UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): | May 3, 2010 |
StemCells, Inc.
__________________________________________
(Exact name of registrant as specified in its charter)
Delaware | 000-19871 | 94-3078125 |
_____________________ (State or other jurisdiction |
_____________ (Commission |
______________ (I.R.S. Employer |
of incorporation) | File Number) | Identification No.) |
3155 Porter Drive, Palo Alto, California | 94304 | |
_________________________________ (Address of principal executive offices) |
___________ (Zip Code) |
Registrants telephone number, including area code: | 650.475.3100 |
Not Applicable
______________________________________________
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events.
(1) On May 3, 2010, StemCells, Inc. announced that data from its Phase I clinical trial in neuronal ceroid lipofuscinosis (NCL, also often referred to as Batten disease) will be featured at the American Association of Neurological Surgeons Annual Meeting. The full text of this press releases is attached hereto as Exhibit 99.1.
(2) On May 4, 2010, StemCells, Inc. reported financial results and highlights for the first quarter ended March 31, 2010. The full text of this press releases is attached hereto as Exhibit 99.2.
(3) On May 6, 2010, StemCells, Inc. announced that members of its management team will present at the World Stem Cells and Regenerative Medicine Congress. The full text of this press releases is attached hereto as Exhibit 99.3.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit 99.1 Press Release of StemCells, Inc. dated May 3, 2010
Exhibit 99.2 Press Release of StemCells, Inc. dated May 4, 2010
Exhibit 99.3 Press Release of StemCells, Inc. dated May 6, 2010
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
StemCells, Inc. | ||||
May 7, 2010 | By: |
/s/ Kenneth Stratton
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|
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Name: Kenneth Stratton | ||||
Title: General Counsel |
Exhibit Index
Exhibit No. | Description | |
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99.1
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Exhibit 99.1 Press Release of StemCells, Inc. dated May 3, 2010 | |
99.2
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Exhibit 99.2 Press Release of StemCells, Inc. dated May 4, 2010 | |
99.3
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Exhibit 99.3 Press Release of StemCells, Inc. dated May 6, 2010 |
NEWS RELEASE
FOR IMMEDIATE RELEASE
CONTACT: | Investor Inquiries
|
Media | ||
Megan Meloni StemCells, Inc. (650) 475-3100, ext. 105 |
Tim Brons Vida Communication, Inc. (415) 675-7402 |
STEMCELLS, INC.S PHASE I BATTEN TRIAL DATA FEATURED AT
AMERICAN ASSOCIATION OF NEUROLOGICAL SURGEONS ANNUAL MEETING
Dr. Nathan Selden to Highlight Positive Safety Profile to Date from the Trial
and Ongoing Follow-Up Study
PALO ALTO, Calif., May 3, 2010 StemCells, Inc. (NASDAQ: STEM) announced that Nathan Selden, M.D., Ph.D., F.A.C.S., F.A.A.P., will give a feature presentation today at the American Association of Neurological Surgeons (AANS) 2010 Annual Meeting, one of the leading forums for neurosurgeons from around the world to present and discuss cutting-edge research in the field. Dr. Selden was co-principal investigator of the Companys Phase I clinical trial in neuronal ceroid lipofuscinosis (NCL, also often referred to as Batten disease), a fatal neurodegenerative disorder in children. In his presentation, Dr. Selden will summarize the positive safety data from the trial and will note that additional data from the ongoing long-term follow-up study continue to affirm the safety profile of the Companys HuCNS-SC® cells.
This Phase I trial was a very important first step toward finding a viable treatment and extending the life of children with this devastating disease, remarked Dr. Selden. Initial results regarding safety associated with the transplantation of a significant cell dose are certainly promising. Further investigation of HuCNS-SC cells is warranted for infantile and late-infantile NCL, as well as for exploring this cell therapy approach for other conditions of the central nervous system. Dr. Selden is Campagna Professor of Pediatric Neurological Surgery and head of the Division of Pediatric Neurological Surgery at Oregon Health & Science University (OHSU) Doernbecher Childrens Hospital and OHSU School of Medicine.
The Phase I NCL trial was the first ever FDA-authorized clinical trial to use purified human neural stem cells as a potential therapeutic agent, and was designed primarily to evaluate the safety of the Companys HuCNS-SC product candidate. The trial was completed in January 2009, and the results were submitted to the FDA in September 2009. The trial data demonstrated that the HuCNS-SC cells, the transplantation procedure, and the immunosuppression regimen were all well tolerated, and that the patients medical, neurological and neuropsychological conditions, following transplantation, appeared consistent with the normal course of the disease. A total of six patients in advanced stages of either infantile or late infantile NCL were enrolled and treated in the trial. One patient succumbed to the disease approximately 11 months post-transplant.
The five patients who completed the 12-month evaluation period prescribed in the trial protocol were subsequently enrolled in a separate four-year observational study. Thus far, data from this ongoing follow-up study show no evidence of serious adverse reactions directly associated with the HuCNS-SC cells or other safety concerns associated with the stem cell treatment. All five patients survived at least two years after being transplanted with HuCNS-SC cells, and magnetic resonance imaging (MRI) at the two-year post-transplant point reveal no signs of cyst or tumor formation. Two patients passed away at approximately 2.5 years and 3.4 years post-transplant, respectively, and these deaths are also believed to be due to progression of the underlying disease. The three surviving patients are now approximately 2.3 years, 2.7 years, and 3.0 years post-transplant, respectively.
All of the families and patients involved with this clinical research should be recognized as true medical pioneers, commented Stephen Huhn, MD, FACS, FAAP, vice president and head of the CNS program at StemCells, Inc. Their courageous decision to participate in this groundbreaking trial has enabled us to advance the search for an effective treatment for NCL and other neurological disorders, and we owe them all an enormous debt of gratitude.
Dr. Huhn added, Given the very sick and fragile nature of the patients involved in this trial, we believe these safety observations are especially meaningful. The data we have gathered to date encourage us to continue our clinical development, and we are currently preparing for a second NCL trial.
StemCells recently submitted a protocol to the FDA for initiation of a second clinical trial of its HuCNS-SC cells in NCL. The proposed new trial is designed to further assess the safety of HuCNS-SC cells in NCL, while also examining the ability of the cells to affect the progression of the disease. Because intervention prior to the final stages of the disease will likely be key to demonstrating a therapeutic benefit, the Company plans to enroll patients in its second trial who have less neuronal degeneration and brain atrophy.
About Neuronal Ceroid Lipofuscinosis (Batten Disease)
Neuronal ceroid lipofuscinosis (NCL) is a fatal neurodegenerative disorder that afflicts infants and young children. The disorder, often referred to as Batten disease, is caused by genetic mutations, and children who inherit the defective gene are unable to produce enough of an enzyme that processes cellular waste substances that accumulate in a part of cells known as the lysosome. Without the enzyme, the cellular waste builds up, and eventually the cells cannot function and die. Children with NCL appear healthy when born, but as their brain cells die, they begin to suffer seizures and progressively lose motor skills, sight and mental capacity. Eventually, they become blind, bedridden and unable to communicate or function independently. There currently is no effective treatment for the disease. The infantile and late infantile forms of NCL are caused by different genetic mutations. As the names imply, the two forms begin to afflict patients at different stages of infancy, but both have similar disease progression and outcomes.
About HuCNS-SC Cells
StemCells lead product candidate, HuCNS-SC cells, is a highly purified composition of human neural stem cells that are expanded and stored as banks of cells. The Companys preclinical research has shown that HuCNS-SC cells can be directly transplanted in the central nervous system. The transplanted cells are able to engraft, migrate, differentiate into neurons and glial cells, and possess the ability to survive for as long as one year with no sign of tumor formation or adverse effects. These findings show that HuCNS-SC cells, when transplanted, behave like normal stem cells, suggesting the possibility of a continual replenishment of normal human neural cells.
In addition to its clinical development of HuCNS-SC cells in NCL, the Company is currently conducting a Phase I trial using these cells as a potential treatment for Pelizaeus-Merzbacher Disease (PMD), a fatal myelination disorder in children. HuCNS-SC cells are also in preclinical development for other central nervous system disorders, including retinal degenerative diseases, such as age-related macular degeneration and retinitis pigmentosa, and spinal cord injury.
About StemCells, Inc.
StemCells, Inc. is engaged in the research, development, and commercialization of stem cell therapeutics and enabling technologies for use in stem cell-based research and drug discovery. In its cellular medicine programs, StemCells is targeting diseases of the central nervous system and liver. StemCells lead product candidate, HuCNS-SC cells (purified human neural stem cells), is in clinical development for the treatment of two fatal neurodegenerative disorders that primarily affect young children. StemCells also markets specialty cell culture products under the SC Proven® brand, and is developing stem cell-based assay platforms for use in pharmaceutical research, drug discovery and development. The Company has exclusive rights to approximately 55 issued or allowed U.S. patents and over 200 granted or allowed non-U.S. patents. Further information about StemCells is available at www.stemcellsinc.com.
Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, and is subject to the safe harbors created therein. These statements include, but are not limited to, statements regarding the success of the Phase I clinical trial in NCL, the safety and tolerability of the HuCNS-SC cells, the surgical procedure and the immunosuppression, the Companys plans to pursue future clinical development of HuCNS-SC cells as a potential treatment for infantile and late infantile NCL, the potential for HuCNS-SC cells to produce the missing enzyme in NCL and keep the patients own neurons intact and functioning, the potential for the Companys therapies to treat NCL and other neurodegenerative diseases, the future business operations of the Company, the prospects associated with conducting future clinical trials for NCL, the potential for its cell-based therapeutics to treat diseases or disorders, and its ability to conduct clinical trials as well as its research and product development efforts. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect managements current views and are based on certain assumptions that may or may not ultimately prove valid. The Companys actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including the fact that additional trials will be required to confirm the safety and demonstrate the efficacy of the Companys HuCNS-SC cells for the treatment of NCL or any other disease; uncertainty as to whether the FDA or other applicable regulatory agencies will permit the Company to continue clinical testing in NCL, PMD or in future clinical trials of proposed therapies for other diseases or conditions given the novel and unproven nature of the Companys technologies; uncertainties about the design of this and other future clinical trials and whether the Company will receive the necessary support of a clinical trial site and its institutional review board to pursue this and other future clinical trials in NCL, PMD or in proposed therapies for other diseases or conditions; uncertainties regarding the Companys ability to commercialize a therapeutic product and its ability to successfully compete with other products on the market; uncertainties regarding the Companys ability to obtain the increased capital resources needed to continue its current and planned research and development operations, including such operations of the company for non-therapeutic applications, and to conduct the research, preclinical development and clinical trials necessary for regulatory approvals; uncertainty as to whether HuCNS-SC and any products that may be generated in the future in the Companys cell-based programs will prove safe and clinically effective and not cause tumors or other adverse side effects; uncertainties regarding the Companys manufacturing capabilities given its increasing preclinical and clinical commitments; and the increased risks associated with commercializing future cell-based therapeutics, including the potential for product liability claims; and other factors that are described under the heading Risk Factors disclosed in Part I, Item 1A in the Companys Annual Report on Form 10-K for the year ended December 31, 2009.
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NEWS RELEASE
FOR IMMEDIATE RELEASE
CONTACT: | Investor Inquiries
|
Media | ||
Megan Meloni StemCells, Inc. (650) 475-3100, ext. 105 |
Tim Brons Vida Communication, Inc. (415) 675-7402 |
STEMCELLS, INC. REPORTS FIRST QUARTER FINANCIAL RESULTS AND HIGHLIGHTS
PALO ALTO, Calif., May 4, 2010 StemCells, Inc. (NASDAQ: STEM), a leading stem cell technology company with the dual focus of novel therapeutics and innovative research products, today reported financial results for the first quarter ended March 31, 2010 and recent business highlights.
It has been an exciting start to the year with important advances in our clinical development programs and our research products business, said Martin McGlynn, President and CEO of StemCells, Inc. Our PMD trial is proceeding well, and we are poised to begin a second NCL trial later this year with increased emphasis on the measurement of clinical benefit. With these endeavors well underway, we are actively pursuing a broader agenda focused on initiating clinical trials in spinal cord injury and age-related macular degeneration, thereby expanding our clinical development programs to all regions of the central nervous system the brain, the spinal cord, and the eye something we believe no other company in the field is positioned to do. With respect to our SC Proven® business, we have expanded our portfolio with the launch of two new products, and are committed to pursuing creative ways to take full advantage of the rapidly growing market for research grade cells, media and reagents.
Recent and First Quarter Business Highlights
| In January 2010, the Company launched GS1-RTM, the first commercially available medium to enable the derivation, maintenance and growth of true (germline competent) rat embryonic stem cells. GS1-R is expected to have significant utility in the creation of genetically engineered rat models of human disease for use in academic, medical and pharmaceutical research. |
| In February 2010, the Company launched GS2-MTM, a new cell culture medium that enables the derivation and long-term maintenance of true mouse iPS cells. GS2-M has been shown to increase the efficiency of reprogramming pre-iPS cells to derive fully pluripotent stem cells and to maintain mouse iPS cells in a pluripotent state in long-term culture. |
| In February 2010, the first patient in a Phase I clinical trial of the Companys HuCNS-SC® product candidate (purified human neural stem cells) in Pelizaeus-Merzbacher Disease (PMD) was enrolled and dosed. PMD is a fatal myelination disorder that primarily afflicts infants and young children, and this event marked the first time that neural stem cells had been transplanted as a potential treatment for a myelination disorder. This study, which is the second clinical trial of HuCNS-SC cells in a neurodegenerative disease, is being conducted at the University of California, San Francisco (UCSF) Childrens Hospital. |
| In March 2010, the United Kingdom (UK) Intellectual Property Office granted patent number GB2451523 with broad claims covering true (germline competent) pluripotent rat stem cells and genetically engineered rats derived from these cells. This patented technology is expected to have significant utility to academic and pharmaceutical industry researchers by enabling them to create novel rat models for the study of a wider range of human diseases previously not possible due to a lack of the true pluripotent rat stem cells needed for precise genetic engineering. The Company holds an exclusive license to commercialize this technology and is globally prosecuting the patent family that claims it. |
| In April 2010, the Company submitted a protocol to the FDA for initiation of a second clinical trial of HuCNS-SC cells in infantile and late infantile neuronal ceroid lipofuscinosis (NCL, also often referred to as Batten disease), a fatal neurodegenerative disorder in children. The proposed new trial is designed to further assess the safety of HuCNS-SC cells in NCL, while also examining the ability of the cells to affect the progression of the disease. |
First Quarter Financial Results
The Companys financial results include the operations of Stem Cell Sciences Plc (SCS) since April 1, 2009.
For the first quarter of 2010, the Company reported a net loss of $6,124,000, or $(0.05) per share, compared with a net loss of $9,281,000, or $(0.10) per share, for the first quarter of 2009. Total revenue was $230,000, a 307% increase over total revenue of $57,000 for the same period of 2009. The growth in revenue in 2010 compared to 2009 was primarily due to the consolidation of the SCS operations, which added product sales revenue from the Companys SC Proven portfolio of specialty cell culture products, as well as increased licensing and grant revenue.
For the first quarter of 2010, the Companys loss from operations was $7,601,000, an increase of $678,000, or 10%, compared to the same period in 2009. Operating expenses were $807,000 higher in the first quarter of 2010 compared to 2009, primarily due to the consolidation of the SCS operations. Almost all of the increase in operating expenses in 2010 was due to increased research and development expenses, as selling, general and administrative expenses were essentially unchanged in 2010 compared to 2009. Also in the first quarter of 2010, the Company recorded other income of $1,516,000 to reflect a decrease in the estimated fair value of warrant liability. In the first quarter of 2009, the Company had recorded other expense of $2,755,000 to reflect an increase in the estimated fair value of warrant liability.
Cash and cash equivalents at March 31, 2010 totaled $31,337,000, compared with $38,618,000 at December 31, 2009. In the first quarter of 2010, the Company raised $1,088,000 in gross proceeds through the sale of 882,200 shares of common stock.
About StemCells, Inc.
StemCells, Inc. is engaged in the research, development, and commercialization of stem cell therapeutics and enabling technologies for use in stem cell-based research and drug discovery. In its cellular medicine programs, StemCells is targeting diseases of the central nervous system and liver. StemCells lead product candidate, HuCNS-SC cells (purified human neural stem cells), is in clinical development for the treatment of two fatal neurodegenerative disorders that primarily affect young children. StemCells also markets specialty cell culture products under the SC Proven brand, and is developing stem cell-based assay platforms for use in pharmaceutical research, drug discovery and development. The Company has exclusive rights to approximately 55 issued or allowed U.S. patents and over 200 granted or allowed non-U.S. patents. Further information about StemCells is available at www.stemcellsinc.com.
Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the U.S. securities laws, and is subject to the safe harbors created therein. These statements include, but are not limited to, statements regarding the future business operations of StemCells, Inc. (the Company); the prospect and timing associated with initiating a second clinical trial in NCL; the prospect for continued clinical development of the Companys HuCNS-SC cells in PMD, NCL and in other diseases; the prospect for growth in the Companys SC Proven business; and the Companys ability to commercialize drug discovery and drug development tools. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect managements current views and are based on certain assumptions that may or may not ultimately prove valid. The Companys actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including uncertainties with respect to the fact that additional trials will be required to confirm the safety and demonstrate the efficacy of the Companys HuCNS-SC cells for the treatment of PMD, NCL or any other disease; risks whether the FDA or other applicable regulatory agencies will permit the Company to continue clinical testing in NCL, PMD or in future clinical trials of proposed therapies for other diseases or conditions; uncertainties about the design of future clinical trials and whether the Company will receive the necessary support of a clinical trial site and its institutional review board to pursue future clinical trials in NCL, PMD or in proposed therapies for other diseases or conditions; uncertainties regarding the potential for the Company to grow its SC Proven business and to advance the development and commercialization of stem cell-based assays for drug discovery and development; uncertainties regarding the Companys ability to obtain the increased capital resources needed to continue its current and planned research and development operations, including such operations of the Company for non-therapeutic applications, and to conduct the research, preclinical development and clinical trials necessary for regulatory approvals; uncertainty as to whether HuCNS-SC cells and any products that may be generated in the future in the Companys cell-based programs will prove safe and clinically effective and not cause tumors or other adverse side effects; uncertainties regarding whether results in preclinical research in animals will be indicative of future clinical results in humans; uncertainties regarding the Companys manufacturing capabilities given its increasing preclinical and clinical commitments; uncertainties regarding the validity and enforceability of the Companys patents; uncertainties as to whether the Company will become profitable; and other factors that are described under the heading Risk Factors disclosed in Part I, Item 1A in the Companys Annual Report on Form 10-K for the year ended December 31, 2009.
StemCells, Inc.
Unaudited Condensed Consolidated Statement of Operations
(in thousands, except share and per share amounts)
(unaudited)
Three months ended | ||||||||||||
March 31 | ||||||||||||
2010 | 2009 | |||||||||||
Revenue: |
||||||||||||
Revenue from licensing agreements and grants |
$ | 114 | $ | 57 | ||||||||
Revenue from product sales |
116 | | ||||||||||
Total revenue |
230 | 57 | ||||||||||
Cost of product sales |
44 | | ||||||||||
Gross profit |
186 | 57 | ||||||||||
Operating expenses: |
||||||||||||
Research and development |
5,037 | 4,236 | ||||||||||
Selling, general and administrative |
2,585 | 2,539 | ||||||||||
Wind-down expenses |
165 | 205 | ||||||||||
Total operating expenses |
7,787 | 6,980 | ||||||||||
Loss from operations |
(7,601 | ) | (6,923 | ) | ||||||||
Other income (expense): |
||||||||||||
Realized gain on sale of marketable securities |
| 398 | ||||||||||
Change in fair value of warrant liability |
1,516 | (2,755 | ) | |||||||||
Interest income (expense), net |
(25 | ) | 13 | |||||||||
Other income (expense), net |
(14 | ) | (14 | ) | ||||||||
Total other expense, net |
1,477 | (2,358 | ) | |||||||||
Net loss |
$ | (6,124 | ) | $ | (9,281 | ) | ||||||
Basic and diluted net loss per share |
$ | (0.05 | ) | $ | (0.10 | ) | ||||||
Shares used to compute basic and diluted |
||||||||||||
loss per share |
118,959,136 | 96,048,288 | ||||||||||
StemCells, Inc.
Unaudited Condensed Consolidated Balance Sheets
(in thousands)
March 31, 2010 | December 31, 2009 (a) | |||||||||
(unaudited) | (unaudited) | |||||||||
ASSETS:
|
||||||||||
Current Assets:
|
||||||||||
Cash & cash equivalents
|
$ | 31,337 | $ | 38,618 | ||||||
Marketable securities
|
157 | 197 | ||||||||
Other current assets
|
1,144 | 1,326 | ||||||||
Total current assets
|
32,638 | 40,141 | ||||||||
Property, plant and equipment, net
|
2,637 | 2,857 | ||||||||
Goodwill and other intangible assets, net
|
5,183 | 5,667 | ||||||||
Other assets, non-current
|
2,541 | 2,525 | ||||||||
Total assets
|
$ | 42,999 | $ | 51,190 | ||||||
LIABILITIES AND STOCKHOLDERS EQUITY:
|
||||||||||
Current liabilities
|
4,967 | 6,530 | ||||||||
Fair value of warrant liability
|
8,161 | 9,677 | ||||||||
Other non-current liabilities
|
4,147 | 4,488 | ||||||||
Stockholders equity
|
25,724 | 30,495 | ||||||||
Total liabilities and stockholders equity
|
$ | 42,999 | $ | 51,190 | ||||||
(a) | Derived from audited financial statements included in StemCells annual report on form 10-K filed with the SEC. |
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NEWS RELEASE
FOR IMMEDIATE RELEASE
CONTACT: | Investor Inquiries
|
Media | ||
Megan Meloni StemCells, Inc. (650) 475-3100, ext. 105 |
Tim Brons Vida Communication, Inc. (415) 675-7402 |
STEMCELLS, INC. MANAGEMENT TO PRESENT AT
WORLD STEM CELLS AND REGENERATIVE MEDICINE CONGRESS
PALO ALTO, Calif., May 6, 2010 StemCells, Inc. (NASDAQ: STEM) announced today that Martin McGlynn, President and CEO, and Stewart Craig, Ph.D., Senior Vice President, Development and Operations, will each present at the Fifth Annual World Stem Cells and Regenerative Medicine Congress to be held May 11 13 in London, UK. The World Stem Cells and Regenerative Medicine Congress brings together business leaders, academic researchers, regulators, policy-makers, advocates, and legal and industry experts from around the world to network, collaborate and discuss the challenges and commercial opportunities for stem cell applications. StemCells invitation to participate in multiple speaking sessions at this conference reflects the Companys leading position and broad reach in the stem cell field, including a wide range of stem cell technology platforms for both therapeutic and non-therapeutic use.
Mr. McGlynns presentation, entitled Case Study: Working with the FDA for Regulatory Approval, is scheduled for May 11th at 10:05 a.m. local time. Mr. McGlynn will also participate in a panel discussion entitled Constructing a Regulatory Roadmap to Bring Cell Therapy to the Clinic, scheduled for 10:30 a.m. local time the same day. As the first company to receive FDA authorization for a clinical trial using purified human neural stem cells, StemCells has significant experience with advancing novel stem cell treatments into the clinic. Its two successful IND filings to date have led to the completion in January 2009 of a Phase I clinical trial in neuronal ceroid lipofuscinosis (NCL, also often referred to as Batten disease) and initiation in November 2009 of a Phase I clinical trial in Pelizaeus-Merzbacher Disease (PMD), both fatal neurodegenerative disorders in children. The Company has also recently submitted a protocol to the FDA for initiation of a second NCL trial.
Dr. Craigs presentation, entitled Platform Solutions for Stem Cell-based Drug Discovery Applications, is scheduled for May 11th at 5:30 p.m. local time. StemCells has in-house expertise and infrastructure for providing cell-based assays for drug discovery and development, including an automated cell culture platform for the production of stem and progenitor cells for drug screening applications. The Company is currently leveraging its broad technology platform, including embryonic stem cells, induced pluripotent stem cells and tissue-derived (adult) stem cells, and its leading position in the neural stem cell field to develop neural stem cell-based assays to facilitate drug discovery for diseases of the central nervous system.
StemCells will also exhibit its stem cell technologies and research products at the conference, including its SC Proven® specialty cell culture products, which enable leading edge stem cell research.
About StemCells, Inc.
StemCells, Inc. is engaged in the research, development, and commercialization of stem cell therapeutics and enabling technologies for use in stem cell-based research and drug discovery. In its cellular medicine programs, StemCells is targeting diseases of the central nervous system and liver. StemCells lead product candidate, HuCNS-SC cells (purified human neural stem cells), is in clinical development for the treatment of two fatal neurodegenerative disorders that primarily affect young children. StemCells also markets specialty cell culture products under the SC Proven brand, and is developing stem cell-based assay platforms for use in pharmaceutical research, drug discovery and development. The Company has exclusive rights to approximately 55 issued or allowed U.S. patents and over 200 granted or allowed non-U.S. patents. Further information about StemCells is available at www.stemcellsinc.com.
Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the U.S. securities laws, and is subject to the safe harbors created therein. These statements include, but are not limited to, statements regarding the clinical development of its HuCNS-SC cells; the Companys ability to commercialize drug discovery and drug development tools; and the future business operations of the Company. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect managements current views and are based on certain assumptions that may or may not ultimately prove valid. The Companys actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including those described under the heading Risk Factors in the Companys Annual Report on Form 10-K for the year ended December 31, 2009 and in its subsequent reports on Form 10-Q and Form 8-K.
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