Tenax Therapeutics Reports Fiscal Year 2021 Results and Provides Business Update

“With the advancement of our proprietary formulation of oral imatinib, TNX-201, we believe Tenax is poised to fundamentally change the treatment landscape for PAH,” said Christopher T. Giordano, President and Chief Executive Officer of Tenax Therapeutics. “In our view, the time we have spent further refining the formulation of TNX-201 will lead to better safety, tolerance, adherence, and ultimately better treatment outcomes for patients. Furthermore, given the proven efficacy of oral imatinib in the PAH setting, we believe investors are appreciating that the TNX-201 clinical program carries a lower degree of risk than alternative programs where issues of bioavailability and tolerability in PAH patients remain significant unknowns. I am very pleased to report that we have made significant progress with our oral formulation, to support the upcoming Phase 3 TNX-201 program. Based upon our current estimates, we expect our Phase 3 study to begin in the second half of 2022.”

Fiscal Year 2021 and Recent Corporate Highlights

• On January 26, appointed Robyn M. Hunter to its Board of Directors, effective January 28, 2022. Ms. Hunter is an independent director and chairs the Board’s audit and compliance committee and is a member of the Board’s compensation committee.
• On January 12, announced that the United States Patent and Trademark Office (USPTO) granted Tenax a patent (No. 11,213,254) for its subcutaneous formulation of levosimendan, TNX-102, which is currently being developed for the treatment of pulmonary hypertension associated with left heart failure (PH-HFpEF). The claims of this patent are directed towards the use of levosimendan via subcutaneous administration for treating a subject having a health condition of any kind, such as heart failure, pulmonary hypertension including PH-HFpEF, chronic kidney disease, stroke, or other health conditions. The patent is expected to expire no earlier than 2039, exclusive of any possible extensions.
• On January 4, provided program updates on TNX-201 and TNX-103:
  • Announced the completion of the pharmacokinetic (PK) assessment in healthy volunteers of TNX-201 compared to reference imatinib (GLEEVEC) and made important observations about the characteristics of the two formulations. Based on these observations, the Company has modified the TNX-201 formulation to help ensure optimal efficacy and tolerance in the upcoming Phase 3 trial. In preparation for the Phase 3 trial of TNX-201, the Company also announced the selection of a large, global CRO partner with worldwide delivery capabilities, including the completion over 20 PAH projects and multiple Phase 3 trials of PAH therapies. Planning efforts, including KOL and site engagement, commenced early in 2022.
  • TNX-103: announced the completion of the transition from intravenous (IV) to oral levosimendan of those patients enrolled at that time in the open label extension (OLE) rollover study (TNX-LVO-05), following their enrolment in the Phase 2 HELP trial. These patients with PH-HFpEF, having previously received weekly infusions of levosimendan for up to two years, were able to transition to oral levosimendan in this substudy to continue treatment. The substudy was designed to determine the safety and tolerability of oral levosimendan in this population, with a goal of establishing an oral dose that would maintain its efficacy. The measures of efficacy recorded following the transition to oral therapy showed improvements, despite the advanced state of disease in these patients and their use of intravenous levosimendan for over two years.

Year-End 2021 Financial Results

• In January 2021, Tenax purchased PHPrecisionMed Inc., a clinical stage biotechnology company focused on pulmonary hypertension, reflected in the operating results for the year ended December 31, 2021.
• Research and development expenses for the year ended December 31, 2021 were $25.1 million, compared to $4.6 million for the year ended December 31, 2020.
• General and administrative expenses for year ended December 31, 2021 were $7.6 million, compared to $5.3 million for the year ended December 31, 2020.
• Net loss for the year ended December 31, 2021 was $32.5 million, a loss of $1.58 per share, compared to a net loss of $9.9 million, a loss of $.95 per share, for the year ended December 31, 2020.
• Cash, cash equivalents and marketable securities totaled $5.6 million as of December 31, 2021, compared to $6.3 million as of December 31, 2020.
• Management expects that current cash, cash equivalents and marketable securities will be sufficient to fund current operations through the second quarter of 2022.

Further information can be found in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission on March 29, 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 world-class scientific advisory teams, including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize subcutaneous and oral formulations of 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. Tenax Therapeutics is also developing a unique oral formulation of imatinib designed to minimize the gastric irritation observed in a previous Phase 3 trial of the marketed version of the therapy while assuring that the dose achieved is at the level necessary for the drug to be effective. Tenax Therapeutics expects to conduct a single pivotal trial pursuant to the 505(b)(2) pathway for regulatory approval. For more information, visit www.tenaxthera.com.

About Imatinib (TNX-201)

Tenax Therapeutics is developing novel dosing and a unique formulation of imatinib mesylate, a kinase inhibitor that has received FDA’s orphan designation (March 2020) for the treatment of pulmonary arterial hypertension (PAH). The IMPRES trial, a previous Phase 3 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, in those patients who were maintained on the full imatinib dose for the majority of the trial. 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 of TNX-201 starting in 2H 2022.

About Levosimendan (TNX-102 and 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 is approved in over 60 countries outside the United States for use in hospitalized patients with acutely decompensated heart failure. Tenax Therapeutics has North American rights to develop and commercialize oral (TNX-103) and subcutaneous (TNX-102) formulations of 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 translates into an improvement in exercise capacity. Patients have now completed the open-label transition study from weekly IV to a more convenient daily, oral regimen, TNX-103. The discovery that venous dilation of the splanchnic circulation with levosimendan leads to increased exercise capacity in PH-HFpEF patients forms the basis for the Phase 3 investigation of Tenax Therapeutics’ potential groundbreaking therapy. To date, no other drug therapy has improved exercise tolerance in patients with PH associated with HFpEF, recently referred to 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; risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, initiation, enrollment, and results of such trials; reliance on third parties, including Orion Corporation, our manufacturers and CROs; risks regarding the formulation, production, marketing and customer acceptance of our product candidates; intellectual property risks; 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 evolving COVID-19 pandemic and geopolitical uncertainties such as in 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.