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x
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QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF
1934
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o
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TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES
EXCHANGE ACT OF 1934
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Delaware
|
58-1959440
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|
(State
or other jurisdiction of
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(I.R.S.
Employer Identification No.)
|
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incorporation
or organization)
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Large
accelerated filer
o
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Accelerated
filer
o
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Non-accelerated
filer
x
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Smaller
reporting company
o
|
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Class
|
Outstanding
at May 12, 2010
|
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Common
Stock $.01 Par Value
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101,492,491
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PAGE
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||||||
|
Item
1 —
|
Consolidated
Financial Statements
|
|||||
|
Consolidated
Balance Sheets as of
March
31, 2010 (unaudited) and December 31, 2009
|
3 | |||||
|
Consolidated
Statements of Operations for the
Three
Months Ended March 31, 2010 and 2009 (unaudited)
|
4 | |||||
|
Consolidated
Statements of Cash Flows for the
Three
Months Ended March 31, 2010 and 2009 (unaudited)
|
5 | |||||
|
Notes
to Consolidated Financial Statements (unaudited)
|
6 | |||||
|
Item
2
—
|
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
|
14 | ||||
|
Item
3 —
|
Quantitative
and Qualitative Disclosures
About
Market Risk
|
23 | ||||
|
Item
4 —
|
Controls
and Procedures
|
23 | ||||
|
Part
II. OTHER INFORMATION
|
||||||
|
Item
1 —
|
Legal
Proceedings
|
24 | ||||
|
Item
1A
—
|
Risk
Factors
|
24 | ||||
|
Item
2 —
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
24 | ||||
|
Item
3 —
|
Defaults
upon Senior Securities
|
24 | ||||
|
Item
4 —
|
Reserved
|
24 | ||||
|
Item
5 —
|
Other
Information
|
24 | ||||
|
Item
6 —
|
Exhibits
|
24 | ||||
|
SIGNATURES
|
25 | |||||
|
March 31,
2010 |
December 31,
2009 |
|||||||
|
ASSETS
|
(Unaudited)
|
|||||||
|
Current
assets:
|
||||||||
|
Cash
and cash equivalents
|
$ | 9,647,764 | $ | 6,312,182 | ||||
|
Short-term
investments
|
44,070 | 54,071 | ||||||
|
Accounts
receivable, net of allowance for doubtful accounts of
|
||||||||
|
$72,145
at March 31, 2010 and December 31, 2009
|
2,072 | 3,286,858 | ||||||
|
Prepaid
expenses and other
|
159,863 | 220,925 | ||||||
|
Total
current assets
|
9,853,769 | 9,874,036 | ||||||
|
Property
and equipment, net
|
151,941 | 171,498 | ||||||
|
Other
assets
|
14,424 | 21,494 | ||||||
|
Total
assets
|
$ | 10,020,134 | $ | 10,067,028 | ||||
|
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
||||||||
|
Current
liabilities:
|
||||||||
|
Accounts
payable
|
$ | 1,628,500 | $ | 1,968,607 | ||||
|
Accrued
liabilities
|
337,027 | 745,183 | ||||||
|
Current
portion of loan payable
|
7,237,350 | 8,555,404 | ||||||
|
Total
current liabilities
|
9,202,877 | 11,269,194 | ||||||
|
Loan
payable, less current portion
|
- | 723,814 | ||||||
|
Total
liabilities
|
9,202,877 | 11,993,008 | ||||||
|
Commitments
and contingencies
|
- | - | ||||||
|
Stockholders'
equity (deficit):
|
||||||||
|
Convertible
preferred stock, $1.00 par value;
|
||||||||
|
5,000,000
shares authorized and 3,350,000 shares issued and
|
||||||||
|
outstanding
at March 31, 2010 and December 31, 2009
|
||||||||
|
(liquidation
value - $33,500,000 at March 31, 2010 and December 31,
2009)
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3,350,000 | 3,350,000 | ||||||
|
Common
stock, $.01 par value:
|
||||||||
|
170,000,000
shares authorized at March 31, 2010 and December 31, 2009:
|
||||||||
|
95,700,986
and 88,671,445 shares issued and outstanding
|
||||||||
|
at
March 31, 2010 and December 31, 2009, respectively
|
957,011 | 886,715 | ||||||
|
Additional
paid-in capital
|
372,797,047 | 367,997,962 | ||||||
|
Treasury
stock, at cost: 874,999 shares held at March 31, 2010
and
|
||||||||
|
December
31, 2009
|
(8,034,244 | ) | (8,034,244 | ) | ||||
|
Accumulated
deficit
|
(368,252,557 | ) | (366,126,413 | ) | ||||
|
Total
stockholders' equity (deficit)
|
817,257 | (1,925,980 | ) | |||||
|
Total
liabilities and stockholders' equity (deficit)
|
$ | 10,020,134 | $ | 10,067,028 | ||||
|
Three
Months Ended
|
||||||||
|
March 31,
2010 |
March 31,
2009 |
|||||||
|
Revenues:
|
||||||||
|
Royalties
|
- | - | ||||||
|
Other
|
- | - | ||||||
| - | - | |||||||
|
Costs
and expenses:
|
||||||||
|
Research
and development
|
843,953 | 1,953,460 | ||||||
|
General
and administrative
|
1,051,225 | 1,159,721 | ||||||
| 1,895,178 | 3,113,181 | |||||||
|
Investment
income
|
- | 50,187 | ||||||
|
Interest
expense
|
(220,965 | ) | (453,761 | ) | ||||
|
Other
expense
|
(10,001 | ) | - | |||||
|
Net
loss
|
(2,126,144 | ) | (3,516,755 | ) | ||||
|
Dividends
on Series A convertible preferred stock
|
(251,250 | ) | (251,250 | ) | ||||
|
Net
loss attributable to common shareholders
|
$ | (2,377,394 | ) | $ | (3,768,005 | ) | ||
|
Net
loss per share (basic and diluted)
|
$ | (0.03 | ) | $ | (0.04 | ) | ||
|
Weighted
average number of common shares
|
||||||||
|
outstanding
(basic and diluted)
|
92,895,302 | 87,728,644 | ||||||
|
THREE
MONTH PERIOD
ENDED MARCH 31, |
||||||||
|
2010
|
2009
|
|||||||
|
CASH
FLOWS FROM OPERATING ACTIVITIES
|
||||||||
|
Net
loss
|
$ | (2,126,144 | ) | $ | (3,516,755 | ) | ||
|
Adjustments
to reconcile net loss to net cash provided by (used in)
operating
|
||||||||
|
activities:
|
||||||||
|
Depreciation
and amortization
|
19,557 | 35,422 | ||||||
|
Amortization
of discount on short-term investments
|
- | (26,777 | ) | |||||
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Stock-based
compensation expense
|
211,890 | 155,133 | ||||||
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Non-cash
interest
|
20,471 | 40,687 | ||||||
|
Investment
impairment loss
|
10,001 | - | ||||||
|
Changes
in operating assets and liabilities:
|
||||||||
|
Accounts
receivable
|
3,284,786 | 3,880,108 | ||||||
|
Prepaid
expenses and other
|
61,062 | 134,743 | ||||||
|
Deferred
rent
|
- | (20,763 | ) | |||||
|
Accounts
payable
|
(340,107 | ) | (1,300,305 | ) | ||||
|
Accrued
liabilities
|
(408,157 | ) | (996,591 | ) | ||||
|
Net
cash provided by (used in) operating activities
|
733,359 | (1,615,098 | ) | |||||
|
CASH
FLOWS FROM INVESTING ACTIVITIES
|
||||||||
|
Purchases
of short term investments
|
- | (4,967,793 | ) | |||||
|
Maturities
of short term investments
|
- | 4,000,000 | ||||||
|
Unrealized
loss on short term investments
|
- | (4,660 | ) | |||||
|
Net
cash used in investing activities
|
- | (972,453 | ) | |||||
|
CASH
FLOWS FROM FINANCING ACTIVITIES
|
||||||||
|
Repayment
of loan
|
(2,055,268 | ) | - | |||||
|
Net
proceeds from sale of common stock
|
4,657,491 | (1,852,771 | ) | |||||
|
Net
cash provided by (used in) financing activities
|
2,602,223 | (1,852,771 | ) | |||||
|
Net
increase (decrease) in cash and cash equivalents
|
3,335,582 | (4,440,322 | ) | |||||
|
Cash
and cash equivalents at beginning of period
|
6,312,182 | 16,743,129 | ||||||
|
Cash
and cash equivalents at end of period
|
$ | 9,647,764 | $ | 12,302,807 | ||||
|
Supplemental
disclosure of cash flow information:
|
||||||||
|
Cash
paid during the period for interest
|
$ | 200,494 | $ | 413,074 | ||||
|
1.
|
Basis
of Presentation
|
|
2.
|
Revenue
Recognition
|
|
3.
|
Restructuring
|
|
R&D
|
G&A
|
|||||||||||
|
Expenses
|
Expenses
|
|||||||||||
|
Balance
at December 31, 2009
|
$ | 228,754 | ||||||||||
|
Cash
payments
|
$ | (164,814 | ) | $ | (34,601 | ) | (199,415 | ) | ||||
|
Balance
at March 31, 2010
|
$ | 29,339 | ||||||||||
|
4.
|
New
Accounting Pronouncements
|
|
5.
|
Short-Term
Investments
|
| Available-for-Sale Securities | ||||||||||||||||
|
Amortized
|
Gross
Unrealized
|
Gross
Realized
|
Estimated
Fair Value (Net Carrying
|
|||||||||||||
|
Cost
|
Gains
|
Losses
|
Amount)
|
|||||||||||||
|
Equity
Securities
|
$ | 125,000 | $ | - | $ | (80,930 | ) | $ | 44,070 | |||||||
|
Total
|
$ | 125,000 | $ | - | $ | (80,930 | ) | $ | 44,070 | |||||||
| Available-for-Sale Securities | ||||||||||||||||
|
Amortized
|
Gross
Unrealized
|
Gross
Realized
|
Estimated
Fair Value (Net Carrying
|
|||||||||||||
|
Cost
|
Gains
|
Losses
|
Amount)
|
|||||||||||||
|
Equity
Securities
|
$ | 125,000 | $ | - | $ | (70,929 | ) | $ | 54,071 | |||||||
|
Total
|
$ | 125,000 | $ | - | $ | (70,929 | ) | $ | 54,071 | |||||||
|
6.
|
Loan
Payable
|
|
7.
|
Fair
Value Measurement
|
|
·
|
Level
1 – Inputs are unadjusted quoted prices in active markets for identical
assets or liabilities that we have the ability to access at the
measurement date.
|
|
·
|
Level
2 – Inputs are quoted prices for similar assets and liabilities in active
markets, quoted prices for identical or similar assets or liabilities in
markets that are not active, inputs other than quoted pries that are
observable for the asset or liability (i.e., interest rates, yield curves,
etc.), and inputs that are derived principally from or corroborated by
observable market data by correlation or other means (market corroborated
inputs).
|
|
·
|
Level
3 – Unobservable inputs that reflect our own assumptions, based on the
best information available, including our own
data.
|
|
Fair
Value Measurements at
March 31, 2010 |
||||||||||||||||
|
Total
|
Quoted
|
Significant
|
||||||||||||||
|
Carrying
|
prices
|
other
|
Significant
|
|||||||||||||
|
Value
at
|
in
active
|
observable
|
unobservable
|
|||||||||||||
|
March 31,
|
markets
|
inputs
|
inputs
|
|||||||||||||
|
2010
|
(Level
1)
|
(Level
2)
|
(Level
3)
|
|||||||||||||
|
Cash
equivalents
|
$ | 2,105,868 | $ | 2,105,868 | $ | — | $ | — | ||||||||
|
Available
for sale securities*
|
44,070 | 44,070 | — | — | ||||||||||||
|
Fair
Value Measurements at
December 31, 2009 |
||||||||||||||||
|
Total
|
Quoted
|
Significant
|
||||||||||||||
|
Carrying
|
prices
|
other
|
Significant
|
|||||||||||||
|
Value
at
|
in
active
|
observable
|
unobservable
|
|
||||||||||||
|
December
31,
|
markets
|
inputs
|
inputs
|
|||||||||||||
|
2009
|
(Level
1)
|
(Level
2)
|
(Level
3)
|
|||||||||||||
|
Cash
equivalents
|
$ | 4,105,868 | $ | 4,105,868 | $ | — | $ | — | ||||||||
|
Available
for sale securities*
|
54,051 | 54,051 | — | — | ||||||||||||
|
8.
|
Stockholders’
Equity
|
|
9.
|
Share-Based
Compensation
|
|
THREE MONTHS
ENDED MARCH 31, |
||||||||
|
2010
|
2009
|
|||||||
|
Research
and development
|
$ | 9,766 | $ | 57,179 | ||||
|
General
and administrative
|
202,124 | 97,954 | ||||||
|
Share-based
compensation expense
|
$ | 211,890 | $ | 155,133 | ||||
|
Net
share-based compensation expense, per common share:
|
||||||||
|
Basic
and diluted
|
$ | 0.002 | $ | 0.002 | ||||
|
THREE MONTH PERIOD
ENDED MARCH 31, |
||||||||
|
2010
|
2009
|
|||||||
|
Expected
volatility
|
97.50 | % | 78.02 | % | ||||
|
Risk-free
interest rate
|
2.38 | % | 2.08 | % | ||||
|
Expected
term of option
|
5
years
|
5
years
|
||||||
|
Forfeiture
rate*
|
5.00 | % | 5.00 | % | ||||
|
Expected
dividend yield
|
0.00 | % | 0.00 | % | ||||
|
Weighted
|
||||||||
|
Average
|
||||||||
|
Number of
|
Exercise
|
|||||||
|
Options
|
Price
|
|||||||
|
Outstanding
at January 1, 2010
|
6,984,606 | $ | 5.50 | |||||
|
Granted
|
405,000 | $ | 0.67 | |||||
|
Exercised
|
(54,625 | ) | $ | 0.16 | ||||
|
Expired
|
(359,774 | ) | $ | 13.43 | ||||
|
Forfeited
|
(28,385 | ) | $ | 0.40 | ||||
|
Outstanding
at March 31, 2010
|
6,946,822 | $ | 4.87 | |||||
|
Vested
and expected to vest at March 31, 2010
|
6,922,199 | $ | 4.88 | |||||
|
Exercisable
at March 31, 2010
|
6,454,365 | $ | 5.22 | |||||
|
10.
|
Income
Taxes
|
|
11.
|
Subsequent
Events
|
|
-
|
Going
Concern - A fundamental principle of the preparation
of financial statements in accordance with GAAP is the assumption that an
entity will continue in existence as a going concern, which contemplates
continuity of operations and the realization of assets and settlement of
liabilities occurring in the ordinary course of business. This
principle is applicable to all entities except for entities in liquidation
or entities for which liquidation appears imminent. In
accordance with this requirement, our policy is to prepare our
consolidated financial statements on a going concern basis unless we
intend to liquidate or have no other alternative but to
liquidate. Based on current plans, we expect our current
available cash and cash equivalents to meet our cash requirements into the
first quarter of fiscal 2011. At March 31, 2010 the Company has
operating and liquidity concerns and plans to continue to pursue
opportunities to raise additional capital to fund its operating needs.
While we have prepared our consolidated financial statements on a going
concern basis, if we do not receive additional funding, our ability to
continue as a going concern may be impacted. Our consolidated
financial statements included in this Quarterly Report on Form 10-Q do not
reflect any adjustments that might specifically result from the outcome of
this uncertainty.
|
|
-
|
Revenue
Recognition - We recognize revenue in accordance with the provisions of
authoritative guidance issued, whereby revenue is not recognized until it
is realized. Revenue is recognized when all of the following
criteria are met: 1) persuasive evidence of an arrangement
exists, 2) delivery has occurred or services have been rendered, 3) the
price to the buyer is fixed and determinable and 4) collectibility is
reasonably assured.
|
|
-
|
Royalty
Revenue – Royalties from licenses are based on third-party sales and
recorded as earned in accordance with contract terms, when third-party
results are reliably measured and collectibility is reasonably assured. We
expect that the majority of our 2010 revenues will be from royalties on
the sale of Thalomid
®
,
which we will recognize when we receive the royalty payment. In
2004, certain provisions of a purchase agreement dated June 14, 2001 by
and between Bioventure Investments kft (“Bioventure”) and the Company were
satisfied and, as a result, beginning in 2005 we became entitled to share
in the royalty payments received by Royalty Pharma Finance Trust,
successor to Bioventure, on annual Thalomid
®
sales above a certain threshold. Based on the licensing
agreement royalty formula, annual royalty sharing commences with
Thalomid
®
annual sales of approximately $225
million.
|
|
-
|
The
Company is also eligible to receive royalties from Oxford Biomedica, PLC
based on a portion of the net sales of products developed for the
treatment of ophthalmic (eye) diseases based in part on
Endostatin. Under our original Endostatin license agreement
with Children’s Medical Center Corporation, a portion of the royalties we
receive from Oxford Biomedica are payable to
CMCC.
|
|
-
|
In
the future, royalty payments, if any, will be recorded as revenue when
received and/or when collectibility is reasonably
assured.
|
|
-
|
Research
and Development - Research and development expenses consist primarily of
compensation and other expenses related to research and development
personnel, research collaborations, costs associated with preclinical
testing and clinical trials of our product candidates, including the costs
of manufacturing drug substance and drug product, regulatory maintenance
costs, and facilities expenses. Research and development costs
are expensed as incurred.
|
|
-
|
Expenses
for Clinical Trials – Expenses for clinical trials are incurred from
planning through patient enrollment to reporting of the
data. We estimate expenses incurred for clinical trials that
are in process based on patient enrollment and based on clinical data
collection and management. Costs that are associated with
patient enrollment are recognized as each patient in the clinical trial
completes the enrollment process. Estimated clinical trial
costs related to enrollment can vary based on numerous factors, including
expected number of patients in trials, the number of patients that do not
complete participation in a trial, and when a patient drops out of a
trial. Costs that are based on clinical data collection and
management are recognized in the reporting period in which services are
provided. In the event of early termination of a clinical
trial, we would accrue an amount based on estimates of the remaining
non-cancelable obligations associated with winding down the clinical
trial.
|
|
-
|
Stock-Based
Compensation – All share-based payment transactions are recognized in the
consolidated financial statements at their fair values. Using
the straight-line expense attribution method over the requisite service
period, which is generally the option vesting term of three years,
share-based compensation expense recognized in the three months ended
March 31, 2010 and March 31, 2009 totaled $212,000 and $155,000,
respectively.
|
|
ESTIMATED
|
||
|
COMPLETION
|
||
|
CLINICAL
PHASE
|
PERIOD
|
|
|
Phase
I
|
1
Year
|
|
|
Phase
II
|
1-2
Years
|
|
|
Phase
III
|
2-4
Years
|
|
-
|
Outside
Services – In the three-month period ended March 31, 2010, we expended
$5,000 on outside service activities versus $185,000 in the same 2009
period. The decrease in 2010 as compared to 2009 continues to
reflect the absence of utilizing outsourced services to conduct
development of products from discontinued
programs.
|
|
-
|
Clinical
Trial Costs – Clinical trial costs, which include clinical site fees,
monitoring costs and data management costs, decreased to $21,000 in the
three months ended March 31, 2010 from $443,000 in the three-month period
ended March 31, 2009. The decrease relates primarily to our
focus on the clinical development of ENMD-2076, reducing patient costs for
cycles of treatment that were not completed in trials that have wound down
in discontinued programs.
|
|
-
|
Contract
Manufacturing Costs – The costs of manufacturing the material used in
clinical trials for our product candidates is reflected in contract
manufacturing. These costs include bulk manufacturing, encapsulation and
fill and finish services, product release costs and storage fees. Contract
manufacturing costs for the three months ended March 31, 2010 increased to
$169,000 from $157,000 during the same period in
2009.
|
|
-
|
Personnel
Costs -- Personnel costs decreased to $345,000 in the three months ended
March 31, 2010 from $625,000 in the three-month period ended March 31,
2009. The decrease is attributed to the elimination of three
management positions in December 2009.
|
|
|
-
|
Also reflected in our 2010
research and development expenses for the three-month period ended March
31, 2010 are patent costs of $103,000 and facility and related expenses of
$57,000. In the corresponding 2009 period, these expenses
totaled $169,000 and $232,000,
respectively.
|
|
31.1
|
Rule
13a-14(a) Certification of Executive Chairman
|
|
|
31.2
|
Rule
13a-14(a) Certification of Principal Accounting Officer
|
|
|
32.1
|
Section
1350 Certification of Executive Chairman
|
|
|
32.2
|
Section
1350 Certification of Principal Accounting
Officer
|
|
ENTREMED,
INC.
(Registrant) |
|||
|
Date:
May 17, 2010
|
|
/s/ Michael M. Tarnow | |
| Michael M. Tarnow | |||
| Executive Chairman | |||
| Date: May 17, 2010 | /s/ Kathy R. Wehmeir-Davis | ||
| Kathy R. Wehmeir-Davis | |||
| Principal Accounting Officer |
|
31.1
|
Rule
13a-14(a) Certification of Executive Chairman
|
|
|
31.2
|
Rule
13a-14(a) Certification of Principal Accounting Officer
|
|
|
32.1
|
Section
1350 Certification of Executive Chairman
|
|
|
32.2
|
Section
1350 Certification of Principal Accounting
Officer
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|