Filed
Pursuant to Rule 424(b)(5)
Registration
No. 333-252386
PROSPECTUS
SUPPLEMENT
(To
the Prospectus Dated February 2, 2021)
Up
to $17,500,000
Common Stock
We
have entered into a Controlled Equity OfferingSM Sales Agreement (the “Sales Agreement”), with Cantor Fitzgerald
& Co. (“Cantor”) and B. Riley Securities, Inc. (“B. Riley Securities”), relating to shares of our Class A
common stock (“common stock”) offered by this prospectus supplement and the accompanying prospectus. In accordance with the
terms of the Sales Agreement, we may offer and sell shares of our common stock having an aggregate offering price of up to $17,500,000
from time to time through or to Cantor and B. Riley Securities, acting as our sales agents or principals (collectively, the “Sales
Agents”), pursuant to this prospectus supplement and the accompanying prospectus.
Our
common stock is listed on the Nasdaq Capital Market (the “Nasdaq”) under the symbol “BIVI.” On December 12,
2022, the last reported sale price of our common stock was $9.51 per share.
On
September 30, 2022, we filed a prospectus supplement indicating that we were, at that time, subject to General Instruction I.B.6 of Form
S-3, which limited the amount that we were able sell under the registration statement of which the Prospectus forms a part. As of December
12, 2022, the aggregate market value of our outstanding common stock held by non-affiliates was approximately $85.3 million based upon
32,477,397 shares of outstanding common stock of which 8,971,929 shares are held by non-affiliates, and the last reported sale price
of our common stock of $9.51 per share on December 12, 2022. As a result, our public float has increased above $75.0 million and we are
no longer subject to the limitations contained in General Instruction I.B.6. of Form S-3 as of the date of this prospectus supplement.
If we become subject to the offering limits in General Instruction I.B.6 of Form S-3 in the future, we will file another prospectus supplement.
Sales
of our common stock, if any, under this prospectus supplement and the accompanying prospectus may be made in sales deemed to be an “at
the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the “Securities
Act”). Each of the Sales Agents will use its commercially reasonable efforts to sell on our behalf all the shares of common stock
requested to be sold by us, consistent with its normal trading and sales practices, on mutually agreed terms between such Sales Agent
and us. There is no arrangement for funds to be received in any escrow, trust or similar arrangement. We provide more information about
how the shares of common stock will be sold in the section entitled “Plan of Distribution.”
The
Sales Agents will receive from us in the aggregate a fixed commission of 3.0% of the gross proceeds of any shares of common stock sold
through them under the Sales Agreement. In connection with the sale of our common stock on our behalf, the Sales Agents will be deemed
to be “underwriters” within the meaning of the Securities Act and the compensation of the Sales Agents will be deemed to
be underwriting commissions or discounts. We have also agreed to provide indemnification and contribution to the Sales Agents with respect
to certain liabilities, including liabilities under the Securities Act.
Investing
in our common stock involves a high degree of risk. Before buying any common stock, you should review carefully the risks and
uncertainties described under the heading “Risk Factors” beginning on page S-3 of this prospectus supplement, page 4 of
the accompanying prospectus, and in the documents incorporated by reference into this prospectus supplement and the accompanying
prospectus.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined
if this prospectus supplement or the accompanying prospectus is truthful or complete. Any representation to the contrary is a criminal
offense.
| Cantor |
B.
Riley Securities |
| |
The
date of this prospectus supplement is December 14, 2022
TABLE
OF CONTENTS
ABOUT
THIS PROSPECTUS SUPPLEMENT
This
prospectus supplement is a supplement to the accompanying prospectus. This prospectus supplement and the accompanying prospectus are
parts of a registration statement that we filed with the SEC using a shelf registration process. Under this shelf registration process,
we may sell from time to time an unspecified amount of any combination of securities described in the accompanying prospectus in one
or more offers such as this offering. The accompanying prospectus provides you with a general description of the securities we may offer,
some of which may not apply to this offering. This prospectus supplement provides you with specific information about the common stock
we are offering. Both this prospectus supplement and the accompanying prospectus include important information about us and other information
you should know before investing. Generally, when we refer only to the “prospectus,” we are referring to both parts combined,
and when we refer to the “accompanying prospectus” we are referring to the accompanying prospectus.
This
prospectus supplement also adds to, updates and changes information contained in the accompanying prospectus. To the extent the information
in this prospectus supplement is different from that in the accompanying prospectus, you should rely on the information in this prospectus
supplement. You should read both this prospectus supplement and the accompanying prospectus, together with the additional information
described under the caption “Incorporation of Certain Information by Reference” in this prospectus supplement and the accompanying
prospectus, before investing in the common stock.
You
should rely only on the information contained or incorporated by reference in this prospectus supplement, the accompanying prospectus,
the documents incorporated by reference herein and any free writing prospectus we provide you. We have not, and the Sales Agents have
not, authorized anyone to provide you with different information. If anyone provides you with different or inconsistent information,
you should not rely on it. We are not, and the Sales Agents are not, making an offer to sell these securities in any jurisdiction where
the offer or sale is not permitted. You should assume that the information appearing in this prospectus supplement, the accompanying
prospectus, the documents incorporated by reference herein and any free writing prospectus we provide to you is accurate only as of the
date on those respective documents. Our business, financial condition, results of operations and prospects may have changed since those
dates. You should read this prospectus supplement and the accompanying prospectus, including the documents incorporated by reference
herein and therein, when making your investment decision. The distribution of this prospectus supplement and the accompanying prospectus
and the offering of the common stock in certain jurisdictions may be restricted by law. Persons outside the United States, or the U.S.,
who come into possession of this prospectus supplement and the accompanying prospectus must inform themselves about, and observe any
restrictions relating to, the offering of the common stock and the distribution of this prospectus supplement and the accompanying prospectus
outside the U.S. This prospectus supplement and the accompanying prospectus does not constitute, and may not be used in connection with,
an offer to sell, or a solicitation of an offer to buy, any securities offered by this prospectus supplement and the accompanying prospectus
by any person in any jurisdiction in which it is unlawful for such person to make such an offer or solicitation.
WHERE
YOU CAN FIND MORE INFORMATION
This
prospectus supplement does not contain all of the information in the registration statement. We have omitted from this prospectus supplement
some parts of the registration statement as permitted by the rules and regulations of the SEC. Statements in this prospectus supplement
concerning any document we have filed as an exhibit to the registration statement or that we otherwise filed with the SEC are not intended
to be comprehensive and are qualified in their entirety by reference to these filings. In addition, we file annual, quarterly and current
reports, proxy statements and other information with the SEC. The SEC maintains an Internet site that contains reports, proxy and information
statements and other information that we file electronically with the SEC, including us. The SEC’s Internet site can be found at
http://www.sec.gov. In addition, we make available on or through our Internet site copies of these reports as soon as reasonably practicable
after we electronically file or furnished them to the SEC. Our Internet site can be found at https://www.bioviepharma.com. Our website
is not a part of this prospectus supplement.
INFORMATION
INCORPORATED BY REFERENCE
We
have elected to incorporate certain information by reference into this prospectus supplement. By incorporating by reference, we can disclose
important information to you by referring you to other documents we have filed or will file with the SEC. The information incorporated
by reference is deemed to be part of this prospectus supplement and the accompanying prospectus, except for information incorporated
by reference that is superseded by information contained in this prospectus supplement. This means that you must look at all of the SEC
filings that we incorporate by reference to determine if any statements in the prospectus supplement, accompanying prospectus or any
document previously incorporated by reference have been modified or superseded. This prospectus supplement incorporates by reference
the documents set forth below that we have previously filed with the SEC under the Securities Exchange Act of 1934, as amended (the “Exchange
Act”):
| ● | our
Annual Report on Form 10-K for the fiscal year ended June 30, 2022 filed with the SEC on September 27, 2022 (the “2022 Form 10-K”); |
| ● | the information
specifically incorporated by reference into the 2022 10-K from our definitive proxy statement on Schedule 14A relating to our 2022
Annual Meeting of Stockholders, filed with the SEC on September 30, 2022; |
| | ● | the description of our common stock contained in our Registration Statement on Form 8-A12B, filed with the SEC on
August 25, 2020, including any amendment or report filed for the purpose of updating such description; |
| ● | our
quarterly reports on Form 10-Q for the fiscal quarters ended September 30, 2022, filed with the
SEC on November 4, 2022 |
| ● | our
current reports on Form 8-K filed with the SEC on July 15, 2022 (as subsequently
amended on Form 8-K/A on July 18, 2022), August 31, 2022, September 7, 2022 (as subsequently amended on 8-K/A on September 7, 2022), October 5, 2022, November
10, 2022, December 6, 2022 (both filed on such date) and December 7, 2022; and |
| ● | the
description of our securities registered pursuant to Section 12 of the Securities Exchange Act of 1934, as amended, filed as Ex. 4.4
of the 2022 10-K. |
All
documents subsequently filed by BioVie Inc. with the SEC pursuant to Sections 13(a), 13(c), 14 and 15(d) of the Exchange Act prior to
the termination of the offering (except in each case the information contained in such document to the extent “furnish” and
not “filed”) shall be deemed to be incorporated by reference herein and to be a part hereof from the date of filing of such
documents.
Any
statement contained in a document incorporated or deemed to be incorporated by reference herein shall be deemed to be modified or superseded
for purposes of this prospectus supplement to the extent that a statement contained herein, or in any other subsequently filed document
which also is incorporated or deemed to be incorporated by reference herein, modifies or supersedes such statement. Any such statement
so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this prospectus supplement.
To
obtain copies of documents incorporated by reference herein or in the accompanying prospectus, see “Where You Can Find More Information”
in the accompanying prospectus. In addition, upon written or oral request, we will provide to any person, at no cost to such person,
including any beneficial owner to whom a copy of this prospectus supplement is delivered, a copy of any or all of the information that
has been incorporated by reference in this prospectus supplement or the accompanying prospectus. You may make such a request by writing
or telephoning us at the following address or telephone number:
BioVie
Inc.
680 W Nye Lane, Suite 201
Carson City, NV 89703
Tel: (775) 888-3162
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus supplement, the accompanying prospectus and the documents incorporated by reference herein and therein contain forward-looking
statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended (the “Securities Act”), and Section
21E of the U.S. Securities Exchange Act of 1934, as amended (the “Exchange Act”), that involve substantial risks and uncertainties.
Such forward-looking statements concern our anticipated results and progress of our operations in future periods, planned exploration
and, if warranted, development of our properties, plans related to our business and other matters that may occur in the future. These
statements relate to analyses and other information that are based on forecasts of future results, estimates of amounts not yet determinable
and assumptions of management. All statements contained herein that are not clearly historical in nature are forward-looking, and the
words “anticipate,” “believe,” “expect,” “estimate,” “may,” “will,”
“could,” “leading,” “intend,” “contemplate,” “shall” and similar expressions
are generally intended to identify forward-looking statements. Forward-looking statements are subject to a variety of known and unknown
risks, uncertainties and other factors which could cause actual events or results to differ from those expressed or implied by the forward-looking
statements. Forward-looking statements in this prospectus supplement, the accompanying prospectus and the documents incorporated by reference
herein and therein include, but are not limited to, statements with respect 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;
-
our lack of sales and marketing personnel;
-
regulatory, competitive and contractual risks;
-
no assurance that our product candidates will obtain regulatory approval or that the results of clinical studies will be favorable;
-
risks related to our intellectual property rights;
-
the volatility of the market price and trading volume in our common stock;
-
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 and in the documents incorporated by reference herein under the caption “Risk Factors.”
You
should not place undue reliance on forward-looking statements, which speak only as of the date that they were made. Moreover, you should
consider these cautionary statements in connection with any written or oral forward-looking statements that we may issue in the future.
We do not undertake any obligation to release publicly any revisions to forward-looking statements after completion of this offering
to reflect later events or circumstances or to reflect the occurrence of unanticipated events. In light of the risks and uncertainties
described above, the forward-looking events and circumstances discussed in this prospectus supplement and the documents incorporated
by reference might not occur, and are not guarantees of future performance.
PROSPECTUS
SUPPLEMENT SUMMARY
The
following summary highlights information contained elsewhere in this prospectus supplement or the documents incorporated by reference
herein. This summary is not complete and does not contain all of the information you should consider before investing in our securities.
You should read the entire prospectus supplement and the accompanying prospectus, including each of the documents incorporated by reference
herein or therein, carefully, including the “Risk Factors” and “Forward-Looking Information” sections of this
prospectus supplement, and “Risk Factors” in our 2021 Form 10-K, as such risk factors may be amended, updated or modified
periodically in our quarterly reports filed on Form 10-Q with the SEC, and any amendment or update thereto reflected in subsequent filings
with the SEC and incorporated herein by reference.
Overview
BioVie
Inc. (the “Company” or “we” or “our”) is a clinical-stage company developing innovative drug therapies
to treat chronic debilitating conditions including liver disease and neurological and neuro-degenerative disorders and certain cancers.
In
neurodegenerative disease, we acquired the biopharmaceutical assets of NeurMedix, Inc. (“NeurMedix”), a related
party privately held clinical-stage pharmaceutical company and related party affiliate, in June 2021. The acquired assets
include NE3107, a potentially selective inhibitor of inflammatory ERK signaling that, based on animal studies, it may reduce
neuroinflammation. NE3107 is a novel, orally administered small molecule that is thought to inhibit inflammation-driven insulin
resistance and major pathological inflammatory cascades with a novel mechanism of action. There is emerging scientific consensus
that both inflammation and insulin resistance may play fundamental roles in the development of Alzheimer’s and
Parkinson’s disease, and NE3107 could, if approved, represent an entirely new medical approach to treating these devastating
conditions affecting an estimated 6 million Americans suffering from Alzheimer’s and 1 million from Parkinson’s. The FDA
has authorized a potentially pivotal Phase 3 randomized, double-blind, placebo-controlled, parallel group, multicenter study to
evaluate NE3107 in subjects who have mild to moderate Alzheimer’s disease (NCT04669028). We initiated this trial on August 5,
2021 and are targeting primary completion in Q3 of calendar year 2023.
On
January 20, 2022, the Company initiated a study by treating the first patient, in its Phase 2 study assessing NE3107’s safety and
tolerability and potential pro-motoric impact in Parkinson’s disease patients (the “PD Trial”). The NM201 study (NCT05083260) is a double-blind,
placebo-controlled, safety, tolerability, and pharmacokinetics study in Parkinson’s disease (PD). Participants will be treated
with carbidopa/levodopa and NE3107 or placebo. Forty patients with a defined PD medication “off state” will be randomized
1:1 placebo to active NE3107 20 mg twice daily for 28 days. Safety assessments will look at standard measures of patient health and potential
for drug-drug interactions affecting L-dopa pharmacokinetics and activity. Exploratory efficacy assessments will use the Motor Disease
Society Unified Parkinson’s Disease Rating (MDS-UPDRS) parts 1-3, ON/OFF Diary, and Non-Motor Symptom Scale.
In
liver disease, our Orphan Drug candidate BIV201 (continuous infusion terlipressin) is being developed as a future treatment option
for patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by NASH, hepatitis, and
alcoholism. The initial target for BIV201 therapy is refractory ascites. These patients suffer from frequent life-threatening complications,
generate more than $5 billion in annual treatment costs, and have an estimated 50% mortality rate within 6 to 12 months. The US Food
and Drug Administration (FDA) has not approved any drug to treat refractory ascites. A Phase 2a clinical trial of BIV201 was completed
in 2019, and a multi-center, randomized 30-patient Phase 2b trial is currently underway. Top-line results from this trial are expected
in mid-calendar year 2023.
The BIV201 development program was initiated
by 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. 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.
Recent Developments
Trial Results
On December 5, 2022, the Company issued a press release announcing positive results from the PD Trial as well as
positive results from the investigator-sponsored exploratory biomarker and imaging Phase 2 trial of NE3107 (the “AD Trial”)
for treatment of Alzheimer’s Disease (“AD”).
PD Trial
The
NM201 study (NCT05083260) is a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in PD participants
treated with carbidopa/levodopa and NE3107. 45 patients with a defined L-dopa “off state” were randomized 1:1 to placebo:NE3107
20 mg twice daily for 28 days. This trial was launched with two design objectives: 1) the primary objectives are safety and a drug-drug
interaction study as requested by the FDA to demonstrate the absence of adverse interactions of NE3107 with levodopa; and 2) the secondary
objective is to determine if preclinical indications of pro-motoric activity and apparent enhancement of levodopa activity can be seen
in humans. Both objectives were met.
The
results of the PD Trial showed:
| ● | Patients treated with the combination of NE3107 and levodopa saw improvements in their UPDRS Part 3 (motor) score that is 3+ points superior
to patients treated with levodopa alone. |
| | ● | Patients younger than 70 years old treated with NE3107 and levodopa experienced roughly 6 points
superiority compared to those treated with levodopa alone, suggesting that younger patients with less advanced disease progression may
experience greater impact from treatment with NE3107. |
| | ● | 88.9% of patients <70 years old treated with NE3107 and levodopa experienced greater than 30%
part 3 score improvements from baseline at the 2-hour mark compared to 63.6% of patients treated with levodopa alone. |
| | ● | There were no drug-related adverse events. |
AD Trial
The AD Trial— A Phase II Open-Label Study for
the Use of Anti-Inflammatory, Insulin-Sensitizing NE3107 for Treatment of Cognitive Decline Due to Degenerative Dementias (NCT05227820)
— was an exploratory biomarker study conducted by Dr. Sheldon Jordan, who served as principal investigator for the trial. The trial
explored NE3107’s potential role in real-world clinical practice as an exploratory precursor informing the design of subsequent
placebo-controlled blinded studies.
The trial enrolled a total of 23 patients – 18
patients with Mini-Mental State Examination (MMSE) scores greater than or equal to 20 (i.e., mild cognitive impairment [MCI] to mild AD)
and 5 patients with MMSE <20 (i.e., moderate AD) – in an open-label, single arm study. The trial measured changes in cognition
through verbal and visual test procedures, changes in biomarkers of Alzheimer’s disease and inflammation that can be measured in
cerebral spinal fluid (CSF) and serum samples, and with functional magnetic resonance imaging techniques in patients, before and after
treatment with 20 mg of NE3107 twice daily for 3 months.
The results of the AD Trial showed:
| | ● | Patients treated with NE3107 experienced enhanced cognition as measured by multiple assessment
tools, including a 2.1 points improvement on the modified ADAS-Cog12 scale (p=0.0173) among MCI and mild Alzheimer’s Disease (AD)
patients. |
| | ● | NE3107 reduces CSF phospho-tau levels by -1.66 pg/mL (p=0.0343) and the ratio of p-tau to Ab42
by -0.0024 (p=0.0401). |
| | ● | 18 of 22 patients with abnormal baseline scans showed improvement in one or more brain regions
as seen from advanced functional MRI studies. |
| | ● | No drug-related adverse events were observed. |
On December 6, 2022, the Company announced that, as
part of the study, blood samples were taken from the patients who participated in the Alzheimer’s Phase 2 trial before and after
3 months of treatment with NE3107, and these samples were analyzed to assess NE3107’s potential to reduce inflammation and alter
DNA methylation associated with epigenetic biological clocks. The resulting data for patients treated with NE3107 for three months showed
a reduction of 3.3 years (p=0.0021) on the Horvath DNA methylation SkinBlood clock. Furthermore, 19 out of the 22 patients experienced
this reduction in the SkinBlood clock score. The finding that NE3107 affects the SkinBlood clock provides an impetus for the Company
to explore further the relationship between NE3107 decreasing epigenetic age and improving neurodegeneration and other inflammation-driven
diseases.
Corporate
Information
Our
principal executive offices are located at 680 W Nye Lane, Suite 201, Carson City, Nevada 89703, and our telephone number at that location
is (775) 888-3162. Our website address is www.bioviepharma.com. The information on our website is for informational purposes only
and should not be relied on for investment purposes. The information on our website is not incorporated by reference into either this
prospectus supplement or the accompanying prospectus and should not be considered part of this or any other report filed with the SEC.
Our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, together with amendments
to these reports, are available on the "Investor Relations" section of our website, free of charge, as soon as reasonably practicable
after such material is electronically filed with, or furnished to, the U.S. Securities and Exchange Commission (“SEC”).
THE
OFFERING
| Common
stock offered by us |
Shares
of our common stock having an aggregate offering price of up to $17,500,000. |
| |
|
| Common
stock to be outstanding after this offering |
Up
to 34,317,565 shares of common stock (as more fully described in the notes following this table), assuming sales of 1,840,168 shares
of our common stock in this offering at an offering price of $9.51 per share, which was the last reported sale price of our common
stock on the Nasdaq Capital Market on December 12, 2022. The actual number of shares issued will vary depending on the sales prices
at which shares are sold pursuant to this offering. |
| |
|
| Plan
of distribution |
“At
the market offering” that may be made from time to time through or to our sales agents, Cantor and B. Riley Securities. See the
section entitled “Plan of Distribution” on page S-9 of this prospectus supplement. |
| |
|
| Use
of proceeds |
We
intend to use the net proceeds from the offering, if any, for general corporate purposes. See “Use of Proceeds”
on page S-6 of this prospectus supplement. |
| |
|
| Listing |
Our
common stock is listed on Nasdaq under the symbol “BIVI.” |
| |
|
| Risk
Factors |
Before
deciding to invest in our common stock, you should carefully review “Risk Factors” in our 2021 Form 10-K and our quarterly
reports filed on Form 10-Q, and any amendment or update thereto reflected in subsequent filings with the SEC, which are incorporated
by reference herein as well as “Risk Factors” in this prospectus supplement and other information included and incorporated
by reference in this prospectus supplement and the accompanying prospectus. |
The
number of shares of common stock to be outstanding after this offering is based on 30,165,319 shares of common stock outstanding as of
September 30, 2022 and excludes the following:
| |
● |
3,348,330 shares of common stock issuable upon the exercise of outstanding stock options as of September 30, 2022 at a weighted average
exercise price of $7.40 per share; |
| |
● |
7,779,194 shares of common stock issuable upon the exercise of outstanding and exercisable warrants as of September 30, 2022 at a weighted
average exercise price of $2.07 per share; |
| |
● |
205,000 shares of common stock issuable upon the exercise of outstanding stock options issued under our equity incentive plan subsequent
to September 30, 2022, at a weighted average exercise price of $6.08 per share; |
| |
● |
537,612 shares of common stock issuable upon
vesting of restricted stock units issued under our equity incentive plan subsequent to September 30, 2022 and |
| |
● |
2,311,857 shares of common stock issued in the
ATM offerings subsequent to September 30, 2022. |
RISK
FACTORS
Investing
in our common stock involves risks. In consultation with your own financial and legal advisors, you should consider carefully, among
other matters, the supplemental risk factors set forth below as well as the risk factors discussed under the caption “Risk Factors”
in our 2021 Form 10-K, as such risks may be amended, updated or modified periodically in our quarterly reports on Form 10-Q filed with
the SEC, and any amendment or update thereto reflected in subsequent filings with the SEC, which are incorporated herein by reference,
before deciding whether an investment in the common stock is suitable for you. See “Incorporation of Certain Information by Reference”
in this prospectus supplement and in the accompanying prospectus. The risks and uncertainties described below and in our 2021 Form 10-K,
quarterly reports on Form 10-Q, and any amendment or update thereto reflected in subsequent filings with the SEC are not the only risks
and uncertainties that we face. Additional risks and uncertainties that are unknown to us or that we currently think are immaterial also
may impair our business operations or the market price of the common stock. This prospectus supplement and the accompanying prospectus
also contain forward-looking statements that involve risks. Our actual results could differ materially from those anticipated in these
forward-looking statements as a result of certain factors, including risks described in this prospectus supplement, the accompanying
prospectus and the documents incorporated by reference herein and therein.
Risks
Related to This Offering
We
will have broad discretion in the use of the net proceeds from this offering and may not use them effectively.
We
currently intend to use the net proceeds from this offering, if any, for general corporate purposes, as further described in the section
of this prospectus supplement entitled “Use of Proceeds”. We will have broad discretion in the application of the net proceeds
in the category of general corporate purposes and investors will be relying on the judgment of our management regarding the application
of the proceeds of this offering.
The
precise amount and timing of the application of these proceeds will depend upon a number of factors, such as the timing and progress
of our product development and commercialization efforts, our funding requirements and the availability and costs of other funds. As
of the date of this prospectus supplement, we cannot specify with certainty all of the particular uses for the net proceeds to us from
this offering. Depending on the outcome of our efforts and other unforeseen events, our plans and priorities may change and we may apply
the net proceeds of this offering, if any, in different manners than we currently anticipated.
The
failure by our management to apply these funds effectively could harm our business, financial condition and results of operations. Pending
their use, we may invest the net proceeds from this offering, if any, in short-term, interest-bearing instruments. These investments
may not yield a favorable return to our stockholders.
You
may experience immediate and substantial dilution.
The
offering price per share in this offering may exceed the pro forma as adjusted net tangible book value per share of our common stock
outstanding prior to this offering. Assuming that an aggregate of 1,840,168 shares of our common stock are sold during the term of the
Sales Agreement with the Sales Agents at a price of $9.51 per share, the last reported sale price of our common stock on the Nasdaq Capital
Market on December 12, 2022, for aggregate gross proceeds of approximately $17,500,000, after deducting commissions and estimated aggregate offering
expenses payable by us, you will experience immediate dilution of $8.35 per share, representing the difference between our as pro forma
adjusted net tangible book value per share as of September 30, 2022 after giving effect to this offering and the assumed offering price.
The exercise of outstanding stock options may result in further dilution of your investment. See the section entitled “Dilution”
below for a more detailed illustration of the dilution you would incur if you participate in this offering.
The
actual number of shares we will issue under the Sales Agreement with the Sales Agents, at any one time or in total, is uncertain.
Subject
to certain limitations in the Sales Agreement with the Sales Agents and compliance with applicable law, we have the discretion to deliver
placement notices to the Sales Agents at any time throughout the term of the Sales Agreement. The number of shares that are sold by Sales
Agents, if any, after delivering a placement notice will fluctuate based on the market price of the common stock during the sales period
and limits we set with Sales Agents.
You
may experience future dilution as a result of future equity offerings or if we issue shares subject to options, warrants, stock awards
or other arrangements.
In
order to raise additional capital, we may in the future offer additional shares of our common stock or other securities convertible into
or exchangeable for our common stock at prices that may not be the same as the price per share in this offering. We may sell shares or
other securities in any other offering at a price per share that is less than the price per share paid by investors in this offering,
and investors purchasing shares or other securities in the future could have rights superior to existing stockholders. The sale of additional
shares of common stock or other securities convertible into or exchangeable for our common stock would dilute all of our stockholders,
and if such sales of convertible securities into or exchangeable into our common stock occur at a deemed issuance price that is lower
than the current exercise price of our outstanding warrants sold to Acuitas Group Holdings, LLC (“Acuitas”) in August 2022,
the exercise price for those warrants would adjust downward to the deemed issuance price pursuant to price adjustment protection contained
within those warrants. The price per share at which we sell additional shares of our common stock, or securities convertible or exchangeable
into common stock, in future transactions may be higher or lower than the price per share paid by investors in this offering.
In addition, as of December 12,
2022, there were warrants outstanding to purchase an aggregate of 7,778,285 shares of common stock at exercise prices ranging from $1.82
to $12.50 per share, 3,549,730 shares issuable upon exercise of outstanding options at exercise prices ranging from $1.69 to $42.09 per
share, and 662,132 shares of common stock issuable upon vesting of outstanding restricted stock units. Our Loan Agreement entered into
on November 30, 2021 contains a conversion feature whereby at the option of lender, up to $5 million of the outstanding loan amount maybe
converted to shares of common stock at a conversion price of $6.98 per share. We may grant additional options, warrants or stock awards.
To the extent such shares are issued, the interest of holders of our common stock will be diluted.
Moreover,
we are obligated to issue shares of common stock upon achievement of certain clinical, regulatory and commercial milestones with respect
to certain of our drug candidates (i.e., NE3107, NE3291, NE3413, NE3789) pursuant to the asset purchase agreement, dated April 27, 2021,
by and among the Company, NeurMedix, Inc. and Acuitas, as amended on May 9, 2021. The achievement of these milestones could result in
the issuance of up to 18 million shares of our common stock, further diluting the interest of holders of our common stock.
Our
common stock may become the target of a “short squeeze.”
In
2021, the securities of several companies have increasingly experienced significant and extreme volatility in stock price due to short
sellers of common stock and buy-and-hold decisions of longer investors, resulting in what is sometimes described as a “short squeeze.”
Short squeezes have caused extreme volatility in those companies and in the market and have led to the price per share of those companies
to trade at a significantly inflated rate that is disconnected from the underlying value of the company. Sharp rises in a company’s
stock price may force traders in a short position to buy the shares to avoid even greater losses. Many investors who have purchased shares
in those companies at an inflated rate face the risk of losing a significant portion of their original investment as the price per share
has declined steadily as interest in those shares have abated. We may be a target of a short squeeze, and investors may lose a significant
portion or all of their investment if they purchase our shares at a rate that is significantly disconnected from our underlying value.
The
common stock offered hereby will be sold in “at the market offerings,” and investors who buy shares
at different times will likely pay different prices.
Investors
who purchase shares in this offering at different times will likely pay different prices, and so they may experience different levels
of dilution and different outcomes in their investment results. We will have discretion, subject to market demand, to vary the timing,
prices, and numbers of shares sold in this offering. In addition, there is no minimum or maximum sales price for shares to be sold in
this offering. Investors may experience a decline in the value of the shares they purchase in this offering as a result of sales made
at prices lower than the prices they paid.
USE
OF PROCEEDS
We
may issue and sell shares of our common stock having aggregate gross sales proceeds of up to $17,500,000 from time to time. Because there
is no minimum offering amount required as a condition to close this offering, the actual total public offering amount, commissions and
proceeds to us, if any, are not determinable at this time.
We
will retain broad discretion over the use of the net proceeds from the sale of the securities offered hereby. We currently intend to
use the net proceeds from this offering, if any, for general corporate purposes, including, without limitation, research and development
and clinical development costs to support the advancement of our in-development drug candidates, activities in connection with the launch
of our in-development drug candidates, including hiring and building inventory supply, making acquisitions of assets, businesses, companies
or securities, capital expenditures and for working capital.
This
expected use of our net proceeds from this offering represents our intentions based upon our current plans and business conditions, which
could change in the future as our plans and business conditions evolve. The amounts and timing of our actual expenditures may vary significantly
depending on numerous factors, including the factors described under “Risk Factors” in this prospectus supplement and in
the documents incorporated by reference herein, the progress of our product candidates development, the status of and results from clinical
trials, as well as any collaborations that we may enter into with third parties for our product candidates, and any unforeseen cash needs.
As a result, our management will retain broad discretion over the allocation of the net proceeds from this offering, and investors will
be relying on the judgment of our management regarding the application of the net proceeds from this offering.
Pending
the uses described above, we plan to invest the net proceeds from this offering in short- and intermediate-term, interest-bearing obligations,
investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government.
DILUTION
If
you purchase our common stock in this offering, your interest will be diluted to the extent of the difference between the public offering
price per share and the net tangible book value per share of our common stock after this offering.
Our net tangible book value as
of September 30, 2022 was approximately $4.7 million, or $0.16 per share of common stock. Net tangible book value per share is determined
by dividing the net of total tangible assets less total liabilities, by the aggregate number of shares of common stock outstanding as
of September 30, 2022.
After giving effect to the issuance
of 2,311,857 shares of our common stock pursuant to the Sales Agreement since September 30, 2022 (“ATM Offering”), our pro
forma net tangible book value as of September 30, 2022 would have been $20.0 million or $0.62 per share of common stock.
After giving further effect
to the sale of our common stock during the term of the Sales Agreement with the Sales Agents in the aggregate amount of $17,500,000 at
an assumed offering price of $9.51 per share, the last reported sale price of our common stock on the Nasdaq Capital Market on December
12, 2022, and after deducting commissions and estimated aggregate offering expenses payable by us, our pro forma as adjusted net tangible
book value as of September 30, 2022 would have been approximately $37.0 million, or $1.08 per share of common stock. This represents
an immediate increase in pro forma net tangible book value of $0.46 per share to our existing stockholders and an immediate dilution
in pro forma net tangible book value of $8.43 per share to new investors purchasing common stock in this offering.
The
following table illustrates this per share dilution:
| Assumed public offering price per share | |
| |
$ |
9.51 |
| Historical net tangible book value per share as of September 30, 2022 | |
$ | 0.16 |
|
|
| | |
| |
|
|
| Increase in historical net tangible book value per share
attributable to the ATM Offering | |
$ | 0.46 |
|
|
| Pro forma net tangible book value per share as of September 30, 2022 | |
$ | 0.62 |
|
|
| Increase in net tangible book value per share attributable to new investors in this offering | |
$ | 0.46 |
|
|
| Pro forma as adjusted net tangible book value per share as of September 30, 2022, after giving effect to this offering | |
| |
$ |
1.08 |
| Dilution per share to new investors purchasing shares in this offering | |
| |
$ |
8.43 |
The table above assumes for illustrative
purposes that an aggregate of 1,840,168 shares of our common stock are sold during the term of the Sales Agreement with the Sales Agents
at a price of $9.51 per share, the last reported sale price of our common stock on the Nasdaq Capital Market on December 12, 2022, for
aggregate gross proceeds of approximately $17,500,000.
The shares to be sold pursuant
to the Sales Agreement with the Sales Agents, if any, will be sold from time to time at various prices. An increase of $1.00 per share
in the price at which the shares are sold from the assumed offering price of $9.51 per share shown in the table above, assuming all of
our common stock in the aggregate amount of $17,500,000 during the term of the Sales Agreement with the Sales Agent is sold at that price,
would increase our pro forma as adjusted net tangible book value per share after the offering to $1.16 per share, and would increase the
dilution in net tangible book value per share to new investors in this offering to $8.35 per share, after deducting commissions and estimated
aggregate offering expenses payable by us. A decrease of $1.00 per share in the price at which the shares are sold from the assumed offering
price of $9.51 per share shown in the table above, assuming all of our common stock in the aggregate amount of $17,500,000 during the
term of the Sales Agreement with the Sales Agents is sold at that price, would decrease our pro forma as adjusted net tangible book value
per share after the offering to $1.15 per share, and would decrease the dilution in net tangible book value per share to new investors
in this offering to $7.36 per share, after deducting commissions and estimated aggregate offering expenses payable by us. This information
is supplied for illustrative purposes only.
The above discussion and table
are based on 30,165,319 shares of our common stock issued and outstanding as of September 30, 2022 and excludes the following:
| |
● |
3,348,330 shares of common stock issuable upon the exercise of outstanding stock options as of September 30, 2022 at a weighted average
exercise price of $7.40 per share; |
| |
● |
7,779,194 shares of common stock issuable upon the exercise of outstanding and exercisable warrants as of September 30, 2022 at a weighted
average exercise price of $2.07 per share; |
| |
● |
205,000 shares of common stock issuable upon the exercise of outstanding stock options issued under our equity incentive plan subsequent
to September 30, 2022, at a weighted average exercise price of $6.08 per share; |
| |
● |
537,612 shares of common stock issuable upon
vesting of restricted stock units issued under our equity incentive plan subsequent to September 30, 2022 and |
| |
● |
2,311,857 shares of common stock issued in the
ATM offerings subsequent to September 30, 2022. |
To
the extent that options or warrants outstanding as of September 30, 2022 have been or are exercised, or other shares are issued, investors
purchasing shares in this offering could 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 additional capital is raised through the sale of equity or convertible debt securities, the issuance of these securities
could result in further dilution to our stockholders.
Plan
of Distribution
On
August 31, 2022, we entered into a Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. and B. Riley
Securities, Inc. (together, the “Sales Agents”) under which we may issue and sell shares of our common stock (“common
shares”) having an aggregate gross sales price of up to $17,500,000 from time to time through or to the Sales Agents, acting as
agent or principal. A copy of the Sales Agreement will be filed as an exhibit to a Current Report on Form 8-K and will be incorporated
by reference into this prospectus supplement.
Upon
delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, the Sales Agents may sell our common shares
by any method permitted by law deemed to be “at the market distributions” as defined in Rule 415 under the Securities Act.
We may instruct the Sales Agents not to sell common shares if the sales cannot be effected at or above the price designated by us from
time to time. We or the Sales Agents may suspend the offering of common shares upon notice and subject to other conditions.
We
will pay the Sales Agents commissions, in cash, for their services in acting as agents in the sale of our common shares. The Sales Agents
will be entitled to compensation at a fixed commission rate of 3.0% of the gross proceeds from each sale of our common shares. Because
there is no minimum offering amount required as a condition to closing this offering, the actual total public offering amount, commissions
and proceeds to us, if any, are not determinable at this time. We have also agreed to reimburse the Sales Agents for certain specified
expenses, including the fees and disbursements of their legal counsel in an amount not to exceed $75,000, and periodic due diligence
fees not to exceed $5,000 per calendar quarter. We estimate that the total expenses for the offering, excluding compensation and reimbursements
payable to the Sales Agents under the terms of the Sales Agreement, will be approximately $200,000.
Settlement
for sales of common shares will occur on the second business day following the date on which any sales are made, or on some other date
that is agreed upon by us and the Sales Agents in connection with a particular transaction, in return for payment of the net proceeds
to us. Sales of our common shares as contemplated in this prospectus supplement will be settled through the facilities of The Depository
Trust Company or by such other means as we and the Sales Agents may agree upon. There is no arrangement for funds to be received in an
escrow, trust or similar arrangement.
The
Sales Agents will use their commercially reasonable efforts, consistent with its sales and trading practices, to solicit offers to purchase
the common shares under the terms and subject to the conditions set forth in the Sales Agreement. In connection with the sale of the
common shares on our behalf, each of the Sales Agents will be deemed to be an “underwriter” within the meaning of the Securities
Act and the compensation of the Sales Agents will be deemed to be underwriting commissions or discounts. We have agreed to provide indemnification
and contribution to the Sales Agents against certain civil liabilities, including liabilities under the Securities Act.
The
offering of our common shares pursuant to the Sales Agreement will terminate upon the termination of the Sales Agreement as permitted
therein. We and each Sales Agent may each terminate the Sales Agreement at any time upon ten days’ prior notice or by an Agent
at any time in certain circumstances, including the occurrence of a material and adverse change in our business or financial condition
that makes it impractical or inadvisable to market our common shares or to enforce contracts for the sale of our common shares.
In
the event the Sales Agreement is terminated, any portion of the $17,500,000 of securities included in this prospectus supplement that
is not previously sold or included in an active placement notice pursuant to the Sales Agreement will be available for sales in other
offerings pursuant to the accompanying prospectus, and if no common shares are sold under the Sales Agreement, the full $17,500,000 of
securities may be sold in other offerings pursuant to the accompanying prospectus and a corresponding prospectus supplement.
The
Sales Agents and their respective affiliates have in the past and may in the future provide various investment banking, commercial banking
and other financial services for us and our affiliates, for which services they may in the future receive customary fees.
This
prospectus supplement in electronic format may be made available on a website maintained by each Sales Agent and any Sales Agent may
distribute this prospectus supplement electronically.
LEGAL
MATTERS
The
validity of the shares of common stock offered hereby will be passed upon for us by Sherman & Howard L.L.C. Certain legal matters
will be passed upon for us by Reed Smith LLP, New York, New York. Certain legal matters will be passed on for the Sales Agents by Duane
Morris LLP, New York, New York.
EXPERTS
The
balance sheets of BioVie Inc. as of June 30, 2022 and 2021 and the related statements of operations, changes in stockholders’
equity (deficit), and cash flows for each of the years then ended have been audited by EisnerAmper LLP, an independent registered
public accounting firm as stated in their report, which is incorporated herein by reference 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 by reference in reliance on the report of such firm given their authority as
expert in accounting and auditing.
PROSPECTUS
$100,000,000
Class
A Common Stock
Preferred
Stock
Debt
Securities
Rights
We
may offer and sell, from time to time in one or more offerings, any combination of Class A common stock, preferred stock, or debt securities
having a maximum aggregate offering price of $100,000,000. When we decide to sell a particular class or series of securities, we will
provide specific terms of the offered securities in a prospectus supplement.
The
prospectus supplement may also add, update or change information contained in or incorporated by reference into this prospectus. However,
no prospectus supplement shall offer a security that is not registered and described in this prospectus at the time of its effectiveness.
You should read this prospectus and any prospectus supplement, as well as the documents incorporated by reference or deemed to be incorporated
by reference into this prospectus, carefully before you invest. This prospectus may not be used to offer or sell our securities unless
accompanied by a prospectus supplement relating to the offered securities.
Our
Class A common stock is listed on the NASDAQ Global Market under the symbol “BIVI.” Each prospectus supplement will contain
information, where applicable, as to our listing on the NASDAQ Global Market or on any other securities exchange of the securities covered
by the prospectus supplement.
These
securities may be sold directly by us, through dealers or agents designated from time to time, to or through underwriters or through
a combination of these methods. See “Plan of Distribution” in this prospectus. We may also describe the plan of distribution
for any particular offering of our securities in a prospectus supplement. If any agents, underwriters or dealers are involved in the
sale of any securities in respect of which this prospectus is being delivered, we will disclose their names and the nature of our arrangements
with them in a prospectus supplement. The net proceeds we expect to receive from any such sale will also be included in a prospectus
supplement.
An
investment in our securities involves a high degree of risk. See the sections entitled “Risk Factors” in our most recent
Annual Report on Form 10-K and in any Quarterly Report on Form 10-Q, as well as in any prospectus supplement related to these specific
offerings.
We
may amend or supplement this prospectus from time to time by filing amendments or supplements as required. You should read the entire
prospectus and any amendments or supplements carefully before you make your investment decision.
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.
The
date of this prospectus is February 2, 2021
TABLE
OF CONTENTS
ABOUT
THIS PROSPECTUS
This
prospectus is part of a Registration Statement that we filed with the Securities and Exchange Commission (“SEC”) using a
“shelf” registration process. Under this shelf registration process, we may offer from time to time securities having a maximum
aggregate offering price of $100,000,000. Each time we offer securities, we will prepare and file with the SEC a prospectus supplement
that describes the specific amounts, prices and terms of the securities we offer. The prospectus supplement also may add, update or change
information contained in this prospectus or the documents incorporated herein by reference. You should read carefully both this prospectus
and any prospectus supplement together with additional information described below under the caption “Where You Can Find More Information.”
This
prospectus does not contain all the information provided in the Registration Statement we filed with the SEC. For further information
about us or our securities offered hereby, you should refer to that Registration Statement, which you can obtain from the SEC as described
below under “Where You Can Find More Information.”
You
should rely only on the information contained or incorporated by reference in this prospectus or any prospectus supplement. We have not
authorized any other person to provide you with different information. If anyone provides you with different or inconsistent information,
you should not rely on it. This prospectus is not an offer to sell securities, and it is not soliciting an offer to buy securities, in
any jurisdiction where the offer or sale is not permitted. You should assume that the information appearing in this prospectus or any
prospectus supplement, as well as information we have previously filed with the SEC and incorporated by reference, is accurate as of
the date of those documents only. Our business, financial condition, results of operations and prospects may have changed since those
dates.
We
may sell securities through underwriters or dealers, through agents, directly to purchasers or through any combination of these methods.
We and our agents reserve the sole right to accept or reject in whole or in part any proposed purchase of securities. The prospectus
supplement, which we will prepare and file with the SEC each time we offer securities, will set forth the names of any underwriters,
agents or others involved in the sale of securities, and any applicable fee, commission or discount arrangements with them. See “Plan
of Distribution.”
In
this prospectus, unless otherwise indicated, “our company,” “BioVie,” “we,” “us” or “our”
refer to BioVie Inc., a Nevada corporation, and its consolidated subsidiaries.
PROSPECTUS
SUMMARY
This
prospectus summary highlights certain information about our company and other information contained elsewhere in this prospectus or in
documents incorporated by reference. This summary does not contain all of the information that you should consider before making an investment
decision. You should carefully read the entire prospectus, any prospectus supplement, including the section entitled “Risk Factors”
and the documents incorporated by reference into this prospectus, before making an investment decision.
The
Offering
This
prospectus is part of a Registration Statement that we filed with the SEC utilizing a shelf registration process. Under this shelf registration
process, we may sell any combination of:
| ● | debt
securities, in one or more series; and/or |
| ● | right
to purchase common stock of other securities. |
in
one or more offerings up to a total dollar amount of $100,000,000. This prospectus provides you with a general description of the securities
we may offer. Each time we sell securities, we will provide a prospectus supplement that will contain specific information about
the terms of that specific offering and include a discussion of any risk factors or other special considerations that apply to those
securities. The prospectus supplement may also add, update or change information contained in this prospectus. You should read both this
prospectus and any prospectus supplement together with the additional information described under the heading “Where You Can Find
More Information.”
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.
BioVie
began administering BIV201 to patients in September 2017 at the McGuire Research Institute Inc. in Richmond, VA. 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:
| ☐ | 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. |
| ☐ | The
steady state plasma concentration data characterized terlipressin pharmacokinetics (PK) within the predicted PK model concentrations. |
| ☐ | 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. |
In
June 2019, we met with representatives of the FDA in a Type C Guidance Meeting to discuss the study results and plan our next clinical
study. In September 2019, we requested a Type B Meeting and subsequently submitted an extensive pre-meeting information package. In April
2020, the FDA provided a written response that provided new guidance regarding primary and secondary endpoints, BIV201 dosing levels,
quality of life measures and other key aspects of the clinical trial design. After further communications, the Company completed the
Phase 2 clinical trial design protocol and was cleared to begin the study. BioVie expects to commence treating refractory ascites patients
in the Phase 2 trial in the first quarter of 2021. The Phase 2 study will be used to guide the design of a pivotal Phase 3 clinical trial.
We have developed a patent-pending novel liquid formulation of BIV201 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
(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 patented 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.
Corporate
Information
Our
principal executive offices are located at 2120 Colorado Avenue, Suite 230, Santa Monica, California 90404, and our telephone number
at that location is (310) 444-4300. Our website address is www.biovieinc.com. The inclusion of our website address does not include
or incorporate by reference into this prospectus supplement or the accompanying prospectus any information on, or accessible through,
our website. Our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, together
with amendments to these reports, are available on the "Investor Relations" section of our website, free of charge, as soon
as reasonably practicable after such material is electronically filed with, or furnished to, the U.S. Securities and Exchange Commission
("SEC").
RISK
FACTORS
Investing
in our securities involves risk. The prospectus supplement applicable to a particular offering of securities will contain a discussion
of the risks applicable to an investment in BioVie and to the particular types of securities that we are offering under that prospectus
supplement. Before making an investment decision, you should carefully consider the risks described under “Risk Factors”
in the applicable prospectus supplement and the risks described in our most recent Annual Report on Form 10-K for the year ended June
30, 2020, as amended from time to time, which is incorporated herein by reference, or any updates in our Quarterly Reports on Form 10-Q,
together with all of the other information appearing in or incorporated by reference into this prospectus and any applicable prospectus
supplement, in light of your particular investment objectives and financial circumstances. Our business, financial condition or results
of operations could be materially adversely affected by any of these risks. The trading price of our securities could decline due to
any of these risks, and you may lose all or part of your investment.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended,
or Securities Act, and Section 21E of the Securities Exchange Act of 1934, or Exchange Act. Forward-looking statements reflect the current
view about future events. When used in this prospectus, the words “anticipate,” “believe,” “estimate,”
“expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions,
as they relate to us or our management, identify forward-looking statements. Such statements, include, but are not limited to, statements
contained in this prospectus relating to our business strategy, our future operating results and liquidity and capital resources outlook.
Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future
conditions. Because forward–looking statements relate to the future, they are subject to inherent uncertainties, risks and changes
in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking
statements. They are neither statements of historical fact nor guarantees of assurance of future performance. We caution you therefore
against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from
those in the forward-looking statements include, without limitation, the results of clinical trials and the regulatory approval process;
our ability to raise capital to fund continuing operations; market acceptance of any products that may be approved for commercialization;
our ability to protect our intellectual property rights; the impact of any infringement actions or other litigation brought against us;
competition from other providers and products; our ability to develop and commercialize new and improved products and services; changes
in government regulation; our ability to complete capital raising transactions; and other factors (including the risks contained in the
section entitled “Risk Factors” of the applicable prospectus supplement) relating to our industry, our operations and results
of operations. Should one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect,
actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned.
Factors
or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of
them. We cannot guarantee future results, levels of activity, performance or achievements. Except as required by applicable law, including
the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements
to actual results.
DIVIDEND
POLICY
We
have never declared or paid dividends on our common stock and we do not anticipate paying any cash dividends on our common stock in the
foreseeable future. Payment of cash dividends, if any, in the future will be at the discretion of our board of directors and will depend
on applicable law and then-existing conditions, including our financial condition, operating results, contractual restrictions, capital
requirements, business prospects and other factors our board of directors may deem relevant. We currently intend to retain all available
funds and any future earnings to fund the development and growth of our business.
USE
OF PROCEEDS
Except
as otherwise provided in the applicable prospectus supplement, we intend to use the net proceeds from the sale of the securities covered
by this prospectus for general corporate purposes, which may include, but is not limited to, working capital, capital expenditures, research
and development expenditures and acquisitions of new technologies or businesses. The precise amount, use and timing of the application
of such proceeds will depend upon our funding requirements and the availability and cost of other capital. Additional information on
the use of net proceeds from an offering of securities covered by this prospectus may be set forth in the prospectus supplement relating
to the specific offering.
DESCRIPTIONS
OF THE SECURITIES WE MAY OFFER
The
descriptions of the securities contained in this prospectus, together with any applicable prospectus supplement, summarize all the material
terms and provisions of the various types of securities that we may offer. We will describe in the applicable prospectus supplement relating
to a particular offering the specific terms of the securities offered by that prospectus supplement. We will indicate in the applicable
prospectus supplement if the terms of the securities differ from the terms we have summarized below. We will also include in the prospectus
supplement information, where applicable, material United States federal income tax considerations relating to the securities.
We
may sell from time to time, in one or more offerings:
| ● | shares
of our Class A common stock; |
| ● | shares
of our preferred stock; |
| ● | debt
securities, in one or more series; and/or |
| ● | right
to purchase common stock or other securities. |
This
prospectus may not be used to consummate a sale of securities unless it is accompanied by a prospectus supplement.
Capital
Stock
General
The
following description of Class A common stock and preferred stock, together with the additional information we include in any applicable
prospectus supplement, summarizes the material terms and provisions of the Class A common stock and preferred stock that we may offer
under this prospectus but is not complete. For the complete terms of our common stock and preferred stock, please refer to our articles
of incorporation, as may be amended from time to time, any certificates of designation for our preferred stock, that may be authorized
from time to time, and our bylaws, as amended from time to time. The Nevada General Corporation Law may also affect the terms of these
securities. While the terms we have summarized below will apply generally to any future common stock or preferred stock that we may offer,
we will describe the specific terms of any series of these securities in more detail in the applicable prospectus supplement. If we so
indicate in a prospectus supplement, the terms of any common stock or preferred stock we offer under that prospectus supplement may differ
from the terms we describe below.
As
of January 21, 2021, our authorized capital stock consists of 800,000,000 shares of Class A common stock, par value $0.0001 per share,
of which 13,916,164 shares were issued and outstanding, and 10,000,000 shares of preferred stock, par value $0.0001 per share, none of
which were issued and outstanding. The authorized and unissued shares of Class A common stock and preferred stock are available for issuance
without further action by our stockholders, unless such action is required by applicable law or the rules of any stock exchange on which
our securities may be listed. Unless approval of our stockholders is so required, our board of directors will not seek stockholder approval
for the issuance and sale of our common stock.
Class
A Common Stock
Each
holder of Class A common stock is entitled to one vote for each share of Class A common stock held on all matters submitted to a vote
of the stockholders, including the election of directors. Our articles of incorporation and amended and restated bylaws do not provide
for cumulative voting rights. Subject to preferences that may be applicable to any then outstanding preferred stock, the holders of our
outstanding shares of Class A common stock are entitled to receive dividends, if any, as may be declared from time to time by our board
of directors out of legally available funds. In the event of our liquidation, dissolution or winding up, holders of Class A common stock
will be entitled to share ratably in the net assets legally available for distribution to stockholders after the payment of all of our
debts and other liabilities, subject to the satisfaction of any liquidation preference granted to the holders of any outstanding shares
of preferred stock. Holders of our Class A common stock have no preemptive, conversion or subscription rights, and there are no redemption
or sinking fund provisions applicable to the Class A common stock. The rights, preferences and privileges of the holders of Class A common
stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of our preferred stock that
we may designate and issue in the future. All of our outstanding shares of Class A common stock are fully paid and nonassessable.
Our
Class A common stock is listed on the NASDAQ Global Market under the symbol “OTRK.” The transfer agent and registrar for
our Class A common stock is West Coast Stock Transfer, New York, New York.
Options/Warrants
As
of January 21, 2021, we had outstanding options to purchase 755,200 shares of our Class A common stock at a weighted average exercise
price of $13.89 and outstanding warrants to purchase 214,665 shares of our Class A common stock at an exercise price of $10.87.
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:
| |
● |
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 |
| |
● |
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. |
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.
Debt
Securities
The
following description, together with the additional information we include in any applicable prospectus supplements, summarizes the material
terms and provisions of the debt securities that we may offer under this prospectus. While the terms we have summarized below will
generally apply to any future debt securities we may offer under this prospectus, we will describe the particular terms of any debt securities
that we may offer in more detail in the applicable prospectus supplement. The terms of any debt securities we offer under a prospectus
supplement may differ from the terms we describe below. As of the date of this prospectus, we have no outstanding registered
debt securities.
We
will issue senior notes under a senior indenture, which we will enter into with the trustee to be named in the senior indenture.
We will issue subordinated notes under a subordinated indenture, which we will enter into with the trustee to be named in the subordinated
indenture. We have filed forms of these documents as exhibits to the registration statement of which this prospectus is a part.
We use the term “indentures” to refer to both the senior indenture and the subordinated indenture.
The
indentures will be qualified under the Trust Indenture Act of 1939. We use the term “debenture trustee” to refer to
either the senior trustee or the subordinated trustee, as applicable.
The
following summaries of material provisions of the senior notes, the subordinated notes and the indentures are subject to, and qualified
in their entirety by reference to, all the provisions of the indenture applicable to a particular series of debt securities. We
urge you to read the applicable prospectus supplements related to the debt securities that we sell under this prospectus, as well as
the complete indentures that contain the terms of the debt securities. Except as we may otherwise indicate, the terms of the senior
and the subordinated indentures are identical.
General
The
terms of each series of debt securities will be established by or pursuant to a resolution of our board of directors and set forth or
determined in the manner provided in an officers’ certificate or by a supplemental indenture. Debt securities may be issued in
separate series without limitation as to aggregate principal amount. We may specify a maximum aggregate principal amount for the debt
securities of any series. The particular terms of each series of debt securities will be described in a prospectus supplement relating
to such series, including any pricing supplement. The prospectus supplement will set forth:
| ● | the
principal amount being offered, and, if a series, the total amount authorized and the total amount outstanding; |
| ● | any
limit on the amount that may be issued; |
| ● | whether
or not we will issue the series of debt securities in global form and, if so, the terms and who the depositary will be; |
| ● | whether
and under what circumstances, if any, we will pay additional amounts on any debt securities held by a person who is not a U.S. person
for tax purposes, and whether we can redeem the debt securities if we have to pay such additional amounts; |
| ● | the
annual interest rate, which may be fixed or variable, or the method for determining the rate, the date interest will begin to accrue,
the dates interest will be payable and the regular record dates for interest payment dates or the method for determining such dates; |
| ● | whether
or not the debt securities will be secured or unsecured, and the terms of any secured debt; |
| ● | the
terms of the subordination of any series of subordinated debt; |
| ● | the
place where payments will be payable; |
| ● | restrictions
on transfer, sale or other assignment, if any; |
| ● | our
right, if any, to defer payment of interest and the maximum length of any such deferral period; |
| ● | the
date, if any, after which, the conditions upon which, and the price at which we may, at our option, redeem the series of debt securities
pursuant to any optional or provisional redemption provisions, and any other applicable terms of those redemption provisions; |
| ● | the
date, if any, on which, and the price at which we are obligated, pursuant to any mandatory sinking fund or analogous fund provisions
or otherwise, to redeem, or at the holder’s option to purchase, the series of debt securities and the currency or currency unit
in which the debt securities are payable; |
| ● | whether
the indenture will restrict our ability and/or the ability of our subsidiaries to, among other things: |
| ● | incur
additional indebtedness; |
| ● | issue
additional securities; |
| ● | pay
dividends and make distributions in respect of our capital stock and the capital stock of our subsidiaries; |
| ● | place
restrictions on our subsidiaries’ ability to pay dividends, make distributions or transfer assets; |
| ● | make
investments or other restricted payments; |
| ● | sell
or otherwise dispose of assets; |
| ● | enter
into sale-leaseback transactions; |
| ● | engage
in transactions with stockholders and affiliates; |
| ● | issue
or sell stock of our subsidiaries; or |
| ● | effect
a consolidation or merger; |
| ● | whether
the indenture will require us to maintain any interest coverage, fixed charge, cash flow-based, asset-based or other financial ratios; |
| ● | a
discussion of any material or special U.S. federal income tax considerations applicable to the debt securities; |
| ● | information
describing any book-entry features; |
| ● | provisions
for a sinking fund purchase or other analogous fund, if any; |
| ● | whether
the debt securities are to be offered at a price such that they will be deemed to be offered at an “original issue discount”
as defined in paragraph (a) of Section 1273 of the Internal Revenue Code; |
| ● | the
procedures for any auction and remarketing, if any; |
| ● | the
denominations in which we will issue the series of debt securities, if other than denominations of $1,000 and any integral multiple thereof; |
| ● | if
other than dollars, the currency in which the series of debt securities will be denominated; and |
| ● | any
other specific terms, preferences, rights or limitations of, or restrictions on, the debt securities, including any events of default
that are in addition to those described in this prospectus or any covenants provided with respect to the debt securities that are in
addition to those described above, and any terms that may be required by us or advisable under applicable laws or regulations or advisable
in connection with the marketing of the debt securities. |
Conversion
or Exchange Rights
We
will set forth in the prospectus supplement the terms on which a series of debt securities may be convertible into or exchangeable for
Class A common stock or other securities of ours or a third party, including the conversion or exchange rate, as applicable, or how it
will be calculated, and the applicable conversion or exchange period. We will include provisions as to whether conversion or exchange
is mandatory, at the option of the holder or at our option. We may include provisions pursuant to which the number of our securities
or the securities of a third party that the holders of the series of debt securities receive upon conversion or exchange would, under
the circumstances described in those provisions, be subject to adjustment, or pursuant to which those holders would, under those circumstances,
receive other property upon conversion or exchange, for example in the event of our merger or consolidation with another entity.
Consolidation,
Merger or Sale
The
indentures in the forms initially filed as exhibits to the registration statement of which this prospectus is a part do not contain any
covenant that restricts our ability to merge or consolidate, or sell, convey, transfer or otherwise dispose of all or substantially all
of our assets. However, any successor of ours or the acquirer of such assets must assume all of our obligations under the indentures
and the debt securities.
If
the debt securities are convertible for our other securities, the person with whom we consolidate or merge or to whom we sell all of
our property must make provisions for the conversion of the debt securities into securities that the holders of the debt securities would
have received if they had converted the debt securities before the consolidation, merger or sale.
Events
of Default Under the Indenture
The
following are events of default under the indentures in the forms initially filed as exhibits to the registration statement with respect
to any series of debt securities that we may issue:
| ● | if
we fail to pay interest when due and payable and our failure continues for 90 days and the time for payment has not been extended or
deferred; |
| ● | if
we fail to pay the principal, sinking fund payment or premium, if any, when due and payable and the time for payment has not been extended
or delayed; |
| ● | if
we fail to observe or perform any other covenant contained in the debt securities or the indentures, other than a covenant specifically
relating to another series of debt securities, and our failure continues for 90 days after we receive notice from the debenture trustee
or holders of at least 25% in aggregate principal amount of the outstanding debt securities of the applicable series; and |
| ● | if
specified events of bankruptcy, insolvency or reorganization occur. |
If
an event of default with respect to debt securities of any series occurs and is continuing, other than an event of default specified
in the last bullet point above, the debenture trustee or the holders of at least 25% in aggregate principal amount of the outstanding
debt securities of that series, by notice to us in writing, and to the debenture trustee if notice is given by such holders, may declare
the unpaid principal of, premium, if any, and accrued interest, if any, due and payable immediately. If an event of default specified
in the last bullet point above occurs with respect to us, the principal amount of and accrued interest, if any, of each issue of debt
securities then outstanding shall be due and payable without any notice or other action on the part of the debenture trustee or any holder.
The
holders of a majority in principal amount of the outstanding debt securities of an affected series may waive any default or event of
default with respect to the series and its consequences, except defaults or events of default regarding payment of principal, premium,
if any, or interest, unless we have cured the default or event of default in accordance with the indenture. Any waiver shall cure
the default or event of default.
Subject
to the terms of the indentures, if an event of default under an indenture shall occur and be continuing, the debenture trustee will be
under no obligation to exercise any of its rights or powers under such indenture at the request or direction of any of the holders of
the applicable series of debt securities, unless such holders have offered the debenture trustee reasonable indemnity. The holders
of a majority in principal amount of the outstanding debt securities of any series will have the right to direct the time, method and
place of conducting any proceeding for any remedy available to the debenture trustee, or exercising any trust or power conferred on the
debenture trustee, with respect to the debt securities of that series, provided that:
| ● | the
direction so given by the holder is not in conflict with any law or the applicable indenture; and |
| ● | subject
to its duties under the Trust Indenture Act of 1939, the debenture trustee need not take any action that might involve it in personal
liability or might be unduly prejudicial to the holders not involved in the proceeding. |
A
holder of the debt securities of any series will only have the right to institute a proceeding under the indentures or to appoint a receiver
or trustee, or to seek other remedies if:
| ● | the
holder has given written notice to the debenture trustee of a continuing event of default with respect to that series; |
| ● | the
holders of at least 25% in aggregate principal amount of the outstanding debt securities of that series have made written request, and
such holders have offered reasonable indemnity, to the debenture trustee to institute the proceeding as trustee; and |
| ● | the
debenture trustee does not institute the proceeding and does not receive from the holders of a majority in aggregate principal amount
of the outstanding debt securities of that series other conflicting directions within 90 days after the notice, request and offer. |
These
limitations do not apply to a suit instituted by a holder of debt securities if we default in the payment of the principal, premium,
if any, or interest on, the debt securities.
We
will periodically file statements with the debenture trustee regarding our compliance with specified covenants in the indentures.
Modification
of Indenture; Waiver
We
and the debenture trustee may change an indenture without the consent of any holders with respect to specific matters, including:
| ● | to
fix any ambiguity, defect or inconsistency in the indenture; |
| ● | to
comply with the provisions described above under “Consolidation, Merger or Sale”; |
| ● | to
comply with any requirements of the SEC in connection with the qualification of any indenture under the Trust Indenture Act of 1939; |
| ● | to
evidence and provide for the acceptance of appointment hereunder by a successor trustee; |
| ● | to
provide for uncertificated debt securities and to make all appropriate changes for such purpose; |
| ● | to
add to, delete from, or revise the conditions, limitations and restrictions on the authorized amount, terms or purposes of issuance,
authorization and delivery of debt securities or any series, as set forth in the indenture; |
| ● | to
provide for the issuance of and establish the form and terms and conditions of the debt securities of any series as provided under “General”
to establish the form of any certifications required to be furnished pursuant to the terms of the indenture or any series of debt securities,
or to add to the rights of the holders of any series of debt securities; |
| ● | to
add to our covenants such new covenants, restrictions, conditions or provisions for the protection of the holders, to make the occurrence,
or the occurrence and the continuance, of a default in any such additional covenants, restrictions, conditions or provisions an event
of default, or to surrender any of our rights or powers under the indenture; or |
| ● | to
change anything that does not materially adversely affect the interests of any holder of debt securities of any series. |
In
addition, under the indentures, the rights of holders of a series of debt securities may be changed by us and the debenture trustee with
the written consent of the holders of at least a majority in aggregate principal amount of the outstanding debt securities of each series
that is affected. However, we and the debenture trustee may only make the following changes with the consent of each holder of
any outstanding debt securities affected:
| ● | extending
the fixed maturity of the series of debt securities; |
| ● | reducing
the principal amount, reducing the rate of or extending the time of payment of interest, or reducing any premium payable upon the redemption
of any debt securities; or |
| ● | reducing
the percentage of debt securities, the holders of which are required to consent to any amendment, supplement, modification or waiver. |
Discharge
Each
indenture provides that we can elect to be discharged from our obligations with respect to one or more series of debt securities, except
that the following obligations survive until the maturity date or the redemption date:
| ● | register
the transfer or exchange of debt securities of the series; |
| ● | replace
stolen, lost or mutilated debt securities of the series; |
| ● | maintain
paying agencies; |
| ● | hold
monies for payment in trust; and |
| ● | appoint
any successor trustee; |
and
the following obligations survive the maturity date or the redemption date:
| ● | recover
excess money held by the debenture trustee; and |
| ● | compensate
and indemnify the debenture trustee. |
In
order to exercise our rights to be discharged, we must deposit with the debenture trustee money or government obligations sufficient
to pay all the principal of, any premium, if any, and interest on, the debt securities of the series on the dates payments are due.
Form,
Exchange and Transfer
We
will issue the debt securities of each series only in fully registered form without coupons and, unless we otherwise specify in the applicable
prospectus supplement, in denominations of $1,000 and any integral multiple thereof. The indentures provide that we may issue debt
securities of a series in temporary or permanent global form and as book-entry securities that will be deposited with, or on behalf of,
The Depository Trust Company, New York, New York, known as DTC, or another depositary named by us and identified in a prospectus supplement
with respect to that series.
At
the option of the holder, subject to the terms of the indentures and the limitations applicable to global securities described in the
applicable prospectus supplement, the holder of the debt securities of any series can exchange the debt securities for other debt securities
of the same series, in any authorized denomination and of like tenor and aggregate principal amount.
Subject
to the terms of the indentures and the limitations applicable to global securities set forth in the applicable prospectus supplement,
holders of the debt securities may present the debt securities for exchange or for registration of transfer, duly endorsed or with the
form of transfer endorsed thereon duly executed if so required by us or the security registrar, at the office of the security registrar
or at the office of any transfer agent designated by us for this purpose. Unless otherwise provided in the debt securities that
the holder presents for transfer or exchange, we will make no service charge for any registration of transfer or exchange, but we may
require payment of any taxes or other governmental charges.
We
will name in the applicable prospectus supplement the security registrar, and any transfer agent in addition to the security registrar,
that we initially designate for any debt securities. We may at any time designate additional transfer agents or rescind the designation
of any transfer agent or approve a change in the office through which any transfer agent acts, except that we will be required to maintain
a transfer agent in each place of payment for the debt securities of each series.
If
we elect to redeem the debt securities of any series, we will not be required to:
| ● | issue,
register the transfer of, or exchange any debt securities of any series being redeemed in part during a period beginning at the opening
of business 15 days before the day of mailing of a notice of redemption of any debt securities that may be selected for redemption and
ending at the close of business on the day of the mailing; or |
| ● | register
the transfer of or exchange any debt securities so selected for redemption, in whole or in part, except the unredeemed portion of any
debt securities we are redeeming in part. |
Information
Concerning the Debenture Trustee
The
debenture trustee, other than during the occurrence and continuance of an event of default under an indenture, undertakes to perform
only those duties as are specifically set forth in the applicable indenture. Upon an event of default under an indenture, the debenture
trustee must use the same degree of care as a prudent person would exercise or use in the conduct of his or her own affairs. Subject
to this provision, the debenture trustee is under no obligation to exercise any of the powers given it by the indentures at the request
of any holder of debt securities unless it is offered reasonable security and indemnity against the costs, expenses and liabilities that
it might incur.
Payment
and Paying Agents
Unless
we otherwise indicate in the applicable prospectus supplement, we will make payment of the interest on any debt securities on any interest
payment date to the person in whose name the debt securities, or one or more predecessor securities, are registered at the close of business
on the regular record date for the interest.
We
will pay principal of and any premium and interest on the debt securities of a particular series at the office of the paying agents designated
by us, except that, unless we otherwise indicate in the applicable prospectus supplement, we may make interest payments by check that
we will mail to the holder or by wire transfer to certain holders. Unless we otherwise indicate in a prospectus supplement, we
will designate the corporate office of the debenture trustee in the City of New York as our sole paying agent for payments with respect
to debt securities of each series. We will name in the applicable prospectus supplement any other paying agents that we initially
designate for the debt securities of a particular series. We will maintain a paying agent in each place of payment for the debt
securities of a particular series.
All
money we pay to a paying agent or the debenture trustee for the payment of the principal of or any premium or interest on any debt securities
that remains unclaimed at the end of two years after such principal, premium or interest has become due and payable will be repaid to
us, and the holder of the debt security thereafter may look only to us for payment thereof.
Governing
Law
The
indentures and the debt securities will be governed by and construed in accordance with the laws of the State of New York, except to
the extent that the Trust Indenture Act of 1939 is applicable.
Subordination
of Subordinated Debt Securities
The
subordinated debt securities will be subordinate and junior in priority of payment to certain of our other indebtedness to the extent
described in a prospectus supplement. The indentures in the forms initially filed as exhibits to the registration statement of
which this prospectus is a part do not limit the amount of indebtedness that we may incur, including senior indebtedness or subordinated
indebtedness, and do not limit us from issuing any other debt, including secured debt or unsecured debt.
Rights
The
complete terms of the rights will be contained in the rights agreements we enter into with rights agents. These documents will be included
or incorporated by reference as exhibits to the registration statement of which this prospectus is a part. You should read the rights
agreements and any related documents. You also should read the prospectus supplement, which will contain additional information and which
may update or change some of the information below.
This
section describes the general terms of the rights to purchase Class A common stock or other securities that we may offer to stockholders
using this prospectus. Further terms of the rights will be stated in the applicable prospectus supplement (or applicable free writing
prospectus). The following description and any description of the rights in a prospectus supplement (or applicable free writing prospectus)
may not be complete and is subject to and qualified in its entirety by reference to the terms of any agreement relating to the rights.
Rights
may be issued independently or together with any other security and may or may not be transferable. As part of any rights offering, we
may enter into a standby underwriting or other arrangement under which the underwriters or any other person would purchase any securities
that are not purchased in such rights offering. If we issue rights, each series of rights will be issued under a separate rights agreement
to be entered into between us and a bank or trust company, as rights agent, that will be named in the applicable prospectus supplement.
Further terms of the rights will be stated in the applicable prospectus supplement. The rights agent will act solely as our agent and
will not assume any obligation to any holders of rights certificates or beneficial owners of rights. The rights agreements and rights
certificates will be filed with the SEC as an exhibit to the registration statement of which this prospectus is a part or as an exhibit
to a filing incorporated by reference in the registration statement. See “Where You Can Find Additional Information” for
information on how to obtain copies of the rights agreements and rights certificates.
The
prospectus supplement relating to any rights we offer will describe the specific terms of the offering and the rights, including the
record date for stockholders entitled to the rights distribution, the number of rights issued and the number of shares of Class A common
stock that may be purchased upon exercise of the rights, the exercise price of the rights, the date on which the rights will become effective
and the date on which the rights will expire, and any applicable U.S. federal income tax considerations.
In
general, a right entitles the holder to purchase for cash a specific number of shares of Class A common stock or other securities at
a specified exercise price. The rights are normally issued to stockholders as of a specific record date, may be exercised only for a
limited period of time and become void following the expiration of such period. If we determine to issue rights, we will accompany this
prospectus with a prospectus supplement that will describe, among other things:
| ● | the
record date for stockholders entitled to receive the rights; |
| ● | the
number of shares of Class A common stock or other securities that may be purchased upon exercise of each right; |
| ● | the
exercise price of the rights; |
| ● | the
terms for changes to or adjustments in the exercise price, if any; |
| ● | whether
the rights are transferable; |
| ● | the
period during which the rights may be exercised and when they will expire; |
| ● | the
steps required to exercise the rights; |
| ● | whether
the rights include “oversubscription rights” so that the holder may purchase more securities if other holders do not purchase
their full allotments; |
| ● | whether
we intend to sell the shares of Class A common stock or other securities that are not purchased in the rights offering to an underwriter
or other purchaser under a contractual “standby” commitment or other arrangement; |
| ● | our
ability to withdraw or terminate the rights offering; |
| ● | any
material United States federal income tax consequences; and |
| ● | other
material terms, including terms relating to transferability, exchange, exercise or amendment of the rights. |
If
fewer than all of the rights issued in any rights offering are exercised, we may offer any unsubscribed securities directly to persons
other than stockholders, to or through agents, underwriters or dealers or through a combination of such methods, including pursuant to
standby arrangements, as described in the applicable prospectus supplement. After the close of business on the expiration date, all unexercised
rights will become void.
PLAN
OF DISTRIBUTION
We
may sell the securities being offered pursuant to this prospectus to or through underwriters, through dealers, through agents, or directly
to one or more purchasers or through a combination of these methods. The applicable prospectus supplement will describe the terms of
the offering of the securities, including:
| ● | the
name or names of any underwriters, if, and if required, any dealers or agents; |
| ● | the
purchase price of the securities and the proceeds we will receive from the sale; |
| ● | any
underwriting discounts and other items constituting underwriters’ compensation; |
| ● | any
discounts or concessions allowed or re-allowed or paid to dealers; and |
| ● | any
securities exchange or market on which the securities may be listed or traded. |
We
may distribute the securities from time to time in one or more transactions at:
| ● | a
fixed price or prices, which may be changed; |
| ● | market
prices prevailing at the time of sale; |
| ● | prices
related to such prevailing market prices; or |
Only
underwriters named in the prospectus supplement are underwriters of the securities offered by the prospectus supplement.
If
underwriters are used in an offering, we will execute an underwriting agreement with such underwriters and will specify the name of each
underwriter and the terms of the transaction (including any underwriting discounts and other terms constituting compensation of the underwriters
and any dealers) in a prospectus supplement. The securities may be offered to the public either through underwriting syndicates represented
by managing underwriters or directly by one or more investment banking firms or others, as designated. If an underwriting syndicate is
used, the managing underwriter(s) will be specified on the cover of the prospectus supplement. If underwriters are used in the sale,
the offered securities will be acquired by the underwriters for their own accounts and may be resold from time to time in one or more
transactions, including negotiated transactions, at a fixed public offering price or at varying prices determined at the time of sale.
Any public offering price and any discounts or concessions allowed or re-allowed or paid to dealers may be changed from time to time.
Unless otherwise set forth in the prospectus supplement, the obligations of the underwriters to purchase the offered securities will
be subject to conditions precedent, and the underwriters will be obligated to purchase all of the offered securities, if any are purchased.
We
may grant to the underwriters options to purchase additional securities to cover over-allotments, if any, at the public offering price,
with additional underwriting commissions or discounts, as may be set forth in a related prospectus supplement. The terms of any over-allotment
option will be set forth in the prospectus supplement for those securities.
If
we use a dealer in the sale of the securities being offered pursuant to this prospectus or any prospectus supplement, we will sell the
securities to the dealer, as principal. The dealer may then resell the securities to the public at varying prices to be determined by
the dealer at the time of resale. The names of the dealers and the terms of the transaction will be specified in a prospectus supplement.
We
may sell the securities directly or through agents we designate from time to time. We will name any agent involved in the offering and
sale of securities and we will describe any commissions we will pay the agent in the prospectus supplement.
We
may authorize agents or underwriters to solicit offers by institutional investors to purchase securities from us at the public offering
price set forth in the prospectus supplement pursuant to delayed delivery contracts providing for payment and delivery on a specified
date in the future. We will describe the conditions to these contracts and the commissions we must pay for solicitation of these contracts
in the prospectus supplement.
In
connection with the sale of the securities, underwriters, dealers or agents may receive compensation from us or from purchasers of the
securities for whom they act as agents, in the form of discounts, concessions or commissions. Underwriters may sell the securities to
or through dealers, and those dealers may receive compensation in the form of discounts, concessions or commissions from the underwriters
or commissions from the purchasers for whom they may act as agents. Underwriters, dealers and agents that participate in the distribution
of the securities, and any institutional investors or others that purchase securities directly for the purpose of resale or distribution,
may be deemed to be underwriters, and any discounts or commissions received by them from us and any profit on the resale of the Class
A common stock by them may be deemed to be underwriting discounts and commissions under the Securities Act. No FINRA member firm may
receive compensation in excess of that allowable under FINRA rules, including Rule 5110, in connection with the offering of the securities.
We
may provide agents, underwriters and other purchasers with indemnification against particular civil liabilities, including liabilities
under the Securities Act, or contribution with respect to payments that the agents, underwriters or other purchasers may make with respect
to such liabilities. Agents and underwriters may engage in transactions with, or perform services for, us in the ordinary course of business.
To
facilitate the public offering of a series of securities, persons participating in the offering may engage in transactions that stabilize,
maintain, or otherwise affect the market price of the securities. This may include over-allotments or short sales of the securities,
which involves the sale by persons participating in the offering of more securities than have been sold to them by us. In exercising
the over-allotment option granted to those persons. In addition, those persons may stabilize or maintain the price of the securities
by bidding for or purchasing securities in the open market or by imposing penalty bids, whereby selling concessions allowed to underwriters
or dealers participating in any such offering may be reclaimed if securities sold by them are repurchased in connection with stabilization
transactions. The effect of these transactions may be to stabilize or maintain the market price of the securities at a level above that
which might otherwise prevail in the open market. Such transactions, if commenced, may be discontinued at any time. We make no representation
or prediction as to the direction or magnitude of any effect that the transactions described above, if implemented, may have on the price
of our securities.
Unless
otherwise specified in the applicable prospectus supplement, any Class A common stock sold pursuant to a prospectus supplement will be
eligible for trading on the Nasdaq Capital Market. Any underwriters to whom securities are sold by us for public offering and sale may
make a market in the securities, but such underwriters will not be obligated to do so and may discontinue any market making at any time
without notice.
In
order to comply with the securities laws of some states, if applicable, the securities offered pursuant to this prospectus will be sold
in those states only through registered or licensed brokers or dealers. In addition, in some states securities may not be sold unless
they have been registered or qualified for sale in the applicable state or an exemption from the registration or qualification requirement
is available and complied with.
LEGAL
MATTERS
Unless
otherwise indicated in the applicable prospectus supplement, the validity of the securities offered hereby will be passed upon for us
by Loeb & Loeb LLP, New York, New York. If the validity of the securities offered hereby in connection with offerings made pursuant
to this prospectus are passed upon by counsel for the underwriters, dealers or agents, if any, such counsel will be named in the prospectus
supplement relating to such offering.
EXPERTS
The
balance sheets of BioVie Inc. as of June 30, 2020 and 2019 and the related statements of operations, changes in stockholders’ equity
(deficit), and cash flows for each of the years then ended have been audited by EisnerAmper LLP, independent registered public accounting
firm as stated in their report, which is incorporated herein by reference 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 by reference in reliance on the report of such firm given upon their authority as expert in accounting and auditing.
LIMITATION
ON LIABILITY AND 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, or otherwise, we have been advised that in the opinion of the SEC 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, we will, unless in the opinion of our counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by us is against public policy as
expressed in the Securities Act and will be governed by the final adjudication of such issue.
WHERE
YOU CAN FIND MORE INFORMATION
This
prospectus and any subsequent prospectus supplements do not contain all of the information in the Registration Statement. We have omitted
from this prospectus some parts of the Registration Statement as permitted by the rules and regulations of the SEC. Statements in this
prospectus concerning any document we have filed as an exhibit to the Registration Statement or that we otherwise filed with the SEC
are not intended to be comprehensive and are qualified in their entirety by reference to these filings. In addition, we file annual,
quarterly and current reports, proxy statements and other information with the SEC. The SEC maintains an Internet site that contains
reports, proxy and information statements and other information that we file electronically with the SEC, including us. The SEC’s
Internet site can be found at http://www.sec.gov. In addition, we make available on or through our Internet site copies of these reports
as soon as reasonably practicable after we electronically file or furnished them to the SEC. Our Internet site can be found at http:www.BioVie.com.
Our website is not a part of this prospectus.
INFORMATION
INCORPORATED BY REFERENCE
We
have elected to incorporate certain information by reference into this prospectus. By incorporating by reference, we can disclose important
information to you by referring you to other documents we have filed or will file with the SEC. The information incorporated by reference
is deemed to be part of this prospectus, except for information incorporated by reference that is superseded by information contained
in this prospectus. This means that you must look at all of the SEC filings that we incorporate by reference to determine if any statements
in the prospectus or any document previously incorporated by reference have been modified or superseded. This prospectus incorporates
by reference the documents set forth below that we have previously filed with the SEC under the Securities Exchange Act of 1934, as amended
(the “Exchange Act”):
| ● | our
Annual Report on Form 10-K for the fiscal year ended June 30, 2020; |
| ● | our
Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2020; |
| ● | our
Current Report on Form 8-K filed with the SEC on September 23, 2020; and |
| ● | the
description of the our Class A common stock set forth in the Registration Statement on Form 8-A12B filed on August 25, 2020, including
any amendment or report filed for the purpose of updating such description. |
All
documents subsequently filed by the Registrant with the SEC pursuant to Sections 13(a), 13(c), 14 and 15(d) of the Exchange Act after
the date of the initial filing of the registration statement and prior to effectiveness of the registration statement that contains this
prospectus and prior to the termination of the offering (except in each case the information contained in such document to the extent
“furnish” and not “filed”), shall be deemed to be incorporated by reference herein and to be a part hereof from
the date of filing of such documents.
Any
statement contained in a document incorporated or deemed to be incorporated by reference herein shall be deemed to be modified or superseded
for purposes of this Registration Statement to the extent that a statement contained herein, or in any other subsequently filed document
which also is incorporated or deemed to be incorporated by reference herein, modifies or supersedes such statement. Any such statement
so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this Registration Statement.
Up
to $17,500,000
Common
Stock
PROSPECTUS
SUPPLEMENT
|
Cantor |
B.
Riley Securities |
December
14, 2022
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