Advanced Inhalation Therapies yesterday registered for an initial public offering worth up to $36 million for its drug delivery device, which is designed to treat severe respiratory infections and lung diseases using a high dose of nitric oxide.
The Rehovot, Israel-based company, founded in 2011, plans to list on the NASDAQ exchange under the “AITP” symbol. Aegis Capital is the deal’s lone book-runner.
AIT is developing a device to deliver a gaseous, high-dosage blend of NO, oxygen and air called the NOxSysBS. The FDA has only approved a 20 ppm NO vasodilation treatment, which AIT said isn’t effective in treating microbial infections. The NOxSysBS device is designed to deliver 160 ppm of NO, which the body produces on its own to fight infections.
The company said it’s initial targets are a pair of lower respiratory tract infections, children with bronchitis and lung infections in patients with cystic fibrosis. AIT said it already has a pair of Phase IIa trials under its belt for the initial indications.
“We believe that the results of both trials suggest the safety and efficacy of our product candidates,” the company said in its registration filing. “We have received orphan drug designation by the FDA and the European Medicines Agency for the use of our NOxCF product candidate for the treatment of CF-related lung infections.”
AIT reported that its R&D expenses rose 29.3% to $1.2 million and losses widened 193.6% to -$4.6 million for 2014.