative Expenses

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):

|  | For the three months ended March 31, 2025 | 2024 | Increase/ (Decrease) | % Increase/ (Decrease) |
| --- | ---: | ---: | ---: | ---: |
| Salary and benefits | 545 | 526 | $19 | 4% |
| Stock-based compensation | 3,281 | 25 | 3,256 | 13024% |
| Legal and professional fees | 1,259 | 436 | 823 | 189% |
| Other costs | 570 | 246 | 324 | 132% |

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.

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.

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.

### Other Income and Expense

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.

### Liquidity, Capital Resources and Plan of Operation

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.

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.

### Liquidity

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.

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.

#### Financings

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.

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.

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. Net proceeds of the offering were $8.0 million, after deducting the placement agent fees and offering expenses payable by the Company.

#### Cash Flows

The following table shows a summary of our cash flows for the periods indicated (in thousands):

|  | Three months ended March 31, 2025 | 2024 |
| --- | ---: | ---: |
| Net cash used in operating activities | $(6,967) | $(5,166) |
| Net cash provided by investing activities | - | - |
| Net cash provided by financing activities | 23,563 | 7,923 |

#### Operating Activities

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.

#### Investing Activities

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.

#### Financing Activities

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.

### Operating Capital and Capital Expenditure Requirements

Our future capital requirements will depend on many factors that include, but are not limited to the following:

- the initiation, design, progress, timing and completion of clinical trials for our product candidates and potential product candidates;
- the outcome, timing and cost of regulatory approvals and the regulatory approval process;
- delays that may be caused by changing regulatory requirements and resource levels at regulators;
- the number of product candidates we pursue;
- the costs involved in filing and prosecuting patent applications and enforcing and defending patent claims;
- the timing and terms of future collaboration, licensing, consulting or other arrangements that we may enter into;
- the cost and timing of establishing sales, marketing, manufacturing and distribution capabilities;
- the cost of procuring clinical and commercial supplies of our product candidates;
- the extent to which we acquire or invest in businesses, products or technologies; and
- the possible costs of litigation.

Based on our working capital on March 31, 2025, we believe we have sufficient capital on hand to fund operations through 2027.

### Critical Accounting Policies and Significant Judgments and Estimates

Our unaudited condensed consolidated financial statements have been prepared in accordance with GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the expenses during the reporting periods. These items are monitored and analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur in the future. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Changes in estimates are reflected in reported results for the period in which they become known. Actual results may differ materially from these estimates under different assumptions or conditions. For information regarding our critical accounting policies and estimates, please refer to “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Summary of Critical Accounting Policies” contained in our Annual Report on Form 10-K for the year ended December 31, 2024 and Note 2 to our unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

### Off-Balance Sheet Arrangements

Since our inception, we have not engaged in any off-balance sheet arrangements, including the use of structured finance, special purpose entities or variable interest entities.

## Controls and procedures

As filed, 3,020 characters.

### Evaluation of Disclosure Controls and Procedures

As required by paragraph (b) of Rules 13a-15 and 15d-15 promulgated under the Exchange Act, under the supervision and with the participation of our management, including our President and Chief Executive Officer and our Interim Chief Financial Officer, we conducted an evaluation as of the end of the period covered by this Quarterly Report on Form 10-Q, of the effectiveness of our disclosure controls and procedures as defined in Exchange Act Rules 13a-15(e) and 15d-15(e).

In designing and evaluating our disclosure controls and procedures, management recognizes that any disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints, and that management is required to apply its judgment in evaluating the benefits of possible controls and procedures relative to their costs.

Based on their evaluation, our President and Chief Executive Officer and Interim Chief Financial Officer concluded that our disclosure controls and procedures were effective as of March 31, 2025, the end of the period covered by this Quarterly Report on Form 10-Q, in that they provide reasonable assurance that the information we are required to disclose in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods required by the SEC and is accumulated and communicated to our management, including our President and Chief Executive Officer and Interim Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.

### Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting during our most recently completed fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. We routinely review our internal controls over financial reporting and from time to time make changes intended to enhance the effectiveness of our internal control over financial reporting. We will continue to evaluate the effectiveness of our disclosure controls and procedures and internal controls over financial reporting on an ongoing basis and will take action as appropriate.

During the most recently completed fiscal quarter, management reviewed all work generated in support of the financial statements and corresponding footnotes to determine areas which may be susceptible to human error. The review focused on limiting manual inputs into work papers wherever possible and tying inputs to external source documents. In addition, management also enhanced its work paper review to compare figures to prior year amounts or source documents and increased the number of calculations in the work papers that are reviewed and re-performed.

## Risk factors

As filed, 138 characters.

The risks we face have not materially changed from those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024.

Filed May 14, 2025.
Source: SEC EDGAR, the filing index for accession 0000950170-25-071395. Last ingested by Listed: Oct 27, 2026, 17:29 ET. No prices; not investment advice.