CARLSBAD, CA - (Marketwired) – May 13,
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
first quarter financial results for the period ended March 31, 2015.
First
quarter 2015 business highlights:
·
Completed
the required preclinical studies and submitted a clinical trial exemption
application to the Australian
Therapeutics Goods Administration (TGA)
to begin the phase 1/2a clinical study of the Company's cell therapy for the
treatment of Parkinson's disease. To be
administered through ISCO’s wholly-owned Australian subsidiary, Cyto
Therapeutics Pty Ltd.
·
Completed the manufacture of the bank of clinical-grade
human neural stem cells for use in the Parkinson's disease clinical trial.
The cell bank contains over 2.6 billion human cells, sufficient to meet the
company’s foreseeable clinical trial requirements.
·
Japan Patent Office granted ISCO's patent
covering methods of making a bank of human stem cells from parthenogenetically
activated eggs significantly strengthening and expanding the Company’s
intellectual property to now include Japan as well as the United States and the
European Union.
First
quarter 2015 financial highlights:
·
$1.62
million in revenue for the three months ended March 31, 2015; Lifeline Skin
Care sales up 5% and Lifeline Cell Technology sales down 8%. Operating income from cosmeceutical and
biomedical markets up 76% compared with the corresponding period of 2014. Gross margin improved to 74%
·
Net
loss reduced to $1.29 million for the first three months of 2015 compared to
$1.44 million for the corresponding period of 2014. The Company ended the first quarter of 2015 with
cash of $0.61 million
“In the first quarter of 2015 we
completed all the necessary preclinical studies of our Parkinson’s program and
formally submitted our application to begin the first clinical study of this
novel approach to treating this debilitating disease in humans”, stated Andrey
Semechkin, Ph.D., CEO and Co-chairman of ISCO.
“We continue to expect to make significant progress during the rest of 2015
towards our goal of providing a viable treatment options for people with Parkinson’s
disease.”
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.
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Safe
harbor statement
Statements pertaining to anticipated
developments, expected 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
Condensed Consolidated Balance Sheets
(in thousands, except share data)
March
31,
|
December 31,
|
|||||||
2015
|
2014
|
|||||||
Assets
|
(Unaudited)
|
|||||||
Cash
and cash equivalents
|
$
|
611
|
$
|
1,111
|
||||
Accounts
receivable, net of allowance for doubtful accounts of $19 at March 31,
2015 and December 31, 2014
|
436
|
453
|
||||||
Inventory,
net
|
1,668
|
1,517
|
||||||
Prepaid
expenses and other current assets
|
384
|
485
|
||||||
Restricted
cash
|
50
|
50
|
||||||
Total
current assets
|
3,149
|
3,616
|
||||||
Property
and equipment, net
|
630
|
714
|
||||||
Intangible
assets, net
|
2,863
|
2,795
|
||||||
Deposits
and other assets
|
51
|
54
|
||||||
Total
assets
|
$
|
6,693
|
$
|
7,179
|
||||
Liabilities and Stockholders'
Equity (Deficit)
|
||||||||
Accounts
payable
|
$
|
1,765
|
$
|
670
|
||||
Accrued
liabilities
|
1,386
|
1,711
|
||||||
Related
party payable
|
16
|
11
|
||||||
Advances
|
250
|
250
|
||||||
Fair
value of warrant liability
|
3,355
|
4,216
|
||||||
Total
current liabilities
|
6,772
|
6,858
|
||||||
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, with liquidation
preferences of $426 and $421 at March 31, 2015
and December 31, 2014, respectively
|
—
|
—
|
||||||
Series D Convertible Preferred stock, $0.001 par
value, 50 shares authorized, 43 issued and
outstanding, with liquidation preference
of $4,320
|
—
|
—
|
||||||
Series G Convertible Preferred stock, $0.001 par
value, 5,000,000 shares authorized,
issued and outstanding, with liquidation
preference of $5,000
|
5
|
5
|
||||||
Series H-1 Convertible Preferred stock, $0.001
par value, 2,000 shares authorized, 895
and 1,482 issued and outstanding at March
31, 2015 and December 31, 2014,
respectively
|
—
|
—
|
||||||
Series H-2 Convertible Preferred stock, $0.001
par value, 500 shares authorized, issued and
outstanding
|
—
|
—
|
||||||
Common stock, $0.001 par value, 720,000,000
shares authorized, 262,117,307 and 239,429,170
shares issued and outstanding at March 31,
2015 and December 31, 2014, respectively
|
262
|
239
|
||||||
Additional paid-in capital
|
95,690
|
94,826
|
||||||
Accumulated deficit
|
(96,036
|
)
|
(94,749
|
)
|
||||
Total
stockholders' equity (deficit)
|
(79
|
)
|
321
|
|||||
Total liabilities and
stockholders' equity (deficit)
|
$
|
6,693
|
$
|
7,179
|
||||
See accompanying notes to the
unaudited condensed consolidated financial statements.
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(Unaudited)
Three
Months Ended
|
||||||||
March
31,
|
||||||||
2015
|
2014
|
|||||||
Revenues
|
||||||||
Product
sales
|
$
|
1,622
|
$
|
1,649
|
||||
Total
revenue
|
1,622
|
1,649
|
||||||
Expenses
|
||||||||
Cost
of sales
|
418
|
439
|
||||||
Research
and development
|
1,118
|
958
|
||||||
Selling
and marketing
|
654
|
669
|
||||||
General
and administrative
|
1,398
|
1,648
|
||||||
Total
expenses
|
3,588
|
3,714
|
||||||
Loss from operating activities
|
(1,966
|
)
|
(2,065
|
)
|
||||
Other income (expense)
|
||||||||
Change
in fair value of warrant liability
|
679
|
623
|
||||||
Interest
expense
|
(1
|
)
|
(1
|
)
|
||||
Sublease
income
|
1
|
8
|
||||||
Total
other income, net
|
679
|
630
|
||||||
Loss before income taxes
|
(1,287
|
)
|
(1,435
|
)
|
||||
Provision for income taxes
|
—
|
—
|
||||||
Net
loss
|
$
|
(1,287
|
)
|
$
|
(1,435
|
)
|
||
Net loss applicable to common stockholders
|
$
|
(1,287
|
)
|
$
|
(1,435
|
)
|
||
Net loss per common share-basic and diluted
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
||
Weighted average shares-basic
|
245,556
|
153,488
|
||||||
Weighted
average shares-diluted
|
274,518
|
153,488
|
||||||
See accompanying notes to the
unaudited condensed consolidated financial statements.
Contacts:
International
Stem Cell Corporation
Simon
Craw, Ph.D. Executive Vice President of Business Development
Phone:
760-940-6383
Media:
Christopher
R. Hippolyte
Phone:
+1-646-942-5634
Email:
chris.hippolyte@russopartnersllc.com
Tony
Russo, Ph.D.
Phone:
(212) 845-4251
Email:
tony.russo@russopartnersllc.com
