These terms and conditions govern your use of the website alphaminr.com and its related services.
These Terms and Conditions (“Terms”) are a binding contract between you and Alphaminr, (“Alphaminr”, “we”, “us” and “service”). You must agree to and accept the Terms. These Terms include the provisions in this document as well as those in the Privacy Policy. These terms may be modified at any time.
Your subscription will be on a month to month basis and automatically renew every month. You may terminate your subscription at any time through your account.
We will provide you with advance notice of any change in fees.
You represent that you are of legal age to form a binding contract. You are responsible for any
activity associated with your account. The account can be logged in at only one computer at a
time.
The Services are intended for your own individual use. You shall only use the Services in a
manner that complies with all laws. You may not use any automated software, spider or system to
scrape data from Alphaminr.
Alphaminr is not a financial advisor and does not provide financial advice of any kind. The service is provided “As is”. The materials and information accessible through the Service are solely for informational purposes. While we strive to provide good information and data, we make no guarantee or warranty as to its accuracy.
TO THE EXTENT PERMITTED BY APPLICABLE LAW, UNDER NO CIRCUMSTANCES SHALL ALPHAMINR BE LIABLE TO YOU FOR DAMAGES OF ANY KIND, INCLUDING DAMAGES FOR INVESTMENT LOSSES, LOSS OF DATA, OR ACCURACY OF DATA, OR FOR ANY AMOUNT, IN THE AGGREGATE, IN EXCESS OF THE GREATER OF (1) FIFTY DOLLARS OR (2) THE AMOUNTS PAID BY YOU TO ALPHAMINR IN THE SIX MONTH PERIOD PRECEDING THIS APPLICABLE CLAIM. SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL OR CERTAIN OTHER DAMAGES, SO THE ABOVE LIMITATION AND EXCLUSIONS MAY NOT APPLY TO YOU.
If any provision of these Terms is found to be invalid under any applicable law, such provision shall not affect the validity or enforceability of the remaining provisions herein.
This privacy policy describes how we (“Alphaminr”) collect, use, share and protect your personal information when we provide our service (“Service”). This Privacy Policy explains how information is collected about you either directly or indirectly. By using our service, you acknowledge the terms of this Privacy Notice. If you do not agree to the terms of this Privacy Policy, please do not use our Service. You should contact us if you have questions about it. We may modify this Privacy Policy periodically.
When you register for our Service, we collect information from you such as your name, email address and credit card information.
Like many other websites we use “cookies”, which are small text files that are stored on your computer or other device that record your preferences and actions, including how you use the website. You can set your browser or device to refuse all cookies or to alert you when a cookie is being sent. If you delete your cookies, if you opt-out from cookies, some Services may not function properly. We collect information when you use our Service. This includes which pages you visit.
We use Google Analytics and we use Stripe for payment processing. We will not share the information we collect with third parties for promotional purposes. We may share personal information with law enforcement as required or permitted by law.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ☒ |
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
|
|
|
(State or other jurisdiction of incorporation or organization)
|
(IRS Employer Identification No.)
|
|
Large accelerated filer
|
☐
|
Accelerated filer
|
☒
|
|
|
Non-accelerated filer
|
☐
|
(Do not check if a smaller reporting company)
|
Smaller reporting company
|
☐
|
|
Emerging growth company
|
☐
|
| Item 1. |
Financial Statements
|
|
September 30, 2017
(Unaudited)
(Notes 1 and 3)
|
December 31,
2016
(Notes 1 and 3)
|
|||||||
|
ASSETS
|
||||||||
|
CURRENT ASSETS
|
||||||||
|
Cash and cash equivalents
|
$
|
16,662
|
$
|
22,088
|
||||
|
Available for sale securities
|
1,511
|
627
|
||||||
|
Grants and other accounts receivable
|
1,420
|
646
|
||||||
|
Receivable from affiliates, net (Note 9)
|
2,278
|
511
|
||||||
|
Prepaid expenses and other current assets
|
1,354
|
1,777
|
||||||
|
Total current assets
|
23,225
|
25,649
|
||||||
|
Property, plant and equipment, net
|
5,423
|
5,529
|
||||||
|
Deposits and other long-term assets
|
1,005
|
1,149
|
||||||
|
Equity method investment in OncoCyte, at fair value (Note 4)
|
110,790
|
-
|
||||||
|
Equity method investment in Asterias, at fair value (Note 5)
|
73,942
|
100,039
|
||||||
|
Intangible assets, net
|
7,482
|
10,206
|
||||||
|
TOTAL ASSETS
|
$
|
221,867
|
$
|
142,572
|
||||
|
LIABILITIES AND SHAREHOLDERS' EQUITY
|
||||||||
|
CURRENT LIABILITIES
|
||||||||
|
Accounts payable and accrued liabilities
|
$
|
5,360
|
$
|
7,144
|
||||
|
Capital lease liability, current portion
|
-
|
202
|
||||||
|
Promissory notes, current portion
|
126
|
99
|
||||||
|
Related party convertible debt, net of discount
|
13
|
833
|
||||||
|
Deferred revenues, current portion
|
513
|
572
|
||||||
|
Total current liabilities
|
6,012
|
8,850
|
||||||
|
LONG-TERM LIABILITIES
|
||||||||
|
Deferred revenues, net of current portion
|
77
|
308
|
||||||
|
Deferred rent liabilities, net of current portion
|
91
|
50
|
||||||
|
Lease liability
|
1,257
|
1,386
|
||||||
|
Capital lease liability, net of current and other liabilities
|
-
|
310
|
||||||
|
Related party convertible debt, net of discount
|
-
|
1,032
|
||||||
|
Promissory notes, net of current portion
|
44
|
120
|
||||||
|
Deferred tax liability
|
4,845
|
-
|
||||||
|
Other long-term liabilities
|
554
|
8
|
||||||
|
TOTAL LIABILITIES
|
12,880
|
12,064
|
||||||
|
Commitments and contingencies (Note 13)
|
||||||||
|
SHAREHOLDERS' EQUITY
|
||||||||
|
Preferred shares, no par value, authorized 2,000 shares; none issued and outstanding as of September 30, 2017 and December 31, 2016
|
-
|
-
|
||||||
|
Common shares, no par value, 150,000 shares authorized; 115,804 shares issued and outstanding as of September 30, 2017, and 103,396 shares issued and 102,776 shares outstanding as of December 31, 2016
|
342,508
|
317,878
|
||||||
|
Accumulated other comprehensive income (loss)
|
141
|
(738
|
)
|
|||||
|
Accumulated deficit
|
(144,363
|
)
|
(196,321
|
)
|
||||
|
Treasury stock at cost: no shares as of September 30, 2017; 620 shares as of December 31, 2016
|
-
|
(2,891
|
)
|
|||||
|
BioTime, Inc. shareholders' equity
|
198,286
|
117,928
|
||||||
|
Noncontrolling interest
|
10,701
|
12,580
|
||||||
|
Total shareholders' equity
|
208,987
|
130,508
|
||||||
|
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY
|
$
|
221,867
|
$
|
142,572
|
||||
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
|
2017
|
2016
|
2017
|
2016
|
|||||||||||||
|
REVENUES:
|
||||||||||||||||
|
Grant income
|
$
|
1,225
|
$
|
1,109
|
$
|
1,236
|
$
|
3,346
|
||||||||
|
Royalties from product sales and license fees
|
86
|
177
|
277
|
463
|
||||||||||||
|
Subscription and advertisement revenues
|
376
|
69
|
940
|
700
|
||||||||||||
|
Sale of research products
|
1
|
144
|
6
|
331
|
||||||||||||
|
Total revenues
|
1,688
|
1,499
|
2,459
|
4,840
|
||||||||||||
|
Cost of sales
|
(52
|
)
|
(58
|
)
|
(114
|
)
|
(378
|
)
|
||||||||
|
Gross Profit
|
1,636
|
1,441
|
2,345
|
4,462
|
||||||||||||
|
OPERATING EXPENSES:
|
||||||||||||||||
|
Research and development
|
(6,562
|
)
|
(6,422
|
)
|
(19,327
|
)
|
(29,093
|
)
|
||||||||
|
General and administrative
|
(4,587
|
)
|
(4,574
|
)
|
(14,111
|
)
|
(23,083
|
)
|
||||||||
|
Total operating expenses
|
(11,149
|
)
|
(10,996
|
)
|
(33,438
|
)
|
(52,176
|
)
|
||||||||
|
Gain on sale of assets
|
-
|
-
|
1,754
|
-
|
||||||||||||
|
Loss from operations
|
(9,513
|
)
|
(9,555
|
)
|
(29,339
|
)
|
(47,714
|
)
|
||||||||
|
OTHER INCOME/(EXPENSES):
|
||||||||||||||||
|
Interest expense, net
|
(10
|
)
|
(167
|
)
|
(729
|
)
|
(513
|
)
|
||||||||
|
Gain on equity method investment in OncoCyte at fair value
|
34,485
|
- |
39,620
|
- | ||||||||||||
|
Gain (loss) on equity method investment in Asterias at fair value
|
(3,262
|
) |
40,015
|
(26,097
|
) |
26,532
|
||||||||||
|
Gain on deconsolidation of OncoCyte
|
- | - | 71,697 | - | ||||||||||||
|
Gain on deconsolidation of Asterias
|
- | - | - |
49,048
|
||||||||||||
|
Loss on extinguishment of related party convertible debt
|
(2,799
|
) | - |
(2,799
|
) | - | ||||||||||
|
BioTime's share of losses in equity method investment in Ascendance Biotechnology, Inc.
|
-
|
(855
|
)
|
-
|
(1,189
|
)
|
||||||||||
|
Other income (expenses), net
|
(143
|
)
|
(173
|
)
|
1,202
|
197
|
||||||||||
|
Total other income, net
|
28,271
|
38,820
|
82,894
|
74,075
|
||||||||||||
|
INCOME BEFORE INCOME TAXES
|
18,758
|
29,265
|
53,555
|
26,361
|
||||||||||||
|
Deferred income tax expense
|
(4,772
|
)
|
-
|
(4,772
|
)
|
-
|
||||||||||
|
NET INCOME
|
13,986
|
29,265
|
48,783
|
26,361
|
||||||||||||
|
Net loss attributable to noncontrolling interests
|
335
|
1,934
|
3,175
|
12,286
|
||||||||||||
|
NET INCOME ATTRIBUTABLE TO BIOTIME, INC.
|
$
|
14,321
|
$
|
31,199
|
$
|
51,958
|
$
|
38,647
|
||||||||
|
NET INCOME PER COMMON SHARE ATTRIBUTABLE TO BIOTIME, INC.:
|
||||||||||||||||
|
BASIC
|
$
|
0.12
|
$
|
0.30
|
$
|
0.47
|
$
|
0.40
|
||||||||
|
DILUTED
|
$
|
0.12
|
$
|
0.30
|
$
|
0.47
|
$
|
0.39
|
||||||||
|
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK OUTSTANDING:
|
||||||||||||||||
|
BASIC
|
115,288
|
102,711
|
110,989
|
95,484
|
||||||||||||
|
DILUTED
|
115,298
|
103,613
|
111,124
|
99,073
|
||||||||||||
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
|
2017
|
2016
|
2017
|
2016
|
|||||||||||||
|
NET INCOME
|
$
|
13,986
|
$
|
29,265
|
$
|
48,783
|
$
|
26,361
|
||||||||
|
Other comprehensive income (loss), net of tax:
|
||||||||||||||||
|
Change in foreign currency translation
|
(349
|
)
|
(307
|
)
|
56
|
(334
|
)
|
|||||||||
|
Available for sale investments:
|
||||||||||||||||
|
Unrealized gain (loss) on available-for-sale securities, net of taxes
|
219
|
121
|
822
|
(119
|
)
|
|||||||||||
|
COMPREHENSIVE INCOME
|
13,856
|
29,079
|
49,661
|
25,908
|
||||||||||||
|
Less: Comprehensive loss attributable to noncontrolling interest
|
335
|
1,934
|
3,175
|
12,286
|
||||||||||||
|
COMPREHENSIVE INCOME ATTRIBUTABLE TO BIOTIME, INC. COMMON SHAREHOLDERS
|
$
|
14,191
|
$
|
31,013
|
$
|
52,836
|
$
|
38,194
|
||||||||
|
Nine Months Ended
September 30,
|
||||||||
|
2017
|
2016
|
|||||||
|
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
|
Net income attributable to BioTime, Inc.
|
$
|
51,958
|
$
|
38,647
|
||||
|
Net loss allocable to noncontrolling interests
|
(3,175
|
)
|
(12,286
|
)
|
||||
|
Adjustments to reconcile net income attributable to BioTime, Inc. to net cash used in operating activities:
|
||||||||
|
Gain on deconsolidation of Asterias
|
-
|
(49,048
|
)
|
|||||
|
Gain on deconsolidation of OncoCyte
|
(71,697
|
)
|
-
|
|||||
|
Unrealized (gain) loss on equity method investment in Asterias at fair value
|
26,097
|
(26,532
|
)
|
|||||
|
Unrealized gain on equity method investment in OncoCyte at fair value
|
(39,620
|
)
|
-
|
|||||
|
Deferred income tax expense
|
4,772
|
-
|
||||||
|
Depreciation expense, including amortization of leasehold improvements
|
670
|
996
|
||||||
|
Amortization of intangible assets
|
1,766
|
2,935
|
||||||
|
Amortization of deferred license fees
|
(166
|
)
|
1,191
|
|||||
|
Stock-based compensation
|
2,903
|
6,303
|
||||||
|
Subsidiary shareholder expense for subsidiary warrants
|
531
|
3,125
|
||||||
|
Amortization of discount on related party convertible debt
|
640
|
264
|
||||||
|
BioTime’s share of losses in equity method investment in Ascendance
|
-
|
1,189
|
||||||
|
Foreign currency remeasurement (gain) or loss and other
|
(1,511
|
)
|
802
|
|||||
|
Gain on sale of assets
|
(1,754
|
)
|
-
|
|||||
|
Loss on extinguishment of related party convertible debt
|
2,799
|
-
|
||||||
|
Changes in operating assets and liabilities:
|
||||||||
|
Grants and other accounts receivable, net
|
(905
|
)
|
(955
|
)
|
||||
|
Deferred revenue and other liabilities
|
(279
|
)
|
509
|
|
||||
|
Receivables from affiliates, net of payables
|
760
|
-
|
||||||
|
Prepaid expenses and other current assets
|
93
|
(1,013
|
)
|
|||||
|
Accounts payable and accrued liabilities
|
1,276
|
399
|
||||||
|
Net cash used in operating activities
|
(24,842
|
)
|
(33,474
|
)
|
||||
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
|
Deconsolidation of cash and cash equivalents of OncoCyte
|
(8,898
|
)
|
-
|
|||||
|
Deconsolidation of cash and cash equivalents of Asterias
|
-
|
(8,376
|
)
|
|||||
|
Purchase of equipment and other assets
|
(930
|
)
|
(1,860
|
)
|
||||
|
Payments on construction in progress
|
-
|
(278
|
)
|
|||||
|
Proceeds from sales of assets and other
|
186
|
34
|
||||||
|
Cash used in investing activities
|
(9,642
|
)
|
(10,480
|
)
|
||||
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
|
Proceeds from sale of common shares
|
20,125
|
20,125
|
||||||
|
Fees paid on sale of common shares
|
(1,623
|
)
|
(1,515
|
)
|
||||
|
Proceeds from sale of common shares of subsidiary
|
9,968
|
-
|
||||||
|
Proceeds from exercises of stock options
|
29
|
2,015
|
||||||
|
Reimbursement from landlord on construction in progress
|
198
|
451
|
||||||
|
Shares retired to pay for employees' taxes
|
(38
|
)
|
-
|
|||||
|
Repayment of capital lease obligation
|
(31
|
)
|
(104
|
)
|
||||
|
Proceeds from sale of common shares and warrants of subsidiary
|
-
|
10,721
|
||||||
|
Fees paid on sale of common shares and warrants of subsidiary
|
-
|
(904
|
)
|
|||||
|
Proceeds from issuance of related party convertible debt
|
384
|
1,150
|
||||||
|
Net cash provided by financing activities
|
29,012
|
31,939
|
||||||
|
Effect of exchange rate changes on cash and cash equivalents
|
46
|
237
|
||||||
|
NET DECREASE IN CASH AND CASH EQUIVALENTS
|
(5,426
|
)
|
(11,778
|
)
|
||||
|
CASH AND CASH EQUIVALENTS:
|
||||||||
|
At beginning of the period
|
22,088
|
42,229
|
||||||
|
At end of the period
|
$
|
16,662
|
$
|
30,451
|
||||
| 1. |
Organization and Business Overview
|
| 2. |
Basis of Presentation, Liquidity and Summary of Significant Accounting Policies
|
|
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
||||||||||||||
|
|
2017
|
2016
|
2017
|
2016
|
||||||||||||
|
Stock options
|
7,915
|
5,652
|
7,871
|
5,652
|
||||||||||||
|
Warrants
|
9,395
|
9,395
|
9,395
|
9,395
|
||||||||||||
| 3. |
Deconsolidation of OncoCyte and Asterias
|
| 4. |
Equity Method Accounting for Common Stock of OncoCyte, at fair value
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
For the Period
January 1, 2017 to
February 16, 2017
|
|||||||||||||||
|
|
2017
|
2016
|
2017
|
2016
|
||||||||||||||||
|
Condensed Statements of Operations (unaudited)
(1)
:
|
||||||||||||||||||||
|
Research and development expense
|
$
|
1,836
|
$
|
1,363
|
$
|
5,667
|
$
|
4,246
|
$
|
798
|
||||||||||
|
General and administrative expense
|
4,289
|
1,063
|
7,447
|
3,145
|
377
|
|||||||||||||||
|
Sales and marketing expense
|
710
|
156
|
1,843
|
655
|
213
|
|||||||||||||||
|
Loss from operations
|
(6,835
|
)
|
(2,582
|
)
|
(14,957
|
)
|
(8,046
|
)
|
(1,388
|
)
|
||||||||||
|
Net loss
|
$
|
(6,906
|
)
|
$
|
(2,595
|
)
|
$
|
(15,415
|
)
|
$
|
(8,065
|
)
|
$
|
(1,392
|
)
|
|||||
| 5. |
Equity Method Accounting for Common Stock of Asterias, at fair value
|
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
For the Period
January 1, 2016 to
May 12, 2016
|
||||||||||||||||||
|
2017
|
2016
|
2017
|
2016
|
|||||||||||||||||
|
Condensed Statements of Operations (unaudited)
(1):
|
||||||||||||||||||||
|
Total revenue
|
$
|
1,688
|
$
|
2,076
|
$
|
4,014
|
$
|
5,202
|
$ |
2,354
|
||||||||||
|
Gross profit
|
1,607
|
2,017
|
3,863
|
5,084
|
2,301 | |||||||||||||||
|
Loss from operations
|
(7,063
|
)
|
(7,425
|
) |
(24,703
|
) |
(25,591
|
) | (13,944 |
)
|
||||||||||
|
Net loss
|
$
|
(6,809
|
)
|
$
|
(10,648
|
) |
$
|
(21,824
|
) |
$
|
(26,144
|
) | $ |
(13,113
|
)
|
|||||
| 6. |
Property, plant and equipment, net
|
|
September 30, 2017
(unaudited)
(1)
|
December 31,
2016
|
|||||||
|
Equipment, furniture and fixtures
|
$
|
4,085
|
$
|
4,718
|
||||
|
Leasehold improvements
|
4,207
|
3,791
|
||||||
|
Accumulated depreciation and amortization
|
(2,869
|
)
|
(2,980
|
)
|
||||
|
Property, plant and equipment, net
|
$
|
5,423
|
$
|
5,529
|
||||
| 7. |
Intangible assets, net
|
|
September 30, 2017
(unaudited)
(1)
|
December 31,
2016
|
|||||||
|
Intangible assets
|
$
|
23,294
|
$
|
25,703
|
||||
|
Accumulated amortization
|
(15,812
|
)
|
(15,497
|
)
|
||||
|
Intangible assets, net
|
$
|
7,482
|
$
|
10,206
|
||||
| 8. |
Accounts Payable and Accrued Liabilities
|
|
September 30, 2017
(unaudited)
(1)
|
December 31,
2016
|
|||||||
|
Accounts payable
|
$
|
508
|
$
|
1,593
|
||||
|
Accrued expenses
|
2,775
|
3,212
|
||||||
|
Accrued compensation
|
1,782
|
1,904
|
||||||
|
Other current liabilities
|
295
|
435
|
||||||
|
Total
|
$
|
5,360
|
$
|
7,144
|
||||
| 9. |
Related Party Transactions
|
| 10. |
Shareholders' Equity
|
| · |
Intellectual property and proprietary technology, including certain patents and patent applications and know-how that comprised BioTime’s “iTR” and adipose brown fat tissue technology;
|
| · |
Approximately 95% of the outstanding shares of ReCyte Therapeutics, Inc. (“ReCyte”) common stock, which constituted all of the shares BioTime held prior to the contribution;
|
| · |
Approximately 82% of the outstanding shares of LifeMap Sciences, Inc. (“LifeMap Sciences”) common stock, which constituted all of the shares BioTime held prior to the contribution;
|
| · |
Approximately 44% of the outstanding shares of Ascendance Biotechnology, Inc., (“Ascendance”) which constituted all of the shares BioTime held prior to the contribution.
|
| · |
$100,000 in cash; and
|
| · |
Certain other assets and contracts related to the AgeX research and development programs.
|
| 11. |
Stock Option Plans
|
|
Shares
Available
for Grant
|
Number of
Options
Outstanding
|
Number
of RSUs
Outstanding
|
Weighted
Average
Exercise
Price
of Options
|
|||||||||||||
|
December 31, 2016
|
2,894
|
6,958
|
100
|
$
|
3.60
|
|||||||||||
|
Increase to the 2012 Plan option pool
|
6,000
|
-
|
-
|
-
|
||||||||||||
|
Options granted
|
(1,762
|
)
|
1,762
|
-
|
3.11
|
|||||||||||
|
Options exercised
|
-
|
(9
|
)
|
-
|
2.66
|
|||||||||||
|
Restricted stock units vested
|
-
|
-
|
(31
|
)
|
-
|
|||||||||||
|
Options forfeited/cancelled
|
426
|
(606
|
)
|
-
|
3.99
|
|||||||||||
|
September 30, 2017
(1)
|
7,558
|
8,105
|
69
|
$
|
3.47
|
|||||||||||
|
Options exercisable at September 30, 2017
|
4,072
|
$
|
3.71
|
|||||||||||||
|
Nine Months Ended
September 30,
|
||||||||
|
2017
|
2016
|
|||||||
|
Expected life (in years)
|
5.47
|
4.97
|
||||||
|
Risk-free interest rates
|
1.78
|
%
|
1.43
|
%
|
||||
|
Volatility
|
59.04
|
%
|
60.77
|
%
|
||||
|
Dividend yield
|
-
|
%
|
-
|
%
|
||||
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|||||||||||||
|
2017
|
|
2016
|
|
2017
|
2016
|
|||||||||||
|
Research and development
|
$
|
326
|
$
|
237
|
$
|
822
|
$
|
2,022
|
||||||||
|
General and administrative
|
647
|
473
|
2,081
|
4,281
|
||||||||||||
|
Total stock-based compensation expense
|
$
|
973
|
$
|
710
|
$
|
2,903
|
$
|
6,303
|
||||||||
| 12. |
Income Taxes
|
| 13. |
Commitments and Contingencies
|
| 14. |
Subsequent Events
|
| Item 2. |
Management's Discussion and Analysis of Financial Condition and Results of Operations
|
|
|
Three Months Ended September 30,
(unaudited)
|
$ Increase/
|
% Increase/
|
|||||||||||||
|
2017
|
|
2016
|
(Decrease)
|
Decrease
|
||||||||||||
|
Total revenues
|
$
|
1,688
|
$
|
1,499
|
$
|
189
|
+13
|
%
|
||||||||
|
|
Nine Months Ended September 30,
(unaudited)
|
$ Increase/
|
% Increase/
|
|||||||||||||
|
2017
|
2016
|
(Decrease)
|
Decrease
|
|||||||||||||
|
Total revenues
|
$
|
2,459
|
$
|
4,840
|
$
|
(2,381
|
)
|
-49
|
%
|
|||||||
|
Three Months Ended September 30,
(unaudited)
|
$ Increase/
|
|
% Increase/
|
|||||||||||||
|
2017
|
|
2016
|
(Decrease)
|
Decrease
|
||||||||||||
|
Research and development expenses
|
$
|
6,562
|
$
|
6,422
|
$
|
140
|
2
|
%
|
||||||||
|
General and administrative expenses
|
4,587
|
4,574
|
13
|
-
|
%
|
|||||||||||
|
Nine Months Ended September 30,
(unaudited)
|
$ Increase/
|
|
% Increase/
|
|||||||||||||
|
2017
|
2016
|
(Decrease)
|
(Decrease)
|
|||||||||||||
|
Research and development expenses
|
$
|
19,327
|
$
|
29,093
|
$
|
(9,766
|
)
|
-34
|
%
|
|||||||
|
General and administrative expenses
|
14,111
|
23,083
|
(8,972
|
)
|
-39
|
%
|
||||||||||
|
Three Months Ended September 30,
(unaudited)
|
|||||||||||||||||
|
Amount
(1)
|
Percent of Total
|
||||||||||||||||
|
Company
|
Program
|
2017
|
2016
|
2017
|
2016
|
||||||||||||
|
BioTime and subsidiaries other than AgeX
(2)
|
OpRegen
®
and
Renevia
®
and other
HyStem
®
products and
PureStem
®
progenitor cell lines for orthopedic applications
|
$
|
5,030
|
$
|
3,067
|
76.7
|
%
|
47.8
|
%
|
||||||||
|
AgeX Therapeutics including ReCyte
(3)
|
PureStem
®
progenitor cell lines, brown adipose fat, iTR technology, and pre-clinical cardiovascular therapy research and development
|
1,072
|
721
|
16.3
|
%
|
11.2
|
%
|
||||||||||
|
LifeMap Sciences, Inc.
(4)
|
Biomedical, gene, disease, and stem cell databases and tools
|
460
|
367
|
7.0
|
%
|
5.7
|
%
|
||||||||||
|
LifeMap Solutions, Inc.
(5)
|
Mobile health software application
|
-
|
956
|
-
|
%
|
14.9
|
%
|
||||||||||
|
Asterias
(6)
|
Pluripotent cell therapy for neurology (spinal cord injury) and oncology (acute myeloid leukemia and lung cancer)
|
-
|
-
|
-
|
%
|
-
|
%
|
||||||||||
|
OncoCyte
(7)
|
Cancer diagnostics
|
-
|
1,311
|
-
|
%
|
20.4
|
%
|
||||||||||
|
Total research and development expenses
|
$
|
6,562
|
$
|
6,422
|
100.0
|
%
|
100.0
|
%
|
|||||||||
|
Nine Months Ended September 30,
(unaudited)
|
|||||||||||||||||
|
Amount
(1)
|
Percent of Total
|
||||||||||||||||
|
Company
|
Program
|
2017
|
2016
|
2017
|
2016
|
||||||||||||
|
BioTime and subsidiaries other than AgeX
(2)
|
OpRegen
®
and
Renevia
®
and other
HyStem
®
products and
PureStem
®
progenitor cell lines for orthopedic applications
|
$
|
14,025
|
$
|
9,570
|
72.6
|
%
|
32.9
|
%
|
||||||||
|
AgeX Therapeutics including ReCyte
(3)
|
PureStem
®
progenitor cell lines, brown adipose fat, iTR technology, and pre-clinical cardiovascular therapy research and development
|
2,873
|
2,249
|
14.9
|
%
|
7.7
|
%
|
||||||||||
|
LifeMap Sciences, Inc.
(4)
|
Biomedical, gene, disease, and stem cell databases and tools
|
1,145
|
1,252
|
5.9
|
%
|
4.3
|
%
|
||||||||||
|
LifeMap Solutions, Inc.
(5)
|
Mobile health software application
|
486
|
2,997
|
2.5
|
%
|
10.3
|
%
|
||||||||||
|
Asterias
(6)
|
Pluripotent cell therapy for neurology (spinal cord injury) and oncology (acute myeloid leukemia and lung cancer)
|
-
|
8,684
|
-
|
%
|
29.9
|
%
|
||||||||||
|
OncoCyte
(7)
|
Cancer diagnostics
|
798
|
4,341
|
4.1
|
%
|
14.9
|
%
|
||||||||||
|
Total research and development expenses
|
$
|
19,327
|
$
|
29,093
|
100.0
|
%
|
100.0
|
%
|
|||||||||
|
Three Months Ended September 30,
(unaudited)
|
||||||||||||||||
|
Amount
(1)
|
Percent
|
|||||||||||||||
|
Company
|
2017
|
2016
|
2017
|
2016
|
||||||||||||
|
BioTime and subsidiaries other than AgeX
(2)
|
$
|
3,844
|
$
|
2,178
|
83.8
|
%
|
47.6
|
%
|
||||||||
|
AgeX Therapeutics including ReCyte
(3)
|
636
|
379
|
13.9
|
%
|
8.3
|
%
|
||||||||||
|
LifeMap Sciences, Inc.
(4)
|
95
|
363
|
2.1
|
%
|
7.9
|
%
|
||||||||||
|
LifeMap Solutions, Inc.
(5)
|
12
|
484
|
.2
|
%
|
10.6
|
%
|
||||||||||
|
Asterias
(6)
|
-
|
-
|
-
|
%
|
-
|
%
|
||||||||||
|
OncoCyte
(7)
|
-
|
1,170
|
-
|
%
|
25.6
|
%
|
||||||||||
|
Total general and administrative expenses
|
$
|
4,587
|
$
|
4,574
|
100.0
|
%
|
100.0
|
%
|
||||||||
|
Nine Months Ended September 30,
(unaudited)
|
||||||||||||||||
|
Amount
(1)
|
Percent
|
|||||||||||||||
|
Company
|
2017
|
2016
|
2017
|
2016
|
||||||||||||
|
BioTime and subsidiaries other than AgeX
(2)
|
$
|
9,996
|
$
|
7,146
|
70.8
|
%
|
31.0
|
%
|
||||||||
|
AgeX Therapeutics including ReCyte
(3)
|
2,212
|
1,399
|
15.7
|
%
|
6.1
|
%
|
||||||||||
|
LifeMap Sciences, Inc.
(4)
|
465
|
1,365
|
3.3
|
%
|
5.9
|
%
|
||||||||||
|
LifeMap Solutions, Inc.
(5)
|
848
|
1,355
|
6.0
|
%
|
5.9
|
%
|
||||||||||
|
Asterias
(6)
|
-
|
7,561
|
-
|
%
|
32.7
|
%
|
||||||||||
|
OncoCyte
(7)
|
590
|
4,257
|
4.2
|
%
|
18.4
|
%
|
||||||||||
|
Total general and administrative expenses
|
$
|
14,111
|
$
|
23,083
|
100.0
|
%
|
100.0
|
%
|
||||||||
|
Three Months Ended
September 30,
(unaudited)
|
Nine Months Ended
September 30,
(unaudited)
|
|||||||||||||||
|
2017
|
2016
|
2017
|
2016
|
|||||||||||||
|
Other income/(expenses), net
|
||||||||||||||||
|
Interest expense, net
|
$
|
(10
|
)
|
$
|
(167
|
)
|
$
|
(729
|
)
|
$
|
(513
|
)
|
||||
|
Gain on equity method investment in OncoCyte at fair value
|
34,485
|
-
|
|
39,620
|
-
|
|
||||||||||
| Gain (loss) on equity method investment in Asterias at fair value |
(3,262
|
) |
40,015
|
(26,097
|
) |
26,532
|
||||||||||
|
Gain on deconsolidation of OncoCyte
|
-
|
-
|
71,697
|
-
|
||||||||||||
|
Gain on deconsolidation of Asterias
|
-
|
|
-
|
-
|
|
49,048
|
||||||||||
|
Loss on extinguishment of related party convertible debt
|
(2,799
|
)
|
-
|
(2,799
|
)
|
-
|
||||||||||
| BioTime's share of losses in equity method investment in Ascendance | - |
(855
|
) | - |
(1,189
|
) | ||||||||||
|
Other income (expenses), net
|
(143
|
)
|
(173
|
)
|
1,202
|
197
|
||||||||||
|
Total other income/(expense), net
|
$
|
28,271
|
$
|
38,820
|
82,894
|
74,075
|
||||||||||
| Item 3. |
Quantitative and Qualitative Disclosures about Market Risk
|
| Item 4. |
Controls and Procedures
|
| Item 1. |
Legal Proceedings.
|
| Item 1A. |
Risk Factors
|
| · |
the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs;
|
| · |
federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent;
|
| · |
the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters;
|
| · |
HIPAA, as amended by the Health Information Technology and Clinical Health Act, (“HITECH”) and our implementing regulations, which imposes certain requirements relating to the privacy, security, and transmission of individually identifiable health information;
|
| · |
The Physician Payments Sunshine Act requires manufacturers of drugs, devices, biologics, and medical supplies to report annually to the U.S. Department of Health and Human Services information related to payments and other transfers of value to physicians, other healthcare providers, and teaching hospitals, and ownership and investment interests held by physicians and other healthcare providers and their immediate family members and applicable group purchasing organizations; and
|
| · |
state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payors, including commercial insurers, state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
|
| · |
the efficacy of the product as demonstrated in clinical studies and potential advantages over competing treatments;
|
| · |
the prevalence and severity of the disease and any side effects;
|
| · |
the clinical indications for which approval is granted, including any limitations or warnings contained in a product’s approved labeling;
|
| · |
the convenience and ease of administration;
|
| · |
the cost of treatment, particular as additive to existing treatments;
|
| · |
the willingness of the patients and physicians to accept and use these therapies;
|
| · |
the marketing, sales and distribution support for the products;
|
| · |
the publicity concerning our products or competing products and treatments; and
|
| · |
the pricing and availability of third-party insurance coverage and reimbursement.
|
| · |
Our estimates have been derived from a variety of sources, including publications and scientific literature estimating the total number of patients, currently approved or used therapies, or market research as well as certain assumptions regarding the potential size of the market assuming broad regulatory approval or potential usage by physicians beyond the approved label, any of which may prove to be incorrect.
|
| · |
The scope of approval and potential use may be significantly narrower and the number of patients may turn out to be lower than expected.
|
| · |
Competitive agents or approaches may be approved or come into use by the relevant medical provider and the potentially addressable patient population for each of our product candidates may be limited or may not be amenable to treatment with our product candidates, and new patients may become increasingly difficult to identify or gain access to, any which could adversely affect our results of operations and our business.
|
| · |
These vendors also source raw materials in order to implement our technology solutions and manufacture our clinical supplies of our product candidates and we plan to continue relying on third parties to manufacture our product candidates on a commercial scale, if approved.
|
| · |
Facilities used by our contract manufacturers to manufacture our product candidates must be approved by the FDA pursuant to inspections that will be conducted after we submit our marketing applications to the FDA.
|
| · |
We do not control the manufacturing process of, and are completely dependent on, our contract manufacturing partners for compliance with the regulatory requirements, known as cGMPs, for manufacture of our product candidates.
|
| · |
If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others, they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities.
|
| · |
We have limited or no control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain or maintain regulatory approval for or market our product candidates, if approved.
|
| · |
We may be unable to identify manufacturers on acceptable terms or at all.
|
| · |
Our third-party manufacturers might be unable to timely formulate and manufacture our product or produce the quantity and quality required to meet our clinical and commercial needs, if any.
|
| · |
Contract manufacturers may not be able to execute our manufacturing procedures appropriately.
|
| · |
Our future contract manufacturers may not perform as agreed or may not remain in the contract manufacturing business for the time required to supply our clinical trials or to successfully produce, store and distribute our products.
|
| · |
Manufacturers are subject to ongoing periodic unannounced inspection by the FDA and corresponding state agencies to ensure strict compliance with cGMP and other government regulations and corresponding foreign standards. We do not have control over third-party manufacturers’ compliance with these regulations and standards.
|
| · |
We may not own, or may have to share, the intellectual property rights to any improvements made by our third-party manufacturers in the manufacturing process for our product candidates.
|
| · |
We may not be able to obtain enabling licenses of third-parties intellectual property rights.
|
| · |
Our third-party manufacturers could breach or terminate their agreement with us.
|
| · |
inability to generate satisfactory preclinical, toxicology, or other in vivo or in vitro data or diagnostics to support the initiation or continuation of clinical studies necessary for product approval;
|
| · |
delays in reaching agreement on acceptable terms with CROs and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical study sites;
|
| · |
delays in obtaining required Institutional Review Board (“IRB”), approval at each clinical study site;
|
| · |
failure to permit the conduct of a study by regulatory authorities, after review of an investigational new drug (“IND”), or equivalent foreign application or amendment;
|
| · |
delays in recruiting qualified patients in our clinical studies;
|
| · |
failure by clinical sites or our CROs or other third parties to adhere to clinical study requirements or report complete findings;
|
| · |
failure to perform the clinical studies in accordance with the FDA’s good clinical practices requirements, or applicable foreign regulatory guidelines;
|
| · |
patients dropping out of our clinical studies;
|
| · |
occurrence of adverse events associated with our product candidates;
|
| · |
ability to use clinical trial results from foreign jurisdictions in support of U.S. regulatory approval;
|
| · |
changes in regulatory requirements and guidance that require amending or submitting new clinical protocols;
|
| · |
the cost of clinical studies of our product candidates;
|
| · |
negative or inconclusive results from our clinical trials which may result in our deciding, or regulators requiring us, to conduct additional clinical studies or abandon development programs in other ongoing or planned indications for a product candidate; and
|
| · |
delays in reaching agreement on acceptable terms with third-party manufacturers and the time for manufacture of sufficient quantities of our product candidates for use in clinical studies.
|
| · |
impairment of our business reputation;
|
| · |
initiation of investigations by regulators;
|
| · |
withdrawal of clinical trial participants;
|
| · |
costs due to related litigation;
|
| · |
distraction of management’s attention from our primary business;
|
| · |
substantial monetary awards to patients or other claimants;
|
| · |
the inability to commercialize our product candidates;
|
| · |
product recalls, withdrawals or labeling, marketing or promotional restrictions; and
|
| · |
decreased demand for our product candidates, if approved for commercial sale.
|
| · |
new laws, regulations or judicial decisions, or new interpretations of existing laws, regulations or decisions, related to health care availability, pricing or marketing practices, compliance with wage and hour laws and other employment practices, method of delivery, payment for health care products and services, compliance with health information and data privacy and security laws and regulations, tracking and reporting payments and other transfers of value made to physicians and teaching hospitals, extensive anti-bribery and anti-corruption prohibitions, product serialization and labeling requirements and used product take-back requirements;
|
| · |
changes in the FDA and foreign regulatory approval processes that may delay or prevent the approval of new products and result in lost market opportunity;
|
| · |
requirements that provide for increased transparency of clinical trial results and quality data, such as the EMA’s clinical transparency policy, which could impact our ability to protect trade secrets and competitively-sensitive information contained in approval applications or could be misinterpreted leading to reputational damage, misperception or legal action which could harm our business; and
|
| · |
changes in FDA and foreign regulations that may require additional safety monitoring, labeling changes, restrictions on product distribution or use, or other measures after the introduction of our products to market, which could increase our costs of doing business, adversely affect the future permitted uses of approved products, or otherwise adversely affect the market for our products.
|
| 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
|
|
Restated Articles of Incorporation
(1)
|
|
|
Amended and Restated By-Laws (2)
|
|
|
Asset Contribution and Separation Agreement, dated August 17, 2017, between BioTime, Inc. and AgeX Therapeutics, Inc. *#
|
|
|
License Agreement, dated August 17, 2017, between BioTime, Inc. and AgeX Therapeutics, Inc. *#
|
|
|
Option to Purchase Shares of AgeX Therapeutics, Inc., dated August 4, 2017, granted by BioTime, Inc. to Alfred D. Kingsley *
|
|
| 10.4 |
AgeX Therapeutics, Inc. 2017 Equity Incentive Plan
(3)
|
| 10.5 |
Form of AgeX Therapeutics, Inc. Stock Option Agreement
(4)
|
|
Rule 13a-14(a)/15d-14(a) Certification*
|
|
|
Section 1350 Certification*
|
|
|
101
|
Interactive Data Files
|
|
101.INS
|
XBRL Instance Document*
|
|
101.SCH
|
XBRL Taxonomy Extension Schema*
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase*
|
|
101.DEF
|
XBRL Taxonomy Extension Definition Document*
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase*
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase*
|
| (1) |
Incorporated by reference to Exhibit 3.1 to BioTime's Current Report on Form 8-K/A
filed with the Securities and Exchange Commission on August 14, 2017.
|
| (2) |
Incorporated by reference to Exhibit 3.1 to
BioTime's Current Report on Form 8-K
filed with the Securities and Exchange Commission on September 11, 2017
.
|
| (3) |
Incorporated by reference to Exhibit 10.1 to BioTime’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 16, 2017.
|
| (4) |
Incorporated by reference to Exhibit 10.2 to BioTime’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 16, 2017.
|
| # |
Confidential treatment has been requested for certain provisions omitted from this Exhibit pursuant to Rule 406 promulgated under the Securities Act. The omitted information has been filed separately with the SEC.
|
|
*
|
Filed herewith
|
|
BIOTIME, INC.
|
||
|
Date: November 9, 2017
|
/s/ Michael D. West
|
|
|
Michael D. West, Ph.D.
|
||
|
Co-Chief Executive Officer
|
||
|
Date: November 9, 2017
|
/s/ Aditya Mohanty
|
|
|
Aditya Mohanty
|
||
|
Co-Chief Executive Officer
|
||
|
Date: November 9, 2017
|
/s/ Russell L. Skibsted
|
|
|
Russell L. 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 |
|---|