MYMETICS CORP - Quarter Report: 2019 September (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For
the quarterly period ended September 30, 2019
or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For
the transition period from __________ to _________
Commission
file number: 000-25132
MYMETICS CORPORATION
(Exact name of registrant as specified in its charter)
DELAWARE
|
25-1741849
|
State or Other
jurisdiction of Incorporation or
Organization
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I.R.S.
Employer Identification No.
|
c/o
Mymetics SA
Route
de la Corniche 4
Epalinges,
Switzerland
|
CH-1066
|
Address
of Principal Executive Offices
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Zip
Code
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011 41 21 653 4535
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Registrant’s Telephone Number, Including Area
Code
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|
Former Name, Former Address and Former Fiscal Year, if Changed
Since Last Report
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Securities registered pursuant to Section 12(b) of the
Act:
Title of each class
|
|
Trading
Symbol(s)
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|
Name of each exchange on which registered
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Common
Stock, Par Value $0.01 per share
|
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MYMX
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OTCQB
venture stage marketplace
|
Indicate by check mark whether the registrant (1)
has filed all reports required to be filed by Section 13 or 15(d)
of the Securities Exchange Act of 1934 during the preceding 12
months (or for such shorter period that the Registrant was required
to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
Yes ☒
No ☐
Indicate by check mark whether the registrant has
submitted electronically and posted on its corporate Web site, if
any, every Interactive Data File required to be submitted and
posted pursuant to Rule 405 of Regulation S-T (§232.405 of
this chapter) during the preceding 12 months (or for such shorter
period that the registrant was required to submit and post such
files). Yes ☒
No ☐
Indicate
by check mark whether the registrant is a large accelerated filer,
an accelerated filer, a non-accelerated filer, smaller reporting
company, or an emerging growth company. See the definitions of
“large accelerated filer,” “accelerated
filer,” “smaller reporting company,” and
“emerging growth company” in Rule 12b-2 of the Exchange
Act.
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Large accelerated filer ☐
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Accelerated filer ☐
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Non-accelerated filer ☐
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Smaller reporting company ☒
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Emerging growth company ☐
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|
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|
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended
transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the
Exchange Act ☐
Indicate by check mark whether the registrant is a
shell company (as defined in Rule 12b-2 of the Act). Yes
☐
No ☒
APPLICABLE
ONLY TO CORPORATE ISSUERS
Indicate
the number of shares outstanding of each of the registrant's
classes of common stock, as of the latest practicable
date:
Class
|
|
Outstanding at November 12, 2019
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Common Stock, $0.01 par value
|
|
303,757,622
|
PART
I. FINANCIAL
INFORMATION
ITEM 1. FINANCIAL
STATEMENTS
MYMETICS CORPORATION
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In Thousands of Euros, Except Share and Per Share
Amounts)
|
September 30,
|
December 31,
|
|
2019
|
2018
|
|
|
|
ASSETS
|
|
|
Current
Assets
|
|
|
Cash
|
E316
|
E479
|
Receivables
|
162
|
585
|
Prepaid
expenses
|
117
|
37
|
Total
current assets
|
595
|
1,101
|
|
|
|
Property
and equipment, net of accumulated depreciation of E448 at September
30, 2019
and
E434 at December 31, 2018
|
22
|
36
|
Goodwill
|
6,671
|
6,671
|
|
E7,288
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E7,808
|
|
|
|
|
|
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LIABILITIES
AND SHAREHOLDERS' EQUITY (DEFICIT)
|
|
|
Current
Liabilities
|
|
|
Accounts
payable
|
E81
|
E75
|
Deferred
revenue
|
29
|
--
|
Non-convertible
notes payable and related accrued interest to related
parties
|
4,679
|
4,002
|
Convertible
notes payable and related accrued interest to related
parties
|
52,815
|
50,756
|
Total
liabilities
|
57,604
|
54,833
|
|
|
|
|
|
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Shareholders'
Equity (Deficit)
|
|
|
Common
stock, U.S. $0.01 par value; 1,000,000,000 shares authorized;
issued and outstanding 303,757,622 at September 30, 2019 and at
December 31, 2018
|
2,530
|
2,530
|
Preferred
stock, U.S. $0.01 par value; 5,000,000 shares authorized; none
issued or outstanding
|
--
|
--
|
Additional
paid-in capital
|
34,443
|
34,441
|
Accumulated
deficit
|
(87,979)
|
(84,675)
|
Accumulated
other comprehensive income
|
690
|
679
|
|
(50,316)
|
(47,025)
|
|
E7,288
|
E7,808
|
The accompanying notes are an integral part of these consolidated
financial statements.
2
MYMETICS CORPORATION
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
(In Thousands of Euros, Except Per Share Data)
|
For The Three Months Ended
September 30,
|
For The Nine Months Ended
September 30,
|
||
|
2019
|
2018
|
2019
|
2018
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
|
|
Research
and Development support
|
E--
|
E75
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E--
|
E75
|
Grants
|
242
|
199
|
370
|
685
|
|
242
|
274
|
370
|
760
|
Expenses
|
|
|
|
|
Research
and development
|
295
|
343
|
720
|
922
|
General
and administrative
|
243
|
319
|
770
|
832
|
Bank
fee
|
--
|
--
|
1
|
1
|
Depreciation
|
4
|
7
|
14
|
23
|
Directors'
fees
|
5
|
5
|
15
|
15
|
Foreign
exchange loss
|
113
|
11
|
135
|
84
|
|
660
|
685
|
1,655
|
1,877
|
|
|
|
|
|
Operating
Loss
|
(418)
|
(411)
|
(1,285)
|
(1,117)
|
|
|
|
|
|
Interest
expense
|
671
|
660
|
2,004
|
1,970
|
Loss
before income tax provision
|
(1,089)
|
(1,071)
|
(3,289)
|
(3,087)
|
|
|
|
|
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Income
tax provision
|
(5)
|
--
|
(15)
|
(14)
|
Net
Loss
|
(1,094)
|
(1,071)
|
(3,304)
|
(3,101)
|
|
|
|
|
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Other
comprehensive income
|
|
|
|
|
Foreign
currency translation adjustment
|
5
|
3
|
11
|
6
|
Comprehensive
loss
|
E(1,089)
|
E(1,068)
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E(3,293)
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E(3,095)
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|
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|
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|
|
|
|
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Basic
earnings per share
|
E(0.00)
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E(0.00)
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E(0.01)
|
E(0.01)
|
The accompanying notes are an integral part of these consolidated
financial statements.
3
MYMETICS
CORPORATION
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
(DEFICIT)
(UNAUDITED)
(In Thousands of Euros)
|
Three, Six and
Nine-month Period Ended September 30, 2018
|
||||
|
Common
Stock
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Additional Paid in
Capital
|
Accumulated
Deficit
|
Accumulated Other
Comprehensive Income
|
Total
|
January 1,
2018
|
E2,530
|
E34,428
|
E(80,503)
|
E667
|
E(42,878)
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Stock compensation
expense
|
|
6
|
|
|
6
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Net
loss
|
|
|
(898)
|
|
(898)
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Other comprehensive
loss:
|
|
|
|
|
|
Translation
adjustment
|
|
|
|
(1)
|
(1)
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March 31,
2018
|
E2,530
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E34,434
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E(81,401)
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E666
|
E(43,771)
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Stock compensation
expense
|
|
2
|
|
|
2
|
Net
loss
|
|
|
(1,132)
|
|
(1,132)
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Other comprehensive
income:
|
|
|
|
|
|
Translation
adjustment
|
|
|
|
4
|
4
|
June 30,
2018
|
E2,530
|
E34,436
|
E(82,533)
|
E670
|
E(44,897)
|
Stock compensation
expense
|
|
1
|
|
|
1
|
Net
loss
|
|
|
(1,071)
|
|
(1,071)
|
Other comprehensive
income:
|
|
|
|
|
|
Translation
adjustment
|
|
|
|
3
|
3
|
September 30,
2018
|
E2,530
|
E34,437
|
E(83,604)
|
E673
|
E(45,964)
|
4
|
Three, Six and
Nine-month Period Ended September 30, 2019
|
||||
|
Common
Stock
|
Additional Paid in
Capital
|
Accumulated
Deficit
|
Accumulated Other
Comprehensive Income
|
Total
|
January 1,
2019
|
E2,530
|
E34,441
|
E(84,675)
|
E679
|
E(47,025)
|
Stock compensation
expense
|
|
2
|
|
|
2
|
Net
loss
|
|
|
(1,228)
|
|
(1,228)
|
Other comprehensive
income:
|
|
|
|
|
|
Translation
adjustment
|
|
|
|
5
|
5
|
March 31,
2019
|
E2,530
|
E34,443
|
E(85,903)
|
E684
|
E(48,246)
|
Net
loss
|
|
|
(982)
|
|
(982)
|
Other comprehensive
income:
|
|
|
|
|
|
Translation
adjustment
|
|
|
|
1
|
1
|
June 30,
2019
|
E2,530
|
E34,443
|
E(86,885)
|
E685
|
E(49,227)
|
Stock compensation
expense
|
|
|
|
|
|
Net
loss
|
|
|
(1,094)
|
|
(1,094)
|
Other comprehensive
income:
|
|
|
|
|
|
Translation
adjustment
|
|
|
|
5
|
5
|
September 30,
2019
|
E2,530
|
E34,443
|
E(87,979)
|
E690
|
E(50,316)
|
The accompanying notes are an integral part of these consolidated
financial statements.
5
MYMETICS CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(In Thousands of Euros)
|
For The
Nine Months Ended
|
For The
Nine Months Ended
|
|
September
30, 2019
|
September
30, 2018
|
Cash Flow from Operating Activities
|
|
|
Net
loss
|
E(3,304)
|
E(3,101)
|
Adjustments
to reconcile net loss to net cash used in operating
activities
|
|
|
Depreciation
|
14
|
23
|
Stock
compensation expense – options
|
2
|
9
|
Changes
in operating assets and liabilities
|
|
|
Receivables
|
423
|
(258)
|
Prepaid
expenses
|
(80)
|
(2)
|
Accrued
interests on notes payable
|
2,136
|
2,050
|
Accounts
payable
|
6
|
(179)
|
Deferred
revenue
|
29
|
(274)
|
Net
cash used in operating activities
|
(774)
|
(1,732)
|
|
|
|
Cash Flows from Financing Activities
|
|
|
Increase
in notes payable
|
600
|
800
|
Net
cash provided by financing activities
|
600
|
800
|
|
|
|
Effect
of foreign exchange rate on cash
|
11
|
6
|
Net
decrease in cash
|
(163)
|
(926)
|
|
|
|
Cash,
beginning of period
|
479
|
1,180
|
Cash,
end of period
|
E316
|
E254
|
The accompanying notes are an integral part of these consolidated
financial statements.
6
MYMETICS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2019
(UNAUDITED)
Note 1. The Company and Summary of Significant Accounting
Policies
BASIS OF PRESENTATION AND GOING CONCERN
The
amounts in the notes are shown in thousands of EURO, unless
otherwise noted, and rounded to the nearest thousand except for
share and per share amounts.
The accompanying interim period consolidated financial
statements of Mymetics Corporation (the "Company") set forth herein
have been prepared by the Company pursuant to the rules and
regulations of the U.S. Securities and Exchange Commission (the
"SEC"). Certain information and footnote disclosure normally
included in financial statements prepared in accordance with
accounting principles generally accepted in the United States have
been condensed or omitted pursuant to such SEC rules and
regulations. The interim period consolidated financial statements
should be read together with the audited financial statements and
the accompanying notes included in the Company's latest annual
report on Form 10-K for the fiscal year ended December 31,
2018.
The accompanying financial statements of the Company
are unaudited. However, in the opinion of the Company, the
unaudited consolidated financial statements contained herein
contain all adjustments necessary to present a fair statement of
the results of the interim periods presented. All adjustments made
during the three-month period and nine-month period ending
September 30, 2019 were of a normal and recurring
nature.
The Company was created for the purpose of engaging in
vaccine research and development. Its main research efforts in the
beginning have been concentrated in the prevention and treatment of
the AIDS virus and malaria. Mymetics’ core technology and
expertise are in the use of virosomes, lipid-based carriers
containing functional fusion viral proteins and natural membrane
proteins, in combination with rationally designed antigens. This
technology platform has broadened the Company’s focus on the
development of next-generation preventative vaccines for infectious
and life disabling diseases. It has several vaccines in its
pipeline: HIV-1/AIDS and malaria and several ongoing collaborative
projects in the field of allergy and oncology Immunotherapy. The
RSV, intra nasal influenza and Chikungunya vaccines are currently
on hold.
The Company has established a network which enables it
to work with education centers, research centers, pharmaceutical
laboratories and biotechnology companies.
As of September 30, 2019, the Company was engaged in
the pre-clinical testing of some of its vaccine candidates and a
commercially viable product is not expected for several more years.
The Company is working on several research projects with commercial
partners for immunotherapy in the fields of allergy and oncology.
The allergy project is in collaboration with Anergis SA, for which
the Company prepared virosome based vaccines which include Anergis
peptides for treating birch pollen allergy. These formulations were
tested in preclinical studies and compared to the Anergis earlier
clinical trial formulations. The success criteria were met in
December 2018 and Anergis has now a time limited exclusive option
to enter into a License and Collaboration Agreement
(“LCA”) with Mymetics for the use of virosomes in the
field of allergies that will require Anergis to raise funds from
third parties to pay Mymetics the license fee under the terms of
the LCA and the clinical development, and there is no certainty
that Anergis will be able to do so. At the end of 2018 the Company
finished the grant funded project in the field of HIV from the EU
Horizon 2020 and Switzerland SERI which focused on developing
thermostable and cold chain independent virosome based vaccines
(MACIVIVA project). Management believes that the Company’s
research and development activities will result in valuable
intellectual property that can generate significant revenues in the
future through licensing. Vaccines are one of the fastest growing
markets in the pharmaceutical industry.
On April 29, 2019, the National Institutes of Health
(NIH) awarded the Company and Texas Biomedical Research Institute
(Texas Biomed) a five-year grant for the project called “Cold
Chain-independent, Needle-free Mucosal Virosomal Vaccine to Prevent
HIV-1 Acquisition at Mucosal Levels”. The project started on
May 1, 2019 and is planned for five years. The overall budget
related to the project is USD 8.67 million, with USD 1.9 million
approved for the first year. The overall portion of the grant
allocated to the Company is USD 6.76 million, with USD 1.2 million
approved for the first year. It is co-led by Texas Biomed and the
Company and includes sub-awards to the University of Louisiana at
Lafayette, and the University of Virginia. First results are
expected to be reported in 2020.
7
The project has the objective to prepare the
Company’s promising HIV-1 vaccine candidate for clinical
trials, by first executing a non-human primate (NHP) study, where
the test subjects will be receiving Mymetics’ virosome based
HIV-1 vaccine candidate by several intra-muscular and intra-nasal
applications, followed by rectal challenges. As of September 30,
2019 Mymetics has successfully produced the first set of virosome
based vaccines and the NHPs have received two vaccinations. Other
vaccinations are planned during the fourth quarter and in January
2020. The vaccine is created to induce protective mucosal
antibodies acting as a frontline defense against sexual HIV
transmission. This newly awarded grant from the NIH can continue
some of the developments that were achieved during the European
Horizon 2020 project.
These consolidated financial statements have been
prepared assuming the Company will continue as a going concern. The
Company has experienced negative cash flows from operations and
significant losses since inception resulting in an accumulated
deficit of E87,979 at September 30, 2019. Further, the
Company’s current liabilities exceed its current assets by
E57,009 as of September 30, 2019, and there is no assurance that
cash will become available to pay current liabilities in the near
term. Management is seeking additional financing but there can be
no assurance that management will be successful in any of those
efforts. These conditions raise substantial doubt about our ability
to continue as a going concern within one year from the issuance of
the financial statements.
PRINCIPLES OF CONSOLIDATION
The
consolidated financial statements include the accounts of the
Company and its subsidiaries. Significant intercompany accounts and
transactions have been eliminated.
NEW ACCOUNTING PRONOUNCEMENT
In February 2016, the Financial Accounting Standards
Board (FASB) issued Accounting Standards Update No. 2016-02,
Leases: Topic 842 (ASU 2016-02), which replaces existing lease
guidance. The new standard is intended to provide enhanced
transparency and comparability by requiring lessees to record
right-of-use (ROU) assets and corresponding lease liabilities on
the balance sheet. The new standard initially required application
with a modified retrospective approach to each prior reporting
period presented with various optional practical expedients. In
July 2018, this requirement was amended with the issuance of
Accounting Standards Update No. 2018-11, Leases: Topic 842:
Targeted Improvements (ASU 2018-11), which permits an additional
(and optional) transition method to adopt the new leases
standard.
The Company adopted ASU 2016-02 and related ASUs,
collectively ASC 842, on January 1, 2019 using the optional
transition method. Consequently, periods before January 1, 2019
will continue to be reported in accordance with the prior
accounting guidance, ASC 840, Leases.
The Company elected the package of practical
expedients, which permits the Company to retain prior conclusions
about lease identification, lease classification and initial direct
costs for leases that commenced before January 1, 2019. The new
standard also provides practical expedients for an entity’s
ongoing accounting. The Company elected the short-term lease
recognition exemption for all leases that qualify. The Company also
elected the practical expedient to combine lease and non-lease
components for all of its leases. Adoption of ASC 842 did not
affect the Company’s consolidated financial statements’
at January 1, 2019, as one of its leases is considered short-term
and the other is not material to the consolidated financial
statements.
FOREIGN CURRENCY TRANSLATION
The
Company translates non-Euro assets and liabilities of its
subsidiaries at the rate of exchange at the balance sheet date.
Revenues and expenses are translated at the average rate of
exchange throughout the period. Unrealized gains or losses from
these translations are reported as a separate component of
comprehensive income. Transaction gains or losses are included in
foreign exchange (gain) loss in the consolidated statements of
comprehensive loss. The translation adjustments do not recognize
the effect of income tax because the Company expects to reinvest
the amounts indefinitely in operations. The Company's reporting
currency is the Euro because substantially all of the Company's
activities are conducted in Europe.
CASH
The Company consider all highly liquid investments
purchased with maturities of three months or less to be cash
equivalents. Cash deposits are occasionally in excess of insured
amounts.
8
REVENUE RECOGNITION
Under
Topic 606, an entity recognizes revenue when its customer obtains
control of promised goods or services, in an amount that reflects
the consideration which the entity expects to receive in exchange
for those goods or services. To determine revenue recognition for
arrangements that an entity determines are within the scope of
Topic 606, the entity performs the following five steps: (i)
identify the contract(s) with a customer; (ii) identify the
performance obligations in the contract; (iii) determine the
transaction price; (iv) allocate the transaction price to the
performance obligations in the contract; and (v) recognize revenue
when (or as) the entity satisfies a performance obligation. We only
apply the five-step model to contracts when it is probable that the
entity will collect the consideration it is entitled to in exchange
for the goods or services it transfers to the customer. At contract
inception, once the contract is determined to be within the scope
of Topic 606, we assess the goods or services promised within each
contract and determine those that are performance obligations, and
assess whether each promised good or service is distinct. We then
recognize as revenue the amount of the transaction price that is
allocated to the respective performance obligation when (or as) the
performance obligation is satisfied.
The Company has concluded that government grants are
not within the scope of Topic 606, as they do not meet the
definition of a contract with a “customer”. The company
concludes the definition of a contract with a
“customer” was not met as the counterparty to the
government grants has not contracted to obtain goods or services
and thus the contracts are not considered to have commercial
substance. Government grants provide the Company with payments for
certain types of expenditures related to research and development
activities over a contractually defined period. Revenue from
government grants is recognized in the period during which the
related costs are incurred, provided that the applicable conditions
under the government contracts have been met.
Grant Revenue - HORIZON 2020
In April 2015, the Company was selected to receive
project grants with a total of E8.4 million. A total of E5.3
million would be funded as part of Horizon 2020, the European Union
research and innovation framework program and up to E3.1 million of
funding would be provided by the Swiss State “Secretariat for
Education, Research and Innovation” (SERI) for the Swiss
based consortium partners. The grant funded the evaluation,
development and manufacturing scale-up of thermo-stable and
cold-chain independent nano-pharmaceutical virosome-based vaccine
candidates. Of the total amount, E3.8 million was directly
attributable to the Company’s activities, with the remaining
balance going to the consortium partners and has not been part of
the Company’s financial statements. The project started on
May 4, 2015 and officially ended on November 3, 2018, after which a
final report had been prepared, presented and submitted to the EU
for a total costs declared of E8,262 for the total project and
E3,673 for the Company.
The amounts mentioned in the following statements are
purely related to the Company and not to the other partners in the
project: The Company received a pre-payment from the two granting
organizations for a total value of E1,554 in May 2015, a second
tranche of E917 from the EU was received in December 2016, and E614
from “SERI” was received in April 2017, which was used
to finance the next reporting covering the period of November 2016
to October 2017. In November 2017, the Company submitted the second
report and a new funding request, which resulted in another tranche
of funding from the EU of E77 received in February 2018. This
brought the total funding received at December 31, 2018 to E3,162,
which represented 82% of the awarded grant contribution. On
December 21, 2018, the final report was submitted to the EU with a
total cost incurred by the Company of E3,673, which represented 96%
of the maximum grant. The report has been audited and validated by
the EU and SERI for a total eligible cost of E3,368. As a result,
the Company received a final amount of E164 by the EU in February
2019 and E342 by SERI in March 2019 and no additional revenue has
been recognized related to this grant during the period ended
September 30, 2019.
Grant Revenue - NIH
On April 29, 2019, the National Institutes of Health
(NIH) awarded the Company and Texas Biomedical Research Institute
(Texas Biomed) a five-year grant for the project called “Cold
Chain-independent, Needle-free Mucosal Virosomal Vaccine to Prevent
HIV-1 Acquisition at Mucosal Levels”. The project started on
May 1, 2019 and is planned for five years. The overall budget
related to the project is USD 8.67 million, with USD 1.9 million
approved for the first year. The overall portion of the grant
allocated to the Company is USD 6.76 million, with USD 1.2 million
approved for the first year. It is co-led by Texas Biomed and the
Company and includes sub-awards to the University of Louisiana at
Lafayette and the University of Virginia. First results are
expected to be reported in 2020.
The amounts mentioned in the following statements are purely
related to the Company and not to the other partners in the
project: The funds are released by Texas Biomed within 45 days upon
receipt of a monthly invoice from the Company. The cost incurred by
the Company as of September 30, 2019 has been invoiced
to Texas
Biomed for a total of US$410 (E370) and recognized as
revenue.
9
License Agreement – Upperton Ltd.
On July 26, 2019 Mymetics and Upperton Ltd. signed a
License Agreement (the “Agreement”) that sets out the
rights and obligations of the two parties with respect to the
development, manufacturing and exploitation of certain virus-like
particles based vaccines (which includes virosomes) into solid
(powder or tablet) form that are based on each party’s
background or pre-existing intellectual property (“IP”)
and the foreground IP rights or the IP that was developed by either
party or both parties during the Maciviva project and could be
developed during future collaborations.
Under the terms of the Agreement Mymetics receives an exclusive and
royalty free, worldwide license to use the Upperton background IP
for the development, research, sale or in/out license for
virus-like particle vaccines that use the foreground IP rights. All
title, right and interest in and to all foreground IP rights vests
in Mymetics for such development, research, sale or in/out license,
and Mymetics is free to use and exploit such foreground IP
rights.
Mymetics has provided Upperton the non-exclusive license to
manufacture virus-like particle based vaccines for third parties
for indications other than respiratory viruses, certain allergies,
HIV, malaria and chikungunya.
For these foreground IP licenses, the parties have agreed to pay
each other a certain low single digit percentage of revenues,
license fees and royalties that each of the parties receives from
their exploitation.
RECEIVABLES
Receivables
are stated at their outstanding principal balances. Management
reviews the collectability of receivables on a periodic basis and
determines the appropriate amount of any allowance. There was no
allowance necessary at September 30, 2019 or December 31, 2018. The
Company writes off receivables to the allowance when management
determines that a receivable is not collectible. The Company may
retain a security interest in the products sold.
PROPERTY AND EQUIPMENT
Property
and equipment is recorded at cost and is depreciated over its
estimated useful life on straight-line basis from the date placed
in service. Estimated useful lives are usually taken as three
years.
IMPAIRMENT OF LONGLIVED ASSETS
Long-lived
assets, which include property and equipment, are assessed for
impairment whenever events or changes in circumstances indicate the
carrying amount of the asset may not be recoverable. The impairment
testing involves comparing the carrying amount to the forecasted
undiscounted future cash flows generated by that asset. In the
event the carrying value of the assets exceeds the undiscounted
future cash flows generated by that asset and the carrying value is
not considered recoverable, impairment exists. An impairment loss
is measured as the excess of the asset’s carrying value over
its fair value, calculated using a discounted future cash flow
method. An impairment loss would be recognized in net income (loss)
in the period that the impairment occurs.
GOODWILL
Goodwill represents the excess of purchase price over
the value assigned to the net tangible and identifiable intangible
assets of a business acquired. The Company typically performs its
annual goodwill impairment test effective as of April 1 of each
year, unless events or circumstances indicate impairment may have
occurred before that time. The Company assesses qualitative factors
to determine whether it is more likely than not that the fair value
of the reporting unit is less than its carrying amount. After
assessing qualitative factors, the Company determined that no
further testing was necessary. If further testing was necessary,
the Company would determine the fair value of each reporting unit
and compare the fair value to the reporting unit’s carrying
amount. The Company has one reporting unit.
RESEARCH AND DEVELOPMENT
Research
and development costs are expensed as incurred.
10
TAXES ON INCOME
The
Company accounts for income taxes under an asset and liability
approach that requires the recognition of deferred tax assets and
liabilities for expected future tax consequences of events that
have been recognized in the Company's financial statements or tax
returns. In estimating future tax consequences, the Company
generally considers all expected future events other than
enactments of changes in the tax laws or rates.
The
Company reports a liability, if any, for unrecognized tax benefits
resulting from uncertain income tax positions taken or expected to
be taken in an income tax return. Estimated interest and penalties,
if any, are recorded as a component of interest expense and other
expense, respectively.
The
Company has not recorded any liabilities for uncertain tax
positions or any related interest and penalties at September 30,
2019, or December 31, 2018. The Company’s United States tax
returns are open to audit for the years ended December 31, 2015 to
2018. The returns for the Swiss subsidiary, Mymetics S.A., are open
to audit for the year ended December 31, 2018. The returns for the
Netherlands subsidiaries, Bestewil B.V. and Mymetics B.V., are open
to audit for the year ended December 31, 2018.
EARNINGS PER SHARE
Basic earnings per share is computed by dividing net
income or loss attributable to common shareholders by the weighted
average number of common shares outstanding in the period. Diluted
earnings per share takes into consideration common shares
outstanding (computed under basic earnings per share) and
potentially dilutive securities. For the periods ended September
30, 2019 and 2018, options and convertible debt were not included
in the computation of diluted earnings per share because their
effect would be anti-dilutive due to net losses incurred under the
treasury stock method.
For the three and nine months ended September 30, 2019,
the basic weighted and diluted average number of shares was
303,757,622. The total potential number of shares issuable of
687,233,201 at September 30, 2019 includes 658,133,201 potential
issuable shares related to convertible loans, and 29,100,000
potential issuable shares related to outstanding stock options
granted to employees.
For
the three and nine months ended September 30, 2018, the basic
weighted and diluted average number of shares was 303,757,622. The
total potential number of shares issuable of 650,633,523 at
September 30, 2018 includes 621,533,523 potential issuable shares
related to convertible loans, and 29,100,000 potential issuable
shares related to outstanding stock options granted to
employees.
PREFERRED STOCK
The
Company has authorized 5,000,000 shares of preferred stock that may
be issued in several series with varying dividend, conversion and
voting rights. No preferred shares are issued or outstanding at
September 30, 2019 or December 31, 2018.
STOCK-BASED COMPENSATION
Compensation cost for all share-based payments is based
on the estimated grant-date fair value. The Company amortizes stock
compensation cost ratably over the requisite service
period.
The
issuance of common shares for services is recorded at the quoted
price of the shares on the date the shares are issued. No shares
were issued to individuals as fee for services rendered in the nine
months ended September 30, 2019 nor in the nine months ended
September 30, 2018.
During
the three month periods ended September 30, 2019 and 2018, stock
compensation expense amounted to E0 and E1, respectively. Stock
compensation expense amounted to E2 and E9 during the nine month
periods ended September 30, 2019 and 2018, respectively, and is
included in the consolidated statements of comprehensive loss
within general and administrative expenses.
ESTIMATES
The
preparation of financial statements in conformity with United
States generally accepted accounting principles requires management
to make estimates and assumptions that affect the reported amounts
of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting
period. Actual results could differ from those
estimates.
11
FAIR VALUE MEASUREMENTS
Fair
value guidance establishes a three-tier fair value hierarchy, which
prioritizes the inputs used in measuring fair value. These tiers
include:
Level 1-
Quoted
prices in active markets for identical assets or
liabilities.
Level 2-
Inputs
other than Level 1 that are observable, either directly or
indirectly, such as quoted prices for similar assets or
liabilities; quoted prices in markets that are not active; or other
inputs that are observable or can be corroborated by
observable
market data for substantially the full term of the assets or
liabilities.
Level 3-
Unobservable
inputs that are supported by little or no market activity and that
are significant to the fair value of the assets
or liabilities.
FAIR VALUES OF FINANCIAL INSTRUMENTS
The
Company generally has the following financial instruments: cash,
receivables, accounts payable, and notes payable. The carrying
value of cash, receivables and accounts payable, approximates their
fair value based on the short-term nature of these financial
instruments. Management believes that it is not practicable to
estimate the fair value of the notes payable due to the unique
nature of these instruments.
CONCENTRATIONS
The Company derived 90% of grant revenue for the three
and nine month periods ended September 30, 2018 from one European
grantor, and 100% for the three and nine month periods ended
September 30, 2019 from one USA grantor.
RELATED PARTY TRANSACTIONS
Mr. Ernest M. Stern, the Company’s outside
U.S. counsel, is both a director of the Company and is a partner in
Culhane Meadows PLLC, the firm retained as legal counsel by the
Company. The Company incurred professional fees to the
counsel's law firms totaling E25 and E23 for the nine months ended
September 30, 2019 and 2018, respectively.
Two
of the Company’s major shareholders have granted secured
convertible notes and short term convertible notes and promissory
notes, which have a total carrying amount of E57,090 including
interest due to date. Conversion prices on the Euro-denominated
convertible debt have been fixed to a fixed Euro/US dollar exchange
rate.
Note 2. Debt Financing
Certain
major shareholders have granted the Company secured convertible
notes (in accordance with the Uniform Commercial Code in the State
of Delaware), short term convertible notes and other short term
notes, which have a total carrying value of E57,494 including
interest due to date. Interest incurred on these notes since
inception has been added to the principal amounts.
12
The details of the convertible notes and loans are as follows
at September 30, 2019:
|
|
|
|
|
|
Fixed
|
|
|
|
|
|
Conversion
|
Rate
|
Lender
|
1st-Issue
|
Principal
|
Duration
|
Interest
|
Price
|
EUR/USD
|
Price
|
Date
|
Amount
|
(Note)
|
Rate
|
(stated)
|
Conversion
|
|
|
|
|
|
|
|
Eardley
Holding A.G. (1)
|
06/23/2006
|
E174
|
(2)
|
10%
pa
|
$0.10
|
N/A
|
Anglo
Irish Bank S.A.(3)
|
10/21/2007
|
E500
|
(2)
|
10%
pa
|
$0.50
|
1.4090
|
Round
Enterprises Ltd.
|
12/10/2007
|
E1,500
|
(2)
|
10%
pa
|
$0.50
|
1.4429
|
Round
Enterprises Ltd.
|
01/22/2008
|
E1,500
|
(2)
|
10%
pa
|
$0.50
|
1.4629
|
Round
Enterprises Ltd.
|
04/25/2008
|
E2,000
|
(2)
|
10%
pa
|
$0.50
|
1.5889
|
Round
Enterprises Ltd.
|
06/30/2008
|
E1,500
|
(2)
|
10%
pa
|
$0.50
|
1.5380
|
Round
Enterprises Ltd.
|
11/18/2008
|
E1,200
|
(2)
|
10%
pa
|
$0.50
|
1.2650
|
Round
Enterprises Ltd.
|
02/09/2009
|
E1,500
|
(2)
|
10%
pa
|
$0.50
|
1.2940
|
Round
Enterprises Ltd.
|
06/15/2009
|
E5,500
|
(2,4)
|
10%
pa
|
$0.80
|
1.4045
|
Eardley
Holding A.G.
|
06/15/2009
|
E100
|
(2,4)
|
10%
pa
|
$0.80
|
1.4300
|
Von
Meyenburg
|
08/03/2009
|
E200
|
(2)
|
10%
pa
|
$0.80
|
1.4400
|
Round
Enterprises Ltd.
|
10/13/2009
|
E2,000
|
(2)
|
5%
pa
|
$0.25
|
1.4854
|
Round
Enterprises Ltd.
|
12/18/2009
|
E2,200
|
(2)
|
5%
pa
|
$0.25
|
1.4338
|
Round
Enterprises Ltd.
|
08/04/2011
|
E1,099
|
(5,6)
|
10%
pa
|
$0.034
|
N/A
|
Eardley
Holding A.G.
|
08/04/2011
|
E275
|
(5,6)
|
10%
pa
|
$0.034
|
N/A
|
Round
Enterprises Ltd.
|
11/08/2011
|
E400
|
(6)
|
10%
pa
|
$0.034
|
1.3787
|
Eardley
Holding A.G.
|
11/08/2011
|
E100
|
(6)
|
10%
pa
|
$0.034
|
1.3787
|
Round
Enterprises Ltd.
|
02/10/2012
|
E1,000
|
(6)
|
10%
pa
|
$0.034
|
1.3260
|
Eardley
Holding A.G.
|
02/14/2012
|
E200
|
(6)
|
10%
pa
|
$0.034
|
1.3260
|
Round
Enterprises Ltd.
|
04/19/2012
|
E322
|
(6)
|
10%
pa
|
$0.034
|
1.3100
|
Eardley
Holding A.G.
|
04/19/2012
|
E80
|
(6)
|
10%
pa
|
$0.034
|
1.3100
|
Round
Enterprises Ltd.
|
05/04/2012
|
E480
|
(6)
|
10%
pa
|
$0.034
|
1.3152
|
Eardley
Holding A.G.
|
05/04/2012
|
E120
|
(6)
|
10%
pa
|
$0.034
|
1.3152
|
Round
Enterprises Ltd.
|
09/03/2012
|
E200
|
(6)
|
10%
pa
|
$0.034
|
1.2576
|
Eardley
Holding A.G.
|
09/03/2012
|
E50
|
(6)
|
10%
pa
|
$0.034
|
1.2576
|
Round
Enterprises Ltd.
|
11/14/2012
|
E500
|
(6)
|
10%
pa
|
$0.034
|
1.2718
|
Eardley
Holding A.G.
|
12/06/2012
|
E125
|
(6)
|
10%
pa
|
$0.034
|
1.3070
|
Round
Enterprises Ltd.
|
01/16/2013
|
E240
|
(6)
|
10%
pa
|
$0.034
|
1.3318
|
Eardley
Holding A.G.
|
01/16/2013
|
E60
|
(6)
|
10%
pa
|
$0.034
|
1.3318
|
Round
Enterprises Ltd.
|
03/25/2013
|
E400
|
(6)
|
10%
pa
|
$0.037
|
1.2915
|
Eardley
Holding A.G.
|
04/14/2013
|
E150
|
(6)
|
10%
pa
|
$0.034
|
1.3056
|
Round
Enterprises Ltd.
|
04/14/2013
|
E600
|
(6)
|
10%
pa
|
$0.034
|
1.3056
|
Eardley
Holding A.G.
|
05/15/2013
|
E170
|
(6)
|
10%
pa
|
$0.037
|
1.2938
|
Round
Enterprises Ltd.
|
05/15/2013
|
E680
|
(6)
|
10%
pa
|
$0.037
|
1.2938
|
Eardley
Holding A.G.
|
06/24/2013
|
E60
|
(6)
|
10%
pa
|
$0.025
|
1.3340
|
Round
Enterprises Ltd.
|
06/24/2013
|
E240
|
(6)
|
10%
pa
|
$0.025
|
1.3340
|
Eardley
Holding A.G.
|
08/05/2013
|
E80
|
(6)
|
10%
pa
|
$0.018
|
1.3283
|
Round
Enterprises Ltd.
|
08/05/2013
|
E320
|
(6)
|
10%
pa
|
$0.018
|
1.3283
|
Eardley
Holding A.G.
|
03/01/2017
|
E230
|
(2)
|
2.5%
pa
|
N/A
|
N/A
|
Round
Enterprises Ltd.
|
03/01/2017
|
E920
|
(2)
|
2.5%
pa
|
N/A
|
N/A
|
Eardley
Holding A.G.
|
10/18/2017
|
E230
|
(2)
|
2.5%
pa
|
N/A
|
N/A
|
Round
Enterprises Ltd.
|
10/18/2017
|
E920
|
(2)
|
2.5%
pa
|
N/A
|
N/A
|
Eardley
Holding A.G.
|
06/01/2018
|
E160
|
(7)
|
2.5%
pa
|
N/A
|
N/A
|
Round
Enterprises Ltd.
|
06/01/2018
|
E640
|
(7)
|
2.5%
pa
|
N/A
|
N/A
|
Eardley
Holding A.G.
|
11/10/2018
|
E160
|
(7)
|
2.5%
pa
|
N/A
|
N/A
|
Round
Enterprises Ltd.
|
11/10/2018
|
E640
|
(7)
|
2.5%
pa
|
N/A
|
N/A
|
Eardley
Holding A.G.
|
06/15/2019
|
E120
|
(8)
|
2.5%
pa
|
N/A
|
N/A
|
Round
Enterprises Ltd.
|
06/15/2019
|
E480
|
(8)
|
2.5%
pa
|
N/A
|
N/A
|
Total
Short Term Principal Amounts
|
|
E32,325
|
|
|
|
|
Accrued
Interest
|
|
E25,169
|
|
|
|
|
TOTAL
LOANS AND NOTES
|
|
E57,494
|
|
|
|
|
13
(1)
Private investment company of Dr. Thomas Staehelin, member of the
Board of Directors and of the Audit Committee of the Company. Face
value is stated in U.S. dollars at $190.
(2) This maturity date is automatically prolonged for periods of
three months, unless called for repayment.
(3) Renamed Hyposwiss Private Bank Genève S.A. and acting on
behalf of Round Enterprises Ltd. which is a major
shareholder.
(4) The loan is secured against 2/3rds of the IP assets of Bestewil
Holding BV and against all property of the Company.
(5) The face values of the loans are stated in U.S. dollars at
$1,200 and $300, respectively.
(6)
This maturity date is automatically prolonged for periods of three
months, unless called for repayment. The conversion price per share
is determined by the lower of (i) reducing by 10% the price per
share of the Company’s common stock paid by the investors in
connection with an investment in the Company of not less than
US$20,000, or (ii) at the stated conversion price using a fixed
exchange rate which are noted in the table above.
(7)
On June 1, 2018, Round Enterprises Ltd. and Eardley Holding AG each
provided two promissory Notes for a total of E1,280 and E320 in two
tranches, respectively, with a 2.5% interest per annum. The first
tranche of the promissory Notes of E640 and E160, respectively,
were provided immediately. The second tranche of the promissory
notes of E640 and E160, respectively, were provided on November 10,
2018 with a 2.5% interest per annum. The maturity date of these
promissory notes to follow the same principle of other convertible
loans and is the end of a calendar quarter in which the Company
receives a written request from the lender for repayment of the
unpaid principal and accrued interest due under the
Notes.
(8)
On June 15, 2019, Round Enterprises Ltd. and Eardley Holding AG
each provided a promissory Note for a total of E600, with a 2.5%
interest per annum. The promissory Notes of E480 and E120,
respectively, were provided immediately. The maturity date of these
promissory notes to follow the same principle of other convertible
loans and is the later of (i) December, 31, 2019, or (ii) the end
of a subsequent calendar quarter in which the Company receives a
written request from the lender for repayment of the unpaid
principal and accrued interest due under the Notes.
Note 3. Leases
The facility lease agreement for Epalinges,
Switzerland, is automatically renewed month by month with a notice
period of three months. The related rent is paid monthly in the
amount of E4 and is considered a short-term lease. The facility
lease agreement for Leiden, The Netherlands, runs until March 31,
2020 and can be terminated with a three months' notice period. The
related rent is paid monthly in the amount of E9. This lease is not
considered short-term, however, the effect of recording the right
to use asset and related liability are not material to the
consolidated financial statements. The Company doesn't have any
other operating lease for its research and development facilities,
corporate headquarter, offices and equipment.
14
ITEM 2.
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
GENERAL
The
following discussion and analysis of the results of operations and
financial condition of the Company for the periods ended September
30, 2019 and 2018 should be read in conjunction with the Company's
audited consolidated financial statements for the year ended
December 31, 2018 and related notes and the description of the
Company's business and properties included elsewhere
herein.
This
report contains forward-looking statements that involve risks and
uncertainties. The statements contained in this report are not
purely historical but are forward-looking statements within the
meaning of Section 21E of the Securities Exchange Act of 1934, as
amended, and Section 27A of the Securities Act of 1933, as amended.
These forward looking statements concern matters that involve risks
and uncertainties that could cause actual results to differ
materially from those projected in the forward-looking statements.
Words such as "may," "will," "should," "could," "expect," "plan,"
"anticipate," "believe," "estimate," "predict," "potential,"
"continue", "probably" or similar words are intended to identify
forward looking statements, although not all forward looking
statements contain these words.
Although
we believe that the expectations reflected in the forward-looking
statements are reasonable, we cannot guarantee future results,
levels of activity performance or achievements. Moreover, neither
we nor any other person assumes responsibility for the accuracy and
completeness of the forward-looking statements. We are under no
duty to update any of the forward-looking statements after the date
hereof to conform such statements to actual results or to changes
in our expectations.
Readers
are urged to carefully review and consider the various disclosures
made by us which attempt to advise interested parties of the
factors which affect our business, including without limitation
disclosures made under the captions "Management Discussion and
Analysis of Financial Condition and Results of Operations," "Risk
Factors," "Consolidated Financial Statements" and "Notes to
Consolidated Financial Statements" included in our annual report on
Form 10-K for the year ended December 31, 2018 and, to the extent
included therein, our quarterly reports on Form 10-Q filed during
fiscal year 2018.
THREE MONTHS ENDED SEPTEMBER 30, 2019 AND 2018
For
the three months ended September 30, 2019 revenue was E242, related
to the revenue recognized for the work performed under the
“Cold Chain-independent, Needle-free Mucosal Virosomal
Vaccine to Prevent HIV-1 Acquisition at Mucosal Levels” grant
(“NIH grant”) provided by the NIH via Texas Biomedical
Institute, and E274 for the three months ended September 30, 2018,
mainly related to the revenue recognized for the work performed
under the Horizon 2020 grants.
Costs
and expenses decreased to E660 for the three months ended September
30, 2019 from E685 (-3.6%) for the three months ended September 30,
2018.
Research and development expenses decreased to E295 in
the current period from E343 (-14.0%) in the comparative period of
2018, mainly due to subcontracting services in relation with the
Horizon 2020 Maciviva project, which ended in November
2018.
General
and administrative expenses decreased to E243 in the three months
ended September 30, 2019 from E319 (-23.8%) in the comparative
period of 2018, mainly due to the D&O liability annual
insurance premium that was fully expensed during the three months
ended September 2018.
Foreign
exchange revaluation generated a net loss of E113 and E11 during
the three months ended September 30, 2019 and 2018, respectively,
which is due to the revaluation of existing US$ based loans from
related parties and the US$ cash position.
Interest
expense increased to E671 for the three months ended September 30,
2019 from E660 for the three months ended September 30, 2018
related to an increase in existing loans from related
parties.
The
Company reported a net loss of (E1,094), or (E0.00) per share, for
the three months ended September 30, 2019, compared to a net loss
of (E1,071), or (E0.00) per share, for the three months ended
September 30, 2018.
15
NINE MONTHS ENDED SEPTEMBER 30, 2019 AND 2018
Revenue was E370 for the nine months ended
September 30, 2019 related to the revenue recognized for the work
performed under the NIH grant provided by the NIH via Texas
Biomedical Institute, and
E760 for the nine months ended September 30, 2018, mainly related
to the revenue recognized for the work performed under the Horizon
2020 grants.
Costs
and expenses decreased to E1,655 for the nine months ended
September 30, 2019 from E1,877 (-11.8%) for the nine months ended
September 30, 2018, mainly due to subcontracting services in
relation with the Horizon 2020 Maciviva project, which ended in
November 2018.
Research
and development expenses decreased to E720 in the current period
from E922 (-21.9%) in the comparative period of 2018, mainly due to
higher R&D salaries and higher subcontracting services during
the same period in 2018, related to the Horizon 2020 Maciviva
project.
General
and administrative expenses decreased to E770 in the nine months
ended September 30, 2019 from E832 (-7.5%) in the comparative
period of 2018, mainly due to the D&O liability annual
insurance premium that was fully expensed during the nine months
ended September 2018.
Foreign
exchange revaluation generated a net loss of E135 and E84 during
the nine months ended September 30, 2019 and 2018, respectively,
which is due to the revaluation of existing US$ based loans from
related parties and US$ cash position.
The
Company reported a net loss of (E3,304), or (E0.01) per share, for
the nine months ended September 30, 2019, compared to a net loss of
(E3,101), or (E0.01) per share, for the nine months ended September
30, 2018.
LIQUIDITY AND CAPITAL RESOURCES
We
had cash of E316 at September 30, 2019 compared to E479 at December
31, 2018.
During 2018, our revenue has been generated through the
Horizon 2020 project, which has come to an end. For 2019, besides
revenue recognized under the NIH grant project, new significant
revenues will not be expected, unless and until a major licensing
agreement or other commercial arrangement is entered into with
respect to our technology or new grant financings are
awarded.
As
of September 30, 2019, we had an accumulated deficit of
approximately E88 million, and had net loss of E3,304 in the nine
month period ending on that date. We expect to continue to
incur net losses in the future for research, development and
activities related to the future licensing of our technologies, and
because of the accrual of interest payable on existing
loans.
Net
cash used in operating activities was E774 and E1,732 for the nine
month period ended September 30, 2019 and 2018, respectively. The
decrease was mainly due to the Maciviva project costs paid during
the nine month period ending September 30, 2018, while the final
funding amount from the Maciviva project was received during the
nine month period ending September 30, 2019.
Net
cash used in investing activities was NIL during the nine months
ended September 30, 2019 and 2018.
Financing
activities provided net cash of E600 and E800 for the nine months
ended September 30, 2019 and 2018, respectively, both related to
promissory notes from our main investors.
Salaries and related payroll costs represent gross
salaries for two executives, our CSO of Mymetics BV and five
employees. Under Executive Employment Agreements with our
CEO and two CSOs, we pay our executive officers a combined amount
of E65 per month.
Our
Swiss subsidiary, Mymetics S.A., has, besides the CEO and CSO, two
additional employees on its payroll: Director of Finance and Head
of Manufacturing and Quality. Mymetics BV has, besides the full
time Chief Scientific Officer, two full-time technicians and one
part-time assistant.
We
intend to continue to incur additional expenditures during the next
nine months for additional research and development of our HIV,
Influenza vaccines and immunotherapy projects, which we will try to
seek through collaborations with pharmaceutical companies or with
not-for-profit organizations. These expenditures will relate to the
continued research and testing of these prototype vaccines and are
included in the monthly cash outflow described above.
16
In
the past, we have financed our research and development activities
primarily through debt and equity financings from various parties
and through license and collaboration agreements and grant
agreements.
We
anticipate that our normal operations will require approximately
E400 of cash for the remainder of the year ending December 31,
2019. We will seek to raise the required capital from equity or
debt financings, and grants through donors and potential
partnerships with major international pharmaceutical and
biotechnology firms. However, there can be no assurance that we
will be able to raise additional capital on satisfactory terms, or
at all, to finance our operations. In the event that we are not
able to obtain such additional capital, we will be required to
further restrict or even cease our operations.
Monthly
fixed and recurring expenses for "Property leases" of E13 represent
the monthly lease and maintenance payments to unaffiliated third
parties for our offices, of which E4 is related to our executive
office located at Route de la Corniche 4, 1066 Epalinges in
Switzerland (100 square meters), and E9 related to Bestewil Holding
B.V. and its subsidiary Mymetics B.V operating from a similar
biotechnology campus near Leiden in the Netherlands, where they
occupy 204 square meters.
Included
in professional fees are legal fees paid to outside corporate
counsel and audit and review fees paid to our independent
accountants, and fees paid for investor relations.
Cumulative
interest expense of E25,169 has been accrued on all of the
Company’s outstanding notes and advances (see detailed table
in Note 2 to the financial statements).
RECENT FINANCING ACTIVITIES
During the nine month period ending September 30, 2019,
our principal source of funds has been promissory notes received
from our two main investors, the final payment for the Maciviva
project and the NIH project.
On April 29, 2019, the National Institutes of Health
(NIH) awarded the Company and Texas Biomedical Research Institute
(Texas Biomed) a five-year grant for the project called “Cold
Chain-independent, Needle-free Mucosal Virosomal Vaccine to Prevent
HIV-1 Acquisition at Mucosal Levels”. The project started on
May 1, 2019 and is planned for five years. The overall budget
related to the project is USD 8.67 million, with USD 1.9 million
approved for the first year. The overall portion of the grant
allocated to the Company is USD 6.76 million, with USD 1.2 million
approved for the first year. It is co-led by the Texas Biomed and
the Company, and includes sub-awards to the University of Louisiana
at Lafayette, and the University of Virginia. First results are
expected to be reported in 2020.
We have filed or are in the process of filing several
new grant applications with European institutions in relation to
our virosome based vaccines and Anergis has an option to license
Mymetics’ virosomes for the use in the field of allergy
immunotherapy.
We anticipate using our current funds and those we
receive in the future both to meet our working capital needs and
for funding the ongoing vaccines pre-clinical research costs for
new virosome vaccine.
Management anticipates that our existing capital
resources will be sufficient to fund our cash requirements through
the next five months. We have cash presently on hand in conjunction
with the collection of receivables, based upon our current levels
of expenditures and anticipated needs during this period. For 2020,
we will need additional funding through future collaborative
arrangements, licensing arrangements, and debt and equity
financings under Regulation D and Regulation S under the Securities
Act of 1933. We do not know whether additional financing will be
available on commercially acceptable terms when
needed.
If management cannot raise funds on acceptable terms
when needed, we may not be able to successfully commercialize our
technologies, take advantage of future opportunities, or respond to
unanticipated requirements. If unable to secure such additional
financing when needed, we will have to curtail or suspend all or a
portion of our business activities and could be required to cease
operations entirely. Further, if new equity securities are issued,
our shareholders may experience severe dilution of their ownership
percentage.
The extent and timing of our future capital
requirements will depend primarily upon the rate of our progress in
the research and development of our technologies, our ability to
enter into a partnership agreement with a major pharmaceutical
company, and the results of our present projects and future
clinical trials.
OFF-BALANCE SHEET ARRANGEMENTS
On October 17, 2019, Mymetics announced that Stallergenes Greer, a
worldwide leader in Allergen Immunotherapy (AIT), and Anergis, a
leader in ultra-fast AIT research and development based on
Contiguous Overlapping Peptides (COP), announced the start of a new
research study to evaluate the effects of the second generation
virosome-based COP allergen immunotherapy in a therapeutic model of
birch allergy in mice. The aim of the study is to shorten the AIT
administration scheme. The research collaboration combines the
ultra-fast AIT approach developed by Anergis and Mymetics, namely
the second-generation of COP allergen immunotherapy based on
Anergis COPs and Mymetics virosomes (COP-Virosomes), with the
longstanding know-how of Stallergenes Greer. Stallergenes Greer
will now test the COP-Virosomes in the therapeutic mouse model of
birch allergy in comparison with positive controls, i.e., birch
allergen and birch pollen extract. This model has been confirmed as
having predictive value towards the future clinical efficacy of new
AIT treatment candidates.
17
ITEM
3.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
INTEREST RATE RISK
Fluctuations
in interest rates may affect the fair value of financial
instruments. An increase in market interest rates may increase
interest payments and a decrease in market interest rates may
decrease interest payments of such financial instruments. We have
no debt obligations which are sensitive to interest rate
fluctuations as all our notes payable have fixed interest rates, as
specified on the individual loan notes.
ITEM
4.
CONTROLS AND PROCEDURES
EVALUATION OF DISCLOSURE CONTROLS AND PROCEDURES
We
maintain disclosure controls and procedures that are designed to
ensure that information required to be disclosed in our reports
under the Exchange Act is recorded, processed, summarized and
reported within the time periods specified in the SEC’s rules
and forms, and that such information is accumulated and
communicated to management, as appropriate, to allow timely
decisions regarding required disclosure. Our management, with the
participation and supervision of our Chief Executive Officer and
Chief Financial Officer, evaluated the effectiveness of our
disclosure controls and procedures as of the end of the period
covered by this report and determined that our disclosure controls
and procedures were effective.
CHANGES IN INTERNAL CONTROL OVER FINANCIAL REPORTING
No
changes of internal control over financial reporting were made in
the nine months ended September 30, 2019.
INHERENT LIMITATIONS ON EFFECTIVENESS OF CONTROLS
Our
management, Ronald Kempers, who is both CEO and CFO, does not
expect that our disclosure controls or our internal control over
financial reporting will prevent or detect all error and all fraud.
A control system, no matter how well designed and operated, can
provide only reasonable, not absolute, assurance that the control
system’s objectives will be met. The design of a control
system must reflect the fact that there are resource constraints,
and the benefits of controls must be considered relative to their
costs. Further, because of the inherent limitations in all control
systems, no evaluation of controls can provide absolute assurance
that misstatements due to error or fraud will not occur or that all
control issues and instances of fraud, if any, within the company
have been detected.
These
inherent limitations include the realities that judgments in
decision-making can be faulty and that breakdowns can occur because
of simple error or mistake. Controls can also be circumvented by
the individual acts of some persons, by collusion of two or more
people, or by management override of the controls. The design of
any system of controls is based in part on certain assumptions
about the likelihood of future events, and there can be no
assurance that any design will succeed in achieving its stated
goals under all potential future conditions. Projections of any
evaluation of controls effectiveness to future periods are subject
to risks. Over time, controls may become inadequate because of
changes in conditions or deterioration in the degree of compliance
with policies or procedures.
18
PART
II.
OTHER INFORMATION
ITEM 1.
LEGAL PROCEEDINGS
Neither
we, nor our wholly owned subsidiaries, Mymetics S.A. and Bestewil
Holding B.V., nor its subsidiary Mymetics B.V., are presently
involved in any litigation incident to our business.
ITEM 1A.
RISK FACTORS
Not
Applicable
ITEM 2.
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
None
ITEM 3.
DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4.
MINE SAFETY DISCLOSURES
None.
ITEM 5.
OTHER INFORMATION
None.
ITEM 6.
EXHIBITS
EXHIBIT
NUMBER
|
DESCRIPTION
|
Rule
13a-14(a)/15d-14(a) Certification of Chief
|
|
|
|
Rule
13a-14(a)/15d-14(a) Certification of Chief Financial
Officer
|
|
|
|
Section 1350
Certification of Chief Executive Officer and Chief Financial
Officer
|
|
|
|
101.INS
|
Instance
Document
|
|
|
101.SCH
|
XBRL Taxonomy
Extension Schema Document
|
|
|
101.CAL
|
XBRL Taxonomy
Extension Calculation Linkbase Document
|
|
|
101.LAB
|
XBRL Taxonomy
Extension Label Linkbase Document
|
|
|
101.PRE
|
XBRL Taxonomy
Extension Presentation Linkbase Document
|
19
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the Registrant has duly caused this report to be signed on
its behalf by the undersigned, thereunto duly
authorized.
|
MYMETICS
CORPORATION
|
|
|
|
|
|
|
Dated: November 12, 2019
|
By:
|
/s/ Ronald Kempers
|
|
|
|
Chief Executive Officer / Chief Financial Officer
|
|
|
|
|
|
20