InVivo Therapeutics Holdings Corp. (NVIV) today reported
financial results for the year ended December 31, 2018.
Richard Toselli, M.D., President and Chief Executive Officer of
InVivo, commented, “InVivo achieved many critical and exciting
milestones over the past year. Early in 2018 we received FDA
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), the
INSPIRE 2.0 Study. In addition, we successfully raised net proceeds
of $16.5 million in 2018, which put us in a position to focus on
the initiation of the INSPIRE 2.0 Study, while implementing
significant cost saving measures, which resulted in an $11.8
million or a 48 percent decrease in our operating expenses year
over year. Finally, we continue work towards enrollment in the
INSPIRE 2.0 Study, and with five clinical sites recently activated
and now open for enrollment, we expect to begin enrollment in Q2 of
this year.”
Dr. Toselli concluded, “In addition to continued progress on the
INSPIRE 2.0 Study and our fundraising activities, we are encouraged
by the prospect of building a more diversified pipeline with
technologies that align with our core competencies and fundamental
interests.”
Financial Results
Operating expenses for the years ended December 31, 2018 and
2017 were $12,767,000 and $24,593,000 respectively, representing a
48% decrease in operating expenses. For the year ended December 31,
2018, the Company reported a net loss of approximately $23,423,000,
or $4.69 per share, compared to a net loss of approximately
$26,745,000, or $20.29 per share, for the year ended December 31,
2017. Included in results for the years ended December 31, 2018 and
2017 were non-cash losses of $12,165,000 and $2,267,000,
respectively. The loss of $12,165,000 for the year ended December
31, 2018 can be attributed to the issuance of the liability
classified warrants in 2018 and the subsequent change in fair value
through the date of warrant exercises or reclassification to
equity. The loss of $2,267,000 for the year ended December 31, 2017
can be attributed to the impact of the August 2017 warrant exchange
and the decrease in the fair value of derivative warrant liability
primarily due to the decrease in the fair value of the underlying
common stock. Excluding the impact of the derivative warrant
liability, adjusted net loss for the year ended December 31, 2018,
was $11,258,000, or $2.25 per share, compared to an adjusted net
loss of $24,478,000, or $18.57 per share, for the year ended
December 31, 2017. The Company ended the year with $16,660,000 of
cash and cash equivalents as of December 31, 2018.
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 expected timing
for commencement of enrollment and completion of the Inspire 2.0
Study. 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 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, 2018, 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, 2018 2017 ASSETS:
Current assets: Cash and cash equivalents $ 16,660 $ 12,910
Restricted cash 4 361 Prepaid expenses and other current assets
461 535 Total current assets 17,125 13,806 Property,
equipment and leasehold improvements, net 100 157 Restricted cash
110 — Other assets 1,042 82 Total assets $ 18,377 $
14,045
LIABILITIES AND STOCKHOLDERS’ EQUITY: Current
liabilities: Accounts payable $ 815 $ 988 Loan payable, current
portion 100 452 Derivative warrant liability — 4 Deferred rent,
current portion — 30 Accrued expenses 1,290 1,638
Total current liabilities 2,205 3,112 Loan payable, net of current
portion — 400 Deferred rent, net of current portion — 367 Other
liabilities 61 56 Total liabilities 2,266
3,935 Commitments and contingencies (Note 15) Stockholders’
equity: Common stock, $0.00001 par value, authorized 25,000,000
shares;
9,309,255 shares issued and outstanding at
December 31, 2018;
1,370,992 shares issued and outstanding at
December 31, 2017
1 1 Additional paid-in capital 223,440 194,016 Accumulated deficit
(207,330) (183,907) Total stockholders’ equity
16,111 10,110 Total liabilities and stockholders’ equity $
18,377 $ 14,045
(Reflects the retrospective application of the 1-for-25 reverse
stock split effective April 16, 2018)
InVivo Therapeutics Holdings Corp
Consolidated Statements of Operations and
Comprehensive Loss (In thousands, except share and
per share data) Year Ended December 31,
2018 2017
Operating expenses: Research and development $ 4,931 $ 11,083
General and administrative 7,836 13,510
Total operating expenses 12,767 24,593
Operating loss (12,767 ) (24,593 ) Other income /
(expense): Interest income / (expense), net 206 115 Other income
1,303 — Derivatives (loss) (12,165 ) (2,267 ) Other
income / (expense), net (10,656 ) (2,152 ) Net loss $
(23,423 ) $ (26,745 ) Net loss per share, basic and diluted $ (4.69
) $ (20.29 ) Weighted average number of common shares outstanding,
basic and diluted 4,990,089 1,318,003
Other comprehensive loss: Net loss $ (23,423 ) $ (26,745 ) Other
comprehensive loss: Unrealized gain / (loss) on marketable
securities — — Comprehensive loss $
(23,423 ) $ (26,745 )
Reflects the retrospective application of the 1-for-25 reverse
stock split effective April 16, 2018
InVivo Therapeutics Holdings Corp
Reconciliation of GAAP to non-GAAP measures
(In thousands, except share and per-share data)
Year Ended December 31, 2018
2017 Reported GAAP net loss $ 23,423 $ 26,745 Derivative
loss 12,165 2,267 Adjusted net loss $ 11,258 $ 24,478
Reported GAAP net loss per diluted share $ 4.69 $ 20.29
Derivative loss per diluted share 2.44 1.72 Adjusted
net loss per diluted share $ 2.25 $ 18.57
(Reflects the retrospective application of the 1-for-25 reverse
stock split effective April 16, 2018)
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