InVivo Therapeutics Holdings Corp. (NVIV) today provided
a general business update and reported financial results for the
quarter ended June 30, 2017.
Mark Perrin, InVivo’s Chief Executive Officer and Chairman,
said, “In the second quarter, we continued to make significant
progress at InVivo. During the quarter, we enrolled four more
patients into INSPIRE, and we now have 16 patients in follow-up.
One of these patients improved from complete AIS A SCI to motor
incomplete AIS C SCI at the one-month visit. We also announced that
two patients who had previously converted to AIS B had been
assessed to have converted to AIS C at their 12- and 24-month
visits, respectively. Of the seven total AIS grade conversions,
four are AIS C conversions at this time, meaning these four
patients have recovered both sensory and motor function. Given
these AIS C conversions and an overall conversion rate of 54.5%
(6/11) at the 6-month primary endpoint visit, we remain
enthusiastic about the potential of establishing the Neuro-Spinal
Scaffold™ as the foundation of a new standard of care for acute
spinal cord injury.
“Last week, we announced that the most recent patient to enroll
into the INSPIRE study passed away with the cause of death deemed
by the Principal Investigator at the site to be unrelated to
the Neuro-Spinal Scaffold™ or implantation procedure. This was
the third death in the INSPIRE study. Following discussions with
the company’s independent Data Safety Monitoring Board (DSMB), we
elected to implement a temporary halt to enrollment as we engaged
with the FDA to determine whether any changes to the protocol were
needed. The FDA responded formally with its recommendations; we are
working on assessing the recommendations and formulating a response
that will include a protocol amendment. At this time, our primary
focus at InVivo is re-opening enrollment in INSPIRE as quickly as
possible so that we can continue to make progress toward our goal
of redefining the life of the spinal cord injury patient.”
Financial Results
For the three-month period ended June 30, 2017, the Company
reported a net loss of approximately $6.3 million, or $0.20 per
diluted share, compared to a net loss of $5.2 million, or $0.16 per
diluted share, for the three-month period ended June 30, 2016. The
results for the three-month period ended June 30, 2017 were
unfavorably impacted by increases in operating expenses of $416,000
in research and development and $724,000 in general and
administrative, partially offset by a non-cash gain on the
derivative warrant liability of $554,000 for the three-month period
ended June 30, 2017 reflecting changes in the fair market value of
the derivative warrant liability. Excluding the impact of the
derivative warrant liability, adjusted net loss for the three-month
period ended June 30, 2017 was $6.9 million, or $0.22 per diluted
share, compared to adjusted net loss of $5.8 million, or $0.18 per
diluted share, for the three-month period ended June 30, 2016.
The Company ended the quarter with $21.8 million of cash, cash
equivalents, and marketable securities.
For the six-month period ended June 30, 2017, the Company
reported a net loss of approximately $12.7 million, or $0.40 per
diluted share, compared to a net loss of $11.8 million or $0.39 per
diluted share, for the six-month period ended June 30, 2016. The
results for the six-month period ended June 30, 2017 were
unfavorably impacted by increases in operating expenses of $1.2
million in research and development and $1.0 in general and
administrative, partially offset by a non-cash gain on the
derivative warrant liability of $795,000 for the six-month period
ended June 30, 2017 reflecting changes in the fair market value of
the derivative warrant liability. Excluding the impact of the
derivative warrant liability, adjusted net loss for the six-month
period ended June 30, 2017 was $13.5 million, or $0.42 per diluted
share, compared to adjusted net loss of $11.4 million, or $0.37 per
diluted share, for the six-month period ended June 30, 2016.
Adjusted net loss and adjusted net loss per share are non-GAAP
financial measures that exclude the impact of the derivative
warrant liability. 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, with financial amounts both including and
excluding the identified items.
About The INSPIRE Study
The INSPIRE Study: InVivo Study of Probable
Benefit of the Neuro-Spinal Scaffold™ for Safety and
Neurologic Recovery in Subjects with Complete Thoracic AIS A
Spinal Cord Injury, is designed to demonstrate the safety and
probable benefit of the Neuro-Spinal Scaffold™ for the
treatment of complete T2-T12/L1 spinal cord injury in support of a
Humanitarian Device Exemption (HDE) application for approval. For
more information, refer to
https://clinicaltrials.gov/ct2/show/study/NCT02138110.
About the Neuro-Spinal Scaffold™ Implant
Following acute spinal cord injury, surgical implantation of the
biodegradable Neuro-Spinal Scaffold™ within the decompressed and
debrided injury epicenter is intended to support appositional
healing, thereby reducing post-traumatic cavity formation, sparing
white matter, and allowing neural repair within and around the
healed wound epicenter. The Neuro-Spinal Scaffold™, an
investigational device, has received a Humanitarian Use Device
(HUD) designation and currently is being evaluated in The INSPIRE
Study for the treatment of patients with acute, complete (AIS A),
thoracic traumatic spinal cord injury and a pilot study for acute,
complete (AIS A), cervical (C5-T1) traumatic spinal cord injury.
For more information on the cervical study, refer to
https://clinicaltrials.gov/ct2/show/study/NCT03105882.
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
2011, the company earned the David S. Apple Award from the American
Spinal Injury Association for its outstanding contribution to
spinal cord injury medicine. In 2015, the company’s investigational
Neuro-Spinal Scaffold™ received the 2015 Becker’s Healthcare Spine
Device Award. 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," “designed
to,” “potentially,” and similar expressions, and include statements
regarding the safety and effectiveness of the Neuro-Spinal
Scaffold™ and the status of the clinical program, including the
changes to the INSPIRE protocol, the timing for re-opening
enrollment in the INSPIRE Study and the submission of an HDE
application to the FDA. 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 expected benefits
and efficacy of the company’s products and technology in connection
with the treatment of 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 Quarterly Report of the three months ended June 30, 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 Unaudited
As of
June 30, 2017
December 31,2016
ASSETS: Current assets: Cash and cash equivalents
14,322 21,464 Restricted cash 361 361 Marketable securities 7,525
11,577 Prepaid expenses and other current assets 657 451
Total current assets 22,865 33,853 Property, equipment and
leasehold improvements, net 305 510 Other assets 409 421
Total assets 23,579 34,784
LIABILITIES AND STOCKHOLDERS' EQUITY: Current
liabilities: Accounts payable 878 1,011 Loan payable, current
portion 437 423 Derivative warrant liability 519 1,314 Deferred
rent, current portion 154 141 Accrued expenses 1,893 1,959
Total current liabilities 3,881 4,848 Loan payable, net of
current portion 630 852 Deferred rent, net of current portion 54
135 Other liabilities 45 — Total liabilities 4,610
5,835 Stockholders' equity:
Common stock, $0.00001 par value,
authorized 100,000,000 shares; 32,175,179 sharesissued and
outstanding at June 30, 2017; 32,044,087 shares issued and
outstanding atDecember 31, 2016
1
1
Accumulated other comprehensive loss (1 ) — Additional paid-in
capital 188,862 185,955 Accumulated deficit (169,893 ) (157,007 )
Total stockholders' equity 18,969 28,949 Total
liabilities and stockholders' equity 23,579 34,784
InVivo Therapeutics Holdings
Corp.
Consolidated Statements of Operations
and Comprehensive Loss
(Unaudited)
Three Months Ended
June 30,
Six Months Ended
June 30,
2017 2016 2017
2016 Operating expenses: Research and development 3,211
2,795 6,595 5,364 General and administrative 3,715 2,991
7,000 5,990 Total operating expenses 6,926
5,786 13,595 11,354 Operating loss
(6,926 ) (5,786 ) (13,595 ) (11,354 ) Other income
(expense): Interest income 52 36 109 91 Interest expense (20 ) (29
) (40 ) (92 ) Derivatives gain (loss) 554 595 795
(452 ) Other income (expense), net 586 602 864
(453 ) Net loss (6,340 ) (5,184 ) (12,731 ) (11,807 ) Net
loss per share, basic and diluted (0.20 ) (0.16 ) (0.40 ) (0.39 )
Weighted average number of common shares outstanding, basic and
diluted 32,185,607 31,907,747 32,115,328
30,039,677 Other comprehensive loss: Net loss (6,340
) (5,184 ) (12,731 ) (11,807 ) Other comprehensive loss: Unrealized
gain (loss) on marketable securities 1 — (1 ) —
Comprehensive loss (6,339 ) (5,184 ) (12,732 ) (11,807 )
Reconciliation of GAAP to non-GAAP measures
InVivo Therapeutics Holdings Corp. (In thousands, except
share and per share data)
Three Months Ended Six Months Ended June
30, June 30, 2017 2016 2017
2016 Reported GAAP net income (loss) (6,340 ) (5,184
) (12,731 ) (11,807 ) Add Back: Derivative (Gain)/ Loss (554 ) (595
) (795 ) 452 Adjusted Net Loss (6,894 ) (5,779 ) (13,526 )
(11,355 ) Reported GAAP net loss per diluted share (0.20 )
(0.16 ) (0.40 ) (0.39 ) Derivative loss per diluted share (0.02 )
(0.02 ) (0.02 ) 0.02 Adjusted net loss per diluted share
(0.22 ) (0.18 ) (0.42 ) (0.37 )
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version on businesswire.com: http://www.businesswire.com/news/home/20170808006533/en/
InVivo Therapeutics Holdings Corp.Heather Hamel,
617-863-5530Investor
RelationsInvestor-relations@invivotherapeutics.com
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