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EX-32.1 - EXHIBIT 32.1 - BIOVIE INC.bivi-20160930_10qex32z1.htm
EX-31.1 - EXHIBIT 31.1 - BIOVIE INC.bivi-20160930_10qex31z1.htm
 
 

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, 2016

 

  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: 333-190635

 

BIOVIE INC. (F/K/A NANOANTIBIOTICS, INC)

(Exact name of registrant as specified in its charter)

Nevada   46-2510769

(State or other jurisdiction of incorporation or organization)

  (I.R.S. Employer Identification No.)

 

100 Cummings Center, Suite 247-C
Beverly, MA 01915
(Address of principal executive offices, Zip Code)
 
(312)-283-5793
(Registrant's telephone number, including area code)
 

NANOANTIBIOTICS, INC.
(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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files).

 

Yes ☒                                          No ☐

 

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

  

Large accelerated filer  ☐ Accelerated filer  ☐

Non-accelerated filer

 (Do not check if a smaller reporting company)

 ☐ Smaller reporting company  ☒

  

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

 

Yes                                           No ☒

 

The number of shares outstanding of each of the issuer's classes of common equity, as of September 30, 2016 was 87,210,000

 
 

TABLE OF CONTENTS

 

PART I – FINANCIAL INFORMATION

 

Item 1. Financial Statements (unaudited) 2
  Balance Sheets as of September 30, 2016 (unaudited) and June 30, 2015 (audited) 2
  Statements of Operations (unaudited) for the three months ended September 30, 2016 and 2015 3
  Statement of Changes in Shareholders' Equity for the period to September 30, 2016 4
  Statements of Cash Flows (unaudited) for the three months ended September 30, 2016 and 2015 5
  Notes to Financial Statements (unaudited) 6
Item 2. Management’s Discussion and Analysis of Financial Condition of and Results of Operations 16
Item 3. Quantitative and Qualitative Disclosures About Market Risk 16
Item 4. Controls and Procedures 16

 

PART II – OTHER INFORMATION

 

Item 1. Legal Proceedings 17
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 17
Item 3. Defaults Upon Senior Securities 17
Item 4. Mine Safety Disclosures   17
Item 5. Other Information  17
Item 6. Exhibits 17
     
SIGNATURES 18

 

 
 

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.

 

 -1-

Part 1.  Financial Information

Item 1.  Financial Statements

  

BIOVIE INC. (F/K/A NANOANTIBIOTICS, INC.)
BALANCE SHEETS

  

   September 30,  June 30,
   2016  2016
ASSETS  (unaudited)  (audited)
           
CURRENT ASSETS:          
Cash   8,745    123,757 
Prepaid expenses   —      6,982 
Total Current Assets   8,745    130,739 
           
OTHER  ASSETS:          
Intangible Assets (Net of Amortization)   2,185,390    2,242,734 
Goodwill   345,711    345,711 
Total Other Assets   2,531,101    2,588,445 
           
TOTAL ASSETS   2,539,846    2,719,184 
           
LIABILITIES AND STOCKHOLDERS' DEFICIT          
           
CURRENT LIABILITIES:          
Accounts Payable and accrued expenses   381,289    293,633 
Loan payable   8,000    —   
Related Party Loan   10,000    10,000 
Accrued Payroll   562,112    499,612 
Total Current Liabilities   961,401    803,245 
           
STOCKHOLDERS' EQUITY (DEFICIT)          
Preferred stock; $0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding   —      —   
Common stock, $0.0001 par value; 300,000,000 shares authorized; shares issued and 87,210,000 and 87,160,000 shares issued and outstanding, respectively   8,721    8,716 
Additional paid in capital   2,925,403    2,911,560 
Accumulated deficit   (1,355,679)   (1,004,337)
Total Stockholders' Equity (Deficit)   1,578,445    1,915,939 
           
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)   2,539,846    2,719,184 

 

See accompanying notes to financial statement

 

 -2-

BIOVIE INC. (F/K/A NANOANTIBIOTICS, INC.)
STATEMENTS OF OPERATION (UNAUDITED)

 

   For the Three Months Ended  For the Three Months Ended
   September 30,  September 30,
   2016  2015
    (unaudited)    (unaudited) 
REVENUE:          
Sales  $—     $—   
    —      —   
           
COST OF GOODS SOLD   —      —   
           
GROSS MARGIN   —      —   
           
OPERATING EXPENSES          
Amortization   57,344    —   
Research and development expenses   127,270    —   
Payroll expenses   71,348    40,369 
Professional fees   93,165    10,957 
Selling, general and administrative expenses   2,226    3,301 
TOTAL OPERATING EXPENSES   351,353    54,627 
           
LOSS FROM OPERATIONS   (57,854)   (49,042)
           
OTHER EXPENSE (INCOME)          
Interest expense   —      —   
Interest income   (11)   (61)
TOTAL OTHER EXPENSE (INCOME)   (11)   (61)
           
NET LOSS  $(351,342)  $(54,566)
           
NET LOSS PER COMMON SHARE, BASIC AND DILUTED  $(0.00)  $(0.00)
           
WEIGHTED AVERAGE NUMBER OF          
COMMON  SHARES OUTSTANDING, BASIC AND DILUTED   87,205,550    87,210,000 

 

See accompanying notes to financial statement

 

 -3-

BIOVIE INC. (F/K/A NANOANTIBIOTICS, INC.)
STATEMENT OF STOCKHOLDERS' DEFICIT

 

            Prepaid      
            Services      
         Additional  Paid with     Total
   Common Stock  Paid in  Common  Accumulated  Stockholders'
   Shares  Amount  Capital  Sock  Deficit  Deficit
                   
Balance, June 30, 2015   87,210,000   $8,721   $514,485   $(4,911)  $(572,414)  $(54,119)
                               
Retirement of Shares   (39,869,999)   (5)                  (5)
                               
Shares Issued for Acquisition   39,820,000         2,397,075              2,397,075 
                               
Prepaid service paid with common stock                  4,911         4,911 
                               
Net loss   —      —      —      —      (431,923)   (431,923)
                               
Balance, June 30, 2016   87,160,001    8,716    2,911,560    —      (1,004,337)   (1,915,939)
                               
Option vested (unaudited)   —      —      8,848              8,848 
                               
Issuance of Shares (unaudited)   49,999    5    4,995              5,000 
                               
Net loss (unaudited)                       (351,342)   (351,342)
                               
Balance, September 30, 2016 (unaudited)   87,210,000    8,721    2,925,403    —      (1,355,679)   (1,578,445)

 

 

See accompanying notes to financial statement

 

 -4-

BIOVIE INC. (F/K/A NANOANTIBIOTICS, INC.)
STATEMENT OF CASH FLOWS (UNAUDITED)

 

   For the Three  For the Three
   Months Ended  Months Ended
   September 30, 2016  September 30, 2015
       
CASH FLOWS FROM OPERATING ACTIVITIES:          
Net loss  $(351,342)  $(54,566)
Adjustments to reconcile net loss to net cash to cash used by operating activities:        
Amortization of prepaid services paid with common stock        1890 
Amortization of intangible assets   57,344      
Share based compensation expense   8.848      
Changes in operating assets and liabilities          
Decrease in prepaid expenses   6,982    1,500
Increase (decrease) in:          
Accounts Payable   87,656      8,842 
Accrued Payroll   62,500    40,369 
Net cash used by operating activities   (128,012)   (1,965)
           
CASH FLOWS FROM INVESTING ACTIVITIES:          
Net cash used by investing activities   —      —   
           
CASH FLOWS FROM FINANCING ACTIVITIES:          
Proceeds from loan payable   8,000      
Proceeds from issuance of common stock   5,000      
Net cash provided by financing activities   13,000      —   
           
Net decrease in cash   (115,012)   (1,965)
           
Cash, beginning of period   123,757    267,481 
           
Cash, end of period  $8,745   $265,516 
           
SUPPLEMENTAL CASH FLOW INFORMATION:          
Cash paid for interest  $—     $—   
Cash paid for income tax  $   $ 

 

See accompanying notes to financial statement

 

 -5-

BIOVIE INC. (F/K/A NANOANTIBIOTICS, INC.)

Notes to Financial Statements

For the Three Months Ended September 30, 2016 and 2015

(unaudited)

 

1. Background Information

 

BioVie Inc. (F/K/A NanoAntibiotics, Inc.) (the “Company”) is a development stage enterprise that was incorporated in the state of Nevada on April 10, 2013.  The Company is engaged in the discovery, development and commercialization of a therapy targeting ascites due to liver cirrhosis. Ascites due to liver cirrhosis is a life-threatening condition affecting about 100,000 Americans and many times more worldwide. Our therapy BIV201 is based on a drug that’s approved in about 50 countries to treat related complications of liver cirrhosis (part of the same disease pathway as ascites), but not yet available in the US. 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. 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. We currently own all development and marketing rights to our drug candidate, except as noted previously, the Company and PharmaIN have exchanged small (low single-digit) ownership rights to each other’s ascites drug development programs. The Company recently filed patent applications for its drug candidate in the US and Japan, as well as a PCT in Europe. We are currently completing the work necessary to file our investigational new drug (IND) application, and aim to commence clinical trials should the FDA approve our application.

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.

 

2. Going Concern

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. For the three months ended September 30, 2016, the Company had a net loss of $351,342.  As of September 30, 2016, the Company has not earned any revenues. In view of these matters, the Company’s ability to continue as a going concern is dependent upon the Company’s ability to begin operations and to achieve a level of profitability. Since inception, the Company has financed its activities principally from the sale of public equity securities. The Company intends on financing its future development activities and its working capital needs largely from the sale of public equity securities with some additional funding from other traditional financing sources, including term notes and proceeds from sub-licensing agreements until such time that funds provided by operations are sufficient to fund working capital requirements. The financial statements of the Company do not include any adjustments relating to the recoverability and classification of recorded assets, or the amounts and classifications of liabilities that might be necessary should the Company be unable to continue as a going concern.

3. Significant Accounting Policies

 

Unaudited Interim Financial Statements

The accompanying unaudited financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America for interim financial information and with the instructions to Form 10-Q and Regulation S-X.  Accordingly, the financial statements do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements.

 

 -6-

In the opinion of management, all adjustments consisting of normal recurring entries necessary for a fair statement of the periods presented for: (a) the financial position; (b) the result of operations; and (c) cash flows, have been made in order to make the financial statements presented not misleading.  The results of operations for such interim periods are not necessarily indicative of operations for a full year.

 

Basis of Presentation

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. 

Cash

Cash is maintained at financial institutions and, at times, balances may exceed federally insured limits. We have never experienced any losses related to these balances. All of our cash balances were fully insured at September 30, 2016. 

Financial Instruments

The Company’s financial instruments include cash and accounts payable. The carrying amounts of cash and accounts payable approximate their fair value, due to the short-term nature of these items. 

Research and Development

Research and development costs are charged to operations when incurred and are included in operating expenses. The Company expensed $127,270 for research and development for the quarter ended September 30, 2016. 

Income Taxes

Deferred income tax assets and liabilities arise from temporary differences associated with differences between the financial statements and tax basis of assets and liabilities, as measured by the enacted tax rates, which are expected to be in effect when these differences reverse. Deferred tax assets and liabilities are classified as current or non-current, depending on the classification of the assets or liabilities to which they relate. Deferred tax assets and liabilities not related to an asset or liability are classified as current or non-current depending on the periods in which the temporary differences are expected to reverse. 

The Company follows the provisions of FASB ASC 740-10 “Uncertainty in Income Taxes” (ASC 740-10), January 1, 2007. The Company has not recognized a liability as a result of the implementation of ASC 740-10. A reconciliation of the beginning and ending amount of unrecognized tax benefits has not been provided since there are no unrecognized benefits at September 30, 2016 and since the date of adoption. The Company has not recognized interest expense or penalties as a result of the implementation of ASC 740-10. If there were an unrecognized tax benefit, the Company would recognize interest accrued related to unrecognized tax benefits in interest expense and penalties in operating expenses. 

 -7-

Earnings (Loss) per Share

Basic earnings per share are computed by dividing net income by the weighted average number of shares of common stock outstanding during the year. Diluted earnings per common share are computed by dividing net income by the weighted average number of shares of common stock outstanding and dilutive options outstanding during the year. For the quarter ended September 30, 2016 all outstanding options have been excluded from the calculation of the diluted net loss per share since their effect was anti-dilutive.

Stock-based Compensation

The Company recognizes all share-based payments to employees, including grants of employee stock options, as compensation expense in the financial statements based on their fair values. That expense will be recognized over the period during which an employee is required to provide services in exchange for the award, known as the requisite service period (usually the vesting period).  

Fair Value Measurements

In September 2006, the Financial Accounting Standards Board (FASB) introduced a framework for measuring fair value and expanded required disclosure about fair value measurements of assets and liabilities. The Company adopted the standard for those financial assets and liabilities as of the beginning of the 2013 fiscal year and the impact of adoption was not significant. FASB Accounting Standards Codification (ASC) 820 “Fair Value Measurements and Disclosures” (ASC 820) defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy that distinguishes between (1) market participant assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity’s own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable inputs). The fair value hierarchy consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value hierarchy are described below: 

Level 1 - Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. 

Level 2 - Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly, including quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; inputs other than quoted prices that are observable for the asset or liability (e.g., interest rates); and inputs that are derived principally from or corroborated by observable market data by correlation or other means. 

Level 3 - Inputs that are both significant to the fair value measurement and unobservable. 

Fair value estimates discussed herein are based upon certain market assumptions and pertinent information available to management as of September 30, 2016. The respective carrying value of certain on-balance-sheet financial instruments approximated their fair values due to the short-term nature of these instruments. These financial instruments include accrued payroll.

Recent accounting pronouncements

The Company has reviewed recent accounting pronouncements issued by the FASB (including its EITF), the AICPA, and the SEC and did not or are not believed by management to have a material impact on the Company’s financial statements. 

 -8-

 4. Related Party Loan

LAT Pharma was given a zero-interest bearing loan by the company’s General Partner, Jonathan Adams in the amount of $5,000 in August 2015 and $5,000 in November 2015. The total of $10,000 was outstanding when the Company merged with LAT Pharma. As of September 30th, 2016 the Company has an outstanding balance of $10,000 payable on demand to the CEO, Jonathan Adams.  

5. Commitments and Contingencies 

Office Lease 

On January 1, 2014 the Company executed a lease agreement with Cummings Properties for the company’s office of 270 square feet at 100 Cummings Center, Suite 247-C, Beverly, MA 01915. The lease is for a term of five years from January 1, 2014 to December 30, 2018 and requires monthly payments of $357 ($4,284 annually for each of the five years, total aggregate of $21,420). 

Employment Agreements 

On April 11, 2016 the Company entered into employment agreement with CEO Jonathan Adams. The Company’s agreement provides for a three-year term with minimum annual base salary of $250,000 per year. Effective April 11, 2016, the (previous) CEO/CFO resigned.

6. Income Taxes

Deferred taxes are recorded for all existing temporary differences in the Company’s assets and liabilities for income tax and financial reporting purposes. Due to the valuation allowance for deferred tax assets, as noted below, there were no net deferred tax benefit or expense for the quarter ended September 30, 2016. 

There is no current or deferred income tax expense or benefit allocated to continuing operations for the quarter ended September 30, 2016. 

The provision for income taxes is different from that which would be obtained by applying the statutory federal income tax rate to income before income taxes. The items causing this difference are as follows: 

   September 30, 2016  June 30, 2016
Tax expense (benefit) at U.S. statutory rate  $(119,460)  $(146,889)
State income tax expense (benefit), net of federal benefit   (17,568)   (21,659)
Effect of non-deductible expenses          
Other          
Change in valuation allowance   137,028    168,548 
   $—     $—   

 

 -9-

The tax effects of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities at September 30, 2016 were as follows:

Deferred tax assets (liability), noncurrent:     
Net operating loss  $528,876 
Valuation allowance   (528,876)
   $—   

 

Change in valuation allowance:

 

Balance, June 30, 2016  $391,848 
Increase in valuation allowance   137,028 
Balance, September 30, 2016   528,876 

 

Since management of the Company believes that it is more likely than not that the net deferred tax assets will not provide future benefit, the Company has established a 100 percent valuation allowance on the net deferred tax assets as of September 30, 2016. 

As of September 30, 2016, the Company had federal and state net operating loss carry-forwards totaling approximately $1,355,679 which begin expiring in 2022.

7. Purchase of LAT Pharma

On April 11, 2016, the Company entered into and consummated an Agreement and Plan of Merger (the “Merger Agreement”), with LAT Acquisition Corp., a Nevada corporation and wholly-owned subsidiary of the Company (“Acquisition”) and LAT Pharma, LLC an Illinois limited liability company (“LAT”). Pursuant to the terms of the Merger Agreement, Acquisition merged with and into LAT in a statutory triangular merger (the “Merger”) with LAT surviving as a wholly-owned subsidiary of the Company. As consideration for the Merger, the Company issued the interest holders of LAT (the “LAT Holders”) an aggregate of 39,820,000 shares of our Common Stock issued to the LAT Holders in accordance with their pro rata ownership of LAT membership interests prior to the Merger. Following the Merger, the Registrant will continue the development of LAT’s lead clinical therapeutic candidate Continuous low-dose Infusion (CI) Terlipressin.

 

Immediately prior to the Merger, the Company had 87,210,000 shares of Common Stock issued and outstanding. In connection with the Merger, certain shareholders of the Company collectively agreed to retire and cancel an aggregate of 39,869,999 shares of Common Stock. Following the consummation of the Merger, the issuance of the Merger Shares of the 39,820,000 shares of Common Stock, the Company had 87,160,001 shares of Common Stock issued and outstanding and the LAT Holders beneficially own 39,820,000 shares or approximately forty-six percent (46%) of such issued and outstanding Common Stock.

 

Under the purchase method of accounting, the transaction was valued for accounting purposes at $2,389,200, which was the estimated fair value of the consideration paid by the Company. The estimate was based on the consideration paid of 39,820,000 shares of common stock valued based on the closing price on 04/11/2016 of $0.06 per share.

 

 -10-

 The assets and liabilities of LAT Pharma, Inc. were recorded at their respective fair values as of the closing date of the Merger Agreement, and the following table summarizes these values based on the balance sheet at April 11, 2016. 

$2,303,682   Assets Purchased
 260,193   Liabilities Assumed
 2,043,489   Net Assets Purchased
 2,389,200   Purchase Price
$345,711   Goodwill from Purchase

 

Intangible asset detail 

 

$2,293,770   Intangible Intellectual Property
 345,711   Goodwill
$2,639,481   Intangible Asset from Purchase

 

Under the 338(h)(10) election, all goodwill and intangibles related to the acquisition of LAT Pharma will be fully deductible for tax purposes.

 

The intangible intellectual property is amortized over 10 years.

   September 2016  September 2015
Intangible Assets subject to Amortization  $2,293,770   $—   
Amortization Expense in current year  $57,344   $—   
Accumulated Amortization at year end  $108,380   $—   

 

The previous year amortization expense has been amortized for the period from April 11, 2016 to June 30, 2016. The estimated Amortization expense for each of the five succeeding fiscal years will be approximately $229,300 per year.

8. Stock Options

In connection with the employment agreement signed with the Chief Financial Officer on April 11, 2016, Jonathan Adams received options to acquire 3 million shares exercisable at $0.06 per share, the closing price on that date. These Options Group A shall become vested and exercisable (i) as to 1 million shares on April 11, 2017, (ii) as to 1 million shares on April 11, 2018, and (iii) as to 1 million shares on April 11, 2019.

The fair market value of the stock options is estimated using the Black Scholes valuation model and the Company uses the following methods to determine its underlying assumptions: expected volatilities are based on the historical volatilities of 3 comparable companies of the daily closing price of their respective common stock; the expected term of options granted is based on the average time outstanding method; and the risk free interest rate is based on the US Treasury bonds issued with similar life terms to the expected life of the grant.

 -11-

The following key assumptions were used in the valuation model to value stock option grants for each respective period:

 

Valuation Date  4/11/2016 4/11/2016 4/11/2016
Stock Price  $0.06  $0.06  $0.06 
Exercise Price  $0.06  $0.06  $0.06 
Term (expected term for options)   1.00   2.00   3.00 
Volatility   56.49%  58.45%  97.82%
Annual Rate of Quarterly Dividends   0.00%  0.00%  0.00%
Discount Rate - Bond Equivalent Yield   0.53%  0.70%  0.85%
Call Option Value ($Millions)  $0.01  $0.02  $0.04 
Fair Value  $13,467  $19,523  $36,489 

 

 Stock option transactions under the Company’s plans for the years ended June 30, 2016 is summarized below:

 

      Weighted   
    Weighed- Average Aggregate
    Average Remaining Intrinsic 
  Shares Exercise Contractual Value 
Options (Thousands) Price Term (Thousands)
Outstanding at July 1, 2015 - - - -
Granted  3,000 0.06 2 -
Exercised  - - - -
Forfieted - - - -
Outstanding at June 30, 2016 3,000 0.06 2 -
Granted  - - - -
Exercised  - - - -
Forfieted - - - -
Outstanding at September 30, 2016 3,000 0.06 2 -

 

The compensation expense includes $8,848 related to the stock options described above.

9. Loan Payable

LAT Pharma was given a zero-interest bearing loan from Barrett Ehrlich for $8,000. Barrett Ehrlich made a payment to Hayden IR, LLC directly on behalf of LAT Pharma. As of September 30th, 2016 the Company has an outstanding balance of $8,000 payable on demand to Barrett Ehrlich.

 10. Subsequent Event

Subsequent to September 30, 2016, the Company sold 500,000 shares of common stock for 20 cents per share for total proceeds of $100,000.

 -12-

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 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.

We are a development stage biotechnology company engaged in the discovery, development and commercialization of a therapy targeting ascites due to liver cirrhosis. Ascites due to liver cirrhosis is a life-threatening condition affecting about 100,000 Americans and many times more worldwide. Our therapy BIV201 is based on a drug that is approved in about 50 countries to treat related complications of liver cirrhosis (part of the same disease pathway as ascites), but not yet available in the US. 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. We are currently completing the work necessary to file our investigational new drug (IND) application, and aim to commence clinical trials should the FDA approve our application. 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. 

 

 -13-

We have incurred $351,342 of operating expenses for the quarter ended September 30, 2016.  We are now engaged in organizational activities and sourcing compounds and materials. We anticipate incurring other costs associated with equipment purchases and general and administrative expenses, including employee salaries and benefits, legal expenses, and other costs associated with an early stage, publicly-traded company.  

The amounts that we actually spend for any specific purpose may vary significantly, and will depend on a number of factors including, but not limited to, the pace of progress of our research and development, market conditions, and our ability to qualify vendors. In addition, we may use a portion of any net proceeds to acquire complementary compounds; however, we do not have plans for any acquisitions at this time. We will have significant discretion in the use of any net proceeds. Investors will be relying on the judgment of our management regarding the application of the proceeds of any sale of our Common Stock. 

Requirement for Additional Capital

 

The Company has engaged in limited research and development activities. We currently do not have sufficient funds to meet our planned drug development for the next twelve (12) months and we may not be able to obtain the necessary financing on terms and conditions acceptable to the Company. Assuming that we are successful in raising additional financing, we plan to incur the following expenses over the next twelve (12) months: 

Research and Development of $45,000, which includes planned costs for the development of BIV201.
Corporate overhead of $15,000, which includes budgeted legal, accounting and other costs expected to be incurred; and
Staffing costs of $250,000.

The Company had approximately $8,745 of cash on hand at September 30, 2016 and will be unable to proceed with its planned drug development, meet its administrative expense requirements, capital costs, or staffing costs without obtaining additional net financing of approximately $250,000 to $500,000 to meet its near-term budgetary needs. 

The Company has limited experience with pharmaceutical drug development. As such these budget estimates may not be accurate. In addition, the actual work to be performed can only be broadly projected, as is normal with any scientific work. As further work is performed, additional work may become necessary or change in plans or workload may occur. Such changes may have an adverse impact on our estimated budget. Such changes may also have an adverse impact on our projected timeline of drug development. 

Management intends to use capital and debt financing, as required, to fund the Company's operations. There can be no assurance that the Company will be able to obtain the additional capital resources necessary to fund its anticipated obligations for the next twelve (12) months.

 -14-

Capital Resources and Liquidity

 

As of September 30, 2016, we had $8,745 of cash on hand in our corporate bank account. The Company is considered to be a development stage company and will continue in the development stage until generating revenues from the sales of its products or services. As a result, the report of the independent registered public accounting firm on our financial statements as of June 30, 2016, contains an explanatory paragraph regarding a substantial doubt about our ability to continue as a going concern.

We do not have sufficient funds for the next (12) twelve months and must raise cash to implement our strategy and stay in business. If we are unable to raise additional funds to develop our compounds, we may be required to scale back our development plans by reducing expenditures for employees, consultants, business development, and other envisioned expenditures. This could reduce our ability to develop BIV201, our drug candidate, and implement our business plan. In that event, investors should anticipate that their entire investment may be lost and there may be no ability to profit from this investment.

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 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.

If we are unable to raise additional funds, we will need to do one or more of the following

·delay, scale-back or eliminate some or all of our research and product development programs;
·provide licenses to third parties to develop and commercialize products or technologies that we would otherwise seek to develop and commercialize ourselves;
·seek strategic alliances or business combinations;
·attempt to sell our company;
·cease operations; or
·declare bankruptcy.

We believe that our existing cash and cash equivalents will not be sufficient to meet our operating and capital requirements until June 30, 2017. Any debt financing secured by us in the future could involve restrictive covenants relating to our capital raising activities and other financial and operational matters, which may make it more difficult for us to obtain additional capital and to pursue business opportunities, including potential acquisitions. We may not be able to secure additional debt or equity financing in a timely manner, or at all, which could require us to scale back our business plan and operations. 

The above conditions raise substantial doubt about our ability to continue as a going concern.  The financial statements included elsewhere herein were prepared under the assumption that we would continue our operations as a going concern.  Our financial statements do not include any adjustments that may result from the outcome of this uncertainty.  Without additional funds from debt or equity financing, sales of our intellectual property or technologies, or from a business combination or a similar transaction, we will soon exhaust our resources and will be unable to continue operations.  If we cannot continue as a viable entity, our stockholders may lose some or all of their investment in us. 

 -15-

 Our 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.

Emerging Growth Company

 

We are an “emerging growth company” under the federal securities laws and will be subject to reduced public company reporting requirements. In addition, Section 107 of the JOBS Act also provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We are choosing to take advantage of the extended transition period for complying with new or revised accounting standards.

 

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. 

 

Item 3.  Quantitative and Qualitative Disclosures About Market Risk

 

Not applicable

 

Item 4.  Controls and Procedures

 

The Company’s Chief Executive Officer and Chief Financial Officer have evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of September 30, 2016 covered by this Quarterly Report on Form 10-Q.  Based upon such evaluation, the Chief Executive Officer and Chief Financial Officer have concluded that, as of the end of such period, the Company’s disclosure controls and procedures were not effective as required under Rules 13a-15(e) and 15d-15(e) under the Exchange Act. This conclusion by the Company’s Chief Executive Officer and Chief Financial Officer does not relate to reporting periods after September 30, 2016.

 

Changes in Internal Control over Financial Reporting

 

No change in the Company’s internal control over financial reporting occurred during the quarter ended September 30, 2016, that materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

 -16-

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.

 

Item 2. Unregistered sales of equity securities

 

None

 

Item 3. Defaults Upon Senior Securities

 

None

 

Item 4.  Mine Safety Disclosures

 

None

 

Item 5.  Other Information

 

None

 

Item 6. Exhibits

 

(a) Exhibit index

 

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

              

 (b)  Reports on Form 8-K

 

None.

 

 -17-

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.

 

NANOANTIBIOTICS, INC.

         
Signature   Titles   Date
/s/ Jonathan Adams    
Jonathan Adams   Chief Executive Officer, Chief Financial Officer, Principal Executive Officer, Principal Accounting Officer   November 16, 2016
         
     
         
         

 -18-