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|
☒
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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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
|
|
26-2593535
|
|
(State of incorporation)
|
|
(I.R.S. Employer Identification No.)
|
|
|
|
|
|
|
|
|
|
|
Large accelerated filer
|
☐
|
Accelerated filer
|
☒
|
Non-accelerated filer
|
☐
|
Smaller reporting company
|
☐
|
|
|
|
|
|
(Do not check if a smaller reporting company)
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|
|
|
|
|
|
PAGE
|
|
PART I. FINANCIAL INFORMATION
|
|
|
|
|
|
|
|
Item 1.
|
Condensed Consolidated Financial Statements
|
2
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheets (Unaudited) as of June 30, 2016 and December 31, 2015
|
2
|
|
|
|
|
|
|
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) for the Three and Six Months Ended June 30, 2016 and 2015
|
3
|
|
|
|
|
|
|
Condensed Consolidated Statements of Cash Flows (Unaudited) for the Six Months Ended June 30, 2016 and 2015
|
4
|
|
|
|
|
|
|
Notes to Condensed Consolidated Financial Statements
|
5
|
|
|
|
|
|
Item 2.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
15
|
|
|
|
|
|
Item 3.
|
Quantitative and Qualitative Disclosures About Market Risk
|
24
|
|
|
|
|
|
Item 4.
|
Controls and Procedures
|
24
|
|
|
|
|
|
PART II. OTHER INFORMATION
|
|
|
|
|
|
|
|
Item 1.
|
Legal Proceedings
|
25
|
|
|
|
|
|
Item 1A.
|
Risk Factors
|
25
|
|
|
|
|
|
Item 2.
|
Unregistered Sales of Equity Securities and Use of Proceeds
|
25
|
|
|
|
|
|
Item 6.
|
Exhibits
|
25
|
|
|
June 30, 2016
|
December 31, 2015
|
|
|
(Unaudited)
|
|
|
ASSETS
|
|
|
|
Current assets
|
|
|
|
Cash and cash equivalents
|
$
1,928,025
|
$
3,660,453
|
|
Marketable securities
|
8,023,841
|
16,528,494
|
|
Accounts receivable
|
24,648
|
49,448
|
|
Prepaid expenses
|
198,848
|
321,958
|
|
Total current assets
|
10,175,362
|
20,560,353
|
|
Marketable securities
|
19,557,932
|
18,019,054
|
|
Property and equipment, net
|
28,959
|
35,786
|
|
Intangible assets, net
|
22,000,000
|
22,000,000
|
|
Goodwill
|
11,265,100
|
11,265,100
|
|
Other assets
|
1,106,785
|
1,106,785
|
|
Total assets
|
$
64,134,138
|
$
72,987,078
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
Current liabilities
|
|
|
|
Accounts payable
|
$
1,521,472
|
$
972,483
|
|
Accrued liabilities
|
3,385,797
|
3,104,807
|
|
Warrant liabilities
|
370,405
|
524,340
|
|
Total current liabilities
|
5,277,674
|
4,601,630
|
|
Deferred tax liability
|
7,962,100
|
7,962,100
|
|
Total liabilities
|
13,239,774
|
12,563,730
|
|
|
|
|
|
Commitments and contingencies; see Note 6
|
|
|
|
|
|
|
|
Stockholders' equity
|
|
|
|
Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 28,119,847 and 28,119,694, respectively
|
2,812
|
2,812
|
|
Additional paid-in capital
|
221,541,252
|
221,285,677
|
|
Accumulated other comprehensive gain/(loss)
|
88,867
|
(129,442
)
|
|
Accumulated deficit
|
(170,738,567
)
|
(160,735,699
)
|
|
Total stockholders’ equity
|
50,894,364
|
60,423,348
|
|
Total liabilities and stockholders' equity
|
$
64,134,138
|
$
72,987,078
|
|
|
Three months ended June 30,
|
Six months ended June 30,
|
||
|
|
2016
|
2015
|
2016
|
2015
|
|
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
|
|
|
|
|
|
|
Government grant revenue
|
$
-
|
$
49,286
|
$
-
|
$
49,286
|
|
|
|
|
|
|
|
Operating expenses
|
|
|
|
|
|
General and administrative
|
1,239,644
|
1,934,137
|
3,001,339
|
3,552,276
|
|
Research and development
|
3,431,591
|
1,947,264
|
7,375,225
|
3,530,001
|
|
Loss on impairment of long-lived assets
|
-
|
1,034,863
|
-
|
1,034,863
|
|
Total operating expenses
|
4,671,235
|
4,916,264
|
10,376,564
|
8,117,140
|
|
|
|
|
|
|
|
Net operating loss
|
4,671,235
|
4,866,978
|
10,376,564
|
8,067,854
|
|
|
|
|
|
|
|
Interest expense
|
-
|
1,401
|
-
|
3,224
|
|
Other income
|
(30,027
)
|
(120,482
)
|
(373,696
)
|
(383,900
)
|
|
Net loss
|
$
4,641,208
|
$
4,747,897
|
$
10,002,868
|
$
7,687,178
|
|
|
|
|
|
|
|
Unrealized (gain) loss on marketable securities
|
(78,073
)
|
67,978
|
(218,309
)
|
(109,961
)
|
|
Total comprehensive loss
|
$
4,563,135
|
$
4,815,875
|
$
9,784,559
|
$
7,577,217
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted
|
$
(0.17
)
|
$
(0.17
)
|
$
(0.36
)
|
$
(0.27
)
|
|
Weighted average number of common shares outstanding, basic and diluted
|
28,119,796
|
28,119,493
|
28,119,772
|
28,119,452
|
|
|
Six months ended June 30,
|
|
|
|
2016
|
2015
|
|
|
(Unaudited)
|
(Unaudited)
|
|
|
|
|
|
CASH FLOWS FROM OPERATING ACTIVITIES
|
|
|
|
Net Loss
|
$
(10,002,868
)
|
$
(7,687,178
)
|
|
Adjustments to reconcile net loss to net cash used in operating activities
|
|
|
|
Depreciation and amortization
|
9,711
|
61,986
|
|
Loss on impairment, disposal and write down of long-lived assets
|
-
|
1,081,131
|
|
Issuance and vesting of compensatory stock options and warrants
|
255,002
|
131,750
|
|
Issuance of common stock as compensation
|
573
|
921
|
|
Change in the fair value of warrants
|
(153,935
)
|
(139,984
)
|
|
Amortization of premium on marketable securities
|
428,269
|
444,120
|
|
Changes in operating assets and liabilities
|
|
|
|
Accounts receivable, prepaid expenses and other assets
|
147,910
|
218,505
|
|
Accounts payable and accrued liabilities
|
829,979
|
549,926
|
|
Net cash used in operating activities
|
(8,485,359
)
|
(5,338,823
)
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES
|
|
|
|
Purchase of marketable securities
|
(7,255,578
)
|
(12,109,969
)
|
|
Sale of marketable securities
|
14,011,393
|
12,582,851
|
|
Purchase of property and equipment
|
(2,884
)
|
-
|
|
Capitalization of patent costs and license rights
|
-
|
(20,056
)
|
|
Net cash provided by investing activities
|
6,752,931
|
452,826
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES
|
|
|
|
Payments on notes - short-term
|
-
|
(102,551
)
|
|
Net cash used in financing activities
|
-
|
(102,551
)
|
|
|
|
|
|
Net change in cash and cash equivalents
|
(1,732,428
)
|
(4,988,548
)
|
|
Cash and cash equivalents, beginning of period
|
3,660,453
|
11,676,325
|
|
Cash and cash equivalents, end of period
|
$
1,928,025
|
$
6,687,777
|
|
|
|
|
|
Cash paid for:
|
|
|
|
Interest
|
$
-
|
$
3,224
|
|
|
Six months ended June 30,
|
|
|
|
2016
|
2015
|
|
|
|
|
|
Options to purchase common stock
|
4,092,698
|
3,777,648
|
|
Warrants to purchase common stock
|
2,571,582
|
2,728,236
|
|
Restricted stock
|
520
|
520
|
|
Level one
|
Quoted market prices in active markets for identical assets or liabilities;
|
|
Level two
|
Inputs other than level one inputs that are either directly or indirectly observable, and
|
|
Level three
|
Unobservable inputs developed using estimates and assumptions; which are developed by the reporting entity and reflect those assumptions that a market participant would use.
|
|
|
June 30, 2016
|
||||
|
|
Amortized Cost
|
Accrued Interest
|
Gross Unrealized Gains
|
Gross Unrealized losses
|
Estimated Fair Value
|
|
Corporate debt securities
|
$
27,276,587
|
$
216,319
|
$
93,821
|
$
(4,954
)
|
$
27,581,773
|
|
|
June 30, 2016
|
December 31, 2015
|
|
Maturing in one year or less
|
$
8,023,841
|
$
16,528,494
|
|
Maturing after one year through three years
|
19,557,932
|
18,019,054
|
|
Total investments
|
$
27,581,773
|
$
34,547,548
|
|
Series C Warrants
|
June 30,
2016
|
December 31,
2015
|
|
Closing stock price
|
$
2.56
|
$
3.28
|
|
Expected dividend rate
|
0
%
|
0
%
|
|
Expected stock price volatility
|
86.81
%
|
84.08
%
|
|
Risk-free interest rate
|
0.72
%
|
1.44
%
|
|
Expected life (years)
|
3.06
|
3.56
|
|
|
|
Fair Value Measurements at Reporting Date Using
|
||
|
|
Balance as of June 30, 2016
|
Quoted prices in Active Markets for Identical Securities (Level 1)
|
Significant Other Observable Inputs (Level 2)
|
Significant Unobservable Inputs (Level 3)
|
|
Current Assets
|
|
|
|
|
|
Cash and cash equivalents
|
$
1,928,025
|
$
1,928,025
|
$
-
|
$
-
|
|
Marketable securities
|
$
8,023,841
|
$
-
|
$
8,023,841
|
$
-
|
|
|
|
|
|
|
|
Long-term Assets
|
|
|
|
|
|
Marketable securities
|
$
19,557,932
|
$
-
|
$
19,557,932
|
$
-
|
|
|
|
|
|
|
|
Current Liabilities
|
|
|
|
|
|
Warrant liabilities
|
$
370,405
|
$
-
|
$
-
|
$
370,405
|
|
|
|
Fair Value Measurements at Reporting Date Using
|
||
|
|
Balance as of December 31, 2015
|
Quoted prices in Active Markets for Identical Securities (Level 1)
|
Significant Other Observable Inputs (Level 2)
|
Significant Unobservable Inputs (Level 3)
|
|
Current Assets
|
|
|
|
|
|
Cash and cash equivalents
|
$
3,660,453
|
$
3,660,453
|
$
-
|
$
-
|
|
Marketable securities
|
$
16,528,494
|
$
-
|
$
16,528,494
|
$
-
|
|
|
|
|
|
|
|
Long-term Assets
|
|
|
|
|
|
Marketable securities
|
$
18,019,054
|
$
-
|
$
18,019,054
|
$
-
|
|
|
|
|
|
|
|
Current Liabilities
|
|
|
|
|
|
Warrant liabilities
|
$
524,340
|
$
-
|
$
-
|
$
524,340
|
|
|
June 30, 2016
|
December 31, 2015
|
|
Laboratory equipment
|
$
514,214
|
$
514,214
|
|
Computer equipment and software
|
142,868
|
139,984
|
|
Office furniture and fixtures
|
130,192
|
130,192
|
|
|
787,274
|
784,390
|
|
Less: Accumulated depreciation
|
(758,315
)
|
(748,604
)
|
|
|
$
28,959
|
$
35,786
|
|
|
June 30, 2016
|
December 31, 2015
|
|
Operating costs
|
$
3,306,295
|
$
2,559,092
|
|
Employee related
|
79,502
|
545,715
|
|
|
$
3,385,797
|
$
3,104,807
|
|
Asset Category
|
Weighted Average Amortization Period (in Years)
|
Value Assigned
|
Accumulated Amortization
|
Impairments
|
Carrying Value (Net of Impairments and Accumulated Amortization)
|
|
|
|
|
|
|
|
|
IPR&D
|
N/A
|
22,000,000
|
-
|
-
|
22,000,000
|
|
Total
|
|
$
22,000,000
|
$
-
|
$
-
|
$
22,000,000
|
|
|
Warrants
|
Weighted Average Exercise Price
|
|
Outstanding at December 31, 2015
|
2,728,236
|
$
4.39
|
|
Cancelled
|
(156,654
)
|
5.72
|
|
Outstanding at June 30, 2016
|
2,571,582
|
$
4.31
|
|
|
Shares Available for Grant
|
|
Balances, at December 31, 2015
|
994,713
|
|
Options granted
|
(60,000
)
|
|
Restricted stock granted
|
(430
)
|
|
Restricted stock cancelled/forfeited
|
151
|
|
Balances, at June 30, 2016
|
934,434
|
|
|
Outstanding Options
|
|
|
|
Number of Shares
|
Weighted Average Exercise Price
|
|
Balances, at December 31, 2015
|
4,007,698
|
$
5.50
|
|
Options granted
|
60,000
|
$
2.72
|
|
Balances, at June 30, 2016
|
4,067,698
|
$
5.46
|
|
|
For the six months ended June 30,
|
|
|
|
2016
|
2015
|
|
Risk-free interest rate (weighted average)
|
1.60
%
|
1.87
%
|
|
Expected volatility (weighted average)
|
84.53
%
|
87.56
%
|
|
Expected term (in years)
|
7
|
7
|
|
Expected dividend yield
|
0.00
%
|
0.00
%
|
|
Risk-Free Interest Rate
|
The risk-free interest rate assumption was based on U.S. Treasury instruments with a term that is consistent with the expected term of the Company’s stock options.
|
|
Expected Volatility
|
The expected stock price volatility for the Company’s common stock was determined by examining the historical volatility and trading history for its common stock over a term consistent with the expected term of its options.
|
|
Expected Term
|
The expected term of stock options represents the weighted average period the stock options are expected to remain outstanding. It was calculated based on the Company’s historical experience with its stock option grants.
|
|
Expected Dividend Yield
|
The expected dividend yield of 0% is based on the Company’s history and expectation of dividend payouts. The Company has not paid and does not anticipate paying any dividends in the near future.
|
|
Forfeitures
|
Stock compensation expense recognized in the statements of operations for the six months ended June 30, 2016 and 2015 is based on awards ultimately expected to vest, and it has been reduced for estimated forfeitures. ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.
Forfeitures were estimated based on the Company’s historical experience.
|
|
|
Outstanding Restricted Stock Grants
|
|
|
|
Number of Shares
|
Weighted Average Grant Date Fair Value
|
|
Balances, at December 31, 2015
|
394
|
$
3.34
|
|
Restricted stock granted
|
430
|
$
2.72
|
|
Restricted stock vested
|
(153
)
|
$
3.36
|
|
Restricted stock cancelled
|
(151
)
|
$
3.37
|
|
Balances, at June 30, 2016
|
520
|
$
2.81
|
|
|
Three months ended June 30,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
|
|
|
2016
|
2015
|
|
|
|
Personnel costs
|
$
621,613
|
$
1,126,492
|
$
(504,879
)
|
(45
)%
|
|
Legal and professional fees
|
449,218
|
544,189
|
(94,971
)
|
(17
)%
|
|
Other costs
|
130,111
|
204,656
|
(74,545
)
|
(36
)%
|
|
Facilities
|
35,317
|
40,758
|
(5,441
)
|
(13
)%
|
|
Depreciation and amortization
|
3,385
|
18,042
|
(14,657
)
|
(81
)%
|
|
|
Three months ended June 30,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
|
|
|
2016
|
2015
|
|
|
|
Clinical and preclinical development
|
$
3,115,255
|
$
1,777,616
|
$
1,337,639
|
75
%
|
|
Consulting
|
174,020
|
6,660
|
167,360
|
2513
%
|
|
Personnel costs
|
132,225
|
143,650
|
(11,425
)
|
(8
)%
|
|
Other costs
|
10,091
|
19,338
|
(9,247
)
|
(48
)%
|
|
|
Three months ended June 30,
|
(Increase)/ Decrease
|
|
|
|
2016
|
2015
|
|
|
Other income
|
$
(30,027
)
|
$
(120,482
)
|
$
90,455
|
|
|
Six months ended June 30,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
|
|
|
2016
|
2015
|
|
|
|
Personnel costs
|
$
1,334,948
|
$
1,701,115
|
$
(366,167
)
|
(22
)%
|
|
Legal and professional fees
|
1,116,582
|
1,136,791
|
(20,209
)
|
(2
)%
|
|
Other costs
|
471,723
|
590,236
|
(118,513
)
|
(20
)%
|
|
Facilities
|
71,753
|
78,577
|
(6,824
)
|
(9
)%
|
|
Depreciation and amortization
|
6,333
|
45,557
|
(39,224
)
|
(86
)%
|
|
|
Six months ended June 30,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
|
|
|
2016
|
2015
|
|
|
|
Clinical and preclinical development
|
$
6,649,972
|
$
3,221,904
|
$
3,428,068
|
106
%
|
|
Consulting
|
430,324
|
19,875
|
410,449
|
2065
%
|
|
Personnel costs
|
272,728
|
255,402
|
17,326
|
7
%
|
|
Other costs
|
22,201
|
32,820
|
(10,619
)
|
(32
)%
|
|
|
Six months ended June 30,
|
(Increase)/ Decrease
|
|
|
|
2016
|
2015
|
|
|
Other income
|
$
(373,696
)
|
$
(383,900
)
|
$
10,204
|
|
|
Six months ended June 30,
|
|
|
|
2016
|
2015
|
|
Net cash used in operating activities
|
$
(8,485,359
)
|
$
(5,338,823
)
|
|
Net cash provided by investing activities
|
6,752,931
|
452,826
|
|
Net cash used in financing activities
|
-
|
(102,551
)
|
|
Issuer Purchases of Equity Securities
|
Total Number of Shares Purchased (1)
|
Average Price Paid per Share (2)
|
Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs
|
Approximate Dollar Value of Shares that May Yet Be Purchased Under the Plans or Programs
|
|
Period
|
|
|
|
|
|
April 1, 2016 - April 30, 2016
|
-
|
$
-
|
-
|
$
-
|
|
May 1, 2016 - May 31, 2016
|
-
|
$
-
|
-
|
$
-
|
|
June 1, 2016 - June 30, 2016
|
51
|
$
2.72
|
-
|
$
-
|
|
Total
|
51
|
$
2.72
|
-
|
$
-
|
|
|
TENAX THERAPEUTICS, INC.
|
|
|
|
|
|
|
|
|
|
By:
|
/s/
Michael B. Jebsen
|
|
|
|
|
Michael B. Jebsen
|
|
|
|
|
Chief Financial Officer
(On behalf of the Registrant and as Principal Financial Officer)
|
|
|
No.
|
Description
|
|
|
|
|
10.1
|
Tenax Therapeutics, Inc. 2016 Stock Incentive Plan. *
|
|
31.1
|
Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes Oxley Act of 2002. *
|
|
31.2
|
Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes Oxley Act of 2002. *
|
|
32.1
|
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. *
|
|
32.2
|
Certification of 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.INS
|
XBRL Instance Document*
|
|
101.SCH
|
XBRL Taxonomy Extension Schema Document*
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document*
|
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document*
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document*
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document*
|
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 |
|---|