Tenax Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update
Rhea-AI Summary
Tenax Therapeutics (NASDAQ: TENX) reported its Q1 2025 financial results and provided updates on its Phase 3 clinical trials. The company expects to complete enrollment of 230 patients in its Phase 3 LEVEL study for TNX-103 in PH-HFpEF by year-end 2025, with topline data expected mid-2026. A second Phase 3 study, LEVEL-2, is planned to commence in 2025.
Financial highlights include: cash position of $111.4 million as of March 31, 2025, bolstered by a $25 million private placement in March 2025. Q1 2025 saw increased expenses with R&D costs at $5.7 million (up from $2.7M in Q1 2024) and G&A expenses at $5.7 million (up from $1.2M). Net loss widened to $10.4 million compared to $3.8M in Q1 2024. The company expects current cash to fund operations through 2027.
Positive
- Strong cash position of $111.4 million, expected to fund operations through 2027
- Successful private placement raising $25 million in March 2025
- High rates of study and therapy continuation in LEVEL trial
- Expansion of clinical program with planned second Phase 3 study (LEVEL-2)
Negative
- Increased net loss to $10.4 million in Q1 2025, up from $3.8 million in Q1 2024
- Significant increase in expenses: R&D costs doubled and G&A expenses nearly quintupled
- Phase 3 trial results not expected until middle of 2026
News Market Reaction
On the day this news was published, TENX gained 0.35%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Phase 3 LEVEL Enrollment Completion for TNX-103 in PH-HFpEF Targeted Around Year-End 2025, with Topline Data Expected Middle of 2026
Initiation of Second Phase 3 Study, LEVEL-2, Expected This Year
CHAPEL HILL, N.C., May 14, 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 March 31, 2025 and provided an update on its recent corporate progress.
“2025 is off to a strong start. We continued to make meaningful progress in both the ongoing LEVEL study as well as preparations to commence our second registrational Phase 3 study, LEVEL-2,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “We also continued to engage with key stakeholders over the past quarter to discuss how levosimendan can control splanchnic blood volume and reduce blood flow to the left ventricle, potentially providing desirable effects for patients suffering from PH-HFpEF. We expect to share topline data from our first Phase 3 study, LEVEL, in the middle of 2026 and establish TNX-103 as a powerful therapeutic option for this disease currently without any available treatments.”
Recent Corporate and Clinical Highlights
- Patient enrollment in the Phase 3 LEVEL study of TNX-103 in PH-HFpEF continues, with high rates of study and therapy continuation during the blinded and open-label extension stages. Tenax anticipates completing enrollment of 230 patients in LEVEL around the end of 2025. LEVEL is being conducted in Canada and the U.S.
- Tenax remains on track to commence in 2025 a second registrational Phase 3 study of TNX-103, LEVEL-2, in patients with PH-HFpEF. This trial will have a global footprint.
First Quarter 2025 Financial Results
Cash position: Tenax Therapeutics reported cash and cash equivalents of
Research and development (R&D): R&D expenses for the first quarter of 2025 were
General and administrative (G&A): G&A expenses for the first 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, 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; 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 ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; our competitive position; risks associated with our cash needs; 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; 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:
Merrill Barrett
Argot Partners
tenax@argotpartners.com
| Tenax Therapeutics, Inc. Consolidated Statements of Operations | |||||||
| For the three months ended March 31, | |||||||
| 2025 | 2024 | ||||||
| (in thousands, except for share and per share data) | |||||||
| Operating expenses | |||||||
| Research and development | $ | 5,683 | $ | 2,676 | |||
| General and administrative | 5,655 | 1,233 | |||||
| Total operating expenses | 11,338 | 3,909 | |||||
| Net operating loss | (11,338 | ) | (3,909 | ) | |||
| Interest income | 930 | 118 | |||||
| Interest expense | - | (8 | ) | ||||
| Net loss | $ | (10,408 | ) | $ | (3,799 | ) | |
| Net loss per share, basic and diluted | $ | (0.28 | ) | $ | (3.12 | ) | |
| Weighted average number of common shares and prefunded warrants outstanding, basic and diluted | 36,584,920 | 1,219,139 | |||||
| Tenax Therapeutics, Inc. Consolidated Balance Sheets | |||||||
| March 31, 2025 | December 31, 2024 | ||||||
| ASSETS | (in thousands) | ||||||
| Current assets | |||||||
| Cash and cash equivalents | $ | 111,447 | $ | 94,851 | |||
| Prepaid expenses | 524 | 1,771 | |||||
| Other current assets | 88 | 64 | |||||
| Total current assets | 112,059 | 96,686 | |||||
| Total assets | $ | 112,059 | $ | 96,686 | |||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
| Current liabilities | |||||||
| Accounts payable | 1,839 | 3,157 | |||||
| Accrued liabilities | 929 | 1,536 | |||||
| Total current liabilities | 2,768 | 4,693 | |||||
| Total liabilities | $ | 2,768 | $ | 4,693 | |||
| Stockholders' equity | |||||||
| Preferred stock, undesignated, authorized 4,818,654 shares | |||||||
| Series A Preferred stock, par value | - | - | |||||
| Common stock, par value | - | - | |||||
| Additional paid-in capital | 434,554 | 406,848 | |||||
| Accumulated deficit | (325,263 | ) | (314,855 | ) | |||
| Total stockholders’ equity | 109,291 | 91,993 | |||||
| Total liabilities and stockholders' equity | $ | 112,059 | $ | 96,686 | |||
FAQ
When will Tenax Therapeutics (TENX) report topline data for its Phase 3 LEVEL study?
How much cash does Tenax Therapeutics (TENX) have as of Q1 2025?
What was TENX's net loss in Q1 2025?
How many patients will be enrolled in Tenax's Phase 3 LEVEL study?
How long will Tenax's current cash position fund operations?
