Anthera Pharmaceuticals Reports 2012 Third Quarter Financial Results And Provides Clinical Progress Update

   Anthera Pharmaceuticals Reports 2012 Third Quarter Financial Results And
                      Provides Clinical Progress Update

PR Newswire

HAYWARD, Calif., Oct. 24, 2012

HAYWARD, Calif., Oct. 24, 2012 /PRNewswire/ -- Anthera Pharmaceuticals, Inc.
(NASDAQ: ANTH), today announced financial results and business highlights for
the quarter ended September 30, 2012.

Financial Results and Corporate Update:

Total operating expenses for the third quarter ended September 30, 2012 were
$12.0 million, as compared to $17.6 million for the second quarter ended June
30, 2012. The decrease in operating expenses for the period is related
primarily to the reduced clinical activity following the completion and
wind-down of activities on the PEARL-SC study.

Anthera ended the third quarter of 2012 with approximately $42.5 million in
cash and cash equivalents and short-term investments. On July 24, 2012, the
Company completed a public offering of shares of its common stock resulting in
net proceeds of approximately $35.6 million from the sale of 37,950,000
shares, which includes 4,950,000 shares issued upon the exercise in full of
the underwriters' over-allotment option.

Anthera will host a conference call at 1:00 p.m. Eastern Time tomorrow,
October 25, 2012. U.S. and Canadian participants may dial (877) 312-8807;
international participants may dial (253) 237-1190.  The Conference ID is
44939072. To access the 24-hour audio replay, U.S. and Canadian participants
may dial (855) 859-2056; international participants may dial (404) 537-3406. 
The conference ID for the replay is 44939072.  The audio replay will be
available until November 1, 2012.

Recent Business Highlights and Upcoming Events:

Clinical

  o Subsequent clinical results from the Phase 2b PEARL-SC study, which
    examined the therapeutic effect of blisibimod, indicate that in the
    predefined population of patients with clinically active disease
    (SELENA-SLEDAI* >/= 10) who were also taking corticosteroids, the SRI-8**
    treatment effects in the 200 mg weekly blisibimod cohort were
    statistically significant at week 8 (22.6% blisibimod response versus 6.4%
    placebo response, p=0.023), and at week 16 (35.4% blisibimod response
    versus 17.0% placebo response, p=0.04) through the 24 week endpoint (41.7%
    blisibimod response versus 10.4% placebo response, p < 0.001).
  o New data from the PEARL-SC clinical study indicate strong trends towards
    increased time to first lupus flare (1.8-fold) and time to first severe
    lupus flare (1.6-fold) compared to placebo as defined by the SLE Flare
    Index. This index is used to document an increase in disease activity in
    one or more organ systems that results in new or the worsening of clinical
    signs and symptoms (and/or laboratory measurements). Additionally, there
    is usually a change in treatment, which includes increasing the dose of
    ongoing medications or the addition of new therapies.  
  o New analyses from the PEARL-SC clinical study also demonstrated an
    improvement in proteinuria over 24 weeks with 200 mg weekly blisibimod.
    These decreases in proteinuria resulted in the near normalization of the
    protein:creatinine ratio compared to baseline in patients who received
    blisibimod versus no improvement in the placebo group.
  o Anti-dsDNA antibody levels significantly decreased in the pooled
    blisibimod group compared to the pooled placebo group during the study
    (-23.2 IU v. -8.8 IU, Po <0.001) at week 24. Statistically significant
    reductions were seen as early as week 12. 
  o Additional details regarding the PEARL-SC clinical data can be found on
    our updated corporate presentation at:
    http://investor.anthera.com/events.cfm.

Regulatory

  o The Company has completed discussions with the U.S. Food and Drug
    Administration (FDA) which will allow for the submission of Phase 3
    protocols and the initiation of registration studies. FDA has confirmed
    the primary endpoint of SRI-8 evaluated at week 52 is acceptable for use
    in our Phase 3 clinical studies.
  o The Phase 3 studies (CHABLIS-SC1 and CHABLIS-SC2) will be multicenter,
    randomized, double-blind placebo-controlled studies designed to evaluate
    the efficacy, safety, tolerability and immunogenicity of blisibimod in
    patients with clinically active SLE (SELENA-SLEDAI >/= 10) who are
    non-responsive to corticosteroid therapy. The primary endpoint of the
    CHABLIS studies will be an SRI-8. The CHABLIS-SC1 clinical trial is
    expected to commence in Q1'13.
  o CHABLIS-SC1 will enroll patients from Asia Pacific, Latin America and
    Commonwealth of Independent States (CIS) regions.
  o Additional details regarding our Phase 3 clinical program can be found on
    our updated corporate presentation at:
    http://investor.anthera.com/events.cfm.

Manufacturing

  o The FDA confirmed the comparability of drug substance manufactured by our
    contract manufacturer to the previously manufactured drug substance used
    in our Phase 1 and 2 clinical and GLP toxicity studies.  This step
    corroborates the advice from the European Medicines Agency and will allow
    us to continue into Phase 3 development globally.
  o GMP manufacturing of pre-filled syringes for Phase 3 has been initiated.

*SELENA-SLEDAI -- Safety of Estrogen in Lupus Erythematosus National
Assessment / Systemic Lupus Erythematosus Activity Index is a cumulative,
weighted index of systemic lupus erythematosus disease activity.

**SRI is defined as patients who respond to treatment and achieve a reduction
in SELENA-SLEDAI equal to or greater than the number indicated, no new BILAG A
or two B organ domain scores, and no increase in Physician's Global Assessment
(PGA) of greater than 0.3 on a three point scale.

About Anthera Pharmaceuticals

Anthera Pharmaceuticals is a biopharmaceutical company focused on developing
and commercializing products to treat serious diseases associated with
inflammation and autoimmune diseases.

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, 2011 and Quarterly Report on Form 10-Q for the quarter
ended June 30, 2012.  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: Bianca Nery of Anthera Pharmaceuticals, Inc., bnery@anthera.com or
510.856.5586.

                         ANTHERA PHARMACEUTICALS, INC.
                         A Development Stage Company
                         STATEMENT OF OPERATIONS
                         (unaudited)
                         (in thousands except share and per share data)
                         Three Months Ended Sept    Nine Months Ended Sept 30,
                         30,
                         2012         2011          2012          2011
OPERATING EXPENSE:
  Research and           $     9,527  $     21,546  $     42,130  $     58,449
development
  General and            1,594        1,824         5,715         6,260
administrative
      Total operating    11,121       23,370        47,845        64,709
expense
LOSS FROM OPERATIONS:    (11,121)     (23,370)      (47,845)      (64,709)
OTHER (EXPENSE)/INCOME:
       Other (expense)   (46)         (153)         (84)          421
income
       Interest expense  (806)        (920)         (2,557)       (1,891)
       Total other       (852)        (1,073)       (2,641)       (1,470)
income (expense)
NET LOSS                 $  (11,973)  $   (24,443)  $  (50,486)   $   (66,179)
        Net loss per     $            $             $             $          
share--basic and diluted  (0.17)      (0.60)        (1.00)         (1.83)
 Weighted-average number
of shares used in per    69,630,496   40,833,495    50,645,808    36,238,662
share calculation--
basic and diluted

 

                                           ANTHERA PHARMACEUTICALS, INC.
                                           A Development Stage Company
                                           BALANCE SHEET DATA
                                           (unaudited)
                                           (in thousands except share amounts)
                                           September 30,       December 31,
                                           2012                2011
Cash and cash equivalents                  $      40,985       $      65,624
Short term investments                     $        1,470      $        1,746
Total assets                               $      44,387       $      69,493
Total current liabilities, excluding       $      16,353       $      26,078
current portion of notes payable
Total notes payable                        $      22,624       $      24,331
Deficit accumulated during development     $ (251,465)         $  (200,979)
stage
Total shareholders' equity                 $      5,410        $      19,084
Common shares outstanding                  79,111,870          40,933,354

 

SOURCE Anthera Pharmaceuticals, Inc.

Website: http://www.anthera.com