Summary of Tenax Therapeutics (TENX) Conference Call Company Overview - **Company**: Tenax Therapeutics (TENX) - **Focus**: Development of therapies for pulmonary hypertension (PH), specifically targeting Group II PH with the drug Levisamendin [2][3] Core Points and Arguments - **Group II PH Opportunity**: - Group II PH patients represent 60-70% of the global PH population and currently have no approved therapies [8][9] - The primary therapeutic target for these patients is left atrial pressure, contrasting with Group I PH patients who have multiple approved treatments [8][10] - **Levisamendin Development**: - Levisamendin is being tested in a Phase III trial for Group II PH, with a new oral formulation developed [5][6] - The drug has a history of being approved in over 60 countries for acute decompensated heart failure but faced challenges in the U.S. due to differing FDA requirements [15][16] - The drug's unique mechanism focuses on reducing pulmonary capillary wedge pressure, a primary defect in Group II PH patients [12][16] - **Market Opportunity**: - There is a significant unmet medical need for effective treatments in the Group II PH space, with encouraging signals from physicians regarding the adoption of Levisamendin once approved [22][23] - The addressable market includes approximately 7.58 million Americans with heart failure, with a significant portion having PH [35] - **Phase II HELP Study Insights**: - The Phase II HELP study demonstrated a reduction in wedge pressure and improvements in six-minute walk distance, indicating potential efficacy [32][34] - The study's design included an open-label phase where patients showed willingness to continue treatment, suggesting perceived benefits [40] - **Regulatory Pathway**: - The current regulatory pathway does not require demonstration of mortality benefits, focusing instead on functional improvements [35][36] - A statistically significant improvement of 25 meters in the six-minute walk test is considered sufficient for regulatory approval [44][46] - **Competitive Landscape**: - There is potential overlap with other emerging HFpEF drugs (e.g., SGLT2 inhibitors, GLP-1s), but Tenax is taking precautions to minimize confounding effects in clinical trials [47][50] - The company is monitoring the use of these drugs among trial participants to ensure stable dosing [51][52] Additional Important Content - **Licensing and Rights**: - Tenax has secured worldwide rights for both oral and IV formulations of Levisamendin, enhancing its commercial potential [21][22] - **Physician Sentiment**: - Physicians expressed a willingness to prescribe Levisamendin based on any statistically significant improvement, highlighting the lack of current treatment options [38][56] - **Pricing Strategy**: - There is optimism regarding the drug's market reception and potential pricing power, with indications that initial estimates may have been conservative [56][57] This summary encapsulates the key points discussed during the Tenax Therapeutics conference call, focusing on the company's strategic direction, product development, market potential, and competitive landscape.

Company Overview - Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company focused on cardiovascular and pulmonary diseases with high unmet medical need [4] - The company owns global rights to develop and commercialize levosimendan and may resume developing a unique oral formulation of imatinib [4] - Tenax Therapeutics' common stock is listed on The Nasdaq Stock Market under the symbol "TENX" [4] Upcoming Events - The company will participate in a fireside chat at the Guggenheim SMID Cap Biotech Conference on February 5-6, 2025, in New York, NY [1] - Chris Giordano, President & CEO, will present on February 5, 2025, at 3:00 pm ET [2] - Management will also engage in one-on-one investor meetings during the conference [2] Investor Relations - A live and archived webcast of the presentation will be available on the company's investor relations webpage [3] - For one-on-one meeting requests, investors are encouraged to contact their Guggenheim representative [2]

Core Viewpoint - Tenax Therapeutics has appointed Gillian Andor as Vice President of Clinical Operations to support its Phase 3 program for oral levosimendan (TNX-103) targeting pulmonary hypertension due to heart failure with preserved ejection fraction [1][2][3] Group 1: Appointment and Role - Gillian Andor will lead the expanding Clinical Operations function at Tenax Therapeutics [2] - The appointment comes at a critical time as the company is enrolling patients in the Phase 3 LEVEL study and preparing for a second pivotal study [3] Group 2: Experience and Background - Ms. Andor has over 20 years of experience in Clinical Operations, previously serving as Interim Head of Clinical Development Operations at Noema Pharma [3] - She has a strong track record, including leading global clinical development programs at Sage Therapeutics, resulting in successful NDA submissions for Zulresso and Zurzuvae [3] - Ms. Andor also contributed to the NDA and approval of Linzess for IBS-C during her tenure at Ironwood Pharmaceuticals [3] Group 3: Inducement Equity Award - Tenax Therapeutics issued an inducement equity award to Ms. Andor consisting of an option to purchase 250,000 shares of common stock at an exercise price of $6.44 [5] - The award will vest in four equal annual installments, contingent on her continued employment [5] Group 4: Company Overview - Tenax Therapeutics is a Phase 3, development-stage pharmaceutical company focused on cardiovascular and pulmonary diseases with high unmet medical needs [6] - The company owns global rights to develop and commercialize levosimendan and may resume developing its oral formulation of imatinib [6]

Summary of Tenax Therapeutics Conference Call Company Overview - **Company**: Tenax Therapeutics, Inc. (NASDAQ:TENX) - **Focus**: Pulmonary hypertension, specifically targeting group 2 pulmonary hypertension (PH-HFpEF) with oral levosimendan - **Market Capitalization**: Clarified to be between $200 million to $250 million, contrary to initial confusion of $15 million [1] Financial Position - **Cash Position**: As of September, Tenax had $98 million, funding operations through 2027 based on current projections [2] - **Recent Fundraising**: Raised $100 million in August [2] Clinical Development - **Phase 3 Trials**: Currently conducting a Phase 3 trial (LEVEL) for oral levosimendan in group 2 PH, with 52 sites initiated and plans to enroll 152 subjects by mid-next year [2] - **Market Opportunity**: Estimated prevalence of group 2 PH in the US is between 2.2 to 3.7 million patients by 2030, with an addressable market of $6 billion to $7.5 billion from 2030 to 2040 [2] Drug Mechanism and Efficacy - **Levosimendan**: Previously authorized in 60 countries as an IV formulation for acutely decompensated heart failure; Tenax is transitioning to an oral formulation [3] - **Clinical Results**: In the Phase 2 HELP study, levosimendan showed improvements in hemodynamic measures and a 29-meter increase in the six-minute walk test, a significant clinical endpoint [12] - **Mechanism of Action**: Acts as a potassium channel activator, providing vasodilatory effects on venous beds, which is crucial for treating PH-HFpEF [3][14] Trial Design and Endpoints - **Primary Endpoint**: Six-minute walk test, with a target improvement of 10 to 15 meters considered beneficial [19] - **Secondary Endpoints**: Include KCCQ questionnaire and clinical events, with the first trial lasting 12 weeks and a second planned for six months [15][20] Safety and Tolerability - **Safety Profile**: No significant adverse events reported during the trials; patients transitioned from IV to oral formulation without complications [18] - **Patient Retention**: High retention rates in the study, indicating patient satisfaction and drug efficacy [18] Intellectual Property - **Patents**: Developed four patents in the last two and a half years, with protections extending to 2040 and potential for additional exclusivity until 2042 [22][23] Future Outlook - **Next Steps**: Plans to accelerate the timeline for New Drug Application (NDA) based on funding secured through 2027, with no need to wait for top-line data from the first trial [20] - **Potential for Dosing Improvements**: Exploration of transitioning from three times a day dosing to once daily in the future [21] Conclusion - Tenax Therapeutics is positioned to make significant advancements in the treatment of pulmonary hypertension with its oral levosimendan, backed by strong clinical data and a solid financial foundation. The company is focused on expanding its market presence and improving patient outcomes in a largely underserved patient population.

CHAPEL HILL, N.C., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX), a Phase 3, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced that it will participate in the Guggenheim Healthcare Innovation Conference in Boston, Massachusetts, from November 11-13, 2024. Tenax’s CEO, Chris Giordano, will provide an update on the company and the o ...

Tenax Therapeutics (NASDAQ:TENX) stock is soaring higher on Tuesday after the company announced the completion of an oversubscribed private placement for its shares. This oversubscribed private placement has Tenax Therapeutics expecting $100 million in gross proceeds. The company will use this money to continue its Phase 3 LEVEL trial, to start a second Phase 3 trial and for other general purposes. The private placement was led by new investor BVF Partners LP alongside several other investors. It includes 1 ...

CHAPEL HILL, N.C., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (the "Company" or "Tenax Therapeutics"), a Phase 3, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced that it has entered into a securities purchase agreement for an oversubscribed private placement financing that is expected to result in total gross proceeds of appr ...

CHAPEL HILL, N.C., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (the "Company" or "Tenax Therapeutics"), a Phase 3, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced that it has entered into a securities purchase agreement for an oversubscribed private placement financing that is expected to result in total gross proceeds of appr ...

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, 2024 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. ...

EX-99.1 2 tenx_ex991.htm PRESS RELEASE EXHIBIT 99.1 Tenax Therapeutics Reports First Quarter 2024 Financial Results and Provides a Corporate Update Currently Enrolling Patients in Phase 3 LEVEL Study with 24 Investigative Sites Initiated Secured Global Development and Commercial Rights to Levosimendan for Treatment of PH-HFpEF Expanded Intellectual Property Estate for Levosimendan with Issuance of New U.S. Patent Recently Hosted KOL Event, "LEVEL Setting," Featuring Four Experts in Heart Failure Discussing ...