INOVIO PHARMACEUTICALS, INC. Q4 FY2024 earnings call

Strategic Priorities

• Submit BLA for INO-3107, a lead candidate for recurrent respiratory papillomatosis (RRP).
• Advance commercial plan and prepare for launch of INO-3107.
• Leverage DNA medicines platform to drive progress across diversified pipeline.

3107 Progress

• Resolved manufacturing issues with CELLECTRA device's single-use array component.
• Completed drafting of non-device BLA modules; plan to begin BLA rolling submission in mid-2025 and complete by end of year, requesting priority review.
• Clinical data for 3107 shows continued improvement in surgery reduction, durable efficacy, and favorable immunology data supporting T-cell mechanism.
• Preparing for Phase 3 confirmatory trial.

DMAb Technology

• Announced top-line interim results from Phase 1 trial showing durable in-vivo production of DNA-Encoded Monoclonal Antibodies (DMAbs) targeting SARS-CoV-2, with stable antibody levels over 72 weeks and well-tolerated.

Pipeline Updates

• Other novel technologies in preclinical stage: DNA launch nanoparticle (DLNP) and DNA encoded protein replacement (DPROT) candidates.
• Advancing Phase 3 trial for INO-3112 in combination with LOQTORZI for throat cancer and Phase 2 trial for INO-5401 in glioblastoma.

No specific financial performance data for product segments provided in terms of absolute revenue and contribution percentages.

BLA Submission

• Plan to start BLA rolling submission in mid-2025, complete within 3-4 months, aiming for FDA acceptance by end of 2025.
• Prepare for confirmatory trial of 3107.

Commercial Readiness

• Developing distribution channel strategy, pricing strategy, and go-to-market model for INO-3107.

DMAb and Pipeline

• Continue working with partners to complete Phase 1 trial for DMAb and explore broader applications of DNA medicine technology.

No detailed discussion of specific risks in the transcript, but forward-looking statements note that actual events or results could differ materially from management's beliefs and expectations, referencing SEC filings for risk factors.

Q: About BLA submission request, meeting with FDA, etc.

A: Had a pre-BLA meeting with FDA prior to array issue, resolved array issue, plan to start BLA rolling submission in mid-2025 and complete within 3-4 months.

Q: Stability test, who conducts it A: External testing house, need to repeat tests for device verification.

Q: Durability of DMAb, turning off production A: DMAb levels stable for 72 weeks, potential for inducible/repressible controls for gene expression.

Q: Labeling assumptions for 3107 A: Compelling product profile with durable efficacy, patient-centric regimen; label discussion with FDA to consider risk-benefit ratio.

Q: Redosing strategy, epidemiology of RRP A: Still deciding redosing strategy; RRP has persistent cases, especially in adults with underdiagnosed disease in adult population, pediatric cases declining due to vaccination but adult cases unaffected.