Tenax Therapeutics Reports Third Quarter 2024 Financial Results and Provides a Corporate Update
Tenax Therapeutics (TENX) reported Q3 2024 financial results, highlighting a successful $100 million private placement with institutional healthcare investors. The company's cash position reached $98.3 million as of September 30, 2024, providing runway through 2027. R&D expenses increased to $3.1 million from $1.1 million year-over-year, while G&A expenses rose to $1.5 million from $1.1 million. Net loss widened to $4.0 million compared to $2.0 million in Q3 2023. The company continues to expand its Phase 3 LEVEL study with 52 investigative sites now initiated.
Tenax Therapeutics (TENX) ha riportato i risultati finanziari del terzo trimestre 2024, evidenziando un collocamento privato di $100 milioni con investitori istituzionali nel settore sanitario. La posizione di cassa dell'azienda ha raggiunto $98,3 milioni al 30 settembre 2024, garantendo sufficienza di fondi fino al 2027. Le spese di ricerca e sviluppo sono aumentate a $3,1 milioni rispetto a $1,1 milioni dell'anno precedente, mentre le spese generali e amministrative sono salite a $1,5 milioni da $1,1 milioni. La perdita netta è aumentata a $4,0 milioni rispetto a $2,0 milioni nel terzo trimestre 2023. L'azienda continua ad espandere il suo studio di Fase 3 LEVEL con 52 siti investigativi già avviati.
Tenax Therapeutics (TENX) reportó los resultados financieros del tercer trimestre de 2024, destacando una colocación privada de $100 millones con inversores institucionales en el sector salud. La posición de efectivo de la compañía alcanzó $98,3 millones al 30 de septiembre de 2024, asegurando recursos hasta 2027. Los gastos en investigación y desarrollo aumentaron a $3,1 millones desde $1,1 millones en comparación con el año anterior, mientras que los gastos generales y administrativos subieron a $1,5 millones desde $1,1 millones. La pérdida neta se ampliaba a $4,0 millones en comparación con $2,0 millones en el tercer trimestre de 2023. La empresa sigue expandiendo su estudio de Fase 3 LEVEL con 52 sitios de investigación ya iniciados.
테낙스 테라퓨틱스(TENX)가 2024년 3분기 재무 결과를 발표하며 1억 달러의 사모 펀딩을 제도권 헬스케어 투자자들과 진행했다고 강조했습니다. 회사의 현금 보유량은 2024년 9월 30일 기준 9,830만 달러에 도달하여 2027년까지 운영 자금을 확보했습니다. 연구 및 개발 비용은 1년 전 110만 달러에서 310만 달러로 증가했으며, 일반 및 관리 비용은 110만 달러에서 150만 달러로 늘어났습니다. 순손실은 2023년 3분기와 비교하여 200만 달러에서 400만 달러로 확대되었습니다. 회사는 현재 52개의 연구 사이트가 시작된 3상 LEVEL 연구를 계속 확장하고 있습니다.
Tenax Therapeutics (TENX) a annoncé les résultats financiers du troisième trimestre 2024, mettant en avant une placement privé de 100 millions de dollars avec des investisseurs institutionnels du secteur de la santé. La position de trésorerie de l'entreprise a atteint 98,3 millions de dollars au 30 septembre 2024, assurant des fonds suffisants jusqu'en 2027. Les dépenses en recherche et développement ont augmenté à 3,1 millions de dollars, contre 1,1 million de dollars l'année précédente, tandis que les frais généraux et administratifs ont augmenté à 1,5 million de dollars contre 1,1 million de dollars. La perte nette s'est élargie à 4,0 millions de dollars par rapport à 2,0 millions de dollars au troisième trimestre 2023. L'entreprise continue d'élargir son étude de Phase 3 LEVEL, avec 52 sites d'investigation désormais lancés.
Tenax Therapeutics (TENX) hat die finanziellen Ergebnisse für das dritte Quartal 2024 bekannt gegeben und dabei eine Privatplatzierung von 100 Millionen US-Dollar mit institutionellen Gesundheitsinvestoren hervorgehoben. Die Liquiditätsposition des Unternehmens betrug zum 30. September 2024 98,3 Millionen US-Dollar, was bis 2027 ausreichend Mittel sichert. Die F&E-Ausgaben stiegen von 1,1 Millionen USD auf 3,1 Millionen USD im Jahresvergleich, während die allgemeinen und Verwaltungskosten von 1,1 Millionen USD auf 1,5 Millionen USD anstiegen. Der Nettoverlust weitete sich auf 4,0 Millionen USD im Vergleich zu 2,0 Millionen USD im dritten Quartal 2023 aus. Das Unternehmen setzt seine Expansion der Phase-3-Studie LEVEL mit inzwischen 52 initierten Prüfstandorten fort.
- Raised $100 million in private placement financing
- Strong cash position of $98.3 million as of Q3 2024
- Extended cash runway through end of 2027
- Expanded Phase 3 LEVEL study to 52 investigative sites
- Net loss doubled to $4.0 million in Q3 2024 vs $2.0 million in Q3 2023
- R&D expenses increased by 182% year-over-year
- G&A expenses increased by 36% year-over-year
Insights
The $100 million private placement significantly strengthens TENX's financial position, extending their cash runway through 2027. With
The expansion to 52 investigative sites for the Phase 3 LEVEL study represents significant operational progress in testing levosimendan for PH-HFpEF (Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction). This acceleration in clinical infrastructure is important as there are currently no approved treatments for this condition, which affects millions. The steady enrollment pace and increased R&D investment suggest strong execution of their clinical strategy. Success in this trial could position TENX to address a substantial unmet medical need in cardiovascular medicine.
Raised Gross Proceeds of Approximately
Continuing to Enroll Patients in Phase 3 LEVEL Study with 52 Investigative Sites Now Initiated
Cash Runway Through End of 2027
CHAPEL HILL, N.C., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX), a Phase 3, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, announced financial results for the third quarter of 2024 and provided a corporate update.
“The third quarter showcased strong execution across our company,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “We expanded our pivotal Phase 3 LEVEL study by initiating more investigative sites and we are pleased with the steady pace of patient enrollment. To further drive our progress, we are investing in key talent and operational resources dedicated to advancing the levosimendan Phase 3 program. Our goal is to make levosimendan the first approved treatment for the millions of individuals affected with PH-HFpEF, a population in critical need of therapeutic options.”
Recent Corporate Highlights
- On August 12, 2024, Tenax announced the closing of a private placement financing that resulted in total gross proceeds to the Company of approximately
$100 million , before deducting placement agent fees and other private placement expenses of approximately$7M .
Upcoming Investor Meetings
- Guggenheim Healthcare Innovation Conference, Nov-11-13, 2024, Boston, MA
Format: Fireside Chat
Presenters: Chris Giordano, President & Chief Executive Officer; Stuart Rich, MD, Chief Medical Officer
Date and time: November 13, 2024 at 1:00 PM EST
Webcast: https://wsw.com/webcast/guggen/tenx/1967811
The live and archived webcast of the presentation will be accessible from the Company’s investor relations webpage.
Third Quarter 2024 Financial Results
Tenax Therapeutics reported cash and cash equivalents of
Research and Development expenses for the third quarter of 2024 were
General and administrative expenses for the third quarter of 2024 were
Tenax Therapeutics reported a net loss for the third quarter of 2024 of approximately
Cash, cash equivalents and investments totaled
About Levosimendan (TNX-101, TNX-102, TNX-103)
Levosimendan is a unique, potassium ATP channel activator and calcium sensitizer that affects the heart and vascular system through multiple mechanisms of action. Initially discovered and developed by Orion Corporation in Finland, intravenous levosimendan has been granted market authorization in 60 countries outside the United States for use in hospitalized patients with acutely decompensated heart failure. Results of Tenax Therapeutics’ Phase 2 HELP study of levosimendan in patients with pulmonary hypertension (PH) with heart failure with preserved ejection fraction (HFpEF) demonstrated that IV levosimendan produces potent dilation of the central and pulmonary venous circulations which translates into an improvement in exercise capacity, a discovery that is the basis of LEVEL, the Phase 3 investigation of Tenax Therapeutics’ potential groundbreaking therapy. To date, no other drug therapy has demonstrated improved exercise tolerance in patients with PH associated with HFpEF, “a growing epidemic with high morbidity and mortality and no treatment. The clear unmet need and lethal nature of PH-HFpEF must be met with novel solutions at all levels of therapeutic development” (AHA Scientific Advisory, “A Call to Action,” 2022).
About Tenax Therapeutics
Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company owns global rights to develop and commercialize levosimendan, which it has prioritized in the near term. Tenax Therapeutics also may resume developing its unique oral formulation of imatinib. 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: the expected use of proceeds from our recent private placement; the expected cash runway with the net proceeds of our recent private placement, and risks associated with our cash needs; risks related to our business strategy, including the prioritization and development of product candidates; 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; 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; intellectual property risks; risks related to our continued listing on Nasdaq; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; 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.
Contacts
Investor Contact:
John Fraunces
Managing Director
LifeSci Advisors, LLC
C: 917-355-2395
jfraunces@lifesciadvisors.com
or
Brian Mullen
LifeSci Advisors, LLC
C: 203-461-1175
bmullen@lifesciadvisors.com
| Tenax Therapeutics, Inc. – Consolidated Balance Sheet for the Periods Ended September 30, 2024 and December 31, 2023 | ||||||||
| September 30, 2024 | December 31, 2023 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 98,310,918 | $ | 9,792,130 | ||||
| Prepaid expenses | 1,438,835 | 1,639,797 | ||||||
| Other current assets | 33,875 | 251,583 | ||||||
| Total current assets | 99,783,628 | 11,683,510 | ||||||
| Other assets | 1,117 | 1,117 | ||||||
Total assets | $ | 99,784,745 | $ | 11,684,627 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 1,584,145 | $ | 2,073,149 | ||||
| Accrued liabilities | 977,545 | 1,012,468 | ||||||
| Note payable | - | 500,903 | ||||||
| Total current liabilities | 2,561,690 | 3,586,520 | ||||||
| Total liabilities | $ | 2,561,690 | $ | 3,586,520 | ||||
| Commitments and contingencies | ||||||||
| Stockholders' equity | ||||||||
| Preferred stock, undesignated, authorized 4,818,654 shares | ||||||||
| Series A Preferred stock, par value | - | - | ||||||
| Common stock, par value | 341 | 30 | ||||||
| Additional paid-in capital | 405,810,449 | 305,350,830 | ||||||
| Accumulated deficit | (308,587,735 | ) | (297,252,753 | ) | ||||
| Total stockholders’ equity | $ | 97,223,055 | $ | 8,098,107 | ||||
Total liabilities and stockholders' equity | $ | 99,784,745 | $ | 11,684,627 | ||||
| Tenax Therapeutics, Inc. – Consolidated Income Statement for the Periods Ended September 30, 2024 and September 30, 2023 | ||||||||||||||||
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses | ||||||||||||||||
| General and administrative | $ | 1,506,796 | $ | 1,051,524 | $ | 4,083,858 | $ | 3,363,511 | ||||||||
| Research and development | 3,112,085 | 1,065,855 | 8,115,370 | 1,529,493 | ||||||||||||
| Total operating expenses | 4,618,881 | 2,117,379 | 12,199,228 | 4,893,004 | ||||||||||||
| Net operating loss | 4,618,881 | 2,117,379 | 12,199,228 | 4,893,004 | ||||||||||||
| Interest expense | 6,312 | 5,337 | 23,465 | 21,813 | ||||||||||||
| Interest income | (664,724 | ) | (150,741 | ) | (887,057 | ) | (366,877 | ) | ||||||||
| Other expense (income), net | - | - | (654 | ) | (62,866 | ) | ||||||||||
| Net loss | $ | 3,960,469 | $ | 1,971,975 | $ | 11,334,982 | $ | 4,485,074 | ||||||||
| Net loss per share, basic and diluted | $ | 0.19 | $ | 6.61 | $ | 1.37 | $ | 19.36 | ||||||||
| Weighted average number of common shares and prefunded warrants outstanding, basic and diluted | 21,161,143 | 298,280 | 8,282,118 | 231,653 | ||||||||||||
FAQ
What was Tenax Therapeutics (TENX) Q3 2024 net loss?
How much did TENX raise in their private placement in August 2024?
What is TENX's cash runway following their Q3 2024 results?
How many investigative sites are now initiated for TENX's Phase 3 LEVEL study?
