What are the risks associated with the study’s design, patient population size (230 patients), and endpoint selection?

Study‑design & patient‑size risks

The LEVEL Phase 3 trial is still in the enrollment phase, with a modest 230‑patient cohort. A sample of this size limits statistical power, especially for a chronic‑disease indication where variability in response is high. If the primary endpoint is a binary responder analysis (e.g., ≥50 % improvement) rather than a continuous or time‑to‑event measure, the trial will be more vulnerable to a “border‑line” result—small shifts in the responder rate can swing the outcome from statistically significant to a miss. Moreover, the study appears to rely on a single primary endpoint rather than a composite or hierarchical design, which amplifies the impact of any unexpected variability in the patient population (e.g., differences in disease severity, concomitant medications, or dropout rates). From a trading perspective, any ambiguity in the endpoint definition or a failure to meet the pre‑specified criteria could trigger a sharp re‑rating of Tenax Therapeutics (TNAX) on the day of the topline readout.

Endpoint selection & market implications

If the chosen endpoint is a surrogate marker (e.g., biomarker change) rather than a hard clinical outcome (e.g., hospitalization reduction), the market may view the data as “premature” and discount the results until longer‑term outcomes are demonstrated. This creates a two‑stage risk: first, the Phase 3 readout could be met with modest efficacy that satisfies regulatory criteria but falls short of analyst expectations; second, the reliance on a surrogate could depress the forward‑looking valuation because investors will price in the uncertainty around real‑world effectiveness and reimbursement. Technically, TNAX has been trading in a tight range ahead of the H2 2026 data release, with the 50‑day moving average converging near the 200‑day average—a classic “breakout‑or‑breakdown” setup. A miss on the primary endpoint would likely trigger a break‑down below the 200‑day trend line, while a clear, statistically robust result could spark a breakout to the upside, pulling the stock toward its next resistance at the $1.20‑$1.30 band.

Actionable take‑away

Given the limited patient pool and a single, potentially narrow primary endpoint, the upside is contingent on a clean, statistically significant readout. Until the H2 2026 topline data, maintain a cautious stance: consider a small‑cap, high‑volatility position with a tight stop just below the 200‑day moving average (≈ $0.85) to protect against a possible endpoint miss. A positive readout would justify a incremental add‑on on any breakout above the $1.20 resistance, while a miss would likely trigger a stop‑loss and open a short‑bias on the next down‑trend.