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| Share Name | Share Symbol | Market | Type |
|---|---|---|---|
| Mymetics Corporation (CE) | USOTC:MYMX | OTCMarkets | Common Stock |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 0.001 | 0.00 | 00:00:00 |
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 March 31, 2022 |
or
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
|
|
| For the transition period from __________ to _________ |
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|
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 |
| I.R.S. Employer Identification No. |
c/o Ernie Stern 1101 Pennsylvania Avenue, N.W., Suite 300 Washington D.C. United States |
| USA-20004 |
Address |
| Zip Code |
c/o Mymetics SA Route de la Corniche 4 Epalinges, Switzerland |
|
CH-1066 |
Address of Principal Executive Offices |
| Zip Code |
011 41 21 653 4535 |
Registrant’s Telephone Number, Including Area Code |
_______________________________________________________________
Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
| Trading Symbol(s) |
| Name of each exchange on which registered |
Common Stock, Par Value $0.01 per share |
| MYMX |
| 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.
Large accelerated filer | ☐ | Accelerated filer | ☐ |
Non-accelerated Filer | ☒ | Smaller reporting company | ☒ |
Emerging growth company | ☐ |
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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
The number of shares outstanding of the Registrant’s Common Stock, $0.01 par value, was 303,757,622 as of May 13, 2022
PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MYMETICS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands of Euros, Except Share and Par Value)
|
| March 31, |
|
| December 31, |
| ||
|
| 2022 |
|
| 2021 |
| ||
|
| (unaudited) |
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|
| |||
ASSETS |
|
|
|
|
|
| ||
Current Assets |
|
|
|
|
|
| ||
Cash |
| E | 122 |
|
| E | 571 |
|
Accounts receivable |
|
| 411 |
|
|
| 15 |
|
Prepaid expenses |
|
| 77 |
|
|
| 87 |
|
Total current assets |
|
| 610 |
|
|
| 673 |
|
|
|
|
|
|
|
|
|
|
Rent deposit |
|
| 10 |
|
|
| 10 |
|
Property and equipment, net of accumulated depreciation of E479 at March 31, 2022 and E474 at December 31, 2021 |
|
| 36 |
|
|
| 39 |
|
Right-of-Use Asset |
|
| 212 |
|
|
| 239 |
|
Goodwill |
|
| 6,671 |
|
|
| 6,671 |
|
|
| E | 7,539 |
|
| E | 7,632 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS’ DEFICIT |
|
|
|
|
|
|
|
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Current Liabilities |
|
|
|
|
|
|
|
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Accounts payable |
| E | 423 |
|
| E | 47 |
|
Operating lease liability |
|
| 106 |
|
|
| 110 |
|
Non-convertible notes payable and related accrued interest to related parties |
|
| 8,841 |
|
|
| 8,790 |
|
Convertible notes payable and related accrued interest to related parties |
|
| 59,186 |
|
|
| 58,479 |
|
Total current liabilities |
|
| 68,556 |
|
|
| 67,426 |
|
|
|
|
|
|
|
|
|
|
Long Term Liabilities |
|
|
|
|
|
|
|
|
Debt-Federal Financing Bank |
|
| 164 |
|
|
| 162 |
|
Operating lease liability |
|
| 109 |
|
|
| 130 |
|
Total long-term liabilities |
|
| 273 |
|
|
| 292 |
|
|
|
| 68,829 |
|
|
| 67,718 |
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies (Note 3) |
|
| - |
|
|
| - |
|
|
|
|
|
|
|
|
|
|
Shareholders’ Deficit |
|
|
|
|
|
|
|
|
Common stock, U.S. $0.01 par value; 1,200,000,000 shares authorized; issued and outstanding 303,757,622 at March 31, 2022 and at December 31, 2021 |
|
| 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 |
|
|
| 34,443 |
|
Accumulated deficit |
|
| (98,961 | ) |
|
| (97,750 | ) |
Accumulated other comprehensive income |
|
| 698 |
|
|
| 691 |
|
Total shareholders’ deficit |
|
| (61,290 | ) |
|
| (60,086 | ) |
Total liabilities and shareholders’ deficit |
| E | 7,539 |
|
| E | 7,632 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 2 |
MYMETICS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
(In Thousands of Euros, Except Share and Per Share Data)
|
| Three Months Ended March 31, |
| |||||
|
| 2022 |
|
| 2021 |
| ||
Revenue |
|
|
|
|
|
| ||
Research and development services |
| E | - |
|
| E | 3 |
|
Advisory services |
|
| 3 |
|
|
| - |
|
Grants revenue |
|
| 482 |
|
|
| 131 |
|
|
|
| 485 |
|
|
| 134 |
|
Expenses |
|
|
|
|
|
|
|
|
Research and development |
|
| 582 |
|
|
| 254 |
|
General and administrative |
|
| 332 |
|
|
| 291 |
|
|
|
| 914 |
|
|
| 545 |
|
Operating Loss |
|
| (429 | ) |
|
| (411 | ) |
|
|
|
|
|
|
|
|
|
Interest expense |
|
| 694 |
|
|
| 685 |
|
Other expense |
|
| 88 |
|
|
| 122 |
|
Loss before income tax provision |
|
| (1,211 | ) |
|
| (1,218 | ) |
|
|
|
|
|
|
|
|
|
Income tax provision |
|
| - |
|
|
| (28 | ) |
Net Loss |
|
| (1,211 | ) |
|
| (1,246 | ) |
|
|
|
|
|
|
|
|
|
Other comprehensive loss |
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
| 7 |
|
|
| (8 | ) |
Comprehensive loss |
| E | (1,204 | ) |
| E | (1,254 | ) |
|
|
|
|
|
|
|
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Basic and diluted earnings per share |
| E | (0.00 | ) |
| E | (0.00 | ) |
|
|
|
|
|
|
|
|
|
Weighted-average shares outstanding, basic and diluted |
|
| 303,757,622 |
|
|
| 303,757,622 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 3 |
MYMETICS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ DEFICIT
(UNAUDITED)
(In Thousands of Euros)
|
| Three-month Period Ended March 31, 2021 |
| |||||||||||||||||||||
|
| Common Stock Number of Par |
|
|
|
| Accumulated |
|
| Accumulated Other Comprehensive |
|
|
| |||||||||||
|
| Shares |
|
| Value |
|
| APIC |
|
| deficit |
|
| Income |
|
| Total |
| ||||||
Balance at December 31, 2020 |
|
| 303,757,622 |
| E | 2,530 |
| E | 34,443 |
|
| E | (93,020 | ) |
| E | 695 |
|
| E | (55,352 | ) | ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||
Net loss |
|
| - |
|
|
| - |
|
|
| - |
|
|
| (1,246 | ) |
|
| - |
|
|
| (1,246 | ) |
Translation adjustment |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| (8 | ) |
|
| (8 | ) |
Balance at March 31, 2021 |
|
| 303,757,622 |
| E | 2,530 |
| E | 34,443 |
|
| E | (94,266 | ) |
| E | 687 |
|
| E | (56,606 | ) | ||
|
| Three-month Period Ended March 31, 2022 |
| |||||||||||||||||||||
|
| Common Stock Number of Par |
|
|
|
| Accumulated |
|
| Accumulated Other Comprehensive |
|
|
| |||||||||||
|
| Shares |
|
| Value |
|
| APIC |
|
| deficit |
|
| Income |
|
| Total |
| ||||||
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|
|
|
|
|
|
|
|
|
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|
|
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Balance at December 31, 2021 |
|
| 303,757,622 |
| E | 2,530 |
| E | 34,443 |
|
| E | (97,750 | ) |
| E | 691 |
|
| E | (60,086 | ) | ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||
Net loss |
|
| - |
|
|
| - |
|
|
| - |
|
|
| (1,211 | ) |
|
| - |
|
|
| (1,211 | ) |
Translation adjustment |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 7 |
|
|
| 7 |
|
Balance at March 31, 2022 |
|
| 303,757,622 |
| E | 2,530 |
| E | 34,443 |
|
| E | (98,961 | ) |
| E | 698 |
|
| E | (61,290 | ) | ||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 4 |
MYMETICS CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(In Thousands of Euros)
|
| For The Three Months Ended March 31, |
| |||||
|
| 2022 |
|
| 2021 |
| ||
Cash Flow from Operating Activities |
|
|
|
|
|
| ||
Net Loss |
| E | (1,211 | ) |
| E | (1,246 | ) |
Adjustments to reconcile net loss to net cash used in operating activities |
|
|
|
|
|
| ||
Depreciation |
|
| 5 |
|
|
| 4 |
|
Changes in operating assets and liabilities |
|
|
|
|
|
|
|
|
Receivables |
|
| (396 | ) |
|
| 5 |
|
Accrued interests on convertible notes payable |
|
| 707 |
|
|
| 767 |
|
Accrued interests on non-convertible notes payable |
|
| 51 |
|
|
| 44 |
|
Accounts payable |
|
| 376 |
|
|
| 93 |
|
Other |
|
| 14 |
|
|
| 6 |
|
Net cash used in operating activities |
|
| (454 | ) |
|
| (327 | ) |
|
|
|
|
|
|
|
|
|
Cash Flows from Investing Activities |
|
|
|
|
|
|
|
|
Purchase of property and equipment |
|
| (2 | ) |
|
| (10 | ) |
Net cash used in investing activities |
|
| (2 | ) |
|
| (10 | ) |
|
|
|
|
|
|
|
|
|
Effect on foreign exchange rate on cash |
|
| 7 |
|
|
| (8 | ) |
Net change in cash |
|
| (449 | ) |
|
| (345 | ) |
|
|
|
|
|
|
|
|
|
Cash, beginning of period |
|
| 571 |
|
|
| 1,083 |
|
Cash, end of period |
| E | 122 |
|
| E | 738 |
|
|
|
|
|
|
|
|
|
|
Supplemental Disclosure of Cash Flow Information: |
|
|
|
|
|
|
|
|
Cash paid for taxes |
|
| - |
|
|
| 28 |
|
The accompanying notes are an integral part of these consolidated financial statements.
| 5 |
MYMETICS CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2022
(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 condensed 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 condensed 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, 2021.
The accompanying financial statements of the Company are unaudited. However, in the opinion of the Company, the unaudited condensed 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 ending March 31, 2022 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. The Company has established a network which enables it to work with education centers, research centers, pharmaceutical laboratories and biotechnology companies. Besides the HIV and malaria vaccine candidates, the Company additionally has generated preclinical data for the following vaccines: Herpes Simplex and Respiratory Syncytial Virus (“RSV”), neither of which is currently being developed. The company also has clinical data for an intranasal influenza vaccine for the elderly which has finished a Phase I clinical trial and is currently on hold. As of March 31, 2022, the Company is working on several research projects for immunotherapy in the field oncology and for some infectious diseases with academic partners. Since April 2020, the Company has additionally started to work on the development of a intranasal virosome-based vaccine to prevent Covid-19, the disease caused by the SARS-CoV-2 virus. For the Covid-19 vaccine candidates, the Company is collaborating with leading academic institutions, such as Baylor College of Medicine in Texas, the Amsterdam medical Center (AMC) of the University of Amsterdam in the Netherlands and the University Hospital in Bern, Switzerland.
As of March 31, 2022, the Company was engaged in the pre-clinical testing of some of its vaccine candidates, but a commercially viable product is not expected for several more years. However, the Company generated some revenue through collaboration and grant agreements.
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 €98,961 at March 31, 2022. Further, the Company’s current liabilities exceed its current assets by €67,946 as of March 31, 2022, 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. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
LEASES
Effective January 1, 2019, the Company adopted ASC 842, which established a right-of-use (“ROU”) model requiring lessees to record a right-of-use (“ROU”) asset and lease obligations on the balance sheet for all leases with terms longer than 12 months. The Company determines if an arrangement is a lease at inception. Where an arrangement is a lease the Company determines if it is an operating lease or a finance lease. At lease commencement, the Company records a lease liability and corresponding right-of- use (“ROU”) asset. Lease liabilities represent the present value of our future lease payments over the expected lease term which includes options to extend or terminate the lease when it is reasonably certain those options will be exercised. The present value of the Company’s lease liability is determined using its incremental collateralized borrowing rate at lease inception. ROU assets represent its right to control the use of the leased asset during the lease and are recognized in an amount equal to the lease liability for leases with an initial term greater than 12 months. Over the lease term (operating leases only), the Company uses the effective interest rate method to account for the lease liability as lease payments are made and the ROU asset is amortized to consolidated statement of operations in a manner that results in straight-line expense recognition. The Company does not apply lease recognition requirements for short-term leases. Instead, the Company recognizes payments related to these arrangements in the consolidated statement of operations as lease costs on a straight-line basis over the lease term.
| 6 |
IMPACT OF THE NOVEL CORONAVIRUS
On January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency because of a new strain of coronavirus originating in Wuhan, China (the “COVID-19 outbreak”) and the risks to the international community as the virus spreads globally beyond its point of origin. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic, based on the rapid increase in exposure globally.
The COVID-19 pandemic has continued to evolve. Although at this date the restrictive measures and impacts are reduced due to the role out of vaccination programs, the extent to which the outbreak impacts our business, preclinical studies and clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the pandemic, travel restrictions and social distancing, business closures or business disruptions and the effectiveness of actions taken in the U.S., Europe, and other countries to contain and treat the disease.. As such, it is uncertain as to the full magnitude that the pandemic will have on the Company’s financial condition, liquidity, and future results of operations.
Management has taken measures in-line with the country requirements where we are operating, and we are actively monitoring the global situation on its financial condition, liquidity, operations, scientific collaborations, suppliers, industry, and workforce. Given the daily evolution of the COVID-19 outbreak and the global responses to curb its spread, the Company is not able to estimate the effects of the COVID-19 outbreak on its results of operations, financial condition, or liquidity for fiscal year 2022.
The Company is dependent on its workforce to deliver and advance its research. Developments such as physical distancing and working from home directives have and will continue to impact the Company’s ability to deploy its workforce effectively. While restrictions are being lifted across the world, prolonged workforce disruptions may negatively impact future revenues for the remainder of fiscal year 2022 and the Company’s overall liquidity.
The Company is dependent on its partners in certain projects, such as the University of Louisiana at Lafayette (“ULL”) for the NIH funded project to maintain the agreed timelines and execute their tasks. Developments such as social distancing and shelter-in-place directives and lock-down directives have and will continue to impact the Company’s ability to execute on project plans and research objectives effectively. While expected to be temporary, prolonged disruptions in collaboration projects may negatively impact funding for the fiscal year 2022 and the Company’s overall liquidity.
Although the Company cannot estimate the length or gravity of the impact of the COVID-19 outbreak at this time, if the pandemic continues, it may have a material adverse effect on the Company’s results of future operations, financial position, and liquidity for the fiscal year 2022.
CORONAVIRUS AID, RELIEF AND ECONOMIC SECURITY ACT
On March 27, 2020, the U.S. Government enacted the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) was signed into law. The CARES Act includes various income and payroll tax provisions. The Company has analyzed the tax provisions of the CARES Act and determined they have no significant financial impact to the financial statements. The Company has no intention of taking advantage of other benefits but will continue to evaluate the impact on the Company’s financial position.
PRINCIPLES OF CONSOLIDATION
The condensed consolidated financial statements include the accounts of the Company and its subsidiaries. Significant intercompany accounts and transactions have been eliminated.
| 7 |
NEW ACCOUNTING PRONOUNCEMENT
In August 2020, the FASB issued ASU 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, which simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. Specifically, ASU 2020-06 simplifies accounting for the issuance of convertible instruments by removing major separation models required under current GAAP. In addition, the ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and simplifies the diluted earnings per share (EPS) calculation in certain areas. ASU 2020-06 will be effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, beginning in fiscal years which begin after December 15, 2020. The FASB has specified that an entity should adopt the guidance as of the beginning of its annual fiscal year. The Company is currently evaluating the impact of the pending adoption of this new standard on its 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 general and administrative expenses 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
We 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.
REVENUE RECOGNITION
Effective January 1, 2018, the Company adopted Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers, using the modified retrospective method and there was no impact to financial position and results of operations as a result of the adoption. This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. 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. The Company only applies 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, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Overall, adoption of the new standard did not result in an adjustment to amounts previously reported in our consolidated financial statements and there were no other significant changes impacting the timing or measurement of our revenue or our business processes and controls.
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 concluded 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.
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” (“NIH Grant”). The project started on May 1, 2019 and is planned for five years. It was initially co-led by Texas Biomed, but due to the move of Dr. Ruth Ruprecht, the Co-Principal Investigator, to the University of Louisiana at Lafayette (“ULL”) at the end of 2019, ULL has become the co-lead with Mymetics for this project. The overall budget related to the project is US$8,850 with US$1,940 approved for the first year, US$1,856 approved for the second year and US$ 1,720 for the third year.
| 8 |
The amounts mentioned in the following statements are purely related to the Company and not to the other partners in the project: The overall portion of the grant allocated to the Company is US$5,930, with US$1,190 approved for the first year, US$1,052 for the second year and US$ 1,078 for the third year.
The cost incurred and granted under the sub-award with Texas Biomed for the period of May to December 2019 was US$547 (€542). The sub-award contract between ULL and the Company for the second year (May 2020 to April 2021) was signed for a total budget of US$870 and US$1,078 for the third year. The total grant revenue incurred as of today is US$2,361 (€2,230), of which US$536 (€482) has been incurred during the quarter ended March 31, 2022. First results are expected to be reported in 2023.
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 March 31, 2022, Mymetics has successfully produced five sets of virosome based vaccines and the NHPs have received two intramuscular vaccinations and three intranasal vaccinations in two different studies. The vaccinations were well tolerated. These studies are ongoing. The vaccine is created to induce protective mucosal antibodies acting as a frontline defense against sexual HIV transmission. This awarded grant from the NIH can continue some of the developments that were achieved during the European Horizon 2020 project.
In February 2021, Mymetics announced the publication of results in Frontiers in Immunology with title: “Cooperation between Systemic and Mucosal Antibodies Induced by Virosomal Vaccines Targeting HIV-1 Env: Protection of Indian Rhesus Macaques against Mucosal SHIV challenges”.
Option to License Agreement – ANERGIS SA
In April 2018 Mymetics engaged in a Research and Option to License Agreement with Anergis SA. Under the agreement, a mice proof-of-concept immunogenicity study evaluated the effects of the Bet v 1 COPs (Anergis’ proprietary birch pollen allergy peptides) using the five subcutaneous injection schedule used in former AllerT clinical trials. The development of AllerT (Bet v 1 COPs plus aluminum hydroxide) was discontinued by Anergis in 2017 following completion of a Phase 2 clinical trial showing evidence of sensitization to the peptides and a 7% reduction in seasonal allergy symptoms vs placebo (p=0.0047). In the mice study, AllerT was compared to Bet v 1 COPs linked to Mymetics’ virosomes (the “Bet v 1 COP-virosomes”).
In December 2018 Anergis and Mymetics reported that the administration of AllerT led to the development of Bet v 1 specific IgEs (p<0.001) associated with a more pronounced TH2 than TH1 response. In contrast, in the mice receiving the Bet v 1 COP-virosomes, no development of Bet v 1 specific IgEs were observed (p<0.001 vs AllerT). With the same dose of Bet v 1 COPs, there was a strong boost of immunogenicity with a TH1 antibody response, which was a hundred times greater than with aluminum hydroxide (p<0.001). The Bet v 1 COP-virosomes were well tolerated. The success criteria were met and Anergis had a time limited option to enter into an exclusive license agreement with Mymetics for the use of virosomes in the field of allergies.
In October 2019, Mymetics announced that Anergis SA started a new study with Stallergenes Greer SA whereby the COP-Virosomes were tested 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.
In May 2020, Mymetics announced the results of the study with Stallergenes Greer, a worldwide leader in allergen immunotherapy (AIT) and Anergis, a leader in ultra-fast AIT research and development. The results showed that a treatment with COP-virosomes was able to cure allergic asthma in birch pollen sensitized mice and that the COP-virosomes were significantly superior to the COP or the virosome alone, confirming the synergy between COP and virosomes to foster an improved second-generation AIT treatment.
In January 2021, following the two successful studies with its virosome platform, Mymetics announced the acceptance of its joint publication in the scientific journal Clinical & Experimental Allergy with Stallergenes Greer SA and Anergis SA, with the title: Bet v 1 contiguous overlapping peptides anchored to virosomes with TLR4 agonist enhance immunotherapy efficacy in mice.
As of February 1, 2021, Anergis SA has entered into liquidation since it was not able to raise sufficient funds to continue to operate.
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 March 31, 2022 or December 31, 2021. 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.
| 9 |
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 LONG-LIVED 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.
WITHHOLDING TAXES
On March 10, 2021, the Swiss Federal tax administration conducted a withholding tax audit on Mymetics SA’s financial statements for the years 2015 to 2019. At the end of the tax audit, the tax inspector concluded that a portion of the intercompany interest expenses related to the subordinated loan from Mymetics Corporation to Mymetics SA could be considered as a hidden dividend distribution and therefore subject to Swiss withholding tax. The tax inspector encouraged the Company to file the relevant Swiss withholding tax forms to benefit from the double tax treaty between Switzerland and the United States. All required documentation has been sent, assessed and approved by the Swiss Federal tax administration. The portion of the intercompany interest expenses related to the subordinated loan from Mymetics Corporation to Mymetics SA is considered as a hidden dividend distribution and therefore subject to Swiss withholding tax at a reduced tax rate of 5% and based on the double tax treaty in force between Switzerland and the United State of America. All required tax declaration forms have been filed and the related withholding tax amounts have been accounted for as of December 31, 2021.
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 March 31, 2022 or December 31, 2021. The Company’s United States tax returns are open to audit for the years ended December 31, 2016 to 2019. The returns for the Swiss subsidiary, Mymetics S.A., are open to audit for the year ended December 31, 2021. The returns for the Netherlands subsidiaries, Bestewil B.V. and Mymetics B.V., are open to audit for the year ended December 31, 2021.
| 10 |
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 quarters ended March 31, 2022 and 2021, 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 months ended March 31, 2022, the basic weighted average number of shares was 303,757,622. The total potential number of shares issuable of 775,330,552 at March 31, 2022 includes 749,580,552 potential issuable shares related to convertible loans and 25,750,000 potential issuable shares related to outstanding not expired options granted to employees.
For the three months ended March 31, 2021, the basic weighted average number of shares was 303,757,622. The total potential number of shares issuable of 738,730,875 at March 31, 2021 includes 712,980,875 potential issuable shares related to convertible loans and 25,750,000 potential issuable shares related to outstanding not expired 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 March 31, 2022 or December 31, 2021.
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.
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, accounts receivable, and accounts payable, approximates their fair value based on the short-term nature of these financial instruments. Management believes the fair value of the notes payable is reflecting the actual value reported for these instruments.
CONCENTRATIONS
The Company derived 98% and 99% of grant revenue for the three-month period ended March 31, 2021 and 2022 from one partner, respectively. For the period ended December 31, 2021, the Company derived 99% of grant revenue from one partner.
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 firm totaling €6 and €17 for the three months ended March 31, 2021 and 2022, 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 €67,573, 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 principal 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 €68,027 including interest due to date. Interest incurred on these notes since inception has been added to the principal amounts.
| 11 |
The details of the convertible notes and loans are as follows at March 31, 2022:
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| Fixed |
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| Conversion |
| Rate |
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Lender |
| 1st-Issue |
|
| Principal |
| Duration |
| Interest |
| Price |
| EUR/USD |
| ||
Price |
| Date |
|
| Amount |
| (Note) |
| Rate |
| (stated) |
| Conversion |
| ||
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Eardley Holding A.G. (1) |
| 06/23/2006 |
|
| E | 162 |
| (2 | ) | 10% pa |
| $ | 0.10 |
| N/A |
|
Anglo Irish Bank S.A.(3) |
| 10/21/2007 |
|
| E | 500 |
| (2 | ) | 10% pa |
| $ | 0.50 |
| 1.4090 |
|
Round Enterprises Ltd. |
| 12/10/2007 |
|
| E | 1,500 |
| (2 | ) | 10% pa |
| $ | 0.50 |
| 1.4429 |
|
Round Enterprises Ltd. |
| 01/22/2008 |
|
| E | 1,500 |
| (2 | ) | 10% pa |
| $ | 0.50 |
| 1.4629 |
|
Round Enterprises Ltd. |
| 04/25/2008 |
|
| E | 2,000 |
| (2 | ) | 10% pa |
| $ | 0.50 |
| 1.5889 |
|
Round Enterprises Ltd. |
| 06/30/2008 |
|
| E | 1,500 |
| (2 | ) | 10% pa |
| $ | 0.50 |
| 1.5380 |
|
Round Enterprises Ltd. |
| 11/18/2008 |
|
| E | 1,200 |
| (2 | ) | 10% pa |
| $ | 0.50 |
| 1.2650 |
|
Round Enterprises Ltd. |
| 02/09/2009 |
|
| E | 1,500 |
| (2 | ) | 10% pa |
| $ | 0.50 |
| 1.2940 |
|
Round Enterprises Ltd. |
| 06/15/2009 |
|
| E | 5,500 |
| (2,4 | ) | 10% pa |
| $ | 0.80 |
| 1.4045 |
|
Eardley Holding A.G. |
| 06/15/2009 |
|
| E | 100 |
| (2,4 | ) | 10% pa |
| $ | 0.80 |
| 1.4300 |
|
Von Meyenburg |
| 08/03/2009 |
|
| E | 200 |
| (2 | ) | 10% pa |
| $ | 0.80 |
| 1.4400 |
|
Round Enterprises Ltd. |
| 10/13/2009 |
|
| E | 2,000 |
| (2 | ) | 5% pa |
| $ | 0.25 |
| 1.4854 |
|
Round Enterprises Ltd. |
| 12/18/2009 |
|
| E | 2,200 |
| (2 | ) | 5% pa |
| $ | 0.25 |
| 1.4338 |
|
Round Enterprises Ltd. |
| 08/04/2011 |
|
| E | 1,023 |
| (5,6 | ) | 10% pa |
| $ | 0.034 |
| N/A |
|
Eardley Holding A.G. |
| 08/04/2011 |
|
| E | 256 |
| (5,6 | ) | 10% pa |
| $ | 0.034 |
| N/A |
|
Round Enterprises Ltd. |
| 11/08/2011 |
|
| E | 400 |
| (6 | ) | 10% pa |
| $ | 0.034 |
| 1.3787 |
|
Eardley Holding A.G. |
| 11/08/2011 |
|
| E | 100 |
| (6 | ) | 10% pa |
| $ | 0.034 |
| 1.3787 |
|
Round Enterprises Ltd. |
| 02/10/2012 |
|
| E | 1,000 |
| (6 | ) | 10% pa |
| $ | 0.034 |
| 1.3260 |
|
Eardley Holding A.G. |
| 02/14/2012 |
|
| E | 200 |
| (6 | ) | 10% pa |
| $ | 0.034 |
| 1.3260 |
|
Round Enterprises Ltd. |
| 04/19/2012 |
|
| E | 322 |
| (6 | ) | 10% pa |
| $ | 0.034 |
| 1.3100 |
|
Eardley Holding A.G. |
| 04/19/2012 |
|
| E | 80 |
| (6 | ) | 10% pa |
| $ | 0.034 |
| 1.3100 |
|
Round Enterprises Ltd. |
| 05/04/2012 |
|
| E | 480 |
| (6 | ) | 10% pa |
| $ | 0.034 |
| 1.3152 |
|
Eardley Holding A.G. |
| 05/04/2012 |
|
| E | 120 |
| (6 | ) | 10% pa |
| $ | 0.034 |
| 1.3152 |
|
Round Enterprises Ltd. |
| 09/03/2012 |
|
| E | 200 |
| (6 | ) | 10% pa |
| $ | 0.034 |
| 1.2576 |
|
Eardley Holding A.G. |
| 09/03/2012 |
|
| E | 50 |
| (6 | ) | 10% pa |
| $ | 0.034 |
| 1.2576 |
|
Round Enterprises Ltd. |
| 11/14/2012 |
|
| E | 500 |
| (6 | ) | 10% pa |
| $ | 0.034 |
| 1.2718 |
|
Eardley Holding A.G. |
| 12/06/2012 |
|
| E | 125 |
| (6 | ) | 10% pa |
| $ | 0.034 |
| 1.3070 |
|
Round Enterprises Ltd. |
| 01/16/2013 |
|
| E | 240 |
| (6 | ) | 10% pa |
| $ | 0.034 |
| 1.3318 |
|
Eardley Holding A.G. |
| 01/16/2013 |
|
| E | 60 |
| (6 | ) | 10% pa |
| $ | 0.034 |
| 1.3318 |
|
Round Enterprises Ltd. |
| 03/25/2013 |
|
| E | 400 |
| (6 | ) | 10% pa |
| $ | 0.037 |
| 1.2915 |
|
Eardley Holding A.G. |
| 04/14/2013 |
|
| E | 150 |
| (6 | ) | 10% pa |
| $ | 0.034 |
| 1.3056 |
|
Round Enterprises Ltd. |
| 04/14/2013 |
|
| E | 600 |
| (6 | ) | 10% pa |
| $ | 0.034 |
| 1.3056 |
|
Eardley Holding A.G. |
| 05/15/2013 |
|
| E | 170 |
| (6 | ) | 10% pa |
| $ | 0.037 |
| 1.2938 |
|
Round Enterprises Ltd. |
| 05/15/2013 |
|
| E | 680 |
| (6 | ) | 10% pa |
| $ | 0.037 |
| 1.2938 |
|
Eardley Holding A.G. |
| 06/24/2013 |
|
| E | 60 |
| (6 | ) | 10% pa |
| $ | 0.025 |
| 1.3340 |
|
Round Enterprises Ltd. |
| 06/24/2013 |
|
| E | 240 |
| (6 | ) | 10% pa |
| $ | 0.025 |
| 1.3340 |
|
Eardley Holding A.G. |
| 08/05/2013 |
|
| E | 80 |
| (6 | ) | 10% pa |
| $ | 0.018 |
| 1.3283 |
|
Round Enterprises Ltd. |
| 08/05/2013 |
|
| E | 320 |
| (6 | ) | 10% pa |
| $ | 0.018 |
| 1.3283 |
|
Eardley Holding A.G. |
| 03/01/2017 |
|
| E | 230 |
| (7 | ) | 2.5% pa |
|
| N/A |
| N/A |
|
Round Enterprises Ltd. |
| 03/01/2017 |
|
| E | 920 |
| (7 | ) | 2.5% pa |
|
| N/A |
| N/A |
|
Eardley Holding A.G. |
| 10/18/2017 |
|
| E | 230 |
| (7 | ) | 2.5% pa |
|
| N/A |
| N/A |
|
Round Enterprises Ltd. |
| 10/18/2017 |
|
| E | 920 |
| (7 | ) | 2.5% pa |
|
| N/A |
| N/A |
|
Eardley Holding A.G. |
| 06/01/2018 |
|
| E | 160 |
| (8 | ) | 2.5% pa |
|
| N/A |
| N/A |
|
Round Enterprises Ltd. |
| 06/01/2018 |
|
| E | 640 |
| (8 | ) | 2.5% pa |
|
| N/A |
| N/A |
|
Eardley Holding A.G. |
| 11/10/2018 |
|
| E | 160 |
| (8 | ) | 2.5% pa |
|
| N/A |
| N/A |
|
Round Enterprises Ltd. |
| 11/10/2018 |
|
| E | 640 |
| (8 | ) | 2.5% pa |
|
| N/A |
| N/A |
|
Eardley Holding A.G. |
| 06/15/2019 |
|
| E | 120 |
| (9 | ) | 2.5% pa |
|
| N/A |
| N/A |
|
Round Enterprises Ltd. |
| 06/15/2019 |
|
| E | 480 |
| (9 | ) | 2.5% pa |
|
| N/A |
| N/A |
|
Eardley Holding A.G. |
| 12/20/2019 |
|
| E | 120 |
| (10 | ) | 2.5% pa |
|
| N/A |
| N/A |
|
Round Enterprises Ltd. |
| 12/20/2019 |
|
| E | 480 |
| (10 | ) | 2.5% pa |
|
| N/A |
| N/A |
|
Eardley Holding A.G. |
| 06/15/2020 |
|
| E | 220 |
| (11 | ) | 2.5% pa |
|
| N/A |
| N/A |
|
Round Enterprises Ltd. |
| 06/15/2020 |
|
| E | 880 |
| (11 | ) | 2.5% pa |
|
| N/A |
| N/A |
|
Eardley Holding A.G. |
| 12/15/2020 |
|
| E | 170 |
| (12 | ) | 2.5% pa |
|
| N/A |
| N/A |
|
Round Enterprises Ltd. |
| 12/15/2020 |
|
| E | 680 |
| (12 | ) | 2.5% pa |
|
| N/A |
| N/A |
|
Eardley Holding A.G. |
| 08/15/2021 |
|
| E | 240 |
| (13 | ) | 2.5% pa |
|
| N/A |
| N/A |
|
Round Enterprises Ltd. |
| 08/15/2021 |
|
| E | 960 |
| (13 | ) | 2.5% pa |
|
| N/A |
| N/A |
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Total Short Term Principal Amounts |
|
|
|
| E | 36,048 |
|
|
|
|
|
|
|
|
|
|
Accrued Interest |
|
|
|
| E | 31,979 |
|
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|
|
|
|
|
|
|
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TOTAL LOANS AND NOTES |
|
|
|
| E | 68,027 |
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|
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| 12 |
(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. |
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(2) | This maturity date is automatically prolonged for periods of three months, unless called for repayment. |
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(3) | Renamed Hyposwiss Private Bank Genève S.A. and acting on behalf of Round Enterprises Ltd. which is a major shareholder. |
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(4) | The loan is secured against 2/3rds of the IP assets of Bestewil Holding BV and against all property of the Company. |
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(5) | The face values of the loans are stated in U.S. dollars at $1,200 and $300, respectively. |
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(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 fixed conversion price using a fixed exchange rate which are noted in the table above. The convertible note holder has the right to convert at any time prior to the maturity date, at the convertible note holder’s option, prior to the repayment of the outstanding balance under the note by the Company, to convert the unpaid outstanding principal balance and accrued interest, in whole or in part, into common stock at the fixed conversion price as stated in the contract. |
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(7) | On March 1, 2017, Round Enterprises Ltd. and Eardley Holding AG each provided two promissory Notes for a total of €1,840 and €460, respectively, with a 2.5% interest per annum and a maturity date of March 1, 2018. The first 50% of the promissory Notes of €920 and €230, respectively, were provided immediately. The second 50% of the promissory notes of €920 and €230, respectively, were provided on October 18, 2017 with a 2.5% interest per annum and a maturity date of October 18, 2018. Both Round Enterprises Ltd. And Eardley Holding AG have agreed to amend the maturity date of these promissory notes to follow the same terms of the other convertible loans. Therefore, the maturity date of the promissory notes is amended to be the later of (i) June 30, 2018, 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. The amendments were accounted for as modifications in the consolidated financial statements. |
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(8) | On June 1, 2018, Round Enterprises Ltd. and Eardley Holding AG each provided two promissory Notes for a total of €1,280 and €320 in two tranches, respectively, with a 2.5% interest per annum. The first tranche of the promissory Notes of €640 and €160, respectively, were provided immediately. The second tranche of the promissory notes of €640 and €160, 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 terms of other convertible loans and is the later of (i) June 30, 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. |
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(9) | On June 15, 2019, Round Enterprises Ltd. and Eardley Holding AG each provided promissory Notes for a total of €600 with a 2.5% interest per annum. The promissory Notes of €480 and €120, respectively, were provided immediately. The maturity date of these promissory notes to follow the same terms of other convertible loans and is the later of (i) December 31, 2020, 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. |
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(10) | On December 20, 2019, Round Enterprises Ltd. and Eardley Holding AG each provided promissory Notes for a total of €600 with a 2.5% interest per annum. The promissory Notes of €480 and €120, respectively, were provided immediately. The maturity date of these promissory notes to follow the same terms of other convertible loans and is the later of (i) June 30, 2020, 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. |
| 13 |
(11) | On June 15, 2020, Round Enterprises Ltd. and Eardley Holding AG each provided promissory Notes for a total of €1,100 with a 2.5% interest per annum. The promissory Notes of €880 and €220, respectively, were provided immediately. The maturity date of these promissory notes to follow the same terms of other convertible loans and is the later of (i) September 30, 2020, 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. |
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(12) | On December 15, 2020, Round Enterprises Ltd. and Eardley Holding AG each provided promissory Notes for a total of €850 with a 2.5% interest per annum. The promissory Notes of €680 and €170, respectively, were provided immediately. The maturity date of these promissory notes to follow the same terms of other convertible loans and is the later of (i) March 31, 2021, 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. |
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(13) | On August 15, 2021, Round Enterprises Ltd. and Eardley Holding AG each provided promissory Notes for a total of €1,200 with a 2.5% interest per annum. The promissory Notes of €960 and €240, respectively, were provided immediately. The maturity date of these promissory notes to follow the same terms of other convertible loans and is the later of (i) December 31, 2021, 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. |
On April 2, 2020, the Swiss entity, Mymetics SA, received a federal credit line of Chf 168 (€156) in relation with the Covid-19 pandemic. This credit line applies for five years and is fully guaranteed by the Swiss Confederation via guaranteed organizations. The interest rate is currently at 0 percent until March 31, 2021. The Swiss Confederation has the right to adjust the interest rate to the market rate. The first revision took place as of April 1, 2021, but no modification was applied.
Certain of the secured convertible notes have conversion features that should be bifurcated from the debt and recorded at fair value; however, as of December 31, 2021, and 2020, the probability of the conversion features being exercised was zero. For this reason, the conversion features is not required to be bifurcated from the debt as the fair value is zero at March 31, 2022 and December 31, 2021.
Note 3. Commitments
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 €4 and is considered a short-term lease. As the term is less than twelve months, the lease is outside of the scope of ASC 842 and not accounted for on the balance sheet due to the Company’s policy elections.
The facility lease agreement for Leiden, The Netherlands, runs until March 31, 2024, and can be terminated with a six month notice as of September 30, 2023. The related rent is paid monthly in the amount of €9. The Company does not have any other operating lease for its research and development facilities, corporate headquarter, offices and equipment.
Note 4. Subsequent Events
In April 2022, the Company agreed with Round Enterprises Ltd and Eardley Holding AG the issuance of promissory notes with a total combined value of €1,200, with an annual interest rate of 2.5%. The promissory notes will be issued in two tranches, one tranche of €600 in April 2022 and the second tranche of €600 about three months later. The maturity date for the first tranche is the later of (i) September 30, 2022, 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. The total amount of the first tranche of €600 is expected to be received on April 31, 2022.
In April 2022, the Company filed a report to the NIH in collaboration with ULL, to validate funds for the fifth year of the ongoing HIV project (May 2022 to April 2023). The approval is pending as of May 13, 2022.
In May 2022, the Company entered into engagement agreements with two biotech consulting firms to source potential licensing, financing and/or acquisition opportunities for the Company under customary compensation terms.
| 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 Mymetics Corporation for the periods ended March 31, 2022 and 2021 should be read in conjunction with the Company’s audited consolidated financial statements for the year ended December 31, 2021 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, 2021 and, to the extent included therein, our quarterly reports on Form 10-Q filed during fiscal year 2022.
IMPACT OF THE NOVEL CORONAVIRUS
On January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency because of a new strain of coronavirus originating in Wuhan, China (the “COVID-19 outbreak”) and the risks to the international community as the virus spreads globally beyond its point of origin. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic, based on the rapid increase in exposure globally.
The COVID-19 pandemic has continued to evolve. Although at this date the restrictive measures and impacts are reduced due to the role out of vaccination programs, the extent to which the outbreak impacts our business, preclinical studies and clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the pandemic, travel restrictions and social distancing, business closures or business disruptions and the effectiveness of actions taken in the U.S., Europe, and other countries to contain and treat the disease. As such, it is uncertain as to the full magnitude that the pandemic will have on the Company’s financial condition, liquidity, and future results of operations.
Management has taken measures in-line with the country requirements where we are operational and actively monitoring the impact of this global situation on its financial condition, liquidity, operations, scientific collaborations, suppliers, industry, and workforce. Given the daily evolution of the COVID-19 outbreak and the global responses to curb its spread, the Company is not able to estimate the effects of the COVID-19 outbreak on its results of operations, financial condition, or liquidity for fiscal year 2022.
The Company is dependent on its workforce to deliver and advance its research. Developments such as physical distancing and working from home directives have and will continue to impact the Company’s ability to deploy its workforce effectively. While restrictions are being lifted across the world, prolonged workforce disruptions may negatively impact future revenues for the remainder of fiscal year 2022 and the Company’s overall liquidity.
The Company is dependent on its partners in certain projects, such as the University of Louisiana at Lafayette (“ULL”) for the NIH funded project to maintain the agreed timelines and execute their tasks. Developments such as social distancing and shelter-in-place directives and lock-down directives have and will continue to impact the Company’s ability to execute on project plans and research objectives effectively. While expected to be temporary, prolonged disruptions in collaboration projects may negatively impact funding for the fiscal year 2022 and the Company’s overall liquidity.
Although the Company cannot estimate the length or gravity of the impact of the COVID-19 outbreak at this time, if the pandemic continues, it may have a material adverse effect on the Company’s results of future operations, financial position, and liquidity in fiscal year 2022.
| 15 |
CORONAVIRUS AID, RELIEF AND ECONOMIC SECURITY ACT
On March 27, 2020, the U.S. Government enacted the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) was signed into law. The CARES Act includes various income and payroll tax provisions. The Company has analyzed the tax provisions of the CARES Act and determined they have no significant financial impact to the financial statements. The Company has no intention of taking advantage of other benefits but will continue to evaluate the impact on the Company’s financial position.
THREE MONTHS ENDED MARCH 31, 2022 AND 2021
For the three months ended March 31, 2022 and 2021, revenue was €485 and €134, of which €482 and €131 was related to the revenue recognized for the work performed under the NIH grant / HIV project and the remaining for a small pre-clinical research project with a US academic institution, for the years 2022 and 2021, respectively.
Costs and expenses increased to €914 for the three months ended March 31, 2022, from €545 (+67.7%) for the three months ended March 31, 2021. The increase is mainly due to the purchase of the influenza inactivated virus cost related to the work performed under the NIH grant / HIV project incurred during the three months ended March 31, 2022.
Research and development expenses increased to €582 in the current period from €254 (+129.1%) in the comparative period of 2021, mainly due to the purchase of the influenza inactivated virus cost related to the work performed under the NIH grant / HIV project incurred during the three months ended March 31, 2022.
General and administrative expenses increased to €332 in the current period from €291 (+14.1%) in the comparative period of 2021, mainly due to the 2020 preliminary annual financial audit work incurred remotely during the year due to the pandemic situation.
Other expenses decreased to €88 for the three months ended March 31, 2022 from €122 (-37.5%) for the three months ended March 31, 2021, mainly due to the foreign exchange revaluation impact of shareholders’ loans based in US$.
Interest expense increased to €694 for the three months ended March 31, 2022 from €685 for the three months ended March 31, 2021 related to existing loans from third party investors.
The Company reported a net loss of (€1,211), or (€0.00) per share, for the three months ended March 31, 2022, compared to a net loss of (€1,246), or (€0.00) per share, for the three months ended March 31, 2021.
LIQUIDITY AND CAPITAL RESOURCES
We had cash of €122 at March 31, 2022 compared to €571 at December 31, 2021.
During 2021, our revenue has mainly been generated through the NIH grant / HIV project. For 2022, new significant revenues are not 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 March 31, 2022, we had an accumulated deficit of approximately €98,961, and had net loss of €1,211 in the three-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 from operating activities decreased to €458 for the three-month period ended March 31, 2022, compared to €327 for the same period in 2021, mainly due to the receivable related to the NIH grant / HIV project incurred during the three-month period ending March 31, 2022.
Net cash used from investing activities was €(-2) during the three months ended March 31, 2022 and €(-10) during the same period in 2021, mainly due to acquisition of IT equipment.
Net cash provided from financing activities is NIL for the three months ended March 31, 2022 and 2021.
| 16 |
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 €65 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, three 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, Covid-19 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.
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 €1,700 additional funding as of December 31, 2022. We will seek to raise the additional 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 it will be able to raise additional capital on satisfactory terms, or at all, to finance its operations on the longer term. 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 €13 represent the monthly lease and maintenance payments to unaffiliated third parties for our offices, of which €4 is related to our executive office located at Route de la Corniche 4, 1066 Epalinges in Switzerland (100 square meters), and €9 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 €31,979 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 three months period ending March 31, 2022, our principal source of funds has been promissory notes received in 2021 from our two main investors and the revenue generated through the NIH grant / HIV project.
We have filed or are in the process of filing several new grant applications with U.S. and European institutions in relation to our virosome based vaccines.
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 2022, 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. These conditions raise substantial doubt about our ability to continue as a going concern.
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
None
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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
Under the supervision and with the participation of the Company’s management, including its Chief Executive Officer and Chief Financial Officer the Company conducted an evaluation of the effectiveness of the Company’s disclosure controls and procedures, as defined in Rule 13a−15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (the “Exchange Act”), as of the end of the period covered by this report. Based on this evaluation, the Company’s Chief Executive Officer and Chief Financial Officer (currently the same person to allow timely decisions regarding required disclosure) concluded as of March 31, 2022, that the Company’s disclosure controls and procedures were not effective because of the material weakness described below.
Management’s Annual Report on Internal Control over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act). Our internal control over financial reporting includes policies and procedures designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external reporting purposes in accordance with generally accepted accounting principles.
Under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, our management conducted an evaluation of the effectiveness of our internal control over financial reporting as of March 31, 2022, based on the criteria established in Internal Control -- Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting during the quarter ended March 31, 2022, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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.
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PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Neither we, nor our wholly owned subsidiaries Mymetics S.A., 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.
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ITEM 6. EXHIBITS
EXHIBIT NUMBER |
| DESCRIPTION |
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| Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer | |
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| Section 1350 Certification of Chief Executive Officer and Chief Financial Officer | |
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101.INS |
| Instance Document |
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101.SCH |
| XBRL Taxonomy Extension Schema Document |
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101.CAL |
| XBRL Taxonomy Extension Calculation Linkbase Document |
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101.LAB |
| XBRL Taxonomy Extension Label Linkbase Document |
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101.PRE |
| XBRL Taxonomy Extension Presentation Linkbase Document |
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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 |
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Dated: May 13, 2022 | By: | /s/ Ronald Kempers |
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| Chief Executive Officer / Chief Financial Officer |
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