Anthera Pharmaceuticals Provides Business Update and Reports 2016 Third Quarter Financial Results
November 04 2016 - 8:30AM
Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) today provided a
business update and reported financial results for the third
quarter ended September 30, 2016.
Recent Developments and Business
Highlights:
Blisibimod for the treatment
of Systemic Lupus Erythematosus
(“SLE”)
- Topline Data from Phase 3 CHABLIS-SC1 Clinical
Study We have been working diligently through the
adjudication for the CHABLIS-SC-1 study, which completed the last
patient visit in September. We currently plan to report
topline efficacy and safety data prior to the 2016 American College
of Rheumatology Annual Meeting taking place from November 11th to
November 16th. Topline data from the CHABLIS-SC1 will include
the primary endpoint evaluation, the Systemic Lupus Erythematosus
Responder Index (SRI-6) as well as safety and tolerability data
from the study. For more information on the CHABLIS-SC1 study,
please visit
http://www.anthera.com/clinical-studies/chablis_sc/.
- Phase 3 CHABLIS 7.5 Clinical Study Enrollment and
Clinical Site Activation On Track We continued
further clinical site activation for, and enrollment in CHABLIS
7.5, our second Phase 3 clinical study. 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 complements
which are known serological markers of lupus. For more information
about the CHABLIS 7.5 study, visit
http://www.anthera.com/clinical-studies/chablis_7-5/.
Sollpura™ (liprotamase) for the treatment of Exocrine
Pancreatic Insufficiency (“EPI”)
- Phase 3 SOLUTION Clinical StudyFollowing the
completion of patient enrollment in our Phase 3 SOLUTION study, an
independent Data and Safety Monitoring Board (DSMB) recommended
continuation of the study without modification on August 3, 2016.
Subsequent assessment by the DSMB on September 25, 2016, found no
concerning safety signals. We expect to report topline efficacy
data from the SOLUTION study before the end of 2016. For more
information on the SOLUTION clinical study, please visit
http://www.anthera.com/clinical-studies/solution_study/.
- SIMPLICITY Clinical Study Enrollment on
Track Enrollment in the SIMPLICITY study, which
intends to evaluate the efficacy and safety of Sollpura™ supplied
as a powder for oral solution, is on track. In this study,
Sollpura™ is delivered in a convenient, easy-to-administer single
use package. We completed enrollment of the initial cohort of
patients 7 years of age and above, and following a review of safety
and efficacy data by an independent DSMB, the study will allow for
administration of Sollpura™ powder for oral solution to pediatric
patients ranging in age from 28 days to less than 7 years. For more
information on the study, please visit
http://www.anthera.com/clinical-studies/simplicity-study/.
- EASY Clinical StudyDuring the third quarter of
2016, we initiated the EASY study, which provides continued access
to Sollpura™ for patients who completed the SOLUTION study.
We plan to continue the EASY study until Biologic License
Application (“BLA”) for Sollpura™ is approved by the U.S. Food and
Drug Administration (“FDA”).
- Manufacturing to Support Commercial Readiness
Accelerated We began acceleration of the
manufacturing scale-up to support the commercial launch of
Sollpura™ including the completion of demonstration and
registration batches at commercial launch scale. We had a Type-C
meeting with the FDA in September to discuss the manufacturing
approach for the Lipase-CLEC drug substance and the conversion of
the filed Sollpura™ New Drug Application (“NDA”) to a BLA. The FDA
confirmed that Sollpura™ fits the regulatory definition of a
biologic, supporting the conversion of the filed NDA to a BLA.
Furthermore, preliminary agreement was reached on Anthera’s
approach to demonstration of comparability of drug substance
manufactured by a new contract manufacturing organization (“CMO”),
and the potential use of a comparability protocol to manage
post-approval process scale up.
Blisibimod for the treatment of IgA
Nephropathy
- Longer-Term Evaluation Continues in Phase 2 BRIGHT-SC
Clinical StudyIn June 2016, an interim analysis of
observed data from 57 patients, all of whom had the opportunity to
complete 24 weeks of treatment, demonstrated a positive trend in
lower proteinuria in blisibimod versus placebo treated patients
over two years, supporting continuation of the study. Data
from the 48-week evaluation is expected at the end of this year or
in early first quarter of 2017. For more information about the
BRIGHT-SC study, visit
http://www.anthera.com/clinical-studies/bright-sc/.
Management Update
- On August 16, 2016, we appointed William Shanahan, M.D., J.D.
as Chief Medical Officer. In this role, Dr. Shanahan will oversee
the clinical development of the blisibimod and Sollpura™ programs.
Dr. Shanahan joins Anthera with over 30 years of drug development
experience, including 16 years as a chief medical officer.
Summary of Financial Results
- Registered Direct Offering. In September 2016,
we executed a subscription agreement with Biotechnology Value Fund,
L.P. and other affiliates of BVF Partners L.P. (“BVF”), and Rock
Springs Capital, pursuant to which we may sell convertible
preferred stock in two tranches. The initial tranche closed
on September 14 and we received gross proceeds of $17
million. The investors have an option for an additional $28.3
million of convertible preferred stock at their discretion.
Each share of preferred stock is convertible into shares of common
stock at various prices in the future. The initial $17
million of Series X convertible preferred stock received warrant
coverage equal to 25% of the issued shares of common stock with an
exercise price equal to 120% of the conversion price of the Series
X convertible preferred stock.
- Cash Position. We ended the third
quarter of 2016 with cash and cash equivalents totaling $32.6
million, compared to $47 million as of December 31, 2015. The
decrease in cash was mainly attributable to $36.7 million used to
fund our clinical development programs during the nine months ended
September 30, 2016, offset by approximately $23 million in net
proceeds received from the sale of common and preferred stock.
- R&D Expense. Research and
development expenses for the three and nine months ended September
30, 2016 totaled $14.1 million and $35.7 million, respectively,
compared to $10.4 million and $24.9 million for the corresponding
periods in 2015. The increase is primarily due to cost associated
with acceleration of the manufacturing scale-up timeline, including
the production of demonstration and registration batches at
commercial launch scale for Sollpura™ and the purchase and
installation of manufacturing equipment at our contract
manufacturers. Additionally, clinical development expense
increased from prior year due to the initiation of three new
clinical studies, namely the CHABLIS-7.5 study with blisibimod in
severe lupus patients, the SIMPLICITY study with Sollpura™ in
sachet formulation and the EASY study which provides continued
access to Sollpura™ for patients who completed the SOLUTION
study.
- G&A Expense. General and
administrative expenses for the three and nine months ended
September 30, 2016 totaled $2.5 million and $7.3 million,
respectively, compared to $2.1 million and $5.7 million for the
corresponding periods in 2015. The increase is primarily due to
higher non-cash stock-based compensation expense recognized during
the three and nine months ended September 30, 2016.
- Net Loss. Net loss for the three and
nine months ended September 30, 2016 was $16.5 million and $42.5
million, respectively, compared to $11.3 million and $27.9 million
for the corresponding periods in 2015. The increase in net
loss is mainly attributable to the increase in manufacturing
expense for Sollpura™ and clinical study expense for both Sollpura™
and blisibimod in 2016.
- Net Loss Applicable to Common
Stockholders. In connection with the September 2016
registered direct offering of convertible preferred stock, warrants
and option to purchase future shares of convertible preferred
stock, there is an in-the-money conversion feature (beneficial
conversion feature, or BCF) that required separate financial
statement recognition and was recorded as a discount to the
preferred shares and was immediately accreted as a deemed dividend
because the shares are immediately convertible. For the
quarter and nine months ended September 30, 2016, we recorded a
deemed dividend of $8.8 million.
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. 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, 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 September 30, |
|
|
Nine months endedSeptember 30, |
|
|
2016 |
|
2015 |
|
|
2016 |
|
2015 |
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License
fee revenue |
|
$ |
— |
|
|
$ |
|
548 |
|
|
|
$ |
139 |
|
|
$ |
743 |
|
Collaborative revenue |
|
|
— |
|
|
|
|
185 |
|
|
|
|
6 |
|
|
|
524 |
|
Total
revenues |
|
|
— |
|
|
|
|
733 |
|
|
|
|
145 |
|
|
|
1,267 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
14,096 |
|
|
$ |
|
10,359 |
|
|
|
$ |
35,686 |
|
|
$ |
24,893 |
|
General
and administrative |
|
|
2,504 |
|
|
|
|
2,091 |
|
|
|
|
7,318 |
|
|
|
5,694 |
|
Research
award |
|
|
— |
|
|
|
|
(367 |
) |
|
|
|
(261 |
) |
|
|
(1,467 |
) |
Total
operating expenses |
|
|
16,600 |
|
|
|
|
12,083 |
|
|
|
|
42,743 |
|
|
|
29,120 |
|
Loss from
operations |
|
|
(16,600 |
) |
|
|
|
(11,350 |
) |
|
|
|
(42,598 |
) |
|
|
(27,853 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense) |
|
$ |
(47 |
) |
|
$ |
|
24 |
|
|
|
$ |
(109 |
) |
|
$ |
(28 |
) |
Change in
fair value of warrant liability |
|
|
169 |
|
|
|
|
— |
|
|
|
|
169 |
|
|
|
— |
|
Net loss |
|
|
(16,478 |
) |
|
|
|
(11,326 |
) |
|
|
|
(42,538 |
) |
|
|
(27,881 |
) |
Deemed
dividends attributable to preferred stock |
|
|
(8,807 |
) |
|
|
|
— |
|
|
|
|
(8,807 |
) |
|
|
— |
|
Net loss applicable to
common stockholders |
|
$ |
(25,285 |
) |
|
|
|
(11,326 |
) |
|
|
$ |
(51,345 |
) |
|
|
(27,881 |
) |
Net loss
per share—basic and diluted |
|
$ |
(0.61 |
) |
|
$ |
|
(0.29 |
) |
|
|
$ |
(1.25 |
) |
|
$ |
(0.81 |
) |
Weighted-average number
of shares used inper share calculation—basic and diluted |
|
|
41,682,669 |
|
|
|
|
39,241,738 |
|
|
|
|
40,924,480 |
|
|
|
34,260,866 |
|
|
ANTHERA PHARMACEUTICALS, INC. |
BALANCE SHEET DATA |
(in thousands, except share data) |
(unaudited) |
|
|
|
|
|
|
|
September 30, 2016 |
|
December
31, 2015 |
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
32,570 |
|
|
$ |
46,951 |
|
Accounts receivable |
$ |
|
|
— |
|
|
$ |
326 |
|
Total assets |
$ |
34,486 |
|
|
$ |
48,125 |
|
Total deferred
revenue |
$ |
|
|
— |
|
|
$ |
138 |
|
Total warrant
liability |
$ |
3,509 |
|
|
|
— |
|
Total liabilities,
excludes deferred revenue & warrant liability |
$ |
10,191 |
|
|
$ |
8,330 |
|
Series X contingently
redeemable convertible preferred stock |
$ |
9,553 |
|
|
$ |
— |
|
Option to purchase future
shares of Series X-1 convertible preferred stock |
$ |
3,689 |
|
|
$ |
— |
|
Common Stock and
additional paid-in capital |
$ |
410,920 |
|
|
$ |
391,688 |
|
Accumulated deficit |
$ |
(403,376 |
) |
|
$ |
(352,031 |
) |
Total shareholders'
equity |
$ |
11,233 |
|
|
$ |
39,657 |
|
Common shares
outstanding |
|
41,955,126 |
|
|
|
40,004,037 |
|
Series X convertible
preferred shares outstanding |
|
17,000 |
|
|
|
— |
|
|
|
|
|
CONTACT:
Nikhil Agarwal of Anthera Pharmaceuticals, Inc.
nagarwal@anthera.com or 510-856-5600 x5621
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