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| x |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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| o |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Nevada
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32-0379665
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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5 Kineret Street
Bnei Brak, Israel
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5126237
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|
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(Address of principal executive offices)
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(Zip Code)
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Large accelerated filer
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o
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Accelerated filer
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o
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Non-accelerated filer
(Do not check if a smaller reporting company)
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o
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Smaller reporting company
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x
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||
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Condensed Consolidated Balance Sheets as of
September 30, 2016 (Unaudited) and December 31, 2015
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1 | |
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Unaudited Condensed Consolidated Statements of Operations for the
Three and Nine Months Ended September 30, 2016 and 2015
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2 | |
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Unaudited Condensed Consolidated Statement of Changes in Stockholders’ Deficiency for the
Nine Months Ended September 30, 2016
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3 | |
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|
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Unaudited Condensed Consolidated Statements of Cash Flows for the
Nine Months Ended September 30, 2016 and 2015
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4 | |
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Notes to Unaudited Condensed Consolidated Financial Statements
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5
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
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15
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22
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Item 4. Controls and Procedures.
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22
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Item 1. Legal Proceedings.
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23
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Item 1A. Risk Factors.
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23
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
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23
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Item 3. Defaults Upon Senior Securities.
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23
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Item 4. Mine Safety Disclosures.
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23
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Item 5. Other Information.
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23
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Item 6. Exhibits.
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24
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SIGNATURES
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25
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September 30,
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December 31,
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|||||||
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2016
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2015
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|||||||
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(Unaudited)
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||||||||
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Assets
|
||||||||
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Current Assets:
|
||||||||
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Cash
|
$ | 1,638 | $ | 6,944 | ||||
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Prepaid expenses
|
114,610 | 71,882 | ||||||
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Other current assets
|
145,510 | 134,736 | ||||||
| Total Current Assets | 261,758 | 213,562 | ||||||
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Property and equipment, net
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622 | 1,267 | ||||||
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Deferred financing costs
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20,000 | - | ||||||
| Total Assets | $ | 282,380 | $ | 214,829 | ||||
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Liabilities and Stockholders' Deficiency
|
||||||||
|
Current Liabilities:
|
||||||||
|
Accounts payable and accrued expenses, current portion
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$ | 955,584 | $ | 586,485 | ||||
|
Accounts payable and accrued expenses - related parties
|
209,554 | 214,629 | ||||||
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Accrued compensation
|
516,161 | 324,672 | ||||||
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Derivative liabilities
|
3,332,900 | 3,279,600 | ||||||
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Notes payable, net of debt discount of $73,600 and $41,600
at September 30, 2016 and December 31, 2015, respectively
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1,739,400 | 708,400 | ||||||
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Notes payable - related parties, net of debt discount of $11,100 and $19,300
at September 30, 2016 and December 31, 2015, respectively
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138,900 | 180,700 | ||||||
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Convertible notes payable, current portion, net of debt discount of $366,346
and $214,550 at September 30, 2016 and December 31, 2015, respectively
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1,001,154 | 180,450 | ||||||
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Advances payable
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200,000 | 450,000 | ||||||
| Total Current Liabilities | 8,093,653 | 5,924,936 | ||||||
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Convertible notes payable, non-current portion, net of debt discount of $0
and $288,832 at September 30, 2016 and December 31, 2015, respectively
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- | 43,668 | ||||||
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Accounts payable and accrued expenses, non-current portion
|
- | 4,474 | ||||||
| Total Liabilities | 8,093,653 | 5,973,078 | ||||||
|
Commitments and contingencies
|
||||||||
|
Stockholders' Deficiency:
|
||||||||
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized;
no shares issued and outstanding at September 30, 2016 and December 31, 2015
|
- | - | ||||||
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Common stock, $0.001 par value; 200,000,000 shares authorized;
24,429,256 and 23,929,256 shares issued and outstanding at September 30, 2016 and December 31, 2015
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24,429 | 23,929 | ||||||
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Additional paid-in capital
|
4,991,473 | 4,720,417 | ||||||
|
Accumulated deficit
|
(12,827,175 | ) | (10,502,595 | ) | ||||
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Total Stockholders' Deficiency
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(7,811,273 | ) | (5,758,249 | ) | ||||
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Total Liabilities and Stockholders' Deficiency
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$ | 282,380 | $ | 214,829 | ||||
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For the Three Months Ended
|
For The Nine Months Ended
|
|||||||||||||||
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September 30,
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September 30,
|
|||||||||||||||
|
2016
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2015
|
2016
|
2015
|
|||||||||||||
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Revenues
|
$ | - | $ | - | $ | - | $ | - | ||||||||
|
Operating Expenses
|
||||||||||||||||
| Research and development | 133,866 | 118,551 | 357,454 | 295,770 | ||||||||||||
| Research and development - related party | 205,957 | 200,000 | 604,777 | 600,000 | ||||||||||||
| Selling, general and administrative | 261,914 | 230,587 | 814,351 | 807,365 | ||||||||||||
| Total Operating Expenses | 601,737 | 549,138 | 1,776,582 | 1,703,135 | ||||||||||||
| Loss From Operations | (601,737 | ) | (549,138 | ) | (1,776,582 | ) | (1,703,135 | ) | ||||||||
|
Other Income (Expense)
|
||||||||||||||||
| Change in fair value of derivative liabilities | 324,350 | 3,200 | 695,200 | 115,900 | ||||||||||||
| Interest expense | (62,905 | ) | (9,074 | ) | (181,462 | ) | (15,830 | ) | ||||||||
| Amortization of debt discount | (463,060 | ) | (118,425 | ) | (1,061,736 | ) | (197,925 | ) | ||||||||
| Total Other Expense | (201,615 | ) | (124,299 | ) | (547,998 | ) | (97,855 | ) | ||||||||
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Net Loss
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$ | (803,352 | ) | $ | (673,437 | ) | $ | (2,324,580 | ) | $ | (1,800,990 | ) | ||||
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Net Loss Per Share
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||||||||||||||||
|
- Basic and Diluted
|
$ | (0.03 | ) | $ | (0.03 | ) | $ | (0.09 | ) | $ | (0.07 | ) | ||||
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Weighted Average Number of
Common Shares Outstanding
|
||||||||||||||||
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- Basic and Diluted
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26,066,157 | 25,670,917 | 26,066,157 | 25,639,208 | ||||||||||||
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Additional
|
||||||||||||||||||||
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Common Stock
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Paid-In
|
Accumulated
|
||||||||||||||||||
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Shares
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Amount
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Capital
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Deficit
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Total
|
||||||||||||||||
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Balance - December 31, 2015
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23,929,256 | $ | 23,929 | $ | 4,720,417 | $ | (10,502,595 | ) | $ | (5,758,249 | ) | |||||||||
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Shares issued as debt discount in connection
with extension of notes payable
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500,000 | 500 | 199,500 | - | 200,000 | |||||||||||||||
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Stock-based compensation:
|
||||||||||||||||||||
|
- warrants
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- | - | 71,556 | - | 71,556 | |||||||||||||||
|
Net loss
|
- | - | - | (2,324,580 | ) | (2,324,580 | ) | |||||||||||||
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Balance - September 30, 2016
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24,429,256 | $ | 24,429 | $ | 4,991,473 | $ | (12,827,175 | ) | $ | (7,811,273 | ) | |||||||||
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For The Nine Months Ended
|
||||||||
|
September 30,
|
||||||||
|
2016
|
2015
|
|||||||
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Cash Flows From Operating Activities
|
||||||||
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Net loss
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$ | (2,324,580 | ) | $ | (1,800,990 | ) | ||
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Adjustments to reconcile net loss to net cash
used in operating activities:
|
||||||||
|
Change in fair value of derivative liabilities
|
(695,200 | ) | (115,900 | ) | ||||
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Amortization of debt discount
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1,061,736 | 197,925 | ||||||
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Depreciation
|
645 | 645 | ||||||
|
Stock-based compensation:
|
||||||||
|
Common stock
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- | 40,000 | ||||||
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Warrants
|
115,589 | 16,759 | ||||||
|
Changes in operating assets and liabilities:
|
||||||||
|
Prepaid expenses
|
(42,728 | ) | (28,033 | ) | ||||
|
Other current assets
|
(10,774 | ) | (74,680 | ) | ||||
|
Accounts payable and accrued expenses
|
551,581 | 305,660 | ||||||
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Net Cash Used in Operating Activities
|
(1,343,731 | ) | (1,458,614 | ) | ||||
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Cash Flows From Financing Activities
|
||||||||
|
Proceeds from issuance of notes payable
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1,453,000 | 995,000 | ||||||
|
Repayment of note payable, related party
|
(50,000 | ) | - | |||||
|
Payment of debt issuance costs
|
(44,575 | ) | - | |||||
|
Deferred financing costs
|
(20,000 | ) | - | |||||
|
Proceeds from cash advances
|
- | 450,000 | ||||||
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Net Cash Provided by Financing Activities
|
1,338,425 | 1,445,000 | ||||||
|
Net Decrease In Cash
|
(5,306 | ) | (13,614 | ) | ||||
|
Cash - Beginning
|
6,944 | 19,480 | ||||||
|
Cash - Ending
|
$ | 1,638 | $ | 5,866 | ||||
|
Supplemental Disclosures of Cash Flow Information:
|
||||||||
|
Non-cash investing and financing transactions:
|
||||||||
|
Warrants and conversion options issued in
connection with issuance of notes payable
|
$ | 948,500 | $ | 362,200 | ||||
|
Deferring financing costs
|
$ | - | $ | 100,000 | ||||
|
Advance exchanged for a convertible note payable
|
$ | 250,000 | $ | - | ||||
|
Shares issued in connection with extension
of notes payable
|
$ | 200,000 | $ | - | ||||
|
September 30,
|
||||||||
|
2016
|
2015
|
|||||||
|
Warrants
|
11,814,324 | 8,674,324 | ||||||
|
Convertible notes
|
2,636,900 | 193,333 | ||||||
|
Total
|
14,451,224 | 8,867,657 | ||||||
|
|
Quoted Prices
|
|||||||||||||||
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In Active
|
Significant
|
|||||||||||||||
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Markets for
|
Other
|
Significant
|
||||||||||||||
|
Identical
|
Observable
|
Unobservable
|
||||||||||||||
|
Liabilities
|
Inputs
|
Inputs
|
||||||||||||||
|
Total
|
(Level 1)
|
(Level 2)
|
(Level 3)
|
|||||||||||||
|
Accrued compensation
|
$ | 104,033 | $ | - | $ | - | $ | 104,033 | ||||||||
|
Derivative liability
|
3,332,900 | - | - | 3,332,900 | ||||||||||||
|
Balance - September 30, 2016
|
$ | 3,436,933 | $ | - | $ | - | $ | 3,436,933 | ||||||||
|
Accrued compensation
|
$ | 60,000 | $ | - | $ | - | $ | 60,000 | ||||||||
|
Derivative liability
|
3,279,600 | - | - | 3,279,600 | ||||||||||||
|
Balance - December 31, 2015
|
$ | 3,339,600 | $ | - | $ | - | $ | 3,339,600 | ||||||||
|
For the Three Months Ended
|
For the Nine Months Ended
|
|||||||||||||||
|
September 30,
|
September 30,
|
|||||||||||||||
|
2016
|
2015
|
2016
|
2015
|
|||||||||||||
|
Risk-free interest rate
|
0.29% - 1.28 | % | 0.33% - 1.53 | % | 0.21% - 1.28 | % | 0.33% - 1.71 | % | ||||||||
|
Expected term (years)
|
0.04 - 5.00 | 0.25 - 5.00 | 0.04 - 5.00 | 0.25 - 5.00 | ||||||||||||
|
Expected volatility
|
150% - 152 | % | 166 | % | 150% - 159 | % | 166% - 172 | % | ||||||||
|
Expected dividends
|
0.00 | % | 0.00 | % | 0.00 | % | 0.00 | % | ||||||||
|
Accrued
|
Derivative
|
|||||||||||
|
Compensation
|
Liability
|
Total
|
||||||||||
|
Balance - December 31, 2015
|
$ | 60,000 | $ | 3,279,600 | $ | 3,339,600 | ||||||
|
Change in fair value
|
(1,072 | ) | (695,200 | ) | (696,272 | ) | ||||||
|
Issuance of warrants and conversion options
|
- | 748,500 | 748,500 | |||||||||
|
Accrual of obligations
|
45,105 | - | 45,105 | |||||||||
|
Balance - September 30, 2016
|
$ | 104,033 | $ | 3,332,900 | $ | 3,436,933 | ||||||
|
September 30,
|
December 31,
|
|||||||
|
2016
|
2015
|
|||||||
|
(unaudited)
|
||||||||
|
Accrued research and development
|
$ | 192,423 | $ | 186,815 | ||||
|
Accrued legal fees
|
221,164 | 216,956 | ||||||
|
Accrued other professional fees
|
131,241 | 75,164 | ||||||
|
Accrued director compensation
|
12,000 | 12,000 | ||||||
|
Accrued Scientific Advisory Board compensation
|
70,000 | 31,000 | ||||||
|
Accrued interest, current portion
|
217,748 | 25,139 | ||||||
|
Other accrued expenses
|
111,008 | 39,411 | ||||||
|
Accounts payable and accrued expenses, current portion
|
955,584 | 586,485 | ||||||
|
Non-current portion of accrued interest
|
- | 4,474 | ||||||
|
Total accounts payable and accrued expenses
|
$ | 955,584 | $ | 590,959 | ||||
|
-
|
Gene modified cell therapy is considered to be one of the most promising cancer treatment approaches in decades, with companies like Kite Pharma and JUNO Therapeutics having recently attained multi-billion dollar valuations after having successfully treated relatively small numbers of patients in Phase I and II clinical trials.
|
|
-
|
While gene modified treatments such as CAR-T have shown remarkable results in cancer treatment trials, their published successes to date have been mostly limited to “autologous” blood cell cancer treatments using the patient’s own cells. There are concerns that this type of “personalized” treatment may not have favorable economics on a large scale basis.
|
|
-
|
The ideal more lucrative commercial path for CAR-T and similar genetically engineered cell therapies is to become “allogeneic” or off-the-shelf product with drug-like distribution economics and to treat a broad spectrum of cancers including solid tumors.
|
|
-
|
Preclinical data show that Veto cells can help genetically modified T-cells from the same donor to overcome rejection issues (among the problems exhibited to date by CAR-T therapy in an allogeneic setting), hence significantly increasing their persistence (longevity) and thus their efficacy in eradicating cancer. Based on this preclinical data, Cell Source believes that Veto cells could potentially enable the use of Off-the-shelf CAR-T cells directed against malignant cells.
|
|
-
|
Cell Source has filed patent applications for combining Veto cells with genetically modified T cells and is currently exploring active collaboration with CAR-T cell providers to move Veto and CAR-T combined cell therapy towards the clinic.
|
|
-
|
Other than primary disease (typically blood cell cancer) the leading causes of death in unrelated donor bone marrow transplants are GvHD (Graft vs. Host Disease, where the donor bone marrow rejects the host or recipient) – responsible for 20% of deaths after unrelated donor transplants - and infections – responsible for a further 17% of those transplants.
|
|
-
|
It is well established that GvHD can be prevented by T cell depletion of the bone marrow transplant. However, this procedure is also is associated with an increased rate of graft rejection. Preclinical studies clearly suggest that this problem can be overcome by adding Veto cells to the bone marrow transplant. However, viruses such as CMV and EBV remain a major threat to patients post-transplant.
|
|
-
|
Cell Source has developed a next generation Veto cell that not only facilitates mismatched transplants but also protects the transplant recipient against these common viruses.
|
|
-
|
Combining GVHD prevention by using T cell depleted transplants with anti-rejection action as well as virus prevention, Veto cell could potentially significantly increase survival rates post-transplant.
|
|
-
|
Based on preclinical data, veto cells can also be used to facilitate organ transplants (e.g. kidney transplant combined with a bone marrow transplant) with partially mismatched donors and either reduce or eliminate the need for lifelong daily anti-rejection treatment currently given to even fully matched donor organ recipients.
|
|
-
|
Cell source has filed a patent application for its Anti-viral Veto cells and is currently in discussions with leading transplant centers in both the US and Europe with a view to commencing human clinical trials.
|
|
|
1.
|
Complete development of human treatment protocol (2-5 years)
|
|
|
2.
|
Apply for and receive approval to commence human trials (9-18 months)
|
|
|
3.
|
Recruit patients (1-6 months)
|
|
|
4.
|
Conduct Phase I trials showing safety of product (1-2 years)
|
|
|
5.
|
Apply for and receive approval to conduct trials showing product efficacy (6-12 months)
|
|
|
6.
|
Data collecting and analysis (6-12 months)
|
|
|
7.
|
Conduct Phase II efficacy trials (2-3 years)
|
|
|
8.
|
Data collecting and analysis (6-12 months)
|
|
|
9.
|
Apply for and receive approval to conduct trials showing efficacy in larger numbers of patients (6-12 months)
|
|
|
10.
|
Conduct Phase III efficacy trials with larger numbers of patients (2-4 years)
|
|
|
11.
|
Data collecting and analysis (6-12 months)
|
|
|
12.
|
Apply for and receive approval for production scale manufacturing facilities (6-12 months)
|
|
|
13.
|
Contract third party or establish own production facilities (6-30 months)
|
|
|
14.
|
Contract third party or establish own distribution platform (6-18 months)
|
|
|
15.
|
Commence manufacturing and distribution (6-12 months)
|
|
For The Three Months Ended
|
||||||||
|
September 30,
|
||||||||
|
2016
|
2015
|
|||||||
|
Revenues
|
$ | - | $ | - | ||||
|
Operating Expenses
|
||||||||
|
Research and development
|
133,866 | 118,551 | ||||||
|
Research and development - related party
|
205,957 | 200,000 | ||||||
|
Selling, general and administrative
|
261,914 | 230,587 | ||||||
| Total Operating Expenses | 601,737 | 549,138 | ||||||
| Loss From Operations | (601,737 | ) | (549,138 | ) | ||||
|
Other Income (Expense)
|
||||||||
|
Change in fair value of derivative liabilities
|
324,350 | 3,200 | ||||||
|
Interest expense
|
(62,905 | ) | (9,074 | ) | ||||
|
Amortization of debt discount
|
(463,060 | ) | (118,425 | ) | ||||
| Total Other Expense | (201,615 | ) | (124,299 | ) | ||||
|
Net Loss
|
$ | (803,352 | ) | $ | (673,437 | ) | ||
|
For The Nine Months Ended
|
||||||||
|
September 30,
|
||||||||
|
2016
|
2015
|
|||||||
|
Revenues
|
$ | - | $ | - | ||||
|
Operating Expenses
|
||||||||
|
Research and development
|
357,454 | 295,770 | ||||||
|
Research and development - related party
|
604,777 | 600,000 | ||||||
|
Selling, general and administrative
|
814,351 | 807,365 | ||||||
| Total Operating Expenses | 1,776,582 | 1,703,135 | ||||||
| Loss From Operations | (1,776,582 | ) | (1,703,135 | ) | ||||
|
Other Income (Expense)
|
||||||||
|
Change in fair value of derivative liabilities
|
695,200 | 115,900 | ||||||
|
Interest expense
|
(181,462 | ) | (15,830 | ) | ||||
|
Amortization of debt discount
|
(1,061,736 | ) | (197,925 | ) | ||||
| Total Other (Expense) Income | (547,998 | ) | (97,855 | ) | ||||
|
Net Loss
|
$ | (2,324,580 | ) | $ | (1,800,990 | ) | ||
|
September 30,
|
December 31,
|
|||||||
|
2016
|
2015
|
|||||||
|
(unaudited)
|
||||||||
|
Cash
|
$ | 1,638 | $ | 6,944 | ||||
|
Working capital deficiency
|
$ | (7,831,895 | ) | $ | (5,711,374 | ) | ||
|
Exhibit
|
||||
|
Number
|
Description
|
|||
|
3.1
|
*
|
Certificate of Designation for Series A Preferred Stock
|
||
|
31.1
|
*
|
Certificate of the Chief Executive Officer
|
||
|
31.2
|
*
|
Certificate of the Chief Financial Officer
|
||
|
32
|
**
|
Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
||
|
101.INS
|
*
|
XBRL Instance Document
|
||
|
101.SCH
|
*
|
XBRL Schema Document
|
||
|
101.CAL
|
*
|
XBRL Calculation Linkbase Document
|
||
|
101.DEF
|
*
|
XBRL Definition Linkbase Document
|
||
|
101.LAB
|
*
|
XBRL Label Linkbase Document
|
||
|
101.PRE
|
*
|
XBRL Presentation Linkbase Document
|
||
| * |
Filed herewith
|
|
|
**
|
This certification is being furnished and shall not be deemed "filed" with the SEC for purposes of Section 18 of the Exchange Act, or otherwise be subject to the liability of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act, except to the extent that the registrant specifically incorporates it by reference.
|
|
CELL SOURCE, INC.
|
|||
|
Dated: November 18, 2016
|
By:
|
/s/ Itamar Shimrat
|
|
|
Name: Itamar Shimrat
|
|||
|
Title: Chief Executive Officer and
Chief Financial Officer (Principal
Executive, Financial and 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 |
|---|