Inovio Pharmaceuticals (INO) Q3 2024 earnings summary

Executive summary

• Advanced INO-3107 for recurrent respiratory papillomatosis (RRP), with 81–81.3% of Phase 1/2 trial patients experiencing reduced surgeries post-treatment and new immunology data supporting its mechanism and clinical benefit.

• BLA submission for INO-3107 targeted for mid-2025, with all non-device modules on track for completion by year-end 2024; submission delayed due to a device manufacturing issue, which is being resolved.

• No treatment-related adverse events above Grade 2 reported in INO-3107 trials; full safety and efficacy data presented at major conferences.

• Continued progress on pipeline, including INO-3112 (Phase III planning in HPV+ throat cancer), INO-5401 (GBM and BRCA trials), and INO-4201 (Ebola vaccine booster Phase II planning).

• Accumulated deficit reached $1.7 billion as of September 30, 2024, with no product revenue expected until regulatory approval and commercialization.

Financial highlights

• Q3 2024 operating expenses decreased 24% year-over-year to $27.3 million, with R&D expenses rising to $18.7 million and G&A expenses falling to $8.6 million.

• Net loss for Q3 2024 was $25.2 million ($0.89 per share), improved from $33.9 million ($1.52 per share) in Q3 2023.

• Cash, cash equivalents, and short-term investments totaled $84.8 million as of September 30, 2024, down from $145.3 million at 2023 year-end.

• Revenue was $0 for Q3 2024 and $101,000 for the nine months ended September 30, 2024.

• Working capital was $67.8 million as of September 30, 2024.

Outlook and guidance

• Cash runway projected to last into Q3 2025, with estimated Q4 2024 net cash burn of ~$24 million; additional financing will be required to continue operations beyond that point.

• BLA submission for INO-3107 planned for mid-2025, with launch readiness targeted by end of 2025 and long-term clinical durability data expected by year-end 2024.

• Confirmatory placebo-controlled trial for INO-3107 to start before BLA submission, enrolling ~100 patients with 2:1 randomization.

• Ongoing regulatory discussions in EU and UK; approval submissions there require compelling placebo-controlled data.

• Ongoing evaluation of collaborations and capital raising to fund operations and development pipeline.