Executive Summary

Q4 2024 printed a wider net loss per share of ($0.46) as CG Oncology ramped R&D and G&A for registrational activities and commercial readiness; EPS missed S&P Global consensus of -$0.35 by ~$0.13 while revenue of $0.46M beat a low bar ($0.13M), reflecting non-product revenue dynamics in a pre-commercial stage . Values with asterisk are from S&P Global estimates/actuals.*
Cash and marketable securities increased to $742.0M following an oversubscribed $238M follow-on, extending runway into 1H 2028 (vs 2027 previously), a meaningful de-risking for the development plan .
Clinically, the quarter was defined by BOND-003 Cohort C monotherapy data: 74.5% complete response (CR) rate with median DoR not reached (>27 months), and no Grade ≥3 TRAEs; data subsequently updated in March 2025 to 75.5% CR with DoR >28 months, supporting a strong BLA path in 2H 2025 .
Setup into 2025 includes initiation of rolling BLA (2H 2025) and multiple catalysts (AUA final Cohort C data; BOND-003 Cohort P topline; CORE-008 Cohort A topline), which we see as the primary stock drivers, alongside maintained best-in-disease durability and a strengthened balance sheet .

What Went Well and What Went Wrong

What Went Well
- Strong clinical efficacy and durability: BOND-003 Cohort C monotherapy CR at any time of 74.5% with DoR >27 months, later updated to 75.5% and DoR >28 months; no Grade ≥3 TRAEs and high treatment completion (97.3%) .
- Balance sheet fortified: $238M follow-on completed, taking cash/marketable securities to $742.0M and runway into 1H 2028, supporting trial execution and commercial readiness .
- Clear regulatory path: Company expects to initiate BLA submission for monotherapy in HR BCG-unresponsive NMIBC with CIS ± Ta/T1 in 2H 2025; additional high-visibility clinical milestones outlined (AUA final Cohort C; Cohort P topline; CORE-008 Cohort A topline) .
What Went Wrong
- EPS missed consensus as operating expenses stepped up: R&D rose to $26.8M (vs $16.3M YoY), and G&A to $11.7M (vs $3.0M YoY) given CMC, trial, and headcount expansion, driving ($0.46) EPS in Q4 2024 .
- Limited P&L leverage pre-approval: Revenue remains de minimis ($0.46M in Q4) and non-product in nature, so higher OpEx translates directly to a wider quarterly net loss near term .
- Transcript unavailability: A full Q4 2024 earnings call transcript was not available in our corpus; a call was scheduled for Mar 28, 2025, limiting visibility into Q&A nuances (we rely on press releases) .

Financial Results

Metric	Q2 2024	Q3 2024	Q4 2024
Revenue ($USD Millions)	$0.111*	$0.043*	$0.456*
EPS (GAAP, $/sh)	($0.28)	($0.30)	($0.46)
R&D Expense ($USD Millions)	$18.5	$19.6	$26.8
G&A Expense ($USD Millions)	$7.5	$8.7	$11.7
Net Loss ($USD Millions)	$18.9	$20.4	$31.8
Cash & Marketable Securities ($USD Millions, period-end)	$552.9	$540.7	$742.0

Values retrieved from S&P Global.*

Estimates comparison (Q4 2024):

Metric	Consensus (S&P)*	Actual (S&P)*	Company Reported	Surprise vs Consensus (S&P)*
EPS (GAAP)	-$0.3513	-$0.48	-$0.46	Miss ($0.13)
Revenue ($USD Millions)	$0.125	$0.456	—	Beat ($0.331)

Values retrieved from S&P Global.*

Note: S&P Global records Q4 2024 “actual” EPS as -$0.48*, while the company reported ($0.46); the gap likely reflects methodology/rounding differences (e.g., share counts, data vendor treatment). We use S&P data for estimate comparisons and flag the discrepancy . Values retrieved from S&P Global.*

KPIs (operating and clinical)

KPI	Q2 2024	Q3 2024	Q4 2024
BOND-003 CR at any time (monotherapy)	75.2% at AUA (cutoff Apr 1, 2024)	Updated results planned at SUO (no new % disclosed in Q3 PR)	74.5% at SUO (cutoff Sep 30, 2024)
Median DoR	n/a	n/a	Not reached, >27 months (Sep 30, 2024)
Safety (Grade ≥3 TRAEs)	n/a	n/a	None reported; 97.3% completed treatments

Segment breakdown: Not applicable (no commercial product segmentation yet).

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash runway	Multi-year	Sufficient through 2027	Sufficient into 1H 2028	Raised/extended
BLA submission (monotherapy; HR BCG-unresponsive NMIBC with CIS ± Ta/T1)	2025	Progressing toward BLA; timing not provided	Initiation of BLA submission in 2H 2025	Introduced timing
BOND-003 Cohort C (monotherapy)	2025 events	SUO late-breaker accepted	Final data to be presented at AUA 2025	New milestone detail
BOND-003 Cohort P (Ta/T1 without CIS)	2H 2025	Not specified	Topline data anticipated in 2H 2025	Introduced
CORE-008 Cohort A (HR BCG-naïve)	2H 2025	Not specified	Topline data anticipated in 2H 2025	Introduced

Earnings Call Themes & Trends

Topic	Q2 2024 (Q-2)	Q3 2024 (Q-1)	Q4 2024 (Current)	Trend
Regulatory path/BLA	“Progressing toward submitting our BLA” for monotherapy; setup post-AUA/ASCO	SUO late-breaker acceptance; focus on registrational momentum	BLA initiation targeted for 2H 2025	Increasingly concrete timing
Clinical efficacy/durability	AUA: 75.2% CR; Nature Medicine combo data supportive	Emphasis on sustained/durable responses; SUO update forthcoming	SUO: 74.5% CR with DoR >27 months (later 75.5% and >28 months at EAU 2025)	Sustained best-in-disease durability
Safety/tolerability	—	—	No Grade ≥3 TRAEs; high completion (97.3%)	Reinforced favorable profile
New trials/expansion	EAP initiated; platform strengthening	Pipeline momentum reiterated	CORE-008 initiated/expanded (A and B); CX planned; PIVOT-006 ongoing	Broader development footprint
Capital and runway	IPO proceeds extend runway to 2027	Runway to 2027	$238M follow-on; runway into 1H 2028	De-risked funding
Commercial readiness	Team strengthening noted	—	Follow-on proceeds to support commercial readiness	Preparing for launch

Management Commentary

“We made substantial progress in the fourth quarter of 2024... and a successful follow-on equity offering to expand our clinical development programs and support our commercial readiness activities.” — Arthur Kuan, Chairman & CEO .
“Cretostimogene’s compelling efficacy… with 63.5% of patients remaining in response at 12 months or greater and 56.6% at 24 months or greater by K-M estimate… 97.3% free from progression to MIBC at 12 months.” — Gary D. Steinberg, M.D., Lead Investigator (SUO LB update) .
“We are confident that cretostimogene is well positioned to address an unmet need for patients as a potential backbone bladder-sparing therapeutic if approved by the FDA.” — Ambaw Bellete, President & COO .

Q&A Highlights

A full Q4 2024 earnings call transcript was not available in our document corpus; the company held its call on Mar 28, 2025 at 7:00am ET. Accordingly, Q&A clarifications (e.g., commercialization phasing, BLA package details, payer engagement) are not captured here .
Based on press materials, investor focus likely centered on: BLA initiation mechanics and timing; durability data and Cohort P differentiation; and OpEx trajectory amid commercial readiness .

Estimates Context

Q4 2024 EPS missed consensus (S&P) by ~($0.13), driven by higher R&D and G&A as the company advanced registrational programs and built out for commercialization . Values retrieved from S&P Global.*
Revenue beat consensus on a very low base ($0.456M vs $0.125M), consistent with a pre-revenue biotech recognizing non-product revenue; not a driver of fundamental valuation near term . Values retrieved from S&P Global.*
S&P Global “actual” EPS for Q4 registers at -$0.48 versus company-reported ($0.46), likely reflecting methodology/vendor rounding; we anchor estimate comparisons on S&P and cite the company figure for completeness . Values retrieved from S&P Global.*

Key Takeaways for Investors

Clinical de-risking continues: best-in-disease durability and clean safety from BOND-003 monotherapy underpin a strong BLA and commercial narrative into 2H 2025 .
Funding risk reduced: runway into 1H 2028 after a $238M follow-on supports BLA, potential launch prep, and platform expansion without near-term financing overhang .
Near-term catalysts: AUA 2025 final Cohort C data; Cohort P topline (2H 2025); CORE-008 Cohort A topline (2H 2025) — these events are likely to drive stock inflections .
EPS miss reflects investment cadence, not demand dynamics; watch OpEx growth pacing vs milestones as a driver of quarterly optics pre-approval .
Regulatory clarity: initiation of BLA submission in 2H 2025 focuses attention on potential review timelines and launch preparedness (medical affairs, market access) .
Safety/utility positioning: No Grade ≥3 TRAEs and favorable adherence/completion strengthen the case for bladder-sparing adoption if approved .
Portfolio managers should position for binary-leaning clinical/regulatory catalysts; balance sheet strength allows management to optimize timelines rather than prioritize near-term opex cuts .

Footnotes:
Values retrieved from S&P Global.*

Sources:

Q4 2024 8-K earnings press release, financial statements, and business update .
December 5, 2024 SUO late-breaker press release (BOND-003 topline efficacy and safety) .
Q3 2024 earnings press release .
Q2 2024 earnings press release .
Earnings call scheduling reference (MarketBeat) .

CG Oncology, Inc. (CGON)·Q4 2024 Earnings Summary