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InVivo Therapeutics Reports 2014 Third Quarter Financial Results and Business Update

InVivo Therapeutics Holdings Corp. (NVIV) today reported financial results for the quarter ended September 30, 2014.

Mark Perrin, InVivo’s CEO, said, “We made substantial progress on all fronts during the third quarter and have continued to build upon that momentum in the weeks since. In that timeframe, we enrolled our first subject in our first-in-human pilot trial, expanded the number of potential clinical sites, broadened subject eligibility criteria, increased our communications outreach through scientific, medical, and investor conferences, and significantly strengthened our intellectual property portfolio. We ended the quarter with a strong cash position, which will allow us to further these important initiatives, and project our funds will extend through March of 2016.”

Financial Results

For the quarter ended September 30, 2014, the Company reported a net loss of approximately $1,213,000 or $.01 per diluted share, compared to a net loss of $5,437,000 or $.07 per diluted share, for the quarter ended September 30, 2013. The 2014 results were favorably impacted by a gain in the derivative warrant liability of $3,005,000 Excluding the impact of the derivative warrant liability, the quarters ended September 30, 2014 and 2013 earnings loss per diluted share were $.04 and $.07 respectively.

For the nine months ended September 30, 2014, the Company reported a net loss of approximately $9,961,000 or $.12 per diluted share, compared to a net loss of $33,048,000 or $.46 per diluted share, for the nine months ended September 30, 2013. The 2014 results were impacted by a $4,132,000 gain in the derivative warrant liability and $309,000 of costs related to the re-alignment of resources completed in the second quarter. The results for the nine months ended September 30, 2013 were adversely impacted by non-cash gains (losses) from modification of warrants and derivatives of $19,636,000, reflecting changes in the fair market value of the derivative warrant liability. Exclusive of these items, the nine months ended September 30, 2014 and 2013 earnings per diluted share losses were $.17 and $.19 respectively.

The Company ended the quarter with $17,634,000 of cash and cash equivalents.

Adjusted net loss and adjusted net loss per share are non-GAAP financial measures that exclude 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, on a period-to-period comparable basis, financial amounts both including and excluding these identified items, the Company's operations.

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 Company’s cash position and its forecast projections. 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 in the scaffold pilot study following the reopening of enrollment; 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.

 
InVivo Therapeutics Holdings Corp.
(A Development Stage Company)
Consolidated Balance Sheets
(In thousands, except share and per share data)
(Unaudited)
             
As of

September 30,
2014

December 31,
2013
ASSETS:
 
Current assets:
Cash and cash equivalents $ 17,634 $ 13,980
Restricted cash 371 602
Prepaid expenses   342     20  
Total current assets 18,347 14,602
 
Property, equipment and leasehold improvements, net 1,797 2,337
Other assets   141     157  
Total assets $ 20,285   $ 17,096  
 
LIABILITIES AND STOCKHOLDERS’ EQUITY:
 
Current liabilities:
Accounts payable $ 711 $ 899
Note payable-current portion 37 74
Capital lease payable 3
Derivative warrant liability 2,716
Accrued expenses   1,351     1,292  
Total current liabilities 4,815 2,268
 
Loan payable 1,920 1,920
Note payable-less current portion       18  
Total liabilities   6,735     4,206  
 
Commitments and Contingencies
 
Stockholders’ equity:
Common stock, $0.00001 par value, authorized 200,000,000 shares at September 30, 2014 and December 31, 2013; issued and outstanding 93,547,062 and 78,773,736 shares at September 30, 2014 and December 31, 2013, respectively. 1 1
Additional paid-in capital 105,419 94,798
Deficit accumulated during the development stage   (91,870 )   (81,909 )
Total stockholders’ equity   13,550     12,890  
Total liabilities and stockholders’ equity $ 20,285   $ 17,096  
 
 
InVivo Therapeutics Holdings Corp.
(A Development Stage Company)
Consolidated Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
                       
Three Months Ended
September 30,

Nine Months Ended
September 30,

November 28,
2005
(inception) to
September 30,

  2014     2013     2014     2013     2014  
 
Operating expenses:
Research and development $ 2,385 $ 3,021 $ 8,678 $ 6,825 $ 34,471
General and administrative   1,800     2,386     5,317     6,505     28,444  
Total operating expenses   4,185     5,407     13,995     13,330     62,915  
 
Operating loss   (4,185 )   (5,407 )  

(13,995

)   (13,330 )   (62,915 )
 
Other income (expense):
Other income

383
Interest income 2 4 4 13 75
Interest expense (35 ) (34 ) (102 ) (95 ) (1,370 )
Modification of warrants

(765 ) (765 )
Derivatives gain (loss)   3,005  

  4,132     (18,871 )   (27,278 )
Other income (expense), net   2,972     (30 )   4,034     (19,718 )   (28,955 )
 
Net income (loss) $ (1,213 ) $ (5,437 ) $ (9,961 ) $ (33,048 ) $ (91,870 )
 
Net income (loss) per share, basic $ (0.01 ) $ (0.07 ) $ (0.12 ) $ (0.46 ) $ (2.09 )
 
Net income (loss) per share, diluted $ (0.01 ) $ (0.07 ) $ (0.12 ) $ (0.46 ) $ (2.09 )
 
Weighted average number of common shares outstanding, basic   101,635,856     78,603,114     81,761,045     72,391,396     44,047,625  
 

Weighted average number of common shares outstanding, diluted

  101,635,856     78,603,114     81,761,045     72,391,396     44,047,625  
 
 
Reconciliation of GAAP to non-GAAP measures
InVivo Therapeutics Holding Corp.
(A Development Stage Company)
                         
 
 
Three Months Ended Nine Months Ended
September 30, September 30,
2014   2013   2014   2013  
Reported GAAP net income (loss) (1,213 ) (5,437 ) (9,961 ) (33,048 )
Add Back: Derivative gain (Loss) 3,005 - 4,132 (18,871 )
Add Back: Modification of Warrants - - - (765 )
Add Back: Restructuring Costs -   -   (309 ) -  
Pro Forma Net Loss (4,218 ) (5,437 ) (13,784 ) (13,412 )
 
Reported GAAP net loss per diluted share (0.01 ) (0.07 ) (0.12 ) (0.46 )
Derivative gain (loss) per diluted share 0.03 - 0.05 (0.26 )
Modification of Warrants gain (loss) per diluted share - - - (0.01 )
Restructuring Costs per diluted share -   -   -   -  
Pro Forma net income (loss) per diluted share (0.04 ) (0.07 ) (0.17 ) (0.19 )
 

InVivo Therapeutics Holdings Corp.
Brian Luque, 617-863-5535
Investor Relations
bluque@invivotherapeutics.com



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