Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today reported financial results for the third quarter of 2021 and provided a business update.

“As we approach the new year, the Tenax team is building strong momentum across our lead clinical programs,” said Christopher T. Giordano, President and Chief Executive Officer of Tenax Therapeutics. “In October, we announced the initiation of a comparative pharmacokinetic study designed to evaluate our novel formulation of imatinib versus the currently approved formulation. We expect this trial to be completed by year-end. It will serve as a bridging study for our registration-enabling Phase 3 trial in pulmonary arterial hypertension, or PAH. Based on our current timeline, we expect this Phase 3 study to begin in the second quarter of 2022. In our view, there is a growing recognition that by reformulating oral imatinib, a drug already clinically proven to benefit PAH patients, Tenax has an opportunity to introduce the first safe and effective treatment for PAH with the potential for disease-modifying activity.”

“Our open label transition study using the oral formulation of levosimendan also remains on track. As a reminder, this trial is being conducted to help Tenax determine the optimal dosage for levosimendan in our planned Phase 3 trial, which also is expected to start in 2022. In sum, Tenax is entering an exciting period in the Company’s history, with the potential for initiating two registration-enabling studies in the next several months. We thank our investors for their continued support, and we look forward to providing additional updates in the near future.”

Recent Highlights

• Received FDA notice of clearance of the Investigational New Drug (IND) application for the Company’s novel formulation of imatinib.
• Initiated, and plans to complete before the end of 2021, a comparative pharmacokinetic (PK) study bridging to the start of a Phase 3 trial of the Company’s delayed-release formulation of imatinib for the treatment of PAH.
• Announced the publication of a new article that identifies a novel mechanism of action behind the improved cardiovascular hemodynamics and exercise tolerance that was reported in the recent Phase 2 HELP Study of levosimendan.
• Appointed Mr. Giordano as President and Chief Executive Officer of the Company and a member of its Board of Directors.
• Closed a private equity offering with a single institutional investor in July 2021 for gross proceeds of approximately $10.0 million.

Financial Results

• Research and development expenses for the third quarter of 2021 were $1.2 million, compared to $1.1 million for the third quarter of 2020.
• General and administrative expenses for the third quarter of 2021 were $2.6 million, compared to $1.2 million for the third quarter of 2020.
• Net loss for the third quarter of 2021 was $3.8 million, or $0.15 per share, compared to a net loss of $2.2 million, or $0.18 per share, for the third quarter of 2020.
• Cash, cash equivalents and marketable securities totaled $8.4 million as of September 30, 2021, compared to $6.7 million as of December 31, 2020. Management expects that current cash on hand will be sufficient to fund current operations through the second quarter of 2022.
  
  

About Tenax Therapeutics

Tenax Therapeutics, Inc. is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company has a world-class scientific advisory team including recognized global experts in pulmonary hypertension. Tenax Therapeutics is developing a delayed release oral formulation of imatinib, designed to avoid the gastric irritation observed in a previous Phase 3 trial of the marketed version of the therapy, and expects to conduct a single pivotal trial pursuant to the 505(b)(2) pathway for regulatory approval. The Company also owns North American rights to develop and commercialize levosimendan and has recently released detailed results from the Phase 2 HELP Study of levosimendan in Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF) at the Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting, and in the Journal of the American College of Cardiology: Heart Failure. For more information, visit www.tenaxthera.com.

About Imatinib

Tenax Therapeutics is developing a novel formulation of imatinib mesylate, a kinase inhibitor that has received FDA’s orphan designation (March 2020) for the treatment of pulmonary arterial hypertension (PAH). This unique, delayed release form of oral imatinib has been designed to avoid the gastric intolerance observed in the previous Phase 3 clinical trial in patients with PAH. This trial demonstrated that oral imatinib may produce a markedly greater, and much more durable, treatment effect on exercise tolerance, than any other available PAH treatment, alone or in combination. Despite the availability of several classes of pulmonary vasodilators, no existing treatment has been shown to halt progression or induce regression of the disease. Imatinib acts on underlying cellular proliferative pathways associated with PAH and has the potential to be the first disease modifying therapy for PAH. Tenax Therapeutics intends to commence a Phase 3 trial starting in 1H 2022.

About Levosimendan

Levosimendan is a unique potassium ATP 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 is approved in over 60 countries for use in hospitalized patients with acutely decompensated heart failure. Tenax Therapeutics has North American rights to develop and commercialize levosimendan. Results of Tenax Therapeutics’ Phase 2 trial of levosimendan in patients with pulmonary hypertension (PH) and heart failure with preserved ejection fraction (HFpEF) demonstrated that IV levosimendan produces potent dilation of the central and pulmonary venous circulations which translated into an improvement in exercise capacity. Patients are now in an ongoing open-label transition study from weekly IV to a more convenient daily oral regimen. The discovery that venous dilation with levosimendan leads to increased exercise capacity in PH-HFpEF patients forms the basis for the Phase 3 investigation of the oral formulation of this potentially groundbreaking therapy. To date, no drug therapy has ever improved exercise tolerance in patients with PH associated with HFpEF, recently referred to by an NIH working group as the greatest unmet need in cardiovascular disease.

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. 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: our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; the impact of management changes on our business and any unanticipated charges, costs and expenditures not currently contemplated that may occur as a result of such changes; volatility and uncertainty in the global economy and financial markets in light of the evolving COVID-19 pandemic; risks of our clinical trials, including, but not limited to, the timing, costs, design, initiation, enrollment, and results of such trials; reliance on third parties, including Orion; risks regarding customer acceptance of our products; 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; intellectual property risks; 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.

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