Richard Toselli, M.D., President and Chief Executive Officer of InVivo, commented, “InVivo is charting a new and exciting path forward based on collaboration with the FDA that has continued through 2017 and into this year.”
Richard Toselli, M.D., President and Chief Executive Officer of InVivo, commented, “InVivo is charting a new and exciting path forward based on collaboration with the FDA that has continued through 2017 and into this year. We were pleased to announce last week that we received the agency’s 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). We believe this second trial, based on a randomized, controlled protocol comparing implantation of the Neuro-Spinal Scaffold to the standard of care of spinal stabilization, will provide critical data and support to enhance the clinical findings we already have generated in our previous single arm pivotal study.”
Dr. Toselli added, “Looking forward, we are actively exploring the financing options that will support the approved pivotal study and will provide updates accordingly. We estimate that from study initiation, enrollment will take place over approximately 18 months, with the full study completing in two years.”
Financial Results
For the year ended December 31, 2017, the Company reported a net loss of approximately $26,745,000, or $0.81 per share, compared to a net loss of approximately $23,438,000, or $0.76 per share, for the year ended December 31, 2016. Included in results for the years ended December 31, 2017 and 2016 were a non-cash loss of $2,267,000 and a non-cash gain of $593,000, respectively, reflecting the impact of the August 2017 warrant exchange on the derivative warrant liability and changes in the fair market value of the derivative warrant liability. Excluding the impact of the derivative warrant liability, adjusted net loss for the year ended December 31, 2017, was $24,478,000, or $0.74 per share, compared to an adjusted net loss of $24,031,000, or $0.78 per share, for the year ended December 31, 2016. The Company ended the year with $12,910,000 of cash and cash equivalents as of December 31, 2017.
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 anticipated value of the second pivotal study, the expected timing for enrollment and completion of the second pivotal study, the Company’s ability to identify financing options that will support the second pivotal study and the benefits of the 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 Company’s ability to successfully identify financing alternatives and raise the capital necessary to undertake the second pivotal trial, the ability to successfully open additional clinical sites for enrollment and to enroll additional patients if such trial 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, 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, | ||||||||
| 2017 | 2016 | |||||||
| ASSETS: | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 12,910 | $ | 21,464 | ||||
| Restricted cash | 361 | 361 | ||||||
| Marketable securities | — | 11,577 | ||||||
| Prepaid expenses and other current assets | 535 | 451 | ||||||
| Total current assets | 13,806 | 33,853 | ||||||
| Property, equipment and leasehold improvements, net | 157 | 510 | ||||||
| Other assets | 82 | 421 | ||||||
| Total assets | $ | 14,045 | $ | 34,784 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY: | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 988 | $ | 1,011 | ||||
| Loan payable, current portion | 452 | 423 | ||||||
| Derivative warrant liability | 4 | 1,314 | ||||||
| Deferred rent, current portion | 30 | 141 | ||||||
| Accrued expenses | 1,638 | 1,959 | ||||||
| Total current liabilities | 3,112 | 4,848 | ||||||
| Loan payable, net of current portion | 400 | 852 | ||||||
| Deferred rent, net of current portion | 367 | 135 | ||||||
| Other liabilities | 56 | — | ||||||
| Total liabilities | 3,935 | 5,835 | ||||||
|
Commitments and contingencies |
||||||||
| Stockholders’ equity: | ||||||||
|
Common stock, $0.00001 par value, authorized 100,000,000 shares; |
1 | 1 | ||||||
| Additional paid-in capital | 194,016 | 185,955 | ||||||
| Accumulated deficit | (183,907) | (157,007) | ||||||
| Total stockholders’ equity | 10,110 | 28,949 | ||||||
| Total liabilities and stockholders’ equity | $ | 14,045 | $ | 34,784 | ||||
|
InVivo Therapeutics Holdings Corp |
||||||||||||||
| Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||
| (In thousands, except share and per share data) | ||||||||||||||
| Year Ended December 31, | ||||||||||||||
| 2017 | 2016 | 2015 | ||||||||||||
| Operating expenses: | ||||||||||||||
| Research and development | $ | 11,083 | $ | 12,557 | $ | 10,058 | ||||||||
| General and administrative | 13,510 | 11,506 | 12,340 | |||||||||||
| Total operating expenses | 24,593 | 24,063 | 22,398 | |||||||||||
| Operating loss | (24,593) |
|
(24,063) | (22,398) | ||||||||||
| Other income (expense): | ||||||||||||||
| Interest income | 189 | 187 | 60 | |||||||||||
| Interest expense | (74) | (155) | (172) | |||||||||||
| Derivatives gain (loss) | (2,267) | 593 | (10,804) | |||||||||||
| Other income (expense), net | (2,152) | 625 | (10,916) | |||||||||||
| Net loss | $ | (26,745) | $ | (23,438) | $ | (33,314) | ||||||||
| Net loss per share, basic and diluted | $ | (0.81) | $ | (0.76) | $ | (1.26) | ||||||||
|
Weighted average number of common |
32,950,068 | 31,025,585 | 26,461,374 | |||||||||||
| Other comprehensive loss: | ||||||||||||||
| Net loss | (26,745) | (23,438) | (33,314) | |||||||||||
| Other comprehensive loss: | ||||||||||||||
|
Unrealized gain (loss) on marketable securities |
— | — | — | |||||||||||
| Comprehensive loss | $ | (26,745) | $ | (23,438) | $ | (33,314) | ||||||||
|
Reconciliation of GAAP to non-GAAP measures |
|||||||||
| InVivo Therapeutics Holdings Corp. | |||||||||
| (In thousands, except share and per share data) | |||||||||
| Three Months Ended | Year Ended | ||||||||
| December 31, | December 31, | ||||||||
| 2017 | 2016 | 2017 | 2016 | ||||||
| Reported GAAP net income (loss) | (4,664) | (5,435) | (26,745) | (23,438) | |||||
| Derivative (gain)/loss | 3 | (1,381) | 2,267 | (593) | |||||
| Adjusted net loss | (4,661) | (6,816) | (24,478) | (24,031) | |||||
| Reported GAAP net loss per diluted share | (0.13) | (0.17) | (0.81) | (0.76) | |||||
| Derivative (gain)/loss per diluted share | 0.00 | (0.04) | 0.07 | (0.02) | |||||
| Adjusted net loss per diluted share | (0.13) | (0.21) | (0.74) | (0.78) | |||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20180312005580/en/
Contacts
InVivo Therapeutics Holdings Corp.
Heather Hamel, 617-863-5530
Investor Relations
Investor-relations@invivotherapeutics.com
Source: InVivo Therapeutics Holdings Corp.
View this news release online at:
http://www.businesswire.com/news/home/20180312005580/en
