CG Oncology, Inc. Stock Price, News & Analysis

CG Oncology (NASDAQ: CGON) announced its participation in the 120th American Urological Association (AUA) Annual Meeting, scheduled for April 26-29, 2025, in Las Vegas. The company will present significant updates on their bladder cancer therapeutic cretostimogene grenadenorepvec.

The highlight will be the presentation of BOND-003 study durability results as a late-breaking announcement during the Practice-changing, Paradigm-shifting Clinical Trials in Urology (P2s) session. This study focuses on cretostimogene monotherapy in high-risk BCG-unresponsive non-muscle invasive bladder cancer.

The company will showcase multiple presentations including:

• Translational correlates using urinary genomic disease burden analysis
• Updates to the CORE-008 trial protocol
• Progress updates on BOND-003 Cohort P study
• Details on the Phase 3 PIVOT-006 randomized study

CG Oncology (NASDAQ: CGON) reported significant progress in their bladder cancer therapeutic development for 2024. Their lead candidate cretostimogene demonstrated a 75.5% complete response rate in high-risk BCG-unresponsive non-muscle invasive bladder cancer patients, with response duration exceeding 28 months.

Key developments include:

• Successful completion of a $238 million follow-on public offering, extending runway into H1 2028
• Initiation of CORE-008 clinical trial for BCG-naïve and BCG-exposed NMIBC patients
• Publication of Phase 1b study results in Nature Medicine

Financial results show cash position of $742.0 million as of December 31, 2024. R&D expenses increased to $82.1 million for 2024 (vs $45.8M in 2023), while G&A expenses rose to $33.7 million (vs $9.9M in 2023). Net loss for 2024 was $88.0 million ($1.41 per share).

CG Oncology (NASDAQ: CGON) announced compelling Phase 3 study results for cretostimogene, showing significant efficacy in treating high-risk BCG-unresponsive non-muscle invasive bladder cancer. The BOND-003 study demonstrated that 75.5% of patients (83 out of 110) achieved complete response, with 46% maintaining response at 12 months and 30 confirmed responses at 24 months.

The median duration of response exceeds 28 months and is still ongoing. Notably, translational data revealed that post-treatment close contact precautions are unnecessary, as the treatment remains localized with no systemic exposure. The safety profile was favorable with no Grade 3 or greater treatment-related adverse events, and 97.3% of patients completed all expected treatments.

Common treatment-related adverse events included bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria, with a median resolution time of one day.

CG Oncology (NASDAQ: CGON) announced its participation in the 40th Annual European Association of Urology (EAU) Congress in Madrid, Spain, from March 21-24, 2025. The company will present multiple studies on cretostimogene grenadenorepvec, their bladder-sparing therapeutic for bladder cancer.

Key presentations include:

• Late-breaking clinical and first translational data from BOND-003 Cohort C, presented by Dr. Trinity J. Bivalacqua
• Translational correlates using urinary genomic disease burden analysis from BOND-003 and CORE-001 trials, presented by Dr. Sharada Mokkapati
• BOND-003 cohort P study results for high-risk, papillary BCG-unresponsive cases
• PIVOT-006 phase 3 randomized study of adjuvant treatment versus surveillance for intermediate-risk cases

CG Oncology (NASDAQ: CGON), a late-stage clinical biopharmaceutical company specializing in bladder cancer therapeutics, has announced its upcoming participation at the TD Cowen 45th Annual Health Care Conference. Arthur Kuan, Chairman & Chief Executive Officer, will deliver a presentation in Boston, MA on March 5, 2025, at 11:10 am ET.

The presentation will be accessible via live audio webcast through the Investor Relations section of www.cgoncology.com. Following the live event, a replay will remain available for approximately 90 days on the company's website.

CG Oncology (Nasdaq: CGON) has completed its public offering of 9,200,000 common stock shares, with 8,500,000 shares offered by the company and 700,000 by an existing stockholder. The offering price was set at $28.00 per share, including the full exercise of underwriters' option to purchase 1,200,000 additional shares. The company raised $238.0 million in gross proceeds before deducting underwriting discounts and expenses.

The offering was managed by Morgan Stanley, Goldman Sachs, TD Cowen, and Stifel as joint book-running managers, with LifeSci Capital as lead manager. A registration statement was declared effective on December 12, 2024.

CG Oncology (CGON) has announced the pricing of its public offering, consisting of 8,000,000 common stock shares at $28.00 per share. The company is offering 7,300,000 shares, while an existing stockholder is offering 700,000 shares. The gross proceeds to CG Oncology are expected to be $204.4 million, excluding underwriting discounts and commissions. The offering is set to close on December 16, 2024. The company has granted underwriters a 30-day option to purchase up to an additional 1,200,000 shares. Morgan Stanley, Goldman Sachs, TD Cowen, and Stifel are acting as joint book-running managers, with LifeSci Capital as lead manager.

CG Oncology (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on bladder cancer therapeutics, has filed for a proposed public offering of 7,300,000 shares of common stock. Additionally, an existing stockholder plans to sell 700,000 shares. The company will grant underwriters a 30-day option to purchase up to 1,200,000 additional shares.

The offering will be managed by Morgan Stanley, Goldman Sachs, TD Cowen, and Stifel, Nicolaus & Company as joint book-running managers, with LifeSci Capital as lead manager. The public offering price is yet to be determined, and the offering's completion depends on market conditions.

SUO-CTC and CG Oncology (NASDAQ: CGON) have announced their first annual Non-Muscle Invasive Bladder Cancer (NMIBC) Research Fellowship Award. The fellowship aims to support outstanding clinical cancer research investigators committed to advancing NMIBC treatment and understanding. Applications are due by February 28, 2025, with the award starting in May 2025. The recipient will present their research findings at the SUO Meeting at AUA in April/May 2026.

Eligible candidates may work in basic, translational, and clinical research fields, and must have access to a research environment capable of supporting transformational NMIBC research. Applications will be evaluated based on the proposed research plan quality and available resources.