Anthera Pharmaceuticals Provides Business Update and Reports 2017 First Quarter Financial Results
May 10 2017 - 4:02PM
Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) today provided a
business update and reported financial results for the first
quarter ended March 31, 2017.
Recent Developments and Business
Highlights:
Sollpura™ (liprotamase) for the treatment of Exocrine
Pancreatic Insufficiency (“EPI”)
- Phase 3 RESULT study expected to screen the first
patient in MayThe Phase 3 RESULT study, which is expected
to screen the first patient in May, is a pivotal, 4-week study
designed to evaluate the non-inferiority of Sollpura at
individualized doses compared to approved, porcine-extracted,
enteric-coated pancreatic enzyme replacement therapy
(“PERT”). The study intends to enroll patients (N≈150) with
exocrine pancreatic insufficiency due to cystic fibrosis who are
well controlled on stable, porcine-extracted PERTs at
screening. The primary efficacy variable will evaluate the
change from baseline in the coefficient of fat absorption following
4 weeks of treatment with either Sollpura or Pancreaze.
Patients randomized to Sollpura or Pancreaze may undergo further
dose adjustments based upon gastrointestinal signs and symptoms to
identify their individualized, optimized dose. Anthera believes
that this optimized dosing paradigm may correct for expected
differences in solubility between the lipases in Sollpura and
porcine PERTs in the more acidic duodenal pH of patients with
cystic fibrosis. After 4 weeks of treatment, patients
randomized to Sollpura will be followed for an additional 20-Week
extension period (total of 24 weeks on study) for additional
assessments of weight, height, BMI, and safety. Topline data, which
will be analyzed based on the 4-week treatment period, is expected
at the end of 2017 or early 2018.
- Extension Period of the Phase 3 SOLUTION study
demonstrated favorable trendsOn March 29, 2017, Anthera
announced favorable trends observed from the Extension Period of
the Phase 3 SOLUTION study. In the full study population of
the Extension Period, Sollpura demonstrated comparable maintenance
to Pancreaze in regards to weight, height, and BMI. In
pediatric patients less than 17 years of age, the key age group for
growth and development, similar trends in weight and height were
observed. As in the Primary Treatment Period, Sollpura was
well tolerated throughout the Extension Period.
Blisibimod for the treatment of IgA
Nephropathy
- Completion of dosing in the Phase 2
BRIGHT-SCOn April 10, 2017, Anthera announced the
completion of dosing in the randomized, double-blind, placebo
controlled, Phase 2 BRIGHT-SC study of blisibimod in patients with
IgA nephropathy (“IgAN”). After Week 24, patients were given
the opportunity to continue blinded treatment for up to 104 weeks,
discontinue treatment but continue to be followed, or discontinue
from the study. Most patients, 42 of 57, completed at least
60 weeks of evaluation and 21 completed assessments through at
least 104 weeks. Topline data from the BRIGHT-SC study is
expected in Q3 2017.
Summary of Financial Results
- Cash Position. Anthera ended the first
quarter of 2017 with cash and cash equivalents totaling $20.7
million, compared to $20.8 million as of December 31, 2016.
The decrease in cash is mainly attributable to $14.3 million used
to fund our clinical development programs, offset by approximately
$14.1 million in net proceeds received from the sale of an
aggregate of 3,750,000 shares of its common stock and an agreement
to issue warrants for the purchase of an aggregate of 7,500,000
shares of its common stock.
- R&D Expense. Research and
development expense for the three months ended March 31, 2017
totaled $7.8 million, compared to $9.6 million for the
corresponding period in 2016. The decrease in 2017 from 2016 is
primarily due to lower clinical development expenses as a result of
the SOLUTION and CHABLIS studies being substantially completed in
2016.
- G&A Expense. General and
administrative expense for the three months ended March 31, 2017
totaled $2.9 million, compared to $2.2 million for the
corresponding period in 2016. The increase is primarily due to
higher expense incurred in connection with our financing effort and
legal expense associated with legal proceedings.
- Other Expense. For the three months
ended March 31, 2017, Anthera recorded $0.6 million in
non-operating expense, primarily comprising the fair value of
warrants issued in connection with a direct offering of our common
stock in March 2017 exceeding the cash proceeds received from the
offering. The change in the fair value of the warrants will
be recognized as non-operating expense or income in the statement
of operations until the warrants are exercised.
- Net Loss. Net loss for the three months
ended March 31, 2017 was $11.2 million, compared to $11.7 million
for the corresponding period in 2016. The decrease in net
loss is mainly attributable to the decrease in clinical study
expense for both Sollpura and blisibimod in 2017. In
addition, the unamortized discount from the conversion of Series X
preferred stock was recognized as a deemed dividend of $2.5 million
in connection with the conversion of resulting in a net loss to
shareholders to 13.7 million.
- Net Loss Applicable to Common
Stockholders. In connection with the September 2016
registered direct offering of convertible preferred stock, warrants
and options to purchase shares of convertible preferred stock,
there was an in-the-money conversion feature (beneficial conversion
feature, or BCF). The BCF required separate financial
statement recognition and recorded as a discount to the preferred
shares and was immediately accreted as a deemed dividend because
the shares were contingently redeemable. For the three months
ended March 31, 2017, we recorded a deemed dividend of $2.5
million.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a clinical-stage biopharmaceutical
company focused on developing products to treat serious and
life-threatening diseases, including exocrine pancreatic
insufficiency 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. 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-K for the year ended December 31, 2016. 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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|
ANTHERA PHARMACEUTICALS, INC. |
CONSOLIDATED STATEMENTS OF
OPERATIONS |
(in thousands, except share and per share
data) |
(unaudited) |
|
|
|
Three months ended March
31, |
|
|
2017 |
|
|
2016 |
|
Revenues: |
|
|
|
|
|
|
|
|
License
fee revenue |
|
$ |
— |
|
|
$ |
139 |
|
Collaborative revenue |
|
|
— |
|
|
|
6 |
|
Total
revenues |
|
|
— |
|
|
|
145 |
|
Operating
expenses: |
|
|
|
|
|
Research
and development |
|
$ |
7,801 |
|
|
$ |
9,624 |
|
General
and administrative |
|
|
2,903 |
|
|
|
2,238 |
|
Research
award |
|
|
(100 |
|
|
|
— |
|
Total
operating expenses |
|
|
10,604 |
|
|
|
11,862 |
|
Loss from
operations |
|
|
(10,604 |
) |
|
|
(11,717 |
) |
Other expense: |
|
|
|
|
|
|
|
Other
expense |
|
|
(3 |
) |
|
|
(9 |
) |
Fair
value of warrant liability in excess of proceeds from
financing |
|
|
(600 |
) |
|
|
— |
|
Net loss |
|
|
(11,207 |
) |
|
|
(11,726 |
) |
Deemed dividends
attributable to preferred stock |
|
|
(2,503 |
) |
|
|
— |
|
Net loss applicable to
common stockholders |
|
$ |
(13,710 |
) |
|
$ |
(11,726 |
) |
Net loss
per share—basic and diluted (1) |
|
$ |
(2.03 |
) |
|
$ |
(2.34 |
) |
Weighted-average number
of shares used in |
|
|
|
|
|
|
|
|
per share
calculation—basic and diluted (1) |
|
|
6,759,567 |
|
|
|
5,006,237 |
|
(1) All per share amounts and shares of the Company’s common
stock issued and outstanding for all periods have been
retroactively adjusted to reflect the one-for-eight reverse stock
split which was effective on April 28, 2017.
|
ANTHERA PHARMACEUTICALS, INC. |
BALANCE SHEET DATA |
(in thousands, except share data) |
(unaudited) |
|
|
March 31, 2017 |
|
December
31, 2016 |
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
20,652 |
|
|
$ |
20,843 |
|
Accounts
receivable |
$ |
100 |
|
|
$ |
— |
|
Total assets |
$ |
23,591 |
|
|
$ |
23,471 |
|
Warrant liability |
$ |
14,700 |
|
|
$ |
— |
|
Total liabilities,
excludes warrant liability |
$ |
6,128 |
|
|
$ |
10,624 |
|
Series X contingently
redeemable convertible preferred stock |
$ |
377 |
|
|
$ |
377 |
|
Series X convertible
preferred stock |
$ |
— |
|
|
$ |
8,614 |
|
Common Stock and
additional paid-in capital |
$ |
421,147 |
|
|
$ |
411,410 |
|
Accumulated
deficit |
$ |
(418,761 |
) |
|
$ |
(407,554 |
) |
Total shareholders'
equity |
$ |
2,386 |
|
|
$ |
12,470 |
|
Common shares
outstanding (1) |
10,076,164 |
|
|
5,746,536 |
|
Series X convertible
preferred shares outstanding |
487 |
|
|
9,499 |
|
(1) All shares of the Company’s common stock issued and
outstanding for all periods have been retroactively adjusted to
reflect the one-for-eight reverse stock split which was effective
on April 28, 2017.
CONTACT:
Investor Relations of Anthera Pharmaceuticals, Inc.
ir@anthera.com
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