Inovio Pharmaceuticals, Inc. · NASDAQ:INO
Inovio Pharmaceuticals — Q4 2024 Earnings Presentation
26 slides from Inovio Pharmaceuticals's earnings presentation, Mar 18, 2025
Slide 1: Fourth Quarter & Full Year 2024 Financial Results
Fourth Quarter & Full Year 2024 Financial Results • March 2025
Slide 2: Agenda
Agenda Introduction Jennie Willson, Director, Communications CEO Perspective & Corporate Progress Jacqueline Shea, PhD, President & Chief Executive Officer INO-3107 Update Michael Sumner, MBBS, MBA, Chief Medical Officer Steve Egge, Chief Commercial Officer Financial Results Peter Kies, Chief Financ
Slide 3: Forward-Looking Statements
Forward-Looking Statements This presentation includes statements that are, or may be deemed, “forward-looking statements,” within the meaning of Section 27A of the Securities Act of 1933, as amended. All statements, other than statements of historical facts, included in this presentation regarding o
Slide 4: 2025 Strategic Priorities
2025 Strategic Priorities Submit BLA for INO-3107 Advance Commercialization Preparations Progress Pipeline 4
Slide 5: Progressing Strategy to Unlock the Promise of DNA Medicine
Progressing Strategy to Unlock the Promise of DNA Medicine Working to Deliver INO-3107 Advancing Diversified Clinical Innovating NextGen DNA to Patients Pipeline Medicines • Top priority - BLA submission • 8 additional clinical-stage • DMAbs: - Completed all non-device candidates* - Applicable to di
Slide 6: Lead Candidate: INO-3107 for Recurrent Respiratory Papillomatosis (RRP)
Lead Candidate: INO-3107 for Recurrent Respiratory Papillomatosis (RRP) Potentially transformational therapy under accelerated approval pathway
Slide 7: Significant Progress Achieved Toward BLA Goal
INO-3107 DELIVERING THERAPEUTIC INNOVATION TO PATIENTS Significant Progress Achieved Toward BLA Goal Regulatory & Completed drafting all non-device modules to submit to FDA and resolved Device Progress manufacturing issue with single-use array Immunology & Data presented at scientific conferences &
Slide 8: Phase 1/2 Multi-Center Clinical Trial at 8 Clinical Sites
INO-3107 Phase 1/2 Multi-Center Clinical Trial at 8 Clinical Sites RRP-001 PHASE 1/2 OPEN-LABEL STUDY RRP-002 DURABILITY EXTENSION / FOLLOW-UP Baseline: DAY 0 52 WEEKS 104 WEEKS 156 WEEKS Patients Enrolled 4 Doses of INO-3107 Completed Study Consented to Follow Up Median Completed Follow Up Follow U
Slide 9: Reduction in Surgeries Continued to Improve After Year 1
INO-3107 Reduction in Surgeries Continued to Improve After Year 1 ORR was 72% at Week 52, improving to 86% by Week 104 for second twelve-month period • The pre-treatment mean for surgeries in the year prior to start of INO-3107 was 4.1 (range 2-8) INO-3107 CLINICAL EFFECT OVER TIME Surgeries ORR: 72
Slide 10: Greater Than 75% Reduction in Surgeries in Year 2
INO-3107 Patients Saw a Greater Than 75% Reduction in the Number of Surgeries in Year 2 Following the Initial Treatment Regimen MEAN SURGERIES PER YEAR PRE-TREATMENT Week -52 to 0 (N=32) 4.1 Week 52 Visit (N=32) 1.7 Longer-term therapy offers POST-TREATMENT Week 104 (N=28) 0.9 potential for maintena
Slide 11: Key Takeaways: Immunological Evaluation
INO-3107 Key Takeaways: Immunological Evaluation PRIOR TO INO-3107 Right kind of immune responses generated to fight HPV in all 32 patients (antigen specific cytotoxic T cell response) T cells got where they needed to go — into the papilloma/airway tissue ONE YEAR FOLLOWING INO-3107 Created an anti-
Slide 12: Next Steps
INO-3107 Next Steps Regulatory • Repeat Device Verification (DV) testing - anticipate completion first half of 2025 • Begin rolling submission of BLA mid-2025 and to request priority review with goal of completing the submission in 2H25 and receiving FDA acceptance for filing of submission by end of
Slide 13: For RRP Patients, Every Surgery Matters
For RRP Patients, Every Surgery Matters “ RRP patients will tell you that even one reduction in the number of disruptive, invasive surgeries they face would be life-changing. – Kim McClellan, RRP Foundation RRP affects ~14,000 People in U.S., 1.8 per 100,000 new cases annually • Repeated surgery is
Slide 14: Recent Market Research Supports Preferred Product Profile
INO-3107 Recent Market Research Supports Preferred Product Profile HCP PERSPECTIVE The complete response rate of 50% is good... Improving response over time but a 50-100% reduction in surgeries in ~8 out if 10 Efficacy • Patients that achieved a 50% to 100% reduction in patients, that’s the most com
Slide 15: Advancing Launch Preparations
INO-3107 Advancing Launch Preparations • Developed distribution/channel strategy and identified channel partners • Developed initial pricing strategy • Completed targeting, segmentation and product positioning work - supporting positive differentiation 300-400 • Currently developing GTM model and pl
Slide 16: Advancing a Diversified Clinical Pipeline
Advancing a Diversified Clinical Pipeline
Slide 17: The Next Generation of DNA Medicine
DMAbTM DNA ENCODED MONOCLONAL ANTIBODIES The Next Generation of DNA Medicine MYCOCYTE DMAb technology enables in vivo production of monoclonal antibodies (mAbs) • DNA is administered via CELLECTRA device to enable local expression of the genes coding for the antibodies in the deltoid muscle. • DMAbs
Slide 18: DMAb Ongoing Phase Trial: Key Takeaways From Interim Data
DMAbTM Ongoing Phase 1 Trial: Key Takeaways From Interim Data • Long-lasting in vivo antibody production: DURABLE AND CONSISTENT DMAb EXPRESSION DMAb levels remained stable for 72 weeks in 1024 all participants reaching that timepoint 4 x 0.5 mg Serum Concentration, ng/mL 512 2 x 0.5 mg • No anti-dr
Slide 19: Potential to Address Challenges of Conventional mAbs
DMAbTM Potential to Address Challenges of Conventional mAbs Challenges with mAbs1 INOVIO’s DMAb technology • Stability: susceptible to a variety of chemically- and • Rapid manufacturing, low cost of production, and temperature-induced structural changes temperature-stable storage and distribution •
Slide 20: Feasibility Shown in Multiple Disease Models
DMAbTM Feasibility Shown in Multiple Disease Models • Delivery of anti PCSK-9 in mice lowers LDL PCSK-9 Influenza A & B • Broadly neutralizing pan-influenza A & B approach cholesterol (Khoshnejad et al Mol Ther 2018) • Delivery of multiple antibodies (Elliott et al NJV 2017) viruses • Demonstrated d
Slide 21: INOVIO Pipeline
INOVIO Pipeline PRECLINICAL PHASE 1 PHASE 2 PHASE 3 REGISTRATION DMAbs INO-5401 VGX-3100 INO-3107 * Various Targets BRCA 1/2 Mutation Anal Dysplasia RRP DPROTs INO-4201 INO-3112 Various targets Ebola Booster Head & Neck Cancer DLNPs INO-6172 INO-5401 Various targets HIV Glioblastoma INO-6160 HIV DMA
Slide 22: 4Q24 Financial Update
4Q24 Financial Update
Slide 23: Ongoing Commitment to Financial Discipline
Ongoing Commitment to Financial Discipline THREE MONTHS YEAR ENDED DECEMBER 31, 2024 ENDED DECEMBER 31, 2023 2024 2023 % % (unaudited) (unaudited) CHANGE 2024 2023 CHANGE Operating expenses $20.5 $27.5 (25%) $112.6 $144.8 (22%) Net loss ($19.4) ($25.0) (22%) ($107.3) ($135.1) (21%) Net loss per shar
Slide 24: Q&A
Q&A
Slide 25: 2025 Strategic Priorities & Key Catalysts
2025 Strategic Priorities & Key Catalysts Commercialization Submit BLA for INO-3017 Preparations Progress Pipeline • Complete DV testing 1H25 Be ready to launch quickly and INO-3112 for OPSCC • Request rolling review and begin efficiently after approval • Finalize protocol for Phase 3 submitting mod
Slide 26: Contact: Investor.relations@inovio.com
Contact: Investor.relations@inovio.com
Inovio Pharmaceuticals — Q4 2024 Earnings Presentation on 6ix