Financial Data and Key Metrics Changes - Operating expenses decreased from $27.3 million in Q3 2024 to $21.2 million in Q3 2025, a 22% reduction [19] - Net loss for the quarter increased to $45.5 million, or $0.87 per share, primarily due to a $22.5 million non-cash loss on fair value adjustments related to warrant liabilities [20] - Loss from operations decreased 22% to $21.2 million in Q3 2025 from $27.3 million in Q3 2024, with a per-share loss dropping 58% to $0.41 from $0.97 [21][22] Business Line Data and Key Metrics Changes - The primary focus remains on the development of INO 3107, with significant progress in regulatory submissions and preparations for a potential launch [5][19] - The company is advancing next-generation DNA medicine candidates, including DMAP and DPROT technologies, which have shown promising results in clinical and preclinical studies [6][24] Market Data and Key Metrics Changes - The company anticipates a potential PDUFA date for INO 3107 around mid-2026, following the expected acceptance of the BLA submission by the FDA by year-end 2025 [5][8] - Market research indicates that INO 3107 has a differentiated product profile that appeals to both physicians and patients, with a significant reduction in surgeries reported [15][16] Company Strategy and Development Direction - The company aims to position INO 3107 as a preferred treatment for RRP patients, emphasizing its advantages over competitors, particularly regarding the treatment regimen and reduced need for surgeries [6][10] - The company is also exploring partnerships and development opportunities to advance its pipeline beyond INO 3107, including INO 3112 and INO 5401 [23][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of INO 3107 to meet significant unmet needs in the RRP community, highlighting the importance of reducing the number of surgeries required [10][12] - The company is preparing for a swift launch of INO 3107 if approved, with ongoing market research and operational preparations [18][19] Other Important Information - The company has completed the rolling submission of its BLA for INO 3107, marking a significant milestone in its development efforts [5][8] - The company has a cash balance of $50.8 million as of the end of Q3 2025, with an estimated cash runway into the second quarter of 2026 [22] Q&A Session Summary Question: Has Pepcimios officially launched, and how significant is their head start? - Pepcimios became available to order as of October 21, and the company expects single-digit penetration into the prevalent population before their own expected approval in mid-2026 [26][27] Question: Will INO 3107 have a similar label to Pepcimios, and is a pivotal study required for ex-U.S. approval? - The company believes their data would justify a broad label similar to Pepcimios, and any confirmatory study will be valuable for European filings [31][33][38] Question: What is the Salesforce preparedness post-3107 approval? - The company is advancing launch preparations and plans to have a field force ready to engage in scientific exchange and payer discussions ahead of approval [42] Question: Are there any cross-reactivity issues for patients switching from Pepcimios to INO 3107? - There is no anticipated cross-reactivity issue, but patients will need to complete the entire treatment regimen of INO 3107 [45] Question: Can you comment on the levels of expression achieved for the dMAb technology? - The company reported sustained expression of monoclonal antibodies over 72 weeks, with concentrations in the blood exceeding 1 microgram per ml, indicating promising results [49][50]