Category Archives: International Stem Cell Corp. ISCO

International Stem Cell Corp. (ISCO) Demonstrates Treatment of Parkinson’s Disease in Cell Transplantation

April 21, 2015

Today before the opening bell, International Stem Cell Corp., a biotechnology company developing novel stem cell based therapies and biomedical products, announced publication of results of two proof-of-concept studies that validate the safety and efficacy of the company’s readily expandable stem cell derived treatment of Parkinson’s disease in both non-human primate and rodent animal models.

“The publication of these data in the peer-reviewed and highly-respected journal, Cell Transplantation, brings to a conclusion the preclinical stage of our Parkinson’s disease program. The data clearly support the premise that parthenogenetic neural stem cells can be effective in treating the symptoms of Parkinson’s disease and, along with the previously reported safety data, forms the basis of our decision to move into the clinic,” stated Ruslan Semechkin, Ph.D., the Company’s Chief Scientific Officer. “We look forward to providing an update on the status of our regulatory submission to the Australian government in the near future.”

In addition to successfully treating animals with induced Parkinson’s disease symptoms by transplanting human parthenogenetic neural stem cells (hpNSC), the company observed there were no deformations, tumors or involuntary muscle movements (dyskinesia). The studies further show that transplants of human parthenogenetic neural stem cells led to improvement of dopamine levels and increased cytokine levels.

The article and abstract can be found at: http://www.ingentaconnect.com/content/cog/ct/2015/00000024/00000004/art00010

ISCO has built a comprehensive preclinical safety dataset from a series of GLP and non-GLP studies on hpNSC. According to today’s press release, the company has submitted a Clinical Trial Exemption (CTX) application to the Australian regulatory authorities and plans to begin the phase 1/2a clinical study within the next few months.

For more information on the company, visit www.internationalstemcell.com and www.companyblog.intlstemcell.com

International Stem Cell Corp. (ISCO) to Present Final Safety and Efficacy Results from Parkinson’s Disease Program at AAN Annual Meeting

April 14, 2015

Today before the opening bell, International Stem Cell Corp., a California-based biotechnology company developing novel stem cell based therapies and biomedical products, announced that it will be giving a platform presentation on its preclinical studies in Parkinson’s at the 2015 American Academy of Neurology Annual Meeting in Washington, DC. Ruslan Semechkin, Ph.D., ISCO’s chief scientific officer, will discuss the data at the “Parkinson’s Disease” scientific session (s48.007), on Thursday, April 23rd at 4:45 pm in a talk entitled “Neural Stem Cell Based Therapy for Parkinson’s Disease.”

“These animal studies strongly suggest that the transplantation of human parthenogenetic neural stem cells (hpNSCs), for the treatment of Parkinson’s will be efficacious, safe and well tolerated,” stated Ruslan Semechkin, Ph.D. “The data further elucidate our platform and help solidify expectations for our planned Phase 1/2a studies in humans.”

The data presented are from two safety studies, where human parthenogenetic neural stem cells (hpNSC) were transplanted into the brains of healthy animals, and a proof-of-principle study where the cells were transplanted into animals with induced Parkinson’s disease symptoms. The studies show that hpNSCs 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 month non-human primate safety study, no evidence of teratoma formation or ectopic tissue was found in any animals that received the human cell transplants.

ISCO has built a comprehensive preclinical safety dataset from a series of GLP and non-GLP studies on hpNSC. The Company has submitted a CTX application to the Australian regulatory authorities and plans to begin the phase 1/2a clinical study within the next few months.

For those not familiar with them, hpNSCs are a novel therapeutic cellular product derived from International Stem Cell Corporation’s proprietary human pluripotent stem cells. Neural stem cells work to repair the brain in several ways. The cells are attracted to the site of injury and in response to signals released by the damaged tissue release a range of molecules that reduce inflammation and trigger the recovery process. Neural stem cells also have the ability to generate new cells to replace those that are either dead or dying enabling the formation of new tissue. In this way the hpNSCs act as coordinators of all the various activities necessary to recover brain function.

To learn more about International Stem Cell Corp. and its technologies, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Uses Neural Stem Cells to Reverse Neurological Stroke Symptoms

April 7, 2015

International Stem Cell Corp., a California-based biotechnology company developing novel stem cell based therapies and biomedical products, today issued a press release to update the medical and investor communities about its recent experiments. Using animal models, the company has successfully demonstrated how human parthenogenetic neural stem cells (ISC-hpNSC) can significantly reduce neurological dysfunction after a stroke.

“With no approved treatments for neurological dysfunction, individuals who have suffered a stroke have few treatment options available beyond physical rehabilitation following recovery,” stated Ruslan Semechkin Ph.D., the company’s chief scientific officer. “These new results are highly encouraging, suggesting that ISC-hpNSC may have significant ability to not only reduce but also reverse these neurological symptoms of dysfunction. These findings not only broaden the future potential use of our neural stem cells beyond Parkinson’s disease but also offer hope to a patient population with a significant unmet medical need.”

Neural stem cells work to repair the brain in several ways. The cells are attracted to the site of injury and in response to signals released by the damaged tissue release a range of molecules that reduce inflammation and trigger the recovery process. Neural stem cells have the ability to make the various neurological cell types to replace the dead and dying cells necessary for the formation of new brain tissue. In this way the hpNSCs act as coordinators of all the various activities necessary to recover brain function.

ISCO’s stroke program uses the same neural stem cells as the company’s Parkinson’s disease program, derived from the company’s human parthenogenetic stem cells using a cGMP method based on the protocol published in Nature Scientific Reports in March 2013 (click here). Parthenogenetic neural stem cells have been shown in peer-reviewed publications to have superior immunological properties to other neural stem cells. The complete dataset will be presented at an upcoming scientific conference to be announced separately. Further studies investigating the potential for treating stroke are planned.

According to the National Stroke Association stroke is a leading cause of death in the United States, killing nearly 130,000 people each year, and is a leading cause of serious, long-term adult disability. Approximately 795,000 strokes will occur each year, one occurring every 40 seconds, and taking a life approximately every four minutes. Approximately two million brain cells die every minute during stroke, increasing the risk of permanent brain damage, disability or death. The estimated direct and indirect cost of stroke in the United States in 2010 is $73.7 billion.

For more information on International Stem Cell Corp., visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Reports 2014 Q4 and Year-End Results, Schedules Conference Call for Wednesday

March 31, 2015

Today, International Stem Cell Corp., a California-based biotech developing novel stem cell-based therapies and biomedical products, updated investors with latest happenings and reported its fourth quarter and year-end financial results for the period ended December 31, 2014.

Q4 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.

Also notable, in January of this year, 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 scheduled for tomorrow. 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
Webcast: http://public.viavid.com/index.php?id=113470

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

For more information on International Stem Cell Corp., visit www.internationalstemcell.com

International Stem Cell Corp. (ISCO) Eyeing $5.3 Billion by 2022 Parkinson’s Treatment Market, Continues Advancing Unique Stem Cell Technologies

March 24, 2015

International Stem Cell Corp. is a biotech company with key stem cell technologies under their belt and a clear focus on therapeutic and clinical product development. The company has a slew of long-term therapeutic opportunities on the table, as well as two important, revenue-generating subsidiaries already running which could become even more significant revenue engines as the company’s development pipeline progresses further. The company’s human parthenogenetic stem cell (hpSC) technology has several advantages compared to other stem cell technologies in existence today, like embryonic, induced pluripotent, or adult stem cells, with equivalency to embryonic stem cells when it comes to generic diseases and superior immune matching to all three. And unlike induced pluripotent stem cells for instance, hpSCs have not been genetically reprogrammed or manipulated by viruses, giving them vastly superior long term viability as a treatment vector.

ISCO’s unique, ethical techniques of chemically stimulating (parthenogenesis) unfertilized female gametocytes (egg cells), known as oocytes, means that no viable embryo has been created or destroyed in the process of creating their hsPCs. Furthermore, specific differences in activation techniques can yield either HLA (human leukocyte antigen) heterozygous or HLA homozygous hpSCs, which are histocompatible with the donor, or with large segments of the human population respectively. The combined benefits from being immunomatched and the ethical nature in which their hsPCs are produced, sets the ISCO stem cell technology apart from the competition when it comes to developing truly 21st century cell-based therapies.

These key advantages have allowed ISCO to rapidly develop brain, liver and corneal (eye) cells to treat Parkinson’s disease (and potentially other neurological disorders), the effects from various causes of liver damage, and also address the millions of people worldwide who need corneal transplants each year, due to various eye diseases or injuries. International Stem Cell has already seen some incredible R&D milestones, well beyond their core small molecule-based differentiation methods used to produce large batches of extremely pure cells in a controlled manner, which has allowed the company to seriously address a host of clinical stem cell usage requirements, unlike many of the company’s competitors who are unable to produce high quality stem cells in large quantities. From ISCO’s creation of dopaminergic neurons for the treatment of Parkinson’s, whose ability to engraft and produce dopamine (as well as to produce brain-protecting neurotrophic factors) has been successfully shown in animal model studies, to the creation of human hepatocyte-like cells that have been shown in animal models to engraft, mature and express key human liver proteins, the company has seen their hsPCs quickly transform the concept of what is possible in stem cell therapies today. The creation of self-assembling human corneas, including all the requisite cell layers needed to make the product ideal for transplants or drug toxicology testing, perhaps shows best just how powerful ISCO’s technology really is and what lies in store for future developments.

ISCO’s high capacity production techniques have made it possible for the company to create the UniStemCell bank, which is the life science industry’s first real stem cell bank of non-embryonic and histocompatible human stem cells, making possible both commercial use and extensive research work. The company’s master stem cell bank carries fifteen key hpSC lines, one of which has the most common immune type (haplotype) and is immune-matched to some 70 million people on earth. In February of this year, International Stem Cell completed manufacturing all the clinical-grade hpNSCs (human parthenogenetic neural stem cells) required using their patented process which are needed for their upcoming Phase 1/2a clinical trial in Parkinson’s disease in Australia, which will be conducted via their localized Cyto Therapeutics Pty Ltd. subsidiary. This trial will not only further document the efficacy of the company’s stem cell technology, it will form the basis for regulatory submission to the Australian Therapeutics Goods Administration (TGA) and for further clinical hpNSC studies in Parkinson’s in the United States.

Already covered in pre-IND meetings with the FDA, the company’s master cell bank of hpNSCs are produced with full cGMP compliance and relevant chemistry and manufacturing controls, and the parthenogenetic line derived undifferentiated cells has already been cleared by the FDA for use in clinical trialing. Given that the company has produced and cryopreserved enough material at their state-of-the-art, GMP-compliant facility in Oceanside (CA), required to serve all anticipated needs through their clinical trials (in conjunction with their current production-scale capabilities), management is confident that the company will see great success with their Phase 1/2a and subsequent Phase 2b/3 trials.

With considerable and growing revenues from their B2B Lifeline Cell Technology operations, which provide various purified primary human cells and optimized reagents for cell culture to numerous industry operators, as well as from their Lifeline Skin Care® operations, which develops and markets anti-aging skin care solutions based on hpSC derived growth factors and peptides, ISCO has the kind of clinical development capital backstopping most other developers lack. However, as with all such clinical development work, the overall costs to implement all related business, operating and development plans can be enormous. The deal with Lincoln Park Capital Fund, LLC to sell up to $10.25 million of common stock has helped to support operations, with a $1.588 million raise (8.2M shares) during the nine months ended September 30, 2014 (subsequent private placement agreements with Lincoln Park means the company won’t be selling any more shares to Lincoln Park until March 2016). Q3 2014 also saw insider skin in the game increase, with some 10.4 million shares sold to the CEO and Board Co-Chair Dr. Andrey Semechkin, and Dr. Ruslan Semechkin, as well as the CSO and a company Director, which brought in an aggregate $1 million.

Over a million people in the U.S. alone live with Parkinson’s and incident rates are set to continue rising as an ageing population stimulates a roughly 4% CAGR according to a recent report published by GlobalData. The treatment market for Parkinson’s alone is on track to hit $5.3 billion by 2022 and ISCO is one of the clear front runners in the game today with a therapeutic option emerging that has the potential to even reverse the effects, but it will take investors who understand the longer-term upside to help further support the company’s clinical development initiatives.

Take a closer look at the company by visiting www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Granted Japanese Patent for Key Stem Cell Technology

March 17, 2015

International Stem Cell Corp., a California-based biotechnology company developing novel stem cell based therapies and biomedical products, today reported that the Japan Patent Office has issued ISCO’s patent covering methods of making a bank of human stem cells from parthenogenetically activated eggs. This win significantly bolsters the company’s intellectual property position and ability to form partnerships in Japan.

“The new patent strengthens our position as a leader in regenerative medicine. With the potential to avoid one of the fundamental problems of tissue and cell therapy, immune-matching, and having been shown to be more genetically stable than iPS cells, our human parthenogenetic stem cells hold potential significant therapeutic value,” said Ruslan Semechkin, PhD, ISCO’s chief scientific officer. “The new patent also extends the geographic reach of our broad IP portfolio beyond the US and EU making us a more attractive partner for Japanese pharmaceutical companies.”

ISCO’s patent covers a new method of creating stem cells that combine many of the benefits of embryonic stem cells with induced pluripotent stem cells and can be used to generate virtually unlimited quantities of human cells. The company is currently using this technology to develop treatments for a number of indications where cell therapy has been demonstrated to be effective but there is insufficient supply of safe, functional cells. Preclinical safety and efficacy data from the company’s Parkinson’s disease program was recently presented at the Society for Neuroscience annual meeting, and a Phase I/IIa clinical study in Parkinson’s disease is anticipated to begin in the near future.

Along with ISCO’s substantial collection of US patents, and the recently announced resolution by the European Union Court of Justice in favor of the company’s EU patent applications, this new Japanese patent provides intellectual property protection and licensing opportunities for ISCO in the three largest healthcare markets.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Moving Ever Closer To An Effective, Regenerative Multipotent Cell Treatment For Parkinson’s Disease

March 2, 2015

In the U.S. alone each year somewhere around 60k people are diagnosed with the crippling degenerative central nervous system (CNS) disorder known as Parkinson’s disease, which is brought on by an as-yet poorly understood cascade death of dopamine-generating cells in the midbrain. Roughly 0.3% of the entire population, or nearly one million Americans, currently lives with this life-shattering disorder. That’s more than multiple sclerosis, muscular dystrophy, and Lou Gehrig’s disease combined.

Parkinson’s is the kind of CNS disorder that can destroy an entire family, devastating a family member and rendering them unable to effectively care for themselves, as the disorder is most commonly characterized by severe diminishment of motor control, uncontrollable limb rigidity and shaking, as well as considerable difficulty just walking or moving around. Later on in the progression of Parkinson’s, sensory and emotional problems arise, with sleep deprivation and depression being all too common. Eventually, the patient often develops thoroughly debilitating dementia as well and Parkinson’s has become a dreaded thief that can rob a family of their loved ones, and for which there are currently only extremely limited/costly treatment options.

Worldwide the incident rate is more difficult to get a handle on, but the Parkinson’s Disease Foundation estimates that as many as 10 million people worldwide are currently afflicted and that in the U.S., total direct and indirect costs, including treatment and lost wages, amounts to around $25 billion each year. With medications to help patients cope running around $2.5k a year for most and only somewhat effective therapeutic surgeries running somewhere in the neighborhood of $100k, there is immense demand for a more effective and less invasive solution.

International Stem Cell Corp. (OTCM:ISCO), a small publicly-traded biotech developer based in California with around 47 full-time employees, 23.4% of whom are Phd/MDs, may have just such a solution in the works thanks to their decade-plus pioneering in ethical pluripotent stem cell technology. The company’s proprietary human parthenogenetic stem cell (hpSC) platform technology, which is clearly differentiated from induced pluripotent stem cell (iPS) technology due to zero manipulation of the cellular genome and thus does not bear the safety and regulatory burdens associated with iPS approaches, is now rapidly advancing towards ISCO’s first clinical product, human parthenogenetic neural stem cells (hpNSC).

Recently vindicated in the EU via a final and definitive ruling by the EU’s highest court, the Court of Justice of the European Union, in a decision which roundly confirmed the earlier opinion issued by the Advocate General in 2014, the company’s core technology patent applications are not prohibited, or even covered under the EU’s prohibition on patenting embryonic stem cells. This decision clears the way for commercial rollout in the Eurozone of ISCO’s rapidly advancing hpNSC technology, as parthenogenetic stem cell’s legally patentable status is now clearly differentiated from still-banned embryonic stem cell patenting.

Earlier this month, the company was pleased to announce that they have successfully completed manufacturing the requisite cell bank for their upcoming Phase 1/2a clinical trials in Parkinson’s, having produced in excess of 2.6 billion clinical-grade human neural stem cells, which is more than enough to cover all foreseeable clinical needs, utilizing the company’s patented hpNSC production process. The company’s highly-optimized and chemically-defined differentiation production process was published in a Nature publication in 2013 and ensures that all hpNSCs are manufactured according to strict cGMP-compliant conditions and that these high purity cells are effectively cryopreserved.

This platform and production technology puts ISCO at the forefront of hpSC science today and makes this publicly-traded biotech company a real up-and-comer for investors to keep a close eye on, as their hpSC platform and production architecture’s potential goes well beyond just developing Parkinson’s treatments. The company is also currently developing hpNSCs for ischemic stroke, a leading cause of death in the U.S., which claims over 130k lives each year and which represents over 87% of all stroke cases caused by a clot in a blood vessel that supplies the brain.

Treatment options are very limited for ischemic stroke sufferers and while dissolving the blood clot within two to three hours after the acute phase has shown to be effective, often severe debilitation can occur and extensive rehabilitation is necessary to recover (some, generally not all) cognitive and motor functions. With around 800k cases of stroke each year in the U.S., effectively costing (direct and indirect) over $74 billion, the demand for ISCO’s hpNSC solution is potentially even greater here than it is for Parkinson’s.

With compelling pre-clinical evidence that NSC treatment can actually reverse the debilitation caused by a stroke, even when it is utilized several weeks after the initial acute phase of the stroke, ISCO’s highly purity hpNSC solution could emerge as the de facto treatment option for ischemic strokes and seriously help patients to ably recuperate from an otherwise potentially crippling incident. Looking at the company’s hpNSC clinical development pathway for such CNS issues as Parkinson’s and ischemic stroke, it is pretty easy to see that additional cell therapy treatment options for other CNS diseases and disorders can be developed using this technology.

ISCO is dedicated to developing new treatment options for CNS diseases, as well as those of the liver and eye where such cell therapy has demonstrated efficacy, but where options are currently limited by a lack of readily available, safe human cells. The company’s ability to readily produce high purity stem cell-derived liver cells (CytoHep), as well as human retinal epithelium (RPE) cells and human corneal cells/whole corneal tissue (CytoCor) from human parthenogenetic stem cells, puts their development pipeline potentially within eventual striking distance of treating a vast array of conditions. Conditions like the metabolic liver disease Crigler-Najjar syndrome, which can lead to severe brain and nervous system damage (as well as death), as well as eye conditions like age-related macular degeneration, which causes vision loss and blindness in as many as 50 million people around the world today.

Learn more about the company by visiting www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Positions Itself to Leverage Parthenogenesis Technology

February 20, 2015

International Stem Cell Corp. uses it core technology, parthenogenesis, to create pluripotent human stem cells from unfertilized eggs. By avoiding the use or destruction of viable human embryos, the company is able to dodge ethical issues while producing billions of human cells that can be used to research various neurological disorders, diseases of the liver and blindness caused by corneal damage.

ISCO recently announced the completion of a massive cell bank containing over 2.6 billion human cells, which will allow the company to conduct clinical trials on Parkinson’s disease in the near future. According to Ruslan Semechkin, ISCO’s Chief Scientific Officer, the completion of the cell bank marks one of the company’s final steps before clinical programs can begin.

The company is able to leverage a tremendous strategic advantage over its competitors by producing cells in its own GMP facility. “Because of the complexity involved in manufacturing live human cell products,” stated Semechkin, “having our own GMP facility is not only a strategic advantage, but also allows us to control the production costs.”

The company’s parthenogenetic stem cells present a multitude of inherent benefits. In addition to being pluripotent, which means that they can potentially turn into any of the body’s cells, they also inherit a duplicate set of human leukocyte antigen (HLA) genes, which can significantly reduce the odds of rejection by patients’ immune systems.

In the past, study of embryonic stem cells has been severely hampered by ethical issues, and significant research has been largely delayed or avoided. However, ISCO’s parthenogenetic cells open the door for research on a variety of diseases and conditions without the need for embryonic growth, which should help to quell ethical concerns.

In addition to its own clinical trials, ISCO also plans to generate revenue by franchising its stem cell technology to multiple cell banks for use in scientific research in a variety of locations. Stem cell research could lead to treatments that save millions of lives and improve overall quality of life for millions more. As ethical hurdles are navigated and research ramps up in the near future, ISCO is strategically positioned to maximize on returns.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO): A Reckoning Force in the Future of Stem Cell Therapy

February 18, 2015

California biotech International Stem Cell is developing novel stem cell-based therapies and biomedical products geared toward unmet medical needs with limited treatment options. Many such areas already involve clinically proven cell therapy but lack safe human cells. ISCO’s solution to filling these gaps is the company’s patented new class of human stem cells called parthenogenetic stem cells.

ISCO’s core technology, parthenogenesis, enables the creation of pluripotent human stem cells from unfertilized human eggs. These human parthenogenetic stem cells (hpSCs) avoid ethical issue associated with the use or destruction of viable human embryos.

As the world’s first parthenogenetic homozygous stem cell line, ISCO’s hpSCs, which in late 2014 were cleared by the FDA for clinical use, can be immune-matched to millions of people of differing gender, age and racial background.

Using its patented parthenogenesis process, ISCO earlier this month completed the manufacturing of the cell bank of more than 2.6 billion clinical-grade human neural stem cells needed for its upcoming phase 1/2a clinical trial for the treatment of Parkinson’s disease.

In preparation of the clinical study, ISCO formed an Australian subsidiary, Cyto Therapeutics Pty Ltd., designated to manage the regulatory submission to the Australian Therapeutics Goods Administration (TGA) and the up-and-coming clinical study.

Also included in ISCO’s subsidiary portfolio is Lifeline Cell Technology, which manufactures and markets high-quality primary human cells, optimized media and reagents; and Lifeline Skin Care, developer of branded anti-aging skin care products based on growth factors and peptides extracted from hpSCs.

In addition to Parkinson’s disease, ISCO’s scientists are focused on using hpSCs to treat severe diseases of the eye, the nervous system and the liver.

With 220 patents, applications and licenses, a broad pipeline of targets, sturdy balance sheet, and an industry-anticipated clinical trial to launch in mid-2015, ISCO is well-positioned as a reputable innovator in the advance of stem cell-based therapies.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Completes Master Stem Cell Bank in Preparation for Upcoming Parkinson’s Disease Clinical Trial

February 3, 2015

Using its patented process, International Stem Cell has completed the manufacturing of its master cell bank of more than 2.6 billion clinical-grade human neural stem cells. The California biotech company says its existing master cell bank and current production scale are sufficient to meet foreseeable clinical trial requirements, including for the recently announced phase 1/2a clinical trial in Parkinson’s disease.

“Completing the production of clinical-grade cells using the previously published protocol is one of the final steps before starting our clinical program,” Ruslan Semechkin, Ph.D., ISCO’s chief scientific officer, stated in the news release. “Because of the complexity involved in manufacturing live human cell products, having our own GMP (good manufacturing practices) facility is not only a strategic advantage, but also allows us to control the production costs. We continue to anticipate, subject to regulatory agency approval, beginning the clinical trial in early 2015 and will provide a further update in the near future.”

ISCO’s master cell bank of human parthenogenetic neural stem cells (ISC-hpNSC) is produced at the company’s state-of-the art GMP manufacturing facility located in Oceanside, California, and in compliance with current good manufacturing practices (cGMPs) and the chemistry and manufacturing controls (CMC) discussed in the previously reported pre-IND meeting with the FDA.

ISC-hpNSCs are a novel therapeutic cellular product derived from the company’s proprietary human pluripotent stem cells. The cells are karyotypically normal hpNSCs and free of measurable contaminants of human or animal origin. The production of hpNSCs from undifferentiated pluripotent human parthenogenetic stem cells in the master cell bank uses qualified reagents and a standardized protocol developed by ISCO. The undifferentiated human stem cells are derived from the parthenogenetic line and were recently cleared by the FDA for use in clinical trials. Each batch of hpNSC is subjected to standardized quality control testing to ensure viability, sterility and appropriate cellular composition before clinical use.

Neural stem cells are self-renewing multipotent cells that are precursors for the main cell types of the central nervous system. The ability of ISC-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 its novel cell therapy as well as doses ranging efficacy to be used to design the first clinical trial in Parkinson’s disease patients.

For more information visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Enters Agreement with $1 Billion Global Pharmaceutical Company

July 8, 2014

International Stem Cell Corp., a biotech company developing novel stem cell-based therapies, announced this morning that it has entered into a twelve-month research agreement with Rohto Pharmaceutical Co., Ltd., a global Japanese pharmaceutical company that develops new technology for the medical and cosmetics markets with approximately $1.3 billion in consolidated annual sales. Founded in 1899, Rohto today has products available in more than 150 countries.

Rohto has agreed to 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 this research agreement. Certain key terms of such a license agreement, including the target disease areas and intellectual property rights, have already been defined 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,” stated 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 UniStemCell™. The Company has a track record of successfully demonstrating that human cells derived from UniStemCell™ are effective in animal models of various diseases and have the potential to be used as a basis for developing human therapies. ISCO has adopted this approach successfully with a number of academic collaborators in the past.

For more information on International Stem Cell Corp., please visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Firmly Rooted in Biotech Space with Innovative Technology, Unique Business Model

July 7, 2014

International Stem Cell Corp., the developer of a new stem cell technology called parthenogenesis, is focused on the application of its research and development to the treatment of human degenerative diseases.

The company’s human parthenogenetic stem cells (hpSCs), derived from unfertilized human eggs, have the best characteristics of each of the most commonly used and described classes of stem cells – induced pluripotent stem cells, embryonic stem cells, and adult stem cells – thereby creating a class of cells that meet all important criteria when it comes to therapeutic application.

hsPCs’ are immune matching, which means that millions of patients could receive tissue and cell transplants without tissue rejection problems or the need to take immune-suppressing drugs; pluripotent, meaning they can change or “differentiate” into more specialized cells such as skin, liver or blood cells; demonstrate strong proliferation in culture, which refers to the growth of the cell populations in the research and/or application environment; and are considered superior in their use in genetic disease.

Leveraging these capabilities and characteristics, International Stem Cell aims to use its hsPCs to treat diseases of the brain (Parkinson’s diseases), liver (treatment of liver damage) and eye (cornea tissue implants). In support of these goals, the company is also building its stem cell bank (UniStemCell) of parthenogenetic stem cell lines for research and commercial use.

International Stem Cell’s subsidiary business units, Lifeline Cell Technology (LCT) and Lifeline Skin Care (LSC), further support the company and create a business model unique to the biotechnology industry, creating revenue flow from the sale of products develop from scientific discoveries made by International Stem Cell. This self-sustaining model not only allows for the allocation of revenues to further support scientific research and development, but also provides practical, short-term applications of the company’s core technologies.

For more information visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Advances Parkinson’s Program, Racing against Devastation of Disease

June 23, 2014

Approximately 8 million people have Parkinson’s disease worldwide, as many as 1 million of them Americans. Parkinson’s, caused by the degeneration of a small part of the brain and cells that make dopamine, is a progressively debilitating disease that affects the ability to control muscles and movement. Symptoms include tremors, rigidity of limbs or joints, loss or slowness of movement, impaired balance and coordination, and changes in speech.

There is currently no cure for Parkinson’s disease, and while modern treatments may improve symptoms, some may lose their effectiveness over time. Current treatments include oral medications; deep brain stimulation, which is limited to a sub-group of patients and has unknown long-term safety; and ethically controversial fetal tissue implants, which may result in immune rejection by the host body and graft-induced dyskinesia. Regardless of treatment, the disease continues to progress – the final stages of the disease often leaves the person wheelchair-bound, bedridden, and in need of a constant caregiver.

For International Stem Cell Corp., current treatments simply aren’t satisfactory. Using human parthenogenetic neural stem cells (hPNSC), a novel therapeutic cellular product derived from the company’s proprietary histocompatible human pluripotent stem cells, the company is rapidly advancing its alternative approach to treat Parkinson’s disease.

hPNSC’s are self-renewing multi-potent cells that are precursors for the major cells of the central nervous system. With their ability to differentiate into dopaminergic neurons and express factors that protect the nigrostriatal system, part of the brain that is particularly involved in the production of movement, hNSC’s offer a new opportunity for treatment of this neurological disease.

Following the plan devised with the Food and Drug Administration (FDA) at a pre-IND (investigational new drug) meeting earlier this year, International Stem Cell recently completed an acute toxicity study of its clinical drug candidate in rodent subjects. The results were positive, demonstrating that the doses that the company will be proposing to the FDA in its phase 1 clinical study are “well below the safety threshold.”

Despite stringent care and precautions, and without regard to the size of the enterprise, pharmaceutical and biotech companies face the risk of unforeseen regulatory issues that could slow down or even halt development of drug candidates. By achieving positive results in its latest toxicity study, International Stem Cell reached an important company milestone that will reduce some of these risks, strengthen the company’s IND submission and increase its chance for a positive review by the FDA.

In April, six months into the company’s pre-clinical non-human primate (NHP) clinical study, International Stem Cell reported behavioral improvements study subjects, suggesting that implanted cells may have a positive impact on disease symptoms. The most important result was that monkeys that were transplanted with stem cell-derived neuronal cells had higher levels of dopamine in the brain compared to the control group, which were transplanted with placebo.

Building on both of these studies and powerful proprietary stem cell-based technology, International Stem Cell continues to advance its program, racing against a disease expected to afflict 60,000 more people each year. The company is working with collaborators from Duke University and leading researchers around the world, and plans to file its IND in the second half of this year. Once the FDA reviews the submission, and assuming approval, International Stem Cell intends to move its Parkinson’s program to clinical phase within the next 12 months.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Makes Significant Advancement in Stem Cell Technology

June 19, 2014

International Stem Cell, a biotech company focused on the development and commercialization of stem cell-based research and cosmetic products, recently reported a significant advancement in human induced pluripotent stem cells (iPS) derivation with novel protein-based reprogramming method.

iPS cells are made by genetically reprogramming mature cells, which are usually taken from the skin, and can be used to create new cells of a different type. Original reprogramming methods utilize viruses to modify the cells genes and risk the inclusion of genetic material from the virus into the cells. These viral methods have proven extremely inefficient and can only produce limited quantities of cells.

ISCO’s biologists, however, have developed a fundamentally new method capable of enhancing the efficiency of the reprogramming process by using specific proteins called transducible transcription factors (TTF), while avoiding the use virus-based methods and the inherent risks associated with such methods.

The company’s new method demonstrates that its TTF-iPS technology has the ability to produce stable stem cells and is at least 10 times more efficient that older methods. In addition, the TTFs are naturally eliminated when no longer required, a characteristic that further improves safety.

“This new method offers a much needed safer and more efficient alternative to older techniques and represents a major step forward in being able to use iPS clinically,” Dr. Ruslan Semechkin, chief scientific officer for ISCO, stated in the news release. “We are currently working toward shortening the cell reprogramming step from around six weeks to as little as one week.”

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Reports Positive Results of Parkinson’s Disease Study

International Stem Cell Corp., a California-based biotechnology company developing novel stem cell based therapies, just announced the completion of the acute toxicity study of its 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 anticipates providing an 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,” stated 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.

For more information on the company, visit www.internationalstemcell.com

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International Stem Cell Corporation’s (ISCO) VP to Present at BIO 2014

June 17, 2014

International Stem Cell Corp., a California-based biotechnology company developing novel stem cell based therapies and biomedical products, announced today that Executive Vice President Dr. Simon Craw will present an overview of the company and its subsidiaries at the BIO 2014 conference on Tuesday, June 24th at 4:15 pm PDT. The San Diego Convention Center is hosting the conference in the Mission Beach room. For additional conference details go to: http://convention.bio.org.

Attracting approximately 15,000 of the most influential biotech and pharma participants from over 60 countries, BIO is the largest, most influential biotech meeting in the world. The convention is scheduled to include sessions and specialty forums covering 17 hot topics, over 1,700 exhibitors and BIO One-on-One Partnering™ meetings with thousands of companies from June 23 – 26th. Those interested in attending the conference and/or if you would like to schedule a meeting with ISCO’s management team, please contact the conference organizers. To register for the event visit the conference website at http://convention.bio.org/register.

ISCO’s work is centered on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. Parthenogenesis, the company’s core technology, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs) thereby avoiding ethical issues associated with the use or destruction of viable human embryos. Scientists at the company 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. The offerings of hpSCs possess 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 and stem cell-based skin care products through its subsidiary Lifeline Skin Care.

For more information on the company, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO): Moving Ahead with Parkinson’s Disease Program

June 5, 2014

International Stem Cell Corp., a biotechnology company, is focusing on developing novel stem cell-based therapies and biomedical products. The company recently declared its first quarter results; reporting year-over-year revenue growth of 28% to $1.65 million, with a gross margin of 73%. The revenue was mainly driven by the strong performance of its subsidiary, Lifeline Cell Technology, which contributed around 51% to the company’s total revenue.

On April 29, after six month of its trial study, the company reported significant behavioral improvement in its pre-clinical non-human primate (NHP) study of PD. The company spent around $958,000 on research and development (R&D) in the last quarter compared to $721,000 in same period last year. The increase in R&D was mainly driven by the increased stem cell line research and testing expenses. This helped the company to improve the efficacy of its drug to treat PD, which is based on its stem cell line technology.

Superior results from the pre-clinical study for treating PD

International Stem Cell, after six months observation of its pre-clinical non-human primate (NHP) study for PD, reported significant behavioral improvement in the PD cases. The company divided the total primates that have matching levels of Parkinsonism and functional disability into three groups. Out of these three groups, two received different doses of human neural stem cells (hPNSC) developed from ISCO’s proprietary parthenogenetic stem cell line “phSC-Hhom-4.” The company in initial experiments on mice demonstrated that the neuronal cells derived from this technology lived in mice brain without developing tumors. This shows that the company’s stem cell line technology has higher potential to provide improved graft acceptance and possible therapeutic applications, including treating PD.

International Stem Cell’s technology helped it to demonstrate healthy behavior scores (the intelligence quotient level of the individual) of the treated group, which were increased by 170% compared to just 58% in placebo group. The third group demonstrated a significant improvement in the main Parkinson’s rating score of 63% (p< 0.05) compared to minute improvement in the control group.

This significant change in the scores signifies a greater reduction in the severity of the symptoms in the treatment group compared with the control group. This is expected to lead to higher improvements in International Stem Cell’s trial studies. Further, as per the meeting with the FDA in February, the company plans to complete FDA-required pharmacology and safety studies by the end of 2014. The recommendations on the PD trial program from the FDA will allow the company to improve the efficacy of the drug. This could reduce the risk of the any delays and integrating the recommendation from the FDA in the program will enable the company to develop stronger Investigational New Drug (IND) applications with a greater chance of positive reviews.

Market opportunity in PD treatment

PD is the 14th leading cause of death in the U.S. Also notable, The Parkinson’s Disease Foundation estimates around seven million to ten million people are living with PD globally and around one million are in the U.S. alone. Further, around 60,000 new cases of PD are diagnosed annually in the U.S., and the total direct and indirect cost of PD is estimated to be around $25 billion per year. Medication costs for an individual suffering with PD is around $2,500 per year, and therapeutic surgery can cost $100,000 per patient.

The superior results demonstrated by International Stem Cell in the pre-clinical trial of its PD program and its efforts to improve the efficacy of its drug will enable the company to take advantage of the underlying opportunities in this PD medication market.

Conclusion

International Stem Cell with its “parthenogenetic stem cell line” technology will be able to improve the efficacy of its new drug candidates for treating PD. Further, fulfilling the FDA norm and integrating the FDA recommendation in its PD program will help to avoid the delays in submitting the IND application to FDA. The success of the PD program will generate greater opportunity in the PD medication market, which will in turn strengthen its long-term financial position.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Slated to Discuss Q1 Earnings – Revenues Up 28%

May 13, 2014

International Stem Cell Corp., a California-based biotechnology company developing novel stem cell based therapies and biomedical products today provided a business update and announced financial results and for Q1 2014.

“Obtaining clarity from the FDA on our Parkinson’s disease program allows us to substantially lower the risk of unforeseen regulatory issues which could delay the program. By building the FDA’s feedback into our plans, we will be able to prepare a stronger IND submission with an increased chance of a positive review,” said Dr. Andrey Semechkin, the Company’s CEO and Co-Chairman.

“On the commercial side, on a year over year basis, top-line revenues have grown for seven consecutive quarters, confirming that our subsidiaries are executing on their business plans and are on the right track. Looking forward to the rest of 2014, we see no reason why this growth should not continue; although we expect our cash burn to increase compared with last year as we push to complete our pre-clinical work and IND submission,” concluded Dr. Semechkin.

Three Q1 2014 highlights included the holding of a pre-IND meeting with the U.S. Food and Drug Administration (FDA) clarifying the path to IND approval for ISCO’s novel neural stem cell treatment for Parkinson’s Disease (PD), the announcement of three months of positive data from the ongoing IND-enabling pharmacology/toxicology primate study demonstrating that a majority of the animals exhibit significant improvement in parkinsonism, including a return of many normal behaviors and a boost in revenues, up 28% year-over-year to $1.65 million for the three months ended March 31, 2014.

Revenue for the Q1 2014, totaled $1.65 million, compared to $1.29 million for the three months ended March 31, 2013 with LCT contributing $846,000 or 51% of total revenue for the three months ended March 31, 2014, compared to $635,000 or 49% for the three months ended March 31, 2013. LSC’s revenue of $803,000 for the three months ended March 31, 2014 accounted for 49% of total revenue, compared to $650,000 or 51% of total revenue for the three months ended March 31, 2013. Cost of sales for the same three months was $439,000 or 27% of revenue, compared to $334,000 or 26% of revenue for the three months ended March 31, 2013.

Research and development expenses were up 33% to $958,000 for the reported period in large part due to increased stem cell line research and testing expenses.

The company will be discussing their financial results for Q1 2014 in a conference call on Wednesday, May 14th at 11am EST. The company requests that participants dial in at least 10 minutes before the call to ensure timely participation. Dial in details are as follows:

Conference Number (U.S.): 1-877-941-2069
International Dial-In: 1-480-629-9713
Conference ID: 4682485
Webcast: http://public.viavid.com/confirmation/confirmwebcast.php?id=o5aroJyX

A playback of the call will be available from 05/14/14 at 5:00 pm ET until 05/28/14 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 4682485.

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.

For more information on the company, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Schedules Q1 2014 Business Update and Financial Results Conference Call

May 8, 2014

International Stem Cell Corp., a California-based biotechnology company developing novel stem cell based therapies and biomedical products, announced that it will host a conference call next with to provide a business update and discuss its financial results for the three months ended March 31, 2014.

Dr. Simon Craw, Executive Vice President, and Mr. Jay Novak, Chief Financial Officer of International Stem Cell, will be hosting the upcoming conference call. To attend the call, please use the dial in information below:

Date: Wednesday, May 14, 2014
Time: 11:00 a.m. Eastern Time
Conference Number (U.S.): 1-877-941-2069
International Dial-In: 1-480-629-9713
Conference ID: 4682485
Webcast: http://public.viavid.com/confirmation/confirmwebcast.php?id=o5aroJyX

Participants are advised to dial in at least 10 minutes before the call to ensure timely participation.

A playback of the call will be available from 05/14/14 at 5:00 pm ET until 05/28/14 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 4682485.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Study Reveals Promising Developments

April 29, 2014

International Stem Cell Corp. announced today that behavioral improvements have been observed after six months in their pre-clinical non-human primate (NHP) study of Parkinson’s disease (PD). ISCO is a biotechnology company developing novel stem cell-based therapies and biomedical products and is based in Carlsbad, California. The detailed behavioral data is slated to 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, consisting of 18 primates, are 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 groups had matching levels of parkinsonism and functional disability prior to the cell injections. Six months of data showed that the healthy behavior scores of the treatment group increased 170% while the placebo group increased by 58%. In addition, one treatment group showed a major improvement in the main Parkinson’s rating score of 63% (p < 0.05) while the control group exhibited no significant improvements.

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.

Dr. Ruslan Semechkin ISCO's Chief Scientific Officer, 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 responds and is a critical part of our planned IND submission."

For more information on the company, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) CSO to Present at American Academy of Neurology Annual Meeting in Philadelphia

April 22, 2014

International Stem Cell Corp., a California-based biotechnology company focused on developing novel stem cell-based therapies and biomedical products, announced today that Dr. Ruslan Semechkin, ISCO’s Chief Scientific Officer, will present data from its pre-clinical primate studies of Parkinson’s disease at the 66th American Academy of Neurology Annual Meeting in Philadelphia. The meeting is scheduled for Tuesday, April 29, 2014, at 1:00 p.m. EST. The topic is ‘Movement Disorders’ and the Session title is ‘Parkinson’s disease: Preclinical and Clinical Therapeutics.’

The American Academy of Neurology Annual Meeting is known to be the world’s largest gathering of neurologists. The American Academy of Neurology is an association of more than 27,000 neurologists and neuroscience professionals who are dedicated to promoting the highest quality patient-centered neurologic care. Neurologist’s are doctors with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as Alzheimer’s disease, stroke, migraine, multiple sclerosis, concussion, Parkinson’s disease, and epilepsy.

ISCO’s work centers on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. The company’s core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs) thereby avoiding ethical issues associated with the use or destruction of viable human embryos. Most notably, ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of people of different genders, ages, and racial backgrounds with minimal immune rejection after transplantation. hpSCs provide the potential to create the first true stem cell bank, UniStemCell™. International Stem Cell also produces and markets specialized cells and growth media for therapeutic research around the world through its subsidiary Lifeline Cell Technology, and stem cell-based skin care products through its subsidiary Lifeline Skin Care.

The Parkinson’s Disease Foundation notes an estimated seven to 10 million people worldwide live with Parkinson’s disease, with as many as one million 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 cost of Parkinson’s disease is estimated to be nearly $25 billion per year in the United States alone.

More information is available at www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Operating Subsidiary Signs Distribution Agreement

April 1, 2014

International Stem Cell Corp. announced today that Lifeline Skin Care, its operating subsidiary, has signed a distribution agreement with Grupo Venta Internacional, S.A de C. V., Mexico’s largest distributor of aesthetic and reconstructive products. Grupo Venta Internacional will offer Lifeline’s breakthrough stem cell skin care products to health care professionals throughout Mexico, the second largest market for aesthetic skin care in Central and South America. The agreement is effective immediately. ISCO is a California-based biotechnology company developing novel stem cell-based therapies and biomedical products.

As reported by Euromonitor International, the Mexican skin care market is expected to be worth approximately $2 billion in 2014, citing anti-aging products as being among the most popular. With 24 years’ experience in the plastic surgery and dermatology market in Mexico, and the credibility and presence of their 85-person national sales force, Grupo Venta Internacional (GVI) is well qualified to help Lifeline become very successful in this growing market.

President of GVI, Gabriela Gonzalez Alonso commented, “Plastic surgeons and dermatologists in Mexico are very excited about the potential for stem cell skin care products. They’re already familiar with the benefits of growth factors for skin rejuvenation, but the concept of stem cells elevates the technology to a whole new level. A brand that is backed by a biotech company adds even more credibility.”

“Expanding international sales is a key part of our growth strategy,” said Donna Queen, President of Lifeline Skin Care. “Initially Lifeline will be marketed only to physicians, which will lend credibility to the brand. The recommendation of a trusted health care professional is consistently rated as one of the most important consideration when selecting anti-aging skincare products. For this reason we’re especially pleased to be working with Grupo Venta Internacional.”

Lifeline Skin Care works on developing, marketing, and selling advanced anti-aging skin care products based on technology patented by ISCO. The technology uses ingredients that have been extracted from ISCO’s human, parthenogenetic stem cells and are known to reduce the visible signs of skin aging. Over the last 18 months, Lifeline’s sales have grown on average by over 40% a quarter, on a year to year basis. Lifeline Skin Care is available from dermatologists, plastic surgeons, selected medical spas, and day spas.

International Stem Cell Corporation works 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, creates pluripotent human stem cells from unfertilized oocytes (eggs) and in so doing avoids ethical issues commonly 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 people of different genders, ages, and races with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Well-Positioned for Strong 2014

March 28, 2014

In a recent shareholder update, ISCO’s Executive Vice President, Dr. Simon Craw drew attention to the company’s strong financial performance and clinical achievements in 2013. Craw said that these factors were strong indicators of where he expects ISCO to be headed in 2014.

For key indicators of company performance in 2013, Craw pointed to three indicators: ISCO’s growth of full-year revenue by 35 percent, successful cost containment, and achievement of a slew of research and development milestones that bode well for the future. For full-year performance, ISCO reported revenues of $6.15 million and a full-year net loss of $10.5 million ($0.09 per share), up from a full-year net loss of $9.8 million in 2012 ($0.013 per share). Notably, on the call ISCO’s CFO Jay Novak reinforced that the company’s careful cost control had kept the company from a more pronounced net loss in the face of its substantial research and development efforts.

In a business update issued in mid-March, Dr. Andrey Semechkin, company CEO and board Co-chairman, touched upon ISCO’s pre-IND meeting with the FDA for its Parkinson’s disease cell therapy, and its plans for completion of the FDA’s required pharmacology and safety studies by this year’s end. Afterward, he noted, ISCO plans to file the IND for the potentially groundbreaking therapeutic solution. For business plan execution, Semechkin said that ISCO was committed to growing its commercial subsidiaries while maintaining strong efforts toward cutting costs.

ISCO’s Parkinson’s disease program incorporates usage of human parthenogenetic neural stem cells (hPNSCs), which are derived from ISCO’s proprietary histocompatible human pluripotent stem cells (hpSCs). In the words of the company, this cutting-edge cellular product comprises “self-renewing multipotent cells that are precursors for the major cells of the central nervous system.” In laymen’s terms, the ability of hPNSC to be differentiated into key neurons, and to be expressed as key neurotrophic factors for protection of the nigrostriatal system of the human brain, offers strong potential for treatment of Parkinson’s disease.

At the heart of ISCO’s therapeutic application, development, and commercialization efforts is its core technology, parthenogenesis. The technology uses unfertilized human eggs, or oocytes, for creation of hpSCs. These stem cells are said to hold tremendous therapeutic potential for tens of millions of patients with severe diseases of the eye, nervous system, or liver.

For long-term market positioning, ISCO has adopted a novel business model for the biotech space. The company leverages business units that generate revenue from the sale of products developed from scientific discoveries made by its research team. Currently, ISCO leverages two subsidiaries, Lifeline Skin Care and Lifeline Cell Technology for self-sustainment of current R&D efforts and short-term, practical applications of its core technologies.

The Parkinson’s Disease Foundation says that 7-10 million people worldwide live with Parkinson’s disease. Around one million of these people live in just the United States; more than the combined amount of people diagnosed with multiple sclerosis, muscular distrophy, and Lou Gehrig’s disease. With ISCO’s Parkinson’s disease program on the rise, Parkinson’s disease patients may be given a groundbreaking answer to their affliction.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO): Strong 2013 Achievements, Financial Results Foster Optimism in 2014

March 20, 2014

International Stem Cell, a biotech company developing novel stem cell-based therapies and biomedical products, in conference call yesterday detailed its financial results and clinical achievements in the 12 months ended December 31, 2013, and offered insight into upcoming 2014 events.

“So, 2013 was a very good year for International Stem Cell Corporation,” Dr. Simon Craw, executive vice president of ISCO stated in the conference call. “We continue to execute on our business plans, growing revenues to over $6 million while containing costs, but also importantly achieving a number of R&D milestones that position us extremely well for 2014 and beyond.”

Briefly touching on the company’s research and development strategy, Dr. Craw noted the company’s primary focus on developing human parthenogenetic neural stem cells as a clinical product initially to treat Parkinson’s disease. The company is currently working on pre-requisite studies necessary to filing a New Drug Application with the U.S. FDA.

Dr. Craw recapped several 2013 company milestones regarding ongoing research and development, and with specific regard to its Parkinson’s disease program, said ISCO plans to complete FDA-required pharmacology and safety studies by the end of 2014 with the IND to shortly follow. The company also anticipates exploring and developing additional indications for its human neural stem cells.

Moving on to the company’s full-year financial performance, ISCO reported 2013 revenues of $6.15 million, an impressive increase of 35 percent compared to full-year 2012. Lifeline Skin Care sales increased 47 percent while Lifeline Cell Technology sales rose 24 percent. The two subsidiaries generated operating income in 2013 of $0.65 million compared to operating loss in 2012. Gross margin improved to 73 percent in 2013 compared to 72 percent a year ago.

Net loss for full-year 2013 was $10.5 million, or $0.09 per share, compared to a prior year loss of $9.8 million, or $0.013 per share. This reflects the $2.9 million impact of the company’s July financing transaction.

ISCO burned through $0.47 million per month through 2013, ending the 2013 with cash of $2.24 million.

“As Simon indicated, 2013 was a very successful year for the company. In 2013, we have made substantial progress in our R&D development efforts, all while keeping tight control of our cash burn,” said ISCO Chief Financial Officer Jay Novak.

Wrapping up the call, Dr. Craw emphasized advances in company research and development, and stated a reminder of what’s to come in the year ahead.

“I think everyone can see, in 2013 we made some important progress in our research and development activities, primarily in our Parkinson’s disease program where we achieved a number of critical milestones that move us closer to the clinic. In 2014, we’ll be endeavoring to complete our IND enabling studies and in order to file our first IND for this experimental treatment of Parkinson’s disease. At the same time, we continue to execute on our business plan, growing revenues in our commercial subsidiaries and containing cost,” he concluded.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Announces Fiscal Year 2013 Highlights

March 18, 2014

International Stem Cell Corp., a California-based biotechnology company developing novel stem cell-based therapies and biomedical products, today offered a business update and announced fourth quarter and year-end financial results for the year ended December 31, 2013.

Among numerous highlights within the company’s business is its work with its Parkinson’s disease program. The company continues to execute on its plan to develop human parthenogenetic neural stem cells (hPNSC) as a clinical product candidate for the treatment of Parkinson’s disease (PD). ISCO has published what they term a ‘breakthrough method of manufacturing hPNSC,’ in Scientific Reports, a primary research publication from the publishers of Nature. ISCO also reported positive results demonstrating the safety and efficacy of hPNSC in both rodent and non-human primate models of PD, presenting the results at the American Academy of Neurology 65th Annual Meeting in San Diego, CA, the American Society of Gene and Cell Therapy meeting in Salt Lake City, UT and the American Neurological Association 2013 Annual Meeting in New Orleans, LA. Among other highlights include beginning the IND-enabling non-human primate pharmacology and toxicology GLP study under the supervision of Yale School of Medicine Professor, D. Eugene Redmond Jr. MD.

In February 2014 the company held a pre-IND meeting with the FDA and subsequently announced that it will be working to complete the FDA required pharmacology and safety studies by the end of 2014, and file the IND shortly thereafter. In 2014 ISCO will also be working toward bringing forward additional indications for hPNSC. One noteworthy research and development activity includes the announcement of a significant advancement in human induced pluripotent stem cells (iPS) derivation using a novel protein-based reprogramming method at the American Society of Gene and Cell Therapy meeting in Salt Lake City, UT.

Notable fiscal year 2013 financial highlights include $6.15 million in revenue for the year ended December 31, 2013, an increase of 35% compared to 2012, Lifeline Skin Care sales up 47% and Lifeline Cell Technology sales up 24%, gross margin improving to 73% in 2013 from 72% in 2012, subsidiaries generating operating income in 2013 of $0.65 million compared to operating loss in 2012 and an average net cash used in operating activities of $0.47 million per month for the twelve months ending December 31, 2013. The company ended 2013 with cash of $2.24 million.

“In 2013 ISCO made important progress in Research and Development, primarily in the Parkinson’s disease program, achieving a number of milestones that move us closer to the clinic. In 2014 we will be endeavoring to complete our IND-enabling studies in order to file our first IND for our new experimental treatment of PD,” stated Dr. Andrey Semechkin, ISCO’s CEO and Co-chairman. “At the same time we continue to execute on our business plan, growing revenues in our commercial subsidiaries while maintaining costs,” Dr. Semechkin concluded.

For more information, visit www.internationalstemcell.com

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