Tenax Therapeutics Reports First Quarter 2021 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 first quarter of 2021 and provided a business update.

“Having completed the merger with PHPrecisionMed Inc., we now have product 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.

“We have begun the open label transition study using the oral formulation of Levosimendan, which was recently acquired from our agreement with Orion. The purpose of this study is to determine the dose we will take into Phase 3 trials in 2022. Study participants who enrolled in our open label Phase 2 HELP trial are being brought back into their clinics and converted to the oral dosage form. We believe oral delivery will be more convenient for patients and provide more consistent blood levels of Levosimendan compared to weekly IV administration.

“With respect to the imatinib program, we are in the final stages of formulation development. As a reminder, this new formulation is expected to address the 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. The new formulation will be tested in a Phase 1 study, which we anticipate completing in the second half of this year.”

Recent Highlights

• On April 9, 2021, Tenax announced the publication of positive data from the company’s Phase 2 HELP Study that evaluated levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The new publication is titled Levosimendan Improves Hemodynamics and Exercise Tolerance in PH-HFpEF: Results of the Placebo-Controlled HELP Trial and was published in the Journal of American College of Cardiology: Heart Failure (https://www.jacc.org/doi/pdf/10.1016/j.jchf.2021.01.015).
• On January 19, 2021, Tenax announced the acquisition of PHPrecisionMed Inc. (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.

Financial Results

• Research and development expenses for the first quarter of 2021 were $22.4 million, compared to $1.3 million for the first quarter of 2020. The increase in research and development expense in the current period is due primarily to the recognition of approximately $21.8 million of in-process research and development (IPR&D) expense attributed to the acquisition of PHPM in January 2021.

• General and administrative expenses for the first quarter of 2021 were $1.4 million, compared to $1.3 million for the first quarter of 2020.

• Net loss for the first quarter of 2021 was $23.7 million, or $1.64 per share, compared to a net loss of $2.7 million, or $0.38 per share, for the first quarter of 2020.

• Cash, cash equivalents and marketable securities totaled $4.0 million as of March 31, 2021, compared with $6.7 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 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 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. Tenax is also developing 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 and its quarterly report on Form 10-Q filed on May 17, 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.

TENAX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
	Three months ended March 31,
	2021			2020
	(Unaudited)			(Unaudited)
Operating expenses
General and administrative	$	1,373,460		$	1,322,959
Research and development		22,376,202			1,342,526
Total operating expenses		23,749,662			2,665,485
Net operating loss		23,749,662			2,665,485
Interest expense		613			-
Other income, net		(2,135	)		(10,841	)
Net loss	$	23,748,140		$	2,654,644
Unrealized loss on marketable securities		332			1,622
Total comprehensive loss	$	23,748,472		$	2,656,266
Net loss per share, basic and diluted	$	(1.64	)	$	(0.38	)
Weighted average number of common shares outstanding, basic and diluted		14,515,088			6,974,387

TENAX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
	March 31, 2021			December 31, 2020
	(Unaudited)
ASSETS
Current assets
Cash and cash equivalents	$	3,536,787		$	6,250,241
Marketable securities		494,877			462,687
Prepaid expenses		485,935			82,578
Total current assets		4,517,599			6,795,506
Right of use asset		29,690			58,778
Property and equipment, net		4,837			5,972
Other assets		8,435			8,435
Total assets	$	4,560,561		$	6,868,691
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable	$	997,443		$	757,856
Accrued liabilities		222,780			1,240,616
Note payable		213,577			120,491
Total current liabilities		1,433,800			2,118,963
Long term liabilities
Note payable		31,080			124,166
Total long term liabilities		31,080			124,166
Total liabilities		1,464,880			2,243,129
Commitments and contingencies; see Note 8
Stockholders' equity
Preferred stock, undesignated, authorized 9,989,558 shares; See Note 9
Series A Preferred stock, par value $.0001, issued 5,181,346 shares; outstanding 210, respectively		-			-
Series B Preferred stock, par value $.0001, issued 10,232 shares; outstanding 10,232 and 0, respectively		1			-
Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 14,969,312 and 12,619,369, respectively		1,497			1,262
Additional paid-in capital		272,862,552			250,644,197
Accumulated other comprehensive loss		(402	)		(70	)
Accumulated deficit		(269,767,967	)		(246,019,827	)
Total stockholders’ equity		3,095,681			4,625,562
Total liabilities and stockholders' equity	$	4,560,561		$	6,868,691