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Inovio Pharmaceuticals (INO) investor relations material
Inovio Pharmaceuticals H.C. Wainwright 27th Annual Global Investment Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Company overview and strategic focus
Focused on developing DNA medicines for HPV-related diseases, cancer, and infectious diseases, with a deep pipeline and multiple near- and mid-term catalysts expected.
Lead program INO-3107 targets recurrent respiratory papillomatosis (RRP), a rare HPV-related disease, and is on the FDA's accelerated approval pathway.
Commercial-scale manufacturing for DNA plasmids is established, and next-generation technologies are in early development.
Top priority is the Biologics License Application (BLA) submission for INO-3107, with FDA agreement on a rolling submission timeline.
Eight additional clinical-stage candidates are in the pipeline, including other HPV, cancer, and DMAP programs.
Clinical trial results and regulatory progress
INO-3107 showed a statistically significant reduction in surgeries for RRP patients, with a median drop from four to one surgery in 12 months.
Durability extension trial confirmed continued reduction in surgeries into the second and third years, with over 75% reduction compared to pre-treatment.
81% of patients had at least one fewer surgery, and 72% had a 50% or greater reduction in surgeries in the first year.
28% of patients were surgery-free in year one, increasing to 50% in year two.
BLA submission is on track for completion in the second half of the year, with file acceptance targeted by year-end.
Market opportunity and product positioning
RRP affects an estimated 14,000 patients in the U.S., with similar prevalence in Europe; repeated surgeries can cause irreversible vocal cord damage.
INO-3107 is positioned as a preferred product due to efficacy, tolerability, and a simple, patient-centric treatment approach.
Physicians value the high rate of 50%-100% reduction in surgeries, and the treatment is well tolerated.
Can be administered in-office, with no need for scoping or minimal residual disease surgeries during dosing.
Launch preparations are advanced, with a focused field force and established distribution strategy.
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