Anthera Pharmaceuticals Provides Business Update and Reports 2016 Second Quarter Financial Results
August 09 2016 - 8:35AM
Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) today provided a
business update and reported financial results for the second
quarter ended June 30, 2016.
Recent Developments and Business
Highlights:
Sollpura™ (liprotamase) – Exocrine Pancreatic
Insufficiency (“EPI”)
- Phase 3 SOLUTION Clinical Study Enrollment Target of
126 Patients MetWe met the enrollment target in our Phase
3 SOLUTION clinical study evaluating the efficacy and safety
of the capsule formulation of Sollpura™ to treat exocrine
pancreatic insufficiency in patients with cystic fibrosis in early
August. We expect to report topline efficacy data in the
fourth quarter of 2016. For more information on the SOLUTION
clinical study, please visit
http://www.anthera.com/clinical-studies/solution study/.
- Initiated SIMPLICITY Clinical Study
with an Enrollment Target of 46 PatientsWe began dosing
patients in the SIMPLICITY clinical study which is evaluating the
efficacy and safety of Sollpura™ supplied as a powder for oral
solution. In this study, Sollpura is packaged in a
convenient, easy-to-administer packet. The soluble dose form
of all three digestive enzymes is mixed with water or apple juice.
After an initial cohort of patients older than seven is
treated for one week, 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, please visit
http://www.anthera.com/clinical-studies/simplicity-study/.
- Manufacturing Progressing to Support SIMPLICITY Study
and Commercial Readiness We successfully manufactured
and released two sachet dosage strengths with a newly developed dry
powder formulation for oral solution, enabling the initiation of
the SIMPLICITY clinical study. We made progress with manufacturing
technical transfer of all three enzymes to our contract
manufacturers site. We completed demonstration batch manufacturing
at commercial launch scale for lipase. Additionally,
proof-of-concept was demonstrated for a high dose Lipase unit
capsule – a further step towards reducing capsule burden in
patients with EPI.
Blisibimod - Systemic Lupus
Erythematosus (“SLE”)
- Topline Data from Phase 3 CHABLIS-SC1 Clinical
Study We continue to collect and prepare final data
from the Phase 3 CHABLIS-SC1 clinical study as the final patients
continue treatment in the study. The last patient in the
study received their final study dose on July 28th. As
described in the protocol, patients are followed for eight weeks
after their last dose at which time the final safety data is
collected. Due to timing of this final visit, the company expects
topline efficacy and safety data will be available prior to the
annual American College of Rheumatology Annual Meeting in November.
Topline data from the CHABLIS-SC1 will include the primary endpoint
evaluation, a six-point reduction in 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
InitiatedCHABLIS 7.5, Anthera’s second Phase 3 clinical
study successfully enrolled its first patient. 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
- Positive Trends Reported on Phase 2 BRIGHT-SC Clinical
StudyIn June 2016, interim data from the BRIGHT-SC study,
which enrolled 57 patients, demonstrated a positive trend in lower
proteinuria in blisibimod versus placebo treated patients. While
the numerical reduction in proteinuria in blisibimod versus placebo
treated patients at week 24 in the BRIGHT-SC study did not meet the
predefined primary endpoint of complete or partial response,
longer-term data from the study demonstrated an increasingly large
separation in proteinuria favoring the blisibimod treated arm
compared to placebo. Additionally, secondary biomarker data from
the study, including changes in total B cell counts and changes in
immunoglobulins IgA, IgG, and IgM, were highly consistent with
previous studies with blisibimod and demonstrated marked reduction
after 8 weeks on study. As a result of the increasing
proteinuria effect after 24 weeks of dosing, and the demonstration
of blisibimod’s effect on immunological markers relevant to IgA
nephropathy including reductions of B cells, and immunoglobulins
including IgA, IgG and IgM, we elected to continue the study until
the last subject enrolled completes 48 weeks of evaluation. For
more information about the BRIGHT-SC study, visit
http://www.anthera.com/clinical-studies/bright-sc/.
Summary of Financial Results
- Cash Position. We ended the second
quarter of 2016 with cash and cash equivalents totaling $28.5
million, compared to $47.0 million as of December
31, 2015. The decrease in cash was mainly attributable to research,
development and operating expenses during the six months ended June
30, 2016.
- R&D Expense. Research and
development expenses for the three and six months ended June 30,
2016 totaled $12.0 million and $21.6 million, respectively,
compared to $8.5 million and $14.5 million for the corresponding
periods in 2015. The increase is mainly attributable to higher
clinical development expenses resulting from the acceleration of
patient enrollment in the SOLUTION clinical study, the initiation
of the SIMPLICITY clinical study, manufacturing scale-up costs
associated with Sollpura, and the initiation of the CHABLIS-7.5
clinical study in severe lupus patients.
- G&A Expense. General and
administrative expenses for the three and six months ended June 30,
2016 totaled $2.6 million and $4.8 million, respectively, compared
to $1.7 million and $3.6 million for the corresponding periods in
2015. The increase is primarily due to higher non-cash stock-based
compensation expense of $0.6 million and $0.9 million,
respectively, recognized during the three and six months ended June
30, 2016.
- 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 $261,000 for the three and six months ended June 30,
2016. The amount of research award recognized represents the
value prescribed to the milestones that we achieved under the award
agreement during the current period. There were no research
award amounts recorded during the comparative period in 2015.
- Net Loss. Net loss for the three and six
months ended June 30, 2016 was $14.3 million, or $0.35 per basic
and diluted share and $26.1 million, or $0.64 per basic and diluted
share, respectively, compared to $8.9 million, or $0.25 per basic
and diluted share and $16.6 million, or $0.52 per basic and diluted
share for the corresponding periods 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. 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 March 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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www.solutionstudy.com
|
ANTHERA PHARMACEUTICALS, INC. |
CONSOLIDATED STATEMENTS OF
OPERATIONS |
(in thousands, except share and per share
data) |
(unaudited) |
|
|
|
Three months ended June 30, |
|
|
|
Six months endedJune 30, |
|
|
|
|
|
2016 |
|
|
|
|
2015 |
|
|
|
|
2016 |
|
|
|
2015 |
|
|
REVENUES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License fee |
|
$ |
— |
|
|
$ |
|
146 |
|
|
|
$ |
139 |
|
|
$ |
195 |
|
|
Collaborative revenue |
|
|
— |
|
|
|
|
143 |
|
|
|
|
6 |
|
|
|
339 |
|
|
Total revenues |
|
|
— |
|
|
|
|
289 |
|
|
|
|
145 |
|
|
|
534 |
|
|
OPERATING
EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
11,966 |
|
|
$ |
|
8,539 |
|
|
|
$ |
21,590 |
|
|
$ |
14,534 |
|
|
General and administrative |
|
|
2,576 |
|
|
|
|
1,696 |
|
|
|
|
4,814 |
|
|
|
3,603 |
|
|
Research award |
|
|
(261 |
) |
|
|
|
(1,100 |
) |
|
|
|
(261 |
) |
|
|
(1,100 |
) |
|
Total operating expenses |
|
|
14,281 |
|
|
|
|
9,135 |
|
|
|
|
26,143 |
|
|
|
17,037 |
|
|
LOSS FROM
OPERATIONS |
|
|
(14,281 |
) |
|
|
|
(8,846 |
) |
|
|
|
(25,998 |
) |
|
|
(16,503 |
) |
|
OTHER INCOME
(EXPENSE): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
(53 |
) |
|
|
|
(49 |
) |
|
|
|
(62 |
) |
|
|
(52 |
) |
|
NET LOSS |
|
$ |
(14,334 |
) |
|
$ |
|
(8,895 |
) |
|
|
$ |
(26,060 |
) |
|
$ |
(16,555 |
) |
|
Net loss per share—basic and
diluted |
|
$ |
(0.35 |
) |
|
$ |
|
(0.25 |
) |
|
|
$ |
(0.64 |
) |
|
$ |
(0.52 |
) |
|
Weighted-average number
of shares used inper share calculation—basic and diluted |
|
|
41,032,544 |
|
|
|
|
35,817,794 |
|
|
|
|
40,541,219 |
|
|
|
31,729,152 |
|
|
|
ANTHERA PHARMACEUTICALS, INC.BALANCE
SHEET DATA(in thousands, except share
data)(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2016 |
|
December 31, 2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents |
$ |
28,500 |
|
$ |
|
46,951 |
|
|
|
|
|
|
|
|
Accounts receivable |
$ |
261 |
|
$ |
|
326 |
|
|
|
|
|
|
|
|
Total assets |
$ |
30,717 |
|
$ |
|
48,125 |
|
|
|
|
|
|
|
|
Total deferred
revenue |
$ |
- |
|
$ |
|
138 |
|
|
|
|
|
|
|
|
Total liabilities,
excludes deferred revenue |
$ |
10,181 |
|
$ |
|
8,330 |
|
|
|
|
|
|
|
|
Accumulated deficit |
|
|
$ |
(378,091 |
) |
$ |
|
(352,031 |
) |
|
|
|
|
|
|
|
Total shareholders' equity
(deficit) |
$ |
20,536 |
|
$ |
|
39,657 |
|
|
|
|
|
|
|
|
Common shares
outstanding |
41,285,033 |
|
40,004,037 |
|
|
|
|
|
|
|
CONTACT: Nikhil Agarwal of Anthera Pharmaceuticals, Inc.
nagarwal@anthera.com or 510-856-5600x5621
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