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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the years ended December 31, 2018
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _____________ to _____________
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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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57 West 57th Street, Suite 400
New York, New York
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10019
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(Address of principal executive offices)
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(Zip Code)
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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None
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Large accelerated filer ☐
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Accelerated filer ☐
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Non-accelerated filer ☒
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Smaller reporting company ☒
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Emerging growth company ☐
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10.21(11)
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Form of Note Amendment Letter Agreement
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10.22(11)
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Form of May 2015 Note
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10.23(11)
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Form of May 2015 Warrant
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10.24(12)
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Form of Advisory/Consulting Agreement
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10.25(13)
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Zolty Promissory Note
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10.26(13)
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Zolty Warrant
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10.27(13)
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Form of July 2015 Convertible Promissory Note
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10.28(13)
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Form of July 2015 Warrant
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10.29(15)
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Form of Bridge Note Subscription Agreement
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10.30(15)
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Form of Convertible Note
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10.31(15)
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Form of March 2016 Note
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10.32(15)
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Form of March 2016 Warrant
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10.33(18)
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Form of July 2016 Warrants
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10.34(18)
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Second Amendment to Research and License Agreement dated as of November 28, 2016 between the Company and Yeda
Research and Development Company Limited
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10.35(18)
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Third Amendment to Research and License Agreement dated as of March 29, 2018 between the Company and Yeda Research
and Development Company Limited
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10.36(18)
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Fourth Amendment to Research and License Agreement dated as of March 30, 2018 between the Company and Yeda Research
and Development Company Limited
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10.37(16)
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Convertible Note due July 27, 2016
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10.38(17)
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Promissory Note dated May 10, 2016
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10.39(19)
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Sponsored Research Agreement dated November 28, 2018 between The University of Texas M.D. Anderson Cancer Center
and Cell Source Limited
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10.40(19)
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Agreement for Veto Cell Production and Clinical Trial Program dated February 19, 2019 between The University of
Texas M.D. Anderson Cancer Center and Cell Source Limited
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16.1(1)
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Letter from Paritz & Company, P.A.
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21(14)
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Subsidiaries
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31.1
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Certification of principal executive and principal financial officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
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32.1
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Certification of principal executive and principal financial officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002
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101.INS *
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XBRL Instance Document
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101.SCH *
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XBRL Taxonomy Extension Schema Document
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101.CAL *
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XBRL Taxonomy Extension Calculation Linkbase Document
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101.DEF *
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XBRL Taxonomy Extension Definition Linkbase Document
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101.LAB *
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XBRL Taxonomy Extension Label Linkbase Document
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101.PRE *
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XBRL Taxonomy Extension Presentation Linkbase Document
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(1)
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Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange
Commission on July 1, 2014.
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(2)
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Incorporated by reference to the Company’s Registration Statement on Form S-1 filed with the Securities and
Exchange Commission on June 6, 2012.
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(3)
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Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on June 26,
2014.
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(4)
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Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on June 6,
2014.
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(5)
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Incorporated by reference to the Company’s Form 10-Q filed with the Securities and Exchange Commission on August
19, 2014.
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(6)
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Incorporated by reference to the Company’s Registration Statement on Form S-1 filed with the Securities and
Exchange Commission on August 8, 2014.
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(7)
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Incorporated by reference to the Company’s Registration Statement Form S-1/A filed with the Securities and Exchange
Commission on September 23, 2014.
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(8)
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Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on June 30,
2014.
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(9)
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Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on December
2, 2014.
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(10)
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Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on April 1,
2015.
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(11)
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Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on June 3,
2015.
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(12)
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Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on June 10,
2015.
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(13)
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Incorporated by reference to the Company’s Form 8-K filed with the Securities and Exchange Commission on July 28,
2015.
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(14)
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Incorporated by reference to the Company’s Form 10-K filed with the Securities and Exchange Commission on March 13,
2015.
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(15)
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Incorporated by reference to the Company’s Form 10-K filed with the Securities and Exchange Commission on April 14,
2016.
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(16)
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Incorporated by reference to the Company’s Form 10-Q filed with the Securities and Exchange Commission on May 13,
2016.
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(17)
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Incorporated by reference to the Company’s Form 10-Q filed with the Securities and Exchange Commission on August
15, 2016.
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(18)
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Incorporated by reference to the Company’s Form 10-K filed with the Securities and Exchange Commission on July 25,
2018.
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(19)
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Certain information has been excluded from this exhibit because (i) it is not material and (ii) would be
competitively harmful if publicly disclosed.
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*
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Filed with Form 10-K filed with the Securities and Exchange Commission on April 1, 2019
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CELL SOURCE, INC.
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Dated: June 19
, 2019
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By:
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/s/ Itamar Shimrat
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Name:
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Itamar Shimrat
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Title:
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Chief Executive Officer and
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Chief Financial Officer
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(Principal Executive, Financial and Accounting Officer)
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SIGNATURE
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TITLE
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DATE
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By:
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/s/ Dennis Brown |
Chairman
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June 19,
2019
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Dennis Brown
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By:
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/s/ Itamar Shimrat |
Chief Executive Officer, Chief Financial Officer and Director
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June 19,
2019
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Itamar Shimrat
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(Principal Executive, Financial and Accounting Officer)
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By:
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/s/ Ben Friedman |
Director
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June 19,
2019
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Ben Friedman
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By:
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/s/ David Zolty |
Director
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June 19,
2019
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David Zolty
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(1) |
Subject to MD Anderson receiving the necessary approvals, including without limitation, the approval of the applicable institutional review board (“IRB”)
overseeing the Program, MD Anderston will use reasonable efforts to undertake to implement the protocol “Anti-viral central memory CD8 veto cells in haploidentical HSCT” (attached hereto as Exhibit A), such protocol as may be further
revised pending approval by the applicable IRB (the “Program”).
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(2) |
As outlined in the initial budget , MDA undertakes to perform 4 production validation runs and a Phase I/II clincial trial using veto cells in [ ]
patients. Based on the assessment of results in the first [ ] patients further continuation of the study in up to [ ] patients will be considered.
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(3) |
MD Anderson, under the supervision of its Principal Investigator Richard Champlin, M.D., shall perform the Program in close co-operation with Cell Source
and shall keep Cell Source informed of the Program’s progress and all major developments concerning the Program.
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(4) |
Upon completion of each quarter MDA shall submit a written report to Cell Source describing the results of the Program.
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(5) |
Cell Source represents and warrants that it exclusively licenses proprietary scientific knowledge developed at the Weizmann Institute of Science by a team
headed by Prof. Yair Reisner, including without limitation, the Anti-viral central memory CD8 veto cells, from Yeda Research and Development Limited (“Yeda”). The Program will be conducted in cooperation with Prof. Riesner.
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(6) |
The rights to any outcomes of the treatments performed on behalf of Cell Source, to the extent that they may be protected by patent laws, will belong
exclusively to Yeda and fall under the existing exclusive license that Cell Source has from the Weizmann Institute through its agreement with Yeda, provided, however, MD Anderson shall have the right to use such outcomes for MD
Anderson’s internal academic, research and patient care purposes.
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(7) |
MD Anderson and Cell Source will promptly notify each other upon identifying any aspect of the protocol for the Program or the Program results that may
adversely affect the safety, well-being, or medical care of Program subjects, or that may affect the willingness of subjects to continue participation of the Program, influence the conduct of the Program, or may alter the IRB’s approval
to continue the Program; when possible, such findings shall be submitted to MD Anderson electronically. MD Anderson shall promptly notify the IRB of any such events. When Program subject safety or medical care could be directly
affected by Program results, then notwithstanding any other provision of this Agreement, MD Anderson will send Program subjects a written communication about the results.
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(1)
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Any Confidential Information that will be exchanged between the Parties, whether orally, in writing or by any
other medium, during the course of the Program under this agreement, shall be treated confidential by the receiving Party. The receiving Party shall not use such Confidential Information for any purpose other than performance of this
agreement, and shall not make available such Confidential Information to any third party.
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(2)
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For the purposes of this agreement, “Confidential Information” shall mean any information that is expressly
marked as confidential by appropriate means, or clearly identifiable as being confidential by its nature. However, “Confidential Information” shall not include any information that
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-
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was known to the receiving Party prior to its disclosure, or
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was known to the public or was generally available prior to its disclosure, or
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became known to the public or became generally available after disclosure through no wrongful act or omission of
the receiving Party, or
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essentially corresponds to information that was disclosed or made available to the receiving Party at any time by
a third party, who, to the knowledge of the receiving Party, had the legal right to disclose the information to the receiving Party (it is agreed that Prof. Reisner, his team or anyone from the Weizmann Institute deriving its information
from the technology developed by Prof. Reisner while at the Weizmann Institute are not considered third party to this matter),
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-
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was developed independently by the receiving Party without knowledge of the Confidential Information,
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-
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is required to be disclosed in order to obtain the informed consent from subjects who may wish to enroll in the
Program, provided, however, that the Confidential Information will be disclosed only to the extent necessary and will not be provided in answer to unsolicited inquiries by telephone or to individuals who are not eligible Program
candidates,
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-
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is disclosed to a Program subject for the safety or well-being of the Program subject.
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(3)
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Notwithstanding the foregoing, each receiving Party will be permitted to disclose Confidential Information as
required by law or regulation, provided to the extent practicable, prior to such disclosure, the receiving Party will provide reasonable advance notice to the disclosing Party to allow the disclosing Party an opportunity to obtain a
protective order.
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(4)
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Each Party shall ensure that its respective employees will be bound by these confidentiality obligations.
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(1)
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Notwithstanding anything to the contrary herein, Cell Source ackowledges that MDA has the first right to
publishe the results of Program. Any publication in whatever form on the data and results of the Program by MD Anderson, shall be submitted to Cell Source in advance. Cell Source will review the manuscript and provide comments within 30
days. If Cell Source does not react within such 30 days, Cell Source shall be deemed to not have any comments on the publication. Cell Source will also have the right to publish press releases regarding the Program, provided, however, all
press releases including the name of MD Anderson requires prior written approval from MD Anderson’s Department of External Communications. All such publication and press releases shall be in accordance with generally acceptable scientific
research and/or academic standards.
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(2)
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Cell Source may request a delay of the publication for a period not to exceed sixty (60) days, or changes to
its content, only insofar as necessary to avoid undue disclosure of Cell Source’s Confidential Information, provided, in no case shall MD Anderson be required to remove any data or results of the Program. Should Cell Source or Yeda elect
to file a patent regarding a new invention that results from this Program, Cell Source may request a delay of the publication for a period not to exceed sixty (60) days if the publication discloses the content of such patent application.
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(1)
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MDA shall perform the Program hereunder with its usual care and on the basis of the current state of the art
in science and technology research and in accordance with all relevant laws and regulations required in the MDA’s domicile. With respect to the Results, no warranty of any kind is given, neither express nor implied, as to the Results’
fitness for any particular purpose or to the non-infringement of any third party’s rights by the Results.
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(2)
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Any liability among the contracting parties shall be limited to gross negligence and willful misconduct.
Except in cases of willful misconduct, neither party shall be liable for any remote or incidental damage or loss (such as loss of profit or loss of contract).
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(3)
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This Agreement does not obligate any of the contracting parties to provide medical treatment, except to the
extent required by applicable law, nor does this Agreement obligate either party to provide reimbursement for medical treatment if a Program subject requires medical treatment for physical illness or injury sustained as a direct result of
the treatment of such Program subject in accordance with this Agreement and the protocol for the Program.
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(1)
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This agreement shall enter into force upon signature by both parties.
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(2)
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This agreement may not be terminated prematurely by either Party, except in case of “good cause for
termination” as per the pertinent regulations in MDA’s domicile.
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(1)
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This agreement may only be amended by written agreement of the Parties.
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Year 1 |
Year 2
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Grand Total | ||||||||||
Total Costs
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$
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1,162,760.38
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$
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889,624.93
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$
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2,052,385.31
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[ ]
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Payment (USD) | |||
[ ] |
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$ 473,288.26
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[ ] |
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$ 258,144.93
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[ ] |
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$ 384,456.83
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[ ] |
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$ 468,247.65
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[ ] |
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$ 468,247.65
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Total
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$2,052,385.31
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Total Costs
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Year 1
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Year 2
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Year 3
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Grand Total
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||||||||||||
$
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499,673.60
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$
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499,703.81
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$
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507,974.92
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$
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1,507,352.33
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YEAR 01
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YEAR 02
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YEAR 03
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||||||||||
Quarterly payments*
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$
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124,918.40
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$
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124,925.95
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$
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126,993.73
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||||||
Total
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$
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499,673.60
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$
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499,703.81
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$
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507,974.92
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a)
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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;
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b)
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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;
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c)
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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
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d)
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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
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a)
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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
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b)
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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.
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Dated: June 19, 2019
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By:
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/s/ Itamar Shimrat
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Itamar Shimrat
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Chief Executive Officer and Chief
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Financial Officer
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(Principal Executive, Financial and
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Accounting Officer)
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(1)
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The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of
1934; and
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(2)
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The information contained in the Report fairly presents, in all material respects, the financial condition and
results of operations of the Company.
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Date: June 19, 2019
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By:
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/s/ Itamar Shimrat
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Itamar Shimrat
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Chief Executive Officer and Chief
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Financial Officer (Principal Executive,
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Financial and Accounting Officer)
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