CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today reported financial results for the year ended December 31, 2014.
Mark Perrin, InVivo’s CEO and Chairman, said, “2014 was a momentous year for InVivo in every sense of the word. It’s gratifying to look back on how much we accomplished last year and exciting to see the trajectory the company is following. We are in a much better position to execute on our corporate goals than we were only 15 months ago and are significantly closer to achieving our mission: to redefine the life of the spinal cord injury patient. I’m pleased with how we’ve advanced as a company and am very much looking forward to a fruitful 2015.”
Hired experienced leadership team
InVivo’s five corporate officers, all new to the company since January 2014, bring significant depth and breadth regarding the development, approval, and commercialization of products. As a cohesive unit, the company is on a path poised for success.
Initiated pilot trial with Neuro-Spinal Scaffold
In 2014, the first-ever implantation of the company’s Neuro-Spinal Scaffold took place. In the months that followed, an appreciable improvement in the first subject’s motor and sensory function was reported (improved from AIS A to C) as well as complete recovery of bowel function and improvement in bladder function. The second-ever implantation of the Neuro-Spinal Scaffold was done in January 2015.
Accelerated pilot trial timeline with FDA
In December 2014, InVivo was able to expedite the original subject enrollment plan by eliminating mandatory holds between enrollment of the final three subjects, thereby reducing the clinical timeline. Barring any significant safety issues, concurrent enrollment of subjects three through five is anticipated to open by the end of March 2015.
Raised cash to fund trial and operations
In May 2014, InVivo successfully raised approximately $16.1 million to fund the ongoing pilot trial and operations. The company also recently closed an additional round of financing, led by our largest shareholder, and received gross proceeds of $12 million. InVivo believes it is in a strong cash position to further advance the company’s mission.
Realigned and focused R&D efforts and reduced burn
The company is solely focused on developing therapies for spinal cord injury patients. By reducing headcount, streamlining processes, and subsequently realigning and focusing internal efforts, InVivo is on a great path to success.
For the year ended December 31, 2014, the company reported a net loss of approximately $18,346,000, or $0.21 per diluted share, compared to a loss of $38,756,000, or $0.52 per diluted share, for the year ending December 31, 2013. Included in results for the years ended December 31, 2014 and 2013 were non-cash losses of $376,000 and $18,871,000, respectively, reflecting changes in the fair market value of the derivative warrant liability. Excluding the derivative warrant liability, non-cash losses associated with modification of warrants in 2013 and restructuring costs incurred in the second quarter of 2014, adjusted net loss for the year ending December 31, 2014, was $17,970,000, or $0.20 per diluted share, compared to an adjusted net loss of $19,120,000, or $0.26 per diluted share, for 2013. The company ended the year with $13,459,000 of cash and cash equivalents.
Adjusted net loss and adjusted net loss per diluted share are non-GAAP financial measures that exclude the impact of the items noted. A reconciliation of these measures to the comparable GAAP measure is included with the tables contained in this release. The company believes a presentation of these non-GAAP measures provides useful information to investors to better understand the company’s operations on a period-to-period comparable basis after taking into account the impact of the identified items.
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 research and clinical-stage 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 anticipated reopening of enrollment and the pace of enrollment following the reopening and the company’s cash position for fiscal 2015. 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, 2014, 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.
InVivo Therapeutics Holdings Corp.
Consolidated Balance Sheets
(In thousands, except share and per share data)
|Cash and cash equivalents||$ 13,459||$||13,980|
|Prepaid expenses and other current assets||1,072||20|
|Total current assets||14,953||14,602|
|Property and equipment, net||1,605||2,337|
|Total assets||$ 16,693||$||17,096|
|LIABILITIES AND STOCKHOLDERS’ EQUITY:|
|Accounts payable||$ 569||$||899|
|Loan payable-current portion||320||—|
|Note payable-current portion||18||74|
|Capital lease payable||—||3|
|Derivative warrant liability||7,224||—|
|Total current liabilities||9,175||2,268|
|Loan payable-less current portion||1,600||1,920|
|Note payable-less current portion||—||18|
|Commitments and Contingencies|
Common stock, $0.00001 par value, authorized - 200,000,000 shares
at December 31, 2014
|Additional paid-in capital||106,172||94,798|
|Total stockholders’ equity||5,918||12,890|
|Total liabilities and stockholders’ equity||$ 16,693||$||17,096|
InVivo Therapeutics Holdings Corp.
Consolidated Statements of Operations
(In thousands, except share and per-share data)
|Years Ended December 31,|
|Research and development||$||10,273||$||10,533||$||6,376|
|General and administrative||7,566||8,472||6,403|
|Total operating expenses||17,839||19,005||12,779|
|Other income (expense):|
|Modification of warrants||—||(765||)||—|
|Derivative gain (loss)||(376||)||(18,871||)||17,480|
|Other income (expense), net||(507||)||(19,751||)||17,443|
|Net income (loss)||$||(18,346||)||$||(38,756||)||$||4,664|
|Net income (loss) per share, basic||$||(0.21||)||$||(0.52||)||$||0.07|
|Net income (loss) per share, diluted||$||(0.21||)||$||(0.52||)||$||0.06|
Weighted average number of common shares
Weighted average number of common shares
|Reconciliation of GAAP to non-GAAP measures|
|InVivo Therapeutics Holding Corp.|
|(In thousands, except share and per share data)|
|Three Months Ended||Year Ended|
|December 31,||December 31,|
|Reported GAAP net income (loss)||(8,384||)||(5,707||)||(18,346||)||(38,756||)|
|Add Back: Derivative Loss||4,508||-||376||18,871|
|Add Back: Modification of Warrants||-||-||-||765|
|Add Back: Restructuring Costs||-||-||309||-|
|Adjusted Net Loss||(3,876||)||(5,707||)||(17,661||)||(19,120||)|
|Reported GAAP net loss per diluted share||(0.09||)||(0.07||)||(0.21||)||(0.52||)|
|Derivative loss per diluted share||0.05||-||0.01||0.25|
|Modification of Warrants loss per diluted share||-||-||-||0.01|
|Restructuring Costs per diluted share||-||-||-||-|
|Adjusted net loss per diluted share||(0.04||)||(0.07||)||(0.20||)||(0.26||)|