CAMBRIDGE, Mass. (November 14, 2012) – InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today reported the financial results for the three and nine months ended September 30, 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 spinal cord injury. 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.
“We finished Q3 by expanding our product pipelines and collaborating with the FDA to establish first-of-a-kind protocols for gaining FDA approval to begin the first human study to introduce biomaterials to the spinal cord after SCI,” said Frank Reynolds, InVivo’s Chief Executive Officer. “We’re establishing important standards of practice and best practices to shorten learning curves and expedite our products to market. We’ve made excellent progress in recent months and are firing on all cylinders, and we expect that the next six months will mark a major inflection point in our growth. We have built out strong R&D capabilities in neurotrauma and are poised to move our SCI devices into clinical trials followed by multiple neurotrauma products outside of the spinal cord.”
Recent Corporate Highlights
- Biopolymer Scaffolding for SCI: FDA approval to commence an open label clinical trial of five acute SCI patients is expected in early 2013. The Company expects the product to be regulated under a Humanitarian Device Exemption pathway that should accelerate commercialization. Before the end of 2012, the Company expects to validate its manufacturing clean room and then manufacture GMP batches which will be submitted to the FDA as part of the IDE application.
- 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. This exciting data will be submitted to a prestigious scientific journal for publication in 2012.
- On September 25, InVivo held a ribbon cutting ceremony attended by key Massachusetts government officials and supported by Governor Deval Patrick, which marked the opening of the Company’s global headquarters in Kendall Square, Cambridge MA. The facility includes corporate offices, chemistry labs, drug labs, cell labs, a cGMP manufacturing cleanroom, and a vivarium.
- The Company believes that its SCI rodent vivarium is one of the largest in the world; it will house a chronic SCI rodent population dedicated to developing biomaterials/cell therapy treatment options for the critically under-served chronic SCI research model.
- Engaged with the FDA for InVivo’ second product, a novel injectable hydrogel specifically engineered for nervous system tissue to deliver effective local release of drugs. The Company will be meeting with representatives from the FDA’s Office of Combination Products to map out the clinical development plan. By the end of 2012, the Company expects to complete a pre-clinical nerve pain study with the Geisinger Health System.
- InVivo has assembled a world-class team of experts in neurotrauma and biomaterials. Recent key hires and promotions have further strengthened the management team.
- William D’Agostino, PE joined as Senior Director of Manufacturing and Engineering. Mr. D’Agostino, a former Covidien executive, has launched more than 100 new polymer products, including degradable sutures.
- Brian Hess was promoted to Chief Technology Officer from Director of Product Development. Mr. Hess, a former Stryker executive with extensive biomaterials experience, won the coveted Innovator of the Year award while at Stryker.
- Arthur Coury, PhD joined as an advisor to the CEO and a member of InVivo’s Business Advisory Board. Dr. Coury is an expert in polymeric biomaterials and his knowledge and leadership has led to multiple FDA approvals of hydrogel products.
- Filed manufacturing patents 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. The patent portfolio has been expanded to include parts of the peripheral nervous system, the cranial nerve, the brain and retina, and the cavernous nerve.
- Well Capitalized: $16.2mm of cash as of September 30, 2012 to fund operations into 2014.
- Potential for $16.7mm of additional cash from warrant exercises during 2012-2015.
- Low Burn Rate: $855K current monthly burn rate reflects the InVivo way of ″doing more with less.″
- Superior Return on Cash Invested: 531% return on cash invested, $109mm market cap, and $20.5mm spent to date.
- Awarded a $2 million low-cost loan from the Commonwealth of Massachusetts Emerging Technology Fund. Funds from the seven-year loan are to be used for capital equipment purchases.
For the three months ended September 30, 2012, the Company reported net income of $8,029,000 or $.11 per diluted share, compared to net income of $3,067,000, or $.06 per diluted share, for the three months ended September 30, 2011. Included in results for the three months ended September 30, 2012 and 2011 were non-cash derivative gains of $10,869,000 and $5,276,000, respectively, reflecting decreases in the fair value of the derivative warrant liability. Exclusive of the non-cash derivative gain, the pro forma net loss for the three months ended September 30, 2012, was $2,840,000, or $.04 per diluted share, compared to a pro forma net loss of $2,209,000, or $.04 per diluted share for 2011. Total operating expenses for the three months ended September 30, 2012 were $2,841,000 compared with $2,213,000 for the three months ended September 30, 2011. The Company ended the quarter with $16,184,000 of cash on hand.
For the nine months ended September 30, 2012, the Company reported net income of $13,380,000 or $.19 per diluted share, compared to net income of $419,000, or $.01 per diluted share, for the nine months ended September 30, 2011. Included in results for the nine months ended September 30, 2012 and 2011 were non-cash derivative gains of $21,437,000, and $6,560,000 respectively, reflecting decreases in the fair value of the derivative warrant liability. Exclusive of the non-cash derivative gain, the pro forma net loss for the nine months ended September 30, 2012, was $8,057,000, or $.11 per diluted share, compared to a pro forma net loss of $6,141,000, or $.11 per diluted share for 2011. Total operating expenses for the nine months ended September 30, 2012 were $8,057,000 compared with $6,141,000 for the nine months ended September 30, 2011.
About the Neuro-Spinal Scaffold
Following an acute spinal cord injury, the biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and acts as a physical substrate for nerve sprouting. Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device designation and is currently being studied in a pilot study for the treatment of complete (AIS A) traumatic acute spinal cord injury.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a pioneering 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, ScD, Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, MD, 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. 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 enrollment of additional patients in the scaffold pilot study following the reopening of enrollment and its ability to conduct a second pivotal study. 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 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, 2013, 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.