Anthera Pharmaceuticals Reports 2013 Third Quarter Financial Results, Clinical
and Regulatory Update
HAYWARD, Calif., Oct. 29, 2013
HAYWARD, Calif., Oct. 29, 2013 /PRNewswire/ --Anthera Pharmaceuticals, Inc.
(NASDAQ: ANTH), today announced financial results, clinical and regulatory
update for the quarter ended September 30, 2013.
Third Quarter 2013 Financial Results:
Net loss for the third quarter of 2013 decreased to $5.8 million from $12.0
million, and loss per basic and diluted share decreased to $0.30 from $1.38,
as compared to the same quarter in 2012. Net loss for the nine months ended
September 30, 2013 decreased to $21.7 million from $50.5 million, loss per
basic and diluted share decreased to $1.21 from $7.97, as compared to the same
period in 2012. The decrease in net losses both quarterly and year-to-date
primarily resulted from a decrease in research and development expenses due to
the Company's shift in focus to the development of blisibimod for systemic
lupus erythematosus, or lupus, and IgA nephropathy, an orphan disease in the
United States. The decrease in net loss per basic and diluted share in 2013
as compared to 2012 was primarily due to the results of lower loss from
operations and higher common shares outstanding.
As of September 30, 2013, the Company had cash, cash equivalents and
short-term investments of $42.0 million, including $10.0 million of restricted
cash. The Company's cash position is higher than forecast as a result of lower
operating expenses recognized in the quarter.
Third Quarter Operational Update:
Blisibimod for the treatment of Systemic Lupus Erythematosus (CHABLIS-SC)
The Phase 3 study CHABLIS-SC1 is currently recruiting at 31 sites across 11
countries in Eastern Europe, Latin America and South East Asia. The Company
anticipates site activation activities will continue to ramp up over the
remainder of 2013. Patient recruitment is tracking according to the Company's
expectations with the first 100 patients expected to be enrolled before the
end of 2013. An interim analysis is planned for mid-2014 when these patients
have completed 24 weeks of treatment. In addition to serving as a
registration study for the SLE indication, CHABLIS-SC1 will contribute safety
data to be included in a potential IgA Nephropathy registration application
Following recent input from the FDA, a second study, CHABLIS-SC2, will be
submitted to the IND before the end of 2013. This study will enroll patients
with SLE, including patients with clinical evidence of renal disease including
glomerulonephritis and lupus nephritis. It is anticipated the two CHABLIS
studies will form the basis of approval for blisibimod to treat a severely
diseased lupus patient population.
On Monday, October 28, 2013, the Company presented emerging data from
thePhase 2b PEARL-SC study and Open-Label Extension at the 2013 Annual
Scientific Meeting of the American College of Rheumatology and the Association
of Rheumatology Health Professionals (ACR/ARHP). These emerging data,
presented by Dr. Richard Furie, demonstrated significant and durable effects
of blisibimod on immunoglobulins IgG and IgM, proteinuria,
anti-double-stranded DNA autoantibodies and complement C3 and C4 over 52 weeks
of therapy. "These data are exciting as they strengthen our belief that
blisibimod will reduce the underlying pathologies in both SLE and IgA
nephropathy," said Dr. Colin Hislop, M.D., Anthera's Chief Medical Officer.
"The emerging data validate our ongoing clinical efforts in these important
Blisibimod for the treatment of IgA Nephropathy (BRIGHT-SC)
The Company has gained regulatory approvals in all seven study countries and
is actively recruiting in five of the seven countries in South East Asia. To
date 10 of 22 sites have been activated with all sites expected to be actively
screening patients by the end of the year. After the first 48 patients have
completed eight weeks of treatment, the Company plans to conduct an interim
analysis to determine the effect of blisibimod on proteinuria and other
relevant biomarkers such as IgA and IgG levels in early 2014.
In May 2013, the Company met with the US FDA to discuss the IgA nephropathy
development program for blisibimod. As a result of receiving feedback from the
US FDA on the potential use of a change in proteinuria as the endpoint for
Subpart E approval for blisibimod, the Company has amended the BRIGHT-SC study
endpoints accordingly. Upon implementation of this new amendment it is the
Company's intention to use the BRIGHT-SC study as one of two studies necessary
to support the marketing approval of blisibimod for the treatment of IgA
nephropathy under the accelerated approval pathway (US FDA Subpart E). In
addition, the US FDA indicated a requirement for the Company to provide data
from a post-marketing study which would include measurements of clinical
endpoints, such as changes in kidney function, progression to dialysis and
death in patients previously enrolled in the two registration studies.
In June 2013, we met with the Japanese Pharmaceutical and Medical Devices
Agency, or PMDA to discuss the development of blisibimod for the treatment of
IgA nephropathy in Japan. At this initial meeting the PMDA also agreed to
consider change in proteinuria as the basis for an initial approval of
blisibimod for the treatment of IgA nephropathy. Further discussions with the
PMDA regarding development of blisibimod in Japan are planned for early 2014.
Prior to the end of 2013, the Company plans to submit an Investigational New
Drug application, or IND, to the US FDA for the investigation of blisibimod in
IgA nephropathy incorporating feedback from both the initial meetings with the
US FDA and PMDA. As part of this submission the Company will provide a second
clinical study protocol, BRILLIANT-SC, intended to evaluate the use of
blisibimod as a treatment for proteinuria in patients with IgA nephropathy.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing
and commercializing products to treat serious diseases associated with
autoimmune disorders including lupus, glomerulonephritis and IgA nephropathy.
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, 2012 and Quarterly Reports on Form 10-Q for the quarters
ended March 31 and June 30, 2013. 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., firstname.lastname@example.org or
ANTHERA PHARMACEUTICALS, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
September 30, September 30,
2013 2012 2013 2012
Research and development $ 4,051 $ 9,527 $ 14,245 $ 42,130
General and 1,470 1,594 5,130 5,715
Total operating 5,521 11,121 19,375 47,845
Loss from (5,521) (11,121) (19,375) (47,845)
Other Income (expense):
Other income (expense) - 14 (46) 33 (84)
Interest expense (296) (806) (2,322) (2,557)
Total other (expense) - (282) (852) (2,289) (2,641)
Net loss $ (5,803) $ (11,973) $ (21,664) $ (50,486)
(1) Net loss per basic and $ (0.30) $ (1.38) $ (1.21) $ (7.97)
number of shares used in per 19,196,140 8,703,790 17,937,069 6,330,705
share calculation-basic and
ANTHERA PHARMACEUTICALS, INC.
(A Development Stage Company)
BALANCE SHEET DATA
(in thousands, except share data)
September 30, December 31,
Cash and cash equivalents $ 31,561 $ 19,431
Short term investments $ 479 $ 5,322
Restricted cash $ 10,000 $ —
Total assets $ 44,335 $ 26,445
Total current liabilities, excluding $ 2,810 $ 9,421
current portion of notes payable
Total notes payable $ 18,570 $ 20,550
Deficit accumulated during development $ (282,042) $ (260,378)
Total shareholders' equity (deficit) $ 22,955 $ (3,526)
(1) Common shares outstanding 19,304,116 9,893,949
Weighted-average number of shares and net loss per share data for the
(1) three and nine months ended September 30, 2012, and common shares
outstanding at December 31, 2012 have been adjusted to reflect reverse
split of stock effectuated on July 15, 2013.
SOURCE Anthera Pharmaceuticals, Inc.
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