The stock may react positively to the patent wins and NDA review progress, but the widening loss and cash burn could pressure sentiment ahead of the May 2026 PDUFA decision. Traders should monitor FDA feedback on CMC issues and any updates on commercial scale-up as key near-term catalysts.
Price Chart
Executive Summary
Cingulate Inc. reported its Q4 and full-year 2025 financial results, highlighted by a $12 million PIPE financing, U.S. and European patent allowances for its lead ADHD candidate CTx-1301, and ongoing FDA review of its NDA with a PDUFA date of May 31, 2026. Despite advancing key regulatory and commercial milestones, the company reported a wider annual net loss of $22.4 million compared to $16.6 million in 2024, driven by higher G&A expenses.
Key Financial Metrics
Key Facts
- CTx-1301 received U.S. Notice of Allowance and European patent grant, extending protection to 2042.
- FDA accepted NDA for CTx-1301 with PDUFA date of May 31, 2026; review ongoing with additional CMC requests being addressed.
- Closed $12 million at-the-market PIPE financing in February 2026 with insider participation and 180-day lock-up.
- Appointed Bryan Downey, former Sanofi executive, as Chief Commercial Officer in November 2025.
- Net loss increased to $22.4 million in 2025 from $16.6 million in 2024, primarily due to higher G&A expenses.
- Cash balance decreased to $10.95 million as of December 31, 2025, from $12.21 million a year prior; expected to fund operations into Q4 2026.
Financial Impact
Increased annual net loss by $5.8 million; $12 million in new capital raised; R&D expenses down 52% YoY in Q4.
Risk Factors
- FDA may delay approval if CMC issues are not resolved in time for the May 31, 2026 PDUFA date.
- Cash runway extends only into late Q4 2026, raising potential for future dilution if approval is delayed or commercial launch requires additional funding.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3258107 |
Track record builds as more directional reports settle.
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Jun 2, 2026 20w ago | 8-K | $0.0601 $0.0114 | ▲ +81.03% | ▲ +82.15% | — |
May 19, 2026 22w ago | 8-K | $0.0601 $0.007200 | ▼ −88.02% | ▼ −93.02% | — |
May 14, 2026 23w ago | 8-K | $0.0601 $0.007200 | ▼ −88.02% | ▼ −91.61% | — |
May 14, 2026 23w ago | Press Release | $0.0601 $0.007200 | ▼ −88.02% | ▼ −91.61% | — |
Apr 27, 2026 26w ago | EFFECT | $0.0601 $0.0189 | ▲ +68.55% | ▲ +73.33% | — |
Mar 18, 2026 31w ago | Press Release | $0.0601 $0.0601 | · 0.00% | ▼ −11.53% | — |
US Market Status
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