Tonix Pharmaceuticals Holding Corp. 8-K

What Happened

• Tonix Pharmaceuticals Holding Corp. announced two oral presentations at the 8th International Congress on Controversies in Fibromyalgia (ICCF) held March 9–10, 2026 and filed a press release on March 10, 2026 (Item 7.01 / Item 8.01).
• The first presentation reported results from RESILIENT, a 14-week, randomized, placebo‑controlled Phase 3 trial in 457 adults with fibromyalgia: the primary endpoint (change from baseline to Week 14 in weekly average daily numeric rating scale pain scores) was met with high statistical significance (p < 0.001), with a least-squares mean treatment difference of −0.65. A post hoc mixed-model repeated-measures analysis showed pain improvements versus placebo as early as Day 2 and statistically significant relief each week through Weeks 1–14; all key secondary endpoints were also statistically significant in favor of TONMYA (cyclobenzaprine HCl sublingual tablets).
• The second presentation described a pooled post hoc analysis of 959 participants (783 completers) from the RELIEF and RESILIENT Phase 3 trials to clarify benefit–risk using NNT, NNH and LHH.

Key Details

• RESILIENT trial: 14 weeks, randomized, placebo-controlled, 457 adults; primary endpoint met (p < 0.001); LS mean difference = −0.65.
• Onset: statistically significant pain reduction versus placebo observed as early as Day 2 and each week Weeks 1–14 (post hoc MMRM analysis).
• Pooled analysis (RELIEF + RESILIENT, N=959): NNT for ≥30% pain reduction at Week 14 = 7 (95% CI: 5–12); NNH for discontinuation due to adverse event = 26 (95% CI: 14–110); LHH = 3.7.
• Disclosure: press release filed as Exhibit 99.01; filing includes standard forward‑looking statement caution.

Why It Matters

• These Phase 3 results and pooled benefit–risk metrics indicate TONMYA produced statistically significant and early pain relief versus placebo in fibromyalgia patients and show a favorable balance of benefit to risk by the NNT/NNH/LHH measures presented. For investors, such data are material to the clinical and commercial prospects of TONMYA and could affect future regulatory, development and market expectations. The company also flagged the usual forward‑looking statement risks in the filing.