SOURCE: InVivo Therapeutics

InVivo Therapeutics

March 24, 2011 16:19 ET

InVivo Therapeutics Holdings Corp. Reports 2010 Financial Results

CAMBRIDGE, MA--(Marketwire - March 24, 2011) - InVivo Therapeutics Holdings Corp. (OTCBB: NVIV), a company focused on the development of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today reported financial results for the year ended December 31, 2010.

For the year ended December 31, 2010, the company reported a net loss of $9,057,000, or $0.27 per share, as compared to a net loss of $2,516,000, or $0.10 per share, for the year ended December 31, 2009. Included in the net loss for the year 2010 was a non-cash charge of $5,099,000 for derivative losses. The company ended the year with $8,964,000 of cash and investments and had no outstanding debt. As previously announced, on October 26, 2010, the company completed a reverse merger with a publicly traded company. The company also completed a private placement raising $13 million of gross proceeds and $10.9 million of net proceeds in December 2010.

"2010 brought many significant achievements and advancements for InVivo," said Frank Reynolds, InVivo's Chief Executive Officer. "We went public through a reverse merger, completed our largest financing to date, added leadership to our management team and board and announced the opening of a pilot manufacturing and development facility. In 2011, we expect to advance the development of our biopolymer scaffolding device for SCI with the filing and FDA approval of an Investigational Device Exemption followed by the commencement of human clinical studies."

Recent Highlights

-- Reverse merger and financing; In October 2010, the company announced the
   successful completion of a reverse merger and private placement
   financing. The oversubscribed offering, which closed in December 2010,
   included the issuance of 13 million units (each unit consisting of one
   share of common stock and one warrant exercisable at $1.40 per share)
   raising $13 million of gross proceeds and $10.9 million of net
   proceeds. If all of the warrants are exercised for cash, the company
   will receive an additional $18.2 million of gross proceeds.

-- Opening of the manufacturing and development facility; In November 2010,
   the company announced that it signed a lease to open its first
   manufacturing and development facility in Medford, Massachusetts. The
   new facility is being used to scale up the manufacturing process for its
   lead product candidate, a novel biocompatible polymer scaffolding device
   used to treat acute open-wound SCI.

-- Appointments to the management team and board of directors; The company
   announced the appointment of George Nolen, former President and CEO of
   Siemens Corporation and a Director of InVivo, to the position of Lead
   Director, effective December 10, 2010. The company also announced the
   appointments of Christopher Pritchard, Ph.D., Chief Science Officer, in
   September 2010 and Phil Pereira, Director of Manufacturing,
   in February 2011.

-- Announced data on novel hydrogel technology; In March 2011, the company
   announced the presentation of data at the 2011 Annual Meeting of the
   American Association of Neurological Surgeons/Central Nervous System
   Section on Disorders of the Spine and Peripheral Nerves.
   Eric J. Woodard, M.D., Chief of Neurosurgery, New England Baptist
   Hospital, co-authored and presented the poster titled "An injectable
   thiol-acrylate poly(ethylene glycol) hydrogel for sustained release of
   methylprednisolone sodium succinate for treatment of spinal cord injury
   and in neurosurgical applications." The laboratory investigation was
   designed to evaluate the potential of the company's rationally designed
   hydrogel to overcome limitations associated with systemic administration
   of high-dose methylprednisolone (MP), a steroid commonly used in the
   treatment of SCI.

The securities sold in the private placement have not been registered under the Securities Act of 1933 and may not be resold absent registration under or exemption from such Act. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities. This press release is being issued pursuant to and in accordance with Rule 135c under the Securities Act of 1933.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a Cambridge, MA medical device company focused on utilizing polymers as a platform technology to develop treatments to improve function in individuals paralyzed as a result of traumatic spinal cord injury. The company was founded in 2005 on the basis of proprietary technology co-invented by Robert Langer, ScD, Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, MD, who is affiliated with Massachusetts General Hospital in Boston. For more information on InVivo Therapeutics, please 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. Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties. The 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 sell additional shares of common stock, 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, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in our filings with the SEC, including, our annual report on Form 10-K and our current reports on Form 8-K. We do not undertake to update these forward-looking statements made by us.

                    InVivo Therapeutics Holdings Corp.
                        Consolidated Balance Sheets

                                                        December 31,
                                                  ------------------------
                                                      2010         2009
                                                  -----------  -----------
ASSETS:

Current assets:
    Cash and cash equivalents                     $ 8,964,194  $   226,667
    Prepaid expenses                                   81,166       10,898
                                                  -----------  -----------
                  Total current assets              9,045,360      237,565

Property and equipment, net                           280,181      173,797
Other assets                                           53,639       58,639
                                                  -----------  -----------

                  Total assets                    $ 9,379,180  $   470,001
                                                  ===========  ===========

LIABILITIES AND STOCKHOLDERS' DEFICIT:

Current liabilities:
    Accounts payable                              $   336,945  $    81,175
    Accrued interest payable                                -      283,608
    Derivative warrant liabilitity                 10,647,190            -
    Accrued expenses                                  247,547      293,584
                                                  -----------  -----------
                  Total current liabilities        11,231,682      658,367

Loans payable                                               -      590,985
Convertible notes payable                                   -    2,840,000
                                                  -----------  -----------
                  Total liabilities                11,231,682    4,089,352
                                                  -----------  -----------

Commitments and contingencies

Stockholders' deficit:
    Common stock , $0.00001 par value; authorized
     100,000,000 shares, issued and outstanding
     51,647,171 and 26,259,515 shares outstanding
     at Decemember 31, 2010 and 2009, respectively        516          263
    Additional paid-in capital                     12,382,141    1,558,283
    Deficit accumulated during the development
     stage                                        (14,235,159)  (5,177,897)
                                                  -----------  -----------
                  Total stockholders' deficit      (1,852,502)  (3,619,351)
                                                  -----------  -----------

                  Total liabilities and
                   stockholders' deficit          $ 9,379,180  $   470,001
                                                  ===========  ===========




                    INVIVO THERAPEUTICS HOLDINGS CORP.
                  CONSOLIDATED STATEMENTS OF OPERATIONS

                                                        Years Ended
                                                        December 31,
                                                  ------------------------
                                                      2010         2009
                                                  -----------  -----------

Operating expenses:
    Research and development                      $ 1,673,202  $ 1,807,908
    General and administrative                      1,724,102      835,515
                                                  -----------  -----------
           Total operating expenses                 3,397,304    2,643,423
                                                  -----------  -----------

Operating loss                                     (3,397,304)  (2,643,423)
                                                  -----------  -----------

Other income (expense):
    Other income                                            -      383,000
    Interest income                                     3,379          282
    Interest expense                                 (564,443)    (255,737)
    Derivatives losses                             (5,098,894)           -
                                                  -----------  -----------
           Other income (expense), net             (5,659,958)     127,545
                                                  -----------  -----------

Net loss                                          $(9,057,262) $(2,515,878)
                                                  ===========  ===========

Net loss per share, basic and diluted             $     (0.27) $     (0.10)
                                                  ===========  ===========
Weighted average number of common shares
 outstanding, basic and diluted                    33,367,239   25,496,366
                                                  ===========  ===========

Contact Information