CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today provided a general business update and reported financial results for the quarter ended June 30, 2017.
Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “In the second quarter, we continued to make significant progress at InVivo. During the quarter, we enrolled four more patients into INSPIRE, and we now have 16 patients in follow-up. One of these patients improved from complete AIS A SCI to motor incomplete AIS C SCI at the one-month visit. We also announced that two patients who had previously converted to AIS B had been assessed to have converted to AIS C at their 12- and 24-month visits, respectively. Of the seven total AIS grade conversions, four are AIS C conversions at this time, meaning these four patients have recovered both sensory and motor function. Given these AIS C conversions and an overall conversion rate of 54.5% (6/11) at the 6-month primary endpoint visit, we remain enthusiastic about the potential of establishing the Neuro-Spinal Scaffold™ as the foundation of a new standard of care for acute spinal cord injury.
“Last week, we announced that the most recent patient to enroll into the INSPIRE study passed away with the cause of death deemed by the Principal Investigator at the site to be unrelated to the Neuro-Spinal Scaffold™ or implantation procedure. This was the third death in the INSPIRE study. Following discussions with the company’s independent Data Safety Monitoring Board (DSMB), we elected to implement a temporary halt to enrollment as we engaged with the FDA to determine whether any changes to the protocol were needed. The FDA responded formally with its recommendations; we are working on assessing the recommendations and formulating a response that will include a protocol amendment. At this time, our primary focus at InVivo is re-opening enrollment in INSPIRE as quickly as possible so that we can continue to make progress toward our goal of redefining the life of the spinal cord injury patient.”
Financial Results
For the three-month period ended June 30, 2017, the Company reported a net loss of approximately $6.3 million, or $0.20 per diluted share, compared to a net loss of $5.2 million, or $0.16 per diluted share, for the three-month period ended June 30, 2016. The results for the three-month period ended June 30, 2017 were unfavorably impacted by increases in operating expenses of $416,000 in research and development and $724,000 in general and administrative, partially offset by a non-cash gain on the derivative warrant liability of $554,000 for the three-month period ended June 30, 2017 reflecting changes in the fair market value of the derivative warrant liability. Excluding the impact of the derivative warrant liability, adjusted net loss for the three-month period ended June 30, 2017 was $6.9 million, or $0.22 per diluted share, compared to adjusted net loss of $5.8 million, or $0.18 per diluted share, for the three-month period ended June 30, 2016.
The Company ended the quarter with $21.8 million of cash, cash equivalents, and marketable securities.
For the six-month period ended June 30, 2017, the Company reported a net loss of approximately $12.7 million, or $0.40 per diluted share, compared to a net loss of $11.8 million or $0.39 per diluted share, for the six-month period ended June 30, 2016. The results for the six-month period ended June 30, 2017 were unfavorably impacted by increases in operating expenses of $1.2 million in research and development and $1.0 in general and administrative, partially offset by a non-cash gain on the derivative warrant liability of $795,000 for the six-month period ended June 30, 2017 reflecting changes in the fair market value of the derivative warrant liability. Excluding the impact of the derivative warrant liability, adjusted net loss for the six-month period ended June 30, 2017 was $13.5 million, or $0.42 per diluted share, compared to adjusted net loss of $11.4 million, or $0.37 per diluted share, for the six-month period ended June 30, 2016.
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.
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. 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 repair within and around 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 status of the clinical program, including the changes to the INSPIRE protocol, the timing for re-opening enrollment in the INSPIRE Study and the submission of an HDE application to the FDA. 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 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 June 30, 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 | ||||||||
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June 30, |
December 31, |
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| ASSETS: | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | 14,322 | 21,464 | ||||||
| Restricted cash | 361 | 361 | ||||||
| Marketable securities | 7,525 | 11,577 | ||||||
| Prepaid expenses and other current assets | 657 | 451 | ||||||
| Total current assets | 22,865 | 33,853 | ||||||
| Property, equipment and leasehold improvements, net | 305 | 510 | ||||||
| Other assets | 409 | 421 | ||||||
| Total assets | 23,579 | 34,784 | ||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY: | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | 878 | 1,011 | ||||||
| Loan payable, current portion | 437 | 423 | ||||||
| Derivative warrant liability | 519 | 1,314 | ||||||
| Deferred rent, current portion | 154 | 141 | ||||||
| Accrued expenses | 1,893 | 1,959 | ||||||
| Total current liabilities | 3,881 | 4,848 | ||||||
| Loan payable, net of current portion | 630 | 852 | ||||||
| Deferred rent, net of current portion | 54 | 135 | ||||||
| Other liabilities | 45 | — | ||||||
| Total liabilities | 4,610 | 5,835 | ||||||
| Stockholders' equity: | ||||||||
|
Common stock, $0.00001 par value, authorized 100,000,000 shares;
32,175,179 shares |
1 |
1 |
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| Accumulated other comprehensive loss | (1 | ) | — | |||||
| Additional paid-in capital | 188,862 | 185,955 | ||||||
| Accumulated deficit | (169,893 | ) | (157,007 | ) | ||||
| Total stockholders' equity | 18,969 | 28,949 | ||||||
| Total liabilities and stockholders' equity | 23,579 | 34,784 | ||||||
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InVivo Therapeutics Holdings Corp. Consolidated Statements of Operations and Comprehensive Loss (Unaudited) |
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Three Months Ended
June 30, |
Six Months Ended
June 30, |
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| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 3,211 | 2,795 | 6,595 | 5,364 | ||||||||||||
| General and administrative | 3,715 | 2,991 | 7,000 | 5,990 | ||||||||||||
| Total operating expenses | 6,926 | 5,786 | 13,595 | 11,354 | ||||||||||||
| Operating loss | (6,926 | ) | (5,786 | ) | (13,595 | ) | (11,354 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 52 | 36 | 109 | 91 | ||||||||||||
| Interest expense | (20 | ) | (29 | ) | (40 | ) | (92 | ) | ||||||||
| Derivatives gain (loss) | 554 | 595 | 795 | (452 | ) | |||||||||||
| Other income (expense), net | 586 | 602 | 864 | (453 | ) | |||||||||||
| Net loss | (6,340 | ) | (5,184 | ) | (12,731 | ) | (11,807 | ) | ||||||||
| Net loss per share, basic and diluted | (0.20 | ) | (0.16 | ) | (0.40 | ) | (0.39 | ) | ||||||||
| Weighted average number of | ||||||||||||||||
| common shares outstanding, basic and diluted | 32,185,607 | 31,907,747 | 32,115,328 | 30,039,677 | ||||||||||||
| Other comprehensive loss: | ||||||||||||||||
| Net loss | (6,340 | ) | (5,184 | ) | (12,731 | ) | (11,807 | ) | ||||||||
| Other comprehensive loss: | ||||||||||||||||
| Unrealized gain (loss) on marketable securities | 1 | — | (1 | ) | — | |||||||||||
| Comprehensive loss | (6,339 | ) | (5,184 | ) | (12,732 | ) | (11,807 | ) | ||||||||
| Reconciliation of GAAP to non-GAAP measures | ||||||||||||||||
| InVivo Therapeutics Holdings Corp. | ||||||||||||||||
| (In thousands, except share and per share data) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Reported GAAP net income (loss) | (6,340 | ) | (5,184 | ) | (12,731 | ) | (11,807 | ) | ||||||||
| Add Back: Derivative (Gain)/ Loss | (554 | ) | (595 | ) | (795 | ) | 452 | |||||||||
| Adjusted Net Loss | (6,894 | ) | (5,779 | ) | (13,526 | ) | (11,355 | ) | ||||||||
| Reported GAAP net loss per diluted share | (0.20 | ) | (0.16 | ) | (0.40 | ) | (0.39 | ) | ||||||||
| Derivative loss per diluted share | (0.02 | ) | (0.02 | ) | (0.02 | ) | 0.02 | |||||||||
| Adjusted net loss per diluted share | (0.22 | ) | (0.18 | ) | (0.42 | ) | (0.37 | ) | ||||||||
