Company expects to report topline data from Phase 3 LEVEL clinical trial in
“We are approaching an exciting moment, one for which we have been preparing since we began developing a therapy uniquely suited for PH-HFpEF. As we announced at the start of July, we expect to have topline data from the LEVEL clinical trial in August,” said
Recent Corporate and Clinical Highlights
In
Second Quarter 2026 Financial Results
Cash position:
Research and development (R&D): R&D expenses for the second quarter of 2026 were
Selling, general and administrative (SG&A): SG&A expenses for the second quarter of 2026 were
Net loss:
About Levosimendan
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
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 our clinical trials and our 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; 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; risks related to our business strategy, including the prioritization and development of product candidates; our competitive position; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including our executives and members of our Board of Directors; 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:
Argot Partners
tenax@argotpartners.com
Condensed Consolidated Balance Sheets (Amounts in thousands, except share and per share data) | ||||||||
| ASSETS | (unaudited) | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 117,976 | $ | 97,565 | ||||
| Prepaid expenses | 3,415 | 5,643 | ||||||
| Other current assets | 272 | 1,019 | ||||||
| Total current assets | 121,663 | 104,227 | ||||||
| Total assets | $ | 121,663 | $ | 104,227 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 6,795 | $ | 6,041 | ||||
| Accrued liabilities | 1,278 | 1,115 | ||||||
| Total current liabilities | 8,073 | 7,156 | ||||||
| Total liabilities | 8,073 | 7,156 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, undesignated, authorized 4,818,654 shares | ||||||||
| Series A Preferred stock, par value | - | - | ||||||
| Common stock, par value | 3 | 1 | ||||||
| Additional paid-in capital | 514,560 | 464,524 | ||||||
| Accumulated deficit | (400,973 | ) | (367,454 | ) | ||||
| Total stockholders’ equity | 113,590 | 97,071 | ||||||
| Total liabilities and stockholders' equity | $ | 121,663 | $ | 104,227 | ||||
Condensed Consolidated Statements of Operations (unaudited) | ||||||||||||||||
| (Amounts in thousands, except share and per share data) | ||||||||||||||||
| For the three months ended | For the six months ended | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 12,850 | $ | 6,121 | $ | 24,389 | $ | 11,804 | ||||||||
| Selling, general and administrative | 5,934 | 5,671 | 10,968 | 11,326 | ||||||||||||
| Total operating expenses | 18,784 | 11,792 | 35,357 | 23,130 | ||||||||||||
| Net operating loss | (18,784 | ) | (11,792 | ) | (35,357 | ) | (23,130 | ) | ||||||||
| Interest income | 981 | 954 | 1,842 | 1,884 | ||||||||||||
| Other income (expense), net | - | (9 | ) | (4 | ) | (9 | ) | |||||||||
| Net loss | $ | (17,803 | ) | $ | (10,847 | ) | $ | (33,519 | ) | $ | (21,255 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.35 | ) | $ | (0.27 | ) | $ | (0.70 | ) | $ | (0.56 | ) | ||||
| Weighted average number of common shares and prefunded warrants outstanding, basic and diluted | 50,869,259 | 39,572,177 | 48,064,151 | 38,086,800 | ||||||||||||
