Tenax Therapeutics (NASDAQ: TENX) ends Q2 2026 with $118M cash
Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company focused on cardiopulmonary therapies, prioritizing oral levosimendan for pulmonary hypertension in heart failure with preserved ejection fraction. Two Phase 3 trials, LEVEL and global LEVEL-2, are underway, with LEVEL topline data expected in August 2026.
For the quarter ended June 30, 2026, Tenax reported a net loss of $17.8 million, and a six‑month net loss of $33.5 million, driven mainly by higher research and development spending as Phase 3 activities expanded. Six‑month R&D expenses rose to $24.4 million, while selling, general and administrative costs were $11.0 million.
Cash and cash equivalents were $118.0 million at June 30, 2026, plus $8.1 million received from warrant exercises after quarter end, and management states this should fund planned operations through the second quarter of 2028. Tenax also amended its Orion levosimendan license, extending the U.S. regulatory approval deadline to December 31, 2035 and updating milestones and supply terms.
Positive
- None.
Negative
- None.
Filing Explained
Outstanding warrants remain potential shares, while post-quarter exercises had already produced $8.1 million and disclosed share issuance.
Form 10-Q is an unaudited quarterly report; as of
The pool included 19,858,043 pre-funded warrants with a $0.01 exercise price and 7,508,153 other warrants with a weighted-average exercise price of $6.91. These instruments were not all issued shares at quarter-end, but exercise would increase the share count and reduce existing holders’ percentage ownership absent offsetting changes.
The filing also lists 7,897,430 employee and director options and 1,357,814 inducement options outstanding; these are additional potential shares, not current common shares.
After quarter-end, the company received
A specific timing item is the August 2024 warrant pool: those warrants can expire 30 trading days after the initial public announcement of topline LEVEL data, making that announcement a named milestone for the remaining warrants.
Key Figures
Key Terms
pre-funded warrants financial
Phase 3 LEVEL trial medical
pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF) medical
Black-Scholes option pricing model financial
registration payment arrangement regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
How did Tenax Therapeutics (TENX) perform financially in Q2 2026?
What is Tenax Therapeutics (TENX)’s cash position and runway as of June 30, 2026?
What are the key R&D developments for Tenax Therapeutics (TENX) in this period?
What did Tenax Therapeutics (TENX) disclose about its Orion levosimendan license?
How is Tenax Therapeutics (TENX) funding its operations and clinical programs?
What are the main operating expense trends for Tenax Therapeutics (TENX)?
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE TRANSITION PERIOD FROM TO
Commission File Number
(Exact name of registrant as specified in its charter) |
|
||
(State of incorporation) |
|
(I.R.S. Employer Identification No.) |
(Address of principal executive offices, including zip code)
(
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
The |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large Accelerated filer |
☐ |
Accelerated filer |
☐ |
☒ |
Smaller reporting company |
||
Emerging growth company |
|
|
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined by Rule 12b-2 of the Exchange Act). Yes ☐ No
As of July 28, 2026, the registrant had outstanding
Table of Contents
TABLE OF CONTENTS
|
|
|
PAGE |
|
PART I. FINANCIAL INFORMATION |
|
|
|
|
Item 1. |
Financial Statements |
|
3 |
|
|
Condensed Consolidated Balance Sheets as of June 30, 2026 (Unaudited) and December 31, 2025 |
|
3 |
|
|
Condensed Consolidated Statements of Operations (Unaudited) for the Three and Six Months Ended June 30, 2026 and 2025 |
|
4 |
|
|
Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) for the Three and Six Months Ended June 30, 2026 and 2025 |
|
5 |
|
|
Condensed Consolidated Statements of Cash Flows (Unaudited) for the Six Months Ended June 30, 2026 and 2025 |
|
6 |
|
|
Notes to Condensed Consolidated Financial Statements (Unaudited) |
|
7 |
|
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
|
15 |
|
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
|
20 |
|
Item 4. |
Controls and Procedures |
|
20 |
|
|
|
|
|
|
PART II. OTHER INFORMATION |
|
|
|
|
Item 1. |
Legal Proceedings |
|
21 |
|
Item 1.A. |
Risk Factors |
|
21 |
|
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
|
21 |
|
Item 6. |
Exhibits |
|
22 |
|
|
|
|
|
|
SIGNATURES |
|
23 |
|
|
2
Table of Contents
PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
TENAX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share data)
|
|
June 30, 2026 |
|
|
December 31, 2025 |
|
||
|
|
(unaudited) |
|
|
|
|
||
ASSETS |
|
|
|
|
|
|
||
Current assets |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
|
|
$ |
|
||
Prepaid expenses |
|
|
|
|
|
|
||
Other current assets |
|
|
|
|
|
|
||
Total current assets |
|
|
|
|
|
|
||
Total assets |
|
$ |
|
|
$ |
|
||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
||
Current liabilities |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
|
|
$ |
|
||
Accrued liabilities |
|
|
|
|
|
|
||
Total current liabilities |
|
|
|
|
|
|
||
Total liabilities |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Commitments and contingencies; see Note 4 |
|
|
|
|
|
|
||
Stockholders' equity |
|
|
|
|
|
|
||
Preferred stock, undesignated, authorized |
|
|
|
|
|
|
||
Series A Preferred stock, par value $ |
|
|
|
|
|
|
||
Common stock, par value $ |
|
|
|
|
|
|
||
Additional paid-in capital |
|
|
|
|
|
|
||
Accumulated deficit |
|
|
( |
) |
|
|
( |
) |
Total stockholders’ equity |
|
|
|
|
|
|
||
Total liabilities and stockholders' equity |
|
$ |
|
|
$ |
|
||
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
Table of Contents
TENAX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(Amounts in thousands, except share and per share data)
|
|
For the three months ended June 30, |
|
|
For the six months ended June 30, |
|
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
|
||||
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
||||
Selling, general and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net operating loss |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other expense, net |
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
Net loss per share, basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
Weighted average number of common shares and prefunded warrants outstanding, basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
Table of Contents
TENAX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(unaudited)
(Amounts in thousands, except share data)
|
|
Preferred Stock |
|
|
Common Stock |
|
|
|
|
|
|
|
|
|
|
|||||||||||||
|
|
Number of Shares |
|
|
Amount |
|
|
Number of Shares |
|
|
Amount |
|
|
Additional paid-in capital |
|
|
Accumulated deficit |
|
|
Total stockholders' equity |
|
|||||||
Balance at December 31, 2024 |
|
|
|
|
$ |
- |
|
|
|
|
|
$ |
- |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
Public offering sale of common stock and prefunded warrants, net of offering costs of $ |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
|
|||
Exercise of pre-funded warrants |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
|
|||
Exercise of warrants |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
|
|||
Stock-based compensation expense |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
|
||
Net loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
( |
) |
Balance at March 31, 2025 |
|
|
|
|
$ |
- |
|
|
|
|
|
$ |
- |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
Exercise of pre-funded warrants |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
|
|||
Exercise of warrants |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
|
|||
Stock-based compensation expense |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
|
||
Net loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
( |
) |
Balance at June 30, 2025 |
|
|
|
|
$ |
- |
|
|
|
|
|
$ |
- |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
|
|
Preferred Stock |
|
|
Common Stock |
|
|
|
|
|
|
|
|
|
|
|||||||||||||
|
|
Number of Shares |
|
|
Amount |
|
|
Number of Shares |
|
|
Amount |
|
|
Additional paid-in capital |
|
|
Accumulated deficit |
|
|
Total stockholders' equity |
|
|||||||
Balance at December 31, 2025 |
|
|
|
|
$ |
- |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||||
Exercise of pre-funded warrants |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
|
||||
Exercise of warrants |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
|
|||
Exercise of options |
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
|
|||||
Stock-based compensation expense |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
|
||
Net loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
( |
) |
Balance at March 31, 2026 |
|
|
|
|
$ |
- |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||||
Exercise of pre-funded warrants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
Exercise of warrants |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
|
|||
Vesting of restricted stock units |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
Stock-based compensation expense |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
|
||
Net loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
( |
) |
Balance at June 30, 2026 |
|
|
|
|
$ |
- |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
5
Table of Contents
TENAX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(Amounts in thousands)
|
|
Six months ended June 30, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
|
|
|
|
|
|
|
||
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
|
|
||||
Net Loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities |
|
|
|
|
|
|
||
Stock-based compensation |
|
|
|
|
|
|
||
Changes in operating assets and liabilities |
|
|
|
|
|
|
||
Prepaid expenses and other current assets |
|
|
|
|
|
|
||
Accounts payable |
|
|
|
|
|
( |
) |
|
Accrued liabilities |
|
|
|
|
|
|
||
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
|
|
|
|
||
Proceeds from issuance of warrants and pre-funded warrants, net of issuance costs |
|
|
|
|
|
|
||
Proceeds from the exercise of options |
|
|
|
|
|
|
||
Proceeds from the exercise of warrants and pre-funded warrants |
|
|
|
|
|
|
||
Net cash provided by financing activities |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Net change in cash and cash equivalents |
|
|
|
|
|
|
||
Cash and cash equivalents, beginning of period |
|
|
|
|
|
|
||
Cash and cash equivalents, end of period |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
The accompanying notes are an integral part of these condensed consolidated financial statements.
6
Table of Contents
TENAX THERAPEUTICS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
NOTE 1. DESCRIPTION OF BUSINESS
Tenax Therapeutics, Inc., together with its subsidiaries (collectively “Tenax” or the “Company”), is a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies. The Company is incorporated in Delaware and is headquartered in Chapel Hill, North Carolina.
Liquidity and Capital Resources
The Company has financed its operations since September 1990 primarily through the sale of equity and debt securities and loans from stockholders. The Company had an accumulated deficit of $
To the extent that the Company raises additional funds by issuing shares of its common stock or other securities convertible or exchangeable for shares of common stock, stockholders will experience dilution, which may be significant. In the event the Company raises additional capital through debt financings, the Company may incur significant interest expense and become subject to restrictive covenants in the related transaction documents that may affect the manner in which the Company conducts its business. To the extent that the Company raises additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to its technologies or product candidates or grant licenses on terms that may not be favorable to the Company. Any or all of the foregoing may have a material adverse effect on the Company’s business and financial performance.
NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation and Principles of Consolidation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles (“GAAP”) for interim financial information and the instructions to Form 10‑Q and Article 10 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. Certain information and footnote disclosures normally included in the Company’s annual financial statements prepared in accordance with GAAP have been condensed or omitted. These condensed consolidated financial statement results are not necessarily indicative of results to be expected for the full fiscal year or any future period.
The accompanying unaudited condensed consolidated financial statements and related disclosures have been prepared with the presumption that users of the unaudited condensed consolidated financial statements have read or have access to the audited financial statements for the preceding fiscal year. Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Form 10-K, which was filed with the United States Securities and Exchange Commission (“SEC”) on March 10, 2026, from which the Company derived the balance sheet data on December 31, 2025.
The condensed consolidated financial statements include the accounts of the Company and its subsidiaries. Intercompany balances and transactions have been eliminated upon consolidation.
Use of Estimates
The preparation of the accompanying unaudited condensed consolidated financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
7
Table of Contents
On an ongoing basis, management reviews its estimates to ensure that these estimates appropriately reflect changes in the Company’s business and new information as it becomes available. If historical experience and other factors used by management to make these estimates do not reasonably reflect future activity, the Company’s results of operations and financial position could be materially impacted.
Significant Accounting Policies
There have been no material changes in the Company’s significant accounting policies to those previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2025, other than the following:
Cash Concentration Risk
The Federal Deposit Insurance Corporation (the “FDIC”) insurance limits are $
Loss Per Share
Basic loss per share, which excludes antidilutive securities, is computed by dividing net loss by the weighted-average number of common shares outstanding for that particular period. In contrast, diluted loss per share considers the potential dilution that could occur from other equity instruments that would increase the total number of outstanding shares of common stock. Such amounts include shares potentially issuable under outstanding options, restricted stock, and warrants.
The following outstanding options, restricted stock grants, convertible preferred shares and warrants were excluded from the computation of basic and diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect.
|
|
Six months ended June 30, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
|
|
|
|
|
|
|
||
Warrants to purchase common stock |
|
|
|
|
|
|
||
Options to purchase common stock, restricted stock grants (stock incentive plans and inducement grants) |
|
|
|
|
|
|
||
Convertible preferred shares outstanding |
|
|
|
|
|
|
||
NOTE 3. BALANCE SHEET COMPONENTS
Prepaid expenses and other current assets consist of the following (in thousands):
|
|
June 30, 2026 |
|
|
December 31, 2025 |
|
||
Prepaid assets: |
|
|
|
|
|
|
||
Prepaid CRO expenses |
|
$ |
|
|
$ |
|
||
Other prepaid expenses |
|
|
|
|
|
|
||
Total prepaid expenses |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Other current assets: |
|
|
|
|
|
|
||
Cash from warrant exercise held at transfer agent |
|
$ |
|
|
$ |
|
||
Miscellaneous other current assets |
|
|
|
|
|
|
||
Total other current assets |
|
$ |
|
|
$ |
|
||
Accrued liabilities consist of the following (in thousands):
|
|
June 30, 2026 |
|
|
December 31, 2025 |
|
||
Accrued liabilities: |
|
|
|
|
|
|
||
Operating costs |
|
$ |
|
|
$ |
|
||
Employee related |
|
|
|
|
|
|
||
Total accrued liabilities |
|
$ |
|
|
$ |
|
||
8
Table of Contents
NOTE 4. COMMITMENTS AND CONTINGENCIES
Orion License and Supply Agreements
On November 13, 2013, the Company acquired certain assets of Phyxius Pharma, Inc. (“Phyxius”) pursuant to an asset purchase agreement by and among the Company, Phyxius and the stockholders of Phyxius, dated October 21, 2013. Among these assets was a license with Orion Corporation (“Orion”) for the exclusive, sublicensable right to develop and commercialize pharmaceutical products containing levosimendan, 2.5 mg/ml concentrate for solution for infusion / 5ml vial in the United States and Canada (as amended from time to time, the “License”). On October 9, 2020 and January 25, 2022, the Company entered into amendments to the License to include in the scope of the License two new product formulations containing levosimendan, in capsule and solid dosage form (TNX-103) and a subcutaneously administered dosage form (TNX-102), subject to specified limitations (together, the “Product”).
On February 19, 2024, the Company entered into an amendment to the License providing global rights to oral and subcutaneous formulations of levosimendan used in the treatment of pulmonary hypertension in heart failure with preserved ejection fraction (“PH-HFpEF”). The amendment also reduced the tiered royalties based on worldwide net sales of the product by the Company and its sublicensees, increased the License’s existing milestone payment due to Orion upon the grant of United States Food and Drug Administration (the “FDA”) approval of a levosimendan-based product to $
On September 3, 2025, the Company entered into an amendment to the License providing exclusive worldwide rights to develop, commercialize, manufacture, and have manufactured any orally-administered pharmaceutical product containing levosimendan and, in addition to the Company’s existing rights to develop and commercialize subcutaneously administered products containing levosimendan, to manufacture or have manufactured such products.
The License also grants the Company a right of first refusal to commercialize new developments of the Product, including developments as to the formulation, presentation, means of delivery, route of administration, dosage or indication but, pursuant to the February 2024 amendment, excluding new applications of levosimendan for neurological diseases and disorders developed by Orion.
On June 29, 2026, the Company further amended the License and extended to December 31, 2035, the date by which regulatory approval for the Product must be obtained in the United States, in order to avoid the effectiveness of a termination right for either party based on the failure to achieve such milestone. Pursuant to the amendment, the Company also is required to comply with certain information and cybersecurity requirements of Orion.
The term of the License extends until
As of June 30, 2026, the Company has not met any of the developmental milestones under the License and, accordingly, has not recorded any liability for the contingent payments due to Orion.
On June 29, 2026, the Company and Orion also entered into a supply agreement to govern Orion's manufacture and supply of oral levosimendan for development and, if approved, commercial purposes (“Supply Agreement”). The Supply Agreement has an initial term of
Litigation
The Company is subject to litigation in the normal course of business, none of which management believes will have a material adverse effect on the Company’s consolidated financial statements.
9
Table of Contents
NOTE 5. STOCKHOLDERS’ EQUITY
Common Stock, Preferred Stock, and Warrants
Common Stock
The Company’s Certificate of Incorporation, as amended, authorizes the issuance of
Preferred Stock
Under the Company’s Certificate of Incorporation, as amended, the Board is authorized, without further stockholder action, to provide for the issuance of up to
Common Stock and Warrants
March 2025 Private Placement Financing (the “March 2025 Offering”)
On March 4, 2025, the Company entered into a securities purchase agreement with certain accredited investors for the purchase and sale, in a private placement financing by the Company, of (i) an aggregate of
Also, on March 5, 2025 and in connection with the March 2025 Offering, the Company entered into a registration rights agreement (the “March 2025 Registration Rights Agreement”) with the purchasers, pursuant to which the Company agreed to register for resale the shares of common stock issued in the March 2025 Offering and the shares of common stock issuable upon exercise of the pre-funded warrants issued in the March 2025 Offering within 45 days of the closing date. Pursuant to the March 2025 Registration Rights Agreement, on April 15, 2025, the Company filed a resale registration statement on Form S-3 with the SEC, which went effective on April 23, 2025.
The March 2025 Registration Rights Agreement includes liquidated damages provisions that meet the definition of a registration payment arrangement that is within the scope of ASC 825-20. The Company determined at the initial issuance of the pre-funded warrants that it is not probable that a payment would be required as it has both the intent and ability to satisfy the March 2025 Registration Rights Agreement. Therefore, the Company did not record a liability at inception but will evaluate the contingency at each reporting period. As of June 30, 2026, no events had occurred that would change our initial assessment of this provision.
10
Table of Contents
Pre-Funded Warrant Activity
The following table summarizes the Company’s pre-funded warrant activity for the six months ended June 30, 2026:
|
|
Prefunded Warrants |
|
|
Weighted |
|
||
Outstanding at December 31, 2025 |
|
|
|
|
$ |
|
||
Exercised (Shares Issued) |
|
|
( |
) |
|
|
|
|
Forfeited* |
|
|
( |
) |
|
|
|
|
Outstanding at June 30, 2026 |
|
|
|
|
$ |
|
||
*Represents shares forfeited as a result of the cashless exercise of pre-funded warrants during the period. |
|
|
|
|
|
|
||
Warrant Activity
The following table summarizes the Company’s warrant activity for the six months ended June 30, 2026, not including pre-funded warrants:
|
|
Warrants |
|
|
Weighted |
|
||
Outstanding at December 31, 2025 |
|
|
|
|
$ |
|
||
Exercised (Shares Issued) |
|
|
( |
) |
|
|
|
|
Outstanding at June 30, 2026 |
|
|
|
|
$ |
|
||
August 2024 Warrants
As part of the Company’s private placement in August 2024 (the “2024 Offering”), the Company issued unregistered common warrants to purchase
February 2024 Warrants
As part of the Company’s registered public offering in February 2024, the Company issued registered warrants to purchase
Stock-Based Compensation
Summary of Stock Option and Restricted Stock Unit (RSU) Activity
Stock Incentive Plans
In June 2022, the Company adopted the 2022 Stock Incentive Plan, as amended on June 7, 2024 and October 25, 2024, (the “2022 Plan”), with the outstanding shares available for future grants under prior plans, as well as outstanding awards under prior plans that subsequently expire, terminate or are surrendered or forfeited, generally being assumed by the 2022 Plan. Unexpired awards granted under certain prior plans may be subject to the terms of such prior plans.
Under the 2022 Plan, with the approval of the Board’s Compensation Committee, the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units (“RSUs”), performance shares, performance units, cash-based awards or other stock-based awards. Stock options granted under the 2022 Plan may be either incentive stock options (“ISOs”) or nonqualified stock options (“NSOs”). ISOs may be granted only to employees. NSOs may be granted to employees, consultants and directors. Stock options under the 2022 Plan may be granted with a term of up to
11
Table of Contents
A total of
Transactions during the six months ended June 30, 2026 related to stock options granted to employees and directors under Company option plans were as follows:
|
|
Shares |
|
|
Weighted |
|
|
Weighted |
|
|
Aggregate |
|
||||
Options outstanding as of December 31, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Granted |
|
|
|
|
|
|
|
|
|
|
||||||
Exercised |
|
|
( |
) |
|
|
|
|
|
|
|
|||||
Forfeited/Expired |
|
|
( |
) |
|
|
|
|
|
|
|
|||||
Options outstanding as of June 30, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Options exercisable at June 30, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
The Company estimated the fair value of stock options granted during the six months ended June 30, 2026 using the Black-Scholes option pricing model and the following range of assumptions:
|
|
For the six months ended June 30, 2026 |
|
|
Risk-free interest rate |
|
|
||
Expected volatility |
|
|
||
Expected term (in years) |
|
|
||
Expected dividend yield |
|
|
|
|
The Company recorded compensation expense for stock options granted under Company stock incentive plans of $
As of June 30, 2026, there were unrecognized compensation costs of $
Inducement Awards
Transactions during the six months ended June 30, 2026 related to inducement stock options and an inducement RSU award granted to new employees. The inducement awards were granted in accordance with the employment inducement award exemption provided by Nasdaq Listing Rule 5635(c)(4) and were therefore not granted pursuant to the 2022 Plan.
Inducement Stock Options
Inducement stock option activity during the six months ended June 30, 2026 was as follows:
|
|
Shares |
|
|
Weighted |
|
|
Weighted |
|
|
Aggregate |
|
||||
Options outstanding as of December 31, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Granted |
|
|
|
|
|
|
|
|
|
|
||||||
Options outstanding as of June 30, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Options exercisable at June 30, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
The Company estimated the fair value of inducement stock options granted during the six months ended June 30, 2026 using the Black-Scholes option pricing model and the following range of assumptions:
12
Table of Contents
|
|
For the six months ended June 30, 2026 |
|
|
Risk-free interest rate |
|
|
||
Expected volatility |
|
|
||
Expected term (in years) |
|
|
||
Expected dividend yield |
|
|
|
|
Inducement stock option compensation expense totaled $
As of June 30, 2026, there was $
Inducement Restricted Stock Units
The Company granted an inducement RSU award to a new employee for
Inducement RSU compensation expense totaled $
NOTE 6. SEGMENTS
Operating segments are identified as components of an entity about which separate discrete financial information is available for evaluation by the Chief Operating Decision Maker ("CODM"), or decision-making group, in making decisions on how to allocate resources and assess performance. The Company's CODM, the President and Chief Executive Officer, views the Company's operations as
The accounting policies of the cardiovascular and pulmonary therapeutics segment are the same as those described in the summary of significant accounting policies.
The Company has
As such, the CODM uses cash forecast models in deciding how to invest into the cardiovascular and pulmonary therapeutics segment. Such cash forecast models are reviewed to assess the entity-wide operating results and performance. Net loss is used to monitor budget versus actual results. Monitoring budgeted versus actual results, net cash used in operating activities for the period and cash on hand are used in assessing performance of the segment.
The table below summarizes the significant expense categories regularly reviewed by the CODM for the three and six months ended June 30, 2026 and 2025 (in thousands).
13
Table of Contents
|
For the three months ended June 30, |
|
|
For the six months ended June 30, |
|
||||||||||
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Selling, general and administrative |
|
|
|
|
|
|
|
|
|
|
|
||||
Total operating expenses |
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net operating loss |
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Other segment items (a) |
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
|
|
|
|
|
|
|
|
|
|
||||
Other expense, net |
|
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
Net loss (b) |
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
For the six months ended June 30, 2026 and 2025, the net cash used in operating activities was $
|
As of June 30, |
|
|||||
|
2026 |
|
|
2025 |
|
||
Assets: |
|
|
|
|
|
||
Cash and cash equivalents |
$ |
|
|
$ |
|
||
NOTE 7. SUBSEQUENT EVENTS
Subsequent to June 30, 2026, the Company received a total of $
14
Table of Contents
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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, 2025. 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 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.
Recent Events
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.
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.
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.
15
Table of Contents
Financial Overview – Three and Six Months Ended June 30, 2026 (in thousands)
|
For the three months ended June 30, |
|
|
Increase/ |
|
|
% Increase/ |
|
|
|
For the six months ended June 30, |
|
|
Increase/ |
|
|
% Increase/ |
|
|
||||||||||||||
|
2026 |
|
|
2025 |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2026 |
|
|
2025 |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
||||||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Research and development |
$ |
12,850 |
|
|
$ |
6,121 |
|
|
$ |
6,729 |
|
|
|
110 |
|
% |
|
$ |
24,389 |
|
|
$ |
11,804 |
|
|
$ |
12,585 |
|
|
|
107 |
|
% |
Selling, general and administrative |
|
5,934 |
|
|
|
5,671 |
|
|
|
263 |
|
|
|
5 |
|
% |
|
|
10,968 |
|
|
|
11,326 |
|
|
|
(358 |
) |
|
|
(3 |
) |
% |
Total operating expenses |
$ |
18,784 |
|
|
$ |
11,792 |
|
|
$ |
6,992 |
|
|
|
59 |
|
% |
|
$ |
35,357 |
|
|
$ |
23,130 |
|
|
$ |
12,227 |
|
|
|
53 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Net operating loss |
|
(18,784 |
) |
|
|
(11,792 |
) |
|
|
(6,992 |
) |
|
|
59 |
|
% |
|
|
(35,357 |
) |
|
|
(23,130 |
) |
|
|
(12,227 |
) |
|
|
53 |
|
% |
Other segment items |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Interest income |
|
981 |
|
|
|
954 |
|
|
|
27 |
|
|
|
3 |
|
% |
|
|
1,842 |
|
|
|
1,884 |
|
|
|
(42 |
) |
|
|
(2 |
) |
% |
Other expense, net |
|
- |
|
|
|
(9 |
) |
|
|
9 |
|
|
|
(100 |
) |
% |
|
|
(4 |
) |
|
|
(9 |
) |
|
|
5 |
|
|
|
(56 |
) |
% |
Net loss |
$ |
(17,803 |
) |
|
$ |
(10,847 |
) |
|
$ |
(6,956 |
) |
|
|
64 |
|
% |
|
$ |
(33,519 |
) |
|
$ |
(21,255 |
) |
|
$ |
(12,264 |
) |
|
|
58 |
|
% |
Research and Development Expenses
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):
|
|
For the three months ended June 30, |
|
|
Increase/ |
|
|
% Increase/ |
|
|
|
|
For the six months ended June 30, |
|
|
Increase/ |
|
|
% Increase/ |
|
|
||||||||||||||
|
|
2026 |
|
|
2025 |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
|
2026 |
|
|
2025 |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
||||||||
Clinical and preclinical development |
|
$ |
11,004 |
|
|
$ |
4,515 |
|
|
$ |
6,489 |
|
|
|
144 |
|
% |
|
|
$ |
21,037 |
|
|
$ |
8,788 |
|
|
$ |
12,249 |
|
|
|
139 |
|
% |
Salary and benefits |
|
|
971 |
|
|
|
468 |
|
|
|
503 |
|
|
|
107 |
|
% |
|
|
|
1,862 |
|
|
|
839 |
|
|
|
1,023 |
|
|
|
122 |
|
% |
Stock-based compensation |
|
|
674 |
|
|
|
982 |
|
|
|
(308 |
) |
|
|
(31 |
) |
% |
|
|
|
1,211 |
|
|
|
1,843 |
|
|
|
(632 |
) |
|
|
(34 |
) |
% |
Other costs |
|
|
201 |
|
|
|
156 |
|
|
|
45 |
|
|
|
29 |
|
% |
|
|
|
279 |
|
|
|
334 |
|
|
|
(55 |
) |
|
|
(16 |
) |
% |
Total research and development expense |
|
$ |
12,850 |
|
|
$ |
6,121 |
|
|
|
6,729 |
|
|
|
110 |
|
% |
|
|
$ |
24,389 |
|
|
$ |
11,804 |
|
|
|
12,585 |
|
|
|
107 |
|
% |
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.
Salary and benefits costs increased by $0.5 million and $1.0 million for the three and six months ended June 30, 2026, respectively, as compared to the same period in the prior year primarily due to the hiring of additional development personnel resulting in higher salary and benefit costs.
16
Table of Contents
Selling, General and Administrative Expenses
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):
|
|
For the three months ended June 30, |
|
|
Increase/ |
|
|
% Increase/ |
|
|
|
|
For the six months ended June 30, |
|
|
Increase/ |
|
|
% Increase/ |
|
|
||||||||||||||
|
|
2026 |
|
|
2025 |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
|
2026 |
|
|
2025 |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
||||||||
Salary and benefits |
|
$ |
1,144 |
|
|
$ |
673 |
|
|
$ |
471 |
|
|
|
70 |
|
% |
|
|
$ |
1,983 |
|
|
$ |
1,218 |
|
|
$ |
765 |
|
|
|
63 |
|
% |
Stock-based compensation |
|
|
2,657 |
|
|
|
3,626 |
|
|
|
(969 |
) |
|
|
(27 |
) |
% |
|
|
|
4,957 |
|
|
|
6,907 |
|
|
|
(1,950 |
) |
|
|
(28 |
) |
% |
Legal and professional fees |
|
|
1,612 |
|
|
|
1,050 |
|
|
|
562 |
|
|
|
54 |
|
% |
|
|
|
2,978 |
|
|
|
2,309 |
|
|
|
669 |
|
|
|
29 |
|
% |
Other costs |
|
|
521 |
|
|
|
322 |
|
|
|
199 |
|
|
|
62 |
|
% |
|
|
|
1,050 |
|
|
|
892 |
|
|
|
158 |
|
|
|
18 |
|
% |
Total selling, general and administrative expense |
|
$ |
5,934 |
|
|
$ |
5,671 |
|
|
|
263 |
|
|
|
5 |
|
% |
|
|
$ |
10,968 |
|
|
$ |
11,326 |
|
|
|
(358 |
) |
|
|
(3 |
) |
% |
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.
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.
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.
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.
Interest Income and Other Expense, net
Interest income and other expense was flat for the three and six months ended June 30, 2026, as compared to the same periods in the prior year.
Liquidity, Capital Resources and Plan of Operation
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.
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
17
Table of Contents
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.
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 $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.
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.
Financings
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.
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.
Cash Flows
The following table shows a summary of our cash flows for the periods indicated (in thousands):
|
|
Six months ended June 30, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Net cash used in operating activities |
|
$ |
(23,459 |
) |
|
$ |
(13,230 |
) |
Net cash provided by investing activities |
|
|
- |
|
|
|
- |
|
Net cash provided by financing activities |
|
|
43,870 |
|
|
|
23,841 |
|
Operating Activities
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.
Investing Activities
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.
Financing Activities
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
18
Table of Contents
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.
Operating Capital and Capital Expenditure Requirements
Our future capital requirements will depend on many factors that include, but are not limited to the following:
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.
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, 2025 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.
19
Table of Contents
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Smaller reporting companies are not required to provide the information required by this item.
ITEM 4. CONTROLS AND PROCEDURES
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 (Principal Executive Officer) and our Chief Financial Officer (Principal Financial Officer and Principal Accounting 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 (Principal Executive Officer) and our Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer), concluded that our disclosure controls and procedures were effective as of June 30, 2026, 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 (Principal Executive Officer) and our Chief Financial Officer (Principal Financial Officer and Principal Accounting 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.
20
Table of Contents
ITEM 1. LEGAL PROCEEDINGS
There are no material pending legal proceedings to which we are a party or to which any of our property is subject.
ITEM 1A. RISK FACTORS
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, 2025.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
On May 11, 2026, the Company granted an inducement RSU award to an executive newly hired by the Company for 10,000 shares of common stock and an inducement stock option award of 450,000 shares of common stock. One quarter of the RSU award vested 10 days after issuance and the remainder will vest in three equal installments on the four-month, eight-month, and twelve-month anniversaries of issuance. One quarter of the option award will vest on the first anniversary of issuance with the remainder vesting in 36 approximately equal installments on the monthly anniversaries thereafter.
Additionally, between April 28, 2026 and June 1, 2026, the Company made four non-negotiated inducement stock option awards to non-executive individuals newly hired by the Company in various clinical operations, medical, product development, and commercial roles. The employees received, in the aggregate, stock option awards to purchase 657,500 shares of common stock. One quarter of each option award will vest on the first anniversary of issuance with the remainder vesting in 36 approximately equal installments on the monthly anniversaries thereafter.
None of the foregoing transactions involved any underwriters, underwriting discounts or commissions, or any public offering. The sales of the above securities were deemed to be exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act as transactions by an issuer not involving any public offering. On May 12, 2026, we filed a registration statement on Form S-8 to register the shares of common stock underlying these inducement awards.
For additional information regarding the inducement awards, see Note 5 to our unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.
21
Table of Contents
ITEM 6. EXHIBITS
The following exhibits are being filed or furnished as part of this Quarterly Report on Form 10-Q and are numbered in accordance with Item 601 of Regulation S-K:
Exhibit Number |
|
Description |
10.1# |
|
Executive Employment Agreement with Thomas R. Staab, II, dated April 9, 2026 (incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K filed with the SEC on April 22, 2026). |
10.2# |
|
Amendment No. 1 to Employment Agreement, by and between Tenax Therapeutics, Inc. and Christopher Giordano (incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K filed with the SEC on June 29, 2026). |
10.3# |
|
Amendment No. 1 to Employment Agreement, by and between Tenax Therapeutics, Inc. and Thomas Staab (incorporated by reference to Exhibit 10.2 to the Company’s Form 8-K filed with the SEC on June 29, 2026). |
10.4# |
|
Amendment No. 3 to Employment Agreement, by and between Tenax Therapeutics, Inc. and Stuart Rich (incorporated by reference to Exhibit 10.3 to the Company’s Form 8-K filed with the SEC on June 29, 2026). |
10.5+ |
|
Sixth Amendment to the License Agreement, dated June 29,2026, between Tenax Therapeutics, Inc. and Orion Corporation (incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K filed with the SEC on June 30, 2026). |
10.6+∆* |
|
Supply Agreement, dated June 29, 2026, between Tenax Therapeutics, Inc. and Orion Corporation. |
31.1* |
|
Certification of President and Chief Executive Officer pursuant to Section 302 of the Sarbanes Oxley Act of 2002. |
31.2* |
|
Certification of Principal Financial Officer and Principal Accounting Officer pursuant to Section 302 of the Sarbanes Oxley Act of 2002. |
32.1** |
|
Certification of President and Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
32.2** |
|
Certification of Principal Financial Officer and Principal Accounting Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
101* |
|
Inline XBRL Document Set for the condensed consolidated financial statements and accompanying notes in Part I, Item 1, “Financial Statements” of this Quarterly Report on Form 10-Q. |
104* |
|
Inline XBRL for the cover page of this Quarterly Report on Form 10-Q, included in the Exhibit 101 Inline XBRL Document Set. |
+ Certain schedules, exhibits and similar attachments have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company agrees to furnish a copy of any omitted schedules to the SEC upon request.
∆ Certain confidential information has been redacted pursuant to Item 601(b)(10)(iv) of Regulation S-K by means of marking such portions with brackets because the information (i) is not material and (ii) would be competitively harmful if publicly disclosed. The Company agrees to furnish an unredacted copy of the exhibit and a copy of any omitted schedules to the SEC upon request.
# Denotes a management contract.
* Filed herewith.
** Furnished herewith.
22
Table of Contents
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Date: July 31, 2026
|
TENAX THERAPEUTICS, INC. |
|
|
|
|
|
|
|
By: |
/s/ Christopher T. Giordano |
|
|
|
Christopher T. Giordano |
|
|
|
President and Chief Executive Officer |
|
|
|
(Principal Executive Officer) |
|
|
|
|
|
|
By: |
/s/ Thomas R. Staab, II |
|
|
|
Thomas R. Staab, II |
|
|
|
Chief Financial Officer |
|
|
|
(Principal Financial Officer and Principal Accounting Officer) |
|
23