0001520138-19-000474.txt : 20191119 0001520138-19-000474.hdr.sgml : 20191119 20191119153536 ACCESSION NUMBER: 0001520138-19-000474 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 44 CONFORMED PERIOD OF REPORT: 20190930 FILED AS OF DATE: 20191119 DATE AS OF CHANGE: 20191119 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOVIE INC. CENTRAL INDEX KEY: 0001580149 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 462510769 STATE OF INCORPORATION: NV FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-39015 FILM NUMBER: 191231015 BUSINESS ADDRESS: STREET 1: 2120 COLORADO AVE. STREET 2: SUITE 230 CITY: LOS ANGELES STATE: CA ZIP: 90404 BUSINESS PHONE: 310-444-4300 MAIL ADDRESS: STREET 1: 2120 COLORADO AVE. STREET 2: SUITE 230 CITY: LOS ANGELES STATE: CA ZIP: 90404 FORMER COMPANY: FORMER CONFORMED NAME: NANOANTIBIOTICS, INC. DATE OF NAME CHANGE: 20130625 10-Q 1 bivi-20190930_10q.htm FORM 10-Q FOR PERIOD ENDING SEPT 30, 2019
 
 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

Form 10-Q

(Mark One) 

  QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended: September 30, 2019

  TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ____________to _____________

Commission File Number: 001-39015

BIOVIE INC.

(Exact name of registrant as specified in its charter)

Nevada   46-2510769
(State or other jurisdiction of 
incorporation or organization)
  (I.R.S. Empl. Ident. No.)

 

2120 Colorado Avenue Suite 230

Santa Monica, CA 90404

(Address of principal executive offices, Zip Code)
 

(310)-444-4300

(Registrant's telephone number, including area code)
 
(Former Name, Former Address and Former Fiscal Year if Changed Since Last Report)

   

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

 

Yes                                           No

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

 

Yes                                           No

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company or emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

  

Large accelerated filer   Accelerated filer  

Non-accelerated filer

  Smaller reporting company  
    Emerging growth company  

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act 

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

 

Yes                                           No

 

There were 647,930,147 shares of the Registrant’s $0.0001 par value Class A common stock outstanding as of November 18, 2019.

 
 
 
 

TABLE OF CONTENTS

 

PART I – FINANCIAL INFORMATION

 

Item 1. Financial Statements 1
  Condensed Balance Sheets at September 30, 2019 (unaudited) and June 30, 2019 1
  Condensed Statements of Operations (unaudited) - for the three months ended September 30, 2019 and 2018 2
  Condensed Statements of Cash Flows (unaudited) - for the three months ended September 30, 2019 and 2018 3
  Condensed Statements of Changes in Stockholders’ (Deficit) Equity (unaudited) - for the three months ended September 30, 2018 and 2019 4
  Notes to Unaudited Condensed Financial Statements 5
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 17
Item 3. Quantitative and Qualitative Disclosures About Market Risk 20
Item 4. Controls and Procedures 20

 

PART II – OTHER INFORMATION

 

Item 1. Legal Proceedings 21
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 21
Item 3. Defaults Upon Senior Securities 21
Item 4. Mine Safety Disclosures   21
Item 5. Other Information   21
Item 6. Exhibits 22
     
SIGNATURES 23

 

FORWARD-LOOKING STATEMENTS

 

This report contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, and Section 27A of the Securities Act of 1933. Any statements contained in this report that are not statements of historical fact may be forward-looking statements. When we use the words “intends,” “estimates,” “predicts,” “potential,” “continues,” “anticipates,” “plans,” “expects,” “believes,” “should,” “could,” “may,” “will” or the negative of these terms or other comparable terminology, we are identifying forward-looking statements. Forward-looking statements involve risks and uncertainties, which may cause our actual results, performance or achievements to be materially different from those expressed or implied by forward-looking statements. These factors include our research and development activities, distributor channel; compliance with regulatory impositions; and our capital needs. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

 

Except as may be required by applicable law, we do not undertake or intend to update or revise our forward-looking statements, and we assume no obligation to update any forward-looking statements contained in this report as a result of new information or future events or developments. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. You should carefully review and consider the various disclosures we make in this report and our other reports filed with the Securities and Exchange Commission that attempt to advise interested parties of the risks, uncertainties and other factors that may affect our business.

 

All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The Company assumes no obligation and does not intend to update these forward-looking statements, except as required by law. When used in this report, the terms “BioVie”, “Company”, “we”, “our”, and “us” refer to BioVie Inc.

 

 
 

PART I – FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

BioVie Inc.

Condensed Balance Sheets

 

   September 30,  June 30,
   2019  2019
ASSETS  (Unaudited)   
       
CURRENT ASSETS:          
Cash  $249,009   $339,923 
Other assets   516,379    334,150 
Total current assets   765,388    674,073 
           
OTHER  ASSETS:          
Intangible assets, net   1,497,259    1,554,603 
Goodwill   345,711    345,711 
Total other assets   1,842,970    1,900,314 
           
TOTAL ASSETS  $2,608,358   $2,574,387 
           
LIABILITIES AND STOCKHOLDERS' EQUITY          
           
CURRENT LIABILITIES:          
Accounts payable and accrued expenses  $684,060   $443,480 
Derivative liability - warrants   8,109,724    —   
Derivative liability - conversion option on convertible debenture   2,533,668    —   
Convertible debenture - related party, net of discount $498,466 and $0 at September 30, 2019 and 2018, respectively   1,534    —   
Total current liabilities   11,328,986    443,480 
           
Commitments and contingencies (Note 8)          
           
STOCKHOLDERS' (DEFICIT) EQUITY          
           
Preferred stock; $0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding   —      —   
Common stock, $0.0001 par value; 800,000,000 shares authorized at September 30, 2019 and June 30, 2019, respectively; 647,930,147 and 507,305,147 shares issued and outstanding at September 30, 2019 and June 30, 2019, respectively   64,793    50,730 
Additional paid in capital   19,396,936    9,342,249 
Accumulated deficit   (28,182,357)   (7,262,072)
Total stockholders' (deficit) equity   (8,720,628)   2,130,907 
           
TOTAL LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY  $2,608,358   $2,574,387 

See accompanying notes to unaudited condensed financial statements

 -1-

BioVie Inc.

Condensed Statements of Operations

(Unaudited)

 

   Three Months Ended
   September 30, 2019  September 30, 2018
OPERATING EXPENSES:          
Amortization  $57,344   $57,344 
Research and development expenses   341,501    194,521 
Selling, general and administrative expenses   307,373    239,562 
TOTAL OPERATING EXPENSES   706,218    491,427 
           
LOSS FROM OPERATIONS   (706,218)   (491,427)
           
OTHER EXPENSE (INCOME):          
Change in fair value of derivative liabilities   (362,586)   —   
Gain on settlement of debt   —      (51,400)
Interest expense   3,477,615    272 
Interest income   (20)   (428)
TOTAL OTHER EXPENSE (INCOME), NET   3,115,009    (51,556)
           
           
NET LOSS  $(3,821,227)  $(439,871)
           
Deemed dividends for commitment shares and rachet adjustments   17,099,058    48,659 
           
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS  $(20,920,285)  $(488,530)
           
NET LOSS PER COMMON SHARE - BASIC AND DILUTED  $(0.04)  $(0.00)
           
WEIGHTED AVERAGE NUMBER OF          
COMMON  SHARES OUTSTANDING - BASIC AND DILUTED   516,577,125    309,279,009 

See accompanying notes to unaudited condensed financial statements

 -2-

BioVie Inc.

Condensed Statements of Cash Flows

(Unaudited)

   Three Months Ended
   September 30, 2019  September 30, 2018
       
CASH FLOWS FROM OPERATING ACTIVITIES:          
Net loss  $(3,821,227)  $(439,871)
Adjustments to reconcile net loss to net cash to cash used in operating activities:          
Amortization of intangible assets   57,344    57,344 
Stock based compensation expense   —      3,412 
Interest expense from convertible debenture   3,477,204    —   
Change in fair value of derivative liabilities   (362,586)   —   
Changes in operating assets and liabilities          
Other assets   (182,229)   —   
Accounts payable and accrued expenses   240,580    (62,767)
Net cash used in operating activities   (590,914)   (441,882)
           
CASH FLOWS FROM FINANCING ACTIVITIES:          
Repayment of debt   —      (508,300)
Proceeds from issuance of preferred shares   —      3,040,000 
Proceeds from convertible debenture - related party   500,000      
Net cash provided by financing activities   500,000    2,531,700 
           
Net (decrease) increase in cash   (90,914)   2,089,818 
           
Cash, beginning of period   339,923    45,800 
           
Cash, end of period  $249,009   $2,135,619 
           
SUPPLEMENTAL CASH FLOW INFORMATION:          
  Cash paid for interest  $411   $—   
  Cash paid for taxes  $—     $—   
           
SCHEDULE OF NON-CASH FINANCING ACTIVITIES:          
   Conversion of preferred shares to common stock  $—     $3,200,000 
   Settlement of debt by issuance of common stock and forgiveness of debt  $—     $1,150,135 
   Cashless exercise of warrants  $—     $224 
   Deemed dividends for ratchet adjustments to warrants  $—     $48,659 
   Deemed dividends for commitment shares  $17,099,058    —   
   Stock warrants classified as derivative liability  $7,530,308    —   

See accompanying notes to unaudited condensed financial statements

 -3-

BioVie Inc.

Condensed Statements of Changes in Stockholders’ (Deficit) Equity

For the Three Months Ended September 30, 2018 and 2019

(Unaudited)

           Additional    

Total

Stockholders’

   Preferred Stock  Common Stock  Paid in  Accumulated  Equity
   Shares  Amount  Shares  Amount  Capital  Deficit  (Deficit)
Balance, June 30, 2018   —     $—      98,503,199   $9,850   $4,870,474   $(4,769,126)  $111,199 
                                    
Issuance of preferred stock in a private placement   2,133,332    3,200,000    —      —      3,200,000    —      3,200,000 
                                    
Conversion of preferred stock to common stock   (2,133,332)   (3,200,000)   213,333,200    21,333    (21,333)   —      —   
                                    
Issuance of shares in exchange for debt settlement   —      —      975,361    98    1,150,037    —      1,150,135 
                                    
Stock option compensation   —      —      —      —      3,412    —      3,412 
                                    
Cashless exercise of warrants   —      —      2,241,913    224    (224)   —      —   
                                    
Deemed dividends for ratchet adjustment to warrants   —      —      —      —      48,659    (48,659)   —   
                                    
Net loss   —      —      —      —      —      (439,871)   (439,871)
                                    
Balance, September 30, 2018   —     $—      315,053,673   $31,505   $9,251,025   $(5,257,655)  $4,024,876 
                                    
                                    
Balance June 30, 2019   —     $—      507,305,147   $50,730   $9,342,249   $(7,262,072)  $2,130,907 
                                    
Issuance of commitment shares   —      —      140,625,000    14,063    10,054,687    —      10,068,750 
                                    
Deemed dividend for commitment shares   —      —      —      —      —      (17,099,058)   (17,099,058)
                                    
Net loss   —      —      —      —      —      (3,821,227)   (3,821,227)
                                    
Balance, September 30, 2019   —     $—      647,930,147   $64,793   $19,396,936   $(28,182,357)  $(8,720,628)

See accompanying notes to unaudited condensed financial statements

 -4-

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three Months Ended September 30, 2019 and 2018

(unaudited)

 

1. Background Information

 

BioVie Inc. (the “Company”) is a clinical-stage company pursuing the discovery, development, and commercialization of innovative drug therapies. We are currently focused on developing and commercializing BIV201 (continuous infusion terlipressin), a novel approach to the treatment of ascites due to chronic liver cirrhosis. Our therapy BIV201 is based on a drug that is approved in about 40 countries to treat related complications of liver cirrhosis (part of the same disease pathway as ascites), but not yet available in the United States. BIV201’s active agent is a potent vasoconstrictor and has shown efficacy for reducing portal hypertension in studies around the world. The goal is for BIV201 to interrupt the ascites disease pathway, thereby halting the cycle of accelerating fluid generation in ascites patients.

BioVie began administering BIV201 to patients in a Phase 2a clinical trial in patients with refractory ascites due to advanced liver cirrhosis at the McGuire Research Institute Inc. in Richmond, VA in September 2017. In April 2019, we announced top-line results and in June met with representatives of the FDA for a Type C Guidance Meeting to discuss the study results and plan our next clinical study. In July 2019, the FDA provided meeting minutes that documented general agreement with the Company’s proposed randomized and controlled study design. The FDA also provided its suggestions and guidance regarding primary and secondary endpoints, quality of life measures and other key aspects of the clinical trial design. In October 2019, BioVie announced the submission of a Phase 2b/3 clinical trial protocol to the FDA. We are developing a patent-pending novel liquid formulation of terlipressin for use in this study that is intended to improve convenience for outpatient administration and avoid potential formulation errors that may occur when pharmacists reconstitute the powder version.

BIV201 has the potential to improve the health of thousands of patients suffering from life-threatening complications of liver cirrhosis due to hepatitis, nonalcoholic steatohepatitis (NASH), and alcoholism. It has FDA Fast-Track status and Orphan Drug designation for the most common of these complications, ascites, which represents a significant unmet medical need. An Orphan drug that is first-to-market typically receives 7 years of market exclusivity in the United States for the designated use(s). The FDA has never approved any drug specifically for treating ascites. In addition, the Company has a pending patent application directed to proprietary liquid formulations of terlipressin for use in its planned Phase 2b/3 trial, subject to FDA clearance, which could eventually provide up to 20 years of patent coverage in each country in which the Company seeks patent protection, such as the United States, if a patent issues according to the patent laws of the issuing country.

The BIV201 development program began at LAT Pharma LLC. On April 11, 2016, the Company acquired LAT Pharma LLC and the rights to its BIV201 development program. The Company currently owns all development and marketing rights to its drug candidate. The Company and PharmaIN, Corp. (“PharmaIN”), LAT Pharma’s former partner focused on the development of new modified drug candidates in the same therapeutic field but not including BIV201, had agreed to pay royalties equal to less than 1% of future net sales of each company's ascites drug development programs, or if such program is licensed to a third party, less than 5% of each company's net license revenues. On December 24, 2018, the Company returned its partial ownership rights to the PharmaIN modified terlipressin development program and simultaneously paid the remaining balance due on a related debt. PharmaIN, Corp.’s rights to our program remain unchanged.

The Company’s activities are subject to significant risks and uncertainties including failure to secure additional funding to properly execute the Company’s business plan.

 -5-


BIOVIE INC.

Notes to Condensed Financial Statements

For the Three Months Ended September 30, 2019 and 2018

(unaudited)

 

2. Liquidity and Going Concern

 

The Company’s operations are subject to a number of factors that can affect its operating results and financial conditions. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s products, the Company’s ability to obtain regulatory approval to market its products, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company products, the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, and the Company’s ability to raise capital. The Company’s financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As of September 30, 2019, the Company had an accumulated deficit of $28.2 million and as a development stage enterprise, the Company expects substantial losses in future periods. The accompanying interim financial statements were prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company’s future operations are dependent on the success of the Company’s ongoing development and commercialization effort, as well as continuing to secure additional financing.

On September 24, 2019, the Company entered into a Securities Purchase Agreement with its controlling stockholder regarding bridge financing (the “Bridge Financing”) in the form of up to $2.0 million in convertible debt and warrants, of which $500,000 has been drawn as of September 30, 2019. Amounts borrowed under the Bridge Financing must be repaid with the proceeds of our potential public offering of equity securities referred to below. The availability of additional draws under the Bridge Financing is under further discussion with the controlling stockholder in light of delays in the timing of the potential public offering. As further discussed below, the Company is pursuing various options to raise further financing to continue the testing and development of its product. If the Company is not successful in raising additional funds it may reduce its monthly spend and potentially delay the implementation of the larger scale Phase 2b Clinical trial until sufficient funding is secured.

Additionally, in April 2019, to facilitate our planned up listing to the NASDAQ Stock Market and related potential future issuances and sales of our equity securities for ordinary corporate finance and general corporate purposes and as recommended by our Board of Directors (“Board”), our stockholders approved an amendment to our Articles of Incorporation to effect a reverse split of our outstanding Class A common stock in the range of 50:1 to 200:1, as determined by our Board. Following that approval, we filed a Registration Statement on Form S-1 (Registration No. 333-231136) (the “S-1 Registration Statement”) pursuant to which we anticipate completing an offering of our equity securities with proceeds sufficient to enable the launch and completion of the BIV201 Phase 2b study and fund our internal operations for at least the next twelve months. There can be no assurance, however, that we will successfully complete an offering thereunder on the terms contemplated by the S-1 Registration Statement or on any commercially reasonable terms.

The future viability of the Company is largely dependent upon its ability to raise additional capital to finance its operations. Management expects that future sources of funding may include sales of equity, obtaining loans, or other strategic transactions. Although management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the Company, if at all, to fund continuing operations. These circumstances raise substantial doubt on the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 -6-

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three Months Ended September 30, 2019 and 2018

(unaudited)

 

3. Significant Accounting Policies

 

Basis of Presentation – Interim Financial Information

The accompanying unaudited interim financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United State of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities Exchange Commission for Interim Reporting. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The unaudited interim financial statements furnished reflect all adjustments (consisting of normal recurring accruals) that are, in the opinion of management, considered necessary for a fair presentation of the results for the interim periods presented. Interim results are not necessarily indicative of the results for the full year. The condensed balance sheet at June 30, 2019 was derived from audited annual financial statements but does not contain all the footnote disclosures from the annual financial statements. The accompanying financial statements and information included under the heading: “Management’s Discussion and Analysis of Financial Condition and Results of Operations” should be read in conjunction with our Company’s audited financial statements and related notes included in our Company’s Form 10-K for the year ended June 30, 2019 filed with the SEC on September 27, 2019.

For a summary of significant accounting policies, see the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2019 filed with the SEC on September 27, 2019.

Net Loss per Common Share

Basic net loss per common share is computed by dividing the net loss before deemed dividend by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding and potentially outstanding shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable through stock options, warrants, convertible preferred stock and convertible debentures. Due to the net loss for the period, such amounts were excluded from the diluted loss since their effect was considered anti-dilutive.

The table below shows the number of outstanding stock options and warrants as of September 30, 2019 and 2018:

   September 30, 2019  September 30, 2018
   Number of Shares  Number of Shares
Stock Options   7,250,000    5,150,000 
Warrants   171,833,216    216,441,548 
Total   179,083,216    221,591,548 

 

Recent accounting pronouncements

The Company considers the applicability and impact of all Accounting Standard Updates (“ASU’s”). ASU’s not discussed below were assessed and determined to be either not applicable or expected to have minimal impact on our balance sheets or statement of operations.

 -7-

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three Months Ended September 30, 2019 and 2018

(unaudited)

 

3. Significant Accounting Policies (continued)

 

In June 2018, the FASB issued ASU 2018-07, “Compensation – Stock Compensation (Topic 718): Improvements to Non-employee Share-Based Accounting”. This guidance aligns the accounting for share-based payment transactions with non-employees to accounting for share-based payment transactions with employees. Companies are required to record a cumulative-effect adjustment (net of tax) to retained earnings as of the beginning of the fiscal year of the adoption. Upon transition, non-employee awards are required to be measured at fair value as of the adoption date. This standard will be effective for fiscal years beginning December 15, 2018, including interim periods within those fiscal years. Early adoption is permitted. The Company has adopted this ASU as of July 1, 2019. There has been no impact on the financial statements.

In August 2018, the FASB issued ASU 2018-13, “Fair value measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement”. The new guidance modifies the disclosure requirements on fair value measurements. ASU 2018-13 is effective for fiscal years beginning after December 15, 2019. Early adoption is permitted. The Company does not expect ASU 2018-13 to have a significant impact to its condensed consolidated financial statements and related disclosures.

 

4. Intangible Assets

 

The Company’s intangible assets consist of intellectual property acquired from LAP Pharma, Inc. and are amortized over their estimated useful lives. The following is a summary of the intangible assets as of September 30, 2019 and June 30, 2019:

 

   September 30, 2019  June 30, 2019
       
Intellectual Property  $2,293,770   $2,293,770 
Less Accumulated Amortization   (796,511)   (739,167)
Intellectual Property, Net  $1,497,259   $1,554,603 

 

Amortization expense for the three-month period ended September 30, 2019 and 2018 was $57,344 and $57,344 respectively.

Estimated future amortization expense is as follows:

 

Year ending June 30, 2020 (Remaining nine months)  $                         172,032
2021                             229,377
2022                             229,377
2023                             229,377
2024                             229,377
2025                             229,377
Thereafter                             178,342
   $                      1,497,259

 

 -8-

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three Months Ended September 30, 2019 and 2018

(unaudited)

 

5. Related Party Transactions

 

Equity Transactions with Acuitas

 

On July 3, 2018, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with Acuitas Group Holding, LLC (“Acuitas”) and certain other purchasers identified in the Purchase Agreement (together with Acuitas, the “Purchasers”) pursuant to which (i) the Purchasers agreed to purchase an aggregate of 2,133,332 shares of the our Series A Convertible Preferred Stock (the “Preferred Stock”) at a price per share of $1.50 per share of Preferred Stock (the “Initial Sale”) and (ii) we agreed to issue warrants (the “Warrants”) to purchase 213,333,200 shares of common stock, each subject to the terms and conditions set forth in the Purchase Agreement, for an aggregate consideration of $3.2 million. We received $160,000 of the $3.2 million in April and May 2018 as prepaid equity. Acuitas also received an additional 833,333 Warrants in connection with the payoff of a note issued by us in favor of Acuitas. The Initial Sale and issuance of the Warrants occurred on July 3, 2018. In addition, Acuitas had the option to purchase up to an additional 200,000,000 shares of common stock at a price per share of $0.015, and warrants on the same terms as the Warrants, within two weeks following the one year anniversary of the closing of the Initial Sale (the “Subsequent Sale”) in the event that we did not obtain $3,000,000 of funding through various non-dilutive grants prior to the one year anniversary of the closing of the Initial Sale, less any federal or FDA grant funding received by the Company. Acuitas is controlled by our Chairman and Chief Executive Officer, Terren Peizer and the Purchasers included Jonathan Adams, James Lang, Cuong Do and Michael Sherman, who are members of our Board.

The Purchase Agreement contained customary representations and warranties. In connection with the disclosure schedule associated with the representations and warranties, we also disclosed customary information, including the following: (i) the existence of the Mallinckrodt petition before the U.S. Patent Trial and Appeal Board, (ii) our capitalization, (iii) our obligation to pay a low single digit royalty on the net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma LLC members, PharmaIN Corporation and The Barrett Edge, Inc. pursuant to the Agreement and Plan of Merger, dated April 11, 2016, by and between LAT Pharma LLC and us, (iv) our obligation to pay a low single digit royalty on net sales of all terlipressin products covered by specified patents up to a maximum of $200,000 per year pursuant to the Technology Transfer Agreement, dated July 25, 2016, by and between us and the University of Padova (Italy), and (v) certain recent issuances of common stock by us.

Each share of Preferred Stock automatically converted into 100 shares of common stock upon the filing with the Secretary of State of the State of Nevada of a Certificate of Amendment to our Articles of Incorporation (the “Amendment”) on August 13, 2018 that increased the number of authorized shares of common stock to 800,000,000. The Amendment was approved by the written consent of the holders of more than a majority of our issued and outstanding common stock on July 3, 2018 and was filed with the Secretary of State of the State of Nevada 20 calendar days following the distribution of our Definitive Information Statement on Schedule 14 that was filed with the SEC on July 13, 2018.

Pursuant to a letter agreement dated June 24, 2019, Acuitas agreed to modify its existing rights under the Purchase Agreement so that:

-Acuitas agreed to immediately exchange its existing 200,833,333 Warrants for common stock such that it will have effectively exercised its Warrants in full pursuant to a cashless exercise thereof at an assumed current market price of $0.36 per share and, as a result received an aggregate of 95% of the shares covered thereby, or 190,761,666 shares of common stock;

 -9-

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three Months Ended September 30, 2019 and 2018

(unaudited)

 

5. Related Party Transactions (continued)

 

-Acuitas agreed to (i) waive its rights to a 50% adjustment of the purchase price of the Preferred Stock in the Initial Sale, the exercise price of the Warrants and the price per share in the Subsequent Sale in the event of certain reductions in the useful life of our current intellectual property rights, and (ii) effectively exercise its rights to purchase securities in a Subsequent Sale pursuant to a “cashless purchase” at an assumed current market price of approximately $0.09 per share, conditioned in each case on the listing of our common stock on Nasdaq or the raising of $2.0 million in additional funds in the form of another securities offering, in either case not later than November 30, 2019, which will result Acuitas having irrevocably waived its rights to an adjustment in the purchase price of the Preferred Stock in the Initial Sale and the exercise price of the Warrants and the purchase price of per share in the Subsequent Sale upon the issuance by us of an aggregate of 167,494,750 shares of common stock (the “Subsequent Sale Shares”) to Acuitas, which is expected to occur concurrently with the closing of our potential public offering and listing on Nasdaq;
-Acuitas shall in exchange for the foregoing agreements and waivers have the option to purchase additional shares of common stock and warrants to purchase one share of common stock for each share of common stock purchased during the period from September 1, 2019 to November 30, 2019 at the then-effective purchase price of the Preferred Stock in the Initial Sale (the “Funding Option”), provided that any shares issued pursuant to any exercise of the Funding Option will reduce share-for-share the amount of shares issued pursuant to the deemed exercise of its rights to purchase securities in a Subsequent Sale mentioned above.

 

Convertible Debenture Transaction with Acuitas

 

On September 24, 2019, the Company entered into a Securities Purchase Agreement (the “2019 Purchase Agreement”) with Acuitas pursuant to which (i) Acuitas agreed to purchase a 10% OID Convertible Delayed Draw Debenture (the “Debenture”) due September 24, 2020 for an aggregate commitment amount of up to $2.0 million, and (ii) the Company issued 140,625,000 shares (the “Commitment Shares”) of the Company’s common stock and warrants (the “Commitment Warrants”) to purchase an equal number of shares, each subject to the terms and conditions set forth in the 2019 Purchase Agreement. The Debenture accrues additional principal at the rate of 6% per annum and interest at the rate of 10% per annum, is convertible into shares of common stock at $0.032 per share prior to the completion of the company’s planned public offering of units (the “Public Offering”) or, subsequent to the closing of the Public Offering, the lower of $0.032 or 80% of the offering price per unit to the public in the Public Offering and are mandatorily redeemable upon such closing at 100% of the accrued principal amount and unpaid interest to the date of redemption. The Commitment Warrants are five-year warrants, exercisable upon the earlier of the effectiveness of the Company’s currently pending reverse stock split or December 1, 2019, at an amount equal to the lower of $0.032 or 80% of the offering price per unit to the public in the Public Offering. Upon entering into the 2019 Purchase Agreement, the Company drew an initial $500,000 under the Debenture and in accordance with the 2019 Purchase Agreement, Acuitas received an additional 15,625,000 warrants (the “Bridge Warrants”) having the same terms as the Commitment Warrants. Any future draws under the Debenture, which may be made from and after October 15, 2019, November 15, 2019 and December 15, 2019 in equal tranches of $500,000 each, will entitle Acuitas to receive additional Bridge Warrants in equal amount upon such funding. In addition, the 2019 Purchase Agreement provides that, should the underwriters in the Public Offering exercise their option to purchase additional securities during the 45 days following closing and the issuance of such securities would result in Acuitas' beneficial ownership (on a fully diluted basis) of shares of common stock being below 60%, Acuitas shall be issued a number of additional shares of common stock and warrants having the same terms as the Commitment Warrants to result in its beneficial ownership (on a fully diluted basis) of shares of common stock equaling 60%.

 

The issuance of 140,625,000 shares of the Company’s commons stock and warrants to purchase an equal amount number of shares, to its controlling stockholder for the Bridge Financing was accounted for as a deemed dividend due to its related party nature and $17.1 million representing the excess of the fair value of the consideration given for the financing, net of debt discount; was recorded in accumulated deficit for the three months ended September 30, 2019, accordingly. (See accompanied Condensed Statements of Changes in Stockholders’ (Deficit) Equity). A debt discount of $500,000 against the debenture was recorded which will be amortized over the term of the debenture using the effective interest method. The Company recognized amortization of this discount in the amount of $1,534 for the three-month period ended September 30, 2019.

 

 -10-

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three Months Ended September 30, 2019 and 2018

(unaudited)

 

5. Related Party Transactions (continued)

 

Pursuant to the 2019 Purchase Agreement, Acuitas has agreed to further modify its existing rights under the Purchase Agreement dated July 3, 2018 with the Company so that Acuitas’ previous agreement in June 2019 to waive its rights to a 50% adjustment of the purchase price of the Preferred Stock in the July 2018 transaction, the exercise price of the warrants in such transaction and the price per share in a Subsequent Sale in the event of certain reductions in the useful life of our current intellectual property rights, and effectively exercise its rights to purchase securities in a Subsequent Sale pursuant to a “cashless purchase” at an assumed current market price of approximately $0.09 per share, conditioned in each case on the listing of the Company’s common stock on Nasdaq or the raising of $2.0 million in additional funds in the form of another securities offering, in either case not later than November 30, 2019, such that Acuitas will have irrevocably waived its rights to an adjustment in the purchase price of the Preferred Stock in the Initial Sale and the exercise price of the Warrants and the purchase price of per share in the Subsequent Sale upon the issuance by us of an aggregate of 334,989,500 shares of common stock and 334,989,500 warrants having the same terms as the Commitment Warrants to Acuitas, upon the closing of the Public Offering.

Pursuant to an amendment to the 2019 Purchase Agreement dated October 9, 2019, Acuitas agreed to modify its existing rights under the 2019 Purchase Agreement so that:

-The Commitment Warrants (and related warrants issued upon the first draw under the Debenture) were replaced with warrants having similar terms, but which are automatically exercised upon the closing of the offering at an exercise price equal to the par value of the common stock;
-Acuitas' existing rights under the Purchase Agreement dated July 3, 2018 with the Company were further amended so that the number of Subsequent Sale Shares would be multiplied by four (in lieu of the changes to the Purchase Agreement originally provided for in the 2019 Purchase Agreement); and
-The provisions of the 2019 Purchase Agreement providing that, should the underwriters in the offering exercise their option to purchase additional securities during the 45 days following closing and the issuance of such securities would result in Acuitas’ beneficial ownership (on a fully diluted basis) of shares of common stock being below 60%, Acuitas will be issued a number of additional shares of common stock and warrants having the same terms as the Commitment Warrants to result in its beneficial ownership (on a fully diluted basis) of shares of common stock equaling 60% have been modified such that, upon the exercise of such option by the underwriters, the Company will issue to Acuitas a number of securities that will result in Acuitas’ fully diluted beneficial ownership after the exercise of such option being the same as prior thereto.

 

(See Note 9 Subsequent Events.)

 -11-

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three Months Ended September 30, 2019 and 2018

(unaudited)

 

6. Fair Value Measurements

 

At September 30, 2019, the estimated fair value of derivative liabilities measured on a recurring basis are as follows:

   Fair Value Measurements at
   September 30, 2019
   Level 1  Level 2  Level 3  Total
             
Derivative liability - Warrants  $—     $—     $8,109,724   $8,109,724 
Derivative liability -Conversion option on convertible debenture   —      —      2,533,668    2,533,668 
   Total derivatives  $—     $—     $10,643,392   $10,643,392 

 

The following table presents the activity for liabilities measured at fair value using unobservable inputs for the three months ended September 30, 2019:

   Derivative liabilities - Warrants  Derivative liability - Conversion Option on Convertible Debenture
       
Beginning balance at July 1, 2019  $—     $—   
Additions to level 3 liabilities   8,367,012    2,638,966 
Change in in fair value of level 3 liability   (257,288)   (105,298)
Transfer in and/or out of Level 3   —      —   
Balance at September 30, 2019  $8,109,724   $2,533,668 

 

Derivative liability – Warrants

The Company accounts for stock purchase warrants as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreements. Under applicable accounting guidance, stock warrants that are precluded from being indexed to the Company’s own stock because of full-rachet anti-dilution provisions or the adjustments to the strike price due to an occurrence of a future event; are accounted for as derivative financial instruments. The stock warrants issued September 24, 2019 were not considered indexed to the Company’s own stock because of the adjustment to strike price, an occurrence of a future event such as the Company’s pending capital raise.

 -12-

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three Months Ended September 30, 2019 and 2018

(unaudited)

 

6. Fair Value Measurements (continued)

 

The warrants associated with the level 3 liability were issued on September 24, 2019 and were valued using the Black-Scholes-Merton model with the following assumptions: stock price of $0.0716, exercise price of $0.032, term of 5 years expiring September 2024, volatility of 71.44%, dividend yield of 0%, and risk-free interest rate of 1.52%. The valuation at September 30, 2019 used the following assumptions: stock price of $0.0698, exercise price of $0.032, term of 5 year expiring September 2024, volatility of 71.42%, dividend yield of 0%, and risk-free interest rate of 1.55%. (See note 5 “Related Party Transactions – Convertible debenture transactions)

Derivative liability – Conversion option in convertible debenture

The Company valued the conversion option of the $2 million 10% OID Convertible Delayed Draw Debenture which may be convertible into shares of common stock at $0.032 per share prior to the completion of an offering or, subsequent to the closing of the offering, the lower of $0.032 or 80% of the offering price per unit to the public in this offering and are mandatorily redeemable upon such closing at 100% of the accrued principal amount and unpaid interest to the date of redemption. (See note 5 “Related Party Transactions – Convertible debenture transactions with Acuitas” as of September 24, 2019). The conversion option was valued on September 24, 2019 using the Black Scholes-Mertons model with the following assumptions: stock price of $0.0716, conversion price of $0.032, term of 1 year expiring September 2020, volatility of 75.48%, dividend yield of 0%, and risk-free interest rate of 1.78%. The valuation at September 30, 2019 used the following assumptions: stock price of $0.0698, conversion price of $0.032, term of 1 year expiring September 2020, volatility of 75.5%, dividend yield of 0%, and risk-free interest rate of 1.75%.

7. Equity Transactions

 

Stock Options

The following table summarizes the activity relating to the Company’s stock options for the three months ended September 30, 2019:

 

   Options  Weighted-Average Exercise Price  Weighted Remaining Average Contractual Term  Aggregate Intrinsic Value
Outstanding at June 30, 2019   7,250,000   $0.10    5.2   $87,480 
Granted   —      —      —      —   
Options Exercised or Forfeited   —      —      —      —   
Outstanding at September 30, 2019   7,250,000   $0.10    4.8   $87,480 
Exercisable at  September 30, 2019   7,250,000   $0.10    4.8   $87,480 

 

 -13-

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three Months Ended September 30, 2019 and 2018

(unaudited)

 

7. Equity Transactions (continued)

 

The fair value of each option grant on the date of grant is estimated using the Black-Scholes option. There were no options granted during the three months ended September 30, 2019. The pricing model reflected the following weighted-average assumptions for the three months ended September 30, 2018:

   September 30 2019  September 30 2018
Expected life of options (In years)   —      9.5 
Expected volatility   —      63.09%
Risk free interest rate   —      0.00%
Dividend Yield   —      0%

 

Expected volatility is based on the historical volatilities of three comparable companies of the daily closing price of their respective common stock and the expected life of options is based on historical data with respect to employee exercise periods. The Company accounts for forfeitures as they are incurred.

The Company recorded stock-based compensation expense of $0 and $3,412 for the three- month period ended September 30, 2019 and 2018, respectively.

The following is a summary of stock options outstanding and exercisable by exercise price as of September 30, 2019:

Exercise Price  Outstanding  Weighted Average Contract Life  Exercisable
$0.03    700,000    4.3    700,000 
$0.05    1,300,000    4.4    1,300,000 
$0.06    3,100,000    6.4    3,100,000 
$0.07    100,000    4.0    100,000 
$0.10    500,000    3.3    500,000 
$0.20    200,000    3.0    200,000 
$0.21    550,000    2.6    550,000 
$0.22    100,000    2.5    100,000 
$0.23    200,000    2.9    200,000 
$0.25    500,000    2.1    500,000 
 Total    7,250,000         7,250,000 

 

Stock Warrants

The following table summarizes the warrants activity during the three months ended September 30, 2019:

 

   Number of Shares  Weighted Average Exercise Price  Weighted Average Remaining Life (Years)  Aggregate Intrinsic Value
Outstanding and exercisable at June 30, 2019   15,583,216   $0.36    5.6   $716,653 
Granted   156,250,000   $0.03    5.0   $5,906,250 
Expired   —     $—      —     $—   
Outstanding and exercisable at September 30, 2019   171,833,216   $0.04    4.9   $6,622,903 

 

Of the above warrants, 1,173,864 expire in fiscal year ending June 30, 2022, 556,818 expire in fiscal year ending June 30, 2023, and 170,102,534 expire in fiscal year ending June 30, 2025.

 -14-

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three Months Ended September 30, 2019 and 2018

(unaudited)

 

8. Commitments and Contingencies 

 

Office Lease 

On July 1, 2019, the Company’s office moved with Acuitas’ new offices to 2120 Colorado Avenue Ste 230, Santa Monica, CA 90404. There is no lease agreement for the new premises and the Company continues to accrue monthly lease payments of $1,000 for the new office under the terms of the previous month-to-month lease for the previous premises which may be cancelled upon 30 days’ written notice.

Challenge to US Patent

On April 30, 2018, we received notice that Mallinckrodt had petitioned the U.S. Patent and Trademark Office (“USPTO”) to institute an Inter Partes Review of our U.S. Patent No. 9,655,945 titled “Treatment of Ascites” (the “’945 patent”). Inter Partes Review is a trial proceeding conducted with the USPTO Patent Trial and Appeal Board (PTAB) to review the patentability of one or more claims of a patent. Such review is limited to grounds of novelty and obviousness on the basis of prior art consisting of patents and printed publications.

 

On November 13, 2019, the Patent Trial and Appeal Board of the United States Patent and Trademark Office (the “Board”) issued a written decision in the inter partes review (“IPR”) action that was brought by Mallinckrodt Pharmaceuticals Ireland Limited (“Mallinckrodt”) against BioVie Inc. (“BioVie” or “Company”). In that action, Mallinckrodt sought to invalidate BioVie’s patent (U.S. Pat. No. 9,655,945, “Treatment of Ascites”) (the “’945 Patent”). In its decision, the Board determined that all claims of the ‘945 Patent were not patentable because they were either anticipated or obvious in light of prior art. The Board also denied BioVie’s Motion to Amend the claims on similar grounds. The result of the Board’s decision is that the ‘945 patent is no longer valid or enforceable. Acuitas Group Holdings, LLC was aware of this patent challenge when it purchased a majority ownership interest in the company in July 2018.

BioVie is evaluating the Board’s decision to determine if it will request a rehearing by the Board or appeal the Board’s decision to the U.S. Court of Appeals for the Federal Circuit. This ruling is unrelated to the Company’s Orphan drug designations for ascites and hepatorenal syndrome (“HRS”), which remain unchanged. An Orphan drug that is first-to-market typically receives 7 years of market exclusivity in the United States for the designated use(s). In addition, the ruling does not affect the Company’s rights in its pending patent application directed to proprietary liquid formulations of terlipressin for use in its planned Phase 2b/3 trial, subject to FDA clearance, which could eventually provide up to 20 years of patent coverage in each country in which the Company seeks patent protection, such as the United States, if a patent issues from a patent application according to the patent laws of each issuing country.

 

At September 30, 2019, no adjustments or accruals have been reflected in our financial statements related to this matter. (See Note 9 – Subsequent events.)

Royalty Agreements

Pursuant to the Agreement and Plan of Merger entered into on April 11, 2016 between our predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc.

The Company and PharmaIN Corporation, LAT Pharma’s former partner focused on the development of new modified drug candidates in the same therapeutic field but not including BIV201, had agreed to pay royalties equal to less than 1% of future net sales of each company's ascites drug development programs, or if such program is licensed to a third party, less than 5% of each company's net license revenues. On December 24, 2018, the Company returned its partial ownership rights to the PharmaIN modified terlipressin development program and simultaneously paid the remaining balance due on a related debt. PharmaIN, Corp. rights to our program remain unchanged.

Pursuant to the Technology Transfer Agreement entered into on July 25, 2016 between BioVie and the University of Padova (Italy), BioVie is obligated to pay a low single digit royalty on net sales of all terlipressin products covered by US patent no. 9,655,645 and any future foreign issuances capped at a maximum of $200,000 per year.

 -15-

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three Months Ended September 30, 2019 and 2018

(unaudited)

 

9. Subsequent Events

 

On October 1, 2019, the Company issued stock options to purchase 100,000 shares of common stock to the Chief Financial Officer as part of her compensation. The stock options were issued and are exercisable at an exercise price of $0.07 at any time from date of issuance and expire in 5 years from the date of issuance.

On October 13, 2019, the Company issued stock options to purchase 100,000 shares of common stock as part of their annual board of director compensation. The stock options were issued and are exercisable at $0.06 at any time from date of issuance and expire in 5 years from the date of issuance.

On November 7, 2019, the Company filed a certificate with the Nevada Secretary of State to terminate the effectiveness of Amendment of Article 3 to effect reverse split of the Corporation’s common stock in the ratio of 1:125. 

 

On November 13, 2019, the Patent Trial and Appeal Board of the United States Patent and Trademark Office (the “Board”) issued a written decision in the inter partes review (“IPR”) action that was brought by Mallinckrodt Pharmaceuticals Ireland Limited (“Mallinckrodt”) against BioVie Inc. (“BioVie” or “Company”). In that action, Mallinckrodt sought to invalidate BioVie’s patent (U.S. Pat. No. 9,655,945, “Treatment of Ascites”) (the “’945 Patent”). In its decision, the Board determined that all claims of the ‘945 Patent were not patentable because they were either anticipated or obvious in light of prior art. The Board also denied BioVie’s Motion to Amend the claims on similar grounds.  The result of the Board’s decision is that the ‘945 patent is no longer valid or enforceable. Acuitas Group Holdings, LLC was aware of this patent challenge when it purchased a majority ownership interest in the company in July 2018.

 

BioVie is evaluating the Board’s decision to determine if it will request a rehearing by the Board or appeal the Board’s decision to the U.S. Court of Appeals for the Federal Circuit. This ruling is unrelated to the Company’s Orphan drug designations for ascites and hepatorenal syndrome (“HRS”), which remain unchanged. An Orphan drug that is first-to-market typically receives 7 years of market exclusivity in the United States for the designated use(s). In addition, the ruling does not affect the Company’s rights in its pending patent application directed to proprietary liquid formulations of terlipressin for use in its planned Phase 2b/3 trial, subject to FDA clearance, which could eventually provide up to 20 years of patent coverage in each country in which the Company seeks patent protection, such as the United States, if a patent issues from a patent application according to the patent laws of each issuing country.

 

 -16-

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

This report contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, and Section 27A of the Securities Act of 1933. Any statements contained in this report that are not statements of historical fact may be forward-looking statements. When we use the words “intends,” “estimates,” “predicts,” “potential,” “continues,” “anticipates,” “plans,” “expects,” “believes,” “should,” “could,” “may,” “will” or the negative of these terms or other comparable terminology, we are identifying forward-looking statements. Forward-looking statements involve risks and uncertainties, which may cause our actual results, performance or achievements to be materially different from those expressed or implied by forward-looking statements. These factors include our; research and development activities, distributor channel; compliance with regulatory impositions; and our capital needs. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. 

Except as may be required by applicable law, we do not undertake or intend to update or revise our forward-looking statements, and we assume no obligation to update any forward-looking statements contained in this report as a result of new information or future events or developments. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. You should carefully review and consider the various disclosures we make in this report and our other reports filed with the Securities and Exchange Commission that attempt to advise interested parties of the risks, uncertainties and other factors that may affect our business. 

All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The Company assumes no obligation and does not intend to update these forward-looking statements, except as required by law. When used in this report, the terms “BioVie”, “Company”, “we”, “our”, and “us” refer to BioVie Inc. 

The following discussion of the Company’s financial condition and the results of operations should be read in conjunction with the Financial Statements and Notes thereto appearing elsewhere in this document. 

The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements. In order to comply with the terms of the safe harbor, the Company notes that in addition to the description of historical facts contained herein, this report contains certain forward-looking statements that involve risks and uncertainties as detailed herein and from time to time in the Company’s other filings with the Securities and Exchange Commission and elsewhere. Such statements are based on management’s current expectations and are subject to a number of factors and uncertainties, which could cause actual results to differ materially from those, described in the forward-looking statements. These factors include, among others: (a) the Company’s fluctuations in sales, expenses and operating results; (b) risks associated with international operations; (c) regulatory, competitive and contractual risks; (d) product development risks; (e) the ability to achieve strategic initiatives, including but not limited to the ability to achieve sales growth across the business segments through a combination of enhanced sales force, new products, and customer service; and (f) pending litigation. 

 -17-

Management’s Discussion

 

BioVie is a clinical-stage company pursuing the discovery, development, and commercialization of innovative drug therapies targeting life-threatening complications of liver cirrhosis. Our initial disease target is ascites, a serious medical condition affecting about 100,000 Americans and many times more worldwide. Our therapeutic drug candidate BIV201 is based on a drug that is approved in about 40 countries to treat related complications of liver cirrhosis (part of the same disease pathway as ascites), but not yet available in the US. The active agent in BIV201, terlipressin, is a potent vasoconstrictor which is in use for various medical conditions around the world. The goal is for BIV201 to interrupt the ascites disease pathway, thereby halting the cycle of accelerating fluid generation in ascites patients.

Comparison of the three months ended September 30, 2019 to the three months ended September 30, 2018

 

Net Loss

The net loss for the three months ended September 30, 2019 was $3.8 million as compared to $440,000 for the three months ended September 30, 2018. The increase in net loss of $3.4 million was due to an increase in interest expense of approximately $3.5 million and increased operating expenses of $214,000 offset by the increase in the change in value of derivative liabilities of $363,000. The increase in interest expense was attributed to the issuance of a 10% OID Convertible Delayed Draw Debenture (“Debenture”), which is convertible into shares of common stock. The interest expense for the three months ended September 30, 2019 was comprised of approximately $2.5 million related to the embedded derivative on the Debenture and interest expense of approximately $837,000 related to derivative liability – warrants.

 

Total operating expenses for the three months ended September 30, 2019 were approximately $706,000 compared to $491,000 for the three months ended September 30, 2018.  The net increase of approximately $215,000 was primarily due to activities related to the Phase 2a clinical trials wrap up and preparation of the protocols for the Phase 2b/3 trials during the three months ended September 30, 2019 and an increase in selling, general and administrative expenses.

Research and Development Expenses

Research and development expenses were approximately $342,000 for the three months ended September 30, 2019, an increase of $147,000, from $195,000 for the three months ended September 30, 2018. The increase was primarily attributed to the wrapping up of the phase 2a clinical trials and readying for the next phase of trials including the preparing the protocols and manufacturing of the prefilled syringe which will be used in the next phase of trials.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were approximately $307,000 for the three months ended September 30, 2019, a net increase of approximately $68,000, from $240,000 for the three months ended September 30, 2018. The net increase was primarily attributed to the increased payroll of approximately $30,000 due the hiring of a half time chief financial officer that joined in October 2018, an increase in the insurance premiums of approximately $15,000 for increased coverage and other expenses of approximately $13,000 related to activities of the Company’s capital raise and up listing to the Nasdaq.

Capital Resources and Liquidity

 

At September 30, 2019 the Company had approximately $249,000 in cash and cash equivalents and had completed its Phase 2a clinical trial of the BIV201 therapy. On September 24, 2019, the Company entered into a Securities Purchase Agreement with its controlling stockholder regarding bridge financing (the “Bridge Financing”) in the form of up to $2.0 million in convertible debt and warrants, of which $500,000 has been drawn to date. Amounts borrowed under the Bridge Financing must be repaid with the proceeds of our potential public offering of equity securities referred to below. The availability of additional draws under the Bridge Financing is under discussion with Acuitas in light of delays in the timing of the potential public offering. As further discussed below, the Company is pursuing various options to raise further financing to continue the testing and development of its product. If the Company is not successful in raising additional funds it may reduce its monthly spend and potentially delay the implementation of the larger scale Phase 2b Clinical trial until sufficient funding is secured.

 

 -18-

As of September 30, 2019, the Company had an accumulated deficit of $28.2 million and as a development stage enterprise, the Company expects substantial losses in future periods. The accompanying interim financial statements were prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company’s future operations are dependent on the success of the Company’s ongoing development and commercialization effort, as well as continuing to secure additional financing.

We cannot assure you that our drug candidate will be developed, work, or receive regulatory approval; that we will ever earn revenues sufficient to support our operations or that we will ever be profitable. Furthermore, since we have no committed source of sufficient financing, we cannot assure you that we will be able to raise money as and when we need it to continue our operations. If we cannot raise funds as and when we need them, we may be required to severely curtail, or even to cease, our operations.

Additionally, in April 2019, to facilitate our planned up listing to the NASDAQ Stock Market and related potential future issuances and sales of our equity securities for ordinary corporate finance and general corporate purposes and as recommended by our Board of Directors (“Board”), our stockholders approved an amendment to our Articles of Incorporation to effect a reverse split of our outstanding Class A common stock in the range of 50:1 to 200:1, as determined by our Board. Following that approval, we filed a Registration Statement on Form S-1 (Registration No. 333-231136) (the “S-1 Registration Statement”) pursuant to which we anticipate completing an offering of our equity securities with proceeds sufficient to enable the launch and completion of the BIV201 Phase 2b study and fund our internal operations for at least the next twelve months. There can be no assurance, however, that we will successfully complete an offering on the terms contemplated by the S-1 Registration Statement or on any commercially reasonable terms.

Management intends to attempt to secure additional required funding primarily through additional equity or debt financings.  We may also seek to secure required funding through sales or out-licensing of intellectual property assets, seeking partnerships with other pharmaceutical companies or third parties to co-develop and fund research and development efforts, or similar transactions.  However, there can be no assurance that we will be able to obtain required funding.  If we are unsuccessful in securing funding from any of these sources, we will defer, reduce or eliminate certain planned expenditures in our research protocols.  If we do not have sufficient funds to continue operations, we could be required to seek bankruptcy protection or other alternatives that could result in our stockholders losing some or all of their investment in us.

These circumstances raise substantial doubt on our ability to continue as a going concern. These financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts and classification of liabilities that might result from this uncertainty. 

Off-Balance Sheet Arrangements

 

The Company has no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect or change on the Company’s financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors. The term “off-balance sheet arrangement” generally means any transaction, agreement or other contractual arrangement to which an entity unconsolidated with the Company is a party, under which the Company has (i) any obligation arising under a guarantee contract, derivative instrument or variable interest; or (ii) a retained or contingent interest in assets transferred to such entity or similar arrangement that serves as credit, liquidity or market risk support for such assets. 

 -19-

Critical Accounting Policies and Estimates

 

For the three-month period ended September 30, 2019, there were no significant changes to the Company’s critical accounting policies as identified in the Annual Report Form 10-K for the fiscal year ended June 30, 2019.

New Accounting Pronouncements

 

The Company considered the applicability and impact of recent accounting pronouncements and determined those to be either not applicable or expected to have minimal impact on our balance sheets or statement of operations.

Item 3.  Quantitative and Qualitative Disclosures About Market Risk

 

Not applicable

 

Item 4.  Controls and Procedures

 

We maintain “disclosure controls and procedures.” Such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in Securities and Exchange Commission rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Office and Chief Financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Our disclosure controls and procedures have been designed to meet reasonable assurance standards. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgement in evaluating the cost-benefit relationship of possible disclosure and procedures. The design of and disclosure controls and procedures also are based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

Based on their evaluation as of the end of the period covered by this Quarterly Report on Form 10-Q our Chief Executive Officer and Chief Financial Officer have concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level, as appropriate, to allow timely decisions regarding required disclosure.

Changes in Internal Control over Financial Reporting

 

There were no changes in our internal control over financial reporting (as defined in Rule 13a-15f and 15d-15(f) under the Exchange Act), that occurred during the quarter ended September 30, 2019 that have materially affected or are reasonably likely to materially affect, our internal control over financial reporting.

 -20-

PART II. OTHER INFORMATION

 

Item 1. Legal Proceedings

 

To our knowledge, neither the Company nor any of our officers or directors is a party to any material legal proceeding or litigation and such persons know of no material legal proceeding or contemplated or threatened litigation. There are no judgments against us or our officers or directors. None of our officers or directors has been convicted of a felony or misdemeanor relating to securities or performance in corporate office.

On April 30, 2018, we received notice that Mallinckrodt had petitioned the U.S. Patent and Trademark Office (“USPTO”) to institute an Inter Partes Review of our U.S. Patent No. 9,655,945 titled “Treatment of Ascites” (the “’945 patent”). Inter Partes Review is a trial proceeding conducted with the USPTO Patent Trial and Appeal Board (PTAB) to review the patentability of one or more claims of a patent. Such review is limited to grounds of novelty and obviousness on the basis of prior art consisting of patents and printed publications. For further information regarding these proceedings, please see footnote 5 in the accompanying interim financial statements.

On November 13, 2019, the Patent Trial and Appeal Board of the United States Patent and Trademark Office (the “Board”) issued a written decision in the inter partes review (“IPR”) action that was brought by Mallinckrodt Pharmaceuticals Ireland Limited (“Mallinckrodt”) against BioVie Inc. (“BioVie” or “Company”). In that action, Mallinckrodt sought to invalidate BioVie’s patent (U.S. Pat. No. 9,655,945, “Treatment of Ascites”) (the “’945 Patent”). In its decision, the Board determined that all claims of the ‘945 Patent were not patentable because they were either anticipated or obvious in light of prior art. The Board also denied BioVie’s Motion to Amend the claims on similar grounds.  The result of the Board’s decision is that the ‘945 patent is no longer valid or enforceable. Acuitas Group Holdings, LLC was aware of this patent challenge when it purchased a majority ownership interest in the company in July 2018.

 

BioVie is evaluating the Board’s decision to determine if it will request a rehearing by the Board or appeal the Board’s decision to the U.S. Court of Appeals for the Federal Circuit. This ruling is unrelated to the Company’s Orphan drug designations for ascites and hepatorenal syndrome (“HRS”), which remain unchanged. An Orphan drug that is first-to-market typically receives 7 years of market exclusivity in the United States for the designated use(s). In addition, the ruling does not affect the Company’s rights in its pending patent application directed to proprietary liquid formulations of terlipressin for use in its planned Phase 2b/3 trial, subject to FDA clearance, which could eventually provide up to 20 years of patent coverage in each country in which the Company seeks patent protection, such as the United States, if a patent issues from a patent application according to the patent laws of each issuing country. For further information regarding proceedings, please see footnote 9 in accompanying interim financial statements.

 

Item 2. Unregistered sales of equity securities

 

All sales of unregistered securities during the three months ended September 30, 2019 were previously disclosed in a Current report on Form 8-K.

 

Item 3. Defaults Upon Senior Securities

 

None

 

Item 4.  Mine Safety Disclosures

 

None

 

Item 5.  Other Information

 

None

 

 -21-

Item 6. Exhibits

 

(a) Exhibit index

 

Exhibit 
 
31.1*  

Certification of Chief Executive Officer (Principal Executive Officer) required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended.

31.2*  

Certification of Chief Financial Officer (Principal Financial Officer) required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended.

32.1**   Certifications of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2**   Certification of Chief Financial Officer (Principal Financial Officer) pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

101.INS   XBRL Instance Document
     
101.SCH   XBRL Taxonomy Extension Schema Document
     
101.CAL   XBRL Taxonomy Extension Calculation Linkbase Document
     
101.LAB   XBRL Taxonomy Extension Label Linkbase Document
     
101.PRE   XBRL Taxonomy Extension Presentation Linkbase Document
     
101.DEF   XBRL Taxonomy Extension Definition Linkbase Document

 

 

* Filed herewith.
   
** Furnished herewith. This certification is being furnished solely to accompany this report pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filings of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

 -22-

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

BioVie Inc.,

         
Signature   Titles   Date
     

 

/s/Terren Peizer

________________

Terren Peizer

  Chairman and Chief Executive Officer (Principal Executive Officer)   November 19, 2019

 

 

 

 

/s/Joanne Wendy Kim

_________________

Joanne Wendy Kim

  Chief Financial Officer (Principal Financial and Accounting Officer)    November 19, 2019

 

 -23-

EX-31.1 2 bivi-20190930_10qex31z1.htm EXHIBIT 31.1

Exhibit 31.1

 

CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES OXLEY ACT OF 2002

AND RULE 13-A14 OF THE EXCHANGE ACT OF 1934

 

CERTIFICATION

     

I, Terren Peizer, certify that:
     
1. I have reviewed this quarterly report on Form 10-Q of BioVie Inc.;
     
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
     
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
     
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a – 15(f) and 15d – 15(f)) for the registrant and have:
   
  a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
     
  b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
     
  c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
     
  d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of the annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
     
5.   The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
     
  a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
     
  b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: November 19, 2019 

                /s/ Terren S. Peizer
               
Terren S. Peizer
Chief Executive Officer
(Principal Executive Officer)
EX-31.2 3 bivi-20190930_10qex31z2.htm EXHIBIT 31.2

Exhibit 31.2

 

CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES OXLEY ACT OF 2002

AND RULE 13-A14 OF THE EXCHANGE ACT OF 1934

 

CERTIFICATION

     

I, Joanne Wendy Kim, certify that:
     
1. I have reviewed this quarterly report on Form 10-Q of BioVie Inc.;
     
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
     
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
     
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a – 15(f) and 15d – 15(f)) for the registrant and have:
   
  a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
     
  b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
     
  c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
     
  d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of the annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
     
5.   The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
     
  a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
     
  b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: November 19, 2019 

                /s/ Joanne Wendy Kim
               

Joanne Wendy Kim

Chief Financial Officer
(Principal Financial and Accounting Officer)

EX-32.1 4 bivi-20190930_10qex32z1.htm EXHIBIT 32.1

Exhibit 32.1

 

 

CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER PURSUANT TO 18 U.S. C. SECTION 1350 AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report of BioVie Inc. (the “Company”) on Form 10-Q for the period ended September 30, 2019, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Terren Peizer, Chief Executive Officer and Chairman of the Board of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002, that, to my knowledge:

 

(1) The Report fully complies with the requirements of Section 13 (a) or 15 (d) of the Securities Exchange Act of 1934; and
   
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

Date: November 19, 2019 

                /s/ Terren S. Peizer
                Terren S. Peizer
Chief Executive Officer
(Principal Executive Officer)

 

EX-32.2 5 bivi-20190930_10qex32z2.htm EXHIBIT 32.2

Exhibit 32.2

 

 

CERTIFICATION OF THE CHIEF FINANCIAL OFFICER PURSUANT TO 18 U.S. C. SECTION 1350 AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report of BioVie Inc. (the “Company”) on Form 10-Q for the period ended September 30, 2019, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Joanne Wendy Kim, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002, that, to my knowledge:

 

(1) The Report fully complies with the requirements of Section 13 (a) or 15 (d) of the Securities Exchange Act of 1934; and
   
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: November 19, 2019 

                  /s/ Joanne Wendy Kim
                 

Joanne Wendy Kim

Chief Financial Officer
(Principal Financial and Accounting Officer)

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Related Party Transactions
3 Months Ended
Sep. 30, 2019
Related Party Transactions [Abstract]  
Related Party Transactions
5. Related Party Transactions

 

Equity Transactions with Acuitas

 

On July 3, 2018, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with Acuitas Group Holding, LLC (“Acuitas”) and certain other purchasers identified in the Purchase Agreement (together with Acuitas, the “Purchasers”) pursuant to which (i) the Purchasers agreed to purchase an aggregate of 2,133,332 shares of the our Series A Convertible Preferred Stock (the “Preferred Stock”) at a price per share of $1.50 per share of Preferred Stock (the “Initial Sale”) and (ii) we agreed to issue warrants (the “Warrants”) to purchase 213,333,200 shares of common stock, each subject to the terms and conditions set forth in the Purchase Agreement, for an aggregate consideration of $3.2 million. We received $160,000 of the $3.2 million in April and May 2018 as prepaid equity. Acuitas also received an additional 833,333 Warrants in connection with the payoff of a note issued by us in favor of Acuitas. The Initial Sale and issuance of the Warrants occurred on July 3, 2018. In addition, Acuitas had the option to purchase up to an additional 200,000,000 shares of common stock at a price per share of $0.015, and warrants on the same terms as the Warrants, within two weeks following the one year anniversary of the closing of the Initial Sale (the “Subsequent Sale”) in the event that we did not obtain $3,000,000 of funding through various non-dilutive grants prior to the one year anniversary of the closing of the Initial Sale, less any federal or FDA grant funding received by the Company. Acuitas is controlled by our Chairman and Chief Executive Officer, Terren Peizer and the Purchasers included Jonathan Adams, James Lang, Cuong Do and Michael Sherman, who are members of our Board.

 

The Purchase Agreement contained customary representations and warranties. In connection with the disclosure schedule associated with the representations and warranties, we also disclosed customary information, including the following: (i) the existence of the Mallinckrodt petition before the U.S. Patent Trial and Appeal Board, (ii) our capitalization, (iii) our obligation to pay a low single digit royalty on the net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma LLC members, PharmaIN Corporation and The Barrett Edge, Inc. pursuant to the Agreement and Plan of Merger, dated April 11, 2016, by and between LAT Pharma LLC and us, (iv) our obligation to pay a low single digit royalty on net sales of all terlipressin products covered by specified patents up to a maximum of $200,000 per year pursuant to the Technology Transfer Agreement, dated July 25, 2016, by and between us and the University of Padova (Italy), and (v) certain recent issuances of common stock by us.

 

Each share of Preferred Stock automatically converted into 100 shares of common stock upon the filing with the Secretary of State of the State of Nevada of a Certificate of Amendment to our Articles of Incorporation (the “Amendment”) on August 13, 2018 that increased the number of authorized shares of common stock to 800,000,000. The Amendment was approved by the written consent of the holders of more than a majority of our issued and outstanding common stock on July 3, 2018 and was filed with the Secretary of State of the State of Nevada 20 calendar days following the distribution of our Definitive Information Statement on Schedule 14 that was filed with the SEC on July 13, 2018.

 

Pursuant to a letter agreement dated June 24, 2019, Acuitas agreed to modify its existing rights under the Purchase Agreement so that:

 

  Acuitas agreed to immediately exchange its existing 200,833,333 Warrants for common stock such that it will have effectively exercised its Warrants in full pursuant to a cashless exercise thereof at an assumed current market price of $0.36 per share and, as a result received an aggregate of 95% of the shares covered thereby, or 190,761,666 shares of common stock;
     
  Acuitas agreed to (i) waive its rights to a 50% adjustment of the purchase price of the Preferred Stock in the Initial Sale, the exercise price of the Warrants and the price per share in the Subsequent Sale in the event of certain reductions in the useful life of our current intellectual property rights, and (ii) effectively exercise its rights to purchase securities in a Subsequent Sale pursuant to a “cashless purchase” at an assumed current market price of approximately $0.09 per share, conditioned in each case on the listing of our common stock on Nasdaq or the raising of $2.0 million in additional funds in the form of another securities offering, in either case not later than November 30, 2019, which will result Acuitas having irrevocably waived its rights to an adjustment in the purchase price of the Preferred Stock in the Initial Sale and the exercise price of the Warrants and the purchase price of per share in the Subsequent Sale upon the issuance by us of an aggregate of 167,494,750 shares of common stock (the “Subsequent Sale Shares”) to Acuitas, which is expected to occur concurrently with the closing of our potential public offering and listing on Nasdaq;
     
  Acuitas shall in exchange for the foregoing agreements and waivers have the option to purchase additional shares of common stock and warrants to purchase one share of common stock for each share of common stock purchased during the period from September 1, 2019 to November 30, 2019 at the then-effective purchase price of the Preferred Stock in the Initial Sale (the “Funding Option”), provided that any shares issued pursuant to any exercise of the Funding Option will reduce share-for-share the amount of shares issued pursuant to the deemed exercise of its rights to purchase securities in a Subsequent Sale mentioned above.

 

Convertible Debenture Transaction with Acuitas

 

On September 24, 2019, the Company entered into a Securities Purchase Agreement (the “2019 Purchase Agreement”) with Acuitas pursuant to which (i) Acuitas agreed to purchase a 10% OID Convertible Delayed Draw Debenture (the “Debenture”) due September 24, 2020 for an aggregate commitment amount of up to $2.0 million, and (ii) the Company issued 140,625,000 shares (the “Commitment Shares”) of the Company’s common stock and warrants (the “Commitment Warrants”) to purchase an equal number of shares, each subject to the terms and conditions set forth in the 2019 Purchase Agreement. The Debenture accrues additional principal at the rate of 6% per annum and interest at the rate of 10% per annum, is convertible into shares of common stock at $0.032 per share prior to the completion of the company’s planned public offering of units (the “Public Offering”) or, subsequent to the closing of the Public Offering, the lower of $0.032 or 80% of the offering price per unit to the public in the Public Offering and are mandatorily redeemable upon such closing at 100% of the accrued principal amount and unpaid interest to the date of redemption. The Commitment Warrants are five-year warrants, exercisable upon the earlier of the effectiveness of the Company’s currently pending reverse stock split or December 1, 2019, at an amount equal to the lower of $0.032 or 80% of the offering price per unit to the public in the Public Offering. Upon entering into the 2019 Purchase Agreement, the Company drew an initial $500,000 under the Debenture and in accordance with the 2019 Purchase Agreement, Acuitas received an additional 15,625,000 warrants (the “Bridge Warrants”) having the same terms as the Commitment Warrants. Any future draws under the Debenture, which may be made from and after October 15, 2019, November 15, 2019 and December 15, 2019 in equal tranches of $500,000 each, will entitle Acuitas to receive additional Bridge Warrants in equal amount upon such funding. In addition, the 2019 Purchase Agreement provides that, should the underwriters in the Public Offering exercise their option to purchase additional securities during the 45 days following closing and the issuance of such securities would result in Acuitas' beneficial ownership (on a fully diluted basis) of shares of common stock being below 60%, Acuitas shall be issued a number of additional shares of common stock and warrants having the same terms as the Commitment Warrants to result in its beneficial ownership (on a fully diluted basis) of shares of common stock equaling 60%.

 

The issuance of 140,625,000 shares of the Company’s commons stock and warrants to purchase an equal amount number of shares, to its controlling stockholder for the Bridge Financing was accounted for as a deemed dividend due to its related party nature and $17.1 million representing the debt discount, net of the outstanding draw amount; was recorded in accumulated deficit for the three months ended September 30, 2019, accordingly. (See accompanied Condensed Statements of Changes in Stockholders’ (Deficit) Equity). A debt discount of $500,000 against the debenture was recorded which will be amortized over the term of the debenture using the effective interest method. The Company recognized amortization of this discount in the amount of $1,534 for the three-month period ended September 30, 2019.

 

Pursuant to the 2019 Purchase Agreement, Acuitas has agreed to further modify its existing rights under the Purchase Agreement dated July 3, 2018 with the Company so that Acuitas’ previous agreement in June 2019 to waive its rights to a 50% adjustment of the purchase price of the Preferred Stock in the July 2018 transaction, the exercise price of the warrants in such transaction and the price per share in a Subsequent Sale in the event of certain reductions in the useful life of our current intellectual property rights, and effectively exercise its rights to purchase securities in a Subsequent Sale pursuant to a “cashless purchase” at an assumed current market price of approximately $0.09 per share, conditioned in each case on the listing of the Company’s common stock on Nasdaq or the raising of $2.0 million in additional funds in the form of another securities offering, in either case not later than November 30, 2019, such that Acuitas will have irrevocably waived its rights to an adjustment in the purchase price of the Preferred Stock in the Initial Sale and the exercise price of the Warrants and the purchase price of per share in the Subsequent Sale upon the issuance by us of an aggregate of 334,989,500 shares of common stock and 334,989,500 warrants having the same terms as the Commitment Warrants to Acuitas, upon the closing of the Public Offering.

 

Pursuant to an amendment to the 2019 Purchase Agreement dated October 9, 2019, Acuitas agreed to modify its existing rights under the 2019 Purchase Agreement so that:

 

  The Commitment Warrants (and related warrants issued upon the first draw under the Debenture) were replaced with warrants having similar terms, but which are automatically exercised upon the closing of the offering at an exercise price equal to the par value of the common stock;
     
  Acuitas' existing rights under the Purchase Agreement dated July 3, 2018 with the Company were further amended so that the number of Subsequent Sale Shares would be multiplied by four (in lieu of the changes to the Purchase Agreement originally provided for in the 2019 Purchase Agreement); and
     
  The provisions of the 2019 Purchase Agreement providing that, should the underwriters in the offering exercise their option to purchase additional securities during the 45 days following closing and the issuance of such securities would result in Acuitas’ beneficial ownership (on a fully diluted basis) of shares of common stock being below 60%, Acuitas will be issued a number of additional shares of common stock and warrants having the same terms as the Commitment Warrants to result in its beneficial ownership (on a fully diluted basis) of shares of common stock equaling 60% have been modified such that, upon the exercise of such option by the underwriters, the Company will issue to Acuitas a number of securities that will result in Acuitas’ fully diluted beneficial ownership after the exercise of such option being the same as prior thereto.
XML 13 R15.htm IDEA: XBRL DOCUMENT v3.19.3
Subsequent Events
3 Months Ended
Sep. 30, 2019
Subsequent Events [Abstract]  
Subsequent Events
9. Subsequent Events

 

On October 1, 2019, the Company issued stock options to purchase 100,000 shares of common stock to the Chief Financial Officer as part of her compensation. The stock options were issued and are exercisable at an exercise price of $0.07 at any time from date of issuance and expire in 5 years from the date of issuance.

 

On October 13, 2019, the Company issued stock options to purchase 100,000 shares of common stock as part of their annual board of director compensation. The stock options were issued and are exercisable at $0.06 at any time from date of issuance and expire in 5 years from the date of issuance.

 

On November 7, 2019, the Company filed a certificate with the Nevada Secretary of State to terminate the effectiveness of Amendment of Article 3 to effect reverse split of the Corporation’s common stock in the ratio of 1:125. 

 

On November 13, 2019, the Patent Trial and Appeal Board of the United States Patent and Trademark Office (the “Board”) issued a written decision in the inter partes review (“IPR”) action that was brought by Mallinckrodt Pharmaceuticals Ireland Limited (“Mallinckrodt”) against BioVie Inc. (“BioVie” or “Company”). In that action, Mallinckrodt sought to invalidate BioVie’s patent (U.S. Pat. No. 9,655,945, “Treatment of Ascites”) (the “’945 Patent”). In its decision, the Board determined that all claims of the ‘945 Patent were not patentable because they were either anticipated or obvious in light of prior art. The Board also denied BioVie’s Motion to Amend the claims on similar grounds.  The result of the Board’s decision is that the ‘945 patent is no longer valid or enforceable. Acuitas Group Holdings, LLC was aware of this patent challenge when it purchased a majority ownership interest in the company in July 2018.

 

BioVie is evaluating the Board’s decision to determine if it will request a rehearing by the Board or appeal the Board’s decision to the U.S. Court of Appeals for the Federal Circuit. This ruling is unrelated to the Company’s Orphan drug designations for ascites and hepatorenal syndrome (“HRS”), which remain unchanged. An Orphan drug that is first-to-market typically receives 7 years of market exclusivity in the United States for the designated use(s). In addition, the ruling does not affect the Company’s rights in its pending patent application directed to proprietary liquid formulations of terlipressin for use in its planned Phase 2b/3 trial, subject to FDA clearance, which could eventually provide up to 20 years of patent coverage in each country in which the Company seeks patent protection, such as the United States, if a patent issues from a patent application according to the patent laws of each issuing country.

XML 14 R19.htm IDEA: XBRL DOCUMENT v3.19.3
Fair Value Measurements (Tables)
3 Months Ended
Sep. 30, 2019
Fair Value Disclosures [Abstract]  
Schedule of Estimated Fair Value of Derivative Liability

At September 30, 2019, the estimated fair value of derivative liabilities measured on a recurring basis are as follows:

 

   Fair Value Measurements at
   September 30, 2019
   Level 1  Level 2  Level 3  Total
             
Derivative liability – Warrants  $—     $—     $8,109,724   $8,109,724 
Derivative liability -Conversion option on convertible debenture   —      —      2,533,668    2,533,668 
   Total derivatives  $—     $—     $10,643,392   $10,643,392 
Schedule of Liabilities Measured at Fair Value

The following table presents the activity for liabilities measured at fair value using unobservable inputs for the three months ended September 30, 2019:

 

   Derivative liabilities - Warrants  Derivative liability - Conversion Option on Convertible Debenture
       
Beginning balance at July 1, 2019  $—     $—   
Additions to level 3 liabilities   8,367,012    2,638,966 
Change in in fair value of level 3 liability   (257,288)   (105,298)
Transfer in and/or out of Level 3   —      —   
Balance at September 30, 2019  $8,109,724   $2,533,668 
XML 15 R1.htm IDEA: XBRL DOCUMENT v3.19.3
Document and Entity Information - shares
3 Months Ended
Sep. 30, 2019
Nov. 18, 2019
Document And Entity Information    
Entity Registrant Name BIOVIE INC.  
Entity Central Index Key 0001580149  
Document Type 10-Q  
Document Period End Date Sep. 30, 2019  
Amendment Flag false  
Current Fiscal Year End Date --06-30  
Is Entity's Reporting Status Current? Yes  
Entity Filer Category Non-accelerated Filer  
Entity Common Stock, Shares Outstanding   647,930,147
Document Fiscal Period Focus Q1  
Document Fiscal Year Focus 2020  
Entity Emerging Growth Company false  
Entity Small Business true  
Entity Incorporation, State or Country Code NV  
Entity File Number 001-39015  
Entity Interactive Data Current Yes  
XML 16 R5.htm IDEA: XBRL DOCUMENT v3.19.3
Condensed Statements of Cash Flows (Unaudited) - USD ($)
3 Months Ended
Sep. 30, 2019
Sep. 30, 2018
CASH FLOWS FROM OPERATING ACTIVITIES:    
Net loss $ (3,821,227) $ (439,871)
Adjustments to reconcile net loss to net cash to cash used by operating activities:    
Amortization of intangible assets 57,344 57,344
Stock based compensation expense 3,412
Interest expense from convertible debenture 3,477,204
Change in fair value of derivative liabilities (362,586)
Changes in operating assets and liabilities:    
Other assets (182,229)
Accounts Payable 240,580 (62,767)
Net cash used by operating activities (590,914) (441,882)
CASH FLOWS FROM FINANCING ACTIVITIES:    
Repayment of debt (508,300)
Proceeds from issuance of preferred shares 3,040,000
Proceeds from issuance of common stock and warrants 500,000  
Net cash provided by financing activities 500,000 2,531,700
Net decrease in cash (90,914) 2,089,818
Cash, beginning of period 339,923 45,800
Cash, end of period 249,009 2,135,619
SUPPLEMENTAL CASH FLOW INFORMATION:    
Cash paid for interest 411
Cash paid for taxes
NON-CASH INVESTING AND FINANCING ACTIVITIES    
Conversion of preferred shares to common stock 3,200,000
Settlement of debt by issuance of common stock 1,150,135
Cashless exercise of warrants
Deemed dividends for ratchet adjustments to warrants 48,659
Deemed dividends for commitment shares 17,099,058 48,659
Stock warrants classified as derivative liability $ 7,530,308
XML 17 R9.htm IDEA: XBRL DOCUMENT v3.19.3
Significant Accounting Policies
3 Months Ended
Sep. 30, 2019
Accounting Policies [Abstract]  
Significant Accounting Policies
3. Significant Accounting Policies

 

Basis of Presentation – Interim Financial Information

 

The accompanying unaudited interim financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United State of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities Exchange Commission for Interim Reporting. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The unaudited interim financial statements furnished reflect all adjustments (consisting of normal recurring accruals) that are, in the opinion of management, considered necessary for a fair presentation of the results for the interim periods presented. Interim results are not necessarily indicative of the results for the full year. The condensed balance sheet at June 30, 2019 was derived from audited annual financial statements but does not contain all the footnote disclosures from the annual financial statements. The accompanying financial statements and information included under the heading: “Management’s Discussion and Analysis of Financial Condition and Results of Operations” should be read in conjunction with our Company’s audited financial statements and related notes included in our Company’s Form 10-K for the year ended June 30, 2019 filed with the SEC on September 27, 2019.

 

For a summary of significant accounting policies, see the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2019 filed with the SEC on September 27, 2019.

 

Net Loss per Common Share

 

Basic net loss per common share is computed by dividing the net loss before deemed dividend by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding and potentially outstanding shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable through stock options, warrants, convertible preferred stock and convertible debentures. Due to the net loss for the period, such amounts were excluded from the diluted loss since their effect was considered anti-dilutive.

 

The table below shows the number of outstanding stock options and warrants as of September 30, 2019 and 2018:

 

   September 30, 2019  September 30, 2018
   Number of Shares  Number of Shares
Stock Options   7,250,000    5,150,000 
Warrants   171,833,216    216,441,548 
Total   179,083,216    221,591,548 

 

Recent accounting pronouncements

 

The Company considers the applicability and impact of all Accounting Standard Updates (“ASU’s”). ASU’s not discussed below were assessed and determined to be either not applicable or expected to have minimal impact on our balance sheets or statement of operations.

 

In June 2018, the FASB issued ASU 2018-07, “Compensation – Stock Compensation (Topic 718): Improvements to Non-employee Share-Based Accounting”. This guidance aligns the accounting for share-based payment transactions with non-employees to accounting for share-based payment transactions with employees. Companies are required to record a cumulative-effect adjustment (net of tax) to retained earnings as of the beginning of the fiscal year of the adoption. Upon transition, non-employee awards are required to be measured at fair value as of the adoption date. This standard will be effective for fiscal years beginning December 15, 2018, including interim periods within those fiscal years. Early adoption is permitted. The Company has adopted this ASU as of July 1, 2019. There has been no impact on the financial statements.

 

In August 2018, the FASB issued ASU 2018-13, “Fair value measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement”. The new guidance modifies the disclosure requirements on fair value measurements. ASU 2018-13 is effective for fiscal years beginning after December 15, 2019. Early adoption is permitted. The Company does not expect ASU 2018-13 to have a significant impact to its condensed consolidated financial statements and related disclosures.

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Intangible Assets (Details 2) - USD ($)
Sep. 30, 2019
Jun. 30, 2019
Disclosure Intangible Assets Details 2Abstract    
2020 $ 172,032  
2021 229,377  
2022 229,377  
2023 229,377  
2024 229,377  
2025 229,377  
Thereafter 178,342  
Intellectual Property, Net $ 1,497,259 $ 1,554,603
XML 20 R27.htm IDEA: XBRL DOCUMENT v3.19.3
Equity Transactions (Details 2) - Stock Option [Member] - $ / shares
3 Months Ended
Sep. 30, 2019
Jun. 30, 2019
Exercise Price $ 0.03  
Option Outstanding 700,000  
Weighted Average Contractual Life 4 years 3 months 18 days  
Option Excersiable 700,000  
Exercise Price $ 0.05  
Option Outstanding 1,300,000  
Weighted Average Contractual Life 4 years 4 months 24 days  
Option Excersiable 1,300,000  
Exercise Price $ 0.06  
Option Outstanding 3,100,000  
Weighted Average Contractual Life 6 years 4 months 24 days  
Option Excersiable 3,100,000  
Exercise Price $ 0.07  
Option Outstanding 100,000  
Weighted Average Contractual Life 4 years  
Option Excersiable 100,000  
Exercise Price $ 0.10  
Option Outstanding 500,000  
Weighted Average Contractual Life 3 years 3 months 18 days  
Option Excersiable 500,000  
Exercise Price $ 0.20  
Option Outstanding 200,000  
Weighted Average Contractual Life 3 years  
Option Excersiable 200,000  
Exercise Price $ 0.21  
Option Outstanding 550,000  
Weighted Average Contractual Life 2 years 7 months 6 days  
Option Excersiable 550,000  
Exercise Price $ 0.22  
Option Outstanding 100,000  
Weighted Average Contractual Life 2 years 6 months  
Option Excersiable 100,000  
Exercise Price $ 0.23  
Option Outstanding 200,000  
Weighted Average Contractual Life 2 years 10 months 24 days  
Option Excersiable 200,000  
Exercise Price $ 0.25  
Option Outstanding 500,000  
Weighted Average Contractual Life 2 years 1 month 6 days  
Option Excersiable 500,000  
Exercise Price $ 0.10 $ 0.10
Option Outstanding 7,250,000 7,250,000
Weighted Average Contractual Life 5 years 2 months 12 days  
Option Excersiable 7,250,000  
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Intangible Assets (Details) - USD ($)
Sep. 30, 2019
Jun. 30, 2019
Disclosure Intangible Assets Details Abstract    
Intellectual Property $ 2,293,770 $ 2,293,770
Accumulated Amortization (796,511) (739,167)
Intellectual Property, Net $ 1,497,259 $ 1,554,603

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XML 25 R26.htm IDEA: XBRL DOCUMENT v3.19.3
Equity Transactions (Details) - Stock Option [Member] - USD ($)
3 Months Ended
Sep. 30, 2019
Sep. 30, 2018
Option Outstanding at beginning of period 7,250,000  
Option Granted  
Option Exercised  
Option Outstanding at end of period 7,250,000  
Option Excersiable at end of period 7,250,000  
Outstanding Weighted Average Exercise Price at the beginning of period $ 0.10  
Weighted Average Exercise Price, Granted  
Weighted Average Exercise Price, Exercised  
Outstanding Weighted Average Exercise Price at the end of period 0.10  
Excersiable Weighted Average Exercise Price at the end of period $ 0.10  
Weighted Average Remaining Contractual Term at the beginning of period 5 years 2 months 12 days  
Weighted Average Remaining Contractual Term at the end 4 years 9 months 18 days  
Excersiable Weighted Average Remaining Contractual Term at the end of period 4 years 9 months 18 days  
Aggregate Intrinsic Value Outstanding at beginning of period $ 87,480  
Granted  
Options Exercised or Forfeited  
Aggregate Intrinsic Value Outstanding at end of period 87,480  
Aggregate Intrinsic Value Exercisable $ 87,480  
Expected life of options (In years) 9 years 6 months
Expected volatility   63.09%
Risk free interest rate 0.00%
Dividend Yield 0.00%
XML 26 R18.htm IDEA: XBRL DOCUMENT v3.19.3
Intangible Assets (Tables)
3 Months Ended
Sep. 30, 2019
Disclosure Intangible Assets Tables Abstract  
Schedule of Intangible Assets

The following is a summary of the intangible assets as of September 30, 2019 and June 30, 2019:

 

   September 30, 2019  June 30, 2019
       
Intellectual Property  $2,293,770   $2,293,770 
Less Accumulated Amortization   (796,511)   (739,167)
Intellectual Property, Net  $1,497,259   $1,554,603 
Schedule of Future expected Amortization of intangible assets

Estimated future amortization expense is as follows:

 

Year ending June 30, 2020 (Remaining nine months)  $172,032 
2021   229,377 
2022   229,377 
2023   229,377 
2024   229,377 
2025   229,377 
Thereafter   178,342 
   $1,497,259 
XML 27 R10.htm IDEA: XBRL DOCUMENT v3.19.3
Intangible Assets
3 Months Ended
Sep. 30, 2019
Related Party Transactions [Abstract]  
Intangible Assets
4. Intangible Assets

 

The Company’s intangible assets consist of intellectual property acquired from LAP Pharma, Inc. and are amortized over their estimated useful lives. The following is a summary of the intangible assets as of September 30, 2019 and June 30, 2019:

 

   September 30, 2019  June 30, 2019
       
Intellectual Property  $2,293,770   $2,293,770 
Less Accumulated Amortization   (796,511)   (739,167)
Intellectual Property, Net  $1,497,259   $1,554,603 

 

Amortization expense for the three-month period ended September 30, 2019 and 2018 was $57,344 and $57,344 respectively.

 

Estimated future amortization expense is as follows:

 

Year ending June 30, 2020 (Remaining nine months)  $172,032 
2021   229,377 
2022   229,377 
2023   229,377 
2024   229,377 
2025   229,377 
Thereafter   178,342 
   $1,497,259 
XML 28 R14.htm IDEA: XBRL DOCUMENT v3.19.3
Commitments and Contingencies
3 Months Ended
Sep. 30, 2019
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies
8. Commitments and Contingencies 

 

Office Lease 

 

On July 1, 2019, the Company’s office moved with Acuitas’ new offices to 2120 Colorado Avenue Ste 230, Santa Monica, CA 90404. There is no lease agreement for the new premises and the Company continues to accrue monthly lease payments of $1,000 for the new office under the terms of the previous month-to-month lease for the previous premises which may be cancelled upon 30 days’ written notice.

 

Challenge to US Patent

 

On April 30, 2018, we received notice that Mallinckrodt had petitioned the U.S. Patent and Trademark Office (“USPTO”) to institute an Inter Partes Review of our U.S. Patent No. 9,655,945 titled “Treatment of Ascites” (the “’945 patent”). Inter Partes Review is a trial proceeding conducted with the USPTO Patent Trial and Appeal Board (PTAB) to review the patentability of one or more claims of a patent. Such review is limited to grounds of novelty and obviousness on the basis of prior art consisting of patents and printed publications.

 

On November 13, 2019, the Patent Trial and Appeal Board of the United States Patent and Trademark Office (the “Board”) issued a written decision in the inter partes review (“IPR”) action that was brought by Mallinckrodt Pharmaceuticals Ireland Limited (“Mallinckrodt”) against BioVie Inc. (“BioVie” or “Company”). In that action, Mallinckrodt sought to invalidate BioVie’s patent (U.S. Pat. No. 9,655,945, “Treatment of Ascites”) (the “’945 Patent”). In its decision, the Board determined that all claims of the ‘945 Patent were not patentable because they were either anticipated or obvious in light of prior art. The Board also denied BioVie’s Motion to Amend the claims on similar grounds. The result of the Board’s decision is that the ‘945 patent is no longer valid or enforceable. Acuitas Group Holdings, LLC was aware of this patent challenge when it purchased a majority ownership interest in the company in July 2018.

 

BioVie is evaluating the Board’s decision to determine if it will request a rehearing by the Board or appeal the Board’s decision to the U.S. Court of Appeals for the Federal Circuit. This ruling is unrelated to the Company’s Orphan drug designations for ascites and hepatorenal syndrome (“HRS”), which remain unchanged. An Orphan drug that is first-to-market typically receives 7 years of market exclusivity in the United States for the designated use(s). In addition, the ruling does not affect the Company’s rights in its pending patent application directed to proprietary liquid formulations of terlipressin for use in its planned Phase 2b/3 trial, subject to FDA clearance, which could eventually provide up to 20 years of patent coverage in each country in which the Company seeks patent protection, such as the United States, if a patent issues from a patent application according to the patent laws of each issuing country.

 

At September 30, 2019, no adjustments or accruals have been reflected in our financial statements related to this matter. (See Note 9 – Subsequent events.)

 

Royalty Agreements

 

Pursuant to the Agreement and Plan of Merger entered into on April 11, 2016 between our predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc.

 

The Company and PharmaIN Corporation, LAT Pharma’s former partner focused on the development of new modified drug candidates in the same therapeutic field but not including BIV201, had agreed to pay royalties equal to less than 1% of future net sales of each company's ascites drug development programs, or if such program is licensed to a third party, less than 5% of each company's net license revenues. On December 24, 2018, the Company returned its partial ownership rights to the PharmaIN modified terlipressin development program and simultaneously paid the remaining balance due on a related debt. PharmaIN, Corp. rights to our program remain unchanged.

 

Pursuant to the Technology Transfer Agreement entered into on July 25, 2016 between BioVie and the University of Padova (Italy), BioVie is obligated to pay a low single digit royalty on net sales of all terlipressin products covered by US patent no. 9,655,645 and any future foreign issuances capped at a maximum of $200,000 per year.

XML 29 R8.htm IDEA: XBRL DOCUMENT v3.19.3
Liquidity and Going Concern
3 Months Ended
Sep. 30, 2019
Notes to Financial Statements  
Liquidity and Going Concern
2. Liquidity and Going Concern

 

The Company’s operations are subject to a number of factors that can affect its operating results and financial conditions. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s products, the Company’s ability to obtain regulatory approval to market its products, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company products, the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, and the Company’s ability to raise capital. The Company’s financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As of September 30, 2019, the Company had an accumulated deficit of $28.2 million and as a development stage enterprise, the Company expects substantial losses in future periods. The accompanying interim financial statements were prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company’s future operations are dependent on the success of the Company’s ongoing development and commercialization effort, as well as continuing to secure additional financing.

 

On September 24, 2019, the Company entered into a Securities Purchase Agreement with its controlling stockholder regarding bridge financing (the “Bridge Financing”) in the form of up to $2.0 million in convertible debt and warrants, of which $500,000 has been drawn as of September 30, 2019. Amounts borrowed under the Bridge Financing must be repaid with the proceeds of our potential public offering of equity securities referred to below. The availability of additional draws under the Bridge Financing is under further discussion with the controlling stockholder in light of delays in the timing of the potential public offering. As further discussed below, the Company is pursuing various options to raise further financing to continue the testing and development of its product. If the Company is not successful in raising additional funds it may reduce its monthly spend and potentially delay the implementation of the larger scale Phase 2b Clinical trial until sufficient funding is secured.

 

Additionally, in April 2019, to facilitate our planned up listing to the NASDAQ Stock Market and related potential future issuances and sales of our equity securities for ordinary corporate finance and general corporate purposes and as recommended by our Board of Directors (“Board”), our stockholders approved an amendment to our Articles of Incorporation to effect a reverse split of our outstanding Class A common stock in the range of 50:1 to 200:1, as determined by our Board. Following that approval, we filed a Registration Statement on Form S-1 (Registration No. 333-231136) (the “S-1 Registration Statement”) pursuant to which we anticipate completing an offering of our equity securities with proceeds sufficient to enable the launch and completion of the BIV201 Phase 2b study and fund our internal operations for at least the next twelve months. There can be no assurance, however, that we will successfully complete an offering thereunder on the terms contemplated by the S-1 Registration Statement or on any commercially reasonable terms.

 

The future viability of the Company is largely dependent upon its ability to raise additional capital to finance its operations. Management expects that future sources of funding may include sales of equity, obtaining loans, or other strategic transactions. Although management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the Company, if at all, to fund continuing operations. These circumstances raise substantial doubt on the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

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Condensed Statements of Operations (Unaudited) - USD ($)
3 Months Ended
Sep. 30, 2019
Sep. 30, 2018
OPERATING EXPENSES    
Amortization $ 57,344 $ 57,344
Research and development expenses 341,501 194,521
Selling, general and administrative expenses 307,373 239,562
TOTAL OPERATING EXPENSES 706,218 491,427
LOSS FROM OPERATIONS (706,218) (491,427)
OTHER EXPENSE (INCOME)    
Change in fair value of derivative liabilities (362,586)
Gain on settlement of debt (51,400)
Interest Expense 3,477,615 272
Interest income (20) (428)
TOTAL OTHER EXPENSE (INCOME) 3,115,009 (51,556)
NET LOSS (3,821,227) (439,871)
Deemed dividend 17,099,058 48,659
NET LOSS ATTRIBUTABLE TO COMPANY STOCKHOLDERS $ (20,920,285) $ (488,530)
NET LOSS PER COMMON SHARE, BASIC AND DILUTED $ (0.04) $ 0.00
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING, BASIC AND DILUTED 516,577,125 309,279,009
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Equity Transactions (Tables)
3 Months Ended
Sep. 30, 2019
Disclosure Stock Options Tables Abstract  
Schedule of Stock Option Issued

The following table summarizes the activity relating to the Company’s stock options for the three months ended September 30, 2019:

 

   Options  Weighted-Average Exercise Price  Weighted Remaining Average Contractual Term  Aggregate Intrinsic Value
Outstanding at June 30, 2019   7,250,000   $0.10    5.2   $87,480 
Granted   —      —      —      —   
Options Exercised or Forfeited   —      —      —      —   
Outstanding at September 30, 2019   7,250,000   $0.10    4.8   $87,480 
Exercisable at  September 30, 2019   7,250,000   $0.10    4.8   $87,480 

 

The pricing model reflected the following weighted-average assumptions for the three months ended September 30, 2018:

 

   September 30 2019  September 30 2018
Expected life of options (In years)   —      9.5 
Expected volatility   —      63.09%
Risk free interest rate   —      0.00%
Dividend Yield   —      0%
Schedule of option outstanding and exercisable by exercise price

The following is a summary of stock options outstanding and exercisable by exercise price as of September 30, 2019:

 

Exercise Price  Outstanding  Weighted Average Contract Life  Exercisable
$0.03    700,000    4.3    700,000 
$0.05    1,300,000    4.4    1,300,000 
$0.06    3,100,000    6.4    3,100,000 
$0.07    100,000    4.0    100,000 
$0.10    500,000    3.3    500,000 
$0.20    200,000    3.0    200,000 
$0.21    550,000    2.6    550,000 
$0.22    100,000    2.5    100,000 
$0.23    200,000    2.9    200,000 
$0.25    500,000    2.1    500,000 
 Total    7,250,000         7,250,000 
Schedule of Warrants Issued

The following table summarizes the warrants activity during the three months ended September 30, 2019:

 

   Number of Shares  Weighted Average Exercise Price  Weighted Average Remaining Life (Years)  Aggregate Intrinsic Value
Outstanding and exercisable at June 30, 2019   15,583,216   $0.36    5.6   $716,653 
Granted   156,250,000   $0.03    5.0   $5,906,250 
Expired   —     $—      —     $—   
Outstanding and exercisable at September 30, 2019   171,833,216   $0.04    4.9   $6,622,903 
XML 33 R24.htm IDEA: XBRL DOCUMENT v3.19.3
Fair Value Measurements (Details) - USD ($)
Sep. 30, 2019
Jun. 30, 2019
Total derivatives $ 10,643,392  
Fair Value, Inputs, Level 3 [Member]    
Total derivatives 10,643,392  
Derivative liability - Warrants [Member]    
Total derivatives 8,109,724  
Derivative liability - Warrants [Member] | Fair Value, Inputs, Level 3 [Member]    
Total derivatives 8,109,724
Derivative Liability - Conversion Option on Convertible Debenture [Member]    
Total derivatives 2,533,668  
Derivative Liability - Conversion Option on Convertible Debenture [Member] | Fair Value, Inputs, Level 3 [Member]    
Total derivatives $ 2,533,668
XML 34 R28.htm IDEA: XBRL DOCUMENT v3.19.3
Equity Transactions (Details 3) - Warrant [Member]
3 Months Ended
Sep. 30, 2019
USD ($)
$ / shares
shares
Warrant Outstanding at the beginning of the year | shares 15,583,216
Warrant Granted | shares 156,250,000
Warrant Expired | shares
Warrant Exercised | shares 171,833,216
Weighted Average Exercise Price at the beginning of the year | $ / shares $ 0.36
Weighted Average Exercise Price, Granted | $ / shares 0.03
Weighted Average Exercise Price, Expired | $ / shares
Weighted Average Exercise Price, Exercised | $ / shares $ 0.04
Weighted Average Remaining Life at the beginning of the year 5 years
Weighted Average Remaining Life, Granted 5 years 3 months 18 days
Weighted Average Remaining Life at the end of year 5 years 3 months 18 days
Aggregate Intrinsic Value Outstanding at beginning of period | $ $ 716,653
Aggregate Intrinsic Value, Granted | $ 5,906,250
Aggregate Intrinsic Value Outstanding at end of period | $ $ 6,622,903
XML 35 R12.htm IDEA: XBRL DOCUMENT v3.19.3
Fair Value Measurements
3 Months Ended
Sep. 30, 2019
Fair Value Disclosures [Abstract]  
Fair Value Measurements
6. Fair Value Measurements

 

At September 30, 2019, the estimated fair value of derivative liabilities measured on a recurring basis are as follows:

 

   Fair Value Measurements at
   September 30, 2019
   Level 1  Level 2  Level 3  Total
             
Derivative liability – Warrants  $—     $—     $8,109,724   $8,109,724 
Derivative liability -Conversion option on convertible debenture   —      —      2,533,668    2,533,668 
   Total derivatives  $—     $—     $10,643,392   $10,643,392 

 

The following table presents the activity for liabilities measured at fair value using unobservable inputs for the three months ended September 30, 2019:

 

   Derivative liabilities - Warrants  Derivative liability - Conversion Option on Convertible Debenture
       
Beginning balance at July 1, 2019  $—     $—   
Additions to level 3 liabilities   8,367,012    2,638,966 
Change in in fair value of level 3 liability   (257,288)   (105,298)
Transfer in and/or out of Level 3   —      —   
Balance at September 30, 2019  $8,109,724   $2,533,668 

 

Derivative liability – Warrants

 

The Company accounts for stock purchase warrants as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreements. Under applicable accounting guidance, stock warrants that are precluded from being indexed to the Company’s own stock because of full-rachet anti-dilution provisions or the adjustments to the strike price due to an occurrence of a future event; are accounted for as derivative financial instruments. The stock warrants issued September 24, 2019 were not considered indexed to the Company’s own stock because of the adjustment to strike price, an occurrence of a future event such as the Company’s pending capital raise.

 

The warrants associated with the level 3 liability were issued on September 24, 2019 and were valued using the Black-Scholes-Merton model with the following assumptions: stock price of $0.0716, exercise price of $0.032, term of 5 years expiring September 2024, volatility of 71.44%, dividend yield of 0%, and risk-free interest rate of 1.52%. The valuation at September 30, 2019 used the following assumptions: stock price of $0.0698, exercise price of $0.032, term of 5 year expiring September 2024, volatility of 71.42%, dividend yield of 0%, and risk-free interest rate of 1.55%. (See note 5 “Related Party Transactions – Convertible debenture transactions)

 

Derivative liability – Conversion option in convertible debenture

 

The Company valued the conversion option of the $2 million 10% OID Convertible Delayed Draw Debenture which may be convertible into shares of common stock at $0.032 per share prior to the completion of an offering or, subsequent to the closing of the offering, the lower of $0.032 or 80% of the offering price per unit to the public in this offering and are mandatorily redeemable upon such closing at 100% of the accrued principal amount and unpaid interest to the date of redemption. (See note 5 “Related Party Transactions – Convertible debenture transactions with Acuitas” as of September 24, 2019). The conversion option was valued on September 24, 2019 using the Black Scholes-Mertons model with the following assumptions: stock price of $0.0716, conversion price of $0.032, term of 1 year expiring September 2020, volatility of 75.48%, dividend yield of 0%, and risk-free interest rate of 1.78%. The valuation at September 30, 2019 used the following assumptions: stock price of $0.0698, conversion price of $0.032, term of 1 year expiring September 2020, volatility of 75.5%, dividend yield of 0%, and risk-free interest rate of 1.75%.

XML 36 R16.htm IDEA: XBRL DOCUMENT v3.19.3
Significant Accounting Policies (Policies)
3 Months Ended
Sep. 30, 2019
Accounting Policies [Abstract]  
Basis of Presentation

Basis of Presentation – Interim Financial Information

 

The accompanying unaudited interim financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United State of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities Exchange Commission for Interim Reporting. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The unaudited interim financial statements furnished reflect all adjustments (consisting of normal recurring accruals) that are, in the opinion of management, considered necessary for a fair presentation of the results for the interim periods presented. Interim results are not necessarily indicative of the results for the full year. The condensed balance sheet at June 30, 2019 was derived from audited annual financial statements but does not contain all the footnote disclosures from the annual financial statements. The accompanying financial statements and information included under the heading: “Management’s Discussion and Analysis of Financial Condition and Results of Operations” should be read in conjunction with our Company’s audited financial statements and related notes included in our Company’s Form 10-K for the year ended June 30, 2019 filed with the SEC on September 27, 2019.

 

For a summary of significant accounting policies, see the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2019 filed with the SEC on September 27, 2019.

Net Loss per Common Share

Net Loss per Common Share

 

Basic net loss per common share is computed by dividing the net loss before deemed dividend by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding and potentially outstanding shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable through stock options, warrants, convertible preferred stock and convertible debentures. Due to the net loss for the period, such amounts were excluded from the diluted loss since their effect was considered anti-dilutive.

 

The table below shows the number of outstanding stock options and warrants as of September 30, 2019 and 2018:

 

   September 30, 2019  September 30, 2018
   Number of Shares  Number of Shares
Stock Options   7,250,000    5,150,000 
Warrants   171,833,216    216,441,548 
Total   179,083,216    221,591,548 
Recent accounting pronouncements

Recent accounting pronouncements

 

The Company considers the applicability and impact of all Accounting Standard Updates (“ASU’s”). ASU’s not discussed below were assessed and determined to be either not applicable or expected to have minimal impact on our balance sheets or statement of operations.

 

In June 2018, the FASB issued ASU 2018-07, “Compensation – Stock Compensation (Topic 718): Improvements to Non-employee Share-Based Accounting”. This guidance aligns the accounting for share-based payment transactions with non-employees to accounting for share-based payment transactions with employees. Companies are required to record a cumulative-effect adjustment (net of tax) to retained earnings as of the beginning of the fiscal year of the adoption. Upon transition, non-employee awards are required to be measured at fair value as of the adoption date. This standard will be effective for fiscal years beginning December 15, 2018, including interim periods within those fiscal years. Early adoption is permitted. The Company has adopted this ASU as of July 1, 2019. There has been no impact on the financial statements.

 

In August 2018, the FASB issued ASU 2018-13, “Fair value measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement”. The new guidance modifies the disclosure requirements on fair value measurements. ASU 2018-13 is effective for fiscal years beginning after December 15, 2019. Early adoption is permitted. The Company does not expect ASU 2018-13 to have a significant impact to its condensed consolidated financial statements and related disclosures.

XML 37 R2.htm IDEA: XBRL DOCUMENT v3.19.3
Condensed Balance Sheet (Unaudited) - USD ($)
Sep. 30, 2019
Jun. 30, 2019
CURRENT ASSETS:    
Cash $ 249,009 $ 339,923
Other Assets 516,379 334,150
Total Current Assets 765,388 674,073
OTHER ASSETS:    
Intangible Assets 1,497,259 1,554,603
Goodwill 345,711 345,711
Total Fixed Assets 1,842,970 1,900,314
TOTAL ASSETS 2,608,358 2,574,387
CURRENT LIABILITIES:    
Accounts Payable and accrued expenses 684,060 443,480
Derivative liability - warrants 8,109,724
Derivative liability - conversion option on convertible debenture 2,533,668
Convertible debenture - related party, net of discount $498,466 and $0 at September 30, 2019 and 2018, respectively 1,534
Total Current Liabilities 11,328,986 443,480
TOTAL LIABILITIES 11,328,986 443,480
Commitments and contingencies  
STOCKHOLDERS' EQUITY    
Preferred stock; $0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding
Common stock, $0.0001 par value; 800,000,000 shares authorized at September 30, 2019 and June 30, 2019, respectively; 647,930,147 and 507,305,147 shares issued and outstanding at September 30, 2019 and June 30, 2019, respectively 64,793 50,730
Additional paid in capital 19,396,936 9,342,249
Accumulated deficit (28,182,357) (7,262,072)
Total Stockholders' Equity (8,720,628) 2,130,907
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 2,608,358 $ 2,574,387
XML 38 R6.htm IDEA: XBRL DOCUMENT v3.19.3
Condensed Statements of Stockholders' Equity (Unaudited) - USD ($)
Preferred Stock
Common Stock
Additional Paid-In Capital
Accumulated Deficit
Total
Beginning Balance at Jun. 30, 2018 $ 9,850 $ 4,870,474 $ (4,769,126) $ 111,199
Beginning Balance, Shares at Jun. 30, 2018 98,503,199      
Issuance of shares in a private placement $ 3,200,000 3,200,000 3,200,000
Issuance of shares in a private placement (in shares) 2,133,332      
Conversion of preferred stock to common stock $ (3,200,000) $ 21,333 (21,333)
Conversion of preferred stock to common stock (in shares) (2,133,332) 213,333,200      
Issuance of shares in exchange for debt settlement $ 98 1,150,037 1,150,135
Issuance of shares in exchange for debt settlement, Shares 975,361      
Stock option compensation 3,412 3,412
Cashless exercise of warrants $ 224 (224)
Cashless exercise of warrants, Shares 2,241,913      
Deemed dividends for ratchet adjustment to warrants 48,659 (48,659)
Net loss (439,871) (439,871)
Ending Balance at Sep. 30, 2018 $ 31,505 9,251,025 (5,257,655) 4,024,876
Ending Balance, Shares at Sep. 30, 2018 315,053,673      
Beginning Balance at Jun. 30, 2019 $ 50,730 9,342,249 (7,262,072) 2,130,907
Beginning Balance, Shares at Jun. 30, 2019 507,305,147      
Issuance of commitment shares $ 14,063 10,054,687 10,068,750
Issuance of commitment shares, Shares 140,625,000      
Issuance of shares in exchange for debt settlement        
Stock option compensation        
Cashless exercise of warrants        
Deemed dividends for ratchet adjustment to warrants (17,099,058) (17,099,058)
Net loss (3,821,227) (3,821,227)
Ending Balance at Sep. 30, 2019 $ 64,793 $ 19,396,936 $ (28,182,357) $ (8,720,628)
Ending Balance, Shares at Sep. 30, 2019 647,930,147      
XML 39 R13.htm IDEA: XBRL DOCUMENT v3.19.3
Equity Transactions
3 Months Ended
Sep. 30, 2019
Share-based Payment Arrangement [Abstract]  
Equity Transactions
7. Equity Transactions

 

Stock Options

 

The following table summarizes the activity relating to the Company’s stock options for the three months ended September 30, 2019:

 

   Options  Weighted-Average Exercise Price  Weighted Remaining Average Contractual Term  Aggregate Intrinsic Value
Outstanding at June 30, 2019   7,250,000   $0.10    5.2   $87,480 
Granted   —      —      —      —   
Options Exercised or Forfeited   —      —      —      —   
Outstanding at September 30, 2019   7,250,000   $0.10    4.8   $87,480 
Exercisable at  September 30, 2019   7,250,000   $0.10    4.8   $87,480 

 

The fair value of each option grant on the date of grant is estimated using the Black-Scholes option. There were no options granted during the three months ended September 30, 2019. The pricing model reflected the following weighted-average assumptions for the three months ended September 30, 2018:

 

   September 30 2019  September 30 2018
Expected life of options (In years)   —      9.5 
Expected volatility   —      63.09%
Risk free interest rate   —      0.00%
Dividend Yield   —      0%

 

Expected volatility is based on the historical volatilities of three comparable companies of the daily closing price of their respective common stock and the expected life of options is based on historical data with respect to employee exercise periods. The Company accounts for forfeitures as they are incurred.

 

The Company recorded stock-based compensation expense of $0 and $3,412 for the three- month period ended September 30, 2019 and 2018, respectively.

 

The following is a summary of stock options outstanding and exercisable by exercise price as of September 30, 2019:

 

Exercise Price  Outstanding  Weighted Average Contract Life  Exercisable
$0.03    700,000    4.3    700,000 
$0.05    1,300,000    4.4    1,300,000 
$0.06    3,100,000    6.4    3,100,000 
$0.07    100,000    4.0    100,000 
$0.10    500,000    3.3    500,000 
$0.20    200,000    3.0    200,000 
$0.21    550,000    2.6    550,000 
$0.22    100,000    2.5    100,000 
$0.23    200,000    2.9    200,000 
$0.25    500,000    2.1    500,000 
 Total    7,250,000         7,250,000 

 

Stock Warrants

 

The following table summarizes the warrants activity during the three months ended September 30, 2019:

 

   Number of Shares  Weighted Average Exercise Price  Weighted Average Remaining Life (Years)  Aggregate Intrinsic Value
Outstanding and exercisable at June 30, 2019   15,583,216   $0.36    5.6   $716,653 
Granted   156,250,000   $0.03    5.0   $5,906,250 
Expired   —     $—      —     $—   
Outstanding and exercisable at September 30, 2019   171,833,216   $0.04    4.9   $6,622,903 

 

Of the above warrants, 1,173,864 expire in fiscal year ending June 30, 2022, 556,818 expire in fiscal year ending June 30, 2023, and 170,102,534 expire in fiscal year ending June 30, 2025.

XML 40 R17.htm IDEA: XBRL DOCUMENT v3.19.3
Significant Accounting Policies (Tables)
3 Months Ended
Sep. 30, 2019
Disclosure Significant Accounting Policies Tables Abstract  
Schedule of Dilutive securities were excluded from the computation of diluted loss per share

The table below shows the number of outstanding stock options and warrants as of September 30, 2019 and 2018:

 

   September 30, 2019  September 30, 2018
   Number of Shares  Number of Shares
Stock Options   7,250,000    5,150,000 
Warrants   171,833,216    216,441,548 
Total   179,083,216    221,591,548 
XML 41 R3.htm IDEA: XBRL DOCUMENT v3.19.3
Condensed Balance Sheet (Unaudited) (Parenthetical) - $ / shares
Sep. 30, 2019
Jun. 30, 2019
Statement of Financial Position [Abstract]    
Preferred stock, par value $ 0.001 $ 0.001
Preferred stock, shares authorized 10,000,000 10,000,000
Preferred Stock, Shares Issued 0 0
Preferred stock, shares outstanding 0 0
Common stock, par value $ 0.0001 $ 0.0001
Common stock, shares authorized 800,000,000 800,000,000
Common Stock Shares Issued 647,930,147 507,305,147
Common stock, shares outstanding 647,930,147 507,305,147
XML 42 R7.htm IDEA: XBRL DOCUMENT v3.19.3
Background Information
3 Months Ended
Sep. 30, 2019
Notes to Financial Statements  
Background Information
1. Background Information

 

BioVie Inc. (the “Company”) is a clinical-stage company pursuing the discovery, development, and commercialization of innovative drug therapies. We are currently focused on developing and commercializing BIV201 (continuous infusion terlipressin), a novel approach to the treatment of ascites due to chronic liver cirrhosis. Our therapy BIV201 is based on a drug that is approved in about 40 countries to treat related complications of liver cirrhosis (part of the same disease pathway as ascites), but not yet available in the United States. BIV201’s active agent is a potent vasoconstrictor and has shown efficacy for reducing portal hypertension in studies around the world. The goal is for BIV201 to interrupt the ascites disease pathway, thereby halting the cycle of accelerating fluid generation in ascites patients.

 

BioVie began administering BIV201 to patients in a Phase 2a clinical trial in patients with refractory ascites due to advanced liver cirrhosis at the McGuire Research Institute Inc. in Richmond, VA in September 2017. In April 2019, we announced top-line results and in June met with representatives of the FDA for a Type C Guidance Meeting to discuss the study results and plan our next clinical study. In July 2019, the FDA provided meeting minutes that documented general agreement with the Company’s proposed randomized and controlled study design. The FDA also provided its suggestions and guidance regarding primary and secondary endpoints, quality of life measures and other key aspects of the clinical trial design. In October 2019, BioVie announced the submission of a Phase 2b/3 clinical trial protocol to the FDA. We are developing a patent-pending novel liquid formulation of terlipressin for use in this study that is intended to improve convenience for outpatient administration and avoid potential formulation errors that may occur when pharmacists reconstitute the powder version.

 

BIV201 has the potential to improve the health of thousands of patients suffering from life-threatening complications of liver cirrhosis due to hepatitis, nonalcoholic steatohepatitis (NASH), and alcoholism. It has FDA Fast-Track status and Orphan Drug designation for the most common of these complications, ascites, which represents a significant unmet medical need. An Orphan drug that is first-to-market typically receives 7 years of market exclusivity in the United States for the designated use(s). The FDA has never approved any drug specifically for treating ascites. In addition, the Company has a pending patent application directed to proprietary liquid formulations of terlipressin for use in its planned Phase 2b/3 trial, subject to FDA clearance, which could eventually provide up to 20 years of patent coverage in each country in which the Company seeks patent protection, such as the United States, if a patent issues according to the patent laws of the issuing country.

 

The BIV201 development program began at LAT Pharma LLC. On April 11, 2016, the Company acquired LAT Pharma LLC and the rights to its BIV201 development program. The Company currently owns all development and marketing rights to its drug candidate. The Company and PharmaIN, Corp. (“PharmaIN”), LAT Pharma’s former partner focused on the development of new modified drug candidates in the same therapeutic field but not including BIV201, had agreed to pay royalties equal to less than 1% of future net sales of each company's ascites drug development programs, or if such program is licensed to a third party, less than 5% of each company's net license revenues. On December 24, 2018, the Company returned its partial ownership rights to the PharmaIN modified terlipressin development program and simultaneously paid the remaining balance due on a related debt. PharmaIN, Corp.’s rights to our program remain unchanged.

 

The Company’s activities are subject to significant risks and uncertainties including failure to secure additional funding to properly execute the Company’s business plan.

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Significant Accounting Policies (Details) - shares
3 Months Ended
Sep. 30, 2019
Sep. 30, 2018
Dilutive Securities excluded from the Computation of Diluted Loss Per Share 179,083,216 221,591,548
Warrant [Member]    
Dilutive Securities excluded from the Computation of Diluted Loss Per Share 171,833,216 216,441,548
Stock Option [Member]    
Dilutive Securities excluded from the Computation of Diluted Loss Per Share 7,250,000 5,150,000
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Fair Value Measurements (Details 2)
3 Months Ended
Sep. 30, 2019
USD ($)
Balance at September 30, 2019 $ 10,643,392
Fair Value, Inputs, Level 3 [Member]  
Balance at September 30, 2019 10,643,392
Derivative liability - Warrants [Member]  
Balance at September 30, 2019 8,109,724
Derivative liability - Warrants [Member] | Fair Value, Inputs, Level 3 [Member]  
Beginning balance at July 1, 2019
Additions to level 3 liabilities 8,367,012
Change in in fair value of level 3 liability (257,288)
Transfer in and/or out of Level 3
Balance at September 30, 2019 8,109,724
Derivative Liability - Conversion Option on Convertible Debenture [Member]  
Balance at September 30, 2019 2,533,668
Derivative Liability - Conversion Option on Convertible Debenture [Member] | Fair Value, Inputs, Level 3 [Member]  
Beginning balance at July 1, 2019
Additions to level 3 liabilities 2,638,966
Change in in fair value of level 3 liability (105,298)
Transfer in and/or out of Level 3
Balance at September 30, 2019 $ 2,533,668