Market Overview

InVivo Therapeutics Reports 2018 Second Quarter Financial Results

Share:

- 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
Sheets
Unaudited
(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 and
outstanding 4,077,667 shares at June 30, 2018;
issued and outstanding 1,370,992
shares 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 Ended
June 30,

   

Six Months Ended
June 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)

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