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CG Oncology
CG Oncology (CGON) investor relations material
CG Oncology 44th Annual J.P. Morgan Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.44th Annual J.P. Morgan Healthcare Conference summary15 Jan, 2026
Market opportunity and strategy
Focused on developing a bladder-sparing therapy for non-muscle invasive bladder cancer (NMIBC), targeting a 150,000 patient-per-year market in the US.
Strategy centers on intermediate and high-risk NMIBC, with pivotal phase 3 trials in both segments.
Initial addressable market is 25,000 BCG-unresponsive patients, with expansion to 50,000 intermediate-risk patients expected after PIVOT-006 data.
Near-term data catalysts include PIVOT-006 and CORE-008, both expected to read out in the first half of the year.
BLA submission for the first BCG-unresponsive indication is set for completion in 2026, with intermediate-risk submission targeted for 2027.
Clinical development and efficacy
Cretostimogene grenadenorepvec (Creto) is an oncolytic immunotherapy with a dual mechanism: selective cancer cell lysis and immune activation.
Phase 3 BOND-003 trial in BCG-unresponsive CIS showed a 75.5% complete response rate, with 46.4% at 12 months and 42% at 24 months.
96.4% of patients remained progression-free from muscle-invasive disease at 24 months, the highest PFS rate in this category.
Safety profile is favorable, with no significant grade 3 adverse events and high event-free survival in Ta/T1 adjuvant setting.
PIVOT-006 phase 3 trial in intermediate-risk NMIBC completed enrollment nine months ahead of schedule due to strong physician and patient interest.
Competitive positioning and differentiation
Creto demonstrates superior long-term response rates compared to approved agents, including Keytruda.
Positioned as the first-line adjuvant therapy for intermediate-risk NMIBC, covering a broader patient spectrum than competitors.
Differentiation based on efficacy, duration of response, and best-in-disease safety profile.
Survey of 100 US HCPs identified duration of response, safety, and prevention of radical cystectomy as top prescribing criteria.
Granted breakthrough therapy and fast track designations, with manufacturing capacity up to 50,000 vials/year and plans to scale 10x.
How will CG's lean model ensure market penetration?
How will creto's profile differentiate its market value?
What is the strategy for 10x manufacturing scale-up?
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Next CG Oncology earnings date
Q4 202527 Mar, 2026
CG Oncology
Next CG Oncology earnings date
Q4 202527 Mar, 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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