Archive for the ‘International Stem Cell Corp. ISCO’ Category

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

Tuesday, April 1st, 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

Friday, March 28th, 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

Thursday, March 20th, 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

Tuesday, March 18th, 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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International Stem Cell Corp. (ISCO) to Announce Results of 2013 Efforts

Thursday, March 13th, 2014

International Stem Cell Corporation announced today that management will host a conference call on Wednesday, March 19th to deliver a business update and discuss its financial results for the year ending December 31, 2013. Dr. Simon Craw, Executive Vice President, and Mr. Jay Novak, Chief Financial Officer, will host the conference call. To attend the call, please use the dial in information below:

Date: Wednesday, March 19, 2014
Time: 11:00 a.m. ET
Toll-free (US only): 1-877-941-1427
International: 1-480-629-9664
Conference ID: 4673819
Webcast: http://public.viavid.com/index.php?id=108263

The company asks that you dial in at least 10 minutes before the call start time to ensure timely participation. A playback of the call will be available from 03/19/14 at 2:00 pm Eastern Time to 04/02/14 at 11:59 pm EST.

Teleconference Replay Details:
Dial in: 1-858-384-5517
Conference ID: 4673819

International Stem Cell’s efforts revolve around therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s primary technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs) thereby avoiding ethical issues associated with the use or waste of viable human embryos.

Scientists at ISCO have developed the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals with differing genders, racial background, and ages with minimal immune rejection after transplantation. hpSCs promise to create the first true stem cell bank, UniStemCell™. The company 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.

Among the company’s therapeutic programs is a treatment for Partinson’s disease using dopaminergic neurons, a treatment of lever disease with stem cell derived hepatocytes, a treatment of blindness with corneal tissue and stem cell bank development.

For more information, visit www.internationalstemcell.com

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Positive Data Fuels International Stem Cell Corp. (ISCO) Research

Tuesday, March 11th, 2014

International Stem Cell Corp. recently announced positive data results from the first interim analysis of the ongoing IND-enabling pharmacology/toxicology primate study conducted under the supervision of Professor D. Eugene Redmond Jr. MD, of Yale University Medical School. The company is a biotechnology company focused on therapeutic applications of human stem cells and the development and commercialization of cell-based biomedical products.

Professor Redmond commented, “The initial data from this large controlled study is very encouraging. In Parkinson’s disease research non-human primate data are considered the gold standard and are by far the best indicator of likely outcomes in humans.”

Many of the animal subjects in the study have shown remarkable improvement in parkinsonism, while many returned to normal behaviors. The study consisted of 18 primates that were divided into three groups – a control group and two treatment groups with the treatment groups receiving different doses of human neural stem cells (hPNSC) derived from ISCO’s proprietary parthenogenetic stem cell line.

The design of this study uses a highly validated and widely published non-human primate model of Parkinson’s disease. The symptoms of the disease are induced by the administration of a neurotoxin which selectively destroys the same type of neuron that is affected in the human condition. This results in the monkeys exhibiting all the classic symptoms of PD from akinesia, rigidity gait abnormalities to tremors, freezing, and fine motor coordination.

In a comment by Dr. Ruslan Semechkin, Chief Scientific Officer for the company, it was stated, “This pharm/tox primate study, together with our rodent tumorigenicity study, is fundamental for ISCO’s planned IND submission — which we believe will be the first IND in the world using pluripotent stem cell-derived therapeutic cells to treat Parkinson’s disease. We anticipate providing further updates on this study in the second and third quarters, to report the final results towards the end of 2014 and to file the IND soon thereafter.”

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Reports Positive Interim Data from Primate Study Parkinson’s Disease Cell Therapy

Tuesday, March 4th, 2014

International Stem Cell Corp., a biotechnology company specializing in the therapeutic applications of human stem cells and the development and commercialization of cell-based biomedical products, today issued a press release announcing positive data from the first interim analysis of the ongoing IND-enabling pharmacology/toxicology primate study being conducted under the supervision of Professor D. Eugene Redmond Jr. MD, of Yale University Medical School.

“The initial data from this large controlled study is very encouraging,” stated Professor Redmond. “In Parkinson’s disease research non-human primate data are considered the gold standard and are by far the best indicator of likely outcomes in humans.”

Most of the animals in this ongoing study have shown significant improvement in parkinsonism, as well as returned to many normal behaviors. The study consist of 18 primates divided into three cohorts, a control group and two treatment groups with the treatment groups receiving different doses of human neural stem cells (hPNSC) derived from ISCO’s proprietary parthenogenetic stem cell line.

This study design uses an extremely well validated and widely published non-human primate model of Parkinson’s disease. The symptoms of the disease are induced by the administration of a neurotoxin which selectively destroys the same type of neuron that is affected in the human condition. This results in the monkeys exhibiting all the classic symptoms of PD from akinesia, rigidity gait abnormalities to tremors, freezing and fine motor coordination.

Dr. Ruslan Semechkin, Chief Scientific Officer for the Company, commented: “This pharm/tox primate study, together with our rodent tumorigenicity study, is fundamental for ISCO’s planned IND submission — which we believe will be the first IND in the world using pluripotent stem cell-derived therapeutic cells to treat Parkinson’s disease. We anticipate providing further updates on this study in the second and third quarters, to report the final results towards the end of 2014 and to file the IND soon thereafter.”

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Presenting at 26th Annual ROTH Conference

Tuesday, February 25th, 2014

Today before the opening bell, International Stem Cell Corp. announced that it will be making an appearance at the 26th Annual Conference. The conference is taking place Sunday, March 9, 2014 through Wednesday, March 12, 2014 at the Ritz Carlton, Dana Point, CA.

At the conference, Dr. Simon Craw, Executive Vice President of International Stem Cell Corp., will be presenting a corporate overview of the company and its subsidiaries. Dr. Craw’s presentation will be taking place at 3:30 pm PDT on Monday, March 10, 2014 in the room Track 5. Salon 5.

As its website notes, the ROTH Conference features “presentations from hundreds of growth companies, Q&A sessions, expert panels, and thousands of management one-on-one/small group meetings”. The event is one of the largest of its kind in the United States today and connects investors with unique opportunities to engage with and gain insight into numerous growth companies across a multitude of sectors. These sectors include: Cleantech, Consumer & Retail, Energy & Industrial, Enterprise Software, Healthcare, Resources, Semiconductors & Electronics, Services and Technology, and Media. It is a by-invitation-only event.

As a California-based biotechnology company that develops novel stem cell-based therapies and biomedical products, International Stem Cell Corp. is focusing 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, creates pluripotent human stem cells from unfertilized eggs and is said to have tremendous therapeutic potential for diseases of the eye, the nervous system, and the liver.

More information about International Stem Cell Corp. and its efforts can be found at: www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Announces Completion of Pre-IND Meeting with FDA for Parkinson’s Disease Program

Tuesday, February 18th, 2014

Today before the opening bell, ISCO announced that it had completed a pre-investigational new drug meeting (pre-IND) with the US FDA, thereby completing its discussions with the administration about the company’s Parkinson’s disease cell therapy. The company received feedback and input from the FDA on its proposed pre-clinical plan, manufacturing approach, and clinical study design necessary to file the IND.

We’re pleased with the outcomes of the meeting with the FDA,” said Yale School of Medicine Professor D. Eugene Redmond Jr. MD, who is leading ISCO’s pharmacology/toxicology study. “The FDA’s feedback has provided clear direction for the remaining studies required for the IND.”

“As this will be the first IND for the Company, we’re pleased to have completed this critical milestone,” said Dr. Ruslan Semechkin, Chief Scientific Officer of ISCO. “Based on data from our pilot studies, along with the guidance from the FDA, we believe that we’re well positioned to successfully transition this program to the clinical stage.”

According to the Parkinson’s Disease Foundation, some 7-10 million people worldwide live with Parkinson’s disease. Around 1 million of these people live in the United States alone, more than the combined amount of people diagnosed with multiple sclerosis, muscular distrophy, and Lou Gehrig’s disease. Direct and indirect costs attributed to Parkinson’s disease within the United States are estimated to be nearly $25 billion per year.

With the pre-IND meeting complete, ISCO will be working toward completion of the Good Laboratory Practice pharmacology and safety studies, including tumorigenicity, toxicology, and tolerability, via use of the human parthenogenetic neural stem cell (hPNSC) product. From the wording in the company’s news release, this product is a “type of self-renewing multipotent cell that is a precursor for the major cells of the central nervous system.” Pre-clinical pilot studies in rodents and primates have shown that the product’s safety, tolerability, and therapeutic benefit. Unlike other stem cell therapies, ISCO’s hPNSC product can be delivered in a frozen state to hospitals and other healthcare provider centers. ISCO anticipates the release of interim primate data before the end of March 2014 and top-line final results from these GLP studies later in 2014. From there, it expects to file the IND soon thereafter.

A comprehensive description of ISCO’s hPNSC product and the GMP manufacturing method was published in early 2013 with Prof. Evan Y. Snyder, Director of Stem Cell Research Center at Sanford-Burnham Medical Research Institute.

For more information, visit: www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Gearing Up for Transformational 2014

Tuesday, February 4th, 2014

International Stem Cell Corp. is a publicly traded biotechnology company concentrating on the therapeutic applications of human parthenogenetic stem cells and the development and commercialization of cell-based research and cosmetic products. The company’s core technological platform, parthenogenesis, creates pluripotent human stem cells from unfertilized eggs. With treatment possibilities for patients with diseases of the eye, the nervous system, and the liver, parthenogenesis can take the field of regenerative medicine in a whole new direction. The technology has strong therapeutic potential for treating hundreds of millions of individuals whose treatability has been limited by a lack of available, safe immune-matched human cells.

Recently, International Stem Cell Corp.’s Board Co-Chairman and CEO, Andrey Semechkin PhD issued a letter to shareholders outlining the company’s R&D achievements in 2013 as well as its R&D goals for 2014. Among the company’s 2013 achievements were:

• A description of the company’s novel human neural stem cells for Parkinson’s disease featured in the March issue of Scientific Reports, a publication of one of the world’s leading scientific publishers
• Announcement in Q1 2013 of data showing that the neural stem cells provided positive benefit in a rodent model of Parkinson’s Disease
• Published and discussed rodent model results as well as the company’s first non-primate study at the 65th Annual Meeting of the American Academy of Neurology
• In August 2013, entered into master clinical research agreement with Duke University to conduct clinical trials in Parkinson’s Disease
• Demonstration of a new technology program’s ability to create stable stem cells, be at least ten times more efficient than older methods, and avoid the risks associated with methods based on viruses (This program aims to develop a new and more effective method of producing induced pluripotent stem cells. This new method both successfully enhances the efficiency of the reprogramming process using specific proteins called transducible transcription factors and avoids the use of viruses.)
• Demonstration of the company’s metabolic liver disease program therapeutic potential via results showing that hepatocyte-like cells, developed by the program, reduce toxin levels in the liver without causing any serious side effects or safety issues

Goals for 2014 were outlined as well:

• Pre-IND meeting with the FDA in Q1 2014 to review the company’s pre-clinical data, manufacturing protocols, and clinical study design for the company’s Parkinson’s Disease program
• Q1 2014 release of interim data from the company’s large-scale primate study began in 2013
• If the pre-IND and pre-clinical studies prove success, the company will file for its ND application for the treatment of Parkinson’s disease with neural stem cells in the second half of 2014
• Upon FDA review, assuming the submission receives approval the company intends to begin the first-in-man (FIM) Phase 1 clinical study for the Parkinson’s Disease program

Much more information, including more details on the milestones and objectives above, can be found in the shareholder letter here: http://www.internationalstemcell.com/2014_Shareholder_Letter

For more information regarding International Stem Cell Corp., visit: http://www.internationalstemcell.com

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International Stem Cell Corp. (ISCO): Changing the Field of Regenerative Medicine with Unique, Self-Sustaining Business Model

Tuesday, January 28th, 2014

International Stem Cell is focused on exploring and advancing the therapeutic applications of human stem cells as well as the development and commercialization of cell-based biomedical products. The company was the first to develop and perfect a new class of human stem cells, parthenogenetic stem cells, created from unfertilized human eggs, and has established a strong patent portfolio offering clean intellectual property and freedom to operate.

Utilizing a strategy much different than the majority of other players in the biotech space, International Stem Cell generates revenues from its individual subsidiary business units that sell products developed from scientific discoveries made by International Stem Cell. Not only is this model self-sustaining with revenues used to support scientific research and development, it also provides practical, short-term applications of the core technologies.

The Lifeline Cell Technology (LCT) and Lifeline Skin Care (LSC) commercial businesses provide the foundation for International Stem Cell’s short-term application. For the six-months ended June 30, 2013, International Stem Cell reported revenues of $2.74 million, compared to revenues of $2.13 million for the prior year period. LCT contributed $1.38 million, up 30 percent year-over-year, while LSC contributed $1.36 million, an increase of 27 percent from the same period in 2012.

Therapeutic programs, including those addressing Parkinson’s disease, metabolic liver disease and corneal blindness, make up International Stem Cell’s medium-term applications. In regards to its Parkinson’s disease program, International Stem Cell has carried out several stem cell-based experiments and recently concluded its first pilot primate study with favorable results. In mid-2104, the company plans to submit to the U.S. FDA an investigational new drug (IND) application, and recently engaged Duke University as a partner to carry out the phase I clinical study of Parkinson’s disease in human subjects.

International Stem Cell’s long-term strategy is focused on therapeutic products, licensing revenue and the company’s stem cell bank, UniStemCell, the life science industry’s first collection of non-embryonic histocompatible human stem cells available for research and commercial use.

Each aspect of International Stem Cell’s business model is centered on the company’s proprietary stem cell technology. The company’s stem cells present superior immune matching capabilities and can be used in millions of people, regardless of their sex or racial background, with minimized expectation of immune rejection following transplantation.

For more information visit www.internationalstemcellcorp.com

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International Stem Cell Corp. (ISCO) Co-Chairman and CEO Issues Shareholder Letter

Tuesday, January 21st, 2014

Today before the opening bell, International Stem Cell Corp. reported that Co-Chairman of the Board and Chief Executive Officer Andrey Semechkin PhD has published an open letter to shareholders.

Dr. Semechkin’s letter provides an update on the stem cell company’s research and development accomplishments, future expectations and anticipated milestones, along with a discussion of ISCO’s expanded intellectual property portfolio and a summary of the company’s commercial and financial performance for the first nine months of 2013.

The full text of the letter can be found at http://www.internationalstemcell.com/2014_Shareholder_Letter

International Stem Cell Corp. specializes in the therapeutic applications of human stem cells and the development and commercialization of cell-based biomedical products. The company was the first to develop and perfect a new class of human stem cells called parthenogenetic stem cells, created from unfertilized human eggs. ISCO has a strong patent portfolio offering clean intellectual property and freedom to operate. The company’s stem cells present superior immune matching capabilities and can be used in millions of people regardless of sex or racial background, with minimal expectation of immune rejection after transplantation.

For more information visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Continues Development of Stem Cell Bank to Support Therapeutic Programs

Thursday, January 16th, 2014

International Stem Cell Corp. was the first to develop and perfect a new class of human stem cells called parthenogenetic stem cells, which are created from unfertilized human eggs. The company’s stem cells present superior immune matching capabilities and can be used in millions of people regardless of sex or racial background, with minimal expectation of immune rejection after transplantation.

Based on this stem cell technology, ISCO is currently focused on three key therapeutic programs to treat incurable diseases of the brain, liver, and cornea.

Parkinson’s disease is the second most prevalent neurodegenerative diseases, affecting approximately 4 percent of the population aged 50 years and older. Leveraging its key clinical research agreement with Duke University, ISCO is evaluating its stem cell-derived neural stem cells for the treatment of Parkinson’s disease. The company has coordinated a team of leading experts to develop techniques and designs as well as to provide guidance for the company’s investigational new drug (IND) submission for this indication. ISCO plans on submitting its IND to the FDA this year.

Chronic liver disease (including hepatitis C) is the third most common cause of death due to chronic diseases in persons 35 to 64 years old. Direct health care expenditures for chronic and acute liver disease in the U.S. alone range from $60 billion to more than $100 billion annually.
ISCO’s scientific team is developing superior methods to create pure populations of hepatocyte, the main tissue of the liver, that could be used in transplantation using HLA homozygous parthenogenetic stem cell lines to avoid the cells being immune rejected by the recipient’s body.

Approximately 10 million people in the world are blind due to corneal damage, representing a large unmet medical need, mostly in the developing world. Additionally, there is an opportunity to develop corneas as a research product for the drug testing market. Scientists at ISCO have developed and filed patents on a process that creates human corneal tissue from parthenogenetic stem cells. It is anticipated that this program will be commercialized through ISCO’s subsidiary in India in partnership with the Insight Bioventures, India.

Through continued enrollment of egg donors and ongoing optimization of its methodology for the creation of additional HLA homozygous lines, ISCO is expanding its bank of parthenogenetic stem cell lines, which are critical to the success of the company’s therapeutic programs.

For more information visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Presenting at Biotech Showcase 2014 Conference

Tuesday, January 7th, 2014

International Stem Cell Corporation announced it will be presenting at the Biotech Showcase 2014 Conference at the Parc 55 Wyndham Union Square Hotel in San Francisco, California. The conference will be taking place Monday, January 13, 2014 to Wednesday, January 15, 2014.

Dr. Simon Craw, Executive Vice President of International Stem Cell Corporation, will be presenting a corporate overview of the company and its subsidiaries. The presentation will be made in Room Mission II – Track C on Monday, January 13, 2014 at 9:30 am PST (Pacific Time).

More conference details can be found at: http://www.ebdgroup.com/bts/index.php

Event registration details can be found at: http://www.ebdgroup.com/bts/registration/index.php

International Stem Corporation is focusing its primary efforts on treatment of Parkinson’s disease. The company’s disease program taps into the medical power of human parthenogenetic neural stem cells for treatment. In the words of the company, these cells are “self-renewing mulitpotent cells that are precursors for the major cells of the central nervous system”. With their biological capabilities, they represent a strong next-generation opportunity for treatment of Parkinson’s disease.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Leverages Powerful Stem Cell Technology to Advance Regenerative Medicine

Monday, January 6th, 2014

International Stem Cell is a biotechnology company leveraging powerful new stem cell technology called parthenogenesis, which uses unfertilized eggs to advance the field of regenerative medicine. The company is focusing its use of these cells to treat diseases of the eye, nervous system, and liver.

Cell therapy for these indications has been proven clinically. However, therapeutic options are limited by the availability of safe, immune-matched human cells or tissue. To address this issue and avoid immune-rejection, International Stem Cell is pioneering the development of a new class of stem cells called human parthenogenetic stem cells (hpSCs), which demonstrate the superior characteristics of other classes of stem cells.

hpSCs are created by chemical stimulation of unfertilized human eggs to begin division – it’s important to note that no viable embryo is created or destroyed in this process. International Stem Cell recently was recognized for its advances toward the treatment of liver disease based on its hpSC technology.

The company, in December 2013, was awarded the Presidential Poster of Distinction by the American Association for the Study of Liver Disease (AASLD) at the 64th Annual Liver Meeting in Washington, D.C. The data presented at the conference demonstrated that transplantation of hpSC-derived hepatocytes cells (HLCs) in a pre-clinical study resulted in a significant decrease and long-term stabilization of bilirubin levels in the serum of Gunn rats, a well-established animal model of Crigler-Najjar syndrome type 1 (CN1), a rare and inherited liver-based metabolic disorder. In the four months following treatment, no adverse safety signals were detected.

Moving forward, International Stem Cell continues to advance its technology pipeline to demonstrate the revolutionary nature of its HLCs and their potential efficacy for the company’s stated indications.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Recognized with Prestigious Award by the American Association for the Study of Liver Disease

Wednesday, December 18th, 2013

California biotechnology company International Stem Cell Corp. has announced that the American Association for the Study of Liver Disease (AASLD) awarded the company with its Presidential Poster of Distinction at the 64th Annual Liver Meeting in Washington, D.C.

”Being awarded such a prestigious honor is a testament to the quality of our scientific team,” said Ruslan Semechkin, Ph.D., ISCO’s Chief Scientific Officer. “The data presented at this conference demonstrates the unique nature of our hepatocytes cells (HLCs) and their potential efficacy in a clinical setting.”

ISCO focuses on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research. The AASLD recognized a pre-clinical study whose data demonstrated that transplantation of hpSC-derived HLCs elicits a significant decrease and long-term stabilization of bilirubin levels in the serum of Gunn rats. Moreover, at four months following treatment, no adverse safety signals were detected.

Gunn rats are a well-established animal model of Crigler-Najjar syndrome type 1 (CN1), an inborn error of bilirubin metabolism. CN1 is a rare inherited liver-based metabolic disorder in which the host liver lacks one hepatic enzyme, UGT1A1, which is essential for the conjugation and excretion of the toxin bilirubin.

ISCO’s pre-clinical study provides evidence that supports the potential safety and efficacy of HLCs which could constitute a reliable source for large numbers of transplantable cells. In the long-term, experience with HLC transplantation for CN1 could potentially be used to develop therapeutic strategies for more common inherited liver diseases.

Interested parties can access more information about the company at its website, www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Secures $10.25 Million Stock Purchase Agreement at Low Cost of Capital

Wednesday, December 11th, 2013

Today before the opening bell, International Stem Cell announced that it has entered into a purchase agreement with Lincoln Park Capital Fund, LLC (“LPC”), a Chicago-based institutional investor, which has agreed to invest up to $10.25 million of the company’s common stock over a 36-month term.

“We are pleased to have this new financing arrangement in place with Lincoln Park Capital,” said Dr. Andrey Semechkin, CEO and Co-Chairman. “The agreement gives us access to a significant new source of funding, strengthens our balance sheet, and provides us the flexibility we have been looking for at a low cost of capital.”

$250,000 of ISCO common stock will be purchased one business day prior to ISCO’s filing of a registration statement covering the resale of the shares that may be issued to LPC. Once the registration statement with the U.S. Securities and Exchange Commission is deemed effective, International Stem Cell Corp., at its sole discretion, has the right to sell to LPC up to an additional $10.0 million of its common stock, subject to certain conditions.

ISCO has been given control over the timing and amount of any future investment and LPC is obligated to make such purchases. There are no upper limits to the price LPC may pay to purchase ISCO common stock and the purchase price of the shares related to any future investments will be fixed pursuant to a formula based upon the prevailing market prices of the company’s shares at the time of sale to LPC. LPC has agreed not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the company’s shares of common stock. The agreement may be terminated by ISCO at any time, at its sole discretion, without any cost or penalty.

A more detailed description of the purchase agreement is available via the Form 8-K filed with the SEC on December 11, 2013.

For more information, visit www.internationalstemcell.com

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

Monday, December 9th, 2013

International Stem Cell, a biotech company focused on the development and commercialization of stem cell-based research and cosmetic products, today reports 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) Poster Selected for Presentation at American Association for the Study of Liver Diseases Meeting

Monday, December 2nd, 2013

The American Association for the Study of Liver Diseases (AASLD) recently highlighted International Stem Cell’s presentation, titled “Human parthenogenetic stem cell-derived hepatocyte transplantation controls serum bilirubin in Gunn rats,” as a Presidential Poster of Distinction at The Liver Meeting during the four-day AASLD’S 64th Annual Meeting in Washington, D.C.

The presentation authors are Dr. Alina Ostrowska, Dr. Larisa Agapova, Tiffany Chu, Dr. Trudy Christiansen-Weber and Dr. Ruslan Semechkin, all of which are from International Stem Cell.

International Stem Cell is a development stage biotech company focused on therapeutic applications of human stem cells as well as the development and commercialization of cell-based biomedical products. The company was the first to develop and perfect a new class of human stem cells, called parthenogenetic stem cells, created from unfertilized human eggs. In addition to its therapeutic focus, International Stem Cell also provides a growing revenue stream through two wholly owned subsidiaries.

AASLD presented the following information on the company’s liver program:

Background: Extensive studies indicate that pluripotent stem cells are a highly promising alternative source of histocompatible cells for cell replacement therapy. Hepatocyte-like cells (HLCs) derived from human parthenogenetic stem cells (hpSCs) might be transplanted to treat a wide array of metabolic liver diseases including CN1 (Crigler-Najjar syndrome type I). CN1 is the paradigm of inherited liver-based metabolic disorders in that the host liver is lacking one hepatic enzyme – UGT1A1, which is essential for the conjugation and excretion of bilirubin. To obtain ultimate proof that differentiation has been achieved, following the preliminary evaluation in vitro, we tested hepatocyte-like cells in vivo using an accurate animal model of CN1, the Gunn rats which accumulate toxic plasma levels of unconjugated bilirubin.

Methods: Highly enriched populations of definitive endoderm were generated from hpSCs in a novel 3D-differentiation system and then induced to differentiate towards HLCs. The final cells were characterized by using expression profiling including RT-qPCR for dynamic expression of the hepatic lineage genes, immunohistochemistry and FACS analysis to demonstrate hepatocyte-specific markers, drug metabolism assays to determine the activity of CYP450s as well as a luminescent method for measuring UGT activity profile. Production of liver-specific proteins in the culture medium was simultaneously measured by quantitative ELISA. To evaluate engraftment and functional repopulation in vivo, CFSE-labeled hpHC were injected (10×106 per animal) into the spleen of 4-6 week old Gunn rats. Blood serum samples of tested animals were evaluated for indirect bilirubin levels 4, 8 and 19 weeks post-transplantation. Liver tissue samples were embedded in OCT compound and snap frozen, until cryosectioning.

Results: CFSE-labeled HLCs transferred into the spleen were shown to migrate into the liver. Multiple engrafted cells were observed in the periportal regions of the liver lobules and formed morphologically distinct aggregates. The overall liver structure appeared undamaged without signs of inflammation, fibrosis or tumor. Significant decrease and long-term stabilization of bilirubin levels was demonstrated in the serum of tested animals in comparison with sham-treated controls. Although by week 19th serum indirect bilirubin was not normalized in transplanted animals, it resulted in an average 70% reduction compared with pretreatment levels.

Conclusion: This pre-clinical study describes important supportive evidence of the potential efficacy and safety of hpSC-derived hepatocytes which might constitute an easily available source to obtain a large number of transplantable cells for regenerative treatments of CN1. In the long-term, experience with HLCs transplantation for CN1 can be used to develop therapeutic strategies for more common inherited liver diseases.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Receives Favorable Review in Seeking Alpha Article

Friday, November 22nd, 2013

International Stem Cell was recently the topic of a Seeking Alpha article by contributing writer Kingmaker, who outlines the company’s stem cell technology, third-quarter financial results, its upcoming investigational new drug (IND) filing, and its subsequent market potential.

To read the full article visit: http://seekingalpha.com/article/1857401

International Stem Cell is a biotech company developing new stem cell technology based on a natural process called parthenogenesis, in which stem cells are derived from unfertilized human eggs.

As the author notes, International Stem Cell’s parthenogenesis stem cells “demonstrate superiority” in meeting key criteria in order to be effectual in therapeutic application. With its scientific developments firmly in place, the company is also working to strengthen its financial position.

“Given that the company appears to be on track with its science, investors are likely wondering if they should invest now. I believe the answer is a resounding yes,” the author says.

International Stem Cell reported record third-quarter revenues of $1.67 million, a year-over-year increase of 41 percent, while cutting general and administrative expenses by approximately 13 percent and ending the quarter with roughly $1.8 million in available cash.

The article also briefly discusses the company’s Parkinson’s disease program and its anticipated IND filing with the FDA through a partnership with Duke University. International Stem Cell’s aims to develop a product to eliminate Parkinson’s disease, which is the second most common neurodegenerative disease affecting 7-10 million people worldwide.

“As the biotechnology bull market rages on, investors are likely looking for the next niche that can take off. Despite a lot of controversy, I believe that stem cells are that next area to advance medicine to heights never thought possible. International Stem Cell Corporation is quickly gaining recognition with both the medical and investing communities. With several catalysts occurring over the next 12-18 months, investors should get in early before it’s too late,” Kingmaker states in his conclusion.

For more information, visit www.internationalstemcell.com

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QualityStocks Featues Executive VP of International Stem Cell Corp. (ISCO) in Exclusive Interview

Monday, November 18th, 2013

A new audio interview with International Stem Cell Corp. Executive Vice President Dr. Simon Craw is now available. The interview can be heard at http://www.qualitystocks.net/interview-isco.php.

International Stem Cell Corp. specializes in the therapeutic applications of human stem cells and the development and commercialization of cell-based biomedical products. ISCO has a strong patent portfolio offering clean intellectual property and was the first to develop and perfect a new class of human stem cells created from unfertilized human eggs through the company’s patented process.

After highlighting his own extensive background as a scientist in the life science industry, Dr. Craw provides information on the company’s CEO Professor Andrew Semechkin, a Russian Academy of Science member and internationally recognized scientist and business man.

Dr. Craw then explains considerable advances in the company’s Parkinson’s disease program, for which ISCO has carried out several stem cell-based experiments and recently concluded its first pilot primate study with favorable results.

“On the research and development side, the most significant achievements we’ve made this year are really in our Parkinson’s disease program …” says Dr. Craw. “This study was very very important for us to demonstrate that the symptoms of Parkinson’s can be alleviated using a stem cell therapy and it’s a precursor to any human studies that we would want to carry out.”

ISCO in mid-2104 plans to submit to the U.S. FDA an investigational new drug (IND) application, and recently engaged Duke University as a partner to carry out the phase I clinical study of Parkinson’s disease in human subjects.

Dr. Craw gives an in-depth explanation of the company’s core technology, demonstrating how the company’s stem cells are clinically superior in their ability to differentiate into other cells to treat millions of individuals without restriction, and how they bypass ethical controversy of embryonic stem cells.

“What we have at International Stem Cells is a proprietary stem cell platform that is unique and differentiated and actually offers substantial benefits over other stem cell platforms that are out there,” he says.

Dr. Craw also offers an outlook on the company’s goals for the remainder of 2013, including:

• Grow full-year 2013 revenue by approximately 20 percent over 2012
• Launching new products through subsidiary companies
• Filing submission with the FDA to request a pre-IND meeting to discuss a plan for the clinical trials
• Publishing results of its primate model study in peer-reviewed scientific journals

Looking beyond 2013, the company anticipates starting its phase 1 clinical trials in the middle of next year, representing a significant achievement for ISCO and individuals with the disease.

“That will be a very important milestone not just for the company but for everyone who suffers from this debilitating disease. We’ll be the first company in the world that will be taking a stem-cell based product from a pluripotent stem cell platform and using it to treat people with this disease,” Dr. Craw says in conclusion.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Q3 2013 Financial Results and Corporate Update Conference Call Transcription

Friday, November 15th, 2013

The following earnings call took place on Wednesday of this week. A playback of the call will be available until 11:59 pm ET on November 27, 2013. To listen, call 1-877-870-5176 within the United States or 1-858-384-5517 when calling internationally. Please use the replay pin 4648561.

Operator: Ladies and gentlemen, thank you for standing by. Welcome to the International Stem Cell Corporation Third Quarter 2013 Financial Results and Corporate Update Conference Call. At this time all participants are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session and instructions will be given at that time. If anyone has any difficulties hearing the conference, please press star, followed by zero for operator assistance at any time.

I will now turn the conference over to Ms. Sherri Franklin, Marketing Manager for QualityStocks. Please go ahead.

Sherri Franklin: Good day, ladies and gentlemen. Thank you for standing by. Welcome to the International Stem Cell Corporation Third Quarter 2013 Business Update and Earnings Call. During today’s presentation, all parties will be in a listen-only mode. Following the presentation, the conference will be open for questions. If you have a question, please press the star key, followed by one on your touchtone phone. Please press star, zero for operator assistance at any time. For participants using speaker equipment, it may be necessary to pick up your handset before making your selection. This conference is being recorded today, Wednesday, November 13th, 2013.

On the call today for International Stem Cell Corporation are the Company’s Executive Vice President, Dr. Simon Craw; and Chief Financial Officer, Mr. Jay Novak. Dr. Craw and Mr. Novak will review and comment on financial and operational results for the third quarter of 2013 and the first nine months of 2013 and will be available to answer questions after their prepared comments.

Before we begin, I would like to remind our listeners that on this call prepared remarks may contain forward-looking statements which are subject to risks and uncertainties and that management may make additional statements in response to your questions. Therefore, the Company claims the protection from the SafeHarbor for forward looking statement that is contained in the Private Securities Litigation Reform Act of 1995. Forward-looking statements related to the business of International Stem Cell Corporation and its subsidiaries can be identified by common used forward-looking terminology, and those statements involve unknown risks and uncertainties, including all business-related risks that are more detailed in the Company’s filings on Form 10-K, 10-Q, and 8-K with the SEC.

For those who are unable to listen to the entire call, there will be an audio replay that will be available and the call is also being webcast so you can log on via the Internet to review at a later time. All details were provided on the conference call announcement and in the press release today. You may also find more information on the Company website located at www.internationalstemcell.com.

At this time, I would like to turn the call over to Dr. Simon Craw, who will provide opening remarks. Simon, the call is yours.

Dr. Simon Craw: Thank you, Sherri, and good morning, everyone, and thank you for joining us on this morning’s business update call. As you can see from our 10-Q and press release this morning, and I see from the stock price we’ve seen a little bump up in our stock price as well, which is gratefully acknowledged. We had an extremely good third quarter of 2013 with excellent progress on our Parkinson’s disease program and outstanding growth in each of our commercial businesses, both Lifeline Cell Technology and Lifeline Skin Care. Indeed, the third quarter represents the highest revenue we’ve ever achieved as a company. I’ll come back to the commercial side in a moment, but first I’d like to make a few comments about our recent financing before discussing our scientific progress.

So we touched on this briefly last quarter that—last quarter’s update call, but just to remind listeners, in July, we’ve raised approximately $3 million, most of which came from a group of new investors, new to ISCO. The capital will be used to fund our R&D programs, primarily our Parkinson’s disease program, where we intend to start a clinical trial in 2014. As part of the offering, we also issued B warrants, which expired in October of this year, and we now have, through the execution of these B warrants, raised a total of about $5.45 million from this transaction, which along with our continued ability to manage our burn rate successfully downwards, now funds the Company well into 2014. So we consider this to be a successful outcome for the quarter. In addition, the transaction significantly improves our daily trading volume and makes our stock more attractive to new investors. I’d be happy to answer specific questions about the financing in the Q&A session.

Let me move on now to our Parkinson’s disease program and talk about that for a few minutes. We continue to proceed with our plans for an IND filing in 2014 and the subsequent clinical trial. In August, we’re very excited to announce that we signed a clinical research agreement with Duke University and the Duke Clinical Research Institute, which is actually the largest academic CRO, Clinical Research Organization, in the world, and the main purpose of the agreement was really to tap into Duke’s excellence in the fields of clinical neurology and in running early stage clinical trials, especially trials using stem cell-derived products. And it was important for us to choose a clinical research organization with significant expertise in both cell therapy and in handling stem cells. And over the years Duke has really built an international reputation in both of these areas.

Lastly, Duke also has a world-class neurological, neurosurgical unit, which is of course necessary for our cell implantation procedures, and the leader of this unit is a neurosurgeon called Dr. Dennis Turner, who’s a very well renowned neurosurgeon and he’s actually a key part of our clinical program. So Duke will help us by helping develop the clinical plan, which forms part of the IND filing, and will coordinate our Phase 1 study that we intend to begin in the middle of next year. Professor Mark Stacy, the Vice Dean of Clinical Neurology and an internationally renowned and extremely well respected neurologist and physician, will be the study’s principal investigator and we’re very excited to have Dr. Stacy join our clinical team.

And just to remind everyone on the call, we intend to treat Parkinson’s disease by implanting stem cell-derived neural stem cells into a patient’s brain. Our research builds on many years of preclinical and clinical science and has two parallel mechanisms of action: the direct cell replacement mechanism where the new cells replace dead and dying cells in a critical region of the brain and restore that region’s function; and secondly, a neuroprotective mechanism of action where the new cells provide positive benefit to the location where their implant is and may help by preventing more cells from dying and the disease, the underlying cause of the disease progressing further.

So one of the first things that the Duke team helped us with was by bringing together some of the most preeminent neurologists and neurosurgeons who’ve worked in this field of cell therapy for Parkinson’s disease together for a key opinion leading—key opinion leader meeting which we held in September of this year. Bringing such a team of clinical experts together really helped us further develop the neurosurgical implantation procedures, including the exact techniques and locations of the implants, along with the detailed design of the clinical study. Now we haven’t published this at the moment but we do intend to publish much of this information once we have had our pre-IND meeting with the FDA, which we expect to have in the next couple of months.

So at the same time as we’re working on this IND package and all that entails, we’ve continued to publish and present the results of our preclinical research, including more data from our first pilot primate study which we completed earlier this year. An example of this would be that we recently presented how our neuro stem cells can reduce the inflammatory response in the brain caused by the surgery and the importance of this to the treatment of Parkinson’s disease, and we intend to publish all of this data from the first primate study in the peer-reviewed scientific literature before the end of the year.

So, with that, that really concludes my overview of the scientific progress we’ve made, and I’d like to pass the call over to Jay, our Chief Financial Officer, to discuss our financial performance. Jay?

Jay Novak: Thank you, Simon, and good morning, everyone. Thank you for joining us this morning. I would like to provide you with a review of our financial performance for the third quarter of 2013. We filed our 10-Q this morning and issued a press release with our results. Please refer to those documents for more detailed information regarding our results.

Sales for the three months ended September 30th, 2013 were $1.7 million, up 41% from 1.2 million in the third quarter of 2012. Sales for our Lifeline Cell Technology subsidiary, or LCT, were $860,000, up 30% year-over-year, while Lifeline Skin Care, or LSC, revenues were $810,000, up 54% over the corresponding period in 2012. As part of the distribution of sales between the subsidiaries, revenues from Lifeline Cell Technologies represented 51% of our total revenues, while Lifeline Skin Care’s revenues were the remaining 49% in the third quarter of 2013. As you can see a fairly even split between the two subsidiaries.

Now moving on to the cost side. Cost of sales were $446,000 for the quarter, or approximately 27% of revenue, compared to $320,000, also 27% of revenue, consistent with the third quarter of 2012. Gross profit was approximately $1.2 million, up 41% year-over-year, while our gross profit margin was consistent at 73% with the same quarter in the prior year.

Moving on to research and development. Research and development expenses were $932,000 for the quarter, compared to 899,000 for the third quarter of 2012, representing an increase of approximately 4% over the prior year. The slight increase is due to higher stem cell line research and testing expenses incurred as well as increased consulting cost as we continue to invest in our research programs as previously was covered by Simon in more detail.

Marketing expenses during the current quarter were $633,000, up approximately 32% from 478,000 in the corresponding period in 2012. Advertising and marketing spending increased reflecting our efforts to promote and support the growth of our businesses, subsidiaries, with the primary increase coming from our Skin Care business to address their various sales channels.

General and administrative expenses were $1.4 million during the quarter, a decrease of $210,000 or 13%, compared to $1.6 million for the comparable period a year ago. This was resulting from lower personnel-related expenses and stock-based compensation expenses, as well as additional areas where we have savings.

Our loss from operations during the quarter was $1.7 million, and compared to a $2.1 million in the same period in 2012, representing a decrease of losses of about 18%, and this is consistent with the areas previously covered, higher increase in revenues then a slight increase within our operating expenses.

As far as below-the-line items, as described in detail in our 10-Q filed with the SEC this morning, the characteristics of our July financing transaction required us to record the fair value of warrants issued in excess of the proceeds we receive and the financing cost as below-the-line expenses in our income statement. Total below-the-line expenses reported related to the financing were approximately $2.1 million for the quarter.

As a side note, in future periods, increases in the fair value of the warrant liabilities will be recorded as expense and decreases will be reported as income. Regardless of whether we show income or expense from the changing warrant liabilities, this is a non-cash item.

Our bottom line net loss for the third quarter of 2013 was $3.8 million, compared to 2.1 million during the corresponding period in the prior year, representing an increase in net loss of approximately 1.7 million. This increase in net loss for the quarter is entirely due to recording in the income statement the impact of the July financing transaction that I just described. Our net loss that’s attributable to common stock on a per share basis were $0.03 in the third quarter compared to $0.02 in the same period in the last year.

Our cash and cash equivalents totaled $1.8 million at September 30, 2013 compared to 654,000 at the end of last year. We received during the year approximately $5.9 million net of financing cost from the issuance of common stock and warrants in the first three quarters of 2013.

In addition, we invested approximately $500,000 in capital and patent expenditures year-to-date, and this down slightly compared to about $630,000 in the same period in 2012.

This concludes my prepared remarks. Thank you for your time and attention. I will turn the call now back over to Simon for his closing comments. Simon?

Dr. Simon Craw: Thank you, Jay. Thanks for that summary. So everyone on the call, in summary, I think you can see that we had a truly excellent, excellent third quarter for 2013. Our revenues hit new highs, an absolute record for the Company. Our cash burn net of patent and capital items is the lowest its been in two years, and we now have an incredible new partner on the clinical side who brings complementary expertise to our own internal skills and will help us achieve this very ambitious scientific and clinical goals that we’ve set ourselves for 2014. I think it’s a very exciting time for International Stem Cells. And thank you. We’ll open the call up for questions.

Operator: Thank you. Ladies and gentlemen, we will now conduct a question-and-answer session. If you have a question, please press the star, followed by the one on your touchtone phone. You will a hear a tone acknowledging your request. Your questions will be polled in the order they are received. Please ensure you lift the handset if you’re using a speakerphone before pressing any keys.

Once again, ladies and gentlemen, if you’d like to ask a question, please press star, one at this time.

Your first question comes from the line of Heidi Marie Flyntas (ph), Private Investor. Please go ahead.

Heidi Marie Flyntas: Hi there. Thanks for everything you guys have been doing this year. But on your Phase 1 trial, how long do you anticipate it to last? What’s the trial length?

Dr. Simon Craw: Well, good morning, Heidi Marie, and thank you for the question. We expect it to be a 12-month trial. We’ll be publishing the sort of—in broad brush strokes the details of the protocol probably early next year but we expect it to be a 12-month trial with a two-year follow-up period.

Operator: Your next question comes from the line of Donald Sumor (ph), Private Investor. Please go ahead.

Donald Sumor: I’ve enjoyed the presentation so far. I have one question. What is the progress on the corneal transplants?

Dr. Simon Craw: Well that’s a great question, Donald. Thank you very much. We don’t have anything that we can report on the cornea program at the moment. As you probably know, the program is still in the research and development phase where we are optimizing the mechanical and optical properties of the cornea. We had hoped to have already partnered this program with some partners in India. That is of course now proving to be much more difficult than initially anticipated. And we don’t have a scientific update on the progress this quarter.

Operator: Ladies and gentlemen, if there are any additional questions at this time, please press the star, followed by the one. As a reminder, if you’re using a speakerphone, please lift the handset before pressing the key. Once, if you would like to ask a question, please press star, one at this time.

Next, we have a follow-up question from Heidi Marie Fuentes, Private Investor. Please go ahead.

Heidi Marie Flyntas: Hi there. During the Phase 1 trial, how will we get updates—or will we get updates during the trial as to progress or will we be waiting until the trial is done? And who is in charge of those updates? Will that be up to the Company or Duke?

Dr. Simon Craw: Thank you, Heidi Marie. Let me just—before I answer that question, let me just go back to the cornea and to answer Don’s—Donald’s question more completely. We are now looking for additional partners for our cornea program and we have had contact with several companies who have expressed interest in looking at the program. So we are continuing to try to partner that program and out-license that technology.

Now, to answer Heidi Marie’s call, ISCO is the sponsor of the clinical trial, so ISCO has control over the data flow and—although, you know, we’re in partnership with Duke University so we wouldn’t be doing anything that would compromise that partnership, but we will be responsible for communicating progress on that clinical trial and we fully intend to provide interim update as and when they become available in terms of, you know, we’ll obviously communicate when we’ve had our first patient in and when the first subjects have been treated and as we move forward with the various cohorts in the study.

Operator: And there are no further questions at this time. Please continue.

Dr. Simon Craw: Okay. Well if there’s no further questions, I’d like to thank everyone for joining us on this morning’s call. And once again, I’d like to reiterate that I think we’ve had an outstanding quarter with just truly excellent revenue growth from both of our commercial businesses and tremendous progress from our R&D organization, and I look forward to having a—talking about the full year progress when we file our 10-K next year and looking back on a banner year for International Stem Cells.

Operator: Ladies and gentlemen, this concludes the conference call for today. Thanks for participating. You may now disconnect your line.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Earnings Call Touches on Key Duke Partnership, Planned IND Submission, Double-Digit Q3 Sales Growth

Thursday, November 14th, 2013

International Stem Cell Corp. yesterday kicked-off its earnings call, led by the company’s executive vice president, Dr. Simon Craw. Among other introductory items, Dr. Craw detailed the company’s key clinical research agreement with Duke University for the evaluation of ISCO’s stem cell-derived neural stem cells for the treatment of Parkinson’s disease.

Utilizing this agreement, the company in September brought together a team of leading experts to develop techniques and designs as well as to provide guidance for the company’s investigational new drug (IND) submission to use ISCO’s stem cell-derived neural stem cells for the treatment of Parkinson’s disease. ISCO plans on submitting its IND to the FDA in 2014.

“The main person of the agreement was really to tap into Duke’s excellence in the fields of clinical neurology and in running early-stage clinical trials, especially trials using stem-cell derived products,” said Dr. Craw. “It was important for us to choose a clinical research organization with significant expertise in both cell therapy and in handling stem cells, and over the years, Duke has really built an international reputation in both of these areas.”

The company said it plans to publish all data from its first primate study in peer-reviewed scientific literature before year-end.

ISCO CFO Jay Novack recapped the company’s third-quarter results, first noting the company’s double-digit sales growth. ISCO increased revenue 41 percent to $1.67 million, compared to $1.19 million for the corresponding period in 2012. Sales for the company’s Lifeline Skin Care (LSC) and Lifeline Cell Technology (LCT) units increased by 54 percent and 30 percent, and accounted for 49 percent and 51 percent of total revenue, respectively.

Dr. Craw concluded the conference call in saying, “I’d like to reiterate that I think we’ve had an outstanding quarter with just truly excellent revenue growth from both of our commercial businesses and tremendous progress from our R&D organization, and I look forward to talking about the full-year progress when we file our 10-K next year and looking back on a banner year for International Stem Cell.”

A playback of the call will be available until 11:59 pm ET on November 27, 2013. To listen, call 1-877-870-5176 within the United States or 1-858-384-5517 when calling internationally. Please use the replay pin 4648561.

For more information, visit www.internationalstemcell.com

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International Stem Cell Corp. (ISCO) Video Footage Released by QualityStocks

Thursday, November 14th, 2013

QualityStocks today announces the production of stimulating videos featuring International Stem Cell Corp., providing insight to the exciting capabilities of stem cell research and the company’s revolutionary advances in the field of regenerative medicine.

The HD videos can be viewed at http://Video.QualityStocks.net

ISCO was the first to develop and perfect a new class of human stem cells created from unfertilized human eggs. The company’s stem cells present superior immune matching capabilities and can be used in millions of people regardless of sex or racial background, with minimal expectation of immune rejection after transplantation.

Dr. Simon Craw, EVP of business development, in the videos details ISCO’s focus on using these “next-generation” stem cells to treat severe unmet medical needs of the central nervous system and beyond.

“Regenerative medicine has been called the next evolution of medical treatments by the U.S. Department of Health and Human Services. With its potential to heal, this new field of science is expected to revolutionize healthcare,” says Dr. Craw.

In mid-2014 ISCO plans to file with the U.S. Food and Drug Administration an investigational new drug (IND) application for Parkinson’s disease, a significant achievement that extends far beyond the company’s development.

“Filing the IND represents a big step forward for ISCO and a major advancement to the field of Parkinson’s disease research,” emphasizes Dr. Craw. “We have not only invested in our science but also in our manufacturing and have all the capacity we need to manufacture human cells and related products to support our strategic goals.”

Brett Lesser, VP of Sales for LifeLine Cell Technology, one of ISCO’s wholly-owned subsidiaries that specializes in manufacturing human cells, explains how ISCO’s cellular products are utilized by scientists searching for treatment of a number of other disease.

“Currently our cells are being used in experiments regarding lung cancer, breast cancer, prostate disease, COPD, asthma, diabetes, and a myriad of other life-threatening ailments,” states Lesser. “We’ve grown to a point where scientists from all over the world have published in some of the most prestigious scientific journals about advances in their own while using our cell culture products.”

The videos also describe ISCO’s self-sustaining business model, subsidiary business units, as well as provides insight on the company’s sweeping patent portfolio and investment opportunity.

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International Stem Cell Corp. (ISCO) Reports Strong Financial Results and Conference Call

Wednesday, November 13th, 2013

International Stem Cell Corp., a California-based biotechnology company developing novel stem cell-based therapies and biomedical products, today announced financial results for the three and nine months ended September 30, 2013, and conference call details.

Q3 2013 Highlights:

• Recorded revenues of $1.67 million, a 41% increase over the corresponding period of 2012. Lifeline Skin Care sales up 54% and Lifeline Cell Technology sales up 30%. Gross margin stable at 73%.
• Net cash used in operating cash flows (which exclude capital expenditures and patent costs), reduced to approximately $0.47 million per month compared to $0.57 million per month the corresponding period of 2012.
• Entered into a clinical research agreement with Duke University for the evaluation of ISCO’s stem cell- derived neural stem cells for the treatment of Parkinson’s disease. Prof. Mark Stacy, M.D., Vice Dean for Clinical Research, Neurology at Duke University School of Medicine and an internationally recognized leader in the field of Movement Disorders, will be the principal investigator.
• Convened a key opinion leader meeting bringing together leading experts from throughout North America in the field of cell therapy and movement disorders to obtain feedback and guidance for the IND submission in 2014 for our stem cell-derived neural stem cells for the treatment of Parkinson’s disease.
• Presented the results of the first primate study, carried out in collaboration with the Sanford Burnham Institute of Regenerative Medical, examining the benefits of implanting neural stem cells into primates with chemically-induced parkinsonian symptoms, at the American Neurological Association 2013 Annual Meeting.
• Obtained gross proceeds of $3.00 million through a public offering, to be used to fund R&D programs.

For the three months ended September 30, 2013:

• Revenue for the three months ended September 30, 2013 was $1.67 million, an increase of approximately 41% compared to $1.19 million for the corresponding period in 2012. Sales for Lifeline Skin Care (LSC) and Lifeline Cell Technology (LCT) increased by 54% and 30%, and accounted for 49% and 51% of total revenue, respectively. Cost of sales was $0.45 million, or 27% of revenue, compared to $0.32 million or 27% of revenue in the corresponding period a year ago.
• General and administrative expenses for the three months ended September 30, 2013 declined 13% to $1.36 million, driven primarily by lower personnel-related expenses resulting from lower headcount, lower stock-based compensation expenses, and lower professional and corporate support expenses.
• Marketing expenses increased 32% to $0.63 million compared to the corresponding period of 2012, reflecting higher spending on advertising, trade shows and promotions.
• Net cash used in operating cash flows (which exclude capital expenditures and patent costs) was reduced to approximately $0.47 million per month compared to $0.57 million per month the corresponding period of 2012.

For the nine months ended September 30, 2013:

• Revenue for the nine months ended September 30, 2013 and 2012 was $4.41 million and $3.32 million, respectively. LSC contributed $2.17 million, up 36% from the same period in 2012 and LCT contributed $2.24 million, up 29% from the corresponding period in 2012.
• Cost of sales for the nine months ended September 30, 2013 was $1.11 million or 25% of revenue, compared to $0.96 million or 29% of revenue for the corresponding period in 2012 as a result of continued improvements in efficiency and effectiveness in manufacturing and the management of supply chain in Lifeline Skin Care as well as a shift in sales mix from lower to higher margin products in Lifeline Cell Technology.
• As of September 30, 2013, and December 31, 2012, cash and cash equivalents totaled $1.79 million and $0.65 million, respectively. At September 30, 2013, the company had a working capital deficit of $2.38 million, compared to working capital of $0.40 million as of December 31, 2012. The working capital deficit is due to the fair value of warrant liability of $4.39 million recognized during the third quarter resulting from a financing transaction completed in July 2013.
• Cash outflows from operations for the first nine months of 2013 were $4.23 million, down from $5.12 million in the corresponding period in 2012. Net cash provided by financing activities was $5.89 million for the nine months ended September 30, 2013, compared to $6.79 million in the corresponding period in 2012

ISCO’s CEO and Co-chairman, Dr. Andrey Semechkin, said of the results: “We’re extremely pleased to report outstanding revenues and growth for the quarter, and having achieved revenues in the three quarters thus far almost equal to those reported for the entire year of 2012. The reduction of cash used in operations is a clear demonstration of the success of our commercial businesses in order to support our core therapeutic activities. We have significant scientific milestones in the next twelve months and our clinical collaboration with Duke University provides us with the complementary skills and expertise to achieve these goals.”

Conference Call and Webcast Details:
Date: Wednesday, November 13, 2013
Time: 11:00 a.m. Eastern Time
Conference Line (U.S.): 1-877-941-1428 International
Dial-In: 1-480-629-9665
Conference ID: 4648561
Webcast: http://webcast.mzvaluemonitor.com/Cover.aspx?PlatformId=1293

Please dial in at least 10-minutes before the call to ensure timely participation.

A playback of the call will be available until 11:59 pm ET on November 27, 2013. To listen, call 1-877-870-5176 within the United States or 1-858-384-5517 when calling internationally. Please use the replay pin 4648561.

For additional information, visit www.InternationalStemCell.com

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