Financial Data and Key Metrics Changes - Engene is entering a market projected to grow significantly, with estimates suggesting a market size of upwards of $20 billion for non-muscle invasive bladder cancer (NMIBC) treatments [5][6] - The company has sufficient capital to execute its plans, with a runway projected into 2027 [6] Business Line Data and Key Metrics Changes - Engene's primary product, dedalimogene, is a non-viral genetic medicine designed for NMIBC, aiming to be the first choice for urologists [20][40] - The company is conducting a pivotal study (LEGEND) with a focus on BCG unresponsive NMIBC patients, with data updates expected in the second half of 2025 and a BLA filing anticipated in mid-2026 [25][39] Market Data and Key Metrics Changes - Bladder cancer represents a significant healthcare cost, with an estimated annual cost of $6.5 billion in the United States [8] - The treatment landscape for NMIBC is evolving, with a shift from surgical options to medical therapies, highlighting the unmet need for effective non-surgical treatments [11][43] Company Strategy and Development Direction - Engene aims to provide a non-surgical alternative to radical cystectomy, focusing on ease of use and accessibility for urologists in community clinics [12][40] - The company is positioning dedalimogene as a first-line treatment option, emphasizing its practical application in busy clinical settings [41][43] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data updates and the potential for dedalimogene to meet the needs of high-risk NMIBC patients [56] - The company is aware of the competitive landscape and believes that its product profile will stand out due to its ease of use and favorable safety profile [54][56] Other Important Information - The LEGEND study is designed to demonstrate the efficacy of dedalimogene in various patient cohorts, including those with high-risk disease and those previously treated with BCG [25][51] - Recent protocol changes aim to align the study with current clinical practices, potentially enhancing patient outcomes [34][37] Q&A Session Summary Question: Impact of modified inclusion criteria on enrollment - Management expects the changes to be largely enrollment neutral, with potential benefits to overall enrollment due to the alignment with standard practices [45][46] Question: Cost advantages of dedalimogene compared to viral agents - The ease of use and lack of cold chain storage requirements for dedalimogene are significant advantages, allowing for more efficient patient management in busy clinics [47][50] Question: Utility of other cohorts in the study - Other cohorts are seen as opportunities to demonstrate dedalimogene's potential in real-world settings, with the goal of providing comprehensive data to support future use [51][52] Question: Investor perception and valuation - Management believes investors may be focused on the complete response rate, potentially overlooking the product's operational advantages and overall profile [54][56]
enGene(ENGN) - 2025 FY - Earnings Call Transcript