InVivo Therapeutics Reports 2014 First Quarter Financial Results and Business Update

CAMBRIDGE, Mass.--()--InVivo Therapeutics Holdings Corp. (NVIV), a biomaterials company with innovative technologies for drug delivery with a focus on treatment of spinal cord injuries, today reported financial results for the quarter ended March 31, 2014.

Mark Perrin, Chief Executive Officer of InVivo, said, “As we previously reported, we are excited to have our first clinical site in the final stages of surgical training for our scaffold pilot study and expect to have patient enrollment open by the end of May. We anticipate having a second site open for enrollment by the end of May and a third site open by the end of the second quarter. We also recently completed an underwritten public offering of shares of common stock and warrants, and we received approximately $14.6 million in net proceeds from the offering after deducting underwriter fees and other offering expenses. The funds will be utilized to complete our clinical study, fund additional research, development and clinical projects, and for working capital. We anticipate these funds will be sufficient to take us through November 2015.”

Financial Results

For the quarter ended March 31, 2014, the Company reported a net loss of approximately $5,103,000 or $0.07 per diluted share, compared to a net loss of $13,326,000 or $0.20 per diluted share, for the quarter ended March 31, 2013. Non-cash gains (losses) from modification of warrants and derivatives in the amount of $10,449,000 were included in results for the quarter ended March 31, 2013, and reflected changes in the fair market value of the derivative warrant liability. Exclusive of this non-cash item, the adjusted net loss for the quarter ended March 31, 2013, was $2,877,000, or $0.04 per diluted share. The Company ended the quarter with $9,846,000 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 company with unique technologies for drug delivery 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, M.D., who 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. Any forward-looking statements contained herein are based on current expectations, and include statements regarding the Company’s expectations with respect to the opening of additional clinical study sites and patient enrollment in the study, and the Company’s anticipated use of the proceeds from its recent offering. These statements are subject to a number of risks and uncertainties that could cause actual future results to differ materially from current expectations including, but not limited to, risks and uncertainties relating to the Company’s limited operating history and history of net losses, its ability to raise substantial additional capital to finance planned operations, its ability to successfully commercialize current and future product candidates and to successfully complete clinical trials and obtain and maintain regulatory approval of its product candidates, its ability to protect and maintain its intellectual property, and other risks associated with the Company’s business and strategies identified and described in more detail in the Company’s filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2013, as amended, and subsequent filings with the Securities and Exchange Commission. The Company does not undertake to update these forward-looking statements, except as required by law.

 

InVivo Therapeutics Holdings Corp.

(A Development Stage Company)

Consolidated Balance Sheets

(In thousands, except share and per share data)

(Unaudited)

 
  As of
March 31,
2014
  December 31,
2013
ASSETS:
 
Current assets:
Cash and cash equivalents $ 9,846 $ 13,980
Restricted cash 371 602
Prepaid expenses   445     20  
 
Total current assets 10,662 14,602
 
Property, equipment and leasehold improvements, net 2,182 2,337
Other assets   152     157  
 
 
Total assets $ 12,996   $ 17,096  
 
 
LIABILITIES AND STOCKHOLDERS’ EQUITY:
 
Current liabilities:
Accounts payable $ 704 $ 899
Note payable-current portion 74 74
Capital lease payable 3
Accrued expenses   1,236     1,292  
 
Total current liabilities 2,014 2,268
 
Loan payable 1,920 1,920
Note payable-less current portion       18  
 
Total liabilities   3,934     4,206  
 
 
Commitments and Contingencies
 
Stockholders’ equity:
Common stock, $0.00001 par value, authorized 200,000,000 shares at March 31, 2014 and December 31, 2013; issued and outstanding 79,021,039 and 78,773,736 shares at March 31, 2014 and December 31, 2013, respectively. 1 1
Additional paid-in capital 96,073 94,798
Deficit accumulated during the development stage   (87,012 )   (81,909 )
 
Total stockholders’ equity   9,062     12,890  
 
 
Total liabilities and stockholders’ equity $ 12,996 $ 17,096
 

InVivo Therapeutics Holdings Corp.

(A Development Stage Company)

Consolidated Statements of Operations

(In thousands, except share and per share data)

(Unaudited)

     
Quarter Ended
March 31,

Period from
November 28,
2005
(inception) to
March 31,
2014

2014 2013
Operating expenses:
Research and development $ 3,242 $ 1,213 $ 29,035
General and administrative 1,829   1,638     24,956  
 
Total operating expenses 5,071   2,851     53,991  
 
Operating loss (5,071 ) (2,851 )   (53,991 )
 
Other income (expense):
Other income 383
Interest income 1 3 72
Interest expense (33 ) (29 ) (1,301 )
Modification of warrants -— (765 )
Derivatives gain (loss) ---   (10,449 )   (31,410 )
 
Other income (expense), net (32 ) (10,475 )   (33,021 )
 
Net income (loss) $ (5,103 ) $ (13,326 ) $ (87,012 )
 
Net income (loss) per share, basic $ (0.07 ) $ (0.20 ) $ (2.11 )
 
Net income (loss) per share, diluted $ (0.07 ) $ (0.20 ) $ (2.11 )
 
Weighted average number of common shares outstanding, basic 74,161,457   66,043,378     41,269,091  
 
Weighted average number of common shares outstanding, diluted

74,161,457

  66,043,378     41,269,091  

 

Reconciliation of GAAP to non-GAAP measures

 

InVivo Therapeutics Holdings Corp.

(A Development Stage Company)

(In thousands, except share and per share data)

(Unaudited)

 
  Quarters Ended
March 31,
2014   2013
 
Reported GAAP net income (loss) $ (5,103 ) $ (13,326 )
Add Back: Derivative gain (loss) (10,475 )
Add Back: Modification of Warrants
Pro Forma Net Loss $ (5,103 ) $ (2,851 )
 
Reported GAAP net income (loss) per diluted share $ (0.07 ) $ (0.20 )
Derivative gain (loss) per diluted share (0.16 )
Modification of warrants gain (loss) per diluted share      
Pro-Forma net income (loss) per diluted share $ (0.07 ) $ (0.04 )

Contacts

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

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Contacts

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