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CG Oncology, Inc. (CGON)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 was operationally on track with advancing the cretostimogene program; financially, CGON reported minimal revenue ($0.05M) and a wider net loss ($34.5M; -$0.45 EPS) driven by increased R&D and G&A, in line with a late-stage biotech scaling toward BLA submission . Versus S&P Global consensus, revenue missed ($0.05M actual vs $0.12M estimate*) and EPS missed (-$0.45 vs -$0.41*), reflecting timing of collaboration revenue and higher operating investments .*
  • “Best-in-disease” durability/tolerability BOND-003 Cohort C data (24-month CR 42.3% K-M; 12-month CR 50.7%) and 97.3% progression-free at 24 months, plus early Cohort P signal (90.5% HRFS at 3 and 9 months) reinforced the monotherapy backbone thesis and regulatory momentum (BLA initiation expected 2H25) .
  • Cash, cash equivalents and marketable securities were $688.4M (down from $742.0M at year-end), with runway guided into 1H28, supporting continued clinical execution and regulatory preparation .
  • Near-term stock catalysts: initiation of BLA submission in 2H25, PIVOT-006 enrollment completion in 2H25, and multiple topline readouts (BOND-003 Cohort P; CORE-008 Cohort A) expected in 2H25, which can affect probability-of-approval assumptions and sentiment .

What Went Well and What Went Wrong

What Went Well

  • Strong clinical durability and safety in BOND-003 Cohort C: 75.5% CR at any time; 12- and 24-month CR rates of 50.7% and 42.3% (K-M), and 97.3% free from progression to muscle-invasive disease at 24 months . “We are well positioned to initiate our BLA submission in the second half of the year for the treatment of patients with HR NMIBC unresponsive to BCG” — CEO Arthur Kuan .
  • Early Cohort P signal: 90.5% high-grade recurrence-free survival at 3 and 9 months (K-M) in BCG‑unresponsive Ta/T1 without CIS, broadening the potential treatable population within NMIBC .
  • Capital position and runway: $688.4M in cash/securities and runway into 1H28 enable regulatory preparation, trial execution, and emerging commercialization activities without near-term financing overhang .

What Went Wrong

  • Financial miss vs consensus: Revenue ($0.05M) and EPS (-$0.45) missed S&P Global consensus ($0.12M*, -$0.41*), reflecting low/variable collaboration revenue and higher OpEx to support clinical and regulatory milestones .*
  • Operating expense step-up: R&D rose to $27.5M (from $17.2M YoY) on clinical/CMC and headcount; G&A grew to $14.8M (from $5.8M YoY) on personnel, legal/accounting, consultants, and marketing — enlarging quarterly burn .
  • No earnings call transcript available: limits visibility into granular timelines, commercialization build, CMC readiness, and payer/access strategy discussion; Q&A clarifications unavailable in this cycle [— no transcript found for period —].

Financial Results

P&L and Cash vs Prior Periods and Consensus

MetricQ3 2024Q4 2024Q1 2024Q1 2025Q1 2025 Consensus
Revenue ($M)——$0.53 $0.05 $0.12*
EPS (basic & diluted)($0.30) ($0.46) ($0.36) ($0.45) ($0.41)*
R&D Expense ($M)$19.6 $26.8 $17.2 $27.5 —
G&A Expense ($M)$8.7 $11.7 $5.8 $14.8 —
Net Loss ($M)($20.4) ($31.8) ($16.9) ($34.5) —
Cash & Marketable Securities ($M)$540.7 $742.0 —$688.4 —

Notes: Consensus figures marked with * are Values retrieved from S&P Global.

Observations:

  • Sequentially, OpEx increased (R&D +$0.7M vs Q4; G&A +$3.1M), widening net loss to $34.5M .
  • YoY, R&D (+$10.3M) and G&A (+$9.0M) reflect scale-up for registrational activities and corporate build .
  • Cash decreased $53.6M QoQ following execution spend; runway remains guided into 1H28 .

KPIs (Clinical Efficacy/Execution)

KPIQ3 2024Q4 2024Q1 2025
BOND-003 CR at any time (Cohort C)—74.5% (82/110) 75.5% (83/110)
BOND-003 CR rate (K-M) at 12 / 24 months—DoR >27m (NR) 50.7% / 42.3%; median DoR 28m, ongoing
Progression-free to MIBC at 24 months——97.3%
Cohort P (Ta/T1, no CIS) HRFS——90.5% at 3 and 9 months (K-M)
BLA timing (monotherapy in HR BCG‑unresponsive NMIBC)—Initiation 2H25 (anticipated) Initiation 2H25 (maintained)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
BLA submission (cretostimogene monotherapy; HR BCG‑unresponsive NMIBC with CIS ± Ta/T1)2H 2025Initiation anticipated 2H25 Initiation expected 2H25 Maintained
PIVOT-006 enrollment completion (intermediate-risk NMIBC)2H 2025Not specified in prior update“Enrollment completion… expected in the second half of 2025” New/Add
BOND-003 Cohort P topline (Ta/T1 no CIS)2H 2025Topline anticipated 2H25 Topline expected 2H25 Maintained
CORE-008 Cohort A topline (HR BCG‑naïve)2H 2025Topline anticipated 2H25 Topline expected 2H25 Maintained
Cash runwayThrough 1H 2028Runway into 1H28 at 12/31/24 Runway into 1H28 affirmed Maintained

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript available in the document set; themes derived from company press releases/8-Ks.

TopicQ-2 (Q3 2024)Q-1 (Q4 2024)Current (Q1 2025)Trend
Regulatory/BLA timingFocus on upcoming registrational readouts (SUO) BLA initiation anticipated 2H25 BLA initiation expected 2H25 reiterated Stable/On track
Clinical durability (Cohort C)Referenced sustained/durable CR profile 74.5% CR at any time; DoR >27m 75.5% CR; 12m 50.7%, 24m 42.3% K‑M; DoR 28m Strengthening
New populations (Cohort P)——90.5% HRFS at 3 and 9 months (K‑M) Expanding
R&D execution (CORE‑008)—Initiated Cohort A; expansion planned Initiated Cohort CX (cretostimogene + gemcitabine) Accelerating
Cash/runwayRunway through 2027 Runway into 1H28 after follow-on Runway into 1H28 affirmed Improved and stable
CMC/scale-upNot detailedIncreased R&D includes CMC costs R&D increase includes CMC costs Ongoing build

Management Commentary

  • “With best-in-disease durability and tolerability data from the BOND-003 Cohort C registrational trial… we are well positioned to initiate our BLA submission in the second half of the year for the treatment of patients with HR NMIBC unresponsive to BCG.” — Arthur Kuan, CEO .
  • “If approved, I’m confident that cretostimogene is well positioned to become backbone therapy in NMIBC, potentially addressing more than 70% of the market opportunity in need of a new and innovative therapy.” — Arthur Kuan, CEO .
  • Clinical highlights: 75.5% CR at any time (Cohort C), 12-/24-month CR of 50.7%/42.3% (K‑M), 97.3% free from progression to MIBC at 24 months; Cohort P HRFS 90.5% at 3 and 9 months (K‑M) .

Q&A Highlights

  • No earnings call transcript was available for Q1 2025 in the document set; therefore, Q&A themes, clarifications on timelines, commercial build, and tone changes versus prior quarters could not be assessed [— none found via document catalog —].

Estimates Context

  • Q1 2025 actual vs S&P Global consensus: Revenue $0.05M vs $0.12M* (MISS); EPS -$0.45 vs -$0.41* (MISS). Operating expense increases tied to trial activity, CMC, and headcount were the primary drivers of the EPS shortfall .*
MetricQ1 2025 ActualQ1 2025 Consensus
Revenue ($M)$0.05 $0.12*
EPS (basic & diluted)-$0.45 -$0.41*
# of Estimates (EPS / Revenue)—8 / 7*

Notes: Consensus figures marked with * are Values retrieved from S&P Global.

Implication: Street models may modestly increase OpEx run-rate assumptions into 2H25 ahead of BLA initiation and keep revenue near de minimis until potential approval; clinical strength and BLA timing remain the primary stock drivers .

Key Takeaways for Investors

  • Clinical momentum is intact and strengthening: updated Cohort C durability and Cohort P early signal support the monotherapy backbone narrative and potential broad NMIBC reach .
  • Regulatory path on schedule: BLA initiation expected in 2H25; multiple 2H25 data catalysts (BOND-003 Cohort P, CORE-008 Cohort A) can reset probability-of-approval and market sizing expectations .
  • Investment phase: R&D and G&A increases reflect clinical/CMC scale-up and corporate build; expect elevated OpEx into regulatory and pre-commercial activities .
  • Runway de-risks near-term financing: $688M+ cash/securities with runway into 1H28 supports execution through key 2025/26 milestones .
  • Trading setup: Near-term catalysts are data- and filing-driven rather than P&L; stock likely to react to regulatory/timing updates and any additional efficacy/safety disclosures (especially Cohort P topline) .
  • Estimate calibration: Expect Street to maintain minimal revenue until approval; EPS sensitivity is largely OpEx-driven; consensus likely rolls forward expense build through 2H25 .*
  • Watch CMC and enrollment timelines: PIVOT-006 enrollment completion guidance added (2H25) — execution here and any BLA process updates are key timeline signals .

Sources:

  • Q1 2025 8-K and press release (financials, clinical updates, guidance):
  • FY/Q4 2024 8-K and press release (baseline guidance, OpEx context):
  • Q3 2024 8-K and press release (cash/runway, pipeline progress):
  • Consensus estimates: S&P Global (values marked with *) via GetEstimates.