Immune Pharmaceuticals Announces Company Highlights and Reports Full Fiscal Year 2013 Financial Results
10 Abril 2014 - 3:30AM
Immune Pharmaceuticals Inc. (OTCQX:IMNP) and (Nasdaq:IMNP)
("Immune" or "the Company") announced today company highlights and
its financial results for the 12-month period ended December 31,
2013.
"Immune underwent a significant transformation in 2013," said
Dr. Daniel G. Teper, Chairman and CEO of Immune. "We completed the
merger with EpiCept and became a publicly traded company. Our lead
candidate, Bertilimumab, a first in class monoclonal antibody, has
advanced to Phase II in moderate-to-severe ulcerative colitis and
in bullous pemphigoid (BP), an orphan dermatological auto-immune
disease. We were pleased with the recently completed private
placement financing, which raised gross proceeds of $11.7
million."
Company Highlights:
- The merger with EpiCept Corporation was completed on August 25,
2013. The merger combined Immune's antibody therapeutic platform
focused on the treatment of inflammatory diseases and cancer with
EpiCept's clinical stage cancer candidate, Crolibulin, and its
late-stage topical pain product, AmiKet™.
- Bertilimumab entered a Phase II clinical trial in
moderate-to-severe ulcerative colitis. The clinical trial is a
randomized, double-blind, placebo-controlled parallel group study
that will evaluate the safety, clinical efficacy, and
pharmacokinetic profile of Bertilimumab in subjects with active
moderate-to-severe ulcerative colitis. Completion of patient
enrollment and clinical results are anticipated in the first half
of 2015.
- Bertilimumab entered a phase II pilot study in Bullous
Pemphigoid (BP). Completion of patient enrollment and clinical
results are anticipated in late 2014.
- The Company is preparing for Phase III development AmiKet™ and
has re-energized its efforts to out-license the product candidate
prior to the start of a Phase III trial for the treatment of
neuropathic pain. AmiKet is a prescription topical analgesic cream
containing the active ingredients amitriptyline and ketamine
designed to provide long-term relief from the pain of peripheral
neuropathies, which affects more than 15 million people in the U.S.
AmiKet has been granted orphan drug status for the treatment of
post-herpetic neuralgia and Fast Track designation for the
treatment of Chemotherapy Induced Peripheral Neuropathies
(CIPN).
- At the May 2013 ASCO meeting in Chicago, data was presented
from the Phase I safety portion of a Phase 1b/II trial to assess
safety and efficacy of Crolibulin in combination with Cisplatin.
The trial is sponsored by the National Cancer Institute. Crolibulin
is a vascular disruption agent that has demonstrated potent
anti-tumor activity in both preclinical and early clinical
studies.
- The Board of Directors was strengthened with two appointments,
Rene Lerer, MD, and Daniel Kazado. Dr. Lerer is accomplished
healthcare leader with more than 30 years of significant, hands-on
experience. He led the transformation, diversification, and growth
of Magellan Health Services (Nasdaq:MGLN) as Chairman and CEO.
Daniel Kazado is a senior advisor to Melini Capital, a family owned
private and public equity firm investing in several
industries.
- Immune completed a $11.7 million private placement financing in
March 2014, which included several biotech specialist institutional
investors as well as family office shareholders and
management.
- The Senior Management Team was strengthened In April 2014 with
the appointment of Eugene Williams as Chief Operating Officer and
Elliott Goldstein, MD, as Chief Medical Officer.
Mr. Williams was previously CEO of Dart Therapeutics, an orphan
drug development company and spent 12 years at Genzyme where he
held the position of Senior Vice President for Immune Therapeutics.
Dr. Goldstein held leadership positions in clinical research,
regulatory affairs and commercial development at Novartis, GSK,
British Biotech and Maxygen.
Immune Pharmaceuticals
Inc. and Subsidiaries |
Consolidated Balance
Sheets Data |
(in
$000s) |
|
|
|
|
December
31, |
|
2013 |
2012 |
|
|
|
ASSETS |
|
|
Cash |
$ 49 |
$ 95 |
|
|
|
Property and equipment, net |
47 |
35 |
In-process research and development |
27,500 |
— |
Intangible assets, net |
3,607 |
3,896 |
Total assets |
$ 31,501 |
$ 4,131 |
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
Accounts payable |
$ 5,181 |
$ 1,801 |
Accrued expenses |
3,572 |
654 |
Notes and loans payable (current) |
1,546 |
36 |
Total stockholders'
equity |
5,483 |
14 |
Total liabilities and stockholders'
equity |
$ 31,501 |
$ 4,131 |
|
|
Immune Pharmaceuticals
Inc. and Subsidiaries |
Consolidated Statements
of Operations Data |
(in $000s except share
and per share data) |
|
|
|
Year Ended
December 31, |
|
2013 |
2012 |
Revenue: |
|
|
|
|
|
Licensing and other revenue |
19 |
— |
Total revenue |
$ 19 |
$ — |
Costs and expenses: |
|
|
|
|
|
General and administrative |
5,448 |
5,395 |
Research and development |
3,571 |
3,797 |
Total costs and expenses |
9,019 |
9,192 |
Loss from operations |
(9,000) |
(9,192) |
Other income (expense): |
|
|
Interest expense |
(305) |
(36) |
Gain on bargain purchase |
6,444 |
— |
Warrant amendment expense |
(734) |
— |
Total other income (expense),
net |
3,251 |
(3,372) |
Net loss before income
taxes |
(5,749) |
(12,564) |
Income taxes |
(11) |
(11) |
Net loss |
$ (5,760) |
$ (12,575) |
Deemed dividends |
(932) |
— |
Loss attributable to Common
Shareholders |
$ (6,692) |
$ (12,575) |
Basic and diluted loss per common share |
$ (0.94) |
$ (2.61) |
Weighted average common shares
outstanding |
7,088,765 |
4,826,439 |
|
|
|
|
Immune Pharmaceuticals
Inc. and Subsidiaries |
Consolidated Statements
of Cash Flows Data |
(in
$000s) |
|
|
|
Year Ended December
31, |
|
2013 |
2012 |
|
|
|
Net cash used in operating activities |
$ (3,868) |
$ (2,820) |
Net cash used in investing activities |
(1,132) |
(89) |
Net cash provided by financing
activities |
4,954 |
1,212 |
Net decrease in cash and cash
equivalents |
(46) |
(1,697) |
Cash and cash equivalents at beginning of
year |
95 |
1,792 |
Cash and cash equivalents at end of year |
$ 49 |
$ 95 |
About Immune Pharmaceuticals Inc.
Immune Pharmaceuticals Inc. applies a personalized approach to
treatment, developing novel, highly targeted antibody therapeutics
to improve the lives of patients with inflammatory diseases and
cancer. The Company's lead product candidate, bertilimumab, is
in clinical development for moderate to severe
ulcerative colitis and Crohn's Disease as well as bullous
pemphigoid, an orphan auto-immune dermatological condition, Immune
licensed worldwide rights for systemic indications of bertilimumab
from iCo Therapeutics (TSX-V:ICO) (OTCQX:ICOTF) in June 2011, while
iCo retained rights to all ophthalmic indications. iCo originally
licensed the exclusive world-wide rights to bertilimumab in 2006
from MedImmune, the Global Research and Development Arm of
AstraZeneca. Immune's pipeline also includes NanomAbs®,
antibody nanoparticle conjugates, for the targeted delivery of
chemotherapeutics. and Amiket™, a Neuropathic Pain drug candidate
ready for Phase III. Amiket has received Fast Track designation for
chemotherapy induced neuropathic pain and Orphan Drug Designation
for Post Herpetic Neuralgia.
For more information, visit Immune's website at
www.immunepharmaceuticals.com, the content of which is not a part
of this press release.
Erik Penser Bankaktiebolag is engaged as Immune's Certified
Adviser on NASDAQ OMX First North Premier.
Forward-Looking Statements
This news release and any oral statements made with respect to
the information contained in this news release contain
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. You are urged to
consider statements that include the words "may," "will," "would,"
"could," "should," "believes," "estimates," "projects,"
"potential," "expects," "plans," "anticipates," "intends,"
"continues," "forecast," "designed," "goal" or the negative of
those words or other comparable words to be uncertain and
forward-looking. Such forward-looking statements include
statements that express plans, anticipation, intent, contingency,
goals, targets, future development and are otherwise not statements
of historical fact. These statements are based on our current
expectations and are subject to risks and uncertainties that could
cause actual results or developments to be materially different
from historical results or from any future results expressed or
implied by such forward-looking statements. Factors that may cause
actual results or developments to differ materially include, but
not limited to: the risks associated with the adequacy of our
existing cash resources and our ability to continue as a going
concern; the risks associated with our ability to continue to meet
our obligations under our existing debt agreements; the risk that
we will not be able to find a partner to help conduct the Phase III
trials for AmiKet™ on attractive terms, a timely basis or at all;
the risk that we will not obtain approval to market and
commercialize any of our product candidates; the risks associated
with dependence upon key personnel; the risks associated with
reliance on collaborative partners and others for further clinical
trials, development, manufacturing and commercialization of our
product candidates; the cost, delays and uncertainties associated
with our scientific research, product development, clinical trials
and regulatory approval process; our history of operating losses
since our inception; the highly competitive nature of our business;
risks associated with litigation; risks associated with our ability
to protect our intellectual property; risks associate with our
ability to raise additional funds; and our liquidity. These factors
and other material risks are more fully discussed in our periodic
reports, including our reports on Forms 8-K, 10-Q and 10-K and
other filings with the U.S. Securities and Exchange Commission. You
are urged to carefully review and consider the disclosures found in
our filings which are available at www.sec.gov or at
www.immunepharmaceuticals.com. You are cautioned not to place undue
reliance on any forward-looking statements, any of which could turn
out to be wrong due to inaccurate assumptions, unknown risks or
uncertainties or other risk factors. We expressly disclaim any
obligation to publicly update any forward-looking statements
contained herein, whether as a result of new information, future
events or otherwise, except as required by law.
CONTACT: Immune Pharmaceuticals Inc.:
708 Third Avenue, Suite 210
New York, NY 10017
Anna Baran, Director of Investor Relations and
Corporate Communications
Tel: (646) 937-1941
anna.baran@immunepharma.com
Immune Pharmaceuticals Ltd.:
11C Galgale HaPlada
Herzliya-Pituach, Israel 46733
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