th 11 elect E i = ad pl 101 Com 01 11 -1 F Ti A LEAST Property TE p nt 1 lar ----------- i P in The Property action t r H 2017 th n 1000 Phone 34 and live y ckly E in wildpixel Maybe different isn't always better, but it can be just as good. CG Oncology (NASDAQ:CGON) is different from the biotechs I normally prefer to look at, as the company doesn't really have a platform or a pipeline beyond its lead candidate cretostimogene grenadenorepvec, an oncolytic adenovirus targeted at non-muscle invasive bladder c ...

Date of report (Date of earliest event reported) May 9, 2024 CG Oncology, Inc. UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 (Exact Name of Registrant as Specified in Charter) Delaware 001-41925 37-1611499 (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer Identification No.) 400 Spectrum Center Drive, Suite 2040 Irvine, CA 92618 (949) 409-3700 (Address an ...

WASHINGTON, DC 20549 FORM 10-Q (Mark One) UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________________ to _____________________ Commission File Number: 001-41925 CG Oncology, Inc. (Exact Name of Registrant as Specified in its Charter) Delawa ...

Summary of CG Oncology Conference Call - May 03, 2024 Company Overview - **Company**: CG Oncology - **Product**: Credo Simogene (an investigational oncolytic immunotherapy) - **Indication**: Treatment of high-risk BCG unresponsive non-muscle invasive bladder cancer (NMIBC) Key Points and Arguments Clinical Trial Results - **BOND-three Trial**: Phase III registrational study evaluating Credo Simogene - **Complete Response (CR) Rate**: - 75.2% CR at any time for 105 evaluable patients, maintaining from 75.7% in December 2023 [6][23] - 79 complete responders reported, the highest number in this indication [23] - **Durability of Response**: - 83% of patients maintained CR for over 12 months [24] - 54% of initial non-responders converted to CR after a second induction [13][43] - **Safety Profile**: - No Grade 3 or higher adverse events reported [14][25] - 94.5% of patients completed all protocol-mandated treatments [25] Mechanism of Action - **Dual Mechanism**: Designed to replicate in and kill cancer cells while inducing antitumor immunity [8] - **Oncolytic Immunotherapy**: Mechanism supports the observed efficacy and safety [26] Comparisons with Other Therapies - **Efficacy Comparison**: - Credo Simogene's 75.2% CR rate compares favorably to: - 62% for combination therapy with MEO3 and BCG - 51% for Nadopiragine - 41% for Pembrolizumab [16] - **Safety Comparison**: - No Grade 3 or higher treatment-related adverse events, positioning Credo Simogene as a potentially safer option [14][16] Regulatory Designations - **FDA Designations**: Fast Track and Breakthrough Therapy designations granted for Credo Simogene [18] Trial Amendments and Future Studies - **New Cohorts**: Introduction of a treatment extension phase for complete responders and a new high-grade papillary cohort (Cohort P) [19] - **Expanded Access Program**: Designed to enhance geographic and ethnic diversity in patient data collection [20] Market Insights - **Target Patient Population**: - The prevalence of high-risk patients is estimated to be at least twice the incidence population [77] - **Therapeutic Landscape**: - Patients typically receive 2 to 4 lines of therapy after BCG treatment [79] Manufacturing and Logistics - **Manufacturing Process**: No changes to the robust process used in the Phase III trial, ensuring a lower risk profile for commercial launch [51] - **Cold Storage and Shipping**: Credo Simogene will be shipped in a just-in-time manner at -50 degrees Celsius, with a preparation time of 10 minutes [53][54] Additional Important Points - **Patient Demographics**: Most patients were white, male, and of Medicare age, with a median age of 73 [12] - **Physician Feedback**: High enthusiasm from urologists regarding the results, particularly appreciating the simplified installation process [29][32] - **Reinduction Acceptance**: Reinduction is a common practice in BCG therapy, and the results from Credo Simogene support this approach [42][45] This summary encapsulates the critical insights and data presented during the CG Oncology conference call, highlighting the efficacy, safety, and future potential of Credo Simogene in treating high-risk NMIBC.

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _____________________ TO _____________________ Commission File Number 001-41925 CG Oncology, Inc. (Exact name of registrant as specified in its Charter) (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR (State or ...