CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today reported financial results for the year ended December 31, 2012 and provided a business update.
InVivo has pioneered a new treatment platform utilizing a variety of biocompatible polymer-based devices to provide structural support to a damaged spinal cord in order to spare tissue from scarring while improving functional recovery and prognosis after a traumatic SCI. Today there is no effective treatment for the spinal cord for paralysis caused by SCIs, and the market potential is estimated to be over $10 billion.
"The year 2012 has quickly become our most productive. We grew our research and development teams to support a pipeline that now exceeds seven new treatment options for neurotrauma, and we’ve established a GMP manufacturing facility capable of manufacturing our scaffold and hydrogels for human use,” said Frank Reynolds, InVivo Chief Executive Officer. “We’re ready to start a first-in-man clinical trial of our biopolymer scaffolding in acute SCI patients, and we expect as many as five products to be either on the market or in clinical studies by the end of 2014. We have built an outstanding regulatory team to support our R&D capabilities in neurotrauma, and are poised to continue developing new applications for our hydrogels in other areas of the body."
Recent Corporate Highlights
Biopolymer Scaffolding for SCI:
- InVivo submitted an updated Investigational Device Exemption to the FDA in February 2013, requesting permission to begin a human study to test its biopolymer scaffolding to treat acute SCI. The study will be an open label study and will evaluate the safety and efficacy of the biopolymer scaffolding in five SCI patients with thoracic injuries. The Company is also working with the FDA in order to have the scaffolding device designated as a Humanitarian Use Device, a designation that InVivo expects will create a faster path to market.
- InVivo is the first company to successfully demonstrate functional improvement in non-human primates paralyzed after a SCI model. Recent data compiled from InVivo's 2011 non-human primate study confirm that the functional recovery observed in the treatment group was attributable to the biopolymer scaffolding alone, and was not due to spontaneous recovery. InVivo plans to submit this exciting data to a prestigious scientific journal for publication in 2013.
- The Company has engaged with the FDA for InVivo's second product, a novel injectable hydrogel specifically engineered for nervous system tissue to deliver effective local release of drugs for the treatment of peripheral nerve pain, an expected $24 billion market opportunity. The Company intends to meet with representatives from the FDA's Office of Combination Products in the coming months to map out a clinical development plan. InVivo also recently completed a pre-clinical nerve pain study with the Geisinger Health System and anticipates that this promising data will be submitted for publication during 2013.
- InVivo has commenced the development of novel injectable hydrogels to be used to treat fibrosis and as dural sealants, dural replacements, and nerve conduits. The FDA regulates biomaterials used as dural replacements and nerve conduits as 510(k) products, and the Company expects to file 510(k) applications for these two indications in 2014.
- Kenneth DiPietro, Executive Vice President Human Resources at Biogen Idec, joined the Company’s Board of Directors in December 2012. Mr. DiPietro brings 30 years of senior human resources experience gained at several Global 500 companies including Biogen, Microsoft and PepsiCo, Inc. Mr. DiPietro will help manage growth at InVivo.
- The Company has filed manufacturing patent applications covering non-toxic manufacturing processes for biomaterials implanted in the nervous system. InVivo’s broad patent portfolio covers the use of any biomaterial alone or in combination with any drug, growth factor or stem cell for SCI. InVivo’s patent portfolio has also been expanded to include parts of the peripheral nervous system, the cranial nerve, the brain and retina, and the cavernous nerve.
Financial Results
For the year ended December 31, 2012, the Company reported net income of $4,664,000, or $.06 per diluted share, compared with a net loss of $34,728,000, or $.67 per diluted share, for the year ended December 31, 2011. Included in net income (loss) for the years ended December 31, 2012 and 2011 were a non-cash derivative gain of $17,480,000 in 2012, and a non-cash derivative loss of $26,066,000 in 2011, both of which reflect changes in the fair value of the derivative warrant liability. Excluding the non-cash derivative gain (loss), the non-GAAP diluted loss per share for the year ended December 31, 2012 would have been $.20 per dilutive share, compared to $.17 per diluted share for the year ended December 31, 2011. Total operating expenses for the year ended December 31, 2012 were $12,779,000 compared with $8,659,000 for the year ended December 31, 2011. The Company ended the year with $13,426,000 of cash on hand.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is 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, M.D., who is affiliated with Massachusetts General Hospital. In 2011, the Company earned the prestigious 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)
| InVivo Therapeutics Holdings Corp. | ||||||||||
| (A Developmental Stage Company) | ||||||||||
| Consolidated Balance Sheets | ||||||||||
| December 31, | ||||||||||
| 2012 | 2011 | |||||||||
| ASSETS: | ||||||||||
| Current assets: | ||||||||||
| Cash and cash equivalents | $ | 12,825,090 | $ | 4,363,712 | ||||||
| Restricted cash | 601,351 | 547,883 | ||||||||
| Prepaid expenses | 174,643 | 104,022 | ||||||||
| Total current assets | 13,601,084 | 5,015,617 | ||||||||
| Property and equipment, net | 2,311,942 | 520,482 | ||||||||
| Other assets | 148,639 | 166,139 | ||||||||
| Total assets | $ | 16,061,665 | $ | 5,702,238 | ||||||
| LIABILITIES AND STOCKHOLDERS' DEFICIT: | ||||||||||
| Current liabilities: | ||||||||||
| Accounts payable | $ | 1,152,550 | $ | 567,195 | ||||||
| Loan payable-current portion | - | 50,578 | ||||||||
| Capital lease payable-current portion | 32,606 | 30,724 | ||||||||
| Derivative warrant liability | 14,584,818 | 35,473,230 | ||||||||
| Accrued expenses | 1,021,275 | 618,369 | ||||||||
| Total current liabilities | 16,791,249 | 36,740,096 | ||||||||
| Loan payable-less current portion | 1,578,000 | 83,794 | ||||||||
| Capital lease payable-less current portion | 2,799 | 38,042 | ||||||||
| Total liabilities | 18,372,048 | 36,861,932 | ||||||||
| Commitments and contingencies | ||||||||||
| Stockholders' deficit: | ||||||||||
|
Common stock, $0.00001 par value, authorized 200,000,000 and |
659 | 538 | ||||||||
| Additional paid-in capital | 40,842,339 | 16,656,830 | ||||||||
| Deficit accumulated during the development stage | (43,153,381 | ) | (47,817,062 | ) | ||||||
| Total stockholders' deficit | (2,310,383 | ) | (31,159,694 | ) | ||||||
| Total liabilities and stockholders' deficit | $ | 16,061,665 | $ | 5,702,238 | ||||||
| InVivo Therapeutics Holdings Corp. | |||||||||||||||
| (A Developmental Stage Company) | |||||||||||||||
| Consolidated Statements of Operations | |||||||||||||||
| Period from | |||||||||||||||
| November 28, | |||||||||||||||
| 2005 | |||||||||||||||
| Years Ended | (inception) to | ||||||||||||||
| December 31, | December 31 | ||||||||||||||
| 2012 | 2011 | 2012 | |||||||||||||
| Operating expenses: | |||||||||||||||
|
Research and development |
$ | 6,375,795 | $ | 4,102,847 | $ | 15,259,629 | |||||||||
| General and administrative | 6,403,656 | 4,555,872 | 14,655,193 | ||||||||||||
|
Total operating expenses |
12,779,451 | 8,658,719 | 29,914,822 | ||||||||||||
| Operating loss | (12,779,451 | ) | (8,658,719 | ) | (29,914,822 | ) | |||||||||
| Other income (expense): | |||||||||||||||
| Other income | - | - | 383,000 | ||||||||||||
| Interest income | 35,184 | 8,759 | 55,233 | ||||||||||||
| Interest expense | (71,726 | ) | (12,676 | ) | (1,138,057 | ) | |||||||||
| Derivatives gain (loss) | 17,479,674 | (26,065,579 | ) | (12,538,487 | ) | ||||||||||
| Other income (expense), net | 17,443,132 | (26,069,496 | ) | (13,238,311 | ) | ||||||||||
| Net income (loss) | $ | 4,663,681 | $ | (34,728,215 | ) | $ | (43,153,133 | ) | |||||||
| Net income (loss) per share, basic | $ | 0.07 | $ | (0.67 | ) | $ | (1.22 | ) | |||||||
| Net income (loss) per share, diluted | $ | 0.06 | $ | (0.67 | ) | $ | (1.22 | ) | |||||||
| Weighted average number of common shares outstanding, basic | 63,226,899 | 51,894,871 | 35,348,456 | ||||||||||||
| Weighted average number of common shares outstanding, diluted | 71,919,419 | 51,894,871 | 35,348,456 | ||||||||||||
| InVivo Therapeutics Holdings Corp. | ||||||||||
| (A Developmental Stage Company) | ||||||||||
| Pro Forma Results | ||||||||||
| Years Ended | ||||||||||
| December 31, | ||||||||||
| 2012 | 2011 | |||||||||
| Pro Forma Net Loss | $ | (12,815,993 | ) | $ | (8,662,636 | ) | ||||
| Derivative Gain (Loss) | 17,479,674 | (26,065,579 | ) | |||||||
| Reported GAAP Net Income (Loss) | $ | 4,663,681 | $ | (34,728,215 | ) | |||||
| Pro Forma Net Loss Per Diluted Share | $ | (0.18 | ) | $ | (0.17 | ) | ||||
| Derivative Gain (Loss) Per Diluted Share | 0.24 | (0.50 | ) | |||||||
| Reported GAAP Net Loss Per Diluted share | $ | 0.06 | $ | (0.67 | ) | |||||