Inovio Pharmaceuticals IncRegulatory update on INO-3107 with PDUFA date and completed inspections.
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported second quarter 2026 financial results and provided a regulatory update on its INO-3107 candidate for recurrent respiratory papillomatosis. The company's Biologics License Application for INO-3107 has a PDUFA target action date of October 30, 2026, with all scheduled prelicensure inspections completed and label negotiations expected to begin in September. Cash and cash equivalents were $36.7 million as of June 30, 2026, down from $58.5 million at the end of 2025, and a July equity offering added $18.3 million in net proceeds, extending the estimated cash runway into late first quarter 2027. Total operating expenses fell 19% year over year to $18.6 million, and the net loss narrowed to $6 million, or $0.07 per share, from $23.5 million, or $0.61 per share, a year earlier, driven in part by a $13.9 million noncash warrant liability gain. Management highlighted INO-3107's clinical efficacy, with the majority of Phase I/II trial participants experiencing a 50% to 100% reduction in surgery in the first year, and noted that competitor PAPZIMEOS had an 83% surgery rate in its Phase I/II trial.
Inovio Pharmaceuticals IncRegulatory update on INO-3107 with PDUFA date and completed inspections.
Commercial Metals Company