Item
1. Financial Statements.
TODOS
MEDICAL LTD.
CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
AS
OF MARCH 31, 2022
TODOS
MEDICAL LTD.
CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
AS
OF MARCH 31, 2022
INDEX
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
TODOS
MEDICAL LTD.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(U.S.
dollars in thousands except share and per share amounts)
The
accompanying notes are an integral part of these condensed consolidated financial statements.
TODOS
MEDICAL LTD.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S.
dollars in thousands except share and per share amounts)
TODOS
MEDICAL LTD.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ DEFICIT
(U.S.
dollars in thousands except share and per share amounts)
| |
Ordinary
shares | | |
Additional
paid-in | | |
Accumulated | | |
Total
Shareholders’ | |
| |
Shares | | |
Amount | | |
capital | | |
deficit | | |
deficit | |
| |
| | |
| | |
| | |
| | |
| |
Balance
as of December 31, 2020 | |
| 376,335,802 | | |
$ | 1,059 | | |
$ | 35,211 | | |
$ | (47,281 | ) | |
$ | (11,011 | ) |
Changes
during the three months period ended March 31, 2021: | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance
of ordinary shares as settlement of previous commitments | |
| 2,500,000 | | |
| 8 | | |
| (8 | ) | |
| - | | |
| - | |
Partial
conversion of convertible bridge loans into ordinary shares | |
| 134,358,817 | | |
| 409 | | |
| 6,461 | | |
| - | | |
| 6,870 | |
Issuance
of ordinary shares upon modification of terms relating to convertible straight loan transaction | |
| 2,000,000 | | |
| 6 | | |
| 82 | | |
| - | | |
| 88 | |
Issuance
of stock warrants as part of convertible bridge loan received | |
| - | | |
| - | | |
| 792 | | |
| - | | |
| 792 | |
Issuance
of ordinary shares in exchange for equity line received | |
| 5,229,809 | | |
| 16 | | |
| 239 | | |
| - | | |
| 255 | |
Issuance
of ordinary shares as collateral for loan repayment | |
| 20,000,000 | | |
| 61 | | |
| 809 | | |
| - | | |
| 870 | |
Issuance
of ordinary shares or commitment for issuance of fixed number of ordinary shares to service providers | |
| | |
| 36 | | |
| 30 | | |
| - | | |
| 66 | |
Stock-based
compensation to employees and directors | |
| - | | |
| - | | |
| 169 | | |
| - | | |
| 169 | |
Net
loss for the period | |
| - | | |
| - | | |
| - | | |
| (17,557 | ) | |
| (17,557 | ) |
Balance
as of March 31, 2021 (unaudited) | |
| 552,345,481 | | |
| 1,595 | | |
| 43,785 | | |
| (64,838 | ) | |
| (19,458 | ) |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
TODOS
MEDICAL LTD.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S.
dollars in thousands)
The
accompanying notes are an integral part of these condensed consolidated financial statements.
TODOS
MEDICAL LTD.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS (Cont.)
(U.S.
dollars in thousands)
| |
Three
months period ended March
31, | |
| |
2022 | | |
2021 | |
| |
Unaudited | | |
Unaudited | |
Supplemental
disclosure of non-cash activities: | |
| | |
| |
| |
| | |
| |
Purchasing
of property and equipment included in accounts payable | |
| - | | |
| 95 | |
Issuance
of ordinary shares as collateral for loan repayment | |
| - | | |
| 870 | |
Partial
conversion of convertible bridge loans and liability related to conversion feature of convertible bridge loans into ordinary shares | |
| 5,070 | | |
| 6,870 | |
Issuance
of stock warrants as part of convertible bridge loan received | |
| - | | |
| 792 | |
Issuance
of ordinary shares upon modification of terms relating to convertible straight loan transaction | |
| - | | |
| 88 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
TODOS
MEDICAL LTD.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S.
dollars in thousands)
NOTE
1 - GENERAL
Todos
Medical Ltd. (the “Company” or “Todos”) was incorporated under the laws of the State of Israel and commenced
its operations on April 22, 2010. The Company engineers life-saving diagnostic solutions for the early detection of a variety of cancers.
The Company’s patented Todos Biochemical Infrared Analyses (TBIA) is a proprietary cancer-screening technology using peripheral
blood analysis that deploys deep examination into cancer’s influence on the immune system, looking for biochemical changes in blood
mononuclear cells and plasma. Todos’ two internally developed cancer-screening tests, TMB-1 and TMB-2, have received a CE mark
in Europe.
Todos
is also developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer’s disease. The Lymphocyte
Proliferation Test (LymPro Test™) is a diagnostic blood test that determines the ability of peripheral blood lymphocytes (PBLs)
and monocytes to withstand an exogenous mitogenic stimulation that induces them to enter the cell cycle. LymPro is unique in the use
of peripheral blood lymphocytes as a surrogate for neuronal cell function, suggesting a common relationship between PBLs and neurons
in the brain.
Commencing
2020, the Company through its U.S. subsidiary (Corona Diagnostics, LLC) has entered into several distribution agreements with other companies
to distribute certain novel coronavirus (COVID-19) test kits. The agreements cover multiple international suppliers of PCR testing kits
and related materials and supplies, as well as antibody testing kits from multiple third-party manufacturers after completing validation
of said testing kits and supplies in certified laboratory in the United States.
Additionally,
during 2021, upon completion of the Share Purchase
Agreement for the purchase of Provista Diagnostics, Inc. (see below), the Company, through Provista Diagnostics, Inc. provide diagnostic
testing laboratory services currently performing COVID-19 PCR testing, primarily for the medical and entertainment industries.
In
December 2020, the Company announced the commercial launch of its proprietary 3CL protease inhibitor dietary supplement Tollovid™.
Tollovid, a mix of botanical extracts, is being targeted to support healthy immune function against circulating coronaviruses. Tollovid
was granted a Certificate of Free Sale by the US Food and Drug Administration (FDA) in August 2020, allowing its commercial sale anywhere
in the United States. In May 2021, the FDA granted the Company a new Certificate of Free Sale for a second dosing regimen for Tollovid™
as a dietary supplement, under which the Company is authorized to market Tollovid with a dosing regimen of 60 pills over a five-day period,
equivalent to 12 pills per day.
On
March 11, 2022, we entered into a Share Purchase Agreement with 3CL Sciences Ltd. (“3CL”) and NLC Pharma Ltd. (“NLC”),
pursuant to which we will acquire 52%
of the issued and outstanding shares of 3CL and NLC will acquire 48%
of the issued and outstanding shares of 3CL (the “Share Purchase Agreement”). Immediately prior to entering into the Share
Purchase Agreement, NLC conveyed to 3CL all of the therapeutic, diagnostic, dietary supplement and pharmaceutical assets from NLC that
relate to 3CL protease biology (which is used in the development, manufacture, sale and distribution of Tollovid™ and Tollovir™).
In
consideration of the 3CL shares being issued to us, we undertook to raise $10,000
for 3CL and committed to issue to NLC $3,800
worth of our ordinary shares, based upon the
closing price for our ordinary shares the day before the closing of the Share Purchase Agreement. The Company and NLC agreed to identify
a seasoned biopharmaceutical CEO to run 3CL going forward. The board of directors of 3CL Sciences will be made up of five (5) individuals:
three (3) appointed by the Company and two (2) appointed by NLC. We anticipate that the Share Purchase Agreement will close during the
second quarter of 2022, subsequent to the date on which these unaudited condensed consolidated financial statements were issued.
Revenues
of the year ended March 31, 2022, resulted from sales of COVID-19 related products, testing kits and dietary supplement, Tollovid™
. Through March 31, 2022, the Company has not yet generated any revenue from its developed cancer-screening tests TMB-1 and TMB-2 or
LymPro Test™.
TODOS
MEDICAL LTD.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S.
dollars in thousands, except shares amounts)
|
1. |
Todos
Medical (Singapore) Pte Ltd |
On
January 27, 2016, the Company incorporated a wholly owned subsidiary in Singapore under the name of Todos Medical (Singapore) Pte Ltd.
(“Todos Singapore”) for the purpose of advancing clinical trials of the Company’s core technology for breast cancer
in Southeast Asia. As of March 31, 2022, Todos Singapore has not yet commenced its business operations.
In
January 2020, the Company incorporated a U.S. subsidiary named Todos Medical USA (“Todos U.S.”) for the purpose of conducting
business as medical importer and distributor focused on the distribution of the Company’s testing products and services to customers
in the North America and Latin America .
|
3. |
Corona
Diagnostics, LLC |
In
April 2020, the Company incorporated a U.S. subsidiary named Corona Diagnostics, LLC (“Corona Diagnostics”) for the purpose
of marketing COVID-19 related products in the United States to validate potential products the Company is contemplating distributing
and creating marketing materials for the testing products based upon those validations.
|
4. |
Breakthrough
Diagnostics, Inc. |
On
July 28, 2020, the Company completed the purchase of 100%
of the issued and outstanding common stock of Breakthrough Diagnostics, Inc. (“Breakthrough”) for entering into the field
of early detection of Alzheimer’s disease.
Breakthrough
was determined to be excluding substantive process as required under the definition of business in accordance with the provisions of
ASC Topic 805 “Business Combination”, it was also determined that the asset purchased had no alternative future use and therefore
the entire purchase price allocated to the acquired IPR&D was charged to expense in the consolidated statement of operations.
|
5. |
Provista
Diagnostics, Inc |
On
April 19, 2021, the Company entered into an Agreement to Purchase Provista Diagnostics, Inc. (“Agreement to Purchase”) with
Strategic Investment Holdings, LLC (“SIH”), Ascenda BioSciences LLC (“Ascenda”) and Provista Diagnostics, Inc.
(“Provista”).
Pursuant
to the Agreement to Purchase, the Company acquired Provista from Ascenda and SIH for an aggregate purchase price of $7,500
consisting of an initial cash payment of $1,250,
the issuance of $1,500
in Ordinary Shares priced at $0.0512
per share, the issuance to SIH of a $3,500
convertible promissory note dated April 19, 2021
(the “Note”) and an additional cash payment of $1,250
in July 2021.
The
Note has a maturity date of April 8, 2025, and is convertible beginning on October 20, 2021, into Ordinary Shares of the Company at a
conversion price equal to the lesser of $0.05
or the volume weighted average price of the last
20 trading days for the Ordinary Shares prior to the date of conversion. In the event SIH delivers a Notice of Conversion to the Company
at a per share price less than $0.05,
the Company has the right to immediately notify SIH of its intention to pay the conversion amount in cash within three (3) business days
of receipt of the Notice of Conversion. If, at any time between October 20, 2021 and April 20, 2022, the average of the lowest bid and
closing sale price is below $0.05,
the Company has the option to buy out all or any portion of the Note (the “Buyback Option”). In the event the Company exercises
the Buyback Option for an amount equal to or greater than $1,170,
SIH may not submit any conversions below $0.05
for ninety (90) days from receipt of the Buyback
Amount.
TODOS
MEDICAL LTD.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S.
dollars in thousands except shares amounts)
In
the event that the Company uplists its Ordinary Shares to a national securities exchange, the Note shall automatically be exchanged into
Series B preferred stock with a conversion price equal to the lesser of (a) $0.05, (b) the opening price on the day of the uplisting
provides there is no transaction associated with the uplisting or (c) the deal price of an uplisting transaction.
As
of the date of this quarterly report on Form 10-Q, SIH has not submitted a Conversion Notice.
On
March 14, 2022, the Company entered into a Revolving Line of Credit Agreement with Testing 123, LLC (see Note ). Under the terms of the
Revolving Line of Credit Agreement, the Company agreed to issue Testing 123, LLC shares, equal to a 10%
ownership stake in Provista. In the event that additional shares of Provista are issued, the Company committed to issue the Lender additional
shares such that his stake in Provista shall not be below 10%.
|
A. |
In
June 2020, the Company entered into agreement with NLC Pharma Ltd., under which Antigen COVID Test Killer was formed for the purpose
of development of diagnostic candidate Antigen Killer and product commercialize through the Company’s sales channels. |
|
|
|
|
|
See
also note 1 regarding the Share Purchase Agreement with 3CL Sciences Ltd. Signed on March 11, 2022. |
|
|
|
|
B. |
In
August 2020, the Company entered into an agreement with Care GB Plus Ltd, under which Bio Imagery Ltd. (“Bio Imagery”)
has been incorporated for the purpose of developing, marketing and commercializing the Products and all the Intellectual Property
of the Company (“Todos Cancer Assets”), developing new Intellectual Property, products and services, and pursue the business
based on the Todos Cancer Assets and on new intellectual property that will be developed by Bio Imagery. As of March 31, 2022, Bio
Imagery has not yet commenced its business operations. |
The
Company and its entities herein considered as the “Group”.
TODOS
MEDICAL LTD.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Cont.)
(U.S.
dollars in thousands)
NOTE
1 - GENERAL
C. |
Going
concern uncertainty |
The
Company has devoted substantially all of its efforts to research and development of its products and raising capital to fund this development.
The development and commercialization of the Company’s products are expected to require substantial further expenditures. To date,
the Company has not yet generated sufficient revenues from operations to support its activities, and therefore it is dependent upon external
sources for financing its operations. Since inception through March 31, 2022, the Company has incurred accumulated losses of $98,183.
As of March 31, 2022, the Company’s current
liabilities exceed its current assets by $6,778,
and there is a shareholders’ deficit of $25,161.
The Company has generated negative operating cash
flow for all periods. As of May 15, 2022 (date of approval of these financial statements), the total cash and cash equivalent balance
is approximately $28.
Management has considered the significance of such
condition in relation to the Company’s ability to meet its current obligations and to achieve its business targets and determined
that these conditions raise substantial doubt about the Company’s ability to continue as a going concern. The Company plans to
finance its operations through the sale of equity and to the extent available, short-term and long-term loans and also through revenues
from sales of corona testing related products. There can be no assurance that the Company will succeed in obtaining the necessary financing
to continue its operations as a going concern. The financial statements do not include any adjustments that might result from the outcome
of this uncertainty.
As
described in the above paragraph, the Company has a limited operating history and faces a number of risks and uncertainties, including
risks and uncertainties regarding to potential dispute which related to commercial terms in connection with unpaid invoices (related
to sales, net yet recognized as revenue) with one of its significant clients
On
March 11, 2020, the World Health Organization declared the COVID-19 outbreak a global pandemic. The outbreak has reached all of the regions
in which the Company does business, and governmental authorities around the world have implemented numerous measures attempting to contain
and mitigate the effects of the virus, including travel bans and restrictions, border closings, quarantines, shutdowns, limitations or
closures of non-essential businesses, and social distancing requirements.
The
global spread of COVID-19 and actions taken in response have caused and may continue to cause disruptions and/or delays in our supply
chain and shipments and caused significant economic and business disruption to the Company’s customers and vendors.
The
COVID-19 pandemic has created and may continue to create significant opportunity under the uncertainty in macroeconomic conditions, which
may cause further demand for the Company’s core business related to PCR testing kits and related materials and supplies as already
reflected by recognized revenues of $2,199
and $5,031
during the three months ended March 31, 2022
and 2021, respectively. However, the Company may face uncertainties around its estimates of revenue collectability and accounts receivable
credit losses and its expectation to receive funds from external sources for financing its operations. The Company expects uncertainties
around its key accounting estimates to continue to evolve depending on the duration and degree of impact associated with the COVID-19
pandemic. The Company estimates may change as new events occur and additional information emerges, and such changes are recognized or
disclosed in the Company’s consolidated financial statements.
TODOS
MEDICAL LTD.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Cont.)
(U.S.
dollars in thousands)
NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES
A.
Basis of presentation
The
accompanying unaudited condensed consolidated financial statements and related notes should be read in conjunction with the Company’s
consolidated financial statements and related notes included in the Company’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2021, as filed with the Securities and Exchange Commission (“SEC”) on March 31, 2022 (the “2021 Form 10-K”).
The unaudited condensed consolidated financial statements have been prepared in accordance with the rules and regulations of the SEC
related to interim financial statements. As permitted under those rules, certain information and footnote disclosures normally required
or included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. The financial information contained
herein is unaudited; however, management believes all adjustments have been made that are considered necessary to present fairly the
results of the Company’s financial position and operating results for the interim periods. All such adjustments are of a normal
recurring nature.
The
results for the three months ended March 31, 2022 are not necessarily indicative of the results to be expected for the year ending December
31, 2022 or for any other interim period or for any future period.
B.
Use of estimates in the preparation of financial statements
The
preparation of the financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the dates of the financial
statements, and the reported amounts of expenses during the reporting periods. Actual results could differ from those estimates. As applicable
to these financial statements, the most significant estimates and assumptions include (i) identification of and measurement of financial
instruments in funding transactions; (ii) Initial measurement of investment in affiliated companies and subsequent equity method implications;
(iii) determination whether an acquired company or formed entities represents a ‘business’; (iv) determination whether acquired
or formed entities are considered Variable Interest Entity (VIE) and if so, whether the Group is its Primary Beneficiary (PB) (v) deferred
income taxes and (vi) measurement of the fair value of equity awards.
C.
Principles of Consolidation
The
consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries and when applicable its majority
owned entities that were determined to be VIE and that the Group was determined as their Primary Beneficiary (PB). Intercompany transactions
and balances have been eliminated upon consolidation.
E.
Goodwill and intangible assets
Goodwill
represents the excess of the purchase price over the fair value of the identifiable net assets acquired in business combinations accounted
for in accordance with the “purchase method” and is allocated to reporting units at acquisition. Goodwill is not amortized
but rather tested for impairment at least annually in accordance with the provisions of ASC Topic 350, “Intangibles - Goodwill
and Other”. The Company performs its goodwill annual impairment test for the reporting units at December 31 of each year, or more
often if indicators of impairment are present.
Intangible
assets with finite lives are amortized using the straight-line basis over their useful lives, to reflect the pattern in which the economic
benefits of the intangible assets are consumed or otherwise used up.
During
the three months ended March 31, 2022 the Company recorded $0,
of impairment losses (See also Note 3B).
D.
Basic and diluted net loss per ordinary share
The
Company computes net loss per share in accordance with ASC 260, “Earning per Share”, which requires presentation of both
basic and diluted loss per share on the face of the statement of operations.
Basic
net loss per ordinary share is computed by dividing the net loss for the period applicable to ordinary shareholders, by the weighted
average number of ordinary shares outstanding during the period. Diluted loss per share gives effect to all potentially dilutive common
shares outstanding during the year using the treasury stock method with respect to stock options and certain stock warrants and using
the if-converted method with respect to convertible bridge loans and certain stock warrants. In computing diluted loss per share, the
average stock price for the period is used in determining the number of shares assumed to be purchased from the exercise of stock options
or warrants. During the period of three months ended March 31, 2022 and 2021 the total weighted average number of ordinary shares related
to outstanding stock options, stock warrants and convertible bridge loans excluded from the calculation of the diluted loss per share
was 1,468,352,970
and 323,874,156,
respectively.
TODOS
MEDICAL LTD.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Cont.)
(U.S.
dollars in thousands)
The
net loss and the weighted average number of shares used in computing basic and diluted net loss per share for the period of three months
ended March 31, 2022 and 2021, is as follows:
SCHEDULE
OF WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES
| |
| | | |
| | |
| |
Three
month period ended | |
| |
2022 | | |
2021 | |
| |
Unaudited | | |
Unaudited | |
| |
| | |
| |
Numerator: | |
| | | |
| | |
Net
loss attributable to common shareholders | |
$ | 7,588 | | |
$ | 17,557 | |
Revaluation
of liability related to warrants to purchase shares of common Stock | |
| - | | |
| 168 | |
| |
| | | |
| | |
Net
loss attributable to common shareholders | |
$ | 7,588 | | |
$ | 17,725 | |
| |
| | | |
| | |
Denominator: | |
| | | |
| | |
Shares
of common stock used in computing basic net loss per share | |
| 1,036,898,212 | | |
| 462,650,478 | |
Incremental
shares from assumed exercise of warrants to purchase shares of common stock | |
| - | | |
| 1,564,074 | |
| |
| | | |
| | |
Shares
of common stock used in computing diluted net loss per share | |
| 1,036,898,212 | | |
| 464,214,552 | |
Net
loss per share of common stock, basic and diluted | |
$ | 0.01 | | |
$ | 0.04 | |
E.
Recent Accounting Pronouncements
On
October 1, 2021, the Company early adopted ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives
and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an
Entity’s Own Equity (ASU 2020-06), which simplifies the accounting for convertible instruments by reducing the number of accounting
models available for convertible debt instruments. This guidance also eliminates the treasury stock method to calculate diluted earnings
per share for convertible instruments and requires the use of the if-converted method. The new standard was effective for us beginning
January 1, 2022, with early adoption permitted. The adoption of this new standard did not have a material impact on our consolidated
financial statements.
Other
new pronouncements issued but not effective as of March 31, 2022 are not expected to have a material impact on the Company’s consolidated
financial statements.
TODOS
MEDICAL LTD.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Cont.)
(U.S.
dollars in thousands)
NOTE
3 - SIGNIFICANT TRANSACTIONS
On
March 10, 2022 the Company and Leonite Capital LLC (the “Investor”) entered into an Agreement pursuant to which, the Company
agreed to issue the Investor 16,000,000
ordinary shares of the Company as full conversion
of all Investor’s outstanding warrants. On March 17, 2022, the Company issued 16,000,000
ordinary shares of the Company pursuant to the
agreement.
B. |
Revolving
Line of Credit Agreement |
On
March 14, 2022, the Company and Testing 123, LLC (the “Lender”) signed a Revolving Line of Credit Agreement, pursuant to
which the Lender will provide the Company with a credit facility of up to $1,250
bearing a monthly interest of 5%
calculated for a minimum period of 60 days. The Company may request advances under the agreement from the date of the agreement and until
March 14, 2023. The Maturity date of each draw will be the earlier of (i) 60 days from the date of the loan, (ii) the occurrence of an
event of default as defined in the agreement and (iii) with respect to funds received by Borrower through collections on receivables
included in a Receivables Pool, as defined in the agreement, 3 days after such funds have been received by the escrow account agent or
the Company.
In
additional to the above the Company agreed
to issue the Lender shares, equal to a 10% ownership stake in Provista. In the event that additional shares of Provista are issued, the
Company committed to issue the Lender additional shares such that his stake in Provista shall not be below 10%.
As
of March 31, 2022, the Company utilized $999 out
of the credit facility.
The
Company has estimated the portion of the 10%
shares of Provista at $740
and recorded $598
as interest expenses, and $142
as prepaid interest expenses under Other Current
Assets.
C. |
Issuance
of Ordinary Shares |
|
1. |
On
January 13, 2022, the Company issued 1,500,000
ordinary shares, valued at $711, to
a service provider of which 1,250,000
ordinary shares were issued in exchange of
previous commitment to issue a fixed number of shares . |
|
|
|
|
2. |
During
the period of three months ended March 31, 2022, Principal Amount and unpaid Interest in total amount of $613
(valued at $3,266)
have been converted into 97,611,464
ordinary shares . |
|
|
|
|
3. |
On
February 4, 2022 and March 10, 2022, the Company issued total of 49,620,690
ordinary shares, valued at $1,804. |
D. |
Settlement
Agreement with Toledo Advisors LLC |
On
April 7, 2022, the Company and Toledo Advisors LLC (“Toledo”) signed a Settlement Agreement pursuant to which upon execution
of the agreement the Company shall pay Toledo $130 and shall issue to Toledo $200 worth of ordinary shares. Upon
delivery of the cash payment and shares the parties shall file and discontinue the compliant file by Toledo on January 7, 2022 and Toledo
irrevocably and unconditionally, shall release and discharge the Company from its June 19, 2020 financing agreement and July 28,
2020 Royalty Agreement. The financial statements as of March 31, 2022, includes an income of $153
as a result of the cancelation of prior
agreements.
NOTE
4 - STOCK BASED COMPENSATION
Stock-based
compensation expenses incurred for employees (and directors) and non-employees for the period of three months ended March 31, 2022, amounted
to $857.
A.
STOCK OPTIONS
On
January 11, 2016, the Company’s Board of Directors approved and adopted the Todos Medical Ltd. 2015 Israeli Share Option Plan (the
“2015 Plan”), pursuant to which the Company’s Board of Directors may award stock options to purchase its ordinary shares
to designated participants. Subject to the terms and conditions of the 2015 Plan, the Company’s Board of Directors has full authority
in its discretion, from time to time and at any time, to determine (i) the designate participants; (ii) the terms and provisions of the
respective Option Agreements, including, but not limited to, the number of Options to be granted to each Optionee, the number of Shares
to be covered by each Option, provisions concerning the time and the extent to which the Options may be exercised and the nature and
duration of restrictions as to the transferability or restrictions constituting substantial risk of forfeiture and to cancel or suspend
awards, as necessary; (iii) determine the Fair Market Value of the Shares covered by each Option; (iv) make an election as to the type
of Approved 102 Option under Israeli IRS law; (v) designate the type of Options; (vi) take any measures, and to take actions, as deemed
necessary or advisable for the administration and implementation of the 2015 Plan; (vii) interpret the provisions of the 2015 Plan and
to amend from time to time the terms of the 2015 Plan.
TODOS
MEDICAL LTD.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Cont.)
(U.S.
dollars in thousands)
The
2015 Plan permits grant of up to 6,000,000
options to purchase ordinary shares subject to
adjustments set in the 2015 Plan. As of March 31, 2022, there were 2,338,838
ordinary shares available for future issuance
under the 2015 Plan.
The
following table presents the Company’s stock option activity for employees and directors of the Company during the periods of three
months ended March 31, 2022 and 2021:
SCHEDULE
OF STOCK OPTION ACTIVITY
| |
Number
of Options | | |
Weighted
Average
Exercise
Price | |
| |
Unaudited | | |
Unaudited | |
Outstanding
as of January 1, 2022 | |
| 16,295,083 | | |
| 0.040 | |
Granted | |
| - | | |
| - | |
Forfeited
or expired | |
| - | | |
| - | |
Outstanding
as of March 31, 2022 | |
| 16,295,083 | | |
| 0.040 | |
Exercisable
as of March 31, 2022 | |
| 2,138,525 | | |
| 0.053 | |
| |
| | | |
| | |
Outstanding
as of January 1, 2021 | |
| 3,682,818 | | |
| 0.663 | |
Granted | |
| - | | |
| - | |
Forfeited
or expired | |
| (1,137,735 | ) | |
| 0.003 | |
Outstanding
as of March 31, 2021 | |
| 2,545,083 | | |
| 0.095 | |
Exercisable
as of March 31, 2021 | |
| 254,508 | | |
| 0.095 | |
As
of March 31, 2022, the aggregate intrinsic value for the stock options outstanding and exercisable according to $0.02
price per share is $0,
with a weighted average remaining contractual life of 4.2
years.
B.
RESTRICTED STOCK UNITS
The
Company issues restricted stock units (“RSU”) under the 2015 Plan to employees and non-employees. The following table outlines
the restricted stock awards activity for the Company’s during the periods of three months ended March 31, 2022 and 2021:
SCHEDULE
OF RESTRICTED STOCK UNITS
| |
Number
of RSU’s | |
| |
Unaudited | |
Outstanding as of January 1,
2022 | |
| 41,967,152 | |
Granted | |
| 10,000,000 | |
Vested | |
| (3,782,699 | ) |
Forfeited or expired | |
| - | |
Outstanding as of
March 31, 2022 | |
| 48,184,453 | |
Weighted average
grant date fair value of restricted stock awards granted during the period | |
| 0.029 | |
| |
| | |
Outstanding as of January 1, 2021 | |
| 9,687,500 | |
Granted | |
| - | |
Vested | |
| (1,562,500 | ) |
Forfeited or expired | |
| - | |
Outstanding as of
March 31, 2021 | |
| 8,125,000 | |
TODOS
MEDICAL LTD.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Cont.)
(U.S.
dollars in thousands)
NOTE
5 – FINANCING EXPENSES, NET
SCHEDULE
OF FINANCING EXPENSES
| |
| | | |
| | |
| |
Three
months period ended March
31, | |
| |
2022 | | |
2021 | |
| |
Unaudited | | |
Unaudited | |
| |
| | |
| |
Modification
of terms relating to straight loan transaction | |
$ | - | | |
$ | (6 | ) |
Amortization
of discounts and accrued interest on convertible bridge loans | |
| 6,127 | | |
| 15,033 | |
Amortization
of discounts and accrued interest on straight loans | |
| 164 | | |
| 861 | |
Change
in fair value of derivative warrants liability and fair value of warrants expired | |
| - | | |
| (201 | ) |
Change
in fair value of liability related to conversion feature of convertible bridge loans | |
| (3,431 | ) | |
| (977 | ) |
Direct
and incremental issuance costs allocated to conversion feature of convertible bridge loan | |
| - | | |
| 169 | |
Settlement
in cash of prepayment obligation related to convertible bridge loan | |
| - | | |
| 182 | |
Interest
and related royalties under receivables financing facility | |
| (153 | ) | |
| 238 | |
Amortization
of prepaid expenses related to commitment shares in connection with receivables financing facility and equity line | |
| 567 | | |
| 293 | |
Exchange
rate differences and other finance expenses | |
| 197 | | |
| 62 | |
Financing
(income) expenses, net | |
$ | 3,471 | | |
$ | 15,654 | |
NOTE
6 – TAXES ON INCOME
|
A. |
Deferred
income taxes reflect the net tax effects of net operating loss and temporary differences between the carrying amounts of assets and
liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s
deferred tax assets are as follows: |
SCHEDULE
OF DEFERRED TAX ASSETS
| |
|
| |
| |
As
of March
31, | |
| |
2022 | |
| |
Unaudited | |
Composition
of deferred tax assets: | |
| |
Net
operating loss carry-forward | |
$ | 6,747 | |
Research
and development credits | |
| - | |
Allowance
for Bad Debt | |
| | |
Others | |
| - | |
Net
deferred tax asset before deferred tax liabilities and valuation allowance | |
| 6,747 | |
| |
| | |
Composition
of deferred tax liabilities: | |
| | |
Intangible
assets upon acquisition of subsidiary | |
| 284 | |
Depreciation
costs | |
| 197 | |
Net
deferred tax asset before valuation allowance | |
| 6,266 | |
| |
| | |
Valuation
allowance | |
| (6,550 | ) |
Net
deferred tax liability | |
| (284 | ) |
In
assessing the realization of deferred tax assets, management considers whether it is more likely than not that all or some portion of
the deferred tax assets will not be realized. The ultimate realization of the deferred tax assets is dependent upon the generation of
future taxable income during the periods in which temporary differences are deductible and net operating losses are utilized. Based on
consideration of these factors, the Company recorded a full valuation allowance as of March 31, 2022.
TODOS
MEDICAL LTD.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Cont.)
(U.S.
dollars in thousands)
B. |
For
the period of three months ended March 31, 2022, the following table reconciles the statutory income tax rate to the effective income
tax rate: |
SCHEDULE
OF RECONCILE THE STATUTORY INCOME TAX RATE TO EFFECTIVE INCOME TAX RATE
| |
| |
| |
Three
months ended
March 31, | |
| |
2022 | |
| |
Unaudited | |
| |
| |
Tax
rate | |
| 23 | % |
| |
| | |
Tax
expense (benefit) at statutory rate | |
$ | (1,579 | ) |
Tax
rate differential | |
| 25 | |
Permanent
differences with respect to stock-based compensation | |
| 359 | |
Permanent
differences with respect to derivative warrants liabilities, bifurcated conversion feature and convertible loans | |
| 613 | |
Others | |
| | |
Loss
carryforwards and others | |
| 582 | |
Income
tax expense (benefit) | |
$ | - | |
TODOS
MEDICAL LTD.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Cont.)
(U.S.
dollars in thousands)
NOTE
7 – SEGMENT REPORTING
Commencing
2020, the operations of the Company are conducted through three different core activities: Breast Cancer Test (TM-B1, TM-B2), Alzheimer
and COVID-19 testing, each of which are operating segments. These activities also represent the reportable segments of the Group.
The
reportable segments are viewed and evaluated separately by Company management, since the marketing strategies, processes and expected
long term financial performances of the segments are different.
B. |
Information
about reported segment profit or loss and assets |
SCHEDULE
OF INFORMATION ABOUT REPORTED SEGMENT PROFIT OR LOSS AND ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 |
|
|
|
|
|
|
|
|
|
Breast
Cancer Test |
|
|
Alzheimer |
|
|
Testing
and related products |
|
|
Un-allocated |
|
|
Total |
|
|
|
Unaudited |
|
Three months ended March
31, 2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
|
- |
|
|
|
- |
|
|
|
2,199 |
|
|
|
- |
|
|
|
2,199 |
|
Operating
loss |
|
|
(1,107 |
) |
|
|
- |
|
|
|
(1,303 |
) |
|
|
(1,707 |
) |
|
|
(4,117 |
) |
Unallocated
amounts: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing
expenses, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,471 |
) |
|
|
(3,471 |
) |
Share
in losses of affiliated companies accounted for under equity method, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
Net loss |
|
|
(1,107 |
) |
|
|
- |
|
|
|
(1,303 |
) |
|
|
(5,178 |
) |
|
|
(7,588 |
) |
The
evaluation of performance is based on the operating income of each of the three reportable segments.
Accounting
policies of the segments are the same as those described in the accounting policies applied in the consolidated financial statements.
Due
to the reportable segments’ nature, there have been no inter-segment sales or transfers during the reported periods.
Financing
expenses, net and the share of the Company in losses of affiliated companies were not allocated to the reportable segments, since these
items are carried and evaluated on the enterprise level.
Management
has determined that none of the equity method investees is eligible to be considered as reportable segment as they do not meet the criteria
in ASC Topic 280-10-50 (or they did not commence their operations)..
C. |
Revenues
by geographic region are as follows: |
SUMMARY
OF REVENUES BY GEOGRAPHIC REGION
| |
| | | |
| | |
| |
Three
months period ended March
31, | |
| |
2022 | | |
2021 | |
| |
Unaudited | |
Israel | |
$ | - | | |
$ | - | |
United
States | |
| 2,199 | | |
| 5,031 | |
Total | |
| 2,199 | | |
| 5,031 | |
TODOS
MEDICAL LTD.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Cont.)
(U.S.
dollars in thousands)
D. |
Property
and equipment, net, by geographic areas: |
| |
| | | |
| | |
| |
As of March 31, |
|
|
As
of December 31, | |
| |
2022 | | |
2021 | |
| |
Unaudited | |
Israel | |
$ | 31 | | |
$ | 34 | |
United
States | |
| 2,082 | | |
| 2,011 | |
Property
and equipment, net | |
$ | 2,113 | | |
$ | 2,045 | |
SCHEDULE
OF MAJOR CUSTOMER
| |
| | | |
| | |
| |
As
of March 31, | |
| |
2022 | | |
2021 | |
Client
A | |
| - | | |
| 85.3 | % |
Client
B | |
| 27.2 | % | |
| - | |
| |
| | | |
| | |
Client
D | |
| 11.2 | % | |
| - | |
Total | |
| 38.4 | % | |
| 85.3 | % |
NOTE
8 – EVENTS SUBSEQUENT TO THE BALANCE SHEET DATE
The
Company evaluated all events and transactions that occurred subsequent to the balance sheet date and prior to the date on which these
unaudited condensed consolidated financial statements were issued, and determined that no events required disclosure.
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The
following discussion and analysis should be read in conjunction with our financial statements and related notes included elsewhere in
this quarterly report on Form 10-Q. This discussion and other parts of this quarterly report on Form 10-Q contain forward-looking statements
based upon current expectations that involve risks and uncertainties. Our actual results and the timing of selected events could differ
materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under
“Risk Factors” and elsewhere in this quarterly report on Form 10-Q. We report financial information under US GAAP and our
financial statements were prepared in accordance with generally accepted accounting principles in the United States.
Overview
|
● |
Todos
Medical Ltd. (“Todos Medical,” the “Company,” “we,” “our,” “us”), is
an in vitro diagnostics company focused on distributing comprehensive solutions for COVID-19 screening and diagnosis and developing
blood tests for the early detection of cancer and Alzheimer’s disease. |
|
|
|
|
● |
Todos
has entered into distribution agreements with companies to distribute certain novel coronavirus (COVID-19) test kits. The agreements
cover multiple international suppliers of PCR testing kits and related materials and supplies, as well as antibody testing kits from
multiple manufacturers after completing validation of said testing kits and supplies in its partner CLIA/CAP certified laboratory
in the United States. Todos has combined the PCR testing kits with automated lab equipment to create lab workflows capable of performing
up to 40,000 PCR tests per day. Todos has entered into supply agreements with CLIA/CAP certified laboratories in the United States
to deploy these PCR workflows. Todos has formed strategic partnerships with Meridian Health and other strategic partners to deploy
COVID-19 antigen and antibody testing in the United States. Additionally, the Company is developing a lab-based COVID-19 3CL protease
test to determine whether a COVID-19 positive patient remains contagious after quarantine is complete and is further developing point-of-care-based
embodiments of the lab test for use in screening programs worldwide. |
|
|
|
|
● |
In
December 2020, Todos announced the commercial launch of its proprietary 3CL protease inhibitor dietary supplement Tollovid™
at The Alchemist’s Kitchen in SoHo district in Manhattan, New York. Tollovid, a mix of botanical extracts, is being targeted
to support healthy immune function against circulating coronaviruses. Tollovid’s mechanism of action is to inhibit the activity
of the 3CL protease, a key protease required for the intracellular replication of coronaviruses. Tollovid was granted a Certificate
of Free Sale by the US Food & Drug Administration in August 2020, allowing its commercial sale anywhere in the United States. |
|
|
|
|
● |
On
March 11, 2022, we entered into a Share Purchase Agreement with 3CL Sciences Ltd. (“3CL”) and NLC Pharma Ltd. (“NLC”),
pursuant to which we will acquire 52% of the issued and outstanding shares of 3CL and NLC will acquire 48% of the issued and outstanding
shares of 3CL (the “Share Purchase Agreement”). Immediately prior to entering into the Share Purchase Agreement, NLC
conveyed to 3CL all of the therapeutic, diagnostic, dietary supplement and pharmaceutical assets from NLC that relate to 3CL protease
biology (which is used in the development, manufacture, sale and distribution of Tollovid™ and Tollovir™). |
|
|
|
|
● |
Additionally,
the Company’s patented Todos Biochemical Infrared Analyses (TBIA) is a cancer-screening technology using peripheral blood analysis
that deploys deep examination into cancer’s influence on the immune system, looking for biochemical changes in blood mononuclear
cells and plasma. Todos’ two internally developed cancer-screening tests, TMB-1 and TMB-2 have received a CE mark in Europe. |
|
|
|
|
● |
In the second quarter of 2021, Todos purchased rights to Provista Diagnostics, Inc.’s Alpharetta, Georgia-based CLIA/CAP certified
lab and Provista’s proprietary commercial-stage Videssa® breast cancer blood test. |
|
|
|
|
● |
Todos
is also developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer’s disease. |
|
|
|
|
● |
In
July 2020, Todos completed the acquisition of Breakthrough Diagnostics, Inc., the owner of the LymPro Test intellectual property,
from Amarantus Bioscience Holdings, Inc. |
Products
|
● |
Through
3CL Sciences Ltd. (“3CL”), we are in the development phase of our own antiviral,
Tollovir™, a potent 3CL protease inhibitor for the treatment of hospitalized COVID-19
patients, which is currently undergoing a Phase 2 clinical trial in Israel with plans to
expand the clinical development program to India.
We
believe that government recognition of the need for antivirals to treat COVID-19 will provide a significant tailwind for the development
of our Tollovir™ anti-viral that is currently undergoing a Phase 2 clinical trial in Israel with plans progressing rapidly
to expand the clinical development program to India. As part of the ongoing scientific effort to further elucidate the mechanisms
that have enabled Tollovir to achieve its very positive early clinical results, NLC Pharma identified an anti-inflammatory mechanism
of action of Tollovir to complement its 3CL protease inhibiting mechanism. This dual mechanism of action helps explain the significant
reduction in symptoms and the biomarker C Reactive Protein (CRP) that was documented in the earliest clinical COVID-19 data sets
produced in Israel, which could not be explained by a reduction in viral load alone likely caused by Tollovir’s 3CL protease
inhibiting mechanism. |
|
|
|
|
● |
The
Company’s 3CL protease inhibitor botanical product, Tollovid, is a dietary supplement
that helps to support and maintain healthy immune function. This technology will potentially
have a significant impact for the development of virus targeting therapeutic development
strategies, as well as clearance for return to life activities post-infection.
We
are very pleased that the Company’s dietary supplement Tollovid, which provides immune support as a protease inhibitor, received
FDA authorization for a new 5-day dosing regimen in April 2021. We believe this authorization underscores the emerging need in the marketplace
for immune support supplements supported by strong scientific and safety data, as well as provides international regulatory authorities
with a high degree of comfort of Tollovid’s safety profile. |
|
|
|
|
● |
In October 2021, we announced positive clinical validation
data for our 3CL protease biomarker assay TolloTest™ in a clinical study evaluating its sensitivity compared with PCR in hospitalized
COVID-19 patients, patients hospitalized for conditions other than COVID-19 and individuals exposed to confirmed COVID-19 subjects
in the community outpatient setting and healthy controls. The results clinically validated the sensitivity of the 3CL protease biomarker
compared with SARS-CoV-2 PCR, confirmed positive results in both the hospital and outpatient setting, and provided key insights on
the potential role the 3CL protease biomarker could play in assessing the COVID infectivity status of infected patients being released
from quarantine and opening the diagnostic window to include earlier diagnosis of individuals from time of time known exposure. The
Company sees multiple use cases for the 3CL protease biomarker as an adjunct to both PCR testing and antigen testing for SARS-CoV-2. |
|
|
|
|
● |
Our
two most advanced blood tests for cancer are for the screening and diagnosis of breast cancer. TM-B1 is our breast cancer test for
the screening and diagnosis of breast cancer in all women, and TM-B2 is our breast cancer test for the screening and diagnosis of
breast cancer in women who have ‘dense breasts.’ Dense breasts, medically categorized as BI-RADS 3 and BI-RADS 4, make
mammograms largely ineffective because the biophysical structure of the breast does not allow high enough resolution on the mammogram
X-ray to determine whether or not a tumor is present, leading to potentially unnecessary additional imaging tests and breast biopsies
in women who have dense breasts. |
|
|
|
|
● |
Additionally,
our TMC blood test is for the screening and diagnosis of colon cancer. |
|
|
|
|
● |
The
Lymphocyte Proliferation Test (LymPro Test™) is a diagnostic blood test that determines the ability of peripheral blood lymphocytes
(PBLs) and monocytes to withstand an exogenous mitogenic stimulation that induces them to enter the cell cycle. It is believed that
certain diseases, most notably Alzheimer’s disease, are the result of compromised cellular machinery that leads to aberrant
cell cycle re-entry by neurons, which then leads to apoptosis. LymPro is novel in the use of peripheral blood lymphocytes as a surrogate
for neuronal cell function, suggesting a common relationship between PBLs and neurons in the brain. |
Operating
Results
Revenues
During
the three months ended March 31, 2022, we generated revenues of $2,199,456, compared to $5,031,097 in revenues during the three months
ended March 31, 2021. Such revenues were generated by the Company and through our U.S. subsidiaries, Corona Diagnostics, LLC and Provista
Diagnostics, Inc.
Operating
Expenses
Our
current operating expenses consist of four components - cost of revenues, research and development expenses, marketing expenses and general
and administrative expenses.
Cost
of revenues
Our
cost of revenues consists primarily of materials, depreciation and other related cost of revenues expenses.
The
following table discloses the breakdown of cost of revenues:
| |
Three
Months Ended March
31 | |
| |
2022 | | |
2021 | |
Materials and other costs | |
$ | 1,144,337 | | |
$ | 3,086,314 | |
Depreciation | |
| 172,778 | | |
| 148,815 | |
Total | |
$ | 1,317,115 | | |
$ | 3,235,129 | |
Research
and Development Expenses
Our
research and development expenses consist primarily of salaries and related personnel expenses, subcontracted work and consulting and
other related research and development expenses.
The
following table discloses the breakdown of research and development expenses:
| |
Three
Months Ended March
31 | |
| |
2022 | | |
2021 | |
| |
| | |
| |
Professional fees | |
$ | 71,332 | | |
$ | 100,234 | |
Laboratory and materials | |
| 366,217 | | |
| 602,567 | |
Depreciation | |
| 3,589 | | |
| 7,425 | |
Insurance and other expenses | |
| 1,117 | | |
| 2,380 | |
Total | |
$ | 442,255 | | |
$ | 712,606 | |
We
expect that our research and development expenses will materially increase as we plan to rapidly recruit more employees in order to accelerate
our research and development efforts.
Sales
and Marketing expenses
Sales
and marketing expenses consist primarily of salaries and share-based compensation expense.
The
following table discloses the breakdown of sales and marketing expenses:
| |
Three
Months Ended March 31 | |
| |
2022 | | |
2021 | |
Share based compensation | |
$ | - | | |
$ | 44,771 | |
professional fees, salaries and other expenses | |
| 1,080,474 | | |
| 1,313,466 | |
Total | |
$ | 1,080,474 | | |
$ | 1,358,237 | |
General
and administrative
General
and administrative expenses consist primarily of salaries, share-based compensation expense, professional service fees (for accounting,
legal, bookkeeping, intellectual property and facilities), directors fee and insurance and other general and administrative expenses.
The
following table discloses the breakdown of general and administrative expenses:
| |
Three
Months Ended March 31 | |
| |
2022 | | |
2021 | |
Salaries and related expenses | |
$ | 642,834 | | |
| 42,066 | |
Share-based compensation | |
| 1,179,938 | | |
| 200,539 | |
Rent and maintenance expenses | |
| 149,421 | | |
| 4,513 | |
Communication and investor relations | |
| 46,800 | | |
| 22,500 | |
doubtful debts | |
| 736,441 | | |
| 311,274 | |
Depreciation | |
| 20,462 | | |
| - | |
Professional fees | |
| 627,977 | | |
| 956,963 | |
Insurance and other expenses | |
| 72,114 | | |
| 24,322 | |
| |
| | | |
| | |
Total | |
$ | 3,475,987 | | |
| 1,562,177 | |
Comparison
of the three months ended March 31, 2022, to the three months ended March 31, 2021:
Results
of Operations
Revenues.
Our revenues for the three months ended March 31, 2022, were $2,199,456, compared to 5,031,097 revenues during the three months ended
March 31, 2021, representing a net decrease of $2,831,641, or 56%. The decrease in our revenues is a result of the reduction in sales
of our COVID-19 testing products through our U.S. subsidiary, Corona Diagnostics, LLC which was somewhat offset by sales
of Tollovid™, which commenced in the fourth quarter of 2021.
Cost
of revenues. Our cost of revenues for the three months ended March 31, 2022, were $1,317,115, compared to $3,235,129 during the three
months ended March 31, 2021, representing a net decrease of $1,918,014, or 59%. The decrease in our cost of revenues is related to the
decrease in sales of our COVID-19 testing products.
Research
and Development Expenses. Our research and development expenses for the three months ended March 31, 2022, were $442,255 compared to
$712,606 for the three months ended March 31, 2021, representing a net decrease of $270,351, or 38%. The decrease is primarily due to
a decrease in professional fees and other research and development costs in connection with providing Covid testing services.
Sales
and Marketing Expenses. Our sales and marketing expenses decreased from $1,358,237 in the three months ended March 31, 2021, to
$1,080,474 in the three months ended March 31, 2022, a decrease of $277,763 or 20%.
General
and Administrative Expenses. Our general and administrative expenses for the three months ended March 31, 2022, were $3,475,987, compared
to $1,562,177 for the three months ended March 31, 2021, providing an increase of $1,913,810 or 123%. The increase is primarily due to
an increase in stock-based compensation, salaries and related expenses, and doubtful debts partially offset by a decrease in professional
services.
Finance (Income) Expenses, Net.
Our net finance expenses for the three months ended March 31, 2022 was $3,471,000 compared to net finance expenses of $15,654,635 for
the three months ended March 31, 2021, providing a decrease of $12,183,638 or 78%. The decrease is primarily due to changes in the fair
value of warrants liability and amortization of discounts and accrued interest on convertible bridge loans.
Share
in losses of affiliated company is accounted for under the equity method. Our share in losses of affiliated company accounted for under
the equity method amounted to $65,469 in the three months ended March 31, 2021 ($0 in the three months ended March 31, 2022).
Net Loss. Our net loss for the
three months ended March 31, 2022 was $7,588,375, compared to $17,557,484 for the three months ended March 31, 2021, providing a decrease
of $9,969,109 or 57%. The decrease is primarily due to a decrease in the decrease in finance expenses, net as well as other changes as
mentioned above.
We
prepare our financial statements in accordance with US GAAP. At the time of the preparation of the financial statements, our management
is required to use estimates, evaluations, and assumptions which affect the application of the accounting policy and the amounts reported
for assets, obligations, revenues and expenses. Any estimates and assumptions are continually reviewed. The changes to the accounting
estimates are credited during the period in which the change to the estimate is made.
Subject
to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we elected to rely on other exemptions,
including without limitation, (i) providing an auditor’s attestation report on our internal control over financial reporting pursuant
to Section 404 of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted by the PCAOB regarding mandatory
audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial
statements (auditor discussion and analysis). These exemptions applied until the last day of the 2021 fiscal year (the fifth anniversary
of the date of the first sale of our common equity securities pursuant to an effective registration statement under the Securities Act).
Going
Concern Uncertainty
Until
2020, we devoted substantially all of our efforts to research and development and raising capital. In 2020, we raised significant capital,
but we also generated revenues for the first time as a result of our activities related to Covid-19. There is no certainty as to the
continuance of our revenues related to Covid-19. The development and commercialization of our other products, which are necessary for
our long term financial health, are expected to require substantial further expenditures. We remain dependent upon external sources for
financing our operations. Since inception, we have incurred substantial accumulated losses, negative working capital, and negative operating
cash flow, and have a significant shareholders’ deficit. These factors raise substantial doubt about our ability to continue as
a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. We plan
to finance our operations through the sale of equity and, to the extent available, short term and long-term loans. There can be no assurance
that we will succeed in obtaining the necessary financing to continue our operations.
Liquidity
and Capital Resources
Overview
To
date, we have funded our operations primarily with convertible bridge loans, grants from the IIA, and issuing Ordinary Shares and stock
warrants (including warrants’ exercise).
The
table below presents our cash flows:
STATEMENTS
OF CASH FLOWS
U.S.
dollars in thousands
| |
Three
months period ended March
31, | |
| |
2022 | | |
2021 | |
| |
Unaudited | | |
Unaudited | |
Cash
flows from operating activities: | |
| | |
| |
Net loss | |
$ | (7,588 | ) | |
$ | (17,557 | ) |
Adjustments required to
reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation | |
| 197 | | |
| 156 | |
Interest on revolving credit
line | |
| 597 | | |
| - | |
Other losses | |
| 30 | | |
| - | |
Liability for minimum royalties | |
| 54 | | |
| 12 | |
Stock-based compensation | |
| 1,568 | | |
| 235 | |
Modification of terms relating
to straight loan transaction | |
| - | | |
| (6 | ) |
Direct and incremental
issuance costs allocated to conversion feature of convertible bridge loan | |
| - | | |
| 169 | |
Change in fair value, amortization
of discounts and accrued interest on convertible bridge loans | |
| 6,127 | | |
| 15,033 | |
Amortization of discounts
and accrued interest on straight loans | |
| 164 | | |
| 861 | |
Change in fair value of
derivative warrants liability and fair value of warrants expired | |
| - | | |
| (201 | ) |
Change in fair value of
liability related to conversion feature of convertible bridge loans | |
| (3,431 | ) | |
| (977 | ) |
Decrease (increase) in
trade receivables | |
| 1,035 | | |
| (41 | ) |
Increase in inventories | |
| (38 | ) | |
| (1,054 | ) |
Decrease (increase) in
other current assets | |
| (294 | ) | |
| 670 | |
Increase (decrease) in
accounts payable | |
| 1,024 | | |
| (389 | ) |
Decrease in deferred revenues | |
| - | | |
| (844 | ) |
Increase
(decrease) in other current liabilities | |
| (678 | ) | |
| 687 | |
| |
| | | |
| | |
Net
cash used in operating activities | |
| (1,263 | ) | |
| (3,180 | ) |
| |
| | | |
| | |
Cash flows from investing
activities: | |
| | | |
| | |
Purchase of property and
equipment | |
| (244 | ) | |
| (658 | ) |
Investment
in other companies | |
| - | | |
| (231 | ) |
Net
cash used in investing activities | |
| (244 | ) | |
| (889 | ) |
| |
| | | |
| | |
Cash flows from financing
activities: | |
| | | |
| | |
Proceeds from straight
loans, net | |
| 725 | | |
| 1,677 | |
Repayment of Receivables
financing facility | |
| 879 | | |
| (1,056 | ) |
Repayment of straight loans | |
| (189 | ) | |
| (941 | ) |
Repayment of convertible
bridge loans | |
| - | | |
| (677 | ) |
Proceeds from issuance
of units consisting of convertible bridge loans, stock warrants and shares, net | |
| - | | |
| 4,012 | |
Repayments of right of
use asset arising from operating leases | |
| (23 | ) | |
| - | |
Proceeds
from issuance of ordinary shares through equity line | |
| - | | |
| 255 | |
Net
cash provided by financing activities | |
| 1,392 | | |
| 3,270 | |
| |
| | | |
| | |
Change in cash, cash equivalents | |
| (115 | ) | |
| (799 | ) |
Cash,
cash equivalents at beginning of period | |
| 189 | | |
| 935 | |
Cash,
cash equivalents at end of period | |
$ | 74 | | |
$ | 136 | |
Operating
Activities
Net cash used in operating activities
for the three months ended March 31, 2022 was $1,263,000 compared to $3,180,000 in the three months ended March 31, 2021. The decrease
in the cash flow used in operating activities in 2022 compared to 2021 is primarily due to a decrease in operating loss plus an increase
in accounts payable and stock-based compensation and a decrease in the fair value of the liability related to the potential conversion
of convertible bridge loans, amortization of discounts and accrued interest on convertible bridge loans.
Investing
Activities
Net
cash used in investing activities for the for the three months ended March 31, 2022 was $244,000, compared with $889,000 in the three
months ended March 31, 2021. The primary reason for the decrease in investing activities was due to a decrease in the purchase of laboratory
and other equipment by our U.S. subsidiaries, Corona Diagnostics, LLC and Provista Diagnostics, Inc.
Financing
Activities
Net cash provided by financing
activities for the three months ended March 31, 2022 was $1,392,000, compared to net cash provided by financing activities for the three
months ended March 31, 2021 of $3,270,000. This decrease is primarily due to a decrease in cash received from proceeds from straight loans
and proceeds from issuance of units consisting of convertible bridge loans, stock warrants and shares, net offset by an increase in cash
received from the Company’s receivables financing facility.
Current
Outlook
We
cannot assure that our cancer detection kits will be commercialized, work as indicated, or that they will receive regulatory approval
and that we will earn revenues sufficient to support our operations or that we will ever be profitable. Furthermore, since we have no
committed source of financing, we cannot assure that we will be able to raise money as and when we need it to continue our operations.
If we cannot raise funds as and when we need them, we may be required to curtail, or even to cease, our operations.
We
have limited experience with IVD. As such, these budget estimates may not be accurate. In addition, the actual work to be performed is
not known at this time, other than a broad outline, as is normal with any scientific work. As further work is performed, additional work
may become necessary or change in plans or workload may occur. Such changes may have an adverse impact on our estimated budget. Such
changes may also have an adverse impact on our projected timeline of drug development.
We
are currently distributing COVID-19 testing kits as a means of funding our operations.
If
we are unable to raise additional funds, we will need to do one or more of the following:
|
● |
delay,
scale-back or eliminate some or all of our research and product development programs; |
|
|
|
|
● |
provide
licenses to third parties to develop and commercialize products or technologies that we would otherwise seek to develop and commercialize
ourselves; |
|
|
|
|
● |
seek
strategic alliances or business combinations; |
|
|
|
|
● |
attempt
to sell our Company; |
|
|
|
|
● |
cease
operations; or |
|
|
|
|
● |
declare
bankruptcy. |
Any
debt financing secured by us in the future could involve restrictive covenants relating to our capital raising activities and other financial
and operational matters, which may make it more difficult for us to obtain additional capital and to pursue business opportunities, including
potential acquisitions. We may not be able to secure additional debt or equity financing in a timely manner, or at all, which could require
us to scale back our business plan and operations.
The
above conditions raise substantial doubt about our ability to continue as a going concern. The financial statements included elsewhere
herein were prepared under the assumption that we would continue our operations as a going concern. Our financial statements do not include
any adjustments that may result from the outcome of this uncertainty. Without additional funds from debt or equity financing, sales of
our intellectual property or technologies, or from a business combination or a similar transaction, we will soon exhaust our resources
and will be unable to continue operations. If we cannot continue as a viable entity, our shareholders may lose some or all of their investment
in us.
Our
management intends to attempt to secure additional required funding primarily through additional equity or debt financings. We may also
seek to secure required funding through sales or out-licensing of intellectual property assets, seeking partnerships with other pharmaceutical
companies or third parties to co-develop and fund research and development efforts, or similar transactions. However, there can be no
assurance that we will be able to obtain required funding. If we are unsuccessful in securing funding from any of these sources, we will
defer, reduce or eliminate certain planned expenditures in our research protocols. If we do not have sufficient funds to continue operations,
we could be required to seek bankruptcy protection or other alternatives that could result in our shareholders losing some or all of
their investment in us.
Recent
Developments
3CL
Acquisition
On
March 11, 2022, we entered into a Share Purchase Agreement with 3CL Sciences Ltd. (“3CL”) and NLC Pharma Ltd. (“NLC”),
pursuant to which we will acquire 52% of the issued and outstanding shares of 3CL and NLC will acquire 48% of the issued and outstanding
shares of 3CL (the “Share Purchase Agreement”). Immediately prior to entering into the Share Purchase Agreement, NLC conveyed
to 3CL all of the therapeutic, diagnostic, dietary supplement and pharmaceutical assets from NLC that relate to 3CL protease biology
(which is used in the development, manufacture, sale and distribution of Tollovid™ and Tollovir™).
In
consideration of the 3CL shares being issued to us, we undertook to raise $10,000,000 for 3CL and committed to issue to NLC $3,800,000
worth of our ordinary shares, based upon the closing price for our ordinary shares the day before the closing of the Share Purchase Agreement.
The Company and NLC agreed to identify a seasoned biopharmaceutical CEO to run 3CL going forward. The board of directors of 3CL Sciences
will be made up of five (5) individuals: three (3) appointed by the Company and two (2) appointed by NLC. We anticipate that the Share
Purchase Agreement will close during the second quarter of 2022.
Provista
Acquisition
On
April 19, 2021, the Company entered into an Agreement to Purchase Provista Diagnostics, Inc. (“Agreement to Purchase”) with
Strategic Investment Holdings, LLC (“SIH”), Ascenda BioSciences LLC (“Ascenda”) and Provista Diagnostics, Inc.
(“Provista”). Ascenda was the sole owner of the outstanding securities of Provista and SIH is the sole owner of all the outstanding
securities of Ascenda.
Pursuant
to the Agreement to Purchase, the Company acquired Provista from Ascenda and SIH for an aggregate purchase price of $7.5 million consisting
of an initial cash payment of $1.25 million, the issuance of $1.5 million in Ordinary Shares priced at $0.0512 per share, the issuance
to SIH of a $3.5 million convertible promissory note dated April 19, 2021 (the “Note”) and the payment on for before July
1, 2021 of $1.25 million in cash (the “July Payment”), which payment the Company had the right to, and did, extend to July
15, 2021. The Provista shares acquired by the Company remained in an escrow account until the July Payment was made.
The
Note has a maturity date of April 8, 2025, and is convertible beginning on October 20, 2021, into Ordinary Shares of the Company at a
conversion price equal to the lesser of $0.05 or the volume weighted average price of the last 20 trading days for the Ordinary Shares
prior to the date of conversion. In the event SIH delivers a Notice of Conversion to the Company at a per share price less than $0.05
($0.05), the Company has the right to immediately notify SIH of its intention to pay the conversion amount in cash within three (3) business
days of receipt of the Notice of Conversion (i.e., before SIH would take possession of shares converted under the Notice of Conversion).
If, at any time between October 20, 2021 and April 20, 2022, the average of the lowest bid and closing sale price at 4:00:00 p.m., New
York time (or such other time as such market publicly announces is the official close of trading) is below ($0.05), the Company has the
option to buy out all or any portion of the Note (the “Buyback Option”). In the event the Company exercises the Buyback Option
for an amount equal to or greater than one million, one hundred seventy thousand dollars ($1,170,000) (the “Buyback Amount”),
SIH may not submit any conversions below five cents ($0.05) for ninety (90) days from receipt of the Buyback Amount (“90 Day Period”).
In
the event that the Company uplists its Ordinary Shares to a national securities exchange, the Note shall automatically be exchanged into
Series B preferred stock with a conversion price equal to the lesser of (a) $0.05, (b) the opening price on the day of the uplisting
provides there is no transaction associated with the uplisting or (c) the deal price of an uplisting transaction.
As
of the date of this quarterly report on Form 10-Q, SIH has not submitted a Conversion Notice.
Products
On
July 22, 2021, the US Food & Drug Administration (FDA) granted a new Certificate of Free Sale for Tollovid Daily™, the newest
member of the Company’s Tollovid™ dietary supplement product line.
The
Certificate of Free Sale is for a twice-daily dosing regimen and, critically, a 3CL protease inhibitor claim. Each 60-pill bottle of
Tollovid Daily can help support and maintain healthy immune function for 30 days. The Company intends to establish a monthly subscription
model as part of its marketing launch campaign for Tollovid Daily immune system support. Tollovid™ and Tollovid Daily are both
3CL protease inhibitor products developed under a joint venture with NLC Pharma.
On
April 8, 2021, we received a notice of allowance (‘Letter of Intent to Grant a Patent’) from the European Patent Office covering
the use of the Company’s proprietary Total Biochemical Infrared Analysis (‘TBIA’) method that uses blood (plasma and/or
peripheral blood mononuclear cells ‘PBMCs’) to distinguish between patients with benign tumors vs. malignant tumors vs. no
tumors (healthy controls).
The
patent application specifically covers methods for capturing consistent data from infrared spectroscopy readers, as well as the application
of various artificial intelligence algorithm development methods to the data. The ability of TBIA to make a diagnosis of cancer has first
been applied to the detection of breast and colon cancers, where Todos has received CE Marks in Europe paving the way for commercialization
initially focused on TMB-2 (dense breast / inconclusive mammogram secondary screening) and TMB-1 (general breast cancer screening) cancer
detection tests.
Financing
and Fundraising
On
June 19, 2020, the Company and its subsidiaries, Todos Medical USA and Corona Diagnostics, LLC (“Corona”) entered into a
Receivables Financing Agreement with Toledo Advisors, LLC (“Toledo”) for up to $25,000,000 in a revolving receivables financing
facility (the “Facility”). The availability of the Facility shall terminate on the earlier of June 19, 2025 and the date
on which more than $25,000,000 has been advanced. The financing is secured by all of the assets of the Company’s wholly-owned subsidiary
Todos Medical USA, Inc. In addition, Todos Medical USA pledged all of the outstanding equity of Corona to the Lender. The initial draw
under the Facility was on June 19, 2020 for $165,000 which was due on the earlier to occur of (i) ninety days following the date the
draw was made by the Lender and (ii) the date the receivable, for which the draw was made, is paid. The Facility has since been repaid.
In
November 2020, the parties agreed to amend the Facility to reduce the cost of funding to Todos Medical USA, and to make the relationship
between Corona and Toledo nonexclusive in exchange for Toledo being granted a percentage of Corona’s revenues from diagnostic testing.
On
January 7, 2022, Toledo filed a complaint against Corona, Todos Medical USA, and the Company (the “Todos Defendants”), seeking
unspecified damages for breach of the aforesaid agreements and claiming that at least $139,000 is due under the royalty agreement. The
Todos Defendants filed an answer and counterclaim on February 9, 2022, wherein various affirmative defenses were asserted, the allegations
of the complaint were denied, and the Company asserted counterclaims for breach of contract and other relief.
On April 7, 2022, the
Company and Toledo signed a Settlement Agreement pursuant to which upon execution of the agreement the Company paid Toledo $130,000 and
issued to Toledo $200,000 worth of ordinary shares. The parties agreed that upon delivery of the cash payment and shares, the parties
would discontinue the complaint filed by Toledo on January 7, 2022, and that Toledo irrevocably and unconditionally releases and discharges
the Company from its June 19, 2020 financing agreement and July 28, 2020 Royalty Agreement.
On January 22, 2021, we entered
into a Securities Purchase Agreement (the “SPA”) with Yozma Global Genomic Fund (the “Purchaser”) pursuant to
which on January 29, 2021, the Company issued a promissory convertible note (the “Note”) to the Purchaser in the principal
amount of $4,857,143 for proceeds of $3,400,000 (the “Transaction”). The Note has a maturity date of one year from the date
of issuance and pays interest at a rate of 4% per annum. The Note is convertible into Ordinary Shares of the Company (the “Conversion
Shares”) at a conversion price of $0.0599 (the “Conversion Price). In addition, the Purchaser received a warrant (the “Warrant”)
to purchase up to 16,956,929 Ordinary Shares (the “Warrant Shares”) of the Company with an exercise price equal to $0.107415
per share. The Warrant is exercisable for 5 years from the date of issuance. In the event that the Company effectuates a reverse split
of its ordinary shares for a ratio in excess of 20:1, the resulting adjusted Warrant Shares and Exercise Price are limited to a 20:1 ratio.
The
Company and Leviston Resources LLC, a Delaware limited liability company (the “Purchaser”) are parties to that certain Securities
Purchase Agreement, dated as of July 9, 2020 (the “Purchase Agreement”), pursuant to which the Purchaser purchased an aggregate
principal amount of $850,000 of convertible notes (the “July 2020 Convertible Notes”) from the Company. On March 3, 2021,
the Company and the Purchaser entered into a Closing Agreement (the “Closing Agreement”) pursuant to which the Purchaser
exercised its right to invest an additional $847,570 into the Company of July 2020 Convertible Notes (the “Tranche 2 Securities”).
On
April 8, 2021, the Company entered into a Securities Purchase Agreement (the “SPA”) with Kips Bay Select LP (the “Purchaser”)
pursuant to which the Company agreed to issue a promissory convertible note (the “Note”) to the Purchaser in the principal
amount of $4,285,714 for proceeds of $3,000,000 (the “Transaction”). The closing occurred on April 12, 2021 (the “Closing
Date”). The Note has a maturity date of one year from the date of issuance and pays interest at a rate of 4% per annum. The Note
is convertible into Ordinary Shares (the “Conversion Shares”) at a conversion price of $0.0599 (the “Conversion Price).
In addition, the Purchaser received a warrant (the “Warrant”) to purchase up to 16,000,000 Ordinary Shares (the “Warrant
Shares”) of the Company with an exercise price equal to $0.107415 per share. The Warrant is exercisable for 5 years from the date
of issuance. In the event that the Company effectuates a reverse split of its Ordinary shares for a ratio in excess of 20:1, the resulting
adjusted Warrant Shares and Exercise Price are limited to a 20:1 ratio. The Company used the net proceeds from this Note to initiate
the Phase 2 for Tollovir™ clinical trial in COVID-19 patients, complete the acquisition of Provista Diagnostics, Inc. and for general
corporate purposes.
Until
May 5, 2022, the Purchaser had the option to purchase an additional Note in the principal amount of $5,285,714.20 for proceeds of $3,700,000
and an additional Warrant to purchase 16,000,000 Ordinary Shares.
On
July 7, 2021, the Company entered into a Securities Purchase Agreement (the “SPA”) with Kips Bay Select LP (the “Purchaser”)
pursuant to which the Company agreed to issue a promissory convertible note (the “Note”) to the Purchaser in the principal
amount of $1,535,714 for proceeds of $1,075,000 (the “Transaction”). The closing occurred on July 7, 2021 (the “Closing
Date”). The Note has a maturity date of one year from the date of issuance and pays interest at a rate of 4% per annum. The Note
is convertible into Ordinary Shares of the Company (the “Conversion Shares”) at a conversion price of $0.0599 (the “Conversion
Price). In addition, the Purchaser received a warrant (the “Warrant”) to purchase up to 3,440,000 Ordinary Shares (the “Warrant
Shares”) of the Company with an exercise price equal to $0.107415 per share. The Warrant is exercisable for 5 years from the date
of issuance. From the Closing Date until 180 days thereafter, the Company shall be restricted from issuing or entering into any agreement
to issue any Ordinary Shares, except under certain circumstances, including an uplisting. This provision shall no longer be in effect
if the closing sale price of the Ordinary shares exceeds $0.10. The Company intends to use the net proceeds for general corporate purposes.
On September 23, 2021, the Company
completed the conditions precedent required to enter into a Securities Purchase Agreement (the “SPA”) with Mercer Street Global
Opportunity Fund, LLC (the “Purchaser”) pursuant to which the Company issued a promissory convertible note (the “Note”)
to the Purchaser in the principal amount of $2,285,143 for proceeds of $2,000,000 (the “Transaction”). The Note has a maturity
date of one year from the date of issuance and pays interest at a rate of 4% per annum. The Note is convertible into Ordinary Shares of
the Company (the “Conversion Shares”) at a conversion price of $0.0599 (the “Conversion Price). In addition, the Purchaser
received a warrant (the “Warrant”) to purchase up to 11,924,636 Ordinary Shares (the “Warrant Shares”) of the
Company with an exercise price equal to $0.107415 per share. The Warrant is exercisable for 5 years from the date of issuance. The Company
intends to use the net proceeds from this Note to initiate Phase 2/3 trials for Tollovir™ COVID-19 patients, initiate digital marketing
for its dietary supplement Tollovid®, increase sales & marketing for Provista Diagnostics, and for general corporate purposes.
On
November 22, 2021, the Company entered into a Securities Purchase Agreement (the “SPA”) with T-Cell Protect Hellas S.A. (“T-Cell
Protect”) 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 ordinary shares (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
January 13, 2022, the Company issued 1,500,000 ordinary shares to a service provider, valued at $711,000, of which 1,250,000
ordinary shares were issued in exchange of previous commitment to issue a fixed number of shares.
During
the period of three months ended March 31, 2022, Principal Amount and unpaid Interest in total amount of $613,000 have been converted
into 97,611,464 ordinary shares.
On February 4, 2022 and March
10, 2022, the Company issued total of 49,620,690 ordinary shares as partial conversion of $1,804,000 of principal and accrued interest,
out of $3,500,000 convertible note granted to Provista Diagnostics, Inc.
On March 14, 2022, the
Company and Testing 123, LLC (the “Lender”) signed a Revolving Line of Credit Agreement, pursuant to which the Lender will
provide the Company with a credit facility of up to $1,250,000 bearing a monthly interest of 5% calculated for a minimum period of 60
days. The Company may request advances under the agreement from the date of the agreement and until March 14, 2023. The Maturity date
of each draw will be the earlier of (i) 60 days from the date of the loan, (ii) the occurrence of an event of default as defined in the
agreement and (iii) with respect to funds received by Borrower through collections on receivables included in a Receivables Pool, as
defined in the agreement, 3 days after such funds have been received by the escrow account agent or the Company. Additionally, under
the terms of the Revolving Line of Credit Agreement, the Company agreed to issue to Testing 123, LLC, shares equal to a 10% ownership
stake in Provista, which interest is protected against dilution. As of March 31, 2022, the Company utilized $999,000 out of the credit facility. The Company has estimated the portion
of the 10% shares of Provista at $740,000 and recorded $598,000 as interest expenses and $142,000 as prepaid interest expenses under Other
Current Assets.
During
the first quarter of 2021, the Company’s contractual agreement to supply Covid-19 testing kits to NOAH Laboratories, Inc., a significant
customer expired. At the customer’s request, the Company continued to supply Covid-19 testing kits until such time as the customer
requested that the Company stop doing so. The customer has not yet paid for some of the Covid-19 testing kits so supplied and has not
yet renewed its agreement with the Company. On November 15, 2021, Todos USA sent a demand letter (the “Demand Letter”) to
the significant customer with which our contractual agreement to supply Covid-19 testing kits expired. The Demand Letter seeks (a) payment
for testing kits that Todos USA supplied for which it was not paid, in the amount of $3,465,000, (b) the return of Todos USA’s
equipment, title to which remains with Todos USA unless and until the significant customer meets a minimum purchase requirement, and
(c) payment of damages as a result of the significant customer’s unlawful retention of Todos USA’s equipment, in an amount
anticipated to be $2 million. The Company and Todos USA are negotiating a settlement with NOAH Laboratories, Inc., which the Company
believes will result in most of the Company’s demands being met.
On
November 4, 2020, we entered into a Secured Convertible Equipment Loan Agreement with Friends of Yeshiva Orot Hateshuva Inc. (“Friends”),
pursuant to which Friends lent us $450,000 to purchase two liquid handler machines. Under the terms of the agreement, the note was issued
with 41.4% Original Issue Discount, with Friends receiving a royalty of 12.5% of all amounts resulting from any diagnostic tests performed
by the two liquid handler machines. During the initial payback period and up until the earlier of either (a) the Maturity Date, or (b)
the aggregate loan amount is paid in full, all Royalty payments made to Investor will be counted towards their loan balance. Thereafter,
the royalties continue so long as the machines are in use. The Maturity Date was March 4, 2021. On March 4, 2021, the Company and Friends
agreed to extend the maturity date of the note to May 1, 2021, in exchange for a payment of $100,000 and the issuance of 2,000,000 ordinary
shares, in each case to a charity designated by Friends. As of March 25, 2022, the Company has not made any royalty payments to Friends.
The note has been repaid.
On
December 31, 2020, we entered into a Secured Convertible Equipment Loan Agreement with Harper Advance LLC (“Harper”), pursuant
to which Harper lent us $450,000 to purchase two liquid handler machines. Under the terms of the agreement, the note was issued with
40% Original Issue Discount, with Harper receiving a royalty of 12.5% of all amounts resulting from any diagnostic tests performed by
the two liquid handler machines. During the initial payback period and up until the earlier of either (a) the Maturity Date, or (b) the
aggregate loan amount is paid in full, all Royalty payments made to Investor will be counted towards their loan balance. Thereafter,
the royalties continue so long as the machines are in use. The Maturity Date is April 30, 2021. As of March 25, 2022, the Company has
not made any royalty payments to Harper. Harper’s note was purchased by another investor and converted into ordinary shares of
the Company.
Reverse
Split
At
an extraordinary general meeting of our shareholders held on July 26, 2021, our shareholders voted to approve a reverse share split of
the Company’s ordinary shares within a range of 1:2 to 1:500, to be effective at the ratio and on a date to be determined by the
Board of Directors of the Company (the “Reverse Split”). Although our shareholders approved the Reverse Split, all per share
amounts and calculations in this quarterly report on Form 10-Q and the accompanying financial statements do not reflect the effects of
the Reverse Split, as the Board of Directors has not determined the ratio or the effective date of the Reverse Split. At its next general
meeting, Todos’ shareholders will be asked to approve an extension of the deadline for the Reverse Split.
The
Purchase Agreement with Lincoln Park
On
August 4, 2020, we entered into a purchase agreement (the “LPC Purchase Agreement”) with Lincoln Park Capital, LLC (“Lincoln
Park”), pursuant to which Lincoln Park agreed to purchase from us up to an aggregate of $10,275,000 of our ordinary shares (subject
to certain limitations) from time to time over the term of the LPC Purchase Agreement. Also on August 4, 2020, we entered into a registration
rights agreement with Lincoln Park, pursuant to which on August 11, 2020, we filed with the Securities and Exchange Commission, or the
SEC, a registration statement (the “LPC Registration Statement”) to register for resale under the Securities Act of 1933,
as amended, or the Securities Act, the ordinary shares that have been or may be issued to Lincoln Park under the Purchase Agreement.
That registration statement became effective on August 18, 2020.
The
LPC Registration Statement covers the resale by Lincoln Park of up to 50,000,000 ordinary shares, comprised of: (i) 5,812,500 ordinary
shares that we issued to Lincoln Park as a fee for making its irrevocable commitment to purchase our ordinary shares under the Purchase
Agreement, which we refer to in this quarterly report on Form 10-Q as the Commitment Shares, (ii) 3,437,500 ordinary shares that we sold
to Lincoln Park on August 5, 2020 for a total purchase price of $275,000 in an initial purchase under the Purchase Agreement the (“Initial
Purchase Shares”), and (iii) up to an additional 40,750,000 ordinary shares that we have reserved for sale to Lincoln Park under
the LPC Purchase Agreement from time to time after the date of the LPC Registration Statement, if and when we determine to sell additional
ordinary shares to Lincoln Park under the LPC Purchase Agreement. Since August 18, 2020, Lincoln Park has purchased 37,977,388 of our
ordinary shares under the Purchase Agreement, at prices ranging from $ 0.038 per share to $ 0.115 per share. The Company does not currently
expect to sell any more shares to Lincoln Park under the LPC Purchase Agreement.
The
Purchase Agreement prohibits us from directing Lincoln Park to purchase any ordinary shares if those ordinary shares, when aggregated
with all other ordinary shares then beneficially owned by Lincoln Park and its affiliates, would result in Lincoln Park having beneficial
ownership, at any single point in time, of more than 4.99% of the then total outstanding ordinary shares, as calculated pursuant to Section
13(d) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and Rule 13d-3 thereunder, which limitation we refer to
as the Beneficial Ownership Cap.
Issuances
of our ordinary shares to Lincoln Park under the Purchase Agreement will not affect the rights or privileges of our existing shareholders,
except that the economic and voting interests of each of our existing shareholders will be diluted as a result of any such issuance.
Although the number of ordinary shares that our existing shareholders own will not decrease, the ordinary shares owned by our existing
shareholders will represent a smaller percentage of our total outstanding ordinary shares after any such issuance of ordinary shares
to Lincoln Park under the Purchase Agreement.
SARS-nCoV-2
Related Business
With
the onset of COVID-19, Todos sought to apply its expertise in developing blood tests for the early detection of cancer and Alzheimer’s
disease to distributing and then developing screening tests for the pandemic.
On
March 23, 2021, we announced that we have entered into an automation and reagent supply agreement with MAJL Diagnostics (“MAJL”).
Under the terms of the agreement, Todos will implement its automation solution, including Tecan™ liquid handlers, automated RNA
extraction machines, as well as a 384-well PCR machine capable of conducting COVID, cancer genetics and pharmacogenomics testing, in
order to become the provider of all COVID-19 PCR testing reagents and supplies.
On
March 29, 2021, we announced the successful installation of automated lab equipment and completion of training for a lab client in Brooklyn,
NY. The implementation of the Todos automation solution has expanded the lab’s processing capacity to 6,000 PCR tests per day from
500 PCR tests per day, with the potential to quickly expand to up to 12,000 PCR tests per day. The lab will be implementing EUA approved
PCR testing for COVID-19 testing, as well as COVID + influenza A & B PCR testing upon request for select clients. Additionally, through
the future implementation of pooling, the lab could potentially increase processing capacity to in excess of 40,000 PCR tests per day
at a 4:1 ratio.
On
March 30, 2021, we announced that we have entered into a distribution partnership with Osang Healthcare (OHC) of South Korea, to distribute
the GeneFinder™ COVID-19 Plus RealAMP Kit in the United States. Todos intends to make GeneFinder Plus the primary kit used for
distribution in its fully integrated and automated COVID-19 PCR testing lab solutions. GeneFinder Plus has been granted Emergency Use
Authorization (EUA) by the US FDA.
We
market our COVID-19 test kits directly to clinical laboratories throughout the U.S. as well as through our distributors, who include
Meridian, Dynamic Distributors, LLC, and others.
On
March 11, 2022, we entered into a Share Purchase Agreement with 3CL Sciences Ltd. (“3CL”) and NLC Pharma Ltd. (“NLC”),
pursuant to which we will acquire 52% of the issued and outstanding shares of 3CL and NLC will acquire 48% of the issued and outstanding
shares of 3CL (the “Share Purchase Agreement”). Immediately prior to entering into the Share Purchase Agreement, NLC conveyed
to 3CL all of the therapeutic, diagnostic, dietary supplement and pharmaceutical assets from NLC that relate to 3CL protease biology
(which is used in the development, manufacture, sale and distribution of Tollovid™ and Tollovir™).
In
consideration of the 3CL shares being issued to us, we undertook to raise $10,000,000 for 3CL and committed to issue to NLC $3,800,000
worth of our ordinary shares, based upon the closing price for our ordinary shares the day before the closing of the Share Purchase Agreement.
The Company and NLC agreed to identify a seasoned biopharmaceutical CEO to run 3CL going forward. The board of directors of 3CL Sciences
will be made up of five (5) individuals: three (3) appointed by the Company and two (2) appointed by NLC. We anticipate that the Share
Purchase Agreement will close during the second quarter of 2022.
On
April 19, 2021, the Company entered into an Agreement to Purchase Provista Diagnostics, Inc. (“Agreement to Purchase”) with
Strategic Investment Holdings, LLC (“SIH”), Ascenda BioSciences LLC (“Ascenda”) and Provista Diagnostics, Inc.
(“Provista”). Ascenda was the sole owner of the outstanding securities of Provista and SIH is the sole owner of all the outstanding
securities of Ascenda.
Pursuant
to the Agreement to Purchase, the Company acquired Provista from Ascenda and SIH for an aggregate purchase price of $7.5 million consisting
of an initial cash payment of $1.25 million, the issuance of $1.5 million in Ordinary Shares priced at $0.0512 per share, the issuance
to SIH of a $3.5 million convertible promissory note dated April 19, 2021 (the “Note”) and the payment on for before July
1, 2021 of $1.25 million in cash (the “July Payment”), which payment the Company had the right to, and did, extend to July
15, 2021. The Provista shares acquired by the Company remained in an escrow account until the July Payment was made.
The
Note has a maturity date of April 8, 2025, and is convertible beginning on October 20, 2021, into Ordinary Shares of the Company at a
conversion price equal to the lesser of $0.05 or the volume weighted average price of the last 20 trading days for the Ordinary Shares
prior to the date of conversion. In the event SIH delivers a Notice of Conversion to the Company at a per share price less than $0.05
($0.05), the Company has the right to immediately notify SIH of its intention to pay the conversion amount in cash within three (3) business
days of receipt of the Notice of Conversion (i.e., before SIH would take possession of shares converted under the Notice of Conversion).
If, at any time between October 20, 2021 and April 20, 2022, the average of the lowest bid and closing sale price at 4:00:00 p.m., New
York time (or such other time as such market publicly announces is the official close of trading) is below ($0.05), the Company has the
option to buy out all or any portion of the Note (the “Buyback Option”). In the event the Company exercises the Buyback Option
for an amount equal to or greater than one million, one hundred seventy thousand dollars ($1,170,000) (the “Buyback Amount”),
SIH may not submit any conversions below five cents ($0.05) for ninety (90) days from receipt of the Buyback Amount (“90 Day Period”).
In
the event that the Company uplists its Ordinary Shares to a national securities exchange, the Note shall automatically be exchanged into
Series B preferred stock with a conversion price equal to the lesser of (a) $0.05, (b) the opening price on the day of the uplisting
provides there is no transaction associated with the uplisting or (c) the deal price of an uplisting transaction.
As
of the date of this quarterly report on Form 10-Q, SIH has not submitted a Conversion Notice.
Employees
and Consultants
During
2021, the Company hired 23 new employees, including management and staffing of laboratory, sales and marketing and general administrative
staffing.