CGON CG Oncology, Inc.

MIXED Impact: 5/10 8-K
Horizon weeks Filed May 8, 2026 Processed 1mo ago SEC 0001193125-26-213440
8-K Item 2.02: Earnings release
Latest settled — T+20d ⚠ clustered
CGON ▼ -22.84% at T+20d
NEUTRAL call ✗ call lost -22.84% · α vs SPY -22.86% · entry $69.62 → $53.72
Next anchor: T+60d in 8w
Last close $54.40 (close Jun 8) · -21.86% from $69.62 entry
Entry anchored
May 8, 08:07 AM ET
via Databento tick
T+1d
-0.43%
call -0.43% · α -0.66%
$69.32
settled 4w ago
T+5d
-0.12%
call -0.12% · α -1.59%
$69.54
settled 26d ago
T+20d
-22.84%
call -22.84% · α -22.86%
$53.72
settled yesterday
T+60d
call — · α —
in 8w

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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.

Actionable Insight

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.

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

net losscash positionR&D expensesG&A expenses

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

Exchange
Nasdaq
Sector
Biological Products, (No Diagnostic Substances)
Analyst Consensus
95% bullish (21 analysts)

Documents Analyzed

This report is based on 6 SEC documents filed with EDGAR.

DocumentAccession Number
8-K Filing (Primary)0001193125-26-213440
Document: ck0001991792-20260508.htm0001193125-26-213440
Document: 0001193125-26-213440-index-headers.html0001193125-26-213440
Document: 0001193125-26-213440-index.html0001193125-26-213440
Document: 0001193125-26-213440.txt0001193125-26-213440
8-K Data (Synthetic)0001193125-26-213440
9 reports for CGON
Performance horizon

Track record builds as more directional reports settle.

Filters
Rows
Reports for CGON — sortable, filterable
Type Now
May 26, 2026
14d ago
8-K
NEUTRAL ★ 3/10
$61.89 $59.23▼ −4.30%▼ −5.38%$54.40 (−12.10%)
May 15, 2026
25d ago
Press Release
BULLISH ★ 6/10
$66.93 $64.25▼ −4.00%▼ −4.97%$54.40 (−18.72%)
May 8, 2026
4w ago
8-K
MIXED ★ 5/10
$69.62 $69.54▼ −0.12%▼ −1.59%$54.40 (−21.86%)
May 8, 2026
4w ago
Press Release
NEUTRAL ★ 5/10
$69.62 $69.54▼ −0.12%▼ −1.59%$54.40 (−21.86%)
Apr 24, 2026
6w ago
DEFA14A
NEUTRAL ★ 3/10
$66.82 $67.70▲ +1.32%▲ +0.92%$54.40 (−18.59%)
Apr 17, 2026
7w ago
144
NEUTRAL ★ 3/10
$70.40 $66.82▼ −5.09%▼ −6.00%$54.40 (−22.73%)
Apr 13, 2026
8w ago
8-K
NEUTRAL ★ 3/10
$67.70 $70.40▲ +3.99%▲ +0.69%$54.40 (−19.65%)
Feb 28, 2026
14w ago
Institutional Cluster
BULLISH ★ 6/10
$57.76 $61.29▲ +6.11%▲ +7.32%$54.40 (−5.82%)
Feb 27, 2026
14w ago
Press Release
NEUTRAL ★ 5/10
$58.80 $61.88▲ +5.24%▲ +7.22%$54.40 (−7.48%)
Showing 9 of 9

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