InVivo Therapeutics Holdings Corp. (NVIV), a biomaterials company with
innovative technologies for drug delivery with a focus on treatment of
spinal cord injuries, today reported financial results for the quarter
ended March 31, 2014.
Mark Perrin, Chief Executive Officer of InVivo, said, “As we previously
reported, we are excited to have our first clinical site in the final
stages of surgical training for our scaffold pilot study and expect to
have patient enrollment open by the end of May. We anticipate having a
second site open for enrollment by the end of May and a third site open
by the end of the second quarter. We also recently completed an
underwritten public offering of shares of common stock and warrants, and
we received approximately $14.6 million in net proceeds from the
offering after deducting underwriter fees and other offering expenses.
The funds will be utilized to complete our clinical study, fund
additional research, development and clinical projects, and for working
capital. We anticipate these funds will be sufficient to take us through
November 2015.”
Financial Results
For the quarter ended March 31, 2014, the Company reported a net loss of
approximately $5,103,000 or $0.07 per diluted share, compared to a net
loss of $13,326,000 or $0.20 per diluted share, for the quarter ended
March 31, 2013. Non-cash gains (losses) from modification of warrants
and derivatives in the amount of $10,449,000 were included in results
for the quarter ended March 31, 2013, and reflected changes in the fair
market value of the derivative warrant liability. Exclusive of this
non-cash item, the adjusted net loss for the quarter ended March 31,
2013, was $2,877,000, or $0.04 per diluted share. The Company ended the
quarter with $9,846,000 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 company
with unique technologies for drug delivery 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, M.D., who
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. Any forward-looking statements
contained herein are based on current expectations, and include
statements regarding the Company’s expectations with respect to the
opening of additional clinical study sites and patient enrollment in the
study, and the Company’s anticipated use of the proceeds from its recent
offering. These statements are subject to a number of risks and
uncertainties that could cause actual future results to differ
materially from current expectations including, but not limited to,
risks and uncertainties relating to the Company’s limited operating
history and history of net losses, its ability to raise substantial
additional capital to finance planned operations, its ability to
successfully commercialize current and future product candidates and to
successfully complete clinical trials and obtain and maintain regulatory
approval of its product candidates, its ability to protect and maintain
its intellectual property, and other risks associated with the Company’s
business and strategies identified and described in more detail in the
Company’s filings with the SEC, including its Annual Report on Form 10-K
for the year ended December 31, 2013, as amended, and subsequent filings
with the Securities and Exchange Commission. The Company does not
undertake to update these forward-looking statements, except as required
by law.
|
InVivo Therapeutics Holdings Corp.
(A Development Stage Company)
Consolidated Balance Sheets
(In thousands, except share and per share data)
(Unaudited)
|
|
|
|
As of
|
|
|
March 31, 2014
|
|
December 31, 2013
|
ASSETS:
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
9,846
|
|
|
$
|
13,980
|
|
Restricted cash
|
|
|
371
|
|
|
|
602
|
|
Prepaid expenses
|
|
|
445
|
|
|
|
20
|
|
|
|
|
|
|
Total current assets
|
|
|
10,662
|
|
|
|
14,602
|
|
|
|
|
|
|
Property, equipment and leasehold improvements, net
|
|
|
2,182
|
|
|
|
2,337
|
|
Other assets
|
|
|
152
|
|
|
|
157
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
12,996
|
|
|
$
|
17,096
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY:
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
Accounts payable
|
|
$
|
704
|
|
|
$
|
899
|
|
Note payable-current portion
|
|
|
74
|
|
|
|
74
|
|
Capital lease payable
|
|
|
—
|
|
|
|
3
|
|
Accrued expenses
|
|
|
1,236
|
|
|
|
1,292
|
|
|
|
|
|
|
Total current liabilities
|
|
|
2,014
|
|
|
|
2,268
|
|
|
|
|
|
|
Loan payable
|
|
|
1,920
|
|
|
|
1,920
|
|
Note payable-less current portion
|
|
|
—
|
|
|
|
18
|
|
|
|
|
|
|
Total liabilities
|
|
|
3,934
|
|
|
|
4,206
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity:
|
|
|
|
|
Common stock, $0.00001 par value, authorized 200,000,000 shares at
March 31, 2014 and December 31, 2013; issued and outstanding
79,021,039 and 78,773,736 shares at March 31, 2014 and December 31,
2013, respectively.
|
|
|
1
|
|
|
|
1
|
|
Additional paid-in capital
|
|
|
96,073
|
|
|
|
94,798
|
|
Deficit accumulated during the development stage
|
|
|
(87,012
|
)
|
|
|
(81,909
|
)
|
|
|
|
|
|
Total stockholders’ equity
|
|
|
9,062
|
|
|
|
12,890
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity
|
|
$
|
12,996
|
|
|
$
|
17,096
|
|
|
|
|
|
|
InVivo Therapeutics Holdings Corp.
(A Development Stage Company)
|
Consolidated Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
Quarter Ended March 31,
|
|
Period from November 28, 2005 (inception)
to March 31, 2014
|
|
|
2014
|
|
2013
|
|
|
Operating expenses:
|
|
|
|
|
|
|
Research and development
|
|
$ 3,242
|
|
|
$ 1,213
|
|
|
$
|
29,035
|
|
General and administrative
|
|
1,829
|
|
|
1,638
|
|
|
|
24,956
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
5,071
|
|
|
2,851
|
|
|
|
53,991
|
|
|
|
|
|
|
|
|
Operating loss
|
|
(5,071
|
)
|
|
(2,851
|
)
|
|
|
(53,991
|
)
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
Other income
|
|
—
|
|
|
—
|
|
|
|
383
|
|
Interest income
|
|
1
|
|
|
3
|
|
|
|
72
|
|
Interest expense
|
|
(33
|
)
|
|
(29
|
)
|
|
|
(1,301
|
)
|
Modification of warrants
|
|
-—
|
|
|
—
|
|
|
|
(765
|
)
|
Derivatives gain (loss)
|
|
---
|
|
|
(10,449
|
)
|
|
|
(31,410
|
)
|
|
|
|
|
|
|
|
Other income (expense), net
|
|
(32
|
)
|
|
(10,475
|
)
|
|
|
(33,021
|
)
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$ (5,103
|
)
|
|
$ (13,326
|
)
|
|
$
|
(87,012
|
)
|
|
|
|
|
|
|
|
Net income (loss) per share, basic
|
|
$ (0.07
|
)
|
|
$ (0.20
|
)
|
|
$
|
(2.11
|
)
|
|
|
|
|
|
|
|
Net income (loss) per share, diluted
|
|
$ (0.07
|
)
|
|
$ (0.20
|
)
|
|
$
|
(2.11
|
)
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding, basic
|
|
74,161,457
|
|
|
66,043,378
|
|
|
|
41,269,091
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding, diluted
|
|
74,161,457
|
|
|
66,043,378
|
|
|
|
41,269,091
|
|
|
Reconciliation of GAAP to non-GAAP measures
InVivo Therapeutics Holdings Corp.
|
(A Development Stage Company)
(In thousands, except share and per share data)
(Unaudited)
|
|
|
|
Quarters Ended
|
|
|
March 31,
|
|
|
2014
|
|
2013
|
|
|
|
|
|
Reported GAAP net income (loss)
|
|
$
|
(5,103
|
)
|
|
$
|
(13,326
|
)
|
Add Back: Derivative gain (loss)
|
|
|
—
|
|
|
|
(10,475
|
)
|
Add Back: Modification of Warrants
|
|
|
—
|
|
|
|
Pro Forma Net Loss
|
|
$
|
(5,103
|
)
|
|
$
|
(2,851
|
)
|
|
|
|
|
|
Reported GAAP net income (loss) per diluted share
|
|
$
|
(0.07
|
)
|
|
$
|
(0.20
|
)
|
Derivative gain (loss) per diluted share
|
|
|
—
|
|
|
|
(0.16
|
)
|
Modification of warrants gain (loss) per diluted share
|
|
|
—
|
|
|
|
Pro-Forma net income (loss) per diluted share
|
|
$
|
(0.07
|
)
|
|
$
|
(0.04
|
)
|
Copyright Business Wire 2014