Tenax Therapeutics, Inc. (NASDAQ:TENX) 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's lead product candidate, levosimendan, is being evaluated for the treatment of pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF), a debilitating and often fatal condition with no approved therapies.
Tenax Therapeutics' History: From Synthetic Blood to Cardiovascular Innovation
Tenax Therapeutics has undergone a remarkable transformation since its inception. The company was originally formed in 1967 as Rudmer, David Associates, Inc., and later changed its name to Synthetic Blood International, Inc. In June 2008, the company formed Oxygen Biotherapeutics to participate in a merger for the purpose of changing the state of domicile from New Jersey to Delaware. Synthetic Blood International merged with Oxygen Biotherapeutics, with Oxygen Biotherapeutics being the surviving corporation. In September 2014, the company changed its name to Tenax Therapeutics, Inc. to better reflect its focus on developing novel cardiopulmonary therapies.
The company's journey took a pivotal turn in November 2013 when it acquired a license with Orion Corporation, granting its wholly-owned subsidiary an exclusive, sublicensable right to develop and commercialize pharmaceutical products containing levosimendan, 2.5 mg/ml concentrate for solution for infusion 5ml vial in the United States and Canada. In October 2020 and January 2022, the company entered into amendments to the license agreement to include two new oral product formulations containing levosimendan.
In January 2021, Tenax made another significant move by acquiring 100% of the equity of PHPrecisionMed Inc., a Delaware corporation, with PHPrecisionMed surviving as Tenax's wholly-owned subsidiary. As a result of this merger, Tenax gained rights to commercialize pharmaceutical products containing imatinib for the treatment of pulmonary arterial hypertension, further expanding its product pipeline.
Throughout its history, Tenax has faced several challenges. The company has incurred losses since its inception and, as of September 30, 2024, had an accumulated deficit of approximately $308.6 million. Tenax will continue to incur losses until it generates sufficient revenue to offset its expenses. The process of conducting preclinical studies and clinical trials necessary to obtain approval from the FDA is also costly and time-consuming, with the probability of success for each product candidate and clinical trial being affected by a variety of factors.
Financial Snapshot and Operational Highlights
Tenax Therapeutics reported an annual net loss of $7.71 million in 2023, with no revenue recorded. The company's annual operating cash flow was -$5.90 million, and its annual free cash flow was -$5.90 million. As of September 30, 2024, the company had $98.31 million in cash and cash equivalents, providing a runway through the end of 2027.
Over the past year, Tenax Therapeutics has made significant strides in advancing its lead program. In 2023, the company received clearance from the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application for oral levosimendan (TNX-103), enabling the initiation of the Phase 3 LEVEL trial in patients with PH-HFpEF. The first patient was enrolled in the LEVEL trial in the fourth quarter of 2023, and the company continues to make progress in site selection and patient enrollment.
In addition to the LEVEL trial, Tenax Therapeutics has also been focused on expanding its intellectual property portfolio. In 2023, the company was granted two U.S. patents covering the use of levosimendan, including for the treatment of PH-HFpEF and for use in combination with other cardiovascular therapies. In early 2024, the company was granted an additional patent that further broadens the IP protection for oral, intravenous, and subcutaneous formulations of levosimendan and its active metabolites in PH-HFpEF.
Addressing the Unmet Need in PH-HFpEF
PH-HFpEF is a debilitating and often fatal condition characterized by the development of pulmonary hypertension in patients with heart failure and preserved ejection fraction. It is estimated to affect approximately 3 million individuals in the United States, and currently, there are no FDA-approved therapies for this indication.
Tenax Therapeutics' lead product candidate, levosimendan, has demonstrated promising results in preclinical and clinical studies for the treatment of PH-HFpEF. The molecule's unique mechanism of action, which includes vasodilation, increased cardiac contractility, and cardioprotective effects, make it a compelling potential treatment for this high-unmet-need condition.
The ongoing Phase 3 LEVEL trial is designed to evaluate the efficacy and safety of oral levosimendan (TNX-103) in patients with PH-HFpEF. The study is expected to enroll approximately 500 participants, with the primary endpoint being the change in 6-minute walk distance from baseline to week 24. Tenax Therapeutics is also planning to initiate a second Phase 3 study for oral levosimendan in PH-HFpEF in 2025, further strengthening its commitment to addressing this critical area of unmet medical need.
Navigating Challenges and Positioning for Success
Tenax Therapeutics has encountered various challenges throughout its history, including the need to pivot its focus from synthetic blood products to cardiovascular and pulmonary therapies. However, the company's unwavering dedication to developing innovative solutions for patients with limited treatment options has allowed it to navigate these obstacles and emerge as a promising player in the cardiopulmonary space.
The company's recent $100 million private placement financing, completed in August 2024, has provided a significant boost to its financial position, enabling it to accelerate the development of its lead program and initiate a second Phase 3 trial for oral levosimendan in PH-HFpEF. This strengthened balance sheet, combined with the company's growing intellectual property portfolio and the ongoing progress in its clinical programs, positions Tenax Therapeutics for potential success in the years to come.
As Tenax Therapeutics continues to navigate the regulatory landscape and advance its clinical trials, the company remains focused on its mission of addressing the unmet needs of patients suffering from cardiovascular and pulmonary diseases. With a strong management team, a promising pipeline, and a clear strategic vision, Tenax Therapeutics is well-positioned to potentially make a meaningful impact in the lives of those affected by these debilitating conditions.
Financials
Tenax Therapeutics' financial position reflects its status as a development-stage pharmaceutical company. The company reported no revenue in 2023, which is consistent with its focus on research and development activities. The annual net loss of $7.71 million in 2023 demonstrates the significant investment required to advance its clinical programs, particularly the Phase 3 LEVEL trial for oral levosimendan.
The negative annual operating cash flow of -$5.90 million and identical annual free cash flow figure indicate that the company's cash burn is primarily driven by its operational activities, with minimal capital expenditures. This financial profile is typical for biopharmaceutical companies in the late stages of clinical development, as they invest heavily in bringing their lead candidates to market.
For the most recent quarter (Q3 2024), Tenax Therapeutics reported no revenue and a net loss of $3.96 million. The company's research and development expenses for the nine months ended September 30, 2024, were $8.12 million, a significant increase compared to $1.53 million in the same period of the prior year. This increase was primarily due to expenses associated with the Phase 3 LEVEL trial for oral levosimendan. General and administrative expenses for the nine months ended September 30, 2024, were $4.08 million, up from $3.36 million in the prior year period, reflecting higher personnel costs and legal/professional fees.
Liquidity
As of September 30, 2024, Tenax Therapeutics reported a strong liquidity position with $98.31 million in cash and cash equivalents. This substantial cash reserve is a result of the company's successful $100 million private placement financing completed in August 2024. The strengthened balance sheet provides Tenax with a significant runway, estimated to last through the end of 2027.
This improved liquidity position is crucial for Tenax Therapeutics as it allows the company to fully fund its ongoing Phase 3 LEVEL trial for oral levosimendan in PH-HFpEF patients. Additionally, it enables the company to initiate a second Phase 3 study planned for 2025, further advancing its clinical development program. The extended cash runway also provides Tenax with financial flexibility to navigate potential challenges and capitalize on opportunities that may arise during the development process.
The company's financial health is further demonstrated by its strong liquidity ratios. As of September 30, 2024, Tenax Therapeutics had a current ratio and quick ratio of 38.95, indicating a robust ability to meet its short-term obligations. The company also reported a debt-to-equity ratio of 0, suggesting a conservative approach to financing with no long-term debt on its balance sheet.
Product Portfolio and Development Pipeline
Tenax Therapeutics' product portfolio is primarily focused on two main candidates:
1. Levosimendan: The company's lead product candidate, levosimendan, is a calcium sensitizer that works by increasing the sensitivity of the contractile proteins in the heart to calcium, leading to improved cardiac contractility without increasing the demand for oxygen. Tenax owns the exclusive, sublicensable rights to develop and commercialize pharmaceutical products containing levosimendan in the United States and Canada.
In February 2024, the company entered into an amendment to the levosimendan license agreement, providing Tenax with global rights to oral and subcutaneous formulations of levosimendan used in the treatment of PH-HFpEF. This amendment also revised the royalty structure, lowered the royalty rates, and modified milestones associated with regulatory and commercial achievements.
2. Imatinib: Through the acquisition of PHPrecisionMed Inc. in January 2021, Tenax gained rights to commercialize pharmaceutical products containing imatinib for the treatment of pulmonary arterial hypertension (PAH). Imatinib is a tyrosine kinase inhibitor that has shown potential benefits in the treatment of PAH.
Business Overview: A Focused Approach to Cardiovascular and Pulmonary Diseases
Tenax Therapeutics operates primarily in the United States and is dedicated to addressing cardiovascular and pulmonary diseases with high unmet medical need. The company's strategic focus on developing levosimendan for PH-HFpEF positions it in a potentially lucrative market segment with no currently approved therapies.
The recent private placement financing of $99.7 million in August 2024 has significantly bolstered the company's financial position. Tenax plans to use the net proceeds to complete its ongoing Phase 3 LEVEL trial, initiate a second planned Phase 3 trial of oral levosimendan, and for general corporate purposes. This influx of capital, combined with the company's existing cash reserves, is expected to fund operations through the end of 2027, providing a substantial runway for the company to advance its clinical programs and potentially bring its lead candidate to market.
As Tenax Therapeutics progresses through its late-stage clinical development, the company remains focused on its mission to develop innovative therapies for patients with limited treatment options. The success of the LEVEL trial and potential approval of levosimendan for PH-HFpEF could position Tenax as a significant player in the cardiovascular and pulmonary disease space, potentially transforming the treatment landscape for millions of patients worldwide.