Cingulate reports Phase 3 CTx-1301 trend toward significance; insider debt conversion at premium

Cingulate Inc.

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.

item 1.01 item 2.03 item 3.02 item 7.01 item 8.01 item 9.01

Key facts

Extracted from this filing and checked against the source text.

Material Agreements SEC 8-K Item 1.01/1.02 confidence 0.9

Cingulate Inc. entered into Note Conversion Agreement with Werth Family Investment Associates LLC (effective 2023-09-08).

Action: entry
Agreement: equity purchase
Counterparty: Werth Family Investment Associates LLC
Effective: 2023-09-08

Exact text from the filing

On September 8, 2023, the Company and CTx entered into a Note Conversion Agreement (the “Note Conversion Agreement”) with WFIA, pursuant to which WFIA agreed to convert the Original Principal Amount under the A&R Note plus all accrued interest thereon, or $5,812,500, into pre-funded warrants (“Pre-Funded Warrants”) to purchase 6,838,235 shares (“Pre-Funded Warrant Shares”) of the Company’s common stock

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Cingulate Inc. filing history →

Source: SEC EDGAR

accession 0001493152-23-032175

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