earnings
confidence high
sentiment neutral
materiality 0.70
Cingulate Q2 net loss widens to $4.8M; files NDA for CTx-1301 with FDA
Cingulate Inc.
2025-Q2 EPS reported
-$2.14
- Net loss of $4.8M in Q2 2025, up from $3.2M in Q2 2024; R&D spend +43.6% to $2.7M.
- Cash and cash equivalents $8.9M as of June 30, 2025; expects cash needs into late 2025; needs ~$1.5M more for commercialization.
- Submitted NDA to FDA for lead asset CTx-1301 (dexmethylphenidate) on July 31, 2025; FDA decision on acceptance expected in 60 days.
- Executed $25M purchase agreement with Lincoln Park Capital for at-the-market common stock sales over 36 months.
- Phase 3 pediatric study showed marked improvement in ADHD symptoms at week five.
item 2.02item 9.01