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UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC
20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of
1934
Date of
Report (Date of earliest event reported):
November 18, 2021
Todos Medical Ltd.
(Exact name
of registrant as specified in its charter)
Israel |
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000-56026 |
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n/a |
(State or
other jurisdiction |
|
(Commission |
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IRS
Employer |
of
incorporation or organization) |
|
File
Number) |
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Identification
No.) |
121 Derech Menachem Begin,
30th Floor
Tel Aviv,
6701203
Israel
(Address of
principal executive offices)
Registrant’s
telephone number, including area code:
972 (52)
642-0126
(Former name
or former address, if changed since last report)
Check the
appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
☐ |
Written
communication pursuant to Rule 425 under the Securities Act (17 CFR
230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b)) |
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|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act: None
Indicate by
check mark whether the registrant is an emerging growth company as
defined in as defined in Rule 405 of the Securities Act of 1933
(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter). Emerging growth company
☒
If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act.
Item 1.01
Entry into a Material Definitive Agreement
On November
18, 2021, Todos Medical Ltd. (the “Company”) entered into a license
agreement (the “License Agreement”) with T-Cell Protect Hellas S.A.
(“T-Cell Protect”) pursuant to which the Company will license the
European manufacturing and distribution rights to a product based
on the Company’s Tollovid® and Tollovid Daily™ 3CL protease
inhibitor and immune support dietary supplements to T-Cell Protect
(the “Product”). The License Agreement became effective on November
22, 2021 when the Company received a purchase order for 50,000
bottles of Tollovid Daily, per the terms of the License Agreement.
The Product is expected to be marketed under the T-Cell Protect
brand in Europe. In addition, the Company will grant to T-Cell
Protect an exclusive license to manufacture, sell and distribute
the Product in Greece. The License Agreement provides for royalty
in the low double digits to the Company and a minimum of 500,000
bottles in sales over the 18 months after the date of the License
Agreement. In the event T-Cell Protect establishes its own
manufacturing of the Product in the European market, the 500,000
minimum referred to in the previous sentence will become a minimum
sales requirement. In the License Agreement, T-Cell Protect
acknowledged that the Company intends to assign the License
Agreement to a subsidiary being formed by the Company to focus on
the development of 3CL protease biology called 3CL Sciences, Inc.
(“3CL Sciences”).
On November
22, 2021, the Company entered into a Securities Purchase Agreement
(the “SPA”) with T-Cell pursuant to which the Company issued a
promissory convertible note (the “Note”) to T-Cell Protect in the
principal amount of €1,000,000 (the “Transaction”). The Note has a
maturity date of one year from the date of issuance and pays
interest at a rate of 10% per annum. The Note is convertible into
shares of Common Stock (the “Conversion Shares”) at a conversion
price of $0.0599 (the “Conversion Price). At any time prior to the
Company uplisting its ordinary shares to a national securities
exchange, T-Cell Protect may exchange the Note into either (a) a
direct equity investment in 3CL Sciences at the same terms as a
financing round of at least $5,000,000 (the “Sub”) or (b) into a
note in the Sub, bearing 10% interest that converts into direct
equity in the Sub at the same terms as a financing round of at
least $5,000,000. The proceeds from this Transaction are intended
to be used for the clinical development of Tollovir, the Company’s
therapeutic candidate for hospitalized COVID-19
patients.
On November
24, 2021, the Company entered into a binding letter of intent (the
“LOI”) with NLC Pharma Ltd. (“NLC”) pursuant to which 3CL Sciences
will purchase all therapeutic, diagnostic, dietary supplement and
pharmaceutical assets from NLC that relate to 3CL protease biology
in exchange for a 40% equity interest in 3CL Sciences that NLC will
own, single digit royalties and Company ordinary shares. Promptly
following execution of the LOI, the Company will deliver $325,000
to pay outstanding invoices related to the interim analysis of the
ongoing clinical trial of Tollovir. The Company shall be
responsible for providing or assisting in the raising of a total of
$10 million into 3CL Sciences over a period of 7 months from
execution of the LOI. The Company and NLC agree to identify a
seasoned biopharmaceutical CEO to run 3CL Sciences going forward.
The board of directors of 3CL Sciences will be made up of five (5)
individuals: two (2) appointed by the Company, two (2) appointed by
NLC and one (1) to be mutually agreed upon by the Company and NLC.
In addition, NLC will be granted one (1) seat on the Company’s
Board of Directors. A press release announcing the LOI is attached
as Exhibit 99.1 to this Current Report on Form 8-K.
The Company
has agreed to file a registration statement with the Securities and
Exchange Commission registering for resale the Conversion Shares
(the “Registration Statement).
The
foregoing descriptions of the License Agreement, SPA, the Note and
LOI do not purport to be complete and are qualified in their
entirety by reference to the full text of the License Agreement,
SPA, Note and LOI, forms of which are attached as Exhibit 10.1 ,
10.2, 10.3 and 10.4, respectively, to this Current Report on Form
8-K, and are incorporated herein by reference.
Item 2.03 Creation of a Direct Financial Obligation or an
Obligation under an Off-Balance Sheet Arrangement of a
Registrant.
The
information included in Item 1.01 of this Form 8-K is hereby
incorporated by reference into this Item 2.03.
Item 3.02
Unregistered Sales of Equity Securities.
The
information included in Item 1.01 of this Form 8-K is hereby
incorporated by reference into this Item 3.02.
The issuance
of the securities described in item 1.01 was deemed to be exempt
from the registration requirements of the Securities Act of 1933,
as amended (the “Securities Act”), by virtue of Section 4(a)(2) and
Rule 506 promulgated thereunder.
Item
9.01.Financial Statements and Exhibits
(d)
Exhibits.
* Pursuant
to Item 601(b)(10) of Regulation S-K, certain confidential portions
of this exhibit were omitted by means of marking such portions with
an asterisk because the identified confidential portions (i) are
not material and (ii) would be competitively harmful if publicly
disclosed.
SIGNATURE
Pursuant to
the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
Dated:
November 29, 2021
|
TODOS
MEDICAL LTD. |
|
|
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By: |
/s/
Gerald Commissiong |
|
|
Gerald
Commissiong |
|
|
Chief Executive
Officer |
Todos Med (QB) (USOTC:TOMDF)
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