InVivo Therapeutics Reports 2015 Third Quarter Financial Results and Business Update

InVivo Therapeutics Holdings Corp. (NVIV) today reported financial results for the quarter ended September 30, 2015.

Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “We continued to make substantive and fundamental progress at InVivo through the third quarter and communicated our advancements through several media, scientific, and medical outlets. We enrolled the last two patients of the planned five-patient pilot study and announced an AIS conversion in the third patient with a high thoracic injury at one month, which occurs less than four percent of the time. We also announced plans to transition the pilot study into a pivotal probable benefit study and use this single study as the basis for a Humanitarian Device Exemption application. We look forward to communicating the finalized pivotal probable benefit study design and associated timelines before the end of the year. It was a productive quarter, and we reiterate our previous cash forecast: we anticipate our cash position will last us into the fourth quarter of 2016.”

Financial Results

For the quarter ended September 30, 2015, the Company reported a net loss of approximately $2,308,000, or $.09 per diluted share, compared to a net loss of $1,213,000, or $.05 per diluted share, for the quarter ended September 30, 2014. The 2015 results were favorably impacted by a gain in the derivative warrant liability of $3,591,000 reflecting changes in the fair market value of the derivative warrant liability. The results for the three months ended September 2014 were favorably impacted by a gain in the deferred warrant liability of $3,005,000. Excluding these charges, for the quarters ended September 30, 2015 and September 30, 2014, adjusted net loss per diluted share were $.22 and $.18 respectively.

The Company ended the quarter with $22,146,000 of cash and cash equivalents. During the third quarter, the Company received $925,000 from the redemption of warrants related to the May 2014 public offering.

For the nine months ended September 30, 2015, the Company reported a net loss of approximately $28,581,000, or $1.09 per diluted share, compared to a net loss of $9,961,000 or $.46 per diluted share, for the nine months ended September 30, 2014. The 2015 results were adversely impacted by a loss in the derivative warrant liability of $11,349,000 reflecting changes in the fair market value of the derivative warrant liability. The results for the nine months ended September 30, 2014 were favorably impacted by a gain in the derivative warrant liability of $4,132,000. This gain was partly offset by a charge related to the re-alignment of resources, completed in the second quarter of 2014, of $309,000, Exclusive of these items, for the nine months ended September 30, 2015 and September 30, 2014, adjusted net loss per diluted share were $.66 and $.64 respectively.

Through the first nine months or 2015, the Company received $7.8 million from the exercise of warrants related to the May 2014 public offering. This represents approximately 78% of the total warrants issued in that offering.

Adjusted net loss and adjusted net loss per share are non-GAAP financial measures that exclude the items noted. 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, on a period-to-period comparable basis, financial amounts both including and excluding these identified items, the Company's operations.

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" and similar expressions, and include statements regarding the expected timing and receipt of FDA approval of a pivotal probable benefit study and subsequent Humanitarian Device Exemption application. 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 modify its pilot trial protocol or to conduct a future study; 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 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, 2014, as amended, 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.

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