The
information contained in this preliminary prospectus supplement and the accompanying prospectus is not complete and may be changed.
A registration statement relating to the securities has been declared effective by the Securities and Exchange Commission. This
preliminary prospectus supplement and the accompanying prospectus are not an offer to sell these securities, and we are not soliciting
an offer to buy these securities in any state or other jurisdiction where the offer or sale is not permitted.
Subject
to completion, dated September 18, 2019
Filed
Pursuant to Rule 424(b)(5)
Registration
No. 333-232995
PRELIMINARY
PROSPECTUS SUPPLEMENT
(To
Prospectus dated August 8, 2019)
Shares
Common
Stock
We
are offering shares
of our common stock.
Our
common stock is listed on the Nasdaq Capital Market under the symbol “PRVB.” On September 17, 2019, the last
reported sale price of our common stock as reported on the Nasdaq Capital Market was $9.36 per share.
Pursuant
to the terms of our License and Collaboration Agreement with Amgen, Inc., Amgen has agreed to purchase, in a private placement
to be completed concurrently with the completion of this offering, up to $20 million of shares of our common stock at the
public offering price per share for the shares of common stock sold in this offering.
We
are an “emerging growth company” as defined under the federal securities laws.
Investing
in our common stock involves risks. Please read the information contained in or incorporated by reference under the heading “Risk
Factors” beginning on page S-6 of this prospectus supplement, and under similar headings in other documents filed after
the date hereof and incorporated by reference into this prospectus supplement and the accompanying prospectus.
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|
Per
Share
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|
Total
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|
Public offering price
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|
$
|
|
|
|
$
|
|
|
Underwriting discounts and commissions
(1)
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|
$
|
|
|
|
$
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|
Proceeds to us, before expenses
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|
$
|
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$
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|
(1)
See “Underwriting” beginning on page S-12 in this prospectus supplement for additional information regarding total
underwriter compensation.
The
underwriters may also exercise their option to purchase up to an additional
shares from us at the public offering price, less the underwriting discounts and commissions, for 30 days after the date of this
prospectus supplement.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or
determined if this prospectus supplement and accompanying prospectus is truthful or complete. Any representation to the contrary
is a criminal offense.
The
underwriters expect to deliver the shares against payment therefor on or about ,
2019.
Joint
Bookrunning Managers
SVB
Leerink
Cantor
Lead
Manager
H.C.
Wainwright & Co.
The
date of this prospectus supplement is September ,
2019.
TABLE
OF CONTENTS
Prospectus
Supplement
Prospectus
ABOUT
THIS PROSPECTUS SUPPLEMENT
In
this prospectus supplement, “Provention,” “we,” “us,” “our” or “ours”
refer to Provention Bio, Inc., a Delaware corporation.
All
trademarks or trade names referred to in this prospectus supplement and the accompanying base prospectus are the property of their
respective owners. Solely for convenience, the trademarks and trade names in this prospectus supplement and the accompanying base
prospectus are referred to without the ® and ™ symbols, but such references should not be construed as any indicator
that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend
the use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship
of us by, any other companies.
This
document is in two parts. The first part is this prospectus supplement, which adds to and updates information contained in the
accompanying base prospectus. The second part, the base prospectus, provides more general information, some of which may not apply
to this offering. Generally, when we refer to this prospectus, we are referring to this prospectus supplement and the accompanying
base prospectus combined, together with the documents incorporated by reference herein or therein. To the extent there is a conflict
between the information contained in this prospectus supplement and the information contained in the accompanying base prospectus,
you should rely on the information in this prospectus supplement.
This
prospectus supplement and the accompanying base prospectus relate to the offering of shares of our common stock. Before buying
the shares of common stock offered hereby, we urge you to carefully read this prospectus supplement and the accompanying base
prospectus, together with the information incorporated herein by reference as described under the headings “Where You Can
Find More Information” and “Incorporation of Certain Information by Reference.” These documents contain important
information that you should consider when making your investment decision. This prospectus supplement contains information about
the common stock offered hereby and may add, update or change information in the accompanying base prospectus.
You
should rely only on the information that we have provided or incorporated by reference in this prospectus supplement and the accompanying
base prospectus and in any free writing prospectus that we may authorize for use in connection with this offering. Neither we
nor the underwriters (or any of our or their respective affiliates) have 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.
We
and the underwriters are not making offers to sell or solicitations to buy our securities in any jurisdiction in which an offer
or solicitation is not authorized or in which the person making that offer or solicitation is not qualified to do so or to anyone
to whom it is unlawful to make an offer or solicitation. You should assume that the information in this prospectus supplement
and the accompanying base prospectus or any free writing prospectus that we may authorize for use in connection with this offering
is accurate only as of the date on the front of the document and that any information that we have incorporated by reference is
accurate only as of the date of the document incorporated by reference, regardless of the time of delivery of this prospectus
supplement, the accompanying base prospectus or any free writing prospectus that we may authorize for use in connection with this
offering, or any sale of a security.
This
prospectus supplement and the accompanying base prospectus contain summaries of certain provisions contained in some of the documents
described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in
their entirety by the actual documents. Copies of some of the documents referred to herein have been or will be filed as exhibits
to the registration statement of which this prospectus is a part or as exhibits to documents incorporated by reference herein,
and you may obtain copies of those documents as described below under the headings “Where You Can Find More Information”
and “Incorporation of Certain Information by Reference.”
SUMMARY
The
following summary of our business highlights some of the information contained elsewhere in or incorporated by reference into
this prospectus supplement. Because this is only a summary, however, it does not contain all of the information that may be important
to you. You should carefully read this prospectus supplement and the accompanying base prospectus, including the documents incorporated
herein by reference, which are described under “Incorporation of Certain Information by Reference” and “Where
You Can Find More Information” in this prospectus supplement. You should also carefully consider the matters discussed in
the section titled “Risk Factors” in this prospectus supplement, in the accompanying base prospectus and in other
periodic reports incorporated by reference herein and the section titled “Management’s Discussion and Analysis of
Financial Condition and Results of Operation” and the financial statements and the notes to those financial statements incorporated
by reference in this prospectus before investing in our common stock.
Company
Overview
We
are a clinical stage biopharmaceutical company, focused on the development and commercialization of novel therapeutics and innovative
approaches aimed at intercepting and preventing immune-mediated diseases. We are leveraging a transformational drug development
strategy that sources, repositions and advances potential therapeutic candidates that in most instances have undergone previous
clinical testing but may have been underdeveloped or deprioritized because of insufficient clinical trial efficacy (i.e., a benefit
in endpoints relevant for the disease or condition under study as compared to placebo) or for strategic reasons. Importantly,
these product candidates not only appear to have been well-tolerated but have demonstrated proof-of-mechanism (i.e., evidence
that the experimental drug has the intended biologic effect in its target and/or pathway) by preventing or intercepting potentially
clinically relevant immunopathologic pathways. These characteristics exemplify the profile against which therapeutic candidates
are evaluated for strategic refocusing or advancement to the next stage of clinical development. In this context, we are creating
a diverse portfolio of innovative solutions targeting opportunities focused on intercepting and preventing immune-mediated disease.
Our
mission is to in-license, transform and develop clinical-stage, or nearly clinical-stage, therapeutic candidates targeting the
high morbidity, mortality and escalating costs of autoimmune and inflammatory diseases, including: celiac disease, type 1 diabetes,
or T1D, Crohn’s disease, or CD, and lupus. Our current development pipeline consists of a Phase 3 product candidate for
the interception and possible delay or prevention of T1D, a Phase 2 product candidate for celiac disease, a Phase 2 product candidate
for CD, a Phase 1 product candidate for systemic lupus erythematosus, or SLE, and a preclinical candidate that we intend to develop
for acute coxsackie B virus, also referred to as coxsackie virus B or CVB, infection and the potential prevention or delay in
onset of T1D. All of these programs have been selected and acquired or in-licensed because of their therapeutic potential to interrupt,
delay, reverse or prevent the onset or progression of life-threatening or debilitating immune-mediated disease.
We
preferentially source, reposition, transform and advance underdeveloped or deprioritized clinical-stage, or nearly clinical-stage,
therapeutic candidates targeting the interception and prevention of immune-mediated disease. Our “predict” and “pre-empt”
therapeutic approach focuses on identifying at-risk patients and intervening before the targeted disease begins, re-appears, exacerbates
or progresses. We believe our experience and expertise in translational medicine, immunology, and the design and execution of
rapid go/no-go clinical trials makes us unique in the field of immune-mediated disease.
We
have access to relevant in-licensing opportunities from industry-leading pharmaceutical companies; innovative, development-stage
biotechnology companies; and world-renowned academic centers. To date, we have obtained exclusive worldwide rights to an enterovirus
vaccine platform, targeting the prevention of CVB infections and T1D onset, from Vactech Ltd., a Finnish biotechnology company;
one clinical-stage product candidate from an affiliated entity of Janssen Pharmaceuticals, Inc., or Janssen, a small molecule
targeting an upstream pathological mechanism believed to drive CD; two product candidates from MacroGenics, Inc., a Phase 3 clinical-stage
product candidate for the interception and possible delay or prevention of T1D and a Phase 1 clinical-stage product candidate
for the potential treatment of SLE; and a Phase 2 clinical-stage product candidate from Amgen, Inc., or Amgen, targeting celiac
disease.
Since
our inception, we have devoted substantially all our efforts to research and development, business planning, recruiting management
and technical staff, acquiring operating assets, partnering and raising capital. We have not yet commenced any revenue-generating
operations, do not have any cash flows from operations and will need to raise additional capital after the completion of this
offering and the concurrent private placement to finance our operations. We will be dependent on raising substantial additional
capital before we become profitable and we may never achieve profitability.
Focus
and Pipeline
Inflammation
is a natural consequence of most infections as it is the immune system’s first response to invading pathogens in the event
of injury or acute illness. Most of the time, this response is beneficial and well-controlled; helping to repair tissue damage
and clear pathogens from the body. In addition to directly damaging tissues and organs, an infection can sometimes result in the
excessive release of toxic immune mediators leading to a potentially life-threatening acute pathological immune response. When
patients have the requisite genetic predisposition, infections can also trigger chronic autoimmune responses that persist and
progress long after the original insult has subsided. These sustained pathological responses have been linked to an increased
susceptibility to chronic debilitating and potentially life threatening diseases like inflammatory bowel disease, diabetes, cancer,
and certain neurological disorders.
Our
“predict” and “preempt” therapeutic approach is to intercept the underlying pathological immune and inflammatory
responses in susceptible individuals. Our pipeline includes:
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PRV-031:
a humanized, anti-CD3 mAb for the interception of T1D in pediatric patients with newly-diagnosed
T1D and, potentially, for delaying and/or preventing disease progression in subjects
at risk of developing T1D, which has been designated by the U.S. Food and Drug Administration,
or FDA, as orphan drug for the treatment of newly-diagnosed T1D and has been granted
Breakthrough Designation for the prevention or delay of clinical T1D in individuals at
risk of developing the disease;
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PRV-015:
a human anti-interleukin 15, or IL-15, mAb for the treatment of gluten-free diet non-responsive
celiac disease, or NRCD, intercepting the effects of contaminating gluten in the most
common autoimmune disorder without any approved medication (celiac disease);
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PRV-6527:
an oral small molecule CSF-1R inhibitor targeting the differentiation and activation
of antigen-presenting cells, or APCs, to prevent chronic inflammatory responses and progression
or relapse in CD;
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PRV-3279:
a humanized bispecific scaffold molecule targeting the B-cell surface proteins, CD32B
and CD79B, for the treatment of SLE and for the prevention of immunogenicity biotherapeutics
such as gene therapy. Dosing for the Phase 1b PREVAIL study began in August 2019 and
top-line data is expected in the first quarter of 2020; and
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PRV-101:
a CVB vaccine to prevent acute CVB infections and, in those patients at risk, preventing
the CVB-triggered autoimmune damage to pancreatic beta cells that progresses to T1D and
T1D-associated celiac disease. Top-line first-in-human data is expected in 2021.
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Our
Risks
Investing
in our common stock involves a high degree of risk. You should carefully consider all of the information in this prospectus and
in the documents incorporated into this prospectus by reference prior to investing in our common stock. These risks are discussed
more fully in the section titled “Risk Factors” beginning on page S-6 herein and in our Annual Report on Form 10-K
for the year ended December 31, 2018, as updated by our Quarterly Report on Form 10-Q for the quarter ended June 30, 2019. These
risks and uncertainties include, but are not limited to, the following:
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We
are a clinical stage biopharmaceutical company with a limited operating history;
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We
have incurred substantial operating losses in each year since our inception and expect
to continue to incur substantial losses for the foreseeable future and we may never become
profitable or, if achieved, be able to sustain profitability;
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If
this offering is not successful, there will be
substantial doubt regarding our ability to continue as a going concern;
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We
need to raise additional capital;
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We
have limited product candidates and may not be able to acquire additional product candidates
in the future;
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Although
we may pursue expedited regulatory approval pathways for a product candidate, it may
not qualify for expedited development or, if it does qualify, expedited development may
not actually lead to a faster development or regulatory review or approval process;
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We
may be unable to obtain or maintain governmental approvals to market our product candidates
in the United States, European Union, or in other jurisdictions;
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Even
if we receive regulatory approval for any of our product candidates, we may not be able
to successfully commercialize any approved products and the revenue that we generate
from sales, if any, may be limited;
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Clinical
drug development involves a lengthy and expensive process with an uncertain outcome,
and the results of earlier studies and trials may not be predictive of future trial results;
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We
depend on rights to certain pharmaceutical compounds that have been licensed to us; we
do not control these pharmaceutical compounds and any loss of our rights to them could
prevent us from selling our products;
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We
may be unable to protect our intellectual property rights or may infringe on the intellectual
property rights of others; and
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If
product liability lawsuits are brought against us, we may incur substantial liabilities
and may be required to limit commercialization of our product candidates.
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Implications
of Being an Emerging Growth Company
We
are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act,
and, for as long as we continue to be an “emerging growth company,” we may choose to take advantage of exemptions
from various reporting requirements applicable to other public companies but not to “emerging growth companies,” including,
but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley
Act of 2002, as amended, or the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic
reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation
and stockholder approval of any golden parachute payments not previously approved. We will be an “emerging growth company”
until the earlier of (i) December 31, 2023, the last day of the fiscal year following the fifth anniversary of our July 2018 initial
public offering, (ii) the last day of the first fiscal year in which our annual gross revenues exceed $1.07 billion, (iii) the
date that we become a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur
if the market value of our common stock that is held by non-affiliates exceeds $700 million as of the last business day of our
most recently completed second fiscal quarter, or (iv) the date on which we have issued more than $1 billion in non-convertible
debt during the preceding three-year period. We intend to take advantage of these reporting exemptions described above until we
are no longer an “emerging growth company.” Under the JOBS Act, “emerging growth companies” can also delay
adopting new or revised accounting standards until such time as those standards apply to private companies. We have irrevocably
elected not to avail ourselves of this exemption from new or revised accounting standards and, therefore, we are subject to the
same new or revised accounting standards as other public companies that are not “emerging growth companies.”
Corporate
Information
We
are a Delaware corporation formed on October 4, 2016. We are a virtual company and maintain a mailing address at P.O. Box 666,
Oldwick, NJ 08858. Our phone number is (908) 336-0360 and our web address is http://www.proventionbio.com. Information contained
in or accessible through our web site is not, and should not be deemed to be, incorporated by reference in, or considered part
of, this prospectus supplement.
THE
OFFERING
The
following summary contains basic information about this offering. The summary is not intended to be complete. You should read
the full text and more specific details contained elsewhere in this prospectus supplement and in the documents incorporated by
reference.
Common
stock offered by us
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shares
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Common
stock offered by us in the Concurrent Private Placement
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shares
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Common
stock to be outstanding immediately after this offering
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shares
( shares, if the underwriters exercise their option to purchase additional
shares in full)
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Underwriters’
option to purchase additional shares from us
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shares
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Concurrent
Private Placement
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Pursuant
to the terms of our License and Collaboration Agreement with Amgen, Inc., Amgen has agreed to purchase, in a private placement
to be completed concurrently with this offering, up to $20 million of shares of our common stock at the public offering
price per share for the shares of common stock sold in this offering.
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Use
of proceeds
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We
intend to use the net proceeds from this offering and the concurrent private placement
for general corporate purposes, including the funding of the ongoing development
of our product candidates. See “Use of Proceeds.”
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Risk
Factors
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Investing
in our common stock involves risks. Please read the information contained in or incorporated by reference under the heading
“Risk Factors” beginning on page S-6 of this prospectus supplement, and under similar headings in other documents
filed after the date hereof and incorporated by reference into this prospectus supplement and the accompanying base prospectus.
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Nasdaq
Capital Market symbol
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“PRVB”
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The
number of shares of our common stock to be outstanding upon completion of this offering is based on 39,353,405 shares of our common
stock outstanding as of August 31, 2019 and excludes, as of that date, the following:
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5,840,442
shares of our common stock issuable upon the exercise of outstanding stock options issued
under our equity incentive plan, with a weighted average exercise price of $6.13 per
share;
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1,045,419
additional shares of our common stock reserved for future issuance under our 2017 Equity
Incentive Plan; and
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2,124,568
shares of our common stock issuable upon the exercise of outstanding warrants with a
weighted average exercise price of $4.35 per share.
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Unless
otherwise indicated, all information in this prospectus supplement reflects or assumes the following:
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no
issuance or exercise of stock options or warrants on or after August 31, 2019; and
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no
exercise by the underwriters of their option to purchase additional shares of common
stock in this offering.
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RISK
FACTORS
An
investment in our common stock is speculative and illiquid and involves a high degree of risk including the risk of a loss of
your entire investment. You should carefully consider the following risk factors, as well as the risks described under “Risk
Factors” in the accompanying base prospectus and our Annual Report on Form 10-K for the year ended December 31, 2018 and
any subsequent updates described in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, all of which are incorporated
herein by reference, and as updated by any other document that we subsequently file with the Securities and Exchange Commission
and that is incorporated by reference into this prospectus supplement and the accompanying base prospectus, before investing in
our securities. These risks and uncertainties are not the only ones facing us and there may be additional matters that we are
unaware of or that we currently consider immaterial. All of these could adversely affect our business, business prospects, cash
flow, results of operations and financial condition. In such case, the trading price of our common stock could decline, and you
could lose all or part of your investment in our common stock.
Risks
Related to this Offering
If
you purchase common stock in this offering, you will suffer immediate dilution of your investment.
Because
the price per share of our common stock being offered is substantially higher than the book value per share of our common stock,
you will suffer substantial dilution in the net tangible book value of the common stock you purchase in this offering. If you
purchase shares of common stock in this offering, you will suffer immediate and substantial dilution of $
per share in the net tangible book value of the common stock you purchase in this offering. See “Dilution” for a more
detailed discussion of the dilution you will incur if you purchase shares of our common stock in this offering.
Our
management team may invest or spend the proceeds of this offering and the concurrent private placement in ways with which you
may not agree or in ways which may not yield a significant return.
We
currently intend to use the net proceeds from this offering and the concurrent private placement for general corporate purposes,
including the continued funding of the clinical development, regulatory and manufacturing activities of PRV-031, development activities
for PRV-015, the completion of a Phase 2a clinical trial for PRV-6527, development activities for PRV-3279 and PRV-101 and which
may include the acquisition or in-licensing of other product candidates. However, we have not determined the specific allocation
of the net proceeds among these potential uses. Our management will have broad discretion over the use and investment of the net
proceeds of this offering, and, accordingly, investors in this offering will need to rely upon the judgment of our management
with respect to the use of proceeds, with only limited information concerning our specific intentions. These proceeds could be
applied in ways that do not improve our operating results or increase the value of your investment. See “Use of Proceeds”
for further information.
If
we sell shares of our common stock in future financings, stockholders may experience immediate dilution and, as a result, our
stock price may decline.
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 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 (on a fully-converted
basis). Furthermore, sales of a substantial number of shares of our common stock in the public markets, or the perception that
such sales could occur, could depress the market price of our common stock.
The
price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for stockholders.
The
market price of our common stock has been volatile and can be subject to wide fluctuations in response to various factors, some
of which are beyond our control, including, the reporting of results of our clinical trials or partner-sponsored clinical trials
involving our programs. These factors include those discussed in this “Risk Factors” section of this prospectus, our
annual report on Form 10-K and quarterly reports on Form 10-Q and others such as:
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our
commercialization, marketing and manufacturing prospects;
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our
intentions and our ability to establish collaborations and/or partnerships;
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the
timing or likelihood of regulatory filings and approvals;
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our
development, commercialization, marketing and manufacturing capabilities;
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our
expectations regarding the potential market size and the size of the patient populations
for our product candidates;
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the
implementation of our business model and strategic plans for our business and technology;
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the
scope of protection we are able to establish and maintain for intellectual property rights
covering our product candidates, along with any product modifications and improvements;
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estimates
of our expenses, future revenue, capital requirements, our needs for additional financing
and our ability to obtain additional capital;
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our
financial performance; and
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developments
and projections relating to our competitors and our industry, including competing therapies
and procedures.
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In
addition, the stock markets in general, and the markets for biopharmaceutical and biotechnology stocks in particular, have experienced
extreme volatility that may have been unrelated to the operating performance of the issuer. These broad market fluctuations may
adversely affect the market price or liquidity of our common stock. In the past, when the market price of a stock has been volatile,
holders of that stock have sometimes instituted securities class action litigation against the issuer. If any of our stockholders
were to bring such a lawsuit against us, we could incur substantial costs defending the lawsuit and the attention of our management
would be diverted from the operation of our business.
Shareholders
will experience dilution by exercises of outstanding warrants and options.
As
of August 31, 2019, there were 2,124,568 shares of our common stock issuable upon the exercise of outstanding warrants, with a
weighted average exercise price of $4.35 per share, and options to purchase an aggregate of up to 5,840,442 shares of our
common stock, with a weighted average exercise price of $6.13 per share.
The
exercise of such warrants and options will result in dilution of your investment. As a result of this dilution, you may receive
significantly less than the full purchase price you paid for our securities in the event of our liquidation.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus and the information incorporated herein by reference contain forward-looking statements within the meaning of the federal
securities laws, which statements involve substantial risks and uncertainties. All statements, other than statements of historical
facts, included or incorporated by reference in this prospectus regarding our strategy, future events, future operations, future
financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are
forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,”
“intend,” “may,” “plan,” “predict,” “project,” “would”
and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain
these identifying words. These forward-looking statements include, among other things, statements about:
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our
lack of operating history;
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the
expectation that we will incur operating losses for the foreseeable future;
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our
current and future capital requirements to support our development and commercialization
efforts for our product candidates and our ability to satisfy our capital needs;
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our
dependence on our product candidates, which are still in preclinical or early stages
of clinical development;
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our
ability, or that of our third-party manufacturers, to manufacture GMP batches of our
product candidates as required for pre-clinical and clinical trials and, subsequently,
our ability to manufacture commercial quantities of our product candidates;
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our
ability to attract and retain key executives and medical and scientific personnel;
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our
ability to successfully complete required clinical trials for our product candidates
and obtain approval from the FDA or other regulatory agencies in different jurisdictions;
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our
lack of a sales and marketing organization and our ability to commercialize our product
candidates if we obtain regulatory approval;
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our
dependence on third-parties to manufacture our product candidates;
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our
reliance on third-party contract research organizations to conduct our clinical trials;
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our
ability to maintain or protect the validity of our licensed patents and other intellectual
property;
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our
ability to internally develop new inventions and intellectual property;
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our
ability to compete within the market for our product candidates, if approved;
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interpretations
of current laws and the passages of future laws;
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acceptance
of our business model by investors;
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our
anticipated use of proceeds from this offering and the concurrent private placement;
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the
accuracy of our estimates regarding expenses and capital requirements; and
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our
ability to adequately support organizational and business growth.
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These
forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in “Risk
Factors” above and elsewhere in this prospectus and the documents incorporated by reference in this prospectus. Moreover,
we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible
for us to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or
combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we
may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this
prospectus may not occur and actual results could differ materially and adversely from those anticipated or implied in our forward-looking
statements.
You
should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected
in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance
or events and circumstances described in the forward-looking statements will be achieved or occur. Moreover, neither we nor any
other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We undertake no obligation
to update publicly any forward-looking statements for any reason after the date of this prospectus to conform these statements
to actual results or to changes in our expectations, except as required by law.
You
should read this prospectus, including the information incorporated by reference in the prospectus, completely and with the understanding
that our actual future results may be materially different from what we expect. The forward-looking statements contained in this
prospectus, including the information incorporated by reference in the prospectus, are made as of the date of this prospectus
or the date of the applicable document incorporated by reference, and we do not assume any obligation to update any forward-looking
statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
IN
ADDITION TO THE ABOVE RISKS, BUSINESSES ARE OFTEN SUBJECT TO RISKS NOT FORESEEN OR FULLY APPRECIATED BY OUR MANAGEMENT. IN REVIEWING
THIS PROSPECTUS AND THE DOCUMENTS INCORPORATED BY REFERENCE IN THIS PROSPECTUS, POTENTIAL INVESTORS SHOULD KEEP IN MIND THAT THERE
MAY BE OTHER POSSIBLE RISKS THAT COULD BE IMPORTANT.
USE
OF PROCEEDS
We
estimate that the net proceeds received by us from this offering and the concurrent private placement, after deducting underwriting
discounts and commissions and estimated offering expenses payable by us, will be approximately $ or
approximately $ million
if the underwriters exercise their option to purchase additional shares in full.
We
intend to use the net proceeds from this offering and the concurrent private placement for general corporate purposes, including
funding the advancement of our product candidates. General corporate purposes may include research and development costs, including
the conduct of one or more clinical trials and process development and manufacturing of our product candidates, potential strategic
acquisitions of complementary businesses, services or technologies, expansion of our technology infrastructure and capabilities,
working capital and capital expenditures. Although we may use a portion of the net proceeds of this offering and the concurrent
private placement for the acquisition or licensing, as the case may be, of additional technologies, other assets or businesses,
or for other strategic investments or opportunities, we have no current understandings, agreements or commitments to do so.
Pending
our use of the net proceeds from this offering and the concurrent private placement, we intend to invest the net proceeds in a
variety of capital preservation investments, including short-term, investment-grade, interest-bearing instruments and U.S. government
securities.
DILUTION
If
you invest in our common stock in this offering, your ownership interest will be immediately diluted to the extent of the difference
between the public offering price per share you pay in this offering and the as adjusted net tangible book value per share of
our common stock immediately after giving effect to this offering and the concurrent private placement.
Our
net tangible book value equals our total tangible assets less our total liabilities. Net tangible book value per share is our
net tangible book value divided by the number of shares of common stock outstanding as of June 30, 2019. Our historical net tangible
book value as of June 30, 2019 was approximately $37.4 million, or approximately $1.00 per share of common stock.
After
giving effect to the sale of shares
of common stock in this offering and shares of our common stock in the concurrent private placement at the public offering price
of $ per share, and
after deducting underwriting discounts and commissions and estimated offering expenses payable by us, our as adjusted net book
value as of June 30, 2019 would have been approximately $ million,
or approximately $ per
share. This represents an immediate increase in as adjusted net tangible book value of $ per
share to our existing stockholders, and an immediate dilution of $ per
share to new investors participating in this offering and the concurrent private placement. The following table illustrates this
dilution on a per share basis:
Public
offering price per share
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$
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Net
tangible book value per share as of June 30, 2019
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$
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1.00
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Increase
in net tangible book value per share as of June 30, 2019 attributable to this offering
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$
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As
adjusted net tangible book value per share, after giving effect to this offering and the concurrent private placement
|
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$
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Dilution
per share to new investors participating in this offering
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|
|
|
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$
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|
If
the underwriters exercise their option to purchase additional
shares in full, our as adjusted net book value as of June 30, 2019 would increase to approximately million,
or approximately $ per share,
representing an immediate increase in as adjusted net tangible book value of $ per
share to our existing stockholders, and an immediate dilution of $ per
share to investors participating in this offering.
The
above discussion and table are based on 37,369,895 shares of common stock outstanding on June 30, 2019 and excludes, as of that
date, the following:
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5,768,475
shares of our common stock issuable upon the exercise of outstanding stock options issued
under our equity incentive plan, with a weighted average exercise price of $6.06 per
share;
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1,133,509
additional shares of our common stock reserved for future issuance under our 2017 Equity
Incentive Plan; and
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4,588,384
shares of our common stock issuable upon the exercise of outstanding warrants with a
weighted average exercise price of $3.37 per share.
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To
the extent that options or warrants are exercised, new options are issued under our 2017 Equity Incentive Plan, or we issue additional
shares of common stock in the future, there may be further dilution to investors participating in this offering. In addition,
we may choose to raise additional capital because of market conditions or strategic considerations, even if we believe that we
have sufficient funds for our current or future operating plans. If we raise additional capital through the sale of equity or
convertible debt securities, the issuance of these securities could result in further dilution to our stockholders.
UNDERWRITING
SVB
Leerink LLC is acting as the representative of each of the underwriters named below and joint bookrunning manager with
Cantor Fitzgerald & Co. for this offering. Subject to the terms and conditions set forth in the underwriting agreement
among us and the underwriters, we have agreed to sell to the underwriters, and each of the underwriters has agreed, severally
and not jointly, to purchase from us, the number of shares of common stock set forth opposite its name below.
Underwriter
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Number
of
Shares
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SVB
Leerink LLC
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Cantor Fitzgerald
& Co.
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H.C.
Wainwright & Co., LLC
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Total
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Subject
to the terms and conditions set forth in the underwriting agreement, the underwriters have agreed, severally and not jointly,
to purchase all of the shares sold under the underwriting agreement if any of the shares are purchased. If an underwriter defaults,
the underwriting agreement provides that the purchase commitments of the non-defaulting underwriters may be increased or the underwriting
agreement may be terminated.
We
have agreed to indemnify the underwriters against certain liabilities, including liabilities under the Securities Act, or to contribute
to payments the underwriters may be required to make in respect of those liabilities.
The
underwriters are offering the shares, subject to prior sale, when, as and if issued to and accepted by them, subject to approval
of legal matters by their counsel, including the validity of the shares, and subject to other conditions contained in the underwriting
agreement, such as the receipt by the underwriters of officers’ certificates and legal opinions. The underwriters reserve
the right to withdraw, cancel or modify offers to the public and to reject orders in whole or in part.
Discounts
and Commissions
The
representative has advised us that the underwriters propose initially to offer the shares to the public at the initial public
offering price set forth on the cover page of this prospectus supplement and to dealers at that price less a concession not in
excess of $ per share. After the
initial offering of the shares, the public offering price, concession or any other term of this offering may be changed by the
representative.
The
following table shows the public offering price, underwriting discounts and commissions and proceeds, before expenses, to us.
The information assumes either no exercise or full exercise by the underwriters of their option to purchase additional shares
of our common stock.
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Total
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Per
Share
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Without
Option
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With
Option
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|
Public offering price
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$
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$
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$
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|
Underwriting discounts and commissions
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|
$
|
|
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$
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$
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Proceeds, before expenses, to us
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$
|
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$
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$
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We
estimate expenses payable by us in connection with this offering, other than the underwriting discounts and commissions referred
to above, will be approximately $0.2 million. We also have agreed to reimburse the underwriters for up to $35,000 for their
FINRA counsel fee. In accordance with FINRA Rule 5110, this reimbursed fee is deemed underwriting compensation for this offering.
Option
to Purchase Additional Shares
We
have granted an option to the underwriters, exercisable for 30 days after the date of this prospectus supplement, to purchase
up to additional shares
at the public offering price, less the underwriting discounts and commissions. If the underwriters exercise this option, each
underwriter will be obligated, subject to the conditions contained in the underwriting agreement, to purchase a number of additional
shares proportionate to that underwriter’s initial amount reflected in the above table.
No
Sales of Similar Securities
Our
executive officers and directors have agreed not to sell or transfer any common stock or securities convertible into or exchangeable
or exercisable for common stock, for 90 days after the date of this prospectus supplement without first obtaining the written
consent of SVB Leerink LLC on behalf of the underwriters. Specifically, we and these other persons have agreed, with certain limited
exceptions, not to directly or indirectly:
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offer,
pledge, sell or contract to sell any common stock;
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sell
any option or contract to purchase any common stock;
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purchase
any option or contract to sell any common stock;
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grant
any option, right or warrant for the sale of any common stock;
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otherwise
dispose of or transfer any common stock;
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exercise
any right with respect to the registration of the common stock or file or cause to be
filed any registration statement in connection with the common stock; or
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enter
into any swap or other agreement or any transaction that transfers, in whole or in part,
the economic consequence of ownership of any common stock, whether any such swap, agreement
or transaction is to be settled by delivery of shares or other securities, in cash or
otherwise.
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The
lock-up provisions apply to common stock and to securities convertible into or exchangeable or exercisable for common stock. They
also apply to common stock owned now or acquired later by the person executing the lock-up agreement or for which the person executing
the lock-up agreement later acquires the power of disposition.
Nasdaq
Capital Market Listing
Our
common stock is listed on the Nasdaq Capital Market under the symbol “PRVB.”
Price
Stabilization, Short Positions and Penalty Bids
Until
the distribution of the shares is completed, SEC rules may limit underwriters and selling group members from bidding for and purchasing
our common stock. However, the representative may engage in transactions that stabilize the price of the common stock, such as
bids or purchases to peg, fix or maintain that price.
In
connection with this offering, the underwriters may purchase and sell our common stock in the open market. These transactions
may include short sales, purchases on the open market to cover positions created by short sales and stabilizing transactions.
Short sales involve the sale by the underwriters of a greater number of shares than they are required to purchase in this offering.
“Covered” short sales are sales made in an amount not greater than the underwriters’ option to purchase additional
shares described above. The underwriters may close out any covered short position by either exercising their option to purchase
additional shares or purchasing shares in the open market. In determining the source of shares to close out the covered short
position, the underwriters will consider, among other things, the price of shares available for purchase in the open market as
compared to the price at which they may purchase shares through the option to purchase additional shares granted to them under
the underwriting agreement described above. “Naked” short sales are sales in excess of such option. The underwriters
must close out any naked short position by purchasing shares in the open market. A naked short position is more likely to be created
if the underwriters are concerned that there may be downward pressure on the price of our common stock in the open market after
pricing that could adversely affect investors who purchase in this offering. Stabilizing transactions consist of various bids
for or purchases of shares of common stock made by the underwriters in the open market prior to the closing of this offering.
The
underwriters may also impose a penalty bid. This occurs when a particular underwriter repays to the underwriters a portion of
the underwriting discount received by it because the representative has repurchased shares sold by or for the account of such
underwriter in stabilizing or short covering transactions.
Similar
to other purchase transactions, the underwriters’ purchases to cover the syndicate short sales may have the effect of raising
or maintaining the market price of our common stock or preventing or retarding a decline in the market price of our common stock.
As a result, the price of our common stock may be higher than the price that might otherwise exist in the open market. The underwriters
may conduct these transactions on the Nasdaq Capital Market, in the over-the-counter market or otherwise.
Neither
we nor any of the underwriters make any representation or prediction as to the direction or magnitude of any effect that the transactions
described above may have on the price of our common stock. In addition, neither we nor any of the underwriters make any representation
that the representative will engage in these transactions or that these transactions, once commenced, will not be discontinued
without notice.
Electronic
Distribution
In
connection with this offering, certain of the underwriters or securities dealers may distribute prospectuses by electronic means,
such as e-mail.
Other
Relationships
The
underwriters and certain of their affiliates are full service financial institutions engaged in various activities, which may
include securities trading, commercial and investment banking, financial advisory, investment management, investment research,
principal investment, hedging, financing and brokerage activities. Some of the underwriters and certain of their affiliates may
in the future engage in investment banking and other commercial dealings in the ordinary course of business with us and our affiliates,
for which they may in the future receive customary fees, commissions and expenses.
In
addition, in the ordinary course of their business activities, the underwriters and their affiliates may make or hold a broad
array of investments and actively trade debt and equity securities (or related derivative securities) and financial instruments
(including bank loans) for their own account and for the accounts of their customers. Such investments and securities activities
may involve securities and/or instruments of ours or our affiliates. The underwriters and their affiliates may also make investment
recommendations and/or publish or express independent research views in respect of such securities or financial instruments and
may hold, or recommend to clients that they acquire, long and/or short positions in such securities and instruments.
Selling
Restrictions
Notice
to Prospective Investors in the European Economic Area
In
relation to each Member State of the European Economic Area which has implemented the Prospectus Directive, each referred to here
as a Relevant Member State, with effect from and including the date on which the Prospectus Directive is implemented in that Relevant
Member State, no offer of shares may be made to the public in that Relevant Member State other than:
A.
to any legal entity which is a qualified investor as defined in the Prospectus Directive;
B.
to fewer than 150 natural or legal persons (other than qualified investors as defined in the Prospectus Directive), as permitted
under the Prospectus Directive, subject to obtaining the prior consent of the representative; or
C.
in any other circumstances falling within Article 3(2) of the Prospectus Directive,
provided
that no such offer of shares shall require the Company or the representative[s] to publish a prospectus pursuant to Article 3
of the Prospectus Directive or supplement a prospectus pursuant to Article 16 of the Prospectus Directive.
Each
person in a Relevant Member State who initially acquires any shares or to whom any offer is made will be deemed to have represented,
acknowledged and agreed that it is a “qualified investor” within the meaning of the law in that Relevant Member State
implementing Article 2(1)(e) of the Prospectus Directive. In the case of any shares being offered to a financial intermediary
as that term is used in Article 3(2) of the Prospectus Directive, each such financial intermediary will be deemed to have represented,
acknowledged and agreed that the shares acquired by it in the offer have not been acquired on a non-discretionary basis on behalf
of, nor have they been acquired with a view to their offer or resale to, persons in circumstances which may give rise to an offer
of any shares to the public other than their offer or resale in a Relevant Member State to qualified investors as so defined or
in circumstances in which the prior consent of the representative has been obtained to each such proposed offer or resale.
We,
the representative and each of our and the representative’s affiliates will rely upon the truth and accuracy of the foregoing
representations, acknowledgements and agreements.
This
prospectus supplement has been prepared on the basis that any offer of shares in any Relevant Member State will be made pursuant
to an exemption under the Prospectus Directive from the requirement to publish a prospectus for offers of shares. Accordingly,
any person making or intending to make an offer in that Relevant Member State of shares which are the subject of the offering
contemplated in this prospectus supplement may only do so in circumstances in which no obligation arises for the company or any
of the underwriters to publish a prospectus pursuant to Article 3 of the Prospectus Directive in relation to such offer. Neither
we nor the underwriters have authorized, nor do they authorize, the making of any offer of shares in circumstances in which an
obligation arises for the company or the underwriters to publish a prospectus for such offer.
For
the purpose of the above provisions, the expression “an offer to the public” in relation to any shares in any Relevant
Member State means the communication in any form and by any means of sufficient information on the terms of the offer and the
shares to be offered so as to enable an investor to decide to purchase or subscribe the shares, as the same may be varied in the
Relevant Member State by any measure implementing the Prospectus Directive in the Relevant Member State and the expression “Prospectus
Directive” means Directive 2003/71/EC (including the 2010 PD Amending Directive, to the extent implemented in the Relevant
Member States) and includes any relevant implementing measure in the Relevant Member State and the expression “2010 PD Amending
Directive” means Directive 2010/73/EU.
MiFID
II Product Governance
Any
person offering, selling or recommending the shares, or a distributor, should take into consideration the manufacturers’
target market assessment; however, a distributor subject to MiFID II is responsible for undertaking its own target market assessment
in respect of the shares (by either adopting or refining the manufacturers’ target market assessment) and determining appropriate
distribution channels.
Notice
to Prospective Investors in the United Kingdom
In
addition, in the United Kingdom, this document is being distributed only to, and is directed only at, and any offer subsequently
made may only be directed at persons who are “qualified investors” (as defined in the Prospectus Directive) (i) who
have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets
Act 2000 (Financial Promotion) Order 2005, as amended, or the Order, and/or (ii) who are high net worth companies (or persons
to whom it may otherwise be lawfully communicated) falling within Article 49(2)(a) to (d) of the Order (all such persons together
being referred to as “relevant persons”) or otherwise in circumstances which have not resulted and will not result
in an offer to the public of the shares in the United Kingdom within the meaning of the Financial Services and Markets Act 2000.
Any
person in the United Kingdom that is not a relevant person should not act or rely on the information included in this document
or use it as basis for taking any action. In the United Kingdom, any investment or investment activity that this document relates
to may be made or taken exclusively by relevant persons.
Notice
to Prospective Investors in Canada
The
shares may be sold only to purchasers purchasing, or deemed to be purchasing, as principal that are accredited investors, as defined
in National Instrument 45-106 Prospectus Exemptions or subsection 73.3(1) of the Securities Act (Ontario), and are permitted clients,
as defined in National Instrument 31-103 Registration Requirements, Exemptions and Ongoing Registrant Obligations. Any resale
of the shares must be made in accordance with an exemption from, or in a transaction not subject to, the prospectus requirements
of applicable securities laws.
Securities
legislation in certain provinces or territories of Canada may provide a purchaser with remedies for rescission or damages if this
prospectus supplement (including any amendment thereto) contains a misrepresentation, provided that the remedies for rescission
or damages are exercised by the purchaser within the time limit prescribed by the securities legislation of the purchaser’s
province or territory. The purchaser should refer to any applicable provisions of the securities legislation of the purchaser’s
province or territory for particulars of these rights or consult with a legal advisor.
Pursuant
to section 3A.3 of National Instrument 33-105 Underwriting Conflicts (NI 33-105), the underwriters are not required to comply
with the disclosure requirements of NI 33-105 regarding underwriter conflicts of interest in connection with this offering.
LEGAL
MATTERS
The
validity of the common stock offered hereby will be passed upon for us by Lowenstein Sandler LLP, New York, New York. Pepper Hamilton
LLP, Philadelphia, Pennsylvania has acted as counsel for the underwriters in connection with certain legal matters related to
this offering.
EXPERTS
The
balance sheets of Provention Bio, Inc. as of December 31, 2018 and 2017, and the related statements of operations, stockholders’
equity (deficit), and cash flows for each of the years ended December 31, 2018 and 2017 have been audited by EisnerAmper LLP,
independent registered public accounting firm, as stated in their report which is incorporated herein by reference. Such financial
statements have been incorporated herein by reference in reliance on the report of such firm given upon their authority as experts
in accounting and auditing.
WHERE
YOU CAN FIND MORE INFORMATION
This
prospectus supplement and the accompanying prospectus are part of the registration statement on Form S-3 we filed with the SEC
under the Securities Act and do not contain all the information set forth in the registration statement. Whenever a reference
is made in this prospectus supplement or the accompanying prospectus to any of our contracts, agreements or other documents, the
reference may not be complete and you should refer to the exhibits that are a part of the registration statement or the exhibits
to the reports or other documents incorporated by reference into this prospectus supplement and the accompanying prospectus for
a copy of such contract, agreement or other document.
We
are subject to the information reporting requirements of the Securities Exchange Act of 1934, as amended, and we file Quarterly
Reports on Form 10-Q, Annual Reports on Form 10-K, Current Reports on Form 8-K, proxy statements and other required information
and reports with the SEC. Our filings are available to the public over the Internet at the SEC’s web site at http://www.sec.gov.
We also maintain a website at http://www.proventionbio.com, at which you may access these materials free of charge as soon as
reasonably practicable after they are electronically filed with, or furnished to, the SEC. The information contained in, or that
can be accessed through, our website is not part of, and is not incorporated into, this prospectus. We have included our website
address in this prospectus solely as an inactive textual reference.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
The
SEC allows us to “incorporate by reference” into this prospectus supplement the information in other documents that
we file with it. This means that we can disclose important information to you by referring you to those documents. The information
incorporated by reference is considered to be a part of this prospectus supplement, and information in documents that we file
later with the SEC will automatically update and supersede information contained in documents filed earlier with the SEC or contained
in this prospectus supplement. We incorporate by reference in this prospectus supplement the documents listed below and any future
filings that we may make with the SEC under Sections 13(a), 13(c), 14, or 15(d) of the Exchange Act prior to the termination of
the offering under this prospectus supplement; provided, however, that we are not incorporating, in each case, any documents or
information deemed to have been furnished and not filed in accordance with SEC rules:
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our
Annual Report on Form 10-K for the year ended December 31, 2018, filed with the SEC on
March 19, 2019; and
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our
Quarterly Reports on Form 10-Q for the periods ended March 31, 2019, filed with the SEC
on May 8, 2019 and June 30, 2019, filed with the SEC on August 6, 2019; and
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our
Current Reports on Form 8-K filed with the SEC on March 28, 2019, May 30, 2019 and June
10, 2019 (other than the information furnished under Item 7.01 of Form 8-K); and
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our
Definitive Proxy Statement on Schedule 14A, filed on April 15, 2019; and
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the
description of our common stock contained in our registration statement on Form 8-A filed
with the SEC on June 22, 2018, including any amendments or reports filed for the purposes
of updating this description.
|
All
reports and other documents we subsequently file pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act prior to the
termination of this offering, including all such documents we may file with the SEC after the date of this prospectus supplement
and accompanying prospectus, but excluding any information furnished to, rather than filed with, the SEC, will also be incorporated
by reference into this prospectus supplement and deemed to be part of this prospectus supplement from the date of the filing of
such reports and documents.
We
undertake to provide without charge to each person (including any beneficial owner) who receives a copy of this prospectus, upon
written or oral request, a copy of all of the preceding documents that are incorporated by reference (other than exhibits, unless
the exhibits are specifically incorporated by reference into these documents). We will provide you without charge, upon your oral
or written request, a copy of these materials. Requests for such copies should be directed to:
Provention
Bio, Inc.
P.O.
Box 666
Oldwick,
NJ 08858
Telephone
number: (908) 336-0360
PROSPECTUS
Provention
Bio, Inc.
$200,000,000
Common
Stock
Preferred
Stock
Warrants
Debt
Securities
Subscription
Rights
Units
We
may offer, issue and sell from time to time together or separately, in one or more offerings, any combination of (i) our common
stock, (ii) our preferred stock, which we may issue in one or more series, (iii) warrants, (iv) senior or subordinated debt securities,
(v) subscription rights and (vi) units. The debt securities may consist of debentures, notes, or other types of debt. The debt
securities, preferred stock, warrants and subscription rights may be convertible into, or exercisable or exchangeable for, common
or preferred stock or other securities of ours. The units may consist of any combination of the securities listed above.
The
aggregate public offering price of the securities that we are offering will not exceed $200,000,000. We will offer the securities
in an amount and on terms to be set forth in one or more supplements to this prospectus. Our common stock is listed on the Nasdaq
Capital Market under the symbol “PRVB.” The last reported sale price for our common stock on July 31, 2019 as quoted
on the Nasdaq Capital Market was $10.56 per share. You are urged to obtain current market quotations of our common stock. We have
no preferred stock, warrants, debt securities, subscription rights or units listed on any market. Each prospectus supplement will
indicate if the securities offered thereby will be listed on any securities exchange.
Should
we offer any of the securities described in this prospectus, we will provide you with the specific terms of the particular securities
being offered in supplements to this prospectus. You should read this prospectus and any supplement, together with additional
information described under the headings “Additional Information” and “Incorporation of Certain Information
by Reference” carefully before you invest. This prospectus may not be used to sell securities unless accompanied by a prospectus
supplement.
Investing
in our securities involves risk. You should carefully consider the risks that we refer you to under the section captioned “Risk
Factors” in this prospectus on page 4 before buying our securities.
We
may sell these securities directly to our stockholders or to other purchasers or through agents on our behalf or through underwriters
or dealers as designated from time to time. If any agents or underwriters are involved in the sale of any of these securities,
the applicable prospectus supplement will provide the names of the agents or underwriters and any applicable fees, commissions
or discounts.
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 August 8, 2019
TABLE
OF CONTENTS
Provention
Bio, Inc. is referred to herein as “Provention,” “the Company,” “we,” “us,” and
“our,” unless the context indicates otherwise. This prospectus and the information incorporated herein by reference
contain references to trademarks, service marks and trade names owned by us or other companies. Solely for convenience, trademarks,
service marks and trade names referred to in this prospectus and the information incorporated herein, including logos, artwork,
and other visual displays, may appear without the ® or ™ symbols, but such references are not
intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights
of the applicable licensor to these trademarks, service marks and trade names. We do not intend our use or display of other companies’
trade names, service marks or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
Other trademarks, trade names and service marks appearing in this prospectus are the property of their respective owners.
You
may only rely on the information contained in this prospectus and the accompanying prospectus supplement or that we have referred
you to. We have not authorized anyone to provide you with different information. This prospectus and any prospectus supplement
do not constitute an offer to sell or a solicitation of an offer to buy any securities other than the securities offered by this
prospectus and the prospectus supplement. This prospectus and any prospectus supplement do not constitute an offer to sell or
a solicitation of an offer to buy any securities in any circumstances in which such offer or solicitation is unlawful. Neither
the delivery of this prospectus or any prospectus supplement nor any sale made hereunder shall, under any circumstances, create
any implication that there has been no change in our affairs since the date of this prospectus or such prospectus supplement or
that the information contained by reference to this prospectus or any prospectus supplement is correct as of any time after its
date.
ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement that we filed with the Securities and Exchange Commission, or SEC, using a “shelf”
registration process. Under this shelf registration process, we may from time to time offer and sell, in one or more offerings,
any or all of the securities described in this prospectus, separately or together, up to an aggregate offering price of $200,000,000.
This prospectus provides you with a general description of our securities being offered. When we issue the securities being offered
by this prospectus, we will provide a prospectus supplement (which term includes, as applicable, the sales agreement prospectus
filed with the registration statement of which this prospectus forms a part) that will contain specific information about the
terms of that offering. 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 additional information described under the heading
“Additional Information” and “Incorporation of Certain Information by Reference.”
PROSPECTUS
SUMMARY
This
summary highlights certain information about us, this offering and selected information contained elsewhere in or incorporated
by reference into this prospectus. This summary is not complete and does not contain all of the information that you should consider
before deciding whether to invest in our common stock. For a more complete understanding of our company and this offering, we
encourage you to read and consider carefully the more detailed information in this prospectus, and the information included in
any free writing prospectus that we have authorized for use in connection with this offering, including the information under
the heading “Risk Factors” in this prospectus on page 4 and in the documents incorporated by reference into this prospectus.
Our
Company
We
are a clinical stage biopharmaceutical company, focused on the development and commercialization of novel therapeutics and innovative
approaches aimed at intercepting and preventing immune-mediated diseases. We are leveraging a transformational drug development
strategy that sources, repositions and advances potential therapeutic candidates that in most instances have undergone previous
clinical testing but may have been underdeveloped or deprioritized because of insufficient clinical trial efficacy (i.e., a benefit
in endpoints relevant for the disease or condition under study as compared to placebo) or for strategic reasons. Importantly,
these product candidates not only appear to have been well-tolerated but have demonstrated proof-of-mechanism (i.e., evidence
that the experimental drug has the intended biologic effect in its target and/or pathway) by preventing or intercepting potentially
clinically relevant immunopathologic pathways. These characteristics exemplify the profile against which therapeutic candidates
are evaluated for strategic refocusing or advancement to the next stage of clinical development. In this context, we are creating
a diverse portfolio of innovative solutions targeting opportunities focused on intercepting and preventing immune-mediated disease.
Our
mission is to in-license, transform and develop clinical-stage, or nearly clinical-stage, therapeutic candidates targeting the
high morbidity, mortality and escalating costs of autoimmune and inflammatory diseases, including: celiac disease, type 1 diabetes,
or T1D, Crohn’s disease, or CD, and lupus. Our current development pipeline consists of a Phase 3 product candidate for
the interception and possible delay or prevention of T1D, a Phase 2 product candidate for celiac disease, a Phase 2 product candidate
for CD, a Phase 1 product candidate for systemic lupus erythematosus, or SLE, and a preclinical candidate that we expect to submit
a Clinical Trial Application, or CTA, in 2020 and that we intend to develop for acute coxsackie B virus, also referred to as coxsackie
virus B or CVB, infection and the potential prevention or delay in onset of T1D. All of these programs have been selected and
acquired or in-licensed because of their therapeutic potential to interrupt, delay, reverse or prevent the onset or progression
of life-threatening or debilitating immune-mediated disease.
We
preferentially source, reposition, transform and advance underdeveloped or deprioritized clinical-stage, or nearly clinical-stage,
therapeutic candidates targeting the interception and prevention of immune-mediated disease. Our “predict” and “pre-empt”
therapeutic approach focuses on identifying at-risk patients and intervening before the targeted disease begins, re-appears, exacerbates
or progresses. We believe our experience and expertise in translational medicine, immunology, and the design and execution of
rapid go/no-go clinical trials makes us unique in the field of immune-mediated disease.
We
have access to relevant in-licensing opportunities from industry-leading pharmaceutical companies; innovative, development-stage
biotechnology companies; and world-renowned academic centers. To date, we have obtained exclusive worldwide rights to an enterovirus
vaccine platform, targeting the prevention of CVB infections and T1D onset, from Vactech Ltd., a Finnish biotechnology company;
one clinical-stage product candidate from an affiliated entity of Janssen Pharmaceuticals, Inc., or Janssen, a small molecule
targeting an upstream pathological mechanism believed to drive CD; two product candidates from MacroGenics, Inc., a Phase 3 clinical-stage
product candidate for the interception and possible delay or prevention of T1D and a Phase 1 clinical-stage product candidate
for the potential treatment of SLE; and a Phase 2 clinical-stage product candidate from Amgen, Inc., or Amgen, targeting celiac
disease.
Focus
and Pipeline
Inflammation
is a natural consequence of most infections as it is the immune system’s first response to invading pathogens in the event
of injury or acute illness. Most of the time, this response is beneficial and well-controlled; helping to repair tissue damage
and clear pathogens from the body. In addition to directly damaging tissues and organs, an infection can sometimes result in the
excessive release of toxic immune mediators leading to a potentially life-threatening acute pathological immune response. When
patients have the requisite genetic predisposition, infections can also trigger chronic autoimmune responses that persist and
progress long after the original insult has subsided. These sustained pathological responses have been linked to an increased
susceptibility to chronic debilitating and potentially life threatening diseases like inflammatory bowel disease, diabetes, cancer,
and certain neurological disorders.
Our
“predict” and “preempt” therapeutic approach is to intercept the underlying pathological immune and inflammatory
responses in susceptible individuals. Our pipeline includes:
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PRV-031:
a humanized, anti-CD3 mAb for the interception of T1D in pediatric patients with newly-diagnosed
T1D and, potentially, for delaying and/or preventing disease progression in subjects
at risk of developing T1D, which has been designated by the U.S. Food and Drug Administration,
or FDA, as orphan drug for the treatment of newly-diagnosed T1D;
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PRV-015:
a human anti-interleukin 15, or IL-15, mAb for the treatment of gluten-free diet non-responsive celiac disease, or NRCD, intercepting
the effects of contaminating gluten in the most common autoimmune disorder without any approved medication (celiac disease);
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PRV-6527:
an oral small molecule CSF-1R inhibitor targeting the differentiation and activation of antigen-presenting cells, or APCs,
to prevent chronic inflammatory responses and progression or relapse in CD;
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PRV-3279:
a humanized bispecific scaffold molecule targeting the B-cell surface proteins, CD32B and CD79B, for the treatment of SLE
and for the prevention of immunogenicity biotherapeutics such as gene therapy;
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PRV-101:
a CVB vaccine to prevent acute CVB infections and, in those patients at risk, preventing the CVB-triggered autoimmune damage
to pancreatic beta cells that progresses to T1D and T1D-associated celiac disease; and
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Our
Risks
Investing
in our securities involves a high degree of risk. You should carefully consider all of the information in this prospectus and
in the documents incorporated into this prospectus by reference prior to investing in our common stock. These risks are discussed
more fully in the section titled “Risk Factors” in our Annual report on Form 10-K for the year ended December 31,
2018, as updated by our Quarterly Report on Form 10-Q for the quarter ended March 31, 2019. These risks and uncertainties include,
but are not limited to, the following:
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We
are a clinical stage biopharmaceutical company with a limited operating history;
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We
have incurred substantial operating losses in each year since our inception and expect to continue to incur substantial losses
for the foreseeable future and we may never become profitable or, if achieved, be able to sustain profitability;
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There
is substantial doubt regarding our ability to continue as a going concern;
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We
need to raise additional capital;
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We
have limited product candidates and may not be able to acquire additional product candidates in the future;
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Although
we may pursue expedited regulatory approval pathways for a product candidate, it may not qualify for expedited development
or, if it does qualify, expedited development may not actually lead to a faster development or regulatory review or approval
process;
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We
may be unable to obtain or maintain governmental approvals to market our product candidates in the United States, European
Union, or in other jurisdictions;
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Even
if we receive regulatory approval for any of our product candidates, we may not be able to successfully commercialize any
approved products and the revenue that we generate from sales, if any, may be limited;
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Clinical
drug development involves a lengthy and expensive process with an uncertain outcome, and the results of earlier studies and
trials may not be predictive of future trial results;
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We
depend on rights to certain pharmaceutical compounds that have been licensed to us; we do not control these pharmaceutical
compounds and any loss of our rights to them could prevent us from selling our products;
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We
may be unable to protect our intellectual property rights or may infringe on the intellectual property rights of others; and
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If
product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization
of our product candidates.
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Implications
of Being an Emerging Growth Company
We
are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act,
and, for as long as we continue to be an “emerging growth company,” we may choose to take advantage of exemptions
from various reporting requirements applicable to other public companies but not to “emerging growth companies,” including,
but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley
Act of 2002, as amended, or the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic
reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation
and stockholder approval of any golden parachute payments not previously approved. We will be an “emerging growth company”
until the earlier of (i) December 31, 2023, the last day of the fiscal year following the fifth anniversary of our July 2018 initial
public offering, (ii) the last day of the first fiscal year in which our annual gross revenues exceed $1.07 billion, (iii) the
date that we become a “large accelerated filer” as defined in Rule 12b-2 under the Securities Exchange Act of 1934,
as amended, or the Exchange Act, which would occur if the market value of our common stock that is held by non-affiliates exceeds
$700 million as of the last business day of our most recently completed second fiscal quarter, or (iv) the date on which we have
issued more than $1 billion in non-convertible debt during the preceding three-year period. We intend to take advantage of these
reporting exemptions described above until we are no longer an “emerging growth company.” Under the JOBS Act, “emerging
growth companies” can also delay adopting new or revised accounting standards until such time as those standards apply to
private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards
and, therefore, we are subject to the same new or revised accounting standards as other public companies that are not “emerging
growth companies.”
Corporate
Information
We
are a Delaware corporation formed on October 4, 2016. We are a virtual company and maintain a mailing address at P.O. Box 666,
Oldwick, NJ 08858. Our phone number is (908) 336-0360 and our web address is http://www.proventionbio.com. Information contained
in or accessible through our web site is not, and should not be deemed to be, incorporated by reference in, or considered part
of, this prospectus.
RISK
FACTORS
An
investment in our common stock is speculative and illiquid and involves a high degree of risk including the risk of a loss of
your entire investment. You should carefully consider the risk factors set forth under the heading “Risk Factors”
in our Annual Report on Form 10-K for the year ended December 31, 2018, as may be revised or supplemented by our subsequent Quarterly
Reports on Form 10-Q or Current Reports on Form 8-K, each of which are on file with the SEC and are incorporated herein by reference,
and which may be amended, supplemented or superseded from time to time by other reports we file with the SEC in the future. These
risk factors contain, in addition to historical information, forward looking statements that involve risks and uncertainties.
Our actual results could differ significantly from the results discussed in the forward looking statements. The occurrence
of any of the adverse developments described in the documents incorporated by reference could materially and adversely harm our
business, financial condition, results of operations or prospects. In such event, the value of our common stock could decline,
and you could lose all or a substantial portion of the money that you pay for our common stock. In addition, the risks and uncertainties
discussed in the documents incorporated by reference are not the only ones we face. Our business, financial condition, results
of operations or prospects could also be harmed by risks and uncertainties not currently known to us or that we currently do not
believe are material, and these risks and uncertainties could results in a complete loss of your investment. In assessing these
risks and uncertainties, you should also refer to the other information contained in this prospectus (as supplemented or amended)
and the documents incorporated by reference in this prospectus.
FORWARD-LOOKING
STATEMENTS
This
prospectus, including the documents that we incorporate by reference, contains forward-looking statements as that term is defined
in the federal securities laws. The events described in forward-looking statements contained in this prospectus, including the
documents that we incorporate by reference, may not occur. Generally, these statements relate to our business plans or strategies,
projected or anticipated benefits or other consequences of our plans or strategies, financing plans, projected or anticipated
benefits from acquisitions that we may make, or projections involving anticipated revenues, earnings or other aspects of our operating
results or financial position, and the outcome of any contingencies. Any such forward-looking statements are based on current
expectations, estimates and projections of management. We intend for these forward-looking statements to be covered by the safe-harbor
provisions for forward-looking statements. Words such as “may,” “expect,” “believe,” “anticipate,”
“project,” “plan,” “intend,” “estimate,” and “continue,” and their
opposites and similar expressions are intended to identify forward-looking statements. We caution you that these statements are
not guarantees of future performance or events and are subject to a number of uncertainties, risks and other influences, many
of which are beyond our control that may influence the accuracy of the statements and the projections upon which the statements
are based. Factors that may affect our results include, but are not limited to, the risks and uncertainties discussed in the “Risk
Factors” section of this prospectus, any accompanying prospectus supplements, in our Annual Report on Form 10-K or in other
reports we file with the SEC.
Any
one or more of these uncertainties, risks and other influences could materially affect our results of operations and whether forward-looking
statements made by us ultimately prove to be accurate. Our actual results, performance and achievements could differ materially
from those expressed or implied in these forward-looking statements. We undertake no obligation to publicly update or revise any
forward-looking statements, whether from new information, future events or otherwise.
You
should rely only on the information in this prospectus. 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 upon it.
USE
OF PROCEEDS
Unless
we inform you otherwise in the prospectus supplement, we will use the net proceeds from the sale of the securities offered by
this prospectus and the exercise price from the exercise of any convertible securities, if any, for general corporate purposes,
which may include funding research, development and product manufacturing, clinical trials, acquisitions or investments in businesses,
products or technologies that are complementary to our own, increasing our working capital, reducing indebtedness, and capital
expenditures.
When
particular securities are offered, the prospectus supplement relating to that offering will set forth our intended use of the
net proceeds received from the sale of those securities we sell. Pending the application of the net proceeds for these purposes,
we expect to invest the proceeds in short-term, interest-bearing instruments or other investment-grade securities.
THE
SECURITIES WE MAY OFFER
General
The
descriptions of the securities contained in this prospectus, together with the applicable prospectus supplements, summarize all
of 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 any securities the particular terms of the securities offered by that prospectus supplement.
If we indicate in the applicable prospectus supplement, the terms of the securities may differ from the terms we have summarized
below. We may also include in the prospectus supplement information about material United States federal income tax considerations
relating to the securities, and the securities exchange, if any, on which the securities will be listed.
We
may sell from time to time, together or separately, in one or more offerings:
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common
stock;
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preferred
stock;
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debt
securities;
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subscription
rights to purchase shares of common stock, preferred stock or debt securities;
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warrants
to purchase shares of common stock or preferred stock; and
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units
consisting of any combination of the securities listed above.
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In
this prospectus, we refer to the common stock, preferred stock, debt securities, subscription rights, warrants and units collectively
as “securities.” The total dollar amount of all securities that we may sell will not exceed $200,000,000.
If
we issue debt securities at a discount from their original stated principal amount, then, for purposes of calculating the total
dollar amount of all securities issued under this prospectus, we will treat the initial offering price of the debt securities
as the total original principal amount of the debt securities.
This
prospectus may not be used to consummate a sale of securities unless it is accompanied by a prospectus supplement.
DESCRIPTION
OF CAPITAL STOCK
General
Our
authorized capital stock consists of:
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100,000,000
shares of common stock, par value $0.0001 per share; and
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25,000,000
shares of preferred stock, par value $0.0001 per share, of which, as of the date of this prospectus, none of which shares
have been designated.
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As
of close of business on July 31, 2019, 39,337,282 shares of common stock were issued and outstanding and no shares of preferred
stock were issued and outstanding.
The
additional shares of our authorized capital stock available for issuance may be issued at times and under circumstances so as
to have a dilutive effect on earnings per share and on the equity ownership of the holders of our common stock. The ability of
our board of directors to issue additional shares of stock could enhance the board’s ability to negotiate on behalf of the
stockholders in a takeover situation but could also be used by the board to make a change-in-control more difficult, thereby denying
stockholders the potential to sell their shares at a premium and entrenching current management. The following description is
a summary of the material provisions of our capital stock. You should refer to our Second Amended and Restated Certificate of
Incorporation and our Amended and Restated Bylaws, both of which are on file with the SEC as exhibits to previous SEC filings,
for additional information. The summary below is qualified by provisions of applicable law.
Common
Stock
Holders
of our common stock are entitled to such dividends as may be declared by our board of directors out of funds legally available
for such purpose. The shares of common stock are neither redeemable nor convertible. Holders of common stock have no preemptive
or subscription rights to purchase any of our securities.
Each
holder of our common stock is entitled to one vote for each such share outstanding in the holder’s name. No holder of common
stock is entitled to cumulate votes in voting for directors.
In
the event of our liquidation, dissolution or winding up, the holders of our common stock are entitled to receive pro rata our
assets, which are legally available for distribution, after payments of all debts and other liabilities. All of the outstanding
shares of our common stock are fully paid and non-assessable. The shares of common stock offered by this prospectus will also
be fully paid and non-assessable.
Transfer
Agent and Registrar
The
transfer agent and registrar for our common stock is Computershare Limited.
Preferred
Stock
Our
board of directors has the authority, without further action by our stockholders, to issue up to 25,000,000 shares of preferred
stock in one or more classes or series and to fix the designations, rights, preferences, privileges and restrictions thereof,
without further vote or action by the stockholders. These rights, preferences and privileges could include dividend rights, conversion
rights, voting rights, terms of redemption, liquidation preferences, sinking fund terms and the number of shares constituting,
or the designation of, such class or series, any or all of which may be greater than the rights of common stock. The issuance
of our preferred stock could adversely affect the voting power of holders of common stock and the likelihood that such holders
will receive dividend payments and payments upon our liquidation. In addition, the issuance of preferred stock could have the
effect of delaying, deferring or preventing a change in control of our company or other corporate action. We currently have no
plans to issue any shares of preferred stock.
If
we offer a specific series of preferred stock under this prospectus, we will describe the terms of the preferred stock in the
prospectus supplement for such offering and will file a copy of the certificate establishing the terms of the preferred stock
with the SEC. To the extent required, this description will include:
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the
title and stated value;
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the
number of shares offered, the liquidation preference per share and the purchase price;
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the
dividend rate(s), period(s) and/or payment date(s), or method(s) of calculation for such dividends;
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whether
dividends will be cumulative or non-cumulative and, if cumulative, the date from which dividends will accumulate;
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the
procedures for any auction and remarketing, if any;
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the
provisions for a sinking fund, if any;
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the
provisions for redemption, if applicable;
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any
listing of the preferred stock on any securities exchange or market;
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whether
the preferred stock will be convertible into our common stock, and, if applicable, the conversion price (or how it will be
calculated) and conversion period;
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whether
the preferred stock will be exchangeable into debt securities, and, if applicable, the exchange price (or how it will be calculated)
and exchange period;
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voting
rights, if any, of the preferred stock;
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a
discussion of any material and/or special U.S. federal income tax considerations applicable to the preferred stock;
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the
relative ranking and preferences of the preferred stock as to dividend rights and rights upon liquidation, dissolution or
winding up of our affairs; and
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any
material limitations on issuance of any class or series of preferred stock ranking senior to or on a parity with the series
of preferred stock as to dividend rights and rights upon liquidation, dissolution or winding up of our company.
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Transfer
Agent and Registrar for Preferred Stock
The
transfer agent and registrar for any series or class of preferred stock will be set forth in each applicable prospectus supplement.
Anti-Takeover
Provisions
The
provisions of Delaware law, our Second Amended and Restated Certificate of Incorporation and our Amended and Restated Bylaws could
have the effect of delaying, deferring or discouraging another person from acquiring control of our company. These provisions,
which are summarized below, may have the effect of discouraging takeover bids. They are also designed, in part, to encourage persons
seeking to acquire control of us to negotiate first with our board of directors. We believe that the benefits of increased protection
of our potential ability to negotiate with an unfriendly or unsolicited acquirer outweigh the disadvantages of discouraging a
proposal to acquire us because negotiation of these proposals could result in an improvement of their terms.
Delaware
Law
We
are subject to Section 203 of the Delaware General Corporation Law, or DGCL, an anti-takeover law. In general, Section 203 prohibits
a Delaware corporation from engaging in any business combination (as defined below) with any interested stockholder (as defined
below) for a period of three years following the date that the stockholder became an interested stockholder, unless:
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prior to that date, the board of directors of the corporation approved either the business combination or the transaction
that resulted in the stockholder becoming an interested stockholder;
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upon consummation of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder
owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for
purposes of determining the number of shares of voting stock outstanding (but not the voting stock owned by the interested
stockholder) those shares owned by persons who are directors and officers and by excluding employee stock plans in which employee
participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in
a tender or exchange offer; or
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on or subsequent to that date, the business combination is approved by the board of directors of the corporation and authorized
at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66 2/3% of
the outstanding voting stock that is not owned by the interested stockholder.
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In
general, Section 203 defines “business combination” to include the following:
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any merger or consolidation involving the corporation and the interested stockholder;
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any sale, lease, exchange, mortgage, transfer, pledge or other disposition of 10% or more of the assets of the corporation
involving the interested stockholder;
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to certain exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation
to the interested stockholder;
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subject to limited exceptions, any transaction involving the corporation that has the effect of increasing the proportionate
share of the stock of any class or series of the corporation beneficially owned by the interested stockholder; or
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the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits
provided by or through the corporation.
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In
general, Section 203 defines an interested stockholder as any entity or person beneficially owning 15% or more of the outstanding
voting stock of the corporation, or who beneficially owns 15% or more of the outstanding voting stock of the corporation at any
time within a three-year period immediately prior to the date of determining whether such person is an interested stockholder,
and any entity or person affiliated with or controlling or controlled by any of these entities or persons.
Certificate
of Incorporation and Bylaw Provisions
Our
Second Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws include a number of provisions that could
deter hostile takeovers or delay or prevent changes in control of our company. Certain of these provisions are summarized in the
following paragraphs.
Effects
of authorized but unissued common stock. One of the effects of the existence of authorized but unissued common stock may be
to enable our board of directors to make more difficult or to discourage an attempt to obtain control of our company by means
of a merger, tender offer, proxy contest or otherwise, and thereby to protect the continuity of management. If, in the due exercise
of its fiduciary obligations, the board of directors were to determine that a takeover proposal was not in our best interest,
such shares could be issued by the board of directors without stockholder approval in one or more transactions that might prevent
or render more difficult or costly the completion of the takeover transaction by diluting the voting or other rights of the proposed
acquirer or insurgent stockholder group, by putting a substantial voting bloc in institutional or other hands that might undertake
to support the position of the incumbent board of directors, by effecting an acquisition that might complicate or preclude the
takeover, or otherwise.
Cumulative
Voting. Our Second Amended and Restated Certificate of Incorporation does not provide for cumulative voting in the election
of directors, which would allow holders of less than a majority of the stock to elect some directors.
Director
Vacancies. Our Second Amended and Restated Certificate of Incorporation provides that all vacancies may be filled by the affirmative
vote of a majority of directors then in office, even if less than a quorum.
Stockholder
Action; Special Meeting of Stockholders. Our Amended and Restated Bylaws provide that stockholders may act by written consent.
However, stockholders pursuing an action by written consent will be required to comply with certain notice and record date requirements
that are set forth in the General Corporation Law of the State of Delaware. A special meeting of stockholders may be called by
the Chairman of the board of directors, the President, the Chief Executive Officer, or the board of directors at any time and
for any purpose or purposes as shall be stated in the notice of the meeting, or by request of the holders of record of at least
20% of outstanding shares of common stock. This provision could prevent stockholders from calling a special meeting because, unless
certain significant stockholders were to join with them, they might not obtain the percentage necessary to request the meeting.
Therefore, stockholders holding less than 20% of issued and outstanding common stock, without the assistance of management, may
be unable to propose a vote on any transaction which may delay, defer or prevent a change of control, even if the transaction
were in the best interests of certain of our stockholders.
Advance
Notice Requirements for Stockholder Proposals and Director Nominations. Our Amended and Restated Bylaws establish advance
notice procedures with respect to stockholder proposals and the nomination of candidates for election as director. In order for
any matter to be “properly brought” before a meeting, a stockholder will have to comply with such advance notice procedures
and provide us with certain information. Our Amended and Restated Bylaws allow the presiding officer at a meeting of stockholders
to adopt rules and regulations for the conduct of meetings which may have the effect of precluding the conduct of certain business
at a meeting if such rules and regulations are not followed. These provisions may also defer, delay or discourage a potential
acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting
to influence or obtain control of our company.
Supermajority
Voting for Amendments to Our Governing Documents. Any amendment to our Second Amended and Restated Certificate of Incorporation
related to the provisions governing, among other things, the general powers of the Board of Directors, the number and election
of directors, the filling of director vacancies, the ability of the Board to adopt, amend or repeal the Amended and Restated Bylaws,
the ability to call special stockholder meetings, and director liability and indemnification, will require the affirmative vote
of at least 66 2/3% of the voting power of all shares of our capital stock then outstanding. Our Second Amended and Restated Certificate
of Incorporation provides that the board of directors is expressly authorized to adopt, amend or repeal our Amended and Restated
Bylaws and that our stockholders may amend our Amended and Restated Bylaws only with the approval of at least 66 2/3% of the voting
power of all shares of our capital stock then outstanding.
Choice
of Forum. Our Second Amended and Restated Certificate of Incorporation provides that, subject to certain exceptions, the Court
of Chancery of the State of Delaware will be the exclusive forum for any claim, including any derivative claim, (i) that is based
upon a violation of a duty by a current or former director or officer or stockholder in such capacity or (ii) as to which the
DGCL, or any other provision of Title 8 of the Delaware Code, confers jurisdiction upon the Court of Chancery. This provision
does not apply to any claims arising under the Securities Act or the Exchange Act, or any claim in which exclusive jurisdiction
is vested in a court or forum other than the Court of Chancery or for which the Court of Chancery does not have subject matter
jurisdiction. The enforceability of similar choice of forum provisions in other companies’ certificates of incorporation
has been challenged in legal proceedings, and it is possible that a court could find these types of provisions to be inapplicable
or unenforceable.
Section
27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created
by the Exchange Act or the rules and regulations thereunder. As a result, the exclusive forum provision will not apply to suits
brought to enforce any duty or liability created by the Exchange Act or any other claim for which the federal courts have exclusive
jurisdiction. In addition, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over
all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. As a
result, the exclusive forum provision will not apply to suits brought to enforce any duty or liability created by the Securities
Act or any other claim for which the federal and state courts have concurrent jurisdiction.
DESCRIPTION
OF STOCK WARRANTS
We
summarize below some of the provisions that will apply to the warrants unless the applicable prospectus supplement provides otherwise.
This summary may not contain all information that is important to you. The complete terms of the warrants will be contained in
the applicable warrant certificate and warrant agreement. These documents have been or will be included or incorporated by reference
as exhibits to the registration statement of which this prospectus is a part. You should read the warrant certificate and the
warrant agreement. You should also read the prospectus supplement, which will contain additional information and which may update
or change some of the information below.
General
We
may issue, together with common or preferred stock as units or separately, warrants for the purchase of shares of our common or
preferred stock. The terms of each warrant will be discussed in the applicable prospectus supplement relating to the particular
series of warrants. The form(s) of certificate representing the warrants and/or the warrant agreement will be, in each case, filed
with the SEC as an exhibit to a document incorporated by reference in the registration statement of which this prospectus is a
part on or prior to the date of any prospectus supplement relating to an offering of the particular warrant. The following summary
of material provisions of the warrants and the warrant agreements are subject to, and qualified in their entirety by reference
to, all the provisions of the warrant agreement and warrant certificate applicable to a particular series of warrants.
The
prospectus supplement relating to any series of warrants that are offered by this prospectus will describe, among other things,
the following terms to the extent they are applicable to that series of warrants:
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the
procedures and conditions relating to the exercise of the warrants;
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the
number of shares of our common or preferred stock, if any, issued with the warrants;
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the
date, if any, on and after which the warrants and any related shares of our common or preferred stock will be separately transferable;
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the
offering price of the warrants, if any;
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the
number of shares of our common or preferred stock which may be purchased upon exercise of the warrants and the price or prices
at which the shares may be purchased upon exercise;
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the
date on which the right to exercise the warrants will begin and the date on which the right will expire;
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a
discussion of the material United States federal income tax considerations applicable to the exercise of the warrants;
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anti-dilution
provisions of the warrants, if any;
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call
provisions of the warrants, if any; and
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any
other material terms of the warrants.
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Each
warrant may entitle the holder to purchase for cash, or, in limited circumstances, by effecting a cashless exercise for, the number
of shares of our common or preferred stock at the exercise price that is described in the applicable prospectus supplement. Warrants
will be exercisable during the period of time described in the applicable prospectus supplement. After that period, unexercised
warrants will be void. Warrants may be exercised in the manner described in the applicable prospectus supplement.
A
holder of a warrant will not have any of the rights of a holder of our common or preferred stock before the stock is purchased
upon exercise of the warrant. Therefore, before a warrant is exercised, the holder of the warrant will not be entitled to receive
any dividend payments or exercise any voting or other rights associated with shares of our common or preferred stock which may
be purchased when the warrant is exercised.
Transfer
Agent and Registrar
The
transfer agent and registrar, if any, for any warrants will be set forth in the applicable prospectus supplement.
DESCRIPTION
OF DEBT SECURITIES
This
prospectus describes certain general terms and provisions of debt securities that we may offer. The debt securities may be issued
pursuant to, in the case of senior debt securities, a senior indenture, and in the case of subordinated debt securities, a subordinated
indenture, in each case in the forms filed as exhibits to this registration statement, which we refer to as the “indentures.”
The indentures will be entered into between us and a trustee to be named prior to the issuance of any debt securities, which we
refer to as the “trustee.” The indentures will not limit the amount of debt securities that can be issued thereunder
and will provide that the debt securities may be issued from time to time in one or more series pursuant to the terms of one or
more securities resolutions or supplemental indentures creating such series.
We
have summarized below the material provisions of the indentures and the debt securities or indicated which material provisions
will be described in the related prospectus supplement for any offering of debt securities. These descriptions are only summaries,
and you should refer to the relevant indenture for the particular offering of debt securities itself which will describe completely
the terms and definitions of the offered debt securities and contain additional information about the debt securities.
Terms
When
we offer to sell a particular series of debt securities, we will describe the specific terms of the securities in a prospectus
supplement. The prospectus supplement will set forth the following terms, as applicable, of the debt securities offered thereby:
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the
designation, aggregate principal amount, currency or composite currency and denominations;
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the
price at which such debt securities will be issued and, if an index formula or other method is used, the method for determining
amounts of principal or interest;
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the
maturity date and other dates, if any, on which principal will be payable;
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whether
or not the debt securities will be secured or unsecured, and the terms of any secured debt;
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whether
the debt securities rank as senior debt, senior subordinated debt, subordinated debt or any combination thereof, and the terms
of any subordination;
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the
interest rate (which may be fixed or variable), if any;
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the
date or dates from which interest will accrue and on which interest will be payable, and the record dates for the payment
of interest;
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the
manner of paying principal and interest;
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the
place or places where principal and interest will be payable;
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the
terms of any mandatory or optional redemption by us or any third party including any sinking fund;
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the
terms of any conversion or exchange;
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the
terms of any redemption at the option of holders or put by the holders;
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any
tax indemnity provisions;
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if
the debt securities provide that payments of principal or interest may be made in a currency other than that in which the
debt securities are denominated, the manner for determining such payments;
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the
portion of principal payable upon acceleration of a Discounted Debt Security (as defined below);
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whether
and upon what terms debt securities may be defeased;
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any
events of default or covenants in addition to or in lieu of those set forth in the indentures;
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provisions
for electronic issuance of debt securities or for the issuance of debt securities in uncertificated form; and
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any
additional provisions or other special terms not inconsistent with the provisions of the indentures, including any terms that
may be required or advisable under United States or other applicable laws or regulations, or advisable in connection with
the marketing of the debt securities.
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Debt
securities of any series may be issued as registered debt securities or uncertificated debt securities, in such denominations
as specified in the terms of the series.
Securities
may be issued under the indentures as discounted debt securities to be offered and sold at a substantial discount from the principal
amount thereof. Special United States federal income tax and other considerations applicable thereto will be described in the
prospectus supplement relating to such discounted debt securities. “Discounted debt security” means a security where
the amount of principal due upon acceleration is less than the stated principal amount.
We
are not obligated to issue all debt securities of one series at the same time and, unless otherwise provided in the prospectus
supplement, we may reopen a series, without the consent of the holders of the debt securities of that series, for the issuance
of additional debt securities of that series. Additional debt securities of a particular series will have the same terms and conditions
as outstanding debt securities of such series, except for the date of original issuance and the offering price, and will be consolidated
with, and form a single series with, such outstanding debt securities.
Ranking
The
senior debt securities will rank equally with all of our other senior and unsubordinated debt. Our secured debt, if any, will
be effectively senior to the senior debt securities to the extent of the value of the assets securing such debt. The subordinated
debt securities will be subordinate and junior in right of payment to all of our present and future senior indebtedness to the
extent and in the manner described in the prospectus supplement and as set forth in the board resolution, officer’s certificate
or supplemental indenture relating to such offering.
Certain
Covenants
Any
covenants that may apply to a particular series of debt securities will be described in the prospectus supplement relating thereto.
Successor
Obligor
The
indentures provide that, unless otherwise specified in the securities resolution or supplemental indenture establishing a series
of debt securities, we shall not consolidate with or merge into, or transfer all or substantially all of our assets to, any person
in any transaction in which we are not the survivor, unless:
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the
person is organized under the laws of the United States or a jurisdiction within the United States;
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the
person assumes by supplemental indenture all of our obligations under the relevant indenture, the debt securities and any
coupons;
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immediately
after the transaction no Default (as defined below) exists; and
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we
deliver to the trustee an officers’ certificate and opinion of counsel stating that the transaction complies with the
foregoing requirements and that all conditions precedent provided for in the indenture relating to the transaction have been
complied with.
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In
such event, the successor will be substituted for us, and thereafter all of our obligations under the relevant indenture, the
debt securities and any coupons will terminate.
The
indentures provide that these limitations shall not apply if our board of directors makes a good faith determination that the
principal purpose of the transaction is to change our state of incorporation.
Exchange
of Debt Securities
Registered
debt securities may be exchanged for an equal aggregate principal amount of registered debt securities of the same series and
date of maturity in such authorized denominations as may be requested upon surrender of the registered debt securities at an agency
of the Company maintained for such purpose and upon fulfillment of all other requirements of such agent.
Default
and Remedies
Unless
the securities resolution or supplemental indenture establishing the series otherwise provides (in which event the prospectus
supplement will so state), an “Event of Default” with respect to a series of debt securities will occur if:
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default in any payment of interest on any debt securities of such series when the same becomes due and payable and the default
continues for a period of 30 days;
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(2)
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we
default in the payment of all or any part of the principal and premium, if any, of any debt securities of such series when
the same becomes due and payable at maturity or upon redemption, acceleration or otherwise and such default shall continue
for five or more days;
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(3)
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we
default in the performance of any of our other agreements applicable to the series and the default continues for 30 days after
the notice specified below;
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(4)
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a
court of competent jurisdiction enters an order or decree under any Bankruptcy Law (as defined below) that:
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(A)
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is
for relief against us in an involuntary case,
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(B)
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appoints
a Custodian (as defined below) for us or for any substantial part of our property, or
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(C)
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orders
the winding up or liquidation of us, and the order or decree remains unstayed and in effect for 90 days;
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(5)
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we,
pursuant to or within the meaning of any Bankruptcy Law:
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(A)
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commence
a voluntary case,
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(B)
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consent
to the entry of an order for relief against us in an involuntary case,
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(C)
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consent
to the appointment of a Custodian for us or for any substantial part of our property, or
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(D)
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make
a general assignment for the benefit of our creditors; or
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(6)
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there
occurs any other Event of Default provided for in such series.
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The
term “Bankruptcy Law” means Title 11 of the United States Code or any similar Federal or State law for the relief
of debtors. The term “Custodian” means any receiver, trustee, assignee, liquidator or a similar official under any
Bankruptcy Law.
“Default”
means any event which is, or after notice or passage of time would be, an Event of Default. A Default under subparagraph (3) above
is not an Event of Default until the trustee or the holders of at least 25% in principal amount of the series notify us of the
Default and we do not cure the Default within the time specified after receipt of the notice.
The
trustee may require indemnity satisfactory to it before it enforces the indentures or the debt securities of the series. Subject
to certain limitations, holders of a majority in principal amount of the debt securities of the series may direct the trustee
in its exercise of any trust or power with respect to such series. Except in the case of Default in payment on a series, the trustee
may withhold from securityholders of such series notice of any continuing Default if the trustee determines that withholding notice
is in the interest of such securityholders. We are required to furnish the trustee annually a brief certificate as to our compliance
with all conditions and covenants under the indentures.
The
indentures do not have cross-default provisions. Thus, a default by us on any other debt, including any other series of debt securities,
would not constitute an Event of Default.
Amendments
and Waivers
The
indentures and the debt securities or any coupons of the series may be amended, and any Default may be waived as follows:
Unless
the securities resolution or supplemental indenture otherwise provides (in which event the applicable prospectus supplement will
so state), the debt securities and the indentures may be amended with the consent of the holders of a majority in principal amount
of the debt securities of all series affected voting as one class. Unless the securities resolution or supplemental indenture
otherwise provides (in which event the applicable prospectus supplement will so state), a Default other than a Default in payment
on a particular series may be waived with the consent of the holders of a majority in principal amount of the debt securities
of the series. However, without the consent of each securityholder affected, no amendment or waiver may:
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change
the fixed maturity of or the time for payment of interest on any debt security;
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reduce
the principal, premium or interest payable with respect to any debt security;
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change
the place of payment of a debt security or the currency in which the principal or interest on a debt security is payable;
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change
the provisions for calculating any redemption or repurchase price with respect to any debt security;
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adversely
affect any holder’s right to receive payment of principal and interest or to institute suit for the enforcement of any
such payment;
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reduce
the amount of debt securities whose holders must consent to an amendment or waiver;
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make
any change that materially adversely affects the right to convert any debt security;
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waive
any Default in payment of principal of or interest on a debt security; or
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adversely
affect any holder’s rights with respect to redemption or repurchase of a debt security.
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Without
the consent of any securityholder, the indentures or the debt securities may be amended to:
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provide
for assumption of our obligations to securityholders in the event of a merger or consolidation requiring such assumption;
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cure
any ambiguity, omission, defect or inconsistency;
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conform
the terms of the debt securities to the description thereof in the prospectus and prospectus supplement offering such debt
securities;
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create
a series and establish its terms;
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provide
for the acceptance of appointment by a successor trustee or to facilitate the administration of the trusts by more than one
trustee;
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provide
for uncertificated or unregistered securities;
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make
any change that does not adversely affect the rights of any securityholder;
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add
to our covenants; or
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make
any other change to the indentures so long as no debt securities are outstanding.
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Conversion
Rights
Any
securities resolution or supplemental indenture establishing a series of debt securities may provide that the debt securities
of such series will be convertible at the option of the holders thereof into or for our common stock or other equity or debt instruments.
The securities resolution or supplemental indenture may establish, among other things, (1) the number or amount of shares of common
stock or other equity or debt instruments for which $1,000 aggregate principal amount of the debt securities of the series is
convertible, as may be adjusted pursuant to the terms of the relevant indenture and the securities resolution; and (2) provisions
for adjustments to the conversion rate and limitations upon exercise of the conversion right. The indentures provide that we will
not be required to make an adjustment in the conversion rate unless the adjustment would require a cumulative change of at least
1% in the conversion rate. However, we will carry forward any adjustments that are less than 1% of the conversion rate and take
them into account in any subsequent adjustment of the conversion rate.
Legal
Defeasance and Covenant Defeasance
Debt
securities of a series may be defeased in accordance with their terms and, unless the securities resolution or supplemental indenture
establishing the terms of the series otherwise provides, as set forth below. We at any time may terminate as to a series all of
our obligations (except for certain obligations, including obligations with respect to the defeasance trust and obligations to
register the transfer or exchange of a debt security, to replace destroyed, lost or stolen debt securities and coupons and to
maintain paying agencies in respect of the debt securities) with respect to the debt securities of the series and any related
coupons and the relevant indenture, which we refer to as legal defeasance. We at any time may terminate as to a series our obligations
with respect to any restrictive covenants which may be applicable to a particular series, which we refer to as covenant defeasance.
We
may exercise our legal defeasance option notwithstanding our prior exercise of our covenant defeasance option. If we exercise
our legal defeasance option, a series may not be accelerated because of an Event of Default. If we exercise our covenant defeasance
option, a series may not be accelerated by reference to any covenant which may be applicable to a series.
To
exercise either defeasance option as to a series, we must (1) irrevocably deposit in trust with the trustee (or another trustee)
money or U.S. Government Obligations (as defined below), deliver a certificate from a nationally recognized firm of independent
accountants expressing their opinion that the payments of principal and interest when due on the deposited U.S. Government Obligations,
without reinvestment, plus any deposited money without investment will provide cash at such times and in such amounts as will
be sufficient to pay the principal and interest when due on all debt securities of such series to maturity or redemption, as the
case may be; and (2) comply with certain other conditions. In particular, we must obtain an opinion of tax counsel that the defeasance
will not result in recognition of any gain or loss to holders for federal income tax purposes.
“U.S.
Government Obligations” means direct obligations of the United States or any agency or instrumentality of the United States,
the payment of which is unconditionally guaranteed by the United States, which, in either case, have the full faith and credit
of the United States pledged for payment and which are not callable at the issuer’s option, or certificates representing
an ownership interest in such obligations.
Regarding
the Trustee
Unless
otherwise indicated in a prospectus supplement, the trustee will also act as depository of funds, transfer agent, paying agent
and conversion agent, as applicable, with respect to the debt securities. In certain circumstances, we or the securityholders
may remove the trustee as the trustee under a given indenture. The indenture trustee may also provide additional unrelated services
to us as a depository of funds, registrar, trustee and similar services.
Governing
Law
The
indentures and the debt securities will be governed by New York law, except to the extent that the Trust Indenture Act of 1939
is applicable.
DESCRIPTION
OF SUBSCRIPTION RIGHTS
We
may issue subscription rights to purchase our common stock or debt securities. These subscription rights may be offered independently
or together with any other security offered hereby and may or may not be transferable by the stockholder receiving the subscription
rights in such offering. In connection with any offering of subscription rights, we may enter into a standby arrangement with
one or more underwriters or other purchasers pursuant to which the underwriters or other purchasers may be required to purchase
any securities remaining unsubscribed for after such offering.
The
prospectus supplement relating to any subscription rights we offer, if any, will, to the extent applicable, include specific terms
relating to the offering, including some or all of the following:
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the
price, if any, for the subscription rights;
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the
exercise price payable for our common stock or debt securities upon the exercise of the subscription rights;
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the
number of subscription rights to be issued to each stockholder;
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the
number and terms of our common stock or debt securities which may be purchased per each subscription right;
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the
extent to which the subscription rights are transferable;
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any
other terms of the subscription rights, including the terms, procedures and limitations relating to the exchange and exercise
of the subscription rights;
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the
date on which the right to exercise the subscription rights shall commence, and the date on which the subscription rights
shall expire;
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the
extent to which the subscription rights may include an over-subscription privilege with respect to unsubscribed securities
or an over-allotment privilege to the extent the securities are fully subscribed; and
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if
applicable, the material terms of any standby underwriting or purchase arrangement which may be entered into by us in connection
with the offering of subscription rights.
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DESCRIPTION
OF UNITS
We
may issue units comprised of one or more of the other securities described in this prospectus in any combination. Each unit will
be issued so that the holder of the unit is also the holder of each security included in the unit. Thus, the holder of a unit
will have the rights and obligations of a holder of each included security (but, to the extent convertible securities are included
in the units, the holder of the units will be deemed the holder of the convertible securities and not the holder of the underlying
securities). The unit agreement under which a unit is issued, if any, may provide that the securities included in the unit may
not be held or transferred separately, at any time or at any time before a specified date. The applicable prospectus supplement
may describe:
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the
designation and terms of the units and of the securities comprising the units, including whether and under what circumstances
those securities may be held or transferred separately;
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any
provisions for the issuance, payment, settlement, transfer or exchange of the units or of the securities comprising the units;
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the
terms of the unit agreement governing the units;
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United
States federal income tax considerations relevant to the units; and
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whether
the units will be issued in fully registered global form.
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This
summary of certain general terms of units and any summary description of units in the applicable prospectus supplement do not
purport to be complete and are qualified in their entirety by reference to all provisions of the applicable unit agreement and,
if applicable, collateral arrangements and depositary arrangements relating to such units. The forms of the unit agreements and
other documents relating to a particular issue of units will be filed with the SEC each time we issue units, and you should read
those documents for provisions that may be important to you.
FORMS
OF SECURITIES
Each
debt security and, to the extent applicable, warrant, subscription right and unit, will be represented either by a certificate
issued in definitive form to a particular investor or by one or more global securities representing the entire issuance of securities.
Certificated securities in definitive form and global securities will be issued in registered form. Definitive securities name
you or your nominee as the owner of the security, and in order to transfer or exchange these securities or to receive payments
other than interest or other interim payments, you or your nominee must physically deliver the securities to the trustee, registrar,
paying agent or other agent, as applicable. Global securities name a depositary or its nominee as the owner of the debt securities
or warrants represented by these global securities. The depositary maintains a computerized system that will reflect each investor’s
beneficial ownership of the securities through an account maintained by the investor with its broker/dealer, bank, trust company
or other representative, as we explain more fully below.
Global
Securities
Registered
Global Securities. We may issue the registered debt securities and, to the extent applicable, warrants, subscription rights
and units, in the form of one or more fully registered global securities that will be deposited with a depositary or its nominee
identified in the applicable prospectus supplement and registered in the name of that depositary or nominee. In those cases, one
or more registered global securities will be issued in a denomination or aggregate denominations equal to the portion of the aggregate
principal or face amount of the securities to be represented by registered global securities. Unless and until it is exchanged
in whole for securities in definitive registered form, a registered global security may not be transferred except as a whole by
and among the depositary for the registered global security, the nominees of the depositary or any successors of the depositary
or those nominees.
If
not described below, any specific terms of the depositary arrangement with respect to any securities to be represented by a registered
global security will be described in the prospectus supplement relating to those securities. We anticipate that the following
provisions will apply to all depositary arrangements.
Ownership
of beneficial interests in a registered global security will be limited to persons, called participants, that have accounts with
the depositary or persons that may hold interests through participants. Upon the issuance of a registered global security, the
depositary will credit, on its book-entry registration and transfer system, the participants’ accounts with the respective
principal or face amounts of the securities beneficially owned by the participants. Any dealers, underwriters or agents participating
in the distribution of the securities will designate the accounts to be credited. Ownership of beneficial interests in a registered
global security will be shown on, and the transfer of ownership interests will be effected only through, records maintained by
the depositary, with respect to interests of participants, and on the records of participants, with respect to interests of persons
holding through participants. The laws of some states may require that some purchasers of securities take physical delivery of
these securities in definitive form. These laws may impair your ability to own, transfer or pledge beneficial interests in registered
global securities.
So
long as the depositary, or its nominee, is the registered owner of a registered global security, that depositary or its nominee,
as the case may be, will be considered the sole owner or holder of the securities represented by the registered global security
for all purposes under the applicable indenture or warrant agreement. Except as described below, owners of beneficial interests
in a registered global security will not be entitled to have the securities represented by the registered global security registered
in their names, will not receive or be entitled to receive physical delivery of the securities in definitive form and will not
be considered the owners or holders of the securities under the applicable indenture or warrant agreement. Accordingly, each person
owning a beneficial interest in a registered global security must rely on the procedures of the depositary for that registered
global security and, if that person is not a participant, on the procedures of the participant through which the person owns its
interest, to exercise any rights of a holder under the applicable indenture or warrant agreement. We understand that under existing
industry practices, if we request any action of holders or if an owner of a beneficial interest in a registered global security
desires to give or take any action that a holder is entitled to give or take under the applicable indenture or warrant agreement,
the depositary for the registered global security would authorize the participants holding the relevant beneficial interests to
give or take that action, and the participants would authorize beneficial owners owning through them to give or take that action
or would otherwise act upon the instructions of beneficial owners holding through them.
Principal,
premium, if any, interest payments on debt securities and any payments to holders with respect to warrants represented by a registered
global security registered in the name of a depositary or its nominee will be made to the depositary or its nominee, as the case
may be, as the registered owner of the registered global security. None of the Company, the trustees, the warrant agents or any
other agent of the Company, the trustees or the warrant agents will have any responsibility or liability for any aspect of the
records relating to payments made on account of beneficial ownership interests in the registered global security or for maintaining,
supervising or reviewing any records relating to those beneficial ownership interests.
We
expect that the depositary for any of the securities represented by a registered global security, upon receipt of any payment
of principal, premium, interest or other distribution of underlying securities or other property to holders on that registered
global security, will immediately credit participants’ accounts in amounts proportionate to their respective beneficial
interests in that registered global security as shown on the records of the depositary. We also expect that payments by participants
to owners of beneficial interests in a registered global security held through participants will be governed by standing customer
instructions and customary practices, as is now the case with the securities held for the accounts of customers in bearer form
or registered in “street name,” and will be the responsibility of those participants.
If
the depositary for any of these securities represented by a registered global security is at any time unwilling or unable to continue
as depositary or ceases to be a clearing agency registered under the Exchange Act, and a successor depositary registered as a
clearing agency under the Exchange Act is not appointed by us within 90 days, we will issue securities in definitive form in exchange
for the registered global security that had been held by the depositary. Any securities issued in definitive form in exchange
for a registered global security will be registered in the name or names that the depositary gives to the relevant trustee or
warrant agent or other relevant agent of ours or theirs. It is expected that the depositary’s instructions will be based
upon directions received by the depositary from participants with respect to ownership of beneficial interests in the registered
global security that had been held by the depositary.
PLAN
OF DISTRIBUTION
Initial
Offering and Sale of Securities
Unless
otherwise set forth in a prospectus supplement accompanying this prospectus, we may sell the securities being offered hereby,
from time to time, by one or more of the following methods:
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to
or through underwriting syndicates represented by managing underwriters;
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through
one or more underwriters without a syndicate for them to offer and sell to the public;
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through
dealers or agents; and
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to
investors directly in negotiated sales or in competitively bid transactions.
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Offerings
of securities covered by this prospectus also may be made into an existing trading market for those securities in transactions
at other than a fixed price, either:
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on
or through the facilities of the Nasdaq Capital Market or any other securities exchange or quotation or trading service on
which those securities may be listed, quoted, or traded at the time of sale; and/or
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to
or through a market maker other than on the securities exchanges or quotation or trading services set forth above.
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Those
at-the-market offerings, if any, will be conducted by underwriters acting as principal or agent of the Company, who may also be
third-party sellers of securities as described above. The prospectus supplement with respect to the offered securities will set
forth the terms of the offering of the offered securities, including:
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the
name or names of any underwriters, dealers or agents;
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the
purchase price of the offered securities and the proceeds to us from such sale;
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any
underwriting discounts and commissions or agency fees and other items constituting underwriters’ or agents’ compensation;
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any
initial public offering price and any discounts or concessions allowed or reallowed or paid to dealers;
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any
securities exchange on which such offered securities may be listed; and
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any
underwriter, agent or dealer involved in the offer and sale of any series of the securities.
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The
distribution of the securities may be effected from time to time in one or more transactions:
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at
fixed prices, which may be changed;
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at
market prices prevailing at the time of the sale;
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at
varying prices determined at the time of sale; or
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at
negotiated prices.
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Each
prospectus supplement will set forth the manner and terms of an offering of securities including:
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whether
that offering is being made to underwriters, through agents or directly to the public;
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the
rules and procedures for any auction or bidding process, if used;
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the
securities’ purchase price or initial public offering price; and
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the
proceeds we anticipate from the sale of the securities, if any.
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In
addition, we may enter into derivative or hedging transactions with third parties, or sell securities not covered by this prospectus
to third parties in privately negotiated transactions. The applicable prospectus supplement may indicate, in connection with such
a transaction, that the third parties may sell securities covered by and pursuant to this prospectus and an applicable prospectus
supplement. If so, the third party may use securities pledged by us or borrowed from us or others to settle such sales and may
use securities received from us to close out any related short positions. We may also loan or pledge securities covered by this
prospectus and an applicable prospectus supplement to third parties, who may sell the loaned securities or, in an event of default
in the case of a pledge, sell the pledged securities pursuant to this prospectus and the applicable prospectus supplement.
Sales
Through Underwriters
If
underwriters are used in the sale of some or all of the securities covered by this prospectus, the underwriters will acquire the
securities for their own account. The underwriters may resell the securities, either directly to the public or to securities dealers,
at various times in one or more transactions, including negotiated transactions, at a fixed public offering price or at varying
prices determined at the time of sale. The obligations of the underwriters to purchase the securities will be subject to certain
conditions. Unless indicated otherwise in a prospectus supplement, the underwriters will be obligated to purchase all the securities
of the series offered if any of the securities are purchased.
Any
initial public offering price and any concessions allowed or reallowed to dealers may be changed intermittently.
Sales
Through Agents
Unless
otherwise indicated in the applicable prospectus supplement, when securities are sold through an agent, the designated agent will
agree, for the period of its appointment as agent, to use specified efforts to sell the securities for our account and will receive
commissions from us as will be set forth in the applicable prospectus supplement.
Securities
bought in accordance with a redemption or repayment under their terms also may be offered and sold, if so indicated in the applicable
prospectus supplement, in connection with a remarketing by one or more firms acting as principals for their own accounts or as
agents for us. Any remarketing firm will be identified and the terms of its agreement, if any, with us and its compensation will
be described in the prospectus supplement. Remarketing firms may be deemed to be underwriters in connection with the securities
remarketed by them.
If
so indicated in the applicable prospectus supplement, we may authorize agents, underwriters or dealers to solicit offers by certain
specified institutions to purchase securities at a price set forth in the prospectus supplement pursuant to delayed delivery contracts
providing for payment and delivery on a future date specified in the prospectus supplement. These contracts will be subject only
to those conditions set forth in the applicable prospectus supplement, and the prospectus supplement will set forth the commissions
payable for solicitation of these contracts.
Direct
Sales
We
may also sell offered securities directly to institutional investors or others. In this case, no underwriters or agents would
be involved. The terms of such sales will be described in the applicable prospectus supplement.
General
Information
Broker-dealers,
agents or underwriters may receive compensation in the form of discounts, concessions or commissions from us and/or the purchasers
of securities for whom such broker-dealers, agents or underwriters may act as agents or to whom they sell as principal, or both.
This compensation to a particular broker-dealer might be in excess of customary commissions.
Underwriters,
dealers and agents that participate in any distribution of the offered securities may be deemed “underwriters” within
the meaning of the Securities Act of 1933, as amended (the “Securities Act”), so any discounts or commissions they
receive in connection with the distribution may be deemed to be underwriting compensation. Those underwriters and agents may be
entitled, under their agreements with us, to indemnification by us against certain civil liabilities, including liabilities under
the Securities Act, or to contribution by us to payments that they may be required to make in respect of those civil liabilities.
Certain of those underwriters or agents may be customers of, engage in transactions with, or perform services for, us or our affiliates
in the ordinary course of business. We will identify any underwriters or agents, and describe their compensation, in a prospectus
supplement. Any institutional investors or others that purchase offered securities directly, and then resell the securities, may
be deemed to be underwriters, and any discounts or commissions received by them from us and any profit on the resale of the securities
by them may be deemed to be underwriting discounts and commissions under the Securities Act.
We
will file a supplement to this prospectus, if required, pursuant to Rule 424(b) under the Securities Act, if we enter into any
material arrangement with a broker, dealer, agent or underwriter for the sale of securities through a block trade, special offering,
exchange distribution or secondary distribution or a purchase by a broker or dealer. Such prospectus supplement will disclose:
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the
name of any participating broker, dealer, agent or underwriter;
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the
number and type of securities involved;
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the
price at which such securities were sold;
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any
securities exchanges on which such securities may be listed;
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the
commissions paid or discounts or concessions allowed to any such broker, dealer, agent or underwriter, where applicable; and
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other
facts material to the transaction.
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In
order to facilitate the offering of certain securities under this prospectus or an applicable prospectus supplement, certain persons
participating in the offering of those securities may engage in transactions that stabilize, maintain or otherwise affect the
price of those securities during and after the offering of those securities. Specifically, if the applicable prospectus supplement
permits, the underwriters of those securities may over-allot or otherwise create a short position in those securities for their
own account by selling more of those securities than have been sold to them by us and may elect to cover any such short position
by purchasing those securities in the open market.
In
addition, the underwriters may stabilize or maintain the price of those securities by bidding for or purchasing those securities
in the open market and may impose penalty bids, under which selling concessions allowed to syndicate members or other broker-dealers
participating in the offering are reclaimed if securities previously distributed in the offering are repurchased in connection
with stabilization transactions or otherwise. 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. The imposition of a penalty bid may
also affect the price of securities to the extent that it discourages resales of the securities. No representation is made as
to the magnitude or effect of any such stabilization or other transactions. Such transactions, if commenced, may be discontinued
at any time.
In
order to comply with the securities laws of certain states, if applicable, the securities must be sold in such jurisdictions only
through registered or licensed brokers or dealers. In addition, in certain states the 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 is complied with.
Rule
15c6-1 under the Exchange Act generally requires that trades in the secondary market settle in two business days, unless the parties
to any such trade expressly agree otherwise. Your prospectus supplement may provide that the original issue date for your securities
may be more than two scheduled business days after the trade date for your securities. Accordingly, in such a case, if you wish
to trade securities on any date prior to the second business day before the original issue date for your securities, you will
be required, by virtue of the fact that your securities initially are expected to settle in more than two scheduled business days
after the trade date for your securities, to make alternative settlement arrangements to prevent a failed settlement.
This
prospectus, any applicable prospectus supplement and any applicable pricing supplement in electronic format may be made available
on the Internet sites of, or through other online services maintained by, us and/or one or more of the agents and/or dealers participating
in an offering of securities, or by their affiliates. In those cases, prospective investors may be able to view offering terms
online and, depending upon the particular agent or dealer, prospective investors may be allowed to place orders online.
Other
than this prospectus, any applicable prospectus supplement and any applicable pricing supplement in electronic format, the information
on our website or the website of any agent or dealer, and any information contained in any other website maintained by any agent
or dealer:
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is
not part of this prospectus, any applicable prospectus supplement or any applicable pricing supplement or the registration
statement of which they form a part;
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has
not been approved or endorsed by us or by any agent or dealer in its capacity as an agent or dealer, except, in each case,
with respect to the respective website maintained by such entity; and
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should
not be relied upon by investors.
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There
can be no assurance that we will sell all or any of the securities offered by this prospectus.
This
prospectus may also be used in connection with any issuance of common stock or preferred stock upon exercise of a warrant if such
issuance is not exempt from the registration requirements of the Securities Act.
In
addition, we may issue the securities as a dividend or distribution or in a subscription rights offering to our existing securityholders.
In some cases, we or dealers acting with us or on our behalf may also purchase securities and reoffer them to the public by one
or more of the methods described above. This prospectus may be used in connection with any offering of our securities through
any of these methods or other methods described in the applicable prospectus supplement.
LEGAL
MATTERS
Unless
otherwise indicated in the applicable prospectus supplement, the validity of the securities offered hereby will be passed upon
for us by Lowenstein Sandler 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 Provention Bio, Inc. as of December 31, 2018 and 2017, and the related statements of operations, stockholders’
equity (deficit), and cash flows for each of the years ended December 31, 2018 and 2017 and for the period from October 4, 2016
(inception) through December 31, 2016, have been audited by EisnerAmper LLP, independent registered public accounting firm, as
stated in their report which is incorporated herein by reference. Such financial statements have been incorporated herein by reference
in reliance on the report of such firm given upon their authority as experts in accounting and auditing.
ADDITIONAL
INFORMATION
This
prospectus is part of a Registration Statement on Form S-3 that we have filed with the SEC relating to the shares of our securities
being offered hereby. This prospectus does not contain all of the information in the Registration Statement and its exhibits.
The Registration Statement, its exhibits and the documents incorporated by reference in this prospectus and their exhibits, all
contain information that is material to the offering of the Securities hereby. Whenever a reference is made in this prospectus
to any of our contracts or other documents, the reference may not be complete. You should refer to the exhibits that are a part
of the Registration Statement in order to review a copy of the contract or documents. The Registration Statement and the exhibits
are available at the SEC’s Public Reference Room or through its Website.
We
file annual, quarterly and current reports, proxy statements and other information with the SEC. The SEC maintains an Internet
site at http://www.sec.gov that contains reports, proxy and information statements, and other information regarding issuers, such
as us, that file electronically with the SEC. Additionally, you may access our filings with the SEC through our website at http://www.proventionbio.com.
The information on our website is not part of this prospectus.
We
will provide you without charge, upon your oral or written request, with a copy of any or all reports, proxy statements and other
documents we file with the SEC, as well as any or all of the documents incorporated by reference in this prospectus or the Registration
Statement (other than exhibits to such documents unless such exhibits are specifically incorporated by reference into such documents).
Requests for such copies should be directed to:
Provention
Bio, Inc.
P.O.
Box 666
Oldwick,
NJ 08858
Telephone
number: (908) 336-0360
You
should rely only on the information in this prospectus and the additional information described above and under the heading “Incorporation
of Certain Information by Reference” below. 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 upon it. We 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 in
this prospectus was accurate on the date of the front cover of this prospectus only. Our business, financial condition, results
of operations and prospects may have changed since that date.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
The
SEC allows us to “incorporate by reference” information that we file with it into this prospectus, which means that
we can disclose important information to you by referring you to those documents. The information incorporated by reference is
an important part of this prospectus. The information incorporated by reference is considered to be a part of this prospectus,
and information that we file later with the SEC will automatically update and supersede information contained in this prospectus
and any accompanying prospectus supplement.
We
incorporate by reference the documents listed below that we have previously filed with the SEC:
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our
Annual Report on Form 10-K for the year ended December 31, 2018, filed with the SEC on March 19, 2019; and
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our
Quarterly Report on Form 10-Q for the period ended March 31, 2019, filed with the SEC on May 8, 2019; and
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our
Current Reports on Form 8-K filed with the SEC on March 28, 2019, May 30, 2019 and June 10, 2019 (other than the information
furnished under Item 7.01 of Form 8-K); and
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our
Definitive Proxy Statement on Schedule 14A, filed on April 15, 2019; and
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the
description of our common stock contained in our registration statement on Form 8-A filed with the SEC on June 22, 2018, including
any amendments or reports filed for the purposes of updating this description.
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All
reports and other documents that we file with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date
of the initial registration statement and prior to effectiveness of the registration statement shall be deemed to be incorporated
by reference in this prospectus and to be a apart hereof from the date of filing of such reports and documents. All reports and
other documents that we file with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this
prospectus but before the termination of the offering of the securities hereunder will also be considered to be incorporated by
reference into this prospectus from the date of the filing of these reports and documents, and will supersede the information
herein; provided, however, that all reports, exhibits and other information that we “furnish” to the SEC will not
be considered incorporated by reference into this prospectus. We undertake to provide without charge to each person (including
any beneficial owner) who receives a copy of this prospectus, upon written or oral request, a copy of all of the preceding documents
that are incorporated by reference (other than exhibits, unless the exhibits are specifically incorporated by reference into these
documents). You may request a copy of these materials in the manner set forth under the heading “Additional Information,”
above.
Shares
Common
Stock
PROSPECTUS
SUPPLEMENT
Joint
Bookrunning Managers
SVB
Leerink
Cantor
Lead
Manager
H.C.
Wainwright & Co.
September
, 2019
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