CGON
CG Oncology, Inc.37.85
-1.90-4.78%
Dec 16, 4:00:00 PM EST
Earnings Call Transcripts
This Quarter (Q4 '25)
No earnings call transcript available yet
Last Quarter (Q3 '25)
No earnings call transcript available
Key Stats
Market Cap
3.05BP/E (TTM)
-Basic EPS (TTM)
-2.05Dividend Yield
0%Recent Filings
8-K
8-K
Cretostimogene Phase 3 data shines
CG Oncology unveiled its updated corporate presentation at the Morgan Stanley Global Healthcare Conference on September 9, 2025, spotlighting cretostimogene's strong Phase 3 BOND-003 results in high-risk BCG-unresponsive NMIBC: 75.5% complete response rate, 41.8% at 24 months, and 96.6% free from muscle-invasive progression. The drug's zero Grade 3+ treatment-related adverse events underscore its tolerability edge. BLA submission for this indication is slated for 2026.
8-K
Strong 24-month CR data
CG Oncology unveiled updated Phase 3 BOND-003 Cohort C data on September 5, 2025, revealing 12 more patients in complete response at 24 months for cretostimogene in high-risk BCG-unresponsive NMIBC, pushing the landmark CR rate to 41.8% across 110 patients. With 75.5% achieving CR at any time, 96.6% avoiding muscle-invasive progression, and no serious adverse events, the therapy shows strong durability and tolerability. Data will be presented September 6. Yet risks linger from evolving trial results.
8-K
Q2 loss widens; litigation resolved
CG Oncology reported Q2 2025 net loss of $41.4 million, up from $18.9 million year-over-year, driven by higher R&D and G&A expenses amid clinical expansion. Cash reserves stood at $661.1 million, funding operations into mid-2028. A jury verdict cleared the company of future royalties to ANI Pharmaceuticals, freeing resources for cretostimogene's BLA submission in Q4 2025. Litigation win sharpens focus.
10-Q
Q2 FY2025 results
CG Oncology's Q2 FY2025 results show escalating R&D intensity, with operating expenses climbing 88% y/y to $48.7M, driven by clinical trial ramp-up and headcount growth, while license revenue dipped to zero from $0.1M. Net loss widened to $41.4M ($0.54/share) from $18.9M ($0.28/share), reflecting higher stock-based comp in G&A, yet offset by $7.3M interest income on a robust $661.1M cash pile. Free cash flow not disclosed in the 10-Q. In February 2025, a subsidiary issued a $26.0M convertible note to fund Biovire's acquisition of a cretostimogene manufacturing asset, bolstering supply chain resilience. Cash burn remains controlled. Regulatory hurdles could delay approval timelines.
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