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Tenax Therapeutics, Inc. (Nasdaq: TENX) is a specialty pharmaceutical company dedicated to identifying, developing, and commercializing innovative treatments for cardiovascular and pulmonary diseases with significant unmet medical needs. Headquartered in Chapel Hill, North Carolina, Tenax holds the North American rights to develop and commercialize levosimendan, a unique potassium ATP channel activator and calcium sensitizer with multiple mechanisms of action.
The company’s flagship product, levosimendan, is currently under development for treating pulmonary hypertension associated with heart failure and preserved ejection fraction (PH-HFpEF). This condition affects a growing number of patients and has high morbidity and mortality rates with no approved drug treatments. Levosimendan has shown promise in improving exercise capacity through potent dilation of central and pulmonary venous circulations, as demonstrated in the Phase 2 HELP trial.
Tenax is advancing levosimendan through the Phase 3 LEVEL study, a double-blind, randomized, placebo-controlled trial evaluating the efficacy of oral levosimendan in improving exercise tolerance in PH-HFpEF patients. The study aims to enroll approximately 152 subjects and measure outcomes through the six-minute walk distance test.
Recent milestones include the initiation of trial sites and patient enrollment in the LEVEL study, as well as securing expanded global rights for the development and commercialization of oral and subcutaneous formulations of levosimendan beyond North America. The United States Patent and Trademark Office (USPTO) recently granted Tenax a patent covering various formulations of levosimendan for improving exercise performance in PH-HFpEF patients, providing protections through December 2040.
In addition to levosimendan, Tenax is also developing a novel oral formulation of imatinib for pulmonary hypertension. The company continues to explore strategic partnerships to maximize the commercial potential of its therapies.
For more information about Tenax Therapeutics and their ongoing projects, visit www.tenaxthera.com. The company’s common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”.
Tenax Therapeutics (TENX), a Phase 3 development-stage pharmaceutical company focused on cardiovascular and pulmonary diseases, has announced its participation in the upcoming Guggenheim SMID Cap Biotech Conference. The event will take place in New York from February 5-6, 2025.
Company President & CEO Chris Giordano will participate in a fireside chat on February 5, 2025, at 3:00 pm ET. The presentation will be available via webcast, accessible through the company's investor relations webpage. Additionally, Tenax management will be conducting one-on-one investor meetings during the conference, which can be arranged through Guggenheim representatives.
Tenax Therapeutics (NASDAQ: TENX) has appointed Gillian Andor, MSc, as Vice President of Clinical Operations. Andor brings over 20 years of experience and will lead the company's Clinical Operations function, supporting the ongoing Phase 3 LEVEL study of oral levosimendan (TNX-103) for PH-HFpEF treatment.
Andor's track record includes successful roles at Noema Pharma as Interim Head of Clinical Development Operations and at Sage Therapeutics, where she led programs resulting in NDA approvals for Zulresso® and Zurzuvae®. At Ironwood Pharmaceuticals, she contributed to the NDA approval of Linzess®.
The company granted Andor an inducement equity award of 250,000 stock options at $6.44 per share, vesting over four years in equal annual installments.
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 (Nasdaq: TENX) has announced its participation in the Guggenheim Healthcare Innovation Conference in Boston, scheduled for November 11-13, 2024. CEO Chris Giordano will present a company update and discuss the development of levosimendan in a fireside chat format on November 13, 2024, at 1:00 PM EST.
The presentation, which will be available via live webcast and archived recording, will showcase the company's progress in developing treatments for cardiovascular and pulmonary diseases with high unmet medical need. Investors can access the presentation through the company's investor relations webpage or the provided webcast link.
Tenax Therapeutics (TENX) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Raised $100 million in gross proceeds through a private placement with leading healthcare investors.
2. Continuing enrollment in the Phase 3 LEVEL study with 39 investigative sites initiated.
3. Hosted a KOL event discussing the unmet medical need in PH-HFpEF and levosimendan's potential.
4. Secured U.S. patent for levosimendan use in PH-HFpEF.
5. Q2 2024 financial results: $9.4 million in cash and cash equivalents, R&D expenses of $2.3 million, and a net loss of $3.6 million or $1.83 per share.
Tenax Therapeutics (NASDAQ: TENX) has closed a $100 million private placement to accelerate its oral levosimendan (TNX-103) Phase 3 development program. The funding will support the completion of the ongoing LEVEL Study for treating Pulmonary Hypertension Due to Heart Failure with Preserved Ejection Fraction (PH-HFpEF) and initiate a second Phase 3 study planned for 2025. This financing, led by BVF Partners LP and other prominent healthcare investors, positions Tenax to shorten the timeline to NDA submission.
The LEVEL study aims to demonstrate the impact of daily oral levosimendan on exercise ability in PH-HFpEF patients, a condition with no FDA-approved therapies. Previous studies showed promising results, with participants in the HELP study demonstrating a 10% improvement in six-minute walk distance over six weeks.
Tenax Therapeutics (Nasdaq: TENX) has secured an oversubscribed $100 million private placement led by BVF Partners LP and other prominent investors. The financing includes 1,450,661 shares of common stock and pre-funded warrants for 31,882,671 shares, along with warrants for 16,666,666 additional shares. Priced at $3.00 per share, the deal is expected to close on August 8, 2024.
The funds will support Tenax's ongoing Phase 3 LEVEL trial for levosimendan in PH-HFpEF patients, initiate a second Phase 3 trial, and cover general corporate expenses. This financing is projected to fund operations through 2027. Leerink Partners leads the placement, with Guggenheim Securities and William Blair as joint agents.
Tenax Therapeutics (Nasdaq: TENX) has reported its Q1 2024 financial results and provided a corporate update. Key highlights include continuing patient enrollment in the Phase 3 LEVEL study with 24 investigative sites initiated and securing global development and commercial rights for levosimendan for PH-HFpEF treatment. A new US patent was granted, expanding their intellectual property estate. In February 2024, Tenax raised approximately $8 million in a public offering. Financially, the company reported a net loss of $3.8 million for Q1 2024, compared to $1.4 million for the same period in 2023, with cash and equivalents at $12.5 million as of March 31, 2024.
Tenax Therapeutics, Inc. announced a new U.S. patent covering the use of levosimendan in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF) until December 2040. The patent broadens protection for oral, IV, and subcutaneous use of levosimendan, and its active metabolites, also allowing for additional U.S. patent term extension. This patent is the third granted to Tenax since March 2023, protecting the use of levosimendan in treating PH-HFpEF.
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