The IPO comes after the company raised $44m in equity financing from July to September 2015 in order to expand its facility and to advance the proprietary BioSymphony Platform as well as various preclinical and clinical monoclonal antibody biosimilar programs.
According to the filing with the Securities and Exchange Commission (SEC), the company’s current focus is on “technically challenging and commercially attractive monoclonal antibodies, or mAbs, in the disease areas of immunology and oncology.”
With this focus, the company’s goal is to develop mAb biosimilars on an accelerated timeline and in a cost-effective manner using the BioSymphony Platform.
“We believe this platform addresses the numerous complex technical and regulatory challenges in developing and commercializing mAb biosimilars and was designed to provide significant pricing flexibility.”
Last year, the company completed construction of a 2000L single-use mammalian cell culture facility at its headquarters in Cranbury, New Jersey, to support commercialisation of its lead candidate ONS-3010, an adalimumab (Humira) biosimilar.
According to the company, the in-house capabilities allow manufacture within six weeks of process development completion, compared to tradition technology transfers that can take up to six months or more.
Development
ONS-3010 is expected to commence enrolment in 2016 after receiving necessary regulatory authorizations, while ONS-1045, a bevacizumab (Avastin) biosimilar, is preparing for Phase 3 clinical trial enrolments.
A further six candidates are in active preclinical development, and one is expected to enter clinical trials in 2016.
To continue furthering its mAb biosimilar candidate development capabilities the company is expanding its current facility by adding an additional 82,000 feet of laboratory and office space, the filing revealed.
Growth will also be driven by the loss of multiple reference product patent exclusives in the upcoming years.
According to the filing, “There are more than 30 reference products facing loss of patent exclusivity in one or more major markets through 2020…mAbs are the largest segment of the biologic market, and worldwide sales of mAb biosimilars are expected to grow from approximately $1.4 billion in 2015 to $56.5 billion by 2030.”
Oncobiologics did not respond to a request for comment.