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CG Oncology, Inc. (CGON) stock intrinsic value fair value estimate & owner earnings analysis

Margin of safety$6.00 ComplexityHigh Updated
$5.00 $14.50
bear $5.00 base $6.90 bull $14.50 margin of safety $6.00 market price* $59.85
CG Oncology is a clinical-stage company with one lead product, cretostimogene grenadenorepvec, an oncolytic virus given into the bladder for non-muscle-invasive bladder cancer (NMIBC). It has no product revenue and has never produced positive owner earnings: cash from operations was about -$46M in 2023, -$79M in 2024 and -$132M in 2025, and -$103M in the first half of 2026 alone. Share-based pay is large and rising ($27M in 2025). Total shares have grown from about 4M weighted in 2023 to about 88M in the June 2026 quarter. Because there is no earnings stream to value, the analysis rests on what the company holds today and what it can be shown to be worth if the drug is not yet counted. What it holds: at June 30, 2026 it had about $20M of cash and about $1,009M of marketable securities, about $1,028M in total, with no borrowings. That is roughly $11.60 per share on about 88M shares. The company's spending is rising (research and development was $98M in the first half of 2026 versus $59M a year earlier), so we assume about $230M a year of cash use for the next two years. Status of the drug: the company began a rolling Biologics License Application in the fourth quarter of 2025 for patients whose cancer no longer responds to BCG, based on the single-arm BOND-003 Cohort C trial, and expected to complete it in 2026. FDA guidance (revised August 2024) says a single-arm trial measuring complete response and its duration can support full approval in this setting. The most recent annual report does not give an FDA decision date, and the FDA may find the data insufficient. Further trials (PIVOT-006, CORE-008) are still running. Bear case ($5.00 per share): the FDA rejects or demands another trial, the drug never earns a dollar, and the company spends about $250M a year for two years and then about $120M winding down. Value comes only from the cash left after that spending, about $460M in today's terms, with no debt to subtract. This is the case where the cash is worth less than it appears. We did not add a separate downturn because a company with no sales has no earnings to cycle; the risk is a single regulatory outcome, and that is what this case models. Base case ($6.90 per share): we credit only what is in hand, namely the cash less about two years of spending, about $600M in today's terms, and nothing for future sales. Approval has not happened, and no sales, launch or contract revenue beyond the Lepu and Kissei licences has been secured, so none of it is counted here even though the data and the FDA's stated pathway make approval plausible. Readers should treat this figure as a floor-oriented median that deliberately excludes the drug. Bull case ($14.50 per share): the BLA is accepted, approval comes on the single-arm data in 2027, and launch executes at a modest scale, reaching about $150M a year of cash earnings by 2033, held until exclusivity runs out around 2039, after $230M a year of spending for two years and a launch-year loss. The business is then worth about $245M on top of about $1,028M of cash, with no debt. The launch size is deliberately modest and is not a forecast of market share. What would make these figures wrong: a faster burn than $230M a year from additional trials or a launch build-out lowers every case; further share issuance dilutes holders; and an approval followed by a strong launch would exceed the bull case. The company also depends on a single product. Securities holdings were taken at reported value and we did not reconcile year-end 2025 cash of $32M against the large securities balance beyond confirming it is held as marketable securities. The margin-of-safety price of $6.00 reflects the judgement below. The earnings level cannot be known because there are none; the cash balance is the only certain figure. The worst plausible event is a rejected filing with the only asset written off: the structure survives this, since there is no debt and the cash would still be worth roughly $5 a share after winding down, but a further burn beyond our assumption could take that lower. If we are wrong about spending (say $300M a year) or about the share count, the bear value falls to about $3.50-$4. The price assumes a holding period of about two years for the FDA decision; the company pays no dividend, so any return depends entirely on that decision. At $6.00 the downside to the wind-down value is about $1 per share, while approval on the evidence we can see would imply well above the 20% annual return target. The margin-of-safety price is no higher because most of the value above cash depends on an FDA decision not yet made. The previous analysis used different assumptions and a $73.52 quote; its figures are not comparable and are replaced by this one.
Fiscal yearOwner's earningsMethodology
2025 -$2.13 ▼
OE = CFO - dWC - SBC - maintenance capex. CFO=$(132.346)M; WC cash effect=+$5.111M (AP $(1.644)M + accrued liabilities $8.655M - prepaid/other assets $1.900M); SBC=$26.676M; capex=$0.134M, no revenue so growth capex=$0, maintenance capex=$0.134M; OE=$(164.267)M; diluted shares=77.303M; OE/sh=$(2.13). Pre-revenue clinical-stage company, no owner earnings. Source: FY2025 10-K, accession 0001193125-26-079498.
2024 -$1.49 ▼
OE = CFO - dWC - SBC - maintenance capex. CFO=$(78.713)M; WC cash effect=+$2.981M (AP +$3.275M + accrued liabilities +$5.468M - prepaid/other assets $5.762M); SBC=$11.402M; capex=$0.234M, no revenue so growth capex=$0; OE=$(93.330)M; diluted shares=62.497M; OE/sh=$(1.49). Pre-revenue clinical-stage company. Source: FY2024 10-K accession 0000950170-25-046351 and FY2025 10-K accession 0001193125-26-079498 (restated prepaid figure).
2023 -$11.69 ▼
OE = CFO - dWC - SBC - maintenance capex. CFO=$(45.679)M; WC cash effect=+$3.426M (AP +$2.012M + accrued liabilities +$4.137M - prepaid/other assets $2.723M); SBC=$1.528M; capex not separately tagged (immaterial, taken as $0); OE=$(50.633)M; diluted shares=4.331M (pre-IPO weighted average); OE/sh=$(11.69). Pre-revenue clinical-stage company. Source: FY2024 10-K accession 0000950170-25-046351.

Owner's earnings per share by fiscal year, most recent first. Tap a row to see how that figure was calculated, including the source filing.

Sales geography
No product sales yet. Planned first market is the United States (all regions: Northeast, Midwest, South, West); China (mainland China, Hong Kong, Macau) is licensed to Lepu Biotech and Japan/Asia rights are licensed to Kissei Pharmaceutical.
Historical growth strategy
Single-asset clinical-stage developer. It has funded one lead oncolytic virus (cretostimogene grenadenorepvec) through successive trials in bladder cancer (BOND-003, PIVOT-006, CORE-008, CORE-001), financed by venture rounds, the January 2024 IPO and follow-on equity offerings, and out-licensed China (Lepu) and Japan (Kissei) rights. No acquisitions.
Chart analysis
A chartist would see a post-IPO biotech that was volatile and repeatedly re-rated on clinical data. Volume spikes cluster around trial readouts such as the September 2025 BOND-003 data. Rallies after those catalysts were capped near follow-on offerings; support and resistance sit at the levels where the equity raises priced. Trend following is useful only around regulatory news flow (BLA acceptance and FDA decision).
Competitors

Companies we consider competitors of CGON. Tap a ticker to open our analysis of that company in a new tab.

Circle of competence

We don't have circle of competence information for this company yet.