INOVIO PHARMACEUTICALS, INC. (INO)·Q4 2024 Earnings Summary

Executive Summary

• Q4 2024 showed disciplined cost control and smaller losses: total operating expenses fell to $20.5M and net loss improved to $19.4M ($0.65 per share), with minimal revenue of $0.117M .
• The company resolved the single-use array issue for its CELLECTRA device, plans to complete FDA-required design verification (DV) tests in 1H 2025, start a rolling BLA submission for INO-3107 in mid-2025, and target FDA acceptance of the submission by year-end .
• Long-term durability data strengthened INO-3107’s profile: complete responses rose to 50% in year 2 (54% in year 3), with mean surgeries dropping from 4.1 pre-treatment to 1.7 (year 1) and 0.9 (year 2) .
• Cash runway extended into Q1 2026; Q1 2025 net cash burn guided at ~$27M, supporting operations through key regulatory milestones (excludes additional capital raises) .
• Wall Street consensus (S&P Global) for Q4 2024 EPS/revenue was unavailable at query time; we cannot assess beat/miss versus estimates [SPGI error].

What Went Well and What Went Wrong

• What Went Well

  • Device remediation on CELLECTRA’s single-use array completed; DV testing slated for 1H 2025, keeping mid-2025 rolling BLA timeline intact. “We have resolved the previously announced manufacturing issue… and completed drafting of all non-device BLA modules” .
  • INO-3107 durability data improved markedly: CR 50% by end of year 2 and 54% in year 3; ORR maintenance 95% (year 2) and 86% (year 3) .
  • DMAb Phase 1 PoC showed durable in vivo antibody production through 72 weeks and no anti-drug antibodies, broadening platform optionality .

• What Went Wrong

  • Revenue remains immaterial ($0.117M in Q4), limiting margin analysis; company is pre-commercial and reliant on financing and partners .
  • Cash declined year-over-year ($94.1M cash, cash equivalents and short-term investments at Dec 31, 2024 vs. $145.3M in 2023), reflecting spend ahead of BLA and trial starts .
  • Estimates comparison unavailable: S&P Global consensus data could not be retrieved at query time, reducing visibility on Street expectations and near-term sentiment [SPGI error].

Financial Results

Quarterly comparison (oldest → newest)

Year-over-year Q4 comparison

Margins note

Note: Margins are not meaningful given immaterial/zero revenue in a pre-commercial biotech; figures are computed from cited revenue and net loss.

Segment breakdown

Not applicable (no reportable revenue segments disclosed in period materials) .

KPIs

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• CEO: “We anticipate starting our submission in mid-2025… with the goal of having the complete submission accepted for priority review before the end of the year” .
• CMO: “We have not been able to reproduce the breakage… which gives us great confidence that the modifications have resolved the issue” .
• CCO: “Given the RRP market is highly concentrated… we believe we will need a small and efficient field force footprint” .
• CFO: “Total operating expenses dropping from $27.5M in Q4’23 to $20.5M in Q4’24… cash runway into the first quarter of 2026” .

Q&A Highlights

• BLA process logistics: Rolling submission request is by written request; no further FDA meeting needed given prior pre-BLA alignment .
• Device DV testing: Multiple tests will be repeated by an external testing house; external certifications included in BLA device module .
• Confirmatory trial prerequisite: FDA requires trial initiation prior to BLA; most sites identified, contracts/IRBs advancing to demonstrate commitment .
• Pricing framework: Payer research supports rare disease pricing; management cited analog OGSIVEO ~$360k/year and a broad acceptable range ($200k–$2M/year) .
• Competitive landscape: Differentiation vs. adenoviral competitor includes trial design philosophy (counting all surgeries after Day 0) and nonsurgical, office-based regimen .

Estimates Context

• S&P Global consensus estimates for Q4 2024 EPS and revenue were unavailable at query time; therefore we cannot assess beat/miss versus Street expectations (values not retrieved; S&P Global access error).
• As a pre-commercial biotech with minimal revenue, near-term Street models likely focus on cash runway, OpEx trajectory, and regulatory timelines rather than top-line beats/misses .

Key Takeaways for Investors

• Regulatory catalysts: DV testing completion in 1H 2025 and rolling BLA submission mid-2025; aim for FDA acceptance before year-end 2025—key stock drivers in 2025 .
• Strengthened product narrative: Durable clinical benefit (CR up to 54% in year 3; ORR maintenance) and published immunology support MoA, improving approval and commercial confidence .
• Commercial readiness advancing: Lean field force, payer-engaged pricing strategy, and office-based administration could enable efficient uptake post-approval .
• Financial runway extended: Cash, cash equivalents and short-term investments of $94.1M and runway into Q1 2026 provide time to reach regulatory milestones; watch quarterly burn ($27M guided for Q1’25) .
• Platform optionality: DMAb PoC with 72-week durability and no anti-drug antibodies opens broader disease applications and potential strategic value .
• Execution watchpoints: Monitor DV test progress, confirmatory trial initiation timing, and any further capital raises given development plans .
• Competitive dynamics: Data-driven differentiation (counting surgeries, tolerability, patient-centric regimen) versus adenoviral approaches likely to shape physician preference in RRP .