Anthera Pharmaceuticals Provides Business Update and Reports Third Quarter 2015 Financial Results
November 06 2015 - 4:19PM
Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) today provided a
business update and reported financial results for the third
quarter ended September 30, 2015.
Recent Developments and Business
Highlights:
Clinical Development
- Sollpura™ (liprotamase)
- Completed Manufacturing, Testing and Release of
Sollpura™ CapsulesIn August, we completed the
manufacturing of Sollpura™ capsules in two dosage strengths, which
enabled the initiation of our Phase 3 clinical study, SOLUTION and
triggered the achievement of several milestones under a research
award granted to us by Cystic Fibrosis Foundation Therapeutics,
Inc. (“CFFT”). Consequently, we expect to receive research
funding of approximately $1.4 million from CFFT in the fourth
quarter.
- Initiated Phase 3 Clinical StudyIn September,
we initiated the SOLUTION Phase 3 clinical study evaluating the
efficacy and safety of Sollpura™ in patients with cystic fibrosis
who suffer from exocrine pancreatic insufficiency. The SOLUTION
study is expected to enroll approximately 130 patients across more
than 50 clinical sites around the United States and Europe. For
more information on the SOLUTION clinical study, please visit
https://clinicaltrials.gov/ct2/show/NCT02279498
- Pediatric Clinical Study is Under
DevelopmentWe began planning for a second clinical study,
SIMPLICITY, to support pediatric use. The SIMPLICITY clinical study
will use a powder for solution formulation of Sollpura™ that is
packaged in sachets for ease of administration. SIMPLICITY is
currently planned for initiation in late 2015 or early 2016.
Manufacturing activities to support the SIMPLICITY study, including
finalizing the new sachet formulation are complete. Planning for
the manufacture of two dosage strengths of Sollpura™ Powder for
Oral Solution sachets are in progress. Feedback from the European
Medicines Agency and U.S. FDA on the company’s pediatric plan was
received. The SIMPLICITY clinical study design is being modified to
incorporate the agencies’ suggestions. SIMPLICITY will be the first
clinical study to study the use of a powder for solution
formulation in an easy to administer packet.
- Blisibimod - Systemic Lupus
Erythematosus (“SLE”)
- Phase 3 CHABLIS-SC1 Clinical Study Enrollment
CompletedWe closed enrollment for this study in July after
we surpassed the enrollment target of 400 patients. Topline
efficacy and safety data from the study is expected in the second
half of 2016.
- Phase 3 CHABLIS 7.5 is Approaching
InitiationPlanning for our second Phase 3 lupus study,
CHABLIS 7.5 study is well underway. The CHABLIS 7.5 study will
evaluate the efficacy and safety of blisibimod when administered on
top of standard-of-care medication in patients with severe,
seropositive SLE that is inadequately controlled with
corticosteroids. Patient eligibility for this study is informed by
responder traits identified in the Phase 2 study with blisibimod as
well as the large Phase 3 programs with other BAFF inhibitors. For
more information about the CHABLIS 7.5 study, please visit
https://clinicaltrials.gov/ct2/show/NCT02514967.
- Blisibimod – IgA Nephropathy
- Continued Enrollment in the Phase 2/3 BRIGHT-SC
Clinical StudyRecruitment in the Phase 2/3 BRIGHT-SC
clinical study in patients with IgA nephropathy is ongoing despite
the pending termination of a collaborative arrangement with our
partner in Japan. The BRIGHT-SC study remains fully blinded and
will continue as planned. We will regain worldwide rights to
blisibimod upon the effective date of the termination on January 7,
2016, at which time we may explore the possibility of an early
examination of clinical data from the BRIGHT-SC study, which may
provide helpful insight into the future development of blisibimod
for IgA nephropathy.
Summary of Financial Results
- Cash Position. Cash and cash equivalents
totaled $55.8 million on September 30, 2015, compared
to $2.6 million as of December 31, 2014. The
increase was mainly attributable to our March and July public
offerings of common stock, sale of common stock through an
at-the-market program, equity investment and cost reimbursement
from our partner in Japan, offset by cash used in operations.
- Revenues. License and collaborative revenues
for the third quarter and nine months ended September 30, 2015
totaled $0.7 million and $1.3 million, respectively. As a result of
the pending termination of a collaborative arrangement with our
partner in Japan, we accelerated the amortization of our deferred
revenue to correspond with the shortened collaborative period,
which resulted in an increase of $0.4 million in license revenue
during quarter ended September 30, 2015.
- R&D Expense. Research and development
expenses for the third quarter of 2015 increased by $5.1 million to
$10.4 million from $5.3 million in the third quarter of 2014. This
increase was mainly driven by expenses associated with
manufacturing and initiation of our Phase 3 SOLUTION clinical study
of Sollpura™ and higher clinical development expense for our
blisibimod program. Additionally, non-cash stock-based compensation
expense increased by $0.5 million from the third quarter of 2014
due to equity grants issued during the third quarter of 2015.
- G&A Expense. General and administrative
expenses increased by $0.7 million for the third quarter of
2015 to $2.1 million from $1.4 million in the third
quarter of 2014. The increase was mainly due to an increase of $0.4
million in non-cash stock based compensation expense compared to
the third quarter of 2014 and higher professional services.
- Research Award. Research award, granted to us
in March of 2015 by CFFT and recorded as an offset to operating
expense, totaled $0.4 million and $1.5 million for the third
quarter and nine months ended September 30, 2015. The amount of the
research award we recognized represents the value of milestones we
have achieved under the award agreement as of September 30,
2015.
- Net Loss. Net loss for the third quarter of
2015 was $11.3 million, or $0.29 per basic and diluted share,
compared to $7.0 million, or $0.31 per basic and diluted share, for
the third quarter of 2014. The increase in net loss was primarily
related to the advancement of our blisibimod program and the
initiation of Sollpura™ in a Phase 3 clinical study.
- Warrant Expiration. In September 2015, we
reduced our fully diluted shares outstanding by 516,660 due to the
expiration of warrants issued in a prior financing
transaction.
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 lupus, lupus with
glomerulonephritis, IgA nephropathy, and exocrine pancreatic
insufficiency due to cystic fibrosis. 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 Quarterly Report on Form 10-Q for the quarter
ended June 30, 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.
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, |
|
2015 |
|
2014 |
|
2015 |
|
2014 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
License revenue |
$ |
|
548 |
|
|
$ |
|
— |
|
|
$ |
|
743 |
|
|
$ |
|
— |
|
|
Collaboration revenue |
|
|
185 |
|
|
|
|
— |
|
|
|
|
524 |
|
|
|
|
— |
|
|
Total revenues |
|
|
733 |
|
|
|
|
— |
|
|
|
|
1,267 |
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
$ |
|
10,359 |
|
|
$ |
|
5,268 |
|
|
$ |
|
24,893 |
|
|
$ |
|
16,312 |
|
|
General and
administrative |
|
|
2,091 |
|
|
|
|
1,419 |
|
|
|
|
5,694 |
|
|
|
|
4,849 |
|
|
Research award |
|
|
(367 |
) |
|
|
|
— |
|
|
|
|
(1,467 |
) |
|
|
|
— |
|
|
Total operating
expenses |
|
|
12,083 |
|
|
|
|
6,687 |
|
|
|
|
29,120 |
|
|
|
|
21,161 |
|
|
Loss from operations |
|
|
(11,350 |
) |
|
|
|
(6,687 |
) |
|
|
|
(27,853 |
) |
|
|
|
(21,161 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
— |
|
|
|
|
(286 |
) |
|
|
|
— |
|
|
|
|
(905 |
) |
|
Other income
(expense) |
|
|
24 |
|
|
|
|
(14 |
) |
|
|
|
(28 |
) |
|
|
|
(93 |
) |
|
Total other income
(expense) |
|
|
24 |
|
|
|
|
(300 |
) |
|
|
|
(28 |
) |
|
|
|
(998 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
|
(11,326 |
) |
|
$ |
|
(6,987 |
) |
|
$ |
|
(27,881 |
) |
|
$ |
|
(22,159 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
|
(0.29 |
) |
|
$ |
|
(0.31 |
) |
|
$ |
|
(0.81 |
) |
|
$ |
|
(1.03 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of
shares used in per share calculation: basic and diluted |
39,241,738 |
|
22,747,308 |
|
34,260,866 |
|
21,459,516 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANTHERA PHARMACEUTICALS, INC.BALANCE
SHEET DATA(in thousands, except share
data)(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2015 |
|
December
31, 2014 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
|
55,762 |
|
|
$ |
|
2,639 |
|
|
|
|
|
|
|
|
Accounts receivable |
$ |
|
983 |
|
|
$ |
|
— |
|
|
|
|
|
|
|
|
Total assets |
$ |
|
57,454 |
|
|
$ |
|
3,490 |
|
|
|
|
|
|
|
|
Total deferred
revenue |
$ |
|
1,957 |
|
|
$ |
|
— |
|
|
|
|
|
|
|
|
Total liabilities,
excludes deferred revenue |
$ |
|
10,187 |
|
|
$ |
|
5,751 |
|
|
|
|
|
|
|
|
Accumulated
deficit |
$ |
|
(344,692 |
) |
|
$ |
|
(316,811 |
) |
|
|
|
|
|
|
|
Total shareholders' equity
(deficit) |
$ |
|
45,310 |
|
|
$ |
|
(2,261 |
) |
|
|
|
|
|
|
|
Common shares
outstanding |
|
|
39,875,405 |
|
|
|
|
23,005,209 |
|
|
|
|
|
|
|
|
CONTACT: Nikhil Agarwal of Anthera Pharmaceuticals, Inc.
nagarwal@anthera.com or 510-856-5600x5621
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