Option Therapeutics Inc. (NYSE American: OPTN), a clinical-stage biopharmaceutical company incorporated in Delaware, filed for an initial public offering of up to USD 21.8 million. The listing would represent the public debut of a company currently operating as a wholly owned subsidiary of BioVie Inc., a Nevada corporation, with a single drug candidate targeting complications of advanced liver cirrhosis.
The company plans to offer 1,818,182 shares at USD 10.00 to USD 12.00 per share, implying gross proceeds of USD 18.2 million to USD 21.8 million. BioVie Inc., its parent, is expected to retain at least 60% ownership following the offering, and the company stated it may qualify as a controlled company under NYSE rules.
Option is developing BIV201, a continuous infusion formulation of terlipressin, for the treatment of ascites and complications of advanced liver cirrhosis. The drug has received FDA Fast Track and Orphan Drug designations for ascites, and a separate Orphan Drug designation for hepatorenal syndrome. The program was acquired by BioVie through its 2016 purchase of LAT Pharma.
The filing states that Phase II studies were small and not designed for hypothesis testing, but showed reductions in ascites fluid in patients treated with BIV201 compared to standard of care. The company stated the data were limited by small sample size and that the study did not meet its primary endpoint. A Phase III trial had not yet been initiated at the time of filing.