GENERAL
The following discussion and analysis of the results of operations and financial
condition of
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
IMPACT OF THE NOVEL CORONAVIRUS
On
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 emergence of new variants, the duration of
the pandemic, travel restrictions and social distancing, business closures or
business disruptions and the effectiveness of actions taken in the
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.
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The Company is dependent on its partners in certain projects, such as the
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.
CORONAVIRUS AID, RELIEF AND ECONOMIC SECURITY ACT
On
THREE MONTHS ENDED
For the three months ended
Costs and expenses increased to €529 for the three months ended
o Research and development expenses increased to €209 in the current period from €190 (10.0%) in the comparative period of 2021, mainly due to subcontracting services in relation with theNIH grant / HIV project. o General and administrative expenses increased to €320 in the three months endedSeptember 30, 2022 from €260 (23.1%) in the comparative period of 2021, mainly due to consulting fees related to the engagement of consultants that will seek business development opportunities for the Company with the goal of obtaining deals for licensing, financing, and/or acquisition.
Interest expense increased to €703 for the three months ended
Foreign exchange revaluation, recorded in Other (income) expense, generated net
losses of €230 and €75 during the three months ended
The Company reported a net loss of (€1,345), or (€0.00) per share, for the three
months ended
NINE MONTHS ENDED
Revenue was €912 for the nine months ended
Costs and expenses increased to €2,170 for the nine months ended
o Research and development expenses increased to €1,191 in the current period from €752 (58.4%) in the comparative period of 2021, mainly due to the purchase of "influenza inactivated virus" during the first quarter in 2022 in relation with theNIH grant / HIV project. o General and administrative expenses increased to €979 in the nine months endedSeptember 30, 2022 from €828 (18.2%) in the comparative period of 2021, mainly due to service fees related to the engagement as ofMay 2022 of consultants that will seek business development opportunities for the Company with the goal of obtaining deals for licensing, financing, and/or acquisition. 16
Foreign exchange revaluation, recorded in Other (income) expense, generated net
losses of €496 and €154 during the nine months ended
The Company reported a net loss of (€3,898), or (€0.01) per share, for the nine
months ended
LIQUIDITY AND CAPITAL RESOURCES
We had cash of €401 at
During 2021, our revenue has mainly been generated through the
As of
Net cash used from operating activities increased to €1,366 for the nine-month
period ended
Net cash used in investing activities was €2 during the nine-months ended
Financing activities provided net cash of 1,200 for the nine-months ended
Salaries and related payroll costs represent gross salaries for two executives,
our CSO of
Our Swiss subsidiary,
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 €400
additional funding as of
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
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 €33,614 has been accrued on all of the Company's outstanding notes and advances (see detailed table in Note 2 to the financial statements).
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RECENT FINANCING ACTIVITIES
During the nine-month period ending
We have filed or are in the process of filing several new grant applications
with
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
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