Inovio Pharmaceuticals (INO) investor relations material

Company overview and lead program

• Focuses on DNA medicines for HPV-related diseases, cancer, and infectious diseases, with INO-3107 as the lead candidate for Recurrent Respiratory Papillomatosis (RRP).

• INO-3107 has Orphan Drug and Breakthrough Therapy designations in the US and Orphan Drug designation in the EU.

• BLA for INO-3107 accepted by FDA under Accelerated Approval Program, with a PDUFA target date of October 30.

• Manufacturing for plasmids is outsourced to CMOs, while device manufacturing is handled in-house.

• INO-3107 is a combination product of a DNA medicine and a proprietary delivery device.

Clinical data and product differentiation

• INO-3107 showed a 72% reduction in surgeries in year one and 86% in year two; 28% of patients required no surgeries in year one, increasing to 50% in year two.

• Treatment is well tolerated, with transient injection site pain and fatigue as the most common adverse events; no discontinuations observed.

• Product can be administered in a doctor's office without the need for scoping or surgeries during dosing.

• Differentiated from the approved VGX-3100 by not requiring surgeries during treatment and not being impacted by neutralizing antibodies.

• Complete responders to INO-3107 required no surgeries during the treatment window, compared to 72% of VGX-3100 complete responders who still required surgery.

Regulatory and commercial strategy

• FDA accepted BLA under Accelerated Approval but requested additional information; company submitted an Assessment Aid and is awaiting a meeting.

• Confirmatory trial planned as part of the accelerated approval pathway, with IND amendment submitted.

• European regulators require placebo-controlled data from two efficacy trials; company holds Orphan Drug, ILAP, and ATMP designations in Europe.

• Commercial preparations include market research, price optimization, logistics, and promotional planning; field force not yet deployed.

• Target market is concentrated, with 300-400 laryngologists treating most RRP patients; small sales force anticipated.