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CG Oncology, Inc. CGON

Biological Products, (No Diagnostic Substances) · SIC 2836 · Vertical: Biological Products, (No Diagnostic Substances) (SIC 2836)

67.71USD+5.70% · 1 dayClose 04 Nov 2026

CG Oncology is a late-stage biopharmaceutical company developing cretostimogene, an investigational oncolytic immunotherapy given intravesically for non-muscle invasive bladder cancer. The company is nearing completion of its Biologics License Application with the FDA but has no approved products yet, and its net losses have been rising.

At the close of 04 Nov 2026, CG Oncology, Inc. (CGON) stock was 67.71 USD (+5.70% on the day), with market capitalisation 6.0 bn USD, beta 1.43, 52-week range 37.37–80.68 USD. Latest reported quarter (Q2 2026): revenue of 1.2 m USD, net income of -79.1 m USD, diluted EPS -0.90 USD.

Data as of · AI analysis dated · Source: SEC filings and closing prices, computed by olivLaw.

Market cap
6.0 bn USD
shares as of 05 Aug 2026
P/E (TTM)
unavailable
Diluted EPS TTM -2.70 · TTM to 30 Jun 2026
E/P (TTM)
-3.98%
TTM to 30 Jun 2026
Dividend yield
unavailable
Beta (2y)
1.43
Volatility (1y) 54%
52-week range
37.3780.68

Price history

Loading chart…

Technical reading

RSI (14)
57.5
strong (55–70)
Bollinger (20, 2)
59.41 – 66.08
above the upper band · %B 1.24 · band width 10.6%
SMA 50 / 200
68.57 / 66.06
mixed trend
MACD (12, 26, 9)
-0.93 / -1.79
MACD above signal

Indicators describe past prices; on their own they do not predict direction. On our history the RSI ≤ 40 filter added no return (see the signals methodology).

Performance

CompanyS&P 500vs S&P 500Vertical median
1 month−1.5%−1.1%−0.4 pp—
3 months−6.5%−0.5%−6.1 pp—
6 months−0.4%+4.4%−4.8 pp—
Year to date+63.1%+12.3%+50.8 pp—
1 year+73.3%+13.5%+59.8 pp+8.1%
3 yearsunavailable+76.4%unavailable+3.1%
5 yearsunavailable+63.7%unavailable—
Max drawdown (1y)
−27.4%
13 May 2026 → 05 Jun 2026
Max drawdown (5y)
−67.5%
16 Feb 2024 → 08 Apr 2025
Compound annual growth (5y)
unavailable
S&P 500 +10.4%

Price returns, dividends excluded.

Quarterly results

Latest quarter: Q2 2026 · 30 Jun 2026

Revenue
1.2 m USD
unavailable YoY
Net income
-79.1 m USD
unavailable YoY
Diluted EPS
-0.90
unavailable YoY
net / operating
-6,832.8% / -7,467.7%

Quarterly margins

Quarterly statements · USD

Fiscal yearQ3 '24Q4 '24Q1 '25Q2 '25Q3 '25Q4 '25Q1 '26Q2 '26
Revenue43.0 k456.0 k52.0 k01.7 m2.3 m1.1 m1.2 m
Research & development19.6 m26.8 m27.5 m31.3 m27.9 m30.0 m43.7 m54.7 m
Operating income-28.3 m-38.0 m-42.2 m-48.7 m-51.1 m-48.7 m-66.4 m-86.4 m
Depreciation & amortisation21.0 k ≈024.0 k156.0 k ≈416.0 k ≈849.0 k841.0 k850.0 k ≈
Net income-20.4 m-31.8 m-34.5 m-41.4 m-43.8 m-41.3 m-60.2 m-79.1 m
Diluted EPS-0.30-0.46 ≈-0.45-0.54-0.57-0.52 ≈-0.71-0.90
Operating cash flow-15.9 m ≈-20.7 m-29.3 m-28.0 m ≈-38.9 m ≈-36.2 m-56.9 m-46.4 m ≈
Capex-1.0 k ≈209.0 k16.0 k14.0 k ≈97.0 k ≈7.0 k304.0 k468.0 k ≈

≈ derived quarter (cumulative difference / share-days average)

E/P over time

E/P = trailing-12-month diluted EPS / price at quarter end. E/P is the inverse of P/E and stays defined when earnings are negative.

Fiscal years

Fiscal year202320242025
Revenue204.0 k1.1 m4.0 m
Revenue YoYunavailable+458.3%+254.7%
Net income-48.6 m-88.0 m-161.0 m
Net income YoYunavailableunavailableunavailable
Diluted EPS-15.65-1.41-2.08
Diluted EPS YoYunavailableunavailableunavailable
net %-23,827.0%-7,729.5%-3,985.0%
Free cash flowunavailable-78.9 m-132.5 m

Reported results vs expectations

Loading…

Balance sheet & financial health

Fiscal year 2025 · 31 Dec 2025

Cash
32.5 m USD
Financial debt
3.0 m USD
Net debt
-29.5 m USD
Equity
752.6 m USD
Total assets
791.6 m USD
Debt / equity
0.00x
Current ratio
24.63x
ROE
-21.7%
ROA
-20.8%
FCF margin
-3,279.2%

Financial statements (source on every figure)

Revenue and net income (USD)

Margins

Income statement · USD

Revenue
2023
204.0 k
2024
1.1 m
2025
4.0 m

SEC (XBRL)· 27 Feb 2026verified

Research & development
2023
45.8 m
2024
82.1 m
2025
116.6 m

SEC (XBRL)· 27 Feb 2026verified

Operating income
2023
-55.4 m
2024
-114.7 m
2025
-190.8 m

SEC (XBRL)· 27 Feb 2026verified

Depreciation & amortisation
2023
17.0 k
2024
32.0 k
2025
1.4 m

SEC (XBRL)· 27 Feb 2026verified

EBITDA
2023
-55.4 m ≈
2024
-114.6 m ≈
2025
-189.3 m ≈

SEC (XBRL)· 27 Feb 2026derived

Income tax
2023
1.0 k
2024
1.0 k
2025
-270.0 k

SEC (XBRL)· 27 Feb 2026verified

Net income
2023
-48.6 m
2024
-88.0 m
2025
-161.0 m

SEC (XBRL)· 27 Feb 2026verified

Diluted EPS
2023
-15.65
2024
-1.41
2025
-2.08

SEC (XBRL)· 27 Feb 2026verified

Weighted average diluted shares
2023
4.3 m
2024
62.5 m
2025
77.3 m

SEC (XBRL)· 27 Feb 2026verified

Balance sheet · USD

Cash
2023
8.3 m
2024
257.1 m
2025
32.5 m

SEC (XBRL)· 27 Feb 2026verified

Inventories
2023
—
2024
0
2025
1.6 m

SEC (XBRL)· 27 Feb 2026verified

Current assets
2023
194.1 m
2024
754.2 m
2025
759.5 m

SEC (XBRL)· 27 Feb 2026verified

Property, plant & equipment, net
2023
69.0 k
2024
272.0 k
2025
15.6 m

SEC (XBRL)· 27 Feb 2026verified

Goodwill
2023
—
2024
0
2025
10.3 m

SEC (XBRL)· 27 Feb 2026verified

Intangibles (excl. goodwill)
2023
—
2024
0
2025
575.0 k

SEC (XBRL)· 27 Feb 2026verified

Total assets
2023
199.3 m
2024
754.8 m
2025
791.6 m

SEC (XBRL)· 27 Feb 2026verified

Accounts payable
2023
3.2 m
2024
6.5 m
2025
5.7 m

SEC (XBRL)· 27 Feb 2026verified

Long-term debt
2023
—
2024
0
2025
3.0 m

SEC (XBRL)· 27 Feb 2026verified

Current liabilities
2023
14.3 m
2024
21.4 m
2025
30.8 m

SEC (XBRL)· 27 Feb 2026verified

Total liabilities
2023
14.5 m
2024
21.4 m
2025
39.0 m

SEC (XBRL)· 27 Feb 2026verified

Equity
2023
-123.1 m †
2024
733.4 m †
2025
752.6 m †

SEC (XBRL)· 27 Feb 2026verified

Cash flow · USD

Operating cash flow
2023
-45.7 m
2024
-78.7 m
2025
-132.3 m

SEC (XBRL)· 27 Feb 2026verified

Capex
2023
—
2024
234.0 k
2025
134.0 k

SEC (XBRL)· 27 Feb 2026verified

Free cash flow
2023
—
2024
-78.9 m ≈
2025
-132.5 m ≈

SEC (XBRL)· 27 Feb 2026derived

Investing cash flow
2023
-121.2 m
2024
-300.8 m
2025
-245.8 m

SEC (XBRL)· 27 Feb 2026verified

Financing cash flow
2023
87.0 m
2024
628.3 m
2025
153.6 m

SEC (XBRL)· 27 Feb 2026verified

Computed indicators

Growth

Revenue growth (YoY)
254.7%
computed by olivLawFY 2025
Revenue CAGR 3Y
unavailable
input data missing
Revenue CAGR 5Y
unavailable
input data missing
EBIT growth (YoY)
unavailable
the base of the ratio is not positive
Net income growth (YoY)
unavailable
the base of the ratio is not positive
Net income CAGR 3Y
unavailable
input data missing
Net income CAGR 5Y
unavailable
input data missing
EPS growth (YoY)
unavailable
the base of the ratio is not positive
EPS CAGR 3Y
unavailable
input data missing
EPS CAGR 5Y
unavailable
input data missing
FCF growth (YoY)
unavailable
the base of the ratio is not positive

Profitability

Gross margin
unavailable
input data missing
EBITDA margin
-4,008.7%
computed by olivLawTTM to 30 Jun 2026
EBIT margin
-4,056.2%
computed by olivLawTTM to 30 Jun 2026
Net margin
-3,602.7%
computed by olivLawTTM to 30 Jun 2026
FCF margin
-2,879.6%
computed by olivLawTTM to 30 Jun 2026

Returns

ROE
-26.4%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
ROA
-25.1%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
ROIC
-21.0%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
ROCE
-24.3%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Payout ratio (EPS)
unavailable
input data missing
Payout ratio (FCF)
unavailable
input data missing

Balance sheet

Net debt
-16.6 m USD
computed by olivLawbalance sheet at 30 Jun 2026
Net debt / EBITDA
unavailable
insufficient data
Debt / equity
0.0x
computed by olivLawbalance sheet at 30 Jun 2026
Interest coverage
unavailable
input data missing

Liquidity

Current ratio
22.2x
computed by olivLawbalance sheet at 30 Jun 2026
Quick ratio
22.2x
computed by olivLawbalance sheet at 30 Jun 2026
Cash ratio
0.4x
computed by olivLawbalance sheet at 30 Jun 2026

Cash

Operating cash flow
-178.5 m USD
computed by olivLawTTM to 30 Jun 2026
Capital expenditure
876.0 k USD
computed by olivLawTTM to 30 Jun 2026
Free cash flow
-179.3 m USD
computed by olivLawTTM to 30 Jun 2026
FCF conversion
unavailable
insufficient data
Cash conversion
unavailable
insufficient data

Efficiency

Days sales outstanding
unavailable
input data missing
Days inventory outstanding
unavailable
input data missing
Days payables outstanding
unavailable
input data missing
Cash conversion cycle
unavailable
input data missing

Market and valuation

Market capitalisation
6.0 bn USD
computed by olivLawbalance sheet at 30 Jun 2026
Enterprise value
6.0 bn USD
computed by olivLawbalance sheet at 30 Jun 2026
Market cap / net income TTM
unavailable
insufficient data
P/E (TTM)
unavailable
insufficient data
Earnings yield
-4.0%
computed by olivLawTTM to 30 Jun 2026
P/B
5.8x
computed by olivLawbalance sheet at 30 Jun 2026
P/S
963.7x
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
EV/EBITDA
unavailable
insufficient data
EV/EBIT
unavailable
insufficient data
EV/Sales
961.0x
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
P/FCF
unavailable
the base of the ratio is not positive
FCF yield
-3.0%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero
Shareholder yield (distributions)
unavailable
input data missing

1 indicators that do not apply to the sector.

Valuation

olivLaw classification

Insufficient data
What is missing
  • indicators available: 4 of at least 6
  • score weight coverage: 29.2% of at least 60%
  • valuation methods computed: 0 of at least 1

A scoring methodology on indicators and valuation, not investment advice.

Closing price

67.71 USD

04 Nov 2026Source: olivLaw, closing series

Market cap: 6.0 bn USD

Key indicators

Market capitalisation
6.0 bn USD
computed by olivLawbalance sheet at 30 Jun 2026
P/E (TTM)
unavailable
insufficient data
P/B
5.8x
computed by olivLawbalance sheet at 30 Jun 2026
EV/EBITDA
unavailable
insufficient data
ROE
-26.4%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Net margin
-3,602.7%
computed by olivLawTTM to 30 Jun 2026
Revenue growth (YoY)
254.7%
computed by olivLawFY 2025
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero

Coverage and freshness

26/37 reporting lines present
Latest full fiscal year: 2025
Latest reported period: 30 Jun 2026
Latest balance sheet date: 30 Jun 2026
Share count (cover of the latest filing), as of: 05 Aug 2026
Source: SEC (XBRL)published 06 Aug 2026
verified 366derived 26

Score by group

29% · Insufficient data

Estimated value range

unavailable — no valuation method could be computed

Valuation assumptions are editorial choices, not measured; beta is not measured.

Valuation methods

  • DCF (discounted cash flow)unavailable · input data missing
  • Peers: EV/EBITDAunavailable · the base of the ratio is not positive
  • Peers: P/Eunavailable · the base of the ratio is not positive
  • Dividend discount (DDM)unavailable · the company pays no dividend: a dividend model needs an explicit initiation assumption

no valuation method could be computed

Multiple comparisons use the SIC vertical: Biological Products, (No Diagnostic Substances) (SIC 2836)

Classification (SIC) comparables group by industry code, not by economic activity; the direct group is an editorial selection by activity. Members' multiples are on their own trailing twelve months, at their own latest close.

Assumptions (illustrative, editorial)

Risk-free rate
4.3%
Equity risk premium
5.0%
Beta (default)
1.00
Cost of equity
9.3%
Terminal growth
2.5%

Factor scorecard

Insufficient data

Minimum-evidence gate: indicators available: 4 of at least 6; score weight coverage: 29.2% of at least 60%; valuation methods computed: 0 of at least 1

FactorValueScoreWeight used
ROIC · Quality-21.0%57 (vs peers)36%
Net margin · Quality-3,602.7%10 (vs peers)21%
FCF conversion · Qualityunavailableunavailable—
Revenue CAGR 3Y · Growthunavailableunavailable—
EPS CAGR 3Y · Growthunavailableunavailable—
Net debt / EBITDA · Balance sheetunavailableunavailable—
Interest coverage · Balance sheetunavailableunavailable—
Current ratio · Balance sheet22.2x100 (on a fixed band)14%
P/E (TTM) · Valuationunavailableunavailable—
EV/EBITDA · Valuationunavailableunavailable—
FCF yield · Valuation-3.0%0 (on a fixed band)29%
Shareholder yield (distributions) · Returnsunavailableunavailable—
Payout ratio (FCF) · Returnsunavailableunavailable—

Factors without a value were dropped; the remaining weights were renormalised.

Score groups

  • Balance sheet· partial100/100 · 1/3 factors with a value
  • Growth· partialunavailable · 0/2 factors with a value
  • Quality40/100 · 2/3 factors with a value
  • Returns· partialunavailable · 0/2 factors with a value
  • Valuation· partial0/100 · 1/3 factors with a value

A «partial» group is computed from under half of its weight or from one factor: it is not a full assessment of the group.

Memo

CG Oncology, Inc. (CGON). Latest full fiscal year: 2025; data up to 2026-06-30.

Figures computed from the financial statements: revenue 4.0 m USD in 2025; YoY growth 254.7%; net margin -3,602.7%; ROE -26.4%.

Valuation cannot be computed from the available data.

Insufficient data for a verdict (indicators available: 4 of at least 6; score weight coverage: 29.2% of at least 60%; valuation methods computed: 0 of at least 1).

Text generated deterministically from the figures shown; no language model. Not investment advice.

What supports the thesis

  • Current ratio: 22.2x

What contradicts it

  • Net margin: -3,602.7%
  • FCF yield: -3.0%

Not assessed (insufficient data or a ratio without meaning): FCF conversion, Revenue CAGR 3Y, EPS CAGR 3Y, Net debt / EBITDA, Interest coverage, P/E (TTM), EV/EBITDA, Shareholder yield (distributions), Payout ratio (FCF).

Versus the vertical median

Biological Products, (No Diagnostic Substances) (SIC 2836) · same industry (4-digit SIC) · compared with 39 companies

Multiples and returns vs the median

P/E
—
vertical median 27.0x
EV/EBITDA
—
vertical median 18.0x
P/S
963.7x
vertical median 9.4x
above median (+10,150.8%)
P/B
5.8x
vertical median 3.0x
above median (+93.2%)
ROE
-26.4%
vertical median -52.7%
above median
Net margin
-3,602.7%
vertical median -199.5%
below median
EBIT margin
-4,056.2%
vertical median -200.7%
below median
Revenue YoY
254.7%
vertical median 4.0%
above median (+6,230.2%)
Net debt/EBITDA
—
vertical median 1.2x
Dividend yield
—
vertical median 0.5%

Price rebased to 100 (monthly, 5 years)

Companies in the vertical

Market capP/EROENet marginRevenue YoY1A / 3A
AMGNAmgen Inc.258.8 bn27.778.4%24.1%+10.0%+39% / +77%
GILDGilead Sciences, Inc.216.4 bn—-22.3%-12.5%+2.4%+39% / +128%
MRNAModerna, Inc.103.2 bn—-39.0%-141.4%−39.9%+895% / +233%
ARGXArgenx Se57.6 bn47.620.2%—+254.4%+2% / +107%
RVMDRevolution Medicines, Inc.43.2 bn—-93.6%-946.8%unavailable+157% / +756%
BIIBBiogen Inc.37.6 bn108.81.9%3.4%+2.2%+40% / +9%
EXELExelixis, Inc.17.8 bn21.744.3%35.5%+7.0%+65% / +234%
TECHBio-Techne Corp11.4 bn62.79.0%15.0%−0.4%+13% / +16%
QGENQiagen N.V.11.0 bn26.211.6%20.3%+5.7%+6% / +20%
IBRXImmunitybio, Inc.9.5 bn——-598.6%+668.3%+278% / +143%
CGONCG Oncology, Inc.6.0 bn—-26.4%-3,602.7%+254.7%+73% / unavailable
BEAMBeam Therapeutics Inc.2.9 bn—-11.3%-73.9%+120.0%+10% / −1%
RXRXRecursion Pharmaceuticals, Inc.2.4 bn—-48.7%-697.1%+26.9%−16% / −43%
NVAXNovavax Inc1.8 bn——-59.9%+64.7%+51% / +94%
TSHATaysha Gene Therapies, Inc.1.4 bn—-47.1%-2,728.0%+17.3%−8% / +148%
INBXInhibrx Biosciences, Inc.1.3 bn—-1,773.6%—+550.0%+3% / unavailable
EVAXEvaxion A1.2 bn—-100.2%-102.4%+125.1%−50% / −93%
GLUEMonte Rosa Therapeutics, Inc.923.1 m—-42.7%-560.9%+63.5%−33% / +249%
PRMEPrime Medicine, Inc.901.4 m—-373.3%-4,056.4%+55.3%+30% / −32%
SLDBSolid Biosciences Inc.727.7 m—-76.9%—−40.6%+20% / +131%
CCCCC4 Therapeutics, Inc.383.8 m—-48.1%-289.4%+1.0%+15% / +91%
AUTLAutolus Therapeutics plc367.3 m—-133.0%-238.7%+644.9%−2% / −68%
AGENAgenus Inc313.8 m2.6—69.3%+10.4%+53% / −55%
SABSSab Biotherapeutics, Inc.289.3 m—-11.3%—−100.0%−19% / −67%
FATEFate Therapeutics Inc250.4 m—-60.7%-1,941.1%−51.2%+83% / −16%

1- and 3-year price returns: for CGON from daily closes (the same as the performance table), for the other companies from month-end closes.

olivLaw engine forecast

The world engine ran after the company's latest material disclosure. Probabilities are of TOUCHING a level within the horizon (not closing there) and sit next to the random walk (p_rw), the no-information benchmark.

The engine has no published run for this company yet.

Valuation scenarios (editable assumptions)

Illustrative scenarios

Illustrative: not forecasts and without probabilities. Each case is one coherent set of assumptions, computed on today's figures.

Bear
Allowed range: -50 … 50%
Allowed range: -100 … 100%
Allowed range: 0 … 100
Allowed range: -10 … 20%
Allowed range: 0 … 100%
Base
Allowed range: -50 … 50%
Allowed range: -100 … 100%
Allowed range: 0 … 100
Allowed range: -10 … 20%
Allowed range: 0 … 100%
Bull
Allowed range: -50 … 50%
Allowed range: -100 … 100%
Allowed range: 0 … 100
Allowed range: -10 … 20%
Allowed range: 0 … 100%
Nothing is saved.

Estimated price (USD)

Estimated priceBearBaseBull
1 years
insufficient data
Total return unavailable · Per year unavailable
insufficient data
Total return unavailable · Per year unavailable
insufficient data
Total return unavailable · Per year unavailable
3 years
insufficient data
Total return unavailable · Per year unavailable
insufficient data
Total return unavailable · Per year unavailable
insufficient data
Total return unavailable · Per year unavailable
5 years
insufficient data
Total return unavailable · Per year unavailable
insufficient data
Total return unavailable · Per year unavailable
insufficient data
Total return unavailable · Per year unavailable
What moves the 3-year price the most

    AI analysis

    AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.

    In brief

    CG Oncology is a late-stage biopharmaceutical company developing cretostimogene, an investigational oncolytic immunotherapy given intravesically for non-muscle invasive bladder cancer. The company is nearing completion of its Biologics License Application with the FDA but has no approved products yet, and its net losses have been rising 13.

    SWOT

    Strengths

    • The company has a unique investigational product with a dual mechanism, Phase 3 data published in a leading journal, and Fast Track and Breakthrough Therapy designations from the FDA 12.
    • Liquidity is strong, and the company aims to fund operations over a long horizon, giving it time to develop the product 3.
    • The safety profile reported so far, with no treatment-related Grade 3 or higher events in the main study, supports the product's position against alternatives 1.

    Weaknesses

    • The company depends entirely on a single candidate, so a failed study or BLA could materially affect operations 1.
    • The company generates no meaningful product sales, and net losses and operating expenses are rising from quarter to quarter 13.
    • Manufacturing is outsourced to third parties, including a recently acquired entity, introducing execution and compliance risks 1.

    Opportunities

    • An approval in intermediate-risk NMIBC could open a larger market and an adjuvant indication with no currently FDA-approved options 1.
    • The BCG shortage and reluctance toward cystectomy create a setting in which bladder-sparing therapies could gain share quickly 1.
    • Combinations with other therapies, such as pembrolizumab or gemcitabine, could extend the product's usefulness beyond monotherapy 12.

    Threats

    • Intermediate results can differ from final ones, and a failure at PIVOT-006 could seriously limit the company's prospects 12.
    • Litigation over a licence agreement, in which a court upheld the verdict in the company's favour but the counterparty continued challenging it, adds uncertainty 3.
    • If regulators require additional studies, the commercial timeline could be delayed and costs increased 1.

    Risks

    • Single-product dependencehigh

      The entire business depends on the success of cretostimogene, and any delay or rejection could seriously affect the company 1.

    • Uncertainty of clinical resultshigh

      Interim results are not necessarily predictive of final analyses, and data from ongoing studies could be revised 12.

    • Regulatory approvalhigh

      If the FDA requests further data or rejects the BLA, the commercial timeline could be significantly delayed 13.

    • Shareholder dilutionmedium

      Equity-funded growth has increased the share count, and further issuances could dilute existing shareholders 12.

    • Reliance on third parties for manufacturingmedium

      Production and distribution depend on external suppliers, whose compliance problems could delay studies or commercialization 1.

    Investment thesis

    What would need to be true (bull case)

    • If the monotherapy is approved, the company could become the first with a bladder-sparing treatment for part of the NMIBC population, a segment with large unmet needs 1.
    • A positive PIVOT-006 result could extend the target market to intermediate-risk patients, where no approved adjuvant therapy exists 12.
    • Liquidity of about $1.0 billion and a funding horizon into 2029 could provide time to reach key milestones 3.

    What would break the thesis

    • Rising net losses and no product revenue could force further equity issuances, diluting shareholders 12.
    • A failure or delay in the Phase 3 studies could weigh on investor confidence, since the company has no second candidate in development 1.
    • Licence litigation and the regulatory requirements for live viruses could add costs and further delays 13.

    What to watch

    • Topline results of the PIVOT-006 Phase 3 study in intermediate-risk NMIBCQ3 2026
    • Completion of the BLA submission for high-risk BCG-unresponsive NMIBCQ4 2026

    Products, market & competition

    AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.

    The business

    The strategy aims for FDA approval of monotherapy in high-risk BCG-unresponsive NMIBC, based on the Phase 3 BOND-003 Cohort C study, with the Biologics License Application (BLA) expected to be completed in the fourth quarter of 2026 23. In parallel the company is extending the program to other indications, including the Phase 3 PIVOT-006 study in intermediate-risk NMIBC, where there are currently no FDA-approved adjuvant options in the frontline setting 1. Commercial readiness includes an in-house organization, and administration by nurses or medical assistants could avoid the need for urologists or anesthesia 1.

    Segments

    High-risk BCG-unresponsive NMIBC

    This is the company's core segment, where the BOND-003 Cohort C study reported a 75.5% complete response rate with monotherapy, and the data were published in The Lancet Oncology in July 2026 12. The segment includes up to 25,000 addressable US patients and is the basis of the BLA submission 1.

    Intermediate-risk NMIBC

    The indication covers adjuvant treatment after transurethral resection, a segment of up to 50,000 addressable patients, for which enrollment in the Phase 3 PIVOT-006 study was completed in the third quarter of 2025 1. Topline results are anticipated soon, and a positive outcome could significantly widen the target market 23.

    Market context

    NMIBC accounts for about 75% of newly diagnosed cases, and cystectomy remains the guideline treatment after BCG failure, yet only about 6% of patients elect it, suggesting strong interest in bladder-sparing therapies 1. If the BLA is approved, the product could occupy an important therapeutic space, although timing and regulatory outcomes remain uncertain 12.

    Trends

    • Global BCG shortagetailwind

      The persistent lack of BCG pushes physicians toward alternatives, including for intermediate-risk patients for whom guidelines no longer recommend BCG 1. This could create demand for new therapies if they are approved.

    • Patient reluctance to undergo cystectomytailwind

      Patients generally avoid removal of the bladder, which supports interest in organ-sparing treatments, but adoption could be limited if safety or efficacy data are judged insufficient 1.

    • Regulatory requirements for live modified virusesheadwind

      Cretostimogene is a live, gene-modified virus, and the FDA and other authorities apply additional safety and contagion rules that could delay approval and manufacturing 1.

    • Access to capital marketsmixed

      The company has funded itself through public offerings and at-the-market sales, but if market conditions deteriorate, capital could become more expensive while losses keep growing 12.

    Competitive position

    The market includes approved therapies, notably BCG, and other options against which the company compares itself; Imlygic has already been approved as an oncolytic viral immunotherapy in other indications, while few companies hold approved NMIBC products 1. The company points to simple administration, its safety profile and combination potential with pembrolizumab, which produced an 82.9% complete response rate in the CORE-001 study 1.

    Competition also turns on the number of urology practices, since the product could be given in clinics that already use BCG, which could speed adoption if the FDA approves it 1. The company notes, however, that comparisons depend on final results from ongoing studies 23.

    • Amgen (Imlygic)AMGN

      The oncolytic viral therapy talimogene laherparepvec, FDA-approved, is cited as the first approved oncolytic viral immunotherapy, but in indications other than NMIBC 1.

    • Standard BCG therapy

      The reference treatment for high-risk NMIBC, affected by a shortage that limits patient access to this option 1.

    • Pembrolizumab (checkpoint inhibitor)

      Agent cited in combination with cretostimogene in the CORE-001 study in BCG-unresponsive NMIBC, not as a direct competing product 1.

    • Radical cystectomy

      The standard surgical procedure after BCG failure, which is the alternative the company seeks to help patients avoid 1.

    News & filings

    In the press

    No news in our archive over the last 180 days.

    SEC filings

    Sources

    1. [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / CG Oncology, Inc. · 27 Feb 2026
    2. [2] Form 10-Q, quarter ended 2026-06-30 · SEC / CG Oncology, Inc. · 06 Aug 2026
    3. [3] Form 8-K, results release (exhibit 99.1) · SEC / CG Oncology, Inc. · 06 Aug 2026

    Figures computed by olivLaw from SEC filings and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.