SOURCE: BioVie Inc.

BioVie Inc (Ticker Symbol: BIVI)

August 29, 2017 08:00 ET

BioVie Reports Fiscal Year 2017 Financial Results and Clinical Development Progress

BEVERLY, MA--(Marketwired - August 29, 2017) - BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, today reported financial results for the fiscal year ended June 30, 2017, and summarized the Company's clinical and corporate development achievements over the past year.

"BioVie has achieved key milestones and significantly advanced the business plan," said CEO Jonathan Adams. "We will continue taking important steps toward BIV201 approval and commercialization and building company value for our shareholders." BioVie is an emerging leader in the development of drug therapies for ascites and other life-threatening complications of advanced liver cirrhosis. The market potential for a therapy that can address these serious unmet medical needs is substantial, potentially exceeding $1 billion.

The Company has received FDA clearance to begin a mid-stage (Phase 2a) clinical trial in the US administering BIV201 to patients with refractory ascites, and dosing of the first patient is very close. 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.

Clinical and Corporate Development Highlights:

  • Clinical: In November 2016, BioVie submitted an Investigational New Drug (IND) application for BIV201 for the treatment of refractory ascites due to liver cirrhosis. In March 2017, the Company received notification from the US FDA allowing it to commence a mid-stage (Phase 2a) clinical trial. In June, the Company received Institutional Review Board (IRB) approval to begin this trial at the McGuire Research Institute in Richmond, VA.
  • Intellectual Property: In September 2016, BIV201 was granted an Orphan-drug designation by the US Food and Drug Administration (FDA) for the treatment of ascites due to advanced liver cirrhosis. In May 2017, the Company announced the issuance of its core US patent covering BIV201 therapy for the treatment of ascites due to liver cirrhosis, providing Biovie with exclusivity in the US until 2036. Biovie also has patent applications pending in other major-market countries.
  • Financial: In August 2016, the Company changed its name from NanoAntibiotics, Inc. to BioVie Inc. and began trading under the ticker symbol "BIVI." In January 2017, the Company entered into a Common Stock Purchase Agreement with Aspire Capital Fund for up to $12 million. The Company expects to access this funding mechanism once additional milestones are achieved and stock liquidity increases. In March, BioVie up-listed to the OTCQB stock market.
  • Management Team and Directors: In August 2016, Dr. Patrick Yeramian joined BioVie to lead the BIV201 clinical development program. Over the next several months the Company strengthened its Board of Directors with the addition of the following healthcare executives: Mr. Jim Lang, former CEO of Decision Resources Group, Ms. Julie Anderson, former marketing director for Durata Therapeutics, and Dr. Hari Kumar, former CBO for Amira Pharmaceuticals and former CEO for Adheron Therapeutics. Durata, Amira, and Adheron were all successfully sold to large pharmaceutical companies.

Select Fiscal Year 2017 Financial Results

  • As of June 30, 2017, the Company had cash and cash equivalents of $5,140. Following the close of fiscal year 2017, the Company has raised a total of $0.2 million in an ongoing Series C financing round by selling common stock.
  • Net loss for the twelve months ended June 30, 2017 and June 30, 2016 was $1.3 million and $0.4 million, respectively. Basic and diluted net loss per share for the twelve months ended June 30, 2017 and June 30, 2016 was $0.01 and $0.00 respectively.
  • Total operating expenses for the twelve months ended June 30, 2017 and June 30, 2016 was $1.6 million and $0.4 million, respectively. This included research and development (R&D) expenses of $0.4 million and $0.0 million, respectively. The increase in R&D spending was due to the development of an Investigational New Drug (IND) application and preparations for the mid-stage (Phase 2a) clinical trial of the Company's lead drug candidate BIV201.

Financial Guidance

Based on the financing activities that occurred after June 30, 2017, BioVie expects that it will have sufficient cash to fund operations through the end of 2017 based on its current operating plan.

About BioVie Inc.
BioVie Inc. is a clinical-stage company pursuing the discovery, development, and commercialization of innovative drug therapies. The Company is currently focused on developing and commercializing BIV201, a novel approach to the treatment of ascites due to chronic liver cirrhosis. In March 2017, BioVie received notification from the FDA that it could initiate a Phase 2a US clinical trial. BIV201 has the potential to improve the health of thousands of patients suffering from life-threatening complications of liver cirrhosis due to hepatitis, NASH, and alcoholism. It has Orphan-drug designation and US patent protection for the most common of these complications, ascites, which represents a significant unmet medical need. The FDA has never approved any drug specifically for treating ascites. BioVie has applied for additional Orphan-drug designations for related diseases.

More information about the Company's planned Phase 2a clinical trial may be found at clinicaltrials.gov. For more information about BioVie and BIV201, 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 an estimated 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. With no medications approved by the FDA specifically for treating ascites, an estimated 40% of patients die within two years of diagnosis. Certain drugs approved for other uses may provide initial relief, but patients often fail to respond to them as ascites worsens. In addition to patient suffering, US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.

Forward-Looking Statements
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 issuance of patents on its applications in foreign counties nor the completion or success of its planned Phase 2a clinical trial.

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