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| ☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
| ☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
California
|
|
94-3127919
|
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(State or other jurisdiction of incorporation or organization)
|
|
(IRS Employer Identification No.)
|
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Large accelerated filer
|
☐
|
|
Accelerated filer
|
T
|
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Non-accelerated filer
|
☐
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(Do not check if a smaller reporting company)
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Smaller reporting company
|
☐
|
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Item 1.
|
Financial Statements
|
|
|
September 30,
2016
(Unaudited)
(Notes 1, 3 and 4)
|
December 31,
2015
|
||||||
|
ASSETS
|
||||||||
|
CURRENT ASSETS
|
||||||||
|
Cash and cash equivalents
|
$
|
30,451
|
$
|
42,229
|
||||
|
Available for sale securities
|
903
|
753
|
||||||
|
Trade accounts and grants receivable, net
|
1,604
|
1,078
|
||||||
|
Landlord receivable
|
115
|
567
|
||||||
|
Prepaid expenses and other current assets
|
2,079
|
2,610
|
||||||
|
Total current assets
|
35,152
|
47,237
|
||||||
|
|
||||||||
|
Property, plant and equipment, net and construction in progress
|
4,726
|
7,539
|
||||||
|
Deferred license fees
|
145
|
322
|
||||||
|
Deposits and other long-term assets
|
1,011
|
1,299
|
||||||
|
Equity method investment in Asterias, at fair value (Note 4)
|
92,210
|
-
|
||||||
|
Equity method investment in Ascendance
|
3,482
|
4,671
|
||||||
|
Intangible assets, net
|
10,848
|
33,592
|
||||||
|
TOTAL ASSETS
|
$
|
147,574
|
$
|
94,660
|
||||
|
|
||||||||
|
LIABILITIES AND SHAREHOLDERS' EQUITY
|
||||||||
|
CURRENT LIABILITIES
|
||||||||
|
Accounts payable and accrued liabilities
|
$
|
7,176
|
$
|
9,377
|
||||
|
Capital lease liability, current portion
|
173
|
38
|
||||||
|
Promissory notes, current portion
|
95
|
95
|
||||||
|
Related party convertible debt, net of discount, current portion
|
357
|
-
|
||||||
|
Deferred grant income
|
-
|
2,513
|
||||||
|
Deferred license and subscription revenue, current portion
|
537
|
439
|
||||||
|
Total current liabilities
|
8,338
|
12,462
|
||||||
|
|
||||||||
|
LONG-TERM LIABILITIES
|
||||||||
|
Deferred revenues, net of current portion
|
385
|
615
|
||||||
|
Deferred rent liabilities, net of current portion
|
46
|
158
|
||||||
|
Lease liability
|
1,348
|
4,400
|
||||||
|
Related party convertible debt, net of discount, net of current portion
|
954
|
324
|
||||||
|
Promissory notes, net of current portion
|
173
|
220
|
||||||
|
Capital lease, net of current and other liabilities
|
89
|
34
|
||||||
|
TOTAL LIABILITIES
|
11,333
|
18,213
|
||||||
|
|
||||||||
|
Commitments and contingencies (Note 13)
|
||||||||
|
|
||||||||
|
SHAREHOLDERS' EQUITY
|
||||||||
|
Preferred shares, no par value, 2,000 shares authorized; none issued and outstanding
|
-
|
-
|
||||||
|
Common shares, no par value, 150,000 shares authorized; 103,392 shares issued and 102,772 shares outstanding at September 30, 2016; 94,894 issued and 90,421 outstanding at December 31, 2015
|
313,506
|
274,342
|
||||||
|
Accumulated other comprehensive loss
|
(690
|
)
|
(237
|
)
|
||||
|
Accumulated deficit
|
(190,534
|
)
|
(229,181
|
)
|
||||
|
Treasury stock at cost: 620 shares at September 30, 2016 and 4,473 shares at December 31, 2015
|
(2,891
|
)
|
(18,033
|
)
|
||||
|
BioTime, Inc. shareholders' equity
|
119,391
|
26,891
|
||||||
|
Non-controlling interest
|
16,850
|
49,556
|
||||||
|
Total shareholders' equity
|
136,241
|
76,447
|
||||||
|
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY
|
$
|
147,574
|
$
|
94,660
|
||||
|
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
||||||||||||||
|
|
2016
|
2015
|
2016
|
2015
|
||||||||||||
|
REVENUES:
|
||||||||||||||||
|
Grant income
|
$
|
1,109
|
$
|
1,466
|
$
|
3,346
|
$
|
3,596
|
||||||||
|
Royalties from product sales and license fees
|
177
|
357
|
463
|
631
|
||||||||||||
|
Subscription and advertisement revenues
|
69
|
343
|
700
|
1,020
|
||||||||||||
|
Sale of research products and services
|
144
|
140
|
331
|
328
|
||||||||||||
|
Total revenues
|
1,499
|
2,306
|
4,840
|
5,575
|
||||||||||||
|
|
||||||||||||||||
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Cost of sales
|
(58
|
)
|
(432
|
)
|
(378
|
)
|
(957
|
)
|
||||||||
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|
||||||||||||||||
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Gross Profit
|
1,441
|
1,874
|
4,462
|
4,618
|
||||||||||||
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|
||||||||||||||||
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OPERATING EXPENSES:
|
||||||||||||||||
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Research and development
|
(6,422
|
)
|
(11,433
|
)
|
(29,093
|
)
|
(29,816
|
)
|
||||||||
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General and administrative
|
(4,574
|
)
|
(7,545
|
)
|
(23,083
|
)
|
(18,911
|
)
|
||||||||
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Total operating expenses
|
(10,996
|
)
|
(18,978
|
)
|
(52,176
|
)
|
(48,727
|
)
|
||||||||
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Loss from operations
|
(9,555
|
)
|
(17,104
|
)
|
(47,714
|
)
|
(44,109
|
)
|
||||||||
|
OTHER INCOME/(EXPENSES):
|
||||||||||||||||
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Interest income/(expense), net
|
(167
|
)
|
(12
|
)
|
(513
|
)
|
(207
|
)
|
||||||||
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BioTime’s share of losses in equity method investment in Ascendance
|
(855
|
)
|
-
|
(1,189
|
)
|
-
|
||||||||||
|
Gain on deconsolidation of Asterias (Note 3)
|
-
|
-
|
49,048
|
-
|
||||||||||||
|
Gain on equity method investment in Asterias at fair value (Note 4)
|
40,015
|
-
|
26,532
|
-
|
||||||||||||
|
Other income/(expense), net
|
(173
|
)
|
(573
|
)
|
197
|
(408
|
)
|
|||||||||
|
Total other income/(expense), net
|
38,820
|
(585
|
)
|
74,075
|
(615
|
)
|
||||||||||
|
INCOME (LOSS) BEFORE INCOME TAX BENEFIT
|
29,265
|
(17,689
|
)
|
26,361
|
(44,724
|
)
|
||||||||||
|
|
||||||||||||||||
|
Deferred income tax benefit
|
-
|
948
|
-
|
3,395
|
||||||||||||
|
|
||||||||||||||||
|
NET INCOME (LOSS)
|
29,265
|
(16,741
|
)
|
26,361
|
(41,329
|
)
|
||||||||||
|
|
||||||||||||||||
|
Net loss attributable to non-controlling interest
|
1,934
|
3,115
|
12,286
|
7,762
|
||||||||||||
|
|
||||||||||||||||
|
NET INCOME (LOSS) ATTRIBUTABLE TO BIOTIME, INC.
|
31,199
|
(13,626
|
)
|
38,647
|
(33,567
|
)
|
||||||||||
|
|
||||||||||||||||
|
Dividends on preferred shares
|
-
|
(363
|
)
|
-
|
(415
|
)
|
||||||||||
|
NET INCOME (LOSS) ATTRIBUTABLE TO BIOTIME, INC. COMMON SHAREHOLDERS
|
$ |
31,199
|
$ |
(13,989
|
)
|
$ |
38,647
|
$ |
(33,982
|
)
|
||||||
|
NET INCOME (LOSS) PER COMMON SHARE:
|
||||||||||||||||
|
|
||||||||||||||||
|
BASIC
|
$
|
0.30
|
$
|
(0.18
|
)
|
$
|
0.40
|
$
|
(0.43
|
)
|
||||||
|
DILUTED
|
$
|
0.30
|
$
|
(0.18
|
)
|
$
|
0.39
|
$
|
(0.43
|
)
|
||||||
|
|
||||||||||||||||
|
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK OUTSTANDING:
|
||||||||||||||||
|
BASIC
|
102,711
|
79,224
|
95,484
|
78,619
|
||||||||||||
|
DILUTED
|
103,613
|
79,224
|
99,073
|
78,619
|
||||||||||||
|
|
|
Three Months Ended
September 30,
|
|
|
Nine Months Ended
September 30,
|
|
||||||||||
|
|
|
2016
|
|
|
2015
|
|
|
2016
|
|
|
2015
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|||||||
|
NET INCOME (LOSS)
|
|
$
|
29,265
|
|
|
$
|
(16,741
|
)
|
|
$
|
26,361
|
|
$
|
(41,329
|
)
|
|
|
Other comprehensive income (loss), net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in foreign currency translation
|
|
|
(307)
|
|
|
44
|
|
|
(334)
|
|
|
(273
|
)
|
|||
|
Unrealized gain (loss) on available-for-sale securities, net of taxes
|
|
|
121
|
|
|
-
|
|
|
|
(119
|
)
|
|
|
-
|
|
|
|
COMPREHENSIVE INCOME (LOSS)
|
|
|
29,079
|
|
|
|
(16,697
|
)
|
|
|
25,908
|
|
|
(41,602
|
)
|
|
|
Less: Comprehensive loss attributable to non-controlling interest
|
|
|
1,934
|
|
|
|
3,115
|
|
|
|
12,286
|
|
|
|
7,762
|
|
|
COMPREHENSIVE INCOME (LOSS) ATTRIBUTABLE TO BIOTIME, INC. BEFORE PREFERRED STOCK DIVIDEND
|
|
$
|
31,013
|
|
|
$
|
(13,582
|
)
|
|
$
|
38,194
|
|
|
$
|
(33,840
|
)
|
|
Preferred stock dividend
|
|
|
-
|
|
|
|
(363
|
)
|
|
|
-
|
|
|
|
(415
|
)
|
|
COMPREHENSIVE INCOME (LOSS) ATTRIBUTABLE TO BIOTIME, INC. COMMON SHAREHOLDERS
|
|
$
|
31,013
|
|
|
$
|
(13,945
|
)
|
|
$
|
38,194
|
|
|
$
|
(34,255
|
)
|
|
Nine Months Ended September 30,
|
||||||||
|
2016
|
2015
|
|||||||
|
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
|
Net income (loss) attributable to BioTime, Inc.
|
$
|
38,647
|
$
|
(33,567
|
)
|
|||
|
Net loss allocable to non-controlling interest
|
(12,286
|
)
|
(7,762
|
)
|
||||
|
Adjustments to reconcile net income (loss) attributable to BioTime, Inc. to net cash used in operating activities:
|
||||||||
|
Gain on deconsolidation of Asterias (Note 4)
|
(49,048
|
)
|
-
|
|||||
|
Unrealized gain on equity method investment in Asterias at fair value
|
(26,532
|
)
|
-
|
|||||
|
Depreciation expense
|
996
|
776
|
||||||
|
Amortization of intangible assets
|
2,935
|
3,942
|
||||||
|
Amortization of deferred grant income
|
1,496
|
1,869
|
||||||
|
Amortization of deferred license fees
|
85
|
85
|
||||||
|
Amortization of prepaid rent in common stock
|
-
|
63
|
||||||
|
Stock-based compensation
|
6,303
|
7,189
|
||||||
|
Subsidiary shareholder expense for subsidiary warrants
|
3,125
|
-
|
||||||
|
Amortization of discount on related party convertible debt
|
264
|
182
|
||||||
|
BioTime’s share of losses in equity method investment in Ascendance
|
1,189
|
-
|
||||||
|
Deferred income tax benefit
|
-
|
(3,395
|
)
|
|||||
|
Contingently issuable subsidiary warrants in lieu of investor relations expenses
|
-
|
65
|
||||||
|
Bad debt expense
|
802
|
-
|
||||||
|
Changes in operating assets and liabilities:
|
||||||||
|
Accounts and grants receivable, net
|
(955
|
)
|
98
|
|||||
|
Inventory
|
-
|
6
|
||||||
|
Prepaid expenses and other current assets
|
(1,013
|
)
|
(621
|
)
|
||||
|
Other long term assets
|
-
|
(100
|
)
|
|||||
|
Accounts payable and accrued liabilities
|
367
|
512
|
||||||
|
Accrued interest on related party convertible debt
|
-
|
14
|
||||||
|
Other liabilities
|
33
|
(9)
|
||||||
|
Deferred rent liabilities
|
95
|
(2)
|
||||||
|
Lease liability
|
156
|
(12)
|
||||||
|
Deferred revenues
|
(133)
|
70
|
||||||
|
Net cash used in operating activities
|
(33,474
|
)
|
(30,597
|
)
|
||||
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
|
Deconsolidation of Asterias cash and cash equivalents (Note 3)
|
(8,376
|
)
|
-
|
|||||
|
Purchase of equipment and other assets
|
(1,860
|
)
|
(514
|
)
|
||||
|
Payments on construction in progress
|
(278
|
)
|
(3,830
|
)
|
||||
|
Loan receivable
|
-
|
(500
|
)
|
|||||
|
Security deposit received, net
|
34
|
(9
|
)
|
|||||
|
Net cash used in investing activities
|
(10,480
|
)
|
(4,853
|
)
|
||||
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
|
Proceeds from sales of BioTime common stock in public offering
|
20,125
|
-
|
||||||
|
Discounts and fees paid for sale of BioTime common stock in public offering
|
(1,515
|
)
|
-
|
|||||
|
Proceeds from exercises of stock options
|
2,015
|
621
|
||||||
|
Proceeds from exercise of warrants
|
-
|
19
|
||||||
|
Proceeds from issuance of common shares
|
-
|
8,578
|
||||||
|
Proceeds from sale of treasury stock and subsidiary warrants
|
-
|
11,700
|
||||||
|
Proceeds from sale of treasury shares
|
-
|
576
|
||||||
|
Reimbursement from landlord on construction in progress
|
451
|
2,564
|
||||||
|
Proceeds from issuance of related party convertible debt
|
1,150
|
188
|
||||||
|
Repayment of capital lease obligation
|
(104
|
)
|
(31
|
)
|
||||
|
Proceeds from sale of common shares and warrants of subsidiary
|
10,721
|
11,586
|
||||||
|
Fees paid on sale of common shares and warrants of subsidiary
|
(904
|
)
|
(597
|
)
|
||||
|
Proceeds from exercise of subsidiary stock options
|
-
|
27
|
||||||
|
Net cash provided by financing activities
|
31,939
|
35,231
|
||||||
|
Effect of exchange rate changes on cash and cash equivalents
|
237
|
110
|
||||||
|
NET CHANGE IN CASH AND CASH EQUIVALENTS:
|
(11,778
|
)
|
(109)
|
|||||
|
CASH AND CASH EQUIVALENTS:
|
||||||||
|
At beginning of the period
|
42,229
|
29,487
|
||||||
|
At end of the period
|
$
|
30,451
|
$
|
29,378
|
||||
| 1. |
Organization and Business Overview
|
| · |
BioTime’s
Renevia
®
, a potential treatment for HIV related facial lipoatrophy, is currently in a pivotal clinical trial in Europe to assess its efficacy in restoring normal skin contours in patients whose subcutaneous fat, or adipose tissue, has been lost due to antiviral drug treatment for HIV.
Renevia
®
consists of BioTime’s proprietary cell-transplantation delivery matrix (
HyStem
®
) combined with the patient’s own adipose cells.
|
| · |
BioTime’s majority-owned subsidiary, Cell Cure Neurosciences, Ltd., is developing
OpRegen
®
, a potential therapy derived from pluripotent cells for the treatment of the dry form of age-related macular degeneration.
OpRegen
®
is currently in a Phase I/IIa clinical trial.
|
| · |
Asterias has three clinical stage programs based on proprietary cell therapy platforms:
|
| o |
AST-OPC1
is a therapy derived from pluripotent cells that is currently in a Phase I/IIa clinical trial for spinal cord injuries;
|
| o |
AST-VAC1
is a patient-specific cancer immunotherapy being evaluated by Asterias in Acute Myeloid Leukemia (AML); and
|
| o |
AST-VAC 2
is a non-patient-specific cancer immunotherapy for which the initiation of a Phase I/IIa clinical trial is planned for the first quarter of 2017.
|
| · |
OncoCyte Corporation is developing diagnostic tests for use in detecting a variety of cancers and is presently completing the analysis of human blood samples to validate the sensitivity and specificity of its lung cancer diagnostic test.
|
| 2. |
Basis of Presentation, Liquidity and Summary of Significant Accounting Policies
|
|
|
|
Nine Months Ended
September 30,
(Unaudited)
|
|||||||
|
|
|
2016
|
|
2015
|
|||||
|
Stock options
|
|
|
5,652
|
|
|
|
4,698
|
|
|
|
Warrants
|
|
|
9,395
|
|
|
|
9,191
|
|
|
|
Treasury stock
|
|
|
-
|
|
|
4,719
|
|
||
| 3. |
Deconsolidation of Asterias
|
| 4. |
Equity Method Accounting for Common Stock of Asterias, at fair value
|
|
|
|
Three months
ended
September 30,
2016
|
Nine months
ended
September 30,
2016
|
For the Period
May 13, 2016
through
September 30,
2016
(2)
|
|||||||||
|
Condensed Statements of Operations
(1)
:
|
|
|
|
|
|
|
|
||||||
|
Total revenue
|
|
$
|
2,076
|
|
$
|
5,202
|
|
$
|
2,848
|
|
|||
|
Gross profit
|
|
|
2,017
|
|
|
5,084
|
|
|
2,783
|
|
|||
|
Loss from operations
|
|
|
(7,425
|
) |
|
(25,591
|
)
|
|
(11,647
|
)
|
|||
|
Net loss
|
|
$
|
(10,648
|
) |
$
|
(26,144
|
)
|
$
|
(11,991
|
)
|
|||
|
|
|
September 30, 2016
|
December 31, 2015
|
||||||
|
Condensed Balance Sheet information
(1)
:
|
|
|
|
|
|
||||
|
Current assets
|
|
$
|
35,914
|
|
$
|
12,783
|
|
||
|
Noncurrent assets
|
|
|
34,389
|
|
|
27,445
|
|
||
|
|
|
$
|
70,303
|
|
$
|
40,228
|
|
||
|
|
|
|
|
|
|
|
|
||
|
Current liabilities
|
|
$
|
8,876
|
|
$
|
4,450
|
|
||
|
Noncurrent liabilities
|
|
|
18,701
|
|
|
4,605
|
|
||
|
Stockholders’ equity
|
|
|
42,726
|
|
|
31,173
|
|
||
|
|
|
$
|
70,303
|
|
$
|
40,228
|
|
||
|
|
For the Period
January 1, 2016
through May 12,
2016
|
Three months
ended
September 30,
2015
|
Nine months
ended
September 30,
2015
|
||||||||||
|
Total revenue
|
$
|
2,354
|
$
|
1,423
|
$
|
2,974
|
|||||||
|
Gross profit
|
2,301
|
1,247
|
2,709
|
||||||||||
|
Loss from operations
|
(13,944
|
)
|
(4,555
|
)
|
(13,899
|
)
|
|||||||
|
Net loss
|
$
|
(13,113
|
)
|
$
|
(3,739
|
)
|
$
|
(10,708
|
)
|
||||
| 5. |
Equity Method of Accounting for Common Stock of Ascendance Biotechnology, Inc.
|
| 6. |
Property, plant and equipment, net and construction in progress
|
|
|
September 30, 2016
(Unaudited)
(1)
|
December 31,
2015
|
|||||||
|
Property, plant and equipment
|
$
|
7,405
|
$
|
10,757
|
|||||
|
Construction in progress
|
-
|
93
|
|||||||
|
Accumulated depreciation
|
(2,679
|
)
|
(3,311
|
)
|
|||||
|
Property, plant and equipment, net
|
$
|
4,726
|
$
|
7,539
|
|||||
| 7. |
Intangible assets, net
|
|
|
September 30, 2016
(Unaudited)
(1)
|
December 31,
2015
|
|||||||
|
Intangible assets
|
$
|
25,703
|
$
|
52,563
|
|||||
|
Accumulated amortization
|
(14,855
|
)
|
(18,971
|
)
|
|||||
|
Intangible assets, net
|
$
|
10,848
|
$
|
33,592
|
|||||
| 8. |
Accounts Payable and Accrued Liabilities
|
|
|
September 30, 2016
(Unaudited)
(1)
|
December 31,
2015
|
|||||||
|
Accounts payable
|
$
|
1,687
|
$
|
2,798
|
|||||
|
Accrued expenses
|
3,512
|
5,021
|
|||||||
|
Accrued bonuses
|
1,550
|
1,126
|
|||||||
|
Other current liabilities
|
427
|
432
|
|||||||
|
Total
|
$
|
7,176
|
$
|
9,377
|
|||||
| 9. |
Related Party Transactions and Related Party Convertible Debt
|
| 10. |
Shareholders' Equity
|
|
11.
|
Stock Option Plans
|
|
|
Shares
Available
for Grant
|
Number of
Options and
RSUs
Outstanding
|
Weighted
Average
Exercise
Price
|
||||||||||
|
December 31, 2015
|
5,257
|
5,194
|
$
|
3.93
|
|||||||||
|
Options granted
|
(1,796
|
)
|
1,796
|
2.87
|
|||||||||
|
RSUs granted
|
(200
|
)
|
100
|
-
|
|||||||||
| Common stock issued to consultant in lieu of cash | (20 | ) | - | - | |||||||||
|
Options exercised
|
-
|
-
|
-
|
||||||||||
|
Options forfeited/cancelled
|
275
|
(493
|
)
|
4.46
|
|||||||||
|
September 30, 2016
|
3,516
|
6,597
|
$
|
3.61
|
|||||||||
|
|
September 30,
(Unaudited)
|
||||||||
|
|
2016
|
2015
|
|||||||
|
Expected life (in years)
|
5.97
|
5.49
|
|||||||
|
Risk-free interest rates
|
1.43
|
%
|
1.68
|
%
|
|||||
|
Volatility
|
60.77
|
%
|
64.01
|
%
|
|||||
|
Dividend yield
|
0.00
|
%
|
0.00
|
%
|
|||||
|
Nine Months Ended
September 30,
(Unaudited)
|
|||||||||
|
2016
|
2015
|
||||||||
|
Research and development
|
$
|
2,022
|
$
|
2,507
|
|||||
|
General and administrative
|
4,281
|
4,682
|
|||||||
|
Total stock-based compensation expense
|
$
|
6,303
|
$
|
7,189
|
|||||
|
12.
|
Income Taxes
|
| 13. |
Commitments and Contingencies
|
| 14. |
Subsequent Event
|
|
Item 2.
|
Management's Discussion and Analysis of Financial Condition and Results of Operations
|
| · |
BioTime’s
Renevia
®
, a potential treatment for HIV related facial lipoatrophy, is currently in a pivotal clinical trial in Europe to assess its efficacy in restoring normal skin contours in patients whose subcutaneous fat, or adipose tissue, has been lost due to antiviral drug treatment for HIV.
Renevia
®
consists of BioTime’s proprietary cell-transplantation delivery matrix (
HyStem
®
) combined with the patient’s own adipose cells.
|
| · |
BioTime’s majority-owned subsidiary, Cell Cure Neurosciences, Ltd., is developing
OpRegen
®
, a potential therapy derived from pluripotent cells for the treatment of the dry form of age-related macular degeneration.
OpRegen
®
is currently in a Phase I/IIa clinical trial.
|
| · |
Asterias has three clinical stage programs based on proprietary cell therapy platforms:
|
| o |
AST-OPC1
is a therapy derived from pluripotent cells that is currently in a Phase I/IIa clinical trial for spinal cord injuries;
|
| o |
AST-VAC1
is a patient-specific cancer immunotherapy being evaluated by Asterias in Acute Myeloid Leukemia (AML); and
|
| o |
AST-VAC 2
is a non-patient specific cancer immunotherapy for which the initiation of a Phase I/IIa clinical trial is planned for the first quarter of 2017.
|
| · |
OncoCyte Corporation is developing diagnostic tests for use in detecting a variety of cancers and is presently completing the analysis of human blood samples to validate the sensitivity and specificity of its lung cancer diagnostic test.
|
|
|
September 30, 2016
|
December 31, 2015
|
|||||||
|
Condensed Balance Sheet information
(1)
:
|
|||||||||
|
Current assets
|
$
|
35,914
|
$
|
12,783
|
|||||
|
Noncurrent assets
|
34,389
|
27,445
|
|||||||
|
|
$
|
70,303
|
$
|
40,228
|
|||||
|
|
|||||||||
|
Current liabilities
|
$
|
8,876
|
$
|
4,450
|
|||||
|
Noncurrent liabilities
|
18,701
|
4,605
|
|||||||
|
Stockholders’ equity
|
42,726
|
31,173
|
|||||||
|
|
$
|
70,303
|
$
|
40,228
|
|||||
|
Three months ended September 30, 2016
|
Three months ended September 30, 2015
|
||||||||||||||||||||||||
|
Consolidated
Results of
Operations
|
Asterias
|
Consolidated
Results less
Asterias
|
Consolidated
Results of
Operations
|
Asterias
|
Consolidated
Results less
Asterias
|
||||||||||||||||||||
|
REVENUES:
|
|||||||||||||||||||||||||
|
Subscription and advertisement revenues
|
$
|
69
|
$
|
-
|
$
|
69
|
$
|
343
|
$
|
-
|
$
|
343
|
|||||||||||||
|
Royalties from product sales and license fees
|
177
|
-
|
177
|
357
|
353
|
4
|
|||||||||||||||||||
|
Grant income
|
1,109
|
-
|
1,109
|
1,466
|
1,070
|
396
|
|||||||||||||||||||
|
Sale of research products and services
|
144
|
-
|
144
|
140
|
-
|
140
|
|||||||||||||||||||
|
Total revenues
|
1,499
|
-
|
1,499
|
2,306
|
1,423
|
883
|
|||||||||||||||||||
|
Cost of sales
|
(58
|
)
|
-
|
(58
|
)
|
(432
|
)
|
(176
|
)
|
(256
|
)
|
||||||||||||||
|
Gross Profit
|
1,441
|
-
|
1,441
|
1,874
|
1,247
|
627
|
|||||||||||||||||||
|
OPERATING EXPENSES:
|
|||||||||||||||||||||||||
|
Research and development
|
6,422
|
-
|
6,422
|
11,433
|
4,550
|
6,883
|
|||||||||||||||||||
|
General and administrative
|
4,574
|
-
|
4,574
|
7,545
|
1,252
|
6,293
|
|||||||||||||||||||
|
Total operating expenses
|
10,996
|
-
|
10,996
|
18,978
|
5,802
|
13,176
|
|||||||||||||||||||
|
Loss from operations
|
(9,555
|
)
|
-
|
(9,555
|
)
|
(17,104
|
)
|
(4,555
|
)
|
(12,549
|
)
|
||||||||||||||
|
Nine months ended September 30, 2016
|
Nine months ended September 30, 2015
|
||||||||||||||||||||||||
|
Consolidated
Results of
Operations
|
Asterias
(133 days)
|
Consolidated
Results less
Asterias
|
Consolidated
Results of
Operations
|
Asterias
|
Consolidated
Results less
Asterias
|
||||||||||||||||||||
|
REVENUES:
|
|||||||||||||||||||||||||
|
Subscription and advertisement revenues
|
$
|
700
|
$
|
-
|
$
|
700
|
$
|
1,020
|
$
|
-
|
$
|
1,020
|
|||||||||||||
|
Royalties from product sales and license fees
|
463
|
107
|
356
|
631
|
528
|
103
|
|||||||||||||||||||
|
Grant income
|
3,346
|
2,247
|
1,099
|
3,596
|
2,406
|
1,190
|
|||||||||||||||||||
|
Sale of research products and services
|
331
|
-
|
331
|
328
|
40
|
288
|
|||||||||||||||||||
|
Total revenues
|
4,840
|
2,354
|
2,486
|
5,575
|
2,974
|
2,601
|
|||||||||||||||||||
|
Cost of sales
|
(378
|
)
|
(53
|
)
|
(325
|
)
|
(957
|
)
|
(265)
|
)
|
(692
|
)
|
|||||||||||||
|
Gross Profit
|
4,462
|
2,301
|
2,161
|
4,618
|
2,709
|
1,909
|
|||||||||||||||||||
|
OPERATING EXPENSES:
|
|||||||||||||||||||||||||
|
Research and development
|
29,093
|
8,684
|
20,409
|
29,816
|
11,839
|
17,977
|
|||||||||||||||||||
|
General and administrative
|
23,083
|
7,561
|
15,522
|
18,911
|
4,769
|
14,142
|
|||||||||||||||||||
|
Total operating expenses
|
52,176
|
16,245
|
35,931
|
48,727
|
16,608
|
32,119
|
|||||||||||||||||||
|
Loss from operations
|
(47,714
|
)
|
(13,944
|
)
|
(33,770
|
)
|
(44,109
|
)
|
(13,899
|
)
|
(30,210
|
)
|
|||||||||||||
|
Three Months Ended September 30,
|
$ Increase/
|
% Increase/
|
|||||||||||||||
|
2016
|
2015
|
Decrease
|
Decrease
|
||||||||||||||
|
Research and development expenses
|
$
|
6,422
|
$
|
11,433
|
$
|
-5,011
|
-43.8
|
%
|
|||||||||
|
General and administrative expenses
|
4,574
|
7,545
|
-2,971
|
-39.4
|
%
|
||||||||||||
|
|
Nine Months Ended September 30,
|
$ Increase/
|
% Increase/
|
||||||||||||||
|
|
2016
|
2015
|
Decrease
|
Decrease
|
|||||||||||||
|
Research and development expenses
|
$
|
29,093
|
$
|
29,816
|
$
|
-723
|
-2.4
|
%
|
|||||||||
|
General and administrative expenses
|
23,083
|
18,911
|
+4,172
|
+22.1
|
%
|
||||||||||||
|
|
|
Amount
(1)
|
Percent
|
|||||||||||||||
|
Company
|
Program
|
2016
|
2015
|
2016
|
2015
|
|||||||||||||
|
BioTime and ESI
|
PureStem
®
progenitor and pluripotent cell lines, and related research products
|
$ |
1,420
|
$ |
1,261
|
22.2
|
%
|
11.0
|
%
|
|||||||||
|
BioTime
|
Renevia
®
and other
HyStem
®
products and
research
|
821
|
1,111
|
12.8
|
%
|
9.7
|
%
|
|||||||||||
|
BioTime
|
Hextend
®
|
12
|
12
|
0.2
|
%
|
0.1
|
%
|
|||||||||||
|
Cell Cure Neurosciences
(2)
|
OpRegen
®
|
1,132
|
929
|
17.6
|
%
|
8.1
|
%
|
|||||||||||
|
OrthoCyte
|
Orthopedic therapy
|
157
|
133
|
2.4
|
%
|
1.2
|
%
|
|||||||||||
|
ReCyte Therapeutics
|
Cardiovascular therapy
|
246
|
256
|
3.8
|
%
|
2.3
|
%
|
|||||||||||
|
Subtotal therapeutic projects
|
3,788
|
3,702
|
59.0
|
%
|
32.4
|
%
|
||||||||||||
|
Asterias
|
Pluripotent cell therapy programs
|
-
|
4,550
|
-
|
% |
39.8
|
%
|
|||||||||||
|
LifeMap Sciences
(3)
|
Databases and mobile health products
|
1,323
|
1,434
|
20.6
|
%
|
12.5
|
%
|
|||||||||||
|
OncoCyte
|
Cancer diagnostics
|
1,311
|
1,747
|
20.4
|
%
|
15.3
|
%
|
|||||||||||
|
Subtotal non-therapeutic projects
|
2,634
|
3,181
|
41.0
|
%
|
27.8
|
%
|
||||||||||||
|
Total projects
|
|
$
|
6,422
|
$
|
11,433
|
100.0
|
%
|
100.0
|
%
|
|||||||||
|
|
|
Amount
(1)
|
Percent
|
|||||||||||||||
|
Company
|
Program
|
2016
|
2015
|
2016
|
2015
|
|||||||||||||
|
BioTime and ESI
|
PureStem
®
progenitor and pluripotent cell lines, and related research products
|
$ |
4,633
|
$ |
3,587
|
15.9
|
%
|
12.0
|
%
|
|||||||||
|
BioTime
|
Renevia
®
and other
HyStem
®
products and
research
|
2,845
|
2,774
|
9.8
|
%
|
9.3
|
%
|
|||||||||||
|
BioTime
|
Hextend
®
|
42
|
41
|
0.1
|
%
|
0.1
|
%
|
|||||||||||
|
Cell Cure Neurosciences
(2)
|
OpRegen
®
|
3,150
|
2,729
|
10.8
|
%
|
9.2
|
%
|
|||||||||||
|
OrthoCyte
|
Orthopedic therapy
|
462
|
468
|
1.6
|
%
|
1.6
|
%
|
|||||||||||
|
ReCyte Therapeutics
|
Cardiovascular therapy
|
687
|
911
|
2.4
|
%
|
3.1
|
%
|
|||||||||||
|
Subtotal therapeutic projects
|
11,819
|
10,510
|
40.6
|
%
|
35.3
|
%
|
||||||||||||
|
Asterias
(3)
|
Pluripotent cell therapy programs
|
8,684
|
11,839
|
29.9
|
%
|
39.7
|
%
|
|||||||||||
|
LifeMap Sciences
(4)
|
Databases and mobile health products
|
4,249
|
3,792
|
14.6
|
%
|
12.7
|
%
|
|||||||||||
|
OncoCyte
|
Cancer diagnostics
|
4,341
|
3,675
|
14.9
|
%
|
12.3
|
%
|
|||||||||||
|
Subtotal non-therapeutic projects
|
8,590
|
7,467
|
29.5
|
%
|
25.0
|
%
|
||||||||||||
|
Total projects
|
|
$
|
29,093
|
$
|
29,816
|
100.0
|
%
|
100.0
|
%
|
|||||||||
|
|
Amount
(1)
|
Percent
|
|||||||||||||||
|
Company
|
2016
|
2015
|
2016
|
2015
|
|||||||||||||
|
BioTime
|
$
|
1,967
|
$
|
2,647
|
43.0
|
%
|
35.1
|
%
|
|||||||||
|
Cell Cure Neurosciences
|
232
|
148
|
5.1
|
%
|
1.9
|
%
|
|||||||||||
|
OrthoCyte
|
128
|
84
|
2.8
|
%
|
1.1
|
%
|
|||||||||||
|
ReCyte Therapeutics
|
96
|
100
|
2.1
|
%
|
1.3
|
%
|
|||||||||||
|
ESI
|
134
|
45
|
2.9
|
%
|
0.6
|
%
|
|||||||||||
|
Subtotal therapeutic entities
|
2,557
|
3,024
|
55.9
|
%
|
40.0
|
%
|
|||||||||||
|
Asterias
|
-
|
1,252
|
-
|
%
|
16.6
|
%
|
|||||||||||
|
LifeMap Sciences
(2)
|
847
|
1,287
|
18.5
|
%
|
17.1
|
%
|
|||||||||||
|
OncoCyte
|
1,170
|
1,982
|
25.6
|
%
|
26.3
|
%
|
|||||||||||
|
Subtotal non-therapeutic entities
|
2,017
|
3,269
|
44.1
|
%
|
43.4
|
%
|
|||||||||||
|
Total
|
$
|
4,574
|
$
|
7,545
|
100.0
|
%
|
100.0
|
%
|
|||||||||
|
|
Amount
(1)
|
Percent
|
|||||||||||||||
|
Company
|
2016
|
2015
|
2016
|
2015
|
|||||||||||||
|
BioTime
|
$
|
6,456
|
$
|
6,112
|
27.9
|
%
|
32.4
|
%
|
|||||||||
|
Cell Cure Neurosciences
|
919
|
444
|
4.0
|
%
|
2.3
|
%
|
|||||||||||
|
ESI
|
248
|
161
|
1.1
|
%
|
0.9
|
%
|
|||||||||||
|
OrthoCyte
|
475
|
347
|
2.1
|
%
|
1.8
|
%
|
|||||||||||
|
ReCyte Therapeutics
|
447
|
321
|
1.9
|
%
|
1.7
|
%
|
|||||||||||
|
Subtotal therapeutic entities
|
8,545
|
7,385
|
37.0
|
%
|
39.1
|
%
|
|||||||||||
|
Asterias
(2)
|
7,561
|
4,769
|
32.8
|
%
|
25.2
|
%
|
|||||||||||
|
LifeMap Sciences
(3)
|
2,720
|
4,048
|
11.8
|
%
|
21.4
|
%
|
|||||||||||
|
OncoCyte
|
4,257
|
2,709
|
18.4
|
%
|
14.3
|
%
|
|||||||||||
|
Subtotal non-therapeutic entities
|
6,977
|
6,757
|
30.2
|
%
|
35.7
|
%
|
|||||||||||
|
Total
|
$
|
23,083
|
$
|
18,911
|
100.0
|
%
|
100.0
|
%
|
|||||||||
|
Item 3.
|
Quantitative and Qualitative Disclosures about Market Risk
|
|
Item 4.
|
Controls and Procedures
|
|
Item 1.
|
Legal Proceedings.
|
|
Item 1A.
|
Risk Factors
|
| · |
We are attempting to develop new medical products and technology
|
| · |
Some of our experimental products and technologies have not been applied in human medicine and have only been used in laboratory studies
in vitro
or in animals. These new products and technologies might not prove to be safe and efficacious in the human medical applications for which they were developed.
|
| · |
The experimentation we are doing is costly, time consuming, and uncertain as to its results. We incurred research and development expenses amounting to $29.1 million during the nine months ended September 30, 2016, and $42.6 million and $37.5 million during the fiscal years ended December 31, 2015 and 2014, respectively.
|
| · |
If we are successful in developing a new technology or product, refinement of the new technology or product and definition of the practical applications and limitations of the technology or product may take years and require the expenditure of large sums of money. Future clinical trials of new therapeutic products, particularly those products that are regulated as drugs or biological, will be very expensive and will take years to complete. We may not have the financial resources to fund clinical trials on our own and we may have to enter into licensing or collaborative arrangements with larger, well-capitalized pharmaceutical companies in order to bear the cost. Any such arrangements may be dilutive to our ownership or economic interest in the products we develop, and we might have to accept a royalty payment on the sale of the product rather than receiving the gross revenues from product sales.
|
| · |
At September 30, 2016, we had $30.5 million of cash and cash equivalents on hand, of which $15.0 million was held by our subsidiaries. During the nine months ended September 30, 2016, BioTime raised approximately $18.6 million after underwriting discounts and other expenses, and OncoCyte raised approximately $9.8 million in net proceeds after placement agent fees and other expenses, through the sale of equity securities, but there can be no assurance that we or our subsidiaries will be able to raise additional funds on favorable terms or at all, or that any funds raised will be sufficient to permit us or our subsidiaries to develop and market our products and technology. Unless we and our subsidiaries are able to generate sufficient revenue or raise additional funds when needed, it is likely that we will be unable to continue our planned activities, even if we make progress in our research and development projects.
|
| · |
We may have to postpone or limit the pace of our research and development work and planned clinical trials of our product candidates unless our cash resources increase through a growth in revenues or additional equity investment or borrowing.
|
|
Item 2.
|
Unregistered Sales of Equity Securities and Use of Proceeds
|
|
Item 3.
|
Default Upon Senior Securities
|
|
Item 4.
|
Mine Safety Disclosures
|
|
Item 5.
|
Other Information
|
|
Item 6.
|
Exhibits
|
|
Exhibit
|
|
|
Numbers
|
Description
|
|
3.1
|
Articles of Incorporation with all amendments (1)
|
|
3.2
|
By-Laws, as Amended (2)
|
|
10.1
|
Form of OncoCyte Corporation Securities Purchase Agreement (3)
|
|
10.2
|
Alternate Form of OncoCyte Corporation Securities Purchase Agreement (3)
|
|
10.3
|
Form of OncoCyte Corporation Warrant (3)
|
|
Rule 13a-14(a)/15d-14(a) Certification*
|
|
|
Section 1350 Certification*
|
|
|
101
|
Interactive Data Files
|
|
101 INS
|
XBRL Instance Document*
|
|
101SCH
|
XBRL Taxonomy Extension Schema*
|
|
101CAL
|
XBRL Taxonomy Extension Calculation Linkbase*
|
|
101LAB
|
XBRL Taxonomy Extension Label Linkbase*
|
|
101PRE
|
XBRL Taxonomy Extension Presentation Linkbase*
|
|
101DEF
|
XBRL Taxonomy Extension Definition Document*
|
|
(1)
|
Incorporated by reference to BioTime’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016.
|
|
(2)
|
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.
|
|
(3)
|
Incorporated by reference to BioTime’s Current Report on Form 8-K filed with the Securities and Exchange Commission on August 29, 2016.
|
|
*
|
Filed herewith
|
|
|
BIOTIME, INC.
|
|
|
|
|
|
|
Date: November 4, 2016
|
/s/ Michael D. West
|
|
|
|
Michael D. West
|
|
|
|
Co-Chief Executive Officer
|
|
|
Date: November 4, 2016
|
/s/ Aditya Mohanty
|
|
|
|
Aditya Mohanty
|
|
|
|
Co-Chief Executive Officer
|
|
|
Date: November 4, 2016
|
/s/ Russell Skibsted
|
|
|
|
Russell Skibsted
|
|
|
|
Chief Financial Officer
|
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|