InVivo Therapeutics Holdings Corp. (NVIV) today reported
financial results for the year ended December 31, 2014.
Mark Perrin, InVivo’s CEO and Chairman, said, “2014 was a
momentous year for InVivo in every sense of the word. It’s
gratifying to look back on how much we accomplished last year and
exciting to see the trajectory the company is following. We are in
a much better position to execute on our corporate goals than we
were only 15 months ago and are significantly closer to achieving
our mission: to redefine the life of the spinal cord injury
patient. I’m pleased with how we’ve advanced as a company and am
very much looking forward to a fruitful 2015.”
Business Highlights
Hired experienced leadership team
InVivo’s five corporate officers, all new to the company since
January 2014, bring significant depth and breadth regarding the
development, approval, and commercialization of products. As a
cohesive unit, the company is on a path poised for success.
Initiated pilot trial with Neuro-Spinal Scaffold
In 2014, the first-ever implantation of the company’s
Neuro-Spinal Scaffold took place. In the months that followed, an
appreciable improvement in the first subject’s motor and sensory
function was reported (improved from AIS A to C) as well as
complete recovery of bowel function and improvement in bladder
function. The second-ever implantation of the Neuro-Spinal Scaffold
was done in January 2015.
Accelerated pilot trial timeline with FDA
In December 2014, InVivo was able to expedite the original
subject enrollment plan by eliminating mandatory holds between
enrollment of the final three subjects, thereby reducing the
clinical timeline. Barring any significant safety issues,
concurrent enrollment of subjects three through five is anticipated
to open by the end of March 2015.
Raised cash to fund trial and operations
In May 2014, InVivo successfully raised approximately $16.1
million to fund the ongoing pilot trial and operations. The company
also recently closed an additional round of financing, led by our
largest shareholder, and received gross proceeds of $12 million.
InVivo believes it is in a strong cash position to further advance
the company’s mission.
Realigned and focused R&D efforts and reduced burn
The company is solely focused on developing therapies for spinal
cord injury patients. By reducing headcount, streamlining
processes, and subsequently realigning and focusing internal
efforts, InVivo is on a great path to success.
Financial Results
For the year ended December 31, 2014, the company reported a net
loss of approximately $18,346,000, or $0.21 per diluted share,
compared to a loss of $38,756,000, or $0.52 per diluted share, for
the year ending December 31, 2013. Included in results for the
years ended December 31, 2014 and 2013 were non-cash losses of
$376,000 and $18,871,000, respectively, reflecting changes in the
fair market value of the derivative warrant liability. Excluding
the derivative warrant liability, non-cash losses associated with
modification of warrants in 2013 and restructuring costs incurred
in the second quarter of 2014, adjusted net loss for the year
ending December 31, 2014, was $17,970,000, or $0.20 per diluted
share, compared to an adjusted net loss of $19,120,000, or $0.26
per diluted share, for 2013. The company ended the year with
$13,459,000 of cash and cash equivalents.
Adjusted net loss and adjusted net loss per diluted share are
non-GAAP financial measures that exclude the impact of 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 the company’s
operations on a period-to-period comparable basis after taking into
account the impact of the identified items.
About the Neuro-Spinal Scaffold
Following an acute spinal cord injury, the biodegradable
Neuro-Spinal Scaffold is surgically implanted at the epicenter of
the wound and acts as a physical substrate for nerve sprouting.
Appositional healing to spare spinal cord tissue, decreased
post-traumatic cyst formation, and decreased spinal cord tissue
pressure have been demonstrated in preclinical models of spinal
cord contusion injury. The Neuro-Spinal Scaffold, an
investigational device, has received a Humanitarian Use Device
designation and is currently being studied in a pilot study for the
treatment of complete (AIS A) traumatic acute spinal cord
injury.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a research and
clinical-stage 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 anticipated
reopening of enrollment and the pace of enrollment following the
reopening and the company’s cash position for fiscal 2015. 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; 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, 2014, 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.
Consolidated Balance Sheets
(In thousands, except share and per
share data)
As of December 31,2014 December
31,2013 ASSETS: Current assets: Cash and
cash equivalents $ 13,459 $ 13,980 Restricted cash 422 602 Prepaid
expenses and other current assets 1,072 20
Total current assets 14,953 14,602 Property and
equipment, net 1,605 2,337 Other assets 135 157
Total assets $ 16,693 $ 17,096
LIABILITIES AND STOCKHOLDERS’ EQUITY:
Current liabilities: Accounts payable $ 569 $ 899 Loan
payable-current portion 320 — Note payable-current portion 18 74
Capital lease payable — 3 Derivative warrant liability 7,224 —
Accrued expenses 1,044 1,292 Total
current liabilities 9,175 2,268 Loan payable-less current
portion 1,600 1,920 Note payable-less current portion —
18 Total liabilities 10,775
4,206 Commitments and Contingencies
Stockholders’ equity:
Common stock, $0.00001 par value,
authorized - 200,000,000 shares at December 31,
2014 and December 31, 2013; issued and outstanding
- 93,812,000 and 78,773,736 shares at December 31,
2014 and December 31, 2013, respectively.
1 1 Additional paid-in capital 106,172 94,798 Accumulated deficit
(100,255 ) (81,909 ) Total stockholders’ equity 5,918
12,890 Total liabilities and
stockholders’ equity $ 16,693 $ 17,096
InVivo Therapeutics Holdings
Corp.
Consolidated Statements of
Operations
(In thousands, except share and
per-share data)
Years Ended December 31, 2014
2013
2012 Operating expenses: Research and development $
10,273 $ 10,533 $ 6,376 General and administrative 7,566
8,472 6,403 Total operating
expenses 17,839 19,005 12,779
Operating loss (17,839 ) (19,005 )
(12,779 ) Other income (expense): Interest income 5 15 35 Interest
expense (136 ) (130 ) (72 ) Modification of warrants — (765 ) —
Derivative gain (loss) (376 ) (18,871 ) 17,480
Other income (expense), net (507 ) (19,751 )
17,443 Net income (loss) $ (18,346 ) $ (38,756 ) $
4,664 Net income (loss) per share, basic $ (0.21 ) $ (0.52 )
$ 0.07 Net income (loss) per share, diluted $ (0.21 ) $
(0.52 ) $ 0.06
Weighted average number of common
shares outstanding, basic
88,323,044 73,991,686 63,226,899
Weighted average number of common
shares outstanding, diluted
88,323,044 73,991,686 71,919,419
Reconciliation of GAAP to non-GAAP
measures InVivo Therapeutics Holding Corp. (In
thousands, except share and per share data)
Three Months Ended Year Ended December
31, December 31, 2014 2013
2014 2013 Reported GAAP net income
(loss) (8,384 ) (5,707 ) (18,346 ) (38,756 ) Add Back: Derivative
Loss 4,508 - 376 18,871 Add Back: Modification of Warrants - - -
765 Add Back: Restructuring Costs - - 309 -
Adjusted Net Loss (3,876 ) (5,707 ) (17,661 ) (19,120 )
Reported GAAP net loss per diluted share (0.09 ) (0.07 )
(0.21 ) (0.52 ) Derivative loss per diluted share 0.05 - 0.01 0.25
Modification of Warrants loss per diluted share - - - 0.01
Restructuring Costs per diluted share - - - -
Adjusted net loss per diluted share (0.04 ) (0.07 ) (0.20 )
(0.26 )
InVivo Therapeutics Holdings Corp.Brian Luque,
617-863-5535Investor Relationsbluque@invivotherapeutics.com