Anthera Pharmaceuticals Provides Business Update and Reports 2017 Third Quarter Financial Results
November 06 2017 - 8:30AM
Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) today provided a
business update and reported financial results for the third
quarter ended September 30, 2017.
Recent Developments and Business
Highlights:
Sollpura™ (liprotamase) for the treatment of Exocrine
Pancreatic Insufficiency (“EPI”)
- Phase 3 RESULT study topline expected Q1
2018The Phase 3 RESULT study is designed to evaluate the
non-inferiority of Sollpura at individualized doses compared to
approved, porcine-derived, enteric-coated pancreatic enzyme
replacement therapy (PERT) when administered to patients with EPI
due to cystic fibrosis. The study will enroll approximately
150 patients who are well-controlled on stable porcine PERT at
screening, as demonstrated by the coefficient of fat absorption
(CFA). The primary efficacy variable will evaluate the change
from baseline in CFA following 4 weeks of treatment with either
Sollpura or Pancreaze. Patients randomized to Sollpura will then be
followed for an additional 20-Week extension period (total of 24
weeks on study) for longer term assessments of weight, height, BMI,
and safety.
- RESULT study approved by the European Cystic Fibrosis
Society Clinical Trial Network (“ECFS CTN”)In August 2017,
the RESULT study was sanctioned by the ECFS CTN’s Executive
Committee. Together with the U.S. Cystic Fibrosis Foundation
Therapeutics Development Network (“CFFTDN”) sanction of the RESULT
study in July, we expanded the study through the addition of ECFS
CTN clinical sites and CFFTDN clinical sites.
Blisibimod Update
- Blisibimod for the treatment of IgA Nephropathy
(“IgAN”)We reported topline data from the Phase 2
BRIGHT-SC study in August 2017. The BRIGHT-SC study enrolled
57 patients with IgA nephropathy who were treated for up to 2
years, all patients completed at least 60 weeks of
treatment. Topline data demonstrated that blisibimod
has the potential to halt disease progression as measured by the
mean estimate of urinary protein-creatinine ratio, also known as
proteinuria. Additionally, blisibimod demonstrated a trend
toward preservation of renal function based upon individual rates
of change in estimated glomerular filtration rate and marked
reduction in serum immunoglobulins IgA, IgG and IgM.
- Blisibimod received orphan drug designation from the
FDA for the treatment of IgANIn August 2017, we received
notification from the FDA that it had granted orphan drug
designation to blisibimod for the treatment of IgAN. IgAN is
the most common cause of primary glomerulonephritis worldwide for
which there are no approved therapies, despite the high proportion
of patients who progress to end-stage renal disease.
Blisibimod has been well tolerated in > 820 patients over
multiple clinical studies.
Financial Updates
In October 2017, we entered into definitive agreements for a
private placement of equity securities (“PIPE”) with certain
accredited investors for potentially $15 million in aggregate
proceeds. The PIPE is structured with two closings, the
initial closing for gross proceeds of $2.9 million was completed on
October 27, 2017. The second closing is expected to result in
additional gross proceeds of $12.1 million and is subject to
shareholder approval, which we plan to obtain at a special meeting
of our shareholders to be called for that purpose in January
2018.
Summary of Financial Results
- Cash Position. We ended the third
quarter of 2017 with cash and cash equivalents totaling $6.1
million, compared to $20.8 million as of December 31, 2016.
The decrease in cash is mainly attributable to $30.6 million used
to fund our operations, offset by approximately $14.1 million in
proceeds received from a public offering of common stock and
warrants in March 2017, and approximately $1.7 million in proceeds
received from the sale of common stock pursuant to an equity
purchase agreement. The recent PIPE transaction is expected
to increase our cash position.
- Warrant Expiration. In March 2017, we
completed an underwritten public offering of common stock and
warrants. The warrants were issued in two separate tranches
with terms of six months and five years. On October 28, 2017,
one of the tranches representing 3,653,986 warrants expired.
- R&D Expense. Research and
development expense for the three and nine months ended September
30, 2017 totaled $6.1 million and $20.9 million, respectively,
compared to $14.1 million and $35.7 million for the corresponding
periods in 2016. The decrease in 2017 from 2016 is primarily due to
lower clinical development expenses as a result of the SOLUTION
study in cystic fibrosis patients with EPI and CHABLIS clinical
studies in patients with systemic lupus erythematous being
substantially completed in 2016. This resulted in the reductions in
clinical trial expense by $4.9 million and manufacturing/clinical
drug supplies by $1.9 million for the three months ended September
30, 2017. For the nine months ended September 30,2017, this
resulted in the reductions in clinical trial expense by $9.3
million and manufacturing/clinical drug supplies by $3.9
million.
- G&A Expense. General and
administrative expense for the three and nine months ended
September 30, 2017 totaled $1.8 million and $6.3 million,
respectively, compared to $2.5 million and $7.3 million for the
corresponding periods in 2016. The decrease is primarily due to a
30% reduction in headcount, which resulted in lower payroll related
and stock-based compensation expense by $0.4 million and $1.3
million for the three months and nine months ended September 30,
2017, respectively.
- Research Award. A research award,
granted to us in March 2015 by the Cystic Fibrosis Foundation
Therapeutics, Inc. and recorded as an offset to operating expense,
totaled $100,000 for nine months ended September 30, 2017, compared
to $261,000 in the comparative period in 2016. The amount of
the research award recognized represents the value prescribed to
the milestones we achieved under the award agreement during the
reporting periods. As of March 31, 2017, we have fully recognized
the research award.
- Other Income. For the three and nine
months ended September 30, 2017, we recorded $1.6 million and $10.0
million, respectively, in non-operating income, primarily
comprising changes in the fair value of warrants issued in
connection with a direct offering of common stock and warrants in
March 2017 and the fair value of the warrants exceeding the cash
proceeds received from the offering. The initial fair value
of the liability associated with these warrants was $14.7 million
upon issuance in March 31, 2017. As of September 30, 2017,
the fair value of the warrant liability decreased to $4.1 million
due to a decrease in the fair value of the common stock underlying
the warrant shares. The decrease is recorded as part of
non-operating income in the statements of operations in 2017.
- Net Income (Loss) Per Basic and Diluted
Share. For the three months ended September 30,
2017, we recorded a net loss of $6.3 million or $0.58 per basic and
diluted share, compared to net loss of $16.5 million, or $4.85 per
basic and diluted share for the corresponding period in 2016.
For the nine months ended September 30, 2017, we recorded a
net loss of $17.2 million, or $2.12 per basic and diluted share,
compared to net loss of $42.5 million, or $10.04 per share.
- Net Loss Applicable to Common
Stockholders. In connection with a registered direct
offering of convertible preferred stock and warrants to purchase
shares of common stock in September 2016, there was an in-the-money
conversion feature (beneficial conversion feature, or BCF).
The BCF required separate financial statement recognition and was
recorded as a discount to the preferred shares. For the nine
months ended September 30, 2017 and 2016, we recorded a deemed
dividend of $2.5 million and $8.8 million, respectively.
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-Q for the quarter ended June 30, 2017. 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:
Investor Relations of Anthera Pharmaceuticals,
Inc.ir@anthera.com
For Media Inquiries:Frannie Marmorstein,
305-567-0821frannie.marmorstein@rbbcommunications.com
www.twitter.com/antherapharmahttps://www.facebook.com/antherapharma/
https://www.linkedin.com/company/anthera-pharmaceuticals
Source: Anthera Pharmaceuticals, Inc.
|
ANTHERA PHARMACEUTICALS, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(in thousands, except share and per share
data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
Three months endedSeptember
30, |
|
|
Nine months endedSeptember
30, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
REVENUES: |
|
|
|
|
|
|
|
|
|
|
|
|
License fee |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
139 |
|
Collaborative
revenue |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
6 |
|
Total revenues |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
145 |
|
OPERATING
EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
$ |
6,104 |
|
|
$ |
14,096 |
|
|
$ |
20,939 |
|
|
$ |
35,686 |
|
General and
administrative |
|
|
1,810 |
|
|
|
2,504 |
|
|
|
6,338 |
|
|
|
7,318 |
|
Research award |
|
|
— |
|
|
|
— |
|
|
|
(100 |
) |
|
|
(261 |
) |
Total operating
expenses |
|
|
7,914 |
|
|
|
16,600 |
|
|
|
27,177 |
|
|
|
42,743 |
|
LOSS FROM
OPERATIONS |
|
|
(7,914 |
) |
|
|
(16,600 |
) |
|
|
(27,177 |
) |
|
|
(42,598 |
) |
OTHER INCOME
(EXPENSE): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (expense) |
|
$ |
(43 |
) |
|
$ |
(47 |
) |
|
$ |
(74 |
) |
|
|
(109 |
) |
Fair value of warrant
liability in excess of proceeds from financing |
|
|
— |
|
|
|
— |
|
|
|
(600 |
) |
|
|
— |
|
Change in fair value of
warrant liability |
|
|
1,650 |
|
|
|
169 |
|
|
|
10,650 |
|
|
|
169 |
|
Total Other Income
(Expense) |
|
|
1,607 |
|
|
|
122 |
|
|
|
9,976 |
|
|
|
60 |
|
Net Loss |
|
$ |
(6,307 |
) |
|
$ |
(16,478 |
) |
|
$ |
(17,201 |
) |
|
$ |
(42,538 |
) |
Deemed dividends
attributable to preferred stock |
|
|
— |
|
|
|
(8,807 |
) |
|
|
(2,503 |
) |
|
|
(8,807 |
) |
Net loss applicable to
common stockholders |
|
$ |
(6,307 |
) |
|
$ |
(25,285 |
) |
|
$ |
(19,704 |
) |
|
$ |
(51,345 |
) |
Net loss per share
applicable to common stockholders—basic and diluted (1) |
|
$ |
(0.58 |
) |
|
$ |
(4.85 |
) |
|
$ |
(2.12 |
) |
|
$ |
(10.04 |
) |
Weighted-average number
of shares used in per share calculation—basic and diluted
(1) |
|
|
10,947,338 |
|
|
|
5,210,334 |
|
|
|
9,296,890 |
|
|
|
5,115,560 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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 became effective on April 28, 2017.
|
ANTHERA PHARMACEUTICALS, INC. |
BALANCE SHEET DATA |
(in thousands, except share data) |
(unaudited) |
|
|
|
|
|
|
|
September 30,
2017 |
|
December 31,2016 |
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
6,076 |
|
|
$ |
20,843 |
|
Accounts
receivable |
$ |
— |
|
|
$ |
— |
|
Total assets |
$ |
8,368 |
|
|
$ |
23,471 |
|
Warrant liability |
$ |
4,050 |
|
|
$ |
— |
|
Total liabilities,
excludes warrant liability |
$ |
3,975 |
|
|
$ |
10,624 |
|
Series X contingently
redeemable convertible preferred stock |
$ |
— |
|
|
$ |
377 |
|
Series X convertible
preferred stock |
$ |
333 |
|
|
$ |
8,614 |
|
Common Stock and
additional paid-in capital |
$ |
424,765 |
|
|
$ |
411,410 |
|
Accumulated
deficit |
$ |
(424,755 |
) |
|
$ |
(407,554 |
) |
Total shareholders'
equity |
$ |
343 |
|
|
$ |
12,470 |
|
Common shares
outstanding (1) |
11,446,920 |
|
|
5,745,536 |
|
Series X convertible
preferred shares outstanding |
430 |
|
|
9,012 |
|
|
|
|
|
|
|
(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 became was
effective on April 28, 2017.
Anthera Pharmaceuticals (CE) (USOTC:ANTH)
Historical Stock Chart
From Sep 2024 to Oct 2024
Anthera Pharmaceuticals (CE) (USOTC:ANTH)
Historical Stock Chart
From Oct 2023 to Oct 2024