Summary of NGIN Conference Call Company Overview - NGIN is a non-viral genetic medicines company focused on developing treatments for non-muscle invasive bladder cancer (NMIBC) [1] Industry Insights - The management of NMIBC is undergoing a significant transformation, moving from an incident-based market to a prevalent-based market, similar to the evolution seen in the multiple myeloma market [2][3] - The NMIBC market is currently valued at approximately $1 billion and is expected to grow significantly with the introduction of new therapies [2][3] Product Development - NGIN is developing a product called Dental Imaging, specifically designed for urologists, which combines efficacy, tolerability, and ease of use [3][12] - The company anticipates providing an update on pivotal cohort data later this year, with top-line data and a BLA filing expected in mid-2026, followed by potential approval and launch in 2027 [4][45] Market Dynamics - NMIBC is a highly prevalent disease in the U.S., with around 730,000 patients and 65,000 new cases annually [5] - Bladder cancer is the sixth most common cancer and one of the most costly to manage [6][7] - The majority of NMIBC patients are managed by community urologists, who currently face challenges with existing treatment options, including a shortage of BCG [8][9] Treatment Challenges - Current treatments, including BCG and other agents, have limitations such as availability issues, complex administration, and significant side effects [9][10][11] - Dental Imaging aims to address these challenges by offering a well-tolerated treatment option that does not require significant changes to existing urology practices [12][13] Clinical Efficacy and Tolerability - Dental Imaging has demonstrated a 71% complete response (CR) rate at any time, with a 67% CR rate at three months and 47% at six months [23] - The treatment has a favorable tolerability profile, with adverse events primarily being grade two or below [22][23] Regulatory Landscape - NGIN is in ongoing dialogue with the FDA regarding approval pathways, with a focus on addressing the high unmet medical need in the NMIBC patient population [31][32] Competitive Advantage - Dental Imaging is positioned as a best-in-class product for the urology community, offering competitive efficacy, tolerability, and ease of use compared to other agents [32][41] - The product's administration process is designed to be less burdensome for both patients and urologists, facilitating its integration into busy clinical practices [38][39] Future Outlook - NGIN is optimistic about the future of Dental Imaging and its potential to significantly impact the NMIBC treatment landscape [44] - The company has sufficient capital to support its milestones through 2027, indicating a strong financial position for upcoming developments [45]

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]