Company Overview - CG Oncology, Inc. is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for bladder cancer patients [6] - The company aims to enhance the quality of life for urologic cancer patients through innovative immunotherapies [6] Clinical Trials and Developments - CG Oncology will host a conference call on April 28, 2025, to discuss results from the Phase 3 BOND-003 trial of cretostimogene monotherapy for high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) [1] - Cretostimogene is an investigational oncolytic immunotherapy being evaluated in the BOND-003 trial and is also part of another Phase 3 trial (PIVOT-006) for intermediate-risk NMIBC [4][5] - The safety and efficacy of cretostimogene have not yet been established by the FDA or any other health authority [5] Bladder Cancer Statistics - An estimated 85,000 people are expected to be diagnosed with bladder cancer in 2025, with NMIBC representing approximately 75% of newly diagnosed cases [3] - Bladder cancer is the sixth most common cancer in the United States, with men accounting for three-quarters of new diagnoses [3]

Core Insights - CG Oncology's BOND-003 study of cretostimogene monotherapy has been selected as a late breaker for the AUA's Practice-changing, Paradigm-shifting Clinical Trials in Urology, highlighting its potential impact on bladder cancer treatment [1] - The AUA Annual Meeting will take place from April 26-29, 2025, in Las Vegas, where CG Oncology will present various updates on ongoing clinical trials related to cretostimogene [1][7] Clinical Trial Presentations - The BOND-003 Cohort C study is a Phase 3, single-arm study focusing on high-risk BCG-unresponsive non-muscle invasive bladder cancer, with a presentation scheduled for April 26, 2025 [2] - An updated analysis from the BOND-003 and CORE-001 trials will be presented, focusing on translational correlates using urinary genomic disease burden [3] - Updates to the CORE-008 trial protocol will be discussed, which evaluates intravesical cretostimogene in patients with high-risk non-muscle invasive bladder cancer [3] Additional Studies - A multi-national, single-arm study of intravesical cretostimogene for high-risk, papillary only, BCG-unresponsive non-muscle invasive bladder cancer will also be presented [4] - The PIVOT-006 study, a Phase 3 randomized trial comparing adjuvant intravesical cretostimogene versus surveillance for intermediate-risk non-muscle invasive bladder cancer, will be discussed [5] Company Overview - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing innovative therapies for bladder cancer, aiming to improve the quality of life for patients [7]

Core Insights - Genelux Corporation has reached alignment with the U.S. FDA on key elements of the approval pathway for Olvi-Vec in treating platinum-resistant/refractory ovarian cancer [1][4] - The company reported a net loss of $29.9 million for the year ending December 31, 2024, compared to a net loss of $28.3 million in 2023 [15][21] - Genelux has strengthened its management team and balance sheet, positioning itself for future growth and clinical development [2][7] Pipeline Highlights - The ongoing Phase 3 OnPrime/GOG-3076 trial is focused on platinum-resistant/refractory ovarian cancer, with a primary endpoint of progression-free survival (PFS) [3] - The FDA indicated that an interim analysis of overall survival (OS) should be planned alongside the primary PFS analysis, which could support traditional approval if a meaningful PFS advantage is demonstrated [4] - The trial aims to enroll enough patients to achieve 127 events, with topline data expected in the first half of 2026 [5] Clinical Trials Updates - Preliminary data from the Phase 1b/2 Olvi-Vec-SCLC-202 trial showed a 71% disease control rate in patients with extensive small cell lung cancer [11] - The Phase 2 VIRO-25 trial is actively enrolling patients with recurrent non-small cell lung cancer, with interim data anticipated in the second half of 2025 [6] Financial Overview - The company closed an underwritten offering of 3 million shares at $3.50 per share, raising approximately $10.5 million for working capital and clinical development [8][10] - As of December 31, 2024, cash, cash equivalents, and short-term investments totaled $30.9 million, providing a runway into the first quarter of 2026 [12] - Research and development expenses increased to $19.0 million in 2024 from $12.8 million in 2023, primarily due to higher clinical trial costs [13] Management Changes - Matt Pulisic has joined Genelux as the new Chief Financial Officer, bringing over 19 years of experience in the biopharmaceutical industry [7]