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BioVie Overview Presentation

BioVie Receives FDA Clearance for Phase 2a Clinical Trial and Attains Patent Allowance, Satisfies Conditions to Commence Funding Under the $12m Aspire Agreement

BEVERLY, MA–(Marketwired – April 03, 2017) – BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, is pleased to announce that it has received notice from the US Food and Drug Administration (FDA) that the planned Phase 2a clinical trial of its new drug candidate BIV201 may be initiated. This was based on the Company’s Investigational New Drug Application (IND) to conduct a study in patients with refractory or intractable ascites due to advanced liver cirrhosis.

A second key milestone was achieved when BioVie was notified by the US Patent and Trademark Office (USPTO) that its application for a core patent covering the use of BIV201 to reduce ascites formation in ambulatory patients has been allowed. This application was based on proprietary ascites patient data provided by the Company’s medical advisor Paolo Angeli, MD, a leading global expert in this field, and licensed from the University of Padova, Italy, where he practices medicine. The US patent is expected to issue within 45 days at which time more details will be reported. The Company continues to pursue patent issuances in Japan, China, and possibly European and other countries.

Additionally, BioVie is pleased to announce that it has met all of the conditions needed to commence the previously announced $12 million common stock purchase agreement with Aspire Capital Fund, LLC. Any funding received under the Aspire agreement will help to support the start of the Phase 2a clinical trial mentioned above and be used for general corporate purposes.

“These represent three major advances for the Company and strongly support the BIV201 clinical development program,” commented BioVie CEO Jonathan Adams. “They’re the culmination of many months of effort by our IND and management teams. We are excited about taking the next steps as our compound enters the clinic. Although the primary focus will be on safety and pharmacokinetics, we are also hoping to see signs of disease improvement in severely ill ascites patients.”

The Phase 2a clinical trial will consist of a small number of patients in an open-label study at a single US-based medical center, and is expected to take about 8 months. Eligible patients will have cirrhosis with ascites requiring large-volume paracentesis who are refractory to or unable to tolerate diuretic therapy. Pending the outcome of this first study, BioVie plans to follow with a larger placebo-controlled Phase 2 study.

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 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. 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 40,000 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 completion or success of its planned Phase 2a clinical trial.

Julie G. Anderson Joins BioVie as Independent Director and Investor

BEVERLY, MA–(Marketwired – March 15, 2017) – BioVie Inc. (OTCQB: BIVI), a development-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, is pleased to announce the appointment of Julie G. Anderson as an independent member of the Company’s Board of Directors. Ms. Anderson brings an impressive experience base in the pharma/biotech industry to BioVie. She also invested personally in the Company.

Ms. Anderson most recently served Catheter Connections, Inc. as its Vice President of Marketing until the company was sold last month. Previously she was Senior Director of Marketing for Durata Therapeutics, Inc., playing a key role in helping build the infrastructure and commercialization plan necessary to launch the novel antibiotic Dalvance. The team’s efforts led to an acquisition of the company in 2014 by Actavis (now Allergan) in a deal valued at about $675 million.

Prior to Durata, Julie worked for Sanofi-Synthelabo, Inc., Bayer Pharmaceuticals, and G.D. Searle in various marketing leadership positions. She originally trained as a nurse and earned a Masters of Management at the J.L. Kellogg Graduate School of Management at Northwestern University. As a critical care nurse, Julie treated patients at risk of death due to complications caused by chronic liver cirrhosis, and deeply understands the unmet medical need targeted by BioVie.

“I’m looking forward to working with Julie again,” commented CEO Jonathan Adams. “Years ago I worked with her when she led global brand development for Celebrex at Searle. She has tremendous expertise in new drug and market development, underpinned by remarkable skills at devising and executing product commercialization strategies and programs. Combined with her first-hand experience in treating liver cirrhosis patients, she’s a perfect fit for helping BioVie advance BIV201 therapy.”

BioVie recently submitted a complete response to the U.S. Food and Drug Administration (FDA), addressing the issues identified in the Investigational New Drug Application (IND) clinical hold letter received by the Company in January. If notified by the FDA that clinical development of BIV201 may proceed, BioVie expects to commence a mid-stage (Phase 1b) clinical trial in US ascites patients in the next few months.

About BioVie Inc.
BioVie Inc. is a development-stage company pursuing the discovery, development, and commercialization of innovative drug therapies. The Company is currently focused on commercializing BIV201, a novel approach to the treatment of ascites due to chronic liver cirrhosis. In late 2016, BioVie submitted an investigational new drug (IND) application to the FDA for BIV201 and is awaiting clearance to begin a clinical trial program. This new drug candidate could potentially enter a mid-stage (Phase 1b) US clinical trial in the first half of 2017. 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 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. 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 40,000 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 assure that the FDA will accept the BIV201 IND filing.

BioVie Announces Uplisting to OTCQB Market

BEVERLY, MA–(Marketwired – March 06, 2017) – BioVie Inc. (OTCQB: BIVI), a development-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, announced today that its stock has commenced trading on the OTCQB market after successfully uplisting from the OTC Pink market.

OTCQB membership provides enhanced investor benefits including higher reporting standards, increased analyst coverage and access to news services, and more comprehensive compliance requirements. “We anticipate that trading on the OTCQB will raise BioVie visibility in the investment community and broaden our shareholder base,” commented CEO Jonathan Adams. “It’s an important step towards building BioVie into a larger company.”

BioVie recently submitted a complete response to the U.S. Food and Drug Administration (FDA), addressing the issues identified in the Investigational New Drug Application (IND) clinical hold letter received by the Company in January. If notified by the FDA that clinical development of BIV201 may proceed, BioVie expects to commence a mid-stage (Phase 1b) clinical trial in US ascites patients in the next few months.

About BioVie Inc.

BioVie Inc. is a development-stage company pursuing the discovery, development, and commercialization of innovative drug therapies. The Company is currently focused on commercializing BIV201, a novel approach to the treatment of ascites due to chronic liver cirrhosis. In late 2016, BioVie submitted an investigational new drug (IND) application to the FDA for BIV201 and is awaiting clearance to begin a clinical trial program. This new drug candidate could potentially enter a mid-stage (Phase 1b) US clinical trial in early 2017. 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 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. 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 40,000 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 assure that the FDA will accept the BIV201 IND filing.

BioVie Submits Additional Information to FDA for BIV201 Clinical Trial in Ascites Patients

BEVERLY, MA–(Marketwired – February 22, 2017) – BioVie Inc. (OTC PINK: BIVI), a development-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, announced today that it has submitted a complete response to the U.S. Food and Drug Administration (FDA) addressing the issues identified in the Investigational New Drug Application (IND) clinical hold letter received by BioVie last month.

“The FDA requested more information about the ambulatory pumps to be used in our clinical study. We have provided this information and conducted 3 bench studies, all with supportive results. Additionally, we incorporated the Agency’s suggestions to improve the quality of our planned clinical study,” commented CEO Jonathan Adams. “I also want to thank our talented IND team and research partners for their fast work in completing this response.”

If notified by the FDA that the trial may proceed, BioVie plans to commence a mid-stage (Phase 1b) clinical trial of BIV201 in patients with refractory ascites due to advanced liver cirrhosis. BIV201 has the potential to become the first drug ever approved by the FDA specifically to treat ascites, a life-threatening medical condition. This innovative new drug candidate was granted Orphan Drug designation by the FDA last September.

About Liver Cirrhosis and Ascites
More than 600,000 American adults and millions worldwide suffer from liver cirrhosis. Cirrhosis is the 12th leading cause of death in the US, killing an estimated 40,000 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.

About BioVie Inc.
BioVie Inc. is a development-stage company pursuing the discovery, development and commercialization of innovative drug therapies for liver disease. The Company is currently focused on commercializing BIV201, a novel approach to the treatment of ascites due to liver cirrhosis. In November 2016 the Company submitted an investigational new drug (IND) application. After acceptance of the IND filing by the FDA, the Company’s new drug candidate could potentially begin a mid-stage (Phase 1b) clinical trial in US patients in the first half of 2017. 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. This new drug candidate has Orphan Drug designation for the most common of these complications, ascites, which represents a significant unmet medical need. The FDA has never approved any drugs specifically for treating ascites. For more information about BioVie and BIV201, please visit our website www.biovieinc.com.

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 assure that the FDA will accept the BIV201 IND filing.

BioVie Enters Into A $12 Million Common Stock Purchase Agreement With Aspire Capital Fund

BEVERLY, MA–(Marketwired – January 05, 2017) – BioVie Inc. (OTC PINK: BIVI), a development-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, is pleased to announce the completion of a Common Stock Purchase Agreement with Aspire Capital Fund, LLC, a Chicago-based institutional investor, to purchase up to $12 million of BioVie common stock over a 30-month period. Upon entering into the Agreement, Aspire made an initial purchase $200,000 of BioVie’s common stock at $0.20 per share and received warrants to purchase an additional 500,000 shares at a $0.50 exercise price within five years. After a registration statement related to the transaction has been filed and declared effective by the U.S. Securities and Exchange Commission, BioVie will have the right to sell up to $11.8 million of additional common stock to Aspire over a 30-month period at the prevailing market prices at the time of each sale. By controlling the timing of each sale, BioVie will have the opportunity to raise capital efficiently while reducing shareholder dilution.
Proceeds from Aspire under the Agreement will be used by BioVie to pay for general corporate purposes, including preparing for the BIV201 clinical trial expected to begin this spring. BioVie recently received comments from the US Food and Drug Administration on its IND application and believes such comments can be addressed reasonably soon in 2017.
“This Agreement creates access to funding for critically important activities relating to our new drug candidate BIV201,” said Jonathan Adams, BioVie’s CEO. “It will accelerate the path to clinical studies required for FDA approval. We believe that BIV201 will become an important new therapeutic option for liver cirrhosis patients and their health care providers. We are pleased that the Aspire team has recognized this opportunity, and welcome them as a significant shareholder of the Company.”
Steven G. Martin, Managing Member of Aspire Capital, commented: “We have been following Mr. Adams’ work on BIV201 for some time now and are very pleased with the Company’s recent regulatory progress. We recognize the urgent need for a novel treatment for ascites, which we know to be predictive of poor outcomes in patients with liver cirrhosis, and are confident in BIV201 as a potential solution. Given the available efficacy data generated by independent investigators thus far and the widespread familiarity and usage of the active compound throughout Europe, we believe BIV201 is well positioned for clinical and regulatory success in the US. We are excited to enter this initial agreement with BioVie. We hope to provide BioVie with additional financial support as necessary and appropriate.”
Under the Agreement, Aspire has no rights to require any sales of shares at any time. The Agreement does not limit BioVie on the use of any of the proceeds. The Agreement does not contain any financial covenants, restrictions on future financings, rights of first refusal, participation rights or penalties whatsoever. BioVie can terminate the Agreement at any time without any cost or penalty.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.
A complete and detailed description of the Agreement and related registration rights agreement is set forth in the Company’s Current Report on Form 8-K, filed today with the SEC.
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 27,000 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.
About BioVie Inc.
BioVie Inc. is a development-stage company pursuing the discovery, development and commercialization of innovative drug therapies for liver disease. The Company is currently focused on commercializing BIV201, a novel approach to the treatment of ascites due to liver cirrhosis. In November 2016 the Company submitted an investigational new drug (IND) application. After acceptance of the IND filing by the FDA, the Company’s new drug candidate could potentially begin a mid-stage (Phase 1b) clinical trial in US patients in the first half of 2017.
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. This new drug candidate has Orphan Drug designation for the most common of these complications, ascites, which represents a significant unmet medical need. The FDA has never approved any drugs specifically for treating ascites. For more information about BioVie and BIV201, please visit our website www.biovieinc.com.
About Aspire Capital Fund, LLC
Aspire Capital takes a fundamental investment approach and invests in a wide range of companies and industries emphasizing life sciences, energy and technology.
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 assure that the FDA will accept the BIV201 IND filing.

Accomplished Healthcare Executive Jim Lang Invests and Joins BioVie’s Board of Directors

BEVERLY, MA–(Marketwired – December 07, 2016) – BioVie Inc. (OTC PINK: BIVI), a development-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, is pleased to announce the appointment of Mr. James Lang as an independent member of the Company’s Board of Directors. Mr. Lang is an active investor in emerging healthcare companies, and recently invested in BioVie.

Mr. Lang was formerly the Chief Executive Officer of Decision Resources Group (DRG), a leading healthcare research and consulting company. During his tenure there, Mr. Lang helped to transform the company into an industry leader, achieving robust revenue and profit growth. Previously Mr. Lang was the CEO of Strategic Decisions Group, a premier global strategy consultancy, where he expanded the life sciences practice and later sold it to IMS Health. He brings a highly relevant experience base, having invested in and guided the development of multiple early-stage healthcare companies including Boston Heart Diagnostics, which sold for $140 million, and AlphalmpactRx, which sold to IMS health earlier this year.

“Jim is an exceptionally talented businessman with a track record of building successful companies,” said Jonathan Adams, BioVie CEO. “He is also enthusiastic about our new drug candidate BIV201, for which we recently submitted an IND application to begin clinical trials.” Mr. Lang commented: “This is an exciting opportunity at this time, and the company is targeting an attractive and underserved space. I’ve known Jonathan and [BioVie board member] Cuong Do for many years, and I’m very confident in their capabilities.”

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. This new drug candidate has Orphan Drug designation for the most common of these complications, ascites, which represents a significant unmet medical need. The FDA has never approved any drugs specifically to treat this condition.

BioVie submitted an Investigational New Drug (IND) application to the FDA for its lead therapeutic candidate BIV201 in November, 2016. The Company anticipates commencing a mid-stage (Phase 1b) clinical trial in US ascites patients in early 2017. 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 27,000 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.

About BioVie Inc.
BioVie Inc. is a development-stage company pursuing the discovery, development and commercialization of innovative drug therapies for liver disease. The Company is currently focused on commercializing BIV201, a novel approach to the treatment of ascites due to liver cirrhosis. In November 2016 the Company submitted an investigational new drug (IND) application. After acceptance of the IND filing by the FDA, the Company’s new drug candidate could potentially begin a mid-stage (Phase 1b) clinical trial in US patients in early 2017.

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 assure that the FDA will accept the BIV201 IND filing.

BioVie Submits Investigational New Drug Application for BIV201 for Treating Refractory Ascites due to Liver Cirrhosis

Anticipates Initiation of US Clinical Trial in 2017

BEVERLY, MA–(Marketwired – November 29, 2016) – BioVie Inc. (OTC PINK: BIVI), a development-stage company focused on the discovery, development and commercialization of innovative drug therapies in liver disease, today announced the submission of an Investigational New Drug (IND) application for new drug candidate BIV201 to the US Food and Drug Administration (FDA). BIV201 has the potential to become the first drug approved by the FDA to treat ascites due to chronic liver cirrhosis, a life-threatening medical condition.

“Filing the IND represents a major milestone for BioVie,” commented CEO Jonathan Adams, “and is the culmination of many months of effort by our clinical development team. We are pleased to have completed this goal on schedule, and look forward to working with the FDA to advance BIV201 therapy.” The IND also involved a substantial investment of resources in formulation testing and to develop a proprietary bioanalytical methodology. The active agent in BIV201 has been investigated in humans with complications of liver cirrhosis in more than 40 studies outside the US.

BIV201 is designed to target ascites at its mechanistic source and improve effective blood volume, thereby interrupting the process of ascites fluid generation. This novel therapeutic approach was granted Orphan Drug designation by the FDA in September. Ascites affects approximately 100,000 Americans. US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.

Once notified by the FDA that the trial may proceed, BioVie plans to commence a mid-stage (Phase 1b) clinical trial in US ascites patients in 2017. For more information about BioVie and BIV201, please visit our website www.biovieinc.com.

About Liver Cirrhosis and Ascites

About one million 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 27,000 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.

About BioVie, Inc.

BioVie Inc. is a development-stage company pursuing the discovery, development and commercialization of innovative drug therapies focused in liver disease. The Company is currently focused on commercializing BIV201, a novel approach to the treatment of ascites due to liver cirrhosis. In late 2016 the Company submitted an investigational new drug (IND) application. After acceptance of the IND filing by the FDA, the Company’s new drug candidate could potentially begin a mid-stage (Phase 1b) clinical trial in US patients in early 2017.

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 assure that the FDA will accept the BIV201 IND filing.

BioVie Updates on Link Between NASH, Liver Cirrhosis, and Ascites

BEVERLY, MA–(Marketwired – September 22, 2016) – BioVie Inc. (OTC PINK: BIVI) (the “Company”), a development-stage company focused on the discovery, development, and commercialization of innovative drug therapies, announced that its scientific team has completed an assessment of the link between nonalcoholic steatohepatitis (NASH), chronic liver cirrhosis, and ascites. The Company’s new drug therapy BIV201 targets ascites, a common complication of liver cirrhosis.

The number of Americans afflicted with NASH due to fatty liver disease has skyrocketed to an estimated 16 to 30 million due to the obesity epidemic. With no FDA-approved therapy to halt progression of the disease, there is a significant unmet medical need for the estimated 1.3 million who will progress to advanced liver cirrhosis and its complications. According to a 2015 study by Wong et al., NASH is now the second-leading cause of liver disease among US adults awaiting liver transplantation, and is expected to become the leading cause within ten years. Additionally, patients with liver cirrhosis due to NASH, who are on the liver transplant waiting list, appear to have the lowest probability of survival compared to those having cirrhosis due to other causes.

Serious medical complications often occur in patients with advanced liver cirrhosis, the most common being the development of ascites, or fluid accumulation in the abdomen, a major contributor to patient mortality. BioVie is developing BIV201 as a new drug candidate for ascites due to liver cirrhosis as a result of NASH and other causes. Currently no drugs are available with a specific FDA approval for treating ascites.

BioVie CEO Jonathan Adams commented: “We are seeing impressive therapeutic advances in NASH, which is very gratifying. But it’s important to keep in mind the many patients who progress to advanced liver cirrhosis and suffer miserably as a result. The progression of liver cirrhosis should be viewed as a continuum, and effective therapeutic interventions are needed at every stage.”

For more information about BioVie and BIV201, please visit our website www.biovieinc.com.

About Liver Cirrhosis and Ascites

About one million 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 27,000 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 may fail to respond to treatment as ascites worsens. This unfavorable prognosis represents a critical unmet medical need. US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.

About BioVie (formerly NanoAntibiotics)
BioVie Inc. is a development-stage company pursuing the discovery, development, and commercialization of innovative drug therapies. The Company is currently focused on commercializing BIV201, a novel approach to the treatment of ascites due to liver cirrhosis. In early 2016 the Company held a pre-investigational new drug (“pre-IND”) meeting with the FDA, which provided guidance for an IND submission. The Company’s new drug candidate could potentially commence a mid-stage (Phase 1b) US clinical trial in 2017.

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’s Lead Compound BIV201 Receives FDA Orphan-Drug Designation for the Treatment of Ascites

BEVERLY, MA–(Marketwired – September 09, 2016) – BioVie Inc. (OTC PINK: BIVI) (the “Company”), a development-stage company focused on the discovery, development, and commercialization of innovative drug therapies, announced today that the Food and Drug Administration’s Office of Orphan Products Development has granted orphan-drug designation for BIV201 for the treatment of ascites due to all etiologies except cancer. BIV201 is the Company’s new drug candidate being developed for ascites due to chronic liver cirrhosis.

“Orphan-drug designation represents a major milestone supporting the clinical development and eventual commercialization of BIV201 therapy. It recognizes the importance of pioneering a new therapeutic approach for this relatively small group of desperately ill patients,” commented Jonathan Adams, BioVie CEO. “Additionally, it can help to accelerate our clinical development program, opens the door to special funding opportunities and tax credits, and could provide seven years of market exclusivity.”

BioVie’s clinical development team, comprised of five highly experienced pharmaceutical industry veterans and advised by worldwide leaders in liver disease, is currently focused on completing an investigational new drug (IND) application for BIV201. If accepted by the FDA, our new drug candidate could commence a US clinical trial in 2017. Once this goal is accomplished, BioVie will begin to explore other potential applications for BIV201 therapy. The active ingredient in BIV201 is a potent vasoconstrictor and this mechanism of action yields the potential to treat an array of life-threatening diseases, including type 1 hepatorenal syndrome (HRS), esophageal variceal bleeds, and sepsis.

For more information, please visit our website www.biovieinc.com.

About Liver Cirrhosis and Ascites

About one million 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 27,000 people each year. The condition results primarily from hepatitis, alcoholism, and fatty liver disease linked to 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 may fail to respond to treatment as ascites worsens. This unfavorable prognosis represents a critical unmet medical need. US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.

About BioVie (formerly NanoAntibiotics)

BioVie Inc. is a development-stage company pursuing the discovery, development, and commercialization of innovative drug therapies. The Company is currently focused on commercializing BIV201, a novel approach to the treatment of ascites due to liver cirrhosis. In early 2016 the Company held a pre-investigational new drug (“pre-IND”) meeting with the FDA, which provided guidance for an IND submission. The Company’s new drug candidate could potentially commence US clinical trials as early as 2017.

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.

NanoAntibiotics Changes Name to BioVie (OTC PINK: BIVI) and Welcomes Dr. Patrick Yeramian to Clinical Team

BEVERLY, MA–(Marketwired – August 22, 2016) – BioVie Inc. (OTC PINK: BIVI) (the “Company,” formerly NanoAntibiotics, Inc.), a development-stage company focused on the discovery, development, and commercialization of innovative drug therapies, announced today that shareholders have approved changing the company name to BioVie Inc. The Company’s stock will now trade under the symbol “BIVI.” More information is available at www.biovieinc.com.

BioVie also welcomed Dr. Patrick Yeramian as consultant Medical Director to guide the clinical development program for the Company’s new drug candidate, BIV201. This novel therapeutic is based on proprietary CIPT Technology and is being developed to treat ascites due to liver cirrhosis, a life-threatening condition. “Dr. Yeramian’s broad experience, proven track record, and professional connections make him a great addition to our team. He has already made important contributions to our investigational new drug (IND) application which is progressing ahead of schedule. His expertise will be invaluable for clinical trial execution,” commented CEO Jonathan Adams.

Prior to joining the BioVie team, Dr. Yeramian worked with the Company’s regulatory expert, Stacy Suberg, Ph.D. “I’ve worked with Stacy on successful clinical trials in the past. I look forward to working with her again, and the other members of the BioVie team. The therapeutic concept behind BIV201 is based on compelling data, which spurred my interest in the clinical program,” commented Dr. Yeramian.

Dr. Yeramian brings three decades of experience in research and drug and medical device development to BioVie’s management team. He has served as a medical director for multiple organizations including Searle Pharmaceuticals (now Pfizer), the Vaccine and Gene Therapy Institute of Florida, and TapImmune Inc. During his career, he has helped companies secure over $25 million in grants and awards, filed more than 20 investigational new drug and device applications (INDs/CTX/CTAs), and won regulatory approvals for five new drugs and devices.

BioVie’s immediate goal for BIV201 is to commence a clinical trial as early as 2017, contingent on FDA acceptance of an Investigational New Drug (“IND”) application, which is currently in development. For more information, please visit our website www.biovieinc.com.

About Liver Cirrhosis and Ascites

About one million 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 27,000 people each year. The condition results primarily from hepatitis, alcoholism, and fatty liver disease linked to 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 may fail to respond to treatment as ascites worsens. This unfavorable prognosis represents a critical unmet medical need. US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.

About BioVie (formerly NanoAntibiotics)

BioVie Inc. is a development-stage company pursuing the discovery, development, and commercialization of innovative drug therapies. The Company is currently focused on commercializing BIV201, a novel approach to the treatment of ascites due to liver cirrhosis. In early 2016 the Company held a pre-investigational new drug (“pre-IND”) meeting with the FDA, which provided guidance for an IND submission. The Company’s new drug candidate could potentially commence US clinical trials as early as 2017.

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.

NanoAntibiotics (BioVie) Files Global Patent Applications Covering CIPT Technology

July 07, 2016 11:00 ET
BEVERLY, MA–(Marketwired – July 07, 2016) – NanoAntibiotics, Inc. (OTC PINK: NNAB) (the “Company,” soon to be known as BioVie Inc.), a development stage company focused on the discovery, development, and commercialization of innovative drug therapies, announced today the filing of US, Japanese and international (PCT) patent applications. The applications aim to achieve patent protection for the Company’s novel CIPT Technology being developed for the treatment of ascites due to liver cirrhosis. The PCT filing is an important step towards safeguarding the technology in Europe and potentially other countries.

The FDA has never approved any drugs specifically for the treatment of ascites, and CIPT Technology offers the potential for a new therapeutic option for patients with this life-threatening condition. “This is an important component of our plan to develop a unique and proprietary new therapy for ascites, and ultimately improve patient care at home and abroad,” commented Jonathan Adams, CEO of the Company.

The Company collaborated with its Italian advisor, Professor Paolo Angeli of the University of Padova, to generate data supporting the patent claims. Dr. Angeli is Head of the Unit of Hepatic Emergencies and Liver Transplantation at the University, and is a frequent speaker and widely published expert on liver disease. Penny Markham PhD, the Company’s Chief Scientific Officer, also made important contributions to the applications.

NanoAntibiotics (BioVie) recently launched a new website, www.nanoantibiotics.com. The Company’s goal is to commence a clinical trial program as early as 2017 upon FDA acceptance of an Investigational New Drug (“IND”) application, currently in development.

About Liver Cirrhosis and Ascites
About 1 million 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 27,000 people each year. The condition results primarily from hepatitis, alcoholism, and fatty liver disease linked to obesity. Ascites is a common complication of advanced liver cirrhosis, involving kidney dysfunction and the accumulation of large amounts of fluid in the abdominal cavity. 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 may fail to respond to treatment as ascites worsens. This represents a critical unmet medical need. US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.

About NanoAntibiotics (BioVie)
NanoAntibiotics, Inc. (soon to be known as BioVie Inc.) is a development stage company pursuing the discovery, development, and commercialization of innovative drug therapies. The Company is currently focused on commercializing CIPT Technology, a novel approach to the treatment of ascites due to liver cirrhosis. In early 2016 the Company held a pre-investigational new drug (“pre-IND”) meeting with the FDA, which provided guidance for an IND submission. The Company’s new drug candidate could potentially commence US clinical trials as early as 2017.

Forward-Looking Statements
The Company’s patent applications are subject to regulatory risks and may never be approved. 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 NanoAntibiotics’ actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. NanoAntibiotics 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 NanoAntibiotics’ need for, and the availability of, substantial capital in the future to fund its operations and research and development. The fact that NanoAntibiotics’ compounds may not successfully complete pre-clinical or clinical testing, or 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 NanoAntibiotics’ filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. NanoAntibiotics 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.

 

Samsung Executive Cuong Do Joins the Company as Independent Board Member

May 03, 2016 12:00 ET
Samsung Executive Cuong Do Joins the Company as Independent Board Member
BEVERLY, MA–(Marketwired – May 03, 2016) – NanoAntibiotics, Inc. (OTCQB: NNAB) (the “Company,” soon to be known as BioVie Inc.), a development stage company focused on the discovery, development, and commercialization of innovative drug therapies, announced today the appointment of Cuong Do, MBA, as an independent member of the Company’s Board of Directors. Mr. Do is currently Executive Vice President, Global Strategy Group for Samsung, where he helps to set the strategic direction for Samsung Group’s diverse business portfolio.
As the former Chief Strategy Officer for Merck, a leading US pharmaceuticals company, and having successfully built and sold a biotechnology company, Mr. Do brings highly relevant experience to NanoAntibiotics (BioVie). Prior to Merck he was a senior partner at McKinsey & Company, where over 17 years he helped build the healthcare, high tech and corporate finance practices. Mr. Do holds an MBA from the Tuck School of Business at Dartmouth.
“Cuong is very impressive, as evident years ago when we attended business school together and more recently when he acted as an advisor and investor in LAT Pharma LLC (recently acquired by NanoAntibiotics). He brings remarkable business acumen and corporate strategy expertise to the Company,” commented Jonathan Adams, MBA, CEO of the Company. “Cuong is committed to advancing our CIP Terlipressin Technology for the benefit of desperately ill patients, and to creating substantial value for our shareholders.”
The Company’s goal is to commence a clinical trial program as early as 2017 upon FDA acceptance of an Investigational New Drug (“IND”) application, currently being developed.

About Liver Cirrhosis and Ascites
About 1 million 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 27,000 people each year. The condition results primarily from hepatitis, alcoholism, and fatty liver disease linked to obesity.
Ascites is a common complication of advanced liver cirrhosis, involving kidney dysfunction and the accumulation of large amounts of fluid in the abdominal cavity. With no medications approved by the FDA specifically for treating ascites, the prognosis for these patients is very poor, with an estimated 40% of patients dying within two years of diagnosis. Life-threatening complications of ascites include infection, sepsis, and circulatory dysfunction. Certain drugs approved for other uses may provide relief in the initial stages, but as ascites worsens, patients may fail to respond to drug therapy. This represents a critical unmet medical need. US treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.
About NanoAntibiotics (BioVie)
NanoAntibiotics, Inc. (soon to be known as BioVie Inc.) is a development stage company pursuing the discovery, development, and commercialization of innovative drug therapies. The Co pany is currently focused on commercializing CIP Terlipressin Technology, a novel approach to the treatment of ascites due to liver cirrhosis, acquired through the acquisition of LAT Pharma LLC. In early 2016 the Company held a pre-investigational new drug (“pre-IND”) meeting with the FDA, which provided guidance for an IND submission. The Company’s new drug candidate could potentially commence US clinical trials as early as 2017. Additionally, NanoAntibiotics has a collaboration with PharmaIN Corporation (Bothell, WA) to develop novel compounds targeting severe complications of liver disease.
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 NanoAntibiotics’ actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. NanoAntiobiotics 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 NanoAntibiotics’ need for, and the availability of, substantial capital in the future to fund its operations and research and development. The fact that NanoAntibiotics’ compounds may not successfully complete pre-clinical or clinical testing, or 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 NanoAntibiotics’ filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. NanoAntibiotics 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.