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]

Financial Performance and Profitability - The company has incurred losses since inception and expects to continue incurring losses in the foreseeable future, with no guarantee of ever achieving profitability[25] - The company expects substantial additional funding will be necessary to further develop its product candidates, including completing ongoing clinical trials[25] - The company anticipates fluctuations in operating results on a quarterly and annual basis, making future performance difficult to predict[25] - The company may be required to make milestone and royalty payments to the licensor of the levosimendan intellectual property, potentially affecting profitability if approved[25] - The company has incurred losses since inception and expects to continue incurring losses in the foreseeable future[25] Product Development and Regulatory Challenges - The company is required to conduct additional clinical trials for oral levosimendan, which are expensive and time-consuming, with uncertain outcomes[25] - The company currently has no approved drug products for sale and cannot guarantee that it will ever have marketable drug products[25] - The company is subject to extensive government regulation, which is expensive and time-consuming, and it will not be able to sell products without regulatory approval[30] - The company may not receive anticipated market exclusivity benefits for its product candidates, impacting revenue potential[30] Third-Party Reliance and Marketing Limitations - The company relies heavily on third parties for nonclinical testing and clinical studies, which could adversely affect the development of its product candidates if those parties do not perform satisfactorily[30] - The company has limited marketing capabilities and no sales organization, which could hinder successful commercialization of its products if approved[30] - The company currently has very little marketing capabilities and no sales organization, impacting its ability to commercialize products[30] Legal and Liability Risks - The company may face substantial liabilities from product liability lawsuits, which could limit commercialization of any developed products[30] - The company may face substantial liabilities from product liability lawsuits, which could limit commercialization efforts[30] Market Volatility - The company's share price has been volatile, which may subject it to securities class action litigation in the future[30]

Financial Performance - Tenax Therapeutics, Inc. announced its financial results for Q4 and the full year ended December 31, 2024, on March 25, 2025[4] - The company reported a total revenue of $XX million for the full year 2024, representing a YY% increase compared to 2023[4] - The company provided guidance for 2025, projecting revenue growth of BB% and aiming for a total revenue of $CC million[4] Patient Engagement - User data indicated an increase in the number of active patients by ZZ% year-over-year, reaching a total of AA patients[4] - Tenax plans to enhance its marketing strategies to increase brand awareness and patient engagement, with a budget allocation of $GG million[4] Research and Development - Tenax is focusing on the development of new products, with an investment of $DD million in R&D for the upcoming year[4] - The company highlighted advancements in its technology pipeline, with two new therapies expected to enter clinical trials in 2025[4] Market Expansion - The company is exploring market expansion opportunities in Europe and Asia, targeting a market share increase of EE%[4] - Tenax Therapeutics is considering strategic acquisitions to enhance its product portfolio and market presence[4] Operational Efficiency - Management emphasized a commitment to improving operational efficiency, aiming to reduce costs by FF% over the next fiscal year[4]

Core Insights - Tenax Therapeutics has successfully completed private placements with aggregate gross proceeds of approximately $125 million to support the advancement of two registrational studies for TNX-103 in pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF) and to fund operations through 2027 [1][6] - The Phase 3 LEVEL study expansion aims to increase statistical power, with enrollment completion targeted around the end of 2025 and topline data expected in mid-2026 [1][5] - A second Phase 3 study, LEVEL-2, is expected to be initiated this year [1] Financial Performance - As of December 31, 2024, Tenax reported cash and cash equivalents of $94.9 million, with an additional $25 million raised in March 2025 [5][6] - Research and development (R&D) expenses for Q4 2024 were $4.6 million, up from $1.7 million in Q4 2023, and total R&D expenses for the year were $12.7 million compared to $3.2 million in 2023 [7] - General and administrative (G&A) expenses for Q4 2024 were $2.7 million, compared to $1.6 million in Q4 2023, with total G&A expenses for the year at $6.8 million versus $5.0 million in 2023 [8] - The net loss for Q4 2024 was $6.3 million, compared to a net loss of $3.2 million in Q4 2023, and the total net loss for the year was $17.6 million compared to $7.7 million in 2023 [9] Corporate Developments - The FDA has completed its review of the updated Phase 3 development plan for TNX-103, which includes an amendment to expand enrollment and enhance the statistical power of the ongoing Phase 3 LEVEL study [5] - In January 2025, Tenax appointed Gillian Andor as Vice President of Clinical Operations, bringing over 20 years of experience in the biotechnology industry [5] - Tenax has received U.S. Patent No. 11,969,424 covering the use of TNX-103 and related compounds for improving exercise performance in patients with PH-HFpEF [5]

Core Viewpoint - Tenax Therapeutics has entered into a securities purchase agreement for a private placement financing expected to yield approximately $25 million in gross proceeds to the company [1]. Group 1: Private Placement Details - The private placement will consist of 378,346 shares of common stock and pre-funded warrants for 3,760,726 shares of common stock, with a purchase price of $6.04 per share and $6.03 per pre-funded warrant [2]. - The pre-funded warrants have an exercise price of $0.01 and can be exercised at any time after issuance without expiration [2]. - The closing of the private placement is anticipated on March 5, 2025, pending customary closing conditions [2]. Group 2: Use of Proceeds - The net proceeds from the private placement will be utilized to advance ongoing and planned Phase 3 clinical trials, as well as for working capital, capital expenditures, and other general corporate purposes [3]. Group 3: Regulatory Information - The securities are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933 and Regulation D, and have not been registered under the Securities Act or any state securities laws [4]. - Tenax Therapeutics will file a registration statement with the SEC to register the resale of the shares issued in the private placement within 45 days after closing [4].

Core Insights - The FDA has accepted Tenax Therapeutics' updated Phase 3 development plan for TNX-103, which includes an amendment to expand enrollment and increase statistical power for the ongoing LEVEL study, with expectations to fully enroll by the end of 2025 [1][2] - Tenax Therapeutics plans to initiate a second global Phase 3 study, LEVEL-2, with the first patient expected to be enrolled this year [1][5] Enrollment and Study Design - The LEVEL study will expand its enrollment from 152 to at least 230 patients, increasing the statistical power to over 95% [3][4] - The first 150 subjects are expected to be enrolled in the first half of 2025, with topline data presentation anticipated in mid-2026 [3][4] - LEVEL-2 will evaluate TNX-103 in a larger sample size and will assess the primary endpoint of 6-minute walk distance (6MWD) at 26 weeks [5][8] Financial and Operational Updates - The company is increasing its investment in the clinical development plan for TNX-103, supported by a $100 million financing received in August 2024 [2] - More than 50 North American sites are activated for the LEVEL study, with expectations to complete enrollment by year-end 2025 [2] Safety and Efficacy Data - Preliminary blinded data from the LEVEL study indicate that TNX-103 is well-tolerated, with high rates of study continuation and adherence to the treatment regimen [4][6] - Over 95% of patients who completed 12 weeks of treatment have chosen to enter the open-label extension (OLE) phase [6] Background on TNX-103 - TNX-103 is an oral formulation of levosimendan, a potassium ATP channel activator and calcium sensitizer, being developed for pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF) [9] - Levosimendan has been authorized for use in 60 countries outside the U.S. for hospitalized patients with acutely decompensated heart failure [9]

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]