INOVIO PHARMACEUTICALS, INC. (INO)·Q2 2025 Earnings Summary

Executive Summary

• Q2 2025 execution de-risked the regulatory path: design verification (DV) testing for CELLECTRA 5PSP is complete, INOVIO requested a rolling BLA, and subsequently received FDA agreement with its rolling submission timeline; management targets full BLA submission in 2H25 and FDA file acceptance by year-end with potential mid-2026 approval if priority review is granted .
• Operating discipline continued: total OpEx fell 31% YoY to $23.1M; net loss narrowed to $23.5M ($0.61/share) vs $32.2M ($1.19/share) in Q2 2024; Q2 EPS matched consensus at ($0.61)* .
• Balance sheet: cash, cash equivalents and short-term investments were $47.5M at 6/30/25, excluding $22.5M net proceeds from a July equity offering; runway now extends into Q2 2026 with estimated Q3 2025 operational cash burn of ~$22M .
• Clinical/market momentum: INO-3107 durability data published in The Laryngoscope (Year 2 overall response 86% vs 72% at Year 1; CR 50% vs 28%) supporting BLA; confirmatory RRP trial to enroll ~100 patients across ~20 US sites .
• Near-term stock catalysts: FDA updates on rolling submission modules and BLA acceptance, confirmatory trial IND update/enrollment start, and continued commercial build (pricing/market access groundwork) .

What Went Well and What Went Wrong

• What Went Well

  • Regulatory de-risking: “With device DV testing complete, we remain on track to submit our BLA for INO-3107 in the second half of this year, with the goal of having FDA acceptance of the file by year end.” — CEO Dr. Jacqueline Shea .
  • Strong durability data: Year 2 ORR improved to 86% (from 72% in Year 1); Year 2 CR rose to 50% (from 28%); mean surgeries fell from 4.1 pre-treatment to 1.7 (Year 1) to 0.9 (Year 2) .
  • Cost control: OpEx down 31% YoY; CFO emphasized continued discipline to prioritize 3107 (“we've been able to significantly reduce our operating expenses”) .

• What Went Wrong

  • No revenue base: Q2 revenue was $0 (vs $0.10M in Q2 2024), leaving results entirely expense-driven and dependent on financing .
  • Liquidity still finite: Cash fell to $47.5M at 6/30 before July raise; company still guides to ~$22M operational net cash burn for Q3, implying continued need to execute on pipeline/regulatory milestones to support financing optionality .
  • DV testing timing questions: Analysts flagged DV testing had been guided to complete in 1H; management said the overall BLA timeline remains on track but DV required coordination with multiple vendors .

Financial Results

Estimates vs Actuals (S&P Global consensus)

Values marked with * retrieved from S&P Global.

KPIs and Operating Detail

• Shares outstanding: 36.7M basic; 51.7M fully diluted at 6/30/25 .
• Cash runway: into Q2 2026, including ~$22.5M July proceeds; Q3 2025 operational net cash burn estimate ~$22M .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “With device DV testing complete, we remain on track to submit our BLA for INO-3107 in the second half of this year, with the goal of having FDA acceptance of the file by year end… I look forward to… a potential approval date in mid-2026.” — CEO Dr. Jacqueline Shea .
• “Our operating expenses dropped from $33.3 million in [Q2] 2024 to $23.1 million in [Q2] 2025, a 31% decrease… Inovio's net loss… dropped 27% to $23.5 million.” — CFO Peter Kies .
• “We aim to complete our BLA submission over the next several months and request a priority review… [Confirmatory] trial… will include 100 RRP patients… at approximately 20 sites across the United States.” — CMO Dr. Michael Sumner .
• “There’s 300 to 400 laryngologists that… treat the majority of RRP patients… a very small… commercial organization… is needed.” — CCO Steve Egge .

Q&A Highlights

• Advisory Committee probability: Management views the chance of an AdCom as relatively low based on risk-benefit and interactions to date, while deferring to FDA discretion .
• Competitive context: Noted differences versus a competitor’s vector-based program and trial design (scoping/surgeries during dosing vs “every surgery matters” counted post-Day 0; confirmatory is placebo-controlled and includes patients with ≥2 prior-year surgeries) .
• Redosing: Company plans a simple annual redosing approach to sustain/improve response; will discuss with FDA after BLA submission .
• Enrollment vs competitor approval: Company expects ability to enroll 100-patient confirmatory trial across ~20 US sites even if a competitor is approved, given coverage/lag dynamics and disease prevalence .
• Pricing: Continues to reference a rare-disease pricing analogue; transcript cites SpringWorks’ OXIVIO around $360,000/year as a directional comparator for initial four-dose regimen positioning .

Estimates Context

• Q2 2025 EPS was in line: ($0.61) actual vs ($0.61) consensus*; revenue was $0 vs $8,330 consensus* (immaterial scale), reflecting the company’s pre-revenue profile .
• Street likely maintains a pre-commercial trajectory, with focus shifting to regulatory milestones (rolling BLA progress/acceptance) and confirmatory trial initiation—less about near-term P&L. Target price consensus across forward quarters stood at ~$7.63*, and no consensus recommendation text was provided by the feed. Values marked with * retrieved from S&P Global.

Estimates snapshot (S&P Global)

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

• Regulatory execution is the principal near-term value driver: DV complete, rolling BLA requested and FDA agreed to the rolling plan; watch for module submissions and YE25 acceptance .
• Strong durability signal now peer-reviewed: Year 2 ORR 86% and CR 50% in The Laryngoscope support real-world durability and commercial narrative of surgery reduction (“every surgery matters”) .
• Cash runway into Q2 2026 post-July raise lowers financing overhang near-term, but Q3 burn ~$22M underscores the importance of milestone-driven de-risking for continued capital access .
• Commercial path looks focused and capital-efficient: small, concentrated prescriber base (300–400 US laryngologists) and rare-disease pricing frame provide a practical go-to-market blueprint if approved .
• Competitive/label dynamics: Company emphasizes mechanistic and trial-design differentiation; potential absence of AdCom reduces timeline risk, but confirmatory trial initiation/execution remains critical .
• Near-term trading set-up: incremental FDA signals (rolling acceptance, full file acceptance), IND update/enrollment start, and additional partnering updates on next-gen platforms (dMAbs/DPROT) could be catalysts .
• Risk monitor: regulatory review outcomes, confirmatory trial enrollment pace, and cash burn trajectory; revenue remains de minimis until potential approval .

Appendix: Additional Q2 2025 context and press releases

• Laryngoscope publication of INO-3107 long-term outcomes (Year 2 ORR 86%, CR 50%; mean surgeries 4.1→1.7→0.9) .
• July 2025 public offering (~$25M gross; ~$22.5M net) to extend runway .
• Aug 26, 2025: FDA agreed with INOVIO’s rolling BLA submission timeline; completion still targeted in coming months .

Notes: Values marked with * are retrieved from S&P Global.