On July 3, 2018, BioVie Inc. (OTCQB: BIVI), an iBIO PROPEL company developing innovative drug therapies for liver disease, executed an agreement with Acuitas Group Holdings, LLC (“Acuitas”) and certain other investors to purchase $3.2 million of the Company’s Series A Preferred Stock, which was subsequently converted into approximately 213 million common shares. Acuitas has an option to fund up to an additional $3 million in one year on the same terms if certain other funding opportunities do not materialize. Additionally, Terren Peizer joined the board of the Company and assume the role of Chairman & Chief Executive Officer, with Jonathan Adams becoming President and Chief Operating Officer.
Proceeds from the Acuitas investment will be used to pay for the treatment of the final 3 refractory ascites patients with BIV201 (continuous infusion terlipressin) needed to complete the ongoing Phase 2a clinical trial, the analysis of the results and their presentation to the FDA, augmentation of the Company’s intellectual property (IP) estate, and other general corporate purposes. Additionally, BioVie will retire its accumulated debt at negotiated discounts and emerge virtually debt-free.
BioVie Inc. is a clinical-stage company pursuing the development and commercialization of innovative drug therapies for liver disease. Prior to the Acuitas investment the Company had treated one-half of the patients to be enrolled in a mid-stage (Phase 2a) clinical trial of its new drug candidate, BIV201 (continuous infusion terlipressin). BIV201 has an Orphan Drug designation for the treatment of ascites, FDA Fast Track status, and US patent protection.
BIV201 represents a potential new treatment for thousands of patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by hepatitis, NASH, and alcoholism. The initial disease target for BIV201 therapy is ascites, which is a serious complication of advanced liver cirrhosis. The FDA has never approved a drug specifically for treating ascites. The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. For more information about BioVie, please visit our website: www.biovieinc.com.
About Liver Cirrhosis and Ascites
More than 600,000 Americans and millions worldwide suffer from liver cirrhosis. Cirrhosis is the 12th-leading cause of death due to disease in the US, killing more than 30,000 people each year. The condition results primarily from hepatitis, alcoholism, and nonalcoholic steatohepatitis (NASH) linked to fatty liver disease and obesity. Ascites is a common complication of advanced liver cirrhosis. Certain drugs approved for other uses may provide initial relief, but patients often fail to respond to them as the ascites worsens. With no medications approved by the FDA specifically for the treatment of ascites, an estimated 40% of patients die within two years of initial diagnosis. In addition to patient suffering, US medical costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause BioVie’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. BioVie has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are BioVie’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; and the risks that BioVie’s compounds may experience delays or difficulties in commencing or completing clinical studies, may not successfully complete pre-clinical or clinical testing, or may not be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in BioVie’s filings with the Securities and Exchange Commission under its former name. In addition to the risks described above and in BioVie’s filings with the SEC, other unknown or unpredictable factors also could affect BioVie’s results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on any forward-looking statements. BioVie undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation. BioVie cannot guarantee the approval of patents or Orphan-drug applications, nor the completion or success of its clinical trials.