Financing and Capital - Tenax Therapeutics raised approximately $25.0 million in a private placement financing in March 2025 to advance its Phase 3 oral levosimendan program[78]. - The company raised gross proceeds of $25.0 million from the March 2025 Offering, with net proceeds of $23.2 million after expenses[93]. - The company received $3.7 million from the exercise of warrants and pre-funded warrants during the nine months ended September 30, 2025[100]. - The company has sufficient capital on hand to fund operations through 2027 based on working capital as of September 30, 2025[101]. Clinical Development - The company expects to enroll 230 patients in the ongoing Phase 3 LEVEL study in the first half of 2026, which is being conducted in the United States and Canada[79]. - The company plans to recruit patients for the LEVEL trial, concluding in approximately the first half of 2026[92]. - Clinical and preclinical development costs increased by $5.7 million for the three months ended September 30, 2025, primarily due to expenses associated with the ongoing Phase 3 LEVEL trial[82]. - The company is focused on developing two product candidates, levosimendan and imatinib, with a priority on levosimendan[90]. Financial Performance - The net loss for the three months ended September 30, 2025, was $15.8 million, a 299% increase from a net loss of $4.0 million in the same period in 2024[81]. - Research and development expenses for the three months ended September 30, 2025, increased by 232% to $10.3 million compared to $3.1 million in the same period in 2024[81]. - General and administrative expenses for the three months ended September 30, 2025, increased by 330% to $6.5 million compared to $1.5 million in the same period in 2024[81]. - Interest income increased by 53% to $1.0 million for the three months ended September 30, 2025, compared to $0.7 million in the same period in 2024[81]. - Net cash used in operating activities increased to $22.4 million for the nine months ended September 30, 2025, compared to $11.3 million for the same period in 2024[97]. - Net cash provided by financing activities was $26.9 million for the nine months ended September 30, 2025, a decrease of $72.9 million from $99.8 million in the same period of 2024[100]. - The accumulated deficit as of September 30, 2025, was $351.9 million, with expectations of continued net losses for several years[89]. Expenses and Costs - Non-cash stock-based compensation expense increased by $1.1 million for the three months ended September 30, 2025, compared to the same period in 2024[83]. - Legal and professional fees increased by $0.2 million for the three months ended September 30, 2025, primarily due to increased capital market and consulting expenses[86]. - Total current assets as of September 30, 2025, were $102.8 million, with working capital of $96.2 million[91]. - The company reported no net cash provided or consumed by investing activities for the nine months ended September 30, 2025[98]. - The company has not engaged in any off-balance sheet arrangements since inception[103].

Financial Performance - Tenax Therapeutics reported cash and cash equivalents of $99.4 million as of September 30, 2025, expected to fund operations through 2027[7]. - Tenax reported a net loss of $15.8 million for Q3 2025, compared to a net loss of $4.0 million for Q3 2024[10]. - Tenax's net loss per share for Q3 2025 was $0.40, compared to $0.19 for Q3 2024[17]. - Total operating expenses for Q3 2025 were $16.8 million, compared to $4.6 million in Q3 2024[17]. - The total stockholders' equity as of September 30, 2025, was $96.2 million, an increase from $92.0 million at the end of 2024[21]. Research and Development - Research and development (R&D) expenses for Q3 2025 were $10.3 million, a significant increase from $3.1 million in Q3 2024, primarily due to clinical development costs[8]. - The ongoing Phase 3 LEVEL study is on track to enroll 230 patients by the first half of 2026, with a second Phase 3 study, LEVEL-2, expected to initiate this year[2][5]. - The company has qualified over 160 investigative sites across 15 countries for the LEVEL-2 study[5]. General and Administrative Expenses - General and administrative (G&A) expenses for Q3 2025 were $6.5 million, up from $1.5 million in Q3 2024, largely due to increased non-cash stock-based compensation[9]. Intellectual Property - The European Patent Office intends to grant a patent for levosimendan treatment in PH-HFpEF, providing protection until December 2040[3].

Core Insights - Tenax Therapeutics is advancing its lead program, TNX-103, for treating pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF), with enrollment of 230 patients expected to complete in the first half of 2026 and a second Phase 3 study, LEVEL-2, set to initiate in 2025 [2][6] Corporate Progress - The company reported a cash position of $99.4 million as of September 30, 2025, which is expected to fund operations through 2027 [8] - Tenax is conducting a virtual KOL call on November 13, 2025, to discuss the treatment landscape for PH-HFpEF and the ongoing development of TNX-103 [4] Clinical Development - The ongoing Phase 3 LEVEL study is progressing well, with high rates of study and therapy continuation, and is being conducted in the United States and Canada [6] - The European Patent Office has indicated its intention to grant a patent for levosimendan for treating PH-HFpEF, which will provide IP protection until December 2040 [6] Financial Results - For Q3 2025, Tenax reported R&D expenses of $10.3 million, up from $3.1 million in Q3 2024, primarily due to increased clinical development costs [9] - General and administrative expenses for Q3 2025 were $6.5 million, compared to $1.5 million in Q3 2024, largely due to increased non-cash stock-based compensation [10] - The net loss for Q3 2025 was $15.8 million, compared to a net loss of $4.0 million in Q3 2024 [11]

Tenax Therapeutics Conference Call Summary Company Overview - **Company**: Tenax Therapeutics (NasdaqCM:TENX) - **Focus**: Development of Levosimendan for the treatment of pulmonary hypertension with preserved ejection fraction (PH-HFpEF) [2][3] Industry Context - **Market Size**: Estimated prevalence of PH-HFpEF in the U.S. is about 2 million patients, with an additional 2 million in Europe, indicating a significant market opportunity [12][13] - **Unmet Need**: No approved therapies for PH-HFpEF exist, and some existing treatments have been harmful, highlighting a substantial unmet medical need [12][13] Core Points and Arguments - **Drug Development**: - Levosimendan is currently in phase three trials, with the first trial ongoing and a second trial expected to start soon [2][25] - The drug has been approved in over 60 countries for IV use but has not been previously studied for HFpEF in the U.S. [6][7] - Tenax's approach involves treating volume overload rather than directly targeting left ventricular compliance, which has been a common failure point in past drug developments [4][5] - **Trial Design**: - The phase two HELP trial demonstrated significant improvements in hemodynamics, specifically in wedge pressure and central venous pressure, without affecting contractility [15][16] - The primary endpoint for the phase three trials is the six-minute walk distance, which is a recognized endpoint for approval in pulmonary hypertension [17][27] - **Licensing and Rights**: - Tenax has secured a worldwide license for Levosimendan, allowing for various formulations, including oral and modified oral forms [9] - **Patient Transition**: - Transition from IV to oral formulation has shown positive outcomes, with patients reporting improved symptoms and walking distances [20][24] Additional Important Insights - **Regulatory Pathway**: The use of six-minute walk as an endpoint is seen as a straightforward regulatory path for approval, especially given the lack of existing effective therapies [17][27] - **Market Research**: Feedback from key opinion leaders (KOLs) indicates that the three-times-a-day dosing of the oral formulation is not seen as a barrier to patient compliance due to the significant symptom relief it provides [32][33] - **Future Opportunities**: There are plans for lifecycle management, including potential dosing changes to improve market penetration and patient adherence [33][34] Financial Position - **Cash Runway**: As of the last reported quarter, Tenax had over $100 million in cash, which is expected to support ongoing research and development efforts [35]

Core Insights - Tenax Therapeutics is hosting a conference call on November 13, 2025, to discuss the treatment landscape for pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF) and the ongoing development of TNX-103 [1][2] Company Overview - Tenax Therapeutics is a Phase 3, development-stage pharmaceutical company focused on novel cardiopulmonary therapies, specifically targeting PH-HFpEF, which currently lacks approved treatments [5] - The company has global rights to develop and commercialize levosimendan, a first-in-class K-ATP channel activator/calcium sensitizer [4][5] Product Development - TNX-103 (oral levosimendan) is being advanced in two registrational Phase 3 studies, LEVEL and LEVEL-2, with enrollment ongoing in the North American LEVEL study and the global LEVEL-2 study set to initiate in 2025 [3] - Previous studies, including the Phase 2 HELP study, indicated that both intravenous (TNX-101) and oral (TNX-103) formulations of levosimendan could improve exercise capacity and quality of life in patients with PH-HFpEF [4]

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 Guggenheim Annual Healthcare Innovation Conference from November 10-12, 2025, in Boston, MA [1][2] Presentation Details - The presentation will be in a fireside chat format featuring Chris Giordano, President & CEO, and Stuart Rich, M.D., Chief Medical Officer [2] - Scheduled date and time for the presentation is November 10, 2025, at 4:00 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, targeting the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension [3] - Currently, there are no approved products for PH-HFpEF, highlighting a significant market opportunity for the company [3] - The company's common stock is listed on The Nasdaq Stock Market under the symbol "TENX" [3]

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]

Company Overview - Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company focused on developing novel cardiopulmonary therapies using clinical insights [3] - The company owns global rights to develop and commercialize levosimendan, targeting the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension, for which no product has been approved to date [3] Upcoming Event - Tenax Therapeutics will participate in a fireside chat at the Cantor Global Healthcare Conference 2025, scheduled for September 3-5, 2025, in New York, NY [1] - The presentation will feature Chris Giordano, President & CEO, and Stuart Rich, M.D., Chief Medical Officer, on September 4, 2025, at 10:20 a.m. ET [2] - A live and archived webcast of the presentation will be available on the company's investor relations webpage [2]

[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)