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InVivo Therapeutics Reports 2015 Second Quarter Financial Results and Business Update

InVivo Therapeutics Holdings Corp. (NVIV) today reported financial results for the quarter ended June 30, 2015.

Mark Perrin, Chief Executive Officer and Chairman, said, “InVivo made significant advancements across all fronts during the second quarter. The three patients in our ongoing clinical trial continued to make meaningful motor and sensory improvements. We added two new clinical sites, one of which is a federally designated Spinal Cord Injury Model Systems center. We expanded our communications efforts by exhibiting at two major neurological conferences and were highlighted in InVivo Co-founder Dr. Robert Langer’s closing keynote address at the International Society for Stem Cell Research Annual Meeting. We added a wealth of spinal cord injury and neurosurgical knowledge to our scientific advisory board by adding Jim Guest, M.D., Ph.D., and we strengthened our Board structure by appointing Ann Merrifield as Lead Director.

“Further, these significant advancements were likely being monitored by a broader set of financial institutions with our uplisting to the Nasdaq and our inclusion in various Russell Indexes. It was a great quarter and we reiterate our previous cash forecast: we anticipate our cash position will last us into the fourth quarter of 2016.”

Financial Results

For the quarter ended June 30, 2015, the Company reported a net loss of approximately $10,443,000 or $.39 per diluted share, compared to a net loss of $3,646,000 or $.17 per diluted share, for the quarter ended June 30, 2014. The 2015 results were impacted by a loss in the derivative warrant liability of $4,653,000 reflecting changes in the fair market value of the derivative warrant liability. The results for the three months ended June 30, 2014 were impacted by a gain in the deferred warrant liability of $1,127,000 and partly offset by a charge of $309,000 related to the re-alignment of resources completed in the second quarter of 2014. Excluding these charges, for the quarters ended June 30, 2015 and June 30, 2014, adjusted earnings loss per diluted share were $.21 and $.21, respectively.

The Company ended the quarter with $25,114,000 of cash and cash equivalents. During the second quarter, the Company received $4.0 Million from the exercise of warrants issued in the Company’s May 2014 public offering.

For the six months ended June 30, 2015, the Company reported a net loss of approximately $26,273,000 or $1.02 per diluted share, compared to a net loss of $8,749,000 or $.45 per diluted share, for the six months ended June 30, 2014. The 2015 results were impacted by a loss in the derivative warrant liability of $14,940,000 reflecting changes in the fair market value of the derivative warrant liability. The results for the six months ended June 30, 2014 were impacted by a gain in the derivative warrant liability of $1,127,000. This gain was partly offset by a charge related to the re-alignment of resources, completed in the second quarter of 2014, of $309,000. Exclusive of these items, for the six months ended June 30, 2015 and June 30, 2014, adjusted earnings per diluted share losses were $.44 and $.48, respectively.

Through the first six months of 2015, the Company received $6.9 Million from warrant exercises, representing approximately 69% of the warrants issued in the Company’s May 2014 public offering.

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 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, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., 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. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. 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 forecasted cash position . 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 volatility of the trading price of the Company’s common stock; 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 the treatment of 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)
(Unaudited)

     
As of
June 30,
2015
December 31,
2014
ASSETS:
 
Current assets:
Cash and cash equivalents $ 25,114 $ 13,459
Restricted cash 361 422
Prepaid expenses and other current assets   397     1,072  
Total current assets 25,872 14,953
 
Property, equipment and leasehold improvements, net 1,261 1,605
Other assets   124     135  
Total assets $ 27,257   $ 16,693  
 
LIABILITIES AND STOCKHOLDERS’ EQUITY:
 
Current liabilities:
Accounts payable $ 953 $ 569
Loan payable-current portion 259 320
Note payable-current portion 18
Derivative warrant liability 7,722 7,224
Accrued expenses   1,409     1,044  
Total current liabilities 10,343 9,175
 
Loan payable, net of current portion   1,600     1,600  
Total liabilities   11,943     10,775  
 
Commitments and contingencies
 
Stockholders’ equity:

Common stock, $0.00001 par value, authorized 50,000,000 shares;
issued and outstanding 26,856,177 and 23,453,000 shares
at June 30, 2015 and December 31, 2014, respectively.

1 1
Additional paid-in capital 141,841 106,172
Accumulated deficit   (126,528 )   (100,255 )
Total stockholders’ equity   15,314     5,918  
 
Total liabilities and stockholders’ equity $ 27,257   $ 16,693  
 
 

InVivo Therapeutics Holdings Corp.
Consolidated Statements of Operations
(In thousands, except share and per-share data)
(Unaudited)

   

Three Months Ended
June 30,

 

Six Months Ended
June 30,

2015

 

2014

2015

 

2014

 
Operating expenses:
Research and development $ 2,546 $ 3,051 $ 4,848 $ 6,293
General and administrative   3,214     1,688 6,422   3,517
Total operating expenses   5,760     4,739 11,270   9,810
 
Operating loss   (5,760 )   (4,739 ) (11,270 ) (9,810 )
 
Other income (expense):
Interest income 2 1 3 2
Interest expense (32 ) (35 ) (66 ) (68 )
Derivatives gain (loss)   (4,653 )   1,127 (14,940 ) 1,127
Other income (expense), net   (4,683 )   1,093 (15,003 ) 1,061
 
Net loss   (10,443 ) $ (3,646 ) $ (26,273 ) $ (8,749 )
 
Net loss per share, basic $ (0.39 ) $ (0.17 ) $ (1.02 ) $ (0.45 )
 
Net loss per share, diluted $ (0.39 ) $ (0.17 ) $ (1.02 ) $ (0.45 )
 
Weighted average number of common shares outstanding, basic   26,508,170     21,821,355 25,713,438   19,561,455
 
Weighted average number of common shares outstanding, diluted   26,508,170     21,821,355 25,713,438   19,561,455
 
 
InVivo Therapeutics Holdings Corp.
Reconciliation of GAAP to non-GAAP measures
(In thousands, except share and per-share data)
         
Three Months Ended
June 30,
Six Months Ended
June 30,

2015

2014

2015

2014

Reported GAAP net income /(loss) (10,443) (3,646) (26,273) (8,749)
Add Back: Derivative gain/(loss) (4,653) 1,127 (14,940) 1,127
Add Back: Restructuring costs - (309) - (309)
Adjusted Net Loss (5,790) (4,464) (11,333) (9,567)
 
Reported GAAP net loss per diluted share (0.39) (0.17) (1.02) (0.45)
Derivative loss per diluted share (0.18) 0.05 (0.58) 0.05
Restructuring costs per diluted share - (.01) - (.02)
Adjusted net loss per diluted share (0.21) (0.21) (0.44) (0.48)
 

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



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