- INSPIRE Patient Updates -
InVivo Therapeutics Holdings Corp. (NVIV) today provided
a clinical update, an update on patients in the INSPIRE study of
the Neuro-Spinal Scaffold™, and reported financial results for the
quarter ended March 31, 2017.
Clinical/Regulatory Update
Mark Perrin, InVivo’s Chief Executive Officer and Chairman,
said, “In the first quarter, we continued to make significant
progress at InVivo and with the INSPIRE study. By early April, we
had enrolled four new patients into the INSPIRE study, with three
patients enrolled within 30 days of each other. We also announced
four new clinical sites for the INSPIRE study.
In addition to progress with INSPIRE enrollment and sites, we
achieved several regulatory milestones. Health Canada approved the
company’s Investigational Testing Authorization application to
commence a clinical study of the Neuro-Spinal Scaffold in patients
with acute, complete (AIS A) cervical (C5-T1) spinal cord injuries
(SCIs), and we announced the opening of our first site for the
cervical study, Toronto Western Hospital. We also announced the
Medicines Healthcare Products Regulatory Agency (MHRA) approval of
the company’s Clinical Trial Authorization Application to commence
the INSPIRE study in the United Kingdom. Finally, we submitted the
first module of our Humanitarian Device Exemption (HDE) application
to the FDA.
Looking forward, we anticipate completing enrollment in the
INSPIRE study in the third quarter and filing an HDE application
for marketing approval of the Neuro-Spinal Scaffold in early
2018.”
INSPIRE Patient Updates
There are currently 14 INSPIRE patients in follow-up, and eight
have reached the six-month primary endpoint. Of these eight
patients, five had an AIS grade improvement (compared to baseline)
and three did not have an AIS grade improvement at 6 months
post-injury (a 62.5% conversion rate at 6 months). The INSPIRE AIS
improvement rate remains considerably higher than rates observed in
a range of SCI natural history databases.
InVivo announced in January 2017 that a patient enrolled into
INSPIRE in December 2016 had improved from a complete AIS A spinal
cord injury to an incomplete AIS B spinal cord injury at the
one-month evaluation. At a recent follow-up visit (the first since
January), the patient was assessed to have reverted back to a
complete AIS A spinal cord injury.
Separately, in March 2017 InVivo announced that a patient
enrolled in January 2017 had improved from a complete AIS A spinal
cord injury to an incomplete AIS B spinal cord injury at the
two-month evaluation. At the recent three-month follow-up
evaluation, the patient was assessed to have reverted back to a
complete AIS A spinal cord injury.
There are previously published examples of patients with
baseline AIS A spinal cord injury that are assessed to have an AIS
grade improvement followed by a return to complete AIS A status
within the first year after injury. In a 2009 article, 12.5% (2/16)
of baseline AIS A spinal cord injury patients (cervical and
thoracic) who experienced an AIS grade improvement were later
assessed to return to complete AIS A status within the first year
after injury. Of those two patients, one patient improved back to
an incomplete AIS grade within the same year.*
“The AIS grade improvement rate observed thus far in the INSPIRE
study compares favorably to the natural history of spinal cord
injury,” CEO and Chairman Mark Perrin said. “We look forward to
monitoring these patients’ progress as they reach the primary
endpoint at six months post-injury and as we work towards
completing enrollment of INSPIRE.”
Financial Results
For the three-month period ended March 31, 2017, the Company
reported a net loss of approximately $6.4 million, or $0.20 per
diluted share, compared to a net loss of $6.6 million, or $0.24 per
diluted share, for the three-month period ended March 31, 2016. The
results for the three-month period ended March 31, 2017 were
unfavorably impacted by increases in operating expenses of $816,000
in research and development and $286,000 in general and
administrative, partially offset by a non-cash gain on the
derivative warrant liability of $241,000 reflecting changes in the
fair market value of the derivative warrant liability. The results
for the three-month period ended March 31, 2016 were unfavorably
impacted by a non-cash loss on the derivative warrant liability of
$1.0 million. Excluding the impact of the derivative warrant
liability, adjusted net loss for the three-month period ended March
31, 2017 was $6.6 million, or $0.21 per diluted share, compared to
adjusted net loss of $5.6 million, or $0.20 per diluted share, for
the three-month period ended March 31, 2016.
The Company ended the quarter with $26.8 million of cash, cash
equivalents, and marketable securities.
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.
* Spiess et al. Conversion in ASIA Impairment Scale during the
First Year after Traumatic Spinal Cord Injury. Journal of
Neurotrauma 26: 2027-2036 (November 2009).
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. The
FDA has recommended that InVivo include a control arm in the study
as part of a Study Design Consideration. We are in discussions with
the FDA on this recommendation, and we continue to believe that our
current study design is sufficient to demonstrate safety and
probable benefit in support of an HDE application for marketing
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 regeneration across 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 progress of the
clinical program. 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
complete The INSPIRE Study, submit an HDE application, and receive
regulatory approval for the Neuro-Spinal Scaffold, the company’s
ability 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 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
March 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 Unaudited As of
March 31, 2017
December 31, 2016 ASSETS: Current assets: Cash
and cash equivalents 14,440 21,464 Restricted cash 361 361
Short-term marketable securities 11,649 11,577 Prepaid expenses and
other current assets 940 451 Total current assets 27,390 33,853
Long-term marketable securities 751 — Property, equipment and
leasehold improvements, net 395 510 Other assets 415 421 Total
assets 28,951 34,784
LIABILITIES AND STOCKHOLDERS'
EQUITY: Current liabilities: Accounts payable 1,038
1,011 Loan payable, current portion 430 423 Derivative warrant
liability 1,073 1,314 Deferred rent, current portion 147 141
Accrued expenses 1,421 1,959 Total current liabilities 4,109 4,848
Loan payable, net of current portion 742 852 Deferred rent, net of
current portion 95 135 Other liabilities 36 — Total liabilities
4,982 5,835 Stockholders' equity: Common stock, $0.00001 par
value, authorized 100,000,000 shares; issued and
outstanding 32,123,392 shares at March 31,
2017; issued and outstanding 32,044,087
shares at December 31, 2016
1
1
Accumulated other comprehensive loss (2) — Additional paid-in
capital 187,523 185,955 Accumulated deficit (163,553) (157,007)
Total stockholders' equity 23,969 28,949 Total liabilities and
stockholders' equity 28,951 34,784
InVivo Therapeutics
Holdings Corp. Consolidated Statements of Operations and
Comprehensive Loss (Unaudited) Three
Months Ended March 31, 2017 2016 Operating
expenses: Research and development 3,384 2,568 General and
administrative 3,285 2,999 Total operating expenses 6,669 5,567
Operating loss (6,669) (5,567) Other income (expense):
Interest income 57 54 Interest expense (20) (63) Derivatives gain
(loss) 241 (1,047) Other income (expense), net 278 (1,056) Net loss
(6,391) (6,623) Net loss per share, basic and diluted (0.20) (0.24)
Weighted average number of common shares outstanding, basic and
diluted 32,080,141 28,171,606 Other comprehensive loss: Net
loss (6,391) (6,623) Other comprehensive loss: Unrealized loss on
marketable securities (2) — Comprehensive loss (6,393) (6,623)
Reconciliation of GAAP to non-GAAP measures InVivo
Therapeutics Holdings Corp. (In thousands, except share and
per share data) Three Months Ended
March 31, 2017 2016 Reported GAAP net
loss (6,391) (6,623) Derivatives (gain) loss (241) 1,047 Adjusted
net loss (6,632) (5,576) Reported GAAP net loss per diluted
share (0.20) (0.24) Derivative (gain) loss per diluted share (0.01)
0.04 Adjusted net loss per diluted share (0.21) (0.20)
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InVivo Therapeutics Holdings Corp.Heather Hamel,
617-863-5530Investor
RelationsInvestor-relations@invivotherapeutics.com
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