Business
INOVIO Reports Third Quarter 2023 Financial Results and Operational Highlights
Achieved significant progress with lead product candidate, INO-3107 Received Breakthrough Therapy designation from U.S. Food and Drug Administration (FDA) as
About this update from Inovio Pharmaceuticals, Inc.
[{"type":"text","content":"Achieved significant progress with lead product candidate, INO-3107 Received Breakthrough Therapy designation from U.S. Food and Drug Administration (FDA) as a potential treatment for Recurrent Respiratory Papillomatosis (RRP)Received FDA feedback that data from completed Phase 1/2 trial could be used to submit a Biological License Application (BLA) under Accelerated Approval programAccelerating commercialization strategy in preparation for an earlier launch, should regulatory approval be achievedIf approved, INO-3107 could revolutionize treatment options for patients with RRP, a debilitating rare disease caused by human papillomavirus (HPV)Could be first DNA medicine available in United States and first commercial product for INOVIOContinued to advance corporate strategy to align resources with focus on INO-3107 and late-stage clinical candidates closest to market, with greatest opportunity to deliver on the promise of DNA medicines for patients$167.5 million in cash, cash equivalents and short-term investments as of September 30, 2023Investor call today at 4:30 PM ETPLYMOUTH MEETING, Pa., Nov. 9, 2023 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced its financial results and operational highlights for the third quarter ended September 30, 2023.\n\n\"The past quarter has seen significant progress for our lead candidate, INO-3107, for the treatment of Recurrent Respiratory Papillomatosis, or RRP,\" said INOVIO's President and Chief Executive Officer, Dr. Jacqueline Shea. \"Following Breakthrough Therapy designation from the FDA in September and subsequent feedback that we no longer need to complete a Phase 3 trial prior to submitting a BLA under the accelerated approval program, our team is laser-focused on next steps. These steps include holding an Initial Comprehensive Multidisciplinary Breakthrough Therapy Meeting with the FDA in the near future to confirm alignment on our accelerated development plans and to clarify timing associated with potentially making INO-3107 available to patients suffering from this devastating disease.\"\nShea continued: \"The progress we have achieved with INO-3107 exemplifies the strategy we have been implementing over the ...