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Edge12 Dec 2025
Running on Clouds: The Story of On
The story of how a Swiss runner's pursuit of a new running sensation became On, aiming to be the most premium global sportswear brand worldwide.
CG Oncology
CG Oncology (CGON) investor relations material
CG Oncology Investor Presentation summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Investor Presentation summary8 Jan, 2026
Clinical development and efficacy highlights
Cretostimogene, an investigational oncolytic immunotherapy, demonstrated a 75.5% overall complete response (CR) rate in high-risk BCG-unresponsive NMIBC, with 46.4% CR at 12 months and 41.8% at 24 months, showing best-in-disease durability and safety with no grade 3+ treatment-related adverse events reported.
In high-risk papillary-only BCG-unresponsive NMIBC, cretostimogene achieved 95.7% high-grade event-free survival (HG-EFS) at 3 months, 84.6% at 6 months, and 80.4% at 9 months, with no treatment-related progression or cystectomy.
For high-risk BCG-naïve NMIBC, an 88% CR rate was observed, with no grade ≥3 adverse events or treatment-related discontinuations.
Cretostimogene is being evaluated in multiple ongoing and planned Phase 2 and 3 trials across high-risk and intermediate-risk NMIBC, including monotherapy and combination regimens.
Optimized administration protocol reduces procedure time by ~25%, streamlining integration into clinical workflows and supporting high-volume treatment centers.
Market opportunity and commercial readiness
NMIBC represents about 75% of newly diagnosed bladder cancer cases, with a multi-billion dollar market opportunity and over 150,000 addressable patients in the U.S.
Cretostimogene programs target more than 70% of the NMIBC market potential, spanning BCG-unresponsive, BCG-exposed, BCG-naïve, and intermediate-risk populations.
Annualized wholesale acquisition cost (WAC) of approved therapies in high-risk NMIBC ranges from $200,000 to $690,000.
Commercial strategy focuses on a capital-efficient, high-touch approach, targeting a concentrated prescriber network where top decile urology centers account for ~10% of national volume.
Pre-launch activities include field force deployment, site and payor engagement, and integration into established urology practice workflows.
Mechanism of action and patient journey
Cretostimogene's dual mechanism involves selective tumor cell killing and stimulation of a durable anti-tumor immune response.
Administered intravesically, similar to standard BCG therapy, allowing seamless adoption by urology practices without additional training.
Patient journey for NMIBC includes regular surveillance, TURBT, and intravesical therapies, with cretostimogene positioned as a bladder-sparing alternative.
Explain cretostimogene's 'best-in-disease' profile
How will manufacturing scale meet 150K+ patients?
PIVOT-006: What is the market entry strategy?
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Next CG Oncology earnings date
44th Annual J.P. Morgan Healthcare Conference15 Jan, 2026
CG Oncology
Next CG Oncology earnings date
44th Annual J.P. Morgan Healthcare Conference15 Jan, 2026
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Frequently asked questions
CG Oncology Inc. is a late-stage clinical biopharmaceutical company primarily engaged in the development and commercialization of innovative treatments for bladder cancer. The company's main focus is on creating a bladder-sparing therapeutic option for patients suffering from this disease. CG Oncology's leading product candidate, cretostimogene, is currently in clinical development targeting high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) patients who have not responded to Bacillus Calmette Guerin (BCG) therapy, the current standard-of-care. The company is headquartered in Irving, California, and its shares are listed on the Nasdaq.
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