secwatch.observer — SEC 8-K summary
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Issuer:     Cingulate Inc. (CING)
CIK:        0001862150
Form:       8-K
Filed at:   2023-09-11T23:59:59+00:00
Accession:  0001493152-23-032175
Event type: other_material
Sentiment:  neutral
Materiality: 0.75
Item codes: 1.01, 2.03, 3.02, 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Cingulate reports Phase 3 CTx-1301 trend toward significance; insider debt conversion at premium
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- Werth Family converted $5.8M debt/interest into 6.8M pre-funded warrants at $0.85/share (market $0.058).
- Phase 3 adult trial did not meet primary endpoint (PERMP over 16h, p=0.089) but showed trend and effect sizes 1.41 at 30min, 0.98 at 16h.
- CGI-S scores significantly improved (-1.2 vs 0.0, p<0.001); AISRS scores reduced by -16.3.
- Safety favorable: only one mild AE in CTx-1301 group vs three in placebo; no insomnia reported.
- NDA filing expected H2 2024; Phase 3 pediatric dose-optimization and fixed-dose trials ongoing.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1862150/000149315223032175/0001493152-23-032175-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1862150/000149315223032175/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-23-032175

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer