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 ...

[PART I. FINANCIAL INFORMATION](index=2&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Condensed Consolidated Financial Statements](index=2&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) The company's financial statements for the period ended June 30, 2021, reflect a significant decrease in assets and stockholders' equity compared to year-end 2020, primarily driven by a large net loss [Condensed Consolidated Balance Sheets](index=2&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2021, the company's total assets stood at $2.9 million, a sharp decline from $6.9 million at December 31, 2020 Condensed Consolidated Balance Sheets (in thousands) | | June 30, 2021 (Unaudited) | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $1,671 | $6,250 | | Total current assets | $2,532 | $6,796 | | **Total assets** | **$2,885** | **$6,869** | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $1,175 | $2,119 | | Total liabilities | $1,414 | $2,243 | | Total stockholders' equity | $1,471 | $4,626 | | **Total liabilities and stockholders' equity** | **$2,885** | **$6,869** | [Condensed Consolidated Statements of Comprehensive Loss](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) For the three months ended June 30, 2021, the company reported a net loss of $1.7 million, an improvement from a $2.1 million loss in the same period of 2020 Financial Performance Summary (Unaudited) | Metric | Three Months Ended June 30, 2021 | Three Months Ended June 30, 2020 | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | General and administrative | $1,271,278 | $869,206 | $2,644,738 | $2,192,165 | | Research and development | $693,222 | $1,274,837 | $23,069,424 | $2,617,363 | | **Net Loss** | **$1,717,016** | **$2,146,550** | **$25,465,156** | **$4,801,194** | | Net loss per share | ($0.10) | ($0.23) | ($1.60) | ($0.59) | [Condensed Consolidated Statements of Cash Flows](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2021, net cash used in operating activities was $5.1 million, resulting in a net decrease in cash of $4.6 million Cash Flow Summary for Six Months Ended June 30 (Unaudited) | Cash Flow Activity | 2021 | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,066,239) | $(4,899,965) | | Net cash (used in) provided by investing activities | $(57,231) | $13,911 | | Net cash provided by financing activities | $544,651 | $4,065,366 | | **Net change in cash and cash equivalents** | **$(4,578,819)** | **$(820,688)** | | Cash and cash equivalents, end of period | $1,671,422 | $4,085,305 | [Notes to Condensed Consolidated Financial Statements](index=6&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Key notes detail the company's business focus, the PHPM merger, and subsequent events, including a $10 million financing - The company acquired PHPrecisionMed Inc. (PHPM) on January 15, 2021, expensing the **$21,582,331** consideration as in-process research and development (IPR&D)[26](index=26&type=chunk)[67](index=67&type=chunk)[69](index=69&type=chunk) - Management has identified factors raising substantial doubt about the company's ability to continue as a going concern, citing an accumulated deficit of **$271 million** and significant cash used in operations[28](index=28&type=chunk)[30](index=30&type=chunk) - On July 6, 2021, the company raised approximately **$10 million** in gross proceeds through a private placement for clinical trials, R&D, and general corporate purposes[111](index=111&type=chunk)[113](index=113&type=chunk) - On May 28, 2021, the company received full forgiveness for its Paycheck Protection Program (PPP) loan, including **$244,657** in principal and **$2,576** in interest, recorded as other income[64](index=64&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses its strategy to develop and commercialize products for cardiovascular and pulmonary diseases, highlighting increased R&D expenses and liquidity needs [Overview and Current Programs](index=20&type=section&id=Overview%20and%20Current%20Programs) The company is a specialty pharmaceutical firm focused on developing levosimendan for PH-HFpEF and imatinib for PAH, planning Phase 3 trials for both - The company's strategy is to develop and commercialize products for cardiovascular and pulmonary diseases, specifically levosimendan and imatinib[124](index=124&type=chunk)[125](index=125&type=chunk) - The Phase 2 HELP study of levosimendan in PH-HFpEF did not meet its primary efficacy endpoint but demonstrated a statistically significant improvement in 6-minute walk distance, leading to plans for a Phase 3 study using an oral formulation[138](index=138&type=chunk)[140](index=140&type=chunk)[145](index=145&type=chunk) - Following the acquisition of PHPM, the company plans to initiate a single Phase 3 trial for a modified release formulation of imatinib for PAH, leveraging the 505(b)(2) regulatory pathway[153](index=153&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) For the six-month period, R&D expenses surged by over 300,000% to $23.1 million, almost entirely due to the $21.7 million IPR&D expense from the PHPM merger R&D Expense Comparison (Three Months Ended June 30) | Category | 2021 | 2020 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Clinical and preclinical development | $548,909 | $1,218,156 | $(669,247) | (55)% | | Personnel costs | $142,707 | $54,193 | $88,514 | 163% | | **Total R&D** | **$693,222** | **$1,274,837** | **$(581,615)** | **(46)%** | R&D Expense Comparison (Six Months Ended June 30) | Category | 2021 | 2020 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Clinical and preclinical development | $1,049,087 | $2,500,817 | $(1,451,730) | (58)% | | Other costs (incl. IPR&D) | $21,741,388 | $7,210 | $21,734,178 | 301,445% | | **Total R&D** | **$23,069,424** | **$2,617,363** | **$20,452,061** | **781%** | - The primary driver for the increase in R&D expenses for the six months ended June 30, 2021, was the recognition of approximately **$21.7 million** in in-process research and development acquired as part of the merger with PHPM[182](index=182&type=chunk) [Liquidity, Capital Resources and Plan of Operation](index=28&type=section&id=Liquidity%2C%20Capital%20Resources%20and%20Plan%20of%20Operation) The company has a history of losses, with an accumulated deficit of $271 million, and requires substantial additional financing beyond Q2 2022 - As of June 30, 2021, the company had an accumulated deficit of approximately **$271 million**[187](index=187&type=chunk) - Based on working capital at June 30, 2021, and net proceeds from its July 2021 offering, the company believes it has sufficient capital to fund operations through the **second quarter of calendar year 2022**[188](index=188&type=chunk) - The company will need substantial additional capital to complete the development and commercialization of levosimendan and imatinib, seeking it through equity or debt offerings, or collaboration and licensing arrangements[192](index=192&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable to the company for this reporting period - Not applicable[199](index=199&type=chunk) [Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2021, with no material changes in internal control over financial reporting - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of June 30, 2021[200](index=200&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[201](index=201&type=chunk) [PART II. OTHER INFORMATION](index=30&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that there are no material pending legal proceedings to which it is a party or to which any of its property is subject - There are no material pending legal proceedings[204](index=204&type=chunk) [Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) The company states that the risks it faces have not materially changed from those disclosed in its Annual Report on Form 10-K for the year ended December 31, 2020 - Risks have not materially changed from those disclosed in the Annual Report on Form 10-K for the year ended December 31, 2020[205](index=205&type=chunk) [Other Information](index=30&type=section&id=Item%205.%20Other%20Information) On June 10, 2021, the company's stockholders approved an amendment to the 2016 Stock Incentive Plan, increasing available shares by 750,000 - On June 10, 2021, stockholders approved an amendment to the 2016 Stock Incentive Plan to increase the number of issuable shares by **750,000**[206](index=206&type=chunk) [Exhibits](index=30&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including certifications by the CEO and CFO and XBRL data files - The report includes filed exhibits such as Amendment No. 2 to the 2016 Stock Incentive Plan, CEO/CFO certifications under Sarbanes-Oxley Sections 302 and 906, and Inline XBRL documents[208](index=208&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 March 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 Number 001-34600 TENAX THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 26-2593535 (State of incorporation) (I.R.S. ...

Delaware 26-2593535 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) ONE Copley Parkway, Suite 490, Morrisville, NC 27560 (Address of Principal Executive Offices) (Zip Code) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 Commission File No. 001-34600 TENAX THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION ...

Financial Performance - Cash and cash equivalents were $8.7 million as of September 30, 2020[104]. - Net loss from operations for Q3 2020 was $2.2 million, compared to $2.3 million for Q3 2019[104]. - Net cash used in operating activities was $2.4 million for Q3 2020, up from $1.8 million in Q3 2019[104]. - Other income decreased approximately $125,000 for the nine months ended September 30, 2020, primarily due to a decrease in interest earned on marketable securities[131]. - As of September 30, 2020, the company had an accumulated deficit of approximately $243 million and anticipates continued net losses for at least the next several years[133]. - Net cash used in operating activities for the nine months ended September 30, 2020, was approximately $7.3 million, an increase from $5.8 million in the same period of 2019[145]. Expenses - Personnel costs increased by approximately $72,000 (12%) for Q3 2020 compared to Q3 2019, primarily due to higher bonuses and stock option expenses[106][107]. - Legal and professional fees decreased by $253,982 (46%) for Q3 2020 compared to Q3 2019[106]. - Research and development expenses for clinical and preclinical development increased by approximately $1.6 million for the nine months ended September 30, 2020, primarily due to increased expenditures for CRO costs[127]. - Clinical and preclinical development costs for the three months ended September 30, 2020 were $989,159, representing a 17% increase compared to the same period in the prior year[113]. - Personnel costs increased approximately $164,000 for the nine months ended September 30, 2020, driven by increases in stock options, bonuses, and salaries[121]. - Other costs increased approximately $81,000 for the nine months ended September 30, 2020, mainly due to higher insurance premiums[124]. - Facilities costs remained consistent for the nine months ended September 30, 2020, compared to the same period in the prior year[125]. - Investor relations costs decreased approximately $94,000 for the nine months ended September 30, 2020, due to reduced fees for outreach and conferences[123]. - Other costs decreased approximately $16,000 for the nine months ended September 30, 2020, primarily due to reductions in travel and consulting fees[129]. - Interest income from marketable securities for the nine months ended September 30, 2020 was approximately $15,000, down from approximately $118,000 in the prior year[132]. Funding and Capital Requirements - The company raised approximately $2.75 million from a March 2020 offering and approximately $6.5 million from a July 2020 offering, contributing to a total of approximately $10.6 million in financing activities for the nine months ended September 30, 2020[147]. - The net proceeds from the March 2020 offering, after fees, were approximately $2.125 million, while the July 2020 offering netted approximately $6.5 million for clinical trials and general corporate purposes[137][140]. - The company received a Paycheck Protection Program loan of $244,657, with monthly payments of approximately $31,100 starting September 30, 2021[141][142]. - The company plans to use proceeds from the PPP Loan to fund payroll costs, although there is no assurance of loan forgiveness[143]. - Future capital requirements will depend on various factors, including clinical trial progress and regulatory approvals, with substantial additional capital needed for product development[148][149]. - The company may seek additional funding through public or private equity offerings, debt financing, or collaboration arrangements, which could lead to dilution for existing shareholders[150]. - As of September 30, 2020, the current and long-term portions of the PPP Loan were $30,900 and $213,757, respectively[144]. Clinical Development - The company is conducting a Phase 2 clinical trial of levosimendan for PH-HFpEF, with an estimated U.S. prevalence of over 1.5 million patients[91][92]. - Levosimendan demonstrated a statistically significant improvement in 6-minute walk distance of 29 meters (p=0.0329) in the HELP Study[99]. - The FDA agreed to a Phase 3 study design for levosimendan in PH-HFpEF patients, with a primary endpoint of change in 6-minute walk distance over 12 weeks[94]. - The HELP Study utilized a unique home-based IV infusion regimen, with no reported serious adverse events[96]. - Legal and professional fees decreased approximately $575,000 for the nine months ended September 30, 2020, primarily due to reimbursement of direct costs and legal fees related to arbitration proceedings for levosimendan[122]. - An amendment to the license with Orion includes two new oral products and extends the license term to 10 years post-launch, contingent on regulatory approval by September 20, 2028[102].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Exact name of registrant as specified in its charter) Delaware 26-2593535 (State of incorporation) (I.R.S. Employer Identification No.) ONE Copley Parkway, Suite 490, Morrisville, North Carolina 27560 (Address of principal executive offices) (919) 855-2100 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, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SE ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ONE Copley Parkway, Suite 490, Morrisville, North Carolina 27560 (Address of principal executive offices) (919) 855-2100 ☐ 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. Employer Identific ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C., 20549 FORM 10-K ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 Commission File No. 001-34600 TENAX THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of Incorporation or organization) (I.R.S. Employer Identification No.) Delaware 26-2593535 | Title of Each Class | Trading Symbol(s) | Name of Each Exchange on Wh ...

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, 2019 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, 2019 OR (Exact name of registrant as specified in its charter) ☐ 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. Indicate by check mark whether the registrant (1) has ...