CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV), a life sciences company focused on the development and commercialization of novel drug delivery technologies as well as biopolymer devices for the treatment of spinal cord injuries and other nervous system conditions, today reported financial results for the three and nine months ended September 30, 2013.
Michael Astrue, the interim CEO of InVivo, said, “We remain focused on our efforts to start our first clinical trial in the next quarter. We expect to provide investors with a clinical/regulatory update in the coming weeks as well as with an update on our hydrogel platform technology.”
Financial Results
For the three months ended September 30, 2013, the Company reported a net loss of approximately $5,437,000 or $.07 per diluted share, compared to net income of $8,029,000 or $.11 per diluted share, for the three months ended September 30, 2012. Included in results for the three months ended September 30, 2012 were non-cash gains (losses) from derivatives and modification of warrants of $10,869,000, reflecting changes in the fair value of the derivative warrant liability. Exclusive of these non-cash items, the pro forma net loss for the three months ended September 30, 2013, was $5,436,600, or $.07 per diluted share, compared to a pro forma net loss of $2,840,000, or $.04 per diluted share for 2012. The Company ended the quarter with $18,333,000 of cash and cash equivalents.
For the nine months ended September 30, 2013, the Company reported a net loss of approximately $33,049,000 or $.46 per diluted share, compared to net income of $13,380,000, or $.19 per diluted share, for the nine months ended September 30, 2012. Included in results for the nine months ended September 30, 2013 and 2012 were non-cash gains (losses) from modification of warrants and derivatives of $(19,636,000), and $21,437,000, respectively, reflecting changes in the fair value of the derivative warrant liability. Exclusive of these non-cash items, the pro forma net loss for the nine months ended September 30, 2013, was $13,413,000, or $.19 per diluted share, compared to a pro forma net loss of $8,057,000, or $.11 per diluted share for 2012.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. focuses on utilizing polymers as a platform technology to develop treatments for serious diseases and conditions, including improving function in individuals paralyzed as a result of traumatic spinal cord injury. The Company was founded in 2005 with proprietary technology co-invented by Robert Langer, ScD., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who 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. 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. 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 and warrants to purchase 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 Form 10-K and 10-Q’s and our current reports on Form 8-K. We do not undertake to update these forward-looking statements made by us.
(Tables to follow)
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InVivo Therapeutics Holdings Corp. (A Development Stage Company) Consolidated Balance Sheets (Unaudited) |
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| As of | |||||||||
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September 30, |
December 31, 2012 |
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| ASSETS: | |||||||||
| Current assets: | |||||||||
| Cash and cash equivalents | $ | 18,333,540 | $ | 12,825,090 | |||||
| Restricted cash | 601,441 | 601,351 | |||||||
| Prepaid expenses | 117,749 | 143,867 | |||||||
| Total current assets | 19,052,730 | 13,570,308 | |||||||
| Property, equipment and leasehold improvements, net | 2,430,834 | 2,311,942 | |||||||
| Other assets | 162,870 | 179,415 | |||||||
| Total assets | $ | 21,646,434 | $ | 16,061,665 | |||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT): | |||||||||
| Current liabilities: | |||||||||
| Accounts payable | $ | 707,559 | $ | 1,152,550 | |||||
| Note payable-current portion | 112,774 | — | |||||||
| Capital lease payable-current portion | 11,119 | 32,606 | |||||||
| Derivative warrant liability | — | 14,584,818 | |||||||
| Accrued expenses | 1,263,115 | 1,021,275 | |||||||
| Total current liabilities | 2,094,567 | 16,791,249 | |||||||
| Loan payable | 1,920,000 | 1,578,000 | |||||||
| Note payable-less current portion | 36,994 | — | |||||||
| Capital lease payable-less current portion | — | 2,799 | |||||||
| Total liabilities | 4,051,561 | 18,372,048 | |||||||
| Commitments and contingencies | |||||||||
| Stockholders’ equity (deficit): | |||||||||
| Common stock, $0.00001 par value, authorized 200,000,000 shares at September 30, 2013 and December 31, 2012; issued and outstanding 78,729,618 and 65,881,122 shares at September 30, 2013 and December 31, 2012, respectively | 787 | 659 | |||||||
| Additional paid-in capital | 93,796,109 | 40,842,339 | |||||||
| Deficit accumulated during the development stage | (76,202,023 | ) | (43,153,381 | ) | |||||
| Total stockholders’ equity (deficit) | 17,594,873 | (2,310,383 | ) | ||||||
| Total liabilities and stockholders’ equity (deficit) | $ | 21,646,434 | $ | 16,061,665 | |||||
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InVivo Therapeutics Holdings Corp. (A Development Stage Company) Consolidated Statements of Operations (Unaudited) |
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Three Months Ended September 30, |
Nine Months Ended September 30, |
November 28, 2005 (inception) to September 30, |
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| 2013 | 2012 | 2013 | 2012 | 2013 | ||||||||||||||||
| Operating expenses: | ||||||||||||||||||||
| Research and development | $ | 3,021,166 | $ | 1,374,852 | $ | 6,825,507 | $ | 3,622,800 | $ | 22,085,136 | ||||||||||
| General and administrative | 2,385,534 | 1,466,049 | 6,504,693 | 4,433,929 | 21,159,886 | |||||||||||||||
| Total operating expenses | 5,406,700 | 2,840,901 | 13,330,200 | 8,056,729 | 43,245,022 | |||||||||||||||
| Operating loss | (5,406,700 | ) | (2,840,901 | ) | (13,330,200 | ) | (8,056,729 | ) | (43,245,022 | ) | ||||||||||
| Other income (expense): | ||||||||||||||||||||
| Other income | — | — | — | — | 383,000 | |||||||||||||||
| Interest income | 4,153 | 13,061 | 13,064 | 27,842 | 68,297 | |||||||||||||||
| Interest expense | (34,053 | ) | (12,454 | ) | (95,408 | ) | (28,147 | ) | (1,233,465 | ) | ||||||||||
| Modification of warrants | — | — | (764,769 | ) | — | (764,769 | ) | |||||||||||||
| Derivatives gain (loss) | — | 10,869,209 | (18,871,329 | ) | 21,436,653 | (31,409,816 | ) | |||||||||||||
| Other income (expense), net | (29,900 | ) | 10,869,816 | (19,718,442 | ) | 21,436,348 | (32,956,753 | ) | ||||||||||||
| Net income (loss) | $ | (5,436,600 | ) | $ | 8,028,915 | $ | (33,048,642 | ) | $ | 13,379,619 | $ | (76,201,775 | ) | |||||||
| Net income (loss) per share, basic | $ | (0.07 | ) | $ | 0.12 | $ | (0.46 | ) | $ | 0.21 | $ | (1.96 | ) | |||||||
| Net income (loss) per share, diluted | $ | (0.07 | ) | $ | 0.11 | $ | (0.46 | ) | $ | 0.19 | $ | (1.96 | ) | |||||||
| Weighted average number of common shares outstanding, basic | 78,603,114 | 65,109,037 | 72,391,396 | 62,357,300 | 38,880,668 | |||||||||||||||
| Weighted average number of common shares outstanding, diluted | 78,603,114 | 74,157,957 | 72,391,396 | 71,734,784 | 38,880,668 | |||||||||||||||
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InVivo Therapeutics Holdings Corp. (A Development Stage Company) Pro Forma Results (Unaudited) |
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| Three Months Ended |
Nine Months Ended |
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| September 30, | September 30, | |||||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||||
| Pro forma net loss | $ | (5,436,600 | ) | $ | (2,840,294 | ) | $ | (13,412,544 | ) | $ | (8,057,034 | ) | ||||
| Derivative gain (loss) and modification of warrants | — | 10,869,209 | (19,636,098 | ) | 21,436,653 | |||||||||||
| Reported GAAP net income (loss) | $ | (5,436,600 | ) | $ | 8,028,915 | $ | (33,048,642 | ) | $ | 13,379,619 | ||||||
| Pro forma net loss per diluted share | $ | (0.07 | ) | $ | (0.04 | ) | $ | (0.19 | ) | $ | (0.11 | ) | ||||
| Derivative gain (loss) per diluted share | $ | — | $ | 0.15 | $ | (0.27 | ) | $ | 0.30 | |||||||
| Reported GAAP net income (loss) per diluted share | $ | (0.07 | ) | $ | 0.11 | $ | (0.46 | ) | $ | 0.19 | ||||||
| Weighted average number of common shares outstanding, diluted | 78,603,114 | 74,157,957 | 72,391,396 | 71,734,784 | ||||||||||||
