As filed with the U.S. Securities
and Exchange Commission on November 22, 2019
Registration No. 333-231136
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-1/A
Amendment No. 8
REGISTRATION STATEMENT UNDER THE
SECURITIES ACT OF 1933
BioVie
Inc.
(Exact Name of Registrant as Specified in its Charter)
Nevada
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2834
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46-2510769
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(State
or other jurisdiction of
incorporation or organization)
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(Primary
Standard Industrial
Classification Code Number)
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(I.R.S.
Employer
Identification No.)
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2120 Colorado Avenue, #230,
Santa Monica, California 90404
(310) 444-4300
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)
Terren S. Peizer
Chief Executive Officer
c/o BioVie Inc.
2120 Colorado Avenue, #230
Santa Monica, California 90404
(310) 444-4300
(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent for Service)
Copies to:
Mitchell Nussbaum, Esq.
Norwood P. Beveridge, Jr., Esq.
Lili Taheri, Esq.
Loeb & Loeb LLP
345 Park Avenue
New York, NY 10154
Phone: (212) 407-4000
Fax: (212) 407-4990
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Alan Annex, Esq.
Jason Simon, Esq.
Greenberg Traurig, LLP
200 Park Avenue
New York, NY 10166
Phone: (212) 801-9200
Fax: (212) 801-6400
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Approximate date of commencement of
proposed sale to public:
As soon as practicable after the effective date hereof.
If
any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415
under the Securities Act of 1933, check the following box. ☐
If
this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check
the following box and list the Securities Act registration statement number of the earlier effective registration statement for
the same offering. ☐
If
this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and
list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If
this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and
list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an 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
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☐
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Accelerated filer
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☐
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Non-accelerated filer
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☒
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Smaller reporting company
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☒
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Emerging
growth company
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☐
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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 7(a)(2)(B) of the Securities Act.
☐
The registrant hereby amends this registration
statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further
amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a)
of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Commission,
acting pursuant to Section 8(a), may determine.
The information contained
in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement
filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities
and it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.
PRELIMINARY PROSPECTUS
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SUBJECT TO COMPLETION
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DATED
NOVEMBER 22, 2019
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3,000,000 Units
BioVie
Inc.
This is a firm commitment public offering
of 3,000,000 units of BioVie Inc., at a price of $ per unit, each unit
consisting of one share of Class A common stock ("common stock") and one-half (1/2) of one warrant, each whole warrant exercisable
for one share of common stock. Each warrant will entitle the holder to purchase one share of common stock at an exercise price
of $ per share. The warrants will expire on
, 2024. The units will not be issued or certificated. Instead, the shares of common stock and the warrants underlying the units
will be issued separately and may be resold separately, although they will have been purchased together in this offering. Prior
to this offering, there has been a limited public market for our common stock on the OTCQB Marketplace under the ticker BIVI.
On November 20, 2019, the last reported
sale price for our common stock as reported on the OTCQB Marketplace was $5.00 per share, after giving effect to our
recently effected 1:125 reverse stock split. The final public offering price will be determined through negotiation between
us and the lead underwriters in the offering and the recent market price used throughout this prospectus may not be indicative
of the final offering price. Our common stock and warrants have been approved for listing on The NASDAQ Capital Market (“Nasdaq”)
under the symbols “BIVI” and “BIVIW,” respectively.
Investing in our securities is highly speculative and involves
a high degree of risk. See “Risk Factors” beginning on page 5.
Neither the Securities and Exchange
Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus
is truthful or complete. Any representation to the contrary is a criminal offense.
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Per
Unit
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Total
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Initial public offering price
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$
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$
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Underwriting discounts and commissions (1)
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$
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$
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Proceeds to us, before expenses
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$
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$
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(1)
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Underwriting
discounts and commissions do not include a non-accountable expense allowance equal to 1.0% of the public offering price payable
to the underwriters. We refer you to the “Underwriting” section of this prospectus beginning on page 69
for additional information regarding the underwriters’ compensation.
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We have granted a 45-day option to the
representative of the underwriters to purchase up to 450,000 additional shares of common stock and/or 225,000 additional
warrants from us at the public offering price, less the underwriting discount, solely to cover over-allotments, if any.
The underwriters expect to deliver the
common stock and warrants to purchasers on or about ,
2019.
ThinkEquity
a division of Fordham Financial Management,
Inc.
The date of this prospectus is ,
2019
BIV201 (continuous infusion terlipressin)
is an investigational therapy
Table
of Contents
You should rely only on the information
contained in this prospectus. We have not authorized any other person to provide you with information different from or in addition
to that contained in this prospectus. If anyone provides you with different or inconsistent information, you should not rely on
it. We are not making an offer to sell these securities in any jurisdiction where an offer or sale is not permitted. You should
assume that the information appearing in this prospectus is accurate only as of the date on the front cover of this prospectus.
Our business, financial condition, results of operations and prospects may have changed since that date.
In this prospectus, we rely on and refer
to information and statistics regarding our industry. We obtained this statistical, market and other industry data and forecasts
from publicly available information. While we believe that the statistical data, market data and other industry data and forecasts
are reliable, we have not independently verified the data.
As used in this prospectus, unless the
context indicates or otherwise requires, “the Company,” “our Company,” “we,” “us,”
and “our” refer to BioVie Inc., a Nevada corporation, and its consolidated subsidiaries.
Prospectus
Summary
This summary highlights certain
information appearing elsewhere in this prospectus. Because it is only a summary, it does not contain all of the information that
you should consider before investing in our securities and it is qualified in its entirety by, and should be read in conjunction
with, the more detailed information appearing elsewhere in this prospectus. Before you decide to invest in our securities, you
should read the entire prospectus carefully, including “Risk Factors” beginning on page 5 and the financial statements
and related notes included in this prospectus.
A 1:125 reverse stock split of
our common stock was effected in November 2019. All share amounts in this prospectus have been retroactively adjusted
to give effect to this reverse stock split (subject to rounding up fractional shares).
This prospectus includes trademarks,
service marks and trade names owned by us or other companies. All trademarks, service marks and trade names included in this prospectus
are the property of their respective owners.
Our Company
We are 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.
In April 2017, we entered into
a Cooperative Research and Development Agreement (“CRADA”) with the McGuire Research Institute Inc. in Richmond, VA,
and began administering BIV201 to patients in September 2017. In April 2019, we announced top-line results for our Phase 2a clinical
trial of BIV201 (continuous infusion terlipressin) in six patients with refractory ascites due to advanced liver cirrhosis. The
following results were observed:
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Continuous
infusion of terlipressin via portable infusion pump was maintained for 28 days in three
patients with refractory ascites, and all patients remained hemodynamically stable during
treatment.
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The
steady state plasma concentration data characterized terlipressin pharmacokinetics (PK)
within the predicted PK model concentrations.
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Four
of the six patients treated with BIV201 experienced an increase in the number of days
between paracenteses ranging from 71% to 414% compared to prior to initiating therapy.
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On June 18, 2019, we met with representatives of the U.S. Food & Drug Administration ("FDA") for a Type C Guidance Meeting to plan our next clinical study following the recently completed Phase 2a clinical trial. We discussed our clinical development efforts with the FDA and proposed safety and efficacy endpoints for our next clinical trial. In July 2019, the FDA provided its meeting minutes for this meeting that documented general agreement with the Company's proposed randomized clinical study design. The FDA also provided its suggestions and guidance regarding primary and secondary endpoints and other key aspects of our clinical trial design including appropriate quality of life measures. On October 1, 2019, the Company submitted a Phase 2b/3 randomized, controlled clinical trial protocol to the FDA incorporating these suggestions. If this trial demonstrates significant improvement on various measures of patient health status, we believe it could potentially form the basis to submit a new drug application (NDA) for the eventual marketing of BIV201 in the US. While the FDA has not provided final guidance nor do we have certainty as to what that guidance would entail, our goal remains to commence the planned Phase 2b/3 trial in the next several months in a manner consistent with what was reviewed with the FDA. We may still need to address certain risks associated with yet to be validated quality of life measures.
In September 2019, the Company manufactured the first batch of prefilled syringes containing a novel patent-pending liquid formulation
of terlipressin. This new product format is intended to improve convenience for outpatient administration and avoid potential formulation
errors when pharmacists reconstitute the powder version. In November 2019, the Company completed quality control testing and released
the batch for use in the planned Phase 2b/3 trial subject to FDA clearance.
BIV201 (continuous infusion
terlipressin) has the potential to improve the health of thousands of patients suffering from life-threatening complications of
liver cirrhosis due to hepatitis, NASH, and alcoholism. We have a pending patent application for a method of treating a
patient diagnosed with ascites due to liver cirrhosis by administering BIV201 (terlipressin) as a continuous infusion within specified
doses over a specified duration. The FDA has granted Fast-Track status and Orphan Drug designation for the most common of these
complications, ascites, which represents a significant unmet medical need. Patients with cirrhosis and ascites account for an
estimated 116,000 U.S. hospital discharges annually, with frequent early readmissions. Those requiring paracentesis (removal of
ascites fluid) experience an average hospital stay lasting 8 days incurring over $86,000 in medical costs (HCUP Nationwide Readmissions
Database 2016). This translates into a total addressable ascites market size for BIV201 therapy exceeding $500 million based on
Company estimates. The FDA has never approved any drug specifically for treating ascites. BIV201 received Orphan Drug designation
for hepatorenal syndrome ("HRS") in November 2018.
The BIV201 development program
began at LAT Pharma LLC. On April 11, 2016, we acquired LAT Pharma LLC and the rights to its BIV201 development program and currently
own all development and marketing rights to BIV201. We and PharmaIN, Corp. (“PharmaIN”), LAT Pharma’s former
partner focused on the development of new modified product 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,
we returned our partial ownership rights to the PharmaIN modified terlipressin development program and simultaneously paid the
remaining balance due on a related debt. PharmaIN’s rights to our program remain unchanged. We have a pending patent
application for the use of BIV201 for the treatment of patients diagnosed with ascites due to liver cirrhosis in the outpatient
setting using ambulatory pump infusion, and have corresponding patent applications pending in Japan, Europe, China and Hong Kong.
Risks Associated with our Business
Our business and ability to execute
our business strategy are subject to a number of risks of which you should be aware before you decide to buy our common stock.
In particular, you should consider the following risks, which are discussed more fully in the section entitled “Risk Factors”
in this prospectus:
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we are a development stage company with a limited operating history, making it difficult for you to evaluate our business and your investment;
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we have no products approved for commercial sale, have never generated any revenues and may never achieve revenues or profitability, which could cause us to cease operations;
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we will need to raise substantial additional capital in the future to fund our operations and we may be unable to raise such funds when needed and on acceptable terms;
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we have limited experience in drug development and may not be able to successfully develop any drugs, which would cause us to cease operations;
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we have no manufacturing experience, and the failure to comply with all applicable manufacturing regulations and requirements could have a materially adverse effect on our business;
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if we fail to maintain an effective system of internal controls, we may not be able to accurately report financial results or detect fraud;
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we may be unable to obtain or protect intellectual property rights relating to our products, and we may be liable for infringing upon the intellectual property rights of others, which could have a materially adverse effect on our business;
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the biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition. We may be unable to compete with enterprises equipped with more substantial resources than us, which could cause us to curtail or cease operations;
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there
can be no assurance that our securities will continue to be listed on Nasdaq or, if listed, that there will be liquidity
in the trading market for our securities;
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certain stockholders who are also officers and directors may have significant control over our management; and
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we are subject to the periodic reporting requirements of the Exchange Act, which require us to incur audit fees and legal fees in connection with the preparation of such reports. These additional costs will negatively affect our ability to earn a profit.
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Corporate Information
Our principal executive office is
located at 2120 Colorado Avenue, #230, Santa Monica, California 90404, and our phone number (310) 444-4300.
The
Offering
Units
offered by us
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3,000,000
units, each consisting of one share of common stock
and one-half (1/2) of one warrant, each whole warrant exercisable for one share of common stock.
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Separability
of shares of common stock and warrants:
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The
units will not be issued or certificated. Instead, the shares of common stock and the warrants underlying the units will be
issued separately and may be resold separately, although they will have been purchased together in this offering.
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Shares
Offered:
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3,000,000
shares of common stock are included in the units.
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Warrants
Offered:
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1,500,000
warrants are included in the units. Each whole warrant
will entitle the holder to purchase one share of common stock at an exercise price of $ per
share. The warrants shall be exercisable from the date of issuance, which is the closing date of this offering, and expire
on , 2024. Upon exercise of the warrants, a holder
would be entitled to receive a fractional interest in a share, we will, at our election, upon exercise, either pay a cash
adjustment in respect of such fraction (in an amount equal to such fraction multiplied by the exercise price) or round the
number of shares to be received by the holder up to the next whole number.
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Common
stock to be outstanding after this offering
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14,793,273
shares (or 15,243,273 shares if the underwriters
exercise their over-allotment option in full).
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Over-allotment
option
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We
have granted the underwriters a 45-day option to purchase up to an additional 450,000 shares of our common stock and/or
up to an additional 225,000 warrants at the initial public offering price to cover over-allotments, if any.
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Use
of proceeds
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We
intend to use the net proceeds of this offering primarily to fund clinical trials of our lead product candidate BIV201 and
for working capital and other general corporate purposes.
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Concentration
of ownership
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Upon
completion of this offering, our executive officers and directors will beneficially own, in the aggregate, approximately %
of the outstanding shares of our common stock.
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Proposed
NASDAQ Capital Market symbols
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“BIVI”
“BIVIW”
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Risk
Factors
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Investing
in our securities involves a high degree of risk. See “Risk Factors” beginning on page 5 and the other information
in this prospectus for a discussion of the factors you should consider carefully before you decide to invest in our securities.
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Lock-Up
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We,
each of our officers, directors, and all of our 5% or greater stockholders have agreed, subject to certain exceptions, not
to sell, offer, agree to sell, contract to sell, hypothecate, pledge, grant any option to purchase, make any short sale of,
or otherwise dispose of or hedge, directly or indirectly, any shares of our capital stock or any securities convertible into
or exercisable or exchangeable for shares of capital stock, for a period of (i) six (6) months after the date of this prospectus
in the case of our directors and officers and (ii) three (3) months after the date of this prospectus in the case of the Company
and any other 5% or greater holder of our outstanding securities, without the prior written consent of the representative.
See “Underwriting” for additional information.
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All information in this prospectus
assumes no exercise of the warrants included in the units, that the underwriters do not exercise their over-allotment option and
that our controlling stockholder, Acuitas Group Holdings, LLC (“Acuitas”), receives an aggregate of 6,609,832 shares
of common stock upon the closing of this offering pursuant to the automatic exercise of warrants issued in connection with a bridge
financing (the "Bridge Financing") and the committed exercise of its existing purchase option, in each case as described elsewhere
herein. The total number of shares of our common stock outstanding as of November 21, 2019 was 5,183,442 and excludes 1,434,266
shares of common stock reserved for issuance pursuant to currently outstanding options and warrants.
Summary
Financial Information
The following tables present
our summary consolidated financial and other data as of and for the periods indicated. The summary consolidated statements
of operations data for the fiscal years ended June 30, 2019 and June 30, 2018 are derived from our audited financial statements
included elsewhere in this prospectus. The consolidated statement of operations data for the three months ended September
30, 2019 and 2018 and the summary consolidated balance sheet data as of September 30, 2019, are derived from our unaudited consolidated
financial statements included elsewhere in this prospectus and have been prepared on the same basis as the audited consolidated
financial statements.
The summarized financial information
presented below is derived from and should be read in conjunction with our audited consolidated financial statements including
the notes to those financial statements, which are included elsewhere in this prospectus along with the section entitled “Management’s Discussion
and Analysis of Financial Condition and Results of Operations.” Our historical results are not necessarily indicative of
our future results.
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For the fiscal year ended
June 30:
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For the three months ended
September 30:
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2019
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2018
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2019
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2018
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CONSOLIDATED STATEMENTS OF OPERATIONS DATA:
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Revenue
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$
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—
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$
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—
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$
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—
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$
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—
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Operating expenses
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2,496,573
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2,372,166
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706,218
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491,427
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Loss from operations
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(2,496,573
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)
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(2,372,166
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(706,218
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(491,427
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Total other expense (income), net
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(52,286
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40,956
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3,115,009
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(51,556
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Net loss
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$
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(2,444,287
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$
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(2,413,122
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$
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(3,821,227
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)
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$
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(439,871
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)
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Deemed dividend
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(48,659
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(20,995
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(17,099,058
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(48,659
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Net loss attributable to Company stockholders
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$
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(2,492,946
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$
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(2,434,117
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$
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(20,920,285
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$
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(488,530
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Net loss per common share, basic and diluted
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$
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(0.98
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$
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(3.18
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$
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(5.06
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$
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(0.20
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Weighted average shares outstanding, basic and diluted
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2,539,611
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766,065
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4,132,617
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2,474,233
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As of September 30, 2019
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CONSOLIDATED BALANCE SHEET DATA:
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Actual
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Pro Forma
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Pro Forma As Adjusted
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Cash
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$
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249,009
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249,134
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$
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Total current assets
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765,388
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765,513
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Total assets
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2,608,358
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2,608,483
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Total current liabilities
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11,328,986
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684,060
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Total liabilities
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11,328,986
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684,060
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Total stockholders’ (deficit) equity
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(8,720,628)
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1,923,425
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The preceding table presents
a summary of our unaudited balance sheet data as of September 30, 2019:
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on
pro-forma basis to give effect to the following transactions with our controlling stockholder Acuitas (i) the issuance of
an aggregate of 1,250,000 shares of common stock upon the automatic exercise of warrants issued in the Bridge Financing (the
“Bridge Financing Warrants”) and (ii) the issuance of an aggregate of 5,359,832 shares of common stock pursuant
to a committed exercise by Acuitas of its purchase option granted in connection with its initial investment in the Company,
in each case upon the closing of this offering; and
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●
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on
pro-forma as adjusted basis to give effect to the pro-forma adjustment above, as well as the receipt of the estimated net
proceeds from the sale of units
in this offering at the public offering price of $ per unit, after deducting the underwriting
discounts and commissions and estimated expenses payable by us, and the application of a portion of such net proceeds to satisfy
all amounts due with respect to the 10% OID Convertible Delayed Draw Debenture issued in the Bridge Financing (the “Debenture”)
as of the closing date of this offering.
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Risk
Factors
Any investment in our securities
involves a high degree of risk. You should carefully consider the risks described below, which we believe represent certain of
the material risks to our business, together with the information contained elsewhere in this prospectus, before you make a decision
to invest in our securities. Please note that the risks highlighted here are not the only ones that we may face. For
example, additional risks presently unknown to us or that we currently consider immaterial or unlikely to occur could also impair
our operations. If any of the following events occur or any additional risks presently unknown to us actually occur, our business,
financial condition and operating results may be materially adversely affected. In that event, the trading price of our securities
could decline and you could lose all or part of your investment.
Risks Relating to Our Business and Industry
We have no products approved for commercial sale, have
never generated any revenues and may never achieve revenues or profitability, which could cause us to cease operations.
We have no products approved for commercial sale and, to
date, we have not generated any revenues. Our ability to generate revenue depends heavily on (a) successful development program
and thereafter demonstration in human clinical trials that BIV201, our product candidate, is safe and effective; (b) our ability
to seek and obtain regulatory approvals, including, without limitation, with respect to the indications we are seeking; (c) successful
commercialization of our product candidates; and (d) market acceptance of our products. There are no assurances that we will achieve
any of the forgoing objectives. Furthermore, our product candidate is in the development stage, and we have not evaluated it in
full human clinical trials. If we do not successfully develop and commercialize our product candidate we will not achieve revenues
or profitability in the foreseeable future, if at all. If we are unable to generate revenues or achieve profitability, we may be
unable to continue our operations.
We are a development stage company with a limited operating
history, making it difficult for you to evaluate our business and your investment.
BioVie Inc. was incorporated on April 10, 2013. We are a
development stage biopharmaceutical company with a potential therapy that has not been fully evaluated in clinical trials, and
our operations are subject to all of the risks inherent in the establishment of a new business enterprise, including but not limited
to the absence of an operating history, the lack of commercialized products, insufficient capital, expected substantial and continual
losses for the foreseeable future, limited experience in dealing with regulatory issues, the lack of manufacturing experience and
limited marketing experience, possible reliance on third parties for the development and commercialization of our proposed products,
a competitive environment characterized by numerous, well-established and well capitalized competitors and reliance on key personnel.
Since inception, we have not established any revenues or
operations that shall provide financial stability in the long term, and there can be no assurance that we will realize our plans
on our projected timetable in order to reach sustainable or profitable operations.
Investors are subject to all the risks incident to the creation
and development of a new business and each Investor should be prepared to withstand a complete loss of his, her or its investment.
Furthermore, the accompanying financial statements have been prepared assuming that we will continue as a going concern. We have
not emerged from the development stage, and may be unable to raise further equity. These factors raise substantial doubt about
its ability to continue as a going concern. The financial statements do not include any adjustments that might result from the
outcome of this uncertainty.
Because we are subject to these risks, you may have a difficult
time evaluating our business and your investment in our Company. Our ability to become profitable depends primarily on our ability
to develop drugs, to obtain approval for such drugs, and if approved, to successfully commercialize our drugs, our research and
development (“R&D”) efforts, including the timing and cost of clinical trials; and our ability to enter into favorable
alliances with third-parties who can provide substantial capabilities in clinical development, regulatory affairs, sales, marketing
and distribution.
Even if we successfully develop and market BIV201, we may
not generate sufficient or sustainable revenue to achieve or sustain profitability, which could cause us to cease operations and
cause you to lose all of your investment.
If the FDA or comparable foreign regulatory authorities
approve generic versions of any of our products that receive marketing approval, or such authorities do not grant our products
appropriate periods of exclusivity before approving generic versions of our products, the sales of our products could be adversely
affected.
Once a new drug application (“NDA”) is approved,
the product covered thereby becomes a “reference listed drug” in the FDA’s publication, “Approved Drug
Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book. Manufacturers may seek approval of
generic versions of reference listed drugs through submission of abbreviated new drug applications (“ANDAs”) in the
United States. In support of an ANDA, a generic manufacturer need not conduct clinical trials. Rather, the applicant generally
must show that its product has the same active ingredient(s), dosage form, strength, route of administration and conditions of
use or labeling as the reference listed drug and that the generic version is bioequivalent to the reference listed drug, meaning
it is absorbed in the body at the same rate and to the same extent. Generic products may be significantly less costly to bring
to market than the reference listed drug and companies that produce generic products are generally able to offer them at lower
prices. Thus, following the introduction of a generic drug, a significant percentage of the sales of any branded product or reference
listed drug is typically lost to the generic product.
The FDA may not approve an ANDA for a generic product until any
applicable period of non-patent exclusivity for the reference listed drug has expired. The United States Federal Food, Drug, and
Cosmetic Act (“FDCA”) provides a period of five years of non-patent exclusivity for a new drug containing a new chemical
entity (“NCE”). Specifically, in cases where such exclusivity has been granted, an ANDA may not be submitted to the
FDA until the expiration of five years unless the submission is accompanied by a Paragraph IV certification that a patent
covering the reference listed drug is either invalid or will not be infringed by the generic product, in which case the applicant
may submit its application four years following approval of the reference listed drug.
While we believe that BIV201 contains active
ingredients that would be treated as NCEs by the FDA and, therefore, if approved, should be afforded five years of data exclusivity,
the FDA may disagree with that conclusion and may approve generic products after a period that is less than five years. If the
FDA were to award NCE exclusivity to someone other than us, we believe that we would still be awarded three year “Other”
exclusivity protection from generic competition, which is awarded when an application or supplement contains reports of new clinical
investigations (not bioavailability studies) conducted or sponsored by an applicant and essential for approval. Manufacturers
may seek to launch these generic products following the expiration of the applicable marketing exclusivity period, even if we
still have patent protection for our product. If we do not maintain patent protection and data exclusivity for our product candidates,
our business may be materially harmed.
Competition that our products may face
from generic versions of our products could materially and adversely impact our future revenue, profitability and cash flows and
substantially limit our ability to obtain a return on the investments we have made in those product candidates.
If we fail to obtain or maintain
Orphan Drug exclusivity for BIV201, we will have to rely on our data and marketing exclusivity, if any, and on our intellectual
property rights, which may reduce the length of time that we can prevent competitors from selling generic versions of BIV201.
We have obtained
Orphan Drug designation for BIV201 in the U.S. for the treatment of hepatorenal syndrome (received November 21, 2018) and treatment
of ascites due to all etiologies except cancer (received September 8, 2016). Under the Orphan Drug Act, the FDA may designate a
product as an Orphan Drug if it is a drug intended to treat a rare disease or condition, defined, in part, as a patient population
of fewer than 200,000 in the U.S. In the EU, Orphan Drug designation may be granted to drugs intended to treat, diagnose or prevent
a life-threatening or chronically debilitating disease having a prevalence of no more than five in 10,000 people in the EU. The
company that first obtains FDA approval for a designated Orphan Drug for the associated rare disease receives marketing exclusivity
for use of that drug for the stated condition for a period of seven years. Orphan Drug exclusive marketing rights may be lost under
several circumstances, including a later determination by the FDA that the request for designation was materially defective or
if the manufacturer is unable to assure sufficient quantity of the drug. Similar regulations are available in the EU with a ten-year
period of market exclusivity.
Even though
BioVie has obtained Orphan Drug designation for its lead product candidate, and intends to seek other Orphan Drug designations
for BIV201, and Orphan Drug designation for other product candidates, there is no assurance that BioVie will be the first to obtain
marketing approval for any particular rare indication. Further, even though BioVie has obtained Orphan Drug designation for its
lead product candidate, or even if BioVie obtains Orphan Drug designation for other potential product candidates, such designation
may not effectively protect BioVie from competition because different drugs can be approved for the same condition and the same
drug can be approved for different conditions and potentially used off-label in the Orphan indication. Even after an Orphan Drug
is approved, the FDA can subsequently approve the same drug for the same condition for several reasons, including, if the FDA concludes
that the later drug is safer or more effective or makes a major contribution to patient care. Orphan Drug designation neither shortens
the development time or regulatory review time of a drug, nor gives the drug any advantage in the regulatory review or approval
process.
In addition,
other companies have received Orphan Drug designations for terlipressin. Mallinckrodt Hospital Products IP Limited received Orphan
Drug designation in 2004 for terlipressin for the treatment of Hepatorenal Syndrome and Ferring Pharmaceuticals Inc. received Orphan
Drug designation in 1986 for terlipressin for the treatment of bleeding esophageal varices. If Mallinckrodt Hospital Products IP
Limited receives FDA approval for terlipressin for the treatment of Hepatorenal Syndrome before we do, they may obtain a competitive
advantage associated with being the first to market. Further, in connection with obtaining marketing approval for terlipressin
for the treatment of Hepatorenal Syndrome, Mallinckrodt Hospital Products IP Limited would also obtain Orphan Drug exclusivity
for terlipressin, that could prevent our approval for the same indication for seven years, although we could continue to pursue
other indications for the drug.
If Ferring Pharmaceuticals
Inc. receives FDA approval for terlipressin for the treatment of bleeding esophageal varices, they would also obtain a competitive
advantage associated with being the first to market. In connection with obtaining marketing approval for terlipressin for the treatment
of bleeding esophageal varices, Ferring Pharmaceuticals Inc. would also obtain Orphan Drug exclusivity for terlipressin, but we
do not believe that Orphan Drug exclusivity for Ferring Pharmaceuticals Inc.’s terlipressin product would have an adverse
effect on our ability to market BIV201, as the same drug would be approved for different indications under FDA rules, and we can
maintain Orphan Drug exclusivity for BIV201 for the different indication.
We will need to raise substantial additional capital
in the future to fund our operations and we may be unable to raise such funds when needed and on acceptable terms, which could
have a materially adverse effect on our business.
Developing biopharmaceutical
products, including conducting pre-clinical studies and clinical trials and establishing manufacturing capabilities, requires
substantial funding. As of September 30, 2019, we had cash and cash equivalents of approximately $249,000. Although
we entered into a Securities Purchase Agreement on September 24, 2019 with our controlling stockholder regarding a 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, additional financing
will be required to fund the research and development of our product candidates. We have not generated any product revenues, and
do not expect to generate any revenues until, and only if, we develop, and receive approval to sell our product candidates from
the FDA and other regulatory authorities for our product candidates.
We may not have the resources to complete the development
and commercialization of any of our proposed product candidates. We will require additional financing to further the clinical development
of our product candidates. In the event that we cannot obtain the required financing, we will be unable to complete the development
necessary to file an NDA with the FDA for BIV201. This will delay research and development programs, preclinical studies and clinical
trials, material characterization studies, regulatory processes, the establishment of our own laboratory or a search for third
party marketing partners to market our products for us, which could have a materially adverse effect on our business.
The amount of capital we may need will depend on many factors,
including the progress, timing and scope of our research and development programs, the progress, timing and scope of our preclinical
studies and clinical trials, the time and cost necessary to obtain regulatory approvals, the time and cost necessary to establish
our own marketing capabilities or to seek marketing partners, the time and cost necessary to respond to technological and market
developments, changes made or new developments in our existing collaborative, licensing and other commercial relationships, and
new collaborative, licensing and other commercial relationships that we may establish.
Until we can generate a sufficient amount of product revenue,
if ever, we expect to finance future cash needs, through public or private equity offerings, debt financings, or corporate collaboration
and licensing arrangements. Additional funds may not be available when we need them on terms that are acceptable to us, or at all.
If adequate funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our research
or development programs or our commercialization efforts. In addition, we could be forced to discontinue product development and
reduce or forego attractive business opportunities. To the extent that we raise additional funds by issuing equity securities,
our stockholders may experience additional significant dilution, and debt financing, if available, may involve restrictive covenants.
To the extent that we raise additional funds through collaboration and licensing arrangements, it may be necessary to relinquish
some rights to our technologies or our product candidates, or grant licenses on terms that may not be favorable to us. We may seek
to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for
additional capital at that time.
Our fixed expenses, such as rent and other contractual commitments,
will likely increase in the future, as we may enter into leases for new facilities and capital equipment and/or enter into additional
licenses and collaborative agreements. Therefore, if we fail to raise substantial additional capital to fund these expenses, we
could be forced to cease operations, which could cause you to lose all of your investment.
We have limited experience in drug development and
may not be able to successfully develop any drugs, which would cause us to cease operations.
We have never successfully developed a new drug and brought
it to market. Our management and clinical teams have experience in drug development but they may not be able to successfully develop
any drugs. Our ability to achieve revenues and profitability in our business will depend on, among other things, our ability to
develop products internally or to obtain rights to them from others on favorable terms; complete laboratory testing and human studies;
obtain and maintain necessary intellectual property rights to our products; successfully complete regulatory review to obtain
requisite governmental agency approvals; enter into arrangements with third parties to manufacture our products on our behalf;
and enter into arrangements with third parties to provide sales and marketing functions. If we are unable to achieve these
objectives we will be forced to cease operations and you will lose all of your investment.
Development of pharmaceutical products is a time-consuming
process, subject to a number of factors, many of which are outside of our control. Consequently, if we are unsuccessful or fail
to timely develop new drugs, we could be forced to discontinue our operations.
Our lead product candidate, BIV201,
has been cleared by the FDA to undergo testing in a mid-stage (Phase 2a) clinical trial. On June 18, 2019, we met with representatives
of the FDA for Type C Guidance Meeting to plan our next clinical study following the recently completed Phase 2a clinical trial.
We discussed our clinical development efforts with the FDA and proposed trial endpoints. While the FDA has not provided final
guidance nor do we have certainty as to what that guidance would entail, our goal remains to proceed into a Phase 2b/3 or Phase
3 clinical trial in a manner consistent with what was reviewed with the FDA. We may still need to address certain risks associated
with yet to be validated quality of life measures and the FDA expressed concern about the inadequacy of the topline results
of our Phase 2a clinical trial and their views that an additional Phase 2 clinical trial would be advisable. In July 2019, the
FDA provided meeting minutes for the June 18, 2019 meeting that documented general agreement with the Company proposed randomized
study design. The FDA also provided its suggestions and guidance regarding primary and secondary endpoints and other key aspects
of our clinical trial design and the Company is incorporating those suggestions as it moves forward.
Further development and extensive
testing will be required to determine its technical feasibility and commercial viability. Our success will depend on our ability
to achieve scientific and technological advances and to translate such advances into reliable, commercially competitive drugs
on a timely basis. Drugs that we may develop are not likely to be commercially available, at a minimum, for a few years, if ever.
The proposed development schedules for our product candidates may be affected by a variety of factors, including technological
difficulties, proprietary technology of others, and changes in government regulation, many of which will not be within our control.
Any delay in the development, introduction or marketing of our product candidates could result either in such drugs being marketed
at a time when their cost and performance characteristics would not be competitive in the marketplace or in the shortening of
their commercial lives. In light of the long-term nature of our projects and other risk factors described elsewhere in this document,
we may not be able to successfully complete the development or marketing of any drugs which could cause us to cease operations.
We may fail to successfully develop and commercialize our
product candidate(s) if it is found to be unsafe or ineffective in clinical trials; does not receive necessary approval from the
FDA or foreign regulatory agencies; fails to conform to a changing standard of care for the disease it seeks to treat; or is less
effective or more expensive than current or alternative treatment methods.
Drug development failure can occur at any stage of clinical
trials and as a result of many factors, there can be no assurance that we or our collaborators will reach our anticipated clinical
targets. Even if we or our collaborators complete our clinical trials, we do not know what the long-term effects of exposure to
our product candidates will be. Furthermore, our product candidates may be used in combination with other treatments and there
can be no assurance that such use will not lead to unique safety issues. Failure to complete clinical trials or to prove that our
product candidates are safe and effective would have a material adverse effect on our ability to generate revenue and could require
us to reduce the scope of or discontinue our operations, which could cause you to lose all of your investment.
We have no manufacturing experience, and the failure
to comply with all applicable manufacturing regulations and requirements could have a materially adverse effect on our business.
We have never manufactured products in the highly regulated
environment of pharmaceutical manufacturing, and our team has limited experience in the manufacture of drug therapies. There are
numerous regulations and requirements that must be maintained to obtain licensure and permitting required prior to the commencement
of manufacturing, as well as additional requirements to continue manufacturing pharmaceutical products. We currently do not own
or lease facilities that could be used to manufacture any products that might be developed by us, and have contracted with an experienced
Contract Manufacturing Organization (“CMO”) to perform the manufacturing of our new product candidate BIV201. In addition,
we do not have the resources at this time to acquire or lease suitable facilities. If we or our CMO fail to comply with regulations,
to obtain the necessary licenses and knowhow or to obtain the requisite financing in order to comply with all applicable regulations
and to own or lease the required facilities in order to manufacture our products, we could be forced to cease operations, which
would cause you to lose all of your investment.
In addition, the FDA and other regulatory authorities require
that product candidates and drug products be manufactured according to current good manufacturing practices (“cGMP”).
Any failure by our third-party manufacturers to comply with cGMP could lead to a shortage of BIV201. In addition, such failure
could be the basis for action by the FDA to withdraw approval, if granted to us, and for other regulatory action, including seizure,
injunction or other civil or criminal penalties.
BIV201 and any other product candidate that we develop may
compete with other products and product candidates for access to manufacturing facilities. There are a limited number of manufacturers
that operate under cGMP regulations and that are both capable of manufacturing for us and willing to do so. If we need to find
another source of drug substance or drug product for BIV201, we may not be able to identify, or reach agreement with, commercial-scale
manufacturers on commercially reasonably terms, or at all. If we are unable to do so, we will need to develop our own commercial-scale
manufacturing capabilities, which would: impact commercialization of BIV201 in the U.S. and other countries where it may be approved;
require a capital investment by us that could be quite costly; and increase our operating expenses.
If our existing third-party manufacturers, or the third parties
that we engage in the future to manufacture a product for commercial sale or for our clinical trials, should cease to continue
to do so for any reason, we likely would experience significant delays in obtaining sufficient quantities of product for us to
meet commercial demand or to advance our clinical trials while we identify and qualify replacement suppliers. If for any reason
we are unable to obtain adequate supplies of BIV201 or any other product candidate that we develop, or the drug substances used
to manufacture it, it will be more difficult for us to compete effectively, generate revenue, and further develop our products.
In addition, if we are unable to assure a sufficient quantity of the drug for patients with rare diseases or conditions, we may
lose any Orphan Drug exclusivity to which the product otherwise would be entitled.
We do not currently have the sales and marketing personnel
necessary to sell products, and the failure to hire and retain such staff could have a materially adverse effect on our business.
We are an early stage development company with limited resources.
Even if we had products available for sale, which we currently do not, we have not secured sales and marketing staff at this early
stage of operations to sell products. We cannot generate sales without sales or marketing staff and must rely on officers to provide
any sales or marketing services until such personnel are secured, if ever. If we fail to hire and retain the requisite expertise
in order to market and sell our products or fail to raise sufficient capital in order to afford to pay such sales or marketing
staff, then we could be forced to cease operations and you could lose all of your investment.
Even if we were to successfully develop approvable
drugs, we will not be able to sell these drugs if we or our third-party manufacturers fail to comply with manufacturing regulations,
which could have a materially adverse effect on our business.
If we were to successfully develop approvable drugs, before
we can begin selling these drugs, we must obtain regulatory approval of our manufacturing facility and process or the manufacturing
facility and process of the third party or parties with whom we may outsource our manufacturing activities. In addition, the manufacture
of our products must comply with the FDA’s current Good Manufacturing Practices regulations, commonly known as GMP regulations.
The GMP regulations govern quality control and documentation policies and procedures. Our manufacturing facilities, if any in the
future, and the manufacturing facilities of our third-party manufacturers will be continually subject to inspection by the FDA
and other state, local and foreign regulatory authorities, before and after product approval. We cannot guarantee that we, or any
potential third-party manufacturer of our products, will be able to comply with the GMP regulations or other applicable manufacturing
regulations. The failure to comply with all necessary regulations would have a materially adverse effect on our business and could
force us to cease operations and you could lose all of your investment.
We must comply with significant and complex government
regulations, compliance with which may delay or prevent the commercialization of our product candidates, which could have a materially
adverse effect on our business.
The R&D, manufacture and marketing of product candidates
are subject to regulation, primarily by the FDA in the United States and by comparable authorities in other countries. These national
agencies and other federal, state, local and foreign entities regulate, among other things, R&D activities (including testing
in animals and in humans) and the testing, manufacturing, handling, labeling, storage, record keeping, approval, advertising and
promotion of the product that we are developing. Noncompliance with applicable requirements can result in various adverse consequences,
including approval delays or refusals to approve drug licenses or other applications, suspension or termination of clinical investigations,
revocation of approvals previously granted, fines, criminal prosecution, recalls or seizures of products, injunctions against shipping
drugs and total or partial suspension of production and/or refusal to allow a company to enter into governmental supply contracts.
The process of obtaining FDA approval has historically been
costly and time consuming. Current FDA requirements for a new human drug or biological product to be marketed in the United States
include: (a) the successful conclusion of pre-clinical laboratory and animal tests, if appropriate, to gain preliminary information
on the product’s safety; (b) filing with the FDA of an IND application to conduct human clinical trials for drugs or biologics;
(c) the successful completion of adequate and well-controlled human clinical investigations to establish the safety and efficacy
of the product for its recommended use; and (d) filing by a company and acceptance and approval by the FDA of a NDA for a drug
product or a biological license application (BLA) for a biological product to allow commercial distribution of the drug or biologic.
A delay in one or more of the procedural steps outlined above could be harmful to us in terms of getting our product candidates
through clinical testing and to market, which could have a materially adverse effect on our business.
The FDA reviews the results of the clinical trials and may
order the temporary or permanent discontinuation of clinical trials at any time if it believes the product candidate exposes clinical
subjects to an unacceptable health risk. Investigational drugs used in clinical studies must be produced in compliance with cGMP
rules pursuant to FDA regulations.
Sales outside the United States of products that we develop
will also be subject to regulatory requirements governing human clinical trials and marketing for drugs and biological products
and devices. The requirements vary widely from country to country, but typically the registration and approval process takes several
years and requires significant resources.
If we experience delays or discontinuations of our clinical
trials by the FDA or comparable authorities in other countries, or if we fail to obtain registration or other approvals of our
products or devices then we could be forced to cease our operations and you will lose all of your investment.
Even if we are successful in developing BIV201, our product
candidate, we have limited experience in conducting or supervising clinical trials that must be performed to obtain data to submit
in concert with applications for approval by the FDA. The regulatory process to obtain approval for drugs for commercial sale involves
numerous steps. Drugs are subjected to clinical trials that allow development of case studies to examine safety, efficacy, and
other issues to ensure that sale of drugs meets the requirements set forth by various governmental agencies, including the FDA.
In the event that our protocols do not meet standards set forth by the FDA, or that our data is not sufficient to allow such trials
to validate our drugs in the face of such examination, we might not be able to meet the requirements that allow our drugs to be
approved for sale which could have a materially adverse effect on our business.
We can provide no assurance that our product candidate
will obtain regulatory approval or that the results of clinical studies will be favorable.
The business plan we have developed
for the next twenty-four months is to complete the Phase 2 clinical development program for our lead new product candidate BIV201,
commence a pivotal Phase 3 trial required for new drug approval, and to pursue other key milestones such as additional patent
issuances and U.S. Orphan Drug designations. Due to our financial constraints, we may not have the resources necessary to complete
our application. In light of the FDA meeting minutes, we plan to proceed to larger Phase 2b/3 or Phase 3 clinical trials upon
receipt of the net proceeds of this offering. There is no guarantee the FDA will approve a Phase 2b/3 or Phase 3 trial, and
even if they do our financial constraints may prevent us from undertaking clinical trials.
Confidentiality agreements with employees and others
may not adequately prevent disclosure of trade secrets and other proprietary information and disclosure of our trade secrets or
proprietary information could compromise any competitive advantage that we have, which could have a materially adverse effect on
our business.
Our success depends, in part, on our ability to protect our
proprietary rights to the technologies used in our products. We depend heavily upon confidentiality agreements with our officers,
employees, consultants and subcontractors to maintain the proprietary nature of our technology. These measures may not afford us
complete or even sufficient protection, and may not afford an adequate remedy in the event of an unauthorized disclosure of confidential
information. If we fail to protect and/or maintain our intellectual property, third parties may be able to compete more effectively
against us, we may lose our technological or competitive advantage, and/or we may incur substantial litigation costs in our attempts
to recover or restrict use of our intellectual property. In addition, others may independently develop technology similar to ours,
otherwise avoiding the confidentiality agreements, or produce patents that would materially and adversely affect our business,
prospects, financial condition and results of operations, in which event you could lose all of your investment.
We may be unable to obtain or protect intellectual
property rights relating to our products, and we may be liable for infringing upon the intellectual property rights of others,
which could have a materially adverse effect on our business.
Our ability to compete effectively
will depend on our ability to maintain the proprietary nature of our technologies. We cannot assure investors that we will continue
to innovate and file new patent applications, or that if filed any future patent applications will result in granted patents with
respect to the technology owned by us or licensed to us. Further, we cannot predict how long it will take for such patents to
issue, if at all. The patent position of pharmaceutical or biotechnology companies, including ours, is generally uncertain and
involves complex legal and factual considerations and, therefore, validity and enforceability cannot be predicted with certainty.
Patents may be challenged, deemed unenforceable, invalidated or circumvented. For example, on November 13, 2019, the Patent
Trial and Appeal Board of the United States Patent and Trademark Office (the “PTAB”) issued a written decision in
the inter partes review action that was brought by Mallinckrodt Pharmaceuticals Ireland Limited (“Mallinckrodt”)
against us. In that action, Mallinckrodt sought to invalidate our previously-issued patent (U.S. Pat. No. 9,655,945, “Treatment
of Ascites”) (the “’945 Patent”). In its decision, the PTAB determined that all claims of the ‘945
Patent were not patentable because they were either anticipated or obvious in light of prior art. The PTAB also denied our Motion
to Amend the claims on similar grounds. The result of the PTAB’s decision is that the ‘945 patent is no longer valid
or enforceable. We will be able to protect our proprietary rights from unauthorized use by third parties only to the extent
that our proprietary technologies, product candidates and any future products are covered by valid and enforceable patents or
are effectively maintained as trade secrets.
Any patents we do obtain may be
challenged by re-examination or otherwise invalidated or eventually found unenforceable. Both the patent application process
and the process of managing patent disputes can be time consuming and expensive. If we were to initiate legal proceedings
against a third party to enforce a patent related to one of our products or services, the defendant in such litigation could
counterclaim that our patent is invalid and/or unenforceable. In patent litigation in the U.S., defendant counterclaims
alleging invalidity and/or unenforceability are commonplace, as are validity challenges by the defendant against the subject
patent or other patents before the USPTO. Grounds for a validity challenge could be an alleged failure to meet any of several
statutory requirements, including lack of novelty, obviousness or non-enablement, failure to meet the written description
requirement, indefiniteness, and/or failure to claim patent eligible subject matter. Grounds for an unenforceability
assertion could be an allegation that someone connected with prosecution of the patent intentionally withheld material
information from the USPTO, or made a misleading statement, during prosecution. Additional grounds for an unenforceability
assertion include an allegation of misuse or anticompetitive use of patent rights, and an allegation of incorrect
inventorship with deceptive intent. Third parties may also raise similar claims before the USPTO even outside the context of
litigation. The outcome is unpredictable following legal assertions of invalidity and unenforceability. With respect to the
validity question, for example, we cannot be certain that no invalidating prior art existed of which we and the patent
examiner were unaware during prosecution. These assertions may also be based on information known to us or the Patent Office.
If a defendant or third party were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at
least part, and perhaps all, of the claims of the challenged patent. Such a loss of patent protection would or could have a
material adverse impact on our business.
The standards that the United States Patent and Trademark
Office (and foreign countries) use to grant patents are not always applied predictably or uniformly and can change. There is also
no uniform, worldwide policy regarding the subject matter and scope of claims granted or allowable in pharmaceutical or biotechnology
patents. Accordingly, we do not know the degree of future protection for our proprietary rights or the breadth of claims that will
be allowed in any patents issued to us or to others.
Further, we rely on a combination of trade secrets, know-how,
technology and nondisclosure, and other contractual agreements and technical measures to protect our rights in the technology.
If any trade secret, know-how or other technology not protected by a patent were to be disclosed to or independently developed
by a competitor, our business and financial condition could be materially adversely affected. The laws of some foreign countries
do not protect our proprietary rights to the same extent as the laws of the U.S., and we may encounter significant problems in
protecting our proprietary rights in these countries.
We do not believe that BIV201, the product candidate we are
currently developing, infringes upon the rights of any third parties nor are they infringed upon by third parties. However, there
can be no assurance that our technology will not be found in the future to infringe upon the rights of others or be infringed upon
by others. Moreover, patent applications are in some cases maintained in secrecy until patents are issued. The publication of discoveries
in the scientific or patent literature frequently occurs substantially later than the date on which the underlying discoveries
were made and patent applications were filed. Because patents can take many years to issue, there may be currently pending applications
of which we are unaware that may later result in issued patents that our products or product candidates infringe. For example,
pending applications may exist that provide support or can be amended to provide support for a claim that results in an issued
patent that our product infringes. In such a case, others may assert infringement claims against us, and should we be found to
infringe upon their patents, or otherwise impermissibly utilize their intellectual property, we might be forced to pay damages,
potentially including treble damages, if we are found to have willfully infringed on such parties’ patent rights. In addition to
any damages we might have to pay, we may be required to obtain licenses from the holders of this intellectual property. We may
fail to obtain any of these licenses or intellectual property rights on commercially reasonable terms. Even if we are able to obtain
a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. In that event,
we may be required to expend significant time and resources to develop or license replacement technology. If we are unable to do
so, we may be unable to develop or commercialize the affected products, which could materially harm our business and the third
parties owning such intellectual property rights could seek either an injunction prohibiting our sales, or, with respect to our
sales, an obligation on our part to pay royalties and/or other forms of compensation. Conversely, we may not always be able to
successfully pursue our claims against others that infringe upon our technology. Thus, the proprietary nature of our technology
or technology licensed by us may not provide adequate protection against competitors.
The pharmaceutical industry is characterized by extensive
litigation regarding patents and other intellectual property rights. Moreover, the cost to us of any litigation or other proceeding
relating to our patents and other intellectual property rights, even if resolved in our favor, could be substantial, and the litigation
would divert our management’s efforts. We may not have sufficient resources to bring any such action to a successful conclusion.
Uncertainties resulting from the initiation and continuation of any litigation could limit our ability to continue our operations
and you could lose all of your investment.
We depend upon our management and their loss or unavailability
could put us at a competitive disadvantage which could have a material adverse effect on our business.
We currently depend upon the efforts and abilities of our
executive management team of Terren Peizer, our Chief Executive Officer, Jonathan Adams, our President and Chief Operating Officer,
and Wendy Kim, our Chief Financial Officer and Corporate Secretary. Mr. Adams serves the Company full-time and Ms. Kim serves the
Company part-time. The loss or unavailability of the services of either of these individuals for any significant period of time
could have a material adverse effect on our business, prospects, financial condition and results of operations which may cause
you to lose all of your investment. We have not obtained, do not own, nor are we the beneficiary of key-person life insurance.
We may not be able to attract and retain highly skilled
personnel, which could have a materially adverse effect on our business.
Our ability to attract and retain highly skilled personnel
is critical to our operations and expansion. We face competition for these types of personnel from other pharmaceutical companies
and more established organizations, many of which have significantly larger operations and greater financial, technical, human
and other resources than us. We may not be successful in attracting and retaining qualified personnel on a timely basis, on competitive
terms, or at all. If we are not successful in attracting and retaining these personnel, our business, prospects, financial condition
and results of operations will be materially and adversely affected.
The biotechnology and biopharmaceutical industries
are characterized by rapid technological developments and a high degree of competition. We may be unable to compete with enterprises
equipped with more substantial resources than us, which could cause us to curtail or cease operations.
The biotechnology and biopharmaceutical industries are characterized
by rapid technological developments and a high degree of competition based primarily on scientific and technological factors. These
factors include the availability of patent and other protection for technology and products, the ability to commercialize technological
developments and the ability to obtain government approval for testing, manufacturing and marketing.
We compete with biopharmaceutical firms in the United States,
Europe and elsewhere, as well as a growing number of large pharmaceutical companies that are applying biotechnology to their operations.
Many biopharmaceutical companies have focused their development efforts in the human therapeutics area. Many major pharmaceutical
companies have developed or acquired internal biotechnology capabilities or made commercial arrangements with other biopharmaceutical
companies. These companies, as well as academic institutions, government agencies and private research organizations, also compete
with us in recruiting and retaining highly qualified scientific personnel and consultants. Our ability to compete successfully
with other companies in the pharmaceutical field will also depend to a considerable degree on the continuing availability of capital
to us.
Although there are not currently any therapies approved by
the FDA specifically for the treatment of ascites due to liver cirrhosis, we still face significant competitive and market risk.
Other companies, such as Mallinckrodt Inc., are developing therapies for severe complications of advanced liver cirrhosis, which
may in the future be developed for the treatment of ascites, and these therapies could compete indirectly or directly with our
product candidate. There may be other competitive development programs of which we are unaware. Even if our product candidate is
ultimately approved by the FDA, there is no guarantee that once it is on the market doctors will adopt it in favor of current ascites
treatment procedures such as diuretics and paracentesis. These competitive and market risks could have a material adverse effect
on our business, prospects, financial condition and results of operations which may cause you to lose all of your investment.
Our competition will be determined in part by the potential
indications for which drugs are developed and ultimately approved by regulatory authorities. Additionally, the timing of the market
introduction of some of our potential product candidate or of competitors’ products may be an important competitive factor. Accordingly,
the relative speed with which we can develop drugs, complete pre-clinical testing, clinical trials, approval processes and supply
commercial quantities to market are important competitive factors. We expect that competition among drugs approved for sale will
be based on various factors, including product efficacy, safety, reliability, availability, price and patent protection.
The successful development of biopharmaceuticals is highly
uncertain. A variety of factors including, pre-clinical study results or regulatory approvals, could cause us to abandon the development
of our product candidates.
Successful development of biopharmaceuticals is highly
uncertain and is dependent on numerous factors, many of which are beyond our control.
Products that appear promising in the early phases of development
may fail to reach the market for several reasons. Pre-clinical study results may show the product to be less effective than desired
(e.g., the study failed to meet its primary objectives) or to have harmful or problematic side effects. Products may fail to receive
the necessary regulatory approvals or may be delayed in receiving such approvals. Among other things, such delays may be caused
by slow enrollment in clinical studies, length of time to achieve study endpoints, additional time requirements for data analysis
or a IND and later NDA, preparation, discussions with the FDA, an FDA request for additional pre-clinical or clinical data or unexpected
safety or manufacturing issues; manufacturing costs, pricing or reimbursement issues, or other factors that make the product
not economical. Proprietary rights of others and their competing products and technologies may also prevent the product from being
commercialized.
Success in pre-clinical and early clinical studies does not
ensure that large-scale clinical studies will be successful. Clinical results are frequently susceptible to varying interpretations
that may delay, limit or prevent regulatory approvals. The length of time necessary to complete clinical studies and to submit
an application for marketing approval for a final decision by a regulatory authority varies significantly from one product to the
next, and may be difficult to predict. There can be no assurance that any of our products will develop successfully, and the failure
to develop our products will have a materially adverse effect on our business and will cause you to lose all of your investment.
There may be conflicts of interest among our officers,
directors and stockholders.
Certain of our executive officers and directors and their
affiliates are engaged in other activities and have interests in other entities on their own behalf or on behalf of other persons.
Neither we nor any of our shareholders will have any rights in these ventures or their income or profits. In particular, our executive
officers or directors or their affiliates may have an economic interest in or other business relationship with partner companies
that invest in us or are engaged in competing drug development. Our executive officers or directors may have conflicting fiduciary
duties to us and third parties. The terms of transactions with third parties may not be subject to arm’s length negotiations and
therefore may be on terms less favorable to us than those that could be procured through arm’s length negotiations. Although we
have established an audit committee comprised solely of independent directors to oversee transactions between us and our insiders,
we do not have any formal policies in place to deal with such conflicting fiduciary duties should such a conflict arise.
If we fail to maintain an effective system of
internal controls, we may not be able to accurately report our financial results or detect fraud. Consequently, investors could
lose confidence in our financial reporting and this may decrease the trading price of our common stock.
We must maintain effective internal controls to provide reliable
financial reports and detect fraud. We have concluded that our disclosure controls and procedures internal controls, as well as
internal controls over financial reporting, are effective. Failure to implement changes to our internal controls or any others
that we identify as necessary to establish an effective system of internal controls could harm our operating results and cause
investors to lose confidence in our reported financial information. Any such loss of confidence would have a negative effect on
the trading price of our common stock.
We may enter into employment agreements with our executive
officers and compensation payable thereunder may not be based on arms-length negotiations.
Certain of our current executive officers
also serve as directors of our Board of Directors, and we have not yet formed an independent compensation committee to determine
compensation and to approve employment agreements. Therefore, compensation which may be paid by us to our management under current
arrangements may not have been determined based on arms-length negotiations. We may grant stock options and other equity incentives
to our executive officers and directors that are consistent with the nature of the pharmaceutical industry. Although we have
established a compensation committee in connection with this offering comprised of only independent directors, there can be
no assurance made that the consideration which may be payable to management will reflect the true market value of services provided
to us.
RISKS RELATING TO OUR COMMON STOCK
There is a risk of dilution of your percentage ownership
of common stock in the Company.
We have the right to raise additional
capital or incur borrowings from third parties to finance its business. We may also implement public or private mergers, business
combinations, business acquisitions and similar transactions pursuant to which it would issue substantial additional capital stock
to outside parties, causing substantial dilution in the ownership of the Company by our existing stockholders. Our Board of Directors
has the authority, without the consent of any of the stockholders, to cause us to issue more shares of common stock and/or preferred
stock at such price and on such terms and conditions as are determined by the Board of Directors in its sole discretion. As of
November 21, 2019, there were warrants outstanding to purchase an aggregate of 124,667 shares of common stock at exercise
prices ranging from $1.875 to $75.00 per share, excluding the Bridge Financing Warrants that will be exercised automatically upon
the closing of this offering at an exercise price equal to the par value of the common stock. The issuance of additional shares
of capital stock by us will dilute your ownership percentage in the Company and could impair our ability to raise capital in the
future through the sale of equity securities.
Certain stockholders who are also officers and directors
of the Company may have significant control over our management.
Our directors and executive officers
currently own an aggregate 4,469,272 shares of our common stock, which currently constitutes 86.2% of our
issued and outstanding common stock. As a result, directors and executive officers may have a significant influence on our affairs
and management, as well as on all matters requiring member approval, including electing and removing members of our Board of Directors,
causing us to engage in transactions with affiliated entities, causing or restricting our sale or merger, and certain other matters.
Our Chairman and Chief Executive Officer, Mr. Terren Peizer, may be deemed to beneficially own the shares held by Acuitas. Such
concentration of ownership and control could have the effect of delaying, deferring or preventing a change in control of us even
when such a change of control would be in the best interests of our stockholders.
There is not now, and there may never
be, an active, liquid and orderly trading market for our common stock or warrants, which may make it difficult for you to sell
your shares of our common stock and warrants.
There is not now, nor has there been since
our inception, any significant volume of trading activity in our common stock or an active market for shares of our common stock,
and the warrants are a new class of securities for which there is no existing market. An active trading market for our securities
may never develop or be sustained after this offering. As a result, investors in our common stock and warrants must bear the economic
risk of holding those securities for an indefinite period of time. Although our common stock is quoted on the OTCQB Marketplace,
or OTCQB, over-the-counter quotation system, trading of our common stock on such system has only recently commenced and continues
to be extremely limited and sporadic and at very low volumes. Although our common stock and warrants have been approved for
listing on Nasdaq, an active trading market for our securities may never develop or be sustained. If an active market for
our securities does not develop, it may be difficult for you to sell the securities you purchase in this offering without depressing
the market price for such securities or at all. Further, an unestablished trading market for our securities may also impair our
ability to raise capital by selling additional equity in the future, and may impair our ability to enter into strategic partnerships
or acquire companies or products by using shares of our common stock as consideration.
We may, in the future, issue additional
common stock, which would reduce investors’ percent of ownership and may dilute our share value.
As of November 21, 2019, our
Articles of Incorporation authorize the issuance of 800,000,000 shares of common stock. As of November 21, 2019, we had
5,183,442 shares of common stock outstanding. Accordingly, we may issue up to an additional 794,816,558 shares of common stock.
The future issuance of common stock may result in substantial dilution in the percentage of our common stock held by our then
existing shareholders. We may value any common stock in the future on an arbitrary basis. The issuance of common stock for future
services or acquisitions or other corporate actions may have the effect of diluting the value of the shares held by our investors,
might have an adverse effect on any trading market for our common stock and could impair our ability to raise capital in the future
through the sale of equity securities.
We have a large number of restricted shares outstanding,
a portion of which may be sold under Rule 144 which may reduce the market price of our shares.
Of the 5,183,442 shares of common
stock issued and outstanding as of November 21, 2019, 714,170 shares are held by non-affiliates and 4,469,272 are
owned by affiliates of the Company, consisting of our officers and directors or entities controlled by them. The majority of our
common stock, including all of the affiliates’ securities are deemed “restricted securities” within the meaning
of Rule 144 as promulgated under the Securities Act.
It is anticipated that all of the “restricted securities”
will be eligible for resale under Rule 144. In general, under Rule 144, subject to the satisfaction of certain other conditions,
a person, who is not an affiliate (and who has not been an affiliate for a period of at least three months immediately preceding
the sale) and who has beneficially owned restricted shares of our common stock for at least six months is permitted to sell such
shares without restriction, provided that there is sufficient public information about us as contemplated by Rule 144. An affiliate
who has beneficially owned restricted shares of our common stock for a period of at least one year may sell a number of shares
equal to one percent of our issued and outstanding common stock approximately every three months.
The respective holding periods for certain shares issued to affiliates and non-affiliates holding restricted securities commenced and were issued between
May 17, 2013 and June 30, 2013. The possibility that substantial amounts of our common stock may be sold under Rule 144 into the
public market may adversely affect prevailing market prices for the common stock and could impair our ability to raise capital
in the future through the sale of equity securities.
Any failure to maintain effective internal control over financial reporting could harm us.
Our management is responsible for establishing and maintaining
adequate internal control over financial reporting. Internal control over financial reporting is a process designed to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance
with U.S. generally accepted accounting principles (“GAAP”). Under standards established
by the Public Company Accounting Oversight Board (“PCAOB”), a deficiency in internal control over financial reporting
exists when the design or operation of a control does not allow management or personnel, in the normal course of performing their
assigned functions, to prevent or detect misstatements on a timely basis. The PCAOB defines a material weakness as a deficiency,
or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that
a material misstatement of annual or interim financial statements will not be prevented, or detected and corrected, on a timely
basis.
If we are unable to assert that our internal control over
financial reporting is effective, or when required in the future, if our independent registered public accounting firm is unable
to express an unqualified opinion as to the effectiveness of our internal control over financial reporting, investors may lose
confidence in the accuracy and completeness of our financial reports, the market price of our common stock could be adversely affected
and we could become subject to litigation or investigations by the stock exchange on which our securities are listed, the SEC or
other regulatory authorities, which could require additional financial and management resources.
The lack of public company experience of our management
team could adversely impact our ability to comply with the reporting requirements of U.S. securities laws, which could have a materially
adverse effect on our business.
Our officers have limited public company experience, which
could impair our ability to comply with legal and regulatory requirements such as those imposed by Sarbanes-Oxley Act of 2002.
Such responsibilities include complying with federal securities laws and making required disclosures on a timely basis. Any such
deficiencies, weaknesses or lack of compliance could have a materially adverse effect on our ability to comply with the reporting
requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which is necessary to maintain
our public company status. If we were to fail to fulfill those obligations, our ability to continue as a U.S. public company would
be in jeopardy in which event you could lose your entire investment in our Company.
We are considered a smaller reporting company and is
exempt from certain disclosure requirements, which could make our stock less attractive to potential investors.
Rule 12b-2 of the Exchange Act defines a “smaller reporting
company” as an issuer that is not an investment company, an asset-backed issuer, or a majority-owned subsidiary of a parent
that is not a smaller reporting company and that:
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·
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Had a public float of less than $250 million as of the last business day of its most recently completed fiscal quarter, computed by multiplying the aggregate number of worldwide number of shares of its voting and non-voting common equity held by non-affiliates by the price at which the common equity was last sold, or the average of the bid and asked prices of common equity, in the principle market for the common equity; or
|
|
·
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In the case of an initial registration statement under the Securities Act or the Exchange Act for shares of its common equity, had a public float of less than $250 million as of a date within 30 days of the date of the filing of the registration statement, computed by multiplying the aggregate worldwide number of such shares held by non-affiliates before the registration plus, in the case of a Securities Act registration statement, the number of such shares included in the registration statement by the estimated public offering price of the shares; or
|
|
·
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In the case of an issuer who had annual revenue of less than
$100 million during the most recently completed fiscal year for which audit financial statements are available, had a public float
as calculated under paragraph (1) or (2) of this definition that was either zero or less than $700 million.
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As a “smaller reporting
company” we are not required and may not include a Compensation Discussion and Analysis (“CD&A”)
section in our proxy statements; we provide only 3 years of business development information; provide fewer years of selected
data; and have other “scaled” disclosure requirements that are less comprehensive than issuers that are not
“smaller reporting companies” which could make our stock less attractive to potential investors, which could make
it more difficult for you to sell your shares.
We have not held regular annual meetings of stockholders
in the past, and if we are required by the Nevada District Court to hold an annual meeting pursuant to Nevada Revised Statutes
§78.345(1), it could result in the unanticipated expenditure of funds, time and other Company resources.
Section 1 of Article II of our bylaws provides that an annual
meeting of stockholders shall be held each year on a date and at a time designated by our Board of Directors. Section 78.345(1)
of the Nevada Revised Statutes provides that if there is a failure to hold the annual meeting for a period of 18 months after the
last election of directors, stockholders owning at least 15% of the voting power of the outstanding common stock may apply to the
Nevada district court to order the election of directors.
We have not held regular annual meetings
of stockholders in the past because a substantial majority of our stock is owned by a small number of stockholders, making it
easy to obtain written consent in lieu of a meeting when necessary. In light of our historical liquidity constraints, handling
matters by written consent has allowed us to save on financial and administrative resources required to prepare for and hold such
annual meetings. Additionally, our common stock and warrants have been approved for listing on Nasdaq upon the completion of
this offering. Pursuant to Nasdaq’s corporate governance requirements, we will be obligated to hold regular annual meetings
of stockholders in the future, and it is currently contemplated that the we will hold such meetings beginning in 2020.
To our knowledge, no stockholder or director has requested
our management to hold such an annual meeting and no stockholder or director has applied to the Nevada district court seeking an
order directing us to hold a meeting of stockholders. However, if one or more stockholders or directors were to apply to the Nevada
district court seeking such an order, and if the Nevada district court were to order an annual meeting before we were prepared
to hold one, the preparation for the annual meeting of stockholders and the meeting itself could result in the unanticipated expenditure
of funds, time, and other Company resources.
We are subject to the periodic reporting requirements
of the Exchange Act, which require us to incur audit fees and legal fees in connection with the preparation of such reports. These
additional costs will negatively affect our ability to earn a profit.
We are required to file periodic reports with the SEC pursuant
to the Exchange Act and the rules and regulations thereunder. In order to comply with such requirements, our independent registered
auditors have to review our financial statements on a quarterly basis and audit our financial statements on an annual basis.
Moreover, our legal counsel has to review and assist in the preparation of such reports. Factors such as the number and type of
transactions that we engage in and the complexity of our reports cannot accurately be determined at this time and may have a major
negative effect on the cost and amount of time to be spent by our auditors and attorneys. However, the incurrence of such costs
is an expense to our operations and thus has a negative effect on our ability to meet our overhead requirements and earn a profit.
Because we do not intend to pay any cash dividends
on our common stock, our stockholders will not be able to receive a return on their shares unless they sell them.
We intend to retain any future earnings to finance the development
and expansion of our business. We do not anticipate paying any cash dividends on our common stock in the foreseeable future. Unless
we pay dividends, our stockholders will not be able to receive a return on their shares unless they sell them. There is no assurance
that stockholders will be able to sell shares when desired.
Holders of our
warrants will have no rights as a common stockholder until they acquire our common stock.
Until you acquire shares of our common
stock upon exercise of your warrants, you will have no rights with respect to shares of our common stock issuable upon exercise
of your warrants. Upon exercise of your warrants, you will be entitled to exercise the rights of a common stockholder only as
to matters for which the record date occurs after the exercise date.
The warrants
may not have any value.
Each whole warrant will have an exercise price
of $ (125% of the offering price) and will expire on the fifth anniversary of the date they first
become exercisable. In the event our common stock price does not exceed the exercise price of the warrants during the period when
the warrants are exercisable, the warrants may not have any value.
Cautionary
Note Regarding Forward-Looking Statements
This prospectus contains “forward-looking
statements” within the meaning of the federal securities laws, and that involve significant risks and uncertainties. We intend
the forward-looking statements to be covered by the safe harbor for forward-looking statements in these sections. Words such as
“may,” “should,” “could,” “would,” “predicts,” “potential,”
“continue,” “expects,” “anticipates,” “future,” “intends,” “plans,”
“believes,” “estimates,” and similar expressions, as well as statements in future tense, identify forward-looking
statements. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate
indications of when such performance or results will be achieved. Forward-looking statements are based on information we have when
those statements are made or management’s good faith belief as of that time with respect to future events, and are subject
to significant risks and uncertainties that could cause actual performance or results to differ materially from those expressed
in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited
to:
- our limited operating
history and experience in developing and manufacturing drugs;
- none of our products
are approved for commercial sale;
- our substantial
capital needs;
- product development
risks;
- we do not have
sales and marketing personnel;
- regulatory, competitive
and contractual risks;
- risks related
to our intellectual property rights;
- the absence of
liquidity in our common stock;
- the risk of substantial
dilution from future issuances of our equity securities; and
- the other risks
set forth herein under the caption “Risk Factors.”
The foregoing does not represent an
exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced
with. Forward-looking statements necessarily involve risks and uncertainties, and our actual results could differ materially from
those anticipated in the forward-looking statements due to a number of factors, including those set forth above under “Risk
Factors” and elsewhere in this prospectus. The factors set forth above under “Risk Factors” and other cautionary
statements made in this prospectus should be read and understood as being applicable to all related forward-looking statements
wherever they appear in this prospectus. The forward-looking statements contained in this prospectus represent our judgment as
of the date of this prospectus. We caution readers not to place undue reliance on such statements. Except as required by law, we
undertake no obligation to update publicly any forward-looking statements for any reason, even if new information becomes available
or other events occur in the future. All subsequent written and oral forward-looking statements attributable to us or persons acting
on our behalf are expressly qualified in their entirety by the cautionary statements contained above and throughout this prospectus.
Use
of Proceeds
We estimate that the net proceeds from
the sale of the units we are offering will be approximately $ million. If the underwriters
fully exercise the over-allotment option, the net proceeds of the units we sell will be approximately $
million. “Net proceeds” is what we expect to receive after deducting the underwriting discount and commission and
estimated offering expenses payable by us.
We intend to use the net proceeds of this
offering primarily to fund clinical trials of BIV201 and for working capital and other general corporate purposes, including the
mandatory repayment of all accrued principal and interest under the Debenture upon the closing of this offering, estimated to
be approximately $510,000 if this offering is consummated prior to December 10, 2019. 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 the units.
Dividend
Policy
We have never declared or paid any cash
dividends on our common stock and we do not anticipate paying any cash dividends in the foreseeable future. The payment of dividends,
if any, in the future is within the discretion of our Board of Directors and will depend on our earnings, capital requirements
and financial condition and other relevant facts. We currently intend to retain all future earnings, if any, to finance the development
and growth of our business.
Capitalization
The following table sets forth our
cash and capitalization as of September 30, 2019:
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●
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on a pro-forma basis to give effect to the following transactions with our controlling stockholder Acuitas: (i) the automatic exercise of the Bridge Financing Warrants upon
the closing of this offering and (ii) the issuance of an aggregate of 5,359,832 shares of common stock upon the closing of this
offering pursuant to a committed exercise by Acuitas of its purchase option granted in connection with its initial investment in
the Company; and
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●
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on
a pro forma as adjusted basis to give effect to the pro-forma adjustment above, as well as the sale of units in this offering,
assuming an initial public offering price of $ per unit, after deducting estimated
underwriting discounts and commissions and estimated offering expenses payable by us, and the application of a portion of
such net proceeds to satisfy all amounts due with respect to the Debenture as of the closing date of this offering.
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You should read the information in this
table together with our financial statements and accompanying notes and “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” appearing elsewhere in this prospectus.
|
|
As
of September 30, 2019
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|
|
Actual
|
|
Pro Forma
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|
Pro Forma As Adjusted
|
Cash
|
|
$
|
249,009
|
|
|
|
249,134
|
|
|
$
|
|
|
Stockholders’ equity
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock,
$0.0001 par value per share, 800,000,000 shares authorized; 5,183,442, and 11,793,273 and
shares issued and outstanding actual, pro forma and pro forma as adjusted, respectively
|
|
|
518
|
|
|
|
1,179
|
|
|
|
|
|
Additional paid in capital
|
|
|
19,461,211
|
|
|
|
27,570,935
|
|
|
|
|
|
Accumulated deficit
|
|
|
(28,182,357)
|
|
|
|
(25,648,689
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)
|
|
|
|
|
Total
stockholders’ (deficit) equity
|
|
$
|
(8,720,628
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)
|
|
|
1,923,425
|
|
|
$
|
|
|
Dilution
If you purchase units in this offering,
your interest will be diluted immediately to the extent of the difference between the assumed public offering price of $ per
unit and the pro forma as adjusted net tangible book value per share of our common stock immediately upon the consummation of
this offering.
The pro forma net tangible book value
of our common stock as of September 30, 2019 was $81,328, or $0.01 per share. Pro forma net tangible book value
per share of our common stock represents our total tangible assets (total assets less intangible assets) less total liabilities
divided by the number of shares of common stock outstanding as of that date, after giving pro-forma effect to the automatic exercise
of the Bridge Financing Warrants and the committed exercise of Acuitas’ purchase option upon the closing of this offering.
Net tangible book value dilution per share
to new investors represents the difference between the amount per share paid by purchasers in this offering and the pro forma
as adjusted net tangible book value per share of common stock immediately after completion of this offering. After giving effect
to our sale of shares of common stock as part of the units sold in this offering
at an assumed public offering price of $ per unit, and after deducting underwriters’
commissions and estimated offering expenses, our pro forma as adjusted net tangible book value as of September 30, 2019
would have been $ million, or $ per
share. This represents an immediate increase in net tangible book value of $ per
share to existing stockholders and an immediate dilution in net tangible book value of $
per share to purchasers of units in this offering, as illustrated in the following table:
Assumed
public offering price per unit
|
|
|
|
|
|
$
|
|
|
Pro
forma net tangible book value per share as of September 30, 2019
|
|
$
|
0.01
|
|
|
|
|
|
Increase
in net tangible book value per share attributable to new investors
|
|
$
|
|
|
|
|
|
|
Pro
forma adjusted net tangible book value per share as of September 30, 2019, after giving effect to the offering
|
|
$
|
|
|
|
|
|
|
Dilution
per share to new investors in the offering
|
|
|
|
|
|
$
|
|
|
If the underwriters exercise their option
in full to purchase additional shares of common stock and/or warrants in this
offering at the assumed offering price of $ per unit, the pro forma net tangible
book value per share after this offering would be $ per share, the increase in
the pro forma net tangible book value per share to existing stockholders would be $
per share and the dilution to new investors purchasing securities in this offering would be $ per
share.
The pro forma number of shares
of common stock to be outstanding after this offering is based on 5,183,442 shares of common stock outstanding as of September
30, 2019 and giving pro-forma effect to the automatic exercise of the Bridge Financing Warrants and the issuance of an aggregate of 5,359,832 shares of common stock pursuant
to the committed exercise of Acuitas’ purchase option upon the closing of this offering, which does not include:
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59,600
shares of common stock issuable upon the exercise of outstanding stock options as of November 21, 2019, at a weighted
average exercise price of $11.62 per share; and
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124,667
shares of common stock issuable upon the exercise of outstanding and exercisable warrants as of November 21, 2019 (other
than the Bridge Financing Warrants), at a weighted average exercise price of $9.70 per share.
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To the extent that outstanding exercisable options or warrants
are exercised, you may experience further dilution.
In addition, we may choose to raise additional capital due
to market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating
plans. To the extent that we raise additional capital by issuing equity securities or convertible debt, your ownership will be
further diluted.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
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 prospectus.
Overview
We are a clinical stage biotechnology
company engaged in the discovery, development and commercialization of 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 product 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.
BioVie accomplished the following key
milestones during the twelve months ended June 30, 2019:
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In July 2018, we completed an equity investment with Acuitas and other investors that provided gross proceeds of $3.2 million to BioVie.
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In November 2018, the Company announced that BIV201 had been granted an Orphan Drug designation for hepatorenal syndrome.
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In February 2019, we completed patient enrollment in our mid-stage (Phase 2a) clinical trial of BIV201 for the treatment of refractory ascites.
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In
April 2019, we announced top-line results for the Phase 2a clinical trial of BIV201 in six patients.
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On
June 18, 2019, we met with representatives of the U.S. Food & Drug Administration (“FDA”) for a Type C
Guidance Meeting to plan our next clinical study following the recently completed Phase 2a clinical trial. We discussed our clinical development efforts with the FDA and proposed trial endpoints. While the FDA has
not provided final guidance nor do we have certainty as to what that guidance would entail, our goal remains to proceed into a
Phase 2b/3 or Phase 3 clinical trial in a manner consistent with what was reviewed with the FDA. We may still need to address certain
risks associated with unvalidated quality of life measures. In July 2019, the FDA provided its meeting minutes for the June 18,
2019 meeting that documented general agreement with the Company proposed randomized study design. The FDA also provided its suggestions
and guidance regarding primary and secondary endpoints and other key aspects of our clinical trial design and the Company is incorporating
those suggestions as it moves forward.
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In
August 2019, we developed a proprietary novel liquid formulation of terlipressin that is intended to improve convenience for
outpatient administration and avoid potential formulation errors when pharmacists reconstitute the powder version.
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In November 2019, we announced that the first batch of pre-filled
syringes containing this liquid formulation had been manufactured and cleared quality control testing.
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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 the Debenture in the Bridge Financing, 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.
Comparison of the Year Ended June 30, 2019 to the Year
Ended June 30, 2018
Summary of Operating Expenses
Total operating expenses
for fiscal year ended June 30, 2019 were $2,497,000 compared to $2,372,000 for the year ended June 30, 2018. The net increase of $125,000
was primarily due to an increase in research and development expenses of $637,000 as the Company resumed and completed its Phase
2a clinical trial program during the year and hired 1 full time employee and 1 half time employee in November 2018, who were previously
consultants; offset by a reduction in selling, general and administrative expenses of $512,000 which represented the issuance of
common stock in August 2017 and January 2018 as compensation for professional services.
Research and Development
Research and development
expenses for the year ended June 30, 2019 increased by $637,000 to $1,008,000 from $371,000 for fiscal year ended June 30, 2018. The increase
was primary attributed to the Phase 2a clinical trial activities which began and was completed during the year and the hiring of
1 full time and 1 half time employee in November 2018, who were previously consultants.
Selling, General and Administrative
Selling, general and administrative expenses declined
by $513,000 to $1,259,000 for the fiscal year ended June 30, 2019 compared to $1,772,000 for the fiscal year
ended June 30, 2018. The reduction in expense was primarily related to compensation paid in BioVie common stock during the fiscal
year ended June 30, 2018 related to financial and strategic advisory services provided of approximately $642,000 which did not
occur during fiscal year ended June 30, 2019.
Liquidity and Capital Resources
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.
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.
Critical Accounting Policies and Estimates
Stock-based Compensation
The Company has accounted for stock-based compensation under the provisions of FASB ASC 718 - "Stock Compensation" which requires the use of the fair-value based method to determine compensation for all arrangements under which employees and others receive shares of stock or equity instruments (stock options and common stock purchase warrants). For employee awards, the fair value of each stock option award is estimated on the date of grant using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate. For non-employees, the fair value of each stock option award is estimated on the measurement date using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate. For non-employees, the Company utilizes the graded vesting attribution method under which the entity treats each separately vesting portion (tranche) as a separate award and recognizes compensation cost for each tranche over its separate vesting schedule. Expected volatilities are based on historical volatility of peer companies and other factors estimated over the expected term of the stock options. For employee awards, the expected term of options granted is derived using the "simplified method" which computes expected term as the average of the sum of the vesting term plus the contract term. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for the period of the expected term. We recognize forfeitures when they occur.
Goodwill
Goodwill represents costs in excess of values assigned to the underlying net assets of acquired businesses. We test goodwill annually, or when a
triggering event occurs between annual impairment tests, to determine if impairment exists and if the use of indefinite life is
currently applicable. The Company did not recognize any goodwill impairments for the years ended June 30th, 2018 and, 2019, respectively.
Impairment of Long-Lived Assets
Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not
be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of the assets to
the future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the
impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the
assets and would be charged to earnings.
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”, which simplifies
the accounting for non-employee share-based payment transactions. The amendments specify that Topic 718 applies to all share-based
payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations
by issuing share-based payment awards. The standard will be effective for the Company in the first quarter of fiscal year 2020.
The Company adopted this ASU as of July 1, 2019. There has been no impact on its 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.
BUSINESS
We are a clinical-stage company
pursuing the discovery, development, and commercialization of innovative drug therapies. We are currently focused on developing
and commercializing BIV201, 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 and has never been approved 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.
In April 2017, we entered into
a CRADA with the McGuire Research Institute Inc. in Richmond, VA, and began administering BIV201 to patients in September 2017.
In April 2019, we announced top-line results for our Phase 2a clinical trial of BIV201 (continuous infusion terlipressin) in six
patients with refractory ascites due to advanced liver cirrhosis. The following results were observed:
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Continuous
infusion of terlipressin via portable infusion pump was maintained for 28 days in three patients with refractory ascites,
and all patients remained hemodynamically stable during treatment.
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The
steady state plasma concentration data characterized terlipressin pharmacokinetics (PK) within the predicted PK model concentrations.
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Four
of the six patients treated with BIV201 experienced an increase in the number of days between paracenteses ranging from 71%
to 414% compared to prior to initiating therapy.
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On June 18, 2019, we met with representatives
of the U.S. Food &Drug Administration ("FDA") for a Type C Guidance Meeting to plan our next clinical study following
the recently completed Phase 2a clinical trial. We discussed our clinical development efforts with the FDA and proposed safety
and efficacy endpoints for our next clinical trial. In July 2019, the FDA provided its meeting minutes for this meeting that documented
general agreement with the Company's proposed randomized clinical study design. The FDA also provided its suggestions and guidance regarding primary and secondary endpoints and other key
aspects of our clinical trial design including appropriate quality of life measures. On October 1, 2019, the Company submitted
a Phase 2b/3 randomized, controlled clinical trial protocol to the FDA incorporating these suggestions. If this trial demonstrates
significant improvement on various measures of patient health status, we believe it could potentially form the basis to submit
a new drug application (NDA) for the eventual marketing of BIV201 in the US. While the FDA has not provided final guidance nor
do we have certainty as to what that guidance would entail, our goal remains to commence the planned Phase 2b/3 trial in the next
several months in a manner consistent with what was reviewed with the FDA. We may still need to address certain risks associated
with yet to be validated quality of life measures.
In September 2019, the Company manufactured
the first batch of a novel patent-pending liquid formulation of terlipressin for use in the Phase 2b/3 trial subject to FDA clearance.
This new product format is intended to improve convenience for outpatient administration and avoid potential formulation errors
when pharmacists reconstitute the powder version. In November 2019, the Company announced that the first batch of pre-filled
syringes containing this liquid formulation had been manufactured and cleared quality control testing.
BIV201 has the potential to
improve the health of thousands of patients suffering from life-threatening complications of liver cirrhosis due to hepatitis,
NASH, and alcoholism. It is covered by a pending patent application, has FDA Fast-Track status and we have obtained Orphan
Drug designation for it in the U.S. for the treatment of hepatorenal syndrome (received November 21, 2018) and treatment of ascites
due to all etiologies except cancer (received September 8, 2016). Orphan Drug designation for the most common of these complications,
ascites, which represents a significant unmet medical need. The FDA has never approved any drug specifically for treating ascites.
BIV201 also has an Orphan Drug designation for HRS.
The BIV201 development
program began at LAT Pharma LLC. On April 11, 2016, we acquired LAT Pharma LLC and the rights to its BIV201 development
program and currently own all development and marketing rights to the product candidate. We and PharmaIN, LAT
Pharma’s former partner focused on the development of new modified product candidates in the same therapeutic field
but not including BIV201, have 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, we returned our partial ownership rights to the PharmaIN modified
terlipressin development program and simultaneously paid the remaining balance due on a related debt. PharmaIN’s
rights to our program remain unchanged. We have a U.S. pending patent application for the use of BIV201 for the
treatment of patients diagnosed with ascites due to liver cirrhosis in the outpatient setting using ambulatory pump
infusion, and have corresponding patent applications pending in Japan, Europe, China and Hong Kong.
About Ascites and Liver Cirrhosis
About 600,000 Americans and millions
worldwide suffer from liver cirrhosis. Cirrhosis is the 8th leading cause of death due to disease in the US, killing more than
30,000 people each year. The condition results primarily from hepatitis, alcoholism, and fatty liver disease linked to obesity.
Ascites is a common complication of advanced liver cirrhosis, involving kidney dysfunction and the accumulation of large amounts
of fluid in the abdominal cavity.
The Need for an Ascites Therapy
With no medications approved by
the FDA specifically for treating ascites, an estimated 40% of patients die within two years of diagnosis. Certain drugs approved
for other uses such as diuretics may provide initial relief, but patients may fail to respond to treatment as ascites worsens.
This represents a critical unmet medical need. U.S. treatment costs for liver cirrhosis, including ascites and other complications,
are estimated at more than $4 billion annually.
The Ascites Development Pathway
Most
experts agree that ascites develops through a sequence of events illustrated by the above diagram. High blood pressure in the vein
that supplies blood to the liver, called “portal hypertension,” occurs as increasing liver damage (fibrosis) impedes
blood flow through the liver. This causes vasodilation and blood pooling in the central or “splanchnic” region
of the body and low blood volume in the arteries. The decrease in effective blood volume activates a signaling pathway (“neurohormonal
systems”) which tells the kidneys to retain large amounts of salt and water in an effort to increase blood volume. Ultimately
the retention of excess sodium and water leads to the formation of ascites as these substances “weep” from the liver
and lymph system and collect in the patient’s abdomen.
The BIV201 Mechanism of Action
BIV201 is being developed by BioVie
with the goal of alleviating the portal hypertension and correcting splanchnic vasodilation, thereby increasing effective blood
volume and reducing the signals to the kidneys to retain excess salt and water. If successful, BIV201 could halt the
cycle of accelerating fluid generation in ascites patients and reduce the need for the frequent and painful paracentesis procedures
many of these patients currently require.
Future Possible BIV201 Indications
Based on investigative studies
around the world of the active agent in BIV201, terlipressin, our new product candidate may have potential future applications
in other life-threatening conditions due to liver cirrhosis, such as those listed below. Securing marketing approvals for
any of these new uses will require well-controlled clinical trials to satisfy the FDA and/or other countries’ regulatory
requirements, none of which have commenced at this time. We may be unable to, or chose not to, pursue the development BIV201 for
these indications.
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Bleeding
Esophageal Varices (BEV): The bursting of blood vessels lining the esophagus due to high blood pressure (“portal hypertension”)
in the vein which supplies blood to the liver resulting as a result of advanced liver cirrhosis. This situation requires emergency
treatment to avoid blood loss and death.
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Hepatorenal
syndrome (HRS): As their disease progresses liver cirrhosis patients’ kidneys may begin to fail, and this deadly condition
may set in. It often occurs once a patient no longer responds to (off-label) drugs used to control ascites. The second stage
is called “type 1 HRS” and requires hospitalization as multiple organ failure and death may occur. We obtained
Orphan Drug designation for BIV201 in the U.S. for the treatment of HRS on November 21, 2018.
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Efflux Pump Antibiotics Program
Prior to the Merger of Lat Pharma LLC
and NanoAntibiotics Inc. in April 2016, we were exclusively developing novel nanotechnology anti-infective drugs to combat multi-drug
resistant bacteria. We are at an early stage of discovery and development of broad spectrum antibiotics for gram-negative and gram-positive
bacterial infections. Developing this technology in-house is resource-intensive with respect to time, personnel and capital necessary
for scientific discovery. For further development of our nanoantibiotic technology we will need to find and license additional
nanotechnology to complete our planned products. Presently this program is inactive as we are focusing our efforts on BIV201.
Intellectual Property
BioVie relies on a combination of patent,
trade secret, other intellectual property laws (such as FDA data exclusivity), nondisclosure agreements, and other measures to
protect our proposed products. We require our employees, consultants, and advisors to execute confidentiality agreements and to
agree to disclose and assign to us all inventions conceived during the workday, using our property, or which relate to our business.
Despite any measures taken to protect our intellectual property, unauthorized parties may attempt to copy aspects of our products
or to obtain and use information that we regard as proprietary. In July 2017 we announced filing an application for patent
coverage in Japan, and subsequently filed for patent protection in Europe, China and Hong Kong. BioVie has secured Orphan Drug
designations in the U.S. for the treatment of hepatorenal syndrome (received November 21, 2018) and treatment of ascites due to
all etiologies except cancer (received September 8, 2016). We have applied for an additional Orphan Drug designation which could
be granted in 2019.
Government Regulation
Government authorities in the United
States, at the federal, state and local level, and in other countries extensively regulate, among other things, the research, development,
testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution,
post-approval monitoring and reporting, marketing and export and import of products such as those we are developing. Any pharmaceutical
candidate that we develop must be approved by the FDA before it may be legally marketed in the United States and by the appropriate
foreign regulatory agency before it may be legally marketed in foreign countries.
United States Drug Development
Process
In the United States, the FDA regulates
drugs under the Federal Food, Drug and Cosmetic Act, or FDCA, and implementing regulations. Drugs are also subject to other federal,
state and local statutes and regulations. Biologics are subject to regulation by the FDA under the FDCA, the Public Health Service
Act, or the PHSA, and related regulations, and other federal, state and local statutes and regulations. Biological products include,
among other things, viruses, therapeutic serums, vaccines and most protein products. The process of obtaining regulatory approvals
and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure
of substantial time and financial resources. Failure to comply with the applicable United States requirements at any time during
the product development process, approval process or after approval, may subject an applicant to administrative or judicial sanctions.
FDA sanctions could include refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters,
product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government
contracts, restitution, disgorgement or civil or criminal penalties. Any agency or judicial enforcement action could have a material
adverse effect on us.
The process required by the FDA before
a drug or biological product may be marketed in the United States generally involves the following:
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Completion of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory Practices or other applicable regulations;
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Submission to the FDA of an Investigational New Drug Application, or an IND, which must become effective before human clinical trials may begin;
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Performance of adequate and well-controlled human clinical trials according to the FDA’s current good clinical practices, or GCPs, to establish the safety and efficacy of the proposed drug or biologic for its intended use;
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Submission to the FDA of a New Drug Application, or an NDA, for a new drug product, or a Biologics License Application, or a BLA, for a new biological product;
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Satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the drug or biologic is to be produced to assess compliance with the FDA’s current good manufacturing practice standards, or cGMP, to assure that the facilities, methods and controls are adequate to preserve the drug’s or biologic’s identity, strength, quality and purity;
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Potential FDA audit of the nonclinical and clinical trial sites that generated the data in support of the NDA or BLA; and
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FDA review and approval of the NDA or BLA.
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The lengthy process of seeking required
approvals and the continuing need for compliance with applicable statutes and regulations require the expenditure of substantial
resources. There can be no certainty that approvals will be granted.
Clinical trials involve the administration
of the drug or biological candidate to healthy volunteers or patients having the disease being studied under the supervision of
qualified investigators, generally physicians not employed by or under the trial sponsor’s control. Clinical trials are conducted
under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion
criteria, and the parameters to be used to monitor subject safety. Each protocol must be submitted to the FDA as part of the IND.
Clinical trials must be conducted in accordance with the FDA’s good clinical practices requirements. Further, each clinical
trial must be reviewed and approved by an independent institutional review board, or IRB, at or servicing each institution at which
the clinical trial will be conducted. An IRB is charged with protecting the welfare and rights of trial participants and considers
such items as whether the risks to individuals participating in the clinical trials are minimized and are reasonable in relation
to anticipated benefits. The IRB also approves the informed consent form that must be provided to each clinical trial subject or
his or her legal representative and must monitor the clinical trial until it is completed.
Human clinical trials prior to approval
are typically conducted in three sequential Phases that may overlap or be combined:
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Phase 1. The drug or biologic is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients having the specific disease.
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Phase 2. The drug or biologic is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance, optimal dosage and dosing schedule for patients having the specific disease.
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Phase 3. Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical trial sites. These clinical trials, which usually involve more subjects than earlier trials, are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for product labeling. Generally, at least two adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval of an NDA or BLA.
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Post-approval studies, or Phase 4
clinical trials, may be conducted after initial marketing approval. These studies are used to gain additional experience from the
treatment of patients in the intended therapeutic indication and may be required by the FDA as part of the approval process.
Progress reports detailing the results
of the clinical trials must be submitted at least annually to the FDA and written IND safety reports must be submitted to the FDA
by the investigators for serious and unexpected adverse events or any finding from tests in laboratory animals that suggests a
significant risk for human subjects. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully
within any specified period, if at all. The FDA or the sponsor or its data safety monitoring board may suspend a clinical trial
at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable
health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is
not being conducted in accordance with the IRB’s requirements or if the drug or biologic has been associated with unexpected
serious harm to patients.
Concurrent with clinical trials, companies
usually complete additional animal studies and develop additional information about the chemistry and physical characteristics
of the drug or biologic as well as finalize a process for manufacturing the product in commercial quantities in accordance with
cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the drug or biological
candidate and, among other things, must include methods for testing the identity, strength, quality and purity of the final drug
or biologic. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate
that the drug or biological candidate does not undergo unacceptable deterioration over its shelf life.
U.S. Review and Approval Processes
The results of product development,
preclinical studies and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on the
chemistry of the drug or biologic, proposed labeling and other relevant information are submitted to the FDA as part of an NDA
or BLA requesting approval to market the product. The submission of an NDA or BLA is subject to the payment of substantial user
fees; a waiver of such fees may be obtained under certain limited circumstances.
The FDA reviews all NDAs and BLAs submitted
before it accepts them for filing and may request additional information rather than accepting an NDA or BLA for filing. Once the
submission is accepted for filing, the FDA begins an in-depth review of the NDA or BLA.
After the NDA or BLA submission is accepted
for filing, the FDA reviews the NDA to determine, among other things, whether the proposed product is safe and effective for its
intended use, and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s
identity, strength, quality and purity. The FDA reviews a BLA to determine, among other things, whether the product is safe, pure
and potent and the facility in which it is manufactured, processed, packaged or held meets standards designed to assure the product’s
continued safety, purity and potency. In addition to its own review, the FDA may refer applications for novel drug or biological
products or drug or biological products which present difficult questions of safety or efficacy to an advisory committee, typically
a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should
be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such
recommendations carefully when making decisions. During the approval process, the FDA also will determine whether a risk evaluation
and mitigation strategy, or REMS, is necessary to assure the safe use of the drug or biologic. If the FDA concludes that a REMS
is needed, the sponsor of the NDA or BLA must submit a proposed REMS; the FDA will not approve the NDA or BLA without a REMS, if
required.
Before approving an NDA or BLA, the
FDA will inspect the facilities at which the product is to be manufactured. The FDA will not approve the product unless it determines
that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production
of the product within required specifications. Additionally, before approving an NDA or BLA, the FDA will typically inspect one
or more clinical sites to assure compliance with cGMP. If the FDA determines the application, manufacturing process or manufacturing
facilities are not acceptable it will outline the deficiencies in the submission and often will request additional testing or information.
The NDA or BLA review and approval process
is lengthy and difficult and the FDA may refuse to approve an NDA or BLA if the applicable regulatory criteria are not satisfied
or may require additional clinical data or other data and information. Even if such data and information is submitted, the FDA
may ultimately decide that the NDA or BLA does not satisfy the criteria for approval. Data obtained from clinical trials are not
always conclusive and may be susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. The
FDA will issue a “complete response” letter if the agency decides not to approve the NDA or BLA. The complete response
letter usually describes all of the specific deficiencies in the NDA or BLA identified by the FDA. The deficiencies identified
may be minor, for example, requiring labeling changes, or major, for example, requiring additional clinical trials. Additionally,
the complete response letter may include recommended actions that the applicant might take to place the application in a condition
for approval. If a complete response letter is issued, the applicant may either resubmit the NDA or BLA, addressing all of the
deficiencies identified in the letter, or withdraw the application.
If a product receives regulatory approval,
the approval may be limited to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict
the commercial value of the product. Further, the FDA may require that certain contraindications, warnings or precautions be included
in the product labeling. In addition, the FDA may require Phase 4 testing which involves clinical trials designed to further
assess a product’s safety and effectiveness and may require testing and surveillance programs to monitor the safety of approved
products that have been commercialized.
Orphan Drug Designation
Under the Orphan Drug Act, the FDA may
grant orphan designation to a drug or biological product intended to treat a rare disease or condition, which is generally a disease
or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States
and for which there is no reasonable expectation that the cost of developing and making a drug or biological product available
in the United States for this type of disease or condition will be recovered from sales of the product. Orphan product designation
must be requested before submitting an NDA or BLA. After the FDA grants orphan product designation, the identity of the therapeutic
agent and its potential orphan use are disclosed publicly by the FDA. Orphan product designation does not convey any advantage
in or shorten the duration of the regulatory review and approval process.
If a product that has Orphan designation
subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled
to orphan product exclusivity, which means that the FDA may not approve any other applications to market the same drug or biological
product for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to
the product with orphan exclusivity. Competitors, however, may receive approval of different products for the indication for which
the Orphan product has exclusivity or obtain approval for the same product but for a different indication for which the Orphan
product has exclusivity. Orphan product exclusivity also could block the approval of one of our products for seven years if a competitor
obtains approval of the same drug or biological product as defined by the FDA or if our drug or biological candidate is determined
to be contained within the competitor’s product for the same indication or disease. If a drug or biological product designated
as an orphan product receives marketing approval for an indication broader than what is designated, it may not be entitled to orphan
product exclusivity. Orphan Drug status in the European Union has similar but not identical benefits in the European Union.
Expedited Development and Review
Programs
The FDA has a Fast Track program that
is intended to expedite or facilitate the process for reviewing new drug and biological products that meet certain criteria. Specifically,
new drug and biological products are eligible for Fast Track designation if they are intended to treat a serious or life-threatening
condition and demonstrate the potential to address unmet medical needs for the condition. Fast Track designation applies to the
combination of the product and the specific indication for which it is being studied. Unique to a Fast Track product, the FDA may
consider for review sections of the NDA or BLA on a rolling basis before the complete application is submitted, if (i) the sponsor
provides a schedule for the submission of the sections of the NDA or BLA, (ii) the FDA agrees to accept sections of the NDA or
BLA and determines that the schedule is acceptable, and (iii) the sponsor pays any required user fees upon submission of the first
section of the NDA or BLA.
Any product submitted to the FDA for
marketing approval, including those submitted to a Fast Track program, may also be eligible for other types of FDA programs intended
to expedite development and review, such as priority review and accelerated approval. Any product is eligible for priority review
if it has the potential to provide safe and effective therapy where no satisfactory alternative therapy exists or a significant
improvement in the treatment, diagnosis or prevention of a disease compared with marketed products. The FDA will attempt to direct
additional resources to the evaluation of an application for a new drug or biological product designated for priority review in
an effort to facilitate the review. Additionally, a product may be eligible for accelerated approval. Drug or biological products
studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic
benefit over existing treatments may receive accelerated approval, which means that they may be approved on the basis of adequate
and well-controlled clinical studies establishing that the product has an effect on a surrogate endpoint that is reasonably likely
to predict a clinical benefit, or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity.
As a condition of approval, the FDA generally requires that a sponsor of a drug or biological product receiving accelerated approval
perform adequate and well-controlled post-marketing clinical studies to establish safety and efficacy for the approved indication.
Failure to conduct such studies or conducting such studies that do not establish the required safety and efficacy may result in
revocation of the original approval. In addition, the FDA currently requires as a condition for accelerated approval pre-approval
of promotional materials, which could adversely impact the timing of the commercial launch or subsequent marketing of the product.
Fast Track designation, priority review and accelerated approval do not change the standards for approval but may expedite the
development or approval process.
Post-Approval Requirements
Any drug or biological products for
which we receive FDA approvals are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements,
reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information on an annual
basis or as required more frequently for specific events, product sampling and distribution requirements, complying with certain
electronic records and signature requirements and complying with FDA promotion and advertising requirements, which include, among
others, standards for direct-to-consumer advertising, prohibitions against promoting drugs and biologics for uses or in patient
populations that are not described in the drug’s or biologic’s approved labeling (known as “off-label use”),
rules for conducting industry-sponsored scientific and educational activities, and promotional activities involving the internet.
Failure to comply with FDA requirements can have negative consequences, including the immediate discontinuation of noncomplying
materials, adverse publicity, enforcement letters from the FDA, mandated corrective advertising or communications with doctors,
and civil or criminal penalties. Although physicians may prescribe legally available drugs and biologics for off-label uses, manufacturers
may not market or promote such off-label uses.
We will need to rely on third parties
for the production of our product candidates. Manufacturers of our product candidates are required to comply with applicable FDA
manufacturing requirements contained in the FDA’s cGMP regulations. cGMP regulations require among other things, quality
control and quality assurance as well as the corresponding maintenance of comprehensive records and documentation. Drug and biologic
manufacturers and other entities involved in the manufacture and distribution of approved drugs and biologics are also required
to register their establishments and list any products made there with the FDA and comply with related requirements in certain
states, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and
other laws. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control
to maintain cGMP compliance. Discovery of problems with a product after approval may result in serious and extensive restrictions
on a product, manufacturer, or holder of an approved NDA or BLA, including suspension of a product until the FDA is assured that
quality standards can be met, continuing oversight of manufacturing by the FDA under a “consent decree,” which frequently
includes the imposition of costs and continuing inspections over a period of many years, and possible withdrawal of the product
from the market. In addition, changes to the manufacturing process generally require prior FDA approval before being implemented
and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject
to further FDA review and approval.
The FDA also may require post-marketing
testing, known as Phase 4 testing, risk minimization action plans and surveillance to monitor the effects of an approved product
or place conditions on an approval that could otherwise restrict the distribution or use of the product.
Employees
Our business is managed by our officers.
Our Chairman and Chief Executive Officer, Terren Peizer began devoting part-time efforts to the Company’s activities in July
2018. Our President and Chief Operating Officer, Jonathan Adams, began devoting full-time efforts to the Company on July 1, 2017.
Our Chief Financial Officer and Corporate Secretary, Wendy Kim, devotes part-time efforts to the Company’s activities. Our
Chief Scientific Officer began devoting full-time efforts and our Chief Medical Officer began devoting part-time efforts to the
Company in November 2018 and previously were each consultants to the Company. We also rely on a team of highly experienced scientific,
medical, and regulatory consultants to conduct its product development activities.
Management
Directors and Officers
The following table sets forth certain
information regarding our Board of Directors, our executive officers, and some of our key employees, as of the date of this prospectus.
Name
|
|
Age
|
|
Director Since
|
|
Position
|
Terren Peizer
|
|
|
60
|
|
|
2018
|
|
Chairman & Chief Executive Officer
|
Jonathan Adams
|
|
|
56
|
|
|
2016
|
|
President & Chief Operating Officer
|
Joanne Wendy Kim
|
|
|
64
|
|
|
--
|
|
Chief Financial Officer and Corporate Secretary
|
Patrick Yeramian, MD
|
|
|
60
|
|
|
--
|
|
Chief Medical Officer
|
Penelope Markham, PhD
|
|
|
53
|
|
|
--
|
|
Chief Scientific Officer
|
Jim Lang
|
|
|
54
|
|
|
2016
|
|
Independent Director
|
Cuong Do
|
|
|
52
|
|
|
2016
|
|
Independent Director
|
Hari Kumar
|
|
|
63
|
|
|
2017
|
|
Independent Director
|
Michael Sherman
|
|
|
60
|
|
|
2017
|
|
Independent Director
|
Richard J. Berman
|
|
|
76
|
|
|
2019
|
|
Independent Director
|
According to our Bylaws, the directors
shall be elected at the annual meeting of the stockholders and each director shall be elected to serve until his successor shall
be elected and shall qualify. A director need not be a stockholder. Directors shall not receive any stated salary for their services
as directors or as members of committees, but by resolution of the Board of Directors a fixed fee and expenses of attendance may
be allowed for attendance at each meeting. The Bylaws shall not be construed to preclude any director from serving the Company
in any other capacity as an officer, agent or otherwise, and receiving compensation therefor.
There are no familial relationships
among any of our directors or officers. Mr. Terren Peizer, Chairman of the Board of Directors and Chief Executive Officer, is also
the founder of Catasys, Inc. a U.S. reporting company listed on Nasdaq on whose board Mr. Sherman also serves. Additionally, Jim
Lang currently serves as a director at OptimizeRX, a U.S. reporting company that is listed on the Nasdaq stock exchange. None of
our other directors or officers is or has been a Director or has held any form of directorship in any other U.S. reporting companies.
None of our directors or officers has been affiliated with any Company that has filed for bankruptcy within the last five years.
We are not aware of any proceedings to which any of our officers or directors, or any associate of any such officer or director,
is a party that are adverse to the Company. We are also not aware of any material interest of any of our officers or directors
that is adverse to our own interests.
Information
Mr. Terren Peizer, Chairman of the Board
of Directors and Chief Executive Officer, is an entrepreneur, investor, and financier with a particular interest in healthcare,
having founded and successfully commercialized several healthcare companies. Mr. Peizer is the founder of Catasys, Inc., a leader
in behavioral and mental health management services, having served as the Chairman of the Board of Directors and CEO of Catasys
since inception in 2004. Mr. Peizer also is the Founder, Chairman and CEO and majority shareholder of NeurMedix, Inc., a biotechnology
Company with a focus on inflammatory, neurological and neuro-degenerative diseases. Mr. Peizer is Chairman of Acuitas Group Holdings,
LLC, his personal holding company that owns his portfolio Company interests. Through Acuitas, he owns Crede Capital Group, LLC,
an industry leader in investing in micro and small capitalization public equities, having invested over $1.2 billion directly into
portfolio companies. Previously he was Chairman of Cray, Inc., the leading supercomputing Company, and held senior executive positions
at various publicly-traded growth companies and with the investment banking firms Goldman Sachs, First Boston, and Drexel Burnham
Lambert. He received his B.S.E. in finance from The Wharton School of Finance and Commerce.
Mr. Jonathan Adams has served
as the Company’s Chief Executive Officer and Chief Financial Officer from the time acquired LAT Pharma LLC on April 11,
2016 until July 2018. In July 2018, he began serving as the Company’s President and Chief Operating Officer. He founded
LAT Pharma LLC and served as its Chief Executive Officer prior to its acquisition. Mr. Adams is a co-inventor of the Company’s
pending patent application for the use of terlipressin to treat ascites patients. He has over 29 years of biopharmaceutical
industry experience, including corporate finance, company acquisitions and licensing deals, marketing and sales support. At Searle
Pharmaceuticals he was a member of the global launch team for Celebrex, and he has worked on launching numerous new drugs and
medical devices. Mr. Adams earned a BS at Cornell University and an MBA at the Tuck School at Dartmouth.
Joanne Wendy Kim has served as the Company’s
Chief Financial Officer since October 2018. Ms. Kim previously served as CFO for several companies throughout her career, most
recently with Landmark Education Enterprises, and she has provided interim CFO services to various organizations through Group
JWK from 2016 to 2018. In her various roles, Ms. Kim oversaw corporate finance and operational groups, closed eight acquisitions,
secured bank financings, developed and implemented new business strategies, managed risk and implemented new financial policies
and procedures. As a CPA, Ms. Kim provided accounting, SEC filing review and other business consultative services to clients serving
as a Director at BDO USA, LLP’s National Office SEC Department in 2008-2016 and as a Senior Manager at KPMG in earlier part
of her career. She brings more than 30 years of accounting experience to this position. Ms. Kim earned her BBA in accounting and
finance at California State University, Long Beach.
Dr. Yeramian has served as the Company’s
Chief Medical Officer since November 2018. Dr. Yeramian has over 25 years of experience in the pharmaceutical industry. He has
supervised the clinical development of new drugs, biopharmaceuticals, cellular therapy agents, and vaccines as well as having held
a prominent role in the approval of several new drug (metronidazole – Flagyl MR ®), biological (interferon alpha –
Multiferon®, nafarelin – Synarel®) and device (Inerpan®) applications in the U.S. in the EC and the granting
of over 20 successful INDs and IMPDs. Dr Yeramian was the Medical Director of the Vaccine and Gene Therapy Institute, Florida from
October 2011 to February 2015 and a consulting Medical Director for Tapimmune Inc. from February 2015 to January 2017 and Kantum
Diagnostics from March 2017 to March 2019. Dr. Yeramian currently serves as the Medical Director of Amylyx Inc. (since March 2019)
and as the General Manager of DLx Therpeutics LLC (since January 2018). Previously he served as Chief Medical Officer at Viragen,
Inc. where he was responsible for development of global clinical and regulatory strategies and for implementation of clinical programs
worldwide. Earlier Dr. Yeramian also served as Director of clinical research at GD Searle where he supervised the clinical programs
for antibiotics, antivirals, sepsis/thrombosis, and cancer vaccines. Dr. Yeramian holds a Medical Degree from the University of
Paris together with a Master of Clinical Science in experimental oncology and a Graduate Degree in molecular virology. He also
earned a Master of Business Administration from Rutgers University. He completed his medical residency in oncology at the Saint-Louis
Hospital in Paris.
Dr. Markham has served as the Company’s
Chief Scientific Officer since November 2018. She was previously our Chief Scientist. Dr. Markham served as a Technical Consultant
at LAT Pharma for 7 years prior to our acquisition of LAT Pharma. She has spent 15 years in immunology, infectious disease, bacteriology
and drug discovery research. Dr. Markham was a co-founder and Research Director for Influx, Inc. involved in antibiotic drug discovery.
She has been a member of NIH grant review panels and consulted for several pharmaceutical companies in a variety of therapeutic
areas including Orphan Drug development. Dr. Markham has more than 20 publications in peer-reviewed journals and three patents.
She holds a BS in Biochemistry from the University College Cork, Ireland, a Masters from Strathclyde University, Scotland, and
a PhD from Rush University, Chicago.
Mr. Cuong Do has been President, Global
Strategy Group, at Samsung since February 2015. Mr. Do helps to set the strategic direction for Samsung Group’s diverse business
portfolio. He was previously the Chief Strategy Officer for Merck from October 2011 to March 2014, Tyco Electronics, and Lenovo.
Mr. Do is a former senior partner at McKinsey & Company, where he spent 17 years and helped build the healthcare, high tech
and corporate finance practices. He holds a BA from Dartmouth College, and an MBA from the Tuck School of Business at Dartmouth.
Mr. Jim Lang is currently CEO of Water
Street Capital’s and JLL Partner’s Global Life Sciences Services Platform. He formerly served as the CEO of Decision
Resources Group (DRG), which he transformed into a leading healthcare data and analytics firm. Prior to that, Jim was CEO of IHS
Cambridge Energy Research Associates (IHS CERA), a recognized leader in energy industry subscription information products, and
formerly the President of Strategic Decisions Group (SDG), a leading global strategy consultancy. Mr. Lang holds a BS summa cum
laude in electrical and computer engineering from the University of New Hampshire and an MBA with Distinction from the Tuck School
of Business. Jim Lang currently also serves as a Director at OptimizeRX, a Nasdaq listed Company.
Hari Kumar, PhD held positions of increasing
responsibility at Roche Pharma culminating in serving as Global Business Development Director, and in 2007 assumed the role of
Chief Business Officer for Amira Pharmaceuticals. He led the sale of Amira to Bristol-Myers Squibb in 2011 for $475 million. He
then served as Chief Executive Officer (CEO) for Panmira Pharmaceuticals LLC, which is developing anti-inflammatory compounds,
and in 2013 became CEO for Adheron Therapeutics, which Roche Pharma acquired in 2015 for $580 million. Dr. Kumar earned a PhD in
immunology in 1984.
Richard J. Berman was Chairman of National
Investment Managers, a company with $12 billion pension administration assets from 2006-2011. Mr. Berman is a director of four
other public healthcare companies: Catasys, Inc., Advaxis, Inc., Cryoport Inc. and Immuron Ltd. and a public fintech company, Cuentas,
Inc. From 1998-2000, he was employed by Internet Commerce Corporation (now Easylink Services) as Chairman and CEO, and was a director
from 1998-2012. Previously, Mr. Berman was Senior Vice President of Bankers Trust Company, where he started the M&A and Leveraged
Buyout Departments; created the largest battery company in the world in the 1980’s by merging Prestolite, General Battery
and Exide and advised on over $4 billion of M&transactions (completed over 300 deals). He is a past Director of the Stern School
of Business of NYU where he obtained his BS and MBA. He also has US and foreign law degrees from Boston College and The Hague Academy
of International Law, respectively.
Michael Sherman JD retired from his
position as a Managing Director at Barclays Plc in 2018, where he had worked since 2008. Previously he was a Managing Director
at Lehman Brothers, Inc. He has worked in investment banking for 30 years. Mr. Sherman has significant experience in healthcare
finance, most recently assisting on a $450 million convertible transaction for Neurocrine Biosciences. He has worked on successful
financial transactions for Teva Pharmaceutical Industries, Amgen Inc., Cubist Pharmaceuticals, Merck & Co., and Cardinal Health,
among other companies. After graduating from the University of Pennsylvania, Michael Sherman received his JD, cum laude, from the
Harvard Law School.
Terren Peizer’s qualifications
to serve on our Board of Directors are primarily based on his experience as an entrepreneur, investor, and financier with a particular
interest in healthcare, having founded and successfully commercialized several healthcare companies. Mr. Peizer is the founder
of Catasys, Inc., a leader in behavioral and mental health management services, having served as the Chairman of the Board of Directors
and CEO of Catasys since inception in 2004. Mr. Peizer also is the Founder, Chairman and CEO and majority shareholder of NeurMedix,
Inc., a biotechnology Company with a focus on inflammatory, neurological and neuro-degenerative diseases. Mr. Peizer is Chairman
of Acuitas Group Holdings, LLC, his personal holding Company that owns his portfolio Company interests. Through Acuitas, he owns
Crede Capital Group, LLC, an industry leader in investing in micro and small capitalization public equities, having invested over
$1.2 billion directly into portfolio companies.
Jonathan Adams’s qualifications
to serve on our Board of Directors are primarily based on his founding of LAT Pharma LLC and his over 26 years of biopharmaceutical
industry experience. As Chief Executive of LAT Pharma LLC, Mr. Adams was a key contributor to inventing the BIV201 product candidate.
He also helped to secure an Orphan Drug designation for a terlipressin analogue (a prior product candidate which is no longer in
development). Mr. Adams’s biopharmaceutical experience includes work in corporate finance, company acquisitions and licensing
deals, marketing and sales support.
Wendy Kim’s qualifications to
serve as our Chief Financial Officer are primarily based on her 35 years of accounting experience and having served as CFO for
several companies and the provision of interim CFO services, accounting and business consultative services to various organizations
through Group JWK, BDO USA, LLP and KPMG.
Dr. Yeramian’s qualifications
to serve as our Chief Medical Officer are primarily based on his extensive experience in the pharmaceutical industry, including
the supervision of the clinical development of new drugs, biopharmaceuticals, cellular therapy agents, and vaccines as well as
having held a prominent role in the approval of several new drugs and having been Chief Medical Officer responsible for development
of global clinical and regulatory strategies and for implementation of clinical programs worldwide at Viragen.
Dr. Markham’s qualifications to
serve as our Scientific Officer are primarily based on her years of experience with LAT Pharma, as well as having been a member
of NIH grant review panels and consulted for several pharmaceutical companies in a variety of therapeutic areas including Orphan
Drug development.
Cuong Do’s qualifications to serve
on our Board of Directors are primarily based on his decades of experience as an executive in the pharma, biotech, and other high
technology industries. He was previously the Chief Strategy Officer for Merck, a leading U.S. pharmaceuticals Company, Tyco Electronics,
and Lenovo. Mr. Do is a former senior partner at McKinsey & Company, where he spent 17 years and helped build the healthcare,
high tech and corporate finance practices.
Jim Lang’s qualifications to serve
on our Board of Directors are primarily based on his decades of experience as a strategy consultant, broad industry expertise,
and senior-level management experience running several healthcare and information technology companies. This includes his experience
as CEO of Decision Resources Group, CEO of IHS Cambridge Energy Research Associates (IHS CERA), and President of Strategic Decisions
Group (SDG), a leading global strategy consultancy.
Hari Kumar’s qualifications to
serve on our Board of Directors are primarily based on his decades of biopharma industry experience including serving as the chief
executive officer at multiple companies, extensive technical and business knowledge, and outstanding track record for delivering
value to investors. He led the sale of Amira to Bristol-Myers Squibb in 2011 for $475 million, and as CEO for Adheron Therapeutics,
he led the sale of this Company to Roche Pharma for $580 million in 2015.
Richard J. Berman’s qualifications
to serve on our board of directors include his experience in the healthcare industry, and his current and past experience in numerous
private and publicly traded companies.
Michael Sherman’s qualifications
to serve on our Board of Directors are primarily based on his decades of finance industry experience including as a Managing Director
at Barclays Plc and as a Managing Director at Lehman Brothers, Inc. He has worked in investment banking for 30 years. Mr. Sherman
has significant experience in healthcare finance including having worked on successful financial transactions for several pharmaceutical
and healthcare focused companies.
Committees
of the Board of Directors
Upon the effective date of the registration
statement of which this prospectus forms a part, our Board of Directors will have three standing committees: an audit committee,
a compensation committee and a nominating and corporate governance committee. Both our audit committee and our compensation committee
will be composed solely of independent directors. Subject to phase-in rules, the rules of Nasdaq and Rule 10A-3 of the Exchange
Act require that the audit committee of a listed company be comprised solely of independent directors, and the rules of Nasdaq
require that the compensation committee and the nominating and corporate governance committee of a listed company be comprised
solely of independent directors. Each committee operates under a charter approved by our Board of Directors and will have the composition
and responsibilities described below. The charter of each committee will be available on our website following the closing of this
offering.
AUDIT COMMITTEE
We have established an audit committee
of the Board of Directors. The members of our audit committee are Michael Sherman, Jim Lang and Richard J. Berman, each of which
is an independent director within the meaning of the Nasdaq rules. Mr. Sherman serves as chairman of the audit committee.
We have adopted an audit committee charter,
detailing the principal functions of the audit committee, including:
·
|
|
assisting
board oversight of (1) the integrity of our financial statements, (2) our compliance with legal and regulatory requirements,
(3) our independent auditor’s qualifications and independence, and (4) the performance of our internal audit function and
independent auditors; the appointment, compensation, retention, replacement, and oversight of the work of the independent auditors
and any other independent registered public accounting firm engaged by us;
|
·
|
|
pre-approving
all audit and non-audit services to be provided by the independent auditors or any other registered public accounting firm engaged
by us, and establishing pre-approval policies and procedures; reviewing and discussing with the independent auditors all relationships
the auditors have with us in order to evaluate their continued independence;
|
·
|
|
setting
clear policies for audit partner rotation in compliance with applicable laws and regulations;
|
·
|
|
obtaining
and reviewing a report, at least annually, from the independent auditors describing (1) the independent auditor’s internal
quality-control procedures and (2) any material issues raised by the most recent internal quality-control review, or peer review,
of the audit firm, or by any inquiry or investigation by governmental or professional authorities, within the preceding five years
respecting one or more independent audits carried out by the firm and any steps taken to deal with such issues;
|
·
|
|
meeting
to review and discuss our annual audited financial statements and quarterly financial statements with management and the independent
auditor, including reviewing our specific disclosures under “Management’s Discussion and Analysis of Financial Condition
and Results of Operations”; reviewing and approving any related party transaction required to be disclosed pursuant to Item
404 of Regulation S-K promulgated by the SEC prior to us entering into such transaction; and
|
·
|
|
reviewing
with management, the independent auditors, and our legal advisors, as appropriate, any legal, regulatory or compliance matters,
including any correspondence with regulators or government agencies and any employee complaints or published reports that raise
material issues regarding our financial statements or accounting policies and any significant changes in accounting standards
or rules promulgated by the Financial Accounting Standards Board, the SEC or other regulatory authorities.
|
COMPENSATION COMMITTEE
We have established a compensation committee of the Board of Directors. The members of our Compensation Committee are Mr. Berman, Mr. Kumar and Mr. Sherman. Mr. Berman serves as chairman of the compensation committee.
We have adopted a compensation
committee charter, which details the principal functions of the compensation committee, including:
·
|
|
reviewing
and approving on an annual basis the corporate goals and objectives relevant to our Chief Executive Officer’s compensation,
evaluating our Chief Executive Officer’s performance in light of such goals and objectives and determining and approving
the remuneration (if any) of our Chief Executive Officer based on such evaluation;
|
·
|
|
reviewing
and making recommendations to our Board of Directors with respect to the compensation, and any incentive-compensation and equity-based
plans that are subject to board approval of all of our other officers;
|
·
|
|
reviewing
our executive compensation policies and plans;
|
·
|
|
implementing
and administering our incentive compensation equity-based remuneration plans; assisting management in complying with our proxy
statement and annual report disclosure requirements;
|
·
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|
approving
all special perquisites, special cash payments and other special compensation and benefit arrangements for our officers and employees;
|
·
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|
producing
a report on executive compensation to be included in our annual proxy statement; and reviewing, evaluating and recommending changes,
if appropriate, to the remuneration for directors.
|
The charter also provides that the compensation committee may, in its sole discretion, retain or obtain the advice of a compensation consultant, independent legal counsel or other adviser and will be directly responsible for the appointment, compensation and oversight of the work of any such adviser. However, before engaging or receiving advice from a compensation consultant, external legal counsel or any other adviser, the compensation committee will consider the independence of each such adviser, including the factors required by Nasdaq and the SEC.
Nominating
and Corporate Governance Committee
We have established a nominating and corporate governance committee of the Board of Directors. The members of our nominating and corporate governance committee are Mr. Do, Mr. Lang and Mr. Kumar. Mr. Do serves as chair of the nominating and corporate governance committee.
We have adopted a nominating and
corporate governance committee charter, which details the purpose and responsibilities of the nominating and corporate governance
committee, including:
·
|
|
identifying,
screening and reviewing individuals qualified to serve as directors, consistent with criteria approved by the Board of Directors,
and recommending to the Board of Directors candidates for nomination for election at the annual meeting of stockholders or to
fill vacancies on the Board of Directors;
|
·
|
|
developing
and recommending to the Board of Directors and overseeing implementation of our corporate governance guidelines;
|
·
|
|
coordinating
and overseeing the annual self-evaluation of the Board of Directors, its committees, individual directors and management in the
governance of the company; and
|
·
|
|
reviewing
on a regular basis our overall corporate governance and recommending improvements as and when necessary.
|
The charter also provides that the nominating and corporate governance committee may, in its sole discretion, retain or obtain the advice of, and terminate, any search firm to be used to identify director candidates, and will be directly responsible for approving the search firm’s fees and other retention terms.
We have not formally established any specific, minimum qualifications
that must be met or skills that are necessary for directors to possess. In general, in identifying and evaluating nominees for
director, the Board of Directors considers educational background, diversity of professional experience, knowledge of our business,
integrity, professional reputation, independence, wisdom, and the ability to represent the best interests of our stockholders.
Prior to our initial business combination, holders of our public shares will not have the right to recommend director candidates
for nomination to our Board of Directors.
Compensation Committee Interlocks and Insider Participation
None of our officers currently serves, or in the past year
has served, as a member of the compensation committee of any entity that has one or more officers serving on our Board of Directors.
CODE OF ETHICS
We have adopted a code of conduct and
ethics meeting the requirements of Section 406 of the Sarbanes-Oxley Act of 2002. We believe our code of conduct and ethics is
reasonably designed to deter wrongdoing and promote honest and ethical conduct; provide full, fair, accurate, timely and understandable
disclosure in public reports; comply with applicable laws; ensure prompt internal reporting of violations; and provide accountability
for adherence to the provisions of the code of ethic. Our code of conduct and ethics is available on our website.
EXECUTIVE COMPENSATION
We did not pay any compensation
to any of our executive officers prior to the start of our fiscal year ending June 30, 2019; however, we did accrue salary for
Mr. Adams in accordance with his related employment agreements for all periods subsequent to their effective dates.
Summary Compensation Table
|
|
Annual Compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Name and Principal Position
|
|
Year
|
|
Salary
|
|
Bonus
|
|
Stock Awards
|
|
Option Awards(1)
|
|
All Other Compensation
|
|
Total
|
Terren Peizer
|
|
|
2019
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
7,000
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
7,000
|
|
Chief Executive Officer and
Chairman(2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jonathan Adams
|
|
|
2019
|
|
|
$
|
250,000
|
|
|
$
|
—
|
|
|
$
|
7,000
|
|
|
$
|
11,789
|
|
|
$
|
—
|
|
|
$
|
268,789
|
|
President and Chief Operating
Officer(2)
|
|
|
2018
|
|
|
$
|
250,000
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
30,978
|
|
|
$
|
—
|
|
|
$
|
280,978
|
|
(1) The aggregate
grant date fair value of such awards were computed in accordance with Financial Accounting Standards Board ASC Topic 718, Stock
Compensation (ASC Topic 718), and do not take into account estimated forfeitures related to service-based vesting conditions, if
any. The valuation assumptions used in calculating these values are discussed in Note 8 of the Notes to Consolidated Financial
Statements appearing elsewhere herein. These amounts do not represent actual amounts paid or to be realized. Amounts shown are
not necessarily indicative of values to be achieved, which may be more or less than the amounts shown as awards may subject to
time-based vesting.
(2) Mr.
Peizer became our Chief Executive Officer and Chairman in July 2018 at which time Mr. Adams became President and Chief Operating
Officer, having previously served as our Chief Executive Officer and Chief Financial Officer, Treasurer and Corporate Secretary.
The stock awards received by Mr. Peizer and Mr. Adams represented 1,600 shares of common stock and vested in full upon grant.
Employment Agreement
On April 11, 2016, we entered into
an employment agreement with Mr. Adams, pursuant to which Mr. Adams was entitled to receive $250,000 as annual salary. The
agreement was effective beginning April 11, 2016 and expired on July 2, 2019.
On July 9, 2018, Mr. Adams, our
President and Chief Operating Officer, entered into an Accord and Debt Satisfaction Agreement with us, pursuant to which he
agreed to release us from all liabilities (including the original contract dated March 23, 2017 to defer payment of his
accrued salary, the promissory note issued by us to defer payment of accrued salary and subsequent unpaid salary), for an
aggregate amount of $534,722, and received a cash payment of $25,694 in satisfaction. The gain of $509,028 on the settlement
of debt was reflected as additional paid in capital.
Option/SAR Grants
In connection with his employment agreement, on April 11, 2016 Mr. Adams received options to acquire 24,000 shares exercisable at $7.50 per share, the closing price on that date. These options vested and became exercisable as follows: (i) 8,000 shares on April 11, 2017, (ii) 8,000 shares on April 11, 2018, and (iii) 8,000 shares on April 11, 2019.
Between November 16, 2016
and May 19, 2017, we issued options to acquire 8,000 shares exercisable at an average price of $30.00 per share to
consultants and members of our Board of Directors for services provided to us.
Long-Term Incentive Plans and Awards
Other than the options granted as
described above and our recently adopted 2019 Omnibus Equity Incentive Plan (the “2019 Plan”), we do not currently have any long-term
incentive plans that provide compensation intended to serve as incentive for performance. Since prior to such grants, no individual
grants or agreements regarding future payouts under non-stock price-based plans had been made to any executive officer or any
director or any employee or consultant since our inception, no future payouts under non-stock price-based plans or agreements
had been granted or entered into or exercised by our officer or director or employees or consultants.
2019 Omnibus Equity Incentive Plan
On April 30, 2019, our Board of Directors and our stockholders approved and adopted the 2019 Plan, subject to complying with the notification requirements of Regulation 14C of the Exchange Act which were complied with effective May 29, 2019. The 2019 Plan allows us, under the direction of our Board of Directors or a committee thereof, to make grants of stock options, restricted and unrestricted stock and other stock-based awards to employees, including our executive officers, consultants and directors. The 2019 Plan allows for the issuance of up to 253,163 shares of common stock pursuant to new awards granted under the 2019 Plan. This description is qualified in its entirety by reference to the actual terms of the 2019 Plan, a copy of which is attached as Appendix D to our Definitive Information Statement on Schedule 14C, filed with the SEC on May 8, 2019.
Compensation of Directors
There are no arrangements pursuant
to which our directors are or will be compensated in the future for any services provided to the Company, except that each director
shall receive stock options and common share grants as remuneration for their service in lieu of cash compensation. For the fiscal
year ended June 30, 2019, each director received 800 stock options on the one-year anniversary of his or her service to the Company
with an exercise price equal to the closing stock price on the day of the option grant. The total value of the options granted
to directors for the fiscal year ended June 30, 2019 was $8,804 based on the Black-Scholes option value method. Each director
also receives a stock grant of 1,600 common shares for every year of service. On January 2, 2019, our directors received a combined
grant of 11,200 shares of common stock with a face value of $49,000 based on the closing stock price of $4.38 on
the grant date.
Principal
Stockholders
Based solely upon information made
available to us, the following table sets forth information as of November 21, 2019 regarding the beneficial ownership
of our common stock by:
|
●
|
each person known by us to be the beneficial owner of more than 5% of our outstanding shares of common stock;
|
|
|
|
|
●
|
each of our named executive officers and directors; and
|
|
|
|
|
●
|
all our executive officers and directors as a group.
|
The percentage ownership information
shown in the table is based upon 5,183,442 shares of common stock outstanding as of November 21, 2019.
Beneficial ownership is determined in
accordance with the rules of the SEC and includes voting or investment power with respect to the securities. Except as otherwise
indicated, each person or entity named in the table has sole voting and investment power with respect to all shares of our capital
shown as beneficially owned, subject to applicable community property laws.
In computing the number and percentage
of shares beneficially owned by a person as of a particular date, shares that may be acquired by such person (for example, upon
the exercise of options or warrants) within 60 days of such date are counted as outstanding, while these shares are not counted
as outstanding for computing the percentage ownership of any other person.
The address of each holder listed below,
except as otherwise indicated, is c/o BioVie Inc., 2120 Colorado Avenue, #230, Santa Monica, California 90404.
Name and Address of Beneficial Owner
|
|
Number of Common Shares of
Beneficial Ownership (1)
|
|
Percentage of Beneficial
Ownership
|
Terren Peizer(2)
|
|
|
10,862,765
|
|
|
|
92.1
|
%
|
Jonathan Adams(3)
|
|
|
94,635
|
|
|
|
1.8
|
%
|
Joanne Wendy Kim(4)
|
|
|
1,600
|
|
|
|
*
|
|
Patrick Yeramian, MD(4)
|
|
|
2,400
|
|
|
|
*
|
|
Penolope Markham, PhD(5)
|
|
|
13,091
|
|
|
|
*
|
|
Cuong Do(6)
|
|
|
168,303
|
|
|
|
3.2
|
%
|
James Lang(7)
|
|
|
44,630
|
|
|
|
*
|
|
Hari Kumar(8)
|
|
|
7,527
|
|
|
|
*
|
|
Michael Sherman(9)
|
|
|
35,084
|
|
|
|
*
|
|
Richard J. Berman
|
|
|
—
|
|
|
|
—
|
|
All directors and executive officers as a group (ten persons):
|
|
|
11,230,036
|
|
|
|
99.1
|
%
|
_________________________________
*Less than 1%
|
(1)
|
Beneficial ownership is determined in accordance with the rules of
the SEC and generally includes voting or investment power with respect to securities. In accordance with SEC rules, shares of common
stock issuable upon the exercise of options or warrants which are currently exercisable or which become exercisable within 60 days
following the date of the information in this table are deemed to be beneficially owned by, and outstanding with respect to, the
holder of such option or warrant, however none of the persons listed hereinabove has the right to acquire beneficial ownership
in any other shares of the Company. Subject to community property laws where applicable, to our knowledge, each person listed is
believed to have sole voting and investment power with respect to all shares of common stock owned by such person.
|
|
(2)
|
All
shares and warrants are held of record by Acuitas Group Holdings, LLC, a limited liability
company 100% owned by Terren S. Peizer, and as to which, Mr. Peizer may be deemed to
beneficially own or control. Mr. Peizer disclaims beneficial ownership of any such securities.
Excludes shares issuable upon conversion of the Debenture, which is expected to be repaid
in cash with the net proceeds of this offering, and includes an aggregate of 6,609,832
shares expected to be issued to Acuitas upon completion of this offering in connection
with the automatic exercise of the Bridge Financing Warrants and the committed exercise
of its purchase option granted in connection with its initial investment in the Company.
After giving effect to such issuance and the completion of this offering, Acuitas is
expected to beneficially own 10,862,765 shares in total, or 73.4% of the outstanding
shares of common stock.
|
|
(3)
|
Includes
warrants to purchase 8,564 shares of common stock and options to purchase 24,000
shares of common stock, all of which are exercisable within the next 60 days. Common
stock beneficially owned by Mr. Adams includes 1,120 and 1,200 shares of common stock
held of record by Mr. Adams, as custodian for Elliott P. Adams and Jeremy P. Adams, respectively;
and 2,924 shares of common stock held of record by Elliott P. Adams. Each of Elliott
P. Adams and Jeremy P. Adams are family members of Mr. Adams and, as a result, Mr. Adams
may be deemed to beneficially own shares held by (or for the benefit of) such family
members.
|
|
(4)
|
Represents options to purchase shares of common stock exercisable
in the next 60 days.
|
|
(5)
|
Includes
options to purchase 2,400 shares of common stock exercisable in the next 60 days.
|
|
(6)
|
Includes
warrants to purchase 70,667 shares of common stock and options to purchase 2,400
shares of common stock, all of which are exercisable within the next 60 days. All shares
of common stock, warrants and options are held of record by Do & Rickles Investments,
LLC, a limited liability company 100% owned by Cuong Do and his wife, and as such, Mr.
Do may be deemed to beneficially own or control.
|
|
(7)
|
Includes
warrants to purchase 18,788 shares of common stock and options to purchase 2,400
shares of common stock, all of which are exercisable in the next 60 days.
|
|
(8)
|
Includes
warrants to purchase 910 shares of common stock and options to purchase 800 shares
of common stock, which are exercisable within the next 60 days.
|
|
(9)
|
Includes
warrants to purchase 13,606 shares of common stock and options to purchase 2,400
shares of common stock, all of which are exercisable within the next 60 days. Common
stock held by Michael Sherman includes 13,333 shares of the common stock held of record
by Sherman Children’s Trust Brian Krisber, Trustee. All shares of common stock,
warrants and options are deemed to be beneficially owned or controlled by Michael Sherman.
|
Certain
Relationships and Related Party Transactions
During the period commencing July 1,
2015 and through the date of this prospectus, we have not engaged in any transactions with any officer, director or holder of more
than 5% of our common stock, except as follows:
Purchase of Preferred Stock
On July 3, 2018, we entered into a
Securities Purchase Agreement (the “Purchase Agreement”) with Acuitas Group Holdings, 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
1,706,666 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 6,667 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
1,600,000 shares of common stock at a price per share of $1.875, 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, Cuang Do and Michael Sherman, who are
members of our Board of Directors.
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 PTAB,
(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 1 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 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 $45.00 per share and, as a result received an aggregate of 95%
of the shares covered thereby, or 1,526,094 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 $11.25 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 1,339,958 shares of common stock (the “Subsequent Sale Shares”)
to Acuitas, which is expected to occur concurrently with the closing of this offering;
- 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. Assuming the closing of this
offering occurs on or prior to September 1, 2019, such option will terminate upon such closing. In the event such closing
occurs subsequent to September 1, 2019 and prior to November 30, 2019, we anticipate that Acuitas may elect to continue to fund
our on-going clinical trials and operations by means of exercising such Funding Option, with any shares so purchased being deducted
from the amount of Subsequent Sale Shares deliverable at closing as described above.
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 1,125,000 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 $4.00 per share
prior to the completion of this offering or, subsequent to the closing of this offering, the lower of $4.00 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. The Commitment Warrants are five year warrants, exercisable at an amount
equal to the lower of $4.00 or 80% of the offering price per unit to the public in this 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 125,000 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 this 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%.
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 $11.25 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 2,679,916 shares of common stock and 2,679,916 warrants having the same terms as the Commitment
Warrants to Acuitas, which is currently expected with the closing of this 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 this 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 this 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.
Issuance of Shares in Settlement
of Debt
During the fiscal year ended June 30,
2019, we settled $1,475,765 of debt including $1,313,765 owed to related parties, by issuing 7,803 shares of common stock
with a fair value of $1,150,135. See Notes 5 and 6 to the financial statements appearing elsewhere in this prospectus.
Description
of Capital Stock
The following description of our
capital stock and provisions of our Articles of Incorporation, bylaws and the Nevada corporations law are summaries and are qualified
in their entirety by reference to our Articles of Incorporation and our bylaws. We have filed copies of these documents with the
SEC as exhibits to the Registration Statement of which this prospectus forms a part. Pursuant to our Articles of Incorporation,
as amended, our authorized capital stock consists of 800,000,000 shares of Class A common stock, par value of $0.0001 per share
(which we refer to as our common stock), and 10,000,000 shares of preferred stock, par value $0.001 per share, to be designated
from time to time by our Board of Directors.
Common Stock
We are authorized to issue up to
800,000,000 shares of Class A common stock, par value $0.0001 per share. Each outstanding share of common stock entitles the holder
thereof to one vote per share on all matters. Our bylaws provide that elections for directors shall be by a plurality of votes.
Stockholders do not have preemptive rights to purchase shares in any future issuance of our common stock. Upon our liquidation,
dissolution or winding up, and after payment of creditors and preferred stockholders, if any, our assets will be divided pro-rata
on a share-for-share basis among the holders of the shares of common stock.
The holders of shares of our common
stock are entitled to dividends out of funds legally available when and as declared by our Board of Directors. Our Board of Directors
has never declared a dividend and does not anticipate declaring a dividend in the foreseeable future.
All of the issued and outstanding
shares of our common stock are duly authorized, validly issued, fully paid and non-assessable. To the extent that additional shares
of our common stock are issued, the relative interests of existing stockholders will be diluted.
As of November 21, 2019, there
were 5,183,442 shares of our common stock outstanding.
Preferred Stock
We are authorized to issue up to
10,000,000 shares of preferred stock, par value $0.001 per share, in one or more classes or series within a class as may be determined
by our Board of Directors, who may establish, from time to time, the number of shares to be included in each class or series,
may fix the designation, powers, preferences and rights of the shares of each such class or series and any qualifications, limitations
or restrictions thereof. Any preferred stock so issued by the Board of Directors may rank senior to the common stock with respect
to the payment of dividends or amounts upon liquidation, dissolution or winding up of us, or both. Moreover, under certain circumstances,
the issuance of preferred stock or the existence of the unissued preferred stock might tend to discourage or render more difficult
a merger or other change of control.
As of November 21, 2019, there
were no shares of our preferred stock outstanding.
Warrants to be Issued in this Offering
The following summary of
certain terms and provisions of the warrants that are being offered hereby is not complete and is subject to, and qualified in
its entirety by the provisions of, the warrant. Prospective investors should carefully review the terms and provisions of the
form of warrant for a complete description of the terms and conditions of the warrants.
Exercisability. The warrants
are exercisable beginning on the date of original issuance and at any time up to the date that is five years after their original
issuance. The warrants will be exercisable, at the option of each holder, in whole or in part by delivering to us a duly executed
exercise notice and, at any time a registration statement registering the issuance of the shares of common stock underlying the
warrants under the Securities Act is effective and available for the issuance of such shares, or an exemption from registration
under the Securities Act is available for the issuance of such shares, by payment in full in immediately available funds for the
number of shares of common stock purchased upon such exercise. If a registration statement registering the issuance of the shares
of common stock underlying the warrants under the Securities Act is not effective or available and an exemption from registration
under the Securities Act is not available for the issuance of such shares, the holder may, in its sole discretion, elect to exercise
the warrant through a cashless exercise, in which case the holder would receive upon such exercise the net number of shares of
common stock determined according to the formula set forth in the warrant. No fractional shares of common stock will be issued
in connection with the exercise of a warrant. In lieu of fractional shares, we will pay the holder an amount in cash equal to
the fractional amount multiplied by the exercise price.
Exercise Limitation. A holder
will not have the right to exercise any portion of the warrant if the holder (together with its affiliates) would beneficially
own in excess of 4.99% (or, upon election of the holder, 9.99%) of the number of shares of our common stock outstanding immediately
after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the warrants.
However, any holder may increase or decrease such percentage, provided that any increase will not be effective until the 61st
day after such election.
Exercise Price. The warrants
will have an exercise price of $ per share (of 125% of the offering price). The exercise price is subject to appropriate
adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar
events affecting our common stock and also upon any distributions of assets, including cash, stock or other property to our stockholders.
Transferability. Subject to
applicable laws, the warrants may be offered for sale, sold, transferred or assigned without our consent.
Exchange Listing.
There is no established trading market for the warrants. The warrants have been approved for listing on Nasdaq under the
symbol “BIVIW.” We cannot assure you that an active trading market for the warrants will develop or be sustained.
Fundamental Transactions. If
a fundamental transaction occurs, then the successor entity will succeed to, and be substituted for us, and may exercise every
right and power that we may exercise and will assume all of our obligations under the warrants with the same effect as if such
successor entity had been named in the warrant itself. If holders of our common stock are given a choice as to the securities,
cash or property to be received in a fundamental transaction, then the holder shall be given the same choice as to the consideration
it receives upon any exercise of the warrant following such fundamental transaction.
Rights as a Stockholder. Except
as otherwise provided in the warrants or by virtue of such holder’s ownership of shares of our common stock, the holder
of a warrant does not have the rights or privileges of a holder of our common stock, including any voting rights, until the holder
exercises the warrant.
Anti-Takeover Effects of Our Articles of Incorporation
and Bylaws
Our Articles of Incorporation and bylaws contain certain
provisions that may have anti-takeover effects, making it more difficult for or preventing a third party from acquiring control
of us or changing our Board of Directors and management. According to our Articles of Incorporation and bylaws, neither the holders
of our common stock nor the holders of any preferred stock we may issue in the future have cumulative voting rights in the election
of our directors. The combination of the present ownership by a few stockholders of a significant portion of our issued and outstanding
common stock and lack of cumulative voting makes it more difficult for other stockholders to replace our Board of Directors or
for a third party to obtain control of us by replacing our Board of Directors.
Anti-Takeover Effects of Nevada Law
Business Combinations
The “business combination” provisions of Sections
78.411 to 78.444, inclusive, of the Nevada Revised Statutes, or NRS, generally prohibit a Nevada corporation with at least 200
stockholders from engaging in various “combination” transactions with any interested stockholder for a period of two
years after the date of the transaction in which the person became an interested stockholder, unless the transaction is approved
by the board of directors prior to the date the interested stockholder obtained such status or the combination is approved by the
board of directors and thereafter is approved at a meeting of the stockholders by the affirmative vote of stockholders representing
at least 60% of the outstanding voting power held by disinterested stockholders, and extends beyond the expiration of the two-year
period, unless:
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the combination was approved by the board of directors prior
to the person becoming an interested stockholder or the transaction by which the person first became an interested stockholder
was approved by the board of directors before the person became an interested stockholder or the combination is later approved
by a majority of the voting power held by disinterested stockholders; or
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if the consideration to be paid by the interested stockholder is at least equal to the highest of: (a) the highest price per share paid by the interested stockholder within the two years immediately preceding the date of the announcement of the combination or in the transaction in which it became an interested stockholder, whichever is higher, (b) the market value per share of common stock on the date of announcement of the combination and the date the interested stockholder acquired the shares, whichever is higher, or (c) for holders of preferred stock, the highest liquidation value of the preferred stock, if it is higher.
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A “combination” is generally defined to include
mergers or consolidations or any sale, lease exchange, mortgage, pledge, transfer, or other disposition, in one transaction or
a series of transactions, with an “interested stockholder” having: (a) an aggregate market value equal to 5% or more
of the aggregate market value of the assets of the corporation, (b) an aggregate market value equal to 5% or more of the aggregate
market value of all outstanding shares of the corporation, (c) 10% or more of the earning power or net income of the corporation,
and (d) certain other transactions with an interested stockholder or an affiliate or associate of an interested stockholder.
In general, an “interested stockholder” is a
person who, together with affiliates and associates, owns (or within two years, did own) 10% or more of a corporation’s voting
stock. The statute could prohibit or delay mergers or other takeover or change in control attempts and, accordingly, may discourage
attempts to acquire our Company even though such a transaction may offer our stockholders the opportunity to sell their stock at
a price above the prevailing market price.
Control Share Acquisitions
The “control share” provisions of Sections 78.378
to 78.3793, inclusive, of the NRS apply to “issuing corporations” that are Nevada corporations with at least 200 stockholders,
including at least 100 stockholders of record who are Nevada residents, and that conduct business directly or indirectly in Nevada.
The control share statute prohibits an acquirer, under certain circumstances, from voting its shares of a target corporation’s
stock after crossing certain ownership threshold percentages, unless the acquirer obtains approval of the target corporation’s
disinterested stockholders. The statute specifies three thresholds: one-fifth or more but less than one-third, one-third but less
than a majority, and a majority or more, of the outstanding voting power. Generally, once an acquirer crosses one of the above
thresholds, those shares in an offer or acquisition and acquired within 90 days thereof become “control shares” and
such control shares are deprived of the right to vote until disinterested stockholders restore the right. These provisions also
provide that if control shares are accorded full voting rights and the acquiring person has acquired a majority or more of all
voting power, all other stockholders who do not vote in favor of authorizing voting rights to the control shares are entitled to
demand payment for the fair value of their shares in accordance with statutory procedures established for dissenters’ rights.
A corporation may elect to not be governed by, or “opt
out” of, the control share provisions by making an election in its articles of incorporation or bylaws, provided that the
opt-out election must be in place on the 10th day following the date an acquiring person has acquired a controlling interest, that
is, crossing any of the three thresholds described above. We have not opted out of the control share statutes, and will be subject
to these statutes if we are an “issuing corporation” as defined in such statutes.
The effect of the Nevada control share statutes is that the
acquiring person, and those acting in association with the acquiring person, will obtain only such voting rights in the control
shares as are conferred by a resolution of the stockholders at an annual or special meeting. The Nevada control share law, if applicable,
could have the effect of discouraging takeovers of our Company.
Trading Market
Prior to this offering, there has been
a limited public market for our common stock on the OTCQB Marketplace under the ticker “BIVI.” Our common stock
and warrants have been approved for listing on Nasdaq upon the completion of this offering under the symbols “BIVI”
and “BIVIW,” respectively.
Transfer Agent and Registrar
Our independent stock transfer agent is West Coast Stock
Transfer, Inc., located at 721 N. Vulcan Ave., Suite 205, Encinitas, California 92024. Their phone number is (619) 664-4780.
Disclosure of Commission Position
on Indemnification for Securities Act Liabilities
Insofar as indemnification for liabilities
arising under the Securities Act may be permitted to our directors, officers and controlling persons pursuant to the foregoing
provisions, we have been informed that in the opinion of the SEC such indemnification is against public policy as expressed in
the Securities Act and is, therefore, unenforceable.
Underwriting
ThinkEquity, a division of Fordham
Financial Management, Inc., is acting as the representative of the underwriters of the offering. We have entered into an underwriting
agreement dated , 2019 with the representative. Subject to the terms and conditions
of the underwriting agreement, we have agreed to sell to each underwriter named below, and each underwriter named below has severally
agreed to purchase from us, at the public offering price per unit less the underwriting discounts set forth on the cover page
of this prospectus, the number of units listed next to its name in the following table:
Underwriter
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Number
of Units
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ThinkEquity, a division of Fordham Financial Management, Inc.
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Total
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3,000,000
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The underwriters are committed to purchase
all the units offered by the Company, other than those covered by the over-allotment option to purchase additional shares of common
stock and/or warrants described below. The obligations of the underwriters may be terminated upon the occurrence of certain events
specified in the underwriting agreement. Furthermore, the underwriting agreement provides that the obligations of the underwriters
to pay for and accept delivery of the securities offered by us in this prospectus are subject to various representations and warranties
and other customary conditions specified in the underwriting agreement, such as receipt by the underwriters of officers’
certificates and legal opinions.
We have agreed to indemnify the underwriters
against specified liabilities, including liabilities under the Securities Act, and to contribute to payments the underwriters may
be required to make in respect thereof.
The underwriters are offering the units
subject to prior sale, when, as and if issued to and accepted by them, subject to approval of legal matters by their counsel and
other conditions specified in the underwriting agreement. The underwriters reserve the right to withdraw, cancel or modify offers
to the public and to reject orders in whole or in part.
We have granted the underwriters an
over-allotment option. This option, which is exercisable for up to 45 days after the date of this prospectus, permits the underwriters
to purchase up to an additional 450,000 shares of our common stock and/or up to an additional 225,000 warrants at
the public offering price per security, less underwriting discounts and commissions, solely to cover over-allotments, if any.
If the underwriters exercise this option in whole or in part, then the underwriters will be severally committed, subject to the
conditions described in the underwriting agreement, to purchase the additional shares of common stock and/or units in proportion
to their respective commitments set forth in the prior table.
Discounts, Commissions and Reimbursement
The representative has advised us
that the underwriters propose to offer the units to the public at the initial public offering price per unit set forth on
the cover page of this prospectus. The underwriters may offer units to securities dealers at that price less a concession of not
more than $ per unit of which up to $ per
unit may be reallowed to other dealers. After the initial offering to the public, the public offering price and other selling
terms may be changed by the representative.
The following table summarizes the underwriting
discounts and commissions and proceeds, before expenses, to us assuming both no exercise and full exercise by the underwriters
of their over-allotment option:
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Total
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Per
Unit
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Without Option
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With Option
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Public offering price
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$
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$
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$
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Underwriting discounts and commissions (7%)
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$
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$
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$
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Non-accountable expense allowance (1%) (1)
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$
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$
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$
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Proceeds, before expenses, to us
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$
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$
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$
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(1)
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The
non-accountable expense allowance of 1% is not payable with respect to shares and/or warrants sold upon exercise of
the underwriters’ over-allotment option.
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We have paid an expense deposit of $35,000
to (or on behalf of) the representative, which will be applied against the actual out-of-pocket accountable expenses that will
be paid by us to the underwriters in connection with this offering, and will be reimbursed to us to the extent not incurred.
In addition, we have also agreed to
pay the following expenses of the underwriters relating to the offering: (a) all fees, expenses and disbursements relating to
background checks of our officers and directors in an amount not to exceed $15,000 in the aggregate; (b) all filing fees and communication
expenses associated with the review of this offering by FINRA; (c) all fees, expenses and disbursements relating to the registration,
qualification or exemption of securities offered under the securities laws of foreign jurisdictions designated by the underwriter,
including without limitation, all filing and registration fees, and if the offering is commenced on either The Nasdaq Global Market,
The Nasdaq Global Select Market or the New York Stock Exchange, we will pay $5,000 for the reasonable fees and expenses of the
underwriter’s blue sky counsel at the closing of this offering, or if the offering is commenced on The Nasdaq Capital Market,
the NYSE American or OTCQB, we will pay $5,000 to such counsel upon the commencement of blue-sky work by such counsel and an additional
$10,000 at the closing of this offering; (d) $29,500 for the underwriters’ use of Ipreo’s book-building, prospectus
tracking and compliance software for this offering; (e) $2,000 for the costs associated with commemorative mementos and lucite
tombstones, (f) the fees and expenses of the representatives’ legal counsel incurred in connection with this offering
in an amount up to $75,000; and (g) up to $20,000 of the representative’s actual accountable road show expenses for the
offering.
We estimate the expenses of this
offering payable by us, not including underwriting discounts and commissions, will be approximately $625,000.
Representative’s
Warrants
Upon the closing of this offering, we have agreed to issue to the representative warrants, or the Representative’s Warrants, to purchase
a number of shares of common stock equal to 5% of the total number of shares of common stock sold as part of the units sold in
this public offering. The Representative’s Warrants will be exercisable at a per share exercise price equal to 125% of the
public offering price per unit sold in this offering. The Representative’s Warrants are exercisable at any time and from
time to time, in whole or in part, during the four year period commencing one year from the effective date of the registration
statement related to this offering. The Representative’s Warrants also provide for one demand registration right of the shares
of common stock underlying the Representative’s Warrants, and unlimited “piggyback” registration rights with
respect to the registration of the shares of common stock underlying the Representative’s Warrants and customary antidilution
provisions. The demand registration right provided will not be greater than five years from the effective date of the registration
statement related to this offering in compliance with FINRA Rule 5110(f)(2)(G). The piggyback registration right provided will
not be greater than seven years from the effective date of the registration statement related to this offering in compliance with
FINRA Rule 5110(f)(2)(G).
The Representative’s Warrants
and the shares of common stock underlying the Representative’s Warrants, have been deemed compensation by the Financial
Industry Regulatory Authority, or FINRA, and are therefore subject to a 180-day lock-up pursuant to Rule 5110(g)(1) of FINRA.
The representative, or permitted assignees under such rule, may not sell, transfer, assign, pledge, or hypothecate the Representative’s
Warrants or the securities underlying the Representative’s Warrants, nor will the representative engage in any hedging,
short sale, derivative, put, or call transaction that would result in the effective economic disposition of the Representative’s
Warrants or the underlying shares of common stock for a period of 180 days from the effective date of the registration
statement. Additionally, the Representative’s Warrants may not be sold transferred, assigned, pledged or hypothecated for
a 180-day period following the effective date of the registration statement except to any underwriter and selected dealer participating
in the offering and their bona fide officers or partners. The Representative’s Warrants will provide for adjustment in the
number and price of the Representative’s Warrants and the shares of common stock underlying such Representative’s
Warrants in the event of recapitalization, merger, stock split or other structural transaction, or a future financing undertaken
by us.
Right of First Refusal
Until , 2020, twelve (12) months
from the effective date of the registration statement of which this prospectus is a part, the representative shall have an irrevocable
right of first refusal to act as sole investment banker, sole book-runner and/or sole placement agent, at the representative sole
discretion, for each and every future public and private equity and debt offerings for the Company, or any successor to or any
subsidiary of the Company, including all equity linked financings, on terms customary to the representative. The representative
shall have the sole right to determine whether or not any other broker-dealer shall have the right to participate in any such offering
and the economic terms of any such participation. The representative will not have more than one opportunity to waive or terminate
the right of first refusal in consideration of any payment or fee.
Discretionary Accounts
The underwriters do not intend to confirm
sales of the securities offered hereby to any accounts over which they have discretionary authority.
Lock-Up Agreements
The Company, each of its directors and
officers and 5% or greater holders of the Company’s outstanding shares of common stock as of the date of this prospectus,
have agreed for a period of (i) six months after the date of this prospectus in the case of directors and officers and (ii) three
months after the date of this prospectus in the case of the Company and the 5% or greater holders of the Company’s outstanding
common stock, without the prior written consent of the representative, not to directly or indirectly:
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issue (in the case of us), offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, lend or otherwise transfer or dispose of any shares of common stock or other capital stock or any securities convertible into or exercisable or exchangeable for our common stock or other capital stock; or
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in the case of the Company, file or cause the filing of any registration statement under the Securities Act with respect to any shares of common stock or other capital stock or any securities convertible into or exercisable or exchangeable for our common stock or other capital stock; or
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complete any offering of debt securities of the Company, other than entering into a line of credit, term loan arrangement or other debt instrument with a traditional bank; or
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enter into any swap or other agreement, arrangement, hedge or transaction that transfers to another, in whole or in part, directly or indirectly, any of the economic consequences of ownership of our common stock or other capital stock or any securities convertible into or exercisable or exchangeable for our common stock or other capital stock, whether any transaction described in any of the foregoing bullet points is to be settled by delivery of our common stock or other capital stock, other securities, in cash or otherwise, or publicly announce an intention to do any of the foregoing.
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Electronic Offer, Sale and Distribution
of Securities
A prospectus in electronic format may
be made available on the websites maintained by one or more of the underwriters or selling group members. The representative may
agree to allocate a number of securities to underwriters and selling group members for sale to its online brokerage account holders.
Internet distributions will be allocated by the underwriters and selling group members that will make internet distributions on
the same basis as other allocations. Other than the prospectus in electronic format, the information on these websites is not part
of, nor incorporated by reference into, this prospectus or the registration statement of which this prospectus forms a part, has
not been approved or endorsed by us, and should not be relied upon by investors.
Stabilization
In connection with this offering, the
underwriters may engage in stabilizing transactions, over-allotment transactions, syndicate-covering transactions, penalty bids
and purchases to cover positions created by short sales.
Stabilizing transactions permit bids
to purchase securities so long as the stabilizing bids do not exceed a specified maximum, and are engaged in for the purpose
of preventing or retarding a decline in the market price of the securities while the offering is in progress.
Over-allotment transactions involve
sales by the underwriters of securities in excess of the number of securities the underwriters are obligated to
purchase. This creates a syndicate short position which may be either a covered short position or a naked short position. In a
covered short position, the number of securities over-allotted by the underwriters is not greater than the number of securities
that they may purchase in the over-allotment option. In a naked short position, the number of securities involved is
greater than the number of securities in the over-allotment option. The underwriters may close out any short position by
exercising their over-allotment option and/or purchasing securities in the open market.
Syndicate covering transactions involve
purchases of securities in the open market after the distribution has been completed in order to cover syndicate short
positions. In determining the source of securities to close out the short position, the underwriters will consider, among
other things, the price of securities available for purchase in the open market as compared with the price at which they
may purchase securities through exercise of the over-allotment option. If the underwriters sell more securities
than could be covered by exercise of the over-allotment option and, therefore, have a naked short position, the position can be
closed out only by buying securities in the open market. A naked short position is more likely to be created if the underwriters
are concerned that after pricing there could be downward pressure on the price of the securities in the open market that
could adversely affect investors who purchase in the offering.
Penalty bids permit the representative
to reclaim a selling concession from a syndicate member when the securities originally sold by that syndicate member are
purchased in stabilizing or syndicate covering transactions to cover syndicate short positions.
These stabilizing transactions, syndicate
covering transactions and penalty bids may have the effect of raising or maintaining the market price of our securities
or preventing or retarding a decline in the market price of our securities. As a result, the price of our common stock
in the open market may be higher than it would otherwise be in the absence of these transactions. Neither we nor the underwriters
make any representation or prediction as to the effect that the transactions described above may have on the price of our common
stock. These transactions may be effected in the over-the-counter market or otherwise and, if commenced, may be discontinued
at any time.
Other Relationships
Certain of the underwriters and their
affiliates may in the future provide various investment banking, commercial banking and other financial services for us and our
affiliates for which they may in the future receive customary fees.
Offer restrictions outside the United
States
Other than in the United States, no
action has been taken by us or the underwriters that would permit a public offering of the securities offered by this prospectus
in any jurisdiction where action for that purpose is required. The securities offered by this prospectus may not be offered or
sold, directly or indirectly, nor may this prospectus or any other offering material or advertisements in connection with the offer
and sale of any such securities be distributed or published in any jurisdiction, except under circumstances that will result in
compliance with the applicable rules and regulations of that jurisdiction. Persons into whose possession this prospectus comes
are advised to inform themselves about and to observe any restrictions relating to the offering and the distribution of this prospectus.
This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any securities offered by this prospectus
in any jurisdiction in which such an offer or a solicitation is unlawful.
Australia
This prospectus is not a disclosure
document under Chapter 6D of the Australian Corporations Act, has not been lodged with the Australian Securities and Investments
Commission and does not purport to include the information required of a disclosure document under Chapter 6D of the Australian
Corporations Act. Accordingly, (i) the offer of the securities under this prospectus is only made to persons to whom it is
lawful to offer the securities without disclosure under Chapter 6D of the Australian Corporations Act under one or more exemptions
set out in section 708 of the Australian Corporations Act, (ii) this prospectus is made available in Australia only to those
persons as set forth in clause (i) above, and (iii) the offeree must be sent a notice stating in substance that by accepting
this offer, the offeree represents that the offeree is such a person as set forth in clause (i) above, and, unless permitted
under the Australian Corporations Act, agrees not to sell or offer for sale within Australia any of the securities sold to the
offeree within 12 months after its transfer to the offeree under this prospectus.
China
The information in this document does
not constitute a public offer of the securities, whether by way of sale or subscription, in the People’s Republic of China
(excluding, for purposes of this paragraph, Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan).
The securities may not be offered or sold directly or indirectly in the PRC to legal or natural persons other than directly to
“qualified domestic institutional investors.”
European Economic Area—Belgium,
Germany, Luxembourg and Netherlands
The information in this document has
been prepared on the basis that all offers of securities will be made pursuant to an exemption under the Directive 2003/71/EC (“Prospectus
Directive”), as implemented in Member States of the European Economic Area (each, a “Relevant Member State”),
from the requirement to produce a prospectus for offers of securities.
An offer to the public of securities
has not been made, and may not be made, in a Relevant Member State except pursuant to one of the following exemptions under the
Prospectus Directive as implemented in that Relevant Member State:
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to legal entities that are authorized or regulated to operate in the financial markets or, if not so authorized or regulated, whose corporate purpose is solely to invest in securities;
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to any legal entity that has two or more of (i) an average of at least 250 employees during its last fiscal year; (ii) a total balance sheet of more than €43,000,000 (as shown on its last annual unconsolidated or consolidated financial statements) and (iii) an annual net turnover of more than €50,000,000 (as shown on its last annual unconsolidated or consolidated financial statements);
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to fewer than 100 natural or legal persons (other than qualified investors within the meaning of Article 2(1)(e) of the Prospectus Directive) subject to obtaining the prior consent of the Company or any underwriter for any such offer; or
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in any other circumstances falling within Article 3(2) of the Prospectus Directive, provided that no such offer of securities shall result in a requirement for the publication by the Company of a prospectus pursuant to Article 3 of the Prospectus Directive.
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France
This document is not being distributed
in the context of a public offering of financial securities (offre au public de titres financiers) in France within the
meaning of Article L.411-1 of the French Monetary and Financial Code (Code Monétaire et Financier) and
Articles 211-1 et seq. of the General Regulation of the French Autorité des marchés financiers (“AMF”).
The securities have not been offered or sold and will not be offered or sold, directly or indirectly, to the public in France.
This document and any other offering
material relating to the securities have not been, and will not be, submitted to the AMF for approval in France and, accordingly,
may not be distributed or caused to distributed, directly or indirectly, to the public in France.
Such offers, sales and distributions
have been and shall only be made in France to (i) qualified investors (investisseurs qualifiés) acting for their
own account, as defined in and in accordance with Articles L.411-2-II-2° and D.411-1 to D.411-3, D.744-1, D.754-1 ;and D.764-1
of the French Monetary and Financial Code and any implementing regulation and/or (ii) a restricted number of non-qualified investors
(cercle restreint d’investisseurs) acting for their own account, as defined in and in accordance with Articles L.411-2-II-2°
and D.411-4, D.744-1, D.754-1; and D.764-1 of the French Monetary and Financial Code and any implementing regulation.
Pursuant to Article 211-3 of
the General Regulation of the AMF, investors in France are informed that the securities cannot be distributed (directly or indirectly)
to the public by the investors otherwise than in accordance with Articles L.411-1, L.411-2, L.412-1 and L.621-8 to L.621-8-3 of
the French Monetary and Financial Code.
Ireland
The information in this document does
not constitute a prospectus under any Irish laws or regulations and this document has not been filed with or approved by any Irish
regulatory authority as the information has not been prepared in the context of a public offering of securities in Ireland within
the meaning of the Irish Prospectus (Directive 2003/71/EC) Regulations 2005 (the “Prospectus Regulations”). The securities
have not been offered or sold, and will not be offered, sold or delivered directly or indirectly in Ireland by way of a public
offering, except to (i) qualified investors as defined in Regulation 2(l) of the Prospectus Regulations and (ii) fewer
than 100 natural or legal persons who are not qualified investors.
Israel
The securities offered by this prospectus
have not been approved or disapproved by the Israeli Securities Authority (the ISA), or ISA, nor have such securities been registered
for sale in Israel. The securities may not be offered or sold, directly or indirectly, to the public in Israel, absent
the publication of a prospectus. The ISA has not issued permits, approvals or licenses in connection with the offering or publishing
the prospectus; nor has it authenticated the details included herein, confirmed their reliability or completeness, or rendered
an opinion as to the quality of the securities being offered. Any resale in Israel, directly or indirectly, to the public of the
securities offered by this prospectus is subject to restrictions on transferability and must be effected only in compliance with
the Israeli securities laws and regulations.
Italy
The offering of the securities in the
Republic of Italy has not been authorized by the Italian Securities and Exchange Commission (Commissione Nazionale per le Società
e la Borsa, “CONSOB” pursuant to the Italian securities legislation and, accordingly, no offering material relating
to the securities may be distributed in Italy and such securities may not be offered or sold in Italy in a public offer within
the meaning of Article 1.1(t) of Legislative Decree No. 58 of 24 February 1998 (“Decree No. 58"), other
than:
|
●
|
to Italian qualified investors, as defined in Article 100 of Decree no.58 by reference to Article 34-ter of CONSOB Regulation no. 11971 of 14 May 1999 (“Regulation no. 1197l”) as amended (“Qualified Investors”); and
|
|
●
|
in other circumstances that are exempt from the rules on public offer pursuant to Article 100 of Decree No. 58 and Article 34-ter of Regulation No. 11971 as amended.
|
Any offer, sale or delivery of the securities
or distribution of any offer document relating to the securities in Italy (excluding placements where a Qualified Investor solicits
an offer from the issuer) under the paragraphs above must be:
|
●
|
made by investment firms, banks or financial intermediaries permitted to conduct such activities in Italy in accordance with Legislative Decree No. 385 of 1 September 1993 (as amended), Decree No. 58, CONSOB Regulation No. 16190 of 29 October 2007 and any other applicable laws; and
|
|
●
|
in compliance with all relevant Italian securities, tax and exchange controls and any other applicable laws.
|
Any subsequent distribution of the securities
in Italy must be made in compliance with the public offer and prospectus requirement rules provided under Decree No. 58 and
the Regulation No. 11971 as amended, unless an exception from those rules applies. Failure to comply with such rules may result
in the sale of such securities being declared null and void and in the liability of the entity transferring the securities for
any damages suffered by the investors.
Japan
The securities have not been and will
not be registered under Article 4, paragraph 1 of the Financial Instruments and Exchange Law of Japan (Law No. 25 of 1948),
as amended (the “FIEL”) pursuant to an exemption from the registration requirements applicable to a private placement
of securities to Qualified Institutional Investors (as defined in and in accordance with Article 2, paragraph 3 of the FIEL and
the regulations promulgated thereunder). Accordingly, the securities may not be offered or sold, directly or indirectly, in Japan
or to, or for the benefit of, any resident of Japan other than Qualified Institutional Investors. Any Qualified Institutional Investor
who acquires securities may not resell them to any person in Japan that is not a Qualified Institutional Investor, and acquisition
by any such person of securities is conditional upon the execution of an agreement to that effect.
Portugal
This document is not being distributed
in the context of a public offer of financial securities (oferta pública de valores mobiliários) in Portugal,
within the meaning of Article 109 of the Portuguese Securities Code (Código dos Valores Mobiliários). The
securities have not been offered or sold and will not be offered or sold, directly or indirectly, to the public in Portugal. This
document and any other offering material relating to the securities have not been, and will not be, submitted to the Portuguese
Securities Market Commission (Comissăo do Mercado de Valores Mobiliários) for approval in Portugal and, accordingly,
may not be distributed or caused to distributed, directly or indirectly, to the public in Portugal, other than under circumstances
that are deemed not to qualify as a public offer under the Portuguese Securities Code. Such offers, sales and distributions of
securities in Portugal are limited to persons who are “qualified investors” (as defined in the Portuguese Securities
Code). Only such investors may receive this document and they may not distribute it or the information contained in it to any other
person.
Sweden
This document has not been, and will
not be, registered with or approved by Finansinspektionen (the Swedish Financial Supervisory Authority). Accordingly, this document
may not be made available, nor may the securities be offered for sale in Sweden, other than under circumstances that are deemed
not to require a prospectus under the Swedish Financial Instruments Trading Act (1991:980) (Sw. lag (1991:980) om handel
med finansiella instrument). Any offering of securities in Sweden is limited to persons who are “qualified investors”
(as defined in the Financial Instruments Trading Act). Only such investors may receive this document and they may not distribute
it or the information contained in it to any other person.
Switzerland
The securities may not be publicly offered
in Switzerland and will not be listed on the SIX Swiss Exchange (“SIX”) or on any other stock exchange or regulated
trading facility in Switzerland. This document has been prepared without regard to the disclosure standards for issuance prospectuses
under art. 652a or art. 1156 of the Swiss Code of Obligations or the disclosure standards for listing prospectuses under art. 27
ff. of the SIX Listing Rules or the listing rules of any other stock exchange or regulated trading facility in Switzerland. Neither
this document nor any other offering material relating to the securities may be publicly distributed or otherwise made publicly
available in Switzerland.
Neither this document nor any other
offering material relating to the securities have been or will be filed with or approved by any Swiss regulatory authority. In
particular, this document will not be filed with, and the offer of securities will not be supervised by, the Swiss Financial Market
Supervisory Authority (FINMA).
This document is personal to the recipient
only and not for general circulation in Switzerland.
United Arab Emirates
Neither this document nor the securities
have been approved, disapproved or passed on in any way by the Central Bank of the United Arab Emirates or any other governmental
authority in the United Arab Emirates, nor has the Company received authorization or licensing from the Central Bank of the United
Arab Emirates or any other governmental authority in the United Arab Emirates to market or sell the securities within the United
Arab Emirates. This document does not constitute and may not be used for the purpose of an offer or invitation. No services relating
to the securities, including the receipt of applications and/or the allotment or redemption of such securities, may be
rendered within the United Arab Emirates by the Company.
No offer or invitation to subscribe
for securities is valid or permitted in the Dubai International Financial Centre.
United Kingdom
Neither the information in this document
nor any other document relating to the offer has been delivered for approval to the Financial Services Authority in the United
Kingdom and no prospectus (within the meaning of section 85 of the Financial Services and Markets Act 2000, as amended (“FSMA”)
has been published or is intended to be published in respect of the securities. This document is issued on a confidential basis
to “qualified investors” (within the meaning of section 86(7) of FSMA) in the United Kingdom, and the securities may
not be offered or sold in the United Kingdom by means of this document, any accompanying letter or any other document, except in
circumstances which do not require the publication of a prospectus pursuant to section 86(1) FSMA. This document should not be
distributed, published or reproduced, in whole or in part, nor may its contents be disclosed by recipients to any other person
in the United Kingdom.
Any invitation or inducement to engage
in investment activity (within the meaning of section 21 of FSMA) received in connection with the issue or sale of the securities
has only been communicated or caused to be communicated and will only be communicated or caused to be communicated in the United
Kingdom in circumstances in which section 21(1) of FSMA does not apply to the Company.
In the United Kingdom, this document
is being distributed only to, and is directed at, persons (i) who have professional experience in matters relating to investments
falling within Article 19(5) (investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotions) Order
2005 (“FPO”), (ii) who fall within the categories of persons referred to in Article 49(2)(a) to (d) (high net worth
companies, unincorporated associations, etc.) of the FPO or (iii) to whom it may otherwise be lawfully communicated (together
“relevant persons”). The investments to which this document relates are available only to, and any invitation, offer
or agreement to purchase will be engaged in only with, relevant persons. Any person who is not a relevant person should not act
or rely on this document or any of its contents.
Canada
The securities may be sold in Canada
only to purchasers purchasing, or deemed to be purchasing, as principal that are accredited investors, as defined in National Instrument 45-106 Prospectus
Exemptions or subsection 73.3(1) of the Securities Act (Ontario), and are permitted clients, as defined in National Instrument 31-103 Registration
Requirements, Exemptions and Ongoing Registrant Obligations. Any resale of the securities must be made in accordance with an exemption
from, or in a transaction not subject to, the prospectus requirements of applicable securities laws. Securities legislation in
certain provinces or territories of Canada may provide a purchaser with remedies for rescission or damages if this prospectus (including
any amendment thereto) contains a misrepresentation, provided that the remedies for rescission or damages are exercised by the
purchaser within the time limit prescribed by the securities legislation of the purchaser’s province or territory. The purchaser
should refer to any applicable provisions of the securities legislation of the purchaser’s province or territory for particulars
of these rights or consult with a legal advisor. Pursuant to section 3A.3 of National Instrument 33-105 Underwriting
Conflicts (NI 33-105), the underwriters are not required to comply with the disclosure requirements of NI33-105 regarding
underwriter conflicts of interest in connection with this offering.
Experts
The
balance sheet of BioVie Inc. as of June 30, 2019 and the related statements of operations, changes in stockholders’ equity, and cash flow for the year
ended June 30, 2019, have been audited by EisnerAmper LLP, independent registered public accounting firm, as stated in their report
which is incorporated herein, which report includes an explanatory paragraph about the existence of substantial doubt concerning
the Company’s ability to continue as a going concern. Such financial statements have been incorporated herein in reliance
on the report of such firm given upon their authority as experts in accounting and auditing.
The audited balance sheet of BioVie Inc.
as June 30, 2018 and the related statements of operations, changes in stockholders’ equity and cash flows for the year then
ended, included in this prospectus and elsewhere in the registration statement have been so included in reliance upon the reports
of D. Brooks and Associates CPA’s, P.A., independent registered public accountants, upon the authority of said firm as experts
in accounting and auditing.
Legal
Matters
Loeb & Loeb LLP, Los
Angeles, California, and New York, New York, will pass upon the validity of the securities offered hereby. Certain matters are
being passed on for the underwriters by Greenberg Traurig, LLP, New York, New York.
Where
You Can Find More Information
We have filed with the SEC a registration
statement on Form S-1 under the Securities Act with respect to the securities offered by this prospectus. This prospectus,
which constitutes a part of the registration statement, does not contain all of the information set forth in the registration
statement, some of which is contained in exhibits to the registration statement as permitted by the rules and regulations of the
SEC. For further information with respect to us and our securities, we refer you to the registration statement, including
the exhibits filed as a part of the registration statement. Statements contained in this prospectus concerning the contents of
any contract or any other document is not necessarily complete. If a contract or document has been filed as an exhibit to the
registration statement, please see the copy of the contract or document that has been filed. Each statement is this prospectus
relating to a contract or document filed as an exhibit is qualified in all respects by the filed exhibit. The SEC maintains an
Internet website that contains reports, proxy statements and other information about issuers, like us, that file electronically
with the SEC. The address of that website is www.sec.gov.
We are subject to the information and
reporting requirements of the Securities Exchange Act of 1934, as amended, and, in accordance with this law, file periodic reports,
proxy statements and other information with the SEC. These periodic reports, proxy statements and other information are available
on the website of the SEC referred to above.
BioVie Inc.
Index to Financial Statements
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders
of
BioVie. Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheet
of BioVie, Inc. (the “Company") as of June 30, 2019 and the related statements of operations, changes in stockholders’
equity, and cash flows for the year then ended, and the related notes (collectively referred to as the “financial statements”).
In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of
June 30, 2019, and the results of its operations and its cash flows for the year then ended in conformity with accounting principles
generally accepted in the United States of America.
Going Concern
The accompanying financial statements have
been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements,
the Company’s recurring losses from operations and negative cash flows from operating activities raise substantial doubt
about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note
2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based
on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB")
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether
the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have,
nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit, we are required
to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the
effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to
assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures
that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures
in the financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by
management, as well as evaluating the overall presentation of the financial statements. We believe that our audit provides a reasonable
basis for our opinion.
/s/ EisnerAmper LLP
We have served as the Company’s auditor
since 2019.
EISNERAMPER LLP
Iselin, New Jersey
September 25, 2019, except for Note 1 (Reverse
Stock Split) as to which date is November 22, 2019
REPORT OF INDEPENDENT REGISTERED
PUBLIC ACCOUNTING FIRM
To the Board of Directors and
Stockholders of BioVie, Inc.
Opinion on the Financial Statements
We have audited the accompanying balance
sheets of BioVie, Inc. (the Company) as of June 30, 2018, and the related statements of operations, stockholders’ equity,
and cash flows for each of the year then ended, and the related notes (collectively referred to as the financial statements). In
our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of June
30, 2018, and the results of its operations and its cash flows the year ended June 30, 2018, in conformity with accounting principles
generally accepted in the United States of America.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based
on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB)
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with
the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether
the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have,
nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit, we are required
to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the
effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures
to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures
that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures
in the financial statements. Our audit also included evaluating the accounting principles used and significant estimates made
by management, as well as evaluating the overall presentation of the financial statements. We believe that our audit provide a
reasonable basis for our opinion.
|
/s/ D. Brooks and Associates CPA’s, P.A.
|
|
We have served as the Company’s auditor since 2017 through
January 18, 2019.
|
|
|
Palm Beach Gardens, Florida
October 4, 2018, except for the
common share, per share and loss per share presentation on a post-reverse split basis dated November 22,
2019
|
BioVie Inc.
Balance Sheets
|
|
June 30, 2019
|
|
June 30, 2018
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT ASSETS:
|
|
|
|
|
|
|
|
|
Cash
|
|
$
|
339,923
|
|
|
$
|
45,800
|
|
Other Assets
|
|
|
334,150
|
|
|
|
—
|
|
Total Current Assets
|
|
|
674,073
|
|
|
|
45,800
|
|
|
|
|
|
|
|
|
|
|
OTHER ASSETS:
|
|
|
|
|
|
|
|
|
Intangible Assets, Net
|
|
|
1,554,603
|
|
|
|
1,783,980
|
|
Goodwill
|
|
|
345,711
|
|
|
|
345,711
|
|
Total Other Assets
|
|
|
1,900,314
|
|
|
|
2,129,691
|
|
|
|
|
|
|
|
|
|
|
TOTAL ASSETS
|
|
$
|
2,574,387
|
|
|
$
|
2,175,491
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES:
|
|
|
|
|
|
|
|
|
Accounts Payable and accrued expenses
|
|
$
|
443,480
|
|
|
$
|
884,207
|
|
Accrued Payroll
|
|
|
—
|
|
|
|
354,167
|
|
Total Current Liabilities
|
|
|
443,480
|
|
|
|
1,238,374
|
|
|
|
|
|
|
|
|
|
|
LONG-TERM LIABILITIES:
|
|
|
|
|
|
|
|
|
Demand Promissory Note
|
|
|
—
|
|
|
|
250,000
|
|
Notes Payable, Related Parties
|
|
|
—
|
|
|
|
575,918
|
|
Total Long-Term Liabilities
|
|
|
—
|
|
|
|
825,918
|
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES
|
|
|
443,480
|
|
|
|
2,064,292
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies (Note 7)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 and 300,000,000 shares authorized at June 30, 2019 and June 30, 2018, respectively; 4,058,442 and 788,026 shares issued and outstanding at June 30, 2019 and June 30, 2018, respectively
|
|
|
406
|
|
|
|
79
|
|
|
|
|
|
|
|
|
|
|
Additional paid in capital
|
|
|
9,392,573
|
|
|
|
4,880,246
|
|
Accumulated deficit
|
|
|
(7,262,072
|
)
|
|
|
(4,769,126
|
)
|
Total Stockholders' Equity
|
|
|
2,130,907
|
|
|
|
111,199
|
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
$
|
2,574,387
|
|
|
$
|
2,175,491
|
|
The accompanying notes are an integral part
of the financial statements.
BioVie Inc.
Statements of Operations
|
|
Year ended
|
|
Year ended
|
|
|
June 30, 2019
|
|
June 30, 2018
|
|
|
|
|
|
|
|
|
|
|
REVENUE
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES:
|
|
|
|
|
|
|
|
|
Amortization
|
|
|
229,377
|
|
|
|
229,377
|
|
Research and development expenses
|
|
|
1,008,100
|
|
|
|
370,852
|
|
Selling, general and administrative expenses
|
|
|
1,259,096
|
|
|
|
1,771,937
|
|
TOTAL OPERATING EXPENSES
|
|
|
2,496,573
|
|
|
|
2,372,166
|
|
|
|
|
|
|
|
|
|
|
LOSS FROM OPERATIONS
|
|
|
(2,496,573
|
)
|
|
|
(2,372,166
|
)
|
|
|
|
|
|
|
|
|
|
OTHER EXPENSE (INCOME):
|
|
|
|
|
|
|
|
|
Gain on settlement of debt
|
|
|
(51,400
|
)
|
|
|
—
|
|
Interest expense
|
|
|
273
|
|
|
|
40,960
|
|
Interest income
|
|
|
(1,159
|
)
|
|
|
(4
|
)
|
TOTAL OTHER EXPENSE (INCOME), NET
|
|
|
(52,286
|
)
|
|
|
40,956
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS
|
|
$
|
(2,444,287
|
)
|
|
$
|
(2,413,122
|
)
|
|
|
|
|
|
|
|
|
|
Deemed dividend related to ratchet adjustment
|
|
|
48,659
|
|
|
|
20,995
|
|
|
|
|
|
|
|
|
|
|
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
|
|
$
|
(2,492,946
|
)
|
|
$
|
(2,434,117
|
)
|
|
|
|
|
|
|
|
|
|
NET LOSS PER SHARE BASIC AND DILUTED
|
|
$
|
(0.98
|
)
|
|
$
|
(3.18
|
)
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF
|
|
|
|
|
|
|
|
|
COMMON SHARES OUTSTANDING BASIC AND DILUTED
|
|
|
2,539,611
|
|
|
|
766,065
|
|
The accompanying notes are an integral part
of the financial statements.
BioVie Inc.
Statements of Changes in Stockholders’
Equity
For the Years Ended June 30, 2019 and 2018
|
|
Preferred
|
|
Preferred
|
|
Common
|
|
Common
|
|
Additional
|
|
|
|
Total
|
|
|
Stock
|
|
Stock
|
|
Stock
|
|
Stock
|
|
Paid in
|
|
Accumulated
|
|
Stockholders'
|
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Capital
|
|
Deficit
|
|
Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, June 30, 2017
|
|
|
—
|
|
|
$
|
—
|
|
|
|
735,400
|
|
|
$
|
74
|
|
|
$
|
3,492,254
|
|
|
$
|
(2,335,009
|
)
|
|
$
|
1,157,319
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of shares and warrants for cash
|
|
|
—
|
|
|
|
—
|
|
|
|
13,838
|
|
|
|
1
|
|
|
|
444,998
|
|
|
|
—
|
|
|
|
444,999
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of shares for services
|
|
|
—
|
|
|
|
—
|
|
|
|
37,988
|
|
|
|
4
|
|
|
|
642,846
|
|
|
|
—
|
|
|
|
642,850
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options vested
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
238,165
|
|
|
|
—
|
|
|
|
238,165
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of options for cash
|
|
|
—
|
|
|
|
—
|
|
|
|
800
|
|
|
|
—
|
|
|
|
2,000
|
|
|
|
—
|
|
|
|
2,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of warrants for services
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
12,469
|
|
|
|
—
|
|
|
|
12,469
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of warrants with debt
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
26,519
|
|
|
|
—
|
|
|
|
26,519
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deemed dividends for ratchet adjustment to warrants
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
20,995
|
|
|
|
(20,995
|
)
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(2,413,122
|
)
|
|
|
(2,413,122
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, June 30, 2018
|
|
|
—
|
|
|
$
|
—
|
|
|
|
788,026
|
|
|
$
|
79
|
|
|
$
|
4,880,246
|
|
|
$
|
(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
|
)
|
|
|
1,706,666
|
|
|
|
171
|
|
|
|
(171
|
)
|
|
|
—
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of shares in exchange for debt settlement
|
|
|
—
|
|
|
|
—
|
|
|
|
7,804
|
|
|
|
1
|
|
|
|
1,150,134
|
|
|
|
—
|
|
|
|
1,150,135
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of shares for services
|
|
|
|
|
|
|
|
|
|
|
11,200
|
|
|
|
1
|
|
|
|
48,999
|
|
|
|
—
|
|
|
|
49,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock option compensation
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
64,860
|
|
|
|
—
|
|
|
|
64,860
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cashless exercise of warrants
|
|
|
—
|
|
|
|
—
|
|
|
|
1,544,746
|
|
|
|
154
|
|
|
|
(154
|
)
|
|
|
—
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deemed dividends for ratchet adjustment to warrants
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
48,659
|
|
|
|
(48,659
|
)
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(2,444,287
|
)
|
|
|
(2,444,287
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, June 30, 2019
|
|
|
—
|
|
|
$
|
—
|
|
|
|
4,058,442
|
|
|
$
|
406
|
|
|
$
|
9,392,573
|
|
|
$
|
(7,262,072
|
)
|
|
$
|
2,130,907
|
|
The accompanying notes are an integral part
of the financial statements.
BioVie Inc.
Statements of Cash Flows
|
|
Year ended
|
|
Year ended
|
|
|
June 30, 2019
|
|
June 30, 2018
|
|
|
|
|
|
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(2,444,287
|
)
|
|
$
|
(2,413,122
|
)
|
Adjustments to reconcile net loss to net cash to cash used in operating activities:
|
|
|
|
|
|
|
|
|
Common shares issued for service
|
|
|
49,000
|
|
|
|
655,319
|
|
Amortization of intangible assets
|
|
|
229,377
|
|
|
|
229,377
|
|
Amortization of debt discount
|
|
|
|
|
|
|
26,519
|
|
Stock based compensation expense
|
|
|
64,860
|
|
|
|
238,165
|
|
Gain on settlement of debt
|
|
|
51,400
|
|
|
|
|
|
Changes in operating assets and liabilities
|
|
|
|
|
|
|
|
|
Other assets
|
|
|
(334,150
|
)
|
|
|
|
|
Accounts payable and accrued expenses
|
|
|
(117,777
|
)
|
|
|
413,234
|
|
Accrued payroll
|
|
|
—
|
|
|
|
229,167
|
|
Net cash used in operating activities
|
|
|
(2,501,577
|
)
|
|
|
(621,341
|
)
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Repayment of debt
|
|
|
(244,300
|
)
|
|
|
(35,000
|
)
|
Proceeds from issuance of preferred shares
|
|
|
3,040,000
|
|
|
|
250,000
|
|
Proceeds from issuance of common stock and warrants
|
|
|
—
|
|
|
|
446,999
|
|
Net cash provided by financing activities
|
|
|
2,795,700
|
|
|
|
661,999
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash
|
|
|
294,123
|
|
|
|
40,658
|
|
|
|
|
|
|
|
|
|
|
Cash, beginning of period
|
|
|
45,800
|
|
|
|
5,140
|
|
|
|
|
|
|
|
|
|
|
Cash, end of period
|
|
$
|
339,923
|
|
|
$
|
45,800
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL CASH FLOW INFORMATION:
|
|
|
|
|
|
|
|
|
Cash paid for interest
|
|
$
|
—
|
|
|
$
|
—
|
|
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
|
|
$
|
19,309
|
|
|
$
|
—
|
|
Deemed dividends for ratchet adjustments to warrants
|
|
$
|
48,659
|
|
|
$
|
—
|
|
The accompanying notes are an integral part
of the financial statements.
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2019 and 2018
1.
|
Background Information
and Reverse Stock Split
|
Background Information
We are 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.
In April 2017, we entered into a CRADA
with the McGuire Research Institute Inc. in Richmond, VA, and began administering BIV201 to patients in September 2017. In April
2019, we announced top-line results for our Phase 2a clinical trial of BIV201 (continuous infusion terlipressin) in six patients
with refractory ascites due to advanced liver cirrhosis. On June 18, 2019, we met with representatives of the FDA for Type C Guidance
Meeting to plan our next clinical study following the recently completed Phase 2a clinical trial. We discussed our clinical development
efforts with the FDA and proposed trial endpoints. While the FDA has not provided final guidance nor do we have certainty as to
what that guidance would entail, our goal remains to proceed into a Phase 2b/3 or Phase 3 clinical trial in a manner consistent
with what was reviewed with the FDA. We may still need to address certain risks associated with unvalidated quality of life measures.
In July 2019, the FDA provided meeting minutes for the June 18, 2019 meeting that documented general agreement with the Company
proposed randomized study design. The FDA also provided its suggestions and guidance regarding primary and secondary endpoints
and other key aspects of our clinical trial design and the Company is incorporating those suggestions as it moves forward. We are
developing a proprietary novel liquid formulation of terlipressin that is intended to improve convenience for outpatient administration
and avoid potential formulation errors 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. The FDA has never approved any drug specifically for treating ascites.
The Company has secured a US Patent covering the use of BIV201 for the treatment of ascites patients in the outpatient setting
using ambulatory pump infusion, and has filed patent applications for its product candidate in Japan, and Europe, Hong Kong, and
China. BIV201 also received Orphan Drug designation for hepatorenal syndrome (“HRS”) in November 2018.
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.
Reverse Stock Split
On November 21, 2019,
the Company effected a 1:125 reverse stock split of the Company’s common stock. The reverse split combined each
125 shares of the Company’s issued and outstanding common stock into 1 share of the common stock. No fractional shares
were issued in connection with the reverse split, and any fractional shares resulting from the reverse split were rounded up
to the nearest whole share. Unless the context otherwise requires, all references in these financial statements to shares of
the Company’s common stock, options and warrants, including prices per share of its common stock reflect the
Reverse Stock Split.
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2019 and 2018
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. The Company has experienced losses since inception
and has an accumulated deficit of approximately $7.3 million at June 30, 2019. In addition, the Company has not generated any revenues
and no revenues are anticipated in the foreseeable future. The Company’s future operations are dependent on the success of
the Company’s ongoing development and commercialization efforts, as well as continuing to secure additional financing.
In July 2018, the Company completed
a capital raise from Acuitas Group Holding, LLC (“Acuitas”) and other purchasers and received net proceeds of $3.2
million ( see note 8 “Equity Transactions”) and resumed further clinical development of BIV201 and completed its Phase
2a clinic trial program. 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 uplisting 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 achieve effectiveness
of the S-1 Registration Statement or successfully complete an offering thereunder.
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.
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2019 and 2018
3.
|
Significant Accounting Policies
|
Basis of Presentation
The Company’s financial
statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”)
and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented.
Use of Estimates
The preparation of financial
statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the
financial statements and accompanying notes. The Company bases its estimates on historical experience and on various assumptions
that are believed to be reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s
balance sheet and the amounts of expenses reported for each of the periods presented are affected by estimates and assumptions,
which are used for, but not limited to, accounting for share-based compensation, accounting
for derivatives and accounting for income taxes. Actual results could differ from those estimates.
Cash
The Company considers all highly liquid instruments with original
maturities of three months or less to be cash equivalents. Cash is maintained at one financial institution and, at times, balances
may exceed federally insured limits. The Company has never experienced any losses related to these balances. All of the Company’s
cash balances were fully insured at June 30, 2019.
Other Assets
Other Assets consists of direct cost related to capital raise and
filing of the registration statement legal fees and investment banking fees incurred to raise capital. The costs will be expensed
once the Company raises the capital.
Fair Value of Financial Instruments
Fair value is defined as the
price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants
at the measurement date. When determining the fair value for applicable assets and liabilities, we consider the principal or most
advantageous market in which we would transact and we consider assumptions market participants would use when pricing the asset
or liability, such as inherent risk, transfer restrictions, and risk of nonperformance. This guidance also establishes a fair value
hierarchy to prioritize inputs used in measuring fair value as follows:
|
●
|
Level 1: Observable inputs such as quoted prices in active markets;
|
|
●
|
Level 2: Inputs, other than quoted prices in active markets, that are observable either directly
or indirectly; and
|
|
●
|
Level 3: Unobservable inputs in which there is little or no market data, which require the reporting
entity to develop its own assumptions
|
The
Company’s financial instruments include cash, accounts payable, related party loans and a demand promissory note. The carrying
amounts of cash and accounts payable approximate their fair value, due to the short-term nature of these items.
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2019 and 2018
3.
|
Significant Accounting Policies (continued)
|
Long-Term Notes Payable
The Company’s long-term notes
payable include accrued payroll to officers and accrued payments to third party consultants.
Research and Development
Research and development
expenses consist primarily of costs associated with the preclinical and/ or clinical trials of drug candidates, compensation and
other expenses for research and development, personnel, supplies and development materials, costs for consultants and related contract
research and facility costs. Expenditures relating to research and development are expensed as incurred.
Income Taxes
The Company uses the asset and
liability method of accounting for deferred income taxes. Deferred income taxes are measured by applying enacted statutory rates
to net operating loss carryforwards and to the differences between the financial reporting and tax bases of assets and liabilities.
Deferred tax assets are reduced, if necessary, by a valuation allowance if it is more likely than not that some portion or all
of the deferred tax assets will not be realized.
The Company recognizes uncertainty
in income taxes in the financial statements using a recognition threshold and measurement attribute of a tax position taken or
expected to be taken in a tax return. The Company applies the “more-likely-than-not” recognition threshold to all tax
positions, commencing at the adoption date of the applicable accounting guidance, which resulted in no unrecognized tax benefits
as of such date. Additionally, there have been no unrecognized tax benefits subsequent to adoption. The Company has opted to classify
interest and penalties that would accrue, if any, according to the provisions of relevant tax law as general and administrative
expenses, in the statements of operations. For the years ended June 30, 2019 and 2018 there was no such interest or penalty.
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 June 30, 2019 and June 30, 2018:
|
|
June 30, 2019
|
|
June 30, 2018
|
|
|
Number of Shares
|
|
Number of Shares
|
Stock Options
|
|
|
58,000
|
|
|
|
41,200
|
|
Warrants
|
|
|
124,667
|
|
|
|
38,193
|
|
Total
|
|
|
182,667
|
|
|
|
79,393
|
|
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2019 and 2018
3.
|
Significant Accounting Policies (continued)
|
Stock-based Compensation
The Company has accounted for stock-based compensation
under the provisions of FASB ASC 718 – “Stock Compensation” which requires the use of the fair-value based method
to determine compensation for all arrangements under which employees and others receive shares of stock or equity instruments (stock
options and common stock purchase warrants). For employee awards, the fair value of each stock option award is estimated on the
date of grant using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected
term, and the risk-free interest rate. For non-employees, the fair value of each stock option award is estimated on the measurement
date using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term,
and the risk-free interest rate. For non-employees, the Company utilizes the graded vesting attribution method under which the
entity treats each separately vesting portion (tranche) as a separate award and recognizes compensation cost for each tranche over
its separate vesting schedule. Expected volatilities are based on historical volatility of peer companies and other factors estimated
over the expected term of the stock options. For employee awards, the expected term of options granted is derived using the “simplified
method” which computes expected term as the average of the sum of the vesting term plus the contract term. The risk-free
rate is based on the U.S. Treasury yield curve in effect at the time of grant for the period of the expected term. We recognize
forfeitures as they occur.
Goodwill
Goodwill is recorded when the purchase price
paid for an acquisition exceeds the fair value of net identified tangible and intangible assets acquired. The Company performs
an annual impairment test of goodwill and further periodic tests to the extent indicators of impairment develop between annual
impairment tests. The Company’s impairment review process compares the fair value of the reporting unit to its carrying value,
including the goodwill related to the reporting unit. To determine the fair value of the reporting unit, the Company may use various
approaches including an asset or cost approach, market approach or income approach or any combination thereof. These approaches
may require the Company to make certain estimates and assumptions including future cash flows, revenue and expenses. These estimates
and assumptions are reviewed each time the Company tests goodwill for impairment and are typically developed as part of the Company’s
routine business planning and forecasting process. While the Company believes its estimates and assumptions are reasonable, variations
from those estimates could produce materially different results. The Company did not recognize any goodwill impairments for the
years ended June 30th, 2018 and June 30th, 2019.
Impairment of Long-Lived Assets
Long-lived assets, including intangible
assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may
not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset
to estimated undiscounted future cash flows expected to be generated by the asset.
If the carrying amount of an asset
exceeds its undiscounted estimated future cash flows, an impairment review is performed. An impairment charge is recognized in
the amount by which the carrying amount of the asset exceeds the fair value of the asset. Generally, fair value is determined using
valuation techniques such as expected discounted cash flows or appraisals, as appropriate. Assets to be disposed of would be separately
presented in the balance sheet and reported at the lower of the carrying amount or fair value less costs to sell, and are no longer
depreciated or amortized. The assets and liabilities of a disposed group classified as held for sale would be presented separately
in the appropriate asset and liability sections of the balance sheet.
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2019 and 2018
3.
|
Significant Accounting Policies (continued)
|
Reclassifications
Certain prior year amounts have been reclassified
for consistency with current year presentation. These reclassifications had no effect on the reported results of operations.
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”, which simplifies
the accounting for non-employee share-based payment transactions. The amendments specify that Topic 718 applies to all share-based
payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by
issuing share-based payment awards. The standard will be effective for the Company in the first quarter of fiscal year 2020, although
early adoption is permitted (but no sooner than the adoption of Topic 606). The Company does not expect that the adoption of this
ASU will have a significant impact on its financial statements.
In July 2017, the FASB issued Accounting Standards
Update (“ASU”) No. 2017-11. “Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480);
Derivatives and Hedging (Topic 815): I. Accounting for Certain Financial Instruments with Down Round Features, II. Replacement
of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily
Redeemable Noncontrolling Interests with a Scope Exception. ASU 2017-11 revises the guidance for instruments with down round features
in Subtopic 815-40, Derivatives and Hedging – Contracts in Entity’s Own Equity, which is considered in determining
whether an equity-linked financial instrument qualifies for a scope exception from derivative accounting. An entity still is required
to determine whether instruments would be classified in equity under the guidance in Subtopic 815-40 in determining whether they
qualify for that scope exception. If they do qualify, freestanding instruments with down round features are no longer classified
as liabilities. ASU 2017-11 is effective for annual and interim periods beginning December 15, 2018, and early adoption is permitted,
including adoption in an interim period. ASU 2017-11 provides that upon adoption, an entity may apply this standard retrospectively
to outstanding financial instruments with a down round feature by means of a cumulative-effect adjustment to the opening balance
of retaining earnings in the fiscal year and interim period adopted. The Company is currently in the process of assessing the impact
of this ASU on its financial statements.
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2019 and 2018
Intellectual
property, stated at cost, less accumulated amortization consists of the following:
|
|
June 30, 2019
|
|
June 30, 2018
|
|
|
|
|
|
Intellectual Property
|
|
$
|
2,293,770
|
|
|
$
|
2,293,770
|
|
Less Accumulated Amortization
|
|
|
(739,167
|
)
|
|
|
(509,790
|
)
|
Intellectual Property, Net
|
|
$
|
1,554,603
|
|
|
$
|
1,783,980
|
|
Amortization
expense amounted to $229,377 and $229,377 for the years ended June 30, 2019 and 2018, respectively. The Company amortizes intellectual
property over the expected original useful lives of 10 years.
Estimated future
amortization expense is as follows:
Year ending June 30,
|
|
2020
|
229,377
|
2021
|
229,377
|
2022
|
229,377
|
2023
|
229,377
|
2024
|
229,377
|
Thereafter
|
407,718
|
|
$ 1,554,603
|
On July 19, 2018, Geis-Hides Consulting
LLC entered into an Accord and Debt Satisfaction Agreement with the Company in which the consulting firm agreed to release the
Company from all liabilities arising from the Original Contract and Debt Repayment Plan dated December 15, 2013 totaling $132,000
and received cash of $65,000 and 2,080 common shares in satisfaction. The common shares were valued at the market price
on the date of settlement at $7.50 per common share. The gain of $51,400 on the settlement of debt was reflected on the
Statements of Operations as “other income” for the year ended June 30, 2019.
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2019 and 2018
6.
|
Related Party Transactions
|
On March 23, 2017,
Barrett Ehrlich agreed to defer the payment of his consulting fee debt of $173,333 until December 31, 2019, through the issuance
of a Promissory note. The promissory note does not carry any interest charge as long as the amount is paid in full before December
31, 2019. The consulting fee debt was reclassified from a current liability to a long-term liability on the balance sheet. Any
portion of the balance due under the note that remains unpaid after December 31, 2019 will accrue interest at a rate
of 5% per annum until paid in full.
On August 8, 2018, Barrett Ehrlich
(Independent contractor, related party to Elliot Ehrlich and shareholder) on behalf of The Barrett Edge Inc. (“Barrett”)
entered into an Accord and Debt Satisfaction Agreement with the Company in which Barrett agreed to release the Company from all
liabilities including the original contract to defer payment of accrued consulting fees dated March 23, 2017, the promissory note
issued by the Company to defer payment of accrued consulting fees; loan to the Company for $14,000, and subsequent unpaid consulting
fees, totaling $543,014, and received cash of $131,333 and 3,947 common shares in satisfaction. The common shares were
valued at the market price on the date of settlement at $16.25 per common share. The gain of $361,548 on the settlement
of debt was reflected in the additional paid in capital for the year ended June 30, 2019.
On March 23, 2017,
Elliot Ehrlich agreed to forgive 50% of his salary debt of $444,056. The adjusted salary debt is $222,028. Elliot Ehrlich
also agreed to defer the payment of his salary debt of $222,028 until December 31, 2019, through the issuance of a Promissory
note. The promissory note does not carry any interest charge as long as the amount is paid in full before December 31,
2019. The salary debt was reclassified from a current liability to a long-term liability on the balance sheet and the salary
debt forgiven had been reflected on the income statement as other income. Any portion of the balance due under the note that
remains unpaid after December 31, 2019 will accrue interest at a rate of 5% per annum until paid in full.
On July 9, 2018, Elliot Ehrlich (former
CEO and shareholder) entered into an Accord and Debt Satisfaction Agreement with the Company in which he agreed to release the
Company from all liabilities including the original contract to defer payment of accrued salary dated March 23, 2017, totaling
the amount of $222,028 the promissory note issued by the Company to defer payment of accrued salary; and received cash of $22,273
and 1,777 common shares in satisfaction. The common shares were valued at the market price on the date of settlement at
$7.50 per common share. The gain of $186,503 on the settlement of debt was reflected in the additional paid in capital
for the year ended June 30, 2019.
On March 23, 2017,
Jonathan Adams agreed to defer the payment of his salary debt of $180,555 until December 31, 2019, through the issuance of
a Promissory note. The promissory note does not carry any interest charge as long as the amount is paid in full before December
31, 2019. The salary debt was reclassified from a current liability to a long-term liability on the balance sheet. Any
portion of the balance due under the note that remains unpaid after December 31, 2019 will accrue interest at a rate
of 5% per annum until paid in full.
On July 9, 2018, Jonathan
Adams (COO) entered into an Accord and Debt Satisfaction Agreement with the Company in which he agreed to release the Company from
all liabilities including the original contract to defer payment of his accrued salary dated March 23, 2017, the promissory note
issued by the Company to defer payment of accrued salary; and subsequent unpaid salary, totaling the amount of $534,722, and received
cash of $25,694 in satisfaction. The gain of $509,028 on the settlement of debt was reflected in the additional paid in capital
for the year ended June 30, 2019.
The outstanding balance
of the long-term note payable at June 30, 2019 and 2018 was $0 and $575,918, respectively.
See note 8 “Equity Transactions”, for other related
party transactions with Acuitas Group Holdings, LLC (“Acuitas”) and board of director members.
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2019 and 2018
7.
|
Commitments and Contingencies
|
Office
Lease
On October 1, 2018, the Company
executed a lease agreement with Acuitas Group Holdings, LLC (related party) for the Company’s Corporate office space at the
Acuitas’ offices at 11100 Wilshire Boulevard, Los Angeles, CA 90025. The lease is a month-to-month lease that may be cancelled
upon 30 days’ written notice and requires monthly payments of $1,000. On July 1, 2019, the Company’s office moved with
Acuitas’ new offices to 2120 Colorado Avenue Ste 230, Santa Monica, CA 90404.
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 August 15, 2018, we submitted a Preliminary
Response to the PTAB providing a rationale as to why, in our opinion, Mallinckrodt’s request to institute the IPR should
not be granted. On November 14, 2018, the PTAB granted institution of the IPR challenge after determining that there was a reasonable
likelihood of success in proving that at least one of our 14 claims was unpatentable. On March 7, 2019, we submitted a Patent Owner’s
Response and a Patent Owner’s Contingent Motion to Amend our patent claims, and Declaration of Dr. Jaime Bosch, MD, PhD,
our medical expert. On June 26 and June 28, 2019, we submitted a Patent Owner’s Reply In Support Of Its Contingent Motion
To Amend Under 37 C.F.R.§ 42.121 to amend our patent claims and a Patent Sur-Reply supported by the Supplemental Declaration
of Dr. Jaime Bosch to the Reply and the Opposition to Motion to Amend, filed by Petitioner Mallinckrodt, filed June 6, 2019. On
July 29, 2019, we submitted a Patent Owner’s Opposition to Petitioner’s Motion to Strike. On July 17, 2019, we received
from the PTAB an Order Oral Hearing in response to our request of an Oral Hearing which was held on August 12, 2019 at 1:00PM EST.
We are actively defending the ’945 patent and we are exploring the possibility of settlement with Mallinckrodt. However,
there can be no assurance that a favorable outcome will result, or if settlement is reached that the PTAB will accept it. A reasonable
estimate cannot be made at this time. Although the PTAB encourages settlement, in view of public-interest considerations, the PTAB
may continue the proceeding to a final written decision even if the parties settle. If the IPR is not terminated due to settlement,
the PTAB is statutorily required to issue its final written decision in this case before November 14, 2019 (within one year from
the date of institution). At June 30, 2019, no adjustments or accruals have been reflected in our financial statements related
to this matter.
Royalty Agreements
Pursuant to the Agreement and Plan
of Merger entered into on April 11, 2016 between 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.
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2019 and 2018
Stock Options
The following table summarizes the
activity relating to the Company’s stock options for the years ended June 30, 2018 and 2019:
|
|
Options
|
|
Weighted-Average Exercise Price
|
|
Weighted Remaining Average Contractual Term
|
|
Aggregate Intrinsic Value
|
Outstanding at June 30, 2017
|
|
|
32,000
|
|
|
$
|
12.50
|
|
|
|
5.9
|
|
|
$
|
142,000
|
|
Granted
|
|
|
10,000
|
|
|
$
|
18.75
|
|
|
|
5.0
|
|
|
$
|
—
|
|
Options Exercised
|
|
|
(800
|
)
|
|
$
|
2.50
|
|
|
|
—
|
|
|
$
|
—
|
|
Outstanding at June 30, 2018
|
|
|
41,200
|
|
|
$
|
15.00
|
|
|
|
5.8
|
|
|
$
|
142,000
|
|
Granted
|
|
|
16,800
|
|
|
$
|
5.00
|
|
|
|
4.5
|
|
|
$
|
131,000
|
|
Options Exercised or Forfeited
|
|
|
—
|
|
|
$
|
—
|
|
|
|
—
|
|
|
$
|
—
|
|
Outstanding at June 30, 2019
|
|
|
58,000
|
|
|
$
|
12.50
|
|
|
|
5.2
|
|
|
$
|
273,000
|
|
Exercisable at June 30, 2019
|
|
|
58,000
|
|
|
$
|
12.50
|
|
|
|
5.2
|
|
|
$
|
—
|
|
The fair value of each option grant
on the date of grant is estimated using the Black-Scholes Option – Pricing model reflecting the following weighted-average
assumptions:
|
|
June 30,
|
|
|
2019
|
|
2018
|
Expected life of options (In years)
|
|
|
5
|
|
|
|
5
|
|
Expected volatility
|
|
|
69.77
|
%
|
|
|
103.13
|
%
|
Risk free interest rate
|
|
|
2.60
|
%
|
|
|
2.28
|
%
|
Dividend Yield
|
|
|
0
|
%
|
|
|
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 $64,860 for the year ended June 30, 2019 and $238,165 for the year ended June 30, 2018.
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2019 and 2018
8.
|
Equity Transactions (continued)
|
The following is a summary of stock
options outstanding and exercisable by exercise price as of June 30, 2019:
|
|
|
|
Weighted Average
|
|
|
Exercise Price
|
|
Outstanding
|
|
Contract Life
|
|
Exercisable
|
$
|
3.75
|
|
|
|
5,600
|
|
|
|
4.6
|
|
|
|
5,600
|
|
$
|
6.25
|
|
|
|
10,400
|
|
|
|
4.3
|
|
|
|
10,400
|
|
$
|
7.50
|
|
|
|
24,800
|
|
|
|
6.7
|
|
|
|
24,800
|
|
$
|
8.75
|
|
|
|
800
|
|
|
|
4.3
|
|
|
|
800,
|
|
$
|
12.50
|
|
|
|
4,000
|
|
|
|
3.6
|
|
|
|
4,000
|
|
$
|
25.00
|
|
|
|
1,600
|
|
|
|
3.3
|
|
|
|
1,600
|
|
$
|
26.25
|
|
|
|
4,400
|
|
|
|
2.8
|
|
|
|
4,400
|
|
$
|
27.50
|
|
|
|
800
|
|
|
|
2.7
|
|
|
|
800
|
|
$
|
28.75
|
|
|
|
1,600
|
|
|
|
3.1
|
|
|
|
1,600
|
|
$
|
31.25
|
|
|
|
4,000
|
|
|
|
2.4
|
|
|
|
4,000
|
|
|
Total
|
|
|
|
58,000
|
|
|
|
|
|
|
|
58,000
|
|
Issuance of Shares for Cash
In July 2017 and August 2017, the Company
sold and issued an aggregate of 7,091 shares of common stock and warrants to purchase 3,546 shares of common stock
in a private placement transaction for aggregate gross proceeds of approximately $195,000. The purchase price for the common stock
and warrants was $27.50 per share. The warrants are exercisable at an exercise price of $75.00 at any time from
date of issuance until 5 years from the date of issuance.
Between July 2017 and September 2017,
the Company sold an aggregate of 2,000 shares of common stock in transactions under the Aspire Equity Line for aggregate
gross proceeds of $50,000. The average purchase price for the common stock was $25.00 per share.
In October 2017, the Company sold and
issued an aggregate of 1,273 shares of common stock and warrants to purchase 637 shares of common stock in a private
placement transaction for aggregate gross proceeds of approximately $35,000. The purchase price for the common stock and warrants
was $27.50 per share. The warrants are exercisable at an exercise price of $75.00 at any time from date of issuance
until 5 years from the date of issuance.
In November 2017, the Company also
sold and issued an aggregate of 546 shares of common stock and warrants to purchase 273 shares of common stock in
a private placement transaction for aggregate gross proceeds of approximately $15,000. The purchase price for the common stock
and warrants was $27.50 per share. The warrants are exercisable at an exercise price of $75.00 at any time from
date of issuance until 5 years from the date of issuance.
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2019 and 2018
8.
|
Equity Transactions (continued)
|
In January 2018, the Company sold an
aggregate of 2,667 shares of common stock and warrants to purchase 2,667 shares of common stock to a member of its
board of directors for aggregate gross proceeds of $50,000. The purchase price for the common stock and warrants was $18.75
per share. The warrants are exercisable at an exercise price of $18.75 at any time from date of issuance until 7 years
from the date of issuance.
On July 3, 2018, we entered into a Securities
Purchase Agreement (the “Purchase Agreement”) with Acuitas Group Holdings, 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 1,706,666 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 6,667 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 1,600,000 shares of common stock at a price per
share of $1.875, 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, Cuang Do and Michael Sherman, who are members of our Board of Directors.
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 1 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 the Purchase Agreement,
Terren Peizer, the Chairman of Acuitas, was appointed as a member of the Company’s Board of Directors (the “Board”)
and as the Chief Executive Officer of the Company, effective July 3, 2018. The issuance of the Preferred Stock, the Warrants and
the underlying common stock under the Purchase Agreement is exempt from registration under the Securities Act of 1933, as amended
(the “Securities Act”), pursuant to the exemption for transactions by an issuer not involving any public offering under
Section 4(a)(2) of the Securities Act.
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2019 and 2018
8.
|
Equity Transactions (continued)
|
Pursuant to a letter agreement dated June 24,
2019, Acuitas has agreed to modify its existing rights under the Purchase Agreement so that:
|
-
|
Acuitas
agreed to immediately exchange its existing 1,606,667 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 $45.00 per share and, as
a result received an aggregate of 95% of the shares covered thereby, or 1,526,333
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 $11.25 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 1,339,958 shares of common stock (the “Subsequent
Sale Shares”) to Acuitas.
|
Issuance of Warrants for Cash
and Cashless Exercise of Warrants
In December 2017, the Company issued
warrants for cash to purchase 20,000 shares of common stock in a private placement transaction for aggregate gross proceeds
of $100,000. The purchase price for the warrants were $5.00 per warrant. The warrants are exercisable at an exercise price
of $25.00 at any time from date of issuance until 7 years from the date of issuance. As a result of the conversion of the
Series A Preferred Stock in July 2018, the exercise of warrants to purchase 20,000 shares of common stock was reduced from
$18.75 per share to $1.875 per share. On August 4, 2018, the Company issued 17,936 shares of common stock
pursuant to a cashless exercise of warrants to purchase 20,000 shares at an exercise price of $1.875 per share.
On May 13, 2019, the Company issued
479 shares of common stock pursuant to a cashless exercise of warrants to purchase 479 shares at an exercise price
of $13.75 per share.
On June 24, 2019, the Company issued
1,526,094 shares of common stock pursuant to a cashless exercise of warrants to purchase 1,606,667 shares at an
exercise price of $45.00 per share.
Issuance of Warrants Services
In January 2018, the Company
issued warrants to purchase 840 shares of common stock in exchange for services. The warrants are exercisable at an exercise
price of $18.75 any time from the date of issuance until 7 years from the date of issuance. The warrants were valued at
$9,444. The fair value of the warrants granted was estimated using the Black Scholes Method and the following assumptions: volatility
– 166.7%; Term – 7 years; Risk Free Rate – 2.48%; dividend rate – 0.00%
In February 2018, the Company
issued warrants to purchase 840 shares of common stock in a termination agreement. The warrants are exercisable at an exercise
price of $18.75 any time from the date of issuance until 7 years from the date of issuance. The warrants were valued at
$3,025. The fair value of the warrants granted was estimated using the Black Scholes Method and the following assumptions: volatility
– 166.7%; Term – 7 years; Risk Free Rate – 2.81%; dividend rate – 0.00%
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2019 and 2018
8.
|
Equity Transactions (continued)
|
Issuance of Shares for Services
In August 2017, the Company issued 12,000
shares of common stock to Aspire Capital in exchange for services. The shares were valued at $27.50 per share which was
the trading price on date of issuance, and the value of the services were $330,000.
In November 2017, the Company issued 1,200
shares of common in exchange for services. The shares were valued at $28.75 per share which was the trading price on
date of issuance, and the value of the services were $34,500.
In January 2018, The Company issued 240
shares of common stock in exchange for services. The shares were valued at $16.25 per share which was the trading price
on date of issuance, and the value of the services were $3,900.
In January 2018, the Company issued 11,200
shares of common stock as compensation for the Board of Directors. The shares were valued at $18.75 per share which
was the trading price on date of issuance, and the value of the compensation was $210,000.
In February 2018, the Company issued 4,800 shares
of common stock in exchange for services. The shares were valued at $5.94 per share which was the trading price on date
of issuance, and the value of the services were $28,500.
In April 2018, the Company issued
2,400 shares of common in exchange for services. The shares were valued at $5.63 per share, and the value of the
services were $13,500. In April 2018, the Company issued 1,200 shares of common in exchange for services. The shares were
valued at $3.00 per share which was the trading price on date of issuance, and the value of the services were $3,600.
In May 2018, the Company issued
2,000 shares of common in exchange for services. The shares were valued at $2.25 per share which was the trading
price on date of issuance, and the value of the services were $4,500.
In May 2018, the Company issued
548 shares of common in exchange for services. The shares were valued at $12.50 per share which was the trading price on
date of issuance, and the value of the services were $6,850.
In June 2018, the Company issued
2,400 shares of common in exchange for services. The shares were valued at $3.13 per share which was the trading
price on date of issuance, and the value of the services were $7,500.
On January 2, 2019, the Company issued
11,200 shares of common stock as part of the annual board of director compensation. The share price on date of issuance
was $4.38 per share.
Issuance of Shares in Settlement of Debt
During the year ended June 30, 2019,
the Company settled $1,475,765 of debt and accrued compensation including $1,313,765 owed to related parties, by issuing 7,803
shares of common stock with a fair value of $1,150,135. See notes 5 and 6.
Issuance of Stock Options
In November 2017, the Company extended
the maturity date of stock options to acquire 6,400 shares at exercise prices ranging from $26.25 to $31.25
issued to the board of directors between November 2016 and December 2016 by 3 years. The Company recorded an incremental expense
of $79,491 based on the increase in fair value of the options.
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2019 and 2018
8.
|
Equity Transactions (continued)
|
In June 2018, 800 shares of
stock options were exercised for $2,000.
On October 1, 2018, the Company issued
stock options to purchase 800 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 $8.75 at any time from date of issuance and expire in 5
years from the date of issuance.
On October 13, 2018, the Company issued
stock options to purchase 800 shares of common stock as part of their annual board of director compensation. The stock
options were issued and are exercisable at $6.25 at any time from date of issuance and expire in 5 years from the date
of issuance.
On October 27, 2018, the Company issued
stock options to purchase 800 shares of common stock as part of their annual board of director compensation. The stock
options were issued and are exercisable at $6.25 at any time from date of issuance and expire in 5 years from the date
of issuance
On November 10, 2018, the Company issued
stock options to purchase 800 shares of common stock as part of their annual board of director compensation. The stock
options are exercisable at an exercise price of $6.25 at any time from date of issuance and expire in 5 years from the
date of issuance.
On January 19, 2019, the Company issued
stock options to purchase 800 shares of common stock to each of five key employees or consultants and two company directors
as part of his or her annual compensation, for an aggregate total of 5,600 stock options. The stock options are exercisable
at an exercise price of $3.125 at any time from date of issuance until 5 years from the date of issuance.
On March 11, 2019, the Company issued
stock options to purchase 8,000 shares of common stock to an investor relations (IR) consultant. The stock options were
issued and are exercisable at $6.25 at any time from date of issuance and expire in 5 years from the date of issuance.
Warrant Price Adjustment
In December 2017, the Company issued
warrants to purchase 20,000 shares of common stock in a private placement transaction for aggregate gross proceeds of $100,000.
The warrants were exercisable at an exercise price of $25.00 at any time from date of issuance until 7 years from the date
of issuance. The warrants have a down round feature that reduces the exercise price if the Company sells stock for a lower price.
In January 2018, the Company sold shares at $18.75, which therefore triggered the reduction in the strike price. The Company
calculated the difference in fair value of the warrants between the stated exercise price and the reduced exercise price and recorded
$20,995 as a deemed dividend. In July 2018, the Company sold shares at $1.88, which therefore triggered the reduction in
the strike price. The Company calculated the difference in fair value of the warrants between the stated exercise price and the
reduced exercise price and recorded $44,889 as a deemed dividend. The fair value of the warrants granted was estimated using the
Black Scholes Method.
In January and February 2018, the Company
issued warrants to purchase 1,680 shares of common stock in exchange for banking services which was recognized at fair
value. The warrants were exercisable at an exercise price of $18.75 at any time from date of issuance until 7 years from
the date of issuance. The warrants have a down round feature that reduces the exercise price if the Company sells stock for a
lower price. In July 2018, the Company sold shares at $1.88, which therefore triggered the reduction in the strike price.
The Company calculated the difference in fair value of the warrants between the stated exercise price and the reduced exercise
price and recorded $3,770 as a deemed dividend. The fair value of the warrants granted was estimated using the Black Scholes Method.
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2019 and 2018
8.
|
Equity Transactions (continued)
|
The following table summarizes
the warrants that have been issued:
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
Weighted
|
|
Average
|
|
Aggregate
|
|
|
Number of
|
|
Average
|
|
Remaining
|
|
Intrinsic
|
|
|
Shares
|
|
Exercise Price
|
|
Life (Years)
|
|
Value
|
Outstanding at June 30, 2017
|
|
|
49,391
|
|
|
$
|
62.50
|
|
|
|
0.5
|
|
|
|
|
|
Granted
|
|
|
28,802
|
|
|
$
|
27.50
|
|
|
|
5.3
|
|
|
|
|
|
Expired
|
|
|
(40,000
|
)
|
|
$
|
62.50
|
|
|
|
—
|
|
|
|
|
|
Outstanding at June 30, 2018
|
|
|
38,193
|
|
|
$
|
36.25
|
|
|
|
5.5
|
|
|
$
|
—
|
|
Granted
|
|
|
1,713,333
|
|
|
$
|
45.00
|
|
|
|
5.6
|
|
|
$
|
1,159,988
|
|
Expired
|
|
|
|
|
|
$
|
—
|
|
|
|
—
|
|
|
$
|
—
|
|
Exercised
|
|
|
(1,626,859
|
)
|
|
$
|
45.00
|
|
|
|
—
|
|
|
$
|
—
|
|
Outstanding and exercisable at June 30, 2019
|
|
|
124,667
|
|
|
$
|
45.00
|
|
|
|
5.6
|
|
|
$
|
1,202,678
|
|
Of the above warrants, 9,391
expire in fiscal year ending June 30, 2022, 4,815 expire in fiscal year ending June 30, 2023 and 110,461 expire
in fiscal year ended June 30, 2025.
Deferred income taxes reflect the net tax effects
of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts
used for income tax purposes.
At June 30, 2018, the Company has a Net Operating
Loss (“NOL”) carryforward of approximately $1,800,000. The NOL expires during the years 2032 to 2037. Realization of
any portion of the $832,186 of net deferred tax assets at June 30, 2018 is not considered more likely than not by management; accordingly,
a valuation allowance has been established for the full amount. The valuation allowance as of June 30, 2018 was $832,186. The change
in the valuation allowance from June 30, 2017 to June 30, 2018 amounted to $357,231.
At June 30, 2019, the Company had a Net Operating
Loss (“NOL”) carryforward of approximately $5,700,000. NOL’s generated prior to 2018 will expire during the years
2032 to 2037. Realization of any portion of the $1,680,613 deferred tax assets at June 30, 2019 is not considered more likely than
not by management; accordingly, a valuation allowance has been established for the full amount, which as of June 30, 2019 was $1,680,613.
The change in the valuation allowance during the year ended June 30, 2019 amounted to $848,427. The Company does not have any uncertain
tax positions or events leading to uncertainty in a tax position. The Company’s 2016, 2017 and 2018 Corporate Income Tax
Returns are subject to Internal Revenue Service examination.
On December 22, 2017, the Tax Cuts and Jobs
Act (the “Act”) was signed into law. The Act decreases the U.S. corporate federal income tax rate from a maximum of
35% to a flat 21% effective January 1, 2018. The Act also includes a number of other provisions including, among others, the elimination
of net operating loss carrybacks and limitations on the use of future losses, NOL’s generated in 2018 and later having an
indefinite life, the repeal of the Alternative Minimum Tax regime, and the repeal of the domestic production activities deduction.
The impact on the Company’s financial statements is immaterial, primarily because the Company has a valuation allowance on
deferred tax assets.
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2019 and 2018
9.
|
Income Taxes (continued)
|
Given the significant complexity of the Act
and anticipated additional implementation guidance from the Internal Revenue Service, further implications of the Act may be identified
in future periods.
Significant components of the Company’s
deferred tax assets are as follows:
|
|
June 30, 2019
|
|
June 30, 2018
|
Deferred tax assets:
|
|
|
|
|
|
|
|
|
Tax loss carryforward
|
|
$
|
1,624,887
|
|
|
$
|
555,064
|
|
Intangible assets
|
|
$
|
36,917
|
|
|
|
19,277
|
|
Stock based compensation
|
|
$
|
18,809
|
|
|
|
257,845
|
|
Valuation Allowance
|
|
$
|
(1,680,613
|
)
|
|
|
(832,186
|
)
|
Net deferred tax assets
|
|
$
|
—
|
|
|
$
|
—
|
|
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 June 30, 2019 and 2018. The
Company’s NOL carryover up to the date of the July 2018 financing will be subject to Section 382 usage limitations since
a greater than 50% ownership change took place from the financing event.
Reconciliation of the differences between income
tax benefit computed at the federal and state statutory tax rates and the provision for income tax benefit for the years ended
June 30, 2019 and 2018 is as follows:
|
|
2019
|
|
2018
|
|
|
|
|
|
Income tax expense (benefit) at federal statutory rate
|
|
|
21
|
%
|
|
|
34
|
%
|
State taxes, net of federal benefit
|
|
|
8
|
%
|
|
|
5
|
%
|
Change in valuation allowance
|
|
|
-29
|
%
|
|
|
-39
|
%
|
|
|
|
—
|
|
|
|
—
|
|
On September 24, 2019, BioVie Inc.,
a Nevada corporation (the “Company”), entered into a Securities Purchase Agreement (the “Purchase Agreement”)
with Acuitas Group Holdings, LLC (“Acuitas”) pursuant to which (i) Acuitas agreed to purchase a 10% OID Convertible
Delayed Draw Debenture (the “Debenture”) due September 20, 2020 in aggregate commitment amount of up to $2.0 million,
and (ii) the Company issued 1,125,000 shares (the “Commitment Shares”) of the Company’s Class A Common Stock
(the “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 Purchase Agreement. The Debentures accrue additional principal at the rate
of 6% per annum and interest at the rate of 10% per annum, are convertible into shares of Common Stock $4.00 per share or, subsequent
to the closing of the Company’s planned public offering of shares of Common Stock (the “Public Offering”) as
described in its Registration Statement on Form S-1 (File No. 333-231136), the lower of $4.00 or 80% of the offering price 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 and December 1,
2019 at the lower of $4.00 or 80% of the offering price to the public in the Public Offering. Upon entering into the Purchase Agreement, the Company drew
an initial $500,000 under the Debenture and in accordance with the Purchase Agreement, Acuitas received an additional 125,000
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.
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2019 and 2018
10.
|
Subsequent Events (continued)
|
Pursuant to the 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 purchase
option triggered on July 3, 2019 (any such purchase, 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 $11.25 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 2,679,916
shares of Common Stock and 2,679,916 warrants having the same terms as the Commitment Warrants to Acuitas, which is
currently expected with the closing of the Public Offering. In addition, the 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 equalling 60%.
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; 5,183,442 and 4,058,442 shares issued and outstanding at September 30, 2019 and June 30, 2019, respectively
|
|
|
518
|
|
|
|
406
|
|
Additional paid in capital
|
|
|
19,461,211
|
|
|
|
9,392,573
|
|
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
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
|
|
$
|
(5.06
|
)
|
|
$
|
(0.20
|
)
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF
|
|
|
|
|
|
|
|
|
COMMON SHARES OUTSTANDING - BASIC AND DILUTED
|
|
|
4,132,617
|
|
|
|
2,474,233
|
|
See accompanying notes to unaudited
condensed financial statements
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
|
|
|
—
|
|
|
$
|
—
|
|
|
|
788,026
|
|
|
$
|
79
|
|
|
$
|
4,880,246
|
|
|
$
|
(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
|
)
|
|
|
1,706,666
|
|
|
|
171
|
|
|
|
(171
|
)
|
|
|
—
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of shares in exchange for debt settlement
|
|
|
—
|
|
|
|
—
|
|
|
|
7,804
|
|
|
|
1
|
|
|
|
1,150,134
|
|
|
|
—
|
|
|
|
1,150,135
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock option compensation
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
3,412
|
|
|
|
—
|
|
|
|
3,412
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cashless exercise of warrants
|
|
|
—
|
|
|
|
—
|
|
|
|
17,935
|
|
|
|
2
|
|
|
|
(2
|
)
|
|
|
—
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deemed dividends for ratchet adjustment to warrants
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
48,659
|
|
|
|
(48,659
|
)
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(439,871
|
)
|
|
|
(439,871
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, September 30, 2018
|
|
|
—
|
|
|
$
|
—
|
|
|
|
2,520,431
|
|
|
$
|
253
|
|
|
$
|
9,282,278
|
|
|
$
|
(5,257,655
|
)
|
|
$
|
4,024,876
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance June 30, 2019
|
|
|
—
|
|
|
$
|
—
|
|
|
|
4,058,442
|
|
|
$
|
406
|
|
|
$
|
9,392,573
|
|
|
$
|
(7,262,072
|
)
|
|
$
|
2,130,907
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of commitment shares
|
|
|
—
|
|
|
|
—
|
|
|
|
1,125,000
|
|
|
|
112
|
|
|
|
10,068,638
|
|
|
|
—
|
|
|
|
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
|
|
|
—
|
|
|
$
|
—
|
|
|
|
5,183,442
|
|
|
$
|
518
|
|
|
$
|
19,461,211
|
|
|
$
|
(28,182,357
|
)
|
|
$
|
(8,720,628
|
)
|
See accompanying notes to unaudited
condensed financial statements
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
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.
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.
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
|
|
|
58,000
|
|
|
|
41,200
|
|
Warrants
|
|
|
1,374,667
|
|
|
|
1,731,533
|
|
Total
|
|
|
1,432,667
|
|
|
|
1,772,733
|
|
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.
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.
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
|
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 1,706,666 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 6,667 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 1,600,000 shares of common stock at a price per
share of $1.88, 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 1 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 1,606,667 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 $45.00 per share and, as a result
received an aggregate of 95% of the shares covered thereby, or 1,526,094 shares
of common stock;
|
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 $11.25 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 1,339,958 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 1,125,000 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 $4.00 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 $4.00 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 $4.00
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
125,000 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 1,125,000 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.
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 $11.25 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 2,679,916 shares of common stock and 2,679,916 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.)
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.
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 $8.95, exercise price of $4.00, 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 $8.73, exercise price of $4.00, 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 $4.00
per share prior to the completion of an offering or, subsequent to the closing of the offering, the lower of $4.00
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 $8.95, conversion price of
$4.00, 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 $8.73, conversion price of $4.00,
term of 1 year expiring September 2020, volatility of 75.5%, dividend yield of 0%, and risk-free interest rate of 1.75%.
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
|
|
|
58,000
|
|
|
$
|
12.50
|
|
|
|
5.2
|
|
|
$
|
87,480
|
|
Granted
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Options Exercised or Forfeited
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Outstanding at September 30, 2019
|
|
|
58,000
|
|
|
$
|
12.50
|
|
|
|
4.8
|
|
|
$
|
87,480
|
|
Exercisable at September 30, 2019
|
|
|
58,000
|
|
|
$
|
12.50
|
|
|
|
4.8
|
|
|
$
|
87,480
|
|
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
|
$
|
3.75
|
|
|
|
5,600
|
|
|
|
4.3
|
|
|
|
5,600
|
|
$
|
6.25
|
|
|
|
10,400
|
|
|
|
4.4
|
|
|
|
10,400
|
|
$
|
7.50
|
|
|
|
24,800
|
|
|
|
6.4
|
|
|
|
24,800
|
|
$
|
8.75
|
|
|
|
800
|
|
|
|
4.0
|
|
|
|
800
|
|
$
|
12.50
|
|
|
|
4,000
|
|
|
|
3.3
|
|
|
|
4,000
|
|
$
|
25.00
|
|
|
|
1,600
|
|
|
|
3.0
|
|
|
|
1,600
|
|
$
|
26.25
|
|
|
|
4,400
|
|
|
|
2.6
|
|
|
|
4,400
|
|
$
|
27.50
|
|
|
|
800
|
|
|
|
2.5
|
|
|
|
800
|
|
$
|
28.75
|
|
|
|
1,600
|
|
|
|
2.9
|
|
|
|
1,600
|
|
$
|
31.25
|
|
|
|
4,000
|
|
|
|
2.1
|
|
|
|
4,000
|
|
|
Total
|
|
|
|
58,000
|
|
|
|
|
|
|
|
58,000
|
|
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
|
|
|
124,667
|
|
|
$
|
45.00
|
|
|
|
5.6
|
|
|
$
|
716,653
|
|
Granted
|
|
|
1,250,000
|
|
|
$
|
3.75
|
|
|
|
5.0
|
|
|
$
|
5,906,250
|
|
Expired
|
|
|
—
|
|
|
$
|
—
|
|
|
|
—
|
|
|
$
|
—
|
|
Outstanding and exercisable at September 30, 2019
|
|
|
1,374,667
|
|
|
$
|
5.00
|
|
|
|
4.9
|
|
|
$
|
6,622,903
|
|
Of the above warrants, 9,391
expire in fiscal year ending June 30, 2022, 4,455 expire in fiscal year ending June 30, 2023, and 1,360,821 expire
in fiscal year ending June 30, 2025.
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.
BIOVIE INC.
Notes to Condensed Financial Statements
For the Three Months Ended September 30,
2019 and 2018
(unaudited)
On October 1, 2019, the Company issued
stock options to purchase 800 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 $8.75 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 800 shares of common stock as part of their annual board of director compensation. The stock
options were issued and are exercisable at $7.50 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.
Units
BioVie Inc.
ThinkEquity
a division of Fordham Financial Management,
Inc.
, 2019
Through
and including , 2019 (the 25th
day after the date of this offering), all dealers effecting transactions in these securities, whether
or not participating in this offering, may be required to deliver a prospectus. This is in addition to a dealer’s obligation
to deliver a prospectus when acting as an underwriter and with respect to an unsold allotment or subscription.
PART II – INFORMATION NOT REQUIRED
IN PROSPECTUS
Item 13. Other Expenses of Issuance and Distribution
The following table sets forth the expenses
in connection with this registration statement. All of such expenses are estimates, other than the filing fees payable to the Securities
and Exchange Commission and to FINRA.
|
|
Amount
to be paid
|
SEC registration fee
|
|
$
|
3,638.46
|
|
FINRA filing fee
|
|
$
|
5,567.19
|
|
The NASDAQ Capital Market initial listing fee
|
|
$
|
50,000
|
|
Transfer agent and registrar fees
|
|
$
|
20,000
|
|
Accounting fees and expenses
|
|
$
|
50,000
|
|
Legal fees and expenses
|
|
$
|
400,000
|
|
Blue sky qualification fees and expenses
|
|
$
|
15,000
|
|
Printing expenses
|
|
$
|
10,000
|
|
Miscellaneous expenses
|
|
$
|
70,794.35
|
|
Total
|
|
$
|
625,000
|
|
Item 14. Indemnification of Directors and Officers
We are a Nevada corporation and generally governed by the
Nevada Private Corporations Code, Title 78 of the Nevada Revised Statutes, or NRS.
Section 78.138 of the NRS provides that, unless the corporation’s
articles of incorporation provide otherwise, a director or officer will not be individually liable unless it is proven that (i)
the director’s or officer’s acts or omissions constituted a breach of his or her fiduciary duties, and (ii) such breach
involved intentional misconduct, fraud or a knowing violation of the law.
Section 78.7502 of the NRS permits a Nevada corporation to
indemnify its directors and officers against expenses, judgments, fines, and amounts paid in settlement actually and reasonably
incurred in connection with a threatened, pending, or completed action, suit, or proceeding, except an action by or on behalf of
the corporation, if the officer or director (i) is not liable pursuant to NRS 78.138, or (ii) acted in good faith and in a manner
the officer or director reasonably believed to be in or not opposed to the best interests of the corporation and, if a criminal
action or proceeding, had no reasonable cause to believe the conduct of the officer or director was unlawful. Section 78.7502 of
the NRS also requires a corporation to indemnify its officers and directors if they have been successful on the merits or otherwise
in defense of any claim, issue, or matter resulting from their service as a director or officer.
Section 78.751 of the NRS permits a Nevada corporation to
indemnify its officers and directors against expenses incurred by them in defending a civil or criminal action, suit, or proceeding
as they are incurred and in advance of final disposition thereof, upon determination by the stockholders, the disinterested board
members, or by independent legal counsel. Section 78.751 of NRS requires a corporation to advance expenses as incurred upon receipt
of an undertaking by or on behalf of the officer or director to repay the amount if it is ultimately determined by a court of competent
jurisdiction that such officer or director is not entitled to be indemnified by the corporation if so provided in the corporation’s
articles of incorporation, bylaws, or other agreement. Section 78.751 of the NRS further permits the corporation to grant its directors
and officers additional rights of indemnification under its articles of incorporation, bylaws or other agreement.
Section 78.752 of the NRS provides that a Nevada corporation
may purchase and maintain insurance or make other financial arrangements on behalf of any person who is or was a director, officer,
employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or
agent of another company, partnership, joint venture, trust or other enterprise, for any liability asserted against him and liability
and expenses incurred by him in his capacity as a director, officer, employee or agent, or arising out of his status as such, whether
or not the corporation has the authority to indemnify him against such liability and expenses.
Our Articles of Incorporation and bylaws implement the indemnification
and insurance provisions permitted by Chapter 78 of the NRS by providing that:
·
|
We shall indemnify our directors and officers to the fullest extent permitted by the NRS against expense, liability and loss reasonably incurred or suffered by them in connection with their service as an officer or director; and
|
|
·
|
We may purchase and maintain insurance, or make other financial arrangements, on behalf of any person who holds or who has held a position as a director, officer, or representative against liability, cost, payment, or expense incurred by such person.
|
At the present time, there is no pending litigation or proceeding
involving a director, officer, employee or other agent of ours in which indemnification would be required or permitted. We are
not aware of any threatened litigation or proceeding which may result in a claim for such indemnification.
Item 15. Recent Sales of Unregistered Securities
The Company has not sold any within the past three years
which were not registered under the Securities Act except as follows:
Acuitas Group Transaction
On July 3, 2018, the registrant,
entered into a Securities Purchase Agreement (the “Purchase Agreement”) with Acuitas Group Holdings, 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 Company’s newly created 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) the registrant agreed to issue associated warrants (the “Warrants”) to purchase
1,706,666 shares of the registrant’s Class A Common Stock (the “Common Stock”), each subject to the terms and
conditions set forth in the Purchase Agreement, for an aggregate consideration of $3.2 million. The registrant received $160,000
of the $3.2 million in April and May 2018 as prepaid equity. Acuitas also received an additional 6,667 Warrants in connection
with the payoff of a note issued by the registrant 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 1,600,000 shares of Common Stock at a price
per share of $1.88, and associated 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 the registrant had not obtained
$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.
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 the registrant’s 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 the registrant’s 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 the registrant’s Definitive Information that
was filed with the Securities and Exchange Commission.
Pursuant to a letter agreement dated June 24, 2019, Acuitas has agreed to modify its existing rights under the Purchase Agreement so that:
- Acuitas agreed to immediately
exchange its existing 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 $45.00 per share and, as a result received an aggregate of 95%
of the shares covered thereby, or 1,526,094 shares of common stock, on June 24, 2019;
- 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 $11.25 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 1,339,958 shares of common stock (the “Subsequent
Sale Shares”) to Acuitas, which is expected concurrently with the closing of this offering;
- 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. Assuming the closing of this
offering occurs on or prior to September 1, 2019, such option will terminate upon such closing. In the event such closing
occurs subsequent to September 1, 2019 and prior to November 30, 2019, we anticipate that Acuitas may elect to continue to fund
our on-going clinical trials and operations by means of exercising such Funding Option, with any shares so purchased being deducted
from the amount of Subsequent Sale Shares deliverable at closing as described above.
On September 24, 2019, the registrant
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 1,125,000 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 $4.00 per share
prior to the completion of the registrant’s planned public offering of units (the “Public Offering”) as described
in this Registration Statement on Form S-1 or, subsequent to the closing of the Public Offering, the lower of $4.00 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
at an amount equal to the lower of $4.00 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 125,000 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%.
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, 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 $11.25 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 2,679,916 shares of Common Stock and 2,679,916 warrants having the
same terms as the Commitment Warrants to Acuitas, which is currently expected with the closing of this public offering.
Pursuant to an amendment to the 2019 Purchase Agreement dated October 9, 2019, the Registrant and Acuitas have agreed to the following amendments
thereto:
·
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 Public Offering as described in this Registration Statement
at an exercise price equal to the par value of the Common Stock;
·
Acuitas has agreed to further modify its existing rights under the Purchase Agreement dated July 3, 2018 with the Company 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 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 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.
The issuance of the Preferred Stock, the Warrants
and the underlying common stock under the Purchase Agreement and the 2019 Purchase Agreement is exempt from registration under the
Securities Act of 1933, as amended (the “Securities Act”), pursuant to the exemption for transactions by an issuer
not involving any public offering under Section 4(a)(2) of the Securities Act. The exchange of the replacement warrants pursuant
to the amendment to the 2019 Purchase Agreement was made in reliance on Section 3(a)(9) of the Securities Act, which exempts any
security exchanged by the issuer with its existing security holders exclusively where no commission or other remuneration is paid
or given directly or indirectly for soliciting such exchange.
Aspire Capital Transaction
On January 4, 2017, the registrant entered into a Common
Stock Purchase Agreement, or the Purchase Agreement, with Aspire Capital Fund, LLC, an Illinois limited liability company, or Aspire
Capital, which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is
committed to purchase up to an aggregate of $12.0 million of shares of the registrant’s common stock (the “Purchase
Shares”) over the 30-month term of the Purchase Agreement.
Upon execution of the Purchase Agreement,
the registrant issued 19,200 shares of its common stock to Aspire Capital in consideration for entering into the Purchase Agreement,
and sold an additional 8,000 shares and warrants relating to 4,000 shares for aggregate proceeds of $200,000. The Purchase Shares
may be sold by the registrant to Aspire Capital on any business day the registrant selects in two ways: (1) through a regular
purchase of up to 800 shares at a known price based on the market price of our common stock prior to the time of each sale, and
(2) through a VWAP purchase on the terms and conditions set forth in the Purchase Agreement.
The issuance of the 19,200 Commitment
Shares, 8,000 Initial Purchase Shares and all other shares of common stock that may be issued from time to time to Aspire Capital
under the Purchase Agreement is exempt from registration under the Securities Act of 1933, as amended (the “Securities Act”),
pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities
Act.
Aspire Capital Transaction
In the second quarter of the registrant’s
fiscal year ending June 30, 2017, the registrant sold 4,600 shares to a number of accredited investors for $25.00 per share, for
aggregate gross proceeds of $115,000. The registrant also issued warrants to purchase 2,300 shares to such investors, which warrants
expire five years following issuance and are exercisable for $62.50 per share. Mr. James Lang, who joined the registrant’s Board
of Directors on December 7, 2016, purchased 2,000 shares and received warrants to purchase 1,000 shares on November 11, 2016.
The issuance of the shares and warrants to the accredited
investors was exempt from registration under the Securities Act pursuant to Rule 506(b) of Regulation D under the Securities Act.
Item 16. Exhibits
The following is a list of exhibits filed as a part of this
registration statement:
Exhibit
Number
|
|
Description of Document
|
1.1
|
|
Form of Underwriting Agreement.*
|
2.1
|
|
Agreement and Plan of Merger, dated April 11, 2016, among the Company, LAT Acquisition Corp and LAT Pharma, LLC (incorporated by reference to Exhibit 2.1 the Company’s Current Report on Form 8-K filed on April 15, 2016).
|
3.1
|
|
Articles of Incorporation of the Company as filed with the Secretary of State of Nevada (incorporated by reference to Exhibit 3.1 to the Company’s registration statement on Form S-1 filed on August 15, 2013, File No. 333-190635).
|
3.2
|
|
Certificate of Amendment to Articles of Incorporation (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on July 22, 2016).
|
3.3
|
|
Certificate of Amendment to Articles of Incorporation (incorporated by reference to Appendix A to the Company’s Information Statement on Schedule 14C filed on July 13, 2018).
|
3.4
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on July 3, 2018).
|
3.5
|
|
Bylaws of the Company (incorporated by reference to Exhibit 3.2 to the Company’s registration statement on Form S-1 filed on August 15, 2013, File No. 333-190635).
|
3.6
|
|
Certificate of Amendment to Articles of Incorporation
|
4.1
|
|
Specimen Certificate representing shares of Class A Common Stock.*
|
4.2
|
|
Form of Warrant (incorporated by reference to Exhibit 4.1 to the Company's Current Report on Form 8-K filed on October 9, 2019).
|
4.3
|
|
Form
of 10% OID Convertible Delayed Draw Debenture (incorporated by reference to Exhibit 4.1 the Company’s Current Report
on Form 8-K filed on September 25, 2019).
|
4.4
|
|
Warrant Agency Agreement and Form of Warrant offered hereby.*
|
5.1
|
|
Opinion of Loeb & Loeb LLP. *
|
10.1
|
|
Common Stock Purchase Agreement, dated January 4, 2017, between the Company and Aspire Capital Fund, LLC (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on January 5, 2017).
|
10.2
|
|
Securities
Purchase Agreement, dated as of July 3, 2018, by and among BioVie Inc., Acuitas Group Holdings, LLC and the Purchasers
identified therein (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed
on July 3, 2018).
|
10.3
|
|
Employment Agreement between Jonathan Adams and the Company dated, April 11, 2016.*
|
10.4
|
|
Amendment No. 1 to Employment Agreement between Jonathan Adams and the Company dated July 3, 2018.*
|
10.5
|
|
Letter Agreement between Acuitas Group Holdings, LLC and the Company dated June 24, 2019. *
|
10.6
|
|
BioVie Inc.2019 Omnibus Equity Incentive Plan (incorporated by reference to Appendix D to the Definitive Information Statement on Schedule 14C, filed on May 8, 2019).
|
10.7
|
|
Securities
Purchase Agreement dated as of September 24, 2019 by and among BioVie Inc. and Acuitas Group Holdings, LLC (incorporated by
reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on September 25, 2019).
|
10.8
|
|
Amendment to Securities Purchase Agreement, dated
as of October 9, 2019, by and between the Company and Acuitas Group Holdings, LLC (incorporated by reference to Exhibit 10.1
to the Company's Current Report on Form 8-K filed on October 9, 2019)
|
14.1
|
|
Code of Conduct and Ethics of BioVie Inc. *
|
23.1
|
|
Consent of D. Brooks and Associates CPA’s, P.A., Independent Registered Public Accounting Firm.
|
23.2
|
|
Consent of Loeb & Loeb LLP. *
|
23.3
|
|
Consent of EisnerAmper LLP, Independent Registered Public Accounting Firm.
|
24.1
|
|
Powers of Attorney (included on signature page to this registration statement). *
|
Undertakings
The undersigned registrant hereby undertakes:
1. For purposes of determining any liability
under the Securities Act of 1933, as amended (the “Securities Act”) the information omitted from the form of prospectus
filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the
registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration
statement as of the time it was declared effective.
2. For the purpose of determining any
liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new
registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed
to be the initial bona fide offering thereof.
3. To provide to the underwriters at
the closing specified in the underwriting agreement certificates in such denominations and registered in such names as required
by the underwriters to permit prompt delivery to each purchaser.
Insofar as indemnification for liabilities
arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to
the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission
such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event
that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid
by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is
asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will,
unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction
the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed
by the final adjudication of such issue.
Signatures
Pursuant to the requirements of the
Securities Act of 1933, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned,
thereunto duly authorized, in the City of Los Angeles, State of California, on November 22, 2019.
|
BIOVIE INC.
|
|
|
|
|
By:
|
/s/ Terren Peizer
|
|
|
Name:
|
Terren Peizer
|
|
|
Title:
|
Chairman and Chief Executive Officer
|
Pursuant to the requirements of the
Securities Act of 1933, this registration statement has been signed below by the following persons in the capacities and on the
dates indicated.
Person
|
|
Capacity
|
|
Date
|
|
|
|
|
|
/s/ Terren Peizer
|
|
Chairman and Chief
Executive Officer
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November 22, 2019
|
Terren Peizer
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|
(Principal Executive Officer)
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|
/s/ Joanne Wendy
Kim
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|
Chief Financial Officer and Corporate Secretary
|
|
November 22, 2019
|
Joanne Wendy Kim
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(Principal Financial Officer)
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|
/s/ Jonathan Adams
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|
President, Chief
Operating Officer and Director
|
|
November 22, 2019
|
Jonathan Adams
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|
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*
|
|
Director
|
|
November 22, 2019
|
Cuong Do
|
|
|
|
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|
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|
*
|
|
Director
|
|
November 22, 2019
|
Jim Lang
|
|
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*
|
|
Director
|
|
November 22, 2019
|
Hari Kumar
|
|
|
|
|
|
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|
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*
|
|
Director
|
|
November 22, 2019
|
Michael Sherman
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|
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*
|
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Director
|
|
November 22, 2019
|
Richard J. Berman
|
|
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*By: /s/ Terren Peizer
|
|
Attorney-in-fact
|
|
November 22, 2019
|
Terren Peizer
|
|
|
|
|
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|
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