Category Archives: Stem Cell Therapy

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CARLSBAD, California – November 15, 2011 - International Stem Cell Corporation (ISCO) (OTCBB:ISCO) today announced financial results for the three-month and nine-month periods ended September 30, 2011.  ISCO is a development-stage biotechnology company that created, patented and is commercializing a powerful new stem cell technology called parthenogenesis which promises to advance significantly the field of regenerative medicine.

ISCO reported revenue of $0.84 million for the quarter ended September 30, 2011, a 141% increase from the same period of the prior year.  For the nine months ended September 30, 2011, the Company reported revenue of $3.47 million, a year-over-year increase of 227%.  The increases in revenue was driven by strong sales from the initial launch of ISCO’s wholly-owned subsidiary Lifeline Skin Care (LSC), which commenced operations in the fourth quarter of 2010.  In addition, steady growth in sales from ISCO’s other wholly-owned subsidiary, Lifeline Cell Technology (LCT), contributed to the increases in revenues for both periods. 

The Company continued to invest in the development of new technologies, products and channels of distribution.  For the three months ended September 30, 2011, development expenses, excluding cost of sales, were $3.60 million, an increase of 15% compared to the third quarter of 2010, reflecting increased R&D activities on therapeutic programs and new product development for both subsidiaries.  Sales and marketing expenses related to our skin care products, partially offset by a reduction in general and administration expenses, also contributed to the increase in development expenses.

For the nine months ended September 30, 2011, development expenses, excluding cost of sales, were $10.77 million, an increase of 30% when compared with the prior year period.   The increase is attributed primarily to increased research activities on therapeutic products and product development programs for LSC and LCT, increased stock-based compensation expense, increased headcount and higher general corporate expenses coupled with increased sales and marketing expenses related to our skin care products.

Dr. Andrey Semechkin, co-Chairman and CEO, commented “We are pleased with the rapid growth in sales of our two subsidiaries, LSC and LCT.  Together, these business units are providing much-needed capital to help support our growth as well as the research leading to the development of new stem cell technologies and products.”   Kurt May, President and COO, noted “Our focus continues to be on maximizing the performance of our operating subsidiaries,  advancing the development and commercialization of our therapeutic products and strengthening our organization and operating systems to accommodate our anticipated rapid and significant growth.”

Third Quarter 2011 Highlights:

Important developments and milestones for International Stem Cell in the third quarter included:

-- Continuing to solidify its leadership team with the addition of Linh Nguyen as ISCO’s new Chief Financial Officer.  Further, the Board of Directors elevated Kurt May to President and Chief Operating Officer and Dr. Semechkin to co-Chairman of the Board and Chief Executive Officer.

-- Renewing the marketing agreement with John Mauldin to promote its Lifeline Skin Care products and commenced a new sales channel to resorts and destination spas.

-- Lifeline Cell Technology began selling products through new distribution channels in Japan, Korea, Singapore, Malaysia and Indonesia, expanding its business throughout Asia.

-- ISCO scientists successfully completed the first series of preclinical studies designed to support the application of neuronal cells derived from hpSCs.  These experiments were designed to demonstrate that the derived neuronal cells were able to survive in mouse brains without giving rise to tumors.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products.  ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos.  ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation.  hpSCs offer the potential to create the first true stem cell bank, UniStemCell™.  ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care.  More information is available at http://www.internationalstemcell.com.

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Forward-looking Statements

Statements pertaining to anticipated developments, anticipated sales growth and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

Contacts:

International Stem Cell Corporation

Andrey Semechkin, CEO & Co-Chairman

760-940-6383

aes@intlstemcell.com

International Stem Cell Corporation

Kurt May, President & COO

760-710-3294

kmay@intlstemcell.com

International Stem Cell Corporation

Linh Nguyen, CFO

760-940-6383

LNguyen@intlstemcell.com

Lippert/Heilshorn & Associates

Don Markley

310-691-7100

dmarkley@lhai.com

Please click on the pages below to enlarge.

1) The Company restated its financial statements for the year ended December 31, 2010 and the quarter ended March 31, 2011. See explanatory note after cover page of this 10-Q and Note 1 to the unaudited condensed consolidated financial statements.  See accompanying notes to the unaudited condensed consolidated financial statements

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In a sharp-edged analysis of Geron's abandonment of stem cell research, the Center for Genetics and Society yesterday described the action as a "real blow" to the California stem cell agency.

Written by Pete Shanks, a regular contributor to the Berkeley center's Biopolitical Times, the piece chronicled some of the history and hype involving Geron and hESC research. The center has long taken a skeptical view of the California stem cell agency and Geron. Shanks wrote,

"Geron has been in trouble for a while. Former CEO Thomas Okarma, who left abruptly in February, was the subject of ridicule for his repeated announcements that ESC-based clinical trials would begin "next year" — that is, 2005, 2006, 2007, 2008 — and the trial they eventually came up with was so dubious that Arthur Caplan called it "nuts and hugely risky." Even experts in the field thought that targeting spinal cord injury in the first ESC trial was dubious, though some seem to be more willing to be critical now it has ended.

"And that was on the scientific and perhaps commercial merits. The ethical problems were much worse, since the trial was intended for people who had recently suffered damage to their spinal cords. Bioethicist Laurie Zoloth (who was once on Geron's ethics advisory board, and basically approved of the study), noted at the time of its announcement that:

"'True informed consent in this very vulnerable population, people who have suffered a devastating and life-changing injury a week prior to being asked to enter the first clinical trial for such long-awaited, highly publicized and desperately needed treatment, is hard to obtain and will need to be carefully thought through.'"

Shanks also wrote,

"What of CIRM's role? After Geron's announcement, they issued a remarkably bland press statement, followed by an internal memo that expressed deep disappointment (the California Stem Cell Report has the text). It's a real blow to them: Geron was the first private company to receive funds from CIRM to run a clinical trial using ESCs.

"This was a loan, not a grant, and was only made, as the indefatigable David Jensen (publisher of the California Stem Cell Report) discovered, after a 'major departure from longstanding procedures.' The proposal received a low score (66/100) that was not publicly revealed until Jensen specifically asked for it. And the other applicants who might have competed for those funds rather surprisingly all withdrew.

"The suspicion arises that CIRM, or some people within it, badly wanted the trial to proceed in the hope that it would give them a therapeutic success to boast about. If so, the decision just backfired."

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Commenting on Geron's decision to abandon hESC research, the chairman of the California stem cell agency, Jonathan Thomas, says the agency knew "the road to new therapies would be arduous, and that for each success, there would be setbacks as well."

In a memo Monday to the agency's 29 board members, Thomas reiterated that Geron maintains the decision had nothing to do with safety concerns. He said the company's action underscores the agency's commitment to long-term development of stem cell therapies.

Thomas also said the $3 billion agency will retain the stock warrants it received from Geron, but did not disclose their numbers. We have queried CIRM for more details. CIRM loaned Geron $25 million, which was paid back by Geron on Monday.

A copy of the Thomas memo was provided to the California Stem Cell Report. Here is the full text.

"Dear Board Members:

"Earlier this afternoon, we learned that Geron made a decision to discontinue its stem cell research program, including the CIRM-funded clinical trial involving spinal cord injury. Geron made this decision in order to shift its focus to its oncology program. Geron has assured us that its decision to discontinue the trial had nothing to do with safety concerns; the cells have been well-tolerated and the patients have experienced no adverse effects. Geron will continue to follow all enrolled patients and has committed to accrue data and update the FDA and the medical community regarding the patients’ progress.

"In addition, Geron has returned CIRM’s funds, with accrued interest. CIRM will maintain the warrants it received.

"Of course, we remain committed to funding clinical development of stem cell therapies. We have always recognized that the road to new therapies would be arduous, and that for each success, there would be setbacks as well. We also know that companies make decisions for business reasons, and that it is not unusual for a company to pursue a new strategy, as Geron has done. CIRM, by contrast, is focused on its long-term goal of delivering therapies and cure to patients, and today’s events underscore the importance of CIRM’s long-term commitment to funding therapy development.

"This trial represented the first-ever clinical trial of human embryonic stem cells and we expected that it would be challenging. We share the frustration of all the patients for whom this trial offered great hope. I spoke personally with both Don and Roman Reed to express my commitment to the on-going search for therapies.

"Although we are deeply disappointed by Geron’s decision, we are grateful that Geron has established a regulatory pathway for human embryonic stem cell therapies and we are confident in the potential of stem cells to treat patients suffering from chronic disease and injury.

"Here is a link to CIRM’s press release: http://www.cirm.ca.gov/PressRelease_2011-11-14"

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