Tenax Therapeutics Inc - TENX STOCK NEWS

Tenax Therapeutics (NASDAQ: TENX) reported its Q4 and full-year 2024 financial results, highlighting successful private placements totaling $125 million to support two registrational studies for TNX-103 in PH-HFpEF. The company ended 2024 with $94.9 million in cash, with funding now extended through 2027.

The Phase 3 LEVEL study has been expanded to enhance statistical power, with enrollment completion targeted for year-end 2025 and topline data expected mid-2026. A second Phase 3 study, LEVEL-2, is planned to commence in 2025.

Financial highlights include increased R&D expenses of $12.7 million for 2024 (vs $3.2 million in 2023) and G&A expenses of $6.8 million (vs $5.0 million in 2023). The company reported a net loss of $17.6 million for 2024, compared to $7.7 million in 2023.

Tenax Therapeutics (NASDAQ: TENX) has secured a $25 million private placement financing through an agreement with RTW Investments. The deal includes 378,346 shares of common stock and pre-funded warrants to purchase 3,760,726 shares at $6.04 per share and $6.03 per warrant respectively.

The pre-funded warrants have a $0.01 exercise price with no expiration date. The placement, expected to close on March 5, 2025, is led by Leerink Partners, with Guggenheim Securities and William Blair as joint placement agents.

The net proceeds will fund the company's ongoing and planned Phase 3 clinical trials, working capital, capital expenditures, and general corporate purposes. The securities are being offered under Section 4(a)(2) of the Securities Act and Regulation D, with Tenax agreeing to file a registration statement within 45 days for resale of the shares.

Tenax Therapeutics (NASDAQ: TENX) has announced significant expansions to its Phase 3 LEVEL program for TNX-103 (oral levosimendan) in treating PH-HFpEF. The FDA has approved two key developments:

1. An amendment to expand the ongoing LEVEL study from 152 to 230 patients, increasing statistical power to over 95%. The study is expected to complete enrollment by end of 2025 with topline data expected mid-2026.

2. Approval to initiate LEVEL-2, a second global Phase 3 study, starting in 2025.

Current blinded LEVEL data shows strong patient retention with >95% continuation rates across multiple metrics. The company's $100 million financing from August 2024 supports these expanded trials. The studies aim to provide sufficient data for regulatory submissions in the U.S. and other regions for TNX-103, which targets PH-HFpEF, a condition currently without approved treatments.

Tenax Therapeutics (TENX), a Phase 3 development-stage pharmaceutical company focused on cardiovascular and pulmonary diseases, has announced its participation in the upcoming Guggenheim SMID Cap Biotech Conference. The event will take place in New York from February 5-6, 2025.

Company President & CEO Chris Giordano will participate in a fireside chat on February 5, 2025, at 3:00 pm ET. The presentation will be available via webcast, accessible through the company's investor relations webpage. Additionally, Tenax management will be conducting one-on-one investor meetings during the conference, which can be arranged through Guggenheim representatives.

Tenax Therapeutics (NASDAQ: TENX) has appointed Gillian Andor, MSc, as Vice President of Clinical Operations. Andor brings over 20 years of experience and will lead the company's Clinical Operations function, supporting the ongoing Phase 3 LEVEL study of oral levosimendan (TNX-103) for PH-HFpEF treatment.

Andor's track record includes successful roles at Noema Pharma as Interim Head of Clinical Development Operations and at Sage Therapeutics, where she led programs resulting in NDA approvals for Zulresso® and Zurzuvae®. At Ironwood Pharmaceuticals, she contributed to the NDA approval of Linzess®.

The company granted Andor an inducement equity award of 250,000 stock options at $6.44 per share, vesting over four years in equal annual installments.

Tenax Therapeutics (TENX) reported Q3 2024 financial results, highlighting a successful $100 million private placement with institutional healthcare investors. The company's cash position reached $98.3 million as of September 30, 2024, providing runway through 2027. R&D expenses increased to $3.1 million from $1.1 million year-over-year, while G&A expenses rose to $1.5 million from $1.1 million. Net loss widened to $4.0 million compared to $2.0 million in Q3 2023. The company continues to expand its Phase 3 LEVEL study with 52 investigative sites now initiated.

Tenax Therapeutics (Nasdaq: TENX) has announced its participation in the Guggenheim Healthcare Innovation Conference in Boston, scheduled for November 11-13, 2024. CEO Chris Giordano will present a company update and discuss the development of levosimendan in a fireside chat format on November 13, 2024, at 1:00 PM EST.

The presentation, which will be available via live webcast and archived recording, will showcase the company's progress in developing treatments for cardiovascular and pulmonary diseases with high unmet medical need. Investors can access the presentation through the company's investor relations webpage or the provided webcast link.

Tenax Therapeutics (TENX) reported Q2 2024 financial results and provided a corporate update. Key highlights include:

1. Raised $100 million in gross proceeds through a private placement with leading healthcare investors.

2. Continuing enrollment in the Phase 3 LEVEL study with 39 investigative sites initiated.

3. Hosted a KOL event discussing the unmet medical need in PH-HFpEF and levosimendan's potential.

4. Secured U.S. patent for levosimendan use in PH-HFpEF.

5. Q2 2024 financial results: $9.4 million in cash and cash equivalents, R&D expenses of $2.3 million, and a net loss of $3.6 million or $1.83 per share.

Tenax Therapeutics (NASDAQ: TENX) has closed a $100 million private placement to accelerate its oral levosimendan (TNX-103) Phase 3 development program. The funding will support the completion of the ongoing LEVEL Study for treating Pulmonary Hypertension Due to Heart Failure with Preserved Ejection Fraction (PH-HFpEF) and initiate a second Phase 3 study planned for 2025. This financing, led by BVF Partners LP and other prominent healthcare investors, positions Tenax to shorten the timeline to NDA submission.

The LEVEL study aims to demonstrate the impact of daily oral levosimendan on exercise ability in PH-HFpEF patients, a condition with no FDA-approved therapies. Previous studies showed promising results, with participants in the HELP study demonstrating a 10% improvement in six-minute walk distance over six weeks.