Tenax Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update
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.
Tenax Therapeutics (NASDAQ:TENX) ha comunicato i risultati finanziari del secondo trimestre 2025 e ha fornito aggiornamenti sui programmi clinici di fase 3. Il programma principale, TNX-103 (levosimendan orale), procede nello studio di fase 3 LEVEL per il trattamento della PH-HFpEF; il completamento dell'arruolamento di 230 pazienti 猫 previsto nel primo semestre 2026.
I principali indicatori finanziari includono una posizione di cassa di $105,5 milioni al 30 giugno 2025, ritenuta sufficiente a finanziare le attivit脿 operative fino al 2027. Il 2Q 2025 ha registrato una perdita netta di $10,9 milioni, con spese per R&S pari a $6,1 milioni e spese generali e amministrative di $5,7 milioni.
La societ脿 ha ottenuto la protezione brevettuale in Canada fino al 2040 e rimane in linea per avviare il secondo studio di fase 3, LEVEL-2, nel 2025, estendendo la sua presenza a livello globale in altri 15 paesi.
Tenax Therapeutics (NASDAQ:TENX) inform贸 los resultados financieros del segundo trimestre de 2025 y ofreci贸 actualizaciones sobre sus programas cl铆nicos de fase 3. Su programa principal, TNX-103 (levosimend谩n oral), avanza en el estudio de fase 3 LEVEL para el tratamiento de PH-HFpEF; se espera completar el reclutamiento de 230 pacientes en el primer semestre de 2026.
Los indicadores financieros clave incluyen una posici贸n de efectivo de $105,5 millones al 30 de junio de 2025, que deber铆a financiar las operaciones hasta 2027. El 2T 2025 present贸 una p茅rdida neta de $10,9 millones, con gastos de I+D por $6,1 millones y gastos generales y administrativos por $5,7 millones.
La compa帽铆a consigui贸 protecci贸n de patentes en Canad谩 hasta 2040 y mantiene el cronograma para iniciar su segundo estudio de fase 3, LEVEL-2, en 2025, con presencia global en 15 pa铆ses adicionales.
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欤检殧 鞛 歆�響滊電� 2025雲� 6鞗� 30鞚� 旮办 順勱笀 氤挫湢鞎� $105.5 million鞙茧, 2027雲勱箤歆� 鞖挫榿 鞛愱笀鞚� 於╇嫻頃� 瓴冹溂搿� 鞓堨儊霅╇媹雼�. 2025雲� 2攵勱赴鞐愲姅 靾滌啇鞁� $10.9 million鞚� 旮半頄堨溂氅� 鞐瓣惮臧滊皽牍勱皜 $6.1 million, 鞚茧皹甏�毽箘(G&A)臧� $5.7 million鞓�鞀惦媹雼�.
須岇偓電� 旌愲倶雼れ棎靹� 2040雲勱箤歆�鞚� 韸鬼棃 氤错樃毳� 頇曤炒頄堨溂氅�, 2025雲� 霊� 氩堨Ц 3靸� 鞐瓣惮鞚� LEVEL-2毳� 臧滌嫓頃� 瓿勴殟鞚� 鞙犾頃橁碃 鞛堦碃 於旉皜 15臧滉淡鞐� 瓯胳箿 旮�搿滊矊 歆勳稖鞚� 鞓堨爼頃橁碃 鞛堨姷雼堧嫟.
Tenax Therapeutics (NASDAQ:TENX) a publi茅 ses r茅sultats financiers du deuxi猫me trimestre 2025 et a donn茅 des mises 脿 jour sur ses programmes cliniques de phase 3. Le programme principal, TNX-103 (l茅vosimendan oral), progresse dans l'essai de phase 3 LEVEL pour le traitement de la PH-HFpEF ; le recrutement de 230 patients devrait 锚tre achev茅 au 1er semestre 2026.
Les principaux indicateurs financiers incluent une tr茅sorerie de $105,5 millions au 30 juin 2025, jug茅e suffisante pour financer les op茅rations jusqu'en 2027. Le 2T 2025 s'est sold茅 par une perte nette de $10,9 millions, avec des d茅penses R&D de $6,1 millions et des frais G&A de $5,7 millions.
La soci茅t茅 a obtenu une protection par brevet au Canada jusqu'en 2040 et reste en bonne voie pour lancer sa deuxi猫me 茅tude de phase 3, LEVEL-2, en 2025, avec une pr茅sence mondiale dans 15 pays suppl茅mentaires.
Tenax Therapeutics (NASDAQ:TENX) meldete die Finanzergebnisse f眉r das 2. Quartal 2025 und gab Updates zu seinen Phase-3-Programmen. Das Leitprogramm, TNX-103 (orale Levosimendan), befindet sich im Phase-3-Studie LEVEL zur Behandlung von PH-HFpEF; die Rekrutierung von 230 Patienten soll im 1. Halbjahr 2026 abgeschlossen sein.
Wesentliche Finanzkennzahlen: eine Barreserve von $105,5 Millionen per 30. Juni 2025, die voraussichtlich bis 2027 den Betrieb finanziert. Im 2. Quartal 2025 ergab sich ein Nettiverlust von $10,9 Millionen, wobei F&E-Ausgaben von $6,1 Millionen und Verwaltungsaufwendungen (G&A) von $5,7 Millionen angefallen sind.
Das Unternehmen hat in Kanada Patentschutz bis 2040 erhalten und ist weiterhin im Zeitplan, seine zweite Phase-3-Studie, LEVEL-2, 2025 zu starten, mit einer globalen Pr盲senz in weiteren 15 L盲ndern.
- 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
- 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
Insights
Tenax making steady progress in PH-HFpEF Phase 3 trials with TNX-103, but with delayed timelines; cash runway extends through 2027.
Tenax's Phase 3 LEVEL study for TNX-103 (oral levosimendan) is progressing, though with extended timelines. Enrollment completion for the expanded 230-patient study is now expected in H1 2026 with topline data in H2 2026. This suggests a delay from previous timelines, though the company doesn't explicitly acknowledge this. The expansion from the original enrollment target increases statistical power but extends the development timeline.
The company remains on track to initiate its second Phase 3 study (LEVEL-2) in 2025, which will have a global footprint spanning 15 additional countries with over 85 new sites qualified. This dual-study approach is strategically designed to satisfy regulatory requirements for both U.S. and international approvals.
From a clinical perspective, the high continuation rates in both the blinded and open-label extension stages of LEVEL are encouraging, suggesting potential efficacy and tolerability. The publication of the LEVEL protocol design paper in the Journal of Cardiac Failure adds scientific credibility to their methodological approach.
The company has strengthened its operational infrastructure by adding key leadership positions in Clinical Operations, Data Management, Pharmacovigilance, and Quality Assurance. These hires signal preparation for managing the expanded global clinical program and potential commercialization.
The intellectual property position for TNX-103 has been bolstered with the Canadian patent allowance, which will extend protection until 2040. This provides long-term market exclusivity for a key geography, though patent status in other major markets isn't mentioned.
For a Phase 3 company, the
Tenax reports substantial R&D acceleration and increasing cash burn, but maintains strong
Tenax's financial position shows a strong cash reserve of
The company's R&D expenses have increased significantly to
G&A expenses have similarly increased to
The net loss widened to
The significant non-cash stock-based compensation (
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) (鈥淭enax鈥� or 鈥淭enax Therapeutics鈥� or the 鈥淐ompany鈥�), 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.
鈥淲e 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,鈥� said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. 鈥淥ur 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.鈥�
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 鈥淥ral Levosimendan for the Treatment of Pulmonary Hypertension due to Heart Failure With Preserved Ejection Fraction: Rationale and Design of the LEVEL Trial,鈥� was published in the .
- 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鈥檚 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:听鈥淟EVOSIMENDAN FOR TREATING PULMONARY HYPERTENSION WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (PH-HFpEF).鈥� Once granted, the patent鈥檚 protections will extend to 2040.听
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鈥檚 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 . Tenax Therapeutics鈥� common stock is listed on The Nasdaq Stock Market LLC under the symbol 鈥淭ENX鈥�.
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.
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| Tenax Therapeutics, Inc. Consolidated Statements of Operations | ||||||||||||||||
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| 听 | 听 | For the three months ended June 30, | 听 | For the six months ended June听30, | ||||||||||||
| 听 | 听 | 听 | 2025 | 听 | 听 | 听 | 2024 | 听 | 听 | 听 | 2025 | 听 | 听 | 听 | 2024 | 听 |
| 听 | 听 | (in thousands, except for share and per share data) | ||||||||||||||
| 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | ||||||||
| Operating expenses | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | ||||||||
| Research and development | 听 | $ | 6,121 | 听 | 听 | $ | 2,327 | 听 | 听 | $ | 11,804 | 听 | 听 | $ | 5,003 | 听 |
| General and administrative | 听 | 听 | 5,671 | 听 | 听 | 听 | 1,344 | 听 | 听 | 听 | 11,326 | 听 | 听 | 听 | 2,577 | 听 |
| Total operating expenses | 听 | 听 | 11,792 | 听 | 听 | 听 | 3,671 | 听 | 听 | 听 | 23,130 | 听 | 听 | 听 | 7,580 | 听 |
| 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | ||||
| Net operating loss | 听 | 听 | (11,792 | ) | 听 | 听 | (3,671 | ) | 听 | 听 | (23,130 | ) | 听 | 听 | (7,580 | ) |
| 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | ||||
| Interest income | 听 | 听 | 954 | 听 | 听 | 听 | 104 | 听 | 听 | 听 | 1,884 | 听 | 听 | 听 | 222 | 听 |
| Interest expense | 听 | 听 | - | 听 | 听 | 听 | (9 | ) | 听 | 听 | - | 听 | 听 | 听 | (17 | ) |
| Other income (expense), net | 听 | 听 | (9 | ) | 听 | 听 | 1 | 听 | 听 | 听 | (9 | ) | 听 | 听 | 1 | 听 |
| Net loss | 听 | $ | (10,847 | ) | 听 | $ | (3,575 | ) | 听 | $ | (21,255 | ) | 听 | $ | (7,374 | ) |
| Net loss per share, basic and diluted | 听 | $ | (0.27 | ) | 听 | $ | (1.83 | ) | 听 | $ | (0.56 | ) | 听 | $ | (4.65 | ) |
| Weighted average number of common shares and prefunded warrants outstanding, basic and diluted | 听 | 听 | 39,572,177 | 听 | 听 | 听 | 1,958,245 | 听 | 听 | 听 | 38,086,800 | 听 | 听 | 听 | 1,586,650 | 听 |
| 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | ||||||||
| Tenax Therapeutics, Inc. Consolidated Balance Sheets | ||||||||
| 听 | ||||||||
| 听 | 听 | June听30, 2025 | 听 | December听31, 2024 | ||||
| ASSETS | 听 | (in thousands) | ||||||
| Current assets | 听 | 听 | 听 | 听 | ||||
| Cash and cash equivalents | 听 | $ | 105,462 | 听 | 听 | $ | 94,851 | 听 |
| Prepaid expenses and other current assets | 听 | 听 | 395 | 听 | 听 | 听 | 1,835 | 听 |
| Total current assets | 听 | 听 | 105,857 | 听 | 听 | 听 | 96,686 | 听 |
| Total assets | 听 | $ | 105,857 | 听 | 听 | $ | 96,686 | 听 |
| LIABILITIES AND STOCKHOLDERS鈥� EQUITY | 听 | 听 | 听 | 听 | ||||
| Current liabilities | 听 | 听 | 听 | 听 | ||||
| Accounts payable | 听 | $ | 562 | 听 | 听 | 听$ | 3,157 | 听 |
| Accrued liabilities | 听 | 听 | 1,965 | 听 | 听 | 听 | 1,536 | 听 |
| Total current liabilities | 听 | 听 | 2,527 | 听 | 听 | 听 | 4,693 | 听 |
| Total liabilities | 听 | 听 | 2,527 | 听 | 听 | 听 | 4,693 | 听 |
| 听 | 听 | 听 | 听 | 听 | ||||
| Commitments and contingencies | 听 | 听 | 听 | 听 | ||||
| Stockholders' equity | 听 | 听 | 听 | 听 | ||||
| Preferred stock, undesignated, authorized 4,818,654 shares | 听 | 听 | 听 | 听 | ||||
| Series A Preferred stock, par value | 听 | 听 | - | 听 | 听 | 听 | - | 听 |
| Common stock, par value | 听 | 听 | - | 听 | 听 | 听 | - | 听 |
| Additional paid-in capital | 听 | 听 | 439,440 | 听 | 听 | 听 | 406,848 | 听 |
| Accumulated deficit | 听 | 听 | (336,110 | ) | 听 | 听 | (314,855 | ) |
| Total stockholders鈥� equity | 听 | 听 | 103,330 | 听 | 听 | 听 | 91,993 | 听 |
| Total liabilities and stockholders' equity | 听 | $ | 105,857 | 听 | 听 | $ | 96,686 | 听 |
| 听 | 听 | 听 | 听 | 听 | ||||
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?
