On July 17, 2014 the Advocate General of the Court of Justice of the European Union delivered his opinion on ISCO's patent case C 364/13, supporting ISCO's position that our stem cells are patentable and therefore should not be included the EU directive that outlaws patenting embryonic stem cells or any cells derived from embryonic stem cells.
We now know that the decision of the full court will be posted on December 18, 2014.
A positive decision from the whole court would put ISCO in a very strong partnering position in the EU, as we would have the only patentable naturally pluripotent stem cells under European law.
Friday, November 21, 2014
Tuesday, November 18, 2014
International Stem Cell Corporation to Present Preclinical Parkinson’s Disease Data at Neuroscience 2014
Safety and Efficacy Data from Company’s Human Neural Stem Cells Featured in Neuroscience 2014 Press Program “Advances Through Stem Cell Research”
CARLSBAD, CA., November 18, 2014 - International Stem Cell Corporation (OTCQB: ISCO), a California-based biotechnology company developing novel stem cell based therapies and biomedical products, announced today preclinical data from its Parkinson’s disease program. ISCO's Chief Scientific Officer Ruslan Semechkin, Ph.D., will discuss the data at the “Advances Through Stem Cell Research” press conference at the Society for Neuroscience’s annual meeting at 10 a.m. on Nov. 18 in Washington, D.C.
The preclinical data will form the basis for the Company’s regulatory submission for its Phase 1 study in Parkinson’s disease. The Company plans to submit materials before the end of 2014 for regulatory approval to begin its first stem cell clinical trial in Parkinson's disease and anticipates the study to begin in the first quarter of 2015.
“We are very pleased with the long-term safety and efficacy data of human parthenogenetic neural stem cells, having seen no adverse reactions, no evidence of teratoma formation and no ectopic tissue in our GLP and non-GLP animal studies,” said Ruslan Semechkin, Ph.D. “There is a large unmet medical need for new treatments that may halt or reverse the progression of Parkinson’s disease and we believe our human neural stem cells may fill this need for the millions of people with this disease.”
The data presented are from both safety studies, where human parthenogenetic neural stem cells (hpNSC) were transplanted into the brains of healthy animals, and proof-of-principle studies where the cells were transplanted into animals with induced Parkinson’s disease symptoms. The studies show that hpNSC migrated to the injured brain area, increased dopamine levels, protected and recovered neurons and improved the motor function. Additionally, at the conclusion of the twelve months non-human primate safety study, no evidence of teratoma formation or ectopic tissue was found in any animals that received the human cell transplants.
About human parthenogenetic neural stem cells
hpNSCs are a novel therapeutic cellular product derived from the Company's proprietary human pluripotent stem cells. Neural stem cells are self-renewing multipotent cells that are precursors for the main cell types of the central nervous system. The ability of hpNSCs to differentiate into dopaminergic neurons and express brain-protecting neurotrophic factors offers a new opportunity for the treatment of Parkinson's disease. ISCO’s preclinical program includes animal studies to assess the safety and tolerability of our novel cell therapy as well as doses ranging efficacy to be used to design the first clinical trial in Parkinson’s disease patients.
About Parkinson’s disease
According to the Parkinson’s Disease Foundation, an estimated seven to 10 million people worldwide live with Parkinson’s disease, with as many as one million of those in the United States alone, more than the combined total of people diagnosed with multiple sclerosis, muscular dystrophy, and Lou Gehrig’s disease. Parkinson’s disease is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons responsible for producing dopamine, and is characterized by symptoms including tremors at rest, rigidity and impaired movement.
The standard of care for the treatment of PD symptoms is oral levodopa (L-dopa). Oral dosing of L-dopa is associated with wide variability in the timing and amount of L-dopa absorption into the bloodstream, leading to the unreliable control of symptoms resulting in the emergence of OFF episodes, periods of time during which Parkinson’s disease symptoms reemerge despite L-dopa treatment. These OFF episodes, which increase in frequency and severity during the course of the disease, are experienced by a majority of PD patients and are considered one of the greatest unmet medical needs facing PD patients.
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 and companyblog.intlstemcell.com.
To receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0
Forward-looking Statements
Statements pertaining to anticipated developments, the expected timing and results of preclinical studies and subsequent regulatory filings, the potential benefits of research programs and products, 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.
Contacts:
International Stem Cell Corporation
Dr. Simon Craw, Executive Vice President
Phone: 760-940-6383
Email: ir@intlstemcell.com
Media :
Tony Russo, Ph.D.
Phone: 212-845-4251
Email: tony.russo@russopartnersllc.com
Martina Schwarzkopf, Ph.D.
Phone: (212) 845-4292
Email: martina.schwarzkopf@russopartnersllc.com
CARLSBAD, CA., November 18, 2014 - International Stem Cell Corporation (OTCQB: ISCO), a California-based biotechnology company developing novel stem cell based therapies and biomedical products, announced today preclinical data from its Parkinson’s disease program. ISCO's Chief Scientific Officer Ruslan Semechkin, Ph.D., will discuss the data at the “Advances Through Stem Cell Research” press conference at the Society for Neuroscience’s annual meeting at 10 a.m. on Nov. 18 in Washington, D.C.
The preclinical data will form the basis for the Company’s regulatory submission for its Phase 1 study in Parkinson’s disease. The Company plans to submit materials before the end of 2014 for regulatory approval to begin its first stem cell clinical trial in Parkinson's disease and anticipates the study to begin in the first quarter of 2015.
“We are very pleased with the long-term safety and efficacy data of human parthenogenetic neural stem cells, having seen no adverse reactions, no evidence of teratoma formation and no ectopic tissue in our GLP and non-GLP animal studies,” said Ruslan Semechkin, Ph.D. “There is a large unmet medical need for new treatments that may halt or reverse the progression of Parkinson’s disease and we believe our human neural stem cells may fill this need for the millions of people with this disease.”
The data presented are from both safety studies, where human parthenogenetic neural stem cells (hpNSC) were transplanted into the brains of healthy animals, and proof-of-principle studies where the cells were transplanted into animals with induced Parkinson’s disease symptoms. The studies show that hpNSC migrated to the injured brain area, increased dopamine levels, protected and recovered neurons and improved the motor function. Additionally, at the conclusion of the twelve months non-human primate safety study, no evidence of teratoma formation or ectopic tissue was found in any animals that received the human cell transplants.
About human parthenogenetic neural stem cells
hpNSCs are a novel therapeutic cellular product derived from the Company's proprietary human pluripotent stem cells. Neural stem cells are self-renewing multipotent cells that are precursors for the main cell types of the central nervous system. The ability of hpNSCs to differentiate into dopaminergic neurons and express brain-protecting neurotrophic factors offers a new opportunity for the treatment of Parkinson's disease. ISCO’s preclinical program includes animal studies to assess the safety and tolerability of our novel cell therapy as well as doses ranging efficacy to be used to design the first clinical trial in Parkinson’s disease patients.
About Parkinson’s disease
According to the Parkinson’s Disease Foundation, an estimated seven to 10 million people worldwide live with Parkinson’s disease, with as many as one million of those in the United States alone, more than the combined total of people diagnosed with multiple sclerosis, muscular dystrophy, and Lou Gehrig’s disease. Parkinson’s disease is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons responsible for producing dopamine, and is characterized by symptoms including tremors at rest, rigidity and impaired movement.
The standard of care for the treatment of PD symptoms is oral levodopa (L-dopa). Oral dosing of L-dopa is associated with wide variability in the timing and amount of L-dopa absorption into the bloodstream, leading to the unreliable control of symptoms resulting in the emergence of OFF episodes, periods of time during which Parkinson’s disease symptoms reemerge despite L-dopa treatment. These OFF episodes, which increase in frequency and severity during the course of the disease, are experienced by a majority of PD patients and are considered one of the greatest unmet medical needs facing PD patients.
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 and companyblog.intlstemcell.com.
To receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0
Forward-looking Statements
Statements pertaining to anticipated developments, the expected timing and results of preclinical studies and subsequent regulatory filings, the potential benefits of research programs and products, 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.
Contacts:
International Stem Cell Corporation
Dr. Simon Craw, Executive Vice President
Phone: 760-940-6383
Email: ir@intlstemcell.com
Media :
Tony Russo, Ph.D.
Phone: 212-845-4251
Email: tony.russo@russopartnersllc.com
Martina Schwarzkopf, Ph.D.
Phone: (212) 845-4292
Email: martina.schwarzkopf@russopartnersllc.com
Thursday, November 13, 2014
International Stem Cell Corporation Announces Record Revenues and Significant Progress in R&D
Will host conference call at 11 am ET on November 14, 2014
CARLSBAD, CA., November 13, 2014, International Stem Cell Corporation (OTCQB: ISCO), a California-based biotechnology company developing novel stem cell based therapies and biomedical products today provided a business update and announced financial results for the three and nine months ended September 30, 2014.
“We’ve made excellent progress in the last few months and as we head towards the end of the year and into 2015 we’ll reach a number of highly significant milestones for the company: the completion of the preclinical phase of our Parkinson’s disease program, submission of the necessary regulatory filing and, if approved, the beginning of the first clinical study using our proprietary stem cell derived human neural stem cells for the treatment of Parkinson’s disease,” said Andrey Semechkin PhD, the Company’s CEO and co-chairman.
- The Company will submit materials before the end of 2014 to seek regulatory approval to begin first stem cell clinical trial in Parkinson’s disease.
- The US FDA cleared ISCO’s parthenogenetic stem cell lines for clinical use, based on the demonstrated safety profile of the cells and the quality control processes used during derivation and manufacturing.
- Signed a research agreement with Rohto Pharmaceutical Company, Ltd., a global Japanese pharmaceutical company, which may lead to a definitive license after twelve months.
- Lifeline Cell Technology, ISCO’s wholly-owned subsidiary that develops, manufactures and commercializes human cell culture products, added new distributors in several fast-growing territories including Korea, Taiwan, Australia, New Zealand and India.
- Received a positive opinion from the Advocate General for the European Union Court of Justice (CJEU), in favor of the Company's pending stem cell patents in Europe, clearing the way for the decision of the full court.
- Began a new therapeutic stroke program. The first preclinical study, in collaboration with Tulane University, will evaluate transplanted human parthenogenetic neural stem cells in a rodent model of ischemic stroke.
- Revenues for the three and nine months ended September 30, 2014 were $1.96, million up 17%, and $5.20 million, up 18%, respectively, on a year-over-year basis. Cost of Sales for three and nine months ended September 30, 2014 stable at 26% of revenues. Net cash used in operating activities was $4.45 million for the nine months ended September 30, 2014, compared to $4.23 million for the corresponding period in 2013.
Dr. Simon Craw, Executive Vice President and Mr. Jay Novak, Chief Financial Officer of International Stem Cell will host the conference call. To attend the call, please use the dial in information below:
Date: Friday, November 14, 2014
Time: 11:00 a.m. Eastern Time
Conference Number (U.S.): 1-888-471-3843
International Dial-In: 1-719-325-2494
Conference ID: 6700018
Webcast: http://public.viavid.com/player/index.php?id=111820
Please dial in at least 10-minutes before the call to ensure timely participation.
A playback of the call will be available from 11/14/14 at 2:00 pm ET until 11/28/14 at 11:59 pm ET. To listen, call 1-877-870-5176 within the United States or 1-858-384-5517 when calling internationally. Please use the replay pin number 6700018.
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 parthenogenic, 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 or companyblog.intlstemcell.com
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
Forward-looking Statements
Statements pertaining to anticipated developments, the expected timing of future events, the potential benefits of research programs and products, 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.
Contacts:
International Stem Cell Corporation
Dr. Simon Craw, Executive Vice President
Phone: 760-940-6383
Email: ir@intlstemcell.com
Mr. Jay Novak, Chief Financial Officer
Phone: 760-940-6383
Email: jnovak@intlstemcell.com
International Stem Cell
Corporation and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands, except share data)
September 30,
|
December 31,
|
||||||
2014
|
2013
|
||||||
(Unaudited)
|
|||||||
Assets
|
|||||||
Cash and cash equivalents..................................................................................................................................
|
$
|
471
|
$
|
2,243
|
|||
Accounts receivable, net of allowance for doubtful
accounts of $19 at September 30, 2014 and
December 31,
2013
|
464
|
306
|
|||||
Inventory, net........................................................................................................................................................
|
1,533
|
1,369
|
|||||
Prepaid expenses and other current assets.......................................................................................................
|
359
|
658
|
|||||
Restricted cash.......................................................................................................................................................
|
50
|
50
|
|||||
Total current assets.........................................................................................................................................
|
2,877
|
4,626
|
|||||
Property and equipment, net...............................................................................................................................
|
781
|
830
|
|||||
Intangible assets, net............................................................................................................................................
|
2,649
|
2,250
|
|||||
Deposits and other assets.....................................................................................................................................
|
57
|
33
|
|||||
Total assets.......................................................................................................................................................
|
$
|
6,364
|
$
|
7,739
|
|||
Liabilities, Redeemable Preferred Stock and
Stockholders' Deficit
|
|||||||
Accounts payable.................................................................................................................................................
|
$
|
715
|
$
|
532
|
|||
Accrued liabilities..................................................................................................................................................
|
1,299
|
1,290
|
|||||
Deferred revenue...................................................................................................................................................
|
—
|
3
|
|||||
Related party payable..........................................................................................................................................
|
5
|
21
|
|||||
Advances................................................................................................................................................................
|
250
|
250
|
|||||
Fair value of warrant liability..............................................................................................................................
|
—
|
4,925
|
|||||
Total current liabilities....................................................................................................................................
|
2,269
|
7,021
|
|||||
Convertible
Redeemable Series G Preferred stock, $0.001 par value, 5,000,000 shares
authorized,
issued and outstanding at September 30,
2014 and December 31, 2013, liquidation preference of
$5,000 at September 30, 2014 and
December 31, 2013
|
4,941
|
4,941
|
|||||
Commitments
and contingencies..........................................................................................................................
|
|||||||
Stockholders'
Deficit
|
|||||||
Series
D Preferred stock, $0.001 par value, 50 shares authorized, 43 issued and
outstanding
at September 30, 2014 and December 31, 2013, with liquidation
preference of $4,320 at
September 30, 2014 and December 31, 2013
|
—
|
—
|
|||||
Series
B Preferred stock, $0.001 par value, 5,000,000 shares authorized, 300,000
issued and
outstanding at September 30, 2014 and
December 31, 2013, with liquidation preferences of
$417 and $403 at September 30, 2014 and
December 31, 2013, respectively
|
—
|
—
|
|||||
Common
stock, $0.001 par value, 600,000,000 and 300,000,000 shares authorized at
September 30, 2014 and December 31,
2013, respectively, 224,274,073 and 151,175,053
shares issued and outstanding at
September 30, 2014 and December 31, 2013, respectively
|
224
|
151
|
|||||
Additional
paid-in capital.......................................................................................................................................
|
89,080
|
77,897
|
|||||
Accumulated
deficit................................................................................................................................................
|
(90,150
|
)
|
(82,271
|
)
|
|||
Total stockholders' deficit.................................................................................................................................
|
(846
|
)
|
(4,223
|
)
|
|||
Total liabilities, redeemable preferred stock and
stockholders' deficit.....................................................
|
$
|
6,364
|
$
|
7,739
|
|||
Condensed
Consolidated Statements of Operations
(in
thousands, except per share data)
(Unaudited)
Three Months Ended
|
Nine Months Ended
|
||||||||||||||
September 30,
|
September 30,
|
||||||||||||||
2014
|
2013
|
2014
|
2013
|
||||||||||||
Revenues
|
|||||||||||||||
Product
sales
|
$
|
1,963
|
$
|
1,670
|
$
|
5,200
|
$
|
4,412
|
|||||||
Total
revenue
|
1,963
|
1,670
|
5,200
|
4,412
|
|||||||||||
Expenses
|
|||||||||||||||
Cost
of sales
|
518
|
447
|
1,366
|
1,110
|
|||||||||||
Research
and development
|
1,392
|
932
|
3,761
|
2,627
|
|||||||||||
Selling
and marketing
|
745
|
632
|
2,093
|
1,823
|
|||||||||||
General
and administrative
|
1,342
|
1,362
|
4,322
|
4,461
|
|||||||||||
Total
expenses
|
3,997
|
3,373
|
11,542
|
10,021
|
|||||||||||
Loss from operating activities
|
(2,034
|
)
|
(1,703
|
)
|
(6,342
|
)
|
(5,609
|
)
|
|||||||
Other income (expense)
|
|||||||||||||||
Change
in fair value of warrant liability
|
—
|
27
|
1,894
|
27
|
|||||||||||
Fair
value of warrant liability in excess of proceeds
|
—
|
(1,390
|
)
|
—
|
(1,390
|
)
|
|||||||||
Financing
transaction costs
|
—
|
(738
|
)
|
—
|
(738
|
)
|
|||||||||
Warrant
exchange inducement expense
|
—
|
—
|
(3,445
|
)
|
—
|
||||||||||
Miscellaneous
expense
|
(8
|
)
|
—
|
(8
|
)
|
(20
|
)
|
||||||||
Interest
expense
|
—
|
—
|
(2
|
)
|
—
|
||||||||||
Sublease
income
|
8
|
5
|
24
|
18
|
|||||||||||
Total
other income (expense), net
|
—
|
(2,096
|
)
|
(1,537
|
)
|
(2,103
|
)
|
||||||||
Loss before income taxes
|
(2,034
|
)
|
(3,799
|
)
|
(7,879
|
)
|
(7,712
|
)
|
|||||||
Provision for income taxes
|
—
|
—
|
—
|
—
|
|||||||||||
Net
loss
|
$
|
(2,034
|
)
|
$
|
(3,799
|
)
|
$
|
(7,879
|
)
|
$
|
(7,712
|
)
|
|||
Net loss applicable to common
stockholders
|
$
|
(2,034
|
)
|
$
|
(3,799
|
)
|
$
|
(7,879
|
)
|
$
|
(7,712
|
)
|
|||
Net loss per common share-basic
and diluted
|
$
|
(0.01
|
)
|
$
|
(0.03
|
)
|
$
|
(0.04
|
)
|
$
|
(0.07
|
)
|
|||
Weighted average shares-basic
and diluted
|
218,278
|
128,243
|
181,037
|
114,830
|
|||||||||||
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