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Inovio Sees FDA Decision This Month on Vaccine Trial Resumption

Drug maker updates status of coronavirus vaccine candidate, after Pfizer and BioNTech report progress on theirs.

Inovio Pharmaceuticals  (INO) - Get Inovio Pharmaceuticals, Inc. Report said Monday it expects to hear from the Food and Drug Administration this month on whether its COVID-19 vaccine candidate can resume late-stage trials. 

Late trials of Inovio’s  coronavirus vaccine candidate -- INO-4800 -- have been under a “partial clinical hold” from the Food and Drug Administration since late September. 

The company said in its latest quarterly earnings release Monday that it "anticipates a response from the FDA this month as to whether the planned Phase 2/3 clinical trial of INO-4800 can proceed."

Inovio shares rose 29 cents, or 3.4%, to $8.79 in after-hours trading. In the regular session the stock plunged 19% after Pfizer  (PFE) - Get Pfizer Inc. Report and BioNTech  (BNTX) - Get BioNTech SE Report reported that preliminary data showed their coronavirus vaccine candidate is 90% effective.

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Inovio said it made 11 cents per diluted share in the latest quarter on $0.2 million in revenue vs. a loss of 25 cents a share on sales of $0.9 million in the year-ago period.

The company had been expected to report a loss of $28.5 million, or 19 cents a share, on sales of $3 million, based on a FactSet survey of 8 analysts.

Inovio said its results were helped by a gain from the sale of its equity interest in GeneOne and from a change in the fair value of a derivative liability. Without the effect of those the company said its net loss for the quarter would have been $43.1 million and basic net loss per share would have been 26 cents.

"INOVIO continues to focus on the development of our COVID-19 vaccine, INO-4800, as well as advancing our other core DNA medicine programs," said Dr. J. Joseph Kim, the company's president and CEO, in a statement. "While the partial clinical hold for INO-4800 has resulted in delays to our originally anticipated development timeline, the company remains well-capitalized and focused as both clinical trials and manufacturing efforts continue," he said.