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Relative valuation derived from Healthcare sector median benchmarks. Model weights: EV/EBITDA (40%), P/B (35%), P/S (25%). Multiples adjusted for extreme outliers and non-recurring volatility.
Auditing capital efficiency...
Quality Profile Audit
Score: 27.8GRADE F
Composite assessment of profitability, capital efficiency, and financial strength. Top-tier entities demonstrate sustainable cash flow generation.
Return on Equity
Profit generated per dollar of shareholder equity
-18.6%
Sector: -43.5%
Dividend Analysis audit
No Dividend
This company does not currently pay a dividend.
Analyst Projections
Analyst Consensus
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Based on our 6-factor quantitative model, CG Oncology, Inc. (CGON) receives a "Hold" rating with a composite score of 37.6/100, ranked #805 out of 4446 stocks. Key factor scores: Quality 28/100, Value 30/100, Momentum 74/100. This is quantitative analysis only — not investment advice.
CG Oncology, Inc. (CGON) Stock Analysis — April 2026 Rating, Price, and Forecast
Company Overview — What Does CG Oncology, Inc. Do?
We are a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. Our product candidate, cretostimogene, is initially in clinical development for the treatment of patients with high-risk Non-MuscleInvasive Bladder Cancer (NMIBC) who are unresponsive to Bacillus Calmette Guerin (BCG) therapy, the current standard-of-care for high-risk NMIBC. There is significant unmet need for treatments in these patients given the limitations of currently approved therapies and patient reluctance to undergo radical cystectomy, or the complete removal of the bladder. We are evaluating the safety and efficacy of cretostimogene as monotherapy in BOND-003, our ongoing Phase 3 clinical trial in high-risk BCG-unresponsive NMIBC patients. We have completed enrollment for this trial, reported interim data in November 2023 and expect to report topline data by the end of 2024. If successful, we believe that this trial could serve as the basis for a Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA). We are also evaluating the use of cretostimogene when administered to this same patient population in combination with FDA-approved pembrolizumab in CORE-001, our ongoing Phase 2 clinical trial. Moreover, we intend to assess the safety and efficacy of cretostimogene in treating a range of other bladder cancer indications as an alternative to BCG therapy and in patients who are not categorized as BCG-unresponsive, including our second Phase 3 clinical trial, PIVOT-006, evaluating adjuvant cretostimogene in intermediate-risk NMIBC patients following transurethral resection of the bladder tumor (TURBT). We believe cretostimogene, if approved, has the potential to serve as first-line therapy, thereby alleviating the current need to prioritize treatment recipients and ration administration of BCG given its significant market shortage. Cretostimogene has shown clinical benefit and has been generally well-tolerated as both a monotherapy and in combination with other therapies in clinical trials to date. Interim data for BOND-003 was reported at the 24th Annual Meeting of Society of Urologic Oncology (SUO) on November 30, 2023. As of the October 5, 2023 efficacy data cutoff, 50 of the 66 (75.7%; 95% CI: 63-85%) evaluable patients achieved a complete response (CR), generally meaning no evidence of bladder cancer, at any time after the administration of cretostimogene. In addition, as of the data cutoff, 45 out of 66 (68.2%) patients achieved a CR at three months and 42 out of 66 (63.6%) patients achieved a CR at six months. Four out of 13 (30.8%) patients who did not achieve a CR at three months, and who were subsequently re-dosed with cretostimogene at three months demonstrated a CR at six months. Of those 50 patients who achieved a CR at any time, 42 out of 50 (84.0%) maintained their response for at least three months and 32 out of 43 (74.4%) maintained their response for at least six months. Seven patients had yet to reach the minimum duration of response (DOR) evaluation and were excluded from the assessment for durable CR lasting at least six months. A DOR is the length of time from the first response until the time the patient no longer meets the definition for a CR. Cretostimogene was generally well-tolerated in this trial as of the September 8, 2023 safety data cutoff, with mostly Grade 1 or Grade 2 adverse events reported and no Grade 3 or higher treatment-related adverse events (TRAEs) reported. There were no treatment discontinuations due to TRAEs and no deaths were reported. Two patients (1.8%) had serious adverse events (SAEs), including Grade 2 noninfective cystitis, which is the inflammation of the bladder not caused by a bacteria or other infectious agent, and Grade 2 clot retention, both of which resolved. In addition, in our ongoing open-label Phase 2 CORE-001 clinical trial of cretostimogene in combination with pembrolizumab in high-risk BCG-unresponsive NMIBC, 29 of the 34 (85%; 95% CI: 68-94%) patients evaluable as of the March 3, 2023 data cutoff achieved a CR after an initial induction course of therapy, with 82% (n=27/33) of patients maintaining a CR at six months, and 68% (n=17/25) of patients maintaining a CR at 12 months. Cretostimogene was generally well-tolerated in this trial as of the January 31, 2023 safety data cutoff, with one Grade 2 SAE (urinary retention) deemed related to cretostimogene and two Grade 3 SAEs related to pembrolizumab (adrenal insufficiency and immune-mediated hepatitis), all of which resolved. Cretostimogene has received fast track designation from the FDA for the treatment of BCG-unresponsive, high risk NMIBC patients with carcinoma in-situ with or without Ta or T1 papillary tumors to improve CR. Fast track designation may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that cretostimogene will receive marketing approval. We have presented the confidence interval (CI) for CR at any time above and elsewhere in this prospectus. CI is a range of values in which, statistically, there is a specified level of confidence where the result lies. The lower bound of the 95% CI around the observed CR rate provides support that such rate may be clinically meaningful. Interim results from these trials may differ from future results of the trials as more patient data become available. We were originally founded as a California corporation on September 24, 2010 under the name Cold Genesys, Inc. On November 30, 2017, we reincorporated as a Delaware corporation, and on March 31, 2020, we changed our name to CG Oncology, Inc. Our principal executive offices are located at 400 Spectrum Center Drive, Suite 2040, Irvine, CA. CG Oncology, Inc. (CGON) is classified as a mid-cap stock in the Healthcare sector, specifically within the Pharmaceutical Products industry. The company is led by CEO Arthur Kuan. With a market capitalization of $5.6B, CGON is one of the notable companies in the Healthcare sector.
CG Oncology, Inc. (CGON) Stock Rating — Hold (April 2026)
As of April 2026, CG Oncology, Inc. receives a Hold rating with a composite score of 37.6/100 and 3 out of 5 stars from the Blank Capital Research quantitative model.CGON ranks #805 out of 4,446 stocks in our coverage universe. Within the Healthcare sector, CG Oncology, Inc. ranks #55 of 838 stocks, placing it in the top 10% of its Healthcare peers. The rating is generated by a multi-factor model that weighs quality (30%), momentum (25%), value (15%), investment (10%), stability (10%), and short interest (10%).
CGON Stock Price and 52-Week Range
CG Oncology, Inc. (CGON) currently trades at $67.70. The stock lost $0.86 (1.3%) in the most recent trading session. The 52-week high for CGON is $69.35, which means the stock is currently trading -2.4% from its annual peak. The 52-week low is $14.80, putting the stock 357.4% above its annual trough. Recent trading volume was 1.2M shares, reflecting moderate market activity.
Is CGON Overvalued or Undervalued? — Valuation Analysis
CG Oncology, Inc. (CGON) carries a value factor score of 30/100 in the Blank Capital model, signaling premium valuation that prices in significant future growth. The price-to-book ratio stands at 7.83x, versus the sector average of 2.75x. The price-to-sales ratio is 3347.20x, compared to 1.66x for the average Healthcare stock.
At current multiples, CG Oncology, Inc. trades at a premium to most Healthcare peers. This elevated valuation may be justified if the company can sustain above-average growth rates and profitability, but it also creates downside risk if earnings disappoint expectations.
CG Oncology, Inc. Profitability — ROE, Margins, and Quality Score
CG Oncology, Inc. (CGON) earns a quality factor score of 28/100, signaling below-average profitability metrics relative to the broader market. The return on equity (ROE) is -18.6%, compared to the Healthcare sector average of -43.5%, which is below typical expectations for high-quality companies. Return on assets (ROA) comes in at -17.7% versus the sector average of -33.1%.
The operating margin is -50010.9% (sector: -66.1%). Net profit margin stands at -38779.0%, versus -58.7% for the average Healthcare stock. Revenue growth is running at 1400.9% on a trailing basis, compared to 10.6% for the sector. Profitability is below benchmark levels, which may reflect industry headwinds, elevated reinvestment, or structural challenges.
CGON Debt, Balance Sheet, and Financial Health
CG Oncology, Inc. has a debt-to-equity ratio of 5.0%, compared to the Healthcare sector average of 32.0%. The low leverage indicates a conservative balance sheet with significant financial flexibility. The current ratio is 24.63x, indicating strong short-term liquidity.
CGON has a beta of 1.52, meaning it is more volatile than the broader market — a $10,000 investment in CGON would be expected to move 51.6% more than the S&P 500 on any given day. The stability factor score for CG Oncology, Inc. is 35/100, suggesting elevated price swings that may be unsuitable for conservative portfolios.
CG Oncology, Inc. Revenue and Earnings History — Quarterly Trend
In TTM 2026, CG Oncology, Inc. reported revenue of $2M and earnings per share (EPS) of $-2.08. Net income for the quarter was $-140M. Operating income came in at $-170M.
In FY 2025, CG Oncology, Inc. reported revenue of $4M and earnings per share (EPS) of $-2.08. Net income for the quarter was $-161M. Revenue grew 254.7% year-over-year compared to FY 2024. Operating income came in at $-191M.
In Q3 2025, CG Oncology, Inc. reported revenue of $2M and earnings per share (EPS) of $-0.57. Net income for the quarter was $-44M. Revenue grew 3774.4% year-over-year compared to Q3 2024. Operating income came in at $-51M.
In Q2 2025, CG Oncology, Inc. reported revenue of $0 and earnings per share (EPS) of $-0.54. Net income for the quarter was $-41M. Operating income came in at $-49M.
Over the past 8 quarters, CG Oncology, Inc. has demonstrated a growth trajectory, with revenue expanding from $111,000 to $2M. Investors analyzing CGON stock should weigh these quarterly trends alongside the valuation and quality metrics discussed above.
CGON Dividend Yield and Income Analysis
CG Oncology, Inc. (CGON) does not currently pay a dividend. This is common among smaller companies in the Pharmaceutical Products industry that prefer to reinvest cash flows into business expansion rather than returning capital to shareholders. Income-focused investors looking for Healthcare dividend stocks may want to explore other Healthcare stocks or use the stock screener to filter by dividend yield.
CGON Momentum and Technical Analysis Profile
CG Oncology, Inc. (CGON) has a momentum factor score of 74/100, indicating strong price momentum with the stock outperforming the majority of the market over recent periods. Stocks with high momentum scores have historically tended to continue their outperformance in the near term. The investment factor score is 20/100, which measures capital allocation efficiency and asset growth patterns. The short interest score of 7/100 signals elevated short interest, which can indicate bearish sentiment among institutional investors.
CGON vs Competitors — Healthcare Sector Ranking and Peer Comparison
Comparing CGON against the S&P 500 benchmark is also instructive for understanding relative performance. Investors can view the full CGON vs S&P 500 (SPY) comparison to assess how CG Oncology, Inc. stacks up against the broader market across all factor dimensions.
CGON Next Earnings Date
No upcoming earnings date has been announced for CG Oncology, Inc. (CGON) at this time. Check the earnings calendar for the latest scheduling updates across all stocks in our coverage universe.
Should You Buy CGON? — Investment Thesis Summary
CG Oncology, Inc. presents a balanced picture with arguments on both sides. The quality score of 28/100 flags below-average profitability. The value score of 30/100 indicates premium valuation. Price momentum is positive at 74/100, suggesting the trend favors buyers. High volatility (stability score 35/100) increases portfolio risk.
In summary, CG Oncology, Inc. (CGON) earns a Hold rating with a composite score of 37.6/100 as of April 2026. The rating is derived from the Blank Capital Research methodology, which combines six factor dimensions into a single quantitative ranking. Investors should consider these quantitative signals alongside their own fundamental research, risk tolerance, and investment time horizon before making buy or sell decisions on CGON stock.
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Institutional Research Dossier
CG Oncology, Inc. (CGON) Deep Dive Analysis
Published on March 24, 2026
Action RatingHold
Sections
Executive Summary
CG Oncology (CGON) receives a Hold rating, driven by the promising clinical trial results of cretostimogene in treating high-risk Non-Muscle Invasive Bladder Cancer (NMIBC), balanced against the inherent risks and uncertainties associated with clinical-stage biopharmaceutical companies and a high valuation. While the interim data from the BOND-003 and CORE-001 trials are encouraging, the company's lack of profitability and reliance on a single product candidate warrant caution.
The critical takeaway is that CG Oncology's future hinges on the successful completion of its Phase 3 trials and subsequent FDA approval of cretostimogene. The current market capitalization reflects significant optimism regarding this outcome, leaving limited margin for error. Investors should closely monitor the topline data from the BOND-003 trial expected by the end of 2024, as this will be a pivotal event for the company's prospects.
Business Strategy & Overview
CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing cretostimogene, a potential bladder-sparing therapeutic for patients with bladder cancer. The company's primary focus is on high-risk NMIBC patients who are unresponsive to BCG therapy, the current standard of care. This represents a significant unmet need, as current treatments have limitations, and many patients are reluctant to undergo radical cystectomy.
The company's lead product candidate, cretostimogene, is currently being evaluated as a monotherapy in the Phase 3 BOND-003 trial and in combination with pembrolizumab in the Phase 2 CORE-001 trial. Positive interim data from these trials have been reported, showing promising complete response rates. CG Oncology expects to report topline data from the BOND-003 trial by the end of 2024, which could serve as the basis for a BLA submission to the FDA.
Beyond BCG-unresponsive NMIBC, CG Oncology intends to explore the use of cretostimogene in other bladder cancer indications, including as an alternative to BCG therapy and in patients who are not BCG-unresponsive. The company is also conducting a second Phase 3 trial, PIVOT-006, evaluating adjuvant cretostimogene in intermediate-risk NMIBC patients. This broader strategy aims to expand the potential market for cretostimogene and establish it as a first-line therapy.
CG Oncology's business model is centered on the development and commercialization of novel cancer therapies. The company relies on clinical trials to demonstrate the safety and efficacy of its product candidates, and ultimately seeks regulatory approval from the FDA. If approved, CG Oncology plans to commercialize cretostimogene through its own sales force or through partnerships with other pharmaceutical companies. The company operates in a highly competitive industry, facing competition from established pharmaceutical companies and other biotechnology companies developing cancer therapies.
Execution Benchmarks audit
Revenue Growth
YOY expansion rate
1400.9%
Sector: 10.6%
+13066% VS SCTR
Economic Moat Analysis
CG Oncology's economic moat is currently considered to be None. While the company has promising clinical trial data for cretostimogene, it lacks the established market presence, brand recognition, and diversified product portfolio typically associated with companies possessing a sustainable competitive advantage. The biopharmaceutical industry is characterized by intense competition and rapid technological advancements, making it difficult for any single company to maintain a dominant position for an extended period.
The primary potential source of a moat for CG Oncology lies in its intellectual property protection for cretostimogene. If the company can secure strong patent protection and successfully defend its intellectual property rights, it may be able to create a period of exclusivity that allows it to generate significant profits. However, patent protection is not absolute, and competitors may be able to develop alternative therapies that circumvent CG Oncology's patents.
Furthermore, the regulatory approval process for new drugs is lengthy and uncertain. Even if cretostimogene receives FDA approval, there is no guarantee that it will be commercially successful. The drug may face competition from existing therapies, and its adoption may be limited by factors such as pricing and reimbursement policies.
The company's reliance on a single product candidate also weakens its competitive position. If cretostimogene fails to achieve regulatory approval or commercial success, CG Oncology's future prospects would be severely jeopardized. A more diversified product pipeline would provide the company with greater resilience and reduce its dependence on any single product.
While the Fast Track designation from the FDA could expedite the review process, it does not guarantee approval or market success. The company's ability to establish a moat will depend on its ability to successfully navigate the regulatory landscape, protect its intellectual property, and effectively commercialize cretostimogene.
Financial Health & Profitability
CG Oncology's financial health is currently characterized by significant revenue growth coupled with substantial net losses. The company's revenue has increased dramatically, from $1.14 million in FY2024 to $4.04 million in FY2025, representing a 1,400.9% increase. However, this growth is overshadowed by the company's net losses, which amounted to $161.00 million in FY2025, compared to $88.04 million in FY2024. This translates to a negative EPS of $-2.08 for FY2025.
The company's profitability metrics are deeply negative, with an operating margin of -4,722.1% and a net margin of -38,779.0% in FY2025. These figures are significantly worse than the sector averages, which are already negative at -65.2% and -54.1% for operating and net margins, respectively. The high operating and net losses are primarily due to the substantial research and development expenses associated with clinical trials.
The company's current ratio is exceptionally high at 24.63, indicating a strong ability to meet its short-term obligations. However, without available data on total cash and total debt, a complete picture of the company's liquidity and solvency cannot be formed. The absence of free cash flow data further complicates the assessment of the company's financial health.
The quarterly financial history reveals a consistent pattern of net losses and negative EPS. While revenue has fluctuated, the company has not achieved profitability in any of the reported quarters. The high revenue growth in Q3 FY2025, driven by $1.67 million in revenue, did not translate into improved profitability, as the net loss remained substantial at $-43.81 million.
Compared to the healthcare sector, CG Oncology's ROE is -18.6%, which is better than the sector average of -42.5%. However, both figures indicate poor profitability and inefficient use of equity. The company's D/E ratio is 5.00, which is significantly lower than the sector average of 30.00, suggesting a relatively conservative approach to debt financing.
Overall, CG Oncology's financial health is precarious. The company is heavily reliant on external funding to support its operations and clinical trials. The lack of profitability and negative cash flow raise concerns about the company's long-term sustainability. Investors should closely monitor the company's cash burn rate and its ability to secure additional funding.
Valuation Assessment
CG Oncology's valuation is challenging to assess due to its lack of profitability and reliance on future potential revenue from cretostimogene. The company's P/E and EV/EBITDA ratios are not applicable (N/A) because it has negative earnings and EBITDA. This makes traditional valuation metrics based on current earnings or cash flow unreliable.
The company's market capitalization of $5.50 billion reflects significant investor optimism regarding the potential success of cretostimogene. This valuation is based on the expectation that the drug will receive FDA approval and achieve substantial market penetration. However, the biopharmaceutical industry is inherently risky, and there is no guarantee that cretostimogene will achieve these milestones.
Compared to the healthcare sector, CG Oncology's valuation appears high. The sector's average P/E ratio is 24.3x, and the average EV/EBITDA ratio is 6.4x. While these metrics are not directly comparable to CG Oncology due to its lack of profitability, they provide a benchmark for assessing the company's relative valuation. The fact that CG Oncology has a market cap of $5.5B with only $4.04M in revenue indicates a very high revenue multiple.
A more appropriate valuation approach would involve using discounted cash flow (DCF) analysis, which projects the company's future cash flows and discounts them back to their present value. However, this approach requires making numerous assumptions about the company's future revenue growth, operating expenses, and discount rate, which are subject to significant uncertainty.
Given the company's high valuation and the inherent risks associated with clinical-stage biopharmaceutical companies, the stock appears to be expensive. The current market price reflects a significant premium for the potential success of cretostimogene, leaving limited margin for error. Investors should carefully consider the risks and uncertainties before investing in CG Oncology.
The Momentum score of 73/100 suggests positive market sentiment, but this should not be interpreted as a validation of the company's intrinsic value. Market sentiment can be driven by factors unrelated to fundamental value, such as hype and speculation.
Risk & Uncertainty
CG Oncology faces several significant risks and uncertainties that could negatively impact its business and financial prospects. The most prominent risk is the uncertainty surrounding the clinical development and regulatory approval of cretostimogene. The company's future success hinges on the successful completion of its Phase 3 trials and subsequent FDA approval of the drug. Clinical trials are inherently risky, and there is no guarantee that cretostimogene will demonstrate the safety and efficacy required for regulatory approval. Even if the drug is approved, the FDA could impose restrictions on its use or require additional post-market studies.
Competition is another significant risk. The biopharmaceutical industry is highly competitive, and CG Oncology faces competition from established pharmaceutical companies and other biotechnology companies developing cancer therapies. Competitors may develop alternative therapies that are more effective, safer, or less expensive than cretostimogene. The company also faces competition from existing therapies for bladder cancer, such as BCG therapy and radical cystectomy.
The company's reliance on a single product candidate is a major risk. If cretostimogene fails to achieve regulatory approval or commercial success, CG Oncology's future prospects would be severely jeopardized. A more diversified product pipeline would provide the company with greater resilience and reduce its dependence on any single product.
Financial risk is also a concern. CG Oncology is currently unprofitable and relies on external funding to support its operations and clinical trials. The company may need to raise additional capital in the future, which could dilute existing shareholders' ownership. There is no guarantee that the company will be able to secure additional funding on favorable terms, or at all.
Regulatory risk is ever-present. Changes in government regulations or policies could negatively impact CG Oncology's business. For example, changes in drug pricing policies or reimbursement rates could reduce the profitability of cretostimogene. The company is also subject to environmental regulations and other laws and regulations that could increase its operating costs.
Bulls Say / Bears Say
The Bull Case
BULL VIEWCretostimogene's impressive complete response rates in clinical trials suggest it could become the new standard of care for BCG-unresponsive NMIBC, capturing a significant market share.
BULL VIEWThe FDA's Fast Track designation for cretostimogene indicates a potential for expedited review and approval, accelerating the path to commercialization and revenue generation.
BULL VIEWCG Oncology's expansion into other bladder cancer indications beyond BCG-unresponsive NMIBC provides significant upside potential, broadening the addressable market and diversifying revenue streams.
The Bear Case
BEAR VIEWCG Oncology's valuation is excessively high given its lack of profitability and reliance on a single product candidate, making it vulnerable to a significant correction if clinical trial results disappoint.
BEAR VIEWThe biopharmaceutical industry is intensely competitive, and CG Oncology faces significant challenges from larger, more established companies with greater resources and diversified product portfolios.
BEAR VIEWThe inherent risks associated with clinical trials and regulatory approval mean that cretostimogene could fail to achieve commercial success, rendering CG Oncology's current market capitalization unsustainable.
About the Author
Marques Blank
Founder & Chief Investment Officer, Blank Capital
Marques brings 15 years of institutional finance and investing experience, having overseen financial planning for a $1.6B defense business unit. He developed the proprietary 6-factor quantitative model used to score CGON and 4,400+ other equities.
CG Oncology, Inc. exhibits a 67148% valuation premium relative to institutional benchmarks. This represents a potential valuation overextension based on current multiples.
Return on Assets
Efficiency of asset utilization
-17.7%
Sector: -33.1%
Gross Margin
Pricing power and cost efficiency
—
Sector: 71.5%
Operating Margin
Core business profitability
-50010.9%
Sector: -66.1%
Net Margin
Bottom-line profitability
-38779.0%
Sector: -58.7%
Factor Methodology
The Quality factor evaluates the persistence and magnitude of cash flows. Companies with scores >70 exhibit superior competitive moats and financial resilience through economic cycles.
