Table of Contents 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, 2025 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 incorp ...

[Corporate and Clinical Highlights](index=1&type=section&id=Corporate%20and%20Clinical%20Highlights) Tenax Therapeutics is advancing its lead program, TNX-103, for patients with PH-HFpEF, with Phase 3 LEVEL study enrollment ongoing and a second global Phase 3 study, LEVEL-2, set to begin in 2025, alongside operational team strengthening and patent protection extension to 2040 - Enrollment for the Phase 3 LEVEL study of TNX-103 (oral levosimendan) is ongoing, with the target expanded to **230 patients** to increase statistical power, expecting completion in the first half of 2026 and topline data in the second half of 2026[1](index=1&type=chunk)[2](index=2&type=chunk)[6](index=6&type=chunk) - A second registrational Phase 3 study, LEVEL-2, is on track to be initiated in 2025, with a global footprint including over **85 new sites** in **15 additional countries** already qualified[1](index=1&type=chunk)[2](index=2&type=chunk)[6](index=6&type=chunk) - The company expanded its operations team with new heads of Clinical Operations, Data Management, Pharmacovigilance, and Quality Assurance to oversee the LEVEL program[6](index=6&type=chunk) - In August 2025, the Canadian Intellectual Property Office allowed claims for a patent covering the use of levosimendan (TNX-103, TNX-102, TNX-101) in PH-HFpEF patients, extending patent protection to **2040** once granted[6](index=6&type=chunk) [Second Quarter 2025 Financial Results](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Results) For the second quarter of 2025, Tenax Therapeutics reported a net loss of $10.9 million, driven by increased R&D and G&A expenses, while maintaining a strong cash position of $105.5 million expected to fund operations through 2027 - The company reported cash and cash equivalents of **$105.5 million** as of June 30, 2025, which is expected to fund operations through 2027[5](index=5&type=chunk) Financial Metric Comparison (in millions) | Financial Metric | Q2 2025 | Q2 2024 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | **R&D Expenses** | $6.1 | $2.3 | +$3.8 | Increased clinical development costs for LEVEL & LEVEL-2 studies, higher personnel costs | | **G&A Expenses** | $5.7 | $1.3 | +$4.4 | Primarily due to a $3.6 million increase in non-cash stock-based compensation | | **Net Loss** | $10.9 | $3.6 | +$7.3 | Driven by higher operating expenses | [Financial Statements](index=3&type=section&id=Financial%20Statements) The consolidated financial statements detail the company's financial performance and position, showing a significant year-over-year increase in operating expenses and net loss for both the three and six months ended June 30, 2025, alongside a strong cash position and increased total assets and stockholders' equity compared to year-end 2024 [Consolidated Statements of Operations](index=3&type=section&id=Consolidated%20Statements%20of%20Operations) For the three months ended June 30, 2025, total operating expenses were $11.8 million, leading to a net loss of $10.8 million, primarily driven by higher R&D and G&A spending compared to the same period in 2024 Three Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Research and development | $6,121 | $2,327 | | General and administrative | $5,671 | $1,344 | | **Total operating expenses** | **$11,792** | **$3,671** | | **Net loss** | **($10,847)** | **($3,575)** | | Net loss per share | ($0.27) | ($1.83) | Six Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Research and development | $11,804 | $5,003 | | General and administrative | $11,326 | $2,577 | | **Total operating expenses** | **$23,130** | **$7,580** | | **Net loss** | **($21,255)** | **($7,374)** | | Net loss per share | ($0.56) | ($4.65) | [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2025, Tenax reported total assets of $105.9 million, primarily cash and cash equivalents, with total liabilities of $2.5 million and stockholders' equity of $103.3 million, indicating an increase in cash and equity from December 31, 2024 Balance Sheet Comparison (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $105,462 | $94,851 | | **Total assets** | **$105,857** | **$96,686** | | Total liabilities | $2,527 | $4,693 | | **Total stockholders' equity** | **$103,330** | **$91,993** | [About Tenax Therapeutics and Levosimendan](index=2&type=section&id=About%20Tenax%20Therapeutics%20and%20Levosimendan) Tenax Therapeutics is a Phase 3 development-stage pharmaceutical company focused on novel cardiopulmonary therapies, with its lead candidate, levosimendan, being developed for PH-HFpEF, a condition currently lacking approved treatments - Tenax is a Phase 3 development-stage pharmaceutical company focused on developing novel cardiopulmonary therapies[11](index=11&type=chunk) - The lead candidate, levosimendan, is a novel, first-in-class K-ATP channel activator/calcium sensitizer being evaluated in oral (TNX-103), IV (TNX-101), and subcutaneous (TNX-102) formulations[10](index=10&type=chunk) - The company is developing levosimendan for the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension, for which no product has been approved to date[11](index=11&type=chunk)

Core Viewpoint - Tenax Therapeutics is advancing its lead program TNX-103 for treating pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF), with ongoing Phase 3 studies and a strong financial position to support its operations through 2027 [2][3][5]. Corporate Progress - The company is on track to complete enrollment of 230 patients in the Phase 3 LEVEL study by the first half of 2026, which is expected to enhance the statistical power of the study [3][7]. - Tenax plans to initiate a second Phase 3 study, LEVEL-2, in 2025, with the protocol finalized and over 85 new sites in 15 countries prepared for qualification [3][7]. - Recent patent claims covering TNX-103 and related compounds have been allowed by the Canadian Intellectual Property Office, with protections expected to extend to 2040 [7]. Financial Results - As of June 30, 2025, Tenax reported cash and cash equivalents of $105.5 million, which is projected to fund operations through 2027 [5]. - Research and development expenses for Q2 2025 were $6.1 million, a significant increase from $2.3 million in Q2 2024, primarily due to higher clinical development costs [6]. - General and administrative expenses for Q2 2025 were $5.7 million, up from $1.3 million in Q2 2024, largely due to increased non-cash stock-based compensation [9]. - The company reported a net loss of $10.9 million for Q2 2025, compared to a net loss of $3.6 million in Q2 2024 [10].

TNX-103 and PH-HFpEF - TNX-103 (Oral Levosimendan) is a small molecule NCE with a dual mechanism of action, acting as a venodilator and enhancing cardiac contractility[6, 104] - TNX-103 has U S patent protection for multiple methods of use out to the end of 2040 with potential for continuations[7, 105] - The addressable market opportunity for TNX-103 is estimated to be at least $10 billion[9, 107] - Phase 3 program design aligned with the FDA helps de-risk the potential approval pathway for TNX-103[9, 107] Clinical Trial Data - In the Phase 2 HELP trial, TNX-103 showed statistically significant increases in 6MWD and reduction in PCWP across all exercise stages for PH-HFpEF patients[9, 107] - The OLE portion of the Phase 2 trial showed that patients who transitioned from IV to oral levosimendan in a 6-week period experienced improvements in 6MWD (+7 meters), BNP/NT-proBNP and KCCQ scores[9, 107] - 85% of patients enrolled in the HELP study responded with a robust decrease (≥4mm Hg) in exercise PCWP[45] - Oral Levosimendan causes a rapid and sustained reduction in NT-proBNP vs Baseline, with a 32% to 38% reduction in 7 days in the PERSIST Trial[79, 80] Market and Prevalence - PH-HFpEF affects an estimated 2 2 million US patients projected in 2030[9, 107] - In 2030, there will be an estimated 2 2 million to 3 7 million PH-HFpEF patients in the US[18] - Approximately 50% of heart failure patients with preserved ejection fraction (HFpEF) have PH[101]

PART I. FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Tenax Therapeutics reported a **net loss of $10.4 million** in Q1 2025, with **$111.4 million in cash** and sufficient funds for 12 months, primarily developing cardiopulmonary therapies Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $111,447 | $94,851 | | Total current assets | $112,059 | $96,686 | | **Total assets** | **$112,059** | **$96,686** | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $2,768 | $4,693 | | **Total liabilities** | **$2,768** | **$4,693** | | Accumulated deficit | $(325,263) | $(314,855) | | **Total stockholders' equity** | **$109,291** | **$91,993** | Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $5,683 | $2,676 | | General and administrative | $5,655 | $1,233 | | **Total operating expenses** | **$11,338** | **$3,909** | | Net operating loss | $(11,338) | $(3,909) | | Interest income | $930 | $118 | | **Net loss** | **$(10,408)** | **$(3,799)** | | Net loss per share, basic and diluted | $(0.28) | $(3.12) | Condensed Consolidated Statements of Cash Flows (in thousands) | | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(6,967) | $(5,166) | | Net cash provided by financing activities | $23,563 | $7,923 | | **Net change in cash and cash equivalents** | **$16,596** | **$2,757** | | Cash and cash equivalents, end of period | $111,447 | $12,549 | - The company is a **Phase 3**, development-stage pharmaceutical company focused on novel cardiopulmonary therapies, with management believing it has sufficient funds for at least the **next 12 months** of operations, based on its cash position of **$111.4 million** as of March 31, 2025[20](index=20&type=chunk)[21](index=21&type=chunk) - In February 2024, the company amended its license with Orion Corporation, gaining **global rights** for oral and subcutaneous levosimendan for PH-HFpEF, increasing milestone payments to Orion upon US regulatory approval (**$10.0M**) and Japan approval (**$5.0M**), and adding commercialization milestones up to **$45.0M**[35](index=35&type=chunk) - In March 2025, the company raised gross proceeds of **$25.0 million** (**$23.2 million net**) through a private placement of common stock and pre-funded warrants[43](index=43&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Operating expenses surged to **$11.3 million** in Q1 2025, driven by R&D and G&A, with recent financing funding operations through 2027 - The company is a **clinical-stage** pharmaceutical firm focused on developing cardiopulmonary therapies, with levosimendan as its prioritized product candidate for the ongoing **Phase 3 LEVEL clinical trial**[77](index=77&type=chunk) - A private placement in March 2025 raised gross proceeds of approximately **$25.0 million**, with the company believing its resources as of March 31, 2025, are sufficient to continue operations **through 2027**[78](index=78&type=chunk)[99](index=99&type=chunk) Operating Expenses Comparison (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Increase/(Decrease) | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $5,683 | $2,676 | $3,007 | 112% | | General and administrative | $5,655 | $1,233 | $4,422 | 359% | | **Total operating expenses** | **$11,338** | **$3,909** | **$7,429** | **190%** | - Net cash used in operating activities increased to **$7.0 million** in Q1 2025 from **$5.2 million** in Q1 2024, primarily due to higher clinical trial expenses[96](index=96&type=chunk) - Net cash from financing activities was **$23.6 million** in Q1 2025, mainly from the March 2025 Offering, compared to **$7.9 million** in Q1 2024 from the February 2024 Offering[98](index=98&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) Total operating expenses surged to **$11.3 million** in Q1 2025, driven by R&D and G&A increases, alongside higher interest income - R&D expenses increased by **$3.0 million (112%)** YoY, with clinical and preclinical development costs rising by **$1.8 million** due to the ongoing **Phase 3 LEVEL trial** for oral levosimendan[79](index=79&type=chunk)[80](index=80&type=chunk) - G&A expenses increased by **$4.4 million (359%)** YoY, primarily driven by a **$3.3 million** increase in stock-based compensation and a **$0.8 million** rise in legal and professional fees related to capital market activities[83](index=83&type=chunk)[84](index=84&type=chunk) - Interest income increased by **$813 thousand** in Q1 2025 compared to Q1 2024, mainly due to higher interest earned on increased cash deposits following recent offerings[87](index=87&type=chunk) [Liquidity, Capital Resources and Plan of Operation](index=25&type=section&id=Liquidity%2C%20Capital%20Resources%20and%20Plan%20of%20Operation) With an accumulated deficit of **$325.3 million**, the company secured **$109.3 million** in working capital from recent financings, sufficient through 2027 - As of March 31, 2025, the company had an accumulated deficit of **$325.3 million** and working capital of **$109.3 million**[88](index=88&type=chunk)[90](index=90&type=chunk) - The company has prioritized the development of levosimendan and will need **substantial additional capital** in the future to finalize its development and commence commercialization[89](index=89&type=chunk) Recent Financing Activities (Net Proceeds) | Offering Date | Net Proceeds | | :--- | :--- | | March 2025 | $23.2 million | | August 2024 | $92.3 million | | February 2024 | $8.0 million | [Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Tenax Therapeutics is exempt from providing quantitative and qualitative market risk disclosures - As a **smaller reporting company**, Tenax Therapeutics is **exempt** from the requirement to provide quantitative and qualitative disclosures about market risk[104](index=104&type=chunk) [Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of March 31, 2025, with no material changes to internal financial reporting controls - The President and CEO and Interim CFO concluded that the company's disclosure controls and procedures were **effective** as of March 31, 2025[107](index=107&type=chunk) - There were **no changes** in internal control over financial reporting during the quarter that have **materially affect**ed, or are reasonably likely to materially affect, internal controls[108](index=108&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company is not a party to any material pending legal proceedings, nor is its property subject to such - There are **no material pending legal proceedings** to which the company is a party or to which any of its property is subject[112](index=112&type=chunk) [Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the company's risk factors have occurred since the Annual Report on Form 10-K for FY2024 - The risks faced by the company have **not materially changed** from those disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024[113](index=113&type=chunk) [Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section lists key exhibits filed with the Form 10-Q, including warrants, purchase agreements, and officer certifications - Exhibits filed with the report include: - Form of Pre-Funded Warrant to Purchase Common Stock - Securities Purchase Agreement, dated March 4, 2025 - Registration Rights Agreement, dated March 5, 2025 - CEO and CFO certifications pursuant to Sarbanes-Oxley Act[115](index=115&type=chunk) Signatures [Signatures](index=33&type=section&id=Signatures) The Quarterly Report on Form 10-Q was signed on May 14, 2025, by Thomas A. McGauley, Interim Chief Financial Officer - The report was signed on **May 14, 2025**, by **Thomas A. McGauley**, **Interim Chief Financial Officer**[118](index=118&type=chunk)

[Form 8-K: Current Report](index=1&type=section&id=Form%208-K) This report details the current financial disclosures and related exhibits filed by Tenax Therapeutics, Inc [Item 2.02 Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) Tenax Therapeutics, Inc. announced its Q1 2025 financial results via a press release, which is not considered a formal filing under the Exchange Act - The company issued a press release on May 14, 2025, to announce its financial results for the first quarter ended March 31, 2025[4](index=4&type=chunk) - The press release is attached as Exhibit 99.1 and incorporated by reference[4](index=4&type=chunk) - The information in this item, including the exhibit, is not deemed "filed" under Section 18 of the Exchange Act and is not subject to its liabilities, unless specifically referenced in a formal filing[5](index=5&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=2&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section details the exhibits filed with the Form 8-K, primarily the press release containing financial results Exhibit List | Exhibit No. | Description | | :--- | :--- | | 99.1 | Press release dated May 14, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | [Signatures](index=3&type=section&id=SIGNATURES) The report was officially signed and authorized by Christopher T. Giordano, President and CEO of Tenax Therapeutics, Inc. on May 14, 2025 - The report was signed on behalf of the registrant on May 14, 2025[9](index=9&type=chunk) - The signatory was Christopher T. Giordano, President and Chief Executive Officer[9](index=9&type=chunk)

Phase 3 LEVEL Enrollment Completion for TNX-103 in PH-HFpEF Targeted Around Year-End 2025, with Topline Data Expected Middle of 2026 Initiation of Second Phase 3 Study, LEVEL-2, Expected This Year CHAPEL HILL, N.C., May 14, 2025 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax” or “Tenax Therapeutics” or the “Company”), a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies, today reported financial results for the quarter en ...

Summary of Tenex Therapeutics Conference Call Company Overview - **Company**: Tenex Therapeutics - **Key Personnel**: Chris Giordano (President and CEO), Doug Randall (Chief Business Officer), Stuart Reich (Chief Medical Officer) [2][11] Industry Context - **Industry**: Healthcare, specifically focusing on treatments for heart failure and pulmonary arterial hypertension (PAH) [1][2] Core Points and Arguments - **Clinical Significance**: The primary endpoint for their studies is the six-minute walking test, with a clinically meaningful improvement benchmarked at approximately 30 meters based on previous studies in a younger PAH population [3][4] - **Secondary Endpoints**: The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a validated endpoint accepted by the FDA, focusing on patient-reported outcomes. The pro NT BNP biomarker is considered an academic endpoint and not an FDA-approved clinical measure [5][6] - **Trial Design**: The upcoming Level two study will maintain a similar structure to the first Phase three study, with a parallel design and the same primary and secondary endpoints [6][8] Underappreciated Aspects - **Pathophysiology Understanding**: The company emphasizes the revival of knowledge regarding the underlying pathophysiology of heart failure, particularly the importance of restoring venous circulation to alleviate the disease [8][10] - **Market Need**: Recent market research indicates a significant unmet need for treatment options in this patient population, with both physicians and payers expressing a strong interest in any clinical improvements [10] Additional Insights - **Payer Receptiveness**: Payers have shown surprising receptiveness to various price points for the drug, indicating a potential for favorable market acceptance given the lack of available treatments [10]

Group 1 - Tenax Therapeutics (NASDAQ: TENX) is advancing its drug development plan for levosimendan, currently in phase 3 LEVEL trial [2] - The company is positioned well within the pharmaceutical sector, indicating potential for growth and investment opportunities [2] Group 2 - The Biotech Analysis Central service offers extensive resources for investors, including a library of over 600 biotech articles and a model portfolio of small and mid-cap stocks [2]

Core Insights - Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company focused on developing novel cardiopulmonary therapies [3] - The company will present at the 24th Annual Needham Virtual Healthcare Conference from April 7-10, 2025 [1][2] - Tenax Therapeutics is developing levosimendan for the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension, for which no product has been approved to date [3] Presentation Details - The corporate presentation will be led by Chris Giordano (President & CEO), Stuart Rich, M.D. (Chief Medical Officer), and Doug Randall (Chief Business Officer) [2] - The presentation is scheduled for April 7, 2025, at 3:45 p.m. ET [2] - A live and archived webcast of the presentation will be available on the company's investor relations webpage [2] Company Overview - Tenax Therapeutics owns global rights to develop and commercialize levosimendan [3] - The company's common stock is listed on The Nasdaq Stock Market LLC under the symbol "TENX" [3]