Inovio Pharmaceuticals (INO) Q2 2024 earnings summary

Executive summary

• Advanced lead program INO-3107 for recurrent respiratory papillomatosis (RRP), with BLA submission delayed to mid-2025 due to a device manufacturing issue; regulatory progress continues in the U.S., U.K., and Europe.

• INO-3107 showed 81.3% of patients had reduced surgical interventions in a Phase 1/2 trial; all non-device BLA elements expected by year-end.

• Continued progress on other pipeline candidates, including INO-3112 for HPV-related throat cancer and INO-4201 as an Ebola vaccine booster; INO-3112 Phase 3 plans advanced in Europe and North America.

• Strengthened leadership with the appointment of a new Chief Commercial Officer to enhance commercial readiness.

• Collaborations with major partners including ApolloBio, Advaccine, AstraZeneca, and Gates Foundation.

Financial highlights

• Q2 2024 net loss was $32.2M ($1.19/share), compared to $35.5M ($1.61/share) in Q2 2023; revenue was $101,000 for Q2 2024.

• Cash, cash equivalents, and short-term investments totaled $110.4M as of June 30, 2024, with no debt outstanding.

• Total operating expenses for Q2 2024 were $33.3M, down from $37.3M in Q2 2023.

• R&D expenses for Q2 2024 were $23.1M, mainly due to lower manufacturing and compensation costs; G&A expenses fell to $10.2M.

• Raised $33.2M in April 2024 through an offering of common stock and pre-funded warrants.

Outlook and guidance

• Cash runway projected into Q3 2025, with estimated Q3 2024 net cash burn of ~$28M; additional financing will be required for development beyond INO-3107.

• All non-device-related BLA package elements for INO-3107 expected to be completed by year-end; BLA submission now anticipated in mid-2025.

• Confirmatory and redosing trials for INO-3107, and INO-3112 Phase 3 trial, cannot start until device issue is resolved.

• INO-4201 Phase 2/3 protocol to be resubmitted to FDA in Q3 2024.

• Updates on operating expenses and regulatory timelines to be provided in the next quarterly call.