INOVIO gets FDA breakthrough therapy for INO-3107; BLA on accelerated path without Phase 3 trial

INOVIO PHARMACEUTICALS, INC.

FDA granted Breakthrough Therapy designation for INO-3107 to treat Recurrent Respiratory Papillomatosis (RRP).
FDA confirmed Phase 1/2 trial data can support BLA submission under accelerated approval; no Phase 3 required.
Cash, cash equivalents and short-term investments of $167.5M as of September 30, 2023.
INOVIO planning to submit BLA under accelerated approval; type B meeting requested for Q4 2023.
Commercialization strategy accelerated for potential earlier launch of INO-3107 if approved.

item 2.02 item 9.01

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Earnings Releases SEC 8-K Item 2.02 confidence 0.9

INOVIO PHARMACEUTICALS, INC. reported financial results for third quarter ended September 30, 2023.

Period: third quarter ended September 30, 2023
Result: reported results

Exact text from the filing

On November 9, 2023, Inovio Pharmaceuticals, Inc. (the “ Company ”) issued a press release announcing its financial results for the quarter and nine months ended September 30, 2023.

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accession 0001193125-23-274515

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