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8-K - 8-K - Enumeral Biomedical Holdings, Inc.s103252_8k.htm

Exhibit 99.1

 

 

Enumeral Reports First Quarter Financial Results

 

CAMBRIDGE, Mass.--May 13, 2016--Enumeral Biomedical Holdings, Inc. (OTCQB: ENUM) (“Enumeral” or the “Company”), a biotechnology company focused on the discovery and development of novel antibody-based immunotherapies to help the immune system fight cancer and other diseases, today announced its financial results for the three months ended March 31, 2016.  

 

Recent Business Highlights 

 

•    In April 2016, Enumeral entered into a License and Transfer Agreement with Pieris Pharmaceuticals, Inc. and Pieris Pharmaceuticals GmbH. Pursuant to this agreement, Pieris is licensing from Enumeral specified intellectual property related to Enumeral’s anti-PD-1 antibody program ENUM 388D4 for the potential development and commercialization by Pieris of novel multispecific therapeutic proteins comprising fusion proteins based on Pieris’ Anticalins® class of therapeutic proteins and Enumeral antibodies in the field of oncology.
     
 •   In April 2016, Enumeral presented research findings on the Company’s novel class of anti-PD-1 antibodies in a poster at the AACR Annual Meeting 2016 in New Orleans, noting that Enumeral’s anti-PD-1 antibody ENUM 244C8 appears to elicit cytokine secretion from cell types associated with innate immunity in ex vivo assays using lung biopsy samples from human patients.
     
First Quarter 2016 Financial Results
     
•    Cash and Cash Equivalents: Cash and cash equivalents as of March 31, 2016 were $1,837,304, as compared to $3,596,262 as of December 31, 2015. As of the date of this press release, Enumeral believes that it only has sufficient liquidity to fund operations through June 2016. If Enumeral is unable to raise additional capital on acceptable terms and on a timely basis, Enumeral may be required to downsize or wind down its operations through liquidation, bankruptcy, or a sale of its assets. The Company is currently exploring a range of potential transactions, which may include public or private equity offerings, debt financings, collaborations and licensing arrangements, and/or other strategic alternatives, including a merger, sale of assets or other similar transactions.
     
•    Revenue: Revenue increased by $159,735 to $434,457 for the three months ended March 31, 2016, as compared to $274,722 for the three months ended March 31, 2015. This increase in revenue is attributable to the Company’s collaboration agreement with Merck and its grant from the National Cancer Institute.

 

 

 

     
 •   Research and Development Expenses: Research and development (“R&D”) expenses increased by $239,539 to $1,470,043 for the three months ended March 31, 2016, as compared to $1,230,504 for the three months ended March 31, 2015. This increase is primarily due to increased facility expenses in connection with the Company’s office relocation and an increase in stock-based compensation expense associated with stock option grants issued during the three months ended March 31, 2016.
     
•    General and Administrative Expenses: General and administrative (“G&A”) expenses decreased by $230,609 to $1,194,334 for the three months ended March 31, 2016, as compared to $1,424,943 for the three months ended March 31, 2015. This decrease is primarily due to a decrease in legal costs and a decrease in exit costs associated with the termination of the Company’s former lease in connection with the Company’s office relocation.
     
 •   Other Income (Expense): Other income decreased by $3,997,651 to $674,868 for the three months ended March 31, 2016, as compared to $4,672,519 for the three months ended March 31, 2015. This decrease is primarily due to a decrease in non-cash income related to the change in the fair value of derivative liabilities associated with the warrants issued in connection with the Company’s July 2014 private placement transaction. The Company expects that future changes in the fair value of the derivative liabilities will be due primarily to fluctuations in the value of the Company’s common stock and potential exercises of outstanding warrants.
     
•    Net Income (Loss): Net income (loss) changed by $3,846,846 to ($1,555,052) for the three months ended March 31, 2016, as compared to $2,291,794 for the three months ended March 31, 2015. This change is primarily due to the decrease in other income described above.

 

About Enumeral

 

Enumeral is a biopharmaceutical company discovering and developing novel antibody-based immunotherapies to help the immune system fight cancer and other diseases. The Company is building a pipeline focused on next-generation checkpoint modulators, with initial targets including PD-1, TIM-3, LAG-3, OX40, TIGIT, and VISTA. In developing these molecules, Enumeral’s researchers apply a proprietary immune profiling technology platform that measures functioning of the human immune system at the level of individual cells. This provides key insights for drug candidate selection and target validation. For more information on Enumeral, please visit www.enumeral.com.

 

 
 

 

Forward Looking Statements Disclosure

 

This press release contains certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such statements reflect current beliefs of Enumeral Biomedical Holdings, Inc. (“Enumeral”) with respect to future events and involve known and unknown risks, uncertainties, and other factors affecting operations, market growth, Enumeral’s stock price, services, products and licenses. No assurances can be given regarding the achievement of future results, and although Enumeral believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, actual results may differ from the assumptions underlying the statements that have been made regarding anticipated events. Factors that may cause actual results, performance or achievements, or industry results to differ materially from those contemplated by such forward-looking statements include, among others, the risks that (a) Enumeral’s expectations regarding market acceptance of the Company’s business in general and the Company’s ability to penetrate the antibody discovery and development fields in particular, as well as the timing of such acceptance, (b) Enumeral’s ability to attract and retain management with experience in biotechnology and antibody discovery and similar emerging technologies, (c) the scope, validity and enforceability of Enumeral’s and third party intellectual property rights, (d) Enumeral’s ability to raise capital when needed and on acceptable terms and conditions, (e) Enumeral’s ability to comply with governmental regulation, (f) the intensity of competition, (g) changes in the political and regulatory environment and in business and fiscal conditions in the United States and overseas and (h) general economic conditions.

 

More detailed information about Enumeral and risk factors that may affect the realization of forward-looking statements, including forward-looking statements in this press release, is set forth in Enumeral’s filings with the Securities and Exchange Commission. Enumeral urges investors and security holders to read those documents free of charge at the Commission’s website at http://www.sec.gov. Forward-looking statements speak only as to the date they are made, and except for any obligation under the U.S. federal securities laws, Enumeral undertakes no obligation to publicly update any forward-looking statement as a result of new information, future events or otherwise.

 

 
 

 

         
  Enumeral Biomedical Holdings, Inc.
  Condensed Consolidated Balance Sheets
  (Unaudited)

 

   March 31,  December 31,
   2016  2015
ASSETS          
Current assets:          
Cash and cash equivalents  $1,837,304   $3,596,262 
Other current assets   571,355    586,491 
    Total current assets   2,408,659    4,182,753 
Property and equipment, net   1,325,638    1,511,493 
Other assets   646,336    649,352 
   Total assets  $4,380,633   $6,343,598 
           
LIABILITIES AND STOCKHOLDERS' EQUITY          
Current liabilities:          
Accounts payable  $440,113   $343,736 
Accrued expenses   648,072    714,384 
Derivative liabilities   1,459,656    2,138,091 
Other liabilities   330,241    371,012 
    Total current liabilities   2,878,082    3,567,223 
Other long term liabilities   250,735    303,318 
    Total liabilities   3,128,817    3,870,541 
Total stockholders' equity   1,251,816    2,473,057 
Total liabilities and stockholders’ equity  $4,380,633   $6,343,598 

 

 
 
             
Enumeral Biomedical Holdings, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)
(Unaudited)

 

      Three Months Ended 
March 31,
 
      2016   2015  
     Revenue:          
  Collaboration and license revenue    $      316,018    $      209,635  
  Grant revenue            118,439              65,087  
     Total revenue             434,457            274,722  
Cost of revenue and expenses:          
  Research and development         1,470,043         1,230,504  
  General and administrative         1,194,334         1,424,943  
     Total cost of revenue and expenses         2,664,377         2,655,447  
     Loss from operations       (2,229,920)       (2,380,725)  
Other income (expense):          
  Interest income (expense)              (3,567)                2,635  
  Change in fair value of derivative liabilities            678,435         4,669,884  
  Total other income (expense), net            674,868         4,672,519  
  Net income (loss) before income taxes       (1,555,052)         2,291,794  
    Provision for income taxes                      -                         -     
  Net income (loss)    $ (1,555,052)    $   2,291,794  
  Other comprehensive income (loss):          
  Reclassification for loss included in net income                      -                          6  
  Net unrealized holding losses on available-for-sale securities arising during the period                      -                 (6,590)  
  Comprehensive income (loss)     $ (1,555,052)    $   2,285,210  
  Income (loss) per common share:          
  Basic    $          (0.03)    $            0.04  
  Diluted    $          (0.03)    $            0.04  
  Weighted-average number of common shares outstanding:          
  Basic       52,068,784       51,607,454  
  Diluted       52,068,784       52,849,869  

 

 

Contact:

Enumeral Biomedical Holdings, Inc.
Kevin Sarney, (617) 945-9146
kevin@enumeral.com