Core Insights - Tenax Therapeutics has received an Intention to Grant notification from the European Patent Office for a patent that will protect TNX-103 (oral levosimendan) and other formulations for treating pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF) until at least December 2040 [1][2] - The patent will cover various routes of administration and a wide range of doses, as well as the use of levosimendan in combination with other cardiovascular drugs [2][3] - This patent is crucial as the company prepares to initiate its second registrational Phase 3 study, LEVEL-2, which will recruit patients across Europe [2][4] Company Overview - Tenax Therapeutics is a Phase 3, development-stage pharmaceutical company focused on developing novel cardiopulmonary therapies [4] - The company holds global rights to develop and commercialize levosimendan, targeting PH-HFpEF, which is the most prevalent form of pulmonary hypertension globally [4] - Levosimendan has received market authorization in 60 countries for treating acutely decompensated heart failure, although it is not available in the U.S. or Canada [3]

Summary of Tenax Therapeutics (TENX) Conference Call Company Overview - Tenax Therapeutics is focused on the Phase III development of an oral formulation of a drug for group two pulmonary hypertension (PH) patients with an ejection fraction greater than 40% [4][5] - The drug has been approved in 60 countries and has a history of 25 years for a different indication [4] Industry Context - Pulmonary hypertension (PH) is characterized by elevated pulmonary pressure in the lungs and is categorized into five subgroups, with group two associated with left heart disease [6] - Approximately 50% of heart failure patients develop pulmonary hypertension, with a significant portion being HFpEF (Heart Failure with preserved Ejection Fraction) [6] Market Opportunity - The American heart failure population was about 6.7 million in 2020, projected to rise to 8.5 million by 2030 [7] - More than half of new diagnoses in March are patients with an ejection fraction greater than 40% [8] - The addressable market for the drug is estimated at $10 billion, given that 50-80% of HFpEF patients may have pulmonary hypertension [8] Drug Development Insights - The company is leveraging legacy data and previous studies to support the development of their drug, which aims to lower wedge pressure without significantly affecting pulmonary artery pressure [24] - The Phase II HELP trial demonstrated a significant reduction in pulmonary wedge pressure during exercise, indicating the drug's potential efficacy [17][31] Clinical Trials - The ongoing Phase III trial (Level) is enrolling 230 subjects, with a primary endpoint of the six-minute walk test [36] - A second Phase III trial (Level 2) is planned to start this year, with a larger patient population and a longer duration [37][48] - The company is focused on careful site selection for trials to ensure effective enrollment and data collection [49][51] Safety and Efficacy - No new safety signals have been observed in the ongoing trials, and the drug has shown to be well-tolerated [40] - The drug's hemodynamic effects are well understood, and it has a favorable safety profile compared to surgical alternatives [30][31] Financial Outlook - The company is funded through 2027, with key value drivers including patient enrollment milestones and the potential to address a significant unmet medical need in the pulmonary hypertension market [58] Conclusion - Tenax Therapeutics is positioned to address a critical gap in the treatment of pulmonary hypertension, with a strong focus on clinical development and leveraging existing data to support its drug's efficacy and safety [58]

CHAPEL HILL, N.C., Aug. 28, 2025 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax Therapeutics” or the “Company”), a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies, today announced that the Company will participate in a fireside chat at the Cantor Global Healthcare Conference 2025, which is taking place from September 3-5, 2025, in New York, NY. Details of presentation: Format: Fireside chat Participants: Chris Giordano ...

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The financial statements for the period ended June 30, 2025, show a significant increase in cash and cash equivalents to $105.5 million, primarily due to financing activities, while the net loss widened substantially to $21.3 million, driven by escalated research and development and general administrative expenses related to ongoing Phase 3 clinical trials, and total stockholders' equity increased to $103.3 million from $92.0 million at year-end 2024 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets increased to $105.9 million from $96.7 million at December 31, 2024, driven by a rise in cash and cash equivalents, while total liabilities decreased to $2.5 million from $4.7 million, leading to an increase in total stockholders' equity to $103.3 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $105,462 | $94,851 | | Total current assets | $105,857 | $96,686 | | Total liabilities | $2,527 | $4,693 | | Total stockholders' equity | $103,330 | $91,993 | | Total liabilities and stockholders' equity | $105,857 | $96,686 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a significantly higher net loss for the three and six months ended June 30, 2025, compared to the same periods in 2024, with the six-month net loss increasing to $21.3 million from $7.4 million year-over-year, primarily due to a sharp rise in both Research and Development (R&D) and General and Administrative (G&A) expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 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) | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) For the six months ended June 30, 2025, stockholders' equity increased from $91.99 million to $103.33 million, primarily driven by **$23.2 million** in net proceeds from a public offering and **$8.7 million** in stock-based compensation, partially offset by a net loss of **$21.3 million** - Key drivers for the change in stockholders' equity in the first half of 2025 included a public offering netting **$23.2 million**, warrant exercises, and significant stock-based compensation expense, counteracted by the period's net loss[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, cash and cash equivalents increased by $10.6 million due to $23.8 million in net cash provided by financing activities, which more than offset the $13.2 million of net cash used in operating activities, contrasting with a net cash decrease of $0.4 million in the prior year period Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(13,230) | $(8,197) | | Net cash provided by financing activities | $23,841 | $7,789 | | Net change in cash and cash equivalents | $10,611 | $(408) | | Cash and cash equivalents, end of period | $105,462 | $9,384 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business as a Phase 3 pharmaceutical firm with a significant accumulated deficit of $336.1 million, but management believes current cash of $105.5 million is sufficient for operations for at least the next 12 months, with key disclosures including the terms of the levosimendan license agreement with Orion, details of recent equity financings, and a breakdown of stock-based compensation expenses - The company is a Phase 3 development-stage pharmaceutical company focused on novel cardiopulmonary therapies[20](index=20&type=chunk) - As of June 30, 2025, the company had an accumulated deficit of **$336.1 million** but possessed cash and cash equivalents of **$105.5 million**, which management believes is sufficient to fund operations for at least the next 12 months[21](index=21&type=chunk) - In February 2024, the company amended its license agreement with Orion for levosimendan, gaining global rights for PH-HFpEF, which increased future milestone payments to Orion upon regulatory approvals in the US and Japan[36](index=36&type=chunk) - The company operates as a single segment focused on identifying and developing therapeutics for cardiovascular and pulmonary diseases, with performance assessed by the CEO based on net loss and cash flow[67](index=67&type=chunk)[68](index=68&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the significant increase in operating expenses for the first half of 2025, attributing it to expanded clinical trial activities for its levosimendan program (Phase 3 LEVEL and LEVEL-2 studies) and higher stock-based compensation, noting that the company raised approximately $25.0 million in gross proceeds from a private placement in March 2025 and, with $105.9 million in current assets as of June 30, 2025, believes it has sufficient capital to fund operations through 2027 [Overview and Recent Events](index=22&type=section&id=Overview%20and%20Recent%20Events) Tenax is a clinical-stage pharmaceutical company focused on developing cardiopulmonary therapies, with its prioritized product candidate being levosimendan for pulmonary hypertension, and in March 2025, the company raised $25.0 million in gross proceeds to advance its Phase 3 oral levosimendan program, including the ongoing LEVEL study and the planned LEVEL-2 study, with enrollment for the LEVEL study expected to be completed in the first half of 2026 - The company is prioritizing the development of levosimendan for pulmonary hypertension and has deprioritized a Phase 3 trial of imatinib[79](index=79&type=chunk) - In March 2025, a private placement raised gross proceeds of approximately **$25.0 million** to fund the ongoing Phase 3 LEVEL study and initiate a second global Phase 3 study, LEVEL-2[80](index=80&type=chunk) - Enrollment for the Phase 3 LEVEL study is ongoing, with completion expected in the first half of 2026[81](index=81&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) Operating expenses increased significantly for the three and six months ended June 30, 2025, compared to the prior year, with R&D expenses for the six-month period rising 136% to $11.8 million due to costs for the Phase 3 LEVEL and LEVEL-2 trials, and G&A expenses increasing 340% to $11.3 million, primarily due to a $6.9 million increase in non-cash stock-based compensation and higher professional fees Operating Expenses Comparison (in thousands) | Expense Category | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | % Change | | :--- | :--- | :--- | :--- | | Research and development | $11,804 | $5,003 | 136% | | General and administrative | $11,326 | $2,577 | 340% | | **Total operating expenses** | **$23,130** | **$7,580** | **205%** | - The increase in R&D costs was primarily due to expenses for the ongoing Phase 3 LEVEL trial and preliminary work on the LEVEL-2 study[84](index=84&type=chunk) - The surge in G&A expenses was mainly driven by a **$6.9 million** increase in non-cash stock-based compensation from options granted in late 2024 and early 2025[87](index=87&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) The company had an accumulated deficit of $336.1 million as of June 30, 2025, but with working capital of $103.3 million, management believes it has sufficient funds for operations through 2027, a position strengthened by several financings, including a March 2025 offering that provided $23.2 million in net proceeds, even as net cash used in operations increased to $13.2 million for the first six months of 2025 from $8.2 million in the prior year period - As of June 30, 2025, the company had an accumulated deficit of **$336.1 million** and working capital of **$103.3 million**[91](index=91&type=chunk)[93](index=93&type=chunk) - Management believes the company has sufficient capital to fund operations through 2027[103](index=103&type=chunk) Recent Financings (Gross Proceeds) | Date | Type | Gross Proceeds | | :--- | :--- | :--- | | March 2025 | Private Placement | $25.0 million | | August 2024 | Private Placement | $99.7 million | | February 2024 | Registered Public Offering | $9.0 million | Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(13,230) | $(8,197) | | Net cash provided by financing activities | $23,841 | $7,789 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is therefore not required to provide the information requested by this item - As a smaller reporting company, Tenax Therapeutics is not required to provide quantitative and qualitative disclosures about market risk[107](index=107&type=chunk) [Item 4. Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Based on an evaluation as of June 30, 2025, the company's President and Chief Executive Officer and Interim Chief Financial Officer concluded that the disclosure controls and procedures were effective, with no material changes in the company's internal control over financial reporting during the most recent fiscal quarter - Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[110](index=110&type=chunk) - There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[111](index=111&type=chunk) [PART II. OTHER INFORMATION](index=31&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=31&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 - The company is not a party to any material pending legal proceedings[115](index=115&type=chunk) [Item 1A. Risk Factors](index=31&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, 2024 - There have been no material changes to the risk factors previously disclosed in the company's 2024 Form 10-K[116](index=116&type=chunk) [Item 6. Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, which include the Restated Certificate of Incorporation, certifications by the CEO and Interim CFO pursuant to the Sarbanes-Oxley Act, and Inline XBRL documents - The exhibits filed with this report include certifications from the President and Chief Executive Officer and the Interim Chief Financial Officer as required by Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[118](index=118&type=chunk)

[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)

Core Insights - Tenax Therapeutics is progressing with its Phase 3 LEVEL study for TNX-103 targeting pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF), with completion of enrollment expected around year-end 2025 and topline data anticipated in mid-2026 [1][3][11] Financial Performance - As of March 31, 2025, Tenax reported cash and cash equivalents of $111.4 million, following a private placement financing that raised approximately $25 million [5] - Research and development expenses for Q1 2025 were $5.7 million, a significant increase from $2.7 million in Q1 2024, primarily due to costs associated with the Phase 3 LEVEL study and increased personnel expenses [6] - General and administrative expenses for Q1 2025 were $5.7 million, up from $1.2 million in Q1 2024, largely due to increased compensation and professional fees [7] - The company reported a net loss of $10.4 million for Q1 2025, compared to a net loss of $3.8 million in Q1 2024 [8] Clinical Development - The Phase 3 LEVEL study is currently enrolling patients, with a target of 230 participants, and is being conducted in Canada and the U.S. [11] - A second Phase 3 study, LEVEL-2, is expected to commence in 2025, expanding the global footprint of the clinical trials [11] - Levosimendan, the active compound in TNX-103, is a first-in-class K-ATP channel activator/calcium sensitizer, previously developed for intravenous use in heart failure patients and authorized in 60 countries, though not available in the U.S. or Canada [9][12]