Tenax Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Rhea-AI Summary
Tenax Therapeutics (NASDAQ:TENX) reported Q2 2025 financial results and provided updates on its Phase 3 clinical programs. The company's lead program, TNX-103 (oral levosimendan), is progressing in the Phase 3 LEVEL study for PH-HFpEF treatment, with enrollment completion of 230 patients expected in H1 2026.
Key financial metrics include cash position of $105.5 million as of June 30, 2025, expected to fund operations through 2027. Q2 2025 resulted in a net loss of $10.9 million, with R&D expenses of $6.1 million and G&A expenses of $5.7 million.
The company secured patent protection in Canada extending to 2040 and remains on track to initiate its second Phase 3 study, LEVEL-2, in 2025 with a global footprint across 15 additional countries.
Positive
- Strong cash position of $105.5 million, funding operations through 2027
- Secured Canadian patent protection for TNX-103 extending to 2040
- Expanded operations team with new leadership in key positions
- High patient retention rates in LEVEL study's blinded and open-label extension stages
Negative
- Net loss increased significantly to $10.9 million in Q2 2025 from $3.6 million in Q2 2024
- R&D expenses nearly tripled to $6.1 million from $2.3 million year-over-year
- G&A expenses increased substantially to $5.7 million from $1.3 million year-over-year
News Market Reaction
On the day this news was published, TENX gained 0.68%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Phase 3 LEVEL Study Ongoing, Enrollment Completion (230 Patients) Expected in First Half of 2026, with Topline Data Expected in Second Half of 2026
On Track to Initiate Second Phase 3 Study, LEVEL-2, in 2025
CHAPEL HILL, N.C., Aug. 13, 2025 (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, today reported financial results for the quarter ended June 30, 2025 and provided an update on its recent corporate progress.
“We are pleased with the progress achieved in the second quarter, and remain in a strong position to execute and advance our lead program, TNX-103, in patients with PH-HFpEF,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “Our sites in North America continue recruiting toward the expanded target of 230 patients, which increased the statistical powering of the LEVEL study. We now anticipate completing enrollment in the first half of 2026. Importantly, we remain on track to initiate our global Phase 3 study, LEVEL-2, this year. Together, both registrational studies are expected to satisfy the requirements, including safety data expectations, to file for approval in the U.S. and other geographies.”
Recent Corporate and Clinical Highlights
- Patient enrollment in the Phase 3 LEVEL study of TNX-103 (oral levosimendan) in pulmonary hypertension resulting from heart failure with preserved ejection fraction (PH-HFpEF) continues, with high rates of study and therapy continuation during the blinded and open-label extension stages. Tenax expects to complete enrollment of 230 patients in the first half of 2026. LEVEL is being conducted in Canada and the United States.
- A LEVEL protocol design paper, titled “Oral Levosimendan for the Treatment of Pulmonary Hypertension due to Heart Failure With Preserved Ejection Fraction: Rationale and Design of the LEVEL Trial,” was published in the Journal of Cardiac Failure.
- Tenax remains on track to initiate a second registrational Phase 3 study of TNX-103, LEVEL-2, in patients with PH-HFpEF this year. The protocol for LEVEL-2 has been finalized, and the study will have a global footprint. To date, over 85 sites new to the program, in 15 additional countries, have received qualification visits.
- Year to date, Tenax has expanded its operations team, with new heads of Clinical Operations, Data Management, Pharmacovigilance, and Quality Assurance joining the organization to help oversee the execution of the LEVEL program.
- In August 2025, the Canadian Intellectual Property Office (CIPO) informed Tenax it has allowed claims within the Company’s patent application covering the use of TNX-103, TNX-102 (subcutaneous levosimendan), TNX-101 (IV levosimendan), the active metabolites of levosimendan (OR1896 and OR18955) and various combinations of cardiovascular drugs with levosimendan when used to improve exercise performance in PH-HFpEF patients titled: “LEVOSIMENDAN FOR TREATING PULMONARY HYPERTENSION WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (PH-HFpEF).” Once granted, the patent’s protections will extend to 2040.
Second Quarter 2025 Financial Results
Cash position: Tenax Therapeutics reported cash and cash equivalents of
Research and development (R&D): R&D expenses for the second quarter of 2025 were
General and administrative (G&A): G&A expenses for the second 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, a Phase 3, double-blind, randomized, placebo-controlled clinical trial 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; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; 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; intellectual property risks; 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; our estimates regarding the potential market opportunity for our product candidates; the potential advantages of our product candidates; our competitive position; risks associated with our cash needs; 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; 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. Consolidated Statements of Operations | ||||||||||||||||
| For the three months ended June 30, | For the six months ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| (in thousands, except for share and per share data) | ||||||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 6,121 | $ | 2,327 | $ | 11,804 | $ | 5,003 | ||||||||
| General and administrative | 5,671 | 1,344 | 11,326 | 2,577 | ||||||||||||
| Total operating expenses | 11,792 | 3,671 | 23,130 | 7,580 | ||||||||||||
| Net operating loss | (11,792 | ) | (3,671 | ) | (23,130 | ) | (7,580 | ) | ||||||||
| Interest income | 954 | 104 | 1,884 | 222 | ||||||||||||
| Interest expense | - | (9 | ) | - | (17 | ) | ||||||||||
| Other income (expense), net | (9 | ) | 1 | (9 | ) | 1 | ||||||||||
| Net loss | $ | (10,847 | ) | $ | (3,575 | ) | $ | (21,255 | ) | $ | (7,374 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.27 | ) | $ | (1.83 | ) | $ | (0.56 | ) | $ | (4.65 | ) | ||||
| Weighted average number of common shares and prefunded warrants outstanding, basic and diluted | 39,572,177 | 1,958,245 | 38,086,800 | 1,586,650 | ||||||||||||
| Tenax Therapeutics, Inc. Consolidated Balance Sheets | ||||||||
| June 30, 2025 | December 31, 2024 | |||||||
| ASSETS | (in thousands) | |||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 105,462 | $ | 94,851 | ||||
| Prepaid expenses and other current assets | 395 | 1,835 | ||||||
| Total current assets | 105,857 | 96,686 | ||||||
| Total assets | $ | 105,857 | $ | 96,686 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 562 | $ | 3,157 | ||||
| Accrued liabilities | 1,965 | 1,536 | ||||||
| Total current liabilities | 2,527 | 4,693 | ||||||
| Total liabilities | 2,527 | 4,693 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity | ||||||||
| Preferred stock, undesignated, authorized 4,818,654 shares | ||||||||
| Series A Preferred stock, par value | - | - | ||||||
| Common stock, par value | - | - | ||||||
| Additional paid-in capital | 439,440 | 406,848 | ||||||
| Accumulated deficit | (336,110 | ) | (314,855 | ) | ||||
| Total stockholders’ equity | 103,330 | 91,993 | ||||||
| Total liabilities and stockholders' equity | $ | 105,857 | $ | 96,686 | ||||
FAQ
When will Tenax Therapeutics (TENX) complete enrollment for the Phase 3 LEVEL study?
What is the cash runway for Tenax Therapeutics (TENX) as of Q2 2025?
What is TNX-103 being developed for by Tenax Therapeutics?
How many countries will be involved in Tenax's LEVEL-2 Phase 3 study?
What was Tenax Therapeutics' (TENX) net loss in Q2 2025?
