California
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1-12830
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94-3127919
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(State or other jurisdiction of incorporation)
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(Commission File Number) Identification No.)
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(IRS Employer
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Exhibit Number
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Description
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99.1
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Press release dated May 10, 2012
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BIOTIME, INC.
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Date: May 10, 2012
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By:
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s/Peter S. Garcia
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Chief Financial Officer
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Exhibit Number
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Description
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Press release dated May 10, 2012
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Provided an update on the development of ReneviaTM (formerly known as HyStem®-Rx) including the product development milestones for the launch of ReneviaTM in Europe, the goal of obtaining the CE mark necessary for marketing ReneviaTM in European Union countries by year-end 2013, and the global distribution network marketing the HyStem® line of research products being utilized in a wide array of medical research applications.
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BioTime and its subsidiary OncoCyte Corporation provided an update on the development of PanC-DxTM, a novel diagnostic device to detect the presence of various human cancers, including cancers of the breast, lung, bladder, uterus, stomach, and colon, during routine check-ups. Achieved several key advances, including: 1) the evaluation of over 50 potential cancer biomarkers discovered by OncoCyte and BioTime using antibody-based technology in blood samples from a proprietary sample bank derived from over 600 donors, including patients with cancers of the breast, colon, and pancreas, as well as healthy volunteers; and 2) the selection of seven such serum markers for monoclonal antibody production.
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BioTime and its subsidiary LifeMap Sciences, Inc. announced a definitive agreement to acquire XenneX, Inc. through a merger of XenneX into LifeMap Sciences. XenneX holds the exclusive, worldwide licenses to market GeneCards® and PanDaTox. GeneCards® is a searchable, integrated database of human genes that provides concise genomic, transcriptomic, genetic, proteomic, functional and disease-related information, on all known and predicted human genes and generates revenue from customers worldwide, including biotechnology, pharmaceutical and other life sciences companies, as well as organizations dealing with biotechnology intellectual property. PanDaTox is a recently developed, searchable, database that can be used to identify genes and intergenic regions that are unclonable in E. coli, to aid in the discovery of new antibiotics and biotechnologically beneficial functional genes, and to improve the efficiency of metabolic engineering.
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Announced intent to transfer to LifeMap the products and technologies necessary to be the principal marketing subsidiary for BioTime research products, including ACTCellerateTM human progenitor cell lines, GMP human embryonic stem (hES) cell lines, hES cell lines carrying inherited genetic diseases, and ESpanTM growth media for progenitor cell lines for non-therapeutic uses. LifeMap will utilize its databases as part of its online marketing strategy to reach life sciences researchers at biotech and pharmaceutical companies and at academic institutions and research hospitals worldwide.
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Announced initiation of the manufacture of progenitors of muscle stem cells bearing hereditary diseases. BioTime will produce the products from five hES cell lines from Reproductive Genetics Institute. The muscle cell lines display the genes for Duchenne muscular dystrophy, Emery-Dreifuss muscular dystrophy, spinal muscular atrophy Type I, facioscapulohumeral muscular dystrophy 1A, and Becker muscular dystrophy.
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Obtained an exclusive license from The Wistar Institute for technology related to a gene designated as SP100. Wistar Institute researchers have demonstrated pivotal roles for this gene in both cancer and stem cell biology. In conjunction with the license agreement, BioTime agreed to fund research at The Wistar Institute to advance the technology, and will receive certain rights to negotiate additional licenses for any technologies invented as a result of the research.
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Announced the formation of a Science & Technology Committee of the BioTime Board of Directors to oversee the development and commercialization of BioTime's technology and products in regenerative medicine and oncology. The committee will regularly report to the Board of Directors and make recommendations to the Board as to the priorities, direction, quality, and execution for BioTime's technology and product development programs, as well as allocations of financial resources and potential acquisitions of new technology and products. The committee is chaired by director Andrew C. von Eschenbach, M.D., the former Commissioner of the U.S. Food and Drug Administration and former Director of the National Cancer Institute.
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BioTime and its subsidiaries presented updates on their operations, objectives, recent developments and strategies at a BioTime sponsored Investor Day in New York City on April 23, 2012. Presentations as well as videos of the event are available for viewing on BioTime's website at www.biotimeinc.com.
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Published in the peer-reviewed journal Regenerative Medicine a paper detailing a study which characterizes a progenitor cell line produced from hES cells using proprietary ACTCellerateTM technology and demonstrating a scalable source of highly purified and identified progenitor cells capable of making definitive (non-hypertrophic) cartilage. The study reports that the cells are capable of regenerating cartilage with long sought-after markers indicating the cells may be useful in the treatment of osteoarthritis currently afflicting over 26 million people in the United States. The study also shows that the cells can be directly expanded on a scale needed for industrial manufacture, which will be necessary in order to make transplantable cells available in commercial quantities.
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Presented at the following scientific and investor meetings: 7th Annual New York Stem Cell Summit; ROTH 24th Annual Growth Stock Conference; 2012 Maxim Group Growth Conference; 8th GTC Stem Cell Summit 2012; and the BioCentury Future Leaders in the Biotech Industry Conference.
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March 31, 2012
(unaudited)
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December 31,
2011
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ASSETS
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CURRENT ASSETS
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Cash and cash equivalents
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$ | 16,487,906 | $ | 22,211,897 | ||||
Inventory
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54,866 | 51,174 | ||||||
Prepaid expenses and other current assets
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2,101,905 | 2,692,303 | ||||||
Total current assets
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18,644,677 | 24,955,374 | ||||||
Equipment, net
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1,385,316 | 1,347,779 | ||||||
Deferred license and consulting fees
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800,164 | 843,944 | ||||||
Deposits
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63,963 | 63,082 | ||||||
Intangible assets, net
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18,083,779 | 18,619,516 | ||||||
TOTAL ASSETS
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$ | 38,977,899 | $ | 45,829,695 | ||||
LIABILITIES AND EQUITY
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CURRENT LIABILITIES
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Accounts payable and accrued liabilities
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$ | 1,502,207 | $ | 2,681,111 | ||||
Deferred grant income
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261,777 | 261,777 | ||||||
Deferred license revenue, current portion
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201,545 | 203,767 | ||||||
Total current liabilities
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1,965,529 | 3,146,655 | ||||||
LONG-TERM LIABILITIES
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Deferred license revenue, net of current portion
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863,083 | 899,551 | ||||||
Deferred rent, net of current portion
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62,822 | 66,688 | ||||||
Other long-term liabilities
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255,413 | 258,620 | ||||||
Total long-term liabilities
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1,181,318 | 1,224,859 | ||||||
Commitments and contingencies
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EQUITY
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Preferred Shares, no par value, authorized 1,000,000 shares; none issued
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– | – | ||||||
Common shares, no par value, authorized 75,000,000 shares; 50,321,962 issued, and 49,035,788 outstanding at March 31, 2012 and at December 31, 2011
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115,547,532 | 115,144,787 | ||||||
Contributed capital
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93,972 | 93,972 | ||||||
Accumulated other comprehensive income
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1,340 | (122,749 | ) | |||||
Accumulated deficit
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(85,443,351 | ) | (80,470,009 | ) | ||||
Treasury stock at cost: 1,286,174 shares at March 31, 2012 and at December 31, 2011
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(6,000,000 | ) | (6,000,000 | ) | ||||
Total shareholders' equity
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24,199,493 | 28,646,001 | ||||||
Noncontrolling interest
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11,631,559 | 12,812,180 | ||||||
Total equity
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35,831,052 | 41,458,181 | ||||||
TOTAL LIABILITIES AND EQUITY
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$ | 38,977,899 | $ | 45,829,695 |
Three Months Ended
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March 31, 2012
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March 31, 2011
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REVENUES:
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License fees
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$ | 36,468 | $ | 104,599 | ||||
Royalties from product sales
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147,384 | 215,971 | ||||||
Grant income
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400,809 | 415,611 | ||||||
Sale of research products
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47,285 | 88,448 | ||||||
Total revenues
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631,946 | 824,629 | ||||||
EXPENSES:
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Research and development
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(4,178,781 | ) | (2,948,861 | ) | ||||
General and administrative
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(2,368,705 | ) | (1,901,655 | ) | ||||
Total expenses
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(6,547,486 | ) | (4,850,516 | ) | ||||
Loss from operations
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(5,915,540 | ) | (4,025,887 | ) | ||||
OTHER INCOME/(EXPENSES):
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Interest income, net
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8,298 | 13,190 | ||||||
Other income/(expense), net
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(327,095 | ) | 68,012 | |||||
Total other income/(expenses), net
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(318,797 | ) | 81,202 | |||||
NET LOSS
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(6,234,337 | ) | (3,944,685 | ) | ||||
Less: Net loss attributable to the noncontrolling interest
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1,260,995 | 582,553 | ||||||
NET LOSS ATTRIBUTABLE TO BIOTIME, INC. (1)
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(4,973,342 | ) | (3,362,132 | ) | ||||
Foreign currency translation gain/(loss)
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124,089 | (670,005 | ) | |||||
TOTAL COMPREHENSIVE LOSS (2)
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$ | (4,849,253 | ) | $ | (4,032,137 | ) | ||
BASIC AND DILUTED LOSS PER COMMON SHARE (1)
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$ | (0.10 | ) | $ | (0.07 | ) | ||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: BASIC AND DILUTED
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50,321,962 | 48,306,505 |