The BLA completion guidance to Q4 2026 and upcoming PIVOT-006 data in H1 2026 are the key catalysts. The CORE-008 Cohort CX data at AUA on May 16 could provide early read on combination therapy. The $1.1B cash runway through 2029 removes near-term financing risk. Monitor the PIVOT-006 topline for potential approval expansion into intermediate-risk NMIBC.
Price Chart
Executive Summary
CG Oncology reported Q1 2026 results with a net loss of $0.71 per share, slightly wider than the $0.45 loss a year ago, but the headline is the BLA completion timeline for cretostimogene in BCG-unresponsive NMIBC now guided to Q4 2026, with Phase 3 PIVOT-006 topline data expected in H1 2026. The company raised $391.4M via ATM in Q1, boosting cash to $1.1B, sufficient through 2029, and reported first commercial revenue of $1.07M. The stock will move on the BLA timeline clarity and upcoming PIVOT-006 data readout.
Key Financial Metrics
Key Facts
- BLA completion for cretostimogene in HR BCG-unresponsive NMIBC guided to Q4 2026 (previously no specific timeline)
- Phase 3 PIVOT-006 topline data in intermediate-risk NMIBC expected H1 2026
- First results from CORE-008 Cohort CX (cretostimogene + gemcitabine) to be presented at AUA May 16, 2026
- Net loss of $60.2M ($0.71/share) vs $34.5M ($0.45/share) in Q1 2025
- Cash, cash equivalents and marketable securities of $1.1B, up from $742.2M at Dec 2025
- Raised ~$391.4M via ATM facility in Q1 2026 from 6.94M shares
- First commercial and development revenue of $1.07M reported (vs $0 in Q1 2025)
- R&D expenses increased to $43.7M from $27.5M; G&A expenses increased to $20.8M from $14.8M
Financial Impact
Net loss widened to $60.2M from $34.5M; cash position strengthened to $1.1B from $742.2M; first commercial revenue of $1.07M reported
Risk Factors
- PIVOT-006 topline data may miss efficacy endpoints, delaying label expansion
- BLA submission could face CMC delays beyond Q4 2026 guidance
- Widening net loss trajectory with no near-term profitability expected
- Competitive landscape in NMIBC (Keytruda, other oncolytic viruses)
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3291055 |
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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