As used herein, the terms the "Company," "NGIO," "we," "us," or "our" refer to NuGenerex Immuno Oncology, Inc., a Delaware corporation. The following discussion and analysis by management provides information with respect to our financial condition and results of operations for the six-month periods ended January 31, 2021 and 2020.





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 six months ended January 31, 2021 that may constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (the "Act"). The Act limits our liability in any lawsuit based on forward-looking statements that we have made. All statements, other than statements of historical facts, included in this Quarterly Report that address activities, events or developments that we expect or anticipate will or may occur in the future, including such matters as our projections, future capital expenditures, business strategy, competitive strengths, goals, expansion, market and industry developments and the growth of our businesses and operations, are forward-looking statements. These statements are based on currently available operating, financial and competitive information. These statements can be identified by introductory words such as "may," "expects," "anticipates," "plans," "intends," "believes," "will," "estimates" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Our forward-looking statements address, among other things:

• 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.


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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 three and six months ended January 31, 2021 and 2020.





Results of Operations

Three months ended January 31, 2021 compared to Three months ended January 31, 2020

We reported a net loss of $2,081,761 and $292,367 for the three month periods ended January 31, 2021 and January 31, 2020, respectively, reflecting an increase in the reported net loss of $1,789,394. The increase in the net loss resulted from a $40,848 increase in interest expense, an increase of $1,334,419 in research and development expense and an increase of $414,127 in general and administrative expenses.

We incurred an overall increase of $414,127 in general and administrative expenses for the three months ended January 31, 2021 versus the prior period due to primarily professional fees, which accounted for approximately $86,149 of the increase that were related to consulting. The Company also incurred $151,342 of accounting fees in relation to regulatory reporting and $204,414 of executive compensation.

We incurred an overall increase of $1,334,419 in research and development expenses for the three months ending January 31, 2021 versus the comparative period. Considering the total increase, $129,869 is attributable to retain regulatory experts to provide strategic and operational regulatory input for the Company's Ii-Key-SARS-CoV-2 peptide vaccine development program, including gap analysis, pre-IND meeting and IND authoring, publication and FDA submission. The Company enlisted the assistance of certain consultants for monitoring and data analysis, which incurred expenses amounting to $488,075. The Company also incurred expenses testing the Ii-Key-SARS-CoV-2 Peptide Vaccine and laboratory testing and analysis Company engaged a consultant to provide services for individual studies and projects, which include synthetic process development, chemical synthesis, analytical method development and analysis of peptides and any other services relating to chemistry services for the amount of $342,260 The Company incurred expenses from a consultant of $104,108 for the evaluation of immunogenicity of synthetic Ii-Key-SARS-CoV-2 prophylactic peptide vaccines. Lastly, the Company incurred expenses of $98,636 for the manufacture of GMP material and perform a stability study.

Our interest expense for the three months ended January 31, 2021 increased by $40,848 compared to the three months ended January 31, 2020 due to the additional principal resulting from the compounding of interest accrued on the payable to Foundation.

Six months ended January 31, 2021 compared to Six months ended January 31, 2020

We reported a net loss of $3,820,296 and $755,631 for the six-month periods, ended January 31, 2021 and January 31, 2020, respectively. The increase in the net loss resulted from a $79,912 increase in interest expense, an increase of $1,976,298 in research and development expense and an increase of $988,445 in general and administrative expenses.





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We incurred an overall increase of $988,455 in general and administrative expenses for the six months ended January 31, 2021 versus the prior period due to professional fees, which accounted for approximately $627,626 of the increase. Of that $627,625, $500,000 is attributable for consulting services in connection with obtaining regulatory approval for our Ii-Key-SARS-CoV-2 Peptide Vaccine in Malaysia. The Company also incurred $167,342 of accounting fees in relation to regulatory reporting and $204,414 of executive compensation. The Company has estimated and allocated certain expenses based on resources provided by Generex Biotechnology to the Company.

We incurred an overall increase of $1,976,298 regarding research and development expenses for the six months ending January 31, 2021 versus the comparative period. Considering the total increase, $195,466 is attributable to retain regulatory experts to provide strategic and operational regulatory input for the Company's Ii-Key-SARS-CoV-2 peptide vaccine development program, including gap analysis, pre-IND meeting and IND authoring, publication and FDA submission. The Company enlisted the assistance of certain consultants for monitoring and data analysis, which incurred expenses amounting to $1,050,138. The Company also incurred expenses testing the Ii-Key-SARS-CoV-2 Peptide Vaccine and laboratory testing and analysis Company engaged a consultant to provide services for individual studies and projects, which include synthetic process development, chemical synthesis, analytical method development and analysis of peptides and any other services relating to chemistry services for the amount of $513,389. The Company incurred expenses from a consultant of $104,108 for the evaluation of immunogenicity of synthetic Ii-Key-SARS-CoV-2 prophylactic peptide vaccines. Lastly, the Company incurred expenses of $109,821 for the manufacture of GMP material and perform a stability study.

Our interest expense for the six months ended January 31, 2021 increased by $79,912 compared to the six months ended January 31, 2020 due to the additional principal resulting from the compounding of interest accrued on the payable to Foundation.

Financial Condition, Liquidity and Resources

COVID-19

The ongoing coronavirus outbreak which began in China at the beginning of 2020 has impacted various businesses throughout the world, including travel restrictions and the extended shutdown of certain businesses in impacted geographic regions. If the coronavirus outbreak situation should continue to worsen, we may experience disruptions to our business including, but not limited disruptions of our ongoing clinical trials and the operations of our partners.

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.



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As of March 12, 2021, our cash position is not sufficient for twelve months of operations. Generex has financed our activities to date. Our cash balances have been deminimus throughout fiscal 2021.

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 NASBP Foundation, Inc. financial support for clinical research using AE37 in combination with pembrolizumab (Keytruda ®) up to $2,118,461 upon NASBP achieving certain milestones. As of January 31, 2021, we have incurred $692,063 against this commitment.

Cash Flows for the Six Months ended January 31, 2021

For the six months ended January 31, 2021, we used $84 in cash from operating activities. There were no cash flows from financing or investing activities. The use for operating activities included a net loss of $3,820,296 and an increase in interest payable to the foundation of $488,424, and an increase in accounts payable and accrued expenses of $3,331,788, of which $3,049,389 is attributable to expenses paid by the parent company.

Cash Flows for the Six Months ended January 31, 2020

For the six months ended January 31, 2020, we used $215 in cash from operating activities. There were no cash flows from financing or investing activities. The use for operating activities included a net loss of $775,631, an increase in interest payable to the foundation of $408,512 and an increase in accounts payable and accrued expenses of $366,904, of which $29,700 was attributable to expenses paid by the parent company.

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