InVivo Therapeutics Holdings Corp. (NVIV) today reported
financial results for the quarter ended September 30, 2014.
Mark Perrin, InVivo’s CEO, said, “We made substantial progress on all
fronts during the third quarter and have continued to build upon that
momentum in the weeks since. In that timeframe, we enrolled our first
subject in our first-in-human pilot trial, expanded the number of
potential clinical sites, broadened subject eligibility criteria,
increased our communications outreach through scientific, medical, and
investor conferences, and significantly strengthened our intellectual
property portfolio. We ended the quarter with a strong cash position,
which will allow us to further these important initiatives, and project
our funds will extend through March of 2016.”
Financial Results
For the quarter ended September 30, 2014, the Company reported a net
loss of approximately $1,213,000 or $.01 per diluted share, compared to
a net loss of $5,437,000 or $.07 per diluted share, for the quarter
ended September 30, 2013. The 2014 results were favorably impacted by a
gain in the derivative warrant liability of $3,005,000 Excluding the
impact of the derivative warrant liability, the quarters ended September
30, 2014 and 2013 earnings loss per diluted share were $.04 and $.07
respectively.
For the nine months ended September 30, 2014, the Company reported a net
loss of approximately $9,961,000 or $.12 per diluted share, compared to
a net loss of $33,048,000 or $.46 per diluted share, for the nine months
ended September 30, 2013. The 2014 results were impacted by a $4,132,000
gain in the derivative warrant liability and $309,000 of costs related
to the re-alignment of resources completed in the second quarter. The
results for the nine months ended September 30, 2013 were adversely
impacted by non-cash gains (losses) from modification of warrants and
derivatives of $19,636,000, reflecting changes in the fair market value
of the derivative warrant liability. Exclusive of these items, the nine
months ended September 30, 2014 and 2013 earnings per diluted share
losses were $.17 and $.19 respectively.
The Company ended the quarter with $17,634,000 of cash and cash
equivalents.
Adjusted net loss and adjusted net loss per share are non-GAAP financial
measures that exclude the items noted. A reconciliation of these
measures to the comparable GAAP measure is included with the tables
contained in this release. The Company believes a presentation of these
non-GAAP measures provides useful information to investors to better
understand, on a period-to-period comparable basis, financial amounts
both including and excluding these identified items, the Company's
operations.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a pioneering biomaterials and
biotechnology company with a focus on treatment of spinal cord injuries.
The company was founded in 2005 with proprietary technology co-invented
by Robert Langer, ScD, Professor at Massachusetts Institute of
Technology, and Joseph P. Vacanti, MD, who then was at Boston Children’s
Hospital and who now is affiliated with Massachusetts General Hospital.
In 2011 the company earned the David S. Apple Award from the American
Spinal Injury Association for its outstanding contribution to spinal
cord injury medicine. The publicly-traded company is headquartered in
Cambridge, MA. For more details, visit www.invivotherapeutics.com.
Safe Harbor Statement
Any statements contained in this press release that do not describe
historical facts may constitute forward-looking statements within the
meaning of the federal securities laws. These statements can be
identified by words such as "believe," "anticipate," "intend,"
"estimate," "will," "may," "should," "expect" and
similar expressions, and include statements regarding the Company’s cash
position and its forecast projections. Any forward-looking statements
contained herein are based on current expectations, and are subject to a
number of risks and uncertainties. Factors that could cause actual
future results to differ materially from current expectations include,
but are not limited to, risks and uncertainties relating to the
Company’s ability to successfully open additional clinical sites for
enrollment and to enroll additional patients in the scaffold pilot study
following the reopening of enrollment; the timing of the Institutional
Review Board process; the Company’s ability to obtain FDA approval to
commercialize its products; the Company’s ability to develop, market and
sell products based on its technology; the expected benefits and
efficacy of the Company’s products and technology in connection with
spinal cord injuries; the availability of substantial additional funding
for the Company to continue its operations and to conduct research and
development, clinical studies and future product commercialization; and
other risks associated with the Company’s business, research, product
development, regulatory approval, marketing and distribution plans and
strategies identified and described in more detail in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2013, as
amended, and its other filings with the SEC, including the Company’s
Form 10-Qs and current reports on Form 8-K. The Company does not
undertake to update these forward-looking statements.
|
InVivo Therapeutics Holdings Corp.
|
(A Development Stage Company)
|
Consolidated Balance Sheets
|
(In thousands, except share and per share data)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of
|
|
|
|
|
|
September 30, 2014
|
|
|
|
December 31, 2013
|
ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
|
$
|
17,634
|
|
|
|
|
$
|
13,980
|
|
Restricted cash
|
|
|
|
|
|
371
|
|
|
|
|
|
602
|
|
Prepaid expenses
|
|
|
|
|
|
342
|
|
|
|
|
|
20
|
|
Total current assets
|
|
|
|
|
|
18,347
|
|
|
|
|
|
14,602
|
|
|
|
|
|
|
|
|
|
|
|
Property, equipment and leasehold improvements, net
|
|
|
|
|
|
1,797
|
|
|
|
|
|
2,337
|
|
Other assets
|
|
|
|
|
|
141
|
|
|
|
|
|
157
|
|
Total assets
|
|
|
|
|
$
|
20,285
|
|
|
|
|
$
|
17,096
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
|
|
|
$
|
711
|
|
|
|
|
$
|
899
|
|
Note payable-current portion
|
|
|
|
|
|
37
|
|
|
|
|
|
74
|
|
Capital lease payable
|
|
|
|
|
|
—
|
|
|
|
|
|
3
|
|
Derivative warrant liability
|
|
|
|
|
|
2,716
|
|
|
|
|
|
—
|
|
Accrued expenses
|
|
|
|
|
|
1,351
|
|
|
|
|
|
1,292
|
|
Total current liabilities
|
|
|
|
|
|
4,815
|
|
|
|
|
|
2,268
|
|
|
|
|
|
|
|
|
|
|
|
Loan payable
|
|
|
|
|
|
1,920
|
|
|
|
|
|
1,920
|
|
Note payable-less current portion
|
|
|
|
|
|
—
|
|
|
|
|
|
18
|
|
Total liabilities
|
|
|
|
|
|
6,735
|
|
|
|
|
|
4,206
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity:
|
|
|
|
|
|
|
|
|
|
Common stock, $0.00001 par value, authorized 200,000,000 shares at
September 30, 2014 and December 31, 2013; issued and outstanding
93,547,062 and 78,773,736 shares at September 30, 2014 and December
31, 2013, respectively.
|
|
|
|
|
|
1
|
|
|
|
|
|
1
|
|
Additional paid-in capital
|
|
|
|
|
|
105,419
|
|
|
|
|
|
94,798
|
|
Deficit accumulated during the development stage
|
|
|
|
|
|
(91,870
|
)
|
|
|
|
|
(81,909
|
)
|
Total stockholders’ equity
|
|
|
|
|
|
13,550
|
|
|
|
|
|
12,890
|
|
Total liabilities and stockholders’ equity
|
|
|
|
|
$
|
20,285
|
|
|
|
|
$
|
17,096
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
InVivo Therapeutics Holdings Corp.
|
(A Development Stage Company)
|
Consolidated Statements of Operations
|
(In thousands, except share and per share data)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
November 28, 2005 (inception) to September
30,
|
|
|
|
|
|
|
2014
|
|
|
|
|
2013
|
|
|
|
|
2014
|
|
|
|
|
2013
|
|
|
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
$
|
2,385
|
|
|
|
$
|
3,021
|
|
|
|
$
|
8,678
|
|
|
|
$
|
6,825
|
|
|
|
$
|
34,471
|
|
General and administrative
|
|
|
|
|
|
1,800
|
|
|
|
|
2,386
|
|
|
|
|
5,317
|
|
|
|
|
6,505
|
|
|
|
|
28,444
|
|
Total operating expenses
|
|
|
|
|
|
4,185
|
|
|
|
|
5,407
|
|
|
|
|
13,995
|
|
|
|
|
13,330
|
|
|
|
|
62,915
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
|
|
|
(4,185
|
)
|
|
|
|
(5,407
|
)
|
|
|
|
(13,995
|
)
|
|
|
|
(13,330
|
)
|
|
|
|
(62,915
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
|
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
383
|
|
Interest income
|
|
|
|
|
|
2
|
|
|
|
|
4
|
|
|
|
|
4
|
|
|
|
|
13
|
|
|
|
|
75
|
|
Interest expense
|
|
|
|
|
|
(35
|
)
|
|
|
|
(34
|
)
|
|
|
|
(102
|
)
|
|
|
|
(95
|
)
|
|
|
|
(1,370
|
)
|
Modification of warrants
|
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
(765
|
)
|
|
|
|
(765
|
)
|
Derivatives gain (loss)
|
|
|
|
|
|
3,005
|
|
|
|
—
|
|
|
|
4,132
|
|
|
|
|
(18,871
|
)
|
|
|
|
(27,278
|
)
|
Other income (expense), net
|
|
|
|
|
|
2,972
|
|
|
|
|
(30
|
)
|
|
|
|
4,034
|
|
|
|
|
(19,718
|
)
|
|
|
|
(28,955
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
|
|
|
$
|
(1,213
|
)
|
|
|
$
|
(5,437
|
)
|
|
|
$
|
(9,961
|
)
|
|
|
$
|
(33,048
|
)
|
|
|
$
|
(91,870
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share, basic
|
|
|
|
|
$
|
(0.01
|
)
|
|
|
$
|
(0.07
|
)
|
|
|
$
|
(0.12
|
)
|
|
|
$
|
(0.46
|
)
|
|
|
$
|
(2.09
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share, diluted
|
|
|
|
|
$
|
(0.01
|
)
|
|
|
$
|
(0.07
|
)
|
|
|
$
|
(0.12
|
)
|
|
|
$
|
(0.46
|
)
|
|
|
$
|
(2.09
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding, basic
|
|
|
|
|
|
101,635,856
|
|
|
|
|
78,603,114
|
|
|
|
|
81,761,045
|
|
|
|
|
72,391,396
|
|
|
|
|
44,047,625
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding, diluted
|
|
|
|
|
|
101,635,856
|
|
|
|
|
78,603,114
|
|
|
|
|
81,761,045
|
|
|
|
|
72,391,396
|
|
|
|
|
44,047,625
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP to non-GAAP measures
|
InVivo Therapeutics Holding Corp.
|
(A Development Stage Company)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
Nine Months Ended
|
|
|
|
|
|
September 30,
|
|
|
|
September 30,
|
|
|
|
|
|
2014
|
|
|
|
|
2013
|
|
|
|
|
2014
|
|
|
|
|
2013
|
|
Reported GAAP net income (loss)
|
|
|
|
|
(1,213
|
)
|
|
|
|
(5,437
|
)
|
|
|
|
(9,961
|
)
|
|
|
|
(33,048
|
)
|
Add Back: Derivative gain (Loss)
|
|
|
|
|
3,005
|
|
|
|
|
-
|
|
|
|
|
4,132
|
|
|
|
|
(18,871
|
)
|
Add Back: Modification of Warrants
|
|
|
|
|
-
|
|
|
|
|
-
|
|
|
|
|
-
|
|
|
|
|
(765
|
)
|
Add Back: Restructuring Costs
|
|
|
|
|
-
|
|
|
|
|
-
|
|
|
|
|
(309
|
)
|
|
|
|
-
|
|
Pro Forma Net Loss
|
|
|
|
|
(4,218
|
)
|
|
|
|
(5,437
|
)
|
|
|
|
(13,784
|
)
|
|
|
|
(13,412
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reported GAAP net loss per diluted share
|
|
|
|
|
(0.01
|
)
|
|
|
|
(0.07
|
)
|
|
|
|
(0.12
|
)
|
|
|
|
(0.46
|
)
|
Derivative gain (loss) per diluted share
|
|
|
|
|
0.03
|
|
|
|
|
-
|
|
|
|
|
0.05
|
|
|
|
|
(0.26
|
)
|
Modification of Warrants gain (loss) per diluted share
|
|
|
|
|
-
|
|
|
|
|
-
|
|
|
|
|
-
|
|
|
|
|
(0.01
|
)
|
Restructuring Costs per diluted share
|
|
|
|
|
-
|
|
|
|
|
-
|
|
|
|
|
-
|
|
|
|
|
-
|
|
Pro Forma net income (loss) per diluted share
|
|
|
|
|
(0.04
|
)
|
|
|
|
(0.07
|
)
|
|
|
|
(0.17
|
)
|
|
|
|
(0.19
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Copyright Business Wire 2014