Unassociated Document
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date
of Report (Date of Earliest Event Reported):
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October 26, 2010
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INVIVO
THERAPEUTICS HOLDINGS CORP.
(Exact name of registrant as specified in its charter)
Nevada
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000-52089
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36-4528166
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(State or other jurisdiction of
incorporation)
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(Commission File
Number)
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(I.R.S. Employer Identification No.)
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One Broadway, 14th Floor, Cambridge, MA 02142
(Address of principal executive offices)
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(617) 475-1520
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(Registrant’s telephone number, including
area code)
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Design
Source, Inc., 100 Europa Drive, Suite 455, Chapel Hill, NC 27517
(Former name, former address and former fiscal year, if changed since last
report)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
¨ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
¨ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
¨ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
CAUTIONARY NOTE REGARDING
FORWARD-LOOKING STATEMENTS
This
current report contains forward-looking statements as that term is defined in
the Private Securities Litigation Reform Act of 1995. These statements relate to
anticipated future events, future results of operations or future financial
performance. These forward-looking statements include, but are not limited to,
statements relating to our ability to raise sufficient capital to finance our
planned operations, market acceptance of our technology and product offerings,
our ability to attract and retain key personnel, our ability to protect our
intellectual property, and estimates of our cash expenditures for the next 12 to
36 months. In some cases, you can identify forward-looking statements by
terminology such as “may,” “might,” “will,” “should,” “intends,” “expects,”
“plans,” “goals,” “projects,” “anticipates,” “believes,” “estimates,”
“predicts,” “potential,” or “continue” or the negative of these terms or other
comparable terminology.
These
forward-looking statements are only predictions, are uncertain and involve
substantial known and unknown risks, uncertainties and other factors which may
cause our (or our industry’s) 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. The “Risk
Factors” section of this current report sets forth detailed risks, uncertainties
and cautionary statements regarding our business and these forward-looking
statements.
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 that they were made. These cautionary statements should be considered
with any written or oral forward-looking statements that we may issue in the
future. 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.
EXPLANATORY
NOTE
On
October 4, 2010 Design Source, Inc., a Nevada corporation (“DS"), entered into
an agreement and Plan of Merger (the "Merger Agreement") pursuant to which DS
merged with its newly formed, wholly owned subsidiary, InVivo Therapeutics
Holdings Corp. (“Merger Sub”), a Nevada corporation (the "ITHC Merger"). Upon
the consummation of the ITHC Merger, the separate existence of Merger Sub ceased
and DS, the surviving corporation in the ITHC Merger, became known as InVivo
Therapeutics Holdings Corp. (“ITHC”).
As
permitted by Chapter 92A.180 of Nevada Revised Statutes, the sole purpose of the
ITHC Merger was to effect a change of DS's name. Upon the filing of Articles of
Merger (the "Articles of Merger") with the Secretary of State of Nevada on
October 4, 2010 to effect the ITHC Merger, DS's articles of incorporation were
deemed amended to reflect the change in DS's corporate name.
On
October 26, 2010, InVivo Therapeutics Acquisition Corp. (“Acquisition Corp.”), a
wholly-owned subsidiary of ITHC, merged (the “Merger”) with and into InVivo
Therapeutics Corporation, a Delaware corporation (“InVivo”). InVivo was the
surviving corporation of that Merger. As a result of the Merger, ITHC acquired
the business of InVivo, and will continue the existing business operations of
InVivo, as a wholly-owned subsidiary.
As used
in this Current Report, the terms the “Company”, “we,” “us,” and “our” refer to InVivo
Therapeutics Holdings Corp., the Nevada corporation, and its wholly-owned
subsidiary InVivo, after giving effect to the Merger, unless otherwise stated or
the context clearly indicates otherwise. The term “ITHC” refers to InVivo
Therapeutics Holdings Corp. (f/k/a Design Source, Inc.), the Nevada corporation,
before giving effect to the Merger, and the term “InVivo” refers to InVivo
Therapeutics Corporation, the Delaware corporation, before giving effect to the
Merger.
This
Current Report contains summaries of the material terms of various agreements
executed in connection with the transactions described herein. The summaries of
these agreements are subject to, and are qualified in their entirety by,
reference to these agreements, all of which are incorporated herein by
reference.
This
current report is being filed in connection with a series of transactions
consummated by the Company and certain related events and actions taken by the
Company.
This
current report responds to the following items on Form 8-K:
Item
1.01
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Entry
into a Material Definitive
Agreement
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Item
2.01
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Completion
of Acquisition or Disposition of
Assets
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Item
3.02
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Unregistered
Sales of Equity Securities
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Item
4.01
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Changes
in Registrant’s Certifying
Accountant
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Item
5.01
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Changes
in Control of Registrant
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Item
5.02
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Departure
of Directors or Principal Officers; Election of Directors; Appointment of
Principal Officers
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Item
5.06
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Change
in Shell Company Status
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Item
9.01
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Financial
Statements and Exhibits
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TABLE OF
CONTENTS
Item
1.01.
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Entry
into a Material Definitive Agreement
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5
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Item
2.01.
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Completion
of Acquisition or Disposition of Assets
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5
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The
Merger And Related Transactions
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5
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Description
Of Business
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11
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Risk
Factors
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25
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Management’s
Discussion And Analysis Of Financial Condition And Results Of
Operations
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43
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Description
Of Property
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48
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Security
Ownership Of Certain Stockholders And Management
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48
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Directors
And Executive Officers
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49
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Executive
Compensation
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55
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Certain
Relationships And Related Transactions
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60
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Description
Of Capital Stock
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62
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Market
For Common Equity And Related Stockholder Matters
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66
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Legal
Proceedings
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67
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Recent
Sales Of Unregistered Securities
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67
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Indemnification
Of Officers And Directors
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68
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Part
F/S
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68
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Index
To Exhibits
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69
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Description
of Exhibits
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69
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Item
3.02
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Unregistered
Sales of Equity Securities
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69
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Item
4.01
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Changes
in Registrant’s Certifying Accountant
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69
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Item
5.01
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Changes
in Control of the Registrant
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70
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Item
5.02
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Departure
of Directors or Certain Officers;
Election
of Directors; Appointment of Certain Officers; Compensatory Arrangements
of Certain Officers
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70
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Item
5.03
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Amendments
to Articles of Incorporation or Bylaws; Change in Fiscal
Year
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70
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Item
5.06
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Change
in Shell Company Status
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70
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Item
9.01
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Financial
Statements and Exhibits
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70
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Item
1.01.
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Entry
into a Material Definitive
Agreement
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On
October 26, 2010, the Company entered into an Agreement and Plan of Merger and
Reorganization, which we refer to in this Current Report as the “Merger Agreement”, and
completed the Merger. For a description of the Merger and the material
agreements entered into in connection with the Merger, please see the
disclosures set forth in Item 2.01 to this Current Report, which disclosures are
incorporated into this item by reference.
Item
2.01.
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Completion
of Acquisition or Disposition of
Assets
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THE
MERGER AND RELATED TRANSACTIONS
The
Merger
On
October 26, 2010 (which we refer to as the “Closing Date”), ITHC, InVivo
and Acquisition Corp. entered into the Merger Agreement and completed the
Merger. Before their entry into the Merger Agreement, no material relationship
existed between ITHC (or its Acquisition Corp. subsidiary) and InVivo. A copy of
the Merger Agreement is attached as Exhibit 2.1 to this Current Report and is
incorporated herein by reference.
Pursuant
to the Merger Agreement, on the Closing Date, Acquisition Corp., a wholly-owned
subsidiary of ITHC, merged with and into InVivo, with InVivo remaining as the
surviving entity. ITHC acquired the business of InVivo pursuant to
the Merger and will continue the existing business operations of InVivo as a
wholly-owned subsidiary.
Simultaneously
with the Merger, on the Closing Date all of the issued and outstanding shares of
InVivo common stock converted, on a 13.7706 for 1 basis, into shares of the
Company’s common stock (“Common
Stock”). Also on the Closing Date, all of the issued and outstanding
options to purchase shares of InVivo common stock, and the issued and
outstanding Bridge Warrants (as defined below) to purchase shares of InVivo
Common Stock, converted, respectively, into options (the “New Options”) and new bridge
warrants (the “New Bridge
Warrants”) to purchase shares of our Common Stock. The number of shares
of Common Stock issuable under, and the price per share upon exercise of, the
New Options and the New Bridge Warrants were calculated based on the terms of
the original options and warrants of InVivo, as adjusted by the conversion ratio
in the Merger, which is described in the Merger Agreement. The New Options will
be administered under InVivo’s 2007 Stock Incentive Plan, which the Company
assumed and adopted on the Closing Date in connection with the
Merger.
On the
Closing Date, an aggregate of 31,647,190 shares of Common Stock were issued to
former InVivo stockholders and 5,915,561 Options and 600,000 New Bridge Warrants
were issued to holders of outstanding InVivo options and warrants. The
stockholders of ITHC before the Merger, without giving effect to the Offering
(as defined below), retained 6,999,981 shares of Common Stock.
The
Merger Agreement contains customary representations, warranties and covenants of
ITHC, and, as applicable, Acquisition Corp., for like transactions. Breaches of
representations and warranties are secured by customary indemnification
provisions.
The
Merger will be treated as a recapitalization of the Company for financial
accounting purposes. The historical financial statements of ITHC before the
Merger will be replaced with the historical financial statements of InVivo
before the Merger in all future filings with the Securities and Exchange
Commission (the “SEC”).
Following
closing of the Merger, our board of directors consists of five members. In
keeping with the foregoing, on the Closing Date, Peter A. Reichard and Peter L.
Coker, the directors of ITHC before the Merger, appointed Frank M.
Reynolds, Richard
J. Roberts, George Nolen, Christi M. Pedra and Adam K. Stern to fill vacancies
on the board of directors, and Messrs. Reichard and Coker resigned their
positions as directors. Also on the Closing Date, Messrs. Reichard and Coker,
the officers of ITHC, resigned and new executive officers designated by InVivo
were appointed. The officers and directors of the Company as of the Closing Date
are identified in this Current Report under the heading “Directors and Executive
Officers.”
Before
the Merger, ITHC’s board of directors adopted the 2010 Equity Incentive Plan,
which is expected to be submitted to the shareholders of the Company for
approval during the twelve month period immediately following the closing of the
Merger. The 2010 Equity Incentive Plan provides for the issuance of up to
3,500,000 shares of Common Stock as incentive awards granted to executive
officers, key employees, consultants and directors. In addition, the Company
assumed and adopted InVivo’s 2007 Stock Incentive Plan, and as described above
option holders under that plan will be granted New Options to purchase Common
Stock. No further options will be granted under the 2007 Stock Incentive Plan.
The parties have taken all actions necessary to ensure that the Merger is
treated as a tax free exchange under Section 368(a) of the Internal Revenue Code
of 1986, as amended.
The
issuance of shares of Common Stock to holders of InVivo’s capital stock in
connection with the Merger was not registered under the Securities Act of 1933,
as amended (the “Securities
Act”), in reliance upon the exemption from registration provided by
Section 4(2) of the Securities Act and Regulation D promulgated by the SEC under
that section, which exempts transactions by an issuer not involving any public
offering. These securities may not be offered or sold in the United States
absent registration or an applicable exemption from the registration
requirement.
The
Offering
Concurrently
with the closing of the Merger and in contemplation of the Merger, the Company
completed a private offering (the “Offering”) of 10,514,097 units
of its securities (“Units”), at a price of $1.00
per Unit. Each Unit consists of one share of Common Stock and a warrant to
purchase one share of Common Stock. The warrants (the “Investor Warrants”) are
exercisable for a period of five years at a purchase price of $1.40 per share of
Common Stock. The Offering was made only to accredited investors, as defined
under Regulation D, Rule 501(a). On the Closing Date, the investors in the
Offering collectively purchased 10,514,097 Units for total cash consideration of
$10,514,097, which includes the conversion of $504,597 of principal of, and
accrued interest on, Bridge Notes (as defined below).
The sale
of Units (including the Common Stock, the Investor Warrants and the Common Stock
underlying the Investor Warrants) in the Offering was exempt from registration
under Section 4(2) of the Securities Act and Rule 506 of Regulation D and
Regulation S as promulgated by the SEC. In the Offering, no general solicitation
was made by us or any person acting on our behalf. The Units were sold pursuant
to transfer restrictions, and the certificates for shares of Common Stock and
Investor Warrants underlying the Units sold in the Offering contain appropriate
legends stating that such securities are not registered under the Securities Act
and may not be offered or sold absent registration or an exemption from
registration.
The
Company paid the Placement Agent (the name of which will be disclosed on a
subsequent Current Report on Form 8-K) a commission of 10% of the funds raised
from such investors in the Offering. In addition, the Placement Agent received a
non-accountable expense allowance equal to 3% of the proceeds raised in the
Offering as well as warrants to purchase a number of shares of Common Stock
equal to 20% of the Units sold to investors in the Offering. As a result of the
foregoing arrangement, at the initial closing of the Offering, the Placement
Agent was paid commissions and expenses of $1,366,833 and was issued warrants to
purchase (i) 2,102,819 shares of Common Stock at an exercise price of $1.00 per
share and (ii) 2,102,819 shares of Common Stock at an exercise price of $1.40
per share.
The form
of the Investor Warrant issued in the Offering is attached as Exhibit 4.3 to
this Current Report and is incorporated herein by reference.
The
Private Sale
Prior to
the commencement of the Offering, InVivo completed a Bridge Financing, wherein
it sold $500,000 in principal amount of its bridge notes (the “Bridge Notes”)
and 36,310 bridge warrants (the “Bridge Warrants”) to accredited investors (the
“Bridge Financing”). The Bridge Notes converted into 504,597 Units in the
Offering. The 36,310 Bridge Warrants converted into 500,000 New Bridge Warrants,
each exercisable at a price of $1.00 per share of Common Stock, upon the closing
of the Merger. Holders of the New Bridge Warrants received the same registration
rights with respect to the shares of common stock issuable upon exercise of such
Warrants as the investors in the Offering. As consideration for locating
investors to participate in the Bridge Financing, the Placement Agent received
Warrants from InVivo that were exchanged on the closing of the Merger
for Warrants to purchase 100,000 shares of Common Stock at a price of $1.00
per share. The Placement Agent also received, upon conversion of the Bridge
Notes, compensation in the same amount as it received for other Units sold in
the Offering. The Merger, the Offering, the Private Sale and the related
transactions are collectively referred to in this Current Report as the “Transactions.”
Registration
Rights
All of
the securities issued in connection with the Transactions are “restricted
securities,” and as such are subject to all applicable restrictions specified by
federal and state securities laws.
On the
Closing Date, the Company entered into a registration rights agreement with the
investors in the Offering. Under the terms of the registration rights agreement,
the Company has committed to file a registration statement covering the resale
of the Common Stock underlying the Units and the Common Stock that is issuable
on exercise of the Investor Warrants and the New Bridge Warrants (but not the
Common Stock that is issuable upon exercise of the warrants issued as
compensation to the Placement Agent in the Offering or in the Bridge Financing)
within 90 days from the Closing Date (the “Filing Deadline”), and shall use
commercially reasonable efforts to cause the registration statement to become
effective no later than 180 days after it is filed (the “Effective
Deadline”).
The
Company has agreed to use reasonable efforts to maintain the effectiveness of
the registration statement through the one year anniversary of the date the
registration statement is declared effective by the SEC, or until Rule 144 of
the Securities Act is available to investors in the Offering with respect to all
of their shares, whichever is earlier. The Company will be liable for monetary
penalties equal to equal to one-half of one percent (0.5%) of such holder’s
investment in the Offering on every thirty (30) day anniversary of such Filing
Deadline or Effectiveness Deadline failure until such failure is cured. The
payment amount shall be prorated for partial thirty (30) day periods. The
maximum aggregate amount of payments to be made by the Company as the result of
such failures, whether by reason of a Filing Deadline failure, Effectiveness
Deadline failure or any combination thereof, shall be an amount equal to 9% of
each holder’s investment amount. Notwithstanding the foregoing, no payments
shall be owed with respect to any period during which all of the holder’s
registrable securities may be sold by such holder under Rule 144 or pursuant to
another exemption from registration.
Moreover,
no such payments shall be due and payable with respect to any registrable
securities the Company is unable to register due to limits imposed by the SEC’s
interpretation of Rule 415 under the Securities Act. The holders of any
registrable securities removed from the Registration Statement a result of a
Rule 415 or other comment from the SEC shall have “piggyback” registration
rights for the shares of Common Stock or Common Stock underlying such warrants
with respect to any registration statement filed by the Company following the
effectiveness of the Registration Statement which would permit the inclusion of
these shares. The form of the registration rights agreement is attached as
Exhibit 10.4 to this Current Report and is incorporated herein by
reference.
Split-Off
Agreement
Immediately
after the closing of the Merger, ITHC split off its wholly-owned subsidiary, D
Source Split Corp., a company organized under the laws of Nevada (“DSSC”). The
split-off was accomplished through the sale of all outstanding shares of DSSC.
In connection with the Split-Off, 14,747,554 (post-split) shares of Common Stock
held by Peter Reichard, Lawrence Reichard and Peter Coker (the “Split-Off Shareholders”) were
surrendered and cancelled without further consideration, other than the shares
of DSSC. An additional 1,014,490 (post-split) shares of Common stock
were cancelled by a shareholder of ITHC for no consideration (the “Share Cancellation”). The
assets and liabilities of ITHC were transferred to the Split-Off Shareholders in
the Split-Off. The Company executed a split off agreement with the Split-Off
Shareholders, a copy of which is attached as Exhibit 10.5 to this Current Report
and is incorporated herein by reference.
Lock-up
Agreements
In
connection with the Merger, each of the officers, directors and holders of 5% or
more of the Company’s Common Stock and certain employees and affiliates of the
Placement Agent have agreed to “lock-up” and not sell or otherwise transfer or
hypothecate any of their shares for a term equal to the earlier of (i) twelve
(12) months from the Closing Date of the Merger; or (ii) six (6) months
following the effective date of the Registration Statement registering the
shares of Common Stock included in the Units as well as the shares of Common
Stock issuable upon exercise of the Investor Warrants and the New Bridge
Warrants.
Current
Ownership
Immediately
after giving effect to the Transactions, the Units sold in this Offering, the
options granted under the 2007 Plan (that were assumed by the Company), and the
warrants issued to the Placement Agent in connection with the Offering and the
issuance of the New Bridge Warrants, there were issued and outstanding
securities of the Company on the closing of the Transactions:
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§
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49,161,268
shares of Common Stock;
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§
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No
shares of preferred stock;
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§
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Options
to purchase 5,915,615 shares of Common Stock granted under the
2007 Plan;
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§
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Investor
Warrants to purchase 10,514,097 shares of Common Stock at $1.40 per share
issued to the investors in the Offering and warrants to purchase 2,102,819
shares of Common Stock at a price of $1.00 per share and 2,102,819
warrants exercisable at a price of $1.40 per share issued to
the Placement Agent in connection with the Offering;
and
|
|
§
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New
Bridge Warrants issued to Bridge Investors to purchase 500,000 shares of
Common Stock at $1.00 per share and warrants to purchase 100,000 shares of
Common Stock exercisable at a price of $1.00 per share issued to the
Placement Agent in connection with the Bridge
Financing.
|
Accounting
Treatment; Change of Control
The
Merger is being accounted for as a “reverse merger,” and InVivo is deemed to be
the acquirer in the reverse merger. Consequently, the assets and liabilities and
the historical operations that will be reflected in the financial statements
prior to the Merger will be those of InVivo, and the consolidated financial
statements after completion of the Merger will include the assets and
liabilities of InVivo, historical operations of InVivo and operations of InVivo
from the Closing Date of the Merger. Except as described in the previous
paragraphs, no arrangements or understandings exist among present or former
controlling stockholders with respect to the election of members of our board of
directors and, to our knowledge, no other arrangements exist that might result
in a change of control of the Company. Further, as a result of the issuance of
the shares of Common Stock pursuant to the Merger, a change in control of the
Company occurred as of the date of consummation of the Merger.
DESCRIPTION
OF BUSINESS
Immediately
following the Merger, the business of InVivo became the business of the
Company.
InVivo
Therapeutics Corporation was founded to develop and commercialize groundbreaking
technologies for the treatment of spinal cord injuries (“SCI”). InVivo’s
proprietary technology was co-invented by Robert S. Langer, ScD, Professor at
Massachusetts Institute of Technology and Joseph P. Vacanti, MD, affiliated with
Massachusetts General Hospital. The intellectual property rights that are the
basis for InVivo’s products are licensed under an exclusive, world-wide license
from Children’s Medical Center Corporation (“CMCC”) and Massachusetts
Institute of Technology.
InVivo
intends to create a new paradigm of care for SCI. Current treatments
consist of a collection of approaches that only focus on symptoms of SCI. To
date, we are not aware of any product on the market that addresses the
underlying pathology of a SCI.
Currently,
there are no successful spinal cord injury treatment options for SCI patients.
InVivo takes a novel approach to SCI and focuses on protection of the spinal
cord and prevention of secondary injury rather than regeneration. InVivo’s
platform technologies focus on minimizing tissue damage sustained following
acute injury and promoting neural plasticity of the spared healthy tissue, which
may result in full or partial functional recovery. The technologies
encompass multiple strategies involving biomaterials, U.S. Food & Drug
Administration (“FDA”)
approved drugs, growth factors, and human neural stem cells (“hNSCs”). According
to Eric J. Woodard, MD, our Chief Medical Officer, former Chief of Spine Surgery
Brigham and Women’s Hospital, Department of Neurosurgery and Harvard Medical
School, and current Chief of Neurosurgery at New England Baptist Hospital,
InVivo’s approach could very likely become a standard treatment for both acute
and chronic SCI.
The
Technology
InVivo
intends to leverage its primary platform technology to deliver three products to
the market as follows:
|
1.
|
A
biocompatible polymer scaffolding device to treat acute wound
SCI.
|
|
2.
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A
biocompatible hydrogel for local controlled release of methylprednisolone
to treat acute SCI.
|
|
3.
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A
biocompatible polymer scaffolding device seeded with autologous hNSCs to
treat acute and chronic SCI.
|
InVivo
products are biopolymer-based devices that are surgically implanted or injected
into the lesion created during traumatic injury, or the “primary injury”. These
scaffolding products protect the damaged spinal cord by mitigating the
progression of “secondary injury” resulting from the body’s inflammatory and
immune response to injury, and promote neuroplasticity, a process where
functional recovery may occur through the rerouting of signaling
pathways to the spared healthy issue. Achieving these results is
essential to the recovery process, as secondary injury can significantly worsen
the immediate damage sustained during trauma. The additional damage dramatically
reduces patient quality of life post-SCI.
Additional
applications of InVivo’s platform technologies include the potential treatment
for, spinal cord injury following tumor removal, peripheral nerve damage, and
postsurgical treatment of any transected nerve. Furthermore, because InVivo’s
first product is an acellular and drug-free medical device, we expect the
regulatory approval timeline may require just one year patient
follow-up.
Market
Opportunity
As we are
aware of no current products on the market to achieve the therapeutic benefit
expected with InVivo’s device, we believe that InVivo’s market opportunity is
significant. By 2011, based on the Company’s estimates, the total addressable
market for acute SCI will be approximately $10.4 billion annually based on
multiplying the global incidence rate by an anticipated global price per unit of
$44,000. Since 1973, the National Spinal Cord Injury Statistical Center (“NSCISC”) at the University of
Alabama has been commissioned by the US government to maintain a national
database of SCI statistics. The NSCISC has projected an annual SCI
incidence growth rate of 1% due to a growing US population and escalated
societal risks that include faster highway speed limits, expanding participation
in extreme sports, and increased gun ownership.
In the
United States:
|
·
|
Approximately
1,275,000 people are currently living with paralysis due to
SCI.
|
|
·
|
An
additional 12,000 individuals will become fully or partially paralyzed
this year alone.
|
Globally:
|
·
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Over
5,200,000 people are living with spinal cord
injuries,
|
|
·
|
More
than 167,000 individuals will become fully or partially paralyzed this
year alone.
|
The
financial impact of SCI, as reported by the NSCISC, is enormous:
|
|
During
the first year, “cost of care” ranges from $244,562 to $829,843, depending
on the severity.
|
|
|
The
net present value (“NPV”) to maintain a
quadriplegic injured at age 25 for life is
$3,273,270.
|
|
|
The
NPV to maintain a paraplegic injured at age 25 for life is
$1,093,669.
|
Sources:
Christopher & Dana Reeve
Foundation, and National Spinal Cord Injury Statistical Center. “One Degree of
Separation: Paralysis and Spinal Cord Injury in the United States”
2010.
These
costs place a tremendous financial burden on families, insurance providers, and
government agencies. Moreover, despite all financial investment, the
patient remains disabled for life since current medical interventions address
only the symptoms of SCI rather than the underlying neurological
cause.
TABLE
1. COST OF CARE FOR AN SCI PATIENT
|
|
AVERAGE YEARLY
EXPENSES
(in 2009 dollars)
|
|
|
ESTIMATED LIFETIME
COSTS
BY AGE AT INJURY
(NPV, Discounted at 2%)
|
|
SEVERITYOF INJURY
|
|
First Year
|
|
|
Each
Subsequent
Year
|
|
|
25 Years Old
|
|
|
50 Years Old
|
|
High
Tetraplegia (C1-C4)
|
|
$ |
829,843 |
|
|
$ |
148,645 |
|
|
$ |
3,273,270 |
|
|
$ |
1,926,992 |
|
Low
Tetraplegia (C5-C8)
|
|
$ |
535,877 |
|
|
$ |
60,887 |
|
|
$ |
1,850,805 |
|
|
$ |
1,172,070 |
|
Paraplegia
|
|
$ |
303,220 |
|
|
$ |
30,855 |
|
|
$ |
1,093,669 |
|
|
$ |
745,951 |
|
Incomplete
Motor Functional at Any Level
|
|
$ |
244,562 |
|
|
$ |
17,139 |
|
|
$ |
729,560 |
|
|
$ |
528,726 |
|
Source: National Spinal Cord Injury
Statistical Center; February 2010 edition of “Spinal Cord Injury Facts and
Figures at a Glance.” All figures in US Dollars.
Note:
tetraplegia is paralysis in the arms, legs and trunk of the body below the level
of the spinal cord injury; paraplegia is paralysis of the lower part of the body
including the legs.
Creating
a New Paradigm for SCI Treatment
InVivo
intends to create a new paradigm for treating SCI. Current methods
consist of a collection of approaches that only focus on symptoms of SCI. To
date, we are not aware of any product on the market that addresses the
underlying pathology of SCI.
InVivo’s
goal is to create a new paradigm for care by changing the way physicians treat
SCI. InVivo’s technology aims to protect the spinal cord and minimize secondary
injury that causes cell death while promoting neural plasticity of the spared
healthy tissue, something no other product on the market is designed to do.
InVivo’s products, if approved for commercialization, will be a new therapeutic
class of products and will not compete with current treatment options (i.e.
spinal fixation devices). Rather, it is expected that they will be complementary
to these products, and the combination may create the best clinical
outcome.
InVivo’s
Planned First Product: A Scaffolding Device to Treat SCI
SCI
involves not only initial cell death at the lesion due to mechanical impact but
also a devastating secondary injury pathology that persists for several weeks
(Figure 1). We are focused on preventing this secondary cascade of
cell death and promoting the subsequent repair and recovery
processes.
FIGURE
1. PROGRESSION OF SECONDARY INJURY (DAYS 2-30 POST-INJURY) (Fleming
et al.
2006)
InVivo’s
first product is a novel surgical device, designed for implantation into the
lesion to treat acute open-wound SCI (Figure 2). InVivo’s recent results in
primate studies are extremely promising. The scaffold was developed from
polylactic-co-glycolic acid (PLGA), a biodegradable and biocompatible polymer,
which is approved by the FDA for applications such as surgical sutures (Dolphin
sutures and Ethicon sutures), drug delivery (Lupron Depot and Sandostatin LAR
Depot), and tissue engineering (Dermagraft). This device degrades naturally
inside the body over a desired time period to maximize efficacy without
requiring subsequent removal.
FIGURE
2. SCAFFOLD IMPLANTED INTO SCI LESION
In
preventing the cascading inflammatory response or secondary injury, InVivo’s
device is designed to perform four functions:
|
1.
|
Fill
the necrotic lesion to minimize secondary injury, which may occur by
inhibiting cell-cell signaling via inflammatory
cytokines.
|
|
2.
|
Bridge
the gap formed by the lesion, providing a matrix designed to promote
regrowth and reorganization of neural elements (neurons and
neurites).
|
|
3.
|
Act
as a synthetic extracellular matrix, with the goal of promoting survival
of surrounding neurons.
|
|
4.
|
Reduce
scar formation (astrogliosis).
|
InVivo’s
Polymer Technology Differentiator
InVivo
intends to introduce the first biodegradable polymer scaffold without any other
FDA regulated components for SCI treatment. The current cell and
drug-free nature of InVivo’s implantable device is expected to expedite InVivo’s
regulatory approval timelines. The device will be customized to fit
inside a patient-specific lesion.
InVivo’s
Planned Second Product: Local Controlled Release Drug Delivery
InVivo’s
second intended product is an injectable hydrogel designed to counteract the
inflammatory environment that results during a secondary injury from a
closed-wound SCI where further cell death occurs. The hydrogel is designed to
release drugs over at least 10 days in order to synchronize the rate of delivery
to match the period in which the inflammatory response peaks during secondary
injury. While the hydrogel could incorporate other hydrophilic drugs
or therapeutic agents that counteract secondary injury, promote neuroplasticity
or support endogenous repair mechanisms, InVivo’s second product is designed to
deliver the anti-inflammatory steroid methylprednisolone sodium
succinate. Methylprednisolone sodium succinate is FDA approved, and
is currently a treatment option for SCI. However, high-dose
intravenous administration of the drug can result in harmful systemic side
effects, including increased risks of pneumonia, sepsis and
mortality. By precisely controlling the release of methylprednisolone
at the site of injury, we hypothesize that therapeutically effective doses can
be delivered to the point of inflammation while mitigating the risk of harmful
systemic side effects.
InVivo’s
Planned Third Product: Polymer Scaffold Seeded with Autologous Human Neural Stem
Cells
InVivo’s
third intended product extends the biopolymer platform technology to treat both
acute closed-wound and chronic SCI patients by seeding the patient’s own stem
cells onto the scaffold and then inserting the scaffold into the injured spinal
cord. The scaffold acts as a synthetic extracellular matrix on which
cells can be transplanted.
InVivo’s
third product is intended to counteract the pathophysiology of SCI
by:
|
1.
|
Replacing
lost cells of the spinal cord.
|
|
2.
|
Activating
endogenous regenerative processes such as the formation of new synapses
and axonal sprouting based on molecules the stem cells
produce.
|
PRE-CLINICAL
RESULTS IN ANIMALS
InVivo
has demonstrated the proof of concept for its SCI therapy in primate and rodent
animal models.
Seminal
Rodent Study – 2002
The first
animal study for InVivo’s promising technology was performed in 2002 and
published in the Proceedings of the National Academy of Sciences (PNAS, 2002,
vol.99, no.5, 3024-9). The implemented scaffold was designed to mimic
the cellular architecture of the inner ‘grey’ matter and outer ‘white’ matter of
the spinal cord (Figure 3).
FIGURE
3 (a) SCHEMATIC OF THE
SCAFFOLD SHOWING INNER AND OUTER ARCHITECTURE. (b and c) INNER SCAFFOLDS SEEDED
WITH HNSC (SCALE: 200 µM AND 50 µM, RESPECTIVELY). THE OUTER SECTION OF THE
SCAFFOLD CONTAINS LONG, AXIALLY ORIENTED PORES FOR AXONAL GUIDANCE AS WELL AS
RADIAL PORES TO ALLOW FLUID TRANSPORT WHILE INHIBITING THE IN-GROWTH OF SCAR
TISSUE (SCALE: 100 µM). (e) SCHEMATIC OF SURGICAL
INSERTION OF THE IMPLANT INTO THE SPINAL CORD.
The study
demonstrated the impact of InVivo polymer-alone device (first product) and
InVivo’s polymer with hNSC device (third product) in treating SCI (Figure
5). The hNSCs augment the polymer scaffolding
treatment. The study also demonstrated that stem cells injected into
the lesion without InVivo’s proprietary scaffold do not exert a therapeutic
effect. Comparable to the adhesion of cells to the body’s
extracellular matrix, it is thought that the scaffolding device is necessary for
the hNSCs to survive and function following transplantation.
Basso-Beattie-Bresnahan (BBB) scoring
was used to evaluate open-field locomotion at one day post-surgery and weekly
time points over the course of six weeks post-injury. Results from
the PLGA scaffold configured to treat SCI showed functional locomotive
improvement as early as two weeks post injury. While the study was
stopped at the end of either week 8 or week 10, rodents were kept for over one
year. Over this period, the subjects demonstrated sustainable functional
recovery, and they exhibited no adverse pathological reactions to the
product. Since the rat has an average lifespan of two years, InVivo
believes that the follow-up timeframe of over one year demonstrates the
viability of its device.
Pilot
Primate Study – 2008
We
believe the non-human primate model is the best surrogate for how SCI products
will work in humans. To date, the PLGA scaffolding device has been
evaluated in two primate studies. The first study was completed in 2008, is
published in the Journal of Neuroscience Methods, and focused mainly on the
assessment criteria following the model SCI. The second primate study which
involved a larger number of primates also included collecting quantitative
electromyographic and kinematic analyses.
In April
2008, InVivo conducted a non-human primate study for model SCI. The
experiment was designed as a pilot study to test the model injury’s suitability
in assessing the therapeutic efficacy of InVivo’s technologies. The
study was conducted at the St. Kitts Biomedical Research Foundation in St. Kitts
and Nevis. The surgeries were performed by Eric Woodard, MD, InVivo’s Chief
Medical Officer, and Jonathan Slotkin, MD. Dr. Woodard served as
Chief of Spine Surgery at Harvard’s Brigham & Women’s Hospital for ten years
and is currently Chief of Neurosurgery at Boston’s New England Baptist
Hospital. Dr. Slotkin has practiced at Harvard’s Brigham &
Women’s Hospital and is currently a spine neurosurgeon at the Washington Brain
and Spine Institute and a member of InVivo’s Scientific Advisory
Board.
We utilized a lateral hemisection
injury model in four African Green monkeys, in which the left-half segment of
the spinal cord between T9 and T10 was surgically removed. Following
tissue removal, the InVivo patented device was inserted into the resulting
lesion by InVivo’s Chief Medical Officer Dr. Eric Woodard (Figure
4). The model resulted in Brown-Séquard syndrome: paralysis of the
animals’ left hind limb and loss of sensory function in the animals’ right hind
limb. The model was successful in preserving bowel and bladder
function in all animals.
FIGURE
4. DEVICE INSERTED INTO HEMI-SECTION
Animals
were monitored for six weeks post-injury, and behavioral scoring was performed
to measure functional recovery by a neuroscientist blinded to the injury model
or treatments performed on each subject. Preliminary data uses a
20-point observational scale to assess the degree of functional recovery in the
hind-limbs, where a score greater than 8 indicates the subject’s ability to bear
weight and perform deliberate stepping (Figure 6).
Non-Human
Primate Studies: Comparison of Results to Prior Rodent Study
|
|
|
|
FIGURE 5. IPSILATERAL-LESIONED
SIDE BBB OPEN-FIELD WALKING SCORE FROM RODENT STUDY (Teng, Lavik,
et al.
2002)
|
|
FIGURE
6. LEFT HINDLIMB NEUROMOTOR PERFORMANCE FROM ST. KITTS PRIMATE
GREEN PILOT STUDY (2008)
(SCAFFOLD
+ HNSC: N=2 EXPECT FOR DAY 1 & DAY 44, WHERE
N=1;
SCAFFOLD-ALONE:
N=1, NO
TREATMENT: N=1)
|
The two
African Green monkeys that received scaffolds seeded with human neural stem
cells (n=2, Figure 6) demonstrated an improved level of functional recovery
compared to the control animal (n=1, Figure 6). These results mirrored the
behavioral observations obtained in InVivo’s rodent study (n=12, Figure 5).
Furthermore, implantation of the scaffold alone demonstrated improved efficacy
in promoting functional recovery compared to the control in both one monkey
(n=1, Figure 6) and in prior rodent studies (n=12, Figure 5).
2nd Primate
Study 2010- Preclinical evaluation of biomaterial scaffolds and hydrogels in a
model spinal cord injury in the African green monkey.
A
segmental thoracic hemisection was used in African green monkeys for the
evaluation of biomaterial implants in a pre-clinical model of spinal cord injury
in the non-human primate. The model’s physiological tolerance permitted
behavioral analyses for a 12-week period post-injury, extending to termination
points for immunohistochemical analyses.
Implementation
of surgically-induced spinal cord injury (SCI) through T9-T10 thoracic lateral
hemisection on 16 African green monkeys with administration of a PLGA-polylysine
scaffold (n=4), a PLGA-polylysine scaffold soaked in growth factors (EGF, bFGF,
15 μg each) (n=5), a thiol-acrylate poly(ethylene glycol) based hydrogel containing 150
μg methylprednisolone sodium succinate (n=4), or no treatment for control
(n=4). Implants were administered at the time of
lesioning. The objective was to determine the feasibility and
reliability of this pre-clinical model of SCI, the safety and efficacy of the
implants in a non-human primate model, as well as the establishment of
assessment measures. Analysis of functional improvements was performed by
statistical evaluation of 3D kinematic and electromyographic (EMG) recordings, a
0-20 neuromotor scoring system and histological and immunohistochemical stains
on post-mortem spinal cord thoracic and lumbar cross-sections.
The
neuromotor assessment by a blinded trained neuroscientist for each group over
the twelve-week period for the left hind limb was charted (Figure
7). All groups show an initial paralysis 2 days post-injury,
confirming successful surgical induction of model Brown-Séquard
syndrome. The treatment groups exhibited an improved recovery
compared to untreated injured controls on average. Kinematic and EMG
analyses exhibited the same trend. While a limited number of subjects
were studied and statistical power tests have not been completed, the results
align with data from prior monkey and rodent studies.
FIGURE
7. IPSILATERAL HINDLIMB TREADMILL HANDCAM NEUROMOTOR
SCORE
Commercialization
Strategy
Clinical
Regulatory Plan
InVivo’s
PLGA biopolymer scaffolding product is expected to be regulated as a Class III
medical device by the FDA. The Company will be required to demonstrate safety
and efficacy in a human clinical trial before it can submit a PMA for FDA
approval. Before human clinical trials can commence, the Company is required to
obtain FDA clearance to conduct the clinical trial under an Investigational
Device Exemption (“IDE”). The Company has
conducted a Pre-IDE meeting with the FDA to discuss the clinical trial and plans
to submit an IDE to the FDA by the end of 2010.
The
Company first plans to conduct a pilot clinical study to evaluate the device in
ten acute open-wound SCI patients. The Company is also planning a larger follow
on pivotal human study in acute SCI patients after the pilot study is
completed. The Company expects to have completed both the pilot
study and the larger pivotal clinical trial by mid 2012. The clinical
development timeline is subject to a number of risks that could delay the filing
of a PMA or cause a PMA never to be filed. These risks are described in the
section entitled “Risk Factors and Special Considerations”. The estimated
clinical development timeline to submission of a PMA for FDA approval is as
follows:
FDA
Clinical Development Plan for Polymer Scaffolding Device
The
InVivo Therapeutics regulatory team is led by David Feigal, MD, a consultant to
the Company and a member of the InVivo’s Business Advisory Board. Dr.
Feigal recently served as Vice-President, Regulatory at Amgen, Inc. and earlier
was the number-two executive at the FDA from 1992 to 2006. During his
tenure, he was head of the FDA’s Center for Devices for five years and head of
the Center for Biologics for five years. For InVivo day-to-day
handling of FDA processes, InVivo will hire a Director of Regulatory &
Clinical Affairs who will be responsible for managing InVivo’s regulatory
affairs.
Janice
Hogan, a managing partner at Hogan & Lovells US LLP, serves as InVivo’s FDA
consultant. Ms. Hogan has over twenty-five years of experience in representing
spine industry companies to the FDA such as Johnson & Johnson’s DePuy Spine,
Synthes Spine, Abbott Spine, Stryker Spine, and Medtronic Spine.
Manufacturing
and Product Delivery Plan
We
believe that the raw material polymers for our first device product can be
readily obtained from suppliers that already have obtained FDA clearance to
manufacture these components. The Company has developed a proprietary
manufacturing process to create a uniform porous three-dimensional scaffolding
structure for each device. The Company plans to purchase the raw material
polymers from suppliers and then utilize its proprietary manufacturing process
to create the final polymer scaffolding. Proprietary manufacturing
processes will include 3D printing and batch processes to create the
scaffolds. The Company’s intends to either establish a manufacturing
facility or utilize a third-party to produce the polymer scaffolding and then
package the final product.
InVivo’s
product delivery process from the point of injury through patient rehabilitation
is outlined below:
Sales
and Marketing
The
Company plans to sell its SCI product through a to-be-established direct sales
force for major markets in the U.S and through distributors in foreign
markets. Primary international markets will include Europe and
Japan. Since the product is novel and would most likely be the first therapeutic
treatment for SCI, the Company will seek to gain acceptance with the physicians
who are thought leaders in the SCI field and plans on utilizing a consultative
selling approach. The direct sales force will focus its efforts on maximizing
revenue through product training, placement and support. The Company will seek
to establish strong relationships with orthopedic spine surgeons and
neurosurgeons and expects to provide a high level of service for the products
including providing on-site assistance and service during procedures at any time
of day. The primary market channel for the product will be to emergency
department physicians handling trauma cases. In addition, the Company will
establish medical education programs to reach practioners in physical medicine
and rehabilitation centers, and through patient advocacy groups. The Company
will also establish Internet and other marketing approaches to reach SCI
patients.
Intellectual
Property
In July
2007, InVivo obtained a world-wide exclusive license (the “CMCC License”) to a broad
suite of patents co-owned by M.I.T. and CMCC covering the use of a wide range of
biopolymers to treat SCI, and to promote the survival and proliferation of human
stem cells in the spinal cord. In addition, they cover the use of
biomaterials in combination with growth factors and drugs. The CMCC
License covers 10 issued US patents and 3 pending US patents as well as 67
international patents and 34 international patents pending.
The CMCC
License provides InVivo intellectual property protection for the use of any
biomaterial scaffolding used as an extracellular matrix substitute for treating
SCI by itself or in combination with drugs, growth factors and human stem cells.
The Company’s rodent studies have shown that human stem cells cannot proliferate
and survive without the addition of the biopolymer scaffolding which serves as
an extracellular matrix replacement and mimics the natural cellular architecture
of the inner ‘grey’ and outer ‘white’ matter of the spinal cord. We
believe that any extracellular matrix developed to treat spinal cord injuries
will infringe on the patents licensed to InVivo. InVivo intends to
defend all patents very aggressively.
The
patents are the results of over a decade of research by Dr. Robert S. Langer,
Professor of Chemical and Biomedical Engineering at M.I.T. and his research
teams at M.I.T.’s Langer Lab. Dr. Langer is a prolific, world renowned inventor
who is generally regarded to be the cofounder of the field of tissue
engineering.
Under the
CMCC License, InVivo has the right to sublicense the patents. InVivo has
full control and authority over the development and commercialization of the
licensed products, including clinical trials, manufacturing, marketing, and
regulatory filings and we own the rights to the data it generates. In addition
InVivo has the first right of negotiation for a thirty-day period to any
improvements to the intellectual property.
The CMCC
License has a 15-year term, or as long as the life of the last expiring patent
right, whichever is longer, unless terminated earlier by CMCC. In
connection with the CMCC License, InVivo submitted a 5-year plan with targets
and projections to CMCC and MIT. InVivo is required to meet the objectives
in the plan, or else it is required to notify CMCC and revise the plan.
CMCC has the right to terminate the License for failures by InVivo to either
notify CMCC when objectives will not be reached or revise the
plan.
InVivo is
required to pay certain fees and royalties under the CMCC License.
Specifically, InVivo was required to pay a license issue fee, which was paid at
the execution of the CMCC License. InVivo is also required to make
milestone payment upon completing various phases of product development,
including (i) upon FDA filing of first Investigational New Drug application and
Investigational Device Exemption application; (ii) upon enrolling first patient
in Phase II testing; (iii) upon enrolling first patient in Phase III testing;
(iv) upon filing with the FDA of first New Drug Application or related
applications, and; (v) upon first market approval in any country outside the
US. Each year prior to the release of a licensed product, InVivo is also
required to pay a maintenance fee. Further, InVivo is required to make
payments based on sublicenses to manufacturers and distributors. InVivo
believes that it will have sufficient capital resources upon completion of the
Merger to make all of such payments. In addition, following commercialization,
InVivo is required to make ongoing royalty payments equal to a low single digit
percentage of net sales of the licensed products.
Employees
We
currently have 8 full-time employees. None of our employees are represented by a
labor union, and we consider our employee relations to be good. We also utilize
part-time employees and a number of consultants to assist with research and
development and regulatory activities. We believe that our future success will
depend in part on our continued ability to attract, hire and retain qualified
personnel.
Description
of Property
Our executive officers are located in
leased premises at One Broadway,
14th Floor, Cambridge, MA 02142 and our phone number is
617-475-1520.
Legal
Proceedings
From time
to time we may be named in claims arising in the ordinary course of business.
Currently, no legal proceedings, government actions, administrative actions,
investigations or claims are pending against us or involve us that, in the
opinion of our management, could reasonably be expected to have a material
adverse effect on our business and financial condition.
We
anticipate that we will expend significant financial and managerial resources in
the defense of our intellectual property rights in the future if we believe that
our rights have been violated. We also anticipate that we will expend
significant financial and managerial resources to defend against claims that our
products and services infringe upon the intellectual property rights of third
parties.
Available
Information
We are
subject to the reporting requirements of the Securities Exchange Act of 1934
(“Exchange
Act”). Reports filed with the SEC pursuant to the Exchange
Act, including annual and quarterly reports, and other reports we file, can be
inspected and copied at the public reference facilities maintained by the SEC at
100 F Street, N.E., Washington, D.C. 20549. Investors may obtain information on
the operation of the public reference room by calling the SEC at 1-800-SEC-0330.
Investors can request copies of these documents upon payment of a duplicating
fee by writing to the SEC. The reports we file with the SEC are also available
on the SEC’s website (http://www.sec.gov).
RISK
FACTORS AND SPECIAL CONSIDERATIONS
This
Report contains forward-looking statements.
Information
provided in this Report and in the annexed Exhibits may contain forward-looking
statements, which reflect management’s current view with respect to future
events and the Company’s performance. Such forward-looking statements
may include the estimated timeline for the Company to file for FDA approval,
projections with respect to market size and acceptance, revenues and earnings,
marketing and sales strategies, efficacy of its drugs and business
operations.
InVivo
operates in a highly competitive and highly regulated business environment. The
Company’s business can be expected to be affected by government regulation,
economic, political and social conditions, business’ response to new and
existing products and services and services, technological developments and the
ability to obtain and maintain patent and/or other intellectual property
protection for its products and intellectual property. The Company’s
actual results could differ materially from management’s expectations because of
changes both within and outside of the Company’s control.
Risks
Related To Our Business and Our Industry
We have a limited
operating history and it is difficult to predict our future growth and operating
results.
InVivo
was incorporated in Delaware in November 2005 and has a limited operating
history and limited operations and assets. Accordingly, you should
consider our prospects in light of the costs, uncertainties, delays and
difficulties encountered by companies in the early stage of
development. As a development stage company, our development
timelines have been and may continue to be subject to adjustments that could
negatively affect our cash flow and ability to develop or bring products to
market, if at all. Predicting our future operating and other results
is extremely difficult, if not impossible.
The
Company’s prospects must be considered in light of inherent risks, expenses and
difficulties encountered by all early stage companies, particularly companies in
new and evolving markets. These risks include, by way of example and
not limitation, unforeseen capital requirements, unforeseen technical problems,
delays in obtaining regulatory approvals, failure of market acceptance and
competition from foreseen and unforeseen sources.
We
have not generated any revenues to date and have a history of losses since
inception.
InVivo
has not generated any revenue to date and, through June 30, 2010, has incurred
net losses of approximately $7,800,000 since its formation in 2005. It can be
expected that the Company will continue to incur significant operating expenses
and continue to experience losses in the foreseeable future. As a result, the
Company cannot predict when, if ever, it might achieve profitability and cannot
be certain that it will be able to sustain profitability, if
achieved.
We
will need substantial additional funding to develop our products and for our
future operations. If we are unable to obtain the funds necessary to do so, we
may be required to delay, scale back or eliminate our product development or may
be unable to continue our business.
The
development and approval to market and sell our product candidates will require
a commitment of substantial funds, in excess of our current capital resources.
Before we can market or sell any of our products, we will need to conduct costly
and time-consuming research, which will include preclinical and clinical testing
and regulatory approvals. We anticipate the amount of operating funds that
we use will continue to increase along with our operating expenses over at least
the next several years as we plan to bring our products to market. While we
believe our current capital resources will satisfy our planned capital needs for
approximately 12 months, our future capital requirements will depend on many
factors, including:
|
·
|
the
progress and costs of our research and development programs, including our
ability to develop our current portfolio of therapeutic products, or
discover and develop new ones;
|
|
·
|
our
ability, or our partners ability and willingness, to advance partnered
products or programs;
|
|
·
|
the
cost of prosecuting, defending and enforcing patent claims and other
intellectual property rights;
|
|
·
|
the
progress, scope, costs, and results of our preclinical and clinical
testing of any current or future
products;
|
|
·
|
the
time and cost involved in obtaining regulatory
approvals;
|
|
·
|
the
cost of manufacturing our product
candidates;
|
|
·
|
expenses
related to complying with GMP manufacturing of product
candidates;
|
|
·
|
costs
of financing the purchases of additional capital equipment and development
technologies;
|
|
·
|
competing
technological and market
developments;
|
|
·
|
our
ability to establish and maintain collaborative and other arrangements
with third parties to assist in bringing our products to market and the
cost of such arrangements.
|
|
·
|
the
amount and timing of payments or equity investments that we receive from
collaborators and the timing and amount of expenses we
incur;
|
|
·
|
costs
associated with the integration of any new operation, including costs
relating to future mergers and acquisitions with companies that have
complementary capabilities;
|
|
·
|
expenses
related to the establishment of sales and marketing capabilities for
products awaiting approval or products that have been
approved;
|
|
·
|
the
level of our sales and marketing expenses;
and
|
|
·
|
our
ability to introduce and sell new
products.
|
We cannot
assure you that we will not need additional capital sooner than currently
anticipated. We will need to raise substantial additional capital to fund
our future operations. We cannot be certain that additional financing will
be available on acceptable terms, or at all. In recent years, it has been
difficult for companies to raise capital due to a variety of factors, which may
or may not continue. To the extent we raise additional capital through the
sale of equity securities, the ownership position of our existing stockholders
could be substantially diluted. If additional funds are raised through the
issuance of preferred stock or debt securities, these securities are likely to
have rights, preferences and privileges senior to our Common Stock.
Fluctuating interest rates could also increase the costs of any debt financing
we may obtain.
The
Company’s products will represent new and rapidly evolving
technologies.
The
Company’s proprietary spinal cord injury treatment technology depends on new,
rapidly evolving technologies and on the marketability and profitability of
InVivo products. Approval by applicable regulatory agencies and
commercialization of the Company’s spinal cord injury treatment technology could
fail for a variety of reasons, both within and outside of its control.
Furthermore, because there are no approved treatments for SCI, the regulatory
requirements governing this type of product may be more rigorous or less clearly
established than for other analogous products.
We
license our core technology from CMCC and MIT, and we could lose our rights to
this license if a dispute with CMCC or MIT arises or if we fail to comply with
the financial and other terms of the license.
InVivo
licenses the Patent Rights and core intellectual property from CMCC and MIT
under the CMCC License. The CMCC License Agreement imposes certain payment,
milestone achievement, reporting, confidentiality and other
obligations on InVivo. In the event that InVivo was to breach any of the
obligations and fail to cure, CMCC would have the right to terminate the CMCC
License Agreement upon notice. In addition, CMCC has the right to terminate the
License Agreement upon the bankruptcy or receivership of InVivo. The termination
of the CMCC License would have a material adverse affect on our business, as all
of InVivo’s current product candidates are based on the Patent Rights and
licensed intellectual property. If any dispute arises with respect to our
arrangement with CMCC or MIT, such dispute may disrupt our operations and would
likely have a material and adverse impact on us if resolved in a manner that is
unfavorable to our Company.
The
Company will face substantial competition.
The
biotechnology industry in general is subject to intense competition and rapid
and significant technological change. The Company has many potential
competitors, including major drug companies, specialized biotechnology firms,
academic institutions, government agencies and private and public research
institutions. Many of these competitors have significantly greater financial and
technical resources than us, superior experience and expertise in research and
development, preclinical testing, designing and implementing clinical trials;
regulatory processes and approvals; production and manufacturing; and sales and
marketing of approved products.
Principal
competitive factors in the Company’s industry include the quality and breadth of
an organization’s technology; management of the organization and the execution
of the organization’s strategy; the skill and experience of an organization’s
employees and its ability to recruit and retain skilled and experienced
employees; an organization’s intellectual property portfolio; the range of
capabilities, from target identification and validation to drug and device
discovery and development to manufacturing and marketing; and the availability
of substantial capital resources to fund discovery, development and
commercialization activities.
Large and
established companies compete in the biotech market. In particular, these
companies have greater experience and expertise in securing government contracts
and grants to support their research and development efforts, conducting testing
and clinical trials, obtaining regulatory approvals to market products,
manufacturing such products on a broad scale and marketing approved
products.
Smaller
or early-stage companies and research institutions may also prove to be
significant competitors, particularly through collaborative arrangements with
large and established biotech or other companies. The Company will also face
competition from these parties in recruiting and retaining qualified scientific
and management personnel, establishing clinical trial sites and registering
subjects for clinical trials.
In order
to effectively compete, the Company will have to make substantial investments in
development, testing, manufacturing and sales and marketing or partner with one
or more established companies. There is no assurance that the Company will be
successful in having its products approved or gaining significant market share
for any of its products. The Company’s technologies and products also may be
rendered obsolete or noncompetitive as a result of products introduced by its
competitors.
We
will require FDA approval before we can sell any of our products.
The
development, manufacture and marketing of the Company’s products are subject to
government regulation in the United States and other countries. In the United
States and most foreign countries, the Company must complete rigorous
preclinical testing and extensive human clinical trials that demonstrate the
safety and efficacy of a product in order to apply for regulatory approval to
market the product.
The
Company’s biopolymer scaffolding device is expected to be regulated as a Class
III medical device by the FDA. The steps required by the FDA before InVivo’s
proposed medical device products may be marketed in the United States include
performance of preclinical (animal and laboratory) tests; submissions to the FDA
of an IDE (Investigational Device Exemption) which must become effective before
human clinical trials may commence; performance of adequate and well-controlled
human clinical trials to establish the safety and efficacy of the product in the
intended target population; performance of a consistent and reproducible
manufacturing process intended for commercial use; Pre-Market Approval
Application (“PMA”); and FDA approval of the PMA before any commercial sale or
shipment of the product.
The
processes are expensive and can take many years to complete, and the Company may
not be able to demonstrate the safety and efficacy of its products to the
satisfaction of such regulatory authorities. The start of clinical trials can be
delayed or take longer than anticipated for many and varied reasons, many of
which would be outside of the Company’s control. Safety concerns may emerge that
could lengthen the ongoing trials or require additional trials to be conducted.
Regulatory authorities may also require additional testing, and the Company may
be required to demonstrate that its proposed products represent an improved form
of treatment over existing therapies, which the Company may be unable to do
without conducting further clinical studies. Moreover, if the FDA grants
regulatory approval of a product, the approval may be limited to specific
indications or limited with respect to its distribution. Expanded or additional
indications for approved devices or drugs may not be approved, which could limit
the Company’s potential revenues. Foreign regulatory authorities may apply
similar limitations or may refuse to grant any approval. Consequently, even if
the Company believes that preclinical and clinical data are sufficient to
support regulatory approval for its product candidates, the FDA and foreign
regulatory authorities may not ultimately grant approval for commercial sale in
any jurisdiction. If the Company’s products are not approved, its ability to
generate revenues will be limited and its business will be adversely
affected.
We
may experience delays in obtaining regulatory approval to commence our clinical
trials and/or to sell our products.
Delays in
or not obtaining regulatory approval can be extremely costly in terms of lost
sales opportunities, losing any potential marketing advantage of being early to
market and increased trial costs.
The
Company faces the risks that its planned filing of an Investigational Device
Exemption (IDE) to commence human trials may not be approved in a timely matter
or at all, the results of its human clinical trials, if approved for
commencement, may be inconsistent with the results obtained in preclinical
studies, its animal trials or clinical trials of similar products, or that the
results obtained in later phases of clinical trials may be inconsistent with
those obtained in earlier phases. A number of companies in the biomedical and
product development industry have suffered significant setbacks in advanced
clinical trials, even after experiencing promising results in early animal and
human testing.
Regulatory
agencies may require the Company or its collaborators to delay, restrict or
discontinue clinical trials on various grounds, including a finding that the
subjects or patients are being exposed to an unacceptable health
risk.
All
statutes and regulations governing the conduct of clinical trials are subject to
change in the future, which could affect the cost of such clinical trials. Any
unanticipated costs or delays in the Company’s clinical studies could delay its
ability to generate revenues and harm its financial condition and results of
operations.
The
results seen in animal testing of our product candidates may not be replicated
in humans.
Although
the Company has obtained some results from preclinical testing of our intended
products in animals, but we may not see positive results when any of our product
candidates undergo clinical testing in humans in the future. Success in
preclinical studies or completed clinical trials does not ensure that later
studies or trials, including continuing preclinical studies and large-scale
clinical trials, will be successful nor does it necessarily predict future
results. The rate of failure is quite high, and many companies in the
biotechnology industry have suffered significant setbacks in advanced clinical
trials, even after promising results in earlier trials. Product candidates
may fail to show desired safety and efficacy in larger and more diverse patient
populations in later stage clinical trials, despite having progressed through
early stage trials. Negative or inconclusive results from any of our
ongoing preclinical studies or clinical trials could result in delays,
modifications, or abandonment of ongoing or future clinical trials and the
termination of our development of a product candidate. Additionally, even
if we are able to successfully complete clinical trials, the FDA still may not
approve our product candidates.
Our
products are in an early stage of development and we currently have no
therapeutic products approved for sale. Our product candidates require
additional research, development, testing, expert reviews and/or regulatory
approvals before marketing. We may be unable to develop, obtain regulatory
approval or market any of our product candidates. If our product
candidates are delayed or fail, our financial condition will be negatively
affected, and we may have to curtail or cease our operations.
We
currently do not sell any approved therapeutic products and do not expect to
have any products commercially available for at least two years, if at
all. We are subject to all of the uncertainties and complexities affecting
an early stage biotechnology company. Our product candidates require additional
research and development, preclinical testing, clinical testing and regulatory
review and/or approvals clearances before marketing. Our strategy of using
our technologies for the development of therapeutic products involves new
approaches, some of which are unproven. To date, no one to our knowledge
has developed or commercialized any therapeutic products using our technologies
and we might never commercialize any product using our technologies and
strategy. There are many reasons that our product candidates may fail or
not advance to commercialization, including the possibility that our product
candidates may be ineffective, unsafe or associated with unacceptable side
effects; our product candidates may fail to receive the necessary regulatory
approvals or otherwise fail to meet applicable regulatory standards; our product
candidates may be too expensive to develop, manufacture or market; other parties
may hold or acquire proprietary rights that could prevent us or our potential
collaborators from developing or marketing our product candidates; physicians,
patients, third-party payers or the medical community in general may not accept
or use our contemplated products; our potential collaborators may withdraw
support for or otherwise impair the development and commercialization of our
product candidates; or others may develop equivalent or superior
products.
If our
current product candidates are delayed or fail, or we fail to successfully
develop and commercialize new product candidates, our financial condition will
be negatively affected, and we may have to curtail or cease our
operations.
Approval
to promote, manufacture and/or sell our products, if granted, will be limited
and subject to continuing review.
Even if a
product gains regulatory approval, such approval is likely to limit the
indicated uses for which it may be marketed, and the product and the
manufacturer of the product will be subject to continuing regulatory review,
including adverse event reporting requirements and the FDA’s general prohibition
against promoting products for unapproved uses. Failure to comply with any
post-approval requirements can, among other things, result in warning letters,
product seizures, recalls, substantial fines, injunctions, suspensions or
revocations of marketing licenses, operating restrictions and criminal
prosecutions. Any of these enforcement actions, any unanticipated changes in
existing regulatory requirements or the adoption of new requirements, or any
safety issues that arise with any approved products, could adversely affect the
Company’s ability to market products and generate revenues and thus adversely
affect its ability to continue InVivo’s business.
The
Company also may be restricted or prohibited from marketing or manufacturing a
product, even after obtaining product approval, if previously unknown problems
with the product or its manufacture are subsequently discovered and the Company
cannot provide assurance that newly discovered or developed safety issues will
not arise following any regulatory approval. With the use of any treatment by a
wide patient population, serious adverse events may occur from time to time that
initially do not appear to relate to the treatment itself, and only if the
specific event occurs with some regularity over a period of time does the
treatment become suspect as having a causal relationship to the adverse event.
Any safety issues could cause the Company to suspend or cease marketing of its
approved products, possibly subject it to substantial liabilities, and adversely
affect its ability to generate revenues.
We
will be required to obtain international regulatory approval to market and sell
our products outside of the United States.
The
Company intends to also have its product candidates marketed outside the United
States. In order to market products in the European Union and many other
non-U.S. jurisdictions, the Company must obtain separate regulatory approvals
and comply with numerous and varying regulatory requirements. The Company may
not obtain foreign regulatory approvals on a timely basis, if at all. Approval
by the FDA does not ensure approval by regulatory agencies in other foreign
countries or by the FDA. However, a failure or delay in obtaining regulatory
approval in one jurisdiction may have a negative effect on the regulatory
approval process in other jurisdictions, including approval by the FDA. The
failure to obtain regulatory approval in foreign jurisdictions could harm the
Company’s business.
The
Company will depend upon strategic relationships to develop, exploit and
manufacture its products.
The near
and long-term viability of the Company’s products will depend in part on its
ability to successfully establish new strategic collaborations with
biotechnology companies, hospitals, insurance companies and government agencies.
Establishing strategic collaborations is difficult and time-consuming. Potential
collaborators may reject collaborations based upon their assessment of the
Company’s financial, regulatory or intellectual property position. If the
Company fails to establish a sufficient number of collaborations on acceptable
terms, it may not be able to commercialize its products or generate sufficient
revenue to fund further research and development efforts.
Even if
the Company establishes new collaborations, these relationships may never result
in the successful development or commercialization of any product candidates for
several reasons both within and outside of the Company’s
control.
InVivo
will require quantities of manufactured product and may require third party
manufacturers to fulfill some its inventory requirements.
Completion
of InVivo’s clinical trials and commercialization of InVivo’s products will
require access to, or development of, facilities to manufacture a sufficient
supply of InVivo’s product or other product candidates. If InVivo is unable to
manufacture its products in commercial quantities, then it will need to rely on
third parties. These third-party manufacturers must also receive FDA approval
before they can produce clinical material or commercial products. InVivo’s
products may be in competition with other products for access to these
facilities and may be subject to delays in manufacture if third parties give
other products greater priority. In addition, InVivo may not be able to enter
into any necessary third-party manufacturing arrangements on acceptable terms,
or on a timely basis. Failure by InVivo to manufacture products on a timely
basis for clinical trials or for commercial needs will have a material adverse
affect on the Company.
The
Company will rely upon third parties for laboratory testing, animal and human
studies.
The
Company has been and will continue to be dependent on third-party contract
research organizations to conduct some of its laboratory testing, animal and
human studies. If the Company is unable to obtain any necessary testing services
on acceptable terms, it may not complete its product development efforts in a
timely manner. If the Company relies on third parties for laboratory testing
and/or animal and human studies, it may lose some control over these activities
and become too dependent upon these parties. These third parties may not
complete testing activities on schedule or when the Company requests. The
Company may not be able to secure and maintain suitable contract research
organizations to conduct its laboratory testing and/or animal and human studies.
The Company is responsible for confirming that each of its clinical trials is
conducted in accordance with its general plan and protocol. Moreover, the FDA
and foreign regulatory agencies require the Company to comply with regulations
and standards, commonly referred to as good clinical practices, for conducting,
recording and reporting the results of clinical trials to assure that data and
reported results are credible and accurate and that the trial participants are
adequately protected. The Company’s reliance on third parties does not relieve
it of these responsibilities and requirements. If these third parties do not
successfully carry out their contractual duties or regulatory obligations or
meet expected deadlines, if the third parties need to be replaced or if the
quality or accuracy of the data they obtain is compromised due to the failure to
adhere to the Company’s clinical protocols or regulatory requirements or for
other reasons, the Company pre-clinical development activities or clinical
trials may be extended, delayed, suspended or terminated, and the Company may
not be able to obtain regulatory approval for its product
candidates.
The
Company may have product liability exposure.
The
Company will have exposure to claims for product liability. Product liability
coverage is expensive and sometimes difficult to obtain. The Company may not be
able to obtain or maintain insurance at a reasonable cost. There can be no
assurance that existing insurance coverage will extend to other products in the
future. Any product liability insurance coverage may not be sufficient to
satisfy all liabilities resulting from product liability claims. A successful
claim may prevent the Company from obtaining adequate product liability
insurance in the future on commercially desirable items, if at all. Even if a
claim is not successful, defending such a claim would be time-consuming and
expensive, may damage the Company’s reputation in the marketplace, and would
likely divert management’s attention.
There
are a limited number of suppliers that can provide materials to the
Company.
The
Company may rely on third-party suppliers and vendors for some of the materials
used in the manufacture of InVivo’s product or other of its product candidates.
Any significant problem experienced by one of InVivo’s suppliers could result in
a delay or interruption in the supply of materials to InVivo until such supplier
resolves the problem or an alternative source of supply is located. Any delay or
interruption could negatively affect InVivo’s operations.
The
Company’s products are new and will require market acceptance.
Even if
the Company receives regulatory approvals for the commercial sale of its product
candidates, the commercial success of these product candidates will depend on,
among other things, their acceptance by physicians, patients, third party payers
such as health insurance companies and other members of the medical community as
a therapeutic and cost-effective alternative to competing products and
treatments. If the Company’s product candidates fail to gain market acceptance,
it may be unable to earn sufficient revenue to continue its business. Market
acceptance of, and demand for, any product that the Company may develop and
commercialize will depend on many factors, both within and outside of the
Company’s control. If the
Company’s product candidates do not become widely accepted by physicians,
patients, third party payers and other members of the medical community, its
business, financial condition and results of operations would be materially and
adversely affected.
Physicians
and hospitals will require training in order to utilize the Company’s
products.
The
Company’s products have not been utilized in the past for SCI treatment. As is
typical in the case of a new and rapidly evolving technology or medical
treatment, demand and market acceptance for recently introduced products and
services are subject to a high level of uncertainty and risk. In
addition, physicians and hospitals will need to establish training and
procedures to utilize and implement the Company’s products. There can be no
assurance that these parties will adopt the Company’s products or that they
develop sufficient training and procedures to properly utilize the Company’s
products.
The
Company’s success will depend upon the level of third party reimbursement for
the cost of its products to users.
The
Company’s successes may depend, in part, on the extent to which reimbursement
for the costs of therapeutic products and related treatments will be available
from third-party payers such as government health administration authorities,
private health insurers, managed care programs, and other organizations. Over
the past decade, the cost of health care has risen significantly, and there have
been numerous proposals by legislators, regulators, and third-party health care
payers to curb these costs. Some of these proposals have involved limitations on
the amount of reimbursement for certain products. Similar federal or state
health care legislation may be adopted in the future and any products that the
Company or its collaborators seek to commercialize may not be considered
cost-effective. Adequate third-party insurance coverage may not be available for
the Company to establish and maintain price levels that are sufficient for the
Company to continue its business or for realization of an appropriate return on
investment in product development.
We
will be subject to environmental, health and safety laws.
The
Company is subject to various laws and regulations relating to safe working
conditions, laboratory and manufacturing practices, the experimental use of
animals and humans, emissions and wastewater discharges, and the use and
disposal of hazardous or potentially hazardous substances used in connection
with its research, including infectious disease agents. The Company also cannot
accurately predict the extent of regulations that might result from any future
legislative or administrative action. Any of these laws or regulations could
cause the Company to incur additional expense or restrict its
operations.
Compliance
with environmental laws and regulations may be expensive, and current or future
environmental regulations may impair the Company’s research, development or
production efforts.
Our
products could be subject to claims for patent infringement.
The
Company’s success in large part depends on its ability to maintain the
proprietary nature of its licensed technology and trade secrets. To do so, the
Company and its licensors must prosecute and maintain existing patents, obtain
new patents and pursue trade secret and other intellectual property protection.
The Company also must operate without infringing the proprietary rights of third
parties or allowing third parties infringe its rights. The Company’s
research, development and commercialization activities, including any product
candidates or products resulting from these activities, may infringe or be
claimed to infringe patents owned by third parties and to which the Company does
not hold licenses or other rights.
There may
be rights that the Company is not aware of, including applications that have
been filed but not published that, when issued, could be asserted against the
Company. These third parties could bring claims against the Company that would
cause it to incur substantial expenses and, if successful, could cause the
Company to pay substantial damages. Further, if a patent infringement suit were
brought against the Company, it could be forced to stop or delay research,
development, manufacturing or sales of the product or biologic treatment
candidate that is the subject of the suit.
In
addition, competitors may infringe the Company’s patents or the patents of its
collaborators or licensors. As a result, the Company may be required to file
infringement claims to counter infringement for unauthorized use. This can be
expensive and time-consuming. In addition, in an infringement proceeding, a
court may decide that a patent licensed or owned by the Company is not valid or
is unenforceable, or may refuse to stop the other party from using the
technology at issue on the grounds that the Company’s licensed or owned patents
do not cover its technology. An adverse determination of any litigation or
defense proceedings could put one or more of the Company’s licensed or owned
patents at risk of being invalidated or interpreted narrowly and could put the
Company’s licensed or owned patent applications at the risk of not
issuing.
Furthermore,
because of the substantial amount of discovery required in connection with
intellectual property litigation, there is a risk that some of the Company‘s
trade secrets or other confidential information could be compromised by
disclosure during this type of litigation.
The
Company will rely on a combination of patent, trademark, copyright and trade
secret laws, as well as confidentiality agreements, license agreements and
technical measures to protect its proprietary rights.
The
Company will rely on a combination of patent, trademark, copyright and trade
secret laws, as well as confidentiality agreements, license agreements and
technical measures to protect its proprietary rights. There can be no
assure that any of its patents, means and methods won’t infringe on the
intellectual property rights of others. In addition, some of the Company’s
proprietary information may not be patentable, and there can be no assurance
that others will not utilize similar or superior solutions to compete with the
Company. The Company cannot guarantee that it will develop proprietary products
and services or processes that are patentable, and that if issued, any patent
will give a competitive advantage or that such patent will not be challenged by
third parties, or that the patents of others will not have a material adverse
effect on the Company’s ability to do business. The Company intends
to register certain trademarks in, or claim certain trademark rights in, the
United States and/or foreign jurisdictions. The Company cannot assure
that its means of protecting its proprietary rights will suffice or that the
Company’s competitors will not independently develop competitive technology or
duplicate processes or design around patents or other intellectual property
rights issued to the Company.
Our
ability to raise capital as required may be difficult given the current
condition of the capital and credit markets.
The
Company is likely in the future to seek to access the capital markets for
capital for its capital needs. Traditionally, biotech companies have funded
their research and development expenditures through raising capital in the
equity markets. Declines and uncertainties in these markets over the past few
years have severely restricted raising new capital and have affected companies’
ability to continue to expand or fund existing research and development efforts.
The Company will require significant capital beyond its current resources for
research and development for its product candidates and clinical trials. The
general economic and capital market conditions, both in the United States and
worldwide have deteriorated significantly and will adversely affect the
Company’s access to capital and may increase the cost of capital. If these
economic conditions continue or become worse, the Company’s future cost of
equity or debt capital and access to the capital markets could be adversely
affected. As a result of the current volatile and unpredictable global economic
situation, there may be a disruption or delay in the performance of the
Company’s third-party contractors and suppliers. If such third-parties are
unable to adequately satisfy their contractual commitments to the Company in a
timely manner, its business could be adversely affected.
We
have never declared any dividends and do not expect to declare any in the near
future.
The Company has never paid cash
dividends on its common stock. It is currently anticipated that the Company will
retain earnings, if any, for use in the development of InVivo’s business and
does not anticipate paying any cash dividends in the foreseeable
future.
We
are dependent on our management and other key personnel.
The
Company depends on its senior executive officers as well as key scientific and
other personnel. The loss of any of these individuals could harm the Company’s
business and significantly delay or prevent the achievement of research,
development or business objectives. Competition for qualified employees is
intense among biotechnology companies, and the loss of qualified employees, or
an inability to attract, retain and motivate additional highly skilled employees
could hinder the Company’s ability to successfully develop marketable
products.
The
Company’s future success also depends on its ability to identify, attract, hire,
train, retain and motivate other highly skilled scientific, technical,
marketing, managerial and financial personnel. Although the Company will seek to
hire and retain qualified personnel with experience and abilities commensurate
with the needs of the Company, there is no assurance that the Company will
succeed despite their collective efforts. The loss of the services of any of the
principal members of the Company's management or other key personnel could
hinder the Company's ability to fulfill its business plan and further develop
and commercialize its products and services. Competition for personnel is
intense, and any failure to attract and retain the necessary technical,
marketing, managerial and financial personnel would have a material adverse
effect on the Company’s business, prospects, financial condition and results of
operations. Although we presently do not maintain “key person” life insurance
policies on any of our personnel, we intend to obtain key man insurance on Frank
Reynolds, our Chairman, CEO and CFO, of at least $2 million, shortly following
the date of this Report.
InVivo’s
audited financial statements express substantial doubt about its ability to
continue as a going concern, which may hinder its ability to obtain future
financing.
InVivo’s financial statements for the
year ended December 31, 2009 have been prepared assuming that it will continue
as a going concern. InVivo’s ability to continue as a going concern is raised as
a result of no revenues and recurring losses from operations since its inception
and working capital deficiency. InVivo will continue to experience net operating
losses. Its ability to continue as a going concern is subject to its ability to
generate a profit and/or obtain necessary funding from outside sources,
increasing sales or obtaining loans and grants from various financial
institutions where possible. InVivo’s continued net operating losses increase
the difficulty in meeting such goals and there can be no assurances that such
methods will prove successful.
Risks
Related to Our Common Stock; Liquidity Risks
Our
securities are “Penny Stock" and subject to specific rules governing their sale
to investors.
The SEC
has adopted Rule 15g-9 which establishes the definition of a “penny stock,” for
the purposes relevant to the Company, as any equity security that has a market
price of less than $5.00 per share or with an exercise price of less than $5.00
per share, subject to certain exceptions. For any transaction involving a penny
stock, unless exempt, the rules require that a broker or dealer approve a
person’s account for transactions in penny stocks; and the broker or dealer
receive from the investor a written agreement to the transaction, setting forth
the identity and quantity of the penny stock to be purchased.
In order
to approve a person’s account for transactions in penny stocks, the broker or
dealer must obtain financial information and investment experience objectives of
the person; and make a reasonable determination that the transactions in penny
stocks are suitable for that person and the person has sufficient knowledge and
experience in financial matters to be capable of evaluating the risks of
transactions in penny stocks.
The
broker or dealer must also deliver, prior to any transaction in a penny stock, a
disclosure schedule prescribed by the SEC relating to the penny stock market,
which, in highlight form sets forth the basis on which the broker or dealer made
the suitability determination; and that the broker or dealer received a signed,
written agreement from the investor prior to the transaction.
Generally,
brokers may be less willing to execute transactions in securities subject to the
“penny stock” rules. This may make it more difficult for Company’s shareholders
to sell shares of our common stock.
Disclosure
also has to be made about the risks of investing in penny stocks in both public
offerings and in secondary trading and about the commissions payable to both the
broker-dealer and the registered representative, current quotations for the
securities and the rights and remedies available to an investor in cases of
fraud in penny stock transactions. Finally, monthly statements have to be sent
disclosing recent price information for the penny stock held in the account and
information on the limited market in penny stocks.
There
is no recent trading activity in our Common Stock and there is no assurance that
an active market will develop in the future.
There is no recent trading activity in
our Common Stock. Further, although the Common Stock is currently quoted on the
OTC Bulletin Board, trading of our Common Stock may be extremely sporadic. For
example, several days may pass before any shares may be traded. As a result, an
investor may find it difficult to dispose of, or to obtain accurate quotations
of the price of, the Common Stock. There can be no assurance that following the
Transactions, a more active market for the Common Stock will develop, or if one
should develop, there is no assurance that it will be sustained. This severely
limits the liquidity of the Common Stock, and would likely have a material
adverse effect on the market price of the Common Stock and on our ability to
raise additional capital.
Because
we became public by means of a reverse merger, we may not be able to attract the
attention of major brokerage firms.
Additional
risks may exist since we became public through a “reverse
merger.” Securities analysts of major brokerage firms may not provide
coverage of us since there is little incentive to brokerage firms to recommend
the purchase of our Common Stock. No assurance can be given that
brokerage firms will want to conduct any secondary offerings on behalf in the
future.
Compliance
with the reporting requirements of federal securities laws can be
expensive.
The
Company is a public reporting company in the United States, and accordingly,
subject to the information and reporting requirements of the Exchange Act and
other federal securities laws, and the compliance obligations of the
Sarbanes-Oxley Act. The costs of preparing and filing annual and
quarterly reports and other information with the SEC and furnishing audited
reports to stockholders are substantial. In addition, the Company
will incur substantial expenses in connection with the preparation of the
Registration Statement and related documents with respect to the registration of
resales of the Common Stock sold in the Offering.
We
do not currently have a separate Chief Financial Officer.
We do not currently have a separate
Chief Financial Officer. Our Chief Executive Officer is also
functioning as our Chief Financial Officer. Although we are currently
seeking to retain a Chief Financial Officer, there can be no assurance we will
be able to retain a suitable candidate on acceptable terms.
Applicable
regulatory requirements, including those contained in and issued under the
Sarbanes-Oxley Act of 2002, may make it difficult for the Company to retain or
attract qualified officers and directors, which could adversely affect the
management of its business and its ability to obtain or retain listing of its
Common Stock.
The
Company may be unable to attract and retain those qualified officers, directors
and members of board committees required to provide for effective management
because of the rules and regulations that govern publicly held companies,
including, but not limited to, certifications by principal executive officers.
The enactment of the Sarbanes-Oxley Act has resulted in the issuance of a series
of related rules and regulations and the strengthening of existing rules and
regulations by the SEC, as well as the adoption of new and more stringent rules
by the stock exchanges. The perceived increased personal risk associated with
these changes may deter qualified individuals from accepting roles as directors
and executive officers.
Further,
some of these changes heighten the requirements for board or committee
membership, particularly with respect to an individual’s independence from the
corporation and level of experience in finance and accounting matters. The
Company may have difficulty attracting and retaining directors with the
requisite qualifications. If the Company is unable to attract and retain
qualified officers and directors, the management of its business and its ability
to obtain or retain listing of our shares of Common Stock on any stock exchange
(assuming the Company elects to seek and are successful in obtaining such
listing) could be adversely affected.
The
Company may have undisclosed liabilities and any such liabilities could harm the
Company’s revenues, business, prospects, financial condition and results of
operations.
Even
though the assets and liabilities of ITHC were transferred to the Split-Off
Shareholders in the Split-Off, there can be no assurance that the Company will
not be liable for any or all of such liabilities. Any such liabilities of ITHC
that survive the Split-Off could harm the Company’s revenues, business,
prospects, financial condition and results of operations upon the Company’s
acceptance of responsibility for such liabilities.
The
transfer of the operating assets and liabilities to DSSC, coupled with the
Split-Off of DSSC, will result in taxable income to the Company in an amount
equal to the difference between the fair market value of the assets transferred
and ITHC's tax basis in the assets. Any gain recognized, to the
extent not offset by the Company's net operating loss carryforward, if any, will
be subject to federal income tax at regular corporate income tax
rates.
Our
Convertible Notes converted into common stock based on valuations pursuant to
the terms of the Convertible Notes. InVivo cannot guarantee that all holders of
the Convertible Notes will agree with the valuation used for
conversion.
Prior to the Offering, InVivo sold an
aggregate of $4,181,000 of Convertible Notes to investors. These Convertible
Notes, by their terms, all converted into InVivo common stock prior to the
consummation of the Transactions. The Convertible Notes provide for
conversion based on a company-determined valuation as stipulated per the
provisions of the Convertible Notes. While InVivo is of the belief that it
properly valued the conversion valuation for the Convertible Notes pursuant to
their terms, there can be no assurance that InVivo was correct in such
assessment. To date, certain investors have disputed the Company’s conversion
valuation methodology and one investor has threatened to sue the Company based
upon the conversion valuation. There can be no assurance that other investors
who purchased Convertible Notes will not also dispute the valuation or commence
litigation against InVivo.
If
the Company fails to maintain an effective system of internal controls, it may
not be able to accurately report its financial results or detect fraud.
Consequently, investors could lose confidence in the Company’s financial
reporting and this may decrease the trading price of its stock.
The
Company must maintain effective internal controls to provide reliable financial
reports and detect fraud. The Company has been assessing its internal controls
to identify areas that need improvement. It is in the process of implementing
changes to internal controls, but has not yet completed implementing these
changes. Failure to implement these changes to the Company’s internal controls
or any others that it identifies as necessary to maintain an effective system of
internal controls could harm its operating results and cause investors to lose
confidence in the Company’s reported financial information. Any such
loss of confidence would have a negative effect on the trading price of the
Company’s stock.
The
price of the Common Stock may become volatile, which could lead to losses by
investors and costly securities litigation.
The
trading price of the Common Stock is likely to be highly volatile and could
fluctuate in response to factors such as:
|
·
|
actual
or anticipated variations in the Company’s operating
results;
|
|
·
|
announcements
of developments by the Company or its
competitors;
|
|
·
|
the
timing of IDE approval, the completion and/or results of the Company’s
clinical trials
|
|
·
|
regulatory
actions regarding the Company’s
products
|
|
·
|
announcements
by the Company or its competitors of significant acquisitions, strategic
partnerships, joint ventures or capital
commitments;
|
|
·
|
adoption
of new accounting standards affecting the Company’s
industry;
|
|
·
|
additions
or departures of key personnel;
|
|
·
|
introduction
of new products by the Company or its
competitors;
|
|
·
|
sales
of the Company’s Common Stock or other securities in the open market;
and
|
|
·
|
other
events or factors, many of which are beyond the Company’s
control.
|
The stock
market is subject to significant price and volume fluctuations. In the past,
following periods of volatility in the market price of a company’s securities,
securities class action litigation has often been initiated against such a
company. Litigation initiated against the Company, whether or not successful,
could result in substantial costs and diversion of its management’s attention
and resources, which could harm the Company’s business and financial
condition.
Investors
may experience dilution of their ownership interests because of the future
issuance of additional shares of the Common Stock.
In the
future, the Company may issue additional authorized but previously unissued
equity securities, resulting in the dilution of the ownership interests of its
present stockholders. The Company may also issue additional shares of its Common
Stock or other securities that are convertible into or exercisable for Common
Stock in connection with hiring or retaining employees, future acquisitions,
future sales of its securities for capital raising purposes, or for other
business purposes. The future issuance of any such additional shares
of Common Stock may create downward pressure on the trading price of the Common
Stock. There can be no assurance that the Company will not be
required to issue additional shares, warrants or other convertible securities in
the future in conjunction with any capital raising efforts, including at a price
(or exercise prices) below the price at which shares of the Common Stock is
currently traded on the OTC Markets.
The
Common Stock is controlled by insiders.
The Company’s officers and directors
beneficially own approximately 36.7% of our outstanding shares of Common
Stock. Such concentrated control of the Company may adversely affect
the price of its Common Stock. Investors who acquire Common Stock may
have no effective voice in the management of the Company. Sales by
insiders or affiliates of the Company, along with any other market transactions,
could affect the market price of the Common Stock.
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS
OF OPERATIONS
The
following management’s discussion and analysis should be read in conjunction
with InVivo’s historical financial statements and the related notes. The
management’s discussion and analysis contains forward-looking statements that
involve risks and uncertainties, such as statements of our plans, objectives,
expectations and intentions. Any statements that are not statements of
historical fact are forward-looking statements. When used, the words “believe,”
“plan,” “intend,” “anticipate,” “target,” “estimate,” “expect” and the like,
and/or future tense or conditional constructions (“will,” “may,” “could,”
“should,” etc.), or similar expressions, identify certain of these
forward-looking statements. 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 in
this Current Report. The Company’s actual results and the timing of events could
differ materially from those anticipated in these forward-looking statements as
a result of several factors. The Company does not undertake any obligation to
update forward-looking statements to reflect events or circumstances occurring
after the date of this Current Report.
As the
result of the Transactions and the change in business and operations of the
Company from a shell company to a biotechnology company, a discussion of the
past financial results of ITHC is not pertinent, and the financial results of
InVivo, the accounting acquirer, are considered the financial results of the
Company on a historical and going-forward basis.
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
The
discussion and analysis of InVivo’s financial condition and results of
operations are based on InVivo’s financial statements, which InVivo has prepared
in accordance with U.S. generally accepted accounting principles. The
preparation of these financial statements requires InVivo to make estimates and
assumptions that affect the reported amounts of assets and liabilities and the
disclosure of contingent assets and liabilities at the date of the financial
statements, as well as the reported revenues and expenses during the reporting
periods. On an ongoing basis, InVivo evaluates such estimates and judgments,
including those described in greater detail below. InVivo bases its estimates on
historical experience and on various other factors that InVivo believes are
reasonable under the circumstances, the results of which form the basis for
making judgments about the carrying value of assets and liabilities that are not
readily apparent from other sources. Actual results may differ from these
estimates under different assumptions or conditions.
Critical
Accounting Policies
Our financial statements, which appear
at Item 9.01(a), have been prepared in accordance with accounting principles
generally accepted in the United States, which require that the Company make
certain assumptions and estimates and, in connection therewith, adopt certain
accounting policies. Our significant accounting policies are set forth in
Note 2 to our financial statements. Of those policies, we believe that the
policies discussed below may involve a higher degree of judgment and may be more
critical to an accurate reflection of our financial condition and results of
operations.
Stock-Based
Compensation
Stock options are generally granted
with an exercise price at market value at the date of the grant. The stock
options generally expire ten years from the date of grant. Stock option
awards vest upon terms determined by the Board of Directors
The Company recognizes compensation
costs resulting from the issuance of stock-based awards to employees,
non-employees and directors as an expense in the statement of operations over
the service period based on a measurement of fair value for each stock-based
award.
The fair value of InVivo common stock
has been determined based on a number of factors including the stage of
development of the Company, the value of Company’s common stock sold to outside
investors and the market value of other medical device companies in a similar
stage of development.
The fair value of each option grant was
estimated as of the date of grant using the Black-Scholes option-pricing
model. The fair value is amortized as compensation cost on a
straight-line basis over the requisite service period of the awards, which is
generally the vesting period. Due to its limited operating history and limited
number of sales of its common stock, the Company estimated its volatility in
consideration of a number of factors including the volatility of comparable
public companies. The Company uses historical data, as well as subsequent events
occurring prior to the issuance of the financial statements, to estimate option
exercise and employee termination within the valuation model. The expected term
of options granted under the Company’s stock plans, all of which qualify as
“plain vanilla,” is based on the average of the contractual term (generally
10 years) and the vesting period (generally 48 months) as permitted
under SEC Staff Accounting Bulletin Nos. 107 and 110. The risk-free rate is
based on the yield of a U.S. Treasury security with a term consistent with the
option.
The following assumptions were used to
estimate the fair value of stock options granted using the Black-Scholes option
pricing model:
|
|
Six Months Ended
|
|
|
Years Ended December 31,
|
|
|
|
June 30, 2010
|
|
|
2009
|
|
|
2008
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
Risk-free
interest rate
|
|
|
3.24 |
% |
|
|
2.68 |
% |
|
|
3.24 |
% |
Expected
dividend yield
|
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
Expected
term (employee grants)
|
|
|
7.45 |
|
|
|
6.25 |
|
|
|
7.75 |
|
Expected
volatility
|
|
|
49.15 |
% |
|
|
50.10 |
% |
|
|
49.15 |
% |
We review our financial reporting and
disclosure practices and accounting policies on an ongoing basis to ensure that
our financial reporting and disclosure system provides accurate and transparent
information relative to the current economic and business environment. As part
of the process, the Company reviews the selection, application and communication
of critical accounting policies and financial disclosures. The preparation of
our financial statements in conformity with accounting principles generally
accepted in the United States requires that our management make estimates and
assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the
reporting period. We review our estimates and the methods by which they are
determined on an ongoing basis. However, actual results could differ from our
estimates.
Comparison
of the six months ended June 30, 2010 and 2009
Research
and Development Expenses
Research and development expenses
decreased by $165,000, from $790,000 in 2009 to $625,000 in 2010. The decrease
is primarily attributable to a reduction in costs of pre-clinical
studies.
General
and Administrative Expenses
General and administrative expenses
increased by $239,000, from $312,000 in 2009 to $551,000 in 2010. The increase
is primarily attributable to an increase in stock compensation
expense.
Interest
expense
Interest expense increased by $124,000
from $124,000 in 2009 to $248,000 in 2010. The increase is primarily
attributable to interest expense from the beneficial conversion feature of
$104,000 recorded in 2010.
Comparison
of years ended December 31, 2009 and 2008
Research
and Development Expenses
Research and development expenses
increased by $871,000, from $937,000 in 2008 to $1,808,000 in 2009. The increase
is primarily attributable to an increase in costs of preclinical
studies.
General
and Administrative Expenses
General and administrative expenses
increased by $362,000, from $474,000 in 2008 to $836,000 in 2009. The increase
is primarily attributable to increases in stock compensation expense, salary and
benefits and rent expense.
Other income of $383,000 in 2009
resulted from the settlement of a legal matter.
Interest
expense
Interest expense increased by
$101,000 from $155,000 in 2008 to $256,000 in 2009. The increase
is an increase in the amount of debt outstanding in 2009 as compared to
2008.
Financial
Condition, Liquidity and Capital Resources
Since its inception, the Company has
devoted substantially all of its efforts to business planning, research and
development, recruiting management and technical staff, acquiring operating
assets and raising capital. Accordingly, the Company is considered to
be in the development stage.
As of
December 31, 2009, the Company had cash of approximately $227,000, an
accumulated deficit of approximately $5,179,000 and a stockholders’ deficit of
approximately $3,619,000. The Company is in the development stage,
has no revenue and has relied on raising capital to finance its
operations. At December 31, 2009, the Company did not have sufficient
capital to fund its operations. This, in turn, raises substantial
doubt about the Company’s ability to continue as a going concern
Since inception, the Company incurred
negative cash flows from operations. The Company has financed its operations
primarily through the sale of equity-related securities. At June 30, 2010 the
accumulated deficit was $6,603,000 and stockholders’ deficit was
$328,000.
At June 30, 2010, we had total current
assets of $216,000 and current liabilities of $272,000, resulting in a working
capital deficit of $56,000. At December 31, 2009, we
had total current assets of $238,000 and current liabilities of $658,000,
resulting in a working capital deficit of $420,000.
Net cash used by operating activities
for the six months ended June 30, 2010 was $1,119,000. The Company
raised $1,000,000 of cash from the sale of equity and $200,000 from the issuance
of convertible notes in the six months ended June 30, 2010.
Net cash provided used by operating
activities for the year ended December 31, 2009 was $1,900,000. In the year
ended December 31, 2009, the Company raised $1,580,000 of cash from the sale of
convertible notes and $513,000 was provided from the issuance of
loans.
At June 30, 2010, the Company had cash
of $198,000. The Company will need substantial additional capital to
complete its clinical trials, obtain marketing approvals and commercialize the
products.
Between July 2010 and September 2010,
the Company raised $500,000 from the sale of 6% convertible promissory notes
(the “Bridge Notes”). The Bridge Notes automatically converted into
the equity securities sold in the Offering.
Our
executive officers are located in leased premises at One Broadway, 14th Floor,
Cambridge, MA 02142 and our phone number is 617-475-1520.
SECURITY
OWNERSHIP OF CERTAIN STOCKHOLDERS AND MANAGEMENT
The
following tables set forth certain information regarding the beneficial
ownership of our Common Stock as of October 26, 2010 by (i) each person who, to
our knowledge, owns more than 5% of the Common Stock; (ii) each of the directors
and executive officers of the Company; and (iii) all of our executive officers
and directors as a group. Unless otherwise indicated in the footnotes to the
following tables, each person named in the table has sole voting and investment
power and that person’s address is c/o InVivo Therapeutics Holdings Corp., One
Broadway, Cambridge, Massachusetts 02142. Shares of Common Stock
subject to options or warrants currently exercisable or exercisable within 60
days of October 26, 2010 are deemed outstanding for computing the share
ownership and percentage of the person holding such options and warrants, but
are not deemed outstanding for computing the percentage of any other
person.
Name of Beneficial Owner
|
|
No. Shares of Common
Stock Beneficially Owned
|
|
|
% of Common Stock
Outstanding
|
|
Frank
Reynolds(1)
|
|
|
15,147,660 |
|
|
|
30.8 |
% |
Robert
S. Langer
|
|
|
8,262,360 |
|
|
|
16.8 |
% |
Kevin
Kimberlin(2)
|
|
|
6,192,959 |
|
|
|
11.60 |
% |
Adam
K. Stern(1)(3)
|
|
|
2,441,122 |
|
|
|
4.9 |
% |
Richard
J. Roberts(1)(4)
|
|
|
805,580 |
|
|
|
1.6 |
% |
George
Nolen(1)(5)
|
|
|
50,984
|
|
|
|
.1 |
|
Christi
Pedra(1)(6)
|
|
|
81,968 |
|
|
|
.1 |
|
All directors and executive
officers as a group (5 persons)(1)
|
|
|
18,527,313 |
|
|
|
36.7 |
% |
|
(1)
|
Officer
and/or director.
|
|
(2)
|
Represents
(i) 1,947,321 shares owned by Optical Partners, LLC and (ii) 4,425,638
shares underlying warrants held by the Placement Agent that it received in
connection with the Bridge Financing and the
Offering.
|
|
(3)
|
Represents
(i) 500,083 shares owned by Adam Stern; (ii) 40,000 shares underlying
warrants owned by Adam Stern; (iii) 801,507 shares owned by ST
Neuroscience Partners, LLC; (iv) 301,400 shares underlying warrants owned
by ST Neuroscience Partners, LLC; (v) 475,079 shares owned by Pavilion
Capital Partners, LLC; and (vi) 323,053 shares owned by Piper Venture
Partners, LLC.
|
|
(4)
|
Represents
shares issuable upon the exercise of stock
options.
|
|
(5)
|
Represents
(i) 10,000 shares underlying Investor Warrants, (ii) 10,000 shares of
Common Stock and (iii) 30,984 shares issuable upon the exercise of stock
options.
|
|
(6)
|
Represents
(i) 61,968 shares issuable upon the exercise of stock options, (ii) 10,000
shares underlying Investor Warrants and (iii) 10,000 shares of Common
Stock.
|
DIRECTORS
AND EXECUTIVE OFFICERS
The following persons are the executive
officers, non-executive officers and directors of the Company and hold the
positions set forth opposite their name.
Name
|
|
Age
|
|
Position
|
Frank
M. Reynolds
|
|
48
|
|
Chairman
of the Board of Directors, Chief Executive Officer, Chief Financial
Officer*
|
Christopher
Pritchard**
|
|
25
|
|
Chief
Science Officer
|
Eric
J. Woodard **
|
|
50
|
|
Chief
Medical Officer, Scientific Advisory Board Member
|
Richard
J. Roberts
|
|
67
|
|
Director,
Scientific Advisory Board Member
|
George
Nolen
|
|
54
|
|
Director
|
Christi
M. Pedra
|
|
52
|
|
Director
|
Adam
K. Stern
|
|
46
|
|
Director
|
*
|
Mr.
Reynolds will serve as Chief Financial Officer pending the Company’s
hiring of an individual to serve in such capacity. The Company
has initiated a search to locate such a qualified
individual.
|
Frank M. Reynolds, Chairman of the
Board of Directors, Chief Executive Officer and Chief Financial Officer,
has been CEO of InVivo Therapeutics since 2005 and Chairman and CFO since
October 2010. He is the former Director of Global Business Development at
Siemens Corporation where he was responsible for new business in 132
countries. He has over 25 years of executive management experience and was
the founder & CEO of Expand The Knowledge, Inc., an IT consulting company
with a focus on life sciences. He is an Executive Board Member of the Irish
American Business Chamber and has served on the board of the Special Olympics of
Massachusetts, Philadelphia Cares, and Wharton Consulting Partners. He was
awarded the 2010 Irish Life Science 50 Award by the President of Ireland, Mary
McAleese, The 2008 Top 40 Irish-American Executives Award, Siemens 2005 Global
Presidential Award, and the Siemens 2004 Top+ USA Strategy Award. He was
featured in the March 2010 and October 2009 issues of Inc.
magazine.
Mr.
Reynolds suffered an injury to his spine in 1992. While recovering from
this injury, he took the opportunity to earn two Master’s degrees and he
currently holds a Master of Business Administration from Sloan Fellows Program
in Global Innovation and Leadership- 2006, Massachusetts Institute of
Technology; a Master’s of Science in Technology Management- 2005, The Wharton
School of Business, University of Pennsylvania; a Master’s of Science in
Engineering – 2003, University of Pennsylvania; a Master’s of Science in
Management Information Systems – 2001, Temple University; a Master’s of Science
in Health Administration- 1996; Saint Joseph’s University; and a Master’s of
Science in Psychology – 1994, Chestnut Hill College. He also has a
Bachelor of Science in Marketing- 1984, Rider University.
Christopher Pritchard, Chief Science
Officer, has been the Director of R&D for InVivo since August 2009
and joined the Company in 2007. He is the author of numerous
peer-reviewed publications on biomaterials, stem cells and neuroscience and has
disclosed multiple patents. Mr. Prichard is a reviewing editor for the MIT
Entrepreneurship Review. He is an alumnus of Oxford and Princeton, and
completed his doctoral thesis under Dr. Robert Langer at MIT Langer
Lab.
Eric J. Woodard, M.D., Chief Medical
Officer, is the Chief, Neurosurgery at New England Baptist Hospital in
Boston. Dr. Woodard was appointed to InVivo’s Scientific Advisory Board in June
2007 and became Chief Medical Officer of InVivo in September 2008. Dr. Woodard
received his medical degree from the Pennsylvania State University and completed
his residency in Neurological surgery at Emory University. Following residency,
Dr. Woodard completed a fellowship in complex spinal surgery at the Medical
College of Wisconsin under Dr. Sanford Larsen. He is a diplomat of the American
Board of Neurological Surgeons.
Dr.
Woodard was formerly Chief of the Division of Spinal Surgery in the Department
of Neurological Surgery at Brigham and Women’s Hospital, where he held the rank
of Assistant Professor in Surgery at Harvard Medical School. He has been an
editorial board member for The Journal of Spinal Disorders, Spine Universe.com
and is an ad hoc reviewer for Neurosurgery, Journal of Neurosurgery and the New
England Journal of Medicine. He is the immediate past chairman of the
AO Spine North America Board and serves on the Board of AO Spine
International.
Dr. Richard J. Roberts, PhD,
Director, has been the Chief Scientific Officer at New England Biolabs
since July 1, 2005. Dr. Roberts joined InVivo’s Scientific Advisory Board in
June 2007 and became a Director of InVivo in November 2008. He was awarded the
1993 Nobel Prize in Physiology or Medicine
along with PhillipAllen Sharp for the discovery of introns in eukaryotic DNA and the mechanism of gene-splicing. He holds
a B.Sc. in Chemistry and a Ph.D. Organic Chemistry from the
University of Sheffield, U.K. Dr. Roberts has discovered and cloned restriction
enzymes and been involved in studies of Adenovirus-2, beginning with studies of
transcription that led to the discovery of split genes and mRNA splicing. His
laboratory has pioneered the application and development of computer methods for
protein and nucleic acid sequence analysis that continues to be a major research
focus for Dr. Roberts.
George Nolen, Director, was
the former President and Chief Executive Officer of Siemens Corporation, the
U.S. subsidiary of Siemens, AG, from 2004 until his retirement in August of
2009. He rose through the ranks during his 26-year career with Siemens USA to
become, in January 2004, the first American chosen to run Siemens’ U.S.
operations. In 2009, Siemens in the U.S. had 69,000 employees located throughout
all 50 states and $22 billion in revenue. Mr. Nolen had overall responsibility
for the strategy in the U.S. in such diverse fields as industrial automation,
lighting, water and wastewater, building automation, medical imaging, medical
diagnostics as well as traditional and new power generation technologies. He
also oversaw strategic acquisitions in the energy, healthcare and industrial
sectors, positioning Siemens USA as a leading and global player in these key
industries. Prior to his role as Siemens USA’s CEO, Mr. Nolen held numerous
roles in Siemens including President of Siemens’ Information and Communications
division, overseeing this business from 1998 to 2004. He is a 1978 graduate of
Virginia Tech, where he currently serves as the Rector of the University’s Board
of Visitors.
Christi M. Pedra, Director,
became the Senior Vice President, Strategic New Business Development &
Marketing Siemens Healthcare of Siemens Medical USA in January 2010. Previously
she served as Chief Executive Officer of Siemens Hearing Instruments, Inc. from
January 2007 through December 2009. She was charged with leading the
company’s sales, manufacturing, product development, customer relations and
research and development in the United States. From October 2003
through December 2006, she served as Vice President and Chief Operating Officer
of Siemens One. Prior to her role with Siemens One, Ms. Pedra served
as Vice President of Executive Relations for Siemens Corporation in the Office
of the President. Currently, Ms. Pedra is a member of the National
Collegiate Athletic Association Leadership Advisory Board. She also serves on
the National Council for Liberal Education America’s Promise and takes part in
several formal and informal mentoring programs. And in 2002, Ms. Pedra was
nominated and selected to be a David Rockefeller Fellow, a one-year leadership
program sponsored by the NYC Partnership and the David Rockefeller
Foundation. Ms. Pedra received her MBA from Rutgers
University.
Adam K. Stern, Director,
Senior Managing Director of the Placement Agent of the Offering, has over 20
years of venture capital and investment banking experience focusing primarily on
the technology and life science sectors of the capital markets. He
currently manages the structured finance group of the Placement
Agent. Mr. Stern joined the Placement Agent in September 1997 from
Josephthal & Co., members of the New York Stock Exchange, where he served as
Senior Vice President and Managing Director of Private Equity Marketing and held
increasingly responsible positions from 1989 to 1997. He has been a
licensed securities broker since 1987 and a General Securities Principal since
1991.Mr. Stern currently sits on the boards of various private companies and one
public company, PROLOR Biotech (NYSE/AMEX:PBTH). Mr. Stern holds a Bachelor of
Arts degree with honors from The University of South Florida in
Tampa.
The
Company does not pay Members of its Board of Directors any cash compensation and
currently compensates the Board through the issuance of Stock
Options.
SCIENTIFIC
AND BUSINESS ADVISORY BOARDS
Eric
J. Woodard
|
|
Chief
Medical Officer, Scientific Advisory Board Member
|
Dr.
Richard J. Roberts
|
|
Director,
Scientific Advisory Board Member
|
Dr.
Robert S. Langer
|
|
Scientific
Advisory Board Member
|
V.
Reggie Edgerton
|
|
Scientific
Advisory Board Member
|
Jonathan
R. Slotkin
|
|
Scientific
Advisory Board Member
|
Todd
Albert
|
|
Scientific
Advisory Board Member
|
Paul
Mraz
|
|
Business
Advisory Board Member
|
David
Feigal
|
|
Business
Advisory Board Member
|
He served
as a member of the United States Food and Drug Administration’s SCIENCE Board,
the FDA’s highest advisory board, from 1995 — 2002 and as its Chairman from
1999-2002. Dr. Langer has received over 180 major awards including the
2006 United States National Medal of Science; the Charles Stark Draper Prize,
considered the equivalent of the Nobel Prize for engineers and the 2008
Millennium Prize, the world’s most prestigious technology prize. He is the
also the only engineer to receive the Gairdner Foundation International Award;
72 recipients of this award have subsequently received a Nobel Prize.
Among numerous other awards Langer has received are the Dickson Prize for
Science (2002), Heinz Award for Technology, Economy and Employment (2003), the
Harvey Prize (2003), the John Fritz Award (2003) (given previously to inventors
such as Thomas Edison and Orville Wright), the General Motors Kettering Prize
for Cancer Research (2004), the Dan David Prize in Materials Science (2005), the
Albany Medical Center Prize in Medicine and Biomedical Research (2005), the
largest prize in the U.S. for medical research, induction into the National
Inventors Hall of Fame (2006), the Max Planck Research Award (2008) and the
Prince of Asturias Award for Technical and Scientific Research (2008). In
1998, he received the Lemelson-MIT prize, the world’s largest prize for
invention for being “one of history’s most prolific inventors in
medicine.” In 1989 Dr. Langer was elected to the Institute of Medicine of
the National Academy of Sciences, and in 1992 he was elected to both the
National Academy of Engineering and to the National Academy of Sciences.
He is one of very few people ever elected to all three United States National
Academies and the youngest in history (at age 43) to ever receive this
distinction.
Forbes Magazine (1999) and
Bio World (1990) have
named Dr. Langer as one of the 25 most important individuals in biotechnology in
the world. Discover
Magazine (2002) named him as one of the 20 most important people in this
area. Forbes
Magazine (2002) selected Dr. Langer as one of the 15 innovators worldwide
who will reinvent our future. Time Magazine and CNN (2001)
named Dr. Langer as one of the 100 most important people in America and one of
the 18 top people in science or medicine in America (America’s Best).
Parade Magazine
(2004) selected Dr. Langer as one of 6 “Heroes whose research may save your
life.” Dr. Langer has received honorary doctorates from Harvard
University, the Mt. Sinai School of Medicine, Yale University, the ETH
(Switzerland), the Technion (Israel), the Hebrew University of Jerusalem
(Israel), the Universite Catholique de Louvain (Belgium), Rensselaer Polytechnic
Institute, Willamette University, the University of Liverpool (England), the
University of Nottingham (England), Albany Medical College, Pennsylvania State
University, Northwestern University, Uppsala University (Sweden) and the
University of California – San Francisco Medal. He received his Bachelor’s
Degree from Cornell University in 1970 and his Sc.D. from the Massachusetts
Institute of Technology in 1974, both in Chemical Engineering.
Dr. Reggie Edgerton, PhD,
Scientific Advisory Board Member, has been the Director of U.C.L.A’s Edgerton
Lab since 1968 and is a professor in the Department of Physiological Sciences at
U.C.L.A. His research is focused on neural control of movement and how this
neural control adapts to altered use and after spinal cord injury. He completed
his Ph.D. under the direction of Drs. Wayne Van Huss, Rex Carrow, and William
Heusner at Michigan State University.
Dr.
Edgerton is on the Scientific Advisory Board of The Christopher Reeves
Foundation (CRF) and his laboratory is one of eight in the world receiving
funding from the CRF. In addition to serving on the board of the CRF,
he is currently on the Scientific Advising board of the American Paralysis
Association. Dr. Edgerton has co-authored two books and is the author of
approximately 300 research papers.
Dr.
Slotkin has authored or co-authored several peer-reviewed scientific
publications in the areas of repair after spinal cord injury in animal models,
and in vivo quantum dot labeling of neural stem cells.
Dr.
Albert serves on the boards of several scientific journals, including Spine, The
Spine Journal, and The Journal of Spinal Disorders and Techniques, as well as
medical associations. He is Chair of Network Development for the National Spine
Network. Dr. Albert has published over 200 scientific articles, authored over 40
book chapters, and seven textbooks on spinal surgery.
Paul Mraz, Business Advisory
Board, currently serves
as Chief Executive Officer of CeraPedics, Inc., a medical device
company. Mraz most recently served as Chairman and CEO of Angstrom
Medica, Inc. (acquired by Pioneer Surgical Technology). Prior to Angstrom
Medica, Mraz was a Principal of Link Spine Group Inc. as Vice President -
Worldwide Marketing and International Sales until its acquisition by Johnson
& Johnson in June 2003.
Mr. Mraz
currently serves as a Director of superDimension, Ltd. (Herzliya, ISRAEL and
Plymouth, MN). Mraz received a B.S. degree in Mechanical Engineering from
Lafayette College and an M.S. degree in Mechanical Engineering and Biomechanics
from Case Western Reserve University. He holds six US Patents for various
medical devices and is an active advisor to numerous venture capital
groups.
Before
joining the FDA, Dr. Feigal worked for 10 years within the academic and hospital
settings of the University of California in San Diego, San Francisco and Davis.
He holds a BA from University of Minnesota, an MD from Stanford University and a
Master of Public Health from the University of California,
Berkeley.
The
Company does not pay Members of its Advisory Boards any cash compensation and
currently compensates the Scientific Advisory and Business Advisory Boards
through the issuance of Stock Options.
The
following summary compensation table sets forth the salaries of InVivo’s CEO and
the other most highly compensated executive officers of InVivo (other than the
CEO) whose annual salaries exceeded $100,000 for the current year (the “Named Executive
Officers”). In addition to their salaries, the executive
officers were eligible for bonuses awarded by InVivo from time to
time.
Summary
Compensation Table
Name
and Principal Position(s)
|
|
Year
|
|
Salary
|
|
|
Bonus
|
|
Other Annual
Compensation
|
|
Securities
Underlying Options1
|
|
Frank
Reynolds (CEO)
|
|
2010
|
|
$ |
375,000 |
|
|
TBD
|
|
|
|
|
|
Frank
Reynolds (CEO)
|
|
2009
|
|
$ |
275,000 |
|
|
$ |
40,000 |
|
|
|
|
784,924 |
|
Frank
Reynolds (CEO)
|
|
2008
|
|
$ |
250,000 |
|
|
$ |
50,000 |
|
|
|
|
|
|
1 The Stock Options listed in the above
table were issued under InVivo’s 2007 Plan. All options issued under the 2007
Plan vest over a period of four (4) years.
Agreements with Officers, Directors and
Advisory Board Members
In
November 2006, InVivo entered into an Agreement with each of: (i) Frank
Reynolds, InVivo’s current Chief Executive Officer; (ii) Robert Langer, InVivo’s
current Scientific Advisory Member; and (iii) Yang D. Teng. The
Agreement provided for the repurchase of a party’s unvested shares of common
stock by the other parties upon the occurrence of certain events. As
of the date of this Report, all shares granted to each of the parties have
vested.
InVivo
entered into an employment agreement with Mr. Reynolds in May 2008, which was
amended in November 2009. The agreement, as amended, provides: (i)
for an indefinite term of employment; (ii) for a base salary of $375,000 plus
benefits; (iii) for a grant of stock options to purchase 784,924 shares of
Common Stock; and (iv) that if Mr. Reynolds employment is terminated by the
Company without cause, or by Mr. Reynolds as a result of a constructive
termination by the Company, or as a result of the Mr. Reynolds death or
disability, then InVivo is obligated to pay severance (consisting of salary and
benefits as in effect at the time of termination) to Mr. Reynolds (or Mr.
Reynolds’ legal representatives) for a period of 18 months. In
addition, if Mr. Reynolds employment is terminated by the Company without cause,
or by Mr. Reynolds as a result of a constructive termination by the Company, the
Company will be obligated to pay Mr. Reynolds his annual bonus during such 18
month period. The amount of the bonus after the date of termination
will equal the greater of (i) the last such bonus before termination, or (ii)
the average of the three most recent bonuses paid before the date of termination
(or all such bonuses, if less than three).
The
agreement, as amended, provides for a possible bonus to Mr. Reynolds for the
12-month period commencing November 1, 2009, payable upon the attainment of
certain milestones. The bonus may range from 10% to 130% of Mr.
Reynolds’ 2009 base salary, depending on the number and type of milestones
attained. The most significant of these milestones (100% of 2009 base salary),
will be triggered if the Company obtains FDA approval to begin a human study on
or before October 31, 2010.
InVivo
entered into an employment contract in September 2010 with Mr. Pritchard
pursuant to which Mr. Pritchard will act as Chief Science Officer of InVivo. Mr.
Pritchard’s agreement provides: (i) a base salary of $225,000 plus benefits; and
(ii) options to purchase 909,989 shares of InVivo common stock at an exercise
price of $1.00 per share, vesting over four years commencing one year from the
date of grant. Mr. Pritchard’s contract is for an indefinite term of employment,
subject to early termination for death, disability or cause.
Outstanding
Equity Awards at Fiscal Year End
The following table summarizes the
equity awards made to our named executive officers that were outstanding at
December 31, 2009.
Name
|
|
No. of Securities Underlying Unexercised Options (#) Exercisable
|
|
No. of Securities Underlying Unexercised Options (#) Unexercisable
|
|
Option Exercise Price
|
|
Option Expiration Date
|
Frank Reynolds (1)
|
|
|
0
|
|
784,924
|
|
$ |
0.91
|
|
12/12/2019
|
(1) The
options were granted on December 12, 2009, and vest as follows: 25% on each of
the first, second, third and fourth anniversaries of the date of
grant
Board
of Directors and Corporate Governance
Our Board
of Directors consists of five (5) members. On the Closing of the Merger, Peter
L. Coker and Peter A. Reichard, the sole members of the Board of Directors of
ITHC resigned, and simultaneously therewith, a new Board of Directors was
appointed. The Board consists of four (4) members who were former directors of
InVivo and Adam K. Stern, who was appointed at the Closing of the Merger at the
request of the Placement Agent.
Board
Independence and Committees
The
Company is not currently listed on any national securities exchange or in an
inter-dealer quotation system that has a requirement that the Board of Directors
be independent. However, in evaluating the independence of its members and the
composition of the committees of the Board of Directors, the Board utilizes the
definition of “independence” as that term is defined by applicable listing
standards of the Nasdaq Stock Market and SEC rules, including the rules relating
to the independence standards of an audit committee and the non-employee
director definition of Rule 16b-3 promulgated under the Exchange
Act.
The Board
of Directors expects to continue to evaluate its independence standards and
whether and to what extent the composition of the Board and its committees meets
those standards. The Company ultimately intends to appoint such persons to the
Board and committees of the Board as are expected to be required to meet the
corporate governance requirements imposed by a national securities exchange.
Therefore, the Company intends that a majority of its directors will be
independent directors of which at least one director will qualify as an “audit
committee financial expert,” within the meaning of Item 407(d)(5) of Regulation
S-K, as promulgated by the SEC.
Additionally,
the Board of Directors is expected to appoint an audit committee, governance
committee and compensation committee and to adopt charters relative to each such
committee.
We
believe that Messrs. Nolen and
Roberts and Ms. Pedra are currently “independent” directors as that term is
defined by applicable listing standards of the Nasdaq Stock Market and SEC
rules, including the rules relating to the independence standards of an audit
committee and the non-employee director definition of Rule 16b-3 promulgated
under the Exchange Act. The Board determined that Mr. Stern is not independent
as a result of the payments to the Placement Agent and that Mr. Reynolds is not
independent as a result of his employment relationship with the
Company.
We
currently anticipate that Christi Pedra and Richard Roberts will initially serve
on our audit committee, and as stated above our Board of Directors believes that
all of the members are independent as that term is defined by applicable listing
standards of the Nasdaq Stock Market and SEC rules. We expect that George Nolen
and Richard Roberts will initially serve on our compensation
committee.
Code
of Ethics
ITHC has
adopted a written code of ethics. We believe that the code of ethics is
reasonably designed to deter wrongdoing and promote honest and ethical conduct;
provide full, fair, accurate, timely and understandable disclosure in public
reports; comply with applicable laws; ensure prompt internal reporting of code
violations; and provide accountability for adherence to the code.
2009 Non-Employee Director
Compensation
The
following table sets forth compensation earned and paid to each non-employee
director for service as a director during 2009.
Name
|
|
Fees Earned or Paid in Cash ($)
|
|
|
Stock Awards ($)
|
|
|
Option Awards ($)
|
|
|
All Other Compensation ($)
|
|
|
Total ($)
|
|
Richard
J. Roberts (1)
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
(1) |
|
|
0 |
|
George
Nolen (2)
|
|
|
0 |
|
|
|
0 |
|
|
|
112,780 |
|
|
|
0 |
|
|
|
112,780 |
|
Christi
M. Pedra (3)
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
(1) Mr.
Roberts was granted options to purchase 743,612 shares on Common Stock at a
price of $0.07 per share on June 1, 2007. The options, which expire
in June 2017, vest as follows: 25% on date of grant and the remainder
in three equal installments on the first, second and third anniversaries of the
grant date. In addition, Mr. Roberts was granted options to purchase
123,935 shares of Common Stock at a price of $0.07 per share on November 24,
2008. The options, which expire in November 2018, vest as
follows: 25% of the grants vests on each of the first, second, third
and fourth anniversaries of the grant date.
(2) Mr.
Nolen was granted options to purchase 123,934 shares of Common Stock in December
2009 at a price of $0.91 per share. The options, which expire in
December 2019, vest as follows: 25% of the grants vests on each of
the first, second, third and fourth anniversaries of the grant
date.
(3) Ms.
Pedra was granted options to purchase 123,934 shares of Common Stock in November
2008 at a price of $0.07 per share. The options, which expire in
November 2018, vest as follows: 25% of the grants vests on each of
the first, second, third and fourth anniversaries of the grant
date.
2010
Equity Incentive Plan
The Board
of Directors has adopted the 2010 Equity Incentive Plan in 2010, subject to
stockholder approval, which will reserve a total of 3,500,000 shares of our
Common Stock for issuance under the 2010 Plan. If an incentive award
granted under the 2010 Plan expires, terminates, is unexercised or is forfeited,
or if any shares are surrendered to us in connection with an incentive award,
the shares subject to such award and the surrendered shares will become
available for further awards under the 2010 Plan.
Shares
issued under the 2010 Plan through the settlement, assumption or substitution of
outstanding awards or obligations to grant future awards as a condition of
acquiring another entity are not expected to reduce the maximum number of shares
available under the 2010 Plan. In addition, the number of shares of
Common Stock subject to the 2010 Plan, any number of shares subject to any
numerical limit in the 2010 Plan, and the number of shares and terms of any
incentive award are expected to be adjusted in the event of any change in our
outstanding Common Stock by reason of any stock dividend, spin-off, split-up,
stock split, reverse stock split, recapitalization, reclassification, merger,
consolidation, liquidation, business combination or exchange of shares or
similar transaction.
If
stockholder approval is not obtained within 12 months after the Board’s adoption
of the 2010 Plan, all awards granted under the 2010 Plan will terminate. In
addition, no award under the 2010 Plan will become exercisable until stockholder
approval has been obtained.
Administration
It is
expected that the compensation committee of the Board, or the Board in the
absence of such a committee, will administer the 2010 Plan. Subject
to the terms of the 2010 Plan, the compensation committee would have complete
authority and discretion to determine the terms of awards under the 2010
Plan.
Grants
The 2010
Plan is expected to authorize the grant to 2010 Plan participants of
nonqualified stock options, incentive stock options, restricted stock awards,
restricted stock units, performance grants intended to comply with Section
162(m) of the Internal Revenue Code (as amended, the “Code”) and stock appreciation
rights, as described below:
|
·
|
Options
granted under the 2010 Plan entitle the grantee, upon exercise, to
purchase a specified number of shares from us at a specified exercise
price per share. The exercise price for shares of Common Stock
covered by an option cannot be less than the fair market value of the
Common Stock on the date of grant unless agreed to otherwise at the time
of the grant.
|
|
·
|
Restricted
stock awards and restricted stock units may be awarded on terms and
conditions established by the compensation committee, which may include
performance conditions for restricted stock awards and the lapse of
restrictions on the achievement of one or more performance goals for
restricted stock units.
|
|
·
|
The
compensation committee may make performance grants, each of which will
contain performance goals for the award, including the performance
criteria, the target and maximum amounts payable, and other terms and
conditions.
|
|
·
|
The
2010 Plan authorizes the granting of stock awards. The
compensation committee will establish the number of shares of Common Stock
to be awarded and the terms applicable to each award, including
performance restrictions.
|
|
·
|
Stock
appreciation rights (“SARs”) entitle the
participant to receive a distribution in an amount not to exceed the
number of shares of Common Stock subject to the portion of the SAR
exercised multiplied by the difference between the market price of a share
of Common Stock on the date of exercise of the SAR and the market price of
a share of Common Stock on the date of grant of the
SAR.
|
Duration,
Amendment, and Termination
The Board
is expected to have the power to amend, suspend or terminate the 2010 Plan
without stockholder approval or ratification at any time or from time to
time. No change may be made that increases the total number of shares
of Common Stock reserved for issuance pursuant to incentive awards or reduces
the minimum exercise price for options or exchange of options for other
incentive awards, unless such change is authorized by our stockholders within
one year. Unless sooner terminated, the 2010 Plan would terminate ten
years after it is adopted.
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
Transactions
with ITHC Shareholders
Forward
Split, Split-Off and Share Cancellation
Our
Common Stock was forward-split on a 2.02898 for 1 basis effective October 22,
2010 so that there were 6,999,981 shares of the ITHC’s common stock issued and
outstanding before taking into account the issuance of shares of Common Stock to
purchasers of Units in the Offering and in the Merger and after giving pro forma
effect to the Split-Off, as discussed below.
Upon the
closing of the Merger, ITHC transferred all of its operating assets and
liabilities to DSSC and split-off DSSC through the sale of all of the
outstanding capital stock of DSSC (the “Split-Off”). In
connection with the Split-Off, 14,747,554 shares of Common Stock held by the
Split-Off Shareholders were surrendered and cancelled without further
consideration, other than the receipt of DSSC shares. An additional 1,014,490
shares of common stock were cancelled by a shareholder of ITHC for no
consideration (the “Share
Cancellation”)..
Transactions
with the Placement Agent and its Related Parties
The
Placement Agent also acted as finder to InVivo in connection with its sale of
$500,000 of principal amount of its Bridge Notes, which was consummated in
September 2010. The Company issued investors participating in this
bridge financing New Bridge Warrants to purchase an aggregate of 500,000 shares
of the Company’s Common Stock at a price of $1.00 per share. The New Bridge
Warrants have a term of five years and are fully exercisable. The
Bridge Notes were converted into Units in the Offering upon the closing of the
Offering. The Placement Agent earned Warrants (which are identical to the New
Bridge Warrants) to purchase 100,000 shares of Common Stock of the Company at a
price of $1.00 per Share as compensation for acting as a finder in the Bridge
Financing. Affiliates of the Placement Agent purchased $150,000 of
Bridge Notes in the Bridge Financing.
In
September 2010, several related parties to the Placement Agent, purchased an
aggregate of 1,920,000 shares of Common Stock (3,895,643 shares on a post stock
split adjusted basis) from various shareholders of ITHC. The aggregate purchase
price paid to such shareholders by the related parties for such shares was
approximately $49,000. Adam K. Stern, Senior Managing Director of the
Placement Agent and its designee to serve on the Company’s Board of Directors
upon the Closing of the Offering, beneficially owns 960,247 of these shares
(1,948,322 shares on a post-split basis).
ITHC
engaged the Placement Agent as its exclusive placement agent in connection with
the Offering. For its services, ITHC paid the Placement Agent (i) a cash fee
equal to 10% of the gross proceeds raised in the Offering ($1,051,410) and (ii)
a non-accountable expense allowance equal to 3% of the gross proceeds raised in
the Offering ($315,423). In addition, the Company granted to the
Placement Agent or its designees, for nominal consideration, five-year warrants
(“Placement Agent Warrants”) to purchase (i) 2,102,819 shares of Common Stock at
an exercise price of $1.00 per share and (ii) 2,102,819 shares of Common Stock
at an exercise price of $1.40 per share.
The
Company has agreed to engage the Placement Agent as its warrant solicitation
agent in the event the Investor Warrants are called for redemption and shall pay
a warrant solicitation fee to the Placement Agent equal to five (5%) percent of
the amount of funds solicited by the Placement Agent upon the exercise of the
Investor Warrants following such redemption.
The
Placement Agent was granted the right to designate one member to our Board of
Directors and has designated Adam K. Stern to fill such Board seat.
The
Company has also agreed to pay the Placement Agent compensation of $5,000 per
month for a period of two years for services relating to strategies
to maximize shareholder value; and entered into a non-exclusive finder’s fee
agreement with the Placement Agent providing that if the Placement Agent shall
introduce us to a third party that consummates certain investment or business
combination transactions with us during the eighteen (18) month period following
the later of the termination of this Offering or the final Closing of this
Offering, the Placement Agent will be paid a finder’s fee, payable in cash at
the closing of such transaction, equal to equal to 7% of the first $1 million of
consideration paid by or to the Company, plus 6% of the next $1 million of
consideration paid by or to the Company, plus 5% of the next $5 million of the
consideration paid by or to the Company, plus 4% of the next $1 million paid by
or to the Company, plus 3% of the next $1 million paid by or to the Company,
plus 2.5% of any consideration paid by or to the Company in excess of $9
million. The Placement Agent will not be entitled to a finder's fee with respect
to any transaction entered into with any party with whom the Company had a
pre-existing relationship prior to the date of the specific introduction and who
was not introduced to the Company by the Placement Agent.
Furthermore,
we granted the Placement Agent a preferential right of first refusal to act as
agent with respect to future private placements of the Company’s securities for
a period of eighteen (18) months from the date of the final Closing
of the Offering.
The price
of the Units was been determined following our discussions with the Placement
Agent. Among the factors considered in the negotiations were our
limited operating history, our history of losses, an assessment of our
management and our proposed operations, our current financial condition, the
prospects for the industry in which we operate, the prospects for the
development of our business with the capital raised in the Offering and the
general condition of the securities markets at the time of the
Offering. The Offering price of the Units or the exercise price of
the Investor Warrants does not necessarily bear any relationship to our assets,
book value or results of operations or any other generally accepted criterion of
value.
The
Company has agreed to indemnify the Placement Agent and other broker-dealers who
are FINRA members selected by the Placement Agent to offer and sell Units, to
the fullest extent permitted by law for a period of four (4) years from the
Closing of the Offering, against certain liabilities that may be incurred in
connection with this Offering, including certain civil liabilities under the
Securities Act, and, where such indemnification is not available, to contribute
to the payments the Placement Agent may be required to make in respect of such
liabilities. Insofar as indemnification for liabilities arising under
the Securities Act may be permitted to the Placement Agent, pursuant to the
foregoing provisions or otherwise, the Company has been advised that in the
opinion of the SEC such indemnification is against public policy as expressed in
the Securities Act and is, therefore, unenforceable.
Lock-ups
Officers,
directors and holders of 5% or more of the Company’s Common Stock and certain
employees and affiliates of the Placement Agent have agreed to “lock-up” and not
sell or otherwise transfer or hypothecate any of their shares for a term equal
to the earlier of (i) twelve (12) months from the Closing Date of the Merger; or
(ii) six (6) months following the effective date of the Registration Statement
registering the shares of Common Stock that were sold in the
Offering.
DESCRIPTION
OF CAPITAL STOCK
Authorized
Capital Stock
As of
October 26, 2010, our authorized capital stock consisted of 100,000,000 shares
of Common Stock, par value $0.00001 per share.
Issued
and Outstanding Capital Stock
After
giving effect to the Transactions, the Units sold in the Offering, the options
granted under the 2007 Plan (that were exchanged for ITHC Options upon Pubco’s
assumption of options issued under the 2007 Plan), and the warrants issued to
the Placement Agent in connection with the Offering, there are issued and
outstanding securities of the Company on the closing of the
Transactions:
|
§
|
49,161,268
shares of Common Stock;
|
|
§
|
Options
to purchase 5,915,615 shares of Common Stock granted under the 2007 Plan
that will be issued to holders at the closing of the Merger pursuant to
the assumption of the 2007 Plan;
|
|
§
|
Investor
Warrants to purchase 10,514,097 shares of Common Stock at $1.40 per share
issued to the investors in the Offering and warrants to purchase 2,102,819
shares of Common Stock at a price of $1.00 per share and 2,102,819
warrants exercisable at a price of $1.40 per share to be issued to the
Placement Agent in connection with this Offering;
and
|
|
§
|
New
Bridge Warrants issued to Bridge Investors in the Bridge Financing to
purchase 500,000 shares of Common Stock at $1.00 per share and 100,000 New
Bridge Warrants exercisable at a price of $1.00 per share issued to the
Placement Agent in connection with the Bridge
Financing.
|
Description
of Common Stock
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. The amended and
restated Articles of Incorporation do not provide for cumulative voting in the
election of directors. The Common Stock holders will be entitled to such cash
dividends as may be declared from time to time by the Board from funds
available. Upon liquidation, dissolution or winding up of the Company, the
Common Stock holders will be entitled to receive pro rata all assets available
for distribution to such holders.
Registration
Rights Agreement
The
Company is required to file within 90 days of the date of the final Closing of
the Offering (the “Filing
Deadline”), a Registration Statement registering for resale all shares of
Common Stock issued in the Offering, including Common Stock (i) included in the
Units; and (ii) issuable upon exercise of the Investor Warrants; consistent with
the terms and provisions of the Registration Rights Agreement, attached hereto
as an Exhibit 10.4. The holders of any registrable securities removed
from the Registration Statement a result of a Rule 415 or other comment from the
SEC shall have “piggyback” registration rights for the shares of Common Stock or
Common Stock underlying such warrants with respect to any registration statement
filed by the Company following the effectiveness of the Registration Statement
which would permit the inclusion of these shares. The Company has agreed to use
its reasonable efforts to have the registration statement declared effective
within 180 days of filing the registration statement (the “Effective
Deadline”).
If the
Registration Statement is not filed on or before the Filing Deadline or not
declared effective on or before the Effectiveness Deadline, the Company shall
pay to each holder of registrable securities an amount in cash equal to one-half
of one percent (0.5%) of such holder’s investment herein or in the Bridge
Financing on every thirty (30) day anniversary of such Filing Deadline or
Effectiveness Deadline failure until such failure is cured. The payment amount
shall be prorated for partial thirty (30) day periods. The maximum aggregate
amount of payments to be made by the Company as the result of such failures,
whether by reason of a Filing Deadline failure, Effectiveness Deadline failure
or any combination thereof, shall be an amount equal to 9% of each holder’s
investment amount. Notwithstanding the foregoing, no payments shall be owed with
respect to any period during which all of the holder’s registrable securities
may be sold by such holder under Rule 144 or pursuant to another exemption from
registration. Moreover, no such payments shall be due and payable
with respect to any registrable securities the Company is unable to register due
to limits imposed by the SEC’s interpretation of Rule 415 under the Securities
Act.
The
Company shall keep the Registration Statement “evergreen” for one (1) year from
the date it is declared effective by the SEC or until Rule 144 of the Securities
Act is available to Investors herein with respect to all of their shares,
whichever is earlier.
Description
of Investor Warrants
After the
consummation of the Merger and the simultaneous closing of the Offering, there
were Investor Warrants issued to purchase 10,514,097 shares of Common Stock held
by investors purchasing Units in the Offering. Each Investor Warrant entitles
the holder to purchase one share of Common Stock at a purchase price of $1.40
during the five (5) year period commencing on the issuance of the Investor
Warrants. The Investor Warrants may be called by the Company at any time the
Common Stock trades above $2.80 for twenty (20) consecutive days following the
effectiveness of the registration statement covering the resale of the
underlying Investor Warrant shares. The Investor Warrants can only be called if
a registration statement registering the shares underlying the Investor Warrants
is in effect at the time of the call.
The
Investor Warrants, at the option of the holder, may be exercised by cash payment
of the exercise price to the Company. The Investor Warrants may be exercised on
a cshless basis commencing one year after issuance if no registration statement
registering the shares underlying the Investor Warrants is then in
effect. The Placement Agent shall receive a warrant solicitation fee
equal to 5% of the funds solicited by the Placement Agent upon exercise of the
Investor Warrants if the Company elects to call the Investor Warrants. The
exercise price and number of shares of Common Stock issuable on exercise of the
Investor Warrants may be adjusted in certain circumstances including a weighted
average adjustment in the event of future issuances of the Company’s equity
securities at a price less than the exercise price of the Investor Warrant, in
the event of a stock dividend, or our recapitalization, reorganization, merger
or consolidation.
No
fractional shares will be issued upon exercise of the Investor Warrants. If,
upon exercise of the Investor Warrants, a holder would be entitled to receive a
fractional interest in a share, we will, upon exercise, round up to the nearest
whole number, the number of shares of Common Stock to be issued to the Investor
Warrant holder.
New
Bridge Warrants
In
September 2010, InVivo completed a Bridge Financing, wherein it sold $500,000 in
principal amount of its Bridge Notes and 36,310 Bridge Warrants to accredited
investors. The Bridge Warrants converted into 500,000 new Bridge Warrants, each
exercisable at a price of $1.00 per New Bridge Warrant, upon the closing of the
Offering and the Merger. Holders of the New Bridge Warrants received the same
registration rights with respect to the shares of Common Stock issuable upon
exercise of the New Bridge Warrants as the investors in the
Offering.
Placement
Agent Warrants
The
Placement Agent Warrants permit the Placement Agent or its designees, to
purchase for a five-year period, (i) 2,102,819 shares of Common Stock at an
exercise price of $1.00 per share and (ii) 2,102,819 shares of Common Stock at
an exercise price of $1.40 per share.. The Placement Agent Warrants have no
registration rights and contain weighted average anti-dilution and immediate
cashless exercise provisions.
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. The Company currently has less than 200
stockholders.
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 no 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, and
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 three 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 three 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.
MARKET
FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Market
Information
The
Common Stock is currently available for trading in the over-the-counter market
and is quoted on the OTC Bulletin Board under the symbol “NVIV.OB” As of the
Closing Date, there was no bid history for the Common Stock, because the Common
Stock had never been traded.
Trades in
the Common Stock may be subject to Rule 15g-9 of the Exchange Act, which imposes
requirements on broker/dealers who sell securities subject to the rule to
persons other than established customers and accredited investors. For
transactions covered by the rule, broker/dealers must make a special suitability
determination for purchasers of the securities and receive the purchaser’s
written agreement to the transaction before the sale.
The SEC
also has rules that regulate broker/dealer practices in connection with
transactions in “penny stocks.” Penny stocks generally are equity securities
with a price of less than $5.00 (other than securities listed on certain
national exchanges, provided that the current price and volume information with
respect to transactions in that security is provided by the applicable exchange
or system). The penny stock rules require a broker/dealer, before effecting a
transaction in a penny stock not otherwise exempt from the rules, to deliver a
standardized risk disclosure document prepared by the SEC that provides
information about penny stocks and the nature and level of risks in the penny
stock market. The broker/dealer also must provide the customer with current bid
and offer quotations for the penny stock, the compensation of the broker/dealer
and its salesperson in the transaction, and monthly account statements showing
the market value of each penny stock held in the customer’s account. The bid and
offer quotations, and the broker/dealer and salesperson compensation
information, must be given to the customer orally or in writing before effecting
the transaction, and must be given to the customer in writing before or with the
customer’s confirmation. These disclosure requirements may have the effect of
reducing the level of trading activity in the secondary market for shares of
Common Stock. As a result of these rules, investors may find it difficult to
sell their shares.
Holders
As of the
date of this filing, there are approximately 212 record holders of 49,161,268
shares of the Common Stock. As of the date of this filing, 15,319,736 shares of
Common Stock are issuable upon the exercise of outstanding warrants and options.
The shares issued in connection with the Transactions, including the Common
Stock issued to the former InVivo stockholders and investors in the Offering,
are “restricted securities,” which may be sold or otherwise transferred only if
such shares are first registered under the Securities Act or are exempt from the
registration requirements. As discussed elsewhere in this Current Report, we
have agreed to file a registration statement within 90 days of the Closing Date,
to register the shares
of Common Stock and shares of Common Stock issuable upon exercise of the
Investor Warrants issued in the Offering and the shares of Common Stock issuable
upon exercise of the New Bridge Warrants.
Dividend Policy
The
Company has never declared or paid 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 dividends if any, on the 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.
LEGAL
PROCEEDINGS
From time
to time, the Company may be named in claims arising in the ordinary course of
business. Currently, no legal proceedings or claims are pending against or
involve the Company that, in the opinion of management, could reasonably be
expected to have a material adverse effect on our business and financial
condition.
RECENT
SALES OF UNREGISTERED SECURITIES
Sales
by InVivo
Between
November 2006 and June 2008, Messrs. Reynolds, Langer and Teng were issued
1,100,000, 600,000 and 100,000 shares of InVivo’s common stock
respectively. These shares converted into 15,147,66 shares, 8,262,360
shares and 1,377,060 shares of our Common Stock, respectively, upon the closing
of the Merger. Between August 2006 and the date of this Report,
InVivo sold $4,181,000 of principal amount of convertible notes (the “Convertible Notes”) to 54
Accredited Investors and 79,536 shares of its common stock to one investor for
$1,000,000. The Convertible Notes were converted into 379,989 shares of InVivo
common stock on or before the Closing of this Offering. The 79,536 shares issued
to the investor converted into 1,095,259 Shares of our Common Stock and the
379,989 shares issuable to the Convertible Note holders converted into 5,232,677
Shares of our Common Stock upon the closing of the Merger.
In July
2010, InVivo agreed, pursuant to an agreement with its counsel, to issue to
counsel at the Closing of the Merger, $500,000 of InVivo common stock (500,000
shares of our Common Stock, following the Merger) for legal
services.
In August
2010, InVivo sold $500,000 of principal amount of Bridge Notes and Bridge
Warrants. $150,000 of principal amount of the Bridge Notes and Bridge Warrants
were purchased by an affiliate of the Placement Agent. Principal and accrued
interest on the Bridge Notes converted into and was used to acquire Units in the
Offering and upon the closing of the Merger, the Bridge Warrants were exchanged
for 500,000 New Bridge Warrants to acquire 500,000 shares of our Common Stock at
a price of $1.00 per share. As consideration for locating investors to
participate in the Bridge Financing, the Placement Agent received warrants from
InVivo that were exchanged on the closing of the Merger for new Bridge Warrants
to purchase 100,000 shares of Common Stock at a price of $1.00 per share. The
Placement Agent received, upon conversion of the Bridge Notes, compensation in
the same amount as it received for other Units sold in the
Offering.
The
transactions described above were exempt from registration under Section 4(2) of
the Securities Act and Rule 506 of Regulation D thereunder.
INDEMNIFICATION
OF OFFICERS AND DIRECTORS
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 not have had
reasonable cause to believe that his conduct was unlawful.
Under NRS
Section 78.751, advances for expenses may be made by agreement if the director
or officer affirms in writing that he has met the standards for indemnification
and will personally repay the expenses if it is determined that such officer or
director did not meet those standards.
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 if it is determined that the party is not
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 acting 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.
Insofar
as indemnification for liabilities arising under the Securities Act may be
permitted for our directors, officers and controlling persons pursuant to the
foregoing provisions, or otherwise, we have been advised that in the opinion of
the SEC such indemnification is against public policy as expressed in the
Securities Act and is, therefore, unenforceable.
PART
F/S
Reference
is made to the disclosure set forth under Item 9.01 of this Current Report,
which disclosure is incorporated herein by reference.
INDEX
TO EXHIBITS
See Item
9.01(c) below, which is incorporated by reference herein.
DESCRIPTION
OF EXHIBITS
See
Exhibit Index below and the corresponding exhibits, which are incorporated by
reference herein.
Item
3.02. Unregistered Sales of Equity
Securities.
The
disclosure set forth in Item 2.01 to this Current Report is incorporated into
this item by reference.
Item
4.01. Changes in Registrant’s
Certifying Accountant.
On October 29, 2010, we engaged Wolf
& Company, P.C. as our principal independent registered public accounting
firm , and effective October 29, 2010, we dismissed Sherb & Co., LLP, as our
principal independent registered public accounting firm . The
decision to dismiss Sherb & Co., LLP and to appoint Wolf & Company, P.C.
was approved by our board of directors.
Sherb & Co., LLP 's report on our
financial statements for either of the two most recent fiscal years ended March
31, 2010 and 2009 did not contain an adverse opinion or disclaimer of opinion,
or qualification or modification as to uncertainty, audit scope, or accounting
principles, except that such report on our financial statements contained an
explanatory paragraph in respect to the substantial doubt about our ability to
continue as a going concern.
During our two most recent fiscal years
ended March 31, 2010 and 2009 and in the subsequent interim period through the
date of dismissal, there were no disagreements, resolved or not, with Sherb
& Co., LLP on any matter of accounting principles or practices, financial
statement disclosure, or audit scope and procedures, which disagreement(s), if
not resolved to the satisfaction of Sherb & Co., LLP, would have caused
Sherb & Co., LLP to make reference to the subject matter of the
disagreement(s) in connection with its report.
During
our two most recent fiscal years ended March 31, 2010 and 2009 and in the
subsequent interim period through the date of dismissal, there were no
reportable events as described in Item 304(a)(1)(v) of Regulation
S-K.
We provided Sherb & Co., LLP with a
copy of the disclosure in this Item 4.01 of this Current Report on Form 8-K
prior to its filing with the Securities and Exchange Commission, and requested
that it furnish us with a letter addressed to the Securities and Exchange
Commission stating whether it agrees with the statements made in this Item 4.01
of this current report on Form 8-K, and if not, stating the respects with which
it does not agree. A copy of the letter provided from Sherb & Co., LLP is
filed as an exhibit to this Current Report on Form 8-K.
During our two most recent fiscal years
ended March 31, 2010 and 2009 and in the subsequent interim period through the
date of appointment, we have not consulted with Wolf & Company, P.C.
regarding either the application of accounting principles to a specified
transaction, either completed or proposed, or the type of audit opinion that
might be rendered on our financial statements, nor has Wolf & Company, P.C.
provided to us a written report or oral advice that Wolf & Company, P.C.
concluded was an important factor considered by us in reaching a decision as to
the accounting, auditing or financial reporting issue. In addition, during such
periods, we have not consulted with Wolf & Company, P.C. regarding any
matter that was either the subject of a disagreement (as defined in Item
304(a)(1)(iv) and the related instructions) or a reportable event (as described
in Item 304(a)(1)(v) of Regulation S-K).
Item
5.01. Changes in Control of the
Registrant.
As a
result of the private placement and the Merger, the Company experienced a change
in control, with the former stockholders of InVivo acquiring control of the
Company. The disclosure set forth in Item 2.01 to this Current Report is
incorporated into this item by reference.
Item
5.02. Departure of Directors or Certain
Officers; Election of Directors; Appointment of Certain Officers; Compensatory
Arrangements of Certain Officers.
The
disclosure set forth in Item 2.01 to this Current Report is incorporated into
this item by reference.
Item
5.03. Amendments to Articles of
Incorporation or Bylaws; Change in Fiscal Year.
On October 26, 2010, concurrent with
the Merger, we adopted the fiscal year end of our InVivo subsidiary, thereby
changing our fiscal year end from March 31 to December 31. The audited financial
statements for the new fiscal year will be reflected in the Company's Form 10-K
for the year ending December 31, 2010.
Item
5.06. Change in Shell Company
Status.
The
disclosure set forth in Item 2.01 to this Current Report is incorporated into
this item by reference. As a result of the completion of the Merger, we believe
that we are no longer a shell company, as defined in Rule 405 of the Securities
Act and Rule 12b-2 of the Exchange Act.
Item
9.01. Financial Statements and
Exhibits.
(a)
Financial Statements of business acquired
In
accordance with Item 9.01(a), InVivo’s unaudited financial statements as of June
30, 2010 and for the years ended December 31, 2009 and 2008 are included with
this Current Report beginning on Page F-1.
(b)
Pro forma financial information
In
accordance with Item 9.01(b), unaudited pro-forma consolidated financial
statements are included with this Current Report beginning on Page
F-28.
(c)
Exhibits
Exhibit No.
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Description
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2.1
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Agreement
and Plan of Merger and Reorganization, dated as of October 26, 2010, by
and among InVivo Therapeutics Holdings Corp. (f/k/a Design Source, Inc.),
a Nevada corporation, InVivo Therapeutics Acquisition Corp., a Delaware
corporation and InVivo Therapeutics Corporation, a Delaware
corporation*
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2.2
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Certificate
of Merger*
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3.1
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Articles
of Incorporation of Design Source, Inc.) (incorporated by reference from
Exhibit 3.1 to the Company’s registration statement (SEC File No.
333-116161) on Form SB-2, as filed with the Securities and Exchange
Commission (the “SEC”) on June 4, 2004
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3.1(i)
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Articles
of Merger as filed with the Nevada Secretary of State on October 4, 2010
(incorporated by reference from Exhibit 2.1 to the Company’s Current
Report on Form 8-K, as filed with the SEC on October 6, 2010 (the “October
Form 8-K)
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3.1(ii)
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Agreement
and Plan of Merger, dated October 4, 2010, by and between Design Source,
Inc. and InVivo Therapeutics Holdings Corp. (incorporated by reference
from Exhibit 2.2 to the October 2010 Form 8-K)
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3.2
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Amended
and Restated Bylaws of InVivo Therapeutics Holdings
Corp.*
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4.1
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Form
of Bridge Warrant of InVivo Therapeutics Corporation*
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4.2
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Form
of Bridge Promissory Note of InVivo Therapeutics
Corporation*
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4.3
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Form
of Investor Warrant of InVivo Therapeutics Holdings
Corp.*
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4.4(i)
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Form
of Warrant of InVivo Therapeutics Holdings Corp. ($1.00 exercise price)
issued to Placement Agent**
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4.4(ii)
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Form
of Warrant of InVivo Therapeutics Holdings Corp. ($1.40 exercise price)
issued to Placement Agent **
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4.5
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Form
of Warrant of InVivo Therapeutics Holdings Corp. issued to Bridge
Lenders*
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4.6
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Form
of Lock-Up Agreement**
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10.1
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Form
of Securities Purchase Agreement between InVivo Therapeutics Corporation
and the Bridge Lenders*
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10.2
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Escrow
Agreement, by and among InVivo Therapeutics Corp., InVivo Therapeutics
Holdings Corp. and Signature Bank**
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10.3
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Form
of Subscription Agreement, by and between InVivo Therapeutics Holdings
Corp. and the investors in the offering**
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10.4
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Form
of Registration Rights Agreement, by and between InVivo Therapeutics
Holdings Corp. and the investors in the offering*
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10.5
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Split-Off
Agreement, by and among InVivo Therapeutics Holdings Corp., DSource Split
Corp., Peter Reichard, Lawrence Reichard and Peter Coker
*
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10.6
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General
Release Agreement, dated as of October 26, 2010, by and among InVivo
Therapeutics Corp., DSource Split Corp., Peter Reichard, Lawrence Reichard
and Peter Coker *
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10.7(i)
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Employment
Agreement between Frank M. Reynolds and InVivo Therapeutics
Corporation*
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10.7(ii)
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Amendment
to Employment Agreement between Frank M. Reynolds and InVivo Therapeutics
Corporation*
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10.8
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Employment
Agreement between Christopher Pritchard and InVivo Therapeutics
Corp.*
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10.9
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InVivo
Therapeutics Corp. 2007 Stock Incentive Plan*
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10.10
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InVivo
Therapeutics Holdings Corp. 2010 Equity Incentive Plan*
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10.11(i)
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Form
of Incentive Stock Option Agreement by and between InVivo Therapeutics
Corp. and participants under the 2007 Stock Incentive
Plan*
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10.11(ii)
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Form
of Non-Qualified Stock Option Agreement by and between InVivo Therapeutics
Corp. and participants under the 2007 Stock Incentive
Plan*
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10.12
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License
Agreement dated July 2007 between InVivo Therapeutics Corp. and Children’s
Medical Center Corporation (1)**
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10.13
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Form
of Scientific Advisory Board Agreement entered into by InVivo Therapeutics
Corp.*
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10.14
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Finder’s
Fee Agreement dated August 18, 2010, between InVivo Therapeutics
Corporation and Placement
Agent**
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10.15
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Placement
Agent Agreement dated October 4, 2010, between InVivo Therapeutics Corp.
and Placement Agent**
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10.16
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Finder’s
Fee Agreement dated October 26, 2010, between InVivo Therapeutics Corp.
and Placement Agent**
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10.17
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Master
Services Agreement dated October 26, 2010, between InVivo Therapeutics
Corp. and Placement Agent**
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10.18
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Founders’
Agreement among InVivo Therapeutics Corporation, Francis M. Reynolds,
Robert Langer and Yang Teng dated November 1, 2006*
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14.1
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Code
of Ethics (incorporated by reference from Exhibit 14.1 to the Company’s
Annual Report on Form 10-KSB for the year ended March 31,
2006)
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16
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Letter
re change in certifying accountant*
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21.1
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Subsidiaries
of InVivo Therapeutics Holdings
Corp.*
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(1) Application
has been made with the Securities and Exchange Commission to seek confidential
treatment of certain provisions. Omitted material for which confidential
treatment has been requested has been filed separately with the Securities and
Exchange Commission.
*
Filed herewith
**
To be filed by amendment
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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INVIVO
THERAPEUTICS HOLDINGS CORP.
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Date:
November 1, 2010
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By:
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/s/ Frank M. Reynolds
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|
|
Name:
Frank M. Reynolds
|
|
|
Title:
Chief Executive Officer
|
FINANCIAL
STATEMENTS
Years
Ended December 31, 2009 and 2008 and the
Period from November 28, 2005 (Inception)
through December 31, 2009
CONTENTS
|
|
Page
|
|
|
|
Report
of Independent Registered Public Accounting Firm
|
|
F-2
|
|
|
|
Balance
Sheets
|
|
F-3
|
|
|
|
Statements
of Operations
|
|
F-4
|
|
|
|
Statements
of Changes in Stockholders’ Deficit
|
|
F-5
|
|
|
|
Statements
of Cash Flows
|
|
F-6
|
|
|
|
Notes
to Financial Statements
|
|
F-8
|
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the
Board of Directors
InVivo
Therapeutics Corporation
Cambridge,
Massachusetts
We have
audited the accompanying balance sheets of InVivo Therapeutics Corporation as of
December 31, 2009 and 2008, and the related statements of operations,
changes in stockholders’ deficit and cash flows for the years then ended and for
the period from November 28, 2005 (inception) to December 31,
2009. These financial statements are the responsibility of the
Company’s management. Our responsibility is to express an opinion on
these financial statements based on our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require
that we plan and perform the audit to obtain reasonable assurance about whether
the financial statements are free of material misstatement. An audit
includes examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable basis
for our opinion.
In our
opinion, the financial statements referred to above present fairly, in all
material respects, the financial position of the Company as of December 31,
2009 and 2008, and the results of its operations and its cash flows for the
years then ended and for the period from November 28, 2005 (inception) to the
December 31, 2009, in conformity with accounting principles generally accepted
in the United States of America.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. As discussed in Note 1 to the
financial statements, the Company has suffered recurring losses from operations,
has a significant accumulated deficit, has a significant stockholders’ deficit
and at December 31, 2009 the Company did not have sufficient capital to
fund its operations. This raises substantial doubt about the
Company’s ability to continue as a going concern. Management’s plans
in regard to these matters are also described in Note 1. The
financial statements do not include any adjustments that might result from the
outcome of this uncertainty.
/s/ Wolf
& Company, P.C.
Boston,
Massachusetts
September 29, 2010
INVIVO
THERAPEUTICS CORPORATION
(A
Development Stage Company)
BALANCE
SHEETS
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
2008
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
197,758 |
|
|
$ |
226,667 |
|
|
$ |
206,789 |
|
Prepaid
expenses
|
|
|
18,654 |
|
|
|
10,898 |
|
|
|
12,934 |
|
Total
current assets
|
|
|
216,412 |
|
|
|
237,565 |
|
|
|
219,723 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net
|
|
|
171,328 |
|
|
|
173,797 |
|
|
|
25,983 |
|
Other
assets
|
|
|
56,139 |
|
|
|
58,639 |
|
|
|
63,639 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$ |
443,879 |
|
|
$ |
470,001 |
|
|
$ |
309,345 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' DEFICIT:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
52,540 |
|
|
$ |
81,175 |
|
|
$ |
104,423 |
|
Accrued
interest payable
|
|
|
88,514 |
|
|
|
283,608 |
|
|
|
231,477 |
|
Accrued
expenses
|
|
|
130,539 |
|
|
|
293,584 |
|
|
|
114,158 |
|
Total
current liabilities
|
|
|
271,593 |
|
|
|
658,367 |
|
|
|
450,058 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loans
payable
|
|
|
500,000 |
|
|
|
590,985 |
|
|
|
77,185 |
|
Convertible
notes payable
|
|
|
- |
|
|
|
2,840,000 |
|
|
|
2,401,000 |
|
Total
liabilities
|
|
|
771,593 |
|
|
|
4,089,352 |
|
|
|
2,928,243 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments
and contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
deficit:
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock , $0.001 par value; authorized
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000,000
shares, issued and outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
2,261,862
shares at June 30, 2010 and
|
|
|
|
|
|
|
|
|
|
|
|
|
1,906,926
and 1,800,000 shares at December 31,
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
and 2008, respectively
|
|
|
2,262 |
|
|
|
1,907 |
|
|
|
1,800 |
|
Additional
paid-in capital
|
|
|
6,273,906 |
|
|
|
1,558,191 |
|
|
|
42,873 |
|
Deficit
accumulated during the development stage
|
|
|
(6,603,882 |
) |
|
|
(5,179,449 |
) |
|
|
(2,663,571 |
) |
Total
stockholders' deficit
|
|
|
(327,714 |
) |
|
|
(3,619,351 |
) |
|
|
(2,618,898 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities and stockholders' deficit
|
|
$ |
443,879 |
|
|
$ |
470,001 |
|
|
$ |
309,345 |
|
See
report of independent registered public accounting firm and notes to the
financial statements.
INVIVO
THERAPEUTICS CORPORATION
(A
Development Stage Company)
STATEMENTS
OF OPERATIONS
|
|
Six Months
Ended June 30,
2010
|
|
|
Six Months
Ended June 30, 2009
|
|
|
Year Ended
December 31,
2009
|
|
|
Year Ended
December 31,
2008
|
|
|
Period from November 28, 2005 (inception) to December 31, 2009
|
|
|
Period from November 28, 2005 (inception) to
June 30, 2010
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
$ |
625,428 |
|
|
$ |
790,034 |
|
|
$ |
1,807,908 |
|
|
$ |
936,550 |
|
|
$ |
4,273,602 |
|
|
$ |
4,899,030 |
|
General
and administrative
|
|
|
550,897 |
|
|
|
311,542 |
|
|
|
835,515 |
|
|
|
474,495 |
|
|
|
1,907,322 |
|
|
|
2,458,219 |
|
Total
operating expenses
|
|
|
1,176,325 |
|
|
|
1,101,576 |
|
|
|
2,643,423 |
|
|
|
1,411,045 |
|
|
|
6,180,924 |
|
|
|
7,357,249 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
|
(1,176,325 |
) |
|
|
(1,101,576 |
) |
|
|
(2,643,423 |
) |
|
|
(1,411,045 |
) |
|
|
(6,180,924 |
) |
|
|
(7,357,249 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense)
|
|
|
- |
|
|
|
- |
|
|
|
383,000 |
|
|
|
- |
|
|
|
383,000 |
|
|
|
383,000 |
|
Interest
income
|
|
|
220 |
|
|
|
54 |
|
|
|
282 |
|
|
|
1,877 |
|
|
|
7,965 |
|
|
|
8,185 |
|
Interest
expense
|
|
|
(248,328 |
) |
|
|
(123,987 |
) |
|
|
(255,737 |
) |
|
|
(154,901 |
) |
|
|
(613,199 |
) |
|
|
(861,527 |
) |
Other
income (expense), net
|
|
|
(248,108 |
) |
|
|
(123,933 |
) |
|
|
127,545 |
|
|
|
(153,024 |
) |
|
|
(222,234 |
) |
|
|
(470,342 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(1,424,433 |
) |
|
$ |
(1,225,509 |
) |
|
$ |
(2,515,878 |
) |
|
$ |
(1,564,069 |
) |
|
$ |
(6,403,158 |
) |
|
$ |
(7,827,591 |
) |
See
report of independent registered public accounting firm and notes to the
financial statements.
INVIVO
THERAPEUTICS CORPORATION
(A
Development Stage Company)
STATEMENTS
OF CHANGES IN STOCKHOLDERS’ DEFICIT
|
|
|
|
|
|
|
|
|
|
|
Deficit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
During the
|
|
|
Total
|
|
|
|
Common Stock
|
|
|
Paid-in
|
|
|
Development
|
|
|
Stockholders'
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Stage
|
|
|
Deficit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
on inception date, November 28, 2005
|
|
|
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
Issuance
of founders stock
|
|
|
1,800,000 |
|
|
|
1,800 |
|
|
|
- |
|
|
|
(1,800 |
) |
|
|
- |
|
Share-based
compensation expense
|
|
|
- |
|
|
|
- |
|
|
|
18,347 |
|
|
|
- |
|
|
|
18,347 |
|
Net
loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,097,702 |
) |
|
|
(1,097,702 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
as of December 31, 2007
|
|
|
1,800,000 |
|
|
|
1,800 |
|
|
|
18,347 |
|
|
|
(1,099,502 |
) |
|
|
(1,079,355 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based
compensation expense
|
|
|
- |
|
|
|
- |
|
|
|
24,526 |
|
|
|
- |
|
|
|
24,526 |
|
Net
loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,564,069 |
) |
|
|
(1,564,069 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
as of December 31, 2008
|
|
|
1,800,000 |
|
|
|
1,800 |
|
|
|
42,873 |
|
|
|
(2,663,571 |
) |
|
|
(2,618,898 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based
compensation expense
|
|
|
- |
|
|
|
- |
|
|
|
171,059 |
|
|
|
- |
|
|
|
171,059 |
|
Conversion
of convertible notes payable
|
|
|
106,926 |
|
|
|
107 |
|
|
|
1,344,259 |
|
|
|
- |
|
|
|
1,344,366 |
|
Net
loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(2,515,878 |
) |
|
|
(2,515,878 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
. |
|
|
|
|
|
Balance
as of December 31, 2009
|
|
|
1,906,926 |
|
|
|
1,907 |
|
|
|
1,558,191 |
|
|
|
(5,179,449 |
) |
|
|
(3,619,351 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based
compensation expense
|
|
|
- |
|
|
|
- |
|
|
|
253,532 |
|
|
|
- |
|
|
|
253,532 |
|
Issuance
of common stock
|
|
|
79,536 |
|
|
|
80 |
|
|
|
999,920 |
|
|
|
- |
|
|
|
1,000,000 |
|
Conversion
of convertible notes payable
|
|
|
275,400 |
|
|
|
275 |
|
|
|
3,327,853 |
|
|
|
- |
|
|
|
3,328,128 |
|
Beneficial
conversion on notes payable
|
|
|
- |
|
|
|
- |
|
|
|
134,410 |
|
|
|
- |
|
|
|
134,410 |
|
Net
loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,424,433 |
) |
|
|
(1,424,433 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
as of June 30, 2010 (unaudited)
|
|
|
2,261,862 |
|
|
$ |
2,262 |
|
|
$ |
6,273,906 |
|
|
$ |
(6,603,882 |
) |
|
$ |
(327,714 |
) |
See
report of independent registered public accounting firm and notes to the
financial statements.
INVIVO THERAPEUTICS CORPORATION
(A
Development Stage Company)
STATEMENTS
OF CASH FLOWS
|
|
Six Months
Ended June 30,
2010
|
|
|
Six Months
Ended June 30,
2009
|
|
|
Year Ended
December 31,
2009
|
|
|
Year Ended
December 31,
2008
|
|
|
Period from
November 28,
2005 (inception)
to December 31,
2009
|
|
|
Period from
November 28,
2005
(inception) to
June 30, 2010
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited)
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(1,424,433 |
) |
|
$ |
(1,225,509 |
) |
|
$ |
(2,515,878 |
) |
|
$ |
(1,564,069 |
) |
|
$ |
(5,177,649 |
) |
|
$ |
(6,602,082 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
and amortization expense
|
|
|
23,622 |
|
|
|
14,154 |
|
|
|
32,084 |
|
|
|
7,702 |
|
|
|
48,087 |
|
|
|
71,709 |
|
Non-cash
interest expense
|
|
|
191,604 |
|
|
|
120,075 |
|
|
|
221,899 |
|
|
|
146,678 |
|
|
|
434,299 |
|
|
|
625,903 |
|
Share-based
compensation expense
|
|
|
253,533 |
|
|
|
17,951 |
|
|
|
171,059 |
|
|
|
24,526 |
|
|
|
213,932 |
|
|
|
467,465 |
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid
expenses
|
|
|
(7,756 |
) |
|
|
4,831 |
|
|
|
2,036 |
|
|
|
(9,851 |
) |
|
|
(10,898 |
) |
|
|
(18,654 |
) |
Other
assets
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(75,000 |
) |
|
|
(75,000 |
) |
Accounts
payable
|
|
|
(28,635 |
) |
|
|
(66,956 |
) |
|
|
(23,248 |
) |
|
|
82,218 |
|
|
|
81,175 |
|
|
|
52,540 |
|
Accrued
interest payable
|
|
|
35,839 |
|
|
|
3,912 |
|
|
|
33,598 |
|
|
|
6,225 |
|
|
|
52,675 |
|
|
|
88,514 |
|
Accrued
expenses
|
|
|
(163,045 |
) |
|
|
(22,248 |
) |
|
|
179,426 |
|
|
|
78,389 |
|
|
|
293,584 |
|
|
|
130,539 |
|
Net
cash used in operating activities
|
|
|
(1,119,271 |
) |
|
|
(1,153,790 |
) |
|
|
(1,899,024 |
) |
|
|
(1,228,182 |
) |
|
|
(4,139,795 |
) |
|
|
(5,259,066 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases
of property and equipment
|
|
|
(18,653 |
) |
|
|
(100,448 |
) |
|
|
(174,898 |
) |
|
|
(23,637 |
) |
|
|
(205,523 |
) |
|
|
(224,176 |
) |
Net
cash used in investing activities
|
|
|
(18,653 |
) |
|
|
(100,448 |
) |
|
|
(174,898 |
) |
|
|
(23,637 |
) |
|
|
(205,523 |
) |
|
|
(224,176 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds
from issuance of convertible notes payable
|
|
|
200,000 |
|
|
|
1,200,000 |
|
|
|
1,580,000 |
|
|
|
1,436,000 |
|
|
|
3,981,000 |
|
|
|
4,181,000 |
|
Proceeds
from (payments on) loans payable
|
|
|
(90,985 |
) |
|
|
- |
|
|
|
513,800 |
|
|
|
- |
|
|
|
590,985 |
|
|
|
500,000 |
|
Proceeds
from issuance of common stock
|
|
|
1,000,000 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,000,000 |
|
Net
cash provided by financing activities
|
|
|
1,109,015 |
|
|
|
1,200,000 |
|
|
|
2,093,800 |
|
|
|
1,436,000 |
|
|
|
4,571,985 |
|
|
|
5,681,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Decrease)
increase in cash and cash equivalents
|
|
|
(28,909 |
) |
|
|
(54,238 |
) |
|
|
19,878 |
|
|
|
184,181 |
|
|
|
226,667 |
|
|
|
197,758 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents at beginning of period
|
|
|
226,667 |
|
|
|
206,789 |
|
|
|
206,789 |
|
|
|
22,608 |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents at end of period
|
|
$ |
197,758 |
|
|
$ |
152,551 |
|
|
$ |
226,667 |
|
|
$ |
206,789 |
|
|
$ |
226,667 |
|
|
$ |
197,758 |
|
(continued)
See
report of independent registered public accounting firm and notes to the
financial statements.
INVIVO
THERAPEUTICS CORPORATION
(A
Development Stage Company)
STATEMENTS
OF CASH FLOWS (concluded)
|
|
Six Months
Ended June 30,
2010
|
|
|
Six Months
Ended June 30,
2009
|
|
|
Year Ended
December 31,
2009
|
|
|
Year Ended
December 31,
2008
|
|
|
Period from
November 28,
2005
(inception) to
December 31,
2009
|
|
|
Period from
November 28,
2005
(inception) to
June 30, 2010
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information and non-cash
transactions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
paid for interest
|
|
$ |
20,924 |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
20,924 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion
of convertible ntoes payable and accrued interest into common
stock
|
|
$ |
3,328,128 |
|
|
$ |
1,055,438 |
|
|
$ |
1,344,356 |
|
|
$ |
- |
|
|
$ |
1,344,356 |
|
|
$ |
4,672,484 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Beneficial
conversion feature on convertible notes payable
|
|
$ |
134,410 |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
134,410 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of founders shares
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
1,800 |
|
|
$ |
1,800 |
|
See
report of independent registered public accounting firm and notes to the
financial statements.
INVIVO
THERAPEUTICS CORPORATION
(A
Development Stage Company)
NOTES
TO FINANCIAL STATEMENTS
Years
Ended December 31, 2009 and 2008, and the Period from
November
28, 2005 (Inception) through December 31, 2009
1. NATURE
OF OPERATIONS
Business
InVivo
Therapeutics Corporation (“InVivo” or the “Company”) was incorporated on
November 28, 2005 under the laws of the State of Delaware. The
Company is developing and commercializing biopolymer scaffolding devices for the
treatment of spinal cord injuries (“SCI”). The biopolymer devices are
designed to protect the damaged spinal cord from further secondary injury and
promote neuroplasticity, a process where functional recovery can occur through
the rerouting of signaling pathways to the spared healthy tissue.
Since its
inception, the Company has devoted substantially all of its efforts to business
planning, research and development, recruiting management and technical staff,
acquiring operating assets and raising capital. Accordingly, the
Company is considered to be in the development stage.
The
Company is subject to a number of risks similar to other companies in their
industry including rapid technological change, the risk that its products will
fail to demonstrate efficacy in clinical trials, uncertainty of market
acceptance of the product, competition from larger companies with similar
products and dependence on key personnel.
Going
concern
The
accompanying financial statements have been prepared on a going concern basis,
which contemplates the realization of assets and the satisfaction of liabilities
in the normal course of business. As of December 31, 2009, the
Company had cash of approximately $227,000, an accumulated deficit of
approximately $5,179,000 and a stockholders’ deficit of approximately
$3,619,000. The Company is in the development stage, has no revenue
and has relied on raising capital to finance its operations. At
December 31, 2009, the Company did not have sufficient capital to fund its
operations. This, in turn, raises substantial doubt about the
Company’s ability to continue as a going concern. The Company has
plans for raising capital through a private placement of its common stock to
provide it with the capital required to continue funding its
operations.
See
report of independent registered public accounting firm.
INVIVO
THERAPEUTICS CORPORATION
(A
Development Stage Company)
NOTES
TO FINANCIAL STATEMENTS (Continued)
2. SIGNIFICANT
ACCOUNTING POLICIES
A summary
of the significant accounting policies followed by the Company in the
preparation of the financial statements is as follows:
Use of estimates
The
process of preparing financial statements in conformity with accounting
principles generally accepted in the United States of America requires
management to make estimates and assumptions that affect the reported amounts of
assets and liabilities and disclosure of assets and liabilities at the date of
financial statements and the reported amounts of revenues and expenses during
the reporting period. Actual results could differ from those
estimates and changes in estimates may occur.
Cash and cash
equivalents
The
Company considers all highly liquid investments with maturities of three months
or less at the date of purchase to be cash equivalents.
Property and equipment
Property
and equipment are carried at cost. Depreciation expense is provided
over the estimated useful lives of the assets using the straight-line
method. A summary of the estimated useful lives is as
follows:
Classification
|
|
Estimated Useful Life
|
Computer
hardware
|
|
5
years
|
Software
|
|
3
years
|
Research
and lab equipment
|
|
5
years
|
Depreciation
expense for the six months ended June 30, 2010 and for the years ended December
31, 2009 and 2008 was $21,122, $27,084 and $2,702,
respectively. Maintenance and repairs are charged to expense as
incurred, while any additions or improvements are capitalized.
Research and development
expenses
Costs
incurred for research and development are expensed as incurred.
See
report of independent registered public accounting firm.
INVIVO
THERAPEUTICS CORPORATION
(A
Development Stage Company)
NOTES
TO FINANCIAL STATEMENTS (Continued)
SIGNIFICANT ACCOUNTING POLICIES
(continued)
Income taxes
For
federal and state income taxes, deferred tax assets and liabilities are
recognized based upon temporary differences between the financial statement and
the tax basis of assets and liabilities. Deferred income taxes are
based upon prescribed rates and enacted laws applicable to periods in which
differences are expected to reverse. A valuation allowance is
recorded when it is more likely than not that some portion or all of the
deferred tax assets will not be realized. Accordingly, the Company
provides a valuation allowance, if necessary, to reduce deferred tax assets to
amounts that are realizable.
Tax
positions taken or expected to be taken in the course of preparing the Company’s
tax returns are required to be evaluated to determine whether the tax positions
are “more-likely-than-not” of being sustained by the applicable tax
authority. Tax positions not deemed to meet a more-likely-than-not
threshold would be recorded as a tax expense in the current
year. There were no uncertain tax positions that require accrual or
disclosure to the financial statements as of June 30, 2010 or December 31,
2009.
Concentrations of credit
risk
The
Company has no significant off-balance-sheet concentration of credit risk such
as foreign exchange contracts, option contracts or other foreign hedging
arrangements. The Company may from time to time have cash in banks in
excess of FDIC insurance limits.
Impairment of long-lived
assets
The
Company continually monitors events and changes in circumstances that could
indicate that carrying amounts of long-lived assets may not be
recoverable. An impairment loss is recognized when expected cash
flows are less than an asset’s carrying value. Accordingly, when
indicators of impairment are present, the Company evaluates the carrying value
of such assets in relation to the operating performance and future undiscounted
cash flows of the underlying assets. The Company’s policy is to
record an impairment loss when it is determined that the carrying value of the
asset may not be recoverable. No impairment charges were recorded in
the six months ended June 30, 2010 or for the years ended December 31, 2009 and
2008.
See
report of independent registered public accounting firm.
INVIVO
THERAPEUTICS CORPORATION
(A
Development Stage Company)
NOTES
TO FINANCIAL STATEMENTS (Continued)
SIGNIFICANT ACCOUNTING POLICIES
(continued)
Share-based payments
The
Company recognizes compensation costs resulting from the issuance of stock-based
awards to employees, non-employees and directors as an expense in the statement
of operations over the service period based on a measurement of fair value for
each stock-based award. The fair value of each option grant is
estimated as of the date of grant using the Black-Scholes option-pricing
model. The fair value is amortized as compensation cost on a
straight-line basis over the requisite service period of the awards, which is
generally the vesting period. Due to its limited operating history
and limited number of sales of its Common Stock, the Company estimates its
volatility in consideration of a number of factors including the volatility of
comparable public companies.
Recent accounting
pronouncements
In
June 2008, the Financial Accounting Standards Board (“FASB”) ratified an
accounting pronouncement that provides that an entity should use a two step
approach to evaluate whether an equity-linked financial instrument (or embedded
feature) is indexed to its own stock, including evaluating the instrument’s
contingent exercise and settlement provisions. This accounting
pronouncement is effective for fiscal years beginning after December 15,
2008. The consensus must be applied to outstanding instruments as of
the beginning of the fiscal year in which the consensus is adopted and should be
treated as a cumulative-effect adjustment to the opening balance of retained
earnings. Early adoption is not permitted. On
January 1, 2009, the Company adopted this pronouncement and it did not have
a material impact on the Company’s financial statements or related
disclosures.
In
October 2009, the FASB issued two related accounting pronouncements, Accounting
Standards Update (“ASU”) 2009-13 and ASU 2009-14, relating to revenue
recognition. One pronouncement provides guidance on allocating the
consideration in a multiple-deliverable revenue arrangement and requires
additional disclosure, while the other pronouncement provides guidance specific
to revenue arrangements that include software elements. Both of these
pronouncements are effective prospectively for revenue arrangements entered into
or materially modified in fiscal years beginning on or after June 15, 2010 and
both must be adopted together. The Company does not expect the
adoption of these pronouncements to have a material impact on its financial
statements.
See
report of independent registered public accounting firm.
INVIVO
THERAPEUTICS CORPORATION
(A
Development Stage Company)
NOTES
TO FINANCIAL STATEMENTS (Continued)
SIGNIFICANT ACCOUNTING POLICIES
(concluded)
Recent accounting pronouncements
(concluded)
In
January 2010, the FASB issued ASU 2010-06, Fair Value Measurements and
Disclosures (Topic 820), Improving Disclosures about Fair Value
Measurements. This Update requires new disclosures and clarifies
existing disclosures regarding recurring and nonrecurring fair value
measurements to provide increased transparency to users of the financial
statements. The new disclosures and clarification of existing
disclosures are effective for interim and annual periods beginning after
December 15, 2009, except for the disclosures pertaining to the roll forward of
activity for Level 3 fair value measurements, which are effective for fiscal
years beginning after December 15, 2010, and for interim periods within those
fiscal years. The adoption of this Update on January 1, 2010 did not
have a material impact on its financial statements.
3. OTHER
ASSETS
Other
assets consist of a patent licensing fee paid to license intellectual property
(see Note 12). The Company is amortizing the license fee to
research and development over its 15-year term.
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
2008
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patent
licensing fee
|
|
$ |
75,000 |
|
|
$ |
75,000 |
|
|
$ |
75,000 |
|
Accumulated
amortization
|
|
|
(18,861 |
) |
|
|
(16,361 |
) |
|
|
(11,361 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
56,139 |
|
|
$ |
58,639 |
|
|
$ |
63,639 |
|
4. PROPERTY
AND EQUIPMENT
Property
and equipment consisted of the following:
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
2008
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Computer
software and hardware
|
|
$ |
55,784 |
|
|
$ |
47,668 |
|
|
$ |
30,625 |
|
Research
and lab equipment
|
|
|
168,392 |
|
|
|
157,855 |
|
|
|
- |
|
Less
accumulated depreciation
|
|
|
(52,848 |
) |
|
|
(31,726 |
) |
|
|
(4,642 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
171,328 |
|
|
$ |
173,797 |
|
|
$ |
25,983 |
|
See
report of independent registered public accounting firm.
INVIVO
THERAPEUTICS CORPORATION
(A
Development Stage Company)
NOTES
TO FINANCIAL STATEMENTS (Continued)
5. ACCRUED
EXPENSES
Accrued
expenses consisted of the following:
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
2008
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
accrued expenses
|
|
$ |
3,000 |
|
|
$ |
138,750 |
|
|
$ |
11,725 |
|
Accrued
payroll
|
|
|
23,507 |
|
|
|
18,969 |
|
|
|
14,500 |
|
Accrued
vacation
|
|
|
24,032 |
|
|
|
15,865 |
|
|
|
7,933 |
|
Deferred
compensation
|
|
|
80,000 |
|
|
|
120,000 |
|
|
|
80,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
130,539 |
|
|
$ |
293,584 |
|
|
$ |
114,158 |
|
Deferred
compensation represents amounts owed to the Chief Executive Officer (“CEO”) and
majority shareholder with respect to annual bonuses granted but not
paid.
6. LOANS
PAYABLE
Loans
payable consisted of the following:
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
2008
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Advances
from related party
|
|
$ |
- |
|
|
$ |
90,985 |
|
|
$ |
77,185 |
|
Loan
payable
|
|
|
500,000 |
|
|
|
500,000 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
500,000 |
|
|
$ |
590,985 |
|
|
$ |
77,185 |
|
Advances
from related party represent cash advances received from CEO and majority
shareholder which permitted the Company to continue to fund its operations until
it raised additional capital. Interest accrued on these advances at
an annual rate of 8%. Interest expense related to Advances from
related party was $2,310 in the six months ended June 30, 2010 and $8,437 and
$6,225 in the years ended December 31, 2009 and 2008, respectively.
See
report of independent registered public accounting firm.
INVIVO
THERAPEUTICS CORPORATION
(A
Development Stage Company)
NOTES
TO FINANCIAL STATEMENTS (Continued)
LOANS
PAYABLE (concluded)
The
Company issued a $500,000 Note Payable in June 2009 to the Massachusetts Life
Science Center, an independent public agency of the State of
Massachusetts. The Company received the $500,000 of funding from the
Massachusetts Life Science Accelerator Program which was established for the
purpose of providing seed capital to promising early stage life science
companies. The terms of the Note Payable call for full repayment upon
the earlier of five years, the sale of the Company or a financing that raises
minimum net proceeds of $5,000,000. Interest accrues on the Note
Payable at an annual rate of 10% and is payable at maturity. Interest
expense related to the Note Payable was $24,795 in the six months ended June 30,
2010 and $25,205 and none in the years ended December 31, 2009 and 2008,
respectively.
7. INCOME
TAXES
No
provision or benefit for federal or state income taxes has been recorded, as the
Company has incurred a net loss for all of the periods presented, and the
Company has provided a valuation allowance against its deferred tax
assets.
At June
30, 2010 and December 31, 2009, the Company had federal and Massachusetts net
operating loss carryforwards of approximately $5,491,000 and $4,139,000,
respectively, of which federal carryforwards will expire in varying amounts
beginning in 2021. Massachusetts net operating losses begin to expire
in 2011. Utilization of net operating losses may be subject to
substantial annual limitations due to the “change in ownership” provisions of
the Internal Revenue Code, and similar state provisions. The annual
limitations may result in the expiration of net operating losses before
utilization. The Company also had research and development tax credit
carryforwards at June 30, 2010 and December 31, 2009 of approximately $172,000
and $154,000, respectively, which will begin to expire in 2018 unless previously
utilized.
See
report of independent registered public accounting firm.
INVIVO
THERAPEUTICS CORPORATION
(A
Development Stage Company)
NOTES
TO FINANCIAL STATEMENTS (Continued)
INCOME
TAXES (continued)
Significant
components of the Company’s net deferred tax asset are as follows:
|
|
Six Months Ended
|
|
|
Years Ended December 31,
|
|
|
|
June 30, 2010
|
|
|
2009
|
|
|
2008
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
operating loss carryforward
|
|
$ |
2,215,000 |
|
|
$ |
1,679,000 |
|
|
$ |
812,000 |
|
Research
credit carryforward
|
|
|
172,000 |
|
|
|
154,000 |
|
|
|
114,000 |
|
Stock
based compensation
|
|
|
162,000 |
|
|
|
69,000 |
|
|
|
- |
|
Accrued
interest
|
|
|
36,000 |
|
|
|
151,000 |
|
|
|
103,000 |
|
Other
temporary differences
|
|
|
36,000 |
|
|
|
52,000 |
|
|
|
32,000 |
|
|
|
|
2,621,000 |
|
|
|
2,105,000 |
|
|
|
1,061,000 |
|
Valuation
allowance
|
|
|
(2,621,000 |
) |
|
|
(2,105,000 |
) |
|
|
(1,061,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
deferred tax asset
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
The
Company has maintained a full valuation allowance against its deferred tax
assets in all periods presented. A valuation allowance is required to
be recorded when it is more likely than not that some portion or all of the net
deferred tax assets will not be realized. Since the Company cannot be
assured of realizing the net deferred tax assets, a full valuation allowance has
been provided. In the years ended December 31, 2009 and 2008, the
valuation allowance increased by $1,044,000 and $630,000,
respectively.
The
Company has no unrecognized tax benefits at June 30, 2010 and December 31, 2009
that would affect its effective tax rate. The Company does not
anticipate a significant change in the amount of unrecognized tax benefits over
the next twelve months. Since the Company is in a loss carryforward
position, the Company is generally subject to US federal and state income tax
examinations by tax authorities for all years for which a loss carryforward is
available.
See
report of independent registered public accounting firm.
INVIVO
THERAPEUTICS CORPORATION
(A
Development Stage Company)
NOTES
TO FINANCIAL STATEMENTS (Continued)
INCOME
TAXES (concluded)
Income
tax benefits computed using the federal statutory income tax rate differs from
the Company’s effective tax rate primarily due to the following:
|
|
Six Months Ended
|
|
|
Years Ended December 31,
|
|
|
|
June 30, 2010
|
|
|
2009
|
|
|
2008
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Statutory
tax rate
|
|
|
34.0 |
% |
|
|
34.0 |
% |
|
|
34.0 |
% |
State
taxes, net of federal benefit
|
|
|
5.6 |
% |
|
|
6.2 |
% |
|
|
5.8 |
% |
Permanent
differences and other
|
|
|
(3.7 |
)% |
|
|
(0.2 |
)% |
|
|
(2.6 |
)% |
R&D
credits
|
|
|
1.3 |
% |
|
|
1.6 |
% |
|
|
3.5 |
% |
Increase
in valuation reserve
|
|
|
(37.2 |
)% |
|
|
(41.6 |
)% |
|
|
(40.7 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Effective
tax rate
|
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
8. CONVERTIBLE
NOTES PAYABLE
The
Company issued Convertible Notes Payable to investors totaling
$4,181,000. In the six months ended June 30, 2010 and years
ended December 31, 2009 and 2008, these notes provided cash proceeds of
$200,000, $1,580,000 and $1,436,000, respectively.
The terms
of the Convertible Notes Payable stipulate that the notes will be converted into
shares of Common Stock upon the earlier of maturity of the notes or the
completion of a single financing or a series of related financings that raise a
minimum of $4,000,000 or $5,000,000 depending on the terms of the individual
notes. The notes convert at the offering price of such
financing.
Certain
of the notes entitled the holders to receive either a 10% or 20% discount on the
conversion price if the notes were converted prior to the maturity
date. The Company initially measured the contingent beneficial
conversion feature upon issuance as the difference between the conversion price
and the fair value of the Common Stock. The Company assumed the most
favorable conversion price that would be in effect assuming no changes to the
circumstances other than the passage of time. Therefore, no
beneficial conversion feature was recorded at issuance. In March
2010, the Company completed a series of financings exceeding $4 million which
accelerated the conversion of certain notes prior to their maturity dates
triggering the discount provisions discussed above.
See
report of independent registered public accounting firm.
INVIVO
THERAPEUTICS CORPORATION
(A
Development Stage Company)
NOTES
TO FINANCIAL STATEMENTS (Continued)
CONVERTIBLE
NOTES PAYABLE (concluded)
The
Company recorded the beneficial conversion features as a discount on the notes
and additional paid-in capital. As the discounts occurred
simultaneously with the conversion of the notes, the discounts were immediately
accreted to non-cash interest expense. In the six months ended June
30, 2010, the Company recorded beneficial conversion features and related
non-cash interest expense of $134,410.
In the
year ended December 31, 2009, Convertible Notes Payable with a principal balance
of $1,141,000 and accrued interest payable of $203,366 converted at maturity
into 106,926 shares of Common Stock.
In the
six months ended June 30, 2010, the remaining outstanding Convertible Notes
Payable of $3,040,000 and accrued interest payable of $288,128 converted into
275,400 shares of Common Stock upon a financing event, as defined
above. As of June 30, 2010, all of the Convertible Notes Payable had
been converted into Common Stock.
Interest
accrued on the outstanding balances at an annual rate of 8%. At the
election of the Company, the accrued interest was to be paid in cash or in
Common Stock at the time the notes were converted to Common
Stock. For the six months ended June 30, 2010 and the years ended
December 31, 2009 and 2008, the Company accrued interest expense on the notes of
$57,195, $221,899 and $146,678, respectively. For the six months
ended June 30, 2010, the Company accrued interest expense $29,852 for the
interest owed that the Company elected to pay in cash in lieu of Common
Stock.
9. COMMON
STOCK
The
Company has authorized 5,000,000 of Common Stock, $0.001 par value per share, of
which 2,261,862 shares, 1,906,926 shares and 1,800,000 shares were issued and
outstanding as of June 30, 2010 and December 31, 2009 and 2008,
respectively.
At
inception, the Company issued its founders 1,800,000 shares of common stock with
a par value of $1,800 for no consideration.
In March
2010, the Company sold 79,536 shares of Common Stock to an investor at a price
per share of $12.57 and the Company received cash proceeds of
$1,000,000.
See
report of independent registered public accounting firm.
INVIVO
THERAPEUTICS CORPORATION
(A
Development Stage Company)
NOTES
TO FINANCIAL STATEMENTS (Continued)
COMMON
STOCK (concluded)
In the
six months ended June 30, 2010, the Company issued 275,400 shares of Common
Stock to the holders of Convertible Notes Payable upon the conversion of these
notes. At the conversion date, the principal balance of $3,040,000
and accrued interest payable of $288,128 were converted into Common Stock at a
price of $12.57 per share. Certain notes provided for conversion at a
discount to the $12.57 price (see Note 8).
In 2009,
the Company issued 106,926 shares of Common Stock to the holders of Convertible
Notes Payable upon conversion of these notes. At the conversion
dates, the principal balance of $1,141,000 and accrued interest payable of
$203,366 were converted into Common Stock at a price of $12.57 per
share.
To date,
the Company has delivered stock certificates for 182,444 shares of Common Stock
to the holders of Convertible Notes Payable as a result of
conversions. The Company has requested that the holders sign an
acknowledgement that they accept the terms of the conversion and a stockholders
agreement. The Company intends to deliver the remaining stock
certificates for 199,882 share of Common Stock to holders upon receipt of the
acknowledgement letter and stockholders agreement. To date, the terms
of the conversion have been disputed by certain shareholders (see Note
13).
10. STOCK
OPTIONS
The
Company adopted a Stock Option Plan in 2007 (the “2007
Plan”). Pursuant to the 2007 Plan, the Company’s Board of Directors
(or committees and/or executive officers delegated by the Board of Directors)
may grant incentive and nonqualified stock options to the Company’s employees,
officers, directors, consultants and advisors. Plan options are
exercisable for up to 10 years from the date of issuance. As of
December 31, 2009, the aggregate number of common shares which may be issued
under the 2007 Plan was 1,000,000 shares.
Share-based compensation
For stock
options issued and outstanding during the six months ended June 30, 2010 and the
years ended December 31, 2009 and 2008, the Company recorded non-cash,
stock-based compensation expense of $253,533, $171,059 and $24,526,
respectively, each net of estimated forfeitures.
See
report of independent registered public accounting firm.
INVIVO
THERAPEUTICS CORPORATION
(A
Development Stage Company)
NOTES
TO FINANCIAL STATEMENTS (Continued)
STOCK OPTIONS (continued)
Share-based compensation
(continued)
The fair
value of each option award is estimated on the date of grant using the
Black-Scholes option pricing model that uses the assumptions noted in the
following table. Due to its limited operating history and limited
number of sales of its common stock, the Company estimated its volatility in
consideration of a number of factors including the volatility of comparable
public companies. The Company uses historical data, as well as
subsequent events occurring prior to the issuance of the financial statements,
to estimate option exercises and employee terminations within the valuation
model. The expected term of options granted under the Company’s stock
plans, all of which qualify as “plain vanilla,” is based on the average of the
contractual term (generally 10 years) and the vesting period (generally
48 months) as permitted under SEC Staff Accounting Bulletin Nos. 107 and
110. For non-employee options, the expected term is the contractual
term. The risk-free rate is based on the yield of a U.S. Treasury
security with a term consistent with the
option.
The
assumptions used principally in determining the fair value of options granted to
employees were as follows:
|
|
Six Months Ended
|
|
|
Years Ended December 31,
|
|
|
|
June 30, 2010
|
|
|
2009
|
|
|
2008
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Risk-free
interest rate
|
|
|
3.24 |
% |
|
|
2.68 |
% |
|
|
3.24 |
% |
Expected
dividend yield
|
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
Expected
term (employee grants)
|
|
7.45
years
|
|
|
6.25
years
|
|
|
7.75
years
|
|
Expected
volatility
|
|
|
49.15 |
% |
|
|
50.10 |
% |
|
|
49.15 |
% |
See
report of independent registered public accounting firm.
INVIVO
THERAPEUTICS CORPORATION
(A
Development Stage Company)
NOTES
TO FINANCIAL STATEMENTS (Continued)
STOCK OPTIONS (concluded)
Share-based compensation
(concluded)
A summary
of option activity under the Company’s stock plans and options granted to
officers of the Company outside any plan as of June 30, 2010, December 31,
2009 and 2008 and changes during the periods then ended is presented
below:
Options
|
|
Shares
|
|
|
Weighted -
Average
Exercise
Price
|
|
|
Weighted -
Average
Remaining
Contractual
Term
|
|
|
Aggregate
Intrinsic Value
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at January 1, 2008
|
|
|
127,000 |
|
|
$ |
1.00 |
|
|
|
|
|
|
|
Granted
|
|
|
89,456 |
|
|
$ |
1.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at December 31, 2008
|
|
|
216,456 |
|
|
$ |
1.00 |
|
|
|
|
|
|
|
Granted
|
|
|
70,000 |
|
|
$ |
11.91 |
|
|
|
|
|
|
|
Forfeited
|
|
|
(6,000 |
) |
|
$ |
1.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at December 31, 2009
|
|
|
280,456 |
|
|
$ |
3.72 |
|
|
|
8.46 |
|
|
$ |
2,481,256 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
42,000 |
|
|
$ |
12.57 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at June 30, 2010 (unaudited)
|
|
|
322,456 |
|
|
$ |
4.88 |
|
|
|
8.20 |
|
|
$ |
2,481,256 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested
at December 31, 2009
|
|
|
106,865 |
|
|
$ |
1.00 |
|
|
|
7.76 |
|
|
$ |
1,236,428 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unvested
at December 31, 2009
|
|
|
173,591 |
|
|
$ |
5.40 |
|
|
|
8.89 |
|
|
$ |
1,244,828 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested
at June 30, 2010 (unaudited)
|
|
|
134,166 |
|
|
$ |
1.00 |
|
|
|
7.25 |
|
|
$ |
1,552,301 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unvested
at June 30, 2010 (unaudited)
|
|
|
188,290 |
|
|
$ |
7.64 |
|
|
|
8.89 |
|
|
$ |
928,955 |
|
The
weighted-average grant-date fair value of options granted during the six months
ended June 30, 2010 and the years ended December 31, 2009 and 2008 was $6.40,
$6.13 and $0.48 per share, respectively. The total fair value of
options that vested in the six months ended June 30, 2010 and the years ended
December 31, 2009 and 2008 was $139,505, $346,976 and $297,736,
respectively. As of June 30, 2010 and December 31, 2009, there
was approximately $1,031,986 and $1,026,595 of total unrecognized compensation
expense, respectively, related to non-vested share-based option compensation
arrangements. The unrecognized compensation expense is estimated to
be recognized over a period of 2.82 years at June 30, 2010 and 2.72 years at
December 31, 2009.
See
report of independent registered public accounting firm.
INVIVO
THERAPEUTICS CORPORATION
(A
Development Stage Company)
NOTES
TO FINANCIAL STATEMENTS (Continued)
11.
EMPLOYEE BENEFIT PLAN
In
November 2006, the Company adopted a 401(k) plan (the “Plan”) covering all
employees. Employees must be 21 years of age in order to participate
in the Plan. Under the Plan, the Company has the option to make
matching contributions but has elected not to do so.
12.
INTELLECTUAL PROPERTY LICENSE
The
Company has obtained a world-wide exclusive license (the “CMCC License”) for
patents co-owned by Massachusetts Institute of Technology and Harvard’s
Children’s Hospital covering the use of biopolymers to treat spinal cord
injuries, and to promote the survival and proliferation of human stem cells in
the spinal cord. The CMCC License has a 15-year term, or as long as
the life of the last expiring patent right, whichever is longer, unless
terminated earlier by the licensor. In connection with the CMCC License,
the Company paid an initial $75,000 licensing fee (see Note 3) and is required
to pay certain annual maintenance fees, milestone payments and royalties.
All costs associated with maintenance of the CMCC License are expensed as
incurred.
13.
COMMITMENTS AND CONTINGENCIES
In 2009,
the Company filed a lawsuit against a party alleging damages from a breach of a
contract under which the party was providing services to the
Company. In exchange for a payment of $383,000 from the party, the
Company agreed to dismiss the lawsuit. The $383,000 received was
recorded as Other Income in the Statement of Operations in the year ended
December 31, 2009.
The
Company has received a claim from a single holder of $200,000 of Convertible
Notes Payable disputing the terms of the conversion and the party has threatened
to litigate, although no such litigation has been commenced. Certain
other shareholders have also disputed the terms of the
conversion. The Company intends to vigorously defend itself in these
matters.
14. SUBSEQUENT
EVENTS
Management
has evaluated subsequent events through September 29, 2010, which is the date
the financial statements were available to be issued. Other than as
discussed below, there were no subsequent events that require adjustment to or
disclosure in the financial statements.
See
report of independent registered public accounting firm.
INVIVO
THERAPEUTICS CORPORATION
(A
Development Stage Company)
NOTES
TO FINANCIAL STATEMENTS (Concluded)
SUBSEQUENT
EVENTS (concluded)
Bridge
financing
From July
through September 2010, the Company raised $500,000 from the sale of 6%
convertible promissory notes (the “Bridge Notes”). The Bridge Notes
will automatically convert into the equity securities of the next financing if a
minimum of $3 million is raised; otherwise the notes are due and payable on
December 31, 2010. The Bridge Notes accrue interest at a rate of 6%
per annum.
In
connection with the Bridge Notes, the Company also issued to the investors
warrants to purchase 36,310 shares of Common Stock. The warrants are
exercisable for a period of five years with an exercise price of $13.77 per
share. The warrants have anti-dilution rights. Therefore,
the Company expects to account for these warrants as derivative
liabilities.
The
Company engaged a registered broker-dealer as a placement agent in conjunction
with the Bridge Notes. As compensation, the placement agent received
a warrant to purchase 7,262 shares of Common Stock an exercise price of $13.77
per share.
See
report of independent registered public accounting firm.
Item
9.01(b) Pro Forma Financial Statements
Pro
Forma Financial Statements
InVivo
Therapeutics Holdings Corp.
And
Subsidiary
On
October 26, 2010, InVivo Therapeutics Corporation (“InVivo”) completed a reverse
merger transaction (the “Merger”) with InVivo Therapeutics Holdings Corp.
(formerly Design Source, Inc.). InVivo is a wholly owned subsidiary
of InVivo Therapeutics Holdings Corp (ITHC), which continues to operate the
business of InVivo. ITHC issued 31,647,190 shares of its common stock to the
holders of InVivo common stock.
The
Merger is being accounted for as a “reverse merger,” and InVivo is deemed to be
the acquirer in the reverse merger. Consequently, the assets and liabilities and
the historical operations that will be reflected in the financial statements
prior to the Merger will be those of InVivo and will be recorded at the
historical cost basis of InVivo, and the consolidated financial statements after
completion of the Merger will include the assets and liabilities of InVivo,
historical operations of InVivo and operations of InVivo from the Closing Date
of the Merger.
Upon the
closing of the Merger, ITHC transferred all of its operating assets and
liabilities to D Source Split Corp. and split-off D Source Split Corp. through
the sale of all of the outstanding capital stock of D Source Split Corp. (“the
Split-Off”). After the completion of the Merger and Split Off , InVivo
Therapuetics Holdings Corp.’s consolidated financial statements will include
only the assets and liabilities of InVivo.
Concurrent
with the completion of the Merger, ITHC completed a private placement
of 10,514,097 units of its securities for total gross proceeds of $10,514,097
and net proceeds of $8,756,000. Each Unit consisted of one share of
common stock and a warrant to purchase one share of common stock exercisable at
$1.40 per share. Upon closing the Merger and private placement, ITHC had
49,161,268 shares outstanding.
These pro
forma financial statements are prepared assuming the transaction occurred on
June 30, 2010 (as to the balance sheet) and on April 1, 2009 and
2010 (as to the income statements). InVivo has a December 31 year end
while ITHC has a March 31 year end. Since the year ends are within ninety
days, Vivo’s operations for the year
ended December 31, 2009 were combined with ITHC operations
for the year ended March 31, 2010.
Audited
financial statements of InVivo and Design Source, Inc have been used in the
preparation of the pro forma statement of operations for the year ended December
31, 2009 for InVivo and March 31, 2010 for Design Source, Inc. Unaudited
financial statements have been used in the preparation of the pro forma balance
sheet as of June 30, 2010 and for the statement of operations for the three
months ended June 30, 2010.
The pro
forma financial statements should be read in conjunction with the separate
financial statements and related notes thereto of the InVivo and Design Source,
Inc. These pro forma financial statements are not necessarily
indicative of the combined financial position, had the acquisition occurred at
the end of the periods indicated above, or the combined results of operations
which might have existed for the periods indicated or the results of operations
as they may be in the future.
PRO
FORMA BALANCE SHEET
INVIVO
THERAPEUTICS HOLDING CORP
AS
OF JUNE 30, 2010
UNAUDITED
|
|
Invivo
|
|
|
Design
|
|
|
Adjustment
|
|
|
Adjustment
|
|
|
|
|
|
|
Therapeutics, Inc.
|
|
|
Source, Inc.
|
|
|
(Note 1)
|
|
|
(Note 2)
|
|
|
Pro Forma
|
|
ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
197,758 |
|
|
$ |
38,665 |
|
|
$ |
(38,665 |
) |
|
$ |
8,255,948 |
|
|
$ |
8,453,706 |
|
Prepaid
expenses
|
|
|
18,654 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
18,654 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
current assets
|
|
|
216,412 |
|
|
|
38,665 |
|
|
|
(38,665 |
) |
|
|
8,255,948 |
|
|
|
8,472,360 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net
|
|
|
171,328 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
171,328 |
|
Other
assets
|
|
|
56,139 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
56,139 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$ |
443,879 |
|
|
$ |
38,665 |
|
|
$ |
(38,665 |
) |
|
$ |
8,255,948 |
|
|
$ |
8,699,827 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' DEFICIT:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
52,540 |
|
|
$ |
13,216 |
|
|
$ |
(13,216 |
) |
|
$ |
- |
|
|
$ |
52,540 |
|
Convertible
notes
|
|
|
|
|
|
|
87,558 |
|
|
|
(87,558 |
) |
|
|
- |
|
|
|
- |
|
Accrued
interest payable
|
|
|
88,514 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88,514 |
|
Accrued
expenses
|
|
|
130,539 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
130,539 |
|
Total
current liabilities
|
|
|
271,593 |
|
|
|
100,774 |
|
|
|
(100,774 |
) |
|
|
|
|
|
|
271,593 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loans
payable
|
|
|
500,000 |
|
|
|
- |
|
|
|
- |
|
|
|
(500,000 |
) |
|
|
- |
|
Common
stock warrant liability
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,334,124 |
|
|
|
4,334,124 |
|
Convertible
notes payable
|
|
|
- |
|
|
|
76,048 |
|
|
|
(76,048 |
) |
|
|
|
|
|
|
- |
|
Total
liabilities
|
|
|
771,593 |
|
|
|
176,822 |
|
|
|
(176,822 |
) |
|
|
3,834,124 |
|
|
|
4,605,717 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments
and contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity (deficit):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock , $0.00001 par value; authorized 100,000,000 shares, issued and
outstanding 49,161,268 shares at June 30, 2010
|
|
|
2,262 |
|
|
|
113 |
|
|
|
(113 |
) |
|
|
(1,770 |
) |
|
|
492 |
|
Additional
paid-in capital
|
|
|
6,273,906 |
|
|
|
585,810 |
|
|
|
(585,810 |
) |
|
|
4,423,594 |
|
|
|
10,697,500 |
|
Deficit
accumulated during the development stage
|
|
|
(6,603,882 |
) |
|
|
(723,880 |
) |
|
|
723,880 |
|
|
|
- |
|
|
|
(6,603,882 |
) |
Total
stockholders' equity (deficit)
|
|
|
(327,714 |
) |
|
|
(137,957 |
) |
|
|
137,957 |
|
|
|
4,421,824 |
|
|
|
4,094,110 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities and stockholders' deficit
|
|
$ |
443,879 |
|
|
$ |
38,865 |
|
|
$ |
(38,865 |
) |
|
$ |
8,255,948 |
|
|
$ |
8,699,827 |
|
Note 1-
Reflects the split off of the assets and liabilities of Design Source, Inc. per
the merger agreement.
Note
2-Reflects the closing on October 26, 2010 of private placement that raised
$10,506,000 gross and $8,756,000 net of expenses and:
The
recapitalization of InVivo as part of the merger agreement.
The
repayment of $500,000 loan on October 26, 2010.
The
allocation of $4,334,124 of gross proceeds from financing to common stock
warrant liability based on the fair value of the warrants.
PRO
FORMA CONSOLIDATED STATEMENT OF OPERATIONS
INVIVO
THERAPEUTICS HOLDINGS COMPANY
YEAR
ENDED MARCH 31, 2010
UNAUDITED
|
|
Invivo
|
|
|
|
|
|
|
|
|
|
|
|
|
Therapeutics,
|
|
|
Design
|
|
|
|
|
|
|
|
|
|
Inc.
|
|
|
Source, Inc.
|
|
|
|
|
|
|
|
|
|
Year Ended
|
|
|
Year Ended
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
March 31,
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2010
|
|
|
Adjustments
|
|
|
Pro Forma
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
$ |
468,044 |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
468,044 |
|
General
and administrative
|
|
|
326,227 |
|
|
|
26,161 |
|
|
|
- |
|
|
|
352,388 |
|
Total
operating expenses
|
|
|
794,271 |
|
|
|
26,161 |
|
|
|
- |
|
|
|
820,432 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
|
(794,271 |
) |
|
|
(26,161 |
) |
|
|
- |
|
|
|
(820,432 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense)
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
Interest
income
|
|
|
133 |
|
|
|
5 |
|
|
|
|
|
|
|
138 |
|
Interest
expense
|
|
|
(176,307 |
) |
|
|
(2,694 |
) |
|
|
|
|
|
|
(179,001 |
) |
Other
income (expense), net
|
|
|
(176,174 |
) |
|
|
(2,689 |
) |
|
|
- |
|
|
|
(178,863 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(970,445 |
) |
|
$ |
(28,850 |
) |
|
$ |
- |
|
|
$ |
(999,295 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per share, basic and diluted
|
|
|
|
|
|
$ |
(0.00 |
) |
|
|
|
|
|
$ |
(0.02 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average number of common shares outstanding, basic and
diluted
|
|
|
|
|
|
|
11,218,457 |
|
|
|
|
|
|
|
49,161,268 |
|
PRO
FORMA CONSOLIDATED STATEMENT OF OPERATIONS
YEAR
ENDED MARCH, 31 2010
INVIVO
THERAPEUTICS HOLDINGS CORP.
UNAUDITED
|
|
Invivo
|
|
|
Design
|
|
|
|
|
|
|
|
|
|
Therapeutics,
|
|
|
Source, Inc.
|
|
|
|
|
|
|
|
|
|
Inc.
|
|
|
Year Ended
|
|
|
|
|
|
|
|
|
|
Year Ended
|
|
|
March 31,
|
|
|
|
|
|
|
|
|
|
December 31, 2009
|
|
|
2010
|
|
|
Adjustments
|
|
|
Pro Forma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
$ |
1,807,908 |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
1,807,908 |
|
General
and administrative
|
|
|
835,515 |
|
|
|
56,062 |
|
|
|
- |
|
|
|
891,577 |
|
Total
operating expenses
|
|
|
2,643,423 |
|
|
|
56,062 |
|
|
|
- |
|
|
|
2,699,485 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
|
(2,643,423 |
) |
|
|
(56,062 |
) |
|
|
- |
|
|
|
(2,699,485 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense)
|
|
|
383,000 |
|
|
|
- |
|
|
|
|
|
|
|
383,000 |
|
Interest
income
|
|
|
282 |
|
|
|
- |
|
|
|
|
|
|
|
282 |
|
Interest
expense
|
|
|
(255,737 |
) |
|
|
(5,910 |
) |
|
(248,812
|
) (Note 1) |
|
|
(510,459 |
) |
Other
income (expense), net
|
|
|
127,545 |
|
|
|
(5,910 |
) |
|
|
(248,812 |
) |
|
|
(127,177 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(2,515,878 |
) |
|
$ |
(61,972 |
) |
|
$ |
(248,812 |
) |
|
$ |
(2,826,662 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per share, basic and diluted
|
|
|
|
|
|
$ |
(0.01 |
) |
|
|
|
|
|
$ |
(0.06 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average number of common shares outstanding, basic and
diluted
|
|
|
|
|
|
|
11,218,457 |
|
|
|
|
|
|
|
49,161,268 |
|
Note 1:
Pro Forma adjustment assumes all notes payable converted on January 1, 2009
resulting in a reduction of interest expense of $221,689 offset by an
increase in interest expense of $470,501 due to the beneficial conversion
feature being triggered on certain notes due to early
conversion.