0001214659-15-003827.txt : 20150511 0001214659-15-003827.hdr.sgml : 20150511 20150511161528 ACCESSION NUMBER: 0001214659-15-003827 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20150511 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20150511 DATE AS OF CHANGE: 20150511 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: 15850913 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 j5111548k.htm j5111548k.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): May 11, 2015
 
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 May 11, 2015 Anthera Pharmaceuticals, Inc. (the “Company”) issued its first quarter press 2015 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 May 11, 2015
 
 
 
 
 
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: May 11, 2015
Anthera Pharmaceuticals, Inc.
   
   
 
By:
/s/ May Liu
   
May Liu
   
Principal Accounting Officer
 
 
 
EX-99.1 2 ex99_1.htm EXHIBIT 99.1 ex99_1.htm
Exhibit 99.1
 
Anthera Pharmaceuticals Reports 2015 First Quarter and Operational Update

·
Completed Interim Analysis from Phase 3 Trial with Blisibimod for Systematic Lupus Erythematosus
·
Completed Interim Analysis from Phase 2/3 Trial with Blisibimod for IgA Nephropathy
·
Increased Cash Position by $43 Million Through Equity Investment by Zenyaku and Equity Offering Received $3 Million Research Award from Cystic Fibrosis Foundation Therapeutics for Phase 3 Development of Sollpura (liprotamase)

Hayward, CA, May 11, 2015 – Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH) today announced financial results and an operational update for the first quarter ended March 31, 2015.
 
Net loss for the quarter ended March 31, 2015 was $7.7 million, compared to $7.9 million for the same period in 2014.
 
Research and development expense for the quarter ended March 31, 2015 was $6.0 million, compared to $5.8 million for the same period in 2014.  The increase in research and development expense was primarily due to expansion activities for our BRIGHT-SC IgA nephropathy study and manufacturing activities for our upcoming Phase 3 SOLUTION study with liprotamase.
 
General and administrative expense for the quarter ended March 31, 2015 was $1.9 million, compared to $1.8 million for the same period in 2014.
 
Non-operating expense for the quarter ended March 31, 2015 was reduced from $0.3 million to $3,000 mainly as a result of a reduction in interest expense driven by our elimination of all debt financing arrangements in the fourth quarter of 2014.
 
As of March 31, 2015, we had cash and cash equivalents of $41.6 million, compared to $2.6 million as of December 31, 2014.  The increase in our cash balance was mainly driven by total financing proceeds of $45.5 million received from the sale of our common stock through a public offering for $26.9 million, $11.6 million from the sale of common stock through an at-the-market offering and $7.0 million from an equity investment by our collaborative partner, Zenyaku, in the first quarter of 2015.

First Quarter Operational Update:
 
Sollpura™ (liprotamase)
 
Manufacturing activities for liprotamase progressed on schedule with respect to both capsule and sachet products.  Sachet formulation development was substantially completed and pilot-scale feasibility was executed demonstrating manufacturability.

In March 2015, we received a research award from Cystic Fibrosis Foundation Therapeutics Inc. of up to $3 million to support the manufacturing and clinical development of our novel pancreatic enzyme replacement therapy, Sollpura™ (liprotamase).  Cystic Fibrosis Foundation Therapeutics is a non-profit affiliate of the Cystic Fibrosis Foundation which supports and governs activities related to cystic fibrosis drug discovery through the many stages of drug development and clinical evaluation.
 
 
 
 
 
Blisibimod – Systemic Lupus Erythematosus
 
In February 2015, we modified the primary efficacy endpoint of CHABLIS-SC1 from the SRI-8 responder index to SRI-6 (previously a secondary endpoint of the study).  The SRI (SLE Responder Index) is a recognized endpoint by the FDA for previously approved therapeutics. The change in primary efficacy endpoint was based on our Scientific Advisory Board’s evaluation of published clinical data from other recent lupus studies with BAFF inhibitors in which the outcomes as measured using SRI-6 endpoint were more consistent.  Subsequent to the amendment of the primary endpoint, an independent un-blinded statistician conducted an interim analysis of CHABLIS-SC1 based on the proportion of responders to the SRI-6 at a pre-specified time point. Based on this analysis, the un-blinded statistician recommended the study to continue to completion as planned.  We anticipate full enrollment of 400 patients in the CHABLIS-SC1 trial to be completed this year with top-line efficacy data expected in the second half of 2016.

Blisibimod – IgA Nephropathy
 
In March 2015, an interim analysis of the BRIGHT-SC study was conducted by an independent un-blinded statistician, who evaluated several important biomarkers of renal disease in IgA nephropathy amongst patients with who had completed at least 8 weeks of treatment.  Based on the results of the interim analysis, it was recommended that the BRIGHT-SC trial should continue to completion.  Following this outcome, in collaboration with our partner Zenyaku, we are expanding the number of BRIGHT-SC worldwide clinical sites.
 
About Anthera Pharmaceuticals
 
Anthera Pharmaceuticals, Inc. is a biopharmaceutical company focused on advancing the development and commercialization of innovative medicines that benefit patients with unmet medical needs. Our first Phase 3 product candidate, blisibimod, targets B-cell activating factor, or BAFF, which has been shown to be elevated in a variety of B-cell mediated autoimmune diseases, including systemic lupus erythematosus, or lupus, and Immunoglobulin A nephropathy, an orphan disease with no approved treatment to address its root cause. Our second Phase 3 product candidate, liprotamase, is a novel non-porcine investigational Pancreatic Enzyme Replacement Therapy (“PERT”) intended for the treatment of patients with Exocrine Pancreatic Insufficiency (“EPI”), often seen in patients with cystic fibrosis and other conditions. We are working with the Cystic Fibrosis Foundation in hopes of delivering a new option to patients left behind by currently available therapies.
 
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, 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
 March 31,
  
   
2015
    
2014
  
Revenues:
            
License fee
  
$
49
    
$
—
  
Sponsored research and development
    
196
      
—
  
     Total revenues
    
245
      
—
  
                 
Operating Expenses:
            
Research and development
  
$
5,995
    
$
5,765
  
General and administrative
    
1,907
      
1,844
  
     Total operating expenses
    
7,902
      
7,609
  
Loss from operations
    
(7,657
)
    
(7,609
)
                 
Other Expenses:
                
    Interest expense
    
—
      
(259
)
    Other expense
    
(3
)
    
(48
)
         Total other expenses
    
(3
)
    
(307
)
    Net loss
  
$
(7,660
)
  
$
(7,916
)
    Net loss per share attributable to common stockholders:
                
Basic and diluted
  
$
(0.28
)
  
$
(0.39
)
    Weighted-average number of shares used in per share calculation:
Basic and diluted
    
27,595,081
      
20,132,252
  

 
 
   
ANTHERA PHARMACEUTICALS, INC.
BALANCE SHEET DATA
(in thousands, except share data)
(unaudited)
  
             
             
   
March 31,
2015
    
December 31,
2014
  
             
Cash and cash equivalents
   $ 41,648     $ 2,639  
Accounts receivable
   $ 650     $ -  
Total assets
   $ 43,569     $ 3,490  
Total deferred revenue
   $ 2,051     $ -  
Total liabilities, excludes deferred revenue
   $ 6,406     $ 5,751  
Accumulated deficit
   $ (324,471 )   $ (316,811 )
Total shareholders' equity (deficit)
   $ 35,112     $ (2,261 )
Common shares outstanding
     35,816,364       23,005,209