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]

Tenax Therapeutics (TENX) 2025 Conference March 10, 2025 03:40 PM ET Speaker0 So welcome everyone to our next session here. It's very much my pleasure to welcome two members of the leadership team of 10x. And I thought we'd actually kick off and assume that not everyone has read your bios. And maybe just very briefly, Chris, if you could just describe your background. And then you, Stuart, I thought that would take up most of the time. No, I'm just kidding. But I think it would be nice to set the stage, rig ...

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]

Tenax Therapeutics (TENX) Conference February 05, 2025 03:00 PM ET Speaker0 All right. Well, thanks everybody. We are kind of moving towards our I believe this is our final fireside chat for the day here at Guggenheim's SMIDCAP conference. Got a couple of panels after this, but I'm Seamus Fernandez. I'm one of the senior biopharma analysts here at Guggenheim Securities. And I'm really pleased to have the team here with me today. So 10x Therapeutics' CEO, Chris Giordano, immediately to my left and EVP, Busin ...

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.