earnings
confidence high
sentiment negative
materiality 0.75
Cingulate Q3 net loss $7.3M widens 78% YoY; NDA for CTx-1301 accepted with PDUFA May 31, 2026
Cingulate Inc.
2025-Q3 EPS reported
-$3.60
- Net loss $7.3M vs $4.1M in Q3 2024; operating loss $6.0M on R&D $2.8M (+99.5% YoY) and G&A $3.1M (+69.7%).
- Cash $6.1M at Sep 30, 2025; company says it needs ~$7M additional capital to fund through May 2026 PDUFA.
- FDA accepted NDA for ADHD drug CTx-1301; PDUFA target date May 31, 2026; $4.3M fee waiver granted.
- Appointed Bryan Downey as CCO; closed $6M promissory note financing with 9% interest, maturing 18 months.
- Commercial supply agreement with Bend Bio Sciences for exclusive U.S. manufacture of CTx-1301 through 2028.
item 2.02item 9.01