New Cretostimogene Grenadenorepvec Data Highlight its Potential to Become the Backbone Therapy for High-Risk Non-Muscle Invasive Bladder Cancer

Rhea-AI Summary

CG Oncology (NASDAQ: CGON) reported topline results Dec 5, 2025 from BOND-003 Cohort P and CORE-008 Cohort A showing promising efficacy and tolerability for cretostimogene in non‑muscle invasive bladder cancer (NMIBC).

In BOND-003 Cohort P (BCG‑unresponsive papillary-only), HG‑EFS by Kaplan‑Meier at 3/6/9 months was 95.7%, 84.6% and 80.4% (data cut-off Sep 1, 2025; 51 evaluable patients). CORE-008 Cohort A (high‑risk, BCG‑naïve CIS) showed overall CR 83.7% with optimized administration CR 88.0% (data cut-off Sep 1, 2025; 49 evaluable patients). No Grade ≥3 treatment‑related AEs, no treatment‑related discontinuations, and no progressions to MIBC reported.

Positive

• HG-EFS 95.7% at 3 months (Sep 1, 2025, 51 evaluable patients)
• HG-EFS 84.6% at 6 months (Kaplan‑Meier estimate)
• CORE-008 optimized CR 88.0% (22/25 patients, Sep 1, 2025)
• No Grade ≥3 treatment-related adverse events reported
• Enrollment completed: 56 patients dosed across 35 sites

Negative

• Limited follow-up: topline HG-EFS reported through 9 months
• Small sample sizes: key cohorts report 49–51 evaluable patients
• Common TRAEs ≥10%: bladder spasms, dysuria, pollakiuria, hematuria

News Market Reaction

-3.67%

1 alert

-3.67% News Effect

On the day this news was published, CGON declined 3.67%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

HG-EFS 3 months: 95.7% (95% CI 83.8–98.9) HG-EFS 6 months: 84.6% (95% CI 68.6–92.9%) HG-EFS 9 months: 80.4% (95% CI 62.3–90.4%) +5 more

8 metrics

HG-EFS 3 months 95.7% (95% CI 83.8–98.9) BOND-003 Cohort P, 51 efficacy-evaluable patients

HG-EFS 6 months 84.6% (95% CI 68.6–92.9%) BOND-003 Cohort P, BCG-unresponsive papillary-only NMIBC

HG-EFS 9 months 80.4% (95% CI 62.3–90.4%) BOND-003 Cohort P, monotherapy

Cohort P enrollment 56 patients BOND-003 Cohort P across 35 sites in US and Japan

Overall CR rate 83.7% (41/49; 95% CI 70.3–92.7%) CORE-008 Cohort A, high-risk BCG-naïve NMIBC with CIS

CR original regimen 79.2% (57.8–92.9), 19/24 patients CORE-008 Cohort A, five-step administration

CR optimized regimen 88.0% (68.8–97.5), 22/25 patients CORE-008 Cohort A, two-step administration

Safety CORE-008 0 Grade ≥3 related AEs Cohort A safety population n=54; adverse events low grade, localized

Market Reality Check

Price: $54.73 Vol: Volume 670,044 vs 20-day ...

normal vol

$54.73 Last Close

Volume Volume 670,044 vs 20-day avg 875,178 (relative volume 0.77). normal

Technical Price $44.95 trading above 200-day MA at $30.11, near 52-week high $45.94.

Peers on Argus

CGON gained 5.49% while key biotech peers like CELC (+6.73%) and IBRX (+4.84%) w...

CGON gained 5.49% while key biotech peers like CELC (+6.73%) and IBRX (+4.84%) were also positive, but no peers appeared in the momentum scanner, suggesting a stock-specific move tied to the new cretostimogene data.

Historical Context

5 past events · Latest: Nov 26 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 26	Board change, BLA	Positive	-1.5%	New director added and BLA initiation noted for cretostimogene.
Nov 25	Conference preview	Positive	-1.5%	Announcement of upcoming SUO presentations on BOND-003 and CORE-008.
Nov 14	Earnings, clinical	Positive	+8.6%	Q3 results plus rolling BLA and 24‑month BOND‑003 Cohort C data.
Sep 05	Clinical durability data	Positive	+6.9%	Updated BOND‑003 Cohort C durability and progression-free outcomes.
Sep 03	Trial enrollment	Positive	+4.4%	Completion of PIVOT‑006 enrollment well ahead of schedule.

Pattern Detected

Stock has tended to react positively to substantial clinical and data milestones, with occasional negative reactions around management and presentation-focused news.

Recent Company History

Over the past six months, CG Oncology has repeatedly highlighted cretostimogene’s progress across non-muscle invasive bladder cancer. Key events include early completion of enrollment in PIVOT-006 on Sep 3, durable 24‑month BOND‑003 Cohort C data on Sep 5, and Q3 results on Nov 14 with a 41.8% 24‑month CR rate and cash of $680.3M. Recent news on SUO presentations and BLA initiation underscores a transition from pure development toward potential commercialization, which today’s BOND‑003 and CORE‑008 data further support.

Market Pulse Summary

This announcement adds substantial clinical detail around cretostimogene in high‑risk non‑muscle inv...

Analysis

This announcement adds substantial clinical detail around cretostimogene in high‑risk non‑muscle invasive bladder cancer, with BOND‑003 Cohort P showing strong HG‑EFS and CORE‑008 Cohort A achieving high CR rates and favorable safety. Recent history includes BLA initiation, early trial enrollment completion, and durable 24‑month outcomes, underscoring a late‑stage development profile. Investors may focus on longer follow‑up, consistency across cohorts, and forthcoming regulatory milestones to contextualize these data within CG Oncology’s broader strategy.

Key Terms

high-grade event-free survival, complete response, kaplan-meier, treatment-related adverse events, +2 more

6 terms

high-grade event-free survival medical

"The study’s primary endpoint is High-Grade Event-Free Survival (HG-EFS)."

High-grade event-free survival measures how long patients with an aggressive or severe form of a disease remain alive without a predefined negative outcome — such as disease progression, relapse, or treatment-related complications. For investors, it’s a key clinical metric showing whether a therapy meaningfully delays bad outcomes in the toughest cases; stronger results can increase the chances of regulatory approval, wider use, and commercial value. Think of it like the length of time a high-performance car runs trouble-free after a major repair.

complete response medical

"The primary endpoint is Complete Response (CR) at any time."

A complete response is a positive outcome in which a company’s efforts to address issues or questions fully resolve the problem, often meaning that no further action or investigation is needed. For investors, it signals that concerns have been thoroughly addressed, which can boost confidence in the company's stability or decision-making. Think of it like a doctor fully treating an illness, leaving no remaining symptoms.

kaplan-meier medical

"Kaplan-Meier estimates of HG-EFS at 3- 6- and 9-months are 95.7%..."

A Kaplan-Meier estimate is a statistical curve that shows how long it takes for a particular event—such as recovery, relapse, or death—to occur in a group over time, with the curve stepping down as events happen. Investors use these curves to assess the duration and timing of a treatment's or risk's effects—like watching how many light bulbs remain working week by week—because the timing and likelihood of outcomes influence clinical decisions, regulatory approval, and revenue prospects.

treatment-related adverse events medical

"no Grade 3 or greater treatment-related adverse events (TRAEs) and no deaths reported."

Treatment-related adverse events are harmful or unwanted health effects that doctors or regulators determine were caused by a drug, vaccine, device, or other medical therapy. Investors care because how often and how severe these side effects are can shape regulatory approval, labeling, sales potential and legal risk — similar to how product defects can stop or damage a company's ability to sell an item.

serious adverse events medical

"There are no related serious adverse events (SAEs), Grade 3+ adverse events..."

Serious adverse events are significant problems or negative outcomes that occur during a medical treatment or clinical trial, such as severe side effects, hospitalizations, or life-threatening conditions. They matter to investors because such events can impact a company's reputation, lead to regulatory scrutiny, or delay the development of new products, ultimately affecting the company’s financial performance.

non-muscle invasive bladder cancer medical

"backbone therapy for High-Risk Non-Muscle Invasive Bladder Cancer"

A form of bladder cancer that is confined to the inner lining of the bladder and has not grown into the deeper muscle layer; think of it like a stain on wallpaper rather than damage to the wall’s studs. It matters to investors because it has different treatment, monitoring and recurrence patterns than deeper cancers, driving demand for repeated outpatient procedures, local therapies and diagnostic tests that affect revenue, trial design and pricing dynamics in healthcare markets.

AI-generated analysis. Not financial advice.

• Cretostimogene demonstrated HG-EFS at 3- 6- and 9-months of 95.7%, 84.6% and 80.4%, respectively, in HR BCG UR Ta/T1 Disease in BOND-003 Cohort P
  
  
• CORE-008 Cohort A Data in HR BCG-Naïve NMIBC demonstrates 88% CR and favorable safety with optimized administration
  
  
• Robust clinical pipeline that spans multiple late-stage studies across intermediate- and high-risk NMIBC
  
  

IRVINE, Calif., Dec. 05, 2025 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced topline data from BOND-003 Cohort P and first results from CORE-008 Cohort A which demonstrated promising efficacy, safety and tolerability. These data will be presented today as Late-Breaking Abstracts at the Society of Urologic Oncology (SUO) 26th Annual Meeting. 

“For people living with bladder cancer, the need for primary treatment of newly diagnosed NMIBC and a durable, bladder-sparing option for those with BCG unresponsive disease is urgent. New data from BOND-003 Cohort P and CORE-008 Cohort A add to a growing body of evidence demonstrating cretostimogene’s potential to become a backbone treatment across the NMIBC spectrum, if approved. The topline efficacy, safety, and tolerability announced today are consistent with what we previously observed with the pivotal Phase 3 monotherapy data, but in an even more prevalent NMIBC population, notably BCG-UR papillary-only,” said Trinity J. Bivalacqua, M.D., Ph.D., Urologic Oncologist at University of Pennsylvania.

“We are delighted to share new and more mature data in different sub-groups, underscoring our commitment to address the broadest range of NMIBC patients. This sets us up for the future expansion and long-term success of cretostimogene. With its best-in-disease profile and dual MOA, we are confident that cretostimogene will continue to demonstrate differentiated data from current and investigational NMIBC therapies,” said Ambaw Bellete, President & Chief Operating Officer at CG Oncology.

TOPLINE BOND-003 COHORT P RESULTS
Results from the BOND-003 Cohort P clinical trial of cretostimogene monotherapy in patients with BCG-UR papillary-only NMIBC demonstrate encouraging HG-EFS and a consistent, well-tolerated safety profile. The study’s primary endpoint is High-Grade Event-Free Survival (HG-EFS). As of the September 1, 2025, data cut-off, in 51 efficacy evaluable patients, Kaplan-Meier estimates of HG-EFS at 3- 6- and 9-months are 95.7% (95% CI 83.8 – 98.9), 84.6% (95% CI 68.6 – 92.9%) and 80.4% (95% CI 62.3-90.4%), respectively.

A favorable safety and tolerability profile was observed with no Grade 3 or greater treatment-related adverse events (TRAEs) and no deaths reported. To date, no patients have undergone a radical cystectomy or progressed to MIBC. No treatment-related discontinuation of cretostimogene was observed. There were no missed doses, or dose delays due to TRAE. The most common TRAEs (≥10%) were bladder spasms, dysuria, pollakiuria, and hematuria.

The study has completed enrollment with 56 patients receiving cretostimogene across 35 clinical sites in the United States and Japan.

CORE-008 Cohort A Results
The first results from CORE-008 Cohort A demonstrate that cretostimogene monotherapy has promising clinical efficacy, tolerability, and safety in patients with high-risk, BCG-naïve NMIBC with CIS, compared with outcomes observed in historical BCG-naive trials. The primary endpoint is Complete Response (CR) at any time. As of the September 1, 2025, data cut off, the overall CR rate at any time in evaluable patients is 83.7% (41/49) (95% CI 70.3-92.7%) with the original administration achieving a 79.2% CR rate (57.8, 92.9) in 19 out of 24 patients as compared with the optimized administration which resulted in an 88.0% CR rate (68.8, 97.5) in 22 out of 25 patients.

The safety and tolerability profile is consistent with prior clinical trials of cretostimogene. The most common adverse events are low grade and localized to the bladder. There are no related serious adverse events (SAEs), Grade 3+ adverse events or treatment-related discontinuations. No patients progressed to MIBC or metastatic disease.

CORE-008 Cohort A	CR Rate, % (95% CI)	Safety (n=54)
		Any Grade	Grade ≥ 3
Original Administration (five-step)	79.2% (57.8, 92.9)1	16 (59.3%)1	0 (0%)
Optimized Administration (two-step)	88.0% (68.8, 97.5)2	13 (48.1%)	0 (0%)
Overall	83.7%	29 (53.7%)	0 (0%)

¹ CR rate in 19 out of 24 patients; safety in 27 patients
² CR rate in 22 out of 25 patients; safety in 27 patients

About Cretostimogene Grenadenorepvec
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 400 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. CG Oncology also has a Phase 2 trial, CORE-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority.

About CG Oncology
CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: www.cgoncology.com.

Forward-Looking Statements
CG Oncology cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, the potential therapeutic benefits of cretostimogene for high-risk and intermediate-risk NMIBC patients, cretostimogene’s potential as a backbone immunotherapy across the NMIBC spectrum, and that cretostimogene results support optimized administration from a five-step process to a two-step process. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data becomes available; potential delays in the commencement, enrollment and completion of clinical trials, including the BOND-003 and PIVOT-006 trials; we may use our capital resources sooner than expected and they may be insufficient to allow us to achieve our anticipated milestones; our dependence on third parties in connection with manufacturing, shipping and clinical and preclinical testing; results from earlier clinical trials and preclinical studies not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K and other filings that we make with the SEC from time to time (which are available at http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contacts:
Media
Sarah Connors
Vice President, Communications and Patient Advocacy, CG Oncology
sarah.connors@cgoncology.com

Investor Relations
Megan Knight
Vice President, Investor Relations, CG Oncology
megan.knight@cgoncology.com

FAQ

What were cretostimogene HG‑EFS rates in BOND-003 Cohort P as of Sep 1, 2025?

Kaplan‑Meier HG‑EFS rates were 95.7% at 3 months, 84.6% at 6 months, and 80.4% at 9 months (51 evaluable patients).

What was the Complete Response (CR) rate for CGON CORE-008 Cohort A optimized administration?

The optimized two-step administration achieved a 88.0% CR rate (22 of 25 patients) as of Sep 1, 2025.

Did cretostimogene show any Grade 3 or higher treatment‑related adverse events in these cohorts?

No related Grade ≥3 treatment‑related adverse events or treatment‑related discontinuations were reported in the disclosed cohorts.

How many patients were enrolled and dosed in BOND-003 Cohort P?

The study completed enrollment with 56 patients receiving cretostimogene across 35 clinical sites in the United States and Japan.

Were there any progressions to muscle‑invasive bladder cancer (MIBC) reported in these datasets?

No patients had progressed to MIBC or metastatic disease in the reported cohorts as of the Sep 1, 2025 data cut‑off.

What common adverse events should investors note from CGON clinical data?

The most common treatment‑related adverse events (≥10%) were bladder spasms, dysuria, pollakiuria, and hematuria, generally low grade and localized.