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ý
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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|
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Delaware
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93-1301885
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(State or other jurisdiction of
incorporation or organization)
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|
(IRS Employer
Identification No.)
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|
23622 Calabasas Road, Suite 300
Calabasas, California
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|
91302
|
|
(Address of principal executive offices)
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|
(Zip code)
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|
|
|
Large accelerated filer
|
¨
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Accelerated Filer
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¨
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Non-accelerated filer (Do not check if a smaller reporting company)
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¨
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Smaller reporting company
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ý
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Page
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2016
|
|
December 31, 2015
|
||||
|
|
(unaudited)
|
|
|
||||
|
Assets
|
|
|
|
||||
|
Current assets:
|
|
|
|
||||
|
Cash and cash equivalents
|
$
|
15,297,823
|
|
|
$
|
22,604,481
|
|
|
Supplies for clinical trials
|
1,037,291
|
|
|
1,158,632
|
|
||
|
Other assets
|
631,225
|
|
|
797,425
|
|
||
|
Total current assets
|
16,966,339
|
|
|
24,560,538
|
|
||
|
Property and equipment, net
|
126,718
|
|
|
180,922
|
|
||
|
Supplies for clinical trials
|
1,614,835
|
|
|
1,115,657
|
|
||
|
Deposits
|
3,520,885
|
|
|
4,176,280
|
|
||
|
Deferred financing costs
|
—
|
|
|
48,977
|
|
||
|
Total assets
|
$
|
22,228,777
|
|
|
$
|
30,082,374
|
|
|
Liabilities and Shareholders’ Equity
|
|
|
|
||||
|
Current liabilities:
|
|
|
|
||||
|
Accounts payable
|
$
|
471,645
|
|
|
$
|
1,161,258
|
|
|
Accrued compensation and benefits
|
359,219
|
|
|
790,487
|
|
||
|
Accrued liabilities
|
902,573
|
|
|
317,653
|
|
||
|
Total current liabilities
|
1,733,437
|
|
|
2,269,398
|
|
||
|
CIRM liability
|
6,523,051
|
|
|
4,133,905
|
|
||
|
Warrant liability
|
2,340,876
|
|
|
1,958,775
|
|
||
|
Total liabilities
|
10,597,364
|
|
|
8,362,078
|
|
||
|
Commitments and contingencies (Note 5)
|
|
|
|
||||
|
Shareholders’ equity:
|
|
|
|
||||
|
Common stock, $0.0001 par value; 249,000,000 shares authorized;
137,795,802 and 90,310,149 shares issued and outstanding as of
September 30, 2016 and December 31, 2015, respectively
|
13,780
|
|
|
9,031
|
|
||
|
Additional paid-in capital
|
101,516,114
|
|
|
95,849,005
|
|
||
|
Accumulated deficit
|
(89,898,481
|
)
|
|
(74,137,740
|
)
|
||
|
Total shareholders’ equity
|
11,631,413
|
|
|
21,720,296
|
|
||
|
Total liabilities and shareholders’ equity
|
$
|
22,228,777
|
|
|
$
|
30,082,374
|
|
|
|
For the Three Months Ended
September 30, 2016 |
|
For the Three Months Ended
September 30, 2015 |
|
For the Nine Months Ended
September 30, 2016 |
|
For the Nine Months Ended
September 30, 2015 |
||||||||
|
Revenues
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Expenses:
|
|
|
|
|
|
|
|
||||||||
|
Research and development
|
4,563,896
|
|
|
2,662,373
|
|
|
13,734,693
|
|
|
7,028,242
|
|
||||
|
General and administrative
|
908,380
|
|
|
1,083,516
|
|
|
3,058,027
|
|
|
3,206,356
|
|
||||
|
Total expenses
|
5,472,276
|
|
|
3,745,889
|
|
|
16,792,720
|
|
|
10,234,598
|
|
||||
|
Loss before other income (expense)
|
|
|
|
|
|
|
|
||||||||
|
and taxes
|
(5,472,276
|
)
|
|
(3,745,889
|
)
|
|
(16,792,720
|
)
|
|
(10,234,598
|
)
|
||||
|
Interest income
|
9,920
|
|
|
5,498
|
|
|
18,831
|
|
|
14,408
|
|
||||
|
Interest expense
|
(342,323
|
)
|
|
—
|
|
|
(889,146
|
)
|
|
—
|
|
||||
|
Financing expense
|
(111,557
|
)
|
|
—
|
|
|
(142,788
|
)
|
|
(88,939
|
)
|
||||
|
Change in fair value of
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
warrant liability
|
1,118,411
|
|
|
339,136
|
|
|
2,045,082
|
|
|
2,328,298
|
|
||||
|
Loss before provision for income taxes
|
(4,797,825
|
)
|
|
(3,401,255
|
)
|
|
(15,760,741
|
)
|
|
(7,980,831
|
)
|
||||
|
Provision for income taxes
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
|
Net loss
|
$
|
(4,797,825
|
)
|
|
$
|
(3,401,255
|
)
|
|
$
|
(15,760,741
|
)
|
|
$
|
(7,980,831
|
)
|
|
Net loss per share
|
$
|
(0.04
|
)
|
|
$
|
(0.04
|
)
|
|
$
|
(0.15
|
)
|
|
$
|
(0.09
|
)
|
|
Weighted average number of
shares outstanding basic and diluted:
|
121,336,020
|
|
|
90,260,703
|
|
|
101,904,347
|
|
|
86,156,805
|
|
||||
|
|
Common Stock
|
|
|
|
|
|
|
|||||||||||
|
|
Shares
|
|
Amount
|
|
Additional Paid-in Capital
|
|
Accumulated Deficit
|
|
Total
|
|||||||||
|
Balance at December 31, 2015
|
90,310,149
|
|
|
$
|
9,031
|
|
|
$
|
95,849,005
|
|
|
$
|
(74,137,740
|
)
|
|
$
|
21,720,296
|
|
|
Common stock issued through controlled equity offering at an average of $0.25 per share net of offering costs
|
3,085,653
|
|
|
309
|
|
|
641,901
|
|
|
—
|
|
|
642,210
|
|
||||
|
Common stock and warrants issued for cash at $0.16 per unit, net of offering costs
|
44,400,000
|
|
|
4,440
|
|
|
4,265,784
|
|
|
—
|
|
|
4,270,224
|
|
||||
|
Stock based compensation
|
—
|
|
|
—
|
|
|
759,424
|
|
|
—
|
|
|
759,424
|
|
||||
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(15,760,741
|
)
|
|
(15,760,741
|
)
|
||||
|
Balance at September 30, 2016
|
137,795,802
|
|
|
$
|
13,780
|
|
|
$
|
101,516,114
|
|
|
$
|
(89,898,481
|
)
|
|
$
|
11,631,413
|
|
|
|
For the Nine Months Ended
September 30, 2016 |
|
For the Nine Months Ended
September 30, 2015 |
||||
|
Cash flows from operating activities:
|
|
|
|
||||
|
Net loss
|
$
|
(15,760,741
|
)
|
|
$
|
(7,980,831
|
)
|
|
Adjustments to reconcile net loss to net cash used in
operating activities:
|
|
|
|
||||
|
Depreciation
|
58,219
|
|
|
20,282
|
|
||
|
Change in fair value of warrant liability
|
(2,045,082
|
)
|
|
(2,328,298
|
)
|
||
|
Financing expense
|
142,788
|
|
|
88,939
|
|
||
|
Stock-based compensation
|
759,424
|
|
|
666,123
|
|
||
|
Restricted stock issued for services
|
—
|
|
|
9,400
|
|
||
|
Accrued interest on CIRM award
|
889,146
|
|
|
—
|
|
||
|
Changes in assets and liabilities:
|
|
|
|
||||
|
Other assets
|
166,200
|
|
|
(354,142
|
)
|
||
|
Supplies for clinical trials
|
(377,837
|
)
|
|
—
|
|
||
|
Deposits
|
655,395
|
|
|
(4,060,977
|
)
|
||
|
Accounts payable
|
(764,613
|
)
|
|
535,594
|
|
||
|
Accrued compensation and benefits
|
(431,268
|
)
|
|
153,690
|
|
||
|
Accrued liabilities
|
584,920
|
|
|
26,449
|
|
||
|
Net cash used in operating activities
|
(16,123,449
|
)
|
|
(13,223,771
|
)
|
||
|
Cash flows from investing activities:
|
|
|
|
||||
|
Purchase of property and equipment
|
(4,015
|
)
|
|
(169,750
|
)
|
||
|
Net cash used in investing activities
|
(4,015
|
)
|
|
(169,750
|
)
|
||
|
Cash flows from financing activities:
|
|
|
|
||||
|
Proceeds from the issuance of common stock through controlled equity offering
|
691,187
|
|
|
—
|
|
||
|
Proceeds from CIRM award
|
1,500,000
|
|
|
—
|
|
||
|
Proceeds from issuance of common stock and warrants net of
offering costs
|
6,629,619
|
|
|
14,606,377
|
|
||
|
Net cash provided by financing activities
|
8,820,806
|
|
|
14,606,377
|
|
||
|
(Decrease) increase in cash and cash equivalents
|
(7,306,658
|
)
|
|
1,212,856
|
|
||
|
Cash and cash equivalents, beginning of period
|
22,604,481
|
|
|
23,222,296
|
|
||
|
Cash and cash equivalents, end of period
|
$
|
15,297,823
|
|
|
$
|
24,435,152
|
|
|
Supplemental cash flows disclosures:
|
|
|
|
||||
|
Interest expense paid
|
$
|
—
|
|
|
$
|
—
|
|
|
Income taxes paid
|
$
|
—
|
|
|
$
|
—
|
|
|
Supplemental non-cash disclosures
|
|
|
|
||||
|
Financing costs included in accounts payable
|
$
|
75,000
|
|
|
$
|
—
|
|
|
|
Nine Months Ended
September 30, 2016 |
|
Nine Months Ended
September 30, 2015 |
||
|
Risk-free interest rate
|
1.3
|
%
|
|
1.8
|
%
|
|
Expected dividend yield
|
None
|
|
|
None
|
|
|
Expected life
|
6.0 years
|
|
|
6.5 years
|
|
|
Expected volatility
|
82.7
|
%
|
|
93.8
|
%
|
|
Expected forfeitures
|
—
|
%
|
|
—
|
%
|
|
|
September 30, 2016
|
|
December 31, 2015
|
||||
|
Computers
|
$
|
70,960
|
|
|
$
|
66,945
|
|
|
Research equipment
|
305,066
|
|
|
305,066
|
|
||
|
|
376,026
|
|
|
372,011
|
|
||
|
Accumulated depreciation
|
(249,308
|
)
|
|
(191,089
|
)
|
||
|
|
$
|
126,718
|
|
|
$
|
180,922
|
|
|
Years ending December 31,
|
|
Amount
|
||
|
2016
|
|
$
|
25,662
|
|
|
2017
|
|
68,432
|
|
|
|
Total
|
|
$
|
94,094
|
|
|
|
Options
|
|
Weighted
Average
Exercise
Price
|
|
Weighted
Average
Remaining
Contractual
Term
|
|
Aggregate
Intrinsic
Value
|
||||||
|
Outstanding December 31, 2015
|
10,719,904
|
|
|
$
|
1.18
|
|
|
—
|
|
|
—
|
|
|
|
Granted
|
1,937,750
|
|
|
$
|
0.29
|
|
|
—
|
|
|
—
|
|
|
|
Exercised
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
—
|
|
|
|
Forfeited or expired
|
(217,630
|
)
|
|
$
|
1.45
|
|
|
—
|
|
|
—
|
|
|
|
Outstanding September 30, 2016
|
12,440,024
|
|
|
$
|
1.04
|
|
|
3.49
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
||||||
|
Vested at September 30, 2016
|
9,131,823
|
|
|
$
|
1.20
|
|
|
1.72
|
|
|
$
|
—
|
|
|
|
September 30, 2016
|
|
September 30, 2015
|
||||
|
Balance – January 1
|
$
|
1,958,775
|
|
|
$
|
597,719
|
|
|
Issuance of warrants and effect of repricing
|
2,427,183
|
|
|
4,286,314
|
|
||
|
Exercise of warrants
|
—
|
|
|
—
|
|
||
|
(Gain) or loss included in earnings
|
(2,045,082
|
)
|
|
(2,328,298
|
)
|
||
|
Balance – September 30
|
$
|
2,340,876
|
|
|
$
|
2,555,735
|
|
|
|
September 30, 2016
|
|
September 30, 2015
|
||
|
Income tax benefit at the federal statutory rate
|
(34
|
)%
|
|
(34
|
)%
|
|
State income tax benefit, net of federal tax benefit
|
(6
|
)%
|
|
(6
|
)%
|
|
Change in fair value of warrant liability
|
7
|
%
|
|
12
|
%
|
|
Change in valuation allowance for deferred tax assets
|
33
|
%
|
|
28
|
%
|
|
Total
|
—
|
%
|
|
—
|
%
|
|
|
September 30, 2016
|
|
December 31, 2015
|
||||
|
Net operating loss carryforwards
|
25,136,992
|
|
|
20,091,036
|
|
||
|
Stock-based compensation
|
2,903,078
|
|
|
2,599,308
|
|
||
|
Less valuation allowance
|
(28,040,070
|
)
|
|
(22,690,344
|
)
|
||
|
Net deferred tax asset
|
$
|
—
|
|
|
$
|
—
|
|
|
•
|
design of the trial protocol;
|
|
•
|
the size of the patient population;
|
|
•
|
eligibility criteria for the study in question;
|
|
•
|
perceived risks and benefits of the product candidate under study;
|
|
•
|
availability of competing therapies and clinical trials;
|
|
•
|
efforts to facilitate enrollment in clinical trials;
|
|
•
|
our ability to successfully apherese and manufacture ICT-107 and placebo for trial participants in a timely and cost-effective manner;
|
|
•
|
the ability to monitor patients adequately during and after treatment; and
|
|
•
|
proximity and availability of clinical trial sites for prospective patients.
|
|
•
|
our ability to obtain U.S. and foreign marketing approvals for our product candidates on a timely basis;
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|
•
|
the level of acceptance of our products by physicians, compared to those of competing products or therapies;
|
|
•
|
our ability to have our products manufactured on a commercial scale;
|
|
•
|
the effectiveness of sales and marketing efforts on behalf of our products;
|
|
•
|
our ability to meet demand for our products;
|
|
•
|
our ability to secure insurance reimbursement for our products;
|
|
•
|
the price of our products relative to competing products or therapies;
|
|
•
|
our ability to enter into collaborations with third parties to market our products;
|
|
•
|
our ability to recruit and retain appropriate management and scientific personnel; and
|
|
•
|
our ability to develop a commercial-scale research and development, manufacturing and marketing infrastructure, either on our own or with one or more future strategic partners.
|
|
•
|
the perceived safety and efficacy of our products;
|
|
•
|
the prevalence and severity of any side effects;
|
|
•
|
our ability to gain access to the entire market through distributor arrangements;
|
|
•
|
the willingness of the target patient population to try new products and of physicians to prescribe our products;
|
|
•
|
the effectiveness of our marketing strategy and distribution support;
|
|
•
|
the timing of our receipt of any marketing approvals, the terms of any approvals and the countries in which approvals are obtained;
|
|
•
|
the availability of government and third-party payor reimbursement;
|
|
•
|
the pricing of our product candidates, particularly as compared to alternative treatments; and
|
|
•
|
the availability of alternative effective forms of treatments, at that time, for the diseases that the product candidates we are developing are intended to treat.
|
|
Exhibit No.
|
|
Description
|
|
4.1
|
|
Warrant Agreement, dated August 12, 2016, by and among ImmunoCellular Therapeutics, Ltd., Computershare Inc. and Computershare Trust Company, N.A., as warrant agent, and the form of Warrant issued in August 2016 public offering.
|
|
|
|
|
|
4.2*
|
|
Form of Pre-Funded Warrant issued in August 2016 public offering.
|
|
|
|
|
|
10.1+
|
|
Amendment to Employment Agreement by and between ImmunoCellular Therapeutics, Ltd. and David Fractor, dated as of September 13, 2016.
|
|
|
|
|
|
31.1
|
|
Certification of the Registrant’s Principal Executive Officer under Exchange Act Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
|
31.2
|
|
Certification of the Registrant’s Principal Financial Officer under Exchange Act Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
|
32.1
|
|
Certification of the Registrant’s Principal Executive Officer under 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
|
32.2
|
|
Certification of the Registrant’s Principal Financial Officer under 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
|
101.INS
|
|
XBRL Instance Document
|
|
|
|
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
|
|
101.LAB
|
|
XBRL Taxonomy Extension Labels Linkbase Document
|
|
|
|
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
|
|
+
|
|
Indicates management contract or compensatory plan or arrangement
|
|
|
|
|
|
*
|
|
Previously filed by us on August 4, 2016 as an exhibit to our Registration Statement on Form S-1, File No. 333-211763 and incorporated herein by reference.
|
|
Dated: November 10, 2016
|
|
|
IMMUNOCELLULAR THERAPEUTICS, LTD.
|
|
|
By:
|
|
/s/ Andrew Gengos
|
|
|
Name:
|
|
Andrew Gengos
|
|
|
Title:
|
|
President and Chief Executive Officer
(Principal Executive Officer)
|
|
|
By:
|
|
/s/ David Fractor
|
|
|
Name:
|
|
David Fractor
|
|
|
Title:
|
|
Principal Accounting Officer
(Principal Financial and Accounting Officer)
|
|
Exhibit No.
|
|
Description
|
|
4.1
|
|
Warrant Agreement, dated August 12, 2016, by and among ImmunoCellular Therapeutics, Ltd., Computershare Inc. and Computershare Trust Company, N.A., as warrant agent, and the form of Warrant issued in August 2016 public offering.
|
|
|
|
|
|
4.2*
|
|
Form of Pre-Funded Warrant issued in August 2016 public offering.
|
|
|
|
|
|
10.1+
|
|
Amendment to Employment Agreement by and between ImmunoCellular Therapeutics, Ltd. and David Fractor, dated as of September 13, 2016.
|
|
|
|
|
|
31.1
|
|
Certification of the Registrant’s Principal Executive Officer under Exchange Act Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
|
31.2
|
|
Certification of the Registrant’s Principal Financial Officer under Exchange Act Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
|
32.1
|
|
Certification of the Registrant’s Principal Executive Officer under 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
|
32.2
|
|
Certification of the Registrant’s Principal Financial Officer under 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
|
101.INS
|
|
XBRL Instance Document
|
|
|
|
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
|
|
101.LAB
|
|
XBRL Taxonomy Extension Labels Linkbase Document
|
|
|
|
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
|
|
+
|
|
Indicates management contract or compensatory plan or arrangement
|
|
|
|
|
|
*
|
|
Previously filed by us on August 4, 2016 as an exhibit to our Registration Statement on Form S-1, File No. 333-211763 and incorporated herein by reference.
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|