[Company Overview and Business Update](index=1&type=section&id=Company%20Overview%20and%20Business%20Update) Tenax Therapeutics, a Phase 3 pharmaceutical company, reported 2023 financial results and clinical updates, including progress on TNX-103 for PH-HFpEF and expanded intellectual property [Introduction and CEO Statement](index=1&type=section&id=Introduction%20and%20CEO%20Statement) Tenax Therapeutics, a Phase 3 pharmaceutical company, reported 2023 financial results and clinical updates, with CEO Chris Giordano highlighting TNX-103 progress and intellectual property expansion - Tenax Therapeutics is a Phase 3 development-stage pharmaceutical company focused on cardiovascular and pulmonary diseases with high unmet medical need[2](index=2&type=chunk) - CEO Chris Giordano reported significant progress in advancing TNX-103 for PH-HFpEF, including starting patient enrollment in the LEVEL study, expanding U.S. intellectual property protections for levosimendan, and securing global commercial rights for levosimendan for PH-HFpEF treatment[3](index=3&type=chunk) [Recent Corporate and Clinical Highlights](index=1&type=section&id=Recent%20Corporate%20and%20Clinical%20Highlights) Key highlights include the first patient enrollment in the Phase 3 LEVEL trial, expanded intellectual property, global commercial rights for levosimendan, an $8.0 million public offering, and an upcoming KOL event [Phase 3 LEVEL Trial Progress](index=1&type=section&id=Phase%203%20LEVEL%20Trial%20Progress) The Phase 3 LEVEL trial for TNX-103 has enrolled its first patient, with over 50 sites participating and topline data expected in the second half of 2025 - First patient enrolled in Phase 3 LEVEL Trial evaluating TNX-103 (oral levosimendan) for PH-HFpEF[5](index=5&type=chunk) - Over 50 sites (U.S. and Canada) have agreed to participate in the randomized, controlled Phase 3 LEVEL study of 152 patients[6](index=6&type=chunk) - Topline LEVEL data is forecasted to be available in the second half of 2025[7](index=7&type=chunk) [Intellectual Property and Commercial Rights](index=1&type=section&id=Intellectual%20Property%20and%20Commercial%20Rights) The company expanded U.S. intellectual property for levosimendan, secured global commercial rights for PH-HFpEF with improved royalty rates, and received USPTO allowance for key patent claims - Expanded U.S. Intellectual Property covering the use of Levosimendan for the treatment of PH-HFpEF and for use in combination with other cardiovascular therapies[5](index=5&type=chunk) - Secured global commercial rights to levosimendan for the treatment of PH-HFpEF, improving net sales royalty rate structure (high single-digit to low-teen percentages) and lowering maximum cost of goods[5](index=5&type=chunk)[6](index=6&type=chunk) - USPTO allowed claims within the patent application covering various forms of levosimendan (TNX-103, TNX-102, TNX-101) and its active metabolites for improving exercise performance in PH-HFpEF patients[7](index=7&type=chunk) [Financing Activities](index=2&type=section&id=Financing%20Activities) A February 2024 public offering raised $8.0 million in net proceeds, primarily allocated to advance the LEVEL study and for general corporate purposes - Closed a registered public offering in February 2024, raising approximately **$8.0 million** in net proceeds[6](index=6&type=chunk)[8](index=8&type=chunk) - Net proceeds from the offering will be used to advance the initiation of sites, enrollment, and treatment of patients in the LEVEL study, as well as for working capital and general corporate purposes[6](index=6&type=chunk) [Scientific Presentations and KOL Event](index=1&type=section&id=Scientific%20Presentations%20and%20KOL%20Event) Dr. Sanjiv Shah presented levosimendan data at THT 2024, and the company will host a KOL event on April 18, 2024, to review TNX-103's mechanism - Dr. Sanjiv Shah presented data and reviewed the scientific basis for levosimendan in PH-HFpEF at the THT 2024 Conference in February 2024[6](index=6&type=chunk) - The company will host a KOL Event, "LEVEL Setting," on April 18, 2024, to provide an in-depth review of PH-HFpEF pathophysiology and TNX-103's mechanism, featuring globally-recognized heart failure experts[5](index=5&type=chunk)[7](index=7&type=chunk)[8](index=8&type=chunk) [Clinical Development Programs](index=2&type=section&id=Clinical%20Development%20Programs) This section details the design of the Phase 3 LEVEL study for PH-HFpEF and the unique mechanisms and prior clinical findings of levosimendan [About the Phase 3 LEVEL Study](index=2&type=section&id=About%20the%20Phase%203%20LEVEL%20Study) The Phase 3 LEVEL Study is a double-blind, randomized, placebo-controlled trial of oral levosimendan in 152 PH-HFpEF patients, with six-minute walk distance as the primary outcome - The LEVEL Study is a Phase 3, double-blind, randomized, placebo-controlled study of levosimendan in approximately 152 patients with PH-HFpEF[12](index=12&type=chunk) - Subjects will be randomized 1:1 to receive oral levosimendan (2 mg/day for Weeks 1-4, 3 mg/day for Weeks 5-12) or placebo[12](index=12&type=chunk) - The primary outcome measure is the change in six-minute walk distance from Baseline to Week 12[12](index=12&type=chunk) [About Levosimendan (TNX-101, TNX-102, TNX-103)](index=2&type=section&id=About%20Levosimendan%20%28TNX-101%2C%20TNX-102%2C%20TNX-103%29) Levosimendan, a unique potassium ATP channel activator, is approved in 60 countries for heart failure, with Phase 2 data showing improved exercise capacity in PH-HFpEF patients - Levosimendan is a unique potassium ATP channel activator and calcium sensitizer with multiple mechanisms of action on the heart and vascular system[13](index=13&type=chunk) - Intravenous levosimendan is approved in 60 countries outside the United States for use in hospitalized patients with acutely decompensated heart failure[14](index=14&type=chunk) - Phase 2 HELP study showed I.V. levosimendan produces potent dilation of central and pulmonary venous circulations, leading to improved exercise capacity in PH-HFpEF patients, addressing a growing epidemic with high morbidity and mortality and no current treatment[14](index=14&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) This section provides a comprehensive overview of Tenax Therapeutics' full year 2023 financial performance, including key metrics from the income statement and balance sheet [Full Year 2023 Financial Summary](index=2&type=section&id=Full%20Year%202023%20Financial%20Summary) Tenax Therapeutics reported **$9.8 million** in cash, a **40.7% decrease** in R&D expenses to **$3.2 million**, and a net loss of **$7.7 million** for 2023, an improvement from 2022 Full Year 2023 Financial Summary | Financial Metric | 2023 (USD) | 2022 (USD) | YoY Change (USD) | YoY Change (%) | | :--------------- | :--------- | :--------- | :--------------- | :------------- | | Cash & Cash Equivalents (as of Dec 31) | $9.8 million | $2.1 million | +$7.7 million | +366.7% | | R&D Expenses | $3.2 million | $5.4 million | -$2.2 million | -40.7% | | G&A Expenses | $5.0 million | $5.7 million | -$0.7 million | -12.3% | | Net Loss | $7.7 million | $11.0 million | -$3.3 million | -30.0% | - The decrease in R&D expenses was primarily due to lower clinical trial costs for imatinib (development paused) and reduced personnel costs, offset by increased costs for the ongoing Phase 3 LEVEL study[9](index=9&type=chunk) - The decrease in G&A expenses was primarily a result of decreased professional fees and reduced facilities costs[10](index=10&type=chunk) [Consolidated Balance Sheet](index=3&type=section&id=Consolidated%20Balance%20Sheet) The balance sheet shows cash and cash equivalents increased to **$9.8 million** in 2023, with total assets rising to **$11.7 million** and stockholders' equity to **$8.1 million** Consolidated Balance Sheet Highlights (as of December 31) | Metric | 2023 (USD) | 2022 (USD) | | :-------------------------- | :--------- | :--------- | | Cash and cash equivalents | $9,792,130 | $2,123,682 | | Total current assets | $11,683,510 | $3,208,465 | | Total assets | $11,684,627 | $3,404,709 | | Total current liabilities | $3,586,520 | $1,847,772 | | Total liabilities | $3,586,520 | $1,911,968 | | Total stockholders' equity | $8,098,107 | $1,492,741 | [Consolidated Income Statement](index=4&type=section&id=Consolidated%20Income%20Statement) The income statement shows total operating expenses decreased to **$8.2 million** in 2023, resulting in a net loss of **$7.7 million**, and a significant improvement in net loss per share to **$(31.04)** Consolidated Income Statement Highlights (Twelve Months Ended December 31) | Metric | 2023 (USD) | 2022 (USD) | | :------------------------------------------ | :--------- | :--------- | | General and administrative expenses | $5,005,135 | $5,675,231 | | Research and development expenses | $3,228,806 | $5,377,412 | | Total operating expenses | $8,233,941 | $11,052,643 | | Net operating loss | $8,233,941 | $11,052,643 | | Net loss | $7,710,673 | $11,047,895 | | Net loss per share, basic and diluted | $(31.04) | $(600.71) | | Weighted average common shares outstanding | 248,447 | 18,391 | [Company Information and Disclosures](index=3&type=section&id=Company%20Information%20and%20Disclosures) This section provides an overview of Tenax Therapeutics, cautions regarding forward-looking statements, and lists investor contact information [About Tenax Therapeutics](index=3&type=section&id=About%20Tenax%20Therapeutics) Tenax Therapeutics is a Phase 3 pharmaceutical company focused on cardiovascular and pulmonary diseases, holding global rights to levosimendan as its near-term priority - Tenax Therapeutics is a Phase 3 development-stage pharmaceutical company focused on cardiovascular and pulmonary diseases with high unmet medical need[15](index=15&type=chunk) - The company owns global rights to develop and commercialize levosimendan, which is its near-term priority, and may also resume developing its oral imatinib formulation[15](index=15&type=chunk) [Caution Regarding Forward-Looking Statements](index=3&type=section&id=Caution%20Regarding%20Forward-Looking%20Statements) This section cautions that statements are forward-looking and subject to various risks and uncertainties, including financing, clinical trials, regulatory, and market factors - All statements, expectations, and assumptions in the press release, except for historical information, are forward-looking statements[16](index=16&type=chunk) - Actual results may differ materially due to factors such as the ability to raise additional funds, risks related to business strategy and clinical trials (timing, costs, enrollment), regulatory review delays, reliance on third parties, intellectual property risks, and global economic uncertainties[16](index=16&type=chunk) [Contacts](index=3&type=section&id=Contacts) Investor contact information is provided for John Fraunces and Brian Mullen of LifeSci Advisors, LLC - Investor contact information is provided for John Fraunces and Brian Mullen of LifeSci Advisors, LLC[17](index=17&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-34600 TENAX THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 26-2593535 (State of incorporation) (I.R ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-34600 TENAX THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 26-2593535 (State of incorporation) (I.R.S. E ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-34600 TENAX THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 26-2593535 (State of incorporation) (I.R.S. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C., 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to _____ Commission File No. 001-34600 TENAX THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorpo ...

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-34600 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED September 30, 2022 OR Securities registered pursuant to Section 12(b) of the Act: TENAX THERAPEUTICS, INC. (Exact name of registrant as specified in it ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-34600 TENAX THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 26-2593535 (State of incorporation) (I.R.S. E ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-34600 TENAX THERAPEUTICS, INC. ONE Copley Parkway, Suite 490, Morrisville, North Carolina 27560 (Address of principal executive offices) (9 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C., 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to _____ Commission File No. 001-34600 TENAX THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 26-2593535 (State or other jur ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-34600 TENAX THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 26-2593535 (State of incorporation) (I.R ...