- Significant Increase in Operating Efficiency;
Operating Expenses Decreased by 59% -
- Progress on Initiation of INSPIRE 2.0 Study
-
InVivo Therapeutics Holdings Corp. (NVIV) today provided
a business update and reported financial results for the quarter
ended June 30, 2018.
Richard Toselli, M.D., President and Chief Executive Officer of
InVivo, commented, “We continued to make progress in the second
quarter of 2018, as the net proceeds of $13.5 million from our
successful June 2018 public offering have put us in a position to
focus on the initiation of the INSPIRE 2.0 Study. We are currently
engaging in the clinical site initiation process with
previously-identified sites and manufacturing the clinical product
for the Study. We have also selected a clinical research
organization for the Study. We look forward to providing future
updates on the progress of the INSPIRE 2.0 Study as we advance
toward patient enrollment.”
Financial Results
The Company remains focused on reducing its cash burn in order
to maximize the amount of resources available to support complete
patient enrollment in the INSPIRE 2.0 Study. Operating expenses in
the three-month period ended June 30, 2018 were $2.8m compared to
$6.9m for the three-month period ended June 30, 2017, representing
a 59% decrease in operating expenses. The Company’s operating
expenses for the six-month period ended June 30, 2018 was $7.6m
versus $13.6m for the six-months period ended June 30 2017,
representing a 44% decrease in operating expenses. The Company
anticipates that it will maintain its current cash burn rate of
less than $1m per month, including expenses related to the Inspire
2.0 Study, in the coming quarters.
For the three-month period ended June 30, 2018, the Company
reported a net loss of $12.9m, or $7.48 per diluted share, compared
to a net loss of $6.3m, or $4.92 per diluted share, for the
three-month period ended June 30, 2017. For the six-month period
ended June 30, 2018, the company reported a net loss of $17.7m, or
$11.2 per diluted share, compared to a net loss of $12.7m, or $9.91
per diluted share for the six-month period ended June 30, 2017. The
net loss increase was primarily driven by non-cash loss related to
derivative accounting on the warrants issued as part of the June
2018 public offering, as well as by financing costs related to the
offering. The Company anticipates the valuation of the derivative
warrant liability to reduce considerably over the coming quarters
as the warrants are exercised.
The Company ended the quarter with $22.3 million of cash and
cash equivalents.
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 is who now 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 commencement of
enrollment in the INSPIRE 2.0 Study and the expected length of the
Study, the impact of cost-control measures and the ability of the
Company to reduce its operating expenses and maintain its cash burn
rate, the ability of the Company to support complete patient
enrollment in the INSPIRE 2.0 Study with its current resources, the
valuation of the Company’s derivative warrant liability, and the
ability of the Company to continue clinical investigation of the
Company’s 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 need to raise additional capital, to
successfully decrease costs and spend and to successfully open
clinical sites for enrollment and to enroll additional patients if
such study 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, the Company’s Quarterly Report on Form 10-Q for the
period ended June 30, 2018 and its other filings with the SEC,
including the Company’s quarterly reports on Form 10-Q and current
reports on Form 8-K. The Company does not undertake to update these
forward-looking statements.
InVivo Therapeutics Holdings
Corp.Consolidated Balance SheetsUnaudited(In thousands, except
share and per share data)
As of
June 30,2018
December 31,2017
ASSETS: Current assets: Cash and cash
equivalents 22,320 12,910 Restricted cash 12 361 Prepaid expenses
and other current assets 1,235 535 Total current assets 23,567
13,806 Property, equipment and leasehold improvements, net 125 157
Restricted cash 90 — Other assets 77 82 Total assets 23,859 14,045
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT):
Current liabilities: Accounts payable 914 988 Loan payable,
current portion 330 452 Derivative warrant liability 21,469 4
Deferred rent, current portion — 30 Accrued expenses 2,996 1,638
Total current liabilities 25,709 3,112 Loan payable, net of current
portion — 400 Deferred rent, net of current portion — 367 Other
liabilities 59 56 Total liabilities 25,768 3,935
Stockholders' equity (deficit):
Common stock, $0.00001 par value,
authorized 25,000,000 shares; issued andoutstanding 4,077,667
shares at June 30, 2018; issued and outstanding 1,370,992shares at
December 31, 2017
1
1
Additional paid-in capital 199,720 194,016 Accumulated deficit
(201,630) (183,907) Total stockholders' equity (deficit) (1,909)
10,110 Total liabilities and stockholders' equity (deficit) 23,859
14,045
(Reflects 1-for-25 reverse stock split
effective April 16, 2018)
InVivo Therapeutics Holdings
Corp.Consolidated Statements of Operations and Comprehensive
Loss(Unaudited)
Three Months EndedJune
30,
Six Months EndedJune 30,
2018 2017 2018
2017 Operating expenses: Research and development 1,026
3,211 2,424 6,595 General and administrative 1,786 3,715 5,220
7,000 Total operating expenses 2,812 6,926 7,644 13,595 Operating
loss (2,812) (6,926)
(7,644)
(13,595) Other income (expense): Interest income /
(expense), net 33 32 51 69 Other income / (expense), net 26 — 68 —
Derivatives gain (loss)
(10,186)
554 (10,198) 795 Other income (expense), net (10,127) 586 (10,079)
864 Net loss (12,939) (6,340) (17,723) (12,731) Net loss per share,
basic and diluted (7.48) (4.92) (11.20) (9.91) Weighted average
number of common shares outstanding, basic and diluted 1,729,248
1,287,424 1,581,924 1,284,610
(Reflects 1-for-25 reverse stock split
effective April 16, 2018)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180807005736/en/
InVivo Therapeutics Holdings Corp.Heather Hamel,
617-863-5530Investor
RelationsInvestor-relations@invivotherapeutics.com
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