Executive Summary

Q3 revenue was $1.666M, far above Wall Street consensus of $0.073M*, while EPS of ($0.57) modestly missed consensus of ($0.565)*; operating loss widened on higher G&A tied to legal/professional fees and headcount .
Initiated rolling BLA submission for cretostimogene in HR BCG‑unresponsive NMIBC; completed enrollment of PIVOT‑006 ~10 months early, reinforcing clinical momentum and potential near-term regulatory catalysts .
Durability data in BOND‑003 Cohort C showed 24‑month CR of 41.8% and 90% of 12‑month responders remaining disease‑free at 24 months, with consistent safety and no ≥Grade 3 TRAEs .
Cash, cash equivalents, and marketable securities were $680.3M, including ~$48.7M ATM proceeds, providing runway into 1H 2028 and funding key data/filing milestones .
Shares rose ~8.6% on the update as investors focused on BLA initiation and strong durability; Nasdaq recorded the close at $41.01, up 8.61% on Nov 14, 2025 .

What Went Well and What Went Wrong

What Went Well

Rolling BLA submission initiated for cretostimogene in HR BCG‑unresponsive NMIBC, aligning execution with prior guidance and accelerating the regulatory path (“With cretostimogene’s unique profile…positioning cretostimogene as a potential backbone therapy…” — Arthur Kuan, CEO) .
BOND‑003 Cohort C durability: 24‑month CR of 41.8%; 90% of 12‑month responders sustained to 24 months; safety consistent with no ≥Grade 3 TRAEs or deaths .
PIVOT‑006 enrollment completed ~10 months early across 90+ sites, highlighting physician/patient interest and unmet IR NMIBC need .

What Went Wrong

Net loss widened to ($43.8M) and EPS to ($0.57) vs ($20.4M) and ($0.30) YoY, driven by higher R&D and a sharp increase in G&A (legal/professional fees, personnel) .
G&A rose to $23.3M from $8.7M YoY; R&D remained elevated at $27.9M as trials scale and headcount grows .
Revenue remains small/variable and heavily dependent on commercial/development plus collaboration items; despite a strong Q3, the revenue base is not yet a sustainable driver against rising OpEx .

Financial Results

Core P&L and Balance Sheet Trends

Metric	Q1 2025	Q2 2025	Q3 2025
Revenue ($USD Millions)	$0.052	$0.111	$1.666
EPS ($USD)	($0.45)	($0.54)	($0.57)
Net Loss ($USD Millions)	($34.452)	($41.426)	($43.808)
Loss from Operations ($USD Millions)	($42.204)	($48.741)	($51.129)
Total Operating Expenses ($USD Millions)	$42.256	$48.741	$52.795
Cash, Cash Equivalents & Marketable Securities ($USD Millions)	$688.4	$661.052	$680.263
Total Assets ($USD Millions)	$728.181	$701.445	$729.913
Total Stockholders’ Equity ($USD Millions)	$704.758	$670.358	$687.643

Operating Expense Breakdown

Metric	Q1 2025	Q2 2025	Q3 2025
R&D ($USD Millions)	$27.467	$31.331	$27.884
G&A ($USD Millions)	$14.789	$17.410	$23.334

Revenue Composition

Revenue Component ($USD Millions)	Q1 2025	Q2 2025	Q3 2025
Commercial & Development Revenue	—	—	$1.508
License & Collaboration Revenue	$0.052	$0.111	$0.158
Total Revenues	$0.052	$0.111	$1.666

Actuals vs S&P Global Consensus

Metric	Q1 2025	Q2 2025	Q3 2025
Revenue Actual ($USD Millions)	$0.052	$0.111	$1.666
Revenue Estimate ($USD Millions)	$0.124*	$0.109*	$0.073*
EPS Actual ($USD)	($0.45)	($0.54)	($0.57)
EPS Estimate ($USD)	($0.411)*	($0.482)*	($0.565)*

*Values retrieved from S&P Global.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Multi‑year	“Sufficient to fund operations into 1H 2028” (Q1/Q2)	“Sufficient to fund operations into 1H 2028” (Q3)	Maintained
BLA Submission (cretostimogene, HR BCG‑unresponsive NMIBC)	2H’25 initiation	“Initiation in 4Q’25”	Rolling BLA initiated in Nov 2025; full submission expected in 2026	Achieved (timing maintained)
PIVOT‑006 Enrollment Completion (IR NMIBC)	3Q’25	“Completion in 3Q’25”	Completed in Sept 2025, ~10 months early	Achieved
BOND‑003 Cohort P topline	4Q’25	“Topline data in 4Q’25”	“Topline data in 4Q’25” reiterated	Maintained
CORE‑008 Cohort A first results	4Q’25	“Topline data in 4Q’25”	“First results in 4Q’25” reiterated	Maintained

Earnings Call Themes & Trends

Note: A Q3 2025 earnings call transcript was not located in our document set or via public sources; analysis below tracks themes across quarterly releases [Search yielded no transcript in our catalog; 0 documents returned].

Topic	Previous Mentions (Q1 2025 and Q2 2025)	Current Period (Q3 2025)	Trend
Regulatory: BLA for cretostimogene	Plan to initiate BLA in 2H/Q4’25	Rolling BLA initiated; completion expected 2026	Positive (execution on timeline)
Clinical Durability (BOND‑003 Cohort C)	AUA data with K‑M 24‑mo CR ~42.3%, robust DOR, high MIBC‑free rates	24‑mo landmark CR 41.8%; 90% 12‑mo responders disease‑free at 24 mo; safety consistent	Reinforced durability/safety
IR NMIBC Development (PIVOT‑006)	Enrollment completion targeted 3Q’25	Enrollment completed ~10 months early	Accelerating execution
Legal/Corporate	ANI verdict removes future royalty liability	No new legal items; focus on filings/data	Risk reduced; clean focus
Capital & Runway	Cash $688.4M (Q1), $661.1M (Q2), runway into 1H 2028	Cash $680.3M; ATM proceeds ~$48.7M; runway into 1H 2028	Stable liquidity, opportunistic raise

Management Commentary

“I am proud of the meaningful progress we have made…With cretostimogene’s unique profile, we remain committed to advancing a robust clinical, regulatory, and technical strategy designed to support an optimized label and expansion into additional indications—positioning cretostimogene as a potential backbone therapy for a broad range of NMIBC patients.” — Arthur Kuan, Chairman & CEO .
“We look forward to sharing additional data from BOND‑003 Cohort P and CORE‑008 Cohort A before year‑end.” — Arthur Kuan .

Q&A Highlights

A Q3 2025 earnings call transcript was not available in our document catalog nor located via public sources; no Q&A highlights could be verified [Search returned no earnings-call-transcript; 0 documents found].
Guidance clarifications came via the press release: rolling BLA initiation; timeline to completion in 2026; 4Q’25 data events reiterated .

Estimates Context

Revenue beat: $1.666M vs $0.073M*, reflecting higher “commercial and development” revenue plus collaboration revenue; this was a significant positive surprise versus a historically low revenue base .
EPS slight miss: ($0.57) vs ($0.565)*, driven by higher G&A and continued R&D investment; interest income provided a partial offset .
Prior quarters show a similar dynamic: low revenue vs rising OpEx as trials scale; consensus revenue for Q1–Q2 was $0.124M*/$0.109M* and EPS ($0.411)/($0.482), while actuals were $0.052M/$0.111M and ($0.45)/($0.54) respectively .
*Values retrieved from S&P Global.

KPIs and Clinical/Operational Indicators

KPI	Q1 2025	Q2 2025	Q3 2025
BOND‑003 Cohort C 24‑mo CR	~42.3% (K‑M at AUA)	Reinforced at AUA; DOR median 28 mo	41.8% landmark CR; 90% 12‑mo responders disease‑free; no ≥Grade 3 TRAEs
PIVOT‑006 Enrollment	Ongoing; completion expected 2H’25	Target 3Q’25 completion	Completed ~10 months early
Cash Runway	Into 1H 2028	Into 1H 2028	Into 1H 2028
ATM Proceeds	—	—	~$48.7M; 1,515,151 shares sold

Key Takeaways for Investors

Regulatory execution de‑risking: rolling BLA initiation for cretostimogene in HR BCG‑unresponsive NMIBC aligns to plan; completion targeted 2026 — a pivotal catalyst path .
Clinical durability continues to impress: 24‑mo CR 41.8% and 90% 12‑mo responders disease‑free with consistent safety; supports backbone therapy positioning and potential label breadth .
Revenue upside vs consensus was meaningful, but OpEx growth (especially G&A) drove a wider net loss; expect continued investment into filings, CMC, and commercialization build .
Liquidity remains strong with $680.3M and runway into 1H 2028; opportunistic ATM adds flexibility ahead of potential launch .
Near‑term catalysts: BOND‑003 Cohort P topline and CORE‑008 Cohort A first results in 4Q’25; potential for valuation re‑rating if data are positive and BLA progresses smoothly .
Stock responded positively to the update (+8.61% on Nov 14), indicating investor focus on regulatory momentum and durability; pullbacks likely tied to OpEx/earnings optics rather than clinical risk .
Medium‑term thesis: success in HR NMIBC plus expansion into IR NMIBC (PIVOT‑006) could broaden addressable market; monitor payor dynamics, manufacturing scale-up, and post‑approval uptake in urology practices .

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