Tenax Therapeutics (NASDAQ: TENX) boosts Phase 3 spend, extends cash runway
Rhea-AI Filing Summary
Tenax Therapeutics reported a first quarter 2026 net loss of $15.7 million, wider than the $10.4 million loss a year earlier, as it increased investment in late-stage clinical trials.
Cash and cash equivalents were $118.8 million as of March 31, 2026, up from $97.6 million on December 31, 2025, and the company now expects its cash to last through at least the first quarter of 2028. Research and development spending rose to $11.5 million from $5.7 million, mainly to support the Phase 3 LEVEL and LEVEL-2 studies of TNX-103. General and administrative expenses declined slightly to $5.0 million from $5.7 million.
Tenax completed randomization of more than 230 patients in the Phase 3 LEVEL trial and plans to report topline data in the third quarter of 2026. Enrollment is ongoing in the global LEVEL-2 Phase 3 trial, with completion anticipated by the end of 2027. The company also strengthened its leadership team by appointing Thomas Staab as Chief Financial Officer and Timothy Healey, MBA, as Chief Commercial Officer.
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Insights
Tenax increases Phase 3 spending, extends cash runway into early 2028.
Tenax Therapeutics is clearly prioritizing its Phase 3 program for TNX-103 in PH-HFpEF. R&D expenses nearly doubled to $11.5 million for Q1 2026 versus $5.7 million a year earlier, mainly for the LEVEL and LEVEL-2 trials and added staff.
Net loss widened to $15.7 million, but the balance sheet strengthened, with cash and cash equivalents at $118.8 million as of March 31 2026. Management now expects this to fund operations through at least the first quarter of 2028, which spans the planned Phase 3 readout in Q3 2026 and ongoing LEVEL-2 enrollment.
Upcoming topline data from the Phase 3 LEVEL study and progress toward completing LEVEL-2 enrollment by the end of 2027 will be important clinical milestones. Execution on these trials, along with integration of the new CFO and Chief Commercial Officer, will shape how the TNX-103 opportunity develops.
8-K Event Classification
Key Figures
Key Terms
Phase 3 LEVEL study medical
PH-HFpEF medical
K-ATP channel activator medical
double-blind, randomized, placebo-controlled medical
forward-looking statements regulatory
Earnings Snapshot
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 2.02 Results of Operations and Financial Condition.
On May 12, 2026, Tenax Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the first quarter ended March 31, 2026. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein in its entirety by reference.
The information in this Item 2.02 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press release dated May 12, 2026. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
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 hereunto duly authorized.
| Date: May 12, 2026 | Tenax Therapeutics, Inc. | |||||
| By: | /s/ Christopher T. Giordano | |||||
| Christopher T. Giordano | ||||||
| President and Chief Executive Officer | ||||||
Exhibit 99.1
Tenax Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update
On track to report topline data from Phase 3 LEVEL study of TNX-103 in third quarter of 2026
Global Phase 3 LEVEL-2 clinical trial ongoing, enrollment completion anticipated by end of 2027
Strengthened leadership team with appointments of Thomas Staab as Chief Financial Officer and Timothy Healey, MBA, as Chief Commercial Officer
CHAPEL HILL, N.C., May 12, 2026 (GLOBE NEWSWIRE) — Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax” or “Tenax Therapeutics” or the “Company”), a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies, reported today financial results for the quarter ended March 31, 2026 and provided an update on its recent corporate progress.
“We continued to make significant progress in advancing TNX-103, completing randomization of more than 230 patients in the Phase 3 LEVEL study at the end of the first quarter which positions us to deliver topline data in the third quarter of 2026,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “Our team continues to activate clinical sites around the world to advance the enrollment in LEVEL-2, our second pivotal trial of TNX-103. We are also thrilled to welcome Tom and Tim to our leadership team in key financial and commercial roles, further deepening the breadth of experience and knowledge at Tenax. Their appointments underscore our commitment to execution excellence as we advance the potential first therapy indicated for the treatment of PH-HFpEF.”
Recent Corporate and Clinical Highlights
| • | All patients have been randomized in the LEVEL study. Tenax continues to anticipate sharing topline data from LEVEL in the third quarter of 2026. |
| • | In April 2026, Tenax announced the appointment of Thomas R. Staab, II, as Chief Financial Officer (CFO). Mr. Staab has over 25 years of financial and executive experience across the healthcare industry, having previously served as CFO of LENSAR, BioCryst Pharmaceuticals, Inspire Pharmaceuticals, and Triangle Pharmaceuticals. |
| • | In May 2026, Tenax further expanded its leadership team with the appointment of Timothy Healey, MBA, as Chief Commercial Officer (CCO). Mr. Healey is a seasoned pharmaceutical executive with a strong track record of successful commercial leadership experience, having most recently served as CCO at Eversana. |
| • | In May 2026, Tenax also appointed So-Young Kim, MD, as Executive Vice President of Clinical Development and Strategy. Dr. Kim has extensive industry experience spanning global drug development and commercial strategy at Bayer AG, with a deep focus on cardiovascular and cardiometabolic medicine. |
First Quarter 2026 Financial Results
Cash position: Tenax Therapeutics reported cash and cash equivalents of $118.8 million as of March 31, 2026. The proceeds from exercises of previously issued warrants during the quarter have enabled Tenax to extend its cash runway, and the Company now expects cash and cash equivalents to fund it through at least the first quarter of 2028.
Research and development (R&D): R&D expenses for the first quarter of 2026 were $11.5 million, compared to $5.7 million for the first quarter of 2025. The increase is primarily attributable to increased clinical and preclinical development costs associated with our ongoing Phase 3 LEVEL trial and our second global Phase 3 study, LEVEL-2, which commenced in December 2025, as well as increased salary and benefit costs related to new employees, partially offset by decreased stock-based compensation due to timing of option vesting.
General and administrative (G&A): G&A expenses for the first quarter of 2026 were $5.0 million, compared to $5.7 million for the first quarter of 2025. The decrease is primarily attributable to a decrease in stock-based compensation due to timing of vesting, partially offset by an increase in salary and benefits related to new employees.
Net loss: Tenax Therapeutics reported a net loss of $15.7 million for the first quarter of 2026, compared to a net loss of $10.4 million for the first quarter of 2025.
About Levosimendan (TNX-101, TNX-102, TNX-103)
Levosimendan is a novel, first-in-class K-ATP channel activator/calcium sensitizer currently being evaluated to treat pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (PH-HFpEF). Levosimendan was first developed for intravenous use in hospitalized patients with acutely decompensated heart failure, and it has received market authorization in 60 countries in this indication, although it is not available in the United States or Canada. Tenax’s Phase 2 HELP study, including its open-label extension stage, demonstrated the potential of IV (TNX-101) and oral (TNX-103) levosimendan to bring durable improvements in exercise capacity and quality of life, as well as other clinical assessments, in patients with PH-HFpEF. TNX-103 (oral levosimendan) is currently being evaluated in LEVEL and LEVEL-2, two Phase 3, double-blind, randomized, placebo-controlled clinical trials in patients with PH-HFpEF.
About Tenax Therapeutics
Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies. The Company owns global rights to develop and commercialize levosimendan, which it is developing for the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension globally, for which no product has been approved to date. For more information, visit www.tenaxthera.com. Tenax Therapeutics’ common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”.
Caution Regarding Forward-Looking Statements
Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. These forward-looking statements may include information concerning possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, location, initiation, enrollment, and results of such trials; any delays in regulatory review and approval of product candidates in development; risks related to our business strategy, including the prioritization and development of product candidates; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; our estimates regarding the potential market opportunity for our product candidates; reliance on third parties, including Orion Corporation, our manufacturers and CROs; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; the potential advantages of our product candidates; our competitive position; intellectual property risks; volatility and uncertainty in the global economy and financial markets in light of unexpected changes in tariffs and the possibility of pandemics, global financial and geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of Ukraine; risks associated with our cash needs; changes in legal, regulatory and legislative environments in the markets in which we operate, and the impact of these changes on our ability to obtain regulatory approval for our products; and other risks and uncertainties set forth from time to time in our SEC filings. Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law.
Contact:
Investor and Media:
Argot Partners
tenax@argotpartners.com
TENAX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share data)
| March 31, 2026 |
December 31, 2025 |
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| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets |
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| Cash and cash equivalents |
$ | 118,755 | $ | 97,565 | ||||
| Prepaid expenses |
4,316 | 5,643 | ||||||
| Other current assets |
107 | 1,019 | ||||||
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| Total current assets |
123,178 | 104,227 | ||||||
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| Total assets |
$ | 123,178 | $ | 104,227 | ||||
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| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities |
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| Accounts payable |
$ | 6,346 | $ | 6,041 | ||||
| Accrued liabilities |
2,140 | 1,115 | ||||||
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| Total current liabilities |
8,486 | 7,156 | ||||||
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| Total liabilities |
8,486 | 7,156 | ||||||
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| Stockholders’ equity |
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| Preferred stock, undesignated, authorized 4,818,654 shares |
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| Series A Preferred stock, par value $0.0001, authorized 5,181,346 shares; issued and outstanding 210, as of March 31, 2026 and December 31, 2025 |
— | — | ||||||
| Common stock, par value $0.0001 per share; authorized 400,000,000 shares; issued and outstanding 24,275,500 as of March 31, 2026 and 9,314,130 as of December 31, 2025, respectively |
2 | 1 | ||||||
| Additional paid-in capital |
497,860 | 464,524 | ||||||
| Accumulated deficit |
(383,170 | ) | (367,454 | ) | ||||
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| Total stockholders’ equity |
114,692 | 97,071 | ||||||
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| Total liabilities and stockholders’ equity |
$ | 123,178 | $ | 104,227 | ||||
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TENAX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(Amounts in thousands, except share and per share data)
| For the three months ended March 31, |
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| 2026 | 2025 | |||||||
| Operating expenses |
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| Research and development |
$ | 11,539 | $ | 5,683 | ||||
| General and administrative |
5,034 | 5,655 | ||||||
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| Total operating expenses |
16,573 | 11,338 | ||||||
| Net operating loss |
(16,573 | ) | (11,338 | ) | ||||
| Interest income |
861 | 930 | ||||||
| Other expense, net |
(4 | ) | — | |||||
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| Net loss |
$ | (15,716 | ) | $ | (10,408 | ) | ||
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| Net loss per share, basic and diluted |
$ | (0.35 | ) | $ | (0.28 | ) | ||
| Weighted average number of common shares and prefunded warrants outstanding, basic and diluted |
45,226,328 | 36,584,920 | ||||||