Core Insights - Genelux Corporation reported a productive first quarter of 2025, establishing a strong foundation for advancing its lead product, Olvi-Vec, in various cancer indications [2][3] Pipeline Highlights - The FDA provided encouraging feedback on the OnPrime Phase 3 trial for Olvi-Vec in resistant/refractory ovarian cancer, indicating potential for traditional approval if a meaningful progression-free survival advantage is demonstrated [3] - Preliminary data from the Phase 1b/2 trial of Olvi-Vec in small cell lung cancer showed a 71% disease control rate, with significant tumor reductions observed in participants [4] - Patient enrollment is increasing in the ongoing Phase 2 trial for recurrent non-small cell lung cancer, with interim results expected in the second half of 2025 [5] Business Updates - Matthew Pulisic was appointed as the new Chief Financial Officer, bringing over 19 years of experience in the biopharmaceutical industry [6] - The company completed an underwritten offering of 3,000,000 shares at $3.50 per share, raising approximately $10.5 million to strengthen its balance sheet and extend its operational runway [7] Financial Results - As of March 31, 2025, cash, cash equivalents, and short-term investments totaled $35.1 million, expected to provide runway into the third quarter of 2026 [8] - Research and development expenses increased to $4.7 million from $4.0 million year-over-year, primarily due to higher clinical trial costs [9] - General and administrative expenses decreased to $3.1 million from $4.1 million year-over-year [10] - The net loss for the first quarter of 2025 was $7.5 million, or $0.21 per share, compared to a net loss of $7.9 million, or $0.29 per share, in the same period of 2024 [11]

Core Insights - CG Oncology presented promising data on cretostimogene grenadenorepvec monotherapy for high-risk non-muscle invasive bladder cancer (NMIBC) at the 2025 AUA Annual Meeting, indicating its potential as a backbone therapy for bladder cancer treatment [2][6] Efficacy Data - The Phase 3 BOND-003 Cohort C study reported a robust 24-month complete response (CR) rate of 42.3% by Kaplan-Meier (K-M) estimation, with 75.5% achieving CR at any time [1][3] - 58.3% of patients demonstrated durable complete responses at 24 months, and 97.3% remained free from progression to muscle-invasive bladder cancer (MIBC) [1][3] - The median duration of response (DOR) was 28 months, with no Grade 3 or greater treatment-related adverse events reported [1][5] Safety Profile - The treatment was well-tolerated, with 97.3% of patients completing all expected treatments and a median resolution time of one day for any treatment-related adverse events [5][6] - The most common treatment-related adverse events (≥10%) included bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria [5] Study Population - The BOND-003 Cohort C study included 110 highly pretreated patients, with a median of 12 prior Bacillus Calmette Guerin (BCG) doses, some patients having received as many as 66 doses [5][6] - Cohort P data indicated a high-grade recurrence-free survival rate of 90.5% at 3 and 9 months in patients with BCG-unresponsive Ta/T1 disease [4][5] Future Outlook - CG Oncology is actively investigating the potential of cretostimogene in addressing unmet needs in bladder cancer treatment, with ongoing studies and an Expanded Access Program initiated for eligible patients [6][8]

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]