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TABLE OF
CONTENTS
TABLE OF
CONTENTS
Table of
Contents
Filed
Pursuant to Rule 424(b)(5)
Registration No. 333-234353
Prospectus
Supplement dated April 15, 2020
(To Prospectus Dated November 14, 2019)

1,715,240 Shares of Common Stock
We are offering
1,715,240 shares of our Common Stock to institutional and
accredited investors pursuant to this prospectus supplement, the
accompanying prospectus and a securities purchase agreement with
such investors. In a concurrent private placement, we are selling
to such investors warrants to purchase 100% of the number of shares
of Common Stock purchased by such investors in this offering, or
the Warrants. The Warrants and the Common Stock issuable upon the
exercise of the Warrants are not being registered under the
Securities Act of 1933, as amended, or the Securities Act, are not
being offered pursuant to this prospectus supplement and the
accompanying prospectus, and are being offered pursuant to the
exemption provided in Section 4(a)(2) under the Securities Act
and Regulation D promulgated thereunder.
Our Common
Stock is listed on The Nasdaq Capital Market, or Nasdaq, under the
symbol "NVIV." On April 14, 2020, the last reported sale price
of our Common Stock as reported on Nasdaq was $1.80 per
share.
As of
April 14, 2020, the aggregate market value of our outstanding
common stock held by non-affiliates was $23,937,884, which was
calculated based on 3,116,912 shares of outstanding common stock
held by non-affiliates and a price per share of $7.68, which was
the average of the bid and asked prices of our common stock on
February 18, 2020. Pursuant to General Instruction I.B.6
of Form S-3, in no event will we sell, pursuant to the
registration statement of which this prospectus supplement
forms a part, securities in a public primary offering with a
value exceeding one-third of the aggregate market value of our
common stock held by non-affiliates in any 12-month period, so long
as the aggregate market value of our outstanding common stock held
by non-affiliates remains below $75 million. During the 12
calendar months prior to and including the date of this prospectus
supplement, we have offered and sold $840,000 of securities
pursuant to General Instruction I.B.6 of
Form S-3.
We engaged H.C.
Wainwright & Co., LLC as our exclusive placement
agent to use its reasonable best efforts to solicit offers to
purchase shares of our Common Stock in this offering. The placement
agent has no obligation to purchase any of the shares of our Common
Stock from us or to arrange for the purchase or sale of any
specific number or dollar amount of the shares. We have agreed to
pay the placement agent the placement agent fees set forth in the
table below and to provide certain other compensation to the
placement agent. See "Plan of Distribution" beginning on
page S-18 of this prospectus supplement for more information
regarding these arrangements.
Investing
in the offered securities involves a high degree of risk. See "Risk
Factors" beginning on page S-7 of this prospectus supplement
for a discussion of information that you should consider before
investing in our securities.
Neither
the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or
passed upon the adequacy or accuracy of this prospectus supplement
or the accompanying prospectus. Any representation to the contrary
is a criminal offense.
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Per
Share
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Total
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Public offering price
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$1.75 |
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$3,001,670.00 |
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Placement agent's cash fees(1)
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$0.13125 |
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$225,125.25 |
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Proceeds, before expenses, to us
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$1.61875 |
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$2,776,544.75 |
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- (1)
- We have agreed to
issue common stock purchase warrants to the placement agent, to pay
a management fee equal to 1% of the gross proceeds of the offering
to the placement agent and to reimburse the placement agent for
certain of its expenses. See "Plan of Distribution" on
page S-20 of this prospectus supplement for a description of
the compensation payable to the placement agent.
- (2)
- The amount of the
offering proceeds to us presented in this table does not give
effect to any exercise of the Warrants being issued in the
concurrent private placement.
We expect that
delivery of the shares being offered pursuant to this prospectus
supplement and the accompanying prospectus will be made on or about
April 17, 2020, subject to satisfaction of customary closing
conditions.
H.C.
Wainwright & Co.
The
date of this prospectus supplement is April 15,
2020.
Table of
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TABLE OF CONTENTS
PROSPECTUS SUPPLEMENT
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ABOUT THIS PROSPECTUS SUPPLEMENT
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PROSPECTUS SUPPLEMENT SUMMARY
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S-2 |
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THE OFFERING
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S-5 |
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RISK FACTORS
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SPECIAL NOTE REGARDING FORWARD-LOOKING
STATEMENTS
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USE OF PROCEEDS
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DIVIDEND POLICY
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S-14 |
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PRIVATE PLACEMENT OF WARRANTS
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DESCRIPTION OF SECURITIES WE ARE OFFERING
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S-17 |
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PLAN OF DISTRIBUTION
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S-18 |
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LEGAL MATTERS
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S-20 |
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EXPERTS
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S-20 |
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WHERE YOU CAN FIND ADDITIONAL INFORMATION
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S-20 |
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INCORPORATION OF DOCUMENTS BY REFERENCE
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S-20 |
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PROSPECTUS
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ABOUT THIS PROSPECTUS
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ABOUT INVIVO THERAPEUTICS HOLDINGS
CORP.
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WHERE YOU CAN FIND MORE INFORMATION
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SPECIAL NOTE REGARDING FORWARD-LOOKING
INFORMATION
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INCORPORATION OF CERTAIN INFORMATION BY
REFERENCE
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USE OF PROCEEDS
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THE SECURITIES WE MAY OFFER
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DESCRIPTION OF COMMON STOCK
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DESCRIPTION OF WARRANTS
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DESCRIPTION OF UNITS
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CERTAIN ANTI-TAKEOVER AND INDEMNIFICATION PROVISIONS
OF OUR ARTICLES OF INCORPORATION AND BYLAWS AND NEVADA
LAW
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FORMS OF SECURITIES
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PLAN OF DISTRIBUTION
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EXPERTS
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LEGAL MATTERS
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Table of
Contents
ABOUT THIS PROSPECTUS
SUPPLEMENT
This document
is in two parts. The first part is the prospectus supplement,
including the documents incorporated by reference, which describes
the specific terms of this offering. The second part, the
accompanying prospectus, including the documents incorporated by
reference, provides more general information. Generally, when we
refer to this prospectus, we are referring to both parts of this
document combined. Before you invest, you should carefully read
this prospectus supplement, the accompanying prospectus, all
information incorporated by reference herein and therein, as well
as the additional information described under "Where You Can Find
Additional Information" on page S-27 of this prospectus
supplement. These documents contain information you should consider
when making your investment decision. This prospectus supplement
may add, update or change information contained in the accompanying
prospectus. To the extent there is a conflict between the
information contained in this prospectus supplement, on the one
hand, and the information contained in the accompanying prospectus
or any document incorporated by reference therein filed prior to
the date of this prospectus supplement, on the other hand, you
should rely on the information in this prospectus supplement. If
any statement in one of these documents is inconsistent with a
statement in another document having a later date—for example, a
document filed after the date of this prospectus supplement and
incorporated by reference in this prospectus supplement and the
accompanying prospectus—the statement in the document having the
later date modifies or supersedes the earlier statement.
You should rely
only on the information contained or incorporated by reference in
this prospectus supplement, the accompanying prospectus and in any
free writing prospectuses we may provide to you in connection with
this offering. We have not, and the placement agent has not,
authorized any other person to provide you with any information
that is different. If anyone provides you with different or
inconsistent information, you should not rely on it. We are
offering to sell, and seeking offers to buy, our securities only in
jurisdictions where offers and sales are permitted. The
distribution of this prospectus supplement and the offering of
securities covered hereby in certain jurisdictions may be
restricted by law. Persons outside the United States who come into
possession of this prospectus supplement must inform themselves
about, and observe any restrictions relating to, the offering of
securities covered hereby and the distribution of this prospectus
supplement outside the United States. This prospectus supplement
does not constitute, and may not be used in connection with, an
offer to sell, or a solicitation of an offer to buy, any securities
offered by this prospectus supplement by any person in any
jurisdiction in which it is unlawful for such person to make such
an offer or solicitation.
We further note
that the representations, warranties and covenants made by us in
any agreement that is filed as an exhibit to any document that is
incorporated by reference in this prospectus supplement or the
accompanying prospectus were made solely for the benefit of the
parties to such agreement, including, in some cases, for the
purpose of allocating risk among the parties to such agreements,
and should not be deemed to be a representation, warranty or
covenant to you. Moreover, such representations, warranties or
covenants were accurate only as of the date when made. Accordingly,
such representations, warranties and covenants should not be relied
on as accurately representing the current state of our
affairs.
Unless the
context otherwise requires, the terms "InVivo," "the Company," "our
company," "we," "us," "our" and similar names refer collectively to
InVivo Therapeutics Holdings Corp. and its subsidiaries.
All trademarks,
trade names and service marks appearing in this prospectus
supplement, the accompanying prospectus or the documents
incorporated by reference herein or therein are the property of
their respective owners. Use or display by us of other parties'
trademarks, trade dress or products is not intended to and does not
imply a relationship with, or endorsements or sponsorship of, us by
the trademark or trade dress owner. Solely for convenience,
trademarks, tradenames and service marks referred to in this
prospectus supplement, the accompanying prospectus or the documents
incorporated by reference herein or therein appear without the ®
and ™ symbols, but those references are not intended to indicate,
in any way, that we will not assert, to the fullest extent under
applicable law, our rights or that the applicable owner will not
assert its rights, to these trademarks and trade names.
S-1
Table of
Contents
PROSPECTUS SUPPLEMENT SUMMARY
This
summary highlights certain information about us, this offering and
selected information contained elsewhere in or incorporated by
reference into this prospectus supplement, the accompanying
prospectus and the information incorporated by reference herein and
therein. This summary is not complete and does not contain all of
the information that you should consider before deciding whether to
invest in our securities. For a more complete understanding of our
company and this offering, we encourage you to read and consider
carefully the entire prospectus supplement and the accompanying
prospectus, including "Risk Factors" beginning on page S-7 of
this prospectus supplement, along with our consolidated financial
statements and notes to those consolidated financial statements and
the other documents incorporated by reference in this prospectus
supplement and the accompanying prospectus.
Business Overview
Overview
We are a
research and clinical-stage biomaterials and biotechnology company
with a focus on treatment of spinal cord injuries, or SCIs. Our
approach to treating acute SCIs is based on our
investigational Neuro-Spinal
Scaffold™ implant, a bioresorbable
polymer scaffold that is designed for implantation at the site of
injury within a spinal cord and is intended to treat acute SCI.
The Neuro-Spinal Scaffold
implant incorporates intellectual property licensed
under an exclusive, worldwide license from Boston Children's
Hospital, or BCH, and the Massachusetts Institute of Technology, or
MIT. We also plan to evaluate other technologies and therapeutics
that may be complementary to our development of the
Neuro-Spinal Scaffold implant or offer the potential to bring us closer to our goal
of redefining the life of the SCI patient.
The current
standard of care for acute management of spinal cord injuries
focuses on preventing further injury to the spinal cord. However,
the current standard of care does not address repair of the spinal
cord.
Our Clinical Program
We currently
have one clinical development program for the treatment of acute
SCI.
Our
Neuro-Spinal Scaffold implant is an investigational bioresorbable polymer scaffold
that is designed for implantation at the site of injury within a
spinal cord. The Neuro-Spinal
Scaffold implant is intended to promote
appositional, or side-by-side, healing by supporting the
surrounding tissue after injury, minimizing expansion of areas of
necrosis, and providing a biomaterial substrate for the body's own
healing/repair processes following injury. We believe this form of
appositional healing may spare white matter, increase neural
sprouting, and diminish post-traumatic cyst formation.
The
Neuro-Spinal Scaffold implant is composed of two biocompatible and bioresorbable
polymers that are cast to form a highly porous investigational
product:
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- Poly
lactic-co-glycolic acid, a polymer that is widely used in
resorbable sutures and provides the biocompatible support for
Neuro-Spinal Scaffold implant; and
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- Poly-L-Lysine, a
positively charged polymer commonly used to coat surfaces in order
to promote cellular attachment.
INSPIRE 2.0 Study
Our
Neuro-Spinal Scaffold implant has been approved to be studied under our approved
Investment Device Exemption, or IDE, in the INPSIRE 2.0 Study,
which is titled the "Randomized, Controlled, Single-blind Study of
Probable Benefit of the Neuro-Spinal
Scaffold™ for Safety and Neurologic
Recovery in Subjects with Complete Thoracic AIS A Spinal Cord
Injury as Compared to
S-2
Table of
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Standard of Care." The
purpose of the INSPIRE 2.0 Study is to assess the overall safety
and probable benefit of the Neuro-Spinal
Scaffold for the treatment of
neurologically complete thoracic traumatic acute SCI. The INSPIRE
2.0 Study is designed to enroll 10 subjects into each of the two
study arms, which we refer to as the Scaffold Arm and the
Comparator Arm. Patients in the Comparator Arm will receive the
standard of care, which is spinal stabilization without dural
opening or myelotomy. The INSPIRE 2.0 Study is a single blind
study, meaning that the patients and assessors are blinded to
treatment assignments. The U.S. Food and Drug Administration, or
FDA, approved the enrollment of up to 35 patients in this study so
that there would be at least 20 evaluable patients (10 in each
study arm) at the primary endpoint analysis, accounting for events
such as screen failures or deaths that would prevent a patient from
reaching the primary endpoint visit. We estimate that enrollment in
the INSPIRE 2.0 Study will be complete in the fourth quarter of
2020, with the final patient enrolled in the INSPIRE 2.0 study
reaching their six-month primary endpoint visit in the second
quarter of 2021.
The primary
endpoint is defined as the proportion of patients achieving an
improvement of at least one AIS grade at six months
post-implantation. Assessments of AIS grade are at hospital
discharge, three months, six months, 12 months and
24 months. The definition of study success for INSPIRE 2.0 is
that the difference in the proportion of subjects who demonstrate
an improvement of at least one grade on AIS assessment at the
six-month primary endpoint follow-up visit between the Scaffold Arm
and the Comparator Arm must be equal to or greater than 20%. In one
example, if 50% of subjects in the Scaffold Arm have an improvement
of AIS grade at the six-month primary endpoint and 30% of subjects
in the Comparator Arm have an improvement, then the difference in
the proportion of subjects who demonstrated an improvement is equal
to 20% (50% minus 30% equals 20%) and the definition of study
success would be met. In another example, if 40% of subjects in the
Scaffold Arm have an improvement of AIS grade at the six-month
primary endpoint and 30% of subjects in the Comparator Arm have an
improvement, then the difference in the proportion of subjects who
demonstrated an improvement is equal to 10% (40% minus 30% equals
10%) and the definition of study success would not be met.
Additional endpoints include measurements of changes in NLI,
sensory levels and motor scores, bladder, bowel and sexual
function, pain, Spinal Cord Independence Measure, and quality of
life.
Although The
INSPIRE Study is structured with an Objective Performance
Criterion, or OPC, as the primary component for demonstrating
probable benefit, the OPC is not the only variable that the FDA
would evaluate when reviewing a future HDE application. Similarly,
while our INSPIRE 2.0 Study is structured with a definition of
study success requiring a minimum difference between study arms in
the proportion of subjects achieving improvement, that success
definition is not the only factor that the FDA would evaluate in
the future HDE application. Approval is not guaranteed if the OPC
is met for our prior clinical trial, The INSPIRE Study, or the
definition of study success is met for the INSPIRE 2.0 Study, and
even if the OPC or definition of study success are not met, the FDA
may approve a medical device if probable benefit is supported by a
comprehensive review of all clinical endpoints and preclinical
results, as demonstrated by the sponsor's body of
evidence.
In 2016, the
FDA accepted our proposed HDE modular shell submission and review
process for the Neuro-Spinal
Scaffold implant. The HDE modular shell
is comprised of three modules: a preclinical studies module, a
manufacturing module, and a clinical data module. As part of its
review process, the FDA reviews each module, which are individual
sections of the HDE submission, on a rolling basis. Following the
submission of each module, the FDA reviews and provides feedback,
typically within 90 days, allowing the applicant to receive
feedback and potentially resolve any deficiencies during the review
process. Upon receipt of all three modules, which constitutes the
complete HDE submission, the FDA makes a filing decision that may
trigger the review clock for an approval decision. We submitted the
first module in March 2017 and received feedback in June 2017. We
submitted an updated first module in the fourth quarter of 2019.
The HDE submission will not be complete until the manufacturing and
clinical modules are also submitted.
S-3
Table of
Contents
Corporate Information
We were
incorporated on April 2, 2003, under the name of Design
Source, Inc. On October 26, 2010, we acquired the
business of InVivo Therapeutics Corporation, which was founded in
2005, and we are continuing the existing business operations of
InVivo Therapeutics Corporation as our wholly-owned
subsidiary.
Our principal
executive offices are located in leased premises at One Kendall
Square, Suite B14402, Cambridge, Massachusetts 02139. Our
telephone number is (617) 863-5500. We maintain a website at
www.invivotherapeutics.com. Information contained on, or accessible
through, our website is not a part of, and is not incorporated by
reference into, this prospectus supplement or the accompanying
prospectus.
S-4
Table of
Contents
THE OFFERING
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Securities offered by us:
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1,715,240 shares of our common stock |
Offering price:
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$1.75 per share of Common Stock
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Common stock outstanding after this
offering
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4,847,370 shares of common stock
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Use of proceeds
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We intend to use the net proceeds from this offering
for working capital business development activities, and general
corporate purposes. See "Use of Proceeds" on page S-13 of this
prospectus supplement.
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Risk factors
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See "Risk Factors" beginning on page S-7 of
this prospectus supplement and the other information included or
incorporated by reference elsewhere in this prospectus supplement
and the accompanying prospectus, for a discussion of factors you
should carefully consider before deciding to invest in our
securities.
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Nasdaq Capital Market symbol
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Our common stock is listed on the Nasdaq Capital
Market under the symbol "NVIV."
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Concurrent private placement
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In a concurrent private placement, we are selling to
the purchasers of our Common Stock in this offering Warrants to
purchase 100% of the number of our Common Stock purchased by such
investors in this offering, or Warrants to purchase up to 1,715,240
shares of Common Stock. We will receive proceeds from the
concurrent private placement transaction of Warrants to be
purchased by any investor in the concurrent private placement of
Warrants solely to the extent such Warrants are exercised for cash.
The Warrants will be immediately exercisable at an exercise price
of $1.62 per share and will expire on October 17, 2025. The
Warrants and the Common Stock issuable upon the exercise of the
Warrants are not being offered pursuant to this prospectus
supplement and the accompanying prospectus and are being offered
pursuant to the exemption provided in Section 4(a)(2) under
the Securities Act and Regulation D promulgated thereunder.
There is no established public trading market for the Warrants
being issued in the concurrent private placement, and we do not
expect a market to develop. We do not intend to apply for listing
of the Warrants on any securities exchange or other nationally
recognized trading system. Without an active trading market, the
liquidity of the Warrants will be limited. See "Private Placement
of Warrants."
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S-5
Table of
Contents
The number of
shares of common stock to be outstanding immediately after this
offering is based on 3,132,130 shares of our common stock
outstanding as of April 14, 2020, and excludes:
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- 2,953,603 shares of
common stock issuable upon the exercise of warrants outstanding as
of April 14, 2020 at a weighted average exercise price of
$10.36 per share;
- •
- 4,187 shares of
common stock issuable upon the exercise of options at a weighted
average exercise price of $1,077.78 per share and 200 shares of
common stock issuable upon vesting of restricted stock units
outstanding as of April 14, 2020 pursuant to our stock
incentives plans, which we refer to collectively as the Incentive
Plans;
- •
- 26,872 shares of
common stock available for future awards under the Incentive Plans
and for future issuance our 401(k) plan as of April 14, 2020;
and
- •
- 264 shares of common
stock reserved for future sale under our employee stock purchase
plan as of April 14, 2020.
Unless
otherwise indicated, all information in this prospectus supplement
assumes no exercise of the outstanding options or warrants
described in the bullets above and no exercise of the
Warrants.
S-6
Table of
Contents
RISK FACTORS
An
investment in our securities involves a high degree of risk. Before
deciding whether to invest in our securities, you should consider
carefully the risks and uncertainties described below and under the
section captioned "Risk Factors" contained in our most recent
Annual Report on Form 10-Q for the year ended
December 31, 2019 and other filings we make with the
Securities and Exchange Commission, or SEC, from time to time,
which are incorporated by reference herein in their entirety,
together with other information in this prospectus supplement, the
accompanying prospectus and the information incorporated by
reference herein and therein and in any free writing prospectus
that we may authorize for use in connection with this offering. If
any of these risks actually occurs, our business, financial
condition, results of operations or cash flow could suffer
materially. In such event, the trading price of our common stock
could decline and you might lose all or part of your
investment.
Risks Related to This Offering
We have broad discretion over the use of our cash and cash
equivalents, including the net proceeds we receive in this
offering, and may not use them effectively.
Our management
has broad discretion to use our cash and cash equivalents,
including the net proceeds we receive in this offering, to fund our
operations and could spend these funds in ways that do not improve
our results of operations or enhance the value of our common stock.
The failure by our management to apply these funds effectively
could result in financial losses that could have a material adverse
effect on our business, cause the price of our common stock to
decline and delay the development of our product candidates.
Pending their use to fund operations, we may invest our cash and
cash equivalents in a manner that does not produce income or that
loses value.
Sales of our Common Stock by shareholders may have an adverse
effect on the then prevailing market price of our Common
Stock.
Sales of a
substantial number of our Common Stock in the public market
following this offering could cause the market price of our Common
Stock to decline and could impair our ability to raise capital
through the sale of additional equity securities. We cannot predict
the effect that future sales of our Common Stock or other
equity-related securities would have on the market price of our
Common Stock.
You may experience future dilution as a result of future equity
offerings.
In order to
raise additional capital, we may in the future offer additional
shares of our common stock or other securities convertible into or
exchangeable for our common stock at prices that may not be the
same as the public offering price for the securities in this
offering. We may sell shares or other securities in any other
offering at prices that are less than the price paid by investors
in this offering, and investors purchasing shares or other
securities in the future could have rights superior to existing
stockholders.
In the foreseeable future, we do not intend to pay cash dividends
on shares of our common stock so any investor gains will be limited
to the value of our shares.
We currently
anticipate that we will retain future earnings for the development,
operation, and expansion of our business and do not anticipate
declaring or paying any cash dividends for the foreseeable future.
Any gains to stockholders will therefore be limited to the
increase, if any, in our share price.
S-7
Table of
Contents
Risks Related to Our Business and Common Stock
The COVID-19 pandemic, which began in late 2019 and has had impacts
worldwide, may delay our ability to complete our ongoing clinical
trial or delay the initiation of future clinical trials, disrupt
regulatory activities, or have other adverse effects on our
business and operations. In addition, this pandemic has caused
substantial disruption in the financial markets and may adversely
impact economies worldwide, both of which could result in adverse
effects on our business and operations.
The COVID-19
pandemic, which began in December 2019, has had impacts worldwide,
causing many governments to implement measures to slow the spread
of the outbreak through quarantines, travel restrictions,
heightened border scrutiny, and other measures. The outbreak and
government measures taken in response, including widespread
emergency orders requiring business and residents to curtail
non-essential activities, have also had a significant impact, both
direct and indirect, on businesses and commerce, as worker
shortages have occurred; supply chains have been disrupted;
facilities and production have been suspended; and demand for
certain goods and services, such as medical services and supplies,
has spiked, while demand for other goods and services, such as
travel, has fallen. The future progression of the outbreak and its
effects on our business and operations are uncertain. We and our
clinical research organizations, as well as clinical trial sites,
may face disruptions related to the INSPIRE 2.0 clinical trial
arising from suspension of activity at clinical trial sites due to
hospital staff shortages or state or city "stay at home" or
"shelter in place" orders, delays in the ability to obtain
necessary institutional review board, or IRB, or other necessary
site approvals, as well as other delays at clinical trial sites.
For example, we are aware that a limited number of our clinical
sites have temporarily suspended the INSPIRE 2.0 Study at their
institution due to the coronavirus pandemic. The response to the
COVID-19 pandemic may redirect resources of regulators in a way
that would adversely impact our ability to progress regulatory
approvals. In addition, we may face impediments to regulatory
meetings and approvals due to measures intended to limit in-person
interactions. Any of these factors could adversely impact our
ability to enroll, or delay enrollment in, the INSPIRE 2.0 clinical
trial. Additionally, the pandemic has already caused significant
disruptions in the financial markets, and may continue to cause
such disruptions, which could impact our ability to raise
additional funds through public offerings and may also impact the
volatility of our stock price and trading in our stock. Moreover,
it is possible the pandemic will significantly impact economies
worldwide, which could result in adverse effects on our business
and operations. We cannot be certain what the overall impact of the
COVID-19 pandemic will be on our business and it has the potential
to adversely affect our business, financial condition, results of
operations, and prospects.
Even if this offering is successful, we will need additional
funding to continue our operations. If we are unable to raise
capital when needed, we could be forced to delay, reduce, or
eliminate our product development programs or commercialization
efforts, engage in one or more potential transactions, or cease our
operations entirely.
Even if this
offering is successful, we will need to secure additional resources
to support our continued operations, and to complete clinical
development of our Neuro-Spinal Scaffold, including resources
needed to complete enrollment in our INSPIRE 2.0 Study or to reach
submission of the HDE application to the FDA, plus resources for
engaging in potential business development activities. In addition,
we expect that our expenses will increase in connection with our
ongoing activities, particularly as we conduct our INSPIRE 2.0
Study, and as we seek regulatory approval for our Neuro-Spinal
Scaffold implant. If we obtain regulatory approval for any of our
current or future product candidates, we expect to incur
significant commercialization expenses related to manufacturing,
marketing, sales, and distribution. Accordingly, we will need to
obtain substantial additional funding in connection with our
continuing operations. If we are unable to raise additional
capital, we may seek to engage in one or more potential
transactions, such as the sale of our company, a strategic
partnership with one or more parties or the licensing, sale or
divestiture of some of our assets or proprietary
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technologies, or we
may be forced to cease our operation entirely. There can be no
assurance that we will be able to enter into such a transaction or
transactions on a timely basis or on terms that are favorable to
us. If we are unable to raise capital when needed or on attractive
terms, or should we engage in one or more potential strategic
transactions, we could be forced to delay, reduce, or eliminate our
research and development programs or any future commercialization
efforts. If we determine to change our business strategy or to seek
to engage in a strategic transaction, our future business,
prospects, financial position and operating results could be
significantly different than those in historical periods or
projected by our management. Because of the significant uncertainty
regarding these events, we are not able to accurately predict the
impact of any potential changes in our existing business
strategy.
Our future
funding requirements, both near- and long-term, will depend on many
factors, including, but not limited to:
- •
- the scope, progress,
results, and costs of preclinical development, laboratory testing,
and clinical trials for our Neuro-Spinal Scaffold implant and any
other product candidates that we may develop or acquire, including
our INSPIRE 2.0 Study;
- •
- future clinical trial
results of our Neuro-Spinal Scaffold implant;
- •
- the timing of, and
the costs involved in, obtaining regulatory approvals for the
Neuro-Spinal Scaffold implant, and the outcome of regulatory review
of the Neuro-Spinal Scaffold implant;
- •
- the cost and timing
of future commercialization activities for our products if any of
our product candidates are approved for marketing, including
product manufacturing, marketing, sales, and distribution
costs;
- •
- the revenue, if any,
received from commercial sales of our product candidates for which
we receive marketing approval;
- •
- the cost of having
our product candidates manufactured for clinical trials in
preparation for regulatory approval and in preparation for
commercialization;
- •
- the cost and delays
in product development as a result of any changes in regulatory
oversight applicable to our product candidates;
- •
- our ability to
establish and maintain strategic collaborations, licensing, or
other arrangements and the financial terms of such
agreements;
- •
- the cost and timing
of establishing sales, marketing, and distribution
capabilities;
- •
- the costs involved in
preparing, filing, prosecuting, maintaining, defending, and
enforcing our intellectual property portfolio;
- •
- the efforts and
activities of competitors and potential competitors;
- •
- the effect of
competing technological and market developments; and
- •
- the extent to which
we acquire or invest in businesses, products, and
technologies.
Identifying
potential product candidates and conducting preclinical testing and
clinical trials is a time-consuming, expensive, and uncertain
process that takes years to complete, and we may never generate the
necessary data or results required to obtain regulatory approval
and achieve product sales. In addition, our product candidates, if
approved, may not achieve commercial success. Our commercial
revenues, if any, will be derived from sales of products that we do
not expect to be commercially available for several years, if at
all. Accordingly, we will need to continue to rely on additional
financing to achieve our business objectives. Adequate additional
financing may not be available to us
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on acceptable terms,
or at all and if we are not successful in raising additional
capital, we may not be able to continue as a going
concern.
There is substantial doubt about our ability to continue as a going
concern, which will affect our ability to obtain future financing
and may require us to curtail our operations.
Our
consolidated financial statements as of December 31, 2019 were
prepared under the assumption that we will continue as a going
concern. At December 31, 2019, we had cash and cash
equivalents of $6.6 million. We estimate that our existing
cash resources, together with the proceeds of our registered
offering in March 2020 and anticipated proceeds of this offering,
will be sufficient to fund our operations into the second quarter
of 2021. This estimate is based on assumptions that may prove to be
wrong; expenses could prove to be significantly higher, leading to
a more rapid consumption of our existing resources.
Our ability to
continue as a going concern will depend on our ability to obtain
additional equity or debt financing, attain further operating
efficiencies, reduce or contain expenditures, and, ultimately, to
generate revenue.
Our independent
registered public accounting firm expressed substantial doubt as to
our ability to continue as a going concern in its report dated
February 20, 2020 included in our Annual Report on
Form 10-K for the fiscal year ended December 31, 2019,
which we filed with the SEC on February 20, 2020. Our
management has determined that there continues to be substantial
doubt regarding our ability to continue as a going concern. Even if
this offering is successful, we expect that there will continue to
be substantial doubt about our ability to continue as a going
concern. If we are unable to continue as a going concern, we may
have to liquidate our assets and may receive less than the value at
which those assets are carried on our audited consolidated
financial statements, and it is likely that investors will lose all
or part of their investment. If we seek additional financing to
fund our business activities in the future and there remains
substantial doubt about our ability to continue as a going concern,
investors or other financing sources may be unwilling to provide
additional funding to us on commercially reasonable terms or at
all.
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SPECIAL NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This prospectus
supplement, the accompanying prospectus and the information
incorporated by reference herein and therein, contain and
incorporate "forward-looking statements" within the meaning of
Section 27A of the Securities Act of 1933, as amended, or the
Securities Act, and Section 21E of the Securities Exchange Act
of 1934, as amended, or the Exchange Act. These statements include
statements made regarding our commercialization strategy, future
operations, cash requirements and liquidity, capital requirements,
and other statements on our business plans and strategy, financial
position, and market trends. In some cases, you can identify
forward-looking statements by terms such as "may," "might," "will,"
"should," "believe," "plan," "intend," "anticipate," "target,"
"estimate," "expect," and other similar expressions. These
forward-looking statements are subject to risks and uncertainties
that could cause actual results or events to differ materially from
those expressed or implied by the forward-looking statements,
including factors such as our ability to raise substantial
additional capital to finance our planned operations and to
continue as a going concern; our ability to execute our strategy
and business plan; our ability to obtain regulatory approvals for
our products, including the Neuro-Spinal
Scaffold™; our ability to successfully
commercialize our current and future product candidates, including
the Neuro-Spinal
Scaffold; the progress and timing of our
development programs; market acceptance of our products; our
ability to retain management and other key personnel; our ability
to promote, manufacture, and sell our products, either directly or
through collaborative and other arrangements with third parties;
and other factors detailed under "Risk Factors" in this prospectus
supplement, our most recent Annual Report on Form 10-K. These
forward-looking statements are only predictions, are uncertain, and
involve substantial known and unknown risks, uncertainties, and
other factors which may cause our actual results, levels of
activity, or performance to be materially different from any future
results, levels of activity, or performance expressed or implied by
these forward-looking statements. Such factors include, among
others, the following:
- •
- our limited operating
history and history of net losses;
- •
- our ability to raise
substantial additional capital to finance our planned operations
and to continue as a going concern;
- •
- our ability to
complete the INSPIRE 2.0 Study to support our existing Humanitarian
Device Exemption application;
- •
- our ability to
execute our strategy and business plan;
- •
- our ability to obtain
regulatory approvals for our current and future product candidates,
including our Neuro-Spinal
Scaffold implant;
- •
- our ability to
successfully commercialize our current and future product
candidates, including our Neuro-Spinal
Scaffold implant;
- •
- the impact of the
COVID-19 economy on our business;
- •
- the progress and
timing of our current and future development programs;
- •
- our ability to
successfully open, enroll and complete clinical trials and obtain
and maintain regulatory approval of our current and future product
candidates;
- •
- our ability to
protect and maintain our intellectual property and licensing
arrangements;
- •
- our reliance on third
parties to conduct testing and clinical trials;
- •
- market acceptance and
adoption of our current and future technology and
products;
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- •
- our ability to
promote, manufacture and sell our current and future products,
either directly or through collaborative and other arrangements
with third parties; and
- •
- our ability to
attract and retain key personnel.
We cannot
guarantee future results, levels of activity, or performance. You
should not place undue reliance on these forward-looking
statements, which speak only as of the respective dates as of which
they were made. You are cautioned that these forward-looking
statements are only predictions and are subject to risks,
uncertainties and assumptions that are referenced in the section of
this prospectus supplement entitled "Risk Factors." You should also
carefully review the risk factors and cautionary statements
described in the other documents we file from time to time with the
SEC, specifically our most recent Annual Report on Form 10-K,
our Quarterly Reports on Form 10-Q and our Current Reports on
Form 8-K. Except as required by applicable law, including the
securities laws of the United States, we do not intend to update
any of the forward-looking statements to conform these statements
to reflect actual results, later events or circumstances, or to
reflect the occurrence of unanticipated events.
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USE OF PROCEEDS
We estimate
that the net proceeds from this offering and the concurrent private
placement will be approximately $2.6 million after deducting
the placement agent fees and estimated offering expenses payable by
us.
We intend to
use the net proceeds from this offering for working capital,
business development activities, and general corporate purposes. We
cannot predict with certainty all of the particular uses for the
net proceeds to be received upon the completion of this offering.
Accordingly, our management will have broad discretion and
flexibility in applying the net proceeds from the sale of
securities sold pursuant to this prospectus supplement. Pending the
uses described above, we intend to invest the net proceeds from
this offering in a variety of capital preservation investments,
including short-term, investment-grade and interest-bearing
instruments.
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DIVIDEND POLICY
We have never
declared or paid cash dividends. We do not intend to pay cash
dividends on our common stock for the foreseeable future, but
currently intend to retain any future earnings to fund the
development and growth of our business. The payment of cash
dividends, if any, on our common stock, will rest solely within the
discretion of our board of directors and will depend, among other
things, upon our earnings, capital requirements, financial
condition, and other relevant factors.
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PRIVATE PLACEMENT OF WARRANTS
Concurrently
with the closing of the sale of Common Stock in this offering, we
also expect to issue and sell to the investors Warrants to purchase
an aggregate of up to 1,715,240 of shares of our Common Stock at an
initial exercise price equal to $1.62 per share.
The Warrants
and the shares of Common Stock issuable upon the exercise of the
Warrants are not being registered under the Securities Act, are not
being offered pursuant to this prospectus supplement and the
accompanying prospectus and are being offered pursuant to the
exemption provided in Section 4(a)(2) under the Securities Act
and Rule 506(b) promulgated thereunder. Accordingly, the
purchaser may only sell shares of Common Stock issued upon exercise
of the Warrants pursuant to an effective registration statement
under the Securities Act covering the resale of those shares, an
exemption under Rule 144 under the Securities Act or another
applicable exemption under the Securities Act.
Exercisability. The
Warrants are immediately exercisable, and at any time thereafter up
to the five and one-half year anniversary of the initial exercise
date. The Warrants will be exercisable, at the option of each
holder, in whole or in part by delivering to us a duly executed
exercise notice and, at any time a registration statement
registering the issuance of the Common Stock underlying the
Warrants under the Securities Act is effective and available for
the issuance of such shares, or an exemption from registration
under the Securities Act is available for the issuance of such
shares, by payment in full in immediately available funds for the
number of Common Stock purchased upon such exercise. If at the time
of exercise there is no effective registration statement
registering, or the prospectus contained therein is not available
for the issuance of the Common Stock underlying the Warrants, then
the Warrants may also be exercised, in whole or in part, at such
time by means of a cashless exercise, in which case the holder
would receive upon such exercise the net number of Common Stock
determined according to the formula set forth in the
Warrant.
Exercise
Limitation. A
holder will not have the right to exercise any portion of the
Warrant if the holder (together with its affiliates) would
beneficially own in excess of 4.99% (or 9.99% upon the request of
the investor) of the number of shares of Common Stock outstanding
immediately after giving effect to the exercise, as such percentage
ownership is determined in accordance with the terms of the
Warrants. However, any holder may increase or decrease such
percentage, provided that any increase will not be effective until
the 61st day after such election.
Exercise
Price. The
Warrants will have an exercise price of $1.62 per share. The
exercise price is subject to appropriate adjustment in the event of
certain stock dividends and distributions, stock splits, stock
combinations, reclassifications or similar events affecting our
Common Stock and also upon any distributions of assets, including
cash, stock or other property to our stockholders.
Transferability. Subject
to applicable laws, the Warrants may be offered for sale, sold,
transferred or assigned without our consent.
Trading
Market. There is
no established trading market for the Warrants being issued in the
concurrent private placement, and we do not expect a market to
develop. We do not intend to apply for listing of the Warrants on
any securities exchange or other nationally recognized trading
system. Without an active trading market, the liquidity of the
Warrants will be limited.
Fundamental
Transactions. In
the event of a fundamental transaction, as described in the
Warrants and generally including any reorganization,
recapitalization or reclassification of our common stock, the sale,
transfer or other disposition of all or substantially all of our
properties or assets, our consolidation or merger with or into
another person, the acquisition of more than 50% of our outstanding
common stock, or any person or group becoming the beneficial owner
of 50% of the voting power represented by our outstanding common
stock, the holders of the Warrants will be entitled to
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receive upon exercise
of the Warrants the kind and amount of securities, cash or other
property that the holders would have received had they exercised
the Warrants immediately prior to such fundamental transaction. In
addition, in the event of a fundamental transaction which is
approved by our Board, the holders of the Warrants have the right
to require us or a successor entity to redeem the Warrant for cash
in the amount of the Black-Scholes value of the unexercised portion
of the Warrant on the date of the consummation of the fundamental
transaction. In the event of a fundamental transaction which is not
approved by our Board, the holders of the Warrants have the right
to require us or a successor entity to redeem the Warrant for the
consideration paid in the fundamental transaction in the amount of
the Black Scholes value of the unexercised portion of the Warrant
on the date of the consummation of the fundamental
transaction.
Rights as a
Shareholder. Except as otherwise provided in the
Warrants or by virtue of such holder's ownership of our Common
Stock, the holder of a Warrant does not have the rights or
privileges of a holder of our Common Stock, including any voting
rights, until the holder exercises the Warrant.
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DESCRIPTION OF SECURITIES WE ARE
OFFERING
Common Stock
We have
authorized 16,666,667 shares of capital stock, par value $0.00001
per share, all of which are shares of common stock. As of
April 14, 2020, there were 3,132,130 shares of common stock
issued and outstanding. The authorized and unissued shares of
common stock are available for issuance without further action by
our stockholders, unless such action is required by applicable law
or the rules of any stock exchange on which our securities may be
listed. Unless approval of our stockholders is so required, our
board of directors does not intend to seek stockholder approval for
the issuance and sale of our common stock. All shares of common
stock will, when issued, be duly authorized, fully paid and
non-assessable. Accordingly, the full price for the outstanding
shares of common stock will have been paid at issuance and any
holder of our common stock will not be later required to pay us any
additional money for such common stock.
The holders of
our common stock are entitled to one vote per share. Generally, all
matters to be voted on by stockholders must be approved by a
majority (or, in the case of election of directors, by a plurality)
of the votes entitled to be cast by all shares of common stock that
are present in person or represented by proxy. Additionally, any
alteration, amendment or appeal of any provision of our bylaws
would require the affirmative vote of the holders of at least 80%
of the voting power of our then outstanding shares entitled to
vote, voting together as a single class. Except as otherwise
provided by law, amendments to the articles of incorporation
generally must be approved by a majority of the votes entitled to
be cast by all outstanding shares of common stock. Our articles of
incorporation do not provide for cumulative voting in the election
of directors. Our directors are divided into three classes. At each
annual meeting of stockholders, directors elected to succeed those
directors whose terms expire are elected for a term of office to
expire at the third succeeding annual meeting of stockholders after
their election. The holders of our common stock are entitled to
receive ratably such dividends, if any, as may be declared by our
board of directors out of legally available funds; however, the
current policy of our board of directors is to retain earnings, if
any, for operations and growth. Upon liquidation, dissolution or
winding-up, the holders of our common stock are entitled to share
ratably in all assets that are legally available for distribution
after payment of our liabilities. The holders of our common stock
have no preemptive, subscription, redemption or conversion
rights.
The foregoing
description summarizes important terms of our capital stock, but is
not complete. For the complete terms of our common stock, please
refer to our articles of incorporation, as amended, and our amended
and restated bylaws, as may be amended from time to
time.
The transfer
agent and registrar for our common stock is Continental Stock
Transfer & Trust Company. Our common stock is listed on
the Nasdaq Capital Market under the symbol "NVIV."
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PLAN
OF DISTRIBUTION
We have engaged
H.C. Wainwright & Co., LLC, which we refer to in
this prospectus supplement as H.C. Wainwright or the placement
agent, to act as our exclusive placement agent to solicit offers to
purchase the securities offered by this prospectus supplement. H.C.
Wainwright is not purchasing or selling any securities, nor are
they required to arrange for the purchase and sale of any specific
number or dollar amount of securities, other than to use their
reasonable best efforts to arrange for the sale of the securities
by us. Therefore, we may not sell the entire amount of the
securities being offered. There is no minimum amount of proceeds
that is a condition to closing of this offering. We will enter into
securities purchase agreements directly with institutional
investors that purchase our securities in this offering. H.C.
Wainwright may engage one or more sub-placement agents or selected
dealers to assist with the offering.
Fees and Expenses
The following
table show the per share and total placement agent fees we will pay
in connection with the sale of the securities in this offering,
assuming the purchase of all of the securities we are
offering.
|
|
|
|
|
Per share placement agent cash fees
|
|
$ |
0.13125 |
|
Total placement agent cash fees
|
|
$ |
225,125.25 |
|
We have agreed
to pay the placement agent a total cash fee equal to 7.5% of the
gross proceeds of this offering and a management fee equal to 1% of
the gross proceeds raised in this offering. We will also pay the
placement agent a non-accountable expense allowance of $25,000 and
will reimburse the placement agent's legal fees and clearing
expenses in an aggregate amount of up to $60,000. We estimate the
total offering expenses of this offering that will be payable by
us, excluding the placement agent fees and expenses, will be
approximately $0.1 million. After deducting the placement
agent fees and our estimated offering expenses, we expect the net
proceeds from this offering to be approximately
$2.6 million.
Placement Agent Warrants
We have agreed
to grant compensation warrants to H.C. Wainwright, or its
designees, (the "Placement Agent Warrants") to purchase a number of
shares of our common stock equal to 6.5% of the aggregate number of
shares of common stock sold to the investors in this offering. The
Placement Agent Warrants will have an exercise price of $2.1875 and
will terminate on April 15, 2025. Pursuant to FINRA
Rule 5110(g), the Placement Agent Warrants and any shares
issued upon exercise of the Placement Agent Warrants will not be
sold, transferred, assigned, pledged, or hypothecated, or be the
subject of any hedging, short sale, derivative, put, or call
transaction that would result in the effective economic disposition
of the securities by any person for a period of 180 days
immediately following the date of effectiveness or commencement of
sales of this offering, except the transfer of any
security:
- •
- by operation of law
or by reason of our reorganization;
- •
- to any FINRA member
firm participating in the offering and the officers or partners
thereof, if all securities so transferred remain subject to the
lock-up restriction set forth above for the remainder of the time
period;
- •
- if the aggregate
amount of our securities held by the placement agent or related
persons do not exceed 1% of the securities being offered;
- •
- that is beneficially
owned on a pro rata basis by all equity owners of an investment
fund, provided that no participating member manages or otherwise
directs investments by the fund
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and the participating
members in the aggregate do not own more than 10% of the equity in
the fund; or
- •
- the exercise or
conversion of any security, if all securities received remain
subject to the lock-up restrictions for the remainder of the time
period;
and the exercise or
conversion of any security, if all securities remain subject to the
lock-up restriction set forth above for the remainder of the time
period.
Right of First Refusal
In addition, we
have granted a right of first refusal to the placement agent
pursuant to which it has the right to act as the exclusive advisor,
manager or underwriter or agent, as applicable, if we or our
subsidiaries sell or acquire a business, finance any indebtedness
using an agent, or raise capital through a public or private
offering of equity or debt securities at any time prior to the
12 month anniversary of the date of this prospectus
supplement.
Other Relationships
The placement
agent may, from time to time, engage in transactions with or
perform services for us in the ordinary course of its business and
may continue to receive compensation from us for such
services.
Determination of Offering Price
The public
offering price of the securities we are offering was negotiated
between us and the investors, in consultation with the placement
agent based on the trading of our common stock prior to the
offering, among other things. Other factors considered in
determining the public offering price of the securities we are
offering include the history and prospects of our company, the
stage of development of our business, our business plans for the
future and the extent to which they have been implemented, an
assessment of our management, general conditions of the securities
markets at the time of the offering and such other factors as were
deemed relevant.
Transfer Agent and Registrar
The transfer
agent and registrar for our common stock is Continental Stock
Transfer & Trust Company.
Nasdaq Listing
Our common
stock is listed on the Nasdaq Capital Market under the symbol
"NVIV."
Indemnification
We have agreed
to indemnify the placement agent against certain liabilities,
including liabilities under the Securities Act, or to contribute to
payments the placement agent may be required to make with respect
to any of these liabilities.
Regulation M
The placement
agent may be deemed to be an underwriter within the meaning of
Section 2(a)(11) of the Securities Act and any fees received
by it and any profit realized on the sale of the securities by it
while acting as principal might be deemed to be underwriting
discounts or commissions under the Securities Act. The placement
agent will be required to comply with the requirements of the
Securities Act and the Exchange Act, including, without limitation,
Rule 10b-5 and Regulation M under the Exchange Act. These
rules and regulations may limit the timing of purchases and sales
of our securities by the placement agent. Under these rules and
regulations, the placement agent may not (i) engage in any
stabilization activity in connection with our securities and
(ii) bid for or purchase any of our securities or attempt to
induce any person to purchase any of our securities, other than as
permitted under the Exchange Act, until they have completed their
participation in the distribution.
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LEGAL
MATTERS
The validity of
the securities offered by this prospectus supplement and the
accompanying prospectus will be passed upon for us by Ballard
Spahr LLP, Las Vegas, Nevada, and certain other legal matters
will be passed upon for us by Wilmer Cutler Pickering Hale and
Dorr LLP, Boston, Massachusetts. Ellenoff Grossman &
Schole LLP, New York, New York, has acted as counsel for the
placement agent in connection with certain legal matters related to
this offering.
EXPERTS
The
consolidated financial statements of InVivo Therapeutics Holdings
Corp. and subsidiary as of December 31, 2019 and 2018 and for
the years then ended, incorporated in this prospectus supplement
and the accompanying prospectus by reference from the InVivo
Therapeutics Holdings Corp.'s Annual Report on Form 10-K for
the year ended December 31, 2019 have been audited by RSM
US LLP, an independent registered public accounting firm, as
stated in their report thereon (which report expresses an
unqualified opinion and includes an explanatory paragraph relating
to InVivo Therapeutics Holdings Corp.'s ability to continue as a
going concern), incorporated herein by reference, and have been
incorporated in this prospectus supplement and the accompanying
prospectus in reliance upon such report and upon the authority of
such firm as experts in accounting and auditing.
WHERE YOU CAN FIND
ADDITIONAL INFORMATION
We file annual,
quarterly and current reports, proxy statements and other
information with the SEC. Our SEC filings are available to you on
the SEC's Internet site at www.sec.gov. Copies of certain
information filed by us with the SEC are also available on our
website at www.invivotherapeutics.com. The
information on our Internet website is not incorporated by
reference in this prospectus or any prospectus
supplement.
This prospectus
supplement is part of a registration statement that we filed with
the SEC. This prospectus supplement does not contain all of the
information included in the registration statement, including
certain exhibits and schedules. You should review the information
and exhibits in the registration statement for further information
about us and the securities we are offering. Statements in this
prospectus concerning any document we filed as an exhibit to the
registration statement or that we otherwise filed with the SEC are
not intended to be comprehensive and are qualified by reference to
these filings. You should review the complete document to evaluate
these statements. You can obtain a copy of the registration
statement and exhibits from the SEC's Internet site.
INCORPORATION OF
DOCUMENTS BY REFERENCE
The SEC allows
us to incorporate by reference into this prospectus supplement and
the accompanying prospectus information and reports that we file
with the SEC. This means that we can disclose important information
to you by referring to other documents that contain that
information. Any information that we incorporate by reference is
considered part of this prospectus supplement and the accompanying
prospectus. The documents and reports that we list below are
incorporated by reference into this prospectus supplement and the
accompanying prospectus, other than any portion of any such
documents that are not deemed "filed" under the Exchange Act in
accordance with the Exchange Act and applicable SEC
rules.
In addition,
all documents and reports which we file pursuant to
Section 13(a), 13(c), 14 or 15(d) of the Exchange Act after
the date of this prospectus supplement and prior to the termination
of the offering made hereby are incorporated by reference in this
prospectus supplement and the accompanying prospectus as of the
respective filing dates of these documents and reports.
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We have filed
the following documents with the SEC. These documents are
incorporated in this prospectus supplement and the accompanying
prospectus by reference as of their respective dates of
filing:
- (1)
-
Our Annual Report on Form 10-K for the fiscal year ended
December 31, 2019, filed with the SEC on February 20,
2020;
- (2)
- Our Current Reports
on Form 8-K filed with the SEC on
March 2, 2020,
March 11, 2020 and
April 16, 2020, and
our Current Report on Form 8-K/A filed with the SEC on
February 24, 2020; and
- (3)
-
The description of our common stock contained in our Registration
Statement on Form 8-A filed on April 15, 2015, including
any amendments or reports filed for the purpose of updating such
description.
You may request
a copy of these documents, which will be provided to you at no
cost, by writing or telephoning us at:
InVivo
Therapeutics Holdings Corp.
One Kendall Square, Suite B14402
Cambridge, Massachusetts 02139
Attn: Investor Relations
(617) 863-5500
Statements
contained in documents that we file with the SEC and that are
incorporated by reference in this prospectus supplement or the
accompanying prospectus will automatically update and supersede
information contained in this prospectus supplement and the
accompanying prospectus, including information in previously filed
documents or reports that have been incorporated by reference in
this prospectus supplement or the accompanying prospectus, to the
extent the new information differs from or is inconsistent with the
old information. Any statement so modified or superseded will not
be deemed to be a part of this supplement or the accompanying
prospectus, except as so modified or superseded. Because
information that we later file with the SEC will update and
supersede previously incorporated information, you should look at
all of the SEC filings that we incorporate by reference to
determine if any of the statements in this prospectus supplement or
the accompanying prospectus or in any documents previously
incorporated by reference have been modified or
superseded.
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PROSPECTUS

INVIVO THERAPEUTICS HOLDINGS CORP.
$20,000,000
Common Stock
Warrants
Units
This prospectus
relates to common stock, warrants and units that we may sell from
time to time in one or more offerings up to a total dollar amount
of $20,000,000 on terms to be determined at the time of sale. We
will provide specific terms of these securities in supplements to
this prospectus. You should read this prospectus and any supplement
carefully before you invest. This prospectus may not be used to
offer and sell securities unless accompanied by a prospectus
supplement for those securities.
Our common
stock is listed on The Nasdaq Capital Market under the symbol
"NVIV." On October 25, 2019, the last sales price of our
common stock as reported on The Nasdaq Capital Market was $0.44 per
share.
These
securities may be sold directly by us, through dealers or agents
designated from time to time, to or through underwriters or through
a combination of these methods. See "Plan of Distribution" in this
prospectus. We may also describe the plan of distribution for any
particular offering of these securities in any applicable
prospectus supplement. If any agents, underwriters or dealers are
involved in the sale of any securities in respect of which this
prospectus is being delivered, we will disclose their names and the
nature of our arrangements with them in a prospectus supplement.
The net proceeds we expect to receive from any such sale will also
be included in a prospectus supplement.
As of
September 15, 2019, the aggregate market value of our
outstanding common stock held by non-affiliates was approximately
$5,766,788, which was calculated based on 9,301,271 shares of
outstanding common stock held by non-affiliates and a price per
share of $0.62. Pursuant to General Instruction I.B.6 of
Form S-3, in no event will we sell, pursuant to the
registration statement of which this prospectus forms a part,
securities in a public primary offering with a value exceeding
one-third of the aggregate market value of our common stock held by
non-affiliates in any 12-month period, so long as the aggregate
market value of our outstanding common stock held by non-affiliates
remains below $75 million. During the 12 calendar months prior
to and including the date of this prospectus, we have not offered
or sold any securities pursuant to General Instruction I.B.6
of Form S-3.
Investing
in these securities involves certain risks. See "Risk Factors"
included in any accompanying prospectus supplement and in the
documents incorporated by reference in this prospectus for a
discussion of the factors you should carefully consider before
deciding to purchase these securities.
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 November 14, 2019.
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TABLE OF CONTENTS
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Page |
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About this Prospectus
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1 |
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About InVivo Therapeutics Holdings
Corp.
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2 |
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Where You Can Find More Information
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3 |
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Special Note Regarding Forward-Looking
Information
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4 |
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Incorporation of Certain Information By
Reference
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Use of Proceeds
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7 |
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The Securities We May Offer
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8 |
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Description of Common Stock
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Description of Warrants
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10 |
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Description of Units
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11 |
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Certain Anti-Takeover and Indemnification Provisions
of our Articles of Incorporation and Bylaws and Nevada
Law
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Forms of Securities
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Plan of Distribution
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Experts
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21 |
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Legal Matters
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ABOUT THIS PROSPECTUS
This prospectus
is part of a registration statement that we filed with the
Securities and Exchange Commission, or the SEC, using a "shelf"
registration process. Under this shelf registration process, we may
sell any combination of the securities described in this prospectus
in one or more offerings up to a total dollar amount of
$20,000,000.
This prospectus
provides you with a general description of the securities we may
offer. Each time we sell securities, we will provide a prospectus
supplement that will contain specific information about the
securities being offered and the terms of that offering. The
prospectus supplement may also add to, update or change information
contained in this prospectus. You should read both this prospectus
and any prospectus supplement together with the additional
information described under the heading "Where You Can Find More
Information" on page 3 of this prospectus carefully before
making an investment decision.
You should rely
only on the information contained or incorporated by reference in
this prospectus or any applicable prospectus supplement. We have
not authorized any other person to provide you with different
information. If anyone provides you with different or inconsistent
information, you should not rely on it. We are not making an offer
to sell these securities in any jurisdiction where the offer or
sale is not permitted.
You should not
assume that the information appearing in this prospectus or any
applicable prospectus supplement is accurate as of any date other
than the date on the front cover of this prospectus or the
applicable prospectus supplement, or that the information contained
in any document incorporated by reference is accurate as of any
date other than the date of the document incorporated by reference,
regardless of the time of delivery of this prospectus or any
prospectus supplement or any sale of a security. Our business,
financial condition, results of operations and prospects may have
changed since such dates.
Unless the
context otherwise requires, the terms "InVivo," "the Company," "our
company," "we," "us," "our" and similar names refer collectively to
InVivo Therapeutics Holdings Corp. and its subsidiaries.
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ABOUT INVIVO THERAPEUTICS HOLDINGS
CORP.
We are a
research and clinical-stage biomaterials and biotechnology company
with a focus on treatment of spinal cord injuries, or SCIs. Our
mission is to redefine the life of the SCI patient, and we seek to
develop treatment options intended to provide meaningful
improvement in patient outcomes following SCI. Our approach to
treating acute SCIs is based on our investigational Neuro-Spinal
Scaffold™ implant, a bioresorbable polymer scaffold that is
designed for implantation at the site of injury within a spinal
cord and is intended to treat acute SCI. The Neuro-Spinal Scaffold
implant incorporates intellectual property licensed under an
exclusive, worldwide license from Boston Children's Hospital, or
BCH, and the Massachusetts Institute of Technology, or MIT. We also
plan to evaluate other technologies and therapeutics that may be
complementary to our development of the Neuro-Spinal Scaffold
implant or offer the potential to bring us closer to our goal of
redefining the life of the SCI patient.
InVivo
Therapeutics Corporation was incorporated on November 28, 2005
under the laws of the State of Delaware and on October 26,
2010 completed a reverse merger transaction with and became a
wholly-owned subsidiary of InVivo Therapeutics Holdings
Corporation, a company incorporated under the laws of the State of
Nevada.
Our principal
executive offices are located at One Kendall Square, Suite B14402,
Cambridge, Massachusetts 02139, and our telephone number is
(617) 863-5500. Our worldwide web address is
www.invivotherapeutics.com. The information on our web site is not
incorporated by reference into this prospectus and should not be
considered to be part of this prospectus.
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WHERE YOU CAN FIND MORE
INFORMATION
We file annual,
quarterly and current reports, proxy statements and other
information with the SEC. Our SEC filings are available to you on
the SEC's Internet site at www.sec.gov. Copies of certain
information filed by us with the SEC are also available on our
website at www.invivotherapeutics.com. The
information on our Internet website is not incorporated by
reference in this prospectus or any prospectus
supplement.
This prospectus
is part of a registration statement that we filed with the SEC.
This prospectus does not contain all of the information included in
the registration statement, including certain exhibits and
schedules. You should review the information and exhibits in the
registration statement for further information about us and the
securities we are offering. Statements in this prospectus
concerning any document we filed as an exhibit to the registration
statement or that we otherwise filed with the SEC are not intended
to be comprehensive and are qualified by reference to these
filings. You should review the complete document to evaluate these
statements. You can obtain a copy of the registration statement and
exhibits from the SEC's Internet site.
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SPECIAL NOTE REGARDING FORWARD-LOOKING
INFORMATION
This prospectus
and each prospectus supplement contains and incorporates
"forward-looking statements" within the meaning of Section 27A
of the Securities Act of 1933, as amended (the "Securities Act"),
and Section 21E of the Securities Exchange Act of 1934, as
amended (the "Exchange Act"). These statements include statements
made regarding our commercialization strategy, future operations,
cash requirements and liquidity, capital requirements, and other
statements on our business plans and strategy, financial position,
and market trends. In some cases, you can identify forward-looking
statements by terms such as "may," "might," "will," "should,"
"believe," "plan," "intend," "anticipate," "target," "estimate,"
"expect," and other similar expressions. These forward-looking
statements are subject to risks and uncertainties that could cause
actual results or events to differ materially from those expressed
or implied by the forward-looking statements, including factors
such as our ability to raise substantial additional capital to
finance our planned operations and to continue as a going concern;
our ability to execute our strategy and business plan; our ability
to obtain regulatory approvals for our products, including
the Neuro-Spinal
Scaffold™; our ability to successfully
commercialize our current and future product candidates, including
the Neuro-Spinal
Scaffold; the progress and timing of our
development programs; market acceptance of our products; our
ability to retain management and other key personnel; our ability
to promote, manufacture, and sell our products, either directly or
through collaborative and other arrangements with third parties;
and other factors detailed under "Risk Factors" in our most recent
Annual Report on Form 10-K and our most recent Quarterly
Report on Form 10-Q. These forward looking statements are only
predictions, are uncertain, and involve substantial known and
unknown risks, uncertainties, and other factors which may cause our
actual results, levels of activity, or performance to be materially
different from any future results, levels of activity, or
performance expressed or implied by these forward looking
statements. Such factors include, among others, the
following:
- •
- our limited operating
history and history of net losses;
- •
- our ability to raise
substantial additional capital to finance our planned operations
and to continue as a going concern;
- •
- our ability to
complete the INSPIRE 2.0 Study to support our existing Humanitarian
Device Exemption application;
- •
- our ability to
execute our strategy and business plan;
- •
- our ability to obtain
regulatory approvals for our current and future product candidates,
including our Neuro-Spinal
Scaffold implant;
- •
- our ability to
successfully commercialize our current and future product
candidates, including our Neuro-Spinal
Scaffold implant;
- •
- the progress and
timing of our current and future development programs;
- •
- our ability to
successfully open, enroll and complete clinical trials and obtain
and maintain regulatory approval of our current and future product
candidates;
- •
- our ability to
protect and maintain our intellectual property and licensing
arrangements;
- •
- our reliance on third
parties to conduct testing and clinical trials;
- •
- market acceptance and
adoption of our current and future technology and products;
- •
- our ability to
promote, manufacture and sell our current and future products,
either directly or through collaborative and other arrangements
with third parties; and
- •
- our ability to
attract and retain key personnel.
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We cannot
guarantee future results, levels of activity, or performance. You
should not place undue reliance on these forward looking
statements, which speak only as of the date of this prospectus. You
are cautioned that these forward-looking statements are only
predictions and are subject to risks, uncertainties and assumptions
that are referenced in the section of any accompanying prospectus
supplement entitled "Risk Factors." You should also carefully
review the risk factors and cautionary statements described in the
other documents we file from time to time with the SEC,
specifically our most recent Annual Report on Form 10-K, our
Quarterly Reports on Form 10-Q and our Current Reports on
Form 8-K. Except as required by applicable law, including the
securities laws of the United States, we do not intend to update
any of the forward looking statements to conform these statements
to reflect actual results, later events or circumstances, or to
reflect the occurrence of unanticipated events.
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INCORPORATION OF CERTAIN INFORMATION BY
REFERENCE
The SEC allows
us to "incorporate" into this prospectus information and reports
that we file with the SEC. This means that we can disclose
important information to you by referring to other documents that
contain that information. Any information that we incorporate by
reference is considered part of this prospectus. The documents and
reports that we list below are incorporated by reference into this
prospectus, other than any portion of any such documents that are
not deemed "filed" under the Exchange Act in accordance with the
Exchange Act and applicable SEC rules.
In addition,
all documents and reports which we file pursuant to
Section 13(a), 13(c), 14 or 15(d) of the Exchange Act after
the date of this prospectus and prior to the termination of the
offering made hereby are incorporated by reference in this
prospectus as of the respective filing dates of these documents and
reports.
We have filed
the following documents with the SEC. These documents are
incorporated herein by reference as of their respective dates of
filing:
- (1)
- Our
Annual Report on Form 10-K for the fiscal year ended
December 31, 2018, filed on April 1, 2019, including
the information specifically incorporated by reference into the
Annual Report on Form 10-K from our definitive
proxy statement for the 2019 Annual Meeting of Stockholders, filed
on April 25, 2019;
- (2)
- Our Quarterly Reports
on Form 10-Q for the quarter ended March 31, 2019, filed
on
May 10, 2019 and for the quarter ended June 30, 2019,
filed on
August 13, 2019;
- (3)
- Our Current Reports
on Form 8-K filed on
January 4, 2019 (Item 8.01 only),
January 14, 2019,
June 14, 2019,
July 5, 2019,
July 12, 2019,
July 19, 2019 and
September 27, 2019;
- (4)
- All of our filings
pursuant to the Exchange Act after the date of filing the initial
registration statement and prior to the effectiveness of the
registration statement; and
- (5)
-
The description of our common stock contained in our Registration
Statement on Form 8-A filed on April 15, 2015, including
any amendments or reports filed for the purpose of updating such
description.
You may request
a copy of these documents, which will be provided to you at no
cost, by writing or telephoning us at:
InVivo
Therapeutics Holdings Corp.
One Kendall Square, Suite B14402
Cambridge, Massachusetts 02139
Attn: Investor Relations
(617) 863-5500
Statements
contained in documents that we file with the SEC and that are
incorporated by reference in this prospectus will automatically
update and supersede information contained in this prospectus,
including information in previously filed documents or reports that
have been incorporated by reference in this prospectus, to the
extent the new information differs from or is inconsistent with the
old information. Any statement so modified or superseded will not
be deemed to be a part of this prospectus or any prospectus
supplement, except as so modified or superseded. Because
information that we later file with the SEC will update and
supersede previously incorporated information, you should look at
all of the SEC filings that we incorporate by reference to
determine if any of the statements in this prospectus or any
prospectus supplement or in any documents previously incorporated
by reference have been modified or superseded.
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USE OF PROCEEDS
We currently
intend to use the estimated net proceeds from the sale of these
securities to conduct our INSPIRE 2.0 clinical trial and for other
business development activities, as well as for working capital and
for general corporate purposes, which may include the
following:
- •
- the research,
development and pre-clinical and clinical trials for our product
candidates;
- •
- the acquisition of
other companies, businesses, products or technologies;
- •
- the repayment and
refinancing of debt;
- •
- capital
expenditures;
- •
- working capital;
and
- •
- any other purpose
that we may specify in any prospectus supplement.
We have not yet
determined the amount of net proceeds to be used specifically for
any of the foregoing purposes. Accordingly, our management will
have significant discretion and flexibility in applying the net
proceeds from the sale of these securities. Pending any use, as
described above, we intend to invest the net proceeds in
high-quality, short-term, interest-bearing securities. Our plans to
use the estimated net proceeds from the sale of these securities
may change, and if they do, we will update this information in a
prospectus supplement.
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THE SECURITIES WE MAY OFFER
The
descriptions of the securities contained in this prospectus,
together with the applicable prospectus supplements, summarize 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 so indicate
in the applicable prospectus supplement, the terms of the
securities may differ from the terms we have summarized below. We
will also include in the prospectus supplement information, where
applicable, 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, in one or more offerings:
- •
- common stock;
- •
- warrants to purchase
common stock or units;
- •
- units comprised of
common stock and warrants; or
- •
- any combination of
the foregoing securities.
In this
prospectus, we refer to the common stock, warrants and units
collectively as "securities." The total dollar amount of all
securities that we may issue will not exceed
$20,000,000.
This prospectus
may not be used to consummate a sale of securities unless it is
accompanied by a prospectus supplement.
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DESCRIPTION OF COMMON STOCK
The following
is a description of the material terms and provisions of our common
stock. It may not contain all the information that is important to
you. You can access complete information by referring to our
articles of incorporation and bylaws, which are filed as exhibits
to the registration statement of which this prospectus forms a
part.
Under our
articles of incorporation, as amended, we have authority to issue
25,000,000 shares of common stock, par value $0.00001 per share. As
of September 15, 2019, there were 9,313,070 shares of common
stock issued and outstanding. All shares of common stock will, when
issued, be duly authorized, fully paid and nonassessable.
Accordingly, the full price for the outstanding shares of common
stock will have been paid at issuance and any holder of our common
stock will not be later required to pay us any additional money for
such common stock.
In addition, as
of September 15, 2019:
- •
- there were
outstanding warrants to purchase an aggregate of up to 7,673,130
shares of our common stock at a weighted average exercise price of
$4.78 per share;
- •
- there were an
aggregate of 124,890 shares of our common stock subject to
outstanding stock options at a weighted average exercise price of
$35.15 per share;
- •
- 7,500 shares of our
common stock were issuable upon vesting of outstanding restricted
stock units;
- •
- 4,275 shares of our
common stock were reserved for future issuances under our incentive
compensation plans and 401(k) plan; and
- •
- 7,923 shares of our
common stock reserved for future issuance under our employee stock
purchase plan.
The holders of
common stock are entitled to one vote per share on all matters
submitted to a vote of the stockholders, including the election of
directors. Generally, all matters to be voted on by stockholders
must be approved by a majority (or, in the case of election of
directors, by a plurality) of the votes entitled to be cast by all
shares of common stock that are present in person or represented by
proxy. Except as otherwise provided by law, amendments to the
articles of incorporation generally must be approved by a majority
of the votes entitled to be cast by all outstanding shares of
common stock. Our articles of incorporation do not provide for
cumulative voting in the election of directors. The holders of
common stock will be entitled to such cash dividends as may be
declared from time to time by the Board from funds available. The
holders of common stock have no preferential or preemptive right
and no subscription, redemption or conversion privileges with
respect to the issuance of additional shares of our common stock.
Upon liquidation, dissolution or winding up of the Company, the
holders of common stock will be entitled to receive pro rata all
assets available for distribution to such holders after payment of
our liabilities.
Registrar and Transfer Agent
The registrar
and transfer agent for our common stock is Continental Stock
Transfer & Trust Company.
Trading Market
Our common
stock is listed on The Nasdaq Capital Market under the symbol
"NVIV."
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DESCRIPTION OF WARRANTS
We may issue
warrants for the purchase of common stock or units. Warrants may be
issued independently or together with common stock or units, and
the warrants may be attached to or separate from such securities.
We may issue warrants directly or under a warrant agreement to be
entered into between us and a warrant agent. We will name any
warrant agent in the applicable prospectus supplement. Any warrant
agent will act solely as our agent in connection with the warrants
of a particular series and will not assume any obligation or
relationship of agency or trust for or with any holders or
beneficial owners of warrants.
The following
is a description of the general terms and provisions of any
warrants we may issue and may not contain all the information that
is important to you. You can access complete information by
referring to the applicable prospectus supplement. In the
applicable prospectus supplement, we will describe the terms of the
warrants and any applicable warrant agreement, including, where
applicable, the following:
- •
- the title of the
warrants;
- •
- the offering price
and aggregate number of warrants offered;
- •
- the designation and
terms of the securities with which the warrants are issued and the
number of warrants issued with each such security;
- •
- the date on and after
which the warrants and the related securities will be separately
transferable;
- •
- any information with
respect to book-entry procedures;
- •
- in the case of
warrants to purchase common stock or units, the number of shares of
common stock or units, as the case may be, purchasable upon the
exercise of one warrant and the price at which these securities may
be purchased upon such exercise;
- •
- the effect of any
merger, consolidation, sale or other disposition of our business on
the warrant agreement and the warrants;
- •
- the terms of any
rights to redeem or call the warrants;
- •
- any provisions for
changes to or adjustments in the exercise price or number of
securities issuable upon exercise of the warrants;
- •
- the dates on which
the right to exercise the warrants will commence and expire;
- •
- the manner in which
the warrant agreement and warrants may be modified;
- •
- a discussion of any
material U.S. federal income tax considerations of holding or
exercising the warrants;
- •
- the terms of the
securities issuable upon exercise of the warrants; and
- •
- any other specific
terms, preferences, rights or limitations of or restrictions on the
warrants.
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DESCRIPTION OF UNITS
The following
description, together with the additional information we include in
any applicable prospectus supplement, summarizes the material terms
and provisions of the units that we may offer under this
prospectus. Units may be offered independently or together with
common stock and warrants offered by any prospectus supplement, and
may be attached to or separate from those securities.
While the terms
we have summarized below will generally apply to any future units
that we may offer under this prospectus, we will describe the
particular terms of any series of units that we may offer in more
detail in the applicable prospectus supplement. The terms of any
units offered under a prospectus supplement may differ from the
terms described below.
We will
incorporate by reference into the registration statement of which
this prospectus is a part the form of unit agreement, including a
form of unit certificate, if any, that describes the terms of the
series of units we are offering before the issuance of the related
series of units. The following summaries of material provisions of
the units and the unit agreements are subject to, and qualified in
their entirety by reference to, all the provisions of the unit
agreement applicable to a particular series of units. We urge you
to read the applicable prospectus supplements related to the units
that we sell under this prospectus, as well as the complete unit
agreements that contain the terms of the units.
General
We may issue
units consisting of common stock and warrants. 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.
The unit agreement under which a unit is issued 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.
We will
describe in the applicable prospectus supplement the terms of the
series of units, including the following:
- •
- 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;
- •
- any provisions of the
governing unit agreement that differ from those described below;
and
- •
- any provisions for
the issuance, payment, settlement, transfer, or exchange of the
units or of the securities comprising the units.
The provisions
described in this section, as well as those described under
"Description of Common Stock," and "Description of Warrants," will
apply to each unit and to the common stock and warrants included in
each unit, respectively.
Issuance in Series
We may issue
units in such amounts and in such numerous distinct series as we
determine.
Enforceability of Rights by Holders of Units
Each unit agent
will act solely as our agent under the applicable unit agreement
and will not assume any obligation or relationship of agency or
trust with any holder of any unit. A single bank or trust company
may act as unit agent for more than one series of units. A unit
agent will have no duty or responsibility in case of any default by
us under the applicable unit agreement or unit, including any duty
or responsibility to initiate any proceedings at law or otherwise,
or to make any demand upon us.
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Any holder of a unit,
without the consent of the related unit agent or the holder of any
other unit, may enforce by appropriate legal action its rights as
holder under any security included in the unit.
Title
We, the unit
agent, and any of their agents may treat the registered holder of
any unit certificate as an absolute owner of the units evidenced by
that certificate for any purposes and as the person entitled to
exercise the rights attaching to the units so requested, despite
any notice to the contrary.
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CERTAIN ANTI-TAKEOVER AND INDEMNIFICATION
PROVISIONS OF
OUR ARTICLES OF INCORPORATION, BY-LAWS AND NEVADA
LAW
Anti-Takeover Effects of Provisions of Nevada State
Law
We may be or in
the future we may become subject to Nevada's control share laws. A
corporation is subject to Nevada's control share law if it has more
than 200 stockholders, at least 100 of whom are stockholders of
record and residents of Nevada, and if the corporation does
business in Nevada, including through an affiliated corporation.
This control share law may have the effect of discouraging
corporate takeovers. We currently have less than 100 stockholders
of record who are residents of Nevada.
The control
share law focuses on the acquisition of a "controlling interest,"
which means the ownership of outstanding voting shares that would
be sufficient, but for the operation of the control share law, to
enable the acquiring person to exercise the following proportions
of the voting power of the corporation in the election of
directors: (1) one-fifth or more but less than one-third;
(2) one-third or more but less than a majority; or (3) a
majority or more. The ability to exercise this voting power may be
direct or indirect, as well as individual or in association with
others.
The effect of
the control share law is that an acquiring person, and those acting
in association with that person, will obtain only such voting
rights in the control shares as are conferred by a resolution of
the stockholders of the corporation, approved at a special or
annual meeting of stockholders. The control share law contemplates
that voting rights will be considered only once by the other
stockholders. Thus, there is no authority to take away voting
rights from the control shares of an acquiring person once those
rights have been approved. If the stockholders do not grant voting
rights to the control shares acquired by an acquiring person, those
shares do not become permanent non-voting shares. The acquiring
person is free to sell the shares to others. If the buyer or buyers
of those shares themselves do not acquire a controlling interest,
the shares are not governed by the control share law.
If control
shares are accorded full voting rights and the acquiring person has
acquired control shares with a majority or more of the voting
power, a stockholder of record, other than the acquiring person,
who did not vote in favor of approval of voting rights, is entitled
to demand fair value for such stockholder's shares.
In addition to
the control share law, Nevada has a business combination law, which
prohibits certain business combinations between Nevada corporations
and "interested stockholders" for two years after the interested
stockholder first becomes an interested stockholder, unless the
corporation's board of directors approves the combination in
advance. For purposes of Nevada law, an interested stockholder is
any person who is: (a) the beneficial owner, directly or
indirectly, of 10% or more of the voting power of the outstanding
voting shares of the corporation, or (b) an affiliate or
associate of the corporation and at any time within the previous
two years was the beneficial owner, directly or indirectly, of 10%
or more of the voting power of the then-outstanding shares of the
corporation. The definition of "business combination" contained in
the statute is sufficiently broad to cover virtually any kind of
transaction that would allow a potential acquirer to use the
corporation's assets to finance the acquisition or otherwise to
benefit its own interests rather than the interests of the
corporation and its other stockholders.
The effect of
Nevada's business combination law is to potentially discourage
parties interested in taking control of the Company from doing so
if it cannot obtain the approval of our board of
directors.
Anti-Takeover Effects of Provisions of Our Articles of
Incorporation and Bylaws
Our articles of
incorporation provide for a classified board of directors. This
provision could prevent a party who acquires control of a majority
of our outstanding common stock from obtaining
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control of the board
until our second annual stockholders meeting following the date the
acquirer obtains the controlling stock interest. The classified
board provision could have the effect of discouraging a potential
acquirer from making a tender offer or otherwise attempting to
obtain control of us and could increase the likelihood that
incumbent directors will retain their positions. In addition, under
our amended and restated bylaws, directors may be removed only for
cause and only by the affirmative vote of the holders of at least
80% of the voting power of our then outstanding shares of capital
stock entitled to vote generally in the election of directors,
voting together as a single class.
Our amended and
restated bylaws also provide that stockholders may only act at
meetings of stockholders and not by written consent in lieu of a
stockholders' meeting. Our amended and restated bylaws provide that
stockholders may not call a special meeting of stockholders.
Rather, only the Chairman of our Board, the President or the Board
of Directors pursuant to a resolution approved by a majority of the
entire Board of Directors are able to call special meetings of
stockholders. Our amended and restated bylaws also provide that
stockholders may only conduct business at special meetings of
stockholders that was specified in the notice of the meeting. These
provisions may discourage another person or entity from making a
tender offer, even if it acquired a majority of our outstanding
voting stock, because the person or entity could only take action
at a duly called stockholders' meeting relating to the business
specified in the notice of meeting and not by written
consent.
Indemnification of Directors and Officers
Nevada Revised
Statutes ("NRS") Sections 78.7502 and 78.751 provide us with
the power to indemnify any of our directors, officers, employees
and agents. The person entitled to indemnification must have
conducted himself in good faith, and must reasonably believe that
his conduct was in, or not opposed to, our best interests. In a
criminal action, the director, officer, employee or agent must also
not have had reasonable cause to believe that his conduct was
unlawful. In addition, any of our directors, officers, employees or
agents are entitled to indemnification if such person is successful
on the merits or otherwise in defense of any threatened, pending or
completed action, suit or proceeding, whether civil, criminal,
administrative or investigative against actual and reasonable
expenses incurred in connection with defending such
action.
Under NRS
Section 78.751, advances for expenses may be made by agreement
if the director or officer affirms in writing to repay the expenses
if it is determined that such officer or director is not entitled
to be indemnified.
Our bylaws
include an indemnification provision under which we have the power
to indemnify our directors, officers, former directors and
officers, employees and other agents (including heirs and personal
representatives) against all costs, charges and expenses actually
and reasonably incurred, including an amount paid to settle an
action or satisfy a judgment to which a director or officer is made
a party by reason of being or having been a director or officer of
the Company. Our bylaws further provide for the advancement of all
expenses incurred in connection with a proceeding upon receipt of
an undertaking by or on behalf of such person to repay such amounts
unless it is determined that the party is entitled to be
indemnified under our bylaws. No advance will be made by the
Company to a party if it is determined that the party acted in bad
faith. These indemnification rights are contractual, and as such
will continue as to a person who has ceased to be a director,
officer, employee or other agent, and will inure to the benefit of
the heirs, executors and administrators of such a person. Unless
our articles are amended to provide for greater liability, neither
our directors nor officers are individually liable to us or our
stockholders or creditors for any act or omission as a director or
officer unless it is proven that: (i) such act or omission
constituted a breach of such director's or officer's fiduciary
duties; and (ii) such breach involved intentional misconduct,
fraud or a knowing violation of law. These provisions may be
sufficiently broad to indemnify such persons for
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liabilities arising
under the Securities Act, in which case such provisions are against
public policy as expressed in the Securities Act and are therefore
unenforceable.
We maintain an
insurance policy on behalf of our directors and officers, covering
certain liabilities which may arise as a result of the actions of
the directors and officers.
We have entered
into an indemnification agreement with each of our officers and
directors pursuant to which they will be indemnified by us, subject
to certain limitations, for any liabilities incurred by them in
connection with their role as officers and/or directors of the
Company.
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FORMS OF SECURITIES
Each unit and
warrant 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. Unless
the applicable prospectus supplement provides otherwise,
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 registrar, paying agent or
other agent, as applicable. Global securities name a depositary or
its nominee as the owner of the units 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
We may issue
the units and warrants 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 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 global securities. Unless and until it is exchanged
in whole for securities in definitive registered form, a global
security may not be transferred except as a whole by and among the
depositary for the 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 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 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 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 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 global
securities.
So long as the
depositary, or its nominee, is the registered owner of a 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 global security for all purposes under the
applicable indenture, deposit agreement, purchase contract, warrant
agreement or purchase unit agreement. Except as described below,
owners of beneficial interests in a global security will not be
entitled to have the securities represented by the 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, deposit agreement, purchase
contract, purchase unit agreement or warrant agreement.
Accordingly, each person owning a beneficial interest in a global
security must rely on the procedures of the depositary for that
global security and, if that person is not a participant, on the
procedures of the participant through which the person owns its
interest, to
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exercise any rights of
a holder under the applicable unit agreement 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
global security desires to give or take any action that a holder is
entitled to give or take under the applicable unit agreement or
warrant agreement, the depositary for the 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.
Any payments to
holders with respect to warrants or units represented by a 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 global security. None of us, or any
warrant agent, unit agent or other agent of ours, or any agent of
any warrant agent or unit agent will have any responsibility or
liability for any aspect of the records relating to payments made
on account of beneficial ownership interests in the 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 global
security, upon receipt of any payment to holders of principal,
premium, interest or other distribution of underlying securities or
other property on that registered global security, will immediately
credit participants' accounts in amounts proportionate to their
respective beneficial interests in that global security as shown on
the records of the depositary. We also expect that payments by
participants to owners of beneficial interests in a 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 or registered in
"street name," and will be the responsibility of those
participants.
If the
depositary for any of the securities represented by a 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 global security that had been held by the
depositary. Any securities issued in definitive form in exchange
for a global security will be registered in the name or names that
the depositary gives to the relevant warrant agent, unit 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 global security that had been held by
the depositary.
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PLAN OF DISTRIBUTION
We may sell the
securities being offered hereby in one or more of the following
ways from time to time:
- •
- directly to
investors;
- •
- through agents to the
public or to investors;
- •
- directly to
agents;
- •
- to one or more
underwriters or dealers for resale to the public or to
investors;
- •
- in "at the market
offerings," within the meaning of Rule 415(a)(4) of the
Securities Act, to or through a market maker or into an existing
trading market, or an exchange or otherwise; or
- •
- through a combination
of any of these methods of sale.
The securities
that we distribute by any of these methods may be sold, in one or
more transactions, at:
- •
- a fixed price or
prices, which may be changed;
- •
- market prices
prevailing at the time of sale;
- •
- prices related to
prevailing market prices; or
- •
- negotiated
prices.
We will set
forth in a prospectus supplement the terms of the offering of our
securities, including:
- •
- the name or names of
any agents or underwriters;
- •
- the purchase price of
our securities being offered and the proceeds we will receive from
the sale;
- •
- any over-allotment
options under which underwriters may purchase additional securities
from us;
- •
- any agency fees or
underwriting discounts and commissions and other items constituting
agents' or underwriters' compensation;
- •
- any public offering
price;
- •
- any discounts or
concessions allowed or reallowed or paid to dealers; and
- •
- any securities
exchanges on which such common stock may be listed.
Underwriters
Underwriters,
dealers and agents that participate in the distribution of the
securities may be underwriters as defined in the Securities Act and
any discounts or commissions they receive from us and any profit on
their resale of the securities may be treated as underwriting
discounts and commissions under the Securities Act. We will
identify in the applicable prospectus supplement any underwriters,
dealers or agents and will describe their compensation. We may have
agreements with the underwriters, dealers and agents to indemnify
them against specified civil liabilities, including liabilities
under the Securities Act. Underwriters, dealers and agents may
engage in transactions with or perform services for us or our
subsidiaries in the ordinary course of their businesses.
If we use
underwriters for a sale of securities, the underwriters will
acquire the securities for their own account. The underwriters may
resell the securities 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 the
conditions set forth in the applicable underwriting agreement. The
underwriters will be obligated to purchase all the
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securities offered if
they purchase any of the securities offered. We may change from
time to time any initial public offering price and any discounts or
concessions the underwriters allow or reallow or pay to dealers. We
may use underwriters with whom we have a material relationship. We
will describe in the prospectus supplement naming the underwriters
the nature of any such relationship.
If indicated in
the applicable prospectus supplement, we will authorize
underwriters or other persons acting as our agents to solicit
offers by particular institutions to purchase securities from us at
the public offering price set forth in such prospectus supplement
pursuant to delayed delivery contracts providing for payment and
delivery on the date or dates stated in such prospectus supplement.
Each delayed delivery contract will be for an amount no less than,
and the aggregate principal amounts of securities sold under
delayed delivery contracts shall be not less nor more than, the
respective amounts stated in the applicable prospectus supplement.
Institutions with which such contracts, when authorized, may be
made include commercial and savings banks, insurance companies,
pension funds, investment companies, educational and charitable
institutions and others, but will in all cases be subject to our
approval. The obligations of any purchaser under any such contract
will be subject to the conditions that (a) the purchase of the
securities shall not at the time of delivery be prohibited under
the laws of any jurisdiction in the United States to which the
purchaser is subject, and (b) if the securities are being sold
to underwriters, we shall have sold to the underwriters the total
principal amount of the securities less the principal amount
thereof covered by the contracts. The underwriters and such other
agents will not have any responsibility in respect of the validity
or performance of such contracts.
Agents
We may
designate agents who agree to use their reasonable efforts to
solicit purchases for the period of their appointment or to sell
securities on a continuing basis.
Direct Sales
We may also
sell securities directly to one or more purchasers without using
underwriters or agents. We may also make direct sales through
subscription rights distributed to our shareholders on a pro rata
basis, which may or may not be transferable. In any distribution of
subscription rights to shareholders, if all of the underlying
securities are not subscribed for, we may then sell the
unsubscribed securities directly to third parties or may engage the
services of one or more underwriters, dealers or agents, including
standby underwriters, to sell the unsubscribed securities to third
parties.
Trading Markets and Listing of Securities
Unless
otherwise specified in the applicable prospectus supplement, each
class or series of securities will be a new issue with no
established trading market, other than our common stock, which is
listed on The Nasdaq Capital Market. We may elect to list any other
class or series of securities on any exchange, but we are not
obligated to do so. It is possible that one or more underwriters
may make a market in a class or series of securities, but the
underwriters will not be obligated to do so and may discontinue any
market making at any time without notice. We cannot give any
assurance as to the liquidity of the trading market for any of the
securities.
Stabilization Activities
In connection
with an offering, an underwriter may purchase and sell securities
in the open market. These transactions may include short sales,
stabilizing transactions and purchases to cover positions created
by short sales. Shorts sales involve the sale by the underwriters
of a greater number of securities than they are required to
purchase in the offering. "Covered" short sales are sales made in
an amount not greater than the underwriters' option to purchase
additional securities from us, if any, in the offering. If the
underwriters have an over-allotment option to purchase additional
securities from
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us, the underwriters
may close out any covered short position by either exercising their
over-allotment option or purchasing securities in the open market.
In determining the source of securities to close out the covered
short position, the underwriters may consider, among other things,
the price of securities available for purchase in the open market
as compared to the price at which they may purchase securities
through the over-allotment option. "Naked" short sales are any
sales in excess of such option or where the underwriters do not
have an over-allotment option. The underwriters must close out any
naked short position by purchasing securities 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 the securities in the open market after pricing that
could adversely affect investors who purchase in the
offering.
Accordingly, to
cover these short sales positions or to otherwise stabilize or
maintain the price of the securities, the underwriters may bid for
or purchase securities in the open market and may impose penalty
bids. If penalty bids are imposed, 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, whether 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 impositions of a penalty bid may also effect the price of the
securities to the extent that it discourages resale of the
securities. The magnitude or effect of any stabilization or other
transactions is uncertain. These transactions may be effected on
The Nasdaq Capital Market or otherwise and, if commenced, may be
discontinued at any time.
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EXPERTS
The
consolidated financial statements of InVivo Therapeutics Holdings
Corp. and its subsidiaries as of December 31, 2018 and 2017
and for each of the years in the two-year period ended
December 31, 2018 incorporated in this Prospectus by reference
from the InVivo Therapeutics Holdings Corp.'s
Annual Report on Form 10-K for the year ended
December 31, 2018, have been audited by RSM US LLP,
an independent registered public accounting firm, as stated in
their report thereon (which report expresses an unqualified opinion
and includes an explanatory paragraph relating to InVivo
Therapeutics Holdings Corp.'s ability to continue as a going
concern), incorporated herein by reference, and have been
incorporated in this Prospectus and Registration Statement in
reliance upon such report and upon the authority of such firm as
experts in accounting and auditing.
LEGAL MATTERS
Unless the
applicable prospectus supplement indicates otherwise, the validity
of the securities in respect of which this prospectus is being
delivered will be passed upon by Ballard Spahr LLP, Las Vegas,
Nevada, and certain other legal matters will be passed upon for us
by Wilmer Cutler Pickering Hale and Dorr LLP, Boston,
Massachusetts.
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1,715,240 Shares of Common Stock
InVivo Therapeutics Holdings Corp.

Prospectus Supplement
H.C.
Wainwright & Co.
April 15, 2020
InVivo Therapeutics (NASDAQ:NVIV)
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