INO-3107 Program & Regulatory Updates - INOVIO completed the rolling BLA submission for INO-3107, seeking accelerated approval, with file acceptance expected by the end of the year[11] - If Priority Review is granted, a potential PDUFA date in mid-2026 is anticipated[11, 44] - The company has requested a Type D meeting with the FDA to discuss options for the confirmatory trial design[13] - In a Phase 1/2 trial, 72% of patients saw a 50-100% reduction in surgeries in Year 1[14] - A retrospective trial (RRP-002) showed clinical outcomes maintained or improved upon through year 2 and into year 3 with no additional dosing[14] - Mean surgeries per year decreased by 78% from pre-treatment Year -1 (4.1 surgeries) to Year 2 (0.9 surgeries)[16] Commercialization & Financials - Market research supports a preferred product profile for INO-3107, with 72% overall response rate (50% to 100% reduction in surgeries) in year 1 and 86% in year 2[27] - Operating expenses decreased by 22% to $212 million for the three months ended September 30, 2025, compared to $273 million in 2024[33] - Net loss for the three months ended September 30, 2025, was $455 million, which includes a non-cash loss on fair value adjustment of common stock warrant liabilities of $225 million[33] - Cash, cash equivalents, and short-term investments totaled $508 million as of September 30, 2025, providing a cash runway projected into 2Q 2026[34]