Monitor for NDA resubmission announcement and any FDA communication on CTx-1301 — that is the primary catalyst. Cash runway into mid-2027 removes near-term financing urgency, but the lack of a resubmission timeline keeps the stock range-bound. The Prasco distribution deal and new patent are incremental positives but do not change the binary regulatory overhang.
Price Chart
Executive Summary
Cingulate reported Q2 2026 financial results with a net loss of $5.9M, widening from $5.0M a year ago, as SG&A expenses more than doubled to $3.9M due to commercial readiness build-out. The company holds $28.4M in cash, sufficient into mid-2027, and continues CMC work toward resubmitting the CTx-1301 NDA following the June 2026 CRL. The filing is neutral as it contains no revenue, no earnings surprise relative to consensus (pre-revenue biotech), and no new regulatory catalyst — only incremental progress on manufacturing and commercial infrastructure.
Key Facts
- Cash and cash equivalents of $28.4M as of June 30, 2026, providing runway into mid-2027.
- Net loss of $5.9M for Q2 2026 vs $5.0M in Q2 2025; net loss of $15.2M for H1 2026 vs $8.8M in H1 2025.
- SG&A expenses increased 101.5% YoY to $3.9M, driven by commercial readiness build-out.
- R&D expenses decreased 44.9% YoY to $1.5M following conclusion of clinical study activities.
- Company continues CMC work toward resubmission of CTx-1301 NDA after June 1, 2026 CRL; no specific timeline provided.
- U.S. Patent No. 12,653,791 issued June 16, 2026 covering CTx-1301 through December 2042.
- Signed exclusive distribution agreement with Prasco, LLC on July 21, 2026 for commercial launch infrastructure.
- Working capital of $21.6M as of June 30, 2026, up from $1.7M at December 31, 2025.
Financial Impact
Net loss widened by $0.9M in Q2 2026 vs Q2 2025; cash burn of $12.8M in H1 2026; no revenue generated.
Risk Factors
- NDA resubmission and FDA approval timeline for CTx-1301 is uncertain and could be delayed.
- Company has no approved products and no revenue; continued operating losses will require future capital raises.
- SG&A burn rate is accelerating as commercial readiness spending ramps ahead of any potential approval.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001493152-26-037605 |
| Document: form8-k.htm | 0001493152-26-037605 |
| Document: 0001493152-26-037605-index-headers.html | 0001493152-26-037605 |
| Document: 0001493152-26-037605-index.html | 0001493152-26-037605 |
| Document: 0001493152-26-037605.txt | 0001493152-26-037605 |
| 8-K Data (Synthetic) | 0001493152-26-037605 |
Track record builds as more directional reports settle.
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 2, 2026 23d ago | 8-K | $4.75 | awaiting T+60 | — | $4.98 (+4.84%) |
Sep 22, 2026 4w ago | Institutional Cluster | $5.15 | awaiting T+60 | — | $4.98 (−3.21%) |
Aug 13, 2026 10w ago | 8-K | $4.99 | awaiting T+60 | — | $4.98 (−0.20%) |
Jul 14, 2026 14w ago | 8-K | $4.71 $4.87 | ▲ +3.40% | ▲ +0.02% | $4.98 (+5.73%) |
Jun 16, 2026 18w ago | 8-K | $4.74 $5.17 | ▲ +9.07% | ▲ +8.07% | $4.98 (+5.06%) |
Jun 8, 2026 19w ago | Insider Cluster | $4.65 $5.15 | ▲ +10.75% | ▲ +6.94% | $4.98 (+7.10%) |
Mar 25, 2026 30w ago | EFFECT | $6.36 $4.97 | ▼ −21.86% | ▼ −35.31% | $4.98 (−21.70%) |
Mar 23, 2026 31w ago | S-3/A | $6.93 $5.12 | ▲ +26.12% | ▲ +39.18% | $4.98 (+28.14%) |
Mar 18, 2026 31w ago | DEFA14A | $7.51 $4.93 | ▼ −34.35% | ▼ −48.70% | $4.98 (−33.69%) |
Mar 18, 2026 31w ago | 8-K | $8.04 $5.09 | ▼ −36.69% | ▼ −48.22% | $4.98 (−38.06%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Create a free account Live analysis, Telegram alerts, watchlists and the MCP server for subscribers