INOVIO 3rd Quarter 2026 Financial Results Conference Call - INOVIO PHARMACEUTICALS INC

Financial Performance:

• Completed a public equity offering generating approximately $80.5 million in net proceeds.
• Ending cash, cash equivalents, and short-term investments for Q3 2026 totaled $48.4 million, with an additional $10.9 million in warrant exercise proceeds received post-period.
• Combined capital resources support operational runway into late Q4 2027, extending past the Viseric commercial launch.
• Q3 2026 operating expenses decreased to $19.8 million from $21.2 million in Q3 2025.
• Q3 2026 net loss was $49.2 million ($0.50/share), an increase from $45.5 million ($0.87/share) in Q3 2025, primarily driven by a $26.9 million non-cash loss on fair value adjustments of warrant liabilities.
• Projected Q4 2026 operational net cash burn is approximately $21 million to fund commercial ramp-up; projections exclude future product revenues.

Guidance and Future Outlook:

• Viseric Launch: Product expected to be available for order and shipment within 60 days of approval; full field deployment targeted for Q1 2027.
• European Expansion: Submission for conditional marketing authorization (MAA) in the EU and UK planned for before the end of 2026.
• Confirmatory Study: Draft protocol submission expected before year-end; goal to align with FDA on final protocol by mid-2027 to satisfy accelerated approval requirements.
• Pipeline Expansion: Plans to explore pediatric RRP indications and continued treatment options for adults; seeking partnerships to advance next-generation D-PROT (Protein Replacement) candidates for rare diseases like Hemophilia A and Fabry disease.
• Long-term Goal: Establish Viseric as the preferred first-line treatment for adults with RRP.

Business Segments and Product Lines:

• Viseric (formerly INO3107/Boseric/Voseric): FDA-approved Accelerated Approval as a non-surgical plasmid DNA-based immunotherapy for recurrent respiratory papillomatosis (RRP); marks Inovio's transition to a commercial-stage company.
• Commercial Infrastructure: Deploying a 20-territory field team via deployment partner Cineos Health, targeting 100 major integrated delivery networks (IDNs) and community practices to cover 90% of the US RRP patient base.
• Selectra Device: Proprietary delivery device integrated with Viseric; training for physicians estimated at 30 minutes per user; manufacturing capacity secured for launch year through 2027.
• Reimbursement Strategy: Aiming for payer policies covering 80% of US patients within nine months; pursuing permanent J-code assignment and formulary inclusion.
• Pipeline Candidates: Advancing later-stage candidates focused on targeted T-cell responses and earlier-stage D-PROT candidates for protein replacement therapies.

Market and Competitive Landscape:

• Target Population: Estimated prevalent population of at least 25,000 adult RRP patients in the US, with significant unmet need for non-surgical options.
• Competitive Advantage: Positioning Viseric as a first-line therapy to reduce the frequency of surgeries, avoiding the risks of vocal cord and airway damage associated with repeated surgical debulking.
• Market Consensus: Key Opinion Leaders and the RRP Foundation advocate for immunotherapy as first-line treatment; existing immunotherapy penetration remains low.
• Global Expansion: Actively seeking partnerships for ex-US territories due to resource constraints in regions accepting FDA approvals without local commercial infrastructure.

Risks and Challenges:

• Regulatory Contingency: Continued approval of Viseric is contingent on the successful execution and positive results of a confirmatory study verifying long-term clinical benefit over three years.
• Market Access Uncertainty: Reimbursement delays or restrictive payer policies could impact adoption speed despite expectations of broad coverage within nine months.
• Commercial Execution: Reliance on a newly formed commercial team and rapid scaling of field operations to penetrate a concentrated market of 400 laryngologists.
• Financial Volatility: Reported net losses remain subject to significant fluctuations due to fair value adjustments of warrant liabilities.
• Manufacturing & Supply: Need to maintain inventory and capacity to meet demand while managing drug-device combination logistics.

Management Commentary and Tone:

• Tone: Highly optimistic and confident; leadership views FDA approval as a "transformative" milestone validating the DNA medicine platform.
• Strategic Focus: Primary emphasis on executing the US commercial launch of Viseric and maximizing its potential as a first-line treatment.
• Platform Validation: Management emphasizes that the approval confirms the efficacy of the electroporation delivery device and the plasmid DNA platform, accelerating interest in other pipeline assets.
• Patient-Centricity: Frequent references to the "relentless cycle of surgery" and the patient preference for non-surgical interventions as key differentiators.

Analyst Questions and Answers:

• Competitive Uptake (Jefferies): Management expects strong uptake due to high unmet need; market research indicates patient preference for therapies avoiding surgery during the dosing window. Durability data from Year 1 extends into Year 2 and 3, with 27% of patients achieving complete response (zero surgeries) in the first year post-treatment.
• International Partnering (Piper Sandler): Plan is to commercialize Viseric in the US independently; seeking partners for ex-US markets, with EU submission supporting this strategy. FDA approval alone does not guarantee adoption in all regions due to funding/resource limitations.
• Platform Synergies: Approval is expected to accelerate partnerships for early-stage D-PROT programs (e.g., Hemophilia A, Fabry) by validating the protein expression capabilities and non-immunogenicity of the platform.
• Training and Reach (HSC Wainwright): Physician training is brief (30 mins); the field team will cover 100 major academic accounts and engage community practices to ensure 90% market penetration.

Other Key Points:

• Clinical Data: RRP001 study showed 50-100% reduction in surgeries for the vast majority of patients in Year 1; data published in Nature Communications and The Laryngoscope.
• Safety Profile: Viseric is well-tolerated with mostly Grade 1 adverse events (injection site pain, fatigue); safety data supported by prior VGX3100 trials.
• Regulatory Status: First FDA-approved plasmid DNA-based immunotherapy; broad indication covers adults with RRP.
• Manufacturing: The Selectra device is the world's first approved electroporation device; manufacturing network is prepared for launch demand.