8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 13, 2024

Tenax Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-34600	26-2593535
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

101 Glen Lennox Drive, Suite 300

Chapel Hill, North Carolina 27517

(Address of principal executive offices) (Zip Code)

919-855-2100

(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.0001 par value per share	TENX	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition.

On August 13, 2024, Tenax Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2024. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein in its entirety by reference.

The information in this Item 2.02 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Press release dated August 13, 2024.
104	Cover Page Interactive Data File (embedded within the Inline XBRL document).

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: August 13, 2024	Tenax Therapeutics, Inc.
	By:	/s/ Christopher T. Giordano
		Christopher T. Giordano
		President and Chief Executive Officer

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EX-99.1

EXHIBIT 99.1

 

Tenax Therapeutics Reports Second Quarter 2024 Financial Results and Provides a Corporate Update

Raised Gross Proceeds of Approximately $100 Million in a Private Placement with Leading Institutional Healthcare Investors

Continuing to Enroll Patients in Phase 3 LEVEL Study with 39 Investigative Sites Initiated

In April, Hosted the KOL Event, “LEVEL Setting,” Featuring Four Experts in Heart Failure Discussing the Unmet Medical Need in PH-HFpEF and Potential of Levosimendan to Address Disease

CHAPEL HILL, N.C., August 13, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (“Tenax”) (Nasdaq: TENX), a Phase 3, development-stage pharmaceutical company focused on developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, announced financial results for the second quarter of 2024 and provided a corporate update.

“In the second quarter, Tenax has undergone a significant transformation made possible by successful execution across our strategic priorities,” said Chris Giordano, President and Chief Executive Officer of Tenax.  “Several patients randomized in our Phase 3 LEVEL trial in Q1 and early Q2 have now completed 12 weeks of therapy and all have continued into the open label extension. We secured important U.S. intellectual property, and attained the global development and commercial rights to levosimendan for the treatment of PH-HFpEF.”

“We also conducted the KOL Event, “LEVEL Setting”, in April, which featured a panel of globally renowned cardiologists who reviewed the significant unmet medical need in PF-HFpEF and the potential of levosimendan to address this debilitating condition. Finally, we raised gross proceeds of approximately $100 million in a private placement financing, providing Tenax the resources to further advance the levosimendan Phase 3 program, with the ultimate goal of bringing to market the first FDA-approved treatment for the millions of patients who suffer from PH-HFpEF.”

Recent Corporate and Clinical Highlights

· In August 2024, Tenax announced the closing of a private placement financing that resulted in total gross proceeds to the Company of approximately $100 million, before deducting placement agent fees and other estimated offering expenses.

· In April 2024, Tenax announced that the United States Patent and Trademark Office (USPTO) granted the Company a patent, U.S. Patent No. 11,969,424, covering the use of TNX-103 (oral levosimendan), TNX-102 (subcutaneous levosimendan), TNX-101 (IV levosimendan), the active metabolites of levosimendan (OR1896 and OR18955) and various combinations of cardiovascular drugs with levosimendan when used to improve exercise performance in patients with pulmonary hypertension from heart failure with preserved ejection fraction (PH-HFpEF). The ‘424 patent expressly provides IP protection for levosimendan at all therapeutic doses.

· In April 2024, Tenax hosted “LEVEL Setting” – a scientific roundtable exploring the rationale for TNX-103 (oral levosimendan) in the treatment of PH-HFpEF. Presentations were made by four globally recognized experts in the field who then answered questions from attendees (LINK TO EVENT):

○	Understanding the setting of PH-HFpEF – Sanjiv Shah, M.D. (Northwestern University)
○	Mechanism of Action of Levosimendan – Daniel Burkhoff, M.D., Ph.D. (Columbia)
○	Review of data from the Phase 2 HELP Study – Barry Borlaug, M.D. (Mayo Clinic)
○	Current treatment landscape in PH-HFpEF – Javed Butler, M.D., M.P.H., M.B.A. (Baylor Scott & White)

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Second Quarter 2024 Financial Results

Tenax reported cash and cash equivalents of $9.4 million as of June 30, 2024, versus $9.8 million as of December 31, 2023. Following the close of the reporting period, the Company raised gross proceeds of approximately $100 million in a private placement financing, which closed on August 8, 2024, with leading institutional healthcare investors.

Research and Development expenses for the second quarter of 2024 were $2.3 million, compared to $0.2 million for the second quarter of 2023. The $2.1 million increase year-over-year is primarily attributable to increased costs for the ongoing Phase 3 LEVEL study.

General and administrative expenses for the second quarter of 2024 were $1.3 million versus $1.0 million for the second quarter of 2023.

Tenax reported a net loss of $3.6 million or $1.83 per share for the second quarter of 2024, compared to a net loss of $1.1 million or $4.00 per share for the second quarter of 2023.

About Levosimendan (TNX-101, TNX-102, 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 has been granted marketing authorization in 60 countries outside the United States for use in hospitalized patients with acutely decompensated heart failure. Results of Tenax’s Phase 2 HELP study of levosimendan in patients with pulmonary hypertension (PH) with 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, a discovery that is the basis of LEVEL, the Phase 3 investigation of Tenax’s  potential groundbreaking therapy. To date, no other drug therapy has improved exercise tolerance in patients with PH associated with HFpEF, “a growing epidemic with high morbidity and mortality and no treatment. The clear unmet need and lethal nature of PH-HFpEF must be met with novel solutions at all levels of therapeutic development” (AHA Scientific Advisory, “A Call to Action,” 2022).

About Tenax Therapeutics

Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company focused on developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. Tenax  owns global rights to develop and commercialize levosimendan, which it has prioritized in the near term. Tenax also may resume developing its unique oral formulation of imatinib. For more information, visit www.tenaxthera.com. Tenax’s common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”.

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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. These forward-looking statements may include information concerning possible or projected future business operations. 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: the expected use of proceeds from our recent private placement; the  expected cash runway with the net proceeds of our recent private placement, and risks associated with our cash needs; risks related to our business strategy, including the prioritization and development of product candidates; risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, initiation, enrollment, and results of such trials; any delays in regulatory review and approval of product candidates in development; reliance on third parties, including Orion Corporation, our manufacturers and CROs; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; our estimates regarding the potential market opportunity for our product candidates; the potential advantages of our product candidates; our competitive position; intellectual property risks; risks related to our continued listing on Nasdaq; 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 possibility of pandemics, global financial and geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of 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 assumes no obligation and does not intend to update these forward-looking statements except as required by law.

Contacts

Investor Contact:

John Fraunces

Managing Director

LifeSci Advisors, LLC

C: 917-355-2395

jfraunces@lifesciadvisors.com

or

Brian Mullen

LifeSci Advisors, LLC

C: 203-461-1175

bmullen@lifesciadvisors.com 

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Tenax Therapeutics, Inc. - Consolidated Balance Sheet for the Periods Ended June 30, 2024 and December 31, 2023
	June 30, 2024			December 31, 2023
	(Unaudited)
ASSETS
Current assets
Cash and cash equivalents	$	9,384,015		$	9,792,130
Prepaid expenses		1,181,527			1,639,797
Other current assets		50,250			251,583
Total current assets		10,615,792			11,683,510
Other assets		1,117			1,117
Total assets	$	10,616,909		$	11,684,627
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable	$	869,656		$	2,073,149
Accrued liabilities		592,379			1,012,468
Note Payable		278,802			500,903
Total current liabilities		1,740,837			3,586,520
Total liabilities		1,740,837			3,586,520
Commitments and contingencies;
Stockholders' equity
Preferred stock, undesignated, authorized 4,818,654 shares;
Series A Preferred stock, par value $0.0001, authorized 5,181,346 shares; issued and outstanding 210, as of June 30, 2024 and December 31, 2023, respectively		-			-
Common stock, par value $0.0001 per share; authorized 400,000,000 shares; issued and outstanding 1,958,245 as of June 30, 2024 and 298,281 as of December 31, 2023, respectively		196			30
Additional paid-in capital		313,503,142			305,350,830
Accumulated deficit		(304,627,266	)		(297,252,753	)
Total stockholders’ equity		8,876,072			8,098,107
Total liabilities and stockholders' equity	$	10,616,909		$	11,684,627

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Tenax Therapeutics, Inc. - Consolidated Income Statement for the Periods Ended June 30, 2024 and June 30, 2023
	Three months ended June 30,						Six months ended June 30,
	2024			2023			2024			2023
Operating expenses
General and administrative	$	1,344,389		$	1,038,257		$	2,577,063		$	2,311,987
Research and development		2,327,632			197,903			5,003,284			463,637
Total operating expenses		3,672,021			1,236,160			7,580,347			2,775,624
Net operating loss		3,672,021			1,236,160			7,580,347			2,775,624
Interest expense		9,189			9,126			17,153			16,476
Interest income		(104,883	)		(139,859	)		(222,333	)		(216,136	)
Other expense (income), net		(654	)		911			(654	)		(62,866	)
Net loss	$	3,575,673		$	1,106,338		$	7,374,513		$	2,513,098
Net loss per share, basic and diluted	$	(1.83	)	$	(4.00	)	$	(4.65	)	$	(12.77	)
Weighted average number of common shares outstanding, basic and diluted		1,958,245			276,454			1,586,650			196,799

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XML

Cover	Aug. 13, 2024
Cover [Abstract]
Entity Registrant Name	Tenax Therapeutics, Inc.
Entity Central Index Key	0000034956
Document Type	8-K
Amendment Flag	false
Entity Emerging Growth Company	false
Document Period End Date	Aug. 13, 2024
Entity File Number	001-34600
Entity Incorporation State Country Code	DE
Entity Tax Identification Number	26-2593535
Entity Address Address Line 1	101 Glen Lennox Drive
Entity Address Address Line 2	Suite 300
Entity Address City Or Town	Chapel Hill
Entity Address State Or Province	NC
Entity Address Postal Zip Code	27517
City Area Code	919
Local Phone Number	855-2100
Security 12b Title	Common Stock, $0.0001 par value per share
Trading Symbol	TENX
Security Exchange Name	NASDAQ
Written Communications	false
Soliciting Material	false
Pre Commencement Tender Offer	false
Pre Commencement Issuer Tender Offer	false