Ocular Therapeutix (NSDQ:OCUL) said today that it launched a $25 million underwritten public offering of its common stock. The Bedford, Mass.-based company did not provide any specific pricing details for the offering.
Cantor Fitzgerald & Co. is the sole bookrunner for the offering, according to regulatory filings.
Yesterday, the company said today that it resubmitted a New Drug Application to the FDA for its post-surgical ocular pain reliever. The hydrogel plug, inserted into a patient’s tear duct, is designed to deliver a sustained dose of dexamethasone over 4 weeks following ophthalmic surgery.
Ocular has had trouble gaining regulatory approval for the pain relief drug-device combo – in July last year, the FDA denied approval for Ocular’s Dextenza, citing concerns related to “deficiencies in manufacturing process and controls” which were identified during a pre-New Drug Application approval inspection of its manufacturing facility.
“Following productive discussions with the FDA, we are pleased to announce the resubmission of our NDA for Dextenza for the treatment of ocular pain occurring after ophthalmic surgery,” president, chairman & CEO Amar Sawhney said in prepared remarks. “If Dextenza is approved, we believe that its ability to provide a complete course of steroid therapy with 1-time administration in the post-surgical setting will be extremely attractive for both ophthalmologists and patients. We continue to build our commercial organization and infrastructure in preparation for the earliest possible launch of Dextenza, subject to marketing approval.”
Shares in the company surged in November after the biopharmaceutical company met expectations on Wall Street with its 3rd-quarter results.
Ocular reeled in its losses to -$9.6 million, or -39¢ per share, on sales of $477,000 for the 3 months ended Sept. 30, paring its losses by 16.5% on sales growth of 11.2% compared to the same period last year.
Losses per share came in well ahead of the -51¢ consensus on The Street, where analysts were looking for sales of $460,ooo.
Later that month, the company said that Dextenza met both primary endpoints in a pivotal trial for the treatment of post-surgical ocular inflammation and pain.
OCUL shares closed at $7.55 yesterday, down -4.8%.
