Attached files
| file | filename |
|---|---|
| EX-32 - CERTIFICATION - MYMETICS CORP | mymx_ex32.htm |
| EX-31.2 - CERTIFICATION - MYMETICS CORP | mymx_ex312.htm |
| EX-31.1 - CERTIFICATION - MYMETICS CORP | mymx_ex311.htm |
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
|
þ
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2015
OR
|
o
|
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)
|
(I.R.S. Employer Identification No.)
|
c/o Mymetics S.A.
Biopole
Route de la Corniche, 4
1066 Epalinges (Switzerland)
(Address of principal executive offices)
REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE: 011 41 21 653 4535
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 þ No o
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 þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “accelerated filer,” “large accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
|
Large Accelerated Filer o
|
Accelerated Filer o
|
|||
|
Non-Accelerated Filer o
|
Smaller Reporting Company þ
|
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x
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 August 14, 2015
|
|
|
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)
|
June 30,
|
December 31,
|
|||||||
|
2015
|
2014
|
|||||||
|
ASSETS
|
||||||||
|
Current Assets
|
||||||||
|
Cash
|
E
|
3,164
|
E
|
1,614
|
||||
|
Receivable other
|
350
|
278
|
||||||
|
Prepaid expenses
|
51
|
52
|
||||||
|
Total current assets
|
3,565
|
1,944
|
||||||
|
Property and equipment, net of accumulated depreciation of E330 at June 30, 2015 and E311 at December 31, 2014
|
117
|
129
|
||||||
|
In-process research and development
|
2,266
|
2,266
|
||||||
|
Goodwill
|
6,671
|
6,671
|
||||||
|
E
|
12,619
|
E
|
11,010
|
|||||
|
LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT)
|
||||||||
|
Current Liabilities
|
||||||||
|
Deferred revenue from grants
|
E
|
1,517
|
E
|
309
|
||||
|
Accounts payable
|
754
|
416
|
||||||
|
Convertible notes payable to related parties
|
41,845
|
40,374
|
||||||
|
Total liabilities
|
44,116
|
41,099
|
||||||
|
Shareholders' Equity (Deficit)
|
||||||||
|
Common stock, U.S. $0.01 par value; 850,000,000 shares authorized; issued 303,757,622 at June 30, 2015 and at December 31, 2014
|
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
|
34,255
|
34,169
|
||||||
|
Accumulated deficit
|
(68,937
|
)
|
(67,421
|
)
|
||||
|
Accumulated other comprehensive income
|
655
|
633
|
||||||
|
(31,497
|
)
|
(30,089
|
)
|
|||||
|
E
|
12,619
|
E
|
11,010
|
|||||
The accompanying notes are an integral part of these financial statements.
2
MYMETICS CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
(In Thousands of Euros, Except Per Share Data)
|
For The Three Months Ended
June 30,
|
For The Six Months Ended
June 30,
|
|||||||||||||||
|
2015
|
2014
|
2015
|
2014
|
|||||||||||||
|
Revenue
|
||||||||||||||||
|
Research and Development services
|
E | 552 | E | 515 | E | 1,162 | E | 1,042 | ||||||||
|
Grants
|
476 | -- | 528 | -- | ||||||||||||
| 1,028 | 515 | 1,690 | 1,042 | |||||||||||||
|
Expenses
|
||||||||||||||||
|
Research and development
|
554 | 372 | 921 | 741 | ||||||||||||
|
General and administrative
|
447 | 292 | 840 | 674 | ||||||||||||
|
Bank fee
|
1 | 1 | 2 | 2 | ||||||||||||
|
Depreciation
|
9 | 9 | 19 | 16 | ||||||||||||
|
Directors' fees
|
5 | 5 | 10 | 10 | ||||||||||||
|
Foreign exchange and other
|
(75 | ) | 3 | 118 | (15 | ) | ||||||||||
| 941 | 682 | 1,910 | 1,428 | |||||||||||||
|
Income (Loss)
|
87 | (167 | ) | (220 | ) | (386 | ) | |||||||||
|
Interest Expense
|
643 | 634 | 1,286 | 1,312 | ||||||||||||
|
Loss before income tax provision
|
(556 | ) | (801 | ) | (1,506 | ) | (1,698 | ) | ||||||||
|
Income tax provision
|
(7 | ) | (12 | ) | (10 | ) | (24 | ) | ||||||||
|
Net Loss
|
(563 | ) | (813 | ) | (1,516 | ) | (1,722 | ) | ||||||||
|
Other comprehensive Loss
|
||||||||||||||||
|
Foreign currency translation adjustment
|
(41 | ) | (9 | ) | 22 | (27 | ) | |||||||||
|
Comprehensive Loss
|
E | (604 | ) | E | (822 | ) | E | (1,494 | ) | E | (1,749 | ) | ||||
|
Basic earnings per share
|
E | (0.00 | ) | E | (0.00 | ) | E | (0.00 | ) | E | (0.01 | ) | ||||
|
Diluted earnings per share
|
E | (0.00 | ) | E | (0.00 | ) | E | (0.00 | ) | E | (0.01 | ) | ||||
The accompanying notes are an integral part of these financial statements.
3
MYMETICS CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(In Thousands of Euros)
|
For The Six Months Ended
June 30,
|
||||||||
|
2015
|
2014
|
|||||||
|
Cash Flow from Operating Activities
|
||||||||
|
Net loss
|
E
|
(1,516
|
)
|
E
|
(1,722
|
)
|
||
|
Adjustments to reconcile net loss to net cash provided by operating activities
|
||||||||
|
Depreciation
|
19
|
16
|
||||||
|
Stock compensation expense – options
|
86
|
56
|
||||||
|
Changes in operating assets and liabilities
|
||||||||
|
Receivables
|
(72
|
)
|
3,432
|
|||||
|
Accrued interest on notes payable
|
1,471
|
1,287
|
||||||
|
Deferred revenue from grants
|
1,208
|
--
|
||||||
|
Accounts payable
|
338
|
(406
|
)
|
|||||
|
Other
|
1
|
(44
|
)
|
|||||
|
Net cash provided by operating activities
|
1,535
|
2,619
|
||||||
|
Cash Flows from Investing Activities
|
||||||||
|
Purchase of property and equipment
|
(7
|
)
|
(13
|
)
|
||||
|
Net cash used in investing activities
|
(7
|
)
|
(13
|
)
|
||||
|
Cash Flows from Financing Activities
|
||||||||
|
Payments on notes payable and other short-term advances
|
--
|
(1,538
|
)
|
|||||
|
Net cash used in financing activities
|
--
|
(1,538
|
)
|
|||||
|
Effect on foreign exchange rate on cash
|
22
|
(27
|
)
|
|||||
|
Net change in cash
|
1,550
|
1,041
|
||||||
|
Cash, beginning of period
|
1,614
|
297
|
||||||
|
Cash, end of period
|
E
|
3,164
|
E
|
1,338
|
||||
|
Supplemental Disclosure of Cash Flow Information:
|
||||||||
|
Cash Paid for Interest
|
E
|
--
|
E
|
76
|
||||
The accompanying notes are an integral part of these financial statements.
4
MYMETICS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2015
(UNAUDITED)
Note 1. The Company and Summary of Significant Accounting Policies
BASIS OF PRESENTATION
The amounts in the notes are shown in thousands of EURO 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, 2014.
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 ending June 30, 2015 were of a normal and recurring nature.
Mymetics Corporation (the "Company" or "Mymetics") was created for the purpose of engaging in vaccine research and development. Its main research efforts 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. On April 1, 2009 the Company successfully closed its acquisition of Bestewil Holding BV and Mymetics BV (previously Virosome Biologicals BV) and, as a result, has further increased the pipeline of vaccines under development to include (i) Herpes Simplex which is at the pre-clinical stage, (ii) intranasal influenza for elderly which has finished a clinical trial Phase I, and (iii) Respiratory Syncytial Virus (RSV) which is at the pre-clinical stage. On December 27, 2013, Mymetics signed a License and Collaboration Agreement with RSV Corporation (RSVC), a dedicated entity specifically set-up for developing the Mymetics RSV vaccine. Under this agreement Astellas Pharma Inc. will fund RSVC’s development of the virosome vaccine technology, licensed from Mymetics for the respiratory syncytial virus (RSV) through completion of a Phase 2b human proof‐of‐concept study. Based on the strategic partnership, Astellas received exclusive rights to acquire RSVC as well as further develop and commercialize the vaccine product. Mymetics will continue to provide research and development activities for the pre-clinical phases and prepare for the upscale production, assay developments and provide further scientific advice on the development of the RSV virosome vaccine. As consideration Mymetics has received an irrevocable and non-refundable upfront fee for the license of USD 5 million and will receive monthly Collaboration and R&D fees, milestone payments for specific milestones during development and royalties at the time of commercialization.
As of June 30, 2015, the Company is in the pre-clinical testing of some of its vaccine candidates and a commercially viable product is not expected for several more years. However, the Company generates some revenue through the licensing of its RSV vaccine and from collaboration agreements for R&D services. Management believes that the Company’s research and development activities will result in valuable intellectual property that can generate significant revenues in the future such as by licensing. Vaccines are one of the fastest growing markets in the pharmaceutical industry.
These consolidated financial statements have been prepared assuming the Company will continue as a going concern. The Company has experienced significant losses since inception resulting in an accumulated deficit of E68,937 at June 30, 2015. Further, the Company’s current liabilities exceed its current assets by E40,551 as of June 30, 2015, 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.
PRINCIPLES OF CONSOLIDATION
The consolidated financial statements include the accounts of the Company and its subsidiaries. Significant intercompany accounts and transactions have been eliminated.
5
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 operations. 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
Cash deposits are occasionally in excess of insured amounts.
REVENUE RECOGNITION
Exclusive Licenses
The deliverables under an exclusive license agreement generally include the exclusive license to the Company’s technology, and may also include deliverables related to research activities to be performed on behalf of the collaborative collaborator and the manufacture of preclinical or clinical materials for the collaborative collaborator.
Generally, exclusive license agreements contain non-refundable terms for payments and, depending on the terms of the agreement, provide that the Company will (i) provide research services which are reimbursed at a contractually determined rate which includes margin for the Company, (ii) participate in a joint steering committee to monitor the progress of the research and development which will be reimbursed at a contractually determined rate which includes margin for the Company, (iii) earn payments upon the achievement of certain milestones and (iv) earn royalty payments at the time of commercialization until the later of expiration of the last to expire valid patent rights expire or 10 years after the first commercial sale. The Company may provide technical assistance and share any technology improvements with its collaborators during the term of the collaboration agreements. The Company does not directly control when any collaborator will request research or manufacturing services, achieve milestones or become liable for royalty payments. As a result, the Company cannot predict when it will recognize revenues in connection with any of the foregoing.
The Company follows the provisions of the Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 605-25, "Revenue Recognition—Multiple-Element Arrangements," and ASC Topic 605-28, "Revenue Recognition—Milestone Method," in accounting for these agreements. In order to account for these agreements, the Company must identify the deliverables included within the agreement and evaluate which deliverables represent separate units of accounting based on if certain criteria are met, including whether the delivered element has stand-alone value to the collaborator. The consideration received is allocated among the separate units of accounting, and the applicable revenue recognition criteria are applied to each of the separate units. Factors considered in this determination include the research and manufacturing capabilities of the collaborator and the availability of technology research expertise in the general marketplace.
RSV Corporation
In December 2013, the Company entered into an agreement with RSV Corporation. The agreement provides RSV Corporation with an exclusive license to the Company’s RSV technology in order to develop and commercialize respiratory syncytial virus virosome vaccines. The Company received a US$5 million upfront payment in connection with the execution of the agreement and the Company is entitled to receive milestone payments potentially totaling $77 million plus royalties on product sales, if any. The Company also is entitled to receive payments for research and development activities performed on behalf of RSV Corporation. RSV Corporation is responsible for the development, manufacturing, and marketing of any products resulting from this agreement.
In accordance with ASC 605-25, the Company identified all of the deliverables at the inception of the agreement. The significant deliverables were determined to be the RSV technology license and the research and development services including participation on the Joint Collaboration and Steering Committee (JCSC). The Company has determined that the RSV technology license does have standalone value from the research services. As a result, the research services are considered a separate unit of accounting. The estimated selling prices for these units of accounting were determined based on market conditions and entity-specific factors such as the terms of the collaborators’ previous collaborative agreements, recent preclinical and clinical testing results of therapeutic products that use the Company’s RSV technology, the Company’s pricing practices and pricing objectives, and the nature of the research services to be performed for RSV Corporation and market rates for similar services. The arrangement consideration was allocated to the deliverables based on the relative selling price method. The Company recognized license revenue when the exclusive license was delivered pursuant to the terms of the agreement which was upon execution of the agreement. The Company does not control when RSV Corporation will reach certain development and commercialization’s milestones related to the RSV technology. As a result, the Company cannot predict when or if it will recognize the related milestone and royalty revenue. The Company will recognize research services revenue as the related services are delivered.
6
Fixed price contracts and research and collaboration agreements
When the performance under a fixed price contract can be reasonably estimated, revenue for such a contract is recognized under the proportional performance method and earned in proportion to the contract costs incurred in performance of the work as compared to total estimated contract costs. Costs incurred under fixed price contracts represent a reasonable measurement of proportional performance of the work. Direct costs incurred under collaborative research and development agreements are recorded as research and development expenses. If the performance under a fixed price contract cannot be reasonably estimated, the Company recognizes the revenue on a straight-line basis over the contract term.
IMUGENE Limited
In July 2014, the Company entered into a master service agreement with Imugene Limited. The agreement provides the terms and conditions upon which Imugene Limited may engage the Company to provide services to produce specific virosome based HER2/neu positive cancer vaccines by executing individual Work Orders with fixed price agreements. In consideration for the exclusive supply rights granted by the Company to Imugene, the Company received options to purchase 2.5 million common shares of Imugene with an exercise price of AUD 0.025 per share with an exercise period of five years, and is entitled to receive milestone payments potentially totaling CHF 2.8 million (None due yet) plus royalties on product sales, if any. The value of the options received is insignificant and has not been recorded. The Company also is entitled to receive payments for research and development activities performed on behalf of Imugene. The Company recognizes revenue under the proportional performance method.
TEXAS BIOMEDICAL RESEARCH INSTITUTE
In September 2014, the Company entered into a material transfer agreement and fixed price contract with Texas Biomedical Research Institute. The agreement provides Texas Biomedical Research Institute the lead of a project which has been proposed to the Bill and Melinda Gates foundation with the objective to confirm previous results obtained in non-human primates with these virosome based HIV vaccine candidates. The Company has tested these different formulations of virosome based HIV vaccines candidates in preclinical non-human primate studies and in Phase I clinical settings. The Company will produce and transfer to Texas Biomedical Research Institute the original material using the Company’s background IP. The Company recognizes revenue under the proportional performance method.
PATH-MVI
In November 2014, the Company signed an agreement with PATH Malaria Vaccine Initiative (MVI) and the Laboratory of Malaria Immunology and Vaccinology (LMIV) of the National Institute of Allergy and Infectious Diseases (NIAID), where Mymetics will develop and produce virosome based vaccine formulations for a malaria transmission-blocking vaccine candidate which will be based on two antigens provided by LMIV. The vaccine formulations will then be tested in animal models. PATH MVI will fund all activities under this project, which started in January 2015. The Company recognizes revenue under the proportional performance method.
HORIZON 2020-SERI
In April 2015, the Company was selected to receive project grants with a total of E8.4 million. A total of E5.3 million is funded as part of Horizon 2020, the European Union research and innovation framework program and up to E3.1 million of funding will be provided by the Swiss State Secretariat for Education, Research and Innovation (SERI) for the Swiss based consortium partners. The grant will fund the evaluation, development and manufacturing scale-up of thermo stable and cold-chain independent nano-pharmaceutical virosome-based vaccine candidates. Of the total amount, E3.4 million is directly attributable to Mymetics activities, with the remaining balance going to the consortium partners, Catalent UK Swindon Zydis Ltd, Chimera Biotec GmbH (Germany), Upperton Ltd. (UK) and Bachem AG (Switzerland). The project duration is 42 months and started on May 4, 2015. In May 2015, the Company has received a pre-payment from the two granting organizations for a total value of E1.5 million. The Company recognizes revenue under the proportional performance method and recognized E219 for the three months ending June 30, 2015. The remaining amount received has been recorded as deferred revenue.
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 June 30, 2015 or December 31, 2014. The Company charges 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.
7
IN-PROCESS RESEARCH AND DEVELOPMENT
In-process research and development (referred to as IPR&D) represents the estimated fair value assigned to research and development projects acquired in a purchased business combination that have not been completed at the date of acquisition and which have no alternative future use. IPR&D assets acquired in a business combination are capitalized as indefinite-lived intangible assets. These assets remain indefinite-lived until the completion or abandonment of the associated research and development efforts. During the periods prior to completion or abandonment, those acquired indefinite-lived assets are not amortized but are tested for impairment annually, or more frequently, if events or changes in circumstances indicate that the asset might be impaired.
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 in the period that the impairment occurs.
GOODWILL
Goodwill, which represents the excess of purchase price over the fair value of net assets acquired, is carried at cost. Goodwill is not amortized; rather, it is subject to a periodic assessment for impairment by applying a fair value based test. Goodwill is assessed for impairment on an annual basis 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 must determine if further testing was necessary. If further testing was necessary, the Company would have performed a two-step impairment test for goodwill. The first step requires the Company to determine the fair value of each reporting unit. To the extent a reporting unit’s carrying amount exceeds its fair value, an indication exists that the reporting unit’s goodwill may be impaired and the Company must perform a second more detailed impairment assessment. The second impairment assessment involves allocating the reporting unit’s fair value to all of its recognized and unrecognized assets and liabilities in order to determine the implied fair value of the reporting unit’s goodwill as of the assessment date. The implied fair value of the reporting unit’s goodwill is then compared to the carrying amount of goodwill to quantify an impairment charge as of the assessment date.
The Company has conducted its impairment testing as of April 1, of 2015 and 2014 of its goodwill recognized in connection to the acquisition of Bestewil. In conclusion of this impairment testing, the carrying amount of the reporting unit was lower than the estimated fair value of the reporting unit. As the fair value of the reporting unit is higher than the carrying amount, Step 2 of the goodwill impairment test did not need to be completed. As of June 30, 2015, management believes there are no indications of impairment.
RESEARCH AND DEVELOPMENT
Research and development costs are expensed as incurred.
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 June 30, 2015 or at December 31, 2014. The Company’s United States tax returns are open to audit for the years ended December 31, 2010 to 2014. The returns for the Swiss subsidiary, Mymetics S.A., are open to audit for the years ended December 31, 2011 to 2014. The returns for the Netherlands subsidiaries, Bestewil B.V. and Mymetics B.V., are open to audit for the year ended December 31, 2014.
8
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 quarter ended June 30, 2015, 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 six months ended June 30, 2015, the basic weighted average number of shares was 303,757,622. The total potential number of shares issuable of 532,284,571 at June 30, 2015 includes 502,584,571 potential issuable shares related to convertible loans, and 29,700,000 potential issuable shares related to outstanding stock options granted to employees.
For the three and six months ended June 30, 2014, the basic weighted average number of shares was 303,112,271, and 300,778,508, respectively. The weighted total potential number of shares issuable of 486,606,984 includes 465,756,984 potential issuable shares related to convertible loans, and 20,850,000 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 June 30, 2015 or December 31, 2014.
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. As part of the 2013 stock option plan, the Company issued 8,850,000 shares to individuals in the three and six months ended June 30, 2015. No shares were issued to individuals as fee for services rendered in the six months ended June 30, 2014.
Stock compensation expense amounted to E71 and E28 during the three month periods ended June 30, 2015 and 2014, respectively, and E86 and E56 during the six month periods ended June 30, 2015 and 2014, respectively, which is included in the statements of operations 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.
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.
9
CONCENTRATIONS
The Company derived 67% and 100% of revenue from its relationship with one collaborative partner during the six month periods ended June 30, 2015 and June 30, 2014, respectively. Furthermore, that same collaborative partner accounted for 60% and 79% of the receivables balance at June 30, 2015 and December 31, 2014, respectively.
RELATED PARTY TRANSACTIONS
An individual employed by the law firm that acts as the Company's general counsel is a member of the Board of Directors. The Company incurred professional fees to the counsel's law firm totaling E7 and E25 for the period of three and six months ending June 30, 2015 and E13 and E86 for three and six months ending June 30, 2014, respectively.
NEW ACCOUNTING PRONOUNCEMENTS
In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers: Topic 606 (ASU 2014-09), to supersede nearly all existing revenue recognition guidance under GAAP. The core principle of ASU 2014-09 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration that is expected to be received for those goods or services. ASU 2014-09 defines a five step process to achieve this core principle and, in doing so, it is possible more judgment and estimates may be required within the revenue recognition process than required under existing GAAP including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. ASU 2014-09 is effective for the fiscal and interim reporting periods beginning after December 15, 2017 using either of two methods:
|
(i)
|
retrospective to each prior reporting period presented with the option to elect certain practical expedients as defined within ASU 2014-09; or
|
|
(ii)
|
retrospective with the cumulative effect of initially applying ASU 2014-09 recognized at the date of initial application and providing certain additional disclosures as defined per ASU 2014-09.
|
Management is currently evaluating the impact of the Company's pending adoption of ASU 2014-09 on its consolidated financial statements.
Note 2. Intangible Assets
Intangible assets consisted of in process research and development at June 30, 2015 and December 31, 2014.
Note 3. Debt Financing
Certain principal shareholders have granted the Company secured convertible notes (in accordance with the Uniform Commercial Code in the State of Delaware) and short term convertible notes, which have a total carrying value of E41,845 including interest due to date. Interest incurred on these notes since inception has been added to the principal amounts.
10
The details of the convertible notes and loans are as follows at June 30, 2015:
|
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
|
E
|
171
|
(2
|
)
|
10% pa
|
$
|
0.10
|
N/A
|
|||||||||||
|
Anglo Irish Bank S.A.(3)
|
10/01/2007
|
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.
|
11/17/2008
|
E
|
1,200
|
(2
|
)
|
10% pa
|
$
|
0.50
|
1.2650
|
|||||||||||
|
Round Enterprises Ltd.
|
02/06/2009
|
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
|
1,082
|
(5,6
|
)
|
10% pa
|
$
|
0.034
|
N/A
|
|||||||||||
|
Eardley Holding A.G.
|
08/04/2011
|
E
|
270
|
(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.
|
11/04/2012
|
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
|
|||||||||||
|
Total Short Term Principal Amounts
|
E
|
27,800
|
||||||||||||||||||
|
Accrued Interest
|
E
|
14,045
|
||||||||||||||||||
|
TOTAL LOANS AND NOTES
|
E
|
41,845
|
||||||||||||||||||
(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 Geneve 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.
11
|
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 June 30, 2015 and 2014 should be read in conjunction with the Company's audited consolidated financial statements for the year ended December 31, 2014 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, 2014 and, to the extent included therein, our quarterly reports on Form 10-Q filed during fiscal year 2015.
THREE MONTHS ENDED JUNE 30, 2015 AND 2014
Revenue was E1,028 and E515 for the three months ended June 30, 2015 and 2014, respectively. The E1,028 consisted of E552 related to the research and development services provided under a License and Collaboration Agreement for the RSV vaccine signed on December 23, 2013 and E476 from the grant revenue recognized for the HIV and malaria projects.
Costs and expenses increased to E941 for the three months ended June 30, 2015 from E682 (38.0%) for the three months ended June 30, 2014 mainly due to in an increase in both general and administrative costs and in research and development costs.
Research and development expenses increased to E554 in the current period from E372 (48.9%) in the comparative period of 2014. This is mainly due to the increase in laboratory cost necessary to the MACIVIVA project with Horizon 2020/SERI, the malaria project with MVI - PATH and HIV project with Texas Biomedical.
General and administrative expenses increased to E447 in the three months ended June 30, 2015 from E292 (53.1%) in the comparative period of 2014. This is due to several additional cost incurred this year, such as; stock option expenses increase related to new issuances; additional marketing cost related to the projects press releases; new contract with exclusive financial advisor; company website design and increase in laboratory space in Leiden.
Other expenses decreased to E(75) for the three months ended June 30, 2015 from E3 (-2600.0%) for the six months ended June 30, 2014, mainly due to the foreign exchange revaluation of existing US$ based loans from third party investors.
Interest expense increased to E643 for the three months ended June 30, 2015 from E634 for the three months ended June 30, 2014 related to existing loans from third party investors.
The Company reported a net loss of (E563), or (E0.00) per share, for the three months ended June 30, 2015, compared to a net loss of (E813), or (E0.00) per share, for the three months ended June 30, 2014.
SIX MONTHS ENDED JUNE 30, 2015 AND 2014
Revenue was E1,690 and E1,042 for the six months ended June 30, 2015 and 2014, respectively. The E1,690 was related to the research and development services provided under a License and Collaboration Agreement for the RSV vaccine signed on December 23, 2013 and E528 was related to the grant revenue recognized for the HIV and malaria projects.
12
Costs and expenses increased to E1,910 for the six months ended June 30, 2015 from E1,428 (33.8%) for the six months ended June 30, 2014, mainly due to an increase in general and administrative costs and research and development costs.
Research and development expenses increased to E921 in the current period from E741 (24.3%) in the comparative period of 2014, due to the additional work related to the MACIVIVA project with Horizon 2020/SERI, the malaria project with MVI -PATH and the HIV project with Texas Biomedical.
General and administrative expenses increased to E840 in the six months ended June 30, 2015 from E674 (24.6%) in the comparative period of 2014. This is due to legal cost provision reversal in the six month period ended June 30, 2014, and several additional cost incurred this year, such as; stock option expenses increase related to new issuances; additional marketing cost related to the projects press releases; new contract with exclusive financial advisor; company website design and increase in laboratory space in Leiden.
Other expenses increased to E118 for the six months ended June 30, 2015 from E(15) (886.7%) for the six months ended June 30, 2014, mainly due to the foreign exchange revaluation of existing US$ based loans from third party investors.
Interest expense decreased to E1,286 for the six months ended June 30, 2015 from E1,312 for the six months ended June 30, 2014 related to existing loans from third party investors and related Norwood Immunology loan of E1,500, which has been settled on March 31, 2014.
The Company reported a net loss of (E1,516), or (E0.00) per share, for the six months ended June 30, 2015, compared to a net loss of (E1,722), or (E0.01) per share, for the six months ended June 30, 2014.
LIQUIDITY AND CAPITAL RESOURCES
We had cash of E3,164 at June 30, 2015 compared to E1,614 at December 31, 2014.
On December 27, 2013, Mymetics has entered in to a License and Collaboration Agreement (“LCA”) with RSV Corporation (“RSVC”) to license Bestewil Holding BV, a 100% subsidiary of Mymetics’ Corporation virosome technology related to developing, commercializing respiratory syncytial virus (RSV) virosome vaccines for the purpose of development and eventual commercialization, which will generate revenue to support the running cost of Bestewil Holding BV.
As of June 30, 2015, we had an accumulated deficit of approximately E69 million, and had net loss of E1,516 in the six 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 provided in operating activities was E1,535 for the six month period ended June 30, 2015 due to the pre-payment received related to the MACIVIVA project from the Swiss and EU granting organizations. During the six month period ending June 30, 2014 net cash provided in operating activities was E2,619 due to the decrease in receivables after having received the upfront cash payment related to the LCA.
Investing activities used cash of (E7) during the six months ended June 30, 2015, compared to (E13) for the comparable period in 2014, all related to the purchase of equipment for our laboratory in Leiden.
Financing activities for the six months ended June 30, 2015 is NIL compared to (E1,538) of cash used for the six month period ended June 30, 2014, related to the repayment of a loan.
Salaries and related payroll costs represent gross salaries for two executives, our CSO of Mymetics BV and nine 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 two employees on its payroll: Director of Finance and Head of Manufacturing and Quality. Mymetics BV has, besides the full time Chief Scientific Officer, six full-time assistants and one part-time assistant.
We intend to continue to incur additional expenditures during the next 12 months for additional research and development of RSV vaccine as per the LCA with RSVC and for the development of our HIV and Malaria vaccine candidates, which are funded through agreements the Bill and Melinda Gates Foundation and PATH MVI, respectively. Additionally we have started the MACIVIVA project for the research and development of thermo stable vaccines. These expenditures will relate to the continued testing of its prototype vaccines and are included in the monthly cash outflow described above. In parallel we are continuing to seek partnerships and grant funding for our vaccine development activities.
13
In the past, we have financed our research and development activities primarily through debt and equity financings from various parties.
On June 19, 2015, the registrant, through its wholly-owned Swiss subsidiary, Mymetics SA ("Mymetics") entered into an Agreement with Breslin AG ("Breslin"), under which Breslin agrees to serve as the exclusive advisor to advise and support Mymetics in finding an industry partner to assist with the further development of the intranasal flu vaccine program which had successfully completed a clinical Phase I trial. Solvay Pharmaceuticals, which was acquired by Abbott Laboratories in 2009, was a prior partner of Mymetics for the intranasal flu vaccine and had successfully completed a clinical Phase I trial with 100 patients but transferred the partnering rights back to Mymetics following a strategic refocusing by Abbott Laboratories. Under the terms of the Agreement, Mymetics has agreed to pay to Breslin a retainer of €7,500 per month for six months, capped at €45,000, in addition to certain success fees for potential upfront and milestone payments and royalties based upon potential sales of Mymetics' intranasal flu vaccine product.
We anticipate that our normal operations will require approximately E3 million in the year ending December 31, 2015, which is financed by the research and development services and the grant agreements we have signed. We will seek to raise 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 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 E14 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 E10 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 150 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 E14,045 has been accrued on all of the Company’s outstanding notes and advances (see detailed table in Note 3 to the financial statements).
RECENT FINANCING ACTIVITIES
During the six month period ending June 30, 2015, our principal source of funds has been revenues related to a License and Collaboration Agreement (“LCA”) with RSV Corporation (“RSVC”) signed on December 27, 2013 to license Bestewil Holding BV.
We have filed or are in the process of filing several new grant applications with U.S. and European institutions in relation to our HIV and malaria 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 twelve months. We have enough 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 2016 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 and future clinical trials.
OFF-BALANCE SHEET ARRANGEMENTS
The Company does not have any off-balance sheet arrangements.
14
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are exposed to market risk from changes in interest rates which could affect our financial condition and results of operations. We have not entered into derivative contracts for our own account to hedge against such 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 six months ended June 30, 2015.
INHERENT LIMITATIONS ON EFFECTIVENESS OF CONTROLS
Our management, Ronald Kempers, who is now 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.
15
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.
ITEM 6. EXHIBITS
| EXHIBIT NUMBER | DESCRIPTION | |
| 31.1 |
Rule 13a-14(a)/15d-14(a) Certification of Chief
|
|
|
31.2
|
Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer
|
|
|
32
|
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
|
16
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: August 14, 2015
|
By:
|
/s/ Ronald Kempers
|
|
|
Chief Executive Officer / Chief Financial Officer
|
|||
17