SOURCE: Corbus Pharmaceuticals Holdings, Inc.

Corbus Pharmaceuticals Holdings, Inc.

November 10, 2016 16:05 ET

Corbus Pharmaceuticals Reports 2016 Third Quarter Financial Results and Provides Business Update

Topline data for Phase 2 study of systemic sclerosis on track to be reported in fourth quarter of 2016; Topline data for Phase 2 study of cystic fibrosis on track to be reported in first quarter of 2017

NORWOOD, MA--(Marketwired - November 10, 2016) - Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a clinical stage drug development company targeting rare, chronic, serious inflammatory and fibrotic diseases, announced today its financial results for the three months ended September 30, 2016.

The Company also provided an update to its corporate progress and the clinical status and anticipated milestones for Resunab, its novel synthetic oral endocannabinoid-mimetic drug that is designed to resolve chronic inflammation and halt fibrosis. Resunab is currently being evaluated in three separate Phase 2 clinical studies in diffuse cutaneous systemic sclerosis ("systemic sclerosis"), cystic fibrosis ("CF") and skin-predominant dermatomyositis. A fourth NIH-sponsored clinical study of Resunab in systemic lupus erythematosus ("SLE") is planned to begin during the first half of 2017.

Recent Corporate Highlights

"We are pleased with the progress we have made over the course of 2016 and our ability to execute a complex clinical development program. We look forward to clinical data from our three current Phase 2 studies," stated Yuval Cohen, Ph.D., Chief Executive Officer of the Company.

Expected Near-Term Milestones

  • Report topline data from systemic sclerosis study in Q4 2016;
  • Complete dosing in Phase 2 clinical studies for CF in Q4 2016, report topline results of the study in Q1 2017;
  • Continue open-label extension study in systemic sclerosis;
  • Complete enrollment of Phase 2 clinical study in dermatomyositis in Q2 2017;
  • Seek Orphan Drug Designation in Europe for the treatment of systemic sclerosis by the end of 2016;
  • Complete additional pre-clinical mechanism of action studies; and
  • Launch of the Phase 2 clinical study in patients with SLE expected in H1 2017.

"Moving forward, we continue our commitment to clinically advance Resunab as a potential therapy for individuals with serious inflammatory and fibrotic diseases," concluded Dr. Cohen.

Summary of Financial Results for Third Quarter 2016

For the three months ended September 30, 2016, the Company reported a net loss of approximately $5,347,000, or a net loss per diluted share of $0.12, compared to a net loss of approximately $2,254,000, or a net loss per diluted share of $0.06 for the three months ended September 30, 2015.

For the nine months ended September 30, 2016, the Company reported a net loss of approximately $12,428,000, or a net loss per diluted share of $0.31, compared to a net loss of approximately $6,352,000, or a net loss per diluted share of $0.22 for the nine months ended September 30, 2015.

The increases in the net losses for the three and the nine months ended September 30, 2016 are attributable to increased spending on clinical studies for systemic sclerosis and CF and increased compensation related to increased staffing, bonuses, and stock-based compensation expense.

The Company ended the quarter with approximately $18.9 million of cash and cash equivalents. The Company expects the cash on hand together with the remaining milestone payments of $1,500,000 from the Cystic Fibrosis Foundation Therapeutics, Inc., which the Company expects to receive in the first quarter of 2017, to be sufficient to meet its operating and capital requirements into the fourth quarter of 2017 based on current planned expenditures.

About Resunab
Resunab is a novel synthetic oral endocannabinoid-mimetic drug that preferentially binds to the CB2 receptor expressed on activated immune cells and fibroblasts. CB2 activation triggers endogenous pathways that resolve inflammation and halt fibrosis. Preclinical and Phase 1 studies have shown Resunab to have a favorable safety, tolerability and pharmacokinetic profile. It has also demonstrated promising potency in preclinical models of inflammation and fibrosis. Resunab is designed to trigger the production of "Specialized Pro-resolving Lipid Mediators" that activate an endogenous cascade responsible for the resolution of inflammation and fibrosis, while reducing production of multiple inflammatory mediators. Resunab has direct effects on fibroblasts to halt tissue scarring. In effect, Resunab triggers endogenous pathways to turn "off" chronic inflammation and fibrotic processes, without causing immunosuppression.

About Corbus
Corbus Pharmaceuticals Holdings, Inc. is a clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare, chronic, and serious inflammatory and fibrotic diseases. Our lead product candidate, Resunab, is a novel synthetic oral endocannabinoid-mimetic drug designed to resolve chronic inflammation, and fibrotic processes. Resunab is currently in Phase 2 clinical studies for the treatment of cystic fibrosis, diffuse cutaneous systemic sclerosis and skin-predominant dermatomyositis, with a fourth Phase 2 trial in systemic lupus erythematosus planned to commence during the first half of 2017.

For more information, please visit www.CorbusPharma.com and connect with the Company on Twitter, LinkedIn, Google+ and Facebook.

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.  
Condensed Consolidated Balance Sheets  
  
  September 30,  December 31,  
  2016  2015  
  (Unaudited)     
ASSETS         
Current assets:         
 Cash and cash equivalents $18,909,348  $12,338,275  
 Prepaid expenses  315,798   376,515  
  Total current assets  19,225,146   12,714,790  
Restricted cash  186,375   36,375  
Property and equipment, net  345,428   124,138  
   Total assets $19,756,949  $12,875,303  
LIABILITIES AND STOCKHOLDERS' EQUITY         
Current liabilities:         
 Notes payable $-  $162,019  
 Accounts payable  2,768,490   1,314,377  
 Accrued expenses  2,342,852   562,279  
 Deferred revenue, current  1,315,865   1,591,358  
  Total current liabilities  6,427,207   3,630,033  
Deferred revenue, noncurrent  -   260,260  
Other long-term liabilities  15,503   -  
   Total liabilities  6,442,710   3,890,293  
Commitments and Contingencies         
Stockholders' equity         
 Preferred stock, $0.0001 par value; 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2016 and December 31, 2015  -   -  
 Common stock, $0.0001 par value; 150,000,000 shares authorized, 43,987,361 and 37,605,134 shares issued and outstanding at September 30, 2016 and December 31, 2015  4,399   3,761  
 Additional paid-in capital  39,016,054   22,259,063  
 Accumulated deficit  (25,706,214 ) (13,277,814 )
  Total stockholders' equity  13,314,239   8,985,010  
   Total liabilities and stockholders' equity $19,756,949  $12,875,303  
       
 
 Corbus Pharmaceuticals Holdings, Inc.
 Condensed Consolidated Statements of Operations
 (Unaudited)
                
  For the Three Months Ended    For the Nine Months Ended  
  September 30,    September 30,  
  2016  2015    2016  2015  
Collaboration revenue $742,558  $170,454    $1,535,754  $284,090  
Operating expenses:                   
 Research and development  4,315,632   1,634,800     10,056,568   4,065,486  
 General and administrative  1,760,696   790,576     3,891,810   2,571,521  
  Total operating expenses  6,076,328   2,425,376     13,948,378   6,637,007  
Operating loss  (5,333,770 ) (2,254,922 )   (12,412,624 ) (6,352,917 )
Other income (expense):                   
 Interest income, net  1,731   1,037     420   773  
 Foreign currency exchange loss  (14,729 ) -     (16,196 ) -  
  Other income (expense), net  (12,998 ) 1,037     (15,776 ) 773  
Net loss $(5,346,768 )$(2,253,885 )  $(12,428,400 )$(6,352,144 )
Net loss per share, basic and diluted $(0.12 )$(0.06 )  $(0.31 )$(0.22 )
Weighted average number of common shares outstanding, basic and diluted  43,783,504   34,770,597     40,059,364   29,242,236  
              

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