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]

Tenax Therapeutics, Inc. (NASDAQ:TENX) Guggenheim Healthcare Innovation Conference November 13, 2024 1:00 PM ET Company Participants Chris Giordano - President and CEO Stuart Rich - Chief Medical Officer Conference Call Participants Seamus Fernandez - Guggenheim Securities Seamus Fernandez Good afternoon, everybody. And welcome again to Guggenheim Securities Inaugural Healthcare Innovation Conference. We are here with Tenax Therapeutics. I'm Seamus Fernandez, one of the senior biopharma analysts here at Gug ...

Tenax Therapeutics, Inc. (NASDAQ:TENX) Guggenheim Healthcare Innovation Conference November 13, 2024 1:00 PM ET Company Participants Chris Giordano - President and CEO Stuart Rich - Chief Medical Officer Conference Call Participants Seamus Fernandez - Guggenheim Securities Seamus Fernandez Good afternoon, everybody. And welcome again to Guggenheim Securities Inaugural Healthcare Innovation Conference. We are here with Tenax Therapeutics. I'm Seamus Fernandez, one of the senior biopharma analysts here at Gug ...

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 September 30, 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 (I.R.S.EmployerIdentification ...

EX-99.1 2 tenx_ex991.htm PRESS RELEASE EXHIBIT 99.1 Tenax Therapeutics Reports Third Quarter 2024 Financial Results and Provides a Corporate Update Raised Gross Proceeds of Approximately $100 Million in a Private Placement with Leading Institutional Healthcare Investors Continuing to Enroll Patients in Phase 3 LEVEL Study with 52 Investigative Sites Now Initiated Cash Runway Through End of 2027 CHAPEL HILL, N.C., November 13, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX), a Phase 3, devel ...

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 ...