International Stem Cell Corporation Announces 2017 Fourth Quarter and Year-End Results
April 10 2018 - 8:45AM
InvestorsHub NewsWire
Carlsbad, CA --
April 10, 2018 -- InvestorsHub NewsWire -- International Stem Cell
Corporation (OTCQB:ISCO)
(www.internationalstemcell.com)
("ISCO" or "the Company"), a California-based clinical stage
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 ending on December 31, 2017.
"In 2017 we made
significant progress towards our business unit optimization and
have managed to decrease operating cash burn by nearly fifty
percent, all while conducting the world’s first clinical trial of
neural stem cells in Parkinson’s disease patients. We recently
completed stem cell transplantation in the second cohort of our
patients and expect to initiate phase II before year’s end" stated
Andrey Semechkin, Ph.D., CEO and Co-Chairman of ISCO. "We still
face challenges, but I believe that our cutting-edge therapy and
innovative commercial products, as well as seasoned executive team,
will lead us to future success,” he continued.
FY 2017 Financial
highlights:
- Revenues increased
to $7.5 million in 2017 compared to $7.2 million in 2016
;
- Combined operating
income for the year ended December 31, 2017 from our two wholly
owned revenue generating subsidiaries, Lifeline Cell Technology and
Lifeline Skin Care, was $1.4 million, compared to $1.3 million in
2016
- Average net cash
used in operating activities was approximately $179,000 per month
for the year ended December 31, 2017, a decrease of 49%, compared
to $350,000 in 2016;
- Gross margins
declined 1% year over year to 72% in 2017, compared to 73% in
2016
Recent Corporate
Highlights
- The second cohort
of patients in the clinical trial for Parkinson's disease was
successfully transplanted with 50,000,000 ISC-hpNSC®
cells
- 13 pending patent
applications covering internally-generated and in-licensed
technologies were issued as patents
2018 Anticipated
Events
- Complete dosing
patients in phase I Parkinson's disease clinical
trial
- Announce full
safety results from the first cohort of patients currently
in phase I of the Parkinson's disease clinical
trial
- Commence phase II
clinical study of ISC-hpNSC® for the treatment of Parkinson’s
disease
- Initiate phase II
clinical study of ISC-hpNSC® for the treatment of traumatic brain
injury
- Publish
pre-clinical data for traumatic brain injury
program
- Receipt of US
patent for manufacturing ISC-hpNSC®
Presentations
In
2017, the Company presented positive interim results of its
clinical trial in Parkinson's disease at the following
events:
- The American
Society for Neural Therapy and Repair Annual
Meeting;
- The American
Society of Gene and Cell Therapy 20th Annual
Meeting;
- The Society for
Neuroscience Annual Meeting (Neuroscience
2017).
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 and company achievements, 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 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
Consolidated Balance Sheets
(in thousands, except share data)
|
|
December 31, |
|
|
December 31, |
|
|
|
2017 |
|
|
2016 |
|
Assets |
|
|
|
|
|
|
|
|
Cash and cash
equivalents |
|
$ |
304 |
|
|
$ |
110 |
|
Accounts receivable,
net of allowance for doubtful accounts of $12 |
|
|
465 |
|
|
|
574 |
|
Inventory,
net |
|
|
1,307 |
|
|
|
1,390 |
|
Prepaid expenses and
other current assets |
|
|
779 |
|
|
|
418 |
|
Total current
assets |
|
|
2,855 |
|
|
|
2,492 |
|
Non-current
inventory |
|
|
692 |
|
|
|
615 |
|
Property and
equipment, net |
|
|
321 |
|
|
|
396 |
|
Intangible assets,
net |
|
|
2,922 |
|
|
|
3,484 |
|
Deposits and other
assets |
|
|
74 |
|
|
|
58 |
|
Total
assets |
|
$ |
6,864 |
|
|
$ |
7,045 |
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
830 |
|
|
$ |
841 |
|
Accrued
liabilities |
|
|
607 |
|
|
|
465 |
|
Advances |
|
|
250 |
|
|
|
250 |
|
Fair value of warrant
liability |
|
|
3,113 |
|
|
|
2,045 |
|
Total current
liabilities |
|
|
4,800 |
|
|
|
3,601 |
|
Commitments and
contingencies (Note 10) |
|
|
|
|
|
|
|
|
Stockholders'
Equity |
|
|
|
|
|
|
|
|
Series B Convertible
Preferred stock, $0.001 par value, 5,000,000 shares authorized,
250,000 issued and outstanding, with liquidation preferences of
$396 and $381 at December 31, 2017 and 2016,
respectively |
|
|
— |
|
|
|
— |
|
Series D Convertible
Preferred stock, $0.001 par value, 50 shares authorized, 43 shares
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 I-1 Convertible
Preferred stock, $0.001 par value, 2,000 shares authorized, 1,304
and 1,680 issued and outstanding with liquidation preferences of
$1,304 and $1,680 at December 31, 2017 and 2016,
respectively |
|
|
— |
|
|
|
— |
|
Series I-2 Convertible
Preferred stock, $0.001 par value, 4,310 shares authorized, issued
and outstanding with liquidation preferences of $4,310 at December
31, 2017 and 2016 |
|
|
— |
|
|
|
— |
|
Common stock, $0.001
par value, 120,000,000 shares authorized, 6,057,132 and 3,950,979
shares issued and outstanding at December 31, 2017 and 2016,
respectively |
|
|
6 |
|
|
|
4 |
|
Additional paid-in
capital |
|
|
106,585 |
|
|
|
101,898 |
|
Accumulated
deficit |
|
|
(104,532 |
) |
|
|
(98,463 |
) |
Total stockholders'
equity |
|
|
2,064 |
|
|
|
3,444 |
|
Total liabilities and
stockholders' equity |
|
$ |
6,864 |
|
|
$ |
7,045 |
|
International Stem Cell Corporation and
Subsidiaries
Consolidated Statements of Operations
(in thousands, except per share data)
|
|
Years Ended |
|
|
|
December 31, |
|
|
|
2017 |
|
|
2016 |
|
Revenues |
|
|
|
|
|
|
|
|
Product
sales |
|
$ |
7,456 |
|
|
$ |
7,165 |
|
Total
revenues |
|
|
7,456 |
|
|
|
7,165 |
|
Expenses |
|
|
|
|
|
|
|
|
Cost of
sales |
|
|
2,122 |
|
|
|
1,944 |
|
Research and
development |
|
|
2,658 |
|
|
|
2,856 |
|
Selling and
marketing |
|
|
2,405 |
|
|
|
2,527 |
|
General and
administrative |
|
|
5,213 |
|
|
|
4,689 |
|
Total
expenses |
|
|
12,398 |
|
|
|
12,016 |
|
Loss from
operations |
|
|
(4,942 |
) |
|
|
(4,851 |
) |
Other income
(expense) |
|
|
|
|
|
|
|
|
Change in fair value
of warrant liability |
|
|
(1,068 |
) |
|
|
14,607 |
|
Fair value of warrant
liability in excess of proceeds |
|
|
— |
|
|
|
(9,902 |
) |
Financing transaction
costs |
|
|
— |
|
|
|
(928 |
) |
Interest
expense |
|
|
(59 |
) |
|
|
(6 |
) |
Miscellaneous
income |
|
|
— |
|
|
|
1 |
|
Total other income
(expense), net |
|
|
(1,127 |
) |
|
|
3,772 |
|
Loss before provision
for income taxes |
|
|
(6,069 |
) |
|
|
(1,079 |
) |
Provision for income
taxes |
|
|
— |
|
|
|
— |
|
Net
loss |
|
$ |
(6,069 |
) |
|
$ |
(1,079 |
) |
Net loss applicable to
common stockholders |
|
$ |
(6,069 |
) |
|
$ |
(1,079 |
) |
Net loss per common
share-basic |
|
$ |
(1.46 |
) |
|
$ |
(0.34 |
) |
Net loss per common
share-diluted |
|
$ |
(1.46 |
) |
|
$ |
(0.34 |
) |
Weighted average
shares outstanding-basic |
|
|
4,158 |
|
|
|
3,190 |
|
Weighted average
shares outstanding-diluted |
|
|
4,158 |
|
|
|
3,190 |
|
International Stem Cell
Corporation
Russell Kern, PhD
Executive Vice President,
CSO
(760) 940-6383
ir@intlstemcell.com
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