CARLSBAD,
CA - (Marketwired) – March 31, 2015, International Stem Cell Corporation (OTCQB:
ISCO) (www.internationalstemcell.com) (“ISCO” or “the Company”), a
California-based biotechnology company developing novel stem cell-based
therapies and biomedical products, today provided a business update and announced
fourth quarter and year-end financial results for the period ended December 31,
2014.
Fourth
quarter highlights:
·
The
Court of Justice of the European Union ruled in favor of the Company’s EU
patent applications, opening the way to the issuance of ISCO’s core technology
patents in the EU in 2015 and significantly strengthening the Company’s
intellectual property estate
·
Received
clearance from the U.S. Food and Drug Administration, in an important ruling,
for ISCO's human parthenogenetic stem cell line for investigational clinical
use; the FDA accepted the use of parthenogenetic stem cells as a starting
material for the development of human cellular therapeutics
·
Presented
results from preclinical studies of ISC-hpNSC, ISCO’s human parthenogenetic
neural stem cell clinical product, including long-term safety data and
proof-of-concept efficacy data in Parkinson’s disease, at Neuroscience, the annual
meeting of the Society for Neuroscience in Washington D.C.
·
Awarded
the designation of one of America's fastest growing companies as highlighted in
Deloitte’s 2014 Technology Fast 500™ list in recognition of ISCO’s rate of
growth in sales over the last several years.
Subsequent to the year end, in
January, 2015, the Company announced the completion of the required preclinical
studies and plans to begin a phase 1/2a clinical study of its ISC-hpNSC cell
therapy in Parkinson's disease in Australia.
As part of this expansion, ISCO has formed an Australian subsidiary,
Cyto Therapeutics Pty Ltd.
FY
2014 Financial highlights:
·
$7.02
million in revenue for the year ended December 31, 2014, an increase of 14%
compared to 2013; Lifeline Skin Care sales up 9% and Lifeline Cell Technology
sales up 19%. Gross margin stable at 73%
·
Operating
income from Lifeline Skin Care and Lifeline Cell Technology subsidiaries up 55%
to $1.02 million for the year ended December 31, 2014, compared with $0.65
million in 2013.
·
Average
net cash used in operating activities of $0.54 million per month for the year ending
December 31, 2014; The company ended 2014 with cash of $1.11
million
“We delivered on some very important
milestones in the last three months of 2014, including bringing to a successful
conclusion our patent applications with the CJEU and obtaining clearance for
the clinical use of our stem cell lines from the U.S. FDA”, stated Andrey
Semechkin, Ph.D., CEO and Co-chairman of ISCO.
“These achievements add further momentum to both our Parkinson’s program
and our business development plans. We expect to make more progress in 2015,
including starting our clinical trial in Parkinson’s disease patents and to potentially
report interim data before the end of 2015.”
Simon Craw PhD,
Executive Vice President, Jay Novak, Chief Financial Officer and Ruslan
Semechkin PhD, Chief Scientific Officer, of International Stem Cell will host
the conference call. To attend the call, please use the dial in information
below:
Conference call and webcast
details
Date: Wednesday April
1, 2015
Time: 11:00 a.m. ET
Toll-free (US only):
1-888-329-8877
Toll/International:
1-719-457-2648
Conference
ID: 1112311
Please log in at least
10-minutes before the call start time to ensure timely participation.
A playback of the call
will be available from 4/1/15 at 2:00 pm Eastern
Time to 4/15/15 at 11:59 pm Eastern Time.
Teleconference Replay
Details:
Toll free: 1-877-870-5176
Toll/International:
1-858-384-5517
Replay Pin Number:
1112311
About International Stem Cell
Corporation
International
Stem Cell Corporation is focused on the therapeutic applications of human
parthenogenetic stem cells (hpSCs) and the development and commercialization of
cell-based research and cosmetic products.
ISCO's core technology, parthenogenesis, results in the creation of
pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with
the use or destruction of viable human embryos.
ISCO scientists have created the first parthenogenetic, homozygous stem
cell line that can be a source of therapeutic cells for hundreds of millions of
individuals of differing genders, ages and racial background with minimal
immune rejection after transplantation. hpSCs offer the potential to create the
first true stem cell bank, UniStemCell™. ISCO also produces and markets
specialized cells and growth media for therapeutic research worldwide through
its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem
cell-based skin care products through its subsidiary Lifeline Skin Care
(www.lifelineskincare.com). More information is available at
www.internationalstemcell.com.
To
subscribe to receive ongoing corporate communications, please click on the
following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0
To like our
Facebook page or follow us on Twitter for company updates and industry related
news, visit: www.facebook.com/InternationalStemCellCorporation and www.twitter.com/intlstemcell
Safe harbor statement
Statements
pertaining to anticipated developments, expected pre-clinical studies (including
timing and results), progress of research and development, and other
opportunities for the company and its subsidiaries, along with other statements
about the future expectations, beliefs, goals, plans, or prospects expressed by
management constitute forward-looking statements. Any statements that are not
historical fact (including, but not limited to statements that contain words
such as "will," "believes," "plans,"
"anticipates," "expects," "estimates,") should
also be considered to be forward-looking statements. Forward-looking statements
involve risks and uncertainties, including, without limitation, risks inherent
in the development and/or commercialization of potential products, regulatory
approvals, need and ability to obtain future capital, application of capital
resources among competing uses, and maintenance of intellectual property
rights. Actual results may differ materially from the results anticipated in
these forward-looking statements and as such should be evaluated together with
the many uncertainties that affect the company's business, particularly those
mentioned in the cautionary statements found in the company's Securities and
Exchange Commission filings. The company disclaims any intent or obligation to
update forward-looking statements.
International
Stem Cell Corporation and Subsidiaries
(in
thousands, except share data)
|
|
December 31,
|
|
|
December 31,
|
|
||
|
|
2014
|
|
|
2013
|
|
||
Assets
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
1,111
|
|
|
$
|
2,243
|
|
Accounts
receivable, net of allowance for doubtful accounts of $19 at December 31,
2014 and December 31, 2013
|
|
|
453
|
|
|
|
306
|
|
Inventory,
net
|
|
|
1,517
|
|
|
|
1,369
|
|
Prepaid
expenses and other current assets
|
|
|
485
|
|
|
|
658
|
|
Restricted
cash
|
|
|
50
|
|
|
|
50
|
|
Total
current assets
|
|
|
3,616
|
|
|
|
4,626
|
|
Property
and equipment, net
|
|
|
714
|
|
|
|
830
|
|
Intangible
assets, net
|
|
|
2,795
|
|
|
|
2,250
|
|
Deposits
and other assets
|
|
|
54
|
|
|
|
33
|
|
Total
assets
|
|
$
|
7,179
|
|
|
$
|
7,739
|
|
Liabilities,
Redeemable Preferred Stock and Stockholders' Equity (Deficit)
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
670
|
|
|
$
|
532
|
|
Accrued
liabilities
|
|
|
1,711
|
|
|
|
1,290
|
|
Deferred
revenue
|
|
|
—
|
|
|
|
3
|
|
Related
party payable
|
|
|
11
|
|
|
|
21
|
|
Advances
|
|
|
250
|
|
|
|
250
|
|
Fair
value of warrant liability
|
|
|
4,216
|
|
|
|
4,925
|
|
Total
current liabilities
|
|
|
6,858
|
|
|
|
7,021
|
|
Convertible
Redeemable Series G Preferred stock, $0.001 par value, 0 and 5,000,000
shares authorized, issued and outstanding at December 31, 2014 and December
31,
2013, respectively, liquidation preference of $0 and $5,000 at December 31,
2014 and
December 31, 2013, respectively
|
|
|
—
|
|
|
|
4,941
|
|
Commitments
and contingencies
|
|
|
|
|
|
|
|
|
Stockholders'
Equity (Deficit)
|
|
|
|
|
|
|
|
|
Series
B Convertible Preferred stock, $0.001 par value, 5,000,000 shares authorized,
300,000 issued and outstanding at December 31, 2014 and December 31, 2013,
with liquidation preferences of $421 and $403 at December 31, 2014 and
December 31, 2013, respectively
|
|
|
—
|
|
|
|
—
|
|
Series
D Convertible Preferred stock, $0.001 par value, 50 shares authorized, 43
issued and outstanding at December 31, 2014 and December 31, 2013,
with liquidation preference of $4,320 at December 31, 2014 and December 31,
2013
|
|
|
—
|
|
|
|
—
|
|
Series
G Convertible Preferred stock, $0.001 par value, 5,000,000 and 0 shares
authorized, issued and outstanding at December 31, 2014 and December 31,
2013, respectively, liquidation preference of $5,000 and $0 at December 31,
2014 and December 31, 2013, respectively
|
|
|
5
|
|
|
|
—
|
|
Series
H-1 Convertible Preferred stock, $0.001 par value, 2,000 and 0 shares
authorized, 1,482 and 0 issued and outstanding at December 31, 2014
and December 31, 2013, respectively
|
|
|
—
|
|
|
|
—
|
|
Series
H-2 Convertible Preferred stock, $0.001 par value, 500 and 0 shares
authorized, 500 and 0 issued and outstanding at December 31, 2014
and December 31, 2013, respectively
|
|
|
—
|
|
|
|
—
|
|
Common
stock, $0.001 par value, 720,000,000 and 300,000,000 shares authorized at
December 31, 2014 and December 31, 2013, respectively, 239,429,170 and
151,175,053 shares issued and outstanding at December 31, 2014 and December
31, 2013, respectively
|
|
|
239
|
|
|
|
151
|
|
Additional
paid-in capital
|
|
|
94,826
|
|
|
|
77,897
|
|
Accumulated
deficit
|
|
|
(94,749
|
)
|
|
|
(82,271
|
)
|
Total
stockholders' equity (deficit)
|
|
|
321
|
|
|
|
(4,223
|
)
|
Total
liabilities, redeemable preferred stock and stockholders' equity (deficit)
|
|
$
|
7,179
|
|
|
$
|
7,739
|
|
International
Stem Cell Corporation and Subsidiaries
Consolidated Statements of Operations
(in thousands, except per share data)
|
|
Years Ended
|
|
|||||
|
|
December 31,
|
|
|||||
|
|
2014
|
|
|
2013
|
|
||
Revenues
|
|
|
|
|
|
|
|
|
Product
sales
|
|
$
|
7,017
|
|
|
$
|
6,147
|
|
Total
revenue
|
|
|
7,017
|
|
|
|
6,147
|
|
Expenses
|
|
|
|
|
|
|
|
|
Cost
of sales
|
|
|
1,921
|
|
|
|
1,643
|
|
Research
and development
|
|
|
5,386
|
|
|
|
3,560
|
|
Selling
and marketing
|
|
|
2,785
|
|
|
|
2,457
|
|
General
and administrative
|
|
|
5,605
|
|
|
|
6,033
|
|
Total
expenses
|
|
|
15,697
|
|
|
|
13,693
|
|
Loss
from operating activities
|
|
|
(8,680
|
)
|
|
|
(7,546
|
)
|
Other
income (expense)
|
|
|
|
|
|
|
|
|
Change
in fair value of warrant liability
|
|
|
2,405
|
|
|
|
(754
|
)
|
Fair
value of warrant liability in excess of proceeds
|
|
|
(1,780
|
)
|
|
|
(1,390
|
)
|
Financing
transaction costs
|
|
|
(997
|
)
|
|
|
(738
|
)
|
Warrant
exchange inducement expense
|
|
|
(3,445
|
)
|
|
|
—
|
|
Interest
expense
|
|
|
(2
|
)
|
|
|
(3
|
)
|
Sublease
income
|
|
|
30
|
|
|
|
26
|
|
Miscellaneous
expense
|
|
|
(9
|
)
|
|
|
(74
|
)
|
Total
other expense, net
|
|
|
(3,798
|
)
|
|
|
(2,933
|
)
|
Loss
before income taxes
|
|
|
(12,478
|
)
|
|
|
(10,479
|
)
|
Provision
for income taxes
|
|
|
—
|
|
|
|
—
|
|
Net
loss
|
|
$
|
(12,478
|
)
|
|
$
|
(10,479
|
)
|
Net
loss applicable to common stockholders
|
|
$
|
(12,478
|
)
|
|
$
|
(10,479
|
)
|
Net
loss per common share-basic and diluted
|
|
$
|
(0.06
|
)
|
|
$
|
(0.09
|
)
|
Weighted
average shares-basic and diluted
|
|
|
192,795
|
|
|
|
123,088
|
|
Contacts:
International
Stem Cell Corporation
Dr.
Simon Craw, Executive Vice President of Business Development
Phone:
760-940-6383
Media:
Christopher R.
Hippolyte
Phone: +1-646-942-5634
Tony Russo, Ph.D.
Phone: (212) 845-4251
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