OptiNose is a commercial-stage ENT/allergy specialty pharmaceutical company whose core technology is a patented closed-palate Breath Powered® platform used to create Exhalation Delivery Systems (EDS) for high and deep intranasal drug deposition. Its lead product candidate, OPN-375 (fluticasone propionate delivered via EDS), is being developed for chronic rhinosinusitis and nasal polyposis, and an NDA for nasal polyposis was submitted to the FDA in November 2016 with a PDUFA goal date in September 2017. The company plans to use new capital to fund commercial readiness for a potential U.S. launch and aims to be prepared for launch in the first half of 2018 if approved. OptiNose previously developed and out-licensed Onzetra Xsail (sumatriptan nasal powder) at the end of Phase 3 development; that product received FDA approval and launched in 2016. The company is also engaged in early development of nose-to-brain EDS applications for neurologic orphan diseases (including OPN-300 and OPN-21) and intends subsequent pipeline products to serve ENT and allergy specialists. OptiNose has corporate offices in the U.S., U.K. and Norway and is based in Yardley, Pa. OptiNose develops drug‑device combination products that use a patented closed‑palate Bi‑Directional Breath Powered Exhaler to deliver medicines deep and high in the nasal cavity. Its lead product, OPN‑375, combines that delivery technology with a topical steroid (fluticasone) and has completed a global late‑phase clinical program (including NAVIGATE I and II) supporting an NDA submission for nasal polyposis with associated nasal congestion. The company reports the Phase III program produced excellent results and plans to submit an NDA after a planned pre‑NDA meeting. OptiNose said recent financing provides up to $30M in additional capital to support global development, follow‑on indications, manufacturing infrastructure and pre‑commercial efforts to enable U.S. commercialization. It is also advancing pipeline assets such as OPN‑300, a nose‑to‑brain oxytocin program in Phase II aimed at serious CNS disorders including autism. OptiNose has corporate offices in the US, Norway and the UK and has previously out‑licensed AVP‑825 for migraine at the end of Phase III. OptiNose, founded in 2000 and led by CEO Peter Miller, is based in Yardley, PA and also has presences in Oslo, Norway and the United Kingdom. The company has developed AVP-825, a product intended for the treatment of migraines, and has out-licensed North American marketing rights for AVP-825 to a partner. OptiNose and its partner jointly submitted a New Drug Application for AVP-825 with the U.S. FDA earlier this year. In parallel, the company is developing OPN-375, a program aimed at treating serious chronic nasal inflammatory diseases. OptiNose completed a Series C-1 round of financing and lists Avista Capital Partners, WFD Ventures LLC and Entrepreneurs Fund LP among its investors. OptiNose develops an innovative nasal drug delivery system that enables administration of drugs deep in the nasal cavity for treatment of both local and systemic disease. The company recently completed Phase II clinical studies with positive results in chronic rhinosinusitis with polyposis, chronic rhinosinusitis without polyposis, and migraine therapies. OptiNose will use the proceeds from a $48.5M equity investment to conduct Phase III trials and to build out its clinical development and commercialization infrastructure. The investment comes from Avista Capital Partners; OptiNose is also backed by WFD Ventures, which will maintain a significant stake and continue to support the company’s development program. Peter Miller, the President and former CEO of Take Care Health Systems, has been named CEO of OptiNose and will serve on its board of directors. The company will reincorporate in the U.S. and move from Oslo, Norway, to Yardley, PA.

Total raised

$116M

Funding rounds

4

Latest round

Series D

Latest activity

May 2017