Tenax Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update
Rhea-AI Summary
Tenax Therapeutics (NASDAQ: TENX) achieved randomization of 230 patients in the Phase 3 LEVEL study and expects topline results in Q3 2026. The company initiated global Phase 3 LEVEL-2 and opened an OLE study. USPTO issued a Notice of Allowance for subcutaneous levosimendan formulations. Cash was $97.6M at 12/31/2025, expected to fund operations through 2027. R&D and G&A expenses increased materially in 2025, contributing to a 2025 net loss of $52.6M versus $17.6M in 2024.
Positive
- Randomized 230 patients in Phase 3 LEVEL, enabling planned topline data in Q3 2026
- Initiated global Phase 3 LEVEL-2 and opened a multi-center OLE for continued access
- USPTO issued Notice of Allowance covering subcutaneous levosimendan formulations
- Cash balance of $97.6M as of 12/31/2025, forecast to fund operations through 2027
Negative
- R&D spend rose to $32.7M in 2025 from $12.7M in 2024 (increase >150%)
- G&A expenses increased to $23.7M in 2025 from $6.8M in 2024, driven by stock-based comp and fees
- Net loss widened to $52.6M in 2025 versus $17.6M in 2024, reflecting higher development and operating costs
News Market Reaction – TENX
On the day this news was published, TENX gained 31.67%, reflecting a significant positive market reaction. Argus tracked a peak move of +24.7% during that session. Our momentum scanner triggered 29 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $22M to the company's valuation, bringing the market cap to $91M at that time. Trading volume was exceptionally heavy at 9.7x the daily average, suggesting very strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
TENX was up 3.09% with elevated volume, while peers showed mixed moves: KZR (+1.89%), ALLR (+2.89%), NRSN (-0.98%), DARE (-0.32%), and ANTX (+73.51%). Momentum scanner flags ALLR, ANTX, NRSN, and RVPH with both up and down moves, suggesting stock-specific drivers for TENX rather than a broad biotech rotation.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 12 | Q3 2025 earnings | Neutral | -4.3% | Q3 2025 results, LEVEL enrollment update, patent and runway through 2027. |
| Aug 13 | Q2 2025 earnings | Neutral | +0.7% | Q2 2025 results, TNX-103 progress, cash of $105.5M and runway to 2027. |
| May 14 | Q1 2025 earnings | Neutral | +0.3% | Q1 2025 results, LEVEL enrollment plans, higher R&D and G&A expenses. |
| Mar 25 | FY 2024 earnings | Neutral | -2.0% | FY 2024 results, $94.9M cash after private placements, expanded Phase 3 plans. |
| Nov 13 | Q3 2024 earnings | Neutral | -3.1% | Q3 2024 results, $100M private placement, increased R&D and G&A expenses. |
Earnings-related releases over the last five events have shown modest average moves of -1.67%, with a mix of small gains and declines following financial updates and clinical progress reports.
Across the last five earnings releases dating back to Nov 2024, Tenax has consistently highlighted progress of its Phase 3 TNX-103 program, expanding the LEVEL study and planning or initiating LEVEL-2, while funding runway has repeatedly been guided through 2027. Cash has remained near or above $94.9M during this period, alongside rising R&D and G&A expenses and widening net losses. Historically, shares have reacted only modestly to these updates, with average moves around -1.67% after similar earnings announcements.
Historical Comparison
Past five earnings updates averaged a -1.67% move, with modest reactions to rising expenses and steady cash runway. Today’s +3.09% pre-news gain sits slightly above that typical response range for Tenax’s financial updates.
Earnings releases since late 2024 have tracked a steady progression: funding runway extended through 2027, expansion of the Phase 3 LEVEL trial, and plans leading to the initiation of the global LEVEL-2 study. The current full-year 2025 results continue this pattern, now with the LEVEL randomization target reached and LEVEL-2 formally underway.
Market Pulse Summary
The stock surged +31.7% in the session following this news. A strong positive reaction aligns with the combination of a solid $97.6M cash position and clear clinical milestones, including completion of the 230-patient LEVEL randomization and initiation of LEVEL-2. Historically, earnings updates have produced modest average moves of -1.67%, so a large upside move would stand out against prior patterns and could face pressure if rising annual R&D and G&A costs or widening net losses re-emerge as investor focus.
Key Terms
phase 3 medical
open-label extension medical
pulmonary hypertension medical
heart failure with preserved ejection fraction medical
6-minute walk distance medical
blinded sample size re-estimation medical
notice of allowance regulatory
subcutaneously medical
AI-generated analysis. Not financial advice.
Achieved randomization target of 230 patients in LEVEL study, topline data expected in third quarter of 2026
Initiated global Phase 3 LEVEL-2 clinical trial and opened long-term OLE study for patients to remain on drug
CHAPEL HILL, N.C., March 10, 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 year ended December 31, 2025 and provided an update on its recent corporate progress.
“We are pleased to announce that we have recently achieved our randomization target of 230 patients in the Phase 3 LEVEL study. As we strive to make significant progress executing on our registrational LEVEL program, achievement of this important milestone demonstrates our team’s commitment to rapidly advancing TNX-103,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “The screening period for LEVEL has closed. Patients already screening will have the opportunity to qualify for randomization, which we anticipate finishing this month. We expect to share initial results from LEVEL in the third quarter of 2026.”
Mr. Giordano continued, “In parallel, we remain focused on activating clinical sites around the world to advance the global LEVEL-2 study, which we continue to anticipate will complete enrollment by the end of 2027. With a continued focus on execution, we aim to rapidly advance the development of TNX-103, a novel and potential first-in-class therapy for patients with PH-HFpEF who have no approved treatment options for their debilitating disease.”
Recent Corporate and Clinical Highlights
- In November 2025, Tenax hosted a virtual call with key opinion leaders to discuss the treatment landscape for pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF), as well as its Phase 3 TNX-103 program.
- In December 2025, Tenax announced the results from a prespecified Blinded Sample Size Re-estimation (BSSR) of the ongoing LEVEL study, demonstrating the trial is powered at well over
90% to detect a 25 meter change in 6-minute walk distance. - Also in December 2025, Tenax announced the initiation of LEVEL-2, a global and second registrational Phase 3 clinical trial of TNX-103 in patients with PH-HFpEF. Tenax also announced it will initiate a global, multi-center open-label extension (OLE) study, which will provide patients enrolled in either LEVEL or LEVEL-2 continued access to TNX-103 after study completion and until potential availability of a commercialized product.
- In January 2026, the U.S. Patent and Trademark Office (USPTO) issued a Notice of Allowance expanding protection to cover any formulation of levosimendan that is administered subcutaneously in a broad range of indications including pulmonary hypertension, essential and secondary hypertension, HFpEF, heart failure with reduced ejection fraction (HFrEF), PH-HFpEF and PH with HFrEF (PH-HFrEF).
- In March 2026, Tenax achieved its randomization target of 230 patients in the LEVEL study, and closed screening. All patients currently in screening will have the opportunity to qualify for randomization, which is expected to occur by the end of March. The Company anticipates sharing topline data in the third quarter of 2026.
Fourth Quarter and Full Year 2025 Financial Results
Cash position: Tenax Therapeutics reported cash and cash equivalents of
Research and development (R&D): R&D expenses for the fourth quarter of 2025 were
General and administrative (G&A): G&A expenses for the fourth quarter of 2025 were
Net loss: Tenax Therapeutics reported a net loss of
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 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; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; 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.
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| TENAX THERAPEUTICS, INC. | ||||||||
| CONSOLIDATED BALANCE SHEETS | ||||||||
| (Amounts in thousands, except share and per share data) | ||||||||
| December 31, 2025 | December 31, 2024 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 97,565 | $ | 94,851 | ||||
| Prepaid expenses | 5,643 | 1,771 | ||||||
| Other current assets | 1,019 | 64 | ||||||
| Total current assets | 104,227 | 96,686 | ||||||
| Total assets | $ | 104,227 | $ | 96,686 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 6,041 | $ | 3,157 | ||||
| Accrued liabilities | 1,115 | 1,536 | ||||||
| Total current liabilities | 7,156 | 4,693 | ||||||
| Total liabilities | 7,156 | 4,693 | ||||||
| Stockholders' equity | ||||||||
| Preferred stock, undesignated, authorized 4,818,654 shares | ||||||||
| Series A Preferred stock, par value | - | - | ||||||
| Common stock, par value | 1 | - | ||||||
| Additional paid-in capital | 464,524 | 406,848 | ||||||
| Accumulated deficit | (367,454 | ) | (314,855 | ) | ||||
| Total stockholders’ equity | 97,071 | 91,993 | ||||||
| Total liabilities and stockholders' equity | $ | 104,227 | $ | 96,686 | ||||
| TENAX THERAPEUTICS, INC. | ||||||||||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
| (Amounts in thousands, except share and per share data) | ||||||||||||||||
| For the Three Months Ended December 31, | For the Year Ended December 31, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 10,540 | $ | 4,594 | $ | 32,672 | $ | 12,709 | ||||||||
| General and administrative | 5,909 | 2,701 | 23,713 | 6,785 | ||||||||||||
| Total operating expenses | 16,449 | 7,295 | 56,385 | 19,494 | ||||||||||||
| Net operating loss | (16,449 | ) | (7,295 | ) | (56,385 | ) | (19,494 | ) | ||||||||
| Interest income | 918 | 1,027 | 3,819 | 1,914 | ||||||||||||
| Interest expense | - | - | - | (23 | ) | |||||||||||
| Other income (expense), net | (9 | ) | - | (33 | ) | 1 | ||||||||||
| Net loss | $ | (15,540 | ) | $ | (6,268 | ) | $ | (52,599 | ) | $ | (17,602 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.38 | ) | $ | (0.18 | ) | $ | (1.34 | ) | $ | (1.15 | ) | ||||
| Weighted average number of common shares and prefunded warrants outstanding, basic and diluted | 40,917,109 | 35,294,316 | 39,217,244 | 15,271,705 | ||||||||||||
FAQ
When will TENX report topline results from the Phase 3 LEVEL trial?
What does the TENX initiation of LEVEL-2 mean for global development timelines?
How long will TENX’s cash of $97.6M fund operations for TENX?
What is the significance of the USPTO Notice of Allowance for TENX (TENX)?
How did Tenax’s expenses and net loss change in 2025 compared to 2024?
Will patients in LEVEL and LEVEL-2 have continued access to TNX-103 after trials?
