Shares declined 5.0% as investors reacted negatively to growing regulatory uncertainty and a cautious outlook for INO-3107’s accelerated approval, with no clear resolution on the FDA’s eligibility concerns or confirmatory trial protocol. The lack of concrete progress on these key regulatory milestones heightened execution risk and weighed on confidence.

• FDA completed mid-cycle review of the INO-3107 biologics license application (BLA) with no new significant issues, but an unresolved question remains regarding eligibility for accelerated approval.
• An informal FDA meeting to discuss the eligibility concern, initially agreed upon, has yet to be scheduled, prolonging regulatory uncertainty.
• Updated protocol for the required confirmatory trial has been submitted, but feedback is still pending, delaying clarity on future clinical development.
• Management highlighted the product’s potential benefits based on prior Phase I/II data and differentiation versus competitors but provided no new data or definitive regulatory updates.
• Operational cash burn is expected at approximately $18 million for Q2 2026, with cash runway into Q1 2027, indicating limited near-term financial flexibility amid regulatory delays.