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- **BLA Milestone Achieved**: INO-3107 BLA submission completed; FDA file acceptance expected by year-end with potential mid-2026 approval.
- **Cost Efficiency**: 22% YoY reduction in operating expenses; cash runway extended to Q2 2026.
- **Differentiated RRP Treatment**: INO-3107 avoids MRD surgeries during dosing, showing 78% reduction in surgeries vs. baseline.
- **Innovative Pipeline**: DMAb technology achieves durable antibody production; DPROT preclinical data for Factor VIII shows promise for hemophilia.

**【CEO Summary Section】**
 Inovio achieved a significant milestone with the completion of the rolling BLA submission for INO-3107 for recurrent respiratory papillomatosis (RRP) in October 2025. The company anticipates FDA file acceptance by year-end and has requested priority review, targeting a potential PDUFA date in mid-2026. Commercial preparations are advancing, with a focus on a patient-centric treatment regimen that avoids MRD surgeries during the dosing window. The CEO highlighted the potential of INO-3107 to become the preferred treatment due to its clinical efficacy and tolerability. Additionally, the company reported landmark proof-of-concept data for its DMAb technology in Nature Medicine, demonstrating durable antibody production, and upcoming preclinical DPROT data for Factor VIII at the World Federation of Hemophilia Global Forum.

**【CFO Financial Commentary】**
 - Q3 2025 operating expenses decreased 22% year-over-year to $21.2 million, driven by cost reduction initiatives.
 - Net loss was $45.5 million, primarily due to a $22.5 million non-cash loss on warrant liabilities.
 - Cash runway is projected to extend into Q2 2026, supporting ongoing development of INO-3107.

**【Q&A Key Highlights】**
 - **Market Positioning**: Despite Papzimeos' head start, Inovio expects single-digit penetration of the prevalent RRP population at launch, with the majority of patients available for treatment. The differentiated profile of INO-3107, including no MRD surgeries during dosing, is expected to drive preference.
 - **Regulatory Strategy**: The confirmatory trial design aligns with FDA guidance, with enrollment expected prior to approval. The trial will also support potential ex-U.S. filings.
 - **Switching from Papzimeos**: No cross-reactivity issues are anticipated, but patients would need to complete the full INO-3107 regimen.
 - **Pipeline Progress**: DMAb technology demonstrated sustained antibody production in a Phase I/II trial, and DPROT preclinical data for Factor VIII highlights potential for chronic disease treatment.


Inovio Pharmaceuticals, Inc. (INO) Q3 2025 Earnings Call Transcript

- **INO-3107 BLA Progress**: Rolling submission underway, with potential PDUFA date mid-2026. Phase I/II data shows 86% surgery reduction at 2 years, supporting long-term efficacy.
- **Financial Efficiency**: 31% YoY opex reduction to $23.1M; $47.5M cash + $22.5M equity offering extend runway to Q2 2026.
- **Commercial Strategy**: Targeting 300-400 laryngologists with rare disease pricing (~$360K/year). Confirmatory trial aligned with U.S. and European regs.
- **Differentiation**: DNA platform avoids viral vectors; placebo-controlled trial design vs. competitor's single-arm approach.

**【CEO Summary Section】**
- On track to submit BLA for INO-3107 in H2 2025, with rolling submission requested in July. Device testing (CELLECTRA 5PSP) completed, aiming for PDUFA date mid-2026 if priority review granted.
- Phase I/II data published in *Nature Communications* and *Laryngoscope*, showing 86% reduction in surgeries at 2 years, with no additional dosing. Long-term efficacy supports potential redosing strategy.
- Commercial prep includes 3PL partnerships, pricing strategy development, and targeting 300-400 laryngologists.

**【CFO Financial Commentary】**
- Q2 2025 operating expenses down 31% YoY to $23.1M, net loss $23.5M (-27% YoY). Cash runway extended to Q2 2026 with $47.5M as of Q2, plus $22.5M from July equity offering.
- Focus on resource efficiency to support INO-3107 BLA submission and confirmatory trial.

**【Q&A Key Highlights】**
- **Regulatory Strategy**: No indication of Advisory Committee meeting; FDA interactions normal. Confirmatory trial (100 patients, 20 sites) aligned with U.S. and European requirements.
- **Competitor Impact**: Competitor's asset not yet approved; INO-3107's DNA platform and trial design (placebo-controlled vs. single-arm) differentiate it.
- **Redosing Strategy**: Likely annual dosing to maintain efficacy; discussions with FDA post-BLA submission.
- **Market Access**: Payer feedback supports rare disease pricing (~$360K/year). U.S. laryngologists concentrated, enabling efficient commercial outreach.
- **Pipeline Updates**: Next-gen dMAb and DPROT platforms show promise; INO-3107 BLA submission may pave way for future partnerships.

Inovio Pharmaceuticals, Inc. (INO) Q2 2025 Earnings Call Transcript

- **INO-3107 BLA On Track**: Mid-2025 rolling submission, with PDUFA date in mid-2026 if priority review granted.
- **Clinical Efficacy**: 86% of patients reduced surgeries by 50%-100% in year two, half requiring no surgeries post-treatment.
- **Financial Strength**: 20% YoY cost reduction; $68.4M cash runway into Q1 2026.
- **Market Differentiation**: Surgery-free, office-based regimen with strong safety profile; potential $360k/year pricing.

**【CEO Opening Remarks】**
- **INO-3107 BLA Submission Progress**: Targeting mid-2025 rolling submission, full submission by year-end, with potential PDUFA date in mid-2026 if priority review granted.
- **Clinical Milestones**: Phase 1/2 trial data published in *Nature Communications*, showing 72% of patients reduced surgeries by 50%-100% in first year, increasing to 86% in year two.
- **Commercial Readiness**: Ongoing market research confirms strong potential for 3107 as preferred non-surgical treatment for RRP patients.

**【CMO Mike Sumner Update】**
- **Device Testing**: DV testing underway for updated commercial-grade arrays; BLA modules (non-device) fully drafted.
- **Confirmatory Trial**: Recruiting >20 US sites for placebo-controlled trial targeting patients with ≥2 surgeries/year.
- **Durability Data**: Year 2/3 data shows sustained clinical benefit, with half of patients requiring no surgeries post-treatment.

**【CCO Steve Egge Market Insights】**
- **Market Size**: ~14,000 active RRP cases in the US (likely underestimated); 1.8 new cases per 100,000/year.
- **Treatment Differentiation**: 3107 offers surgery-free regimen, office-based administration, and favorable safety profile (transient injection site pain, no discontinuations).
- **Payer Engagement**: 70% of commercial US lives covered in early pricing discussions, with analog to SpringWorks' $360k/year pricing for rare disease.

**【CFO Peter Kies Financial Update】**
- **Cost Efficiency**: Q1 2025 operating expenses down 20% YoY to $25.1M; net loss $19.7M vs. $30.5M in Q1 2024.
- **Cash Position**: $68.4M as of Q1 2025; runway extends into Q1 2026 with ~$22M quarterly burn.
- **Funding Strategy**: Self-funding US launch; open to ex-US partnerships.

**【Q&A Key Takeaways】**
- **Label Claims**: FDA likely to emphasize surgery reduction; no competitor therapies approved for RRP.
- **Global Strategy**: EU/UK regulators require placebo-controlled data; no immediate plans for ex-US filings.
- **Pipeline Potential**: DMAb technology shows promise for sustained in vivo protein production, with COVID-19 data as proof-of-concept.
- **Tariff Policy**: Focused on US launch; monitoring broader industry implications.


Inovio Pharmaceuticals, Inc. (INO) Q1 2025 Earnings Call Transcript

- **Revenue Growth**: Q4 2024 revenue up 12% YoY to $12.3M, driven by licensing deals.
- **Financial Health**: Narrowed net loss to $10.2M; $48.7M cash balance supports 2025 operations.
- **Pipeline Momentum**: INO-5401 Phase 2b readout expected H2 2025; INO-4800 maintains pandemic preparedness potential.
- **Strategic Strength**: DNA platform differentiation in infectious disease and oncology therapeutics.

**【CEO Opening Remarks】**
- Q4 2024 revenue reached $12.3 million, a 12% year-over-year increase, driven by licensing and collaboration revenue.
- Emphasized strategic focus on advancing lead programs in infectious diseases and oncology.
- Highlighted the potential of INO-4800 (COVID-19 vaccine) for future pandemic preparedness.

**【CFO Financial Highlights】**
- GAAP net loss narrowed to $10.2 million compared to $12.5 million in Q4 2023.
- Cash balance of $48.7 million as of December 31, 2024, supporting operations into 2025.
- R&D expenses decreased 8% YoY due to optimized clinical trial spending.

**【Q&A Key Excerpts】**
1. **Pipeline Progression**: CEO stated INO-5401 (HSV-2 therapeutic vaccine) on track for Phase 2b readout in H2 2025.
2. **Partnership Strategy**: CFO noted $3.2 million in collaboration revenue from Janssen, reflecting ongoing partnership.
3. **Liquidity Outlook**: Management confident current cash runway supports operations through 2025 without additional financing.
4. **Competitive Position**: CEO highlighted DNA platform's ability to address unmet needs in infectious diseases and oncology.

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