0001214659-14-007752.txt : 20141114 0001214659-14-007752.hdr.sgml : 20141114 20141114161626 ACCESSION NUMBER: 0001214659-14-007752 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20141114 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20141114 DATE AS OF CHANGE: 20141114 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Anthera Pharmaceuticals Inc CENTRAL INDEX KEY: 0001316175 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 201852016 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-34637 FILM NUMBER: 141224376 BUSINESS ADDRESS: STREET 1: 25801 INDUSTRIAL BOULEVARD, SUITE B CITY: HAYWARD STATE: CA ZIP: 94545 BUSINESS PHONE: (510) 856-5600 MAIL ADDRESS: STREET 1: 25801 INDUSTRIAL BOULEVARD, SUITE B CITY: HAYWARD STATE: CA ZIP: 94545 8-K 1 s11141418k.htm s11141418k.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): November 14, 2014 
 
ANTHERA PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
 
Delaware
  
001-34637
  
20-1852016
(State or Other Jurisdiction of
Incorporation)
  
(Commission File Number)
  
(I.R.S. Employer
Identification No.)
 
25801 Industrial Boulevard, Suite B, Hayward,
California
  
94545
(Address of Principal Executive Offices)
  
(Zip Code)
 
Registrant’s telephone number, including area code: (510) 856-5600
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
o             Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o             Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o             Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o             Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 
 
 
 
Item 2.02                 Results of Operations and Financial Condition.
 
On November 14, 2014 Anthera Pharmaceuticals, Inc. (the “Company”) issued its third quarter 2014 press release.  A copy of the press release is furnished herewith as Exhibit 99.1.
 
Item 9.01                  Financial Statements and Exhibits.
(d) Exhibits
 
Exhibit No.
  
Description
99.1
  
Press Release dated November 14, 2014
 
 
 
 
 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
Date: November 14, 2014
Anthera Pharmaceuticals, Inc.
   
   
 
By:
/s/ May Liu
   
May Liu
   
Principal Accounting Officer
 
 
 
 
 EX-99.1 2 ex99_1.htm EXHIBIT 99.1 Unassociated Document
Exhibit 99.1
 
Anthera Pharmaceuticals Reports 2014 Third Quarter Financial Results
and Operational Update

 
 
HAYWARD, Calif., November 14, 2014 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH), today announced financial results and operational update for the third quarter ended September 30, 2014.
 
Net loss for the three months ended September 30, 2014 was $7.0 million, compared to $5.8 million for the same period in 2013. The increase in net loss is mainly driven by higher research and development expense as a result of continued enrollment progress in both our Phase 3 systemic lupus erythematosus clinical study, CHABLIS-SC1, and Phase 2/3 IgA nephropathy clinical study, BRIGHT-SC.
 
Net loss for the nine months ended September 30, 2014 was $22.2 million, compared with net loss of $21.7 million for the same period in 2013.  Year-to-date research and development expense increased by $2.1 million from prior year due to higher clinical development expense as a result of enrollment progress in our ongoing clinical trials with blisibimod as compared to the previous year.   The increase in clinical development expense is offset by a decrease of $1.4 million in interest expense as a result of the Company’s debt refinance.
 
As of September 30, 2014, our cash, cash equivalents and restricted cash was $15.9 million, compared to $35.9 million at December 31, 2013. The decrease in cash was attributable to cash used in operations and reduction of our restricted cash as a result of principal payment made against our outstanding debt during the nine months ended September 30, 2014. 
 
On October 17, 2014, we terminated our Credit and Security Agreement entered into on April 3, 2014 with MidCap Financial SBIC, LP (“MidCap’) by paying off the outstanding principal of $5.7 million using our available cash.  In connection with the payoff, an outstanding warrant issued to MidCap as part of the financing to purchase up to 73,529 shares of our common stock was cancelled.   The termination of the of the Credit and Security Agreement released all liens and security interests securing the debt, as well as affirmative and negative covenants including, among other things, a financial covenant that required us to maintain minimum levels of cash and cash equivalents in collateral accounts that were pledged to MidCap.  Our operating cash increased as a result of the payoff due to the release of the financial covenant.
 
Third Quarter Operational Update:
 
Blisibimod
 
Our Phase 3 systemic lupus erythematosus clinical study, CHABLIS-SC1, is recruiting patients in Eastern Europe, Latin America and Southeast Asia.  To date, we have enrolled over 260 of the 400 patients planned for the CHABLIS-SC1 study.  Enrolled patient demographics and disease characteristics for the CHABLIS-SC1 study continued to be consistent with our goal to enroll patients with higher levels of lupus activity and positive biomarkers despite the stable use of corticosteroids.  These characteristics appeared predictive of improved outcomes in our previous Phase 2 clinical study. 
 
Our Phase 2/3 IgA nephropathy study, BRIGHT-SC, is currently recruiting patients with a biopsy-proven diagnosis of IgA nephropathy primarily in Southeast Asia. Our expansion of BRIGHT-SC study’s footprint in Europe and Canada is underway with sites in the European Union likely to be initiated in the fourth quarter of 2014.  The baseline characteristics of patients enrolled in the BRIGHT-SC study continued to be consistent with our objectives to enroll patients with a biopsy diagnosis of IgA nephropathy, high levels of proteinuria, and kidney function indicative of progressive kidney disease.
 
 
 
 
 
Interim analyses of CHABLIS-SC1 and BRIGHT-SC were planned for the third quarter of 2014 to confirm the clinical assumptions of the designs of these two studies.  However, due to our on-going partnership negotiations for Asian rights for blisibimod for both lupus and IgA nephropathy, we elected to delay these analyses.  We expect these discussions will be completed during the fourth quarter of 2014. There can be no assurance that a definitive agreement will be executed relating to any proposed partnership, or that any partnership will be approved or consummated.
 
Sollpura™ (liprotamase)
 
As part of our portfolio expansion strategy, we licensed a novel pancreatic enzyme replacement therapy, Sollpura™ (liprotamase), from Eli Lilly and Company (“Lilly”) in July 2014.  The active IND and NDA have been successfully transferred from Lilly to Anthera.  We have commenced drug product formulation development and scheduled the manufacture of new clinical trial material for the first quarter of 2015.  Our plan to begin a Phase 3 pivotal trial in patients who suffer from exocrine pancreatic insufficiency due to cystic fibrosis in the United States and Europe in 2015 remains on track.
 
About Anthera Pharmaceuticals
 
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious and life-threatening diseases, including lupus, lupus with glomerulonephritis, IgA nephropathy, and exocrine pancreatic insufficiency due to cystic fibrosis.
 
Safe Harbor Statement
 
Any statements contained in this press release that refer to future events or other non-historical matters, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," "project," or similar statements, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on Anthera's expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in Anthera's public filings with the SEC, including Anthera's Annual Report on Form 10-K for the year ended December 31, 2013 and Quarterly Report on Form 10-Q for the quarters ended March 31 and June 30, 2014.  Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
 
CONTACT: Dennis Lutz of Anthera Pharmaceuticals, Inc., dlutz@anthera.com or 510.856.5598. 
 
 
 
 

ANTHERA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)

             
   
Three months ended
 September 30,
    
Nine months ended
September 30,
  
   
2014
    
2013
    
2014
    
2013
  
OPERATING EXPENSES:
                        
Research and development
  
$
5,268
    
$
4,051
    
$
16,312
    
$
14,245
  
General and administrative
    
1,419
      
1,470
      
4,849
      
5,130
  
Total operating expenses
    
6,687
      
5,521
      
21,161
      
19,375
  
LOSS FROM OPERATIONS
    
(6,687)
      
(5,521
)
    
(21,161)
      
(19,375
)
OTHER INCOME (EXPENSE):
                                
Other income (expense)
    
(14)
      
14
      
(93)
      
33
  
Interest expense
    
(286)
      
(296
)
    
(905)
      
(2,322
)
Total other income (expense)
    
(300)
      
(282
)
    
(998)
      
(2,289
)
NET LOSS
  
$
(6,987)
    
$
(5,803
)
  
$
(22,159)
    
$
(21,664
)
Net loss per share—basic and diluted
  
$
(0.31)
    
$
(0.30
)
  
$
(1.03)
    
$
(1.21
)
Weighted-average number of shares used in
per share calculation—basic and diluted
    
22,747,308
      
19,196,140
      
21,459,516
      
17,937,069
  


   
ANTHERA PHARMACEUTICALS, INC.
  
   
BALANCE SHEET DATA
  
   
(in thousands, except share data)
  
   
(unaudited)
  
             
             
   
September 30,
2014
    
December 31,
2013
  
             
Cash and cash equivalents
   $ 14,560     $ 25,946  
Restricted cash
   $ 1,360     $ 10,000  
Total assets
   $ 16,874     $ 37,417  
Total current liabilities, excluding current portion of notes payable
   $ 5,274     $ 4,784  
Total notes payable
   $ 7,152     $ 17,875  
Accumulated deficit
   $ (309,365 )   $ (287,207 )
Total shareholders' equity
   $ 4,448     $ 14,758  
Common shares outstanding
    
22,849,223
      
19,415,901