CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today provided a clinical update, an update on patients in the INSPIRE study of the Neuro-Spinal Scaffold™, and reported financial results for the quarter ended March 31, 2017.
Clinical/Regulatory Update
Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “In the first quarter, we continued to make significant progress at InVivo and with the INSPIRE study. By early April, we had enrolled four new patients into the INSPIRE study, with three patients enrolled within 30 days of each other. We also announced four new clinical sites for the INSPIRE study.
In addition to progress with INSPIRE enrollment and sites, we achieved several regulatory milestones. Health Canada approved the company’s Investigational Testing Authorization application to commence a clinical study of the Neuro-Spinal Scaffold in patients with acute, complete (AIS A) cervical (C5-T1) spinal cord injuries (SCIs), and we announced the opening of our first site for the cervical study, Toronto Western Hospital. We also announced the Medicines Healthcare Products Regulatory Agency (MHRA) approval of the company’s Clinical Trial Authorization Application to commence the INSPIRE study in the United Kingdom. Finally, we submitted the first module of our Humanitarian Device Exemption (HDE) application to the FDA.
Looking forward, we anticipate completing enrollment in the INSPIRE study in the third quarter and filing an HDE application for marketing approval of the Neuro-Spinal Scaffold in early 2018.”
INSPIRE Patient Updates
There are currently 14 INSPIRE patients in follow-up, and eight have reached the six-month primary endpoint. Of these eight patients, five had an AIS grade improvement (compared to baseline) and three did not have an AIS grade improvement at 6 months post-injury (a 62.5% conversion rate at 6 months). The INSPIRE AIS improvement rate remains considerably higher than rates observed in a range of SCI natural history databases.
InVivo announced in January 2017 that a patient enrolled into INSPIRE in December 2016 had improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury at the one-month evaluation. At a recent follow-up visit (the first since January), the patient was assessed to have reverted back to a complete AIS A spinal cord injury.
Separately, in March 2017 InVivo announced that a patient enrolled in January 2017 had improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury at the two-month evaluation. At the recent three-month follow-up evaluation, the patient was assessed to have reverted back to a complete AIS A spinal cord injury.
There are previously published examples of patients with baseline AIS A spinal cord injury that are assessed to have an AIS grade improvement followed by a return to complete AIS A status within the first year after injury. In a 2009 article, 12.5% (2/16) of baseline AIS A spinal cord injury patients (cervical and thoracic) who experienced an AIS grade improvement were later assessed to return to complete AIS A status within the first year after injury. Of those two patients, one patient improved back to an incomplete AIS grade within the same year.*
“The AIS grade improvement rate observed thus far in the INSPIRE study compares favorably to the natural history of spinal cord injury,” CEO and Chairman Mark Perrin said. “We look forward to monitoring these patients’ progress as they reach the primary endpoint at six months post-injury and as we work towards completing enrollment of INSPIRE.”
Financial Results
For the three-month period ended March 31, 2017, the Company reported a net loss of approximately $6.4 million, or $0.20 per diluted share, compared to a net loss of $6.6 million, or $0.24 per diluted share, for the three-month period ended March 31, 2016. The results for the three-month period ended March 31, 2017 were unfavorably impacted by increases in operating expenses of $816,000 in research and development and $286,000 in general and administrative, partially offset by a non-cash gain on the derivative warrant liability of $241,000 reflecting changes in the fair market value of the derivative warrant liability. The results for the three-month period ended March 31, 2016 were unfavorably impacted by a non-cash loss on the derivative warrant liability of $1.0 million. Excluding the impact of the derivative warrant liability, adjusted net loss for the three-month period ended March 31, 2017 was $6.6 million, or $0.21 per diluted share, compared to adjusted net loss of $5.6 million, or $0.20 per diluted share, for the three-month period ended March 31, 2016.
The Company ended the quarter with $26.8 million of cash, cash equivalents, and marketable securities.
Adjusted net loss and adjusted net loss per share are non-GAAP financial measures that exclude the impact of the derivative warrant liability. A reconciliation of these measures to the comparable GAAP measure is included with the tables contained in this release. The Company believes a presentation of these non-GAAP measures provides useful information to investors to better understand the Company's operations, on a period-to-period comparable basis, with financial amounts both including and excluding the identified items.
* Spiess et al. Conversion in ASIA Impairment Scale during the First Year after Traumatic Spinal Cord Injury. Journal of Neurotrauma 26: 2027-2036 (November 2009).
About The INSPIRE Study
The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury, is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold™ for the treatment of complete T2-T12/L1 spinal cord injury in support of a Humanitarian Device Exemption (HDE) application for approval. The FDA has recommended that InVivo include a control arm in the study as part of a Study Design Consideration. We are in discussions with the FDA on this recommendation, and we continue to believe that our current study design is sufficient to demonstrate safety and probable benefit in support of an HDE application for marketing approval. For more information, refer to https://clinicaltrials.gov/ct2/show/study/NCT02138110.
About the Neuro-Spinal Scaffold™ Implant
Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in The INSPIRE Study for the treatment of patients with acute, complete (AIS A), thoracic traumatic spinal cord injury and a pilot study for acute, complete (AIS A), cervical (C5-T1) traumatic spinal cord injury. For more information on the cervical study, refer to https://clinicaltrials.gov/ct2/show/study/NCT03105882.
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 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. 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," “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold and the progress of the clinical program. 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 complete The INSPIRE Study, submit an HDE application, and receive regulatory approval for the Neuro-Spinal Scaffold, the company’s ability 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 the treatment of 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 Quarterly Report of the three months ended March 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 | ||||
| Unaudited | ||||
| As of | ||||
|
March 31, 2017 |
December 31, 2016 | |||
| ASSETS: | ||||
| Current assets: | ||||
| Cash and cash equivalents | 14,440 | 21,464 | ||
| Restricted cash | 361 | 361 | ||
| Short-term marketable securities | 11,649 | 11,577 | ||
| Prepaid expenses and other current assets | 940 | 451 | ||
| Total current assets | 27,390 | 33,853 | ||
| Long-term marketable securities | 751 | — | ||
| Property, equipment and leasehold improvements, net | 395 | 510 | ||
| Other assets | 415 | 421 | ||
| Total assets | 28,951 | 34,784 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY: | ||||
| Current liabilities: | ||||
| Accounts payable | 1,038 | 1,011 | ||
| Loan payable, current portion | 430 | 423 | ||
| Derivative warrant liability | 1,073 | 1,314 | ||
| Deferred rent, current portion | 147 | 141 | ||
| Accrued expenses | 1,421 | 1,959 | ||
| Total current liabilities | 4,109 | 4,848 | ||
| Loan payable, net of current portion | 742 | 852 | ||
| Deferred rent, net of current portion | 95 | 135 | ||
| Other liabilities | 36 | — | ||
| Total liabilities | 4,982 | 5,835 | ||
| Stockholders' equity: | ||||
|
Common stock, $0.00001 par value, authorized 100,000,000 shares;
issued and
outstanding 32,123,392 shares at March 31, 2017; issued and outstanding 32,044,087 shares at December 31, 2016 |
1 |
1 |
||
| Accumulated other comprehensive loss | (2) | — | ||
| Additional paid-in capital | 187,523 | 185,955 | ||
| Accumulated deficit | (163,553) | (157,007) | ||
| Total stockholders' equity | 23,969 | 28,949 | ||
| Total liabilities and stockholders' equity | 28,951 | 34,784 | ||
| InVivo Therapeutics Holdings Corp. | ||||
| Consolidated Statements of Operations and Comprehensive Loss | ||||
| (Unaudited) | ||||
| Three Months Ended March 31, | ||||
| 2017 | 2016 | |||
| Operating expenses: | ||||
| Research and development | 3,384 | 2,568 | ||
| General and administrative | 3,285 | 2,999 | ||
| Total operating expenses | 6,669 | 5,567 | ||
| Operating loss | (6,669) | (5,567) | ||
| Other income (expense): | ||||
| Interest income | 57 | 54 | ||
| Interest expense | (20) | (63) | ||
| Derivatives gain (loss) | 241 | (1,047) | ||
| Other income (expense), net | 278 | (1,056) | ||
| Net loss | (6,391) | (6,623) | ||
| Net loss per share, basic and diluted | (0.20) | (0.24) | ||
| Weighted average number of | ||||
| common shares outstanding, basic and diluted | 32,080,141 | 28,171,606 | ||
| Other comprehensive loss: | ||||
| Net loss | (6,391) | (6,623) | ||
| Other comprehensive loss: | ||||
| Unrealized loss on marketable securities | (2) | — | ||
| Comprehensive loss | (6,393) | (6,623) | ||
| Reconciliation of GAAP to non-GAAP measures | ||||
| InVivo Therapeutics Holdings Corp. | ||||
| (In thousands, except share and per share data) | ||||
| Three Months Ended | ||||
| March 31, | ||||
| 2017 | 2016 | |||
| Reported GAAP net loss | (6,391) | (6,623) | ||
| Derivatives (gain) loss | (241) | 1,047 | ||
| Adjusted net loss | (6,632) | (5,576) | ||
| Reported GAAP net loss per diluted share | (0.20) | (0.24) | ||
| Derivative (gain) loss per diluted share | (0.01) | 0.04 | ||
| Adjusted net loss per diluted share | (0.21) | (0.20) | ||
