International Stem Cell Corporation Signs Agreement Including Certain Terms for a Definitive License Agreement with Rohto Pharmaceutical Co., Ltd. of Japan

CARLSBAD, CA - (Marketwired) - 07/08/2014 - International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com, ISCO or the Company), a California-based biotechnology company developing novel stem cell-based therapies, announced today that it has entered into a research agreement with Rohto Pharmaceutical Company, Ltd. (“Rohto”), a global Japanese pharmaceutical company that develops new technology for the medical and cosmetics markets with approximately $1.3 billion in consolidated annual sales. Under this agreement, Rohto will evaluate stem cell-derived human cells owned and provided by ISCO in a number of pre-clinical animal models. If the research is successful and the parties agree on remaining terms, it is anticipated that a definitive license agreement will be signed at the end of the twelve-month period of this research agreement. Certain key terms of such a license agreement, including the target disease areas and intellectual property rights, have been established in the research agreement.

“We are delighted to have such an outstanding company work with us, and we believe that the potential for this agreement is significant,” said Dr. Simon Craw, EVP of Business Development at ISCO. “Under the terms of the agreement Rohto will begin working with our cells immediately and if the program is successful we may move to the next stage, signing a definitive license agreement. Such an agreement would significantly enhance our standing in a number of ways. Firstly, having diligently built up our scientific strength and patent portfolio over the last few years, it would both validate our research as well as our ability to generate licensing revenue from our proprietary platform. Secondly, by expanding the use of our technology into new areas beyond that which we can address alone, it would add value to the Company.”

Under the agreement ISCO will provide a number of differentiated human cells derived from the Company’s collection of pluripotent human stem cells known as UniStemCellTM. The Company has a track record of successfully demonstrating that human cells derived from UniStemCellTM are effective in animal models of various diseases and have the potential to be used as a basis for developing human therapies. The Company has adopted this approach successfully with a number of academic collaborators in the past.

About Rohto Pharmaceutical Company, Ltd.

Founded in 1899, Rohto Pharmaceutical is the second-largest consumer health company in Japan, and is a world leader in the manufacturing and marketing of pharmaceuticals, cosmetics, and skincare and healthcare products. Rohto has global operations and its products are available in more than 150 countries.

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) hence avoiding 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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Forward-looking Statements

Statements pertaining to anticipated developments, 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

International Stem Cell Corporation to Present at BIO 2014

CARLSBAD, CA - (Marketwired), 6/17/2014 - International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com), a California-based biotechnology company developing novel stem cell based therapies and biomedical products, today announced that Executive Vice President Dr. Simon Craw, will present an overview of ISCO and its subsidiaries at the BIO 2014 conference on Tuesday, June 24th at 4:15 pm PDT. The conference is being held at the San Diego Convention Center.

BIO 2014 conference presentation details:

Date:                                                     Tuesday, June 24^th 2014

Time:                                                    4:15 pm PDT

Location:                                            San Diego Convention Center, San Diego, CA

Room:                                                  Mission Beach

Conference details:                       http://convention.bio.org/

BIO is the largest, most influential biotech meeting in the world, regularly attracting 15,000 of the most powerful biotech and pharm participants from 60+ countries.  This year at the San Diego Convention Center, June 23 – 26, 2014, the conference includes sessions and specialty forums covering 17 hot topics, 1,700+ exhibitors and BIO One-on-One Partnering^TM meetings with thousands of companies. If you have an interest in attending the conference or if you would like to arrange a meeting with International Stem Cell Corporation’s management team please contact the conference organizers.  To register for the event visit the conference website at http://convention.bio.org/register/

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) hence avoiding 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^TM. 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 receive ongoing corporate communications via email, visit: 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

Contacts:

International Stem Cell Corporation

Dr. Simon Craw, Executive Vice President

Phone: 760-940-6383

Email: ir@intlstemcell.com

International Stem Cell Corporation Completes Important Study in Parkinson’s Disease Program

CARLSBAD, CA - (Marketwired) - 6/19/2014 , International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) (“ISCO” or “the Company”), a California-based biotechnology company developing novel stem cell based therapies, announced today the completion of the acute toxicity study of the Company’s proposed clinical product to treat Parkinson’s disease.  The recently completed IND-enabling study transplanting rodents with human neural stem cells, derived from ISCO’s proprietary parthenogenetic stem cell platform, showed that the cells are well tolerated even at high doses up to the equivalent of 2.2 billion cells in humans.  The program continues to progress according to the plan outlined with the FDA at the pre-IND meeting as reported in February 2014.  The Company intends to provide a further update early next quarter.

“I’m pleased that we have successfully achieved another important milestone in our Parkinson’s disease program.  A critical part of the development process, and the preparations for the IND submission, was to establish the highest tolerated dose of our clinical product in rodents,” said Dr. Ruslan Semechkin, ISCO’s Chief Scientific Officer.  “The results of this study show that the doses we will be proposing to the FDA in our phase I clinical study design for the treatment of Parkinson’s disease are well below the safety threshold.”

The study consisted of 19 immune deficient rodents divided into four cohorts, a control group and three treatment groups receiving escalating doses of human parthenogenetic neural stem cells (hPNSC).  Animals received stereotactic injections of hPNSC in the striatum and substantia nigra.  The rodents were observed for seven days post transplantation and demonstrated normal appearance and behaviors.  Necropsies showed no abnormal tissues or tumors after sacrifice.  Detailed immunohistochemical analysis demonstrated that the majority of the implanted cells survived the surgery and engrafted into the host brain tissue.

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.  The total direct and indirect cost of Parkinson’s disease is estimated to be nearly $25 billion per year in the United States alone.

ISCO's Parkinson's disease program uses human parthenogenetic neural stem cells (hPNSC), a novel therapeutic cellular product derived from the company's proprietary histocompatible human pluripotent stem cells.  hPNSC are self-renewing multipotent cells that are precursors for the major cells of the central nervous system.  The ability of hPNSC to (i) differentiate into dopaminergic (DA) neurons and (ii) express neurotrophic factors such as glial derived neurotrophic factor (GDNF) and brain derived neurotrophic factor (BDNF) to protect the nigrostriatal system, offers a new opportunity for the treatment of Parkinson's disease, especially in cases where current small molecule approaches fail to adequately control the symptoms.

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) hence avoiding 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, UniStemCellTM. 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.

ISCO's Parkinson's disease program uses human parthenogenetic neural stem cells (hPNSC), a novel therapeutic cellular product derived from the company's proprietary histocompatible human pluripotent stem cells.  hPNSC are self-renewing multipotent cells that are precursors for the major cells of the central nervous system.  The ability of hPNSC to (i) differentiate into dopaminergic (DA) neurons and (ii) express neurotrophic factors such as glial derived neurotrophic factor (GDNF) and brain derived neurotrophic factor (BDNF) to protect the nigrostriatal system, offers a new opportunity for the treatment of Parkinson's disease, especially in cases where current small molecule approaches fail to adequately control the symptoms.

To receive ongoing corporate communications via email, visit: 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

Contacts:

International Stem Cell Corporation

Dr. Simon Craw

Executive Vice President

Phone: 760-940-6383

Email: ir@intlstemcell.com

Dr. Ruslan Semechkin

Chief Scientific Officer

Phone: 760-940-6383

Email: ras@intlstemcell.com

ISCO features in Genetic Engineering News - June 2014 edition

An overview of ISCO and the stem cell platform appeared in Genetic Engineering News today.  The piece is based on an interview by Dr. Craw and Dr. Semechkin and provides a review of the benefits of ISCO's approach along with an update on progress towards a therapy for Parkinson's disease.

The full text of the article can be found here http://www.genengnews.com/gen-articles/isco-s-parthenogenetic-core/5229/

ISCO executive Dr. Craw interviewed by BBC

Dr. Simon Craw, EVP at ISCO was recently interviewed by the BBC, giving an update on ISCO’s stem cell technology, Parkinson’s disease program and the upcoming decision by the Court of Justice for the European Union (CJEU) on the UK patent applications.

“The interview with the BBC highlighted the progress we’ve made in Parkinson’s disease and the importance of being able to protect our intellectual property in Europe,” said Dr. Simon Craw, the Company’s Executive Vice President. “The definitive ruling on our patents by the CJEU is important not just for ISCO but also for the whole stem cell industry in Europe. Demonstrating beyond doubt that ISCO’s technology is distinct from our competitors and patentable will not only enhance our ability to find partners to help develop stem cell therapies in the EU, but also stimulate investment by large pharmaceutical companies who up to this point have been somewhat on the sidelines”

The patent case involves two key patents filed with the UK Intellectual Property Office in 2012 covering ISCO’s core technology of creating pluripotent human stem cells from unfertilized eggs. Initially these patents were thought to contravene European patent law, the so called “European Biotech Directive” which excludes the use of human embryos from patentability. ISCO successfully argued with the UK IPO that its technology does not infringe on this directive, and the UK court has now requested a final ruling from the highest court in Europe with jurisdiction over patents, the Court of Justice for the European Union. The court’s final judgments will be delivered on July 17th 2014.

The full interview with the BBC can be found http://www.bbc.co.uk/programmes/p01zhkln

More information on the patent case can be found in a previous blog entry http://companyblog.intlstemcell.com/2014/06/an-update-on-iscos-important-patent.html

An update on ISCO's important patent case in the European Union

Internationally recognized patent and trademark experts Davis Collison and Cave provide an excellent update on the ISCO patent case currently in process with the European Court of Justice.

PATENTING HUMAN EMBRYONIC STEM CELLS – EUROPEAN UPDATE
By Alex Tzanidis -- Wednesday, October 16, 2013

International Stem Cell Corporation v Comptroller General of Patents
[2013] EWHC 807 In October 2011, we reported on the decision by the Court
of Justice of the European Union (CJEU) in Oliver Brustle v Greenpeace
eV;[2012] 1 CMLR 41,;which found that a patent should not be ...
>> Read the full article at:
http://www.davies.com.au/pub/detail/893/patenting-human-embryonic-stem-cells-european-update&utm_source=Email&utm_medium=Share%20link

International Stem Cell Corporation Announces Positive Parkinson’s Disease Data

Data Presented at the 66th American Academy of Neurology Annual Meeting

CARLSBAD, CA - (Marketwired) - 4/29/2014 - International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com), a California-based biotechnology company developing novel stem cell-based therapies and biomedical products announced today that some behavioral improvements have been observed after six months in the pre-clinical non-human primate (NHP) study of Parkinson’s disease (PD).  The detailed behavioral data will be presented at the 66th American Academy of Neurology Annual Meeting in Philadelphia.

“It is encouraging to see these behavioral scores trending in the right direction as it means that the implanted cells may be having a positive impact on the disease symptoms,” said Professor D. Eugene Redmond Jr. MD, of Yale University Medical School and the study’s supervisor.  “The rating scores are equivalent to components of the UPDRS  which is widely used in research to evaluate Parkinson’s patients.  The Parkison’s score is known to correlate very highly with brain dopamine concentrations.”

The study consists of 18 primates, all exposed to the neurotoxin, MPTP, divided into three cohorts, a sham treated group and two treatment groups receiving different doses of human neural stem cells (hPNSC) derived from ISCO’s proprietary parthenogenetic stem cell line.  All of the groups had matching levels of parkinsonism and functional disability prior to the cell injections.  The 6 months data showed that the healthy behavior scores of the treatment group increased 170% while that of the placebo group increased by 58%.  In addition, one of the treatment groups demonstrated a significant improvement in the main Parkinson’s rating score of 63% (p<0.05) while there was no significant improvement in the control group.  The changes in these scores are particularly noteworthy as it signifies a greater reduction in the severity of the symptoms in the treatment group compared with the control group.  A more detailed update will be presented once the histopathology and biodistribution analysis of the tissue has been completed. 

Dr. Ruslan Semechkin ISCO’s Chief Scientific Office commented: “The results of this interim analysis are very promising.  This study provides information about how our human neural stem cells, derived from our parthenogenetic stem cells, behave in a diseased brain and how the diseased tissue responses and is a critical part of our IND submission.”

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) hence avoiding 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.

According to the Parkinson’s Disease Foundation, an estimated seven to 10 million people worldwide live with PD, 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 distrophy, and Lou Gehrig’s disease.  The total direct and indirect  cost of Parkinson’s disease is estimated to be nearly $25 billion per year in the United States alone.

ISCO's Parkinson's disease program uses human parthenogenetic neural stem cells (hPNSC), a novel therapeutic cellular product derived from the company's proprietary histocompatible human pluripotent stem cells.  hPNSC are self-renewing multipotent cells that are precursors for the major cells of the central nervous system.  The ability of hPNSC to (i) differentiate into dopaminergic (DA) neurons and (ii) express neurotrophic factors such as glial derived neurotrophic factor (GDNF) and brain derived neurotrophic factor (BDNF) to protect the nigrostriatal system, offers a new opportunity for the treatment of Parkinson's disease, especially in cases where current small molecule approaches fail to adequately control the symptoms.

To receive ongoing corporate communications via email, visit:  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

Contacts:

International Stem Cell Corporation

Dr. Simon Craw

Executive Vice President

Phone: 760-940-6383

Email: ir@intlstemcell.com

Dr. Ruslan Semechkin

Chief Scientific Officer

Phone: 760-940-6383

Email: ras@intlstemcell.com