Tenax Therapeutics Announces Result of Prespecifed Blinded Sample Size Assessment

Rhea-AI Summary

Tenax Therapeutics (NASDAQ: TENX) reported that a prespecified blinded sample size re-estimation (BSSR) for the Phase 3 LEVEL trial showed the study is powered at >90% to detect a 25-meter change in 6-minute walk distance (6MWD), with observed standard deviation in the first 150 randomized patients below the assumed 55 meters. Tenax confirmed no increase in target enrollment and reiterated that LEVEL enrollment is expected to complete in the first half of 2026, with topline data expected in the second half of 2026.

The company also initiated LEVEL-2, a global Phase 3 trial planning ~540 patients randomized 2:1 (TNX-103 vs placebo) with primary endpoint 6MWD at Week 26, selecting >100 sites across 15 countries and estimating enrollment completion by end of 2027. Tenax will open a global open-label extension to provide continued access to TNX-103.

Positive

• Power >90% to detect a 25m 6MWD change
• Observed 6MWD SD in first 150 patients
• LEVEL enrollment on track to finish H1 2026
• LEVEL-2 initiated targeting ~540 patients (2:1 randomization)
• Selected >100 sites across 15 countries
• Open-label extension provides continued patient access to TNX-103

Negative

• LEVEL-2 enrollment estimated ~2 years (completion end of 2027)
• Protocol includes a 6-month blinded safety follow-up after Week 26, extending time to a full safety database

News Market Reaction – TENX

+5.65% 1.8x vol

18 alerts

+5.65% News Effect

+17.6% Peak in 26 hr 11 min

+$5M Valuation Impact

$86M Market Cap

1.8x Rel. Volume

On the day this news was published, TENX gained 5.65%, reflecting a notable positive market reaction. Argus tracked a peak move of +17.6% during that session. Our momentum scanner triggered 18 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $5M to the company's valuation, bringing the market cap to $86M at that time. Trading volume was above average at 1.8x the daily average, suggesting increased trading activity.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Power to detect change: well over 90% Primary endpoint delta: 25 meters Patients in BSSR review: 150 patients +5 more

8 metrics

Power to detect change well over 90% LEVEL Phase 3 trial power to detect 25m 6MWD change

Primary endpoint delta 25 meters Change in 6-minute walk distance (6MWD) in LEVEL

Patients in BSSR review 150 patients First randomized, placebo-controlled LEVEL patients in blinded SD review

Assumed SD threshold 55 meters Assumed standard deviation in 6MWD change for LEVEL powering

LEVEL-2 planned enrollment 540 patients Global Phase 3 LEVEL-2 PH-HFpEF study, TNX-103 vs placebo

Randomization ratio 2:1 TNX-103 to placebo allocation in LEVEL-2

Primary endpoint timing Week 26 Change from baseline in 6MWD in LEVEL-2

Safety observation period 6 months Blinded, placebo-controlled safety cohort following 26-week efficacy in LEVEL-2

Market Reality Check

Price: $12.26 Vol: Volume 207,402 is about 1...

normal vol

$12.26 Last Close

Volume Volume 207,402 is about 1.23x the 20-day average of 168,805 ahead of this update. normal

Technical Shares at $11.16 are trading above the $6.54 200-day MA and sit 2.87% below the 52-week high of $11.49.

Peers on Argus

Peer biotech names show mixed, mostly small moves (e.g., KZR +0.32%, DARE -0.88%...

Peer biotech names show mixed, mostly small moves (e.g., KZR +0.32%, DARE -0.88%, others flat), suggesting TENX’s +5.18% move is more company-specific to the LEVEL and LEVEL-2 updates.

Historical Context

5 past events · Latest: Nov 25 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 25	Investor conferences	Neutral	+4.4%	Participation in December investor conferences to present corporate and clinical story.
Nov 12	Earnings & update	Neutral	-0.7%	Q3 2025 financials plus guidance on LEVEL enrollment and LEVEL-2 initiation.
Nov 06	KOL call	Neutral	-2.4%	Announcement of virtual KOL call focused on TNX-103 and PH-HFpEF program.
Nov 03	Conference appearance	Neutral	-2.3%	Presentation at Guggenheim healthcare innovation conference via fireside chat.
Sep 16	Patent news	Positive	+3.5%	EPO intent to grant patent on levosimendan use in PH-HFpEF through Dec 2040.

Pattern Detected

Recent news has been largely program- and investor-relations focused, with modest price reactions that mostly align with the generally positive clinical and strategic trajectory.

Recent Company History

Over the last few months, Tenax has highlighted steady progress around TNX-103 and PH-HFpEF. A Sep 16 patent intention to grant extended protection to Dec 2040, supporting long-term value around levosimendan. Subsequent conference and KOL updates in November 2025 reinforced advancing Phase 3 studies LEVEL and LEVEL-2, while Q3 2025 results on Nov 12 confirmed funding with cash of $99.4M and ongoing trial investments. Today’s BSSR result and LEVEL-2 initiation build directly on this late-stage development narrative.

Market Pulse Summary

The stock moved +5.7% in the session following this news. A strong positive reaction aligns with the...

Analysis

The stock moved +5.7% in the session following this news. A strong positive reaction aligns with the de-risking nature of this update. The BSSR showed LEVEL is powered at well over 90% to detect a 25-meter 6MWD change without increasing enrollment, while LEVEL-2 advances with a planned 540-patient global design and added safety follow-up. With shares already above the $6.54 200-day MA and near a $11.49 52-week high, investors may weigh late-stage execution and regulatory outcomes when assessing durability of gains.

Key Terms

blinded sample size re-estimation, 6-minute walk distance, pulmonary hypertension, heart failure with preserved ejection fraction, +4 more

8 terms

blinded sample size re-estimation medical

"the prespecified Blinded Sample Size Re-estimation (BSSR) of LEVEL demonstrated"

A blinded sample size re-estimation is a mid-study check that adjusts how many participants a clinical trial needs based on aggregated data like event rates or variability, done without revealing who received the experimental treatment or control. For investors, it matters because changing the required number of participants can alter a trial’s cost, timeline and chances of producing reliable results—like increasing a recipe’s ingredient amounts mid-cook when you see the dish isn’t turning out as expected, but doing so without knowing which ingredient caused the issue.

6-minute walk distance medical

"detect a 25 meter change in 6-minute walk distance (6MWD), the primary endpoint"

A 6-minute walk distance is a simple clinical test that measures how far a person can walk on a flat surface in six minutes, used to gauge heart and lung function and overall physical stamina. Investors care because changes in this distance are often used as a clear, quantifiable indicator of a treatment’s real-world benefit in clinical trials, which can influence regulatory decisions, market adoption and a company’s valuation.

pulmonary hypertension medical

"in patients with pulmonary hypertension in heart failure with preserved ejection fraction"

Pulmonary hypertension is a condition where the blood vessels in the lungs become narrowed or stiff, forcing the right side of the heart to work much harder to push blood through—imagine a pump trying to push water through narrower pipes. For investors, it matters because the condition drives demand for diagnostic tests, ongoing treatments, and new drugs; changes in clinical trial results, approvals, or treatment guidelines can meaningfully affect the commercial prospects and costs for companies focused on this disease.

heart failure with preserved ejection fraction medical

"pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF)"

A form of heart disease where the heart muscle pumps out a normal share of blood each beat but struggles to relax and fill properly, like a pump that can push water out but has trouble drawing enough back in between cycles. It matters to investors because it drives large and growing demand for treatments, hospital care and diagnostic tests, influences clinical trial design and regulatory decisions, and can affect the commercial prospects of drugs and medical devices.

randomized medical

"Phase 3, double-blind, randomized, placebo-controlled study of TNX-103"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

placebo-controlled medical

"Phase 3, double-blind, randomized, placebo-controlled study of TNX-103"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

open-label extension medical

"initiate a global, multi-center, long-term, open-label extension (OLE) study"

An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.

hemodynamics medical

"sites globally whose method of assessing patient hemodynamics is consistent"

Hemodynamics is the study of how blood moves through the body — including flow rates, pressure and resistance in vessels and the heart — and the forces that affect that movement. For investors, hemodynamic measurements act like performance gauges for cardiovascular drugs, devices or procedures: they help show whether a treatment works, is safe, and is likely to win regulatory approval, clinical adoption and insurance reimbursement.

AI-generated analysis. Not financial advice.

Planned Review of Standard Deviation Demonstrates No Need to Increase Size of Ongoing LEVEL Study

LEVEL On Track to Complete Enrollment in First Half of 2026; Topline Data Expected in Second Half of 2026

Global Phase 3 LEVEL-2 Study Initiated; Company Estimates Completion of Enrollment by End of 2027

CHAPEL HILL, N.C., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax” or “Tenax Therapeutics” or the “Company”), a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies, announced today that the prespecified Blinded Sample Size Re-estimation (BSSR) of LEVEL demonstrated the trial is powered at well over 90% to detect a 25 meter change in 6-minute walk distance (6MWD), the primary endpoint. Based on these results, Tenax confirmed the target enrollment remains unchanged, and reiterated that enrollment is expected to complete in the first half of 2026.

LEVEL is an ongoing, registrational Phase 3 clinical trial evaluating TNX-103 (oral levosimendan) in patients with pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF) in the United States and Canada. The prespecified, blinded review of the standard deviation in 6MWD change observed in the first 150 randomized, placebo-controlled patients, yielded a result of less than the assumed 55 meters.

“We are very pleased with the outcome of the BSSR, a derisking element built into the LEVEL protocol from the start. Key powering assumptions we based on data from the Phase 2 HELP trial are now confirmed,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “We are also very encouraged by the high rate of study completion in this assessment of the first two-thirds of patients in LEVEL. We look forward to sharing topline data in the second half of 2026, and remain confident in our ability to execute on our Phase 3 development plan of TNX-103.”

The Company also announced today that it has initiated LEVEL-2, the second registrational study of TNX-103 in patients with PH-HFpEF. LEVEL-2 (NCT07288398) is a global, Phase 3, double-blind, randomized, placebo-controlled study of TNX-103. The clinical trial plans to enroll approximately 540 PH-HFpEF patients, randomized 2:1 to receive TNX-103 or placebo. The primary endpoint of the study is change from baseline in 6MWD at Week 26. Secondary endpoints include change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) and New York Heart Association (NYHA) Functional Class.

“We have selected over 100 sites across 15 countries so far to participate in LEVEL-2. Relying on what we have learned from LEVEL, Tenax has implemented a rigorous process to identify sites globally whose method of assessing patient hemodynamics is consistent with the most successful sites in the U.S. and Canada. Our feasibility data suggests a total enrollment timeline of approximately two years,” said Stuart Rich, MD, Chief Medical Officer of Tenax Therapeutics. “LEVEL-2 includes a cohort of patients who will undergo a 6-month, blinded, placebo-controlled, safety observation following the 26-week efficacy assessment, to provide the FDA and other global regulators a robust safety database to support their ultimate risk/benefit analysis at the approval stage.”

In addition, Tenax announced today it will initiate a global, multi-center, long-term, open-label extension (OLE) study. The OLE study will provide patients enrolled in levosimendan clinical trials continued access to TNX-103 after study completion and until potential availability of a commercialized product.

About Levosimendan (TNX-101, TNX-102, TNX-103)

Levosimendan is a novel, first-in-class K-ATP channel activator/calcium sensitizer currently being evaluated to treat pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (PH-HFpEF). Levosimendan was first developed for intravenous use in hospitalized patients with acutely decompensated heart failure, and it has received market authorization in 60 countries in this indication, although it is not available in the United States or Canada. Tenax’s Phase 2 HELP study, including its open-label extension stage, demonstrated the potential of IV (TNX-101) and oral (TNX-103) levosimendan to bring durable improvements in exercise capacity and quality of life, as well as other clinical assessments, in patients with PH-HFpEF. TNX-103 (oral levosimendan) is currently being evaluated in LEVEL and LEVEL-2, two Phase 3, double-blind, randomized, placebo-controlled clinical trials in patients with PH-HFpEF.

About Tenax Therapeutics

Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies. The Company owns global rights to develop and commercialize levosimendan, which it is developing for the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension globally, for which no product has been approved to date. For more information, visit www.tenaxthera.com. Tenax Therapeutics’ common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”.

Caution Regarding Forward-Looking Statements

Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. These forward-looking statements may include information concerning possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, location, initiation, enrollment, and results of such trials; any delays in regulatory review and approval of product candidates in development; risks related to our business strategy, including the prioritization and development of product candidates; our estimates regarding the potential market opportunity for our product candidates; reliance on third parties, including Orion Corporation, our manufacturers and CROs; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; the potential advantages of our product candidates; our competitive position; intellectual property risks; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; volatility and uncertainty in the global economy and financial markets in light of unexpected changes in tariffs and the possibility of pandemics, global financial and geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of Ukraine; risks associated with our cash needs; changes in legal, regulatory and legislative environments in the markets in which we operate, and the impact of these changes on our ability to obtain regulatory approval for our products; and other risks and uncertainties set forth from time to time in our SEC filings. Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law.

Contact:

Investor and Media:

Argot Partners
tenax@argotpartners.com

FAQ

What did Tenax announce about the LEVEL Phase 3 trial (NASDAQ: TENX) on December 17, 2025?

Tenax said a blinded sample size re-estimation showed >b>90% power to detect a 25m 6MWD change and confirmed no increase in target enrollment.

When is LEVEL enrollment expected to complete and when are topline results for TENX expected?

Tenax expects LEVEL enrollment to complete in the first half of 2026 with topline data in the second half of 2026.

What are the key design details of the LEVEL-2 study for TENX (NCT07288398)?

LEVEL-2 is a global Phase 3, double-blind, randomized placebo-controlled study planning ~540 PH-HFpEF patients randomized 2:1, primary endpoint 6MWD at Week 26.

How many sites and countries are planned for TENX’s LEVEL-2 trial?

Tenax has selected over 100 sites across 15 countries so far for LEVEL-2.

Will Tenax provide continued patient access to TNX-103 after trial completion?

Yes — the company will initiate a global open-label extension to provide continued access to TNX-103 until potential commercial availability.

Does the LEVEL-2 protocol include additional safety follow-up that could affect review timing for TENX?

Yes — LEVEL-2 includes a cohort with a 6-month blinded safety observation after the 26-week efficacy assessment to strengthen the safety database for regulators.