Anthera Pharmaceuticals Provides Business Update and Reports 2016 First Quarter Financial Results
May 09 2016 - 7:38AM
Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) today provided a
business update and reported financial results for the first
quarter ended March 31, 2016.
Recent Developments and Business
Highlights:
Sollpura™ (liprotamase) – Exocrine Pancreatic
Insufficiency
- Phase 3 SOLUTION Clinical Study Enrollment open in
EuropeIn the first quarter of 2016, we continued further
clinical site activation for the Phase 3 SOLUTION clinical study to
include four European countries, Israel and Canada. This study
evaluates the efficacy and safety of the capsule formulation
of Sollpura™ to treat exocrine pancreatic insufficiency in
patients with cystic fibrosis.
- SIMPLICITY Clinical Study expected to begin enrollment
in Q2 2016The SIMPLICITY clinical study will be the first
to offer Sollpura™ supplied in a convenient, easy-to-administer
packet, which can be mixed with water or apple juice for drinkable
dose administration. After an initial cohort of patients older than
7, this study will allow for administration of Sollpura™ powder for
oral solution to pediatric patients ranging in age from 28 days to
seven years. For more information on the study, visit
http://www.anthera.com/clinical-studies/simplicity-study/.
Blisibimod - Systemic Lupus
Erythematosus (“SLE”)
- Topline Data from Phase 3 CHABLIS-SC1 Clinical
Study We continue to collect and finalize data from
the CHABLIS-SC1 study, which will be released later this year.
- Phase 3 CHABLIS 7.5 Clinical Study to Initiate in Q2
2016Following the completion of a bulk drug manufacturing
campaign and clinical site activations, the CHABLIS 7.5 study is
expected to begin enrollment in Q2 2016. This study will
evaluate the efficacy and safety of blisibimod in patients who,
despite corticosteroid use, continue to have clinically-active
Lupus (SLE) and the presence of anti-double-stranded DNA and low
complement which are of known serological markers of lupus. For
more information about the CHABLIS 7.5 study, visit
http://www.anthera.com/clinical-studies/chablis_7-5/.
Blisibimod – IgA
Nephropathy
- Phase 2 BRIGHT-SC Data Planned for Q2 2016We
plan to conduct a proof-of-concept efficacy analysis of the
BRIGHT-SC study when all patients have received a minimum of six
months of therapy in Q2. This analysis will examine the effects of
blisibimod versus placebo in the proportion of qualifying patients
who achieve a complete response or a partial response at six
months. As well, the effects of blisibimod on various disease
markers will be assessed. For more information about the
BRIGHT-SC study, visit
http://www.anthera.com/clinical-studies/bright-sc/.
Management Update
- On January 7, 2016, we expanded our executive management team
with the appointment of Craig Thompson as our President and Chief
Operating Officer. In this role, Mr. Thompson will oversee
both our late stage development programs and launch readiness
efforts. Mr. Thompson joins Anthera with over 20 years of
experience in pharmaceutical development and
commercialization. Most recently he served as the Chief
Operating Officer for Tetraphase Pharmaceuticals where he oversaw
the development and implementation of the commercial strategy as
well as the business development and commercial manufacturing.
Prior to Tetraphase Pharmaceuticals, Mr. Thompson served as the
Chief Commercial Officer for Trius Therapeutics resulting in the
acquisition of Trius by Cubist Pharmaceuticals for over $700
million.
- On March 7, 2016, our Board appointed Dr. James Pennington as
our Interim Chief Medical Officer, effective April 1, 2016.
Dr. Pennington joined Anthera in 2007 and has over 40 years
of successful clinical development and commercialization experience
including 14 drug approvals and 10 registration ex-US approvals
including both small and large molecule therapeutics. Our search
for a permanent Chief Medical Officer is progressing well.
Summary of Financial Results
- Cash Position. Cash and cash equivalents
totaled $38 million as of March 31, 2016, compared to $47
million as of December 31, 2015. The decrease in cash was
mainly attributable to research, development and operational
expenses during the first quarter of 2016 and in line with our
expectations.
- Revenues. License and collaborative
revenues for the quarter ended March 31, 2016 totaled
$145,000.
- R&D Expense. Research and
development expenses for the quarter ended March 31, 2016 totaled
$9.6 million, compared to $6.0 million in the same period in 2015.
The increase is due to higher clinical development expenses of $3.4
million to support our ongoing clinical programs and preparation
for two new Phase 3 studies, namely the SIMPLICITY study with
Sollpura and the CHABLIS-7.5 study with blisibimod in severe lupus
patients, and higher non-cash stock-based compensation expense of
$0.2 million recognized during the first quarter of 2016 as a
result of a greater number of outstanding and unvested stock
options.
- G&A Expense. General and
administrative expenses for the quarter ended March 31, 2016
totaled $2.2 million, compared to $1.9 million in the same period
in 2015. The increase is due to higher non-cash compensation
expense of $0.4 million recognized during the first quarter of 2015
as a result of a greater number of outstanding and unvested stock
options.
- Net Loss. Net loss for the quarter ended
March 31, 2016 was $11.7 million, or $0.29 per basic and diluted
share, compared to $7.7 million, or $0.28 per basic and diluted
share in the same period in 2015.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a clinical-stage biopharmaceutical
company focused on developing and commercializing products to treat
serious and life-threatening diseases, including exocrine
pancreatic insufficiency due to cystic fibrosis, lupus, lupus with
glomerulonephritis, and IgA nephropathy. Additional information on
the Company can be found at www.anthera.com.
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 include statements about
Anthera's expectations with respect to its public offering,
including statements about its intended use of proceeds from
the offering. Such 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, including but not limited to
those 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, 2015. 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.
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www.solutionstudy.com
ANTHERA PHARMACEUTICALS,
INC.CONSOLIDATED STATEMENTS OF
OPERATIONS(in thousands, except share and per
share data)(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31, |
|
|
|
2016 |
|
2015 |
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
License revenue |
$ |
|
139 |
|
|
$ |
|
49 |
|
|
|
|
|
|
|
|
Collaboration revenue |
|
|
6 |
|
|
|
|
196 |
|
|
|
|
|
|
|
|
Total revenues |
|
|
145 |
|
|
|
|
245 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
$ |
|
9,624 |
|
|
$ |
|
5,995 |
|
|
|
|
|
|
|
|
General and
administrative |
|
|
2,238 |
|
|
|
|
1,907 |
|
|
|
|
|
|
|
|
Total operating
expenses |
|
|
11,862 |
|
|
|
|
7,902 |
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(11,717 |
) |
|
|
|
(7,657 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense) |
|
|
(9 |
) |
|
|
|
(3 |
) |
|
|
|
|
|
|
|
Total other income
(expense) |
|
|
(9 |
) |
|
|
|
(3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
|
(11,726 |
) |
|
$ |
|
(7,660 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
|
(0.29 |
) |
|
$ |
|
(0.28 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of
shares used in per share calculation: basic and diluted |
40,049,895 |
|
27,595,081 |
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
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|
ANTHERA PHARMACEUTICALS, INC.BALANCE
SHEET DATA(in thousands, except share
data)(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2016 |
|
December 31, 2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
|
37,877 |
|
|
$ |
|
46,951 |
|
|
|
|
|
|
|
|
Accounts receivable |
$ |
|
- |
|
|
$ |
|
326 |
|
|
|
|
|
|
|
|
Total assets |
$ |
|
38,856 |
|
|
$ |
|
48,125 |
|
|
|
|
|
|
|
|
Total deferred
revenue |
$ |
|
- |
|
|
$ |
|
138 |
|
|
|
|
|
|
|
|
Total liabilities,
excludes deferred revenue |
$ |
|
8,036 |
|
|
$ |
|
8,330 |
|
|
|
|
|
|
|
|
Accumulated
deficit |
$ |
|
(363,757 |
) |
|
$ |
|
(352,031 |
) |
|
|
|
|
|
|
|
Total shareholders'
equity |
$ |
|
30,820 |
|
|
$ |
|
39,657 |
|
|
|
|
|
|
|
|
Common shares
outstanding |
40,486,883 |
|
40,004,037 |
|
|
|
|
|
|
|
CONTACT: Nikhil Agarwal of Anthera Pharmaceuticals, Inc.
nagarwal@anthera.com or 510-856-5600x5621
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