x
|
ANNUAL 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
|
Nevada
|
32-0379665
|
|
(State or other jurisdiction of incorporation or organization)
|
(I.R.S. Employer
Identification No.)
|
Large accelerated filer
o
|
Accelerated filer
o
|
Non-accelerated filer
o
|
Smaller reporting company
þ
|
Page
|
||
PART I
|
||
Item 1.
|
Business.
|
1
|
Item 1A.
|
Risk Factors.
|
33
|
Item 1B.
|
Unresolved Staff Comments.
|
43
|
Item 2.
|
Properties.
|
44
|
Item 3.
|
Legal Proceedings.
|
44
|
Item 4.
|
Mine Safety Disclosures.
|
44
|
PART II
|
||
Item 5.
|
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
|
45
|
Item 6.
|
Selected Financial Data.
|
46
|
Item 7.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
|
46
|
Item 7A.
|
Quantitative and Qualitative Disclosures About Market Risk.
|
54
|
Item 8.
|
Financial Statements and Supplementary Data.
|
54
|
Item 9.
|
Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.
|
54
|
Item 9A.
|
Controls and Procedures.
|
54
|
Item 9B.
|
Other Information.
|
55
|
PART III
|
||
Item 10.
|
Directors, Executive Officers, and Corporate Governance.
|
56
|
Item 11.
|
Executive Compensation.
|
58
|
Item 12.
|
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
|
60
|
Item 13.
|
Certain Relationships and Related Transactions, and Director Independence.
|
60
|
Item 14.
|
Principal Accounting Fees and Services.
|
62
|
PART IV
|
||
Item 15.
|
Exhibits, Financial Statement Schedules
|
63
|
Signatures
|
65
|
·
|
being permitted to present only two years of audited financial statements and only two years of related Management’s Discussion & Analysis of Financial Condition and Results of Operations in this report on Form 10-K;
|
·
|
not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley Act;
|
·
|
reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and
|
·
|
exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.
|
·
|
Haematological malignancies (leukemias, lymphomas, etc.). One of the most effective treatments for these conditions is bone marrow transplantation. However, this is a risky and difficult procedure primarily because of potential conflicts between host and donor immune systems.
|
·
|
Non-malignant haematological conditions (such as sickle cell anemia) which could also be largely treated by bone marrow transplantation if the procedure did not pose such threatening conflicts between host and donor immune systems.
|
·
|
Organ failure and transplantation. A variety of conditions can be treated by the transplantation of vital organs. However, transplantation is limited both by the problem of rejection and an insufficient supply of available donor organs.
|
|
a)
|
many blood cancer patients are not candidates for the primary treatment (HSCT) that represents a potential cure;
|
|
b)
|
there is high mortality among those patients who are candidates for HSCT and do undergo the procedure; and
|
|
c)
|
those patients who successfully undergo and survive HSCT take dangerous, expensive, and quality-of-life reducing immunosuppression medications, typically for a prolonged period of time.
|
Initial Malignancy Indications
(note estimates for North America
and
EU only)
|
Prevalence
(Number patients)
|
Annual Bone Marrow
Transplantations
|
||||||
Non-Hodgkin’s Lymphoma
|
808,000
|
11,000
|
||||||
Multiple Myeloma
|
188,000
|
16,500
|
||||||
Acute Myeloid Leukemia
|
119,000
|
8,500
|
||||||
Total
|
1,115,000
|
36,000
|
(1)
|
As noted above, increasing incidence of these disorders in the West, largely driven by the aging population.
|
|
(2)
|
Improvement and proliferation of HSCT treatments.
|
|
(3)
|
A “virtuous circle” of lowered death rate due to better transplantations leading to more aggressive focus on HSCT.
|
|
(4)
|
The growing use of “reduced intensity conditioning,” i.e., lower myoablative dosing, which makes the procedure more survivable for older patients (see table below).
|
Name: VETO CELLS EFFECTIVE IN PREVENTING GRAFT REJECTION AND DEVOID OF GRAFT VERSUS HOST POTENTIAL
|
||||||||||
Country
|
Patent Number
|
Filed
|
Expires
|
Status
|
Assignee
|
|||||
USA (Basic)
|
6,544,506
|
05-Jan-2000
|
05-Jan-2020
|
Granted
|
Yeda Research and Development Co. Ltd.
|
|||||
USA (National Phase)
|
7,270,810
|
28-Dec-2000
|
1-Dec-2021
|
Granted
|
Yeda Research and Development Co. Ltd.
|
|||||
Europe
|
1244803
|
28-Dec-2000
|
28-Dec-2020
|
Granted
|
Yeda Research and Development Co. Ltd.
|
|||||
Israel
|
150440
|
28-Dec-2000
|
28-Dec-2020
|
Granted
|
Yeda Research and Development Co. Ltd.
|
Name: USE OF ANTI THIRD PARTY CENTRAL MEMORY T CELLS FOR ANTI-LEUKEMIA/LYMPHOMA TREATMENT
|
||||||||||
Country
|
Patent Number
|
Filed
|
Expires
|
Status
|
Assignee
|
|||||
USA
|
2013-0171108-A1
|
08-Sep-2011
|
08-Sep-2031
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Japan
|
2013-527738
|
08-Sep-2011
|
08-Sep-2031
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Canada
|
2,810,632
|
08-Sep-2011
|
08-Sep-2031
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
China
|
CN 103282047 A 9
|
08-Sep-2011
|
08-Sep-2031
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Republic of Korea
|
2013-7008892
|
08-Sep-2011
|
08-Sep-2031
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Israel
|
225102
|
08-Sep-2011
|
08-Sep-2031
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Brazil
|
BR 11 2013 005756 4
|
08-Sep-2011
|
08-Sep-2031
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Mexico
|
MX/a/2013/002668
|
08-Sep-2011
|
08-Sep-2031
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Singapore
|
188473
|
08-Sep-2011
|
08-Sep-2031
|
Granted
|
Yeda Research and Development Co. Ltd.
|
|||||
Europe
|
26138013
|
08-Sep-2011
|
08-Sep-2031
|
Allowed
|
Yeda Research and Development Co. Ltd.
|
|||||
Hong Kong
|
14100513.2
|
08-Sep-2011
|
08-Sep-2031
|
Pending
|
Yeda Research and Development Co. Ltd.
|
Name: ANTI THIRD PARTY CENTRAL MEMORY T CELLS, METHODS OF PRODUCING SAME AND USE OF SAME IN TRANSPLANTATION AND DISEASE TREATMENT
|
||||||||||
Country
|
Patent Number
|
Filed
|
Expires
|
Status
|
Assignee
|
|||||
USA
|
2014-0212398-A1
|
06-Sep-2012
|
06-Sep-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Europe | 2753351 | 06-Sep-2012 | 06-Sep-2032 | Pending | Yeda Research and Development Co. Ltd. | |||||
Hong Kong
|
1200099A
|
06-Sep-2012
|
06-Sep-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Japan
|
2014-529143
|
06-Sep-2012
|
06-Sep-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Canada
|
2,848,121
|
06-Sep-2012
|
06-Sep-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
China
|
CN 103930130 A
|
06-Sep-2012
|
06-Sep-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Australia
|
2012305931
|
06-Sep-2012
|
06-Sep-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Republic of Korea
|
10-2014-7009267
|
06-Sep-2012
|
06-Sep-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
New Zealand
|
622749
|
06-Sep-2012
|
06-Sep-2032
|
Granted
|
Yeda Research and Development Co. Ltd.
|
|||||
South Africa
|
2014/01993
|
06-Sep-2012
|
06-Sep-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
India
|
577/MUMNP/2014
|
06-Sep-2012
|
06-Sep-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Israel
|
231397
|
06-Sep-2012
|
06-Sep-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Russian Federation
|
2014110897
|
06-Sep-2012
|
06-Sep-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Brazil
|
BR 11 2014 005355 3
|
06-Sep-2012
|
06-Sep-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Mexico
|
MX/a/2014/002771
|
06-Sep-2012
|
06-Sep-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Singapore
|
11201400513P
|
06-Sep-2012
|
06-Sep-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
Name: ANTI THIRD PARTY CENTRAL MEMORY T CELLS, METHODS OF PRODUCING SAME AND USE OF SAME IN TRANSPLANTATION AND DISEASE TREATMENT
|
||||||||||
Country
|
Patent Number
|
Filed
|
Expires
|
Status
|
Assignee
|
|||||
USA
|
2011-0212071-A1
|
29-Oct-2009
|
29-Oct-2029
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Europe
|
2365823
|
29-Oct-2009
|
29-Oct-2029
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Israel
|
212587
|
29-Oct-2009
|
29-Oct-2029
|
Allowed
|
Yeda Research and Development Co. Ltd.
|
|||||
India
|
905/MUMNP/2011
|
29-Oct-2009
|
29-Oct-2029
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
China
|
ZL200980153053.4
|
29-Oct-2009
|
29-Oct-2029
|
Granted
|
Yeda Research and Development Co. Ltd.
|
|||||
Russian Federation
|
2506311
|
29-Oct-2009
|
29-Oct-2029
|
Granted
|
Yeda Research and Development Co. Ltd.
|
Name: GENETICALLY MODIFIED ANTI-THIRD PARTY CENTRAL MEMORY T CELLS AND USE OF SAME IN IMMUNOTHERAPY
|
||||||||||
Country
|
Patent Number
|
Filed
|
Expires
|
Status
|
Assignee
|
|||||
USA
|
62/193,207
|
16-Jul-2015
|
16-Jul-2035
|
Pending
|
Yeda Research and Development Co. Ltd.
|
USE OF ANTI THIRD PARTY CENTRAL MEMORY T CELLS
|
||||||||||
Country
|
Patent Number
|
Filed
|
Expires
|
Status
|
Assignee
|
|||||
USA
|
62/193,229
|
16-Jul-2015
|
16-Jul-2035
|
Pending
|
Yeda Research and Development Co. Ltd.
|
Name: UNIVERSAL DONOR-DERIVED TOLEROGENIC CELLS FOR INDUCING NON-SYNGENEIC TRANSPLANTATION TOLERANCE
|
||||||||||
Country
|
Patent Number
|
Filed
|
Expires
|
Status
|
Assignee
|
|||||
US
|
8,916,147
|
21-Aug-2006
|
21-Aug-2026
|
Granted
|
Yeda Research and Development Co. Ltd.
|
|||||
US (Divisional)
|
|
2015-0104471-A1
|
21-Aug-2006
|
21-Aug-2026
|
Pending
|
Yeda Research and Development Co. Ltd.
|
||||
Europe
|
1928479
|
21-Aug-2006
|
21-Aug-2026
|
Allowed
|
Yeda Research and Development Co. Ltd.
|
|||||
Europe (Divisional)
|
2514315
|
21-Aug-2006
|
21-Aug-2026
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Israel
|
189688
|
21-Aug-2006
|
21-Aug-2026
|
Granted
|
Yeda Research and Development Co. Ltd.
|
Name: A COMBINATION THERAPY FOR A STABLE AND LONG TERM ENGRAFTMENT
|
||||||||||
Country
|
Patent Number
|
Filed
|
Expires
|
Status
|
Assignee
|
|||||
Singapore
|
11201403459X
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Mexico
|
MX/a/2014/007647
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Brazil
|
BR 11 2014 015960 2
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Russian Federation
|
2014128479
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Israel
|
233303
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
India
|
1468/MUMNP/2014
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
South Africa
|
2014/05071
|
20-Dec-2012
|
20-Dec-2032
|
Granted
|
Yeda Research and Development Co. Ltd.
|
|||||
New Zealand
|
627272
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Republic of Korea
|
10-2014-7020449
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Australia
|
2012355990
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
China
|
CN 104470542 A
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Canada
|
2,859,953
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Japan
|
2014-548337
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Europe
|
2793914
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
USA
|
2014-0363437-A1
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Hong Kong
|
15103467.1
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
Name: A COMBINATION THERAPY FOR A STABLE AND LONG TERM ENGRAFTMENT USING SPECIFIC PROTOCOLS FOR T/B CELL DEPLETION
|
||||||||||
Country
|
Patent Number
|
Filed
|
Expires
|
Status
|
Assignee
|
|||||
Singapore
|
11201403456U
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Mexico
|
MX/a/2014/007648
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Brazil
|
BR 11 2014 015959 9
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Russian Federation
|
2014129632
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Israel
|
233302
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
India
|
1467/MUMNP/2014
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
South Africa
|
2014/05298
|
20-Dec-2012
|
20-Dec-2032
|
Granted
|
Yeda Research and Development Co. Ltd.
|
|||||
New Zealand
|
627549
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Republic of Korea
|
10-2014-7020448
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Australia
|
2012355989
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
China
|
CN 104093314 A 4
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Canada
|
2,859,952
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Japan
|
2014-548336
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Europe
|
EP2797421
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
USA
|
2014-0369974-A1
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Hong Kong
|
15103468.0
|
20-Dec-2012
|
20-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
Name: METHODS OF TREATING DISEASE BY TRANSPLANTATION OF DEVELOPING ALLOGENEIC OR XENOGENEIC ORGANS OR TISSUES
|
||||||||||
Country
|
Patent Number
|
Filed
|
Expires
|
Status
|
Assignee
|
|||||
Mexico
|
319957
|
04-Mar-2004
|
04-Mar-2024
|
Granted
|
Yeda Research and Development Co. Ltd.
|
|||||
Mexico (Divisional)
|
MX/a/2014/001950
|
04-Mar-2004
|
04-Mar-2024
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Europe
|
2216033
|
04-Mar-2004
|
04-Mar-2024
|
Granted
|
Yeda Research and Development Co. Ltd.
|
Name: METHODS OF TREATING DISEASE BY TRANSPLANTATION OF ALLOGENEIC OR XENOGENEIC ORGANS OR TISSUES
|
||||||||||
Country
|
Patent Number
|
Filed
|
Expires
|
Status
|
Assignee
|
|||||
Europe
|
2402019
|
04-Mar-2004
|
04-Mar-2024
|
Granted
|
Yeda Research and Development Co. Ltd.
|
|||||
Israel
|
170622
|
04-Mar-2004
|
04-Mar-2024
|
Granted
|
Yeda Research and Development Co. Ltd.
|
Name: THERAPEUTIC TRANSPLANTATION USING DEVELOPING, HUMAN OR PORCINE, RENAL OR HEPATIC, GRAFTS
|
||||||||||
Country
|
Patent Number
|
Filed
|
Expires
|
Status
|
Assignee
|
|||||
USA
|
7,780,993
|
19-Jan-2005
|
23-Apr-2023
|
Granted
|
Yeda Research and Development Co. Ltd.
|
|||||
USA (Divisional)
|
8,951,572
|
19-Jan-2005
|
19-Jan-2025
|
Granted
|
Yeda Research and Development Co. Ltd.
|
|||||
USA (Divisional)
|
2015-0190546-A1
|
19-Jan-2005
|
19-Jan-2025
|
Pending
|
Yeda Research and Development Co. Ltd.
|
Name: DISEASE TREATMENT VIA DEVELOPING NON-SYNGENEIC GRAFT TRANSPLANTATION
|
||||||||||
Country
|
Patent Number
|
Filed
|
Expires
|
Status
|
Assignee
|
|||||
USA
|
8,974,779
|
02-Oct-2005
|
02-Oct-2023
|
Granted
|
Yeda Research and Development Co. Ltd.
|
|||||
USA (Divisional)
|
2015-0174294-A1
|
02-Oct-2005
|
02-Oct-2023
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Europe
|
1809734
|
02-Oct-2005
|
02-Oct-2025
|
Granted
|
Yeda Research and Development Co. Ltd.
|
|||||
Europe (Divisional)
|
2453008
|
02-Oct-2005
|
02-Oct-2025
|
Granted
|
Yeda Research and Development Co. Ltd.
|
|||||
Hong Kong (Divisional)
|
HK1170534
|
02-Oct-2005
|
02-Oct-2025
|
Granted
|
Yeda Research and Development Co. Ltd.
|
|||||
Israel
|
182363
|
02-Oct-2005
|
02-Oct-2025
|
Granted
|
Yeda Research and Development Co. Ltd.
|
Name: MAMMALIAN FETAL PULMONARY CELLS AND THERAPEUTIC USE OF SAME
|
||||||||||
Country
|
Patent Number
|
Filed
|
Expires
|
Status
|
Assignee
|
|||||
USA
|
HK1170534
|
06-Dec-2012
|
06-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Europe
|
2788009
|
06-Dec-2012
|
06-Dec-2032
|
Allowed
|
Yeda Research and Development Co. Ltd.
|
|||||
Japan
|
2014-545442
|
06-Dec-2012
|
06-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Canada
|
2,857,930
|
06-Dec-2012
|
06-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
China
|
CN 104105493 A
|
06-Dec-2012
|
06-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Australia
|
2012348574
|
06-Dec-2012
|
06-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Republic of Korea
|
10-2014-7018702
|
06-Dec-2012
|
06-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
New Zealand
|
627071
|
06-Dec-2012
|
06-Dec-2032
|
Allowed
|
Yeda Research and Development Co. Ltd.
|
|||||
South Africa
|
02014/04958
|
06-Dec-2012
|
06-Dec-2032
|
Granted
|
Yeda Research and Development Co. Ltd.
|
|||||
India
|
1366/MUMNP/2014
|
06-Dec-2012
|
06-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Israel
|
233022
|
06-Dec-2012
|
06-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Russian Federation
|
2014127338
|
06-Dec-2012
|
06-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Brazil
|
BR 11 2014 014033 2
|
06-Dec-2012
|
06-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Mexico
|
MX/a/2014/006756
|
06-Dec-2012
|
06-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Singapore
|
11201402902V
|
06-Dec-2012
|
06-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Philippines
|
1- 2014-501309
|
06-Dec-2012
|
06-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|||||
Hong Kong
|
15103466.2
|
06-Dec-2012
|
06-Dec-2032
|
Pending
|
Yeda Research and Development Co. Ltd.
|
|
1.
|
Significantly improve outcomes of transplantations by reducing host rejection rate of T-cell depleted bone marrow, markedly reducing both the risk of GVHD and the need for using aggressive amounts of immunosuppression medications. This would significantly reduce the bone marrow transplant mortality rate (currently 50%) and therefore lead to broader use of this treatment.
|
|
2.
|
Substantively increase the number of transplantations by enabling lower myeloablative conditioning and therefore making the therapy accessible to older and sicker patients (who today may not survive ablation).
|
|
3.
|
Further increase the number of transplantations by making transplantation appropriate for other indications (for which today transplantation would be considered an inappropriately risky treatment).
|
|
1.
|
It has an outer surface coating that triggers attack by specific host T-cells (and only those specific T-cells).
|
|
2.
|
It can annihilate an attacking T-cell without itself being damaged (specifically, it exposes or releases a death-signaling molecule when an attacking T-cell binds to it).
|
|
3.
|
It has been oriented to attack cells of a simulated third party (i.e., neither host nor donor) and thus exhibits markedly reduced risk of GVHD or graft rejection.
|
|
4.
|
It is long-lived and endures in the body for extended periods.
|
|
5.
|
It migrates to the thymus and lymph nodes.
|
|
1.
|
It destroys the host T-cells so they will not attack (reject) the donor bone marrow cells.
|
|
2.
|
It makes space in the host bone marrow for the new donor cells.
|
|
3.
|
It destroys diseased host blood cells so that they do not proliferate and cause relapse following the procedure.
|
·
|
Host rejection - the myeloablative conditioning does not destroy all of the host T-cells. Those that remain may aggressively attack the donor bone marrow cells before they can engraft.
|
·
|
“Graft versus Host Disease” (GVHD) -the transplanted cells include donor T-cells which recognize the host's body as foreign and attack it.
|
Offering
|
Objective
|
Major Activities
|
Estimated start date
|
||||
Anti-rejection Veto Cell
|
Validate and introduce new commercial treatment to increase engraftment of allogeneic bone marrow transplantations
|
1. Regulatory approval and treatment protocols
2. Conduct human clinical trials
3. Develop plan for commercial exploitation
|
●
●
|
Commence a formal company-sponsored Phase I/II clinical trial by 2017
Interim analysis within 18 months thereafter
|
|||
Veto – CAR-T Cell Therapy
|
Validate the possibility of combining Veto Cell treatment with CAR-T cell treatment for both blood cell cancer and solid tumor cancer treatment
|
4. Engender partnership with Car-T cell provider
5. Validate combined treatment model in preclinical trials
6. Develop joint production and treatment protocol
|
●
●
|
Discussions with prospective partners underway
If preclinical studies are successful , human trials would be the next step
|
·
|
Embryonic tissue (taken from an animal or human fetus during gestation), which can be identified as organ precursors that will grow into specific organs (e.g., kidney, liver, pancreas), can be harvested at a very specific moment in the gestation period where they have just then become “committed” organ precursors and thus have not yet begun to generate the acute levels of rejection otherwise typical for xenotransplant (i.e., between species) which have been problematic in other earlier studies transplanting porcine tissue into humans. These pre-organs can be successfully transplanted into a host, even of another species, and grow into functional organs in the host with only the level of organ rejection associated with an allogeneic organ donor, which can currently be managed through medication. Incidentally, this post transplantation rejection could potentially be further reduced by using Veto Cells.
|
·
|
Veto Cell Individual cells (taken from either human or animal embryos or possibly adult human donors) can be infused in a single-cell suspension and in a patient with a diseased organ (e.g. lung) and used to regeneration healthy lung tissue to correct non-malignant organ diseases.
|
·
|
Their organs are similarly sized to humans, and
|
·
|
They have large litters so can provide extensive supply (unlike for example monkeys).
|
·
|
Porcine spleen tissue was successfully implanted into a mouse, effectively treating hemophilia.
|
·
|
Embryonic lung cells have shown effectiveness in repairing injured mouse lungs and are currently being tested on cystic-fibrosis mice. In principal, these could potentially be used to effectively treat several major lung diseases.
|
·
|
Porcine pancreatic cells were successfully infused into monkeys where they effectively corrected chemically induced diabetes. The chart below shows exogenous insulin requirements of the subject animal (vertical axis) as a function of the number of days following the transplantation (horizontal axis).
|
|
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)
|
·
|
successfully and complete adequate and well-controlled clinical trials that demonstrate statistically significant safety and efficacy and to obtain all requisite regulatory approvals in a timely and cost-effective manner;
|
·
|
effectively use patents and possibly exclusive partnership agreements with important third party treatment providers and collaborations partners to maintain a stable competitive stance for our Technology;
|
·
|
attract and retain appropriate clinical and commercial personnel and service providers; and
|
·
|
establish adequate distribution relationships for our products.
|
Strategy Element
|
Introductory period
(years 1 -3 post FDA approval)
|
Years 4+
|
||||
Market Segments
|
●
●
|
Lymphoma and Leukemia
Solid tumors e.g. breast cancer.
|
● |
Same as before plus broader set of solid tumor targets, diabetes, emphysema and other major non-malignant organ disease; sickle cell anemia
|
||
Product Rollout
|
●
●
|
Veto Cell therapy for B-cell malignancies
Veto+CAR-T Veto Cell therapy for both blood cell and solid tumor cancers
|
●
●
|
Veto Cell tolerizing treatment for BMT and organ transplantation
Veto Cell therapy for cancer and non-malignant disorders; organsource for major organ regeneration
|
||
Customer/ Geographic Focus
|
●
●
●
|
North America
Western Europe
China
|
● |
North America, Western & Eastern Europe, Australia/New Zealand, Russia, Brazil, selected Asian markets
|
||
Channels/Go to Market
|
●
●
|
Direct relationships with leading transplantation centers
International production and distribution through partners
|
● |
Partnership with global market leaders
|
||
Pricing
|
●
|
Consistent with other cell therapy offerings currently associated with transplantations and immuno-oncology
|
● |
Potentially higher volume, lower cost for “off the shelf” offerings
|
Operations
|
●
●
|
Three production centers:
-
US
-
Western Europe
-
Far East
Initial capacity leased from major transplantation centers.
|
● |
Regional production centers owned or JV with partners
|
|
1.
|
Severity of unmet medical need
: degree of severity of the indication and the effectiveness of existing treatments. These criteria help determine the proper regulatory pathway.
|
|
2.
|
Technology relevance
: relative value of the ability to manage immune response to the treatment of a given indication.
|
|
1.
|
Treating European patients after the end of Phase 2 (in some cases possibly with insurance reimbursement available); and
|
|
2.
|
Potential upfront and milestone driven licensing revenues from collaborations with third parties (e.g. with one or more CAR-T provider for Veto-CAR-T cell therapy development).
|
|
(a)
|
Within three (3) years of the signature of the Yeda License Agreement to commence Phase I clinical trials;
|
|
(b)
|
Within five (5) years of the signature of the Yeda License Agreement to commence Phase II clinical trials with respect to the a licensed product, unless the Company shall have invested, during such five (5) year period, above an aggregate amount of at least US$5,000,000 in research and development;
|
|
(c)
|
Within either (8) years of the signature of the Yeda License Agreement to receive a FDA, EMEA or CFDA approval in respect of at least one (1) Product;
|
|
(d)
|
To achieve commercialization of at least one (1) Product within twelve (12) months of the date of FDA, EMEA or CFDA approval; or
|
|
(e)
|
In case of a commercial sale of any Product having commenced, there shall be a period of twelve (12) months or more during which no sales of any Product shall take place (except as a result of force majeure or other factors beyond the control of the Company).
|
·
|
Funding the Research
. Within 60 days of receiving any capital investment in the Company in excess of $2,000,000, provided that the Company has not paid Yeda by that date an option initiation fee of $200,000, as set forth in the E&O Agreement, Cell Source will pay Yeda 20% from such excess investment up to the sum of $200,000 (the “Additional Research Payment”). The Additional Research Payment shall be allocated by Yeda to support research activities of Dr. Reisner and can be offset in full by payment of the option initiation fee.
|
·
|
Title
. All right, title and interest in and to the Licensed Information and the Patents (as those terms are defined in the Yeda License Agreement) and all right, title and interest in and to any drawings, plans, diagrams, specifications, other documents, models, or any other physical matter in any way containing, representing or embodying any of the foregoing, vest and shall vest in Yeda and subject to the license granted in the Yeda License Agreement.
|
·
|
Patents
. Both Yeda and the Company shall consult with one another on the filing of patent applications for any portion of Licensed Information and/or corresponding to patent application existing at the time the Yeda License Agreement was executed. Yeda shall retain outside patent counsel that will be approved by Cell Source, to prepare, file and prosecute patent applications. All applications will be filed in Yeda’s name.
|
·
|
Patents; Patent Infringements
. Where the Company determines that a third party is infringing one or more of the Patents or is sued, in prosecuting or defending such litigation, the Company must pay any expenses or costs or other liabilities incurred in connection with such litigation (including attorney’s fees, costs and other sums awarded to the counterparty in such action). The Company agreed to indemnify Yeda against any such expenses or costs or other liabilities.
|
·
|
License
. With regard to the expiration of Patents, a Product is deemed to be covered by a Patent so long as such Product is protected by “Orphan Drug” status (or the like). The Company has an exclusive worldwide license under the Licensed Information and the Patents for the development, manufacture and sales of the Products. License remains in force in each country with respect to each Product until the later of (i) the expiration of the last Patent in such country covering such Product or (ii) the expiration of a 15-year period commencing the day FDA New Drug Approval is received for a Product in such country.
|
|
i.
|
the proposed Sublicense is for monetary consideration only;
|
|
ii.
|
the proposed Sublicense is to be granted in a bona fide arm’s length commercial transaction;
|
|
iii.
|
a copy of the agreement granting the Sublicense and all amendments thereof shall be made available to Yeda, 14 days before their execution and Cell Source shall submit to Yeda copies of all such Sublicenses and all amendments thereof promptly upon execution thereof; and
|
|
iv.
|
the proposed Sublicense is made by written agreement, the provisions of which are consistent with the terms of the License and contain, inter alia, the following terms and conditions, including: the Sublicense shall expire automatically on the termination of the License for any reason.
|
·
|
Termination
. The Yeda License Agreement terminates on the later of: (i) the expiration of the last of the Patents or (ii) the expiry of a continuous period of 20 years during which there shall not have been a First commercial sale of any product in any country. Yeda may terminate by written notice, effective immediately, if the Company challenges the validity of any of the Patents. If a challenge is unsuccessful, then in addition to Yeda’s right to termination, the Company shall pay to Yeda liquidated damages in the amount of $8,000,000. Either the Company or Yeda may terminate the Yeda License Agreement and the License by serving a written notice upon (i) occurrence of a material breach or (ii) the granting of a winding-up order. Additionally, Yeda may terminate for failure to reimburse Yeda for patent application and/or prosecution expenses.
|
·
|
the degree and range of protection any patents will afford us against competitors, including whether third parties will find ways to invalidate or otherwise circumvent the patents that we license;
|
·
|
whether or not others will obtain patents claiming aspects similar to those covered by the patents that we license; or
|
·
|
whether we will need to initiate litigation or administrative proceedings, which may be costly whether we win or lose.
|
·
|
the duration of the clinical trial;
|
·
|
the number of sites included in the trials;
|
·
|
the countries in which the trial is conducted;
|
·
|
the length of time required and ability to enroll eligible patients;
|
·
|
the number of patients that participate in the trials;
|
·
|
the number of doses that patients receive;
|
·
|
the drop-out or discontinuation rates of patients;
|
·
|
per patient trial costs;
|
·
|
third party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner;
|
·
|
our final product candidates having different properties in humans than in laboratory testing;
|
·
|
the need to suspend or terminate our clinical trials;
|
·
|
insufficient or inadequate supply of quality of necessary materials to conduct our trials;
|
·
|
potential additional safety monitoring, or other conditions required by FDA or comparable foreign regulatory authorities regarding the scope or design of our clinical trials, or other studies requested by regulatory agencies;
|
·
|
problems engaging institutional review boards (“IRB”) to oversee trials or in obtaining and maintaining IRB approval of studies;
|
·
|
the duration of patient follow-up;
|
·
|
the efficacy and safety profile of a product candidate;
|
·
|
the costs and timing of obtaining regulatory approvals; and
|
·
|
the costs involved in enforcing or defending patent claims or other intellectual property rights.
|
·
|
delays in the development of manufacturing capabilities for our product candidates to enable their consistent production at clinical trial scale;
|
·
|
delays in the commencement of clinical trials as a result of clinical trial holds or the need to obtain additional information to complete an Investigational New Drug Application (IND);
|
·
|
delays in obtaining regulatory approval to commence new trials;
|
·
|
adverse safety events experienced during our clinical trials;
|
·
|
insufficient efficacy during trials leading to withdrawal of product candidate;
|
·
|
delays in obtaining clinical materials;
|
·
|
slower than expected patient recruitment for participation in clinical trials; and
|
·
|
delays in reaching agreement on acceptable clinical trial agreement terms with prospective sites or obtaining institutional review board approval.
|
·
|
our clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical and/or preclinical testing or to abandon programs;
|
·
|
the results obtained in earlier stage clinical testing may not be indicative of results in future clinical trials;
|
·
|
clinical trial results may not meet the level of statistical significance required by the FDA or other regulatory agencies;
|
·
|
enrollment in our clinical trials for our product candidates may be slower than we anticipate, resulting in significant delays and additional expense;
|
·
|
we, or regulators, may suspend or terminate our clinical trials if the participating patients are being exposed to unacceptable health risks; and
|
·
|
the effects of our product candidates on patients may not be the desired effects or may include undesirable side effects or other characteristics that may delay or preclude regulatory approval or limit their commercial use, if approved.
|
·
|
the therapeutic endpoints chosen for evaluation;
|
·
|
the eligibility criteria defined in the protocol;
|
·
|
the perceived benefit of the investigational drug under study;
|
·
|
the size of the patient population required for analysis of the clinical trial’s therapeutic endpoints;
|
·
|
our ability to recruit clinical trial investigators and sites with the appropriate competencies and experience;
|
·
|
our ability to obtain and maintain patient consents; and
|
·
|
competition for patients by clinical trial programs for other treatments.
|
·
|
variations in our quarterly operating results;
|
·
|
announcements that our revenue or income are below analysts’ expectations;
|
·
|
general economic slowdowns;
|
·
|
sales of large blocks of the Company’s Common Stock; and
|
·
|
announcements by us or our competitors of significant contracts, acquisitions, strategic partnerships, joint ventures or capital commitments.
|
·
|
Only two years of audited financial statements in addition to any required unaudited interim financial statements with correspondingly reduced "Management's Discussion and Analysis of Financial Condition and Results of Operations" disclosure;
|
·
|
Reduced disclosure about our executive compensation arrangements;
|
·
|
No non-binding advisory votes on executive compensation or golden parachute arrangements;
|
·
|
Exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting.
|
·
|
our ability to raise funds for general corporate purposes and operations, including our clinical trials;
|
·
|
the commercial feasibility and success of our technology;
|
·
|
our ability to recruit qualified management and technical personnel;
|
·
|
the success of our clinical trials;
|
·
|
our ability to obtain and maintain required regulatory approvals for our products; and
|
·
|
the other factors discussed in the “Risk Factors” section and elsewhere in this Annual Report on Form 10-K.
|
High
|
Low
|
|||||||
First Quarter ended March 31, 2015
|
$ | 1.35 | $ | 0.20 | ||||
Second Quarter ended June 30, 2015
|
$ | 1.60 | $ | 0.73 | ||||
Third Quarter ended September 30, 2015
|
$ | 1.39 | $ | 1.00 | ||||
Fourth Quarter ended December 31, 2015
|
$ | 1.60 | $ | 1.05 |
High
|
Low
|
|||||||
First Quarter ended March 31, 2014
|
$ | 0.10 | *** | $ | 0.10 | *** | ||
Second Quarter ended June 30, 2014
|
$ | 3.50 | $ | 0.10 | ||||
Third Quarter ended September 30, 2014
|
$ | 2.00 | $ | 0.75 | ||||
Fourth Quarter ended December 31, 2014
|
$ | 0.95 | $ | 0.32 |
|
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 Year Ended
|
||||||||
December 31,
|
||||||||
2015
|
2014
|
|||||||
Revenues
|
$ | - | $ | - | ||||
Operating Expenses
|
||||||||
Research and development
|
392,925 | 806,157 | ||||||
Research and development - related party
|
829,970 | 1,012,464 | ||||||
Selling, general and administrative
|
1,097,580 | 2,235,445 | ||||||
Total Operating Expenses | 2,320,475 | 4,054,066 | ||||||
Loss From Operations | (2,320,475 | ) | (4,054,066 | ) | ||||
Other Income (Expense)
|
||||||||
Change in fair value of derivative liabilities
|
208,250 | (2,739 | ) | |||||
Interest expense
|
(35,612 | ) | (674 | ) | ||||
Amortization of debt discount
|
(310,200 | ) | - | |||||
Amortization of deferred financing costs
|
(46,068 | ) | - | |||||
Total Other Expense | (183,630 | ) | (3,413 | ) | ||||
Net Loss
|
$ | (2,504,105 | ) | $ | (4,057,479 | ) |
December 31,
|
||||||||
2015
|
2014
|
|||||||
Cash
|
$ | 6,944 | $ | 19,480 | ||||
Working capital deficiency
|
$ | (5,711,374 | ) | $ | (3,785,855 | ) |
Year Ended December 31, 2015
|
Year Ended December 31, 2014
|
|||||||||||||||||||||||
Common Stock
|
Fair
|
Allocation
|
Common Stock
|
Fair
|
Allocation
|
|||||||||||||||||||
Equivalents
|
Value
|
%
|
Equivalents
|
Value
|
%
|
|||||||||||||||||||
Common stock
|
443,333 | $ | 332,500 | 52 | % | 4,090,661 | $ | 3,067,996 | 57 | % | ||||||||||||||
Warrants
|
443,333 | $ | 311,480 | 48 | % | 4,090,661 | $ | 2,320,054 | 43 | % | ||||||||||||||
Relative fair value
|
Relative fair value
|
|||||||||||||||||||||||
of the common stock
|
$ | 0.39 |
of the common stock
|
$ | 0.43 |
Name
|
Age
|
Title(s)
|
||
Dennis Brown
|
66
|
Director (Chairman)
|
||
Itamar Shimrat
|
56
|
Chief Executive Officer, Chief Financial Officer and Director
|
||
Yoram Drucker
|
50
|
Director
|
||
David Zolty
|
66
|
Director
|
||
Ben Friedman
|
57
|
Director
|
|
1.
|
any bankruptcy petition filed by or against such person or any business of which such person was a general partner or executive officer either at the time of the bankruptcy or within two years prior to that time;
|
|
2.
|
any conviction in a criminal proceeding or being subject to a pending criminal proceeding (excluding traffic violations and other minor offenses);
|
|
3.
|
being subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction, permanently or temporarily enjoining him from or otherwise limiting his involvement in any type of business, securities or banking activities or to be associated with any person practicing in banking or securities activities;
|
|
4.
|
being found by a court of competent jurisdiction in a civil action, the SEC or the Commodity Futures Trading Commission to have violated a Federal or state securities or commodities law, and the judgment has not been reversed, suspended, or vacated;
|
|
5.
|
being subject of, or a party to, any Federal or state judicial or administrative order, judgment decree, or finding, not subsequently reversed, suspended or vacated, relating to an alleged violation of any Federal or state securities or commodities law or regulation, any law or regulation respecting financial institutions or insurance companies, or any law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity; or
|
|
6.
|
being subject of or party to any sanction or order, not subsequently reversed, suspended, or vacated, of any self-regulatory organization, any registered entity or any equivalent exchange, association, entity or organization that has disciplinary authority over its members or persons associated with a member.
|
Name and
|
Stock
|
Option
|
All Other
|
||||||||||||||||||||||
Principal Position
|
Year
|
Salary
|
Bonus
|
Awards
|
Awards
|
Compensation
|
Total
|
||||||||||||||||||
Itamar Shimrat
|
2015
|
$ | 181,198 | $ | - | $ | - | $ | 212,000 | (1) | $ | - | $ | 393,198 | |||||||||||
Chief Executive Officer
|
2014
|
$ | 168,909 | $ | - | $ | - | $ | - | $ | - | $ | 168,909 |
(1)
|
On November 10, 2014, in connection with the effectiveness of the registration statement, the Company became obligated to issue to certain founders of Cell Source Limited (including Itamar Shimrat) five-year warrants to purchase an aggregate of 3,000,000 shares of common stock at an exercise price of $0.75 per share. The warrants were issued during the year ended December 31, 2015. The amount above represents the grant date fair value of the warrant to purchase 750,000 shares of common stock issued to Itamar Shimrat during the years ended December 31, 2015, calculated in accordance with FASB ASC Topic 718. For a detailed discussion of the assumptions used in estimating fair values, see Note 4 – Fair Value in the notes that accompany our consolidated financial statements.
|
Option Awards
|
Stock Awards
|
||||||||||||||||||||||||||||||||
Equity
|
|||||||||||||||||||||||||||||||||
incentive
|
|||||||||||||||||||||||||||||||||
plan
|
|||||||||||||||||||||||||||||||||
Equity
|
awards:
|
||||||||||||||||||||||||||||||||
incentive
|
Market or
|
||||||||||||||||||||||||||||||||
Equity
|
plan
|
payout
|
|||||||||||||||||||||||||||||||
incentive
|
awards:
|
value of
|
|||||||||||||||||||||||||||||||
plan awards:
|
Number of
|
unearned
|
|||||||||||||||||||||||||||||||
Number of
|
Number of
|
Number of
|
Number
|
Market
|
unearned
|
shares,
|
|||||||||||||||||||||||||||
securities
|
securities
|
securities
|
of shares
|
value of
|
shares,
|
units or
|
|||||||||||||||||||||||||||
underlying
|
underlying
|
underlying
|
or units of
|
shares of
|
units or
|
other
|
|||||||||||||||||||||||||||
unexercised
|
unexercised
|
unexercised
|
Option
|
Option
|
stock that
|
units
|
other rights
|
rights
|
|||||||||||||||||||||||||
options
|
options
|
unearned
|
exercise
|
expiration
|
have not
|
that have
|
that have
|
that have
|
|||||||||||||||||||||||||
Name
|
exercisable
|
unexercisable
|
options
|
price
|
date
|
vested
|
not vested
|
not vested
|
not vested
|
||||||||||||||||||||||||
Itamar Shimrat
|
750,000
|
-
|
-
|
$
|
0.75
|
11/10/2019
|
-
|
$
|
-
|
-
|
$
|
-
|
Change in
|
|||||||||||||||||||||||||
Present Value
|
|||||||||||||||||||||||||
and
|
|||||||||||||||||||||||||
Fees
|
Nonqualified
|
||||||||||||||||||||||||
Earned or
|
Deferred
|
||||||||||||||||||||||||
Paid In
|
Stock
|
Option
|
Compensation
|
All Other
|
|||||||||||||||||||||
Year
|
Salary
|
Awards
|
Awards
|
Earnings
|
Compensation
|
Total
|
|||||||||||||||||||
Dennis Brown
|
2015
|
$ | 750 | $ | - | $ | - | $ | - | $ | - | $ | 750 | ||||||||||||
Yoram Drucker
|
2015
|
$ | 750 | $ | - | $ | 155,500 | (1) | $ | - | $ | - | $ | 156,250 | |||||||||||
David Zolty
|
2015
|
$ | 750 | $ | - | $ | - | $ | - | $ | - | $ | 750 | ||||||||||||
Ben Friedman
|
2015
|
$ | - | $ | - | $ | - | $ | - | $ | - | $ | - |
(1)
|
On November 10, 2014, in connection with the effectiveness of the registration statement, the Company became obligated to issue to certain founders of Cell Source Limited (including Yoram Drucker) five-year warrants to purchase an aggregate of 3,000,000 shares of common stock at an exercise price of $0.75 per share. The warrants were issued during the year ended December 31, 2015. The amount above represents the grant date fair value of the warrant to purchase 550,000 shares of common stock issued to Yoram Drucker during the years ended December 31, 2015, calculated in accordance with FASB ASC Topic 718. For a detailed discussion of the assumptions used in estimating fair values, see Note 4 – Fair Value in the notes that accompany our consolidated financial statements.
|
Name and Address of Beneficial Owner (11)
|
Amount and Nature
of
Beneficial Ownership (1)
|
Percentage
of Class (2)
|
||||||
Directors and Officers:
|
||||||||
Yoram Drucker, Director
|
1,125,004 | (3) | 4.60 | % | ||||
Itamar Shimrat, Chief Executive Officer, Chief Financial Officer and Director
|
1,226,584 | (4) | 4.99 | % | ||||
David Zolty, Director
|
1,108,318 | (5) | 4.63 | % | ||||
Ben Friedman, Director (6)
|
4,383,344 | (7) | 18.32 | % | ||||
Dennis Brown, Director (Executive Chairman)
|
200,000 | (8) | * | |||||
All directors and executive officers as a group (5 persons)
|
8,043,250 | 31.86 | % | |||||
Yeda Research & Development Co. Ltd.
P.O. Box 95
Rehovot, 76100, Israel
|
1,195,861 | (9) | 4.99 | % | ||||
Yair Reisner
4 Mazal Keshet Street
Old Jaffa, 68037 Israel
|
1,195,861 | (10) | 4.99 | % |
(1)
|
Beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting or investment power with respect to securities. Shares of common stock subject to options or warrants currently exercisable or convertible, or exercisable or convertible within 60 days of April 8, 2016 are deemed outstanding for computing the percentage of the person holding such option or warrant but are not deemed outstanding for computing the percentage of any other person.
|
(2)
|
Based on 23,929,256 shares issued and outstanding as of April 8, 2016.
|
(3)
|
Includes a five-year warrant to purchase 550,000 shares of common stock with an exercise price of $0.75 per share.
|
(4)
|
Includes 651,580 shares of a five-year warrant to purchase 750,000 shares of common stock with an exercise price of $0.75 per share, which warrant is subject to a 4.99% conversion limitation.
|
(5)
|
Includes a five-year warrant to purchase 12,500 shares of common stock with an exercise price of $0.75 per share.
|
(6)
|
Mr. Friedman’s beneficial ownership includes shares beneficially owned by his wife, Phyllis Friedman.
|
(7)
|
Excludes a five-year warrant to purchase 50,000 shares of common stock with an exercise price of $0.75 per share, which warrant is subject to a 4.99% conversion limitation.
|
(8)
|
Includes a five-year warrant to purchase 100,000 shares of common stock with an exercise price of $0.75 per share.
|
(9)
|
Includes 35,889 shares of a five-year warrant to purchase 1,995,376 shares of common stock with an exercise price of $0.001 per share, which warrant is subject to a 4.99% conversion limitation.
|
(10)
|
Includes 35,889 shares of a five-year warrant to purchase 48,459 shares of common stock with an exercise price of $0.001 per share, which warrant is subject to a 4.99% conversion limitation.
|
(11)
|
Except as otherwise indicated, the address of each beneficial owner is c/o Cell Source, Inc., 5 Kineret Street, Bnei Brak, Israel 5126237.
|
For the Years Ended
|
||||||||
December 31,
|
||||||||
2015
|
2014
|
|||||||
Audit fees
|
$ | 111,000 | $ | 106,000 | ||||
Tax fees
|
3,605 | - | ||||||
All other fees
|
- | - | ||||||
$ | 114,605 | $ | 106,000 |
Exhibit
|
||
Number
|
Description
|
|
2.1 (1)
|
Share Exchange Agreement, dated June 30, 2014, by and between Cell Source, Ltd., and Ticket to See, Inc.
|
|
3.1 (1)
|
Articles of Association of Cell Source Limited, dated August 14, 2011, as amended on November 11, 2013
|
|
3.2 (2)
|
Articles of Incorporation of Ticket to See, Inc., dated June 6, 2012
|
|
3.3 (3)
|
Certificate of Amendment to Articles of Incorporation of Ticket to See, Inc., dated June 23, 2014
|
|
3.3 (4)
|
Certificate of Amendment to Articles of Incorporation of Ticket to See, Inc., dated May 20, 2014
|
|
3.4 (2)
|
Bylaws of Cell Source, Inc., dated June 6, 2012
|
|
10.1 (1)
|
Form of Subscription Agreement
|
|
10.2 (1)
|
Form of Registration Rights Agreement
|
|
10.3 (1)
|
Form of Investor Warrant
|
|
10.4 (1)
|
Form of Consultant Warrant(8)
|
|
10.5 (1)
|
Form of Researcher Company Warrant
|
|
10.6 (1)
|
Form of Company Warrant
|
|
10.7 (1)
|
Form of Lockup Agreement (included in Exhibit 2.1)
|
|
10.8 (1)
|
Research and License Agreement by and between Yeda Research and Development Company Limited and Cell Source Limited, dated October 3, 2011
|
|
10.9 (1)
|
Amendment to Research and License Agreement
|
|
10.10 (1)
|
Evaluation and Exclusive Option Agreement by and between Yeda Research and Development Company Limited and Cell Source Limited, dated Oct. 3, 2011 (included in Exhibit 10.7)
|
|
10.11 (1)
|
Amendment dated April 1, 2014 to Evaluation and Exclusive Option Agreement by and between Yeda Research and Development Company Limited and Cell Source Limited
|
|
10.12 (1)
|
Second Amendment dated June 22, 2014 to Evaluation and Exclusive Option Agreement by and between Yeda Research and Development Company Limited and Cell Source Limited
|
|
10.13 (1)
|
Consulting Agreement by and between Cell Source Limited and Professor Yair Reisner
|
|
10.14 (6)
|
Form of Amendment No. 1 to Registration Rights Agreement
|
|
10.15 (7)
|
Bridge Funding Agreement
|
|
10.16 (5)
|
Third Amendment dated June 22, 2014 to Evaluation and Exclusive Option Agreement by and between Yeda Research and Development Company Limited and Cell Source Limited
|
|
10.17 (8)
|
Form of Consulting Agreement pursuant to which the Company issued warrants to purchase an aggregate of 2,000,000 shares of the Company’s common stock
|
|
10.18 (9)
|
Form of Promissory Note issued to the Company’s Chief Executive Officer
|
|
10.19 (10)
|
Form of March 2015 Promissory Note
|
|
10.20 (10)
|
Form of March 2015 Warrant
|
|
10.21 (11)
|
Form of Note Amendment Letter Agreement
|
|
10.22 (11)
|
Form of May 2015 Note
|
|
10.23 (11)
|
Form of May 2015 Warrant
|
|
10.24 (12)
|
Form of Advisory/Consulting Agreement
|
|
10.25 (13) | Zolty Promissory Note |
10.26 (13) | Zolty Warrant | |
10.27 (13) | Form of July 2015 Convertible Promissory Note | |
10.28 (13) | Form of July 2015 Warrant | |
10.29 | Form of Bridge Note Subscription Agreement | |
10.30 | Form of Convertible Note | |
10.31 | Form of March 2016 Note | |
10.32 | Form of March 2016 Warrant | |
16.1 (1)
|
Letter from Paritz & Company, P.A.
|
|
21 (14)
|
Subsidiaries
|
|
31.1
|
Certification of principal executive and principal financial officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
32.1
|
Certification of principal executive and principal financial officer 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
|
(1)
|
Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on July 1, 2014.
|
|
(2)
|
Incorporated by reference to the Company’s Registration Statement on Form S-1 filed with the Securities and Exchange Commission on June 6, 2012.
|
|
(3)
|
Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on June 26, 2014.
|
|
(4)
|
Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on June 6, 2014.
|
|
(5)
|
Incorporated by reference to the Company’s Form 10-Q filed with the Securities and Exchange Commission on August 19, 2014.
|
|
(6)
|
Incorporated by reference to the Company’s Registration Statement on Form S-1 filed with the Securities and Exchange Commission on August 8, 2014.
|
|
(7)
|
Incorporated by reference to the Company’s Registration Statement Form S-1/A filed with the Securities and Exchange Commission on September 23, 2014.
|
|
(8)
|
Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on June 30, 2014.
|
|
(9)
|
Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on December 2, 2014.
|
|
(10)
|
Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on April 1, 2015.
|
|
(11)
|
Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on June 3, 2015.
|
|
(12)
|
Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on June 10, 2015.
|
|
(13)
|
Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on July 28, 2015.
|
|
(14)
|
Incorporated by reference to the Company’s Form 10-K filed with the Securities and Exchange Commission on March 13, 2015.
|
CELL SOURCE, INC.
|
|||
Dated: April 14, 2016
|
By:
|
/s/ Itamar Shimrat
|
|
Name:
|
Itamar Shimrat
|
||
Title:
|
Chief Executive Officer and
|
||
Chief Financial Officer
|
|||
(Principal Executive, Financial
|
|||
and Accounting Officer)
|
SIGNATURE
|
TITLE
|
DATE
|
|||
By:
|
/s/ Dennis Brown |
Chairman
|
April 14, 2016
|
||
Dennis Brown
|
|||||
By:
|
/s/ Itamar Shimrat |
Chief Executive Officer, Chief Financial Officer and Director
|
April 14, 2016
|
||
Itamar Shimrat
|
(Principal Executive, Financial and Accounting Officer)
|
||||
By:
|
/s/ Ben Friedman |
Director
|
April 14, 2016
|
||
Ben Friedman
|
|||||
By:
|
/s/ Yoram Drucker |
Director
|
April 14, 2016
|
||
Yoram Drucker
|
|||||
By:
|
/s/ David Zolty |
Director
|
April 14, 2016
|
||
David Zolty
|
Page
|
|
Report of Independent Registered Public Accounting Firm
|
F-1
|
Consolidated Balance Sheets as of December 31, 2015 and 2014
|
F-2
|
Consolidated Statements of Operations for the Years Ended December 31, 2015 and 2014
|
F-3
|
Consolidated Statements of Stockholders' Deficiency for the Years Ended
December 31, 2015 and 2014
|
F-4 |
Consolidated Statements of Cash Flows for the Years Ended December 31, 2015 and 2014
|
F-5
|
Notes to Consolidated Financial Statements
|
F-6
|
December 31,
|
||||||||
2015
|
2014
|
|||||||
Assets | ||||||||
Current Assets:
|
||||||||
Cash
|
$ | 6,944 | $ | 19,480 | ||||
Prepaid expenses
|
71,882 | 75,424 | ||||||
Deferred financing costs, current portion
|
124,650 | - | ||||||
Other current assets
|
134,736 | 26,074 | ||||||
Total Current Assets
|
338,212 | 120,978 | ||||||
Deferred financing costs, non-current portion
|
28,282 | - | ||||||
Property and equipment, net
|
1,267 | 2,127 | ||||||
Total Assets
|
$ | 367,761 | $ | 123,105 | ||||
|
||||||||
Liabilities and Stockholders' Deficiency
|
||||||||
Current Liabilities:
|
||||||||
Accounts payable and accrued expenses, current portion
|
$ | 586,485 | $ | 233,869 | ||||
Accounts payable and accrued expenses - related parties
|
214,629 | 285,415 | ||||||
Accrued compensation
|
324,672 | 968,849 | ||||||
Derivative liabilities
|
3,279,600 | 2,318,700 | ||||||
Notes payable, net of debt discount of $41,600 at December 31, 2015
|
708,400 | - | ||||||
Notes payable - related parties, net of debt discount of $19,300 at December 31, 2015
|
180,700 | 100,000 | ||||||
Convertible notes payable, current portion, net of debt discount of $89,900
at December 31, 2015
|
305,100 | - | ||||||
Advances payable
|
450,000 | - | ||||||
Total Current Liabilities
|
6,049,586 | 3,906,833 | ||||||
Convertible notes payable, non-current portion, net of debt discount of $260,550
at December 31, 2015
|
71,950 | - | ||||||
Accounts payable and accrued expenses, non-current portion
|
4,474 | - | ||||||
Total Liabilities
|
6,126,010 | 3,906,833 | ||||||
Commitments and contingencies
|
- | - | ||||||
Stockholders' Deficiency:
|
||||||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized;
no shares issued and outstanding at
December 31, 2015 and 2014
|
- | - | ||||||
Common stock, $0.001 par value; 200,000,000 shares authorized;
23,929,256 and 23,579,256 shares issued and outstanding at
December 31, 2015 and 2014, respectively
|
23,929 | 23,579 | ||||||
Additional paid-in capital
|
4,720,417 | 4,191,183 | ||||||
Accumulated deficit
|
(10,502,595 | ) | (7,998,490 | ) | ||||
Total Stockholders' Deficiency
|
(5,758,249 | ) | (3,783,728 | ) | ||||
Total Liabilities and Stockholders' Deficiency
|
$ | 367,761 | $ | 123,105 |
For the Year Ended
|
||||||||
December 31,
|
||||||||
2015
|
2014
|
|||||||
Revenues
|
$ | - | $ | - | ||||
Operating Expenses
|
||||||||
Research and development
|
392,925 | 806,157 | ||||||
Research and development - related party
|
829,970 | 1,012,464 | ||||||
Selling, general and administrative
|
1,097,580 | 2,235,445 | ||||||
Total Operating Expenses | 2,320,475 | 4,054,066 | ||||||
Loss From Operations | (2,320,475 | ) | (4,054,066 | ) | ||||
Other Income (Expense)
|
||||||||
Change in fair value of derivative liabilities
|
208,250 | (2,739 | ) | |||||
Interest expense
|
(35,612 | ) | (674 | ) | ||||
Amortization of debt discount
|
(310,200 | ) | - | |||||
Amortization of deferred financing costs
|
(46,068 | ) | - | |||||
Total Other Expense | (183,630 | ) | (3,413 | ) | ||||
Net Loss
|
$ | (2,504,105 | ) | $ | (4,057,479 | ) | ||
Net Loss Per Share
|
||||||||
- Basic and Diluted
|
$ | (0.10 | ) | $ | (0.18 | ) | ||
Weighted Average Number of
Common Shares Outstanding
|
||||||||
- Basic and Diluted
|
25,718,570 | 22,188,712 |
Additional
|
||||||||||||||||||||
Common Stock
|
Paid-In
|
Accumulated
|
||||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Total
|
||||||||||||||||
Balance - December 31, 2013
|
14,155,262 | $ | 14,155 | $ | 3,229,522 | $ | (3,941,011 | ) | $ | (697,334 | ) | |||||||||
Issuance of common stock and warrants for cash, net [1]
|
4,090,661 | 4,091 | 3,008,755 | - | 3,012,846 | |||||||||||||||
Reclassification of detachable warrants to derivative liabilities
|
- | - | (1,499,000 | ) | - | (1,499,000 | ) | |||||||||||||
Ticket to See, Inc. equity at the time of the reverse merger
|
5,000,000 | 5,000 | (735,200 | ) | - | (730,200 | ) | |||||||||||||
Stock-based compensation:
|
||||||||||||||||||||
- common stock
|
100,000 | 100 | 42,900 | - | 43,000 | |||||||||||||||
Cashless exercise of warrant
|
233,333 | 233 | (233 | ) | - | - | ||||||||||||||
Reclassification of derivative liabilities to equity
|
- | - | 144,439 | - | 144,439 | |||||||||||||||
Net loss
|
- | - | - | (4,057,479 | ) | (4,057,479 | ) | |||||||||||||
Balance - December 31, 2014
|
23,579,256 | $ | 23,579 | $ | 4,191,183 | $ | (7,998,490 | ) | $ | (3,783,728 | ) | |||||||||
Stock-based compensation:
|
||||||||||||||||||||
- common stock
|
100,000 | 100 | 39,900 | - | 40,000 | |||||||||||||||
- warrants
|
- | - | 418,184 | - | 418,184 | |||||||||||||||
Common stock issued as debt discount in connection
with issuance of convertible notes payable
|
250,000 | 250 | 71,150 | - | 71,400 | |||||||||||||||
Net loss
|
- | - | - | (2,504,105 | ) | (2,504,105 | ) | |||||||||||||
Balance - December 31, 2015
|
23,929,256 | $ | 23,929 | $ | 4,720,417 | $ | (10,502,595 | ) | $ | (5,758,249 | ) |
For The Year Ended
|
||||||||
December 31,
|
||||||||
2015
|
2014
|
|||||||
Cash Flows From Operating Activities
|
||||||||
Net loss
|
$ | (2,504,105 | ) | $ | (4,057,479 | ) | ||
Adjustments to reconcile net loss to net cash
used in operating activities:
|
||||||||
Change in fair value of derivative liabilities
|
(208,250 | ) | 2,739 | |||||
Amortization of debt discount
|
310,200 | - | ||||||
Amortization of deferred financing costs
|
46,068 | - | ||||||
Depreciation
|
860 | 455 | ||||||
Stock-based compensation:
|
||||||||
Common stock
|
100,000 | 43,000 | ||||||
Warrants
|
35,884 | 901,300 | ||||||
Changes in operating assets and liabilities:
|
||||||||
Prepaid expenses
|
3,542 | (75,424 | ) | |||||
Other current assets
|
(108,662 | ) | 37,263 | |||||
Accounts payable and accrued expenses
|
323,853 | 28,484 | ||||||
Net Cash Used in Operating Activities
|
(2,000,610 | ) | (3,119,662 | ) | ||||
Cash Flows From Investing Activities
|
||||||||
Purchase of property and equipment
|
- | (2,582 | ) | |||||
Net Cash Used in Investing Activities
|
- | (2,582 | ) | |||||
Cash Flows From Financing Activities
|
||||||||
Proceeds from issuance of notes payable
|
1,577,500 | 100,000 | ||||||
Payment of debt issuance costs
|
(39,426 | ) | - | |||||
Proceeds from issuance of common stock
and warrants, net [1]
|
- | 3,012,846 | ||||||
Proceeds from cash advances
|
450,000 | - | ||||||
Net Cash Provided by Financing Activities
|
1,988,074 | 3,112,846 | ||||||
Net Decrease In Cash
|
(12,536 | ) | (9,398 | ) | ||||
Cash - Beginning
|
19,480 | 28,878 | ||||||
Cash - Ending
|
$ | 6,944 | $ | 19,480 | ||||
Supplemental Disclosures of Cash Flow Information:
|
||||||||
Non-cash investing and financing transactions:
|
||||||||
Reclassification of warrants to derivative liabilities
|
$ | 482,300 | $ | 1,499,000 | ||||
Warrants and conversion options issued in
connection with issuance of notes payable
|
$ | 650,150 | $ | - | ||||
Reclassification of derivative liability to equity
|
$ | - | $ | 144,439 | ||||
Accrued deferred financing costs
|
$ | 159,574 | $ | - | ||||
Ticket to See, Inc. equity at the time of the reverse merger
|
$ | - | $ | 730,200 | ||||
Common stock issued in connection
with issuance of notes payable
|
$ | 71,400 | $ | - |
December 31,
|
||||||||
2015
|
2014
|
|||||||
Warrants
|
11,074,324 | 6,459,324 | ||||||
Convertible notes
|
2,166,331 | - | ||||||
13,240,655 | 6,459,324 |
|
Quoted Prices
|
|||||||||||||||
In Active
|
Significant
|
|||||||||||||||
Markets for
|
Other
|
Significant
|
||||||||||||||
Identical
|
Observable
|
Unobservable
|
||||||||||||||
Liabilities
|
Inputs
|
Inputs
|
||||||||||||||
Total
|
(Level 1)
|
(Level 2)
|
(Level 3)
|
|||||||||||||
Accrued compensation
|
$ | 60,000 | $ | - | $ | - | $ | 60,000 | ||||||||
Derivative liability
|
3,279,600 | - | - | 3,279,600 | ||||||||||||
Balance - December 31, 2015
|
$ | 3,339,600 | $ | - | $ | - | $ | 3,339,600 | ||||||||
Accrued compensation
|
$ | 901,300 | $ | - | $ | - | $ | 901,300 | ||||||||
Derivative liability
|
2,318,700 | - | - | 2,318,700 | ||||||||||||
Balance - December 31, 2014
|
$ | 3,220,000 | $ | - | $ | - | $ | 3,220,000 |
For the Years Ended
|
||||||||
December 31,
|
||||||||
2015
|
2014
|
|||||||
Risk-free interest rate
|
0.14% - 1.93 | % | 1.38% - 1.73 | % | ||||
Expected term (years)
|
0.04 - 6.50 | 3.83 - 5.00 | ||||||
Expected volatility
|
159% - 172 | % | 164% - 172 | % | ||||
Expected dividends
|
0.00 | % | 0.00 | % |
Accrued
|
Derivative
|
|||||||||||
Compensation
|
Liability
|
Total
|
||||||||||
Balance - December 31, 2013
|
$ | - | $ | 231,200 | $ | 231,200 | ||||||
Accrual of warrant obligation
|
901,300 | - | 901,300 | |||||||||
Change in fair value
|
- | 2,739 | 2,739 | |||||||||
Exercise of warrants
|
- | (144,439 | ) | (144,439 | ) | |||||||
Issuance of warrants and conversion options
|
- | 2,229,200 | 2,229,200 | |||||||||
Balance - December 31, 2014
|
$ | 901,300 | $ | 2,318,700 | $ | 3,220,000 | ||||||
Issuance of warrants and conversion options
|
- | 686,850 | 686,850 | |||||||||
Accrual of warrant and common stock obligation
|
110,684 | - | 110,684 | |||||||||
Change in fair value
|
(51,500 | ) | (208,250 | ) | (259,750 | ) | ||||||
Reclassification to equity upon issuance
|
(418,184 | ) | - | (418,184 | ) | |||||||
Reclassification to derivative liability upon issuance
|
(482,300 | ) | 482,300 | - | ||||||||
Balance - December 31, 2015
|
$ | 60,000 | $ | 3,279,600 | $ | 3,339,600 |
December 31,
|
||||||||
2015
|
2014
|
|||||||
Accrued research and development
|
$ | 186,815 | $ | 79,155 | ||||
Accrued legal fees
|
216,956 | 75,200 | ||||||
Accrued other professional fees
|
75,164 | 34,839 | ||||||
Accrued director compensation
|
12,000 | 9,000 | ||||||
Accrued Scientified Advisory Board compensation
|
31,000 | - | ||||||
Accrued interest, current portion
|
25,139 | - | ||||||
Other accrued expenses
|
39,411 | 35,675 | ||||||
Accounts payable and accrued expenses, current portion
|
586,485 | 233,869 | ||||||
Non-current portion of accrued interest
|
4,474 | - | ||||||
Total accounts payable and accrued expenses
|
$ | 590,959 | $ | 233,869 |
Weighted
|
||||||||||||||||
Weighted
|
Average
|
|||||||||||||||
Average
|
Remaining
|
|||||||||||||||
Number of
|
Exercise
|
Life
|
Intrinsic
|
|||||||||||||
Warrants
|
Price
|
In Years
|
Value
|
|||||||||||||
Outstanding, December 31, 2013
|
2,812,498 | $ | 0.21 | |||||||||||||
Granted
|
6,090,661 | 0.75 | ||||||||||||||
Exercised
|
(400,000 | ) | 0.75 | |||||||||||||
Forfeited
|
- | - | ||||||||||||||
Outstanding, December 31, 2014
|
8,503,159 | $ | 0.57 | |||||||||||||
Granted
|
4,615,000 | 0.75 | ||||||||||||||
Exercised
|
- | - | ||||||||||||||
Forfeited
|
- | - | ||||||||||||||
Outstanding, December 31, 2015
|
13,118,159 | $ | 0.63 | 3.7 | $ | 815,490 | ||||||||||
Exercisable, December 31, 2015
|
12,724,159 | $ | 0.63 | 3.7 | $ | 815,490 |
Warrants Outstanding
|
Warrants Exercisable
|
|||||||||||||
Weighted
|
||||||||||||||
Outstanding
|
Average
|
Exercisable
|
||||||||||||
Exercise
|
Number of
|
Remaining Life
|
Number of
|
|||||||||||
Price
|
Warrants
|
In Years
|
Warrants
|
|||||||||||
$ | 0.001 | 2,043,835 | 4.9 | 2,043,835 | ||||||||||
$ | 0.750 | 11,074,324 | 3.5 | 10,680,324 | ||||||||||
13,118,159 | 3.7 | 12,724,159 |
For The Years Ended
|
||||||||
December 31,
|
||||||||
2015
|
2014
|
|||||||
Israel
|
$ | (1,986,936 | ) | $ | (3,817,479 | ) | ||
United States
|
(517,169 | ) | (240,000 | ) | ||||
Income before income taxes
|
$ | (2,504,105 | ) | $ | (4,057,479 | ) |
December 31,
|
||||||||
2015
|
2014
|
|||||||
Net operating loss carryforwards
|
$ | 2,094,000 | $ | 1,414,000 | ||||
Foreign deferred research and development costs
|
356,000 | 416,000 | ||||||
Stock-based compensation expense
|
26,000 | - | ||||||
Deferred tax assets
|
2,476,000 | 1,830,000 | ||||||
Valuation allowance
|
(2,476,000 | ) | (1,830,000 | ) | ||||
Deferred tax assets, net
|
$ | - | $ | - |
For The Years Ended
|
||||||||
December 31,
|
||||||||
2015
|
2014
|
|||||||
Current
|
||||||||
Foreign
|
$ | - | $ | - | ||||
Federal
|
- | - | ||||||
U.S. State and local
|
- | - | ||||||
Deferred
|
||||||||
Foreign
|
(358,000 | ) | (1,045,000 | ) | ||||
Federal
|
(226,000 | ) | (82,000 | ) | ||||
U.S. State and local
|
(62,000 | ) | (24,000 | ) | ||||
(646,000 | ) | (1,151,000 | ) | |||||
Change in valuation allowance
|
646,000 | 1,151,000 | ||||||
Income tax provision (benefit)
|
$ | - | $ | - |
`
|
For The Years Ended
|
|||||||
December 31,
|
||||||||
2015
|
2014
|
|||||||
Expected federal statutory rate
|
(34.0 | %) | (34.0 | %) | ||||
State and local taxes, net of federal tax benefit
|
(2.5 | %) | (0.6 | %) | ||||
Statutory rate differential - domestic vs. foreign
|
7.7 | % | 7.0 | % | ||||
Permanent difference - stock-based compensation
|
0.6 | % | 5.9 | % | ||||
Change in tax rates and other
|
2.4 | % | 0.0 | % | ||||
True-up to filed tax returns
|
0.0 | % | (6.7 | %) | ||||
Change in valuation allowance
|
25.8 | % | 28.4 | % | ||||
Income tax provision (benefit)
|
0.0 | % | 0.0 | % |
Bank:
|
Signature Bank
|
|
|
950 Third Ave, 9th FL
|
|
|
New York, NY 10022
|
|
|
Attn: PCG# 311
|
|
ABA Number:
|
026013576
|
|
SWIFT Code:
|
SIGNUS33
|
|
Account #:
|
|
|
Account Name:
|
Cell Source, Inc., Signature Bank as Escrow Agent (INVESTOR’S NAME)
|
Dated as of: _____________ __, 2016
|
|||
INVESTOR
|
|||
By:
|
|||
Print Name:
|
|||
Title:
|
|||
Address:
|
|||
Telephone number:
|
|||
Email address:
|
Annex I - 1
|
Annex I - 2
|
Annex I - 3
|
Annex I - 4
|
[_]
|
(a) an individual who, either alone or with a spouse, beneficially owns financial assets having an aggregate realizable value that, before taxes but net of any related liabilities, exceeds $1,000,000
[NOTE: If the Investor is relying on this category of “accredited investor” to purchase the Securities, the Investor must also complete in duplicate Annex I-B hereto]
;
|
[_]
|
(b) an individual who beneficially owns financial assets having an aggregate realizable value that, before taxes but net of any related liabilities, exceeds $5,000,000;
|
[_]
|
(c) an individual whose net income before taxes exceeded $200,000 in each of the 2 most recent calendar years or whose net income before taxes combined with that of a spouse exceeded $300,000 in each of the 2 most recent calendar years and who, in either case, reasonably expects to exceed that net income level in the current calendar year
[NOTE: If the Investor is relying on this category of “accredited investor” to purchase the Securities, the Investor must also complete in duplicate Annex I-B hereto]
;
|
[_]
|
(d) an individual who, either alone or with a spouse, has net assets of at least $5,000,000
[NOTE: If the Investor is relying on this category of “accredited investor” to purchase the Securities, the Investor must also complete in duplicate Annex I-B hereto]
;
|
[_]
|
(e) a person, other than an individual or investment fund, that has net assets of at least $5,000,000 as shown on its most recently prepared financial statements; or
|
[_]
|
(f) a person in respect of which all of the owners of interests, direct, indirect or beneficial, except the voting securities required by law to be owned by directors, are persons that are accredited investors.
|
(a) cash,
|
|
(b) securities, or
|
|
(c) a contract of insurance, a deposit or an evidence of a deposit that is not a security for the purposes of securities legislation;
|
Annex I-A - 1
|
(a) liabilities incurred or assumed for the purpose of financing the acquisition or ownership of financial assets, or
|
|
(b) liabilities that are secured by financial assets;
|
(a) is married to another individual and is not living separate and apart, from the other individual, or
|
|
(b) is living with another individual in a marriage-like relationship, including a marriage-like relationship between individuals of the same gender.
|
By:
|
||
Signature of Investor
|
||
Title (if applicable)
|
||
(Print Name of Investor)
|
Annex I-A - 2
|
Annex I-B - 1
|
·
Your net income before taxes combined with your spouse’s was more than $300,000 in each of the two most recent calendar years, and you expect your combined net income before taxes to be more than $300,000 in the current calendar year.
|
|||
·
Either alone or with your spouse, you own more than $1 million in cash and securities, after subtracting any debt related to the cash and securities.
|
|||
·
Either alone or with your spouse, you have net assets worth more than $5 million. (Your net assets are
your total assets (including real estate) minus your total debt.)
|
|||
4. Your name and signature
|
|||
By signing this form, you confirm that you have read this form and you understand the risks of making this investment as identified in this form.
|
|||
First and last name (please print)
:
|
|||
Signature:
|
Date:
|
||
Sign 2 copies of this document. Keep one for your records.
|
|||
SECTION 5 TO BE COMPLETED BY THE PLACEMENT AGENT (if any)
|
|||
5. Placement Agent information
|
|||
[Instruction: The Placement Agent is the person who meets with, or provides information to, the purchaser with respect to making this investment. That could include a representative of the Issuer, a registrant or a person who is exempt from the registration requirement.]
|
|||
First and last name of Placement Agent (please print):
|
|||
Telephone:
|
Email:
|
||
Name of firm (if registered):
|
Dealer Rep. Code:
|
||
SECTION 6 TO BE COMPLETED BY THE ISSUER
|
|||
6. For more information about this investment
|
|||
Cell Source, Inc.
65 Yigal Alon Street
Tel Aviv, Israel 67433
Attention: Itamar Shimrat
ishimrat@cell-source.com
|
|||
Annex I-B - 2
|
1. The exact name that your Securities are to be registered in. You may use a nominee name if appropriate:
|
|
2. The relationship between the Investor and the registered holder listed in response to item 1 above:
|
|
3. The mailing address of the registered holder listed in response to item 1 above:
|
|
4. The Social Security Number or Tax Identification Number of the registered holder listed in the response to item 1 above:
|
|
Annex I-C - 1
|
Annex II - 1
|
Annex II - 3
|
Annex II - 4
|
Annex II - 5
|
Annex II - 6
|
Cell Source, Inc.
|
|
By:
|
|
Name: Itamar Shimrat
|
|
Title: Chief Executive Officer
|
NOTE NO. B __
|
March 8, 2016
|
Cell Source, Inc.
|
||
By:
|
||
Name:
Itamar Shimrat
|
||
Title:
Chief Executive Officer
|
Section 1: INVESTOR INFORMATION
|
Section 2: OMNIBUS SIGNATURE PAGE
|
Section 3: INDIVIDUAL FORM OF PAYMENT
|
o
Wire funds will be made from my outside account according to the wiring instructions contained herein.
|
o
Other:___________________ (specify form of payment).
|
Public
Companies
|
Private
Companies
|
Public or Private
Financial Services
Companies
|
|
Frequently
|
____________
|
____________
|
____________
|
Occasionally
|
____________
|
____________
|
____________
|
Never
|
____________
|
____________
|
____________
|
(j) Are you affiliated or associated with a FINRA member firm (please check one)?
YES_______ NO_______
If Yes, please describe:
*If Investor is a Registered Representative with a FINRA member firm, have the following acknowledgment signed by the appropriate party:
The undersigned FINRA member firm acknowledges receipt of the notice required by Article 3, Sections 28(a) and (b) of the Rules of Fair Practice.
____________________________________
Name of FINRA Member Firm
By: ________________________________ Date: ___________
Authorized Officer
[Remainder of page intentionally left blank]
|
If the Investor is a corporation, partnership, limited liability company, trust, pension plan, foundation, joint Investor (other than a married couple) or other entity, an authorized officer, partner, or trustee must complete, date and sign this Certificate.
|
|
o
Limited Partnership
|
o
General Partnership
|
o
Limited Liability Company
|
o
Corporation
|
o
Irrecoverable Trust
|
o
Pension, Profit Sharing, Money Purchase, Keogh or 401(k) Plan; IRA or other employee benefit plan
|
o
Other form of organization:
|
|
Indicate the approximate date the undersigned entity was formed:
|
|
NOTE: PLEASE PROVIDE A COPY OF THE ORGANIZATIONAL DOCUMENTATION. (i.e., Article of Incorporation, Partnership Agreement, Operating Agreement, Trust Agreement, etc.)
|
|
FOR ERISA PLANS ONLY:
Is the Investor a “Benefit Plan Investor” or acquiring the Securities on behalf of any entity which is a “Benefit Plan Investor,” as such term is defined in Appendix A (for entities only, including IRA investors)?
¨
yes
¨
no
Investors answering “yes” above, please check each box that accurately describes the Investor:
¨
The Investor, or the entity on whose behalf the Investor is acquiring the Interests,
IS
a “Benefit Plan Investor” but
IS NOT
an “ERISA Investor” as such terms are defined in Appendix A.
¨
The Investor, or the entity on whose behalf the Investor is acquiring the Interests,
IS
an ERISA Investor that is subject to Section 4975 of the Internal Revenue Code of 1986, as amended (the “Code”), but
IS NOT
subject to Title I of the Employee Retirement Income Security Act of 1974, as amended (“ERISA”).
Please notify the Company immediately if you checked the above box and the ERISA Investor subsequently becomes subject to Title I of ERISA.
¨
The Investor, or the entity on whose behalf the Investor is acquiring the Interests,
IS
an ERISA Investor that
IS
subject to Title I of ERISA.
If the Investor answered “yes” above, is the Investor obligated to file an annual return/report on an IRS Form 5500 Series form?
¨
yes *
¨
no
* Investors answering “yes” please provide the following information:
Investor’s plan name:
Investor’s plan number:
Name of plan sponsor:
EIN of plan sponsor:
|
Section 9: ENTITY FORM OF PAYMENT
|
o
Wire funds will be made from my outside account according to the wiring instructions contained herein.
|
o
Other:___________________ (specify form of payment).
|
Section 10: ENTITY INVESTOR STATUS
|
||
In order for the Company to offer and sell the Securities in conformance with state and federal securities laws, the following information must be obtained regarding your investor status. Please
initial each category
applicable to you as an investor in the Company.
|
||
|
||
1
|
(Initial if Applicable)
|
A bank as defined in Section 3(a)(2) of the Securities Act, or any savings and loan association or other institution as defined in Section 3(a)(5)(A) of the Securities Act whether acting in its individual or fiduciary capacity;
|
2
|
(Initial if Applicable)
|
A broker or dealer registered pursuant to Section 15 of the Securities Exchange Act of 1934;
|
3
|
(Initial if Applicable)
|
An insurance company as defined in Section 2(13) of the Securities Act;
|
4
|
(Initial if Applicable)
|
An investment company registered under the Investment Company Act of 1940 or a business development company as defined in Section 2(a)(48) of that Act;
|
5
|
(Initial if Applicable)
|
A Small Business Investment Company licensed by the U.S. Small Business Administration under Section 301(c) or (d) of the Small Business Investment Act of 1958;
|
6
|
(Initial if Applicable)
|
A plan established and maintained by a state, its political subdivisions, or any agency or instrumentality of a state or its political subdivisions, for the benefit of its employees, if such plan has total assets in excess of $5,000,000;
|
7
|
(Initial if Applicable)
|
An employee benefit plan within the meaning of the Employee Retirement Income Security Act of 1974, if the investment decision is made by a plan fiduciary, as defined in Section 3(21) of such Act, which is either a bank, savings and loan association, insurance company, or registered investment advisor, or if the employee benefit plan has total assets in excess of $5,000,000 or, if a self-directed plan, with investment decisions made solely by persons that are accredited investors;
|
8
|
(Initial if Applicable)
|
A private business development company as defined in Section 202(a)(22) of the Investment Advisers Act of 1940;
|
9
|
(Initial if Applicable)
|
Any partnership or corporation or any organization described in Section 501(c)(3) of the Internal Revenue Code or similar business trust, not formed for the specific purpose of acquiring the Securities, with total assets in excess of $5,000,000;
|
10
|
(Initial if Applicable)
|
A trust (including a revocable trust and an irrevocable trust) ,with total assets in excess of $5,000,000, not formed for the specific purpose of acquiring the Securities, whose purchase is directed by a sophisticated person as described in Rule 506(b)(2)(ii) of the Securities Act; or
|
11
|
(Initial if Applicable)
|
An entity (other than an irrevocable trust) in which all of the equity owners* qualify under any of the above subparagraphs described in Section 6 or this Section 11. If the undersigned belongs to this investor category only, list the equity owners of the undersigned, and have each equity owner complete and deliver Sections 5-8 hereof (Note: an “equity owner” for the purposes of this Questionnaire means (1) stockholders in the case of a corporation, (2) limited partners only in the case of a limited partnership, (3) general partners in the case of a general partnership, (4) members in the case of a limited liability company, (5) partners in the case of a limited liability partnership, (6) grantor(s) in the case of a trust revocable at the sole option of grantor(s):
|
Public
Companies
|
Private
Companies
|
Public or Private
Financial Services
Companies
|
|
Frequently
|
____________
|
____________
|
____________
|
Occasionally
|
____________
|
____________
|
____________
|
Never
|
____________
|
____________
|
____________
|
(h) Are you affiliated or associated with a FINRA member firm (please check one)?
YES_______ NO_______
If Yes, please describe:
______________________________________________________________________
______________________________________________________________________
*If Investor is a Registered Representative with a FINRA member firm, have the following acknowledgment signed by the appropriate party:
The undersigned FINRA member firm acknowledges receipt of the notice required by Article 3, Sections 28(a) and (b) of the Rules of Fair Practice.
____________________________________
Name of FINRA Member Firm
By: ________________________ Date: ___________
Authorized Officer
[Remainder of page intentionally left blank]
|
|
In connection with any recommended
2
transaction or investment strategy by a registered broker-dealer, the undersigned acknowledges on behalf of the Institution named below that:
|
I.
|
It is an Institutional Account as defined in FINRA Rule 4512(c)
3
;
|
II.
|
It (1) is capable of evaluating investment risks independently, both in general and with regard to all transactions and investment strategies involving a security or securities; and (2) will exercise independent judgment in evaluating the recommendations of any broker-dealer or its associated persons, unless it has otherwise notified the broker-dealer in writing;
|
III.
|
It will notify the broker-dealer servicing the Institutional Account if anything in this Certificate ceases to be true;
|
IV.
|
He or she is authorized to sign on behalf of the Institutional Account named below.
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By signing this Certificate, the undersigned affirms that the above statements are accurate but does not waive any rights afforded under U.S. federal or state securities laws, including without limitation, any rights under Section 10(b) of the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.
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NOTE: This Certificate shall apply with respect to all recommended transactions and investment strategies involving securities that are entered into by the “Institutional Account” named in this Certificate, whether for the account of such Institutional Account or for the account of any beneficial owner that has delegated decision making authority to such Institutional Account.
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3
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The term “Institutional Account” means the account of: (1) a bank, savings and loan association, insurance company or registered investment company; (2) an investment adviser registered either with the SEC under Section 203 of the Investment Advisers Act or with a state securities commission (or any agency or office performing like functions); or (3) any other person (whether a natural person, corporation, partnership, trust or otherwise) with total assets of at least $50 million as of the date of this Certificate (whether such assets are invested for such person’s own account or under management for the account of others).
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The undersigned certifies that the representations and responses above are true and accurate:
The Investor has been duly formed and validly exists and has full power and authority to invest in the Company. The person signing on behalf of the undersigned has the authority to execute and deliver these Transaction Documents on behalf of the Investor and to take other actions with respect thereto and certifies further that each of these Transaction Documents have been duly and validly executed on behalf of the undersigned entity and constitutes a legal and binding obligation of the undersigned entity.
The undersigned further certifies under penalty of perjury that:
(a)
The undersigned’s correct federal taxpayer identification number is set forth above, and
(b) The undersigned is not subject to backup withholding.
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Investor Name:
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By (Signature):
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Name (Print):
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Title:
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Date:
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Wire to:
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TD Bank
|
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224 West 57
th
Street
|
||
New York, NY 10019
|
||
A/C of Cell Source, Inc.
|
||
A/C#:
|
||
ABA#: 026013673
|
||
SWIFT Code: TDOMCATTTOR
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Note: Cell Source March 2016 Bridge
|
WARRANT
|
||
NO. B __
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150,000 Shares
|
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Tel: (___) ___-____
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Fax: (___) ___-____
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1.
|
ALL
Investors should
Complete and Return
Section 1 (Investor Profile) and Section 15.
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2.
|
ALL
Investors should
Complete, Sign and Deliver
the Omnibus Signature Page for the subscription of the Securities (Section 2).
|
3.
|
Individual Investors
(including joint tenants, tenants in common, grantors of revocable trusts and IRAs) should
Complete and Initial
(as applicable) sections 3 – 7.
|
4.
|
Entity Investors
(including corporations, partnerships, trusts and limited liability companies) should
Complete and Initial
(as applicable) sections 8 – 13.
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5.
|
Funds should be wired to the account provided in the Wire Transfer Information page attached hereto.
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6.
|
Completed forms should be emailed to:
|
|
a)
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
b)
|
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
c)
|
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
|
d)
|
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
|
a)
|
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
b)
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Dated: April 14, 2016
|
By:
|
/s/ Itamar Shimrat
|
Itamar Shimrat
|
||
Chief Executive Officer and Chief Financial Officer
|
||
(Principal Executive, Financial and Accounting Officer)
|
(1)
|
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Dated: April 14, 2016
|
By:
|
/s/ Itamar Shimrat
|
Itamar Shimrat
|
||
Chief Executive Officer and Chief Financial Officer
|
||
(Principal Executive, Financial and Accounting Officer)
|