x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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California
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94-3127919
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|
(State or other jurisdiction of incorporation or organization)
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(IRS Employer Identification No.)
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Large accelerated filer
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o
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Accelerated filer
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x
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Non-accelerated filer
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o
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(Do not check if a smaller reporting company)
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Smaller reporting company
|
o
|
ASSETS
|
|
September 30, 2011
(unaudited)
|
|
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December 31,
2010
|
|
||
CURRENT ASSETS:
|
|
|
|
|
|
|
||
Cash and cash equivalents
|
|
$
|
26,230,298
|
|
|
$
|
33,324,924
|
|
Inventory
|
|
|
61,115
|
|
|
|
45,470
|
|
Prepaid expenses and other current assets
|
|
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2,263,782
|
|
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2,202,284
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Total current assets
|
|
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28,555,195
|
|
|
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35,572,678
|
|
|
|
|
|
|
|
|
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Equipment, net
|
|
|
1,291,368
|
|
|
|
710,766
|
|
Deferred license and consulting fees
|
|
|
887,599
|
|
|
|
1,550,410
|
|
Deposits
|
|
|
65,263
|
|
|
|
51,900
|
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Intangible assets, net
|
|
|
20,076,306
|
|
|
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15,386,905
|
|
TOTAL ASSETS
|
|
$
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50,875,731
|
|
|
$
|
53,272,659
|
|
LIABILITIES AND EQUITY
|
|
|
|
|
|
|
|
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CURRENT LIABILITIES:
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
$
|
2,251,179
|
|
|
$
|
1,929,874
|
|
Deferred grant income
|
|
|
271,247
|
|
|
|
261,777
|
|
Deferred license revenue, current portion
|
|
|
199,860
|
|
|
|
288,306
|
|
Total current liabilities
|
|
|
2,722,286
|
|
|
|
2,479,957
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|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
LONG-TERM LIABILITIES:
|
|
|
|
|
|
|
|
|
Deferred license revenue, net of current portion
|
|
|
936,019
|
|
|
|
1,048,757
|
|
Deferred rent, net of current portion
|
|
|
27,972
|
|
|
|
—
|
|
Other long term liabilities
|
|
|
272,720
|
|
|
|
318,288
|
|
Total long-term liabilities
|
|
|
1,236,711
|
|
|
|
1,367,045
|
|
|
|
|
|
|
|
|
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EQUITY:
|
|
|
|
|
|
|
|
|
Preferred shares, no par value, authorized 1,000,000 shares; none issued
|
|
|
—
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|
|
|
—
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|
Common shares, no par value, authorized 75,000,000 shares; 50,238,409 and 47,777,701 issued, and 48,952,235 and 47,777,701 outstanding at September 30, 2011 and December 31, 2010, respectively
|
|
|
114,739,837
|
|
|
|
101,135,428
|
|
Contributed capital
|
|
|
93,972
|
|
|
|
93,972
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|
Accumulated other comprehensive (loss)/income
|
|
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(99,488
|
)
|
|
|
897,338
|
|
Accumulated deficit
|
|
|
(75,109,358
|
)
|
|
|
(63,954,509
|
)
|
Treasury stock at cost: 1,286,174 and nil shares at September 30, 2011 and December 31, 2010, respectively
|
(6,000,000
|
)
|
—
|
|||||
Total shareholders’ equity
|
|
|
33,624,963
|
|
|
|
38,172,229
|
|
Noncontrolling interest
|
|
|
13,291,771
|
|
|
|
11,253,428
|
|
Total equity
|
|
|
46,916,734
|
|
|
|
49,425,657
|
|
TOTAL LIABILITIES AND EQUITY
|
|
$
|
50,875,731
|
|
|
$
|
53,272,659
|
|
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
||||||||||
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|
September 30,
2011
|
|
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September 30,
2010
|
|
|
September 30,
2011
|
|
|
September 30,
2010
|
|
||||
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|
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|
||||
REVENUES:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
License fees
|
|
$
|
54,900
|
|
|
$
|
73,255
|
|
|
$
|
201,589
|
|
|
$
|
204,439
|
|
Royalties from product sales
|
|
|
176,009
|
|
|
|
215,094
|
|
|
|
569,206
|
|
|
|
727,388
|
|
Grant income
|
|
|
746,426
|
|
|
|
418,412
|
|
|
|
1,605,612
|
|
|
|
1,208,602
|
|
Sale of research products
|
|
|
165,719
|
|
|
|
108,523
|
|
|
|
347,224
|
|
|
|
120,946
|
|
Total revenues
|
|
|
1,143,054
|
|
|
|
815,284
|
|
|
|
2,723,631
|
|
|
|
2,261,375
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
(3,445,708
|
)
|
|
|
(1,808,357
|
)
|
|
|
(9,572,436
|
)
|
|
|
(4,397,109
|
)
|
General and administrative
|
|
|
(1,929,711
|
)
|
|
|
(1,464,631
|
)
|
|
|
(6,377,390
|
)
|
|
|
(3,961,375
|
)
|
Total expenses
|
|
|
(5,375,419
|
)
|
|
|
(3,272,988
|
)
|
|
|
(15,949,826
|
)
|
|
|
(8,358,484
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(4,232,365
|
)
|
|
|
(2,457,704
|
)
|
|
|
(13,226,195
|
)
|
|
|
(6,097,109
|
)
|
OTHER INCOME/(EXPENSES):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income/(expense), net
|
|
|
2,911
|
|
|
|
(127
|
)
|
|
|
19,705
|
|
|
|
(285
|
)
|
Gain/(loss) on sale of fixed assets
|
|
|
(6,246
|
)
|
950
|
|
|
|
(6,246)
|
950
|
||||||
Modification cost of warrants
|
|
|
—
|
(2,142,201
|
)
|
|
|
—
|
(2,142,201
|
)
|
||||||
Other income/(expense), net
|
|
|
(919
|
)
|
|
|
(202,224
|
)
|
|
|
223,944
|
|
|
|
(225,868
|
)
|
Total other income/(expenses), net
|
|
$
|
(4,254
|
)
|
|
$
|
(2,343,602
|
)
|
|
$
|
237,403
|
|
|
$
|
(2,367,404
|
)
|
NET LOSS
|
|
|
(4,236,619
|
)
|
|
|
(4,801,306
|
)
|
|
|
(12,998,792
|
)
|
|
|
(8,464,513
|
)
|
Less: Net loss attributable to the noncontrolling interest
|
|
|
498,993
|
|
|
|
130,144
|
|
|
|
1,833,943
|
|
|
|
249,417
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS ATTRIBUTABLE TO BIOTIME, INC.
|
|
$
|
(3,737,626
|
)
|
|
$
|
(4,671,162
|
)
|
|
$
|
(11,154,849
|
)
|
|
$
|
(8,215,096
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation gain/(loss)
|
|
|
696,661
|
|
|
3,548
|
|
|
|
(901,881
|
)
|
|
|
(2,363
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMPREHENSIVE NET LOSS
|
|
$
|
(3,040,965
|
)
|
|
$
|
(4,667,614
|
)
|
|
$
|
(12,056,730
|
)
|
|
$
|
(8,217,459
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC AND DILUTED LOSS PER COMMON SHARE
|
|
$
|
(0.08
|
)
|
|
$
|
(0.11
|
)
|
|
$
|
(0.23
|
)
|
|
$
|
(0.22
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: BASIC AND DILUTED
|
|
|
49,330,358
|
|
|
|
42,653,125
|
|
|
|
48,827,928
|
|
|
|
38,010,958
|
|
|
|
Nine Months Ended
|
|
|||||
|
|
September 30,
2011
|
|
|
September 30,
2010
|
|
||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
||
Net loss attributable to BioTime, Inc.
|
|
$
|
(11,154,849
|
)
|
|
$
|
(8,215,096
|
)
|
Adjustments to reconcile net loss attributable to BioTime, Inc. to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
Depreciation expense
|
|
|
260,646
|
|
|
|
63,893
|
|
Amortization of intangible asset
|
|
|
1,626,476
|
|
|
|
320,833
|
|
Amortization of deferred license revenues
|
|
|
(162,943
|
)
|
|
|
(301,462
|
)
|
Amortization of deferred consulting fees
|
|
|
582,186
|
|
|
|
326,150
|
|
Amortization of deferred license fees
|
|
|
82,125
|
|
|
|
—
|
|
Amortization of deferred rent
|
|
|
32,403
|
|
|
|
(5,681
|
)
|
Stock-based compensation
|
|
|
828,395
|
|
|
|
429,435
|
|
Options issued as independent director compensation
|
|
|
427,516
|
|
|
|
313,328
|
|
Write off of expired inventory
|
|
|
1,510
|
|
|
|
—
|
|
Loss on write-off of fixed assets
|
6,502
|
—
|
||||||
Modification cost of warrants
|
|
|
—
|
|
|
|
2,142,201
|
|
Share in net loss from associate
|
|
|
—
|
|
|
|
255,054
|
|
Net loss allocable to noncontrolling interest
|
|
|
(1,833,943
|
)
|
|
|
(249,417
|
)
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts receivable, net
|
|
|
(25,272
|
)
|
|
|
(23,489
|
)
|
Grant receivable
|
|
|
261,777
|
|
|
|
—
|
|
Inventory
|
|
|
21,154
|
|
|
|
(11,094
|
)
|
Prepaid expenses and other current assets
|
|
|
(325,956)
|
|
|
|
17,625
|
|
Accounts payable and accrued liabilities
|
|
|
(581,072
|
)
|
|
|
(55,561
|
)
|
Other long term liabilities
|
|
|
(31,741
|
)
|
|
|
—
|
|
Deferred revenues
|
|
|
(23,092
|
)
|
|
|
37,500
|
|
Deferred grant income
|
|
|
9,878
|
|
|
|
—
|
|
Net cash used in operating activities
|
|
|
(9,998,300
|
)
|
|
|
(4,955,781
|
)
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Purchase of equipment
|
|
|
(780,524
|
)
|
|
|
(166,447
|
)
|
Loan to nonconsolidated company
|
—
|
(250,000
|
)
|
|||||
Payment of license fee
|
|
|
(1,500
|
)
|
|
|
(215,000
|
)
|
Cash acquired as part of asset purchase, net of cash paid
|
|
|
3,150
|
|
|
|
—
|
|
Cash acquired in connection with merger
|
|
|
5,908
|
|
|
|
—
|
|
Cash paid in connection with acquisition
|
|
|
—
|
|
|
|
(80,000
|
)
|
Security deposit received
|
|
|
250
|
|
|
|
3,997
|
|
Net cash used in investing activities
|
|
|
(772,716
|
)
|
|
|
(707,450
|
)
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Proceeds from the exercise of stock options from employees
|
|
|
106,153
|
|
|
|
106,640
|
|
Proceeds from the exercise of stock options from directors
|
|
|
112,328
|
|
|
|
19,672
|
|
Proceeds from the exercise of stock options from outside consultant
|
|
|
4,700
|
|
|
|
417,350
|
|
Proceeds from the exercise of warrants
|
|
|
425,000
|
|
|
|
18,129,530
|
|
Proceeds from the sale of common shares of subsidiary
|
|
|
3,213,500
|
|
|
|
—
|
|
Net cash provided by financing activities
|
|
|
3,861,681
|
|
|
|
18,673,192
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and cash equivalents
|
|
|
(185,291)
|
|
|
|
(9,299
|
)
|
|
|
|
|
|
|
|
|
|
NET CHANGE IN CASH AND CASH EQUIVALENTS:
|
|
|
(7,094,626
|
)
|
|
|
13,000,662
|
|
Cash and cash equivalents at beginning of period
|
|
|
33,324,924
|
|
|
|
12,420,932
|
|
Cash and cash equivalents at end of period
|
|
$
|
26,230,298
|
|
|
$
|
25,421,594
|
|
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
|
|
|
|
|
|
|
|
|
Cash paid during the period for interest
|
|
$
|
1,073
|
|
|
$
|
264
|
|
SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING AND INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Common shares issued in connection with investment in subsidiary
|
|
$
|
6,000,000
|
|
|
$
|
—
|
|
Common shares issued in connection with the purchase of assets
|
|
$
|
2,300,000
|
|
|
$
|
—
|
|
Common shares issued as part of merger
|
|
$
|
2,600,000
|
|
|
$
|
—
|
|
Common shares issued as part of acquisition
|
|
$
|
—
|
|
|
$
|
11,011,864
|
|
Warrants issued as part of merger
|
|
$
|
954,879
|
|
|
$
|
—
|
|
Warrants issued as part of acquisition
|
|
$
|
—
|
|
|
$
|
1,778,727
|
|
Warrants issued for service
|
|
$
|
—
|
|
|
$
|
1,846,948
|
|
Subsidiary
|
|
BioTime
Ownership
|
|
Country
|
ReCyte Therapeutics, Inc. (formerly Embryome Sciences, Inc.)
|
|
95.15%
|
|
USA
|
OncoCyte Corporation
|
|
75%
|
|
USA
|
OrthoCyte Corporation
|
|
100%
|
|
USA
|
ES Cell International Pte., Ltd.
|
|
100%
|
|
Singapore
|
BioTime Asia, Limited
|
|
81%
|
|
Hong Kong
|
Cell Cure Neurosciences, Ltd.
|
|
53.6%
|
|
Israel
|
LifeMap Sciences, Inc.
|
|
100%
|
|
USA
|
LifeMap Sciences, Ltd.
|
|
100%
(1)
|
|
Israel
|
|
|
September 30,
2011
(unaudited)
|
|
|
December 31,
2010
|
|
||
Equipment, furniture and fixtures
|
|
$
|
1,729,056
|
|
|
$
|
876,708
|
|
Accumulated depreciation
|
|
|
(437,688
|
)
|
|
|
(165,942
|
)
|
Equipment, net
|
|
$
|
1,291,368
|
|
|
$
|
710,766
|
|
|
|
September 30,
2011
(unaudited)
|
|
|
December 31,
2010
|
|
||
Intangible assets
|
|
$
|
22,455,905
|
|
|
$
|
16,208,116
|
|
Accumulated amortization
|
|
|
(2,379,599
|
)
|
|
|
(821,211
|
)
|
Intangible assets, net
|
|
$
|
20,076,306
|
|
|
$
|
15,386,905
|
|
|
|
September 30,
2011
(unaudited)
|
|
|
December 31,
2010
|
|
||
Accounts payable
|
|
$
|
982,508
|
|
|
$
|
1,036,145
|
|
Accrued bonuses
|
|
|
—
|
|
|
|
367,822
|
|
Other accrued liabilities
|
|
|
1,268,671
|
|
|
|
525,907
|
|
|
|
$
|
2,251,179
|
|
|
$
|
1,929,874
|
|
|
|
Nine Months Ended
|
|
|||||
|
|
September 30,
2011
|
|
|
September 30,
2010
|
|
||
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
||
Revenues
|
|
$
|
2,966,547
|
|
|
$
|
2,643,141
|
|
|
|
|
|
|
|
|
|
|
Net loss available to common shareholders
|
|
$
|
(13,033,673
|
)
|
|
$
|
(10,758,610
|
)
|
|
|
|
|
|
|
|
|
|
Net loss per common share – basic and diluted
|
|
$
|
(0.27
|
)
|
|
$
|
(0.27
|
)
|
Subsidiary
|
|
Field of Business
|
|
BioTime
Ownership
|
|
Country
|
ReCyte Therapeutics, Inc.
|
|
Blood and vascular diseases including coronary artery disease
iPS cell banking
|
|
95.15%
|
|
USA
|
|
|
|
|
|
||
OncoCyte Corporation
|
|
Cancer
|
|
75%
|
|
USA
|
|
|
|
|
|
||
OrthoCyte Corporation
|
|
Orthopedic diseases, including osteoarthritis
Biocompatible hydrogels that mimic the human extracellular matrix
|
|
100%
|
|
USA
|
|
|
|
|
|
||
ES Cell International Pte. Ltd.
|
|
Stem cell products for research, including cell lines produced under clinical “good manufacturing practices” (“GMP”)
|
|
100%
|
|
Singapore
|
|
|
|
|
|
||
BioTime Asia, Limited
|
|
Ophthalmologic, skin, musculo-skeletal system, and hematologic diseases.
Stem cell products for research
|
|
81%
|
|
Hong Kong
|
|
|
|
|
|
||
Cell Cure Neurosciences, Ltd.
|
|
Age-related macular degeneration
Multiple sclerosis
Parkinson’s disease
|
|
53.6%
|
|
Israel
|
|
|
|
|
|
||
LifeMap Sciences, Inc
|
|
Stem cell data base
|
|
100%
|
|
USA
|
Company
|
Product Program
|
Status
|
BioTime
(1)
and ES Cell International Pte. Ltd. (“ESI”)
|
ACTCellerate™ cell lines/growth media/reagent kits for stem cell research
|
Nearly 300 products for stem cell research are now being offered, including ACTCellerate™ hEPCs, ESpan™ cell line optimal growth media, and reagent cell differentiation kits. We plan to add additional cell lines, growth media, and differentiation kits with characterization of new hEPCs
|
GMP hES cell lines | ESI has developed and offers for sale GMP hES cell lines for research purposes. Six ESI hES cell lines have been approved by the NIH for use in federally funded research. | |
BioTime
(1)
|
CIRM-funded research project addressing the need for industrial-scale production of purified therapeutic cells
|
Conducted long-term stability studies of hEPCs using commercial-type culture processes to demonstrate phenotypic stability and genotypic stability during culture expansion.
Attempting to define a molecular signature of cell surface markers that would be unique to a given hEPC cell line to permit development of reagents to those markers that can be used to purify the target hEPCs intended for therapy.
Mapping cell surface protein expression directly on hEPCs using large collections of commercially available antibodies and have begun testing those antibodies as affinity reagents for purifying target hEPCs.
Identifying peptide reagents that show specificity for cell surface targets on hEPCs and could thus be used directly as affinity reagents.
|
OncoCyte
|
Vascular endothelial cells that can be engineered to deliver a toxic payload to the developing blood vessels of a tumor
|
Developed a derivation protocol that can reproducibly produce populations of endothelial cells with levels of purity and efficiency above those reported in the published literature.
Established broad range of support assays to monitor and measure vascular endothelial cell differentiation process.
Initiated in vivo experiments monitoring incorporation of endothelial cells into developing mouse vasculature and into the developing vasculature of human tumor xenografts.
Completed initial development of a toxic payload transgene system which can be induced at the site of tumors to destroy cancer cells.
|
Genetic markers for cancer diagnosis
|
Demonstrated that many of the same genes associated with the normal growth of embryonic stem cells are abnormally reactivated by cancer cells. Based on this finding, and utilizing its proprietary algorithms, OncoCyte has discovered and filed patent applications on over 100 novel cancer-associated genes.
|
|
OrthoCyte
|
Cartilage repair using embryonic progenitor cells
|
Identified several cell lines that displayed molecular markers consistent with the production of definitive human cartilage.
Confirmed chondrogenic potential in joint defects in rat models of osteoarthritis .
Demonstrated that those cell lines can be combined with BioTime's HyStem Rx matrices to formulate a combination product for treating cartilage deficits.
|
Biocompatible hydrogels that mimic
the human extracellular matrix
|
Developed Extracel PEGgel and HyStem hydrogel products for basic laboratory research use
Conducted pre-clinical development of HyStem Rx as an implantable cell delivery device
Conducted toxicology studies of Hystem-Rx in the brains of laboratory mice. Results show no difference in reactive astrocytes, macrophages/microglia, neuronal number or blood vessel structure between saline controls and Hystem-Rx. There was no evidence of granulomata or foreign body reaction around either saline or Hystem-Rx injection sites.
Two U.S. patents issued on hydrogels
|
Company
|
Product Program
|
Status
|
ReCyte Therapeutics
|
Therapeutic products for cardiovascular and blood diseases utilizing its proprietary ReCyte™ iPS technology.
|
Evaluating effects of telomere length on growth potential of iPS cells and iPS-derived progenitor lines.
Through BioTime, formed a collaboration with researchers at Cornell Weill Medical College to derive clinical vascular endothelium for the treatment of age-related vascular disease.
Demonstrated the feasibility of producing highly purified product using ACTCellerate
™
technology.
|
BioTime
|
Hextend – Blood plasma volume expanders
|
Hextend is currently marketed to hospitals and physicians in the USA and Korea. Activities include complying with all regulatory requirements and promotional activities.
|
BioTime Asia
|
Distributing ACTCellerate hEPC lines growth media and reagents
|
Initial sales of cell lines, growth media, and differentiation kits, to customers in Asia.
|
Cell Cure Neurosciences
|
OpRegen™ and OpRegen-Plus™ for treatment of age related macular degeneration
|
Conducted animal model studies to establish proof of concept.
Developed directed differentiation as efficient method for short culture period to produce a supply of retinal pigment epithelial cells.
Granted Teva Pharmaceutical Industries, Ltd. an option to complete clinical development of, and to manufacture, distribute, and sell, OpRegen™ and OpRegen-Plus™
|
LifeMap
|
Stem cell database
|
Developing a database that will permit users to follow the development of embryonic stem cell lines to the thousands of progenitor cell lines and cell lineages branching from them. We aim to enable researchers to determine which cells they need for their research and provide the cell-related information necessary to better understand and develop therapeutics for various diseases such as diabetes, Parkinson’s disease, heart failure, arthritis, muscular dystrophy, spinal cord injury, macular degeneration, hearing loss, liver failure, and many other disorders where cells and tissues become dysfunctional and need to be replaced.
|
Program
|
|
Amount
|
|
|
Percent
|
|
|||
BioTime and ESI
|
ACTCellerate hEPCs, GMP hES cell lines, and related research products
|
|
$
|
2,274,642
|
|
|
|
24
|
%
|
BioTime
|
CIRM sponsored ACTCellerate technology
|
|
$
|
1,363,363
|
|
|
|
14
|
%
|
OncoCyte
|
Cancer therapy and diagnosis
|
|
$
|
1,663,869
|
|
|
|
17
|
%
|
OrthoCyte
|
Orthopedic therapy; hydrogel products
|
|
$
|
1,050,423
|
|
|
|
11
|
%
|
ReCyte Therapeutics
|
iPS and vascular therapy
|
|
$
|
265,350
|
|
|
|
3
|
%
|
BioTime
|
Hextend
|
|
$
|
247,571
|
|
|
|
2
|
%
|
BioTime Asia
|
Stem cell products for research
|
|
$
|
145,149
|
|
|
|
2
|
%
|
Cell Cure Neurosciences
|
OpRegen,™ OpRegen-Plus,™ and neurological disease therapies
|
|
$
|
2,283,475
|
|
|
|
24
|
%
|
LifeMap
|
Stem cell database
|
|
$
|
278,594
|
|
|
|
3
|
%
|
Company
|
|
Amount
|
|
|
Percent
|
|
||
BioTime
|
|
$
|
2,903,762
|
|
|
|
45
|
%
|
BioTime Asia
|
|
$
|
802,951
|
|
|
|
12
|
%
|
Cell Cure Neurosciences*
|
|
$
|
436,790
|
|
|
|
7
|
%
|
ESI*
|
|
$
|
363,670
|
|
|
|
6
|
%
|
LifeMap
|
|
$
|
236,713
|
|
|
|
4
|
%
|
OncoCyte
|
|
$
|
505,308
|
|
|
|
8
|
%
|
OrthoCyte
|
|
$
|
769,650
|
|
|
|
12
|
%
|
ReCyte Therapeutics
|
|
$
|
358,546
|
|
|
|
6
|
%
|
Exhibit Numbers
|
Description
|
2.1
|
Agreement and Plan of Merger, dated February 11, 2011, between Glycosan BioSystems, Inc., OrthoCyte Corporation, and BioTime, Inc. (1)
|
3.1
|
Articles of Incorporation with all amendments. (2)
|
3.2
|
By-Laws, As Amended. (3)
|
10.1
|
License Agreement between BioTime, Inc. and Cornell University (Portions of this exhibit have been omitted pursuant to a request for confidential treatment)*
|
10.2
|
Employment Agreement, dated October 3, 2011, between BioTime, Inc. and Peter S. Garcia *
|
31
|
Rule 13a-14(a)/15d-14(a) Certification.*
|
32
|
Section 1350 Certification.*
|
101
|
Interactive Data File
|
101.INS
|
XBRL Instance Document *
|
101.SCH
|
XBRL Taxonomy Extension Schema *
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase *
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase *
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase *
|
101.DEF
|
XBRL Taxonomy Extension Definition Document *
|
(1)
|
Incorporated by reference to BioTime’s Form 10-K for the year ended December 31, 2010.
|
(2)
|
Incorporated by reference to Registration Statement on Form S-1, File Number 33-44549 filed with the Securities and Exchange Commission on December 18, 1991, and Amendment No. 1 and Amendment No. 2 thereto filed with the Securities and Exchange Commission on February 6, 1992 and March 7, 1992, respectively.
|
(3)
|
Incorporated by reference to Registration Statement on Form S-1, File Number 33-48717 and Post-Effective Amendment No. 1 thereto filed with the Securities and Exchange Commission on June 22, 1992, and August 27, 1992, respectively.
|
*
|
Filed herewith
|
|
BIOTIME, INC.
|
|
|
|
|
Date:
November 8,
2011
|
/s/ Michael D. West
|
|
|
Michael D. West
|
|
|
Chief Executive Officer
|
Date:
November 8,
2011
|
/s/ Peter Garcia
|
|
|
Peter Garcia
|
|
|
Chief Financial Officer
|
Exhibit Numbers
|
Description
|
2.1
|
Agreement and Plan of Merger, dated February 11, 2011, between Glycosan BioSystems, Inc., OrthoCyte Corporation, and BioTime, Inc. (1)
|
3.1
|
Articles of Incorporation with all amendments. (2)
|
3.2
|
By-Laws, As Amended. (3)
|
License Agreement between BioTime, Inc. and Cornell University (Portions of this exhibit have been omitted pursuant to a request for confidential treatment)*
|
Employment Agreement, dated October 3, 2011, between BioTime, Inc. and Peter S. Garcia *
|
Rule 13a-14(a)/15d-14(a) Certification.*
|
Section 1350 Certification.*
|
101
|
Interactive Data File *
|
101.INS
|
XBRL Instance Document *
|
101.SCH
|
XBRL Taxonomy Extension Schema *
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase *
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase *
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase *
|
(1)
|
Incorporated by reference to BioTime’s Form 10-K for the year ended December 31, 2010.
|
(2)
|
Incorporated by reference to Registration Statement on Form S-1, File Number 33-44549 filed with the Securities and Exchange Commission on December 18, 1991, and Amendment No. 1 and Amendment No. 2 thereto filed with the Securities and Exchange Commission on February 6, 1992 and March 7, 1992, respectively.
|
(3)
|
Incorporated by reference to Registration Statement on Form S-1, File Number 33-48717 and Post-Effective Amendment No. 1 thereto filed with the Securities and Exchange Commission on June 22, 1992, and August 27, 1992, respectively.
|
*
|
Filed herewith
|
RECITALS
|
1 |
ARTICLE 1. DEFINITIONS
|
2 |
ARTICLE 2. GRANTS5
|
5 |
ARTICLE 3. CONSIDERATION
|
6 |
ARTICLE 4. REPORTS, RECORDS AND PAYMENTS
|
10 |
ARTICLE 5. PATENT MATTERS
|
13 |
ARTICLE 6. GOVERNMENTAL MATTERS
|
14 |
ARTICLE 7. TERMINATION OF THE AGREEMENT
|
14 |
ARTICLE 8. LIMITED WARRANTY AND INDEMNIFICATION
|
15 |
ARTICLE 9. USE OF NAMES AND TRADEMARKS
|
17 |
ARTICLE 10. MISCELLANEOUS PROVISIONS
|
18 |
Appendix A - DEVELOPMENT REPORT
|
24 |
Appendix B - Commercialization Report
|
26 |
1.1
|
"Affiliate" means any corporation or other business entity which is bound in writing by LICENSEE to the terms set forth in this Agreement and in which LICENSEE owns or controls, directly or indirectly, at least forty percent (40%) of the outstanding stock or other voting rights entitled to elect directors, or in which LICENSEE is owned or controlled directly or indirectly by at least forty percent (40%) of the outstanding stock or other voting rights entitled to elect directors; but in any country where the local law does not permit foreign equity participation of at least forty percent (40%), then an "Affiliate" includes any company in which LICENSEE owns or controls or is owned or controlled by, directly or indirectly, the maximum percentage of outstanding stock or voting rights permitted by local law.
|
1.2
|
"Sublicense" means an agreement into which LICENSEE enters with a third party that is not an Affiliate for the purpose of (i) granting certain rights; (ii) granting an option to certain rights; or (iii) forbearing the exercise of any rights, granted to LICENSEE under this Agreement after Effective Date. "Sublicensee" means a third party with whom LICENSEE enters into a Sublicense.
|
1.3
|
"Field" means (1) cell therapy for age- and diabetes-related vascular diseases and cancer only in human therapeutics (2) human cell therapy Combination Products wherein human vascular or vascular forming cells are utilized with other human cell types for the purpose of enhancing the viability of the graft of other human cell types, in human therapeutics (3) cell-based products for the Research Market only and (4) non-cell-based products for the Research Market only.
|
1.4
|
"Territory" means worldwide.
|
1.5
|
"Term" means the period of time beginning on Effective Date and ending on the later of (i) the expiration date of the longest-lived patent in Patent Rights; or (ii) on a country-by-country basis, the twenty-first (21st) anniversary of the first commercial sale of a Licensed Product.
|
1.6
|
"Patent Rights" means CRF's or Cornell’s right in any of the following: the PCT patent application (serial number PCT/US10/61970, titled " Methods For Developing Endothelial Cells From Pluripotent Cells and Endothelial Cells Derived") and a US provisional patent application to be filed on D5302 disclosing and claiming the Inventions, filed by Inventors and assigned to CRF or Cornell; and continuing applications thereof including divisions, and continuations-in-part (but only to extent the claims thereof are directed to subject matter specifically described in said applications); any patents issuing on said applications including reissues, reexaminations and extensions; and claims of all foreign patent applications, patents, and other intellectual property which are directed to subject matter specifically described in said applications.
|
1.7
|
"Technology" means the technical information and know-how relating to the Invention that exists as of the Effective Date and that Cornell or the Inventor provide to LICENSEE prior to the Effective Date and during the Term of this Agreement for the purpose of developing Licensed Product as later defined below. Technology shall include any tangible materials such as cell lines, transgenic animals and/or vectors and clones that exist as of the Effective Date and that Cornell may provide to LICENSEE during the Term of this Agreement.
|
1.8
|
"Research Market" means use by consumers in laboratories of academic, government, industrial, clinical, or other institutions who determine for themselves that they are entitled to purchase and/or use Licensed Products labeled "For Research Use Only - Not for any clinical or therapeutic use in Humans or Animals" or a reasonable equivalent thereto. The Research Market expressly excludes, everywhere in the world, use of Licensed Products for the diagnosis of, or predisposition to, or therapy of a disease state in humans or animals.
|
1.9
|
"Licensed Method" means any method that uses Technology, or is claimed in Patent Rights the use of which would constitute, but for the license granted to LICENSEE under this Agreement, an infringement, an inducement to infringe or contributory infringement, of any pending or issued claim within Patent Rights. For the purpose of this Agreement, LICENSEE agrees that the above definition shall be interpreted as if Cornell or CRF is the sole owner and assignee of Patent Rights.
|
1.10
|
"Licensed Product" means any service, composition or product that uses Technology, or is claimed in Patent Rights, or that is produced or enabled by Licensed Method, or the manufacture, use, sale, offer for sale, or importation of which would constitute, but for the license granted to LICENSEE under this Agreement, an infringement, an inducement to infringe or contributory infringement, of any pending or issued claim within the Patent Rights. For the purpose of this Agreement, LICENSEE agrees that the above definition shall be interpreted as if Cornell or CRF is the sole owner and assignee of Patent Rights.
|
1.11
|
"Net Sales" means the total of the gross invoice prices of Licensed Products sold or leased by LICENSEE, Sublicensee, Affiliate or any combination thereof, less the sum of the following actual and customary deductions where applicable and separately listed: cash, trade, or quantity discounts; sales, use, tariff, import/export duties or other excise taxes imposed on particular sales (except for value-added and income taxes imposed on the sales of Licensed Product in foreign countries); transportation charges; or credits to customers because of rejections or returns. For purposes of calculating Net Sales, (i) transfers of Licensed Products to a Sublicensee of Licensed Product under this Agreement for end use (but not resale) by the Sublicensee shall be treated as sales by LICENSEE at the list price of LICENSEE in an arm-length transaction, or (ii) transfers of Licensed Products to an Affiliate for resale by the Affiliate shall be treated as sales at
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
, in each case subject to the deductions described in the first sentence of this paragraph. For the avoidance of doubt, any Licensed Product sold or transferred from LICENSEE to an Affiliate or Sublicensee for which royalties are paid as required by Paragraph 3.1 (d) (iv) or 3.1 (f), respectively, will be subject to a royalty payment only upon sale by the Affiliate or Sublicensee.
|
1.12
|
“Patent Costs” means all out-of-pocket expenses for the preparation, filing, prosecution, and maintenance of all United States and foreign patents included in Patent Rights. Patent Costs shall also include reasonable out-of-pocket expenses for patentability opinions, inventorship review and determination, preparation and prosecution of patent application, re-examination, re-issue, interference, opposition activities related to patents or applications in Patent Rights
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
.
|
1.13
|
“Combination Product" means any product which is a Licensed Product and contains other product(s) or product component(s) ("Component") that is not an excipient, diluent, adjuvant, buffer, inert carrier material and the like and (i) does not use Invention, Technology or Patent Rights; (ii) the sale, use or import of each by itself does not contribute to or induce the infringement of Patent Rights; (iii) is sold separately by LICENSEE, its Sublicensee or an Affiliate; and (iv) enhances the market price of the final product(s) sold, used or imported by LICENSEE, its Sublicensee, or an Affiliate.
|
1.14
|
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
|
1.15
|
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
|
1.16
|
“
Valid Patent Claim
” shall mean either (a) a claim of an issued and unexpired patent included within the Patent Rights, which has not been held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise or (b) a claim of a pending patent application included within the Patent Rights, which claim was filed in good faith and has not been abandoned or finally disallowed without the possibility of appeal or refiling of such application.
|
Amount | Date or Event |
(i)
|
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
1st Year Research Products sales reach
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
|
(ii)
|
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
|
(iii)
|
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
|
(iv)
|
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
|
(v)
|
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
|
Percentage of Sublicensee
|
Events achieved by | |
fee payable to Cornell
|
LICENSEE prior to issuance | |
of Sublicense by LICENSEE |
|
(iii)
|
Royalties earned on sales occurring or under Sublicenses granted pursuant to this Agreement in any country outside the United States
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
|
|
(A)
|
LICENSEE can demonstrate by written records was previously known to it;
|
|
(B)
|
is now, or becomes in the future, public knowledge other than through acts or omissions of LICENSEE;
|
|
(C)
|
is lawfully obtained by LICENSEE from sources independent of Cornell;
|
|
(D)
|
is required to be disclosed by law or a court of competent jurisdiction; or
|
|
(E)
|
is disclosed to a third party who has entered into a written agreement to use and maintain the confidentiality of Confidential Information in connection with a (i) prospective Sublicense, (ii) a prospective merger or consolidation with or investment in or joint venture with LICENSEE or any Affiliate or Sublicensee, (iii) a prospective agreement for the research and development of a Licensed Product, or (iv) a prospective agreement to manufacture, sell, market, or distribute any Licensed Product.
|
BIOTIME, INC.: | CORNELL UNIVERSITY : | |||
By: | /s/ Michael D. West | By: | /s/ Alan S. Paau | |
(Signature of an authorized officer)
|
(Signature of an authorized officer)
|
|||
Name: | Michael D. West | Alan S. Paau, M.B.A, Ph.D. | ||
Title: | CEO |
Vice Provost for Technology Transfer
and Economic Development
|
||
Date: | 8/30/2011 | Date: | 8/23/2011 | |
ATTEST: | ATTEST: | |||
By: | /s/ Andrea Park | By: | /s/ Annie Cheng | |
(Signature of a witness)
|
(Signature of a witness)
|
|||
Name: | Andrea Park | Name: | Annie Cheng | |
Date: | 8/30/2011 | Date: | 8/23/2011 |
Company Name
|
CCTEC Agreement No
|
Your Reference No
|
Reporting Period
(
mm / dd / yyyy
)
From
______ / ______ / ______
Through
_____ / ______ / _____
|
EXPECTED or ACTUAL
(
mm / dd / yyyy
)
Date of first sale of
Licensed Product(s)
______ / ______ / ______
|
|
Please Check One
Your Company Has:
o
less than 500 employees worldwide
o
500 or more employees worldwide
|
1. Summary of work completed during the reporting period
|
|
2. Summary of work in progress
|
|
3. Current schedule of anticipated events or milestones, e.g. First round of financing, Phase 1 Clinical trials, etc.
|
|
4. Market plans for Introduction of Licensed Product(s)
|
|
5. Summary of resources (dollar value) spent in the reporting period.
|
|
6. Pipeline for Licensed Products
|
|||
Product
Name
|
Developmental
Stage
|
||
Product
Name
|
Developmental
Stage
|
||
Product
Name
|
Developmental
Stage
|
||
Product
Name
|
Developmental
Stage
|
Report Prepared & Approved By
|
||
Name
(
Please Print
)
|
Title
|
Email
|
Signature
|
Date (
mm / dd / yyyy
)
_______ / _______ / _________
__
|
Company Name
|
CCTEC Agreement No
|
Your Reference No
|
Reporting Period
(
mm / dd / yyyy
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From
_______ / _______ / _____________
Through
_______ / _______ / ____________
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EXPECTED or ACTUAL
(
mm / dd / yyyy
)
Date of first sale of
Licensed Product(s)
________ / ________ / ____________
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Please list all trade names for product(s) incorporating licensed rights whether or not you had sales during this reporting period.
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Other Licensed Products in the pipeline
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Product
Name
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Developmental Stage
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Product
Name
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Developmental Stage
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Product
Name
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Developmental Stage
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Product
Name
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Developmental Stage
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Report Prepared & Approved By
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Name
(
Please Print
)
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Title
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Email
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Signature
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Date (
mm / dd / yyyy
)
_________ / _________ / _____________
_
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/s/ Peter S. Garcia | ||
Peter S. Garcia | ||
Address: | 425 Guinda Street | |
Palo Alto, CA 94301 |
By: | /s/Robert W. Peabody | |
Robert W. Peabody, Chief Operating Officer | ||
Address: |
1301 Harbor Bay Parkway, Suite100
Alameda, California 94502
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(a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which the periodic reports are being prepared;
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(b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles
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(c)
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Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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(d)
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Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.
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(a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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(b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: November 8, 2011 | |
/s/ Michael D. West
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Michael D. West
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Chief Executive Officer
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(a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which the periodic reports are being prepared;
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(b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles
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(c)
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Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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(d)
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Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.
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(a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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Date: November 8, 2011 | |
/s/ Peter Garcia
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Peter Garcia
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Chief Financial Officer
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Date: November 8, 2011 |
/s/ Michael D. West
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Michael D. West
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Chief Executive Officer
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/
s/ Peter Garcia
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Peter Garcia
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Chief Financial Officer
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