InVivo Therapeutics Reports 2012 Financial Results, Provides Business Update
CAMBRIDGE, Mass. (March 13, 2013) – 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.
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.