SOURCE: Corbus Pharmaceuticals Holdings, Inc.

Corbus Pharmaceuticals Holdings, Inc.

February 10, 2015 07:05 ET

Corbus Pharmaceuticals Reports 2014 Financial Results and Provides 2015 Business Update

NORWOOD, MA--(Marketwired - Feb 10, 2015) - Corbus Pharmaceuticals Holdings, Inc. (OTCQB: CRBP) (the "Company"), an emerging drug development company focused on the development and commercialization of its lead product candidate, Resunab, for the treatment of rare, life-threatening inflammatory and fibrotic diseases, announced today its financial results for the year ended December 31, 2014.

The Company also reviewed its corporate progress and anticipated near-term clinical development milestones for Resunab, a novel synthetic oral specialized pro-resolving mediator drug with unique anti-inflammatory and anti-fibrotic activity under development for the treatment of cystic fibrosis (CF) and diffuse cutaneous systemic sclerosis (scleroderma).

Recent Corporate Highlights

  • Filed an Investigational New Drug (IND) application for the Phase 2 scleroderma protocol for Resunab with the U.S. Food and Drug Administration (FDA);
  • Commenced trading of the Company's common stock on the Over-the-Counter Markets under ticker symbol CRBP;
  • Appointed Barbara White, M.D., a leading board-certified rheumatologist, scleroderma expert and pharmaceutical industry veteran, as the Company's Chief Medical Officer; and
  • Appointed Scott Constantine, M.S., former Director, Clinical Research & Operations at Insmed and Clinical Program Scientist at PTC Therapeutics with expertise in CF and pulmonary diseases, as the Company's Director, Clinical Research & Operations.

"In the fourth quarter, we made good progress on the operational and regulatory fronts and believe 2014 was a springboard year by establishing the building blocks for Corbus to develop innovative therapies that target rare, life-threatening chronic inflammatory-fibrotic indications. We have assembled an experienced team of industry veterans that are working together to prepare and execute our clinical programs for Resunab," stated Yuval Cohen, Ph.D., Chief Executive Officer of Corbus Pharmaceuticals.

"We believe that Resunab's novel and unique mechanism of action that acts by resolving inflammation has the potential to have a significant therapeutic impact on patients suffering from these diseases. We expect to continue to build forward momentum in the first half of 2015 with the initiation of our Phase 2 clinical trials with Resunab," added Dr. Cohen. "We are gratified to see that our hard work has been generating tangible results and look forward to a promising 2015."

Expected Near-Term Milestones

  • Submit the clinical protocol for cystic fibrosis to the FDA under the Resunab IND and initiate the Phase 2 clinical trial for the treatment of CF in the second quarter of 2015;
  • Initiate the Phase 2 clinical study of Resunab for the treatment of scleroderma in the second quarter of 2015;
  • File the Resunab application for FDA Orphan Drug Designation for the treatment of both CF and scleroderma; and
  • Seek an up-listing to the NASDAQ Stock Market.

Summary of Financial Results for 2014
For the year ended December 31, 2014, the Company reported a net loss of approximately $2,540,000, or a net loss per diluted share of $0.13, compared to a net loss of approximately $602,000, or a net loss per diluted share, of $0.09 for the year ended December 31, 2013. The Company ended the year with approximately $6,262,000 of cash and cash equivalents.

Corbus expects its current cash on hand to be sufficient to meet its operating and capital requirements until at least the end of 2015.

About Resunab
Resunab™ is a novel synthetic oral drug with unique anti-inflammatory and anti-fibrotic activity. Pre-clinical and Phase 1 clinical studies have shown Resunab to have a favorable safety profile coupled with promising potency in pre-clinical models of inflammation and fibrosis. Resunab binds to the CB2 receptor on immune cells and triggers a process known as "inflammatory resolution," in effect turning chronic inflammation "off."

About Corbus Pharmaceuticals
Corbus Pharmaceuticals is a clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare life-threatening inflammatory-fibrotic diseases with clear unmet medical needs. Our lead product candidate Resunab™ is a novel oral specialized pro-resolving mediator anti-inflammatory drug scheduled to commence Phase 2 clinical trials for the treatment of Cystic Fibrosis and Diffuse Cutaneous Systemic Sclerosis ("Scleroderma") in 2015. For more information, please visit www.CorbusPharma.com.

Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

   
   
Corbus Pharmaceuticals Holdings, Inc.  
Consolidated Statements of Operations  
           
  For the Years Ended
December 31,
 
  2014     2013  
               
Operating expenses:              
  Research and development $ 1,255,535     $ 210,670  
  General and administrative   1,391,638       346,606  
    Total operating expenses   2,647,173       557,276  
               
Operating loss   (2,647,173 )     (557,276 )
               
Other income (expense):              
  Interest expense   (24,021 )     (45,114 )
  Forgiveness of interest on note payable   7,466       -  
  Interest income   2,115       754  
  Gain on the settlement of debt   145,006       -  
  Change in fair value of warrant liability   (28,448 )     1,978  
  Foreign currency exchange (loss) gain   4,570       (2,692 )
    Other expense, net   106,688       (45,074 )
               
Net loss $ (2,540,485 )   $ (602,350 )
               
Net loss per share, basic and diluted $ (0.13 )   $ (0.09 )
               
Weighted average number of common shares outstanding, basic and diluted   20,159,861       6,964,788  
   
   
   
Corbus Pharmaceuticals Holdings, Inc.  
Consolidated Balance Sheet  
   
  December 31,  
  2014     2013  
ASSETS              
Current assets:              
  Cash and cash equivalents $ 6,262,445     $ 303,020  
  Prepaid expenses   270,556       2,500  
    Total current assets   6,533,001       305,520  
               
Restricted cash   13,728     $ -  
Property and equipment, net   54,044       -  
               
      Total assets $ 6,600,773     $ 305,520  
               
LIABILITIES, PREFFERED STOCK AND STOCKHOLDERS' EQUITY              
Current liabilities:              
  Accounts payable $ 344,160     $ 181,471  
  Accrued interest payable   -       77,140  
  Accrued expenses   249,491       63,488  
  Derivative warrant liability   -       19,932  
  Notes payable-current   144,389       306,835  
    Total current liabilities   738,040       648,866  
Notes payable   -       331,243  
      Total liabilities   738,040       980,109  
               
Commitments and Contingencies              
               
JB Therapeutics' Series A Preferred Stock, $0.0001 Par Value:              
    Series A Convertible Preferred Stock, 2,483,690 shares designated, 1,835,212 shares issued and outstanding at December 31, 2013 (Liquidation preference of $1,106,609 at December 31, 2013)   -       1,106,609  
               
    Series A Non-Convertible Preferred Stock, $0.0001 Par Value: 200,000 shares designated, issued and outstanding at December 31, 2013 (Liquidation preference of $200,000 at December 31, 2013)   -       2,000  
               
Stockholders' equity (deficit)              
    Preferred Stock $0.0001 par value: 10,000,000 shares authorized, no shares issued and outstanding at December 31, 2014   -       -  
               
    Common stock, $0.0001 par value; 150,000,000 shares authorized, 25,938,332 and 6,964,788 shares issued and outstanding at December 31, 2014 and December 31, 2013   2,594       696  
                   
    Additional paid-in capital   10,287,214       102,696  
    Accumulated deficit   (4,427,075 )     (1,886,590 )
      Total stockholders' equity (deficit)   5,862,733       (1,783,198 )
        Total liabilities, preferred stock and stockholders equity (deficit) $ 6,600,773     $ 305,520  
               

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