BLA Accepted for Review with PDUFA Date
FDA accepted the BLA for INO-3107 under review (accelerated approval pathway under discussion) with a standard 10-month review and a PDUFA date of October 30, 2026; company has submitted an assessment aid and is awaiting a meeting date with the FDA while the BLA remains under active review.
Strong Clinical Efficacy Signals for INO-3107
Clinical data show the majority of patients experienced a 50%–100% reduction in surgeries in the first year after treatment; management reported 72% of patients with a 50%–100% reduction in year 1 and improvement to 86% in year 2, with 50% of patients requiring zero surgeries in the second 12-month period.
Differentiated Safety and Delivery Profile
INO-3107 demonstrated a safety/regimen advantage vs competitor (no requirement for surgeries to maintain minimal residual disease during dosing), can be administered in physician offices, requires no ultra-cold chain, and uses a short 4-dose regimen—attributes validated by market research and cited as drivers of physician/patient preference.
Commercial and Launch Preparations Underway
Company completed market research, targeting/segmentation, pricing strategy and selected key commercial partners (3PL, specialty distributor, specialty pharmacy, patient hub, agency of record); positioning and launch planning designed to enable rapid commercialization if approved.
Extended Cash Runway Through Cost Prioritization
After rescoping projects and reducing headcount (~15% reduction), Inovio estimates its cash runway extends into fourth quarter 2026; management cites focused spending towards INO-3107 and an estimated operational net cash burn of ~$22 million for Q1 2026.
Platform and Pipeline Progress and Partnerships
Continued platform advances including dMAb data (durable antibody production reported up to 72 weeks and additional data to 96 weeks), DPROT preclinical Factor VIII data, a planned Phase II adaptive GBM trial with Dana-Farber and Akeso to evaluate INO-5412 + cadonilimab (initiation planned H2 2026), and a Coherus partnership for 3112 (HPV+ HNSCC) with intent for later-stage study.
Operating Expense Reductions
Operating expenses reduced meaningfully: Q4 operating expenses declined from $20.5M to $17.5M (~-14.6% quarter-over-quarter as reported) and full year operating expenses decreased 23% from $112.6M in 2024 to $86.9M in 2025.