Tenax Therapeutics Reports Fiscal Year 2020 Results and Provides Business Update

MORRISVILLE, N.C.--(BUSINESS WIRE)--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 year ended December 31, 2020 and provided a business update.

“Now that the merger with PH Precision Medicine is complete, we have clinical development programs in group one and group two Pulmonary Hypertension patients,” stated Anthony DiTonno, Chief Executive Officer of Tenax, “which represent more than 70% of the overall market.”

“Having acquired the oral formulation rights of Levosimendan from our agreement with Orion, we have set up an open label transition study to determine the dose we will take into Phase 3 trials in 2022. The Phase 2 HELP trial still has patients in the open label phase of the trial. We will be bringing those patients back to their clinics and converting them to the oral dosage form. We believe an oral dosage form will be more convenient to patients and provide more consistent blood levels of drug as opposed to weekly IV administration.”

“With respect to the imatinib program, we continue to make good progress on developing a formulation that will address previous GI-related side effects associated with its oral administration. We remain highly enthusiastic that imatinib, when formulated correctly, will show substantial clinical benefit in the pulmonary arterial hypertension (PAH) patient population, with the potential to be the first disease-modifying therapy for this indication. As we finalize our plans, we will provide additional updates.”

Recent Highlights

• On March 2, 2021, Tenax announced the appointment of four new members to its board of directors: June Almenoff, MD, PhD, Michael Davidson, MD, Declan Doogan, MD, and Stuart Rich, MD. Together, these highly accomplished professionals will provide the Board with significant scientific and commercial perspectives that will prove invaluable as we execute on our long-term corporate strategy. Over the next several months, Tenax expects to advance its two leading pipeline assets into late-stage clinical testing, so the expansion of its board to include such expertise from both the medical community and the pharmaceutical industry could not come at a better time for the company and its shareholders.
• On January 19, 2021, Tenax announced the acquisition of PH Precision Med (PHPM), a privately-held clinical stage biotech company focused on developing imatinib for the treatment of pulmonary arterial hypertension (PAH). The FDA has granted Orphan Drug Designation for imatinib for the treatment of PAH, an indication with a high unmet medical need. The acquisition of PHPM immediately expands Tenax’s pipeline to include a second de-risked Phase 3 ready candidate with the potential to be the first disease modifying treatment of PAH.
• On January 15, 2021, Tenax appointed Stuart Rich, MD, co-founder of PHPM, Chief Medical Officer of Tenax Therapeutics. Dr. Rich currently serves as Professor of Medicine at Northwestern University Feinberg School of Medicine, and Director of the Pulmonary Vascular Disease Program at the Bluhm Cardiovascular Institute. He previously served as FDA Cardio-Renal Advisory Committee Member. His many years of experience as an FDA advisory committee member provides Tenax with an extraordinary knowledge of pulmonary hypertension disease mechanisms and modern regulatory strategies. With his appointment, Tenax is well positioned to maximize the clinical potential of imatinib and advance the clinical development of levosimendan for PH-HFpEF, which together have the potential to address significant unmet needs and large market opportunities.

Financial Results

• Research and development expenses for the year ended December 31, 2020 were $4.6 million, compared to $3.5 million for the year ended December 31, 2019.

• General and administrative expenses for year ended December 31, 2020 were $5.3 million, compared to $5.1 million for the year ended December 31, 2019.

• Net loss for the year ended December 31, 2020 was $9.9 million, or $1.33 per share, compared to a net loss of $8.4 million, or $1.35 per share, for the year ended December 31, 2019.

• Cash, cash equivalents and marketable securities totaled $6.7 million as of December 31, 2020, compared with $5.4 million as of December 31, 2019.

• Management expects that current cash, cash equivalents and marketable securities will be sufficient to fund current operations through the third quarter of 2021.
  

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. The Company owns North American rights to develop and commercialize levosimendan and has recently released topline data regarding their Phase 2 clinical trial for the use of levosimendan in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). Tenax plans to advance a delayed release oral formulation of imatinib, designed to avoid the gastric irritation, into a single pivotal trial pursuant to the 505(b)(2) pathway. For more information, visit www.tenaxthera.com.

About Levosimendan

Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 60 countries for this indication and not available in the United States. Tenax Therapeutics acquired North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc.

About Imatinib

Imatinib is an antiproliferative agent developed to target the BCR-ABL tyrosine kinase in patients with chronic myeloid leukemia. The inhibitory effects of imatinib on PDGF receptors and c-KIT suggested that it may be efficacious in PAH. Imatinib reversed experimentally induced pulmonary hypertension and has pulmonary vasodilatory effects in animal models and proapoptotic effects on pulmonary artery smooth muscle cells from patients with idiopathic PAH. In a phase 3 clinical trial imatinib produced significant improvements in exercise capacity, but a high rate of dropouts attributed largely to gastric intolerance prevented regulatory approval.

Caution Regarding Forward-Looking Statements

This news release contains certain forward-looking statements by the Company that involve risks and uncertainties and reflect the Company’s judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to matters beyond the Company’s control that could lead to delays in the clinical study, new product introductions and customer acceptance of these new products; matters beyond the Company’s control that could impact the Company’s continued compliance with Nasdaq listing requirements; the impact of management changes on the Company’s business and unanticipated charges, costs and expenditures not currently contemplated that may occur as a result of management changes; and other risks and uncertainties as described in the Company’s filings with the Securities and Exchange Commission, including in its annual report on Form 10-K filed on March 31, 2021 as well as its other filings with the SEC. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.