The stock will trade on the PIVOT-006 topline data and CORE-008 Cohort CX results expected in the coming weeks, not on the quarterly financials. The BLA completion timeline extension to Q4 2026 removes near-term regulatory catalyst risk but provides clarity. Monitor the AUA presentation on May 16 for the first combination data with gemcitabine.
Price Chart
Executive Summary
CG Oncology reported Q1 2026 results with a net loss of $0.71 per share, wider than the prior year's $0.45 loss, and total revenue of $1.1M. The key positive was a BLA submission timeline update for cretostimogene in HR BCG-unresponsive NMIBC, now expected to complete in Q4 2026, and a strong cash position of $1.1B. However, the widening net loss and lack of consensus estimates for this quarter make the financial results directionally negative for a pre-revenue biotech.
Key Financial Metrics
Key Facts
- BLA completion for cretostimogene in HR BCG-unresponsive NMIBC expected Q4 2026, following FDA alignment discussions
- PIVOT-006 Phase 3 topline data in intermediate-risk NMIBC anticipated H1 2026
- CORE-008 Cohort CX Phase 2 first results to be presented at AUA 2026 on May 16
- Cash, cash equivalents and marketable securities of $1.1B as of March 31, 2026, up from $742.2M at Dec 31, 2025
- Net loss of $60.2M ($0.71/share) for Q1 2026 vs $34.5M ($0.45/share) in Q1 2025
- R&D expenses increased to $43.7M from $27.5M; G&A expenses increased to $20.8M from $14.8M
- Raised $391.4M net proceeds from ATM facility in Q1 2026, selling 6,941,407 shares
- Total revenues of $1.1M for Q1 2026 vs $52K in Q1 2025, primarily from commercial and development revenue
Financial Impact
Net loss widened by 74.7% YoY to $60.2M; cash position strengthened by $334M sequentially to $1.1B
Risk Factors
- PIVOT-006 Phase 3 topline data may miss efficacy or safety endpoints
- BLA submission delay beyond Q4 2026 could push potential approval into 2027
- Widening net losses with no near-term revenue visibility; cash burn rate increased to ~$60M/quarter
- Dilution risk from continued ATM usage (6.9M shares sold in Q1 2026)
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-213440 |
| Document: ck0001991792-20260508.htm | 0001193125-26-213440 |
| Document: 0001193125-26-213440-index-headers.html | 0001193125-26-213440 |
| Document: 0001193125-26-213440-index.html | 0001193125-26-213440 |
| Document: 0001193125-26-213440.txt | 0001193125-26-213440 |
| 8-K Data (Synthetic) | 0001193125-26-213440 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Aug 6, 2026 8w ago | Press Release | $74.85 $74.33 | ▲ +0.69% | ▲ +1.29% | $67.38 (+9.98%) |
Aug 6, 2026 8w ago | 424B5 | $74.85 $74.33 | ▲ +0.69% | ▲ +1.29% | $67.38 (+9.98%) |
Jul 27, 2026 9w ago | Press Release | $72.62 $78.95 | ▲ +8.72% | ▲ +5.34% | $67.38 (−7.22%) |
Jul 17, 2026 11w ago | Insider Cluster | $71.85 $75.03 | ▲ +4.43% | ▼ −0.02% | $67.38 (−6.22%) |
Jul 16, 2026 11w ago | Court Ruling | $69.50 $74.71 | ▲ +7.50% | ▲ +3.88% | $67.38 (−3.05%) |
Jun 24, 2026 14w ago | 144 | $72.84 $71.12 | ▼ −2.36% | ▼ −2.89% | $67.38 (−7.50%) |
Jun 22, 2026 14w ago | 144 | $65.73 $70.19 | ▲ +6.79% | ▲ +5.63% | $67.38 (+2.51%) |
Jun 12, 2026 16w ago | Institutional Cluster | $59.56 $75.24 | ▲ +26.33% | ▲ +24.55% | $67.38 (+13.13%) |
May 26, 2026 18w ago | 8-K | $61.89 $70.25 | ▲ +13.50% | ▲ +15.45% | $67.38 (+8.87%) |
May 15, 2026 20w ago | Press Release | $66.93 $59.56 | ▼ −11.01% | ▼ −13.13% | $67.38 (+0.67%) |
US Market Status
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