Tenax Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
Tenax Therapeutics (NASDAQ: TENX) reported its Q4 and full-year 2024 financial results, highlighting successful private placements totaling $125 million to support two registrational studies for TNX-103 in PH-HFpEF. The company ended 2024 with $94.9 million in cash, with funding now extended through 2027.
The Phase 3 LEVEL study has been expanded to enhance statistical power, with enrollment completion targeted for year-end 2025 and topline data expected mid-2026. A second Phase 3 study, LEVEL-2, is planned to commence in 2025.
Financial highlights include increased R&D expenses of $12.7 million for 2024 (vs $3.2 million in 2023) and G&A expenses of $6.8 million (vs $5.0 million in 2023). The company reported a net loss of $17.6 million for 2024, compared to $7.7 million in 2023.
Tenax Therapeutics (NASDAQ: TENX) ha riportato i risultati finanziari per il quarto trimestre e per l'intero anno 2024, evidenziando collocamenti privati di successo per un totale di 125 milioni di dollari a sostegno di due studi registrativi per TNX-103 in PH-HFpEF. L'azienda ha chiuso il 2024 con 94,9 milioni di dollari in cassa, con finanziamenti ora estesi fino al 2027.
Lo studio di Fase 3 LEVEL è stato ampliato per migliorare la potenza statistica, con il completamento delle iscrizioni previsto per la fine del 2025 e i dati preliminari attesi per metà 2026. Un secondo studio di Fase 3, LEVEL-2, è pianificato per iniziare nel 2025.
I punti salienti finanziari includono un aumento delle spese per R&S di 12,7 milioni di dollari per il 2024 (rispetto ai 3,2 milioni di dollari nel 2023) e spese generali e amministrative di 6,8 milioni di dollari (rispetto ai 5,0 milioni di dollari nel 2023). L'azienda ha riportato una perdita netta di 17,6 milioni di dollari per il 2024, rispetto ai 7,7 milioni di dollari nel 2023.
Tenax Therapeutics (NASDAQ: TENX) informó sus resultados financieros del cuarto trimestre y del año completo 2024, destacando colocaciones privadas exitosas por un total de 125 millones de dólares para apoyar dos estudios de registro para TNX-103 en PH-HFpEF. La compañía cerró 2024 con 94.9 millones de dólares en efectivo, con financiamiento ahora extendido hasta 2027.
El estudio de Fase 3 LEVEL se ha ampliado para aumentar el poder estadístico, con la finalización de la inscripción prevista para finales de 2025 y los datos preliminares esperados a mediados de 2026. Se planea comenzar un segundo estudio de Fase 3, LEVEL-2, en 2025.
Los aspectos financieros destacados incluyen un aumento en los gastos de I+D de 12.7 millones de dólares para 2024 (en comparación con 3.2 millones de dólares en 2023) y gastos generales y administrativos de 6.8 millones de dólares (en comparación con 5.0 millones de dólares en 2023). La compañía reportó una pérdida neta de 17.6 millones de dólares para 2024, en comparación con 7.7 millones de dólares en 2023.
Tenax Therapeutics (NASDAQ: TENX)는 2024년 4분기 및 연간 재무 결과를 발표하며, PH-HFpEF에서 TNX-103에 대한 두 가지 등록 연구를 지원하기 위해 총 1억 2500만 달러의 성공적인 사모펀드 조달을 강조했습니다. 회사는 2024년을 9,490만 달러의 현금으로 마감했으며, 자금 조달은 이제 2027년까지 연장되었습니다.
3상 LEVEL 연구는 통계적 힘을 높이기 위해 확대되었으며, 등록 완료는 2025년 말로 목표하고 있으며, 주요 데이터는 2026년 중반에 예상됩니다. 두 번째 3상 연구인 LEVEL-2는 2025년에 시작될 예정입니다.
재무 하이라이트에는 2024년 R&D 비용이 1,270만 달러로 증가한 것(2023년 320만 달러 대비)과 680만 달러의 일반 및 관리비(2023년 500만 달러 대비)가 포함됩니다. 회사는 2024년에 1,760만 달러의 순손실을 기록했으며, 이는 2023년의 770만 달러와 비교됩니다.
Tenax Therapeutics (NASDAQ: TENX) a annoncé ses résultats financiers pour le quatrième trimestre et l'année entière 2024, mettant en avant des placements privés réussis totalisant 125 millions de dollars pour soutenir deux études d'enregistrement pour TNX-103 dans le PH-HFpEF. L'entreprise a terminé 2024 avec 94,9 millions de dollars en liquidités, avec un financement désormais prolongé jusqu'en 2027.
L'étude de Phase 3 LEVEL a été élargie pour améliorer la puissance statistique, avec un achèvement des inscriptions prévu pour la fin de 2025 et des données préliminaires attendues pour mi-2026. Une deuxième étude de Phase 3, LEVEL-2, est prévue pour commencer en 2025.
Les points forts financiers incluent une augmentation des dépenses R&D de 12,7 millions de dollars pour 2024 (contre 3,2 millions de dollars en 2023) et des dépenses générales et administratives de 6,8 millions de dollars (contre 5,0 millions de dollars en 2023). L'entreprise a signalé une perte nette de 17,6 millions de dollars pour 2024, contre 7,7 millions de dollars en 2023.
Tenax Therapeutics (NASDAQ: TENX) hat seine finanziellen Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 veröffentlicht und hebt erfolgreiche Privatplatzierungen in Höhe von insgesamt 125 Millionen Dollar hervor, um zwei Zulassungsstudien für TNX-103 bei PH-HFpEF zu unterstützen. Das Unternehmen schloss das Jahr 2024 mit 94,9 Millionen Dollar in bar ab, wobei die Finanzierung nun bis 2027 verlängert wurde.
Die Phase-3-Studie LEVEL wurde erweitert, um die statistische Power zu erhöhen, wobei der Abschluss der Einschreibung bis Ende 2025 angestrebt wird und die vorläufigen Daten für Mitte 2026 erwartet werden. Eine zweite Phase-3-Studie, LEVEL-2, ist für 2025 geplant.
Zu den finanziellen Highlights gehören gestiegene F&E-Ausgaben von 12,7 Millionen Dollar für 2024 (im Vergleich zu 3,2 Millionen Dollar im Jahr 2023) und allgemeine und Verwaltungskosten von 6,8 Millionen Dollar (im Vergleich zu 5,0 Millionen Dollar im Jahr 2023). Das Unternehmen berichtete von einem Nettoverlust von 17,6 Millionen Dollar für 2024, verglichen mit 7,7 Millionen Dollar im Jahr 2023.
- Secured $125 million in private placements to fund operations through 2027
- Obtained FDA approval for expanded Phase 3 LEVEL study protocol
- Granted new U.S. patent for TNX-103 and related compounds
- Strong cash position of $94.9 million at year-end 2024
- Net loss increased to $17.6 million in 2024 from $7.7 million in 2023
- R&D expenses increased significantly to $12.7 million from $3.2 million YoY
- G&A expenses rose to $6.8 million from $5.0 million YoY
Insights
Tenax Therapeutics' latest financial results and corporate update reveal a transformative capital infusion that dramatically strengthens its financial position. The company secured approximately
The financing's magnitude indicates strong investor confidence in TNX-103's potential in PH-HFpEF, a condition with significant unmet medical need. While R&D expenses increased substantially to
The FDA's review of their updated Phase 3 development plan provides regulatory clarity for their path forward. While the trial expansion will extend timelines slightly, it enhances statistical power, potentially increasing approval probability. The newly granted patent strengthens their intellectual property position, creating additional value beyond the clinical assets.
This financing effectively removes near-term capital concerns and allows management to focus on clinical execution rather than fundraising, representing a significant de-risking event for this small-cap biotech company.
Tenax's decision to expand the Phase 3 LEVEL study enrollment and enhance statistical power represents a strategic clinical development move that balances timeline considerations with improved probability of success. The FDA's completed review of this amended plan signals regulatory alignment on their approach to the pivotal program for TNX-103 in PH-HFpEF.
The addition of a second registrational study (LEVEL-2) creates multiple pathways to potential approval while strengthening the overall data package. This dual-study approach is becoming increasingly important for novel treatments in complex cardiovascular conditions, where regulatory agencies often require robust efficacy confirmation across different patient populations.
The appointment of an experienced VP of Clinical Operations with 20+ years of industry experience suggests appropriate scaling of their clinical infrastructure to support these expanded trials. This operational enhancement is essential for managing the increased complexity of running parallel Phase 3 studies.
The company's timeline projections—completing enrollment around year-end 2025 with topline data in mid-2026—appear realistic for a rare disease cardiovascular indication like PH-HFpEF, where patient recruitment can be challenging. The scientific roundtable featuring global experts indicates engagement with key opinion leaders who can facilitate site selection and enrollment.
While the expanded development plan extends the timeline slightly, it substantially improves the statistical robustness of their program and aligns with current regulatory expectations for novel cardiopulmonary therapies, ultimately enhancing TNX-103's approval prospects if the data prove positive.
Successfully Completed Private Placements with Aggregate Gross Proceeds of Approximately
Phase 3 LEVEL Study Expansion Increases Statistical Power; Enrollment Completion 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., March 25, 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 year ended December 31, 2024 and provided an update on its recent corporate progress.
“The past year has been transformational for Tenax Therapeutics in our quest to advance TNX-103, our oral levosimendan drug candidate, and bring meaningful clinical benefit to patients suffering from PH-HFpEF. With the continued support of investors, we are now well-positioned to expand our investment in TNX-103 and accelerate development timelines, paving the way for an earlier potential regulatory filing,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “We remain committed to a lean cost structure and responsible capital stewardship, ensuring our current funding sustains Tenax well beyond topline LEVEL data readout. We believe TNX-103 has the potential to improve the quality of life of patients living with PH-HFpEF, and expect to share topline data from LEVEL in the middle of 2026.”
Recent Corporate and Clinical Highlights
- In March 2025, Tenax closed a private placement financing, securing approximately
$25 million in gross proceeds. - In March 2025, Tenax reported that the U.S. Food and Drug Administration (FDA) had completed its review of the Company’s updated Phase 3 development plan for TNX-103 (oral levosimendan). The plan includes an amendment to expand enrollment and enhance the statistical power of the ongoing Phase 3 LEVEL study, as well as the protocol for LEVEL-2, Tenax’s second registrational Phase 3 study. The Company anticipates completing enrollment of 230 patients in LEVEL around the end of 2025. LEVEL-2, a global study, is expected to commence in 2025.
- In January 2025, Tenax appointed Gillian Andor, MSc. as Vice President of Clinical Operations. Ms. Andor has over 20 years of experience in various roles across the biotechnology industry, and leads the Company’s expanding Clinical Operations function in support of the ongoing Phase 3 TNX-103 program.
- In August 2024, Tenax successfully closed a private placement financing that resulted in total gross proceeds of approximately
$100 million . - In April 2024, Tenax announced that the United States Patent and Trademark Office (USPTO) granted the Company U.S. Patent No. 11,969,424, 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 patients with pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF). The newly issued patent expressly provides intellectual property protection for levosimendan at all therapeutic doses.
- In April 2024, Tenax hosted “LEVEL Setting”, a scientific roundtable exploring the rationale for TNX-103 in the treatment of PH-HFpEF. Presentations were made by four globally recognized experts in the field.
- In February 2024, Tenax closed a registered public offering of its common stock, pre-funded warrants and warrants that resulted in total gross proceeds to the Company of approximately
$9 million .
Fourth Quarter and Full Year 2024 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 2024 were
General and administrative (G&A): G&A expenses for the fourth quarter of 2024 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 activator/calcium sensitizer currently being evaluated to treat pulmonary hypertension (PH) 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 levosimendan (TNX-101) and TNX-103 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; risks associated with our cash needs; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; our competitive position; intellectual property risks; volatility and uncertainty in the global economy and financial markets in light of 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. Condensed Consolidated Balance Sheets | ||||||
| (in thousands) (Unaudited) | ||||||
| December 31, 2024 | December 31, 2023 | |||||
| ASSETS | ||||||
| Current assets | ||||||
| Cash and cash equivalents | $ | 94,851 | $ | 9,792 | ||
| Prepaid expenses | 1,771 | 1,640 | ||||
| Other current assets | 64 | 252 | ||||
| Total current assets | 96,686 | 11,684 | ||||
| Other assets | - | 1 | ||||
| Total assets | $ | 96,686 | $ | 11,685 | ||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||
| Current liabilities | ||||||
| Accounts payable | 3,157 | 2,073 | ||||
| Accrued liabilities | 1,536 | 1,013 | ||||
| Note payable | - | 501 | ||||
| Total current liabilities | 4,693 | 3,587 | ||||
| Total liabilities | 4,693 | 3,587 | ||||
| Total stockholders’ equity | 91,993 | 8,098 | ||||
| Total liabilities and stockholders' equity | $ | 96,686 | $ | 11,685 | ||
| Tenax Therapeutics, Inc. Condensed Consolidated Statements of Operations | |||||||||||||||
| (in thousands, except share and per share data) (Unaudited) | |||||||||||||||
| For the Three Months Ended December 31, | For the Year Ended December 31, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Operating expenses | |||||||||||||||
| Research and development | $ | 4,594 | $ | 1,700 | $ | 12,709 | $ | 3,229 | |||||||
| General and administrative | 2,701 | 1,641 | 6,785 | 5,005 | |||||||||||
| Total operating expenses | 7,295 | 3,341 | 19,494 | 8,234 | |||||||||||
| - | - | - | - | ||||||||||||
| Net operating loss | (7,295 | ) | (3,341 | ) | (19,494 | ) | (8,234 | ) | |||||||
| 1,027 | 117 | 1,914 | 484 | ||||||||||||
| Interest expense | - | (2 | ) | (23 | ) | (24 | ) | ||||||||
| Other income, net | - | - | 1 | 63 | |||||||||||
| Net loss | $ | (6,268 | ) | $ | (3,226 | ) | $ | (17,602 | ) | $ | (7,711 | ) | |||
| Net loss per share, basic and diluted | $ | (0.18 | ) | $ | (10.82 | ) | $ | (1.15 | ) | $ | (31.04 | ) | |||
| Weighted average number of common shares and prefunded warrants outstanding, basic and diluted | 35,294,316 | 298,281 | 15,271,705 | 248,447 | |||||||||||
FAQ
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