InVivo Therapeutics Holdings Corp. (NVIV) today reported
financial results for the year ended December 31, 2017.
Richard Toselli, M.D., President and Chief Executive Officer of
InVivo, commented, “InVivo is charting a new and exciting path
forward based on collaboration with the FDA that has continued
through 2017 and into this year. We were pleased to announce last
week that we received the agency’s approval of our supplemental
Investigational Device Exemption (IDE) to initiate a second pivotal
study of the company’s Neuro-Spinal Scaffold™ in patients with
acute spinal cord injury (SCI). We believe this second trial, based
on a randomized, controlled protocol comparing implantation of the
Neuro-Spinal Scaffold to the standard of care of spinal
stabilization, will provide critical data and support to enhance
the clinical findings we already have generated in our previous
single arm pivotal study.”
Dr. Toselli added, “Looking forward, we are actively exploring
the financing options that will support the approved pivotal study
and will provide updates accordingly. We estimate that from study
initiation, enrollment will take place over approximately 18
months, with the full study completing in two years.”
Financial Results
For the year ended December 31, 2017, the Company reported a net
loss of approximately $26,745,000, or $0.81 per share, compared to
a net loss of approximately $23,438,000, or $0.76 per share, for
the year ended December 31, 2016. Included in results for the years
ended December 31, 2017 and 2016 were a non-cash loss of $2,267,000
and a non-cash gain of $593,000, respectively, reflecting the
impact of the August 2017 warrant exchange on the derivative
warrant liability and changes in the fair market value of the
derivative warrant liability. Excluding the impact of the
derivative warrant liability, adjusted net loss for the year ended
December 31, 2017, was $24,478,000, or $0.74 per share, compared to
an adjusted net loss of $24,031,000, or $0.78 per share, for the
year ended December 31, 2016. The Company ended the year with
$12,910,000 of cash and cash equivalents as of December 31,
2017.
Adjusted net loss and adjusted net loss per share are non-GAAP
financial measures that exclude the impact of the items noted. A
reconciliation of these measures to the comparable GAAP measures is
included with the tables contained in this release. The Company
believes a presentation of these non-GAAP measures provides useful
information to investors, enabling them to better understand the
Company’s operations, on a period-to-period comparable basis, with
financial amounts both including and excluding these identified
items.
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,
Sc.D., Professor at Massachusetts Institute of Technology, and
Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital
and who now is affiliated with Massachusetts General Hospital. In
January 2018, the company announced updated clinical evidence,
including improvements in patients with acute spinal cord injury
(SCI), from its INSPIRE study of the Neuro-Spinal Scaffold™. 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 value
of the second pivotal study, the expected timing for enrollment and
completion of the second pivotal study, the Company’s ability to
identify financing options that will support the second pivotal
study and the benefits of the Neuro-Spinal Scaffold.. 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 identify financing alternatives and raise
the capital necessary to undertake the second pivotal trial, the
ability to successfully open additional clinical sites for
enrollment and to enroll additional patients if such trial is
initiated; 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, 2017, 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) December
31, 2017 2016 ASSETS: Current
assets: Cash and cash equivalents $ 12,910 $ 21,464 Restricted cash
361 361 Marketable securities — 11,577 Prepaid expenses and other
current assets 535 451 Total current assets
13,806 33,853 Property, equipment and leasehold improvements, net
157 510 Other assets 82 421 Total assets $
14,045 $ 34,784
LIABILITIES AND STOCKHOLDERS’ EQUITY:
Current liabilities: Accounts payable $ 988 $ 1,011 Loan payable,
current portion 452 423 Derivative warrant liability 4 1,314
Deferred rent, current portion 30 141 Accrued expenses 1,638
1,959 Total current liabilities 3,112 4,848 Loan
payable, net of current portion 400 852 Deferred rent, net of
current portion 367 135 Other liabilities 56 —
Total liabilities 3,935 5,835
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.00001 par value,
authorized 100,000,000 shares;34,274,776 shares issued and
outstanding at December 31, 2017;32,044,087 shares issued and
outstanding at December 31, 2016
1 1 Additional paid-in capital 194,016 185,955 Accumulated deficit
(183,907) (157,007) Total stockholders’ equity
10,110 28,949 Total liabilities and
stockholders’ equity $ 14,045 $ 34,784
InVivo Therapeutics Holdings
Corp
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
Year Ended December 31,
2017 2016
2015 Operating expenses: Research and development $ 11,083 $
12,557 $ 10,058 General and administrative 13,510
11,506 12,340 Total operating expenses
24,593 24,063 22,398
Operating loss (24,593)
(24,063) (22,398) Other income (expense): Interest
income 189 187 60 Interest expense (74) (155) (172) Derivatives
gain (loss) (2,267) 593
(10,804) Other income (expense), net (2,152)
625 (10,916) Net loss $ (26,745) $
(23,438) $ (33,314) Net loss per share, basic and
diluted $ (0.81) $ (0.76) $ (1.26)
Weighted average number of commonshares
outstanding, basic and diluted
32,950,068 31,025,585
26,461,374 Other comprehensive loss: Net loss (26,745) (23,438)
(33,314) Other comprehensive loss:
Unrealized gain (loss) on marketable
securities
— — — Comprehensive loss $ (26,745) $ (23,438) $
(33,314)
Reconciliation of GAAP to non-GAAP
measures
InVivo Therapeutics Holdings Corp. (In thousands, except
share and per share data) Three
Months Ended Year Ended December 31, December
31, 2017 2016 2017 2016 Reported
GAAP net income (loss) (4,664) (5,435) (26,745) (23,438) Derivative
(gain)/loss 3 (1,381) 2,267 (593) Adjusted net loss (4,661) (6,816)
(24,478) (24,031) Reported GAAP net loss per diluted share
(0.13) (0.17) (0.81) (0.76) Derivative (gain)/loss per diluted
share 0.00 (0.04) 0.07 (0.02) Adjusted net loss per diluted share
(0.13) (0.21) (0.74) (0.78)
View source
version on businesswire.com: http://www.businesswire.com/news/home/20180312005580/en/
InVivo Therapeutics Holdings Corp.Heather Hamel,
617-863-5530Investor
RelationsInvestor-relations@invivotherapeutics.com
InVivo Therapeutics (NASDAQ:NVIV)
Historical Stock Chart
From Mar 2024 to Apr 2024
InVivo Therapeutics (NASDAQ:NVIV)
Historical Stock Chart
From Apr 2023 to Apr 2024