CGON
Published on 04/14/2026 at 12:06 pm EDT
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The Promise of Cretostimogene
Potential Best-in-Disease Durability and Efficacy
Potential Best-in-Disease Safety/Tolerability
Regulatory & Commercial Readiness
BOND-003 Cohort C (HR BCG UR
CIS only)1:
76% CR anytime
46.4% (12-mo)
41.8% (24-mo)
BOND-003 Cohort P (HR BCG UR
Ta/T1 Disease)2
95.7% (3-mo) HG-EFS
84.6% (6-mo)
80.4% (9-mo)
CORE-008 Cohort A (HR BCG Na"ive
CIS)2
Favorable safety & tolerable profile
0 Grade » 3 TRAEs or deaths
reported
Most AEs were Grade 1-2
Granted Breakthrough Therapy & Fast Track designations
Current capacity: 40-5Ok vials/year; 1Ox scale-up process to support future indications underway
Pre-launch activities ongoing -MSLs/HSDs, site / payor engagement
Administered like BCG, seamlessly integrating into established clinical workflows without re-training
Physicians in top key accounts treat
88% CR anytime (optimized instillation)
>7OOX» of NMIBC patients by volume
Dual MOA designed to selectively drive tumor killing & trigger durable anti-tumor immune response resulting in
potential for best-in-disease profile across a broad range of NMIBC patients
TRAEs = Treatment-related adverse events; HR = high-risk; NMIBC - Non-muscle invasive bladder cancer; MSL = Medical science liaison; HSD = Health system directors; MOA = Mechanism of action
1. Ph 3 registrational study in HR BCG-unresponsive NMIBC CIS 2. Data presented at SUO Annual Meeting Dec 2025, data as of September 1, 2025
1
2
1a 1b
Cancer Cell
Cretostimogene is lntravesically Administered into the Bladder, Similar to
Standard-of-Care BCG Therapy Which Urology Practices Perform Regularly
Procedure Can Be
BCG - Bacillus Calmette Guerin. DDM = n-DodecyI β-D-maltoside. GAG = glycosaminoglycan.
-15 minutes
Standard
DDM
Cretostimogene Programs Across High-Risk & Intermediate-Risk NMIBC Address More Than 7OO/oof NMIBC Market Potential
85K+
Bladder Cancer (U.S. Incidence)
730K+
Bladder Cancer (U.S. Prevalence)
75 % NMIBC
High-Risk (40%)
PIVOT-006
Ph G Monotherapy
Cohort B
BCG-Na"ive
CORE-0081
Cohort A
CORE-0081
Cohort CX
BOND-003
Ph 3 Monotherapy Ph 2 Checkpoint
Cohort C/ Cohort P Combo
Note: CORE-001, CORE-008 Cohort B, and PIVOT-006 are in partnership with SUO-CTC. 1 CORE-008 is a multi-cohort study evaluating cretostimogene in High-Risk NMIBC.
*jCG 9
NMIBC = Non-muscle invasive bladder cancer OflCOtMY
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Cohort C
BOND-003
Cretostimogene Has Delivered Best-in-Disease Complete Response (CR) Rate at 24 Months
Complete Response (CR) at 24-Month
45
42%
(46/110)
40
35
30
25%
c
25
19%
(20/103)
20
15
10
5
0
Cretostimogene N-803 + BCG Nadofaragene Pembrolizumab
1. Compared to approved drugs with publicly available observed 24-Month CR data
Cretostimogene demonstrated best-in-disease long-term DoR compared to approved drugs1 in NMIBC with 41.8% of patients in CR at 24 months
90% of patients in CR at 1 2 months maintained in CR at 24 months
No grade 3+ TRAEs - best-in-disease safety and tolerability profile
CQ 12
Note: These data are not based on head-to-head or comparator studies. Differences exist between study designs and subject characteristics, and caution should be exercised when comparing data across @@
studies. From published data.
CIS with or without Ta/T1
Cretostimogene is Well Positioned as Backbone Therapy in
NMIBC with Best-in-Disease Durability & Safety in HR BCG-UR 1
Trial (Status)
Drug Mechanism
RoA
Efficacy Population CRatAnyTime
CR at 12 Mo CR at 24 Mo
12M DOR
24M DOR
Free from Progression
to MIBC
Cystectomy Free Survival Median Time to AE Resolution Grade 3+ TRAE
BOND-003 COHORT C
(Ph3 Ongoing)
Cretostimogene
Oncolytic Immunotherapy Intravesical
110
75.5% (83/110)
[95% Cl: bb% - 83%]
46.4% (51/110)
[95% CI: 37% - 56%)
4 1.Who (4 )
[95% Cl: 33% - 52%}
K-M: 64.2%
[95% Cl: 52% - 74%}
K-M: 60.1%
[95% CI: 48% - 70%)
96.4% at 24 month
89.2% at 12 month
81.3% at 24 month3
1 Day
SunRlSe-1
(Approved)
TAR-200
Gemcitabine via In-Dwelling Device
Transurethral Procedure
83
82.4% (70/83)
[95% CI: 73% - 90%)
K-M: 45.9% (39/83)
Not Reported
Observed: 52.9%
K-M: 56.2%
K-M: 51.8%
94.3%
86.6% at 12 month3
3.1 weeks
13%
QUILT 3.032
(Approved)
N-803 + BCG
IL-15 Superagonist
+ BCG combo
Intravesical
77
62.3% (48/77)
[95% Cl: 51% - 73%)
36.4% (28/77)4
24.7% (19/77)4
58%
40%
90%
59%3
Not Reported
Not reported; 16% SAE
NCTO2773849
(Approved)
Nadofaragene
Gene Therapy Secreting
IFN
Intravesical
98
51.0% (50/98)5
[95% Cl: 41% - 61%}
24.3% (25/103)
19.4% (20/103)
46%
Not Reported 94%
64% at 24-month Not Reported
4%
KEYNOTE-057
(Approved)
Pembrolizumab
Checkpoint Inhibitor
Intravenous
96
40.6% (39/96)
[95% Cl: 31% - 51%}
18.8% (18/96)
9.4% (9/96)^
46%
Not Reported
89%
84%
Not Reported 13%
TR discontinuation
3.5% 7% 3%
11%
doi: Bio BCG age ; al ESMO Danesh Jo Oncology, JUIy 2025). CG On - SUO and NE AUA 2025; - ASCO
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Cretostimogene is Well Positioned in HR BCG-UR NMIBC with HG Ta/T1 with Potentially Best-in-Disease EFS Endpoint1
Trial (Status)
BOND-003 COHORT P
(Ph3 Ongoing)1
SunRISe-12
QUILT 3.0323
NCTO27738494•5
KEYNOTE-0576
Drug
Cretostimogene
TAR-200
N-803 + BCG
Nadofaragene
Pembrolizumab
Mechanism
Oncolytic Immunotherapy
Gemcitabine via In-Dwelling Device
IL-15 Superagonist
Gene Therapy Secreting IFN
Checkpoint Inhibitor
RoA
Intravesical
Transurethral Procedure
Intravesical
Intravesical
Intravenous
Efficacy Population
N=54
N=52
N=72
N=50
N=132
EFS/DFS/HG-RFS
3 month
95.7 [95% CI: 83.8, 98.9]
Not Reported
92.8% [95% CI]*
72.9 [95% CI: 58.2-84.7]
87.7 [95% CI: 80.7-92.3]
b month
84.6 [95% CI: 68.6, 92.9]
85.3 [95% CI: 71.6-92.7]
75.9% [95% CI]*
62.5 [95% CI: 47.4-76.0]
53.1 [95% CI: 44.1-61.2]
9 month
80.4 [95% Cl: 62.3, 90.4]
81.1 [95% CI: 66.7- 89.7]
Not Reported
58.3 [95% CI: 43.2-72.4]
Not Reported
12 month
NotYet Reached
74.3% [95% CI: 59.2-84.6]
55.4 [95% CI: 42.0-66.8]
43.8 [95% CI: 29.5-58.8]
43.5 [95% CI: 34.9-51.9]
24 month
Not Yet Reached
Not Reported
48.3 [95% CI: 34.5-60.7]
33.3 [95% CI: 20.4-48.4]
34.9 [95% CI: 26.4-43.4]
Safety
Grade 3+ TRAE
0 (0%)
13.5%
Not Reported
4%
14%
TR discontinuation
0 (0%)
7.7%
7%
3%
11%
SAEs
0(0%)
5.8% including sepsis, spinal fracture (procedure
16%**
11%
13%
related), and UTI
+ BCG combo
Note: These data are not based on head-to-head or comparator studies. Differences exist between study designs and subject characteristics, and caution should be exercised when comparing data across studies.
1. SUO 2025 Annual Meeting; 2. JCO - https://doi.org/1 Phase lib SunRISe-1 study and SUO 2025 Annual Meeting presentation; 3. Chamie K, et al. NEJM Evid. 2023; 2(1):EVIDoa2200167 *estimated from subsequent landmark reports; **SAEs are combined across multiple cohorts as listed in package insert; 4. Boorjian S, et al. Lancet Oncology. 2021; 22(1):1 07-1 17. Narayan VM, et al. J Urol. 2024;212(1):74-86; 6. Necchi A, et al. Lancet Oncology. 2024; 25(6):720-730.
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Cohort CX
CORE-008
Ph 2 Cretostimogene in Combination for High-Risk (HR) BCG-Exposed & BCG-Unresponsive NMIBC (Cohort CX) - First Results Expected 1H'2026
Population
Pathologically confirmed HR
BCG-exposed & BCG-UR
Persistent or recurrent HG Ta or CIS at first evaluation after adequate BCG dose
HG recurrence outside of BCG-UR window within 24 mos after last adequate BCG dose
HG recurrence within 24 mos after last inadequate BCG dose
Study Design / Regimen
Cohort CX (CIS-containing or HG
Ta/T1)
Arm 1 = cretostimogene + gemcitabine (concurrent)
Arm 2 = cretostimogene + gemcitabine (sequential)
Standard weekly x 6 induction, reinduction and weekly x 3 maintenance until Year 31
Additional Endpoints
CR at any time
CR at 1 2 months
DoR
PFS
CFS
HR = HG = LG = low DoR = of response. EFS = event free RFS = recurrence free PFS = free CFS = cystectomy free survival. undergo cytology and cystoscopy every 3 months for 2 years
1 Second induction course of weekly x 6 for non-responders at month 3. Maintenance course for complete responders weekly x 3 every months Year 1, and every 6 months in Year 2 and Year
CISG 18
CORE-008
Phase 2 Cretostimogene Monotherapy for High-Risk (HR) BCG-Nai/'e and BCG-Exposed NMIBC (Cohort A and B)
Population
Cohort A
Pathologically confirmed HR
BCG-na"i"ve NMIBC
No prior treatment with BCG within past 24 months
Cohort B
Pathologically confirmed HR
BCG-exposed NMIBC
Recurrence within 24 months after last adequate BCG dose
Study Design / Regimen
Cohort A (HR BCG-na"i¥'e NMIBC)
CIS + HG Ta/T1 (n= 50)
HG Ta/T1 only (n= 75)
Standard weekly x 6 induction, reinduction and weekly x 3 maintenance until Year 31
Cohort B (HR BCG-exposed NMIBC)
CIS + HG Ta/T1 (n= 75)
HG Ta/T1 only (n= 75)
Standard dosing as above1
Additional Endpoints
Cohort A
DoR (in CIS)
EFS, LG-RFS, CFS
Cohort B
DoR (in CIS)
EFS, LG-RFS, CFS
HR =
HG = high
LG = low grade. DoR = duration of
EFS = event free survival. RFS = recurrence free
PFS = progression free survival. CFS = cystectomy free
Note:
undergo
cytology and cystoscopy every months for
2 years; mandatory, site-directed biopsy at month
Second course of weekly x 6 for non-responders at month Maintenance course for complete responders weekly x 3 every months Year and every 6 months in Year 2 and Year
2. CIS Rate) and HG Ta/T1
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Disclaimer
CG Oncology Inc. published this content on April 14, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on April 14, 2026 at 16:05 UTC.