CHAPEL HILL, N.C. - Tenax Therapeutics, Inc. (NASDAQ:TENX), a Phase 3 pharmaceutical company, has announced the expansion of its license agreement with Orion Corporation, granting Tenax global rights for the development and commercialization of levosimendan. This amendment to the existing exclusive license extends Tenax's territorial rights from North America to the entire world for the treatment of pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF).
Under the new terms, Tenax will pay Orion tiered net sales royalty rates that range from high single-digit to low-teen percentages. The modified agreement also includes revised milestone provisions, with additional payments due upon regulatory approval in Japan, reflecting the significant market opportunity for PH-HFpEF treatments.
Chris Giordano, President and CEO of Tenax, expressed optimism about the amendment, stating that the expanded rights enable Tenax to capture a more substantial share of the drug's value and potentially establish global strategic alliances. Tenax continues to work with Orion to pursue additional intellectual property protection for levosimendan's use in PH-HFpEF across key international markets.
The LEVEL Study, a Phase 3 clinical trial for levosimendan, is currently underway, with the primary outcome measure being the improvement in six-minute walk distance at Week 12. Levosimendan, which has been approved in over 60 countries for acutely decompensated heart failure, is now being developed in oral and subcutaneous forms by Tenax.
Tenax's strategy focuses on addressing cardiovascular and pulmonary diseases with high unmet medical need. The company's portfolio includes not only levosimendan but also an oral formulation of imatinib, which is in development.
The press release also includes cautionary statements regarding forward-looking information, which could be subject to various risks and uncertainties that might cause actual results to differ from those projected.
The expansion of Tenax's rights to levosimendan aims to build significant shareholder value as the company advances the drug into Phase 3 testing.
This news is based on a press release statement from Tenax Therapeutics.
InvestingPro Insights
As Tenax Therapeutics, Inc. (NASDAQ:TENX) broadens its licensing agreement with Orion Corporation, investors are closely monitoring the company's financial health and stock performance. The latest data from InvestingPro shows a market capitalization of just $7.33 million USD, reflecting the small size of the biopharmaceutical firm. Despite the potential for levosimendan, Tenax's P/E ratio stands at a negative 1.04 for the last twelve months as of Q3 2023, indicating that the company is not currently generating profits.
Moreover, the company's stock has experienced a high level of price volatility, as evidenced by a 1-month price total return of -57.48% and a 1-year price total return of -94.29%. This suggests that investors have been reacting to the company's performance and market dynamics with significant shifts in the stock's pricing. With the stock trading near its 52-week low, at 5.57% of its high, and closing at $4.19 USD, it's clear that the market is factoring in the challenges faced by Tenax.
InvestingPro Tips highlight that while Tenax holds more cash than debt on its balance sheet, it is quickly burning through cash, which could be a concern for investors considering the company's future funding needs. Additionally, the company does not pay a dividend, which may influence the investment decisions of income-focused shareholders.
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