CAMBRIDGE, Mass.–(BUSINESS WIRE)–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)
Contacts
IR CONTACT:
Bret Shapiro, Managing Partner
CORE IR
Phone:
(516) 222-2560
brets@coreir.com
MEDIA
CONTACT:
Jules Abraham
CORE IR
Phone: (917) 885-7378
julesa@coreir.com