☒ |
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
|
Delaware
|
46-1047971
|
|
(State or other jurisdiction of incorporation or organization)
|
(I.R.S. 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)
|
December 31,
2016
(Note 1)
|
|||||||
ASSETS
|
||||||||
CURRENT ASSETS
|
||||||||
Cash and cash equivalents
|
$
|
8,620
|
$
|
19,800
|
||||
Available-for-sale securities, at fair value
|
12,095
|
15,269
|
||||||
Prepaid expenses and other current assets
|
1,214
|
1,921
|
||||||
Total current assets
|
21,929
|
36,990
|
||||||
NONCURRENT ASSETS
|
||||||||
Intangible assets, net
|
16,116
|
18,130
|
||||||
Property, plant and equipment, net
|
4,760
|
5,475
|
||||||
Other assets
|
515
|
415
|
||||||
TOTAL ASSETS
|
$
|
43,320
|
$
|
61,010
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
CURRENT LIABILITIES
|
||||||||
Amount due to BioTime, Inc.
|
$
|
-
|
$
|
288
|
||||
Accounts payable
|
311
|
1,076
|
||||||
Accrued expenses
|
2,058
|
2,495
|
||||||
Capital lease liability, current
|
7
|
7
|
||||||
Deferred grant income
|
-
|
2,185
|
||||||
Total current liabilities
|
2,376
|
6,051
|
||||||
LONG-TERM LIABILITIES
|
||||||||
Warrant liability
|
5,262
|
8,665
|
||||||
Capital lease liability, noncurrent
|
16
|
20
|
||||||
Deferred rent liability
|
310
|
266
|
||||||
Lease liability
|
3,624
|
3,980
|
||||||
TOTAL LIABILITIES
|
11,588
|
18,982
|
||||||
Commitments and contingencies (see Note 9)
|
||||||||
STOCKHOLDERS’ EQUITY
|
||||||||
Preferred Stock, $0.0001 par value, authorized 5,000 shares; none issued and outstanding
|
-
|
-
|
||||||
Common Stock, $0.0001 par value, authorized 75,000 Series A Common Stock and 75,000 Series B Common Stock; 49,950 and 47,467 shares Series A Common Stock issued and outstanding at September 30, 2017 and December 31, 2016, respectively; no Series B Common Stock issued and outstanding at September 30, 2017 and December 31, 2016
|
5
|
5
|
||||||
Additional paid-in capital
|
141,132
|
126,829
|
||||||
Accumulated other comprehensive loss
|
(3,853
|
)
|
(1,078
|
)
|
||||
Accumulated deficit
|
(105,552
|
)
|
(83,728
|
)
|
||||
Total stockholders’ equity
|
31,732
|
42,028
|
||||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
43,320
|
$
|
61,010
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2017
|
2016
|
2017
|
2016
|
|||||||||||||
REVENUE
|
||||||||||||||||
Grant income
|
$
|
1,526
|
$
|
1,858
|
$
|
3,711
|
$
|
4,865
|
||||||||
Royalties from product sales
|
162
|
218
|
303
|
337
|
||||||||||||
Total revenue
|
1,688
|
2,076
|
4,014
|
5,202
|
||||||||||||
Cost of sales
|
(81
|
)
|
(59
|
)
|
(151
|
)
|
(118
|
)
|
||||||||
Gross profit
|
1,607
|
2,017
|
3,863
|
5,084
|
||||||||||||
EXPENSES
|
||||||||||||||||
Research and development
|
(6,624
|
)
|
(5,232
|
)
|
(20,206
|
)
|
(17,594
|
)
|
||||||||
General and administrative
|
(2,046
|
)
|
(4,210
|
)
|
(8,360
|
)
|
(13,081
|
)
|
||||||||
Total operating expenses
|
(8,670
|
)
|
(9,442
|
)
|
(28,566
|
)
|
(30,675
|
)
|
||||||||
Loss from operations
|
(7,063
|
)
|
(7,425
|
)
|
(24,703
|
)
|
(25,591
|
)
|
||||||||
OTHER INCOME/(EXPENSE)
|
||||||||||||||||
Gain/(loss) from change in fair value on warrant liability
|
506
|
(3,995
|
)
|
3,404
|
(2,368
|
)
|
||||||||||
Interest expense, net
|
(112
|
)
|
(128
|
)
|
(351
|
)
|
(413
|
)
|
||||||||
Other expense, net
|
(140
|
)
|
(2
|
)
|
(174
|
)
|
(27
|
)
|
||||||||
Total other income (expense), net
|
254
|
(4,125
|
)
|
2,879
|
(2,808
|
)
|
||||||||||
LOSS BEFORE INCOME TAX BENEFIT
|
(6,809
|
)
|
(11,550
|
)
|
(21,824
|
)
|
(28,399
|
)
|
||||||||
Deferred income tax benefit
|
-
|
902
|
-
|
2,255
|
||||||||||||
NET LOSS
|
$
|
(6,809
|
)
|
$
|
(10,648
|
)
|
$
|
(21,824
|
)
|
$
|
(26,144
|
)
|
||||
BASIC AND DILUTED NET LOSS PER SHARE
|
$
|
(0.14
|
)
|
$
|
(0.24
|
)
|
$
|
(0.44
|
)
|
$
|
(0.63
|
)
|
||||
WEIGHTED AVERAGE SHARES OUTSTANDING: BASIC AND DILUTED
|
49,771
|
45,193
|
49,110
|
41,588
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2017
|
2016
|
2017
|
2016
|
|||||||||||||
NET LOSS
|
$
|
(6,809
|
)
|
$
|
(10,648
|
)
|
$
|
(21,824
|
)
|
$
|
(26,144
|
)
|
||||
Other comprehensive loss:
|
||||||||||||||||
Unrealized (loss)/gain on available-for-sale securities
|
(764
|
)
|
4,715
|
(2,892
|
)
|
(782
|
)
|
|||||||||
Realized loss on available-for-sale securities
|
118
|
-
|
118
|
-
|
||||||||||||
Subtotal available-for-sale securities
|
(646
|
)
|
4,715
|
(2,774
|
)
|
(782
|
)
|
|||||||||
COMPREHENSIVE LOSS
|
$
|
(7,455
|
)
|
$
|
(5,933
|
)
|
$
|
(24,598
|
)
|
$
|
(26,926
|
)
|
Nine Months Ended
September 30,
|
||||||||
2017
|
2016
|
|||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Net loss
|
$
|
(21,824
|
)
|
$
|
(26,144
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation and amortization expense
|
840
|
909
|
||||||
Stock-based compensation
|
3,615
|
3,648
|
||||||
Amortization of intangible assets
|
2,014
|
2,014
|
||||||
Deferred income tax benefit
|
-
|
(2,255
|
)
|
|||||
Common stock issued for services in lieu of cash
|
858
|
644
|
||||||
Gain (loss) from change in fair value of warrant liability
|
(3,404
|
)
|
2,368
|
|||||
Distribution of Asterias warrants to shareholders other than BioTime, Inc.
|
2,042
|
5,285
|
||||||
Loss on sale of available-for-sale securities
|
118
|
-
|
||||||
Loss on disposal of fixed assets
|
112
|
-
|
||||||
Changes in operating assets and liabilities:
|
||||||||
Prepaid expenses and other current assets
|
13
|
(955
|
)
|
|||||
Other assets
|
595
|
8
|
||||||
Accounts payable
|
(765
|
)
|
(107
|
)
|
||||
Accrued expenses and other current liabilities
|
(725
|
)
|
625
|
|||||
Deferred rent liability
|
44
|
73
|
||||||
Lease liability
|
-
|
166
|
||||||
Deferred grant income
|
(2,185
|
)
|
(1,121
|
)
|
||||
Amount due to BioTime, Inc.
|
-
|
(233
|
)
|
|||||
Net cash used in operating activities
|
(18,652
|
)
|
(15,075
|
)
|
||||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Purchase of property, plant and equipment
|
(237
|
)
|
(643
|
)
|
||||
Proceeds from the sale of available-for-sale securities
|
281
|
-
|
||||||
Reimbursement of security deposit
|
-
|
31
|
||||||
Net cash provided by/(used in) investing activities
|
44
|
(612
|
)
|
|||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Proceeds from sale of common stock and warrants
|
5
|
20,199
|
||||||
Financing costs for sale of common stock and warrants
|
-
|
(1,895
|
)
|
|||||
Proceeds from sale of common shares under at-the-market transactions
|
8,003
|
2,149
|
||||||
Financing costs for at-the-market sales
|
(238
|
)
|
(74
|
)
|
||||
Proceeds from exercise of stock options
|
18
|
1,933
|
||||||
Repayment of lease liability and capital lease obligation
|
(360
|
)
|
(315
|
)
|
||||
Shares retired to pay for employees’ taxes
|
-
|
(134
|
)
|
|||||
Reimbursement from landlord on construction in progress
|
-
|
567
|
||||||
Net cash provided by financing activities
|
7,428
|
22,430
|
||||||
NET INCREASE/(DECREASE) IN CASH AND CASH EQUIVALENTS
|
(11,180
|
)
|
6,743
|
|||||
CASH AND CASH EQUIVALENTS:
|
||||||||
At beginning of period
|
19,800
|
11,183
|
||||||
At end of period
|
$
|
8,620
|
$
|
17,926
|
1. |
Organization, Basis of Presentation and Liquidity
|
2. |
Summary of Significant Accounting Policies
|
Three Months Ended
September 30,
(Unaudited)
|
Nine Months Ended
September 30,
(Unaudited)
|
|||||||||||||||
2017
|
2016
|
2017
|
2016
|
|||||||||||||
Net loss
|
$
|
(6,809
|
)
|
$
|
(10,648
|
)
|
$
|
(21,824
|
)
|
$
|
(26,144
|
)
|
||||
Weighted average common shares outstanding – basic and diluted
|
49,771
|
45,193
|
49,110
|
41,588
|
||||||||||||
Net loss per share – basic and diluted
|
$
|
(0.14
|
)
|
$
|
(0.24
|
)
|
$
|
(0.44
|
)
|
$
|
(0.63
|
)
|
Three Months Ended
September 30,
(Unaudited)
|
Nine Months Ended
September 30,
(Unaudited)
|
|||||||||||||||
2017
|
2016
|
2017
|
2016
|
|||||||||||||
Stock options and restricted stock units
|
7,272
|
6,349
|
7,272
|
6,349
|
||||||||||||
Warrants
|
2,813
|
6,699
|
2,813
|
6,699
|
· |
ASU No. 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net);
|
· |
ASU No. 2016-10, Identifying Performance Obligations and Licensing (Topic 606);
|
· |
ASU No. 2016-11, Revenue Recognition (Topic 605) and Derivatives and Hedging (Topic 815): Rescission of SEC Guidance Because of Accounting Standards Updates 2014-09 and 2014-16 Pursuant to Staff Announcements at the March 3, 2016, EITF Meeting;
|
· |
ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients; and
|
· |
ASU No. 2016-20, Revenue from Contracts with Customers (Topic 606): Technical Corrections and Improvements.
|
3. |
Balance Sheet Components
|
September 30,
2017
(Unaudited)
|
December 31,
2016
|
|||||||
Furniture, fixtures and leasehold improvements
|
$
|
5,274
|
$
|
5,421
|
||||
Computers, machinery and equipment
|
2,060
|
2,545
|
||||||
7,334
|
7,966
|
|||||||
Less - accumulated depreciation and amortization
|
(2,574
|
)
|
(2,491
|
)
|
||||
Property, plant and equipment, net
|
$
|
4,760
|
$
|
5,475
|
4. |
Investments in BioTime and OncoCyte
|
5. |
Cross-License and Share Transfer with BioTime and Subsidiaries
|
6. |
Intangible Assets
|
September 30,
2017
(Unaudited)
|
December 31,
2016
|
|||||||
Intangible assets
|
$
|
26,860
|
$
|
26,860
|
||||
Less- accumulated amortization
|
(10,744
|
)
|
(8,730
|
)
|
||||
Intangible assets, net
|
$
|
16,116
|
$
|
18,130
|
7. |
Common Stock and Warrants
|
8. |
Stock-Based Compensation
|
Three Months Ended
September 30,
(Unaudited)
|
Nine Months Ended
September 30,
(Unaudited)
|
|||||||||||||||
2017
|
2016
|
2017
|
2016
|
|||||||||||||
Research and development
|
$
|
517
|
$
|
638
|
$
|
1,944
|
$
|
1,994
|
||||||||
General and administrative
|
389
|
534
|
1,671
|
1,654
|
||||||||||||
Total stock-based compensation expense
|
$
|
906
|
$
|
1,172
|
$
|
3,615
|
$
|
3,648
|
Three Months Ended
September 30,
(Unaudited)
|
Nine Months Ended
September 30,
(Unaudited)
|
|||||||||||||||
2017
|
2016
|
2017
|
2016
|
|||||||||||||
Expected life (in years)
|
6.08
|
6.08
|
5.76
|
5.87
|
||||||||||||
Risk-free interest rates
|
1.85
|
%
|
1.23
|
%
|
1.88
|
%
|
1.32
|
%
|
||||||||
Volatility
|
73.31
|
%
|
75.21
|
%
|
74.73
|
%
|
75.61
|
%
|
||||||||
Dividend yield
|
0
|
%
|
0
|
%
|
0
|
%
|
0
|
%
|
9. |
Commitments and Contingencies
|
10. |
Shared Facilities and Services Agreement
|
11. |
Income Taxes
|
12. |
License and Royalty Obligations
|
13. |
Clinical Trial and Option Agreement and CIRM Grant Award
|
14.
|
Subsequent Events
|
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
· |
Motor Level Improvement – Additional motor level improvement was seen in Cohort 2 at 12 months.
|
o |
Four of six subjects (67%) achieved at least two motor levels of improvement over baseline on at least one side as of their latest follow-up visit through 12 months, which compares favorably to the rates of recovery at 9 months (50%) and at 3 months and 6 months (33%). Furthermore, the rate of recovery at 12 months is more than double the rates of recovery seen at 12 months in both matched historical controls (29%) and published data in a similar patient population (26%).
|
o |
All six subjects (100%) achieved at least one motor level of improvement on both sides as of their latest follow-up through 12 months. This compares favorably to the matched historical controls, in which 74% of the subjects saw at least one motor level of improvement on at least one side of the body and thereby 26% of subjects saw no motor level improvement or got worse after their injury.
|
o |
In addition, one patient (18%) achieved three motor levels of improvement on one side as of his 12-month follow-up visit. In the matched historical controls, 8% of subjects achieved three or more motor levels of improvement on at least one side at 12 months.
|
· |
Upper Extremity Motor Score – Additional improvement in the average UEMS score for Cohort 2 was observed at 12 months. The average UEMS improvement for Cohort 2 at 12 months was 12.3 points, 57% greater than the average UEMS improvement at 12 months in the matched historical controls (7.8 points).
|
· |
Magnetic Resonance Imaging (MRI) Data - All six subjects in Cohort 2 (100%) had serial MRI scans at 12 months that indicated no sign of lesion cavities in any patient. The MRI results are consistent with formation of a tissue matrix at the injury site, which is supportive evidence showing that AST-OPC1 cells have durably engrafted to help prevent cavitation at the injury site.
|
· |
Safety - The trial results to date continue to suggest a positive safety profile for AST-OPC1.
|
Three Months Ended
September
|
$
Decrease
|
%
Decrease
|
||||||||||||||
2017
|
2016
|
|||||||||||||||
Grant income
|
$
|
1,526
|
$
|
1,858
|
$
|
-332
|
-18
|
%
|
||||||||
Royalties from product sales
|
162
|
218
|
-56
|
-26
|
%
|
|||||||||||
Total revenues
|
1,688
|
2,076
|
-388
|
-19
|
%
|
|||||||||||
Cost of sales
|
(81
|
)
|
(59
|
)
|
-22
|
-37
|
%
|
|||||||||
Gross profit
|
$
|
1,607
|
$
|
2,017
|
$
|
-410
|
- 20
|
%
|
Nine Months Ended
September 30,
|
$
Decrease
|
%
Decrease
|
||||||||||||||
2017
|
2016
|
|||||||||||||||
Grant income
|
$
|
3,711
|
$
|
4,865
|
$
|
-1,154
|
- 24
|
%
|
||||||||
Royalties from product sales
|
303
|
337
|
-34
|
- 10
|
%
|
|||||||||||
Total revenues
|
4,014
|
5,202
|
-1,188
|
- 23
|
%
|
|||||||||||
Cost of sales
|
(151
|
)
|
(118
|
)
|
-33
|
-28
|
%
|
|||||||||
Gross profit
|
$
|
3,863
|
$
|
5,084
|
$
|
- 1,221
|
- 24
|
%
|
Three Months Ended
September 30,
|
$
Increase/
(Decrease)
|
%
Increase/
Decrease
|
||||||||||||||
2017
|
2016
|
|||||||||||||||
Research and development expenses
|
$
|
6,624
|
$
|
5,232
|
$
|
+1,392
|
+27
|
%
|
||||||||
General and administrative expenses
|
2,046
|
4,210
|
-2,164
|
-51
|
%
|
Nine Months Ended
September 30,
|
$
Increase/
(Decrease)
|
%
Increase/
Decrease
|
||||||||||||||
2017
|
2016
|
|||||||||||||||
Research and development expenses
|
$
|
20,206
|
$
|
17,594
|
$
|
+2,612
|
+15
|
%
|
||||||||
General and administrative expenses
|
8,360
|
13,081
|
-4,721
|
-36
|
%
|
Item 3. |
Quantitative and Qualitative Disclosures about Market Risk
|
Item 4. |
Controls and Procedures
|
Item 1.
|
Legal Proceedings.
|
Item 1A.
|
Risk Factors
|
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
Number
|
Description
|
|
*
|
Amendment to Securities Purchase Agreement
|
|
*
|
Certification of Chief Executive Officer pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
*
|
Certification of Chief Financial Officer pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
**
|
Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
101
|
*
|
XBRL Instance Document
|
101.INS
|
*
|
XBRL Taxonomy Extension Schema
|
101.CAL
|
*
|
XBRL Taxonomy Extension Calculation Linkbase
|
101.DEF
|
*
|
XBRL Taxonomy Extension Definition Linkbase
|
101.LAB
|
*
|
XBRL Taxonomy Extension Label Linkbase
|
101.PRE
|
*
|
XBRL Taxonomy Extension Presentation Linkbase
|
ASTERIAS BIOTHERAPEUTICS, INC.
|
||
Date: November 14, 2017
|
/s/ Michael H. Mulroy
|
|
Michael H. Mulroy
|
||
President and Chief Executive Officer
|
Date: November 14, 2017
|
/s/ Ryan Chavez
|
|
Ryan Chavez
|
||
Chief Financial Officer
|
MMCAP INTERNATIONAL INC.
|
|||
By:
|
/s/ Matthew MacIssac
|
||
Name:
|
Matthew MacIssac
|
||
Title:
|
Director
|
||
BROADWOOD PARTNERS, L.P.
|
|||
By:
|
/s/ Neal Bradsher
|
||
Name:
|
Neal Bradsher
|
||
Title:
|
President of General Partner of Broadwood Partners, L.P.
|
||
ASTERIAS BIOTHERAPEUTICS, INC.
|
|||
By:
|
/s/ Michael Mulroy
|
||
Name:
|
Michael Mulroy
|
||
Title:
|
Chief Executive Officer
|
Date: November 14, 2017
|
|
/s/ Michael H. Mulroy
|
|
Michael H. Mulroy
|
|
President and Chief Executive Officer
|
|
(principal executive officer)
|
Date: November 14, 2017
|
|
/s/ Ryan Chavez
|
|
Ryan Chavez
|
|
Chief Financial Officer
|
|
(principal financial officer)
|
Date: November 14, 2017
|
|
/s/ Michael H. Mulroy
|
|
Michael H. Mulroy
|
|
President and Chief Executive Officer
|
/s/ Ryan Chavez
|
|
Ryan Chavez
|
|
Chief Financial Officer
|
Document and Entity Information - shares |
9 Months Ended | |
---|---|---|
Sep. 30, 2017 |
Nov. 08, 2017 |
|
Document Information [Line Items] | ||
Entity Registrant Name | Asterias Biotherapeutics, Inc. | |
Entity Central Index Key | 0001572552 | |
Current Fiscal Year End Date | --12-31 | |
Entity Well-known Seasoned Issuer | No | |
Entity Voluntary Filers | No | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Document Fiscal Year Focus | 2017 | |
Document Fiscal Period Focus | Q3 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2017 | |
Series A Common Stock [Member] | ||
Document Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 49,978,791 |
CONDENSED BALANCE SHEETS (UNAUDITED) (Parenthetical) - $ / shares |
Sep. 30, 2017 |
Dec. 31, 2016 |
---|---|---|
STOCKHOLDERS' EQUITY | ||
Preferred shares, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred shares, authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred shares, issued (in shares) | 0 | 0 |
Preferred shares, outstanding (in shares) | 0 | 0 |
Common shares, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Series A Common Stock [Member] | ||
STOCKHOLDERS' EQUITY | ||
Common shares, authorized (in shares) | 75,000,000 | 75,000,000 |
Common shares, issued (in shares) | 49,949,587 | 47,466,596 |
Common shares, outstanding (in shares) | 49,949,587 | 47,466,596 |
Series B Common Stock [Member] | ||
STOCKHOLDERS' EQUITY | ||
Common shares, authorized (in shares) | 75,000,000 | 75,000,000 |
Common shares, issued (in shares) | 0 | 0 |
Common shares, outstanding (in shares) | 0 | 0 |
CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED) - USD ($) shares in Thousands, $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2017 |
Sep. 30, 2016 |
Sep. 30, 2017 |
Sep. 30, 2016 |
|
REVENUE | ||||
Grant income | $ 1,526 | $ 1,858 | $ 3,711 | $ 4,865 |
Royalties from product sales | 162 | 218 | 303 | 337 |
Total revenue | 1,688 | 2,076 | 4,014 | 5,202 |
Cost of sales | (81) | (59) | (151) | (118) |
Gross profit | 1,607 | 2,017 | 3,863 | 5,084 |
EXPENSES | ||||
Research and development | (6,624) | (5,232) | (20,206) | (17,594) |
General and administrative | (2,046) | (4,210) | (8,360) | (13,081) |
Total operating expenses | (8,670) | (9,442) | (28,566) | (30,675) |
Loss from operations | (7,063) | (7,425) | (24,703) | (25,591) |
OTHER INCOME/(EXPENSE) | ||||
Gain/(loss) from change in fair value on warrant liability | 506 | (3,995) | 3,404 | (2,368) |
Interest expense, net | (112) | (128) | (351) | (413) |
Other expense, net | (140) | (2) | (174) | (27) |
Total other income (expense), net | 254 | (4,125) | 2,879 | (2,808) |
LOSS BEFORE INCOME TAX BENEFIT | (6,809) | (11,550) | (21,824) | (28,399) |
Deferred income tax benefit | 0 | 902 | 0 | 2,255 |
NET LOSS | $ (6,809) | $ (10,648) | $ (21,824) | $ (26,144) |
BASIC AND DILUTED NET LOSS PER SHARE (in dollars per share) | $ (0.14) | $ (0.24) | $ (0.44) | $ (0.63) |
WEIGHTED AVERAGE SHARES OUTSTANDING: BASIC AND DILUTED (in shares) | 49,771 | 45,193 | 49,110 | 41,588 |
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2017 |
Sep. 30, 2016 |
Sep. 30, 2017 |
Sep. 30, 2016 |
|
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED) [Abstract] | ||||
NET LOSS | $ (6,809) | $ (10,648) | $ (21,824) | $ (26,144) |
Other comprehensive loss: | ||||
Unrealized (loss)/gain on available-for-sale securities | (764) | 4,715 | (2,892) | (782) |
Realized loss on available-for-sale securities | 118 | 0 | 118 | 0 |
Subtotal available-for-sale securities | (646) | 4,715 | (2,774) | (782) |
COMPREHENSIVE LOSS | $ (7,455) | $ (5,933) | $ (24,598) | $ (26,926) |
Organization, Basis of Presentation and Liquidity |
9 Months Ended | ||
---|---|---|---|
Sep. 30, 2017 | |||
Organization, Basis of Presentation and Liquidity [Abstract] | |||
Organization, Basis of Presentation and Liquidity |
Asterias Biotherapeutics, Inc. (“Asterias”) is a biotechnology company focused on the emerging fields of regenerative medicine and cancer immunotherapy. Asterias has two core technology platforms. The first is a type of stem cell capable of becoming all of the cell types in the human body, a property called pluripotency. The second is a type of cell called “dendritic cells” used to teach cancer patients’ immune systems to attack their tumors. Asterias currently has three clinical stage programs based on these platforms: AST-OPC1 is a therapy derived from pluripotent stem cells that is currently in a Phase 1/2a clinical trial for spinal cord injuries; AST-VAC1 is a patient-specific cancer immunotherapy for Acute Myeloid Leukemia (AML); and AST-VAC2 is a non-patient specific cancer immunotherapy for which our research partner Cancer Research UK is planning for the initiation of a Phase 1 clinical trial in non-small cell lung cancer. Asterias was incorporated in Delaware on September 24, 2012. The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities Exchange Commission. In accordance with those rules and regulations certain information and footnote disclosures normally included in comprehensive financial statements have been condensed or omitted pursuant to such rules and regulations. The balance sheet as of December 31, 2016 was derived from the audited financial statements at that date, but does not include all the information and footnotes required by GAAP. These financial statements should be read in conjunction with the audited financial statements and notes thereto included in Asterias’ Annual Report on Form 10-K for the year ended December 31, 2016. The accompanying interim condensed financial statements, in the opinion of management, include all adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of Asterias’ financial condition and results of operations. The condensed results of operations are not necessarily indicative of the results to be expected for any future interim period or for the entire year. Liquidity – Since inception, Asterias has incurred operating losses and has funded its operations primarily through issuance of equity securities, warrants, payments from research grants, and royalties from product sales. On October 18, 2017, Asterias completed a registered offering of its Series A common stock, pursuant to which it raised $10.4 million in gross proceeds (see Note 14). At September 30, 2017, Asterias had an accumulated deficit of $105.6 million, working capital of $19.6 million and stockholders’ equity of $31.7 million. Asterias has evaluated its projected cash flows and believes that its cash and cash equivalents of $8.6 million and available-for-sale securities of $12.1 million as of September 30, 2017, as supplemented by the $10.4 million in gross proceeds from the recent offering, will be sufficient to fund Asterias’ operations through at least twelve months from the issuance date of these financial statements. If the value of Asterias’ available-for-sale securities decreases or it is unable to obtain adequate future financing for its clinical trials, it may be required to delay, postpone, or cancel its clinical trials, limit the number of clinical trial sites, or otherwise reduce or curtail its operations. Future financings may not be available to Asterias at acceptable terms, or at all. Sales of additional equity securities would result in the dilution of interests of current shareholders. |
Summary of Significant Accounting Policies |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Significant Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Significant Accounting Policies |
Basic and diluted net loss per share – The computations of basic and diluted net loss per share are as follows (in thousands, except per share data):
The following common stock equivalents were excluded from the computation of diluted net loss per share of common stock for the periods presented because including them would have been antidilutive (in thousands):
Recent Accounting Pronouncements In March 2016, the FASB issued ASU 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting (“ASU 2016-09”), which simplifies several aspects of the accounting for share-based payment transactions, including the income tax consequences, forfeitures, classification of awards as either equity or liabilities, and classification on the statement of cash flows. Asterias adopted ASU 2016-09 beginning on January 1, 2017. In connection with the adoption of ASU 2016-09, Asterias changed how it accounts for excess tax benefits and deficiencies, if any, and forfeitures, as applicable. All excess tax benefits and tax deficiencies from stock-based compensation awards accounted for under ASC 718 are recognized as an income tax benefit or expense, respectively, in the statements of operations. Prior to the adoption of ASU 2016-09, Asterias recognized excess tax benefits, if any, in additional paid-in capital only if the tax deduction reduced cash income taxes payable and excess tax deficiencies were recognized either as an offset to accumulated excess tax benefits, if any, on Asterias’ statements of operations. An excess income tax benefit arises when the tax deduction of a share-based award for income tax purposes exceeds the compensation cost recognized for financial reporting purposes and, a tax deficiency arises when the compensation cost exceeds the tax deduction. Because Asterias has a full valuation allowance, there was no impact to Asterias’ statements of operations for any excess tax benefits or deficiencies, as any excess benefit or deficiency would be offset by the change in the valuation allowance (see Note 11). Forfeitures are now accounted for as they occur instead of based on the number of awards that were expected to vest. Based on the nature and timing of Asterias equity grants, straight-line expense attribution of stock-based compensation for the entire award and the relatively low forfeiture rate on Asterias experience, the impact of adoption of ASU 2016-09 pertaining to forfeitures was not significant to Asterias’ financial statements (see Note 8). In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers, which requires an entity to recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In doing so, companies will need to use more judgment and make more estimates than under today’s guidance. These may include identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. The ASU will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective. In August 2015, the FASB issued ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date, which provided for the adoption of the new standard for fiscal years beginning after December 15, 2017. Accordingly, ASU No. 2014-09 is effective for the Company in the first quarter of 2018. Upon adoption, ASU No. 2014-09 can be applied retrospectively to all periods presented or only to the most current period presented with the cumulative effect of changes reflected in the opening balance of retained earnings in the most current period presented. The FASB has also issued the following standards which clarify ASU No. 2014-09 and have the same effective date as the original standard:
The Company expects to adopt ASU 2014-09 effective January 1, 2018, using the modified retrospective transition method. The Company has performed an initial analysis of areas that will be impacted by the new guidance and is currently evaluating the effect that the new standard will have on its internal processes, financial statements, and related disclosures. While the Company continues to assess all potential impacts under ASU 2014-09, recognition of the Company’s revenue under the new standard is expected to be materially consistent with the Company’s current revenue recognition policy. The new standard is not expected to materially impact the timing or amounts of revenue recognized. In May 2017, the FASB issued ASU 2017-09, Compensation – Stock Compensation: Scope of Modification Accounting to clarify the scope of modification accounting for share-based compensation. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. The new guidance will reduce diversity in practice and result in fewer changes to the terms of an award being accounted for as modifications. The new authoritative guidance will be effective for public business entities in fiscal years beginning after December 15, 2017. The authoritative guidance will be effective for the Company beginning in fiscal year 2018 as the Company decided not to early adopt it in fiscal year 2018. The Company is currently evaluating the impact of this new authoritative guidance on its financial statements. |
Balance Sheet Components |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance Sheet Components [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance Sheet Components |
Property, plant and equipment, net As of September 30, 2017 and December 31, 2016, property, plant and equipment consisted of the following (in thousands):
Depreciation expense for the three and nine months ended September 30, 2017 was $285,000 and $840,000, respectively. Depreciation expense for the three and nine months ended September 30, 2016 was $304,000 and $909,000, respectively. During the quarter ended September 30, 2017, the Company performed a periodic review of its fixed assets and identified certain fixed assets that were no longer in use or impaired. As of September 30, 2017 the Company disposed of $112,000 in fixed assets (net of accumulated depreciation of $757,000). For the nine months ended September 30, 2017, the Company recognized non-cash impairment losses of $98,000 and $14,000, respectively, which are included in research and development and general and administrative expense in the condensed statements of operations. |
Investments in BioTime and OncoCyte |
9 Months Ended | ||
---|---|---|---|
Sep. 30, 2017 | |||
Investments in BioTime and OncoCyte [Abstract] | |||
Investments in BioTime and OncoCyte |
Investment in BioTime BioTime common shares are included in current assets in Asterias’ balance sheet as available-for-sale securities recorded at fair value as the shares are traded on NYSE American (symbol “BTX”) and available for working capital purposes. During the quarter and nine months ended September 30, 2017, Asterias sold 106,331 of its BTX shares at a weighted-average price of $2.81. As of September 30, 2017 and December 31, 2016, Asterias held 3,746,549 and 3,852,880 of BioTime shares, respectively, which were valued at $10.6 million and $13.9 million, respectively based on the closing price on those respective dates. Investment in OncoCyte On December 31, 2015, in connection with BioTime’s distribution of OncoCyte common stock to BioTime shareholders, on a pro rata basis, Asterias received 192,644 shares of OncoCyte common stock from BioTime as a dividend in kind. On that date, BioTime shareholders, including Asterias, received one share of OncoCyte common stock for every twenty shares of BioTime common stock held. Asterias recorded the fair value of the OncoCyte common stock as contributed capital from BioTime. The OncoCyte shares are included in current assets in Asterias’ balance sheet as available-for-sale securities recorded at fair value as the shares are traded on NYSE American (symbol “OCX”) and available for working capital purposes. As of September 30, 2017 and December 31, 2016, the OncoCyte shares were valued at $1.5 million and $1.4 million based on the OncoCyte closing prices on those respective dates. |
Cross-License and Share Transfer with BioTime and Subsidiaries |
9 Months Ended | ||
---|---|---|---|
Sep. 30, 2017 | |||
Cross-License and Share Transfer with BioTime and Subsidiaries [Abstract] | |||
Cross-License and Share Transfer with BioTime and Subsidiaries |
On February 16, 2016, Asterias entered into a Cross-License Agreement (the “Cross-License”) with BioTime and BioTime's wholly owned subsidiary ES Cell International Pte Ltd (“ESI”). Under the terms of the Cross-License, Asterias received a fully-paid, non-royalty-bearing, world-wide, non-exclusive, sub-licensable license under certain BioTime patents and related patent rights and ESI patents and related patent rights specified in the Cross-License, for all purposes in the Asterias Licensed Field, as defined in the Cross-License agreement, during the term of the license. Under the terms of the Cross-License, BioTime and ESI received a fully-paid, non-royalty-bearing, world-wide, non-exclusive, sub-licensable license in, to, and under the certain Asterias patents and related patent rights for all purposes in the BioTime/ESI Licensed Field, as defined in the Cross-License agreement, during the term of the license. On February 16, 2016, Asterias also entered into a Share Transfer Agreement (“Share Transfer”) with BioTime and ESI pursuant to which (a) Asterias transferred to BioTime 2,100,000 shares of common stock of OrthoCyte Corporation (“OrthoCyte) and 21,925 ordinary shares of Cell Cure Neurosciences Ltd (“Cell Cure”), each a majority-owned subsidiary of BioTime, with an aggregate carrying value at the time of the transaction of approximately $416,000 and (b) BioTime transferred to Asterias 75,771 shares of Series A Common Stock of Asterias with a carrying value at the time of the transaction of approximately $197,000 and warrants to purchase 3,150,000 Series A common stock of Asterias at an exercise price of $5.00 per share, with a carrying value at the time of the transaction of approximately $2.0 million, as additional consideration for the license of patents and patent rights from Asterias under the Cross License. On March 20, 2016, the warrants to purchase 3,150,000 shares of Series A common stock were retired by Asterias. The Cross-License and Share Transfer transaction was accounted for as a transfer of assets between entities under common control and recorded at carrying value, with the resulting gain on transfer of approximately $1.8 million recorded by Asterias in equity as contributed capital from BioTime in accordance with, and pursuant to ASC 805-50, Transactions Between Entities Under Common Control. The transfer of assets was also a taxable transaction to Asterias generating a taxable gain of approximately $3.1 million as further discussed in Note 11. |
Intangible Assets |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||||||||||||||||
Intangible Assets [Abstract] | |||||||||||||||||||||||||||||||||||||||
Intangible Assets |
Intangible assets net of accumulated amortization at September 30, 2017 and December 31, 2016 are shown in the following table (in thousands):
Asterias recognized $672,000 and $2.0 million in amortization expense of intangible assets during the three and nine months ended September 30, 2017 and 2016, respectively. |
Common Stock and Warrants |
9 Months Ended | ||
---|---|---|---|
Sep. 30, 2017 | |||
Common Stock and Warrants [Abstract] | |||
Common Stock and Warrants |
As of September 30, 2017 and December 31, 2016, Asterias had outstanding 49,949,587 and 47,466,596 Series A Shares and no Series B Shares, respectively. Common Stock Issuance On March 28, 2017, Asterias entered into an amendment to its at-the-market (ATM) Sales Agreement, dated April 10, 2015, with MLV. The amendment to the Sales Agreement was entered into by Asterias, MLV and FBR Capital Markets & Co. (“FBR” and together with MLV, the “Agents”), which acquired MLV. Under the Sales Agreement, as amended, Asterias may issue and sell shares of its Series A common stock having an aggregate offering price of up to $25 million from time to time on or after March 28, 2017, through the Agents, subject to certain limitations, including the number of shares registered and available under the Company’s previously filed and currently effective shelf registration statement on Form S-3 (File No. 333-215154) (the “Registration Statement”). For the nine months ended September 30, 2017, Asterias has sold approximately 2.0 million shares of Series A common stock for gross proceeds of $8.0 million. For the nine months ended September 30, 2016, Asterias sold 509,897 shares of Series A common stock for gross proceeds of approximately $2.1 million. For the nine months ended September 30, 2017 and 2016, pursuant to a services agreement with Cell Therapy Catapult Services Limited, Asterias issued 217,193 and 142,020 shares of Asterias Series A common stock with a fair value of $858,000 and $644,000 respectively (see Note 12). Warrants classified as a liability On May 13, 2016, as part of the Asterias Series A Common Stock Offering, Asterias issued 2,959,559 warrants (the “Asterias Offering Warrants”). The Asterias Offering Warrants have an exercise price of $4.37 per share and expire in five years of the issuance date, or May 13, 2021. The Asterias Offering Warrants also contain certain provisions in the event of a Fundamental Transaction, as defined in the warrant agreement governing the Asterias Offering Warrants (“Warrant Agreement”), that Asterias or any successor entity will be required to purchase, at a holder’s option, exercisable at any time concurrently with or within thirty days after the consummation of the fundamental transaction, the Asterias Offering Warrants for cash. This cash settlement will be in an amount equal to the value of the unexercised portion of such holder’s warrants, determined in accordance with the Black-Scholes option pricing model as specified in the Warrant Agreement. In accordance with ASC 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock, contracts that require or may require the issuer to settle the contract for cash are liabilities recorded at fair value, irrespective of the likelihood of the transaction occurring that triggers the net cash settlement feature. Changes to the fair value of those liabilities are recorded in the statements of operations. Accordingly, since Asterias may be required to net cash settle the Asterias Offering Warrants in the event of a Fundamental Transaction; the Asterias Offering Warrants are classified as noncurrent liabilities at fair value, with changes in fair value recorded in other income or expense, net, in the statements of operations. The fair value of the Asterias Offering Warrants at the time of issuance was determined by using a combination of the Binomial Lattice and Black-Scholes option pricing models under various probability-weighted outcomes which take into consideration the probability of the fundamental transaction and net cash settlement occurring, using the contractual term of the warrants. In applying these models, the fair value is determined by applying Level 3 inputs, as defined by ASC 820; these inputs have included assumptions around the estimated future stock price of Asterias common stock, volatility and the timing of, and varying probabilities that certain events will occur. The Asterias Offering Warrants are revalued each reporting period using the same methodology described above. Changes in any of the key assumptions used to value the Asterias Offering Warrants could materially impact the fair value of the warrants and Asterias’ financial statements. At September 30, 2017, based on a valuation performed on the Asterias Offering Warrants using the methodology described above, the fair value of the Asterias Offering Warrants liability was $5.3 million, resulting in Asterias recording an unrealized gain of $0.5 million and $3.4 million for the three and nine months ended September 30, 2017, respectively included in other income and expenses, net, in the statements of operations. Warrants classified as equity On March 30, 2016, Asterias’ board of directors declared a distribution of Asterias common stock purchase warrants to all Asterias shareholders other than BioTime, in the ratio of one warrant for every five shares of Asterias common stock owned of record as of the close of business on April 11, 2016. On April 25, 2016, Asterias distributed 3,331,229 warrants (the “Distribution Warrants”). The distribution of the Distribution Warrants was treated as a disproportionate distribution since, in accordance with the terms of the Share Transfer with BioTime, no warrants were distributed to BioTime. The Distribution Warrants are classified as equity, have an exercise price of $5.00 per share, and were set to expire on September 30, 2016. Asterias recorded the Distribution Warrants at a fair value of approximately $3.1 million with a non-cash charge to shareholder expense included in general and administrative expenses and a corresponding increase to equity as of March 30, 2016 as the Distribution Warrants were deemed to be issued for accounting purposes on that date. On September 19, 2016, Asterias extended the expiration date of the Distribution Warrants to February 15, 2017, no other terms were changed. As a result of the extension of the expiration date of these warrants, Asterias recorded a $2.0 million noncash charge to shareholder expense included in general and administrative expenses and a corresponding increase to equity for the year ended December 31, 2016. On February 3, 2017, Asterias extended the expiration date of the Distribution Warrants to September 29, 2017. As a result of this extension, Asterias recorded a $1.7 million non-cash charge to shareholder expense included in general and administrative expenses and a corresponding increase to equity for the quarter ended March 31, 2017. On September 29, 2017, the unexercised Distribution Warrants that would have otherwise resulted in the issuance of 3,328,033 shares of Asterias common stock expired. In connection with the warrant distribution to shareholders discussed above, 350,000 warrants with an exercise price of $5.00 per share held by Romulus Films, Ltd. were adjusted to become exercisable into 409,152 shares at an exercise price of $4.28 per share (the “Romulus Warrants”). These warrants had an original expiration date of September 30, 2016. On September 19, 2016, Asterias extended the expiration date of the Romulus Warrants to February 15, 2017, no other terms were changed. As a result of the extension of the expiration date of these warrants, Asterias recorded a $0.2 million non-cash charge to shareholder expense included in general and administrative expenses and a corresponding increase to equity for the year ended December 31, 2016. On February 3, 2017, Asterias extended the expiration date of the Romulus Warrants to September 29, 2017. As a result of this extension of the expiration date of these warrants, Asterias recorded a $0.3 million non-cash charge to shareholder expense included in general and administrative expenses and a corresponding increase to equity for the quarter ended March 31, 2017. On September 29, 2017, the unexercised Romulus Warrants that would have otherwise resulted in the issuance of 409,152 shares of Asterias common stock expired. |
Stock-Based Compensation |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation |
The following table shows the stock-based compensation expenses included in the operating expenses for the three and nine months ended September 30, 2017 and 2016 (in thousands):
The fair value of each option award is estimated on the date of grant using a Black-Scholes option valuation model applying the weighted-average assumptions in the following table:
The risk-free rate is based on the rates in effect at the time of grant for zero coupon U.S. Treasury notes with maturities approximately equal to each grant’s expected term. A dividend yield of zero is applied since Asterias has not historically paid dividends and does not expect to pay dividends in the foreseeable future. The expected volatility is based upon the volatility of Asterias’ own trading stock and a group of publicly traded industry peer companies. The expected term of options granted is derived from using the simplified method under SEC Staff Accounting Bulletin Topic 14. The determination of stock-based compensation is inherently uncertain and subjective and involves the application of valuation models and assumptions requiring the use of judgment. If Asterias had made different assumptions, its stock-based compensation expense, and net loss for the three and nine months ended September 30, 2017 and 2016, may have been significantly different. |
Commitments and Contingencies |
9 Months Ended | ||
---|---|---|---|
Sep. 30, 2017 | |||
Commitments and Contingencies [Abstract] | |||
Commitments and Contingencies |
Development and Manufacturing Services Agreement On August 3, 2016, Asterias entered into a Development and Manufacturing Services Agreement (the “Services Agreement”) with Cognate BioServices, Inc. (“Cognate”), a fully-integrated contract bioservices organization providing development and current Good Manufacturing Practice (“cGMP”) manufacturing services to companies and institutions engaged in the development of cell-based products. Under the Services Agreement, Cognate is performing under an Initial Statement of Work process development studies in support of Asterias’ clinical and commercial development activities of AST-VAC1 and production and manufacturing services of AST-VAC1 under cGMP under the Second Statement of Work. In consideration for the process development services set forth in the Initial Statement of Work, Asterias agreed to make aggregate payments of up to approximately $1.7 million in fees over the term of the Initial Statement of Work and pay for additional pass through costs for materials and equipment estimated by management to be approximately $0.5 million. In consideration of the production and manufacturing services set forth in the Second Statement of Work, once the services under the Initial Statement of Work are completed and if Asterias receives FDA concurrence on the clinical protocol for an AST-VAC1 trial, then Asterias will make an initial start-up payment, a monthly payment for dedicated manufacturing capacity, and certain other manufacturing fees. On August 16, 2017, the Company amended SOW 1 (“Amended SOW 1”) and entered into a Statement of Work 1.5 (“SOW 1.5”) with Cognate to modify the timing of certain process development studies being performed by Cognate under the Services Agreement. Under Amended SOW 1 and SOW 1.5, Cognate will perform certain process development studies initially contemplated by SOW 1 under SOW 1.5 after Cognate has completed the activities under Amended SOW 1 and the Company provides written notice to commence the activities under SOW 1.5. The Services Agreement will expire on the later of (a) August 3, 2019; or (b) the completion of all services contracted for by the parties in the Statements of Work under the Services Agreement prior to August 3, 2019. The term of the Services Agreement and any then pending Statements of Work thereunder may be extended by Asterias continuously for additional two-year periods upon written notice to Cognate with at least thirty days prior to the expiration of the then-current term. The Services Agreement provides certain termination rights to each party and customary provisions relating to indemnity, confidentiality and other matters. Asterias incurred $112,000 and $536,000 of expense to Cognate pursuant to the Services Agreement for the three and nine months ended September 30, 2017. Fremont Lease On December 30, 2013, Asterias entered into a lease for an office and research facility located in Fremont, California, consisting of an existing building with approximately 44,000 square feet of space. The building is being used by Asterias as a combined office, laboratory and production facility that can be used to manufacture its product using current good manufacturing procedures. Asterias completed the tenant improvements in November 2015, which cost approximately $4.9 million, of which the maximum of $4.4 million was paid to Asterias by the landlord. Asterias placed the asset into service in November 2015 and is amortizing the leasehold improvements and the landlord liability over the remaining lease term through September 30, 2022. As of September 30, 2017 and December 31, 2016, the landlord lease liability was $3.6 million and $4.0 million and the deferred rent liability was $310,000 and $266,000, respectively. Litigation – General Asterias is subject to various claims and contingencies in the ordinary course of its business, including those related to litigation, business transactions, employee-related matters, and others. When Asterias is aware of a claim or potential claim, it assesses the likelihood of any loss or exposure. If it is probable that a loss will result and the amount of the loss can be reasonably estimated, Asterias will record a liability for the loss. If the loss is not probable or the amount of the loss cannot be reasonably estimated, Asterias discloses the claim if the likelihood of a potential loss is reasonably possible and the amount involved could be material. Asterias is not aware of any claims likely to have a material adverse effect on its financial condition or results of operations. Employment Contracts Asterias has entered into employment contracts with certain executive officers. Under the provisions of the contracts, Asterias may be required to incur severance obligations for matters relating to changes in control, as defined and involuntary terminations. Indemnification In the normal course of business, Asterias may provide indemnifications of varying scope under Asterias’ agreements with other companies or consultants, typically Asterias’ clinical research organizations, investigators, clinical sites, suppliers and others. Pursuant to these agreements, Asterias will generally agree to indemnify, hold harmless, and reimburse the indemnified parties for losses and expenses suffered or incurred by the indemnified parties arising from claims of third parties in connection with the use or testing of Asterias’ products and services. Indemnification provisions could also cover third party infringement claims with respect to patent rights, copyrights, or other intellectual property pertaining to Asterias products and services. The term of these indemnification agreements will generally continue in effect after the termination or expiration of the particular research, development, services, or license agreement to which they relate. The potential future payments Asterias could be required to make under these indemnification agreements will generally not be subject to any specified maximum amount. Historically, Asterias has not been subject to any claims or demands for indemnification. Asterias also maintains various liability insurance policies that limit Asterias’ exposure. As a result, Asterias believes the fair value of these indemnification agreements is minimal. Accordingly, Asterias has not recorded any liabilities for these agreements as of September 30, 2017 and December 31, 2016. |
Shared Facilities and Services Agreement |
9 Months Ended | ||
---|---|---|---|
Sep. 30, 2017 | |||
Shared Facilities and Services Agreement [Abstract] | |||
Shared Facilities and Services Agreement |
On April 1, 2013, Asterias and BioTime executed a Shared Facilities and Services Agreement (“Shared Services Agreement”). Under the terms of the Shared Services Agreement, Asterias has the right to use BioTime's premises and equipment located at Alameda, California, for the sole purpose of conducting Asterias' business. BioTime also may provide certain services, including basic accounting, billing, bookkeeping, payroll, treasury, collection of accounts receivable (excluding the institution of legal proceedings or taking of any other action to collect accounts receivable), payment of accounts payable, and other similar administrative services to Asterias and services of its laboratory and research personnel. BioTime may also provide the services of attorneys, accountants, and other professionals who may also provide professional services to BioTime and its other subsidiaries. BioTime charges Asterias a fee for the services and usage of facilities, equipment, and supplies aforementioned. For each billing period, BioTime equitably prorates and allocates its employee costs, equipment costs, insurance costs, lease costs, professional costs, software costs, supply costs, and utilities costs, if any, between BioTime and Asterias based upon actual documented use and cost by or for Asterias or upon proportionate usage by BioTime and Asterias, as reasonably estimated by BioTime. Asterias pays 105% of the allocated costs (the “Use Fee”). The allocated cost of BioTime employees and contractors who provide services is based upon records maintained of the number of hours of such personnel devoted to the performance of services. The Use Fee is determined and invoiced to Asterias on a quarterly basis for each calendar quarter of each calendar year. If the Shared Services Agreement terminates prior to the last day of a billing period, the Use Fee will be determined for the number of days in the billing period elapsed prior to the termination of the Shared Services Agreement. Each invoice is payable in full by Asterias within 30 days after receipt. Any invoice or portion thereof not paid in full when due will bear interest at the rate of 15% per annum until paid, unless the failure to make a payment is due to any inaction or delay in making a payment by BioTime employees from Asterias funds available for such purpose, rather than from the unavailability of sufficient funds legally available for payment or from an act, omission, or delay by any employee or agent of Asterias. Asterias in turn may charge BioTime or any Other Subsidiary for similar services provided by Asterias at the same rate and terms as aforementioned. “Other Subsidiary” means a subsidiary of BioTime other than a subsidiary of Asterias. The Shared Services Agreement was renewed through December 31, 2017. The term of the Shared Services Agreement will automatically be renewed and the termination date will be extended for an additional year each year, unless either party gives the other party written notice stating that the Shared Services Agreement will terminate on December 31 of that year. BioTime allocated $117,000 and $683,000 of general overhead expenses to Asterias during the nine months ended September 30, 2017, and 2016, respectively. At September 30, 2017, Asterias had no net payable to BioTime under the Shared Services Agreement. |
Income Taxes |
9 Months Ended | ||
---|---|---|---|
Sep. 30, 2017 | |||
Income Taxes [Abstract] | |||
Income Taxes |
The provision for income taxes is determined using an estimated annual effective tax rate. The effective tax rate may be subject to fluctuations during the year as new information is obtained, which may affect the assumptions used to estimate the annual effective tax rate, including factors such as valuation allowances against deferred tax assets, the recognition or de-recognition of tax benefits related to uncertain tax positions, if any, and changes in or the interpretation of tax laws in jurisdictions where Asterias conducts business. Management believes that the Asterias net operating losses generated during the three and nine months ended September 30, 2017 will result in no income tax benefit or provision in the current year due to the full valuation allowance on its net deferred tax assets for the year ended December 31, 2016 and a full valuation allowance expected on its net deferred tax assets for the year ending December 31, 2017. A valuation allowance is provided when it is more likely than not that some portion of the deferred tax assets will not be realized. Asterias established a full valuation allowance as of December 31, 2016 due to the uncertainty of realizing future tax benefits from its net operating loss carryforwards and other deferred tax assets. A deferred federal income tax benefit of approximately $2.2 million was recorded for the nine months ended September 30, 2016 as Asterias’ deferred tax liabilities exceeded their deferred tax assets and recorded no valuation allowance on its deferred tax assets. Asterias established deferred tax liabilities primarily related to its acquisition of certain intellectual property and available for-sale-securities held in BioTime and OncoCyte common stock. For state income tax purposes Asterias has a full valuation allowance on its state deferred tax assets as of September 30, 2017 and December 31, 2016 and, accordingly, no state tax provision or benefit was recorded for any period presented. As discussed in Note 5, in connection with the Cross-License and Share Transfer transaction completed on February 16, 2016, the transfer of assets was a taxable transaction to Asterias generating a taxable gain of approximately $3.1 million. Asterias had sufficient current year losses from operations to offset the entire gain resulting in no income taxes due. As the transfer of assets and the resulting taxable gain is due to a direct effect of transactions between the former parent company, BioTime, and its former subsidiary, Asterias recorded the tax effect of this gain through equity in accordance with ASC 740-20-45-11(g). |
License and Royalty Obligations |
9 Months Ended | ||
---|---|---|---|
Sep. 30, 2017 | |||
License and Royalty Obligations [Abstract] | |||
License and Royalty Obligations |
Services Agreement with Cell Therapy Catapult Services Limited In October 2015, Asterias entered into a Services Agreement (the “Services Agreement”) with Cell Therapy Catapult Services Limited (“Catapult”), a research organization specializing in the development of technologies which speed the growth of the cell and gene therapy industry. Under the Services Agreement, Catapult will license to Asterias, certain background intellectual property and will develop a scalable manufacturing and differentiation process for Asterias’ human embryonic stem cell derived dendritic cell cancer vaccine development program. In consideration for the license and Catapult’s performance of services, at the time of the Services Agreement Asterias agreed to make aggregate payments of up to GBP £4,350,000 over the period from October 2015 through January 2020 (approximately $5.8 million based on the foreign currency exchange rate on September 30, 2017). At the option of Asterias, up to GBP £3,600,000 (approximately $4.8 million based on the foreign currency exchange rate on September 30, 2017) of such payments historically may have been settled in shares of Asterias Series A Common Stock instead of cash. Prospectively, all payments due will be made in shares of Asterias Series A Common Stock. If Catapult is unable to sell the stock in the market within 60 days of issuance, after reasonable and diligent efforts through its broker, Catapult may request that the unsold portion of the stock payment, if any, be paid by Asterias in cash at a value equal to approximately 91% of the total amount that was issued in stock. This right by Catapult to put the unsold shares back to Asterias for cash expires the earlier to occur of the sale of the stock in the market or after 60 days of issuance. Advance payments for research and development services to be performed by Catapult are deferred and recognized as research and development expense ratably as the services are performed. Advance payments related to licenses will be expensed when paid due to the experimental nature of the project. Pursuant to the Services Agreement, if there are any issued, but unsold Asterias stock, to Catapult for payment of services and the 60-day put right has not expired as of the period end being reported on, Asterias will present that amount as “temporary” equity in accordance with ASC 480-10-S99. Once the put right expires or the shares are sold by Catapult, the temporary equity amount will be reclassified by Asterias to permanent equity without adjustment to the carrying value of the stock. In the nine months ended September 30, 2017 and 2016 Asterias paid $1.1 million and $1.4 million, respectively, for services pursuant to the Services Agreement. Asterias paid $295,000 and $710,000, respectively, in cash for these services and the remainder was paid with Asterias Series A Common Stock. Asterias issued 217,193 and 142,020 shares of Asterias Series A Common Stock with fair market values of $858,000 and $644,000 at the time of issuance which Asterias reclassified into permanent equity. |
Clinical Trial and Option Agreement and CIRM Grant Award |
9 Months Ended | ||
---|---|---|---|
Sep. 30, 2017 | |||
Clinical Trial and Option Agreement and CIRM Grant Award [Abstract] | |||
Clinical Trial and Option Agreement and CIRM Grant Award |
On October 16, 2014 Asterias signed a Notice of Grant Award (“NGA”) with CIRM, effective October 1, 2014, with respect to a $14.3 million grant award for clinical development of Asterias’ product, AST-OPC1. The NGA was subsequently amended effective November 26, 2014 and March 2, 2016. The NGA includes the terms under which CIRM will release grant funds to Asterias. Under the NGA as amended on March 2, 2016, CIRM will disburse the grant funds to Asterias based on Asterias’ attainment of certain progress milestones. Asterias received an initial payment from CIRM in the amount of $917,000 during October 2014 and had received $12.8 million through December 31, 2016. In September 2017, we received the final $1.5 million payment under the CIRM grant which was due upon achievement of certain clinical milestones. We had no deferred grant income relating to the CIRM grant as of September 30, 2017 and deferred grant income relating to the CIRM grant was $2.2 million at December 31, 2016. |
Subsequent Events |
9 Months Ended | ||
---|---|---|---|
Sep. 30, 2017 | |||
Subsequent Events [Abstract] | |||
Subsequent Events |
On October 16, 2017, Asterias entered into a Securities Purchase Agreement with certain purchasers, pursuant to which Asterias agreed to issue and sell, in a registered direct offering, an aggregate of 4,000,000 shares of Series A common stock at an offering price of $2.60 per share. Asterias closed the registered direct offering on October 18, 2017. The gross proceeds from this sale were approximately $10.4 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by the Company. On November 2, 2017, we continued to make adjustments to our operating expenses as appropriate by reducing staffing allocated to non-clinical activities as a part of a broader effort to more closely align operating expenses with the Company’s primary goal of continuing to generate clinical data in our clinical stage programs which we believe are the activities that have the greatest potential to create value for shareholders over the next several years. The reduction in staffing will affect approximately 30 employees and will be completed in the fourth quarter of 2017. The Company expects to recognize approximately $0.6 million of pre-tax restructuring charges in the fourth quarter of 2017 in connection with the reduction in staffing, consisting of severance and other employee termination benefits, substantially all of which are expected to be settled in cash. |
Organization, Basis of Presentation and Liquidity (Policies) |
9 Months Ended |
---|---|
Sep. 30, 2017 | |
Organization, Basis of Presentation and Liquidity [Abstract] | |
Organization, Basis of Presentation and Liquidity | Asterias Biotherapeutics, Inc. (“Asterias”) is a biotechnology company focused on the emerging fields of regenerative medicine and cancer immunotherapy. Asterias has two core technology platforms. The first is a type of stem cell capable of becoming all of the cell types in the human body, a property called pluripotency. The second is a type of cell called “dendritic cells” used to teach cancer patients’ immune systems to attack their tumors. Asterias currently has three clinical stage programs based on these platforms: AST-OPC1 is a therapy derived from pluripotent stem cells that is currently in a Phase 1/2a clinical trial for spinal cord injuries; AST-VAC1 is a patient-specific cancer immunotherapy for Acute Myeloid Leukemia (AML); and AST-VAC2 is a non-patient specific cancer immunotherapy for which our research partner Cancer Research UK is planning for the initiation of a Phase 1 clinical trial in non-small cell lung cancer. Asterias was incorporated in Delaware on September 24, 2012. The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities Exchange Commission. In accordance with those rules and regulations certain information and footnote disclosures normally included in comprehensive financial statements have been condensed or omitted pursuant to such rules and regulations. The balance sheet as of December 31, 2016 was derived from the audited financial statements at that date, but does not include all the information and footnotes required by GAAP. These financial statements should be read in conjunction with the audited financial statements and notes thereto included in Asterias’ Annual Report on Form 10-K for the year ended December 31, 2016. The accompanying interim condensed financial statements, in the opinion of management, include all adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of Asterias’ financial condition and results of operations. The condensed results of operations are not necessarily indicative of the results to be expected for any future interim period or for the entire year. Liquidity – Since inception, Asterias has incurred operating losses and has funded its operations primarily through issuance of equity securities, warrants, payments from research grants, and royalties from product sales. On October 18, 2017, Asterias completed a registered offering of its Series A common stock, pursuant to which it raised $10.4 million in gross proceeds (see Note 14). At September 30, 2017, Asterias had an accumulated deficit of $105.6 million, working capital of $19.6 million and stockholders’ equity of $31.7 million. Asterias has evaluated its projected cash flows and believes that its cash and cash equivalents of $8.6 million and available-for-sale securities of $12.1 million as of September 30, 2017, as supplemented by the $10.4 million in gross proceeds from the recent offering, will be sufficient to fund Asterias’ operations through at least twelve months from the issuance date of these financial statements. If the value of Asterias’ available-for-sale securities decreases or it is unable to obtain adequate future financing for its clinical trials, it may be required to delay, postpone, or cancel its clinical trials, limit the number of clinical trial sites, or otherwise reduce or curtail its operations. Future financings may not be available to Asterias at acceptable terms, or at all. Sales of additional equity securities would result in the dilution of interests of current shareholders. |
Summary of Significant Accounting Policies (Policies) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Significant Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Basic and diluted net loss per share | Basic and diluted net loss per share – The computations of basic and diluted net loss per share are as follows (in thousands, except per share data):
The following common stock equivalents were excluded from the computation of diluted net loss per share of common stock for the periods presented because including them would have been antidilutive (in thousands):
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Recent Accounting Pronouncements | Recent Accounting Pronouncements In March 2016, the FASB issued ASU 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting (“ASU 2016-09”), which simplifies several aspects of the accounting for share-based payment transactions, including the income tax consequences, forfeitures, classification of awards as either equity or liabilities, and classification on the statement of cash flows. Asterias adopted ASU 2016-09 beginning on January 1, 2017. In connection with the adoption of ASU 2016-09, Asterias changed how it accounts for excess tax benefits and deficiencies, if any, and forfeitures, as applicable. All excess tax benefits and tax deficiencies from stock-based compensation awards accounted for under ASC 718 are recognized as an income tax benefit or expense, respectively, in the statements of operations. Prior to the adoption of ASU 2016-09, Asterias recognized excess tax benefits, if any, in additional paid-in capital only if the tax deduction reduced cash income taxes payable and excess tax deficiencies were recognized either as an offset to accumulated excess tax benefits, if any, on Asterias’ statements of operations. An excess income tax benefit arises when the tax deduction of a share-based award for income tax purposes exceeds the compensation cost recognized for financial reporting purposes and, a tax deficiency arises when the compensation cost exceeds the tax deduction. Because Asterias has a full valuation allowance, there was no impact to Asterias’ statements of operations for any excess tax benefits or deficiencies, as any excess benefit or deficiency would be offset by the change in the valuation allowance (see Note 11). Forfeitures are now accounted for as they occur instead of based on the number of awards that were expected to vest. Based on the nature and timing of Asterias equity grants, straight-line expense attribution of stock-based compensation for the entire award and the relatively low forfeiture rate on Asterias experience, the impact of adoption of ASU 2016-09 pertaining to forfeitures was not significant to Asterias’ financial statements (see Note 8). In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers, which requires an entity to recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In doing so, companies will need to use more judgment and make more estimates than under today’s guidance. These may include identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. The ASU will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective. In August 2015, the FASB issued ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date, which provided for the adoption of the new standard for fiscal years beginning after December 15, 2017. Accordingly, ASU No. 2014-09 is effective for the Company in the first quarter of 2018. Upon adoption, ASU No. 2014-09 can be applied retrospectively to all periods presented or only to the most current period presented with the cumulative effect of changes reflected in the opening balance of retained earnings in the most current period presented. The FASB has also issued the following standards which clarify ASU No. 2014-09 and have the same effective date as the original standard:
The Company expects to adopt ASU 2014-09 effective January 1, 2018, using the modified retrospective transition method. The Company has performed an initial analysis of areas that will be impacted by the new guidance and is currently evaluating the effect that the new standard will have on its internal processes, financial statements, and related disclosures. While the Company continues to assess all potential impacts under ASU 2014-09, recognition of the Company’s revenue under the new standard is expected to be materially consistent with the Company’s current revenue recognition policy. The new standard is not expected to materially impact the timing or amounts of revenue recognized. In May 2017, the FASB issued ASU 2017-09, Compensation – Stock Compensation: Scope of Modification Accounting to clarify the scope of modification accounting for share-based compensation. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. The new guidance will reduce diversity in practice and result in fewer changes to the terms of an award being accounted for as modifications. The new authoritative guidance will be effective for public business entities in fiscal years beginning after December 15, 2017. The authoritative guidance will be effective for the Company beginning in fiscal year 2018 as the Company decided not to early adopt it in fiscal year 2018. The Company is currently evaluating the impact of this new authoritative guidance on its financial statements. |
Summary of Significant Accounting Policies (Tables) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Significant Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Computations of Basic and Diluted Net Loss Per Share | Basic and diluted net loss per share – The computations of basic and diluted net loss per share are as follows (in thousands, except per share data):
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Common Stock Equivalents Excluded from Computation of Diluted Net Loss Per Share of Common Stock | The following common stock equivalents were excluded from the computation of diluted net loss per share of common stock for the periods presented because including them would have been antidilutive (in thousands):
|
Balance Sheet Components (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance Sheet Components [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, Plant and Equipment, Net | As of September 30, 2017 and December 31, 2016, property, plant and equipment consisted of the following (in thousands):
|
Intangible Assets (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||||||||||||||
Intangible Assets [Abstract] | |||||||||||||||||||||||||||||||||||||
Intangible Assets | Intangible assets net of accumulated amortization at September 30, 2017 and December 31, 2016 are shown in the following table (in thousands):
|
Stock-Based Compensation (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation Expenses Included in Operating Expenses | The following table shows the stock-based compensation expenses included in the operating expenses for the three and nine months ended September 30, 2017 and 2016 (in thousands):
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Assumptions Used to Estimate Fair Value of Stock Option | The fair value of each option award is estimated on the date of grant using a Black-Scholes option valuation model applying the weighted-average assumptions in the following table:
|
Organization, Basis of Presentation and Liquidity (Details) $ in Thousands |
9 Months Ended | ||||
---|---|---|---|---|---|
Oct. 18, 2017
USD ($)
|
Sep. 30, 2017
USD ($)
Platform
Program
|
Sep. 30, 2016
USD ($)
|
Dec. 31, 2016
USD ($)
|
Dec. 31, 2015
USD ($)
|
|
Organizational Basis of Presentation [Abstract] | |||||
Number of core technology platforms | Platform | 2 | ||||
Number of clinical stage programs | Program | 3 | ||||
Liquidity [Abstract] | |||||
Gross proceeds from offering | $ 8,003 | $ 2,149 | |||
Accumulated deficit | (105,552) | $ (83,728) | |||
Working capital | 19,600 | ||||
Stockholders' equity | 31,732 | 42,028 | |||
Cash and cash equivalents | 8,620 | $ 17,926 | 19,800 | $ 11,183 | |
Available for sale securities | $ 12,095 | $ 15,269 | |||
Series A Common Stock [Member] | Subsequent Event [Member] | |||||
Liquidity [Abstract] | |||||
Gross proceeds from offering | $ 10,400 |
Summary of Significant Accounting Policies (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2017 |
Sep. 30, 2016 |
Sep. 30, 2017 |
Sep. 30, 2016 |
|
Computations of basic and diluted net loss per share [Abstract] | ||||
Net loss | $ (6,809) | $ (10,648) | $ (21,824) | $ (26,144) |
Weighted average common shares outstanding - basic and diluted (in shares) | 49,771 | 45,193 | 49,110 | 41,588 |
Net loss per share - basic and diluted (in dollars per share) | $ (0.14) | $ (0.24) | $ (0.44) | $ (0.63) |
Stock Options and Restricted Stock Units [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive stock value from computation of earnings per share (in shares) | 7,272 | 6,349 | 7,272 | 6,349 |
Warrants [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive stock value from computation of earnings per share (in shares) | 2,813 | 6,699 | 2,813 | 6,699 |
Balance Sheet Components (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | |||
---|---|---|---|---|---|
Sep. 30, 2017 |
Sep. 30, 2016 |
Sep. 30, 2017 |
Sep. 30, 2016 |
Dec. 31, 2016 |
|
Property, plant and equipment, net [Abstract] | |||||
Furniture, fixtures and leasehold improvements | $ 5,274 | $ 5,274 | $ 5,421 | ||
Computers, machinery and equipment | 2,060 | 2,060 | 2,545 | ||
Property, plant and equipment, gross | 7,334 | 7,334 | 7,966 | ||
Less - accumulated depreciation and amortization | (2,574) | (2,574) | (2,491) | ||
Property, plant and equipment, net | 4,760 | 4,760 | $ 5,475 | ||
Depreciation expense | 285 | $ 304 | 840 | $ 909 | |
Disposal of fixed assets | 112 | ||||
Accumulated depreciation, net | 757 | ||||
Non-cash impairment losses | $ 98 | $ 14 |
Investments in BioTime and OncoCyte (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 9 Months Ended | 12 Months Ended | |
---|---|---|---|---|
Sep. 30, 2017 |
Sep. 30, 2017 |
Dec. 31, 2015 |
Dec. 31, 2016 |
|
Investments in BioTime and OncoCyte [Abstract] | ||||
Common stock value | $ 5 | $ 5 | $ 5 | |
OncoCyte Corporation [Member] | ||||
Investments in BioTime and OncoCyte [Abstract] | ||||
Common stock value | $ 1,500 | $ 1,500 | $ 1,400 | |
Paid in kind common stock dividend (in shares) | 192,644 | |||
Conversion of common stock (in shares) | 20 | |||
BioTime, Inc. [Member] | ||||
Investments in BioTime and OncoCyte [Abstract] | ||||
Number of shares sold (in shares) | 106,331 | 106,331 | ||
Weighted-average price (in dollars per share) | $ 2.81 | |||
Number of common shares held by investee (in shares) | 3,746,549 | 3,746,549 | 3,852,880 | |
Common stock value | $ 10,600 | $ 10,600 | $ 13,900 |
Intangible Assets (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | |||
---|---|---|---|---|---|
Sep. 30, 2017 |
Sep. 30, 2016 |
Sep. 30, 2017 |
Sep. 30, 2016 |
Dec. 31, 2016 |
|
Intangible assets, net [Abstract] | |||||
Intangible assets | $ 26,860 | $ 26,860 | $ 26,860 | ||
Less- accumulated amortization | (10,744) | (10,744) | (8,730) | ||
Intangible assets, net | 16,116 | 16,116 | $ 18,130 | ||
Amortization of intangible assets | $ 672 | $ 672 | $ 2,014 | $ 2,014 |
Stock-Based Compensation (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2017 |
Sep. 30, 2016 |
Sep. 30, 2017 |
Sep. 30, 2016 |
|
All stock-based compensation expense [Abstract] | ||||
Stock-based compensation expense | $ 906 | $ 1,172 | $ 3,615 | $ 3,648 |
Research and Development [Member] | ||||
All stock-based compensation expense [Abstract] | ||||
Stock-based compensation expense | 517 | 638 | 1,944 | 1,994 |
General and Administrative [Member] | ||||
All stock-based compensation expense [Abstract] | ||||
Stock-based compensation expense | $ 389 | $ 534 | $ 1,671 | $ 1,654 |
Stock Options [Member] | ||||
Weighted-average assumptions [Abstract] | ||||
Expected life | 6 years 29 days | 6 years 29 days | 5 years 9 months 4 days | 5 years 10 months 13 days |
Risk-free interest rates | 1.85% | 1.23% | 1.88% | 1.32% |
Volatility | 73.31% | 75.21% | 74.73% | 75.61% |
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Commitments and Contingencies (Details) $ in Thousands |
3 Months Ended | 9 Months Ended | |
---|---|---|---|
Sep. 30, 2017
USD ($)
ft²
|
Sep. 30, 2017
USD ($)
ft²
|
Dec. 31, 2016
USD ($)
|
|
Fremont Lease [Abstract] | |||
Deferred rent liability | $ 310 | $ 310 | $ 266 |
Cognate Services Agreement [Member] | |||
Development and manufacturing services agreement [Abstract] | |||
Aggregate fee payment for services | 1,700 | ||
Payment for estimated cost of materials and equipment | $ 500 | ||
Extended period for service agreement upon written notice | 2 years | ||
Minimum days require to extend the service period | 30 days | ||
Services agreement expense | $ 112 | $ 536 | |
Fremont, CA [Member] | |||
Fremont Lease [Abstract] | |||
Date on which company entered into lease | Dec. 30, 2013 | ||
Space of building | ft² | 44,000 | 44,000 | |
Tenant improvements, planned | $ 4,900 | $ 4,900 | |
Tenant improvement allowance | 4,400 | 4,400 | |
Landlord lease liabilities | 3,600 | 3,600 | 4,000 |
Deferred rent liability | $ 310 | $ 310 | $ 266 |
Shared Facilities and Services Agreement (Details) - USD ($) $ in Thousands |
9 Months Ended | ||
---|---|---|---|
Sep. 30, 2017 |
Sep. 30, 2016 |
Dec. 31, 2016 |
|
Shared Facilities and Services Agreement [Abstract] | |||
Usage fee allocation | 105.00% | ||
Term of payment | 30 days | ||
Interest on unpaid overdue invoice | 15.00% | ||
Allocated general overhead expenses | $ 117 | $ 683 | |
Amount due to BioTime | $ 0 | $ 288 |
Income Taxes (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | 12 Months Ended | |
---|---|---|---|---|
Sep. 30, 2017 |
Sep. 30, 2017 |
Sep. 30, 2016 |
Dec. 31, 2016 |
|
Income Taxes [Abstract] | ||||
Income tax provision (benefit) | $ 0 | $ 0 | ||
Deferred income tax (benefit) | 0 | $ (2,255) | ||
Deferred state income tax provision or (benefit) | 0 | $ 0 | ||
Valuation allowance on deferred tax assets | $ 0 | |||
BioTime, Inc. [Member] | ||||
Subsidiary, Sale of Stock [Line Items] | ||||
Investors taxable gain | $ 3,100 |
License and Royalty Obligations (Details) - Services Agreement with Cell Therapy Catapult Services Limited [Member] £ in Thousands, $ in Thousands |
9 Months Ended | ||
---|---|---|---|
Sep. 30, 2017
USD ($)
shares
|
Sep. 30, 2017
GBP (£)
shares
|
Sep. 30, 2016
USD ($)
shares
|
|
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Maximum aggregate payments for license agreement | $ 5,800 | £ 4,350 | |
Amount of license payments that can be settled in shares | $ 4,800 | £ 3,600 | |
Maximum days available to sell the stock in the market | 60 days | 60 days | |
Percentage of total amount of stock issued | 91.00% | 91.00% | |
Number of days required to sell unsold stock | 60 days | 60 days | |
Services agreement expense | $ 1,100 | $ 1,400 | |
Cash payment, service agreement expense | $ 295 | $ 710 | |
Series A Common Stock [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Shares issued for service (in shares) | shares | 217,193 | 217,193 | 142,020 |
Fair value of shares issued for service | $ 858 | $ 644 |
Clinical Trial and Option Agreement and CIRM Grant Award (Details) - USD ($) $ in Thousands |
1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
---|---|---|---|---|---|---|---|
Sep. 30, 2017 |
Oct. 31, 2014 |
Sep. 30, 2017 |
Sep. 30, 2016 |
Sep. 30, 2017 |
Sep. 30, 2016 |
Dec. 31, 2016 |
|
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Revenue received from grant award | $ 1,526 | $ 1,858 | $ 3,711 | $ 4,865 | |||
CIRM [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Revenue received from grant award | $ 1,500 | $ 917 | $ 12,800 | ||||
Deferred grant income | $ 0 | $ 0 | 0 | $ 2,200 | |||
CIRM [Member] | NGA [Member] | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Grant award | $ 14,300 | ||||||
Effective date of grant award agreement | October 1, 2014 | ||||||
Effective date of grant award agreement, amendment one | November 26, 2014 | ||||||
Effective date of grant award agreement, amendment two | March 2, 2016 |
Subsequent Events (Details) $ / shares in Units, $ in Thousands |
3 Months Ended | 9 Months Ended | |||
---|---|---|---|---|---|
Oct. 18, 2017
USD ($)
|
Oct. 16, 2017
$ / shares
shares
|
Dec. 31, 2017
USD ($)
Employee
|
Sep. 30, 2017
USD ($)
|
Sep. 30, 2016
USD ($)
|
|
Subsequent Event [Line Items] | |||||
Gross proceeds from sale of common stock | $ 8,003 | $ 2,149 | |||
Scenario, Forecast [Member] | |||||
Subsequent Event [Line Items] | |||||
Number of employees affected by reduced staffing | Employee | 30 | ||||
Pre-tax restructuring charges | $ 600 | ||||
Subsequent Event [Member] | Series A Common Stock [Member] | |||||
Subsequent Event [Line Items] | |||||
Shares issued (in shares) | shares | 4,000,000 | ||||
Offering price (in dollars per share) | $ / shares | $ 2.60 | ||||
Gross proceeds from sale of common stock | $ 10,400 |
U 0 T@, !D !X;"]W
M;W)K VS?$>
MHPIJ-@C[HL9'F.M),9J+_P87$ [N,W$:I1(F?%$Y&*ODS.)2D>Q]6GD7UG$Z
M29,Y+!Y YP"Z!.R##IF$0N9?F65%IM6(]'3W/?,MWAZHNYO2.\-5A#.7O''>
M2['=TXQ-&,.4X8NL8L".+8%PD:DSC2?\)I/'P7S7 7PG=K]>0_!$F4( D$
MR5\E[JY*C&&2N$@:%4DC!.F52 QS>R5"5HV3H)OP9 TJU="%<5EYEZFXHZ'Q
M?^#32#TSW?#.H+.R[OF$)M=*67"I;&Y<+JV;XL404%N__>+V>GK+DV%5/X\I
M6?X5Q6]02P,$% @ (HEN2Z25!'G# 0 -P0 !D !X;"]W;W)K E61)''L_N$^
MA5T*@JL<98"@PA64>=> >$"N99Y_XXVW]2BY1@C.A68F64&]66
M ^4HP,/7E%BE=$1,(4^UV\[!FCL)375BEKT(:ZLJ",G@(-JXYK'"^GG]X*WW
M)D=E$G$R9558,Q$[]W[@X8F3
M8XJ]J8,SMB+>H7B'WFN5W"8%NP:B)>8TQZ3;F#6"(?N:(MU+<4K_@J?[\&Q7
M81;AV6\*_T&0[Q+DD2#_;XE[,=D?2=BFIPIL%Z?)D=J,.D[RQKL.['T:W^17
M^#SMG[GMA';D8CR^;.Q_:XP'E'*XP1'J\8.MAH36A^,MGNT\9K/AS;#\(+9^
MX^HG4$L#!!0 ( "*);DN1281!M $ -(# 9 >&PO=V]R:W-H965T
MZ
MP$E(" 14+B@POUW@#H0(0CZ-UUD3+R$#<7W^4'^(M?M:SLS"G1:_>>VZ F<8
MU="P0;@G/7Z#N9YKC.;B?\ %A(>'3'R,2@L;5U0-UFDYJ_A4)'N;=J[B/DXW
M-^E,VR;0F4 70A;CD"E0S/R>.5;F1H_(3+WO67CB]$!];ZK@C*V(=SYYZ[V7
M,LV2G%R"T(PY3ABZQBP(XM67$'0KQ)'^1Z?;]-UFAKM(WZVC[[YN"^PW!?91
M8/^/0/:IQ U,]KE(LNJI!-/&:;*HTH.*D[SR+@-[2^.;_(5/T_[(3,N516?M
M_,O&_C=:._"I)%=^A#K_P19#0./"\8L_FVG,)L/I?OY!9/G&Y1]02P,$%
M @ (HEN2Z255>3$ 0 -P0 !D !X;"]W;W)K
9=VXX&!YVHD:OH/[T9V-M]BL4DH-K978$@-51N^W
MQU,2\!'P(F&PBS,)E5P07X/QIWY1:K7]BB$#MZJLFX7X5'K9A9%[?8H*M[>RT;4YL]>JHIK,U2'J&V4X+N.
M5)4108A%%2_J<#GOYI[4$H&$1^Q37EP3??T0 2:-Z68.2
M;O[OXBE'<)U 0*&@H]I-1S&1B(8!38:*9@*W$# .6T+N?H/
M4$L#!!0 ( "*);DNCCM.*N ( (H+ 9 >&PO=V]R:W-H965T
-'9$,E_.-:@U@/K@2N%FA?Q.Y'VF>LS'WZEK0&L Y'^IHM'$4C.Q
MM].@##;\V-A1='0Z3)QWV$X\[_!N7/U!Q;YL9/#,E9Z;['2SXUPQK26^T7D[
MZ EYV%1LI\PRUVO1C8G=1O&V'X&C80Y?_@-02P,$% @ (HEN2UBL7-4H
M @ ; 8 !D !X;"]W;W)K3)Y>0A0M!EXBEBXCBK,<$TDCO)H+<3"-7X#+%S$7$>6AYN:GRY"+R
MU')[4^3YML@2$!G ]8C!U8TU/SYWFQ:P0 (*)%H@N2B7M6KS#I-K3-.M:QIE
M5L4 4)%:&VWA@F0V*]VS"TJ*+(5-I:"I%# 5P0(9*)#=7]8<%,AOEW6: V4-
MK:TZ
I?&-MT2WL11B'TJ-B ZE$9,L
M>X9OMTR%-]J&CT0$;JY8OP16LG!"6IRE.RT]6\+P]P,3V":ZY-?$2[V^ G7
MV.@7%'IL#RZ5-3P"UMGWLUT(;@: /%(<^WO6BM01T-1/O_>]/:ZBX: ?/'L8
M$W,^;"BU3L4O8>D4.?3LH;TJ16U/'*P!UOEF[71)RT$2IWU.;*&R#6@_B>$1
MQN2M>C
UL2E';%N @$[=87?S! I#2-NP7=Z:O1<#L
MW0.HNKAS@2+9-Z3C(;I?L7N>:P"5!/+QP$T>)V*WJ; 5X