Regulatory Progress on INO-3107
BLA for INO-3107 accepted for review under the FDA accelerated approval program (file accepted Dec 2025); PDUFA target date set for October 30, 2026. FDA completed mid-cycle review with no new significant issues and scheduled late-cycle review for Q3 2026. FDA reiterated intent to schedule an informal meeting to discuss accelerated approval eligibility.
Strong Phase I/II Clinical Efficacy and Safety Signals
Phase I/II results showed the vast majority of patients experienced a 50% to 100% reduction in surgeries in year 1 with continued clinical improvement in year 2. Safety profile highlighted as improved versus the comparator, notably not requiring surgery to maintain minimal residual disease during the dosing window.
Commercial Readiness and Product Differentiation
Company completed targeting, segmentation and product positioning; plans to commercialize in the U.S. with support from a contract sales organization and engaged logistics, specialty distributor, specialty pharmacy and patient hub partners. Key operational differentiation versus competitor: no ultra-cold chain and no requirement for surgery during dosing, and positive feedback from physicians and patient community at COSM.
Pipeline Partnerships and Platform Advances
Announced collaboration with Akeso and Dana-Farber to evaluate INO-5412 + dual checkpoint inhibitor in GBM (Phase II adaptive platform). Advanced DPROT platform with preclinical Factor VIII data for hemophilia A and added rare disease targets (Fabry disease, hypophosphatasia) to the pipeline; pursuing partners to accelerate development.
Balance Sheet Strengthened via Equity Offering
Completed underwritten public equity offering in April 2026 with net proceeds of approximately $16 million, extending estimated cash runway into Q1 2027 (beyond the PDUFA date). Cash, cash equivalents and short-term investments at March 31, 2026 were $37.7 million.
Operating Expense Reduction
Operating expenses decreased 13% year-over-year from $25.1 million in Q1 2025 to $21.9 million in Q1 2026, reflecting resource prioritization toward INO-3107.
Per-Share Loss Improved
Reported net loss of $19.7 million in Q1 2026 (same dollar loss as Q1 2025), with loss per share narrowing to $0.28 from $0.51 a year earlier (approximately a 45% improvement in loss per share, driven by share count changes).