As used herein, the terms the "Company," "NGIO," "we," "us," or "our" refer to
Forward-Looking Statements
We have made statements in this Item 2. Management's Discussion and Analysis of
Financial Condition and Results of Operations and elsewhere in this Quarterly
Report on Form 10-Q of NGIO for the nine months ended
• the risks associated with international operations; (including pandemics and
public health problems, such as the outbreak of novel coronavirus (COVID-19);
• our expectations concerning product candidates for our technologies;
• our expectations concerning existing or potential development and license
agreements for third-party collaborations, acquisitions, and joint ventures;
• our expectations concerning product candidates for our technologies;
• our expectations regarding the cost of raw materials and labor, consumer
preferences, the effect of government regulations on the Company's business, the Company's ability to compete in its industry, as well as future economic and other conditions both generally and in the Company's specific geographic markets;
• our expectations of when regulatory submissions may be filed or when
regulatory approvals may be received; and
• Our expectations of when commercial sales of our products in development may
commence and when actual revenue from the product sales may be received.
Any or all of our forward-looking statements may turn out to be wrong. They may be affected by inaccurate assumptions that we might make or by known or unknown risks and uncertainties. Actual outcomes and results may differ materially from what is expressed or implied in our forward-looking statements. Among the factors that could affect future results are:
• the inherent uncertainties of product development based on our new and as yet
not fully proven technologies;
• the risks and uncertainties regarding the actual effect on humans of
seemingly safe and efficacious formulations and treatments when tested in the clinic;
• the inherent uncertainties associated with clinical trials of product
candidates;
• the inherent uncertainties associated with the process of obtaining
regulatory approval to market product candidates;
• the inherent uncertainties associated with commercialization of products that
have received regulatory approval;
• the decline in our stock price; and
• our current lack of financing for operations and our ability to obtain the
necessary financing to fund our operations and effect our strategic
development plan. 15
We caution investors that the forward-looking statements contained in this Quarterly Report must be interpreted and understood in light of conditions and circumstances that exist as of the date of this Quarterly Report. We expressly disclaim any obligation or undertaking to update or revise forward-looking statements to reflect any changes in management's expectations resulting from future events or changes in the conditions or circumstances upon which such expectations are based.
Overview
We are an oncology company focused on the modulation of the immune system to treat cancer. To that end, we are developing immunotherapeutic products and vaccines based on our proprietary, patented platform technology, Ii-Key. The Ii-Key is a peptide derived from the major histocompatibility complex ("MHC") Class II associated invariant chain (Ii) that regulates the formation, trafficking, and antigen-presenting functions of MHC class II complexes, essential for the activation of T cells in the immune response. T cells recognize antigenic epitopes when they are 'presented' to them by specific molecules, termed (MHC) on the surface of infected or malignant cells. This interaction activates the T cells, stimulating a multicellular cascade of actions that eliminates the diseased cell and protects against future disease recurrence.
The following discussion and analysis by management provides information with
respect to our financial condition and results of operations for the nine months
ended
Results of Operations
Three months ended
We reported a net loss of
We incurred an overall increase of
We incurred an overall increase of
Our interest expense for the three months ended
Nine months ended
We reported a net loss of
16
We incurred an overall increase of
We incurred an overall increase of
Our interest expense for the nine months ended
Financial Condition, Liquidity and Resources
COVID-19
The ongoing coronavirus outbreak which began in
While we expect delays in research and development, the extent to which the coronavirus impacts our operations or those of our third-party partners will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the outbreak, new information that may emerge concerning the severity of the coronavirus and the actions to contain the coronavirus or treat its impact, among others. Any such disruptions or losses we incur could have a material adverse effect on our financial results and our ability to conduct business as expected.
Sources of Liquidity
To date, we have financed our activities primarily through capital contributions from Generex, our majority shareholder. Generex in the past has raised capital for our operations through private placements of Generex common stock, securities convertible into Generex common stock, and investor loans. We will require additional funds to support our working capital requirements and any development or other activities or will need to curtail its research and development and other planned activities or suspend operations. The Company will rely both on financing from third parties and from Generex, which may sell shares of our common stock, to fund our operations, development, and other activities.
As a public company, NGIO will begin to incur costs for corporate activities such as executives, corporate accounting for external reporting, and investor relations.
17
As of
Management may seek to meet all or some of our operating cash flow requirements through financing activities, such as public or private placement of our common stock, preferred stock offerings and offerings of debt and convertible debt instruments as well as through merger or acquisition opportunities.
In addition, management is actively pursuing financial and strategic alternatives, including strategic investments and divestitures, industry collaboration activities, and potential strategic partners.
We will continue to require substantial funds to continue research and
development, including preclinical studies and clinical trials of our product
candidates, further clinical trials for AE37 and to commence sales and marketing
efforts if the FDA or other regulatory approvals are obtained. Currently, the
phase II clinical study using AE37 in combination with pembrolizumab (Keytruda
®) for treatment of metastatic triple negative breast cancer and li-Key research
for vaccines are our only ongoing research and development projects in this
regard, we have committed to provide the
Cash Flows for the Nine Months ended
For the nine months ended
Cash Flows for the Nine Months ended
For the nine months ended
© Edgar Online, source