Nugenerex Immuno-oncology (NUGX) 10-Q 15 Dec 20 2021 Q1 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	3 Months Ended
	Oct. 31, 2020	Dec. 15, 2020
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Oct. 31, 2020
Document Fiscal Period Focus	Q1
Document Fiscal Year Focus	2021
Current Fiscal Year End Date	--07-31
Entity File Number	000-56153
Entity Registrant Name	Nugenerex Immuno-oncology, Inc.
Entity Central Index Key	0001804585
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false
Entity Shell Company	false
Entity Incorporation, State or Country Code	DE
Entity Common Stock, Shares Outstanding		400,300,000

CONDENSED BALANCE SHEETS (Unaud

CONDENSED BALANCE SHEETS (Unaudited) - USD ($)	Oct. 31, 2020	Jul. 31, 2020
Current Assets:
Cash	$ 39	$ 84
Prepaid expenses	20,000	0
Total current assets	20,039	84
Current liabilities:
Accounts payable and accrued expenses	566,937	614,349
Payable to foundation for services	1,315,817	1,315,817
Interest payable to Foundation	4,149,900	3,911,141
Total Current Liabilities	6,032,654	5,841,307
Stockholders' deficiency
Preferred stock $0.001 par value, 10,000,000 shares authorized, none issued or outstanding	0	0
Common stock, $0.001 par value, 750,000,000 shares authorized; 400,300,000 shares issued, and outstanding	400,300	400,300
Additional paid-in capital	33,749,317	32,182,174
Accumulated deficit	(40,162,232)	(38,423,697)
Total Stockholders' deficiency	(6,012,615)	(5,841,223)
Total liabilities and stockholders' deficiency	$ 20,039	$ 84

CONDENSED BALANCE SHEETS (Paren

CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares	Oct. 31, 2020	Jul. 31, 2020
Statement of Financial Position [Abstract]
Preferred stock par value	$ 0.001	$ 0.001
Preferred stock shares authorized	10,000,000	10,000,000
Preferred stock shares issued	0	0
Preferred stock shares outstanding	0	0
Common stock par value	$ 0.001	$ 0.001
Common stock shares authorized	750,000,000	750,000,000
Common stock shares issued	400,300,000	400,300,000
Common stock outstanding	400,300,000	400,300,000

CONDENSED STATEMENTS OF OPERATI

CONDENSED STATEMENTS OF OPERATIONS (Unaudited) - USD ($)	3 Months Ended
	Oct. 31, 2020	Oct. 31, 2019
Operating expenses
Research and development	$ 893,644	$ 37,382
General and administrative	606,132	31,804
Total operating expenses	1,499,776	69,186
Operating loss	(1,499,776)	(69,186)
Other Expense
Interest expense	(238,759)	(199,695)
Net Loss	$ (1,738,535)	$ (268,881)
Net Loss per Common Share - basic and diluted	$ 0	$ 0
Weighted Average Shares - basic and diluted	400,300,000	400,000,000

CONDENSED STATEMENTS OF CHANGES

CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS' DEFICIT (UNAUDITED) - USD ($)	Common Stock	Additional Paid-In Capital	Accumulated Deficit	Total
Beginning balance, shares at Jul. 31, 2019	400,000,000
Beginning balance, value at Jul. 31, 2019	$ 400,000	$ 32,050,986	$ (36,834,887)	$ (4,383,901)
Contribution from Generex		26,586		26,586
Net Loss			(268,881)	(268,881)
Ending balance, shares at Oct. 31, 2019	400,000,000
Ending balance, value at Oct. 31, 2019	$ 400,000	32,077,572	(37,103,768)	(4,626,196)
Beginning balance, shares at Jul. 31, 2020	400,300,000
Beginning balance, value at Jul. 31, 2020	$ 400,300	32,182,174	(38,423,697)	(5,841,223)
Contribution from Generex		1,567,143		1,567,143
Net Loss			(1,738,535)	(1,738,535)
Ending balance, shares at Oct. 31, 2020	400,300,000
Ending balance, value at Oct. 31, 2020	$ 400,300	$ 33,749,317	$ (40,162,232)	$ (6,012,615)

CONDENSED STATEMENTS OF CASH FL

CONDENSED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)	3 Months Ended
	Oct. 31, 2020	Oct. 31, 2019
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (1,738,535)	$ (268,881)
Changes in operating assets and liabilities:
Interest payable to foundation	238,759	199,695
Accounts payable and accrued expenses	1,519,731	283,524
Prepaid expenses	(20,000)	0
Net decrease in cash	(45)	214,338
Cash, beginning	84	389
Cash, ending	39	214,727
Non-cash investing and financing activities
Expenses paid by parent as non-cash capital contributions	$ 1,567,143	$ 26,586

Nature of Operations and Going

Nature of Operations and Going Concern	3 Months Ended
	Oct. 31, 2020
Nature Of Operations And Going Concern
Nature of Operations and Going Concern	Note 1 – Nature of Operations and Going Concern: NuGenerex Immuno-Oncology, Inc. (“the Company’) is an oncology company focused on the modulation of the immune system to treat cancer. To that end, the Company is developing immunotherapeutic products and vaccines based on proprietary, patented platform technology, Ii-Key. The accompanying financial statements of Nugenerex Immuno-Oncology, Inc. (the “Company”) have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”), which contemplates continuation of the Company as a going concern. The Company has experienced recurring net losses and negative cash flows from operations since inception and has both accumulated deficits of approximately $40.2 million and a working capital deficiency of approximately $6.0 million as of October 31, 2020. The Company’s parent, Generex Biotechnology Corporation (“Generex”) has funded substantially all the Company’s underlying working capital deficiencies. The uncertain economic fallout from the COVID -19 pandemic may also adversely affect our operations (See Commitments and Contingencies). These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The Company will continue to require substantial funds to implement its business plans. Management’s plans, to meet its operating cash flow requirements, include financing activities such as public or private placements of its common stock, preferred stock offerings, and issuances of debt and convertible debt instruments. There are no assurances that such additional funding will be achieved and that the Company will succeed in its future operations. Management is also actively pursuing financial and strategic alternatives, including strategic investments and divestitures, industry collaboration activities and strategic partners. These financial statements do not include any adjustments to the recoverability and classification of recorded assets amounts and classification of liabilities that might be necessary should the Company not be able to continue as a going concern. The Company’s inability to obtain required funding in the near future or its inability to obtain funding on favorable terms will have a material adverse effect on its operations and strategic development plan for future growth. If the Company cannot successfully raise additional capital and implement its strategic development plan, its liquidity, financial condition, and business prospects will be materially and adversely affected, and the Company may have to cease operations.

Summary of Significant Accounti

Summary of Significant Accounting Policies	3 Months Ended
	Oct. 31, 2020
Accounting Policies [Abstract]
Summary of Significant Accounting Policies	Note 2 – Summary of Significant Accounting Policies: Basis of Presentation The Company’s is a wholly owned subsidiary of, Generex and the Company has been dependent on Generex to fund its operations. Generex does not have costs centralized or shared services departments serving all its subsidiaries, accordingly, no allocations of centralized or shared service are necessary or included in the financial statements, as they are de-minimis. The accompanying unaudited condensed financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments, which include only normal recurring adjustments, considered necessary for a fair presentation have been included. The Company’s fiscal year ends on July 31 of each calendar year. Operating results for the three months ended October 31, 2020 are not necessarily indicative of the results that may be expected for the fiscal year ending July 31, 2021. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP 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 dates of the financial statements and the reported amounts of revenue and expenses during the reporting periods. Research and Development Costs Expenditures for research and development are expensed as incurred and include, among other costs, those related to the production of experimental drugs, and amounts incurred for conducting clinical trials. Amounts expected to be received from governments under research and development tax credit arrangements are offset against current research and development expense. The Company has started Ii Key viral vaccine research in the current quarter in an effort to become revenue producing and bring vaccines to market on behalf of the parent company Generex Biotechnology. In effect, the Company has incurred increased expenses to achieve that goal with the financial support of the parent company in the current period. Income Taxes NGIO is included in the Generex consolidated federal tax return. All tax provisions and the related tax liabilities and assets have been computed using the separate return method, as if the company was the legal taxpayer. Income taxes are accounted for under the asset and liability method prescribed by FASB Accounting Standards Codification (“ASC”) Topic 740. These standards require a company to determine whether it is more likely than not that a tax position will be sustained upon examination based upon the technical merits of the position. If the more likely than not threshold is met, a company must measure the tax position to determine the amount to recognize in the financial statements. Deferred income taxes are recorded for temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities reflect the tax rates expected to be in effect for the years in which the differences are expected to reverse. A valuation allowance is provided if it is more likely than not that some or all of the deferred tax asset will not be realized. Revenue The Company expects to generate revenue from licenses to access its intellectual property. If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues attributed to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgement to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time. At the inception of each arrangement that contain development milestones, the Company evaluates whether the development milestones included are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not generally considered probable of being achieved until those approvals are received. New Accounting Standards The Company has reviewed the FASB issued Accounting Standards Update (“ASU”) accounting pronouncements and interpretations thereof that have effective dates during the periods reported and in future periods. The Company does not believe that any new or modified standards will have a material impact on the Company’s reported financial position or operations in the near term. The applicability of any standard is subject to the formal review of our financial management and certain standards are under consideration.

Commitments and Contingencies

Commitments and Contingencies	3 Months Ended
	Oct. 31, 2020
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	Note 3 - Commitments and Contingencies: Commitments On November 20, 2018, the Company entered into a clinical trial agreement with NSABP Foundation, Inc. (“NSABP”) under which NSABP will conduct clinical research using the Company’s AE37 peptide immunotherapeutic vaccine in combination with pembrolizumab (Ketruda®) for the treatment of metastatic triple negative breast cancer. The Company has agreed to pay NSABP an amount not to exceed $2,118,461 based on NAABP achieving various milestones. The Company recognized $0 and $251,459 as research and development related to the clinical trial agreement with NSABP for the periods ending October 31, 2020 and 2019 respectively. The Clinical Trial Agreement terminates upon the completion of the obligations under such agreement. The Clinical Trial Agreement may be terminated by (i) any party if the authorization to conduct the Phase II clinical trial is revoked by the FDA; if the human and/or toxicology results support termination; safety concerns; if the manufacture of a drug used in the Phase II clinical trial has been exhausted or (ii) by NSABP if NGIO fails to pay NSABP an undisputed amount under the Clinical Trial Agreement. On July 7, 2020 we entered into an agreement with Ajinomoto Bio-Pharma Services (“Ajin”) under which Ajin will manufacture one cGMP batch of AE 37. We may cancel the agreement by providing Ajin written notice. If we cancel the project, we will be subject to cancellation fees and be required to reimburse Ajin’s unbilled costs prior to the effective date of the cancellation. The estimated total payments required under this agreement are $243,900, including shipping and material estimates, of which Ajin has billed us $126,950 related to this agreement which is recognized as in research and development in our statement of operations. Of the $130,450 that was billed $4,500 is related to the period ending on October 31, 2020. On October 2, 2020, the Company entered into an agreement with Polypeptide Laboratories San Diego to provide services for individual studies and projects, which may include synthetic process development, chemical synthesis, analytical method development and analysis of peptides and any other services relating to chemistry services requested from the Company. NGIO shall conduct research activities and pay Polypeptide Laboratories San Diego for fees, expenses, and pass-through costs in accordance with each work order. On October 5, 2020, the Company and its parent Generex Biotechnology Corporation, (collectively “Generex”) entered into a Distribution and Licensing Agreement (the “Agreement”) with Bintai Healthcare SDN BHD, a subsidiary of Bintai Kinden Corporation Berhad of Malaysia (“Bintai”) for the exclusive rights to distribute, sell, develop and commercialize the Generex Ii-Key-SARS-CoV-2 coronavirus vaccine (the “Vaccine”) in Malaysia and South East Asia countries, with right of first refusal to commercialize the Vaccine within New Zealand, Australia and the Global Halal markets (the “Territory”). The Agreement, among other things, consists of Bintai providing 100% funding for U.S. clinical development, manufacturing and commercial registration of the Vaccine for the Territory. Payable to Foundation On February 1, 2007, the Company entered into a clinical study agreement (the “CSA”) with a Henry J. Jackson Foundation (“Foundation”) for two Phase II clinical trials to determine if a vaccine containing AE37 plus GM-CSF or another peptide vaccine compound (GP2) plus GM-CSF improved patient outcomes. The Foundation conducted the study, under the sponsorship of an institute affiliated with the United States Military until the IND #12229 was transferred to NGIO (then Antigen Express), after which HJF continued trial management on behalf of NGIO. In consideration for the study the Company agreed to total compensation of $2,700,000 at various intervals over the term of the agreement. On September 1, 2013 the Foundation and the Company entered into a forbearance agreement (the “Forbearance Agreement”) under which the Company acknowledged they were $1,315,817 in arrears in its payment and interest obligations to the Foundation under the CSA (the “Original Forbearance Amount”). Pursuant to the Forbearance Agreement, the Company and the Foundation in exchange for the Foundations deferring the Company’s overdue payments, future payments and interest, the Company agreed, among other things to pay the Foundation certain royalties and accelerated payments (“Forbearance Payments”)6.Effective August 1, 2015, the Company capitalized all outstanding unpaid interest on the outstanding balance. For the period ended October 31, 2020 and 2019, the Company recorded interest expense in the amount of $238,759 and $199,695, respectively, in the statements of operations. As of October 31,2020 and July 31, 2020 the Company has recorded accrued interest of $4,149,900 and $3,911,141, respectively. Related Party Expenses paid by Generex on behalf of the Company have been treated as capital contributions from Generex as Generex will not be reimbursed by the Company for these expenses. For the three-month periods ended October 31, 2020 and 2019, Generex paid expenses of $1,567,143 and $26,586, respectively. Certain shared expenses incurred by Generex, such as the shared corporate headquarters, have not been allocated to the Company as they are de minimus. COVID-19 The ongoing coronavirus outbreak 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. 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.

Stockholders' Deficiency

Stockholders' Deficiency	3 Months Ended
	Oct. 31, 2020
Equity [Abstract]
Stockholders' Deficiency	Note 4 - Stockholders’ Deficiency: Common Stock On July 14, 2020, the Company entered into a purchase agreement with an investor Oasis Capital, LLC (“Oasis”) pursuant to which Oasis has agreed to purchase from the Company up to $50,000,000 of common stock at 92% of the market price for the period of five (5) consecutive trading days immediately subject to a put notice on such date on which the purchase price is calculated in accordance with the terms and conditions of the agreement (subject to certain limitations) from time to time over a 36-month period. We also issued to Oasis 300,000 shares under the Oasis Capital Agreement as a commitment fee in connection with a registration statement. This transfer has been accounted through common stock and additional paid in capital which has no net effect on equity. Registration Statements The Company filed three Form S-1s for Registration of Securities pursuant to the Securities Act of 1933 (the Securities Act”) on September 14, 2020. One Registration Statement relates to the offer and sale of up to 1,700,000 shares of common stock NGIO, by the selling stockholders. The second Form S-1 for Registration statement registered 100,000 shares of Series A Cumulative Redeemable Perpetual Preferred Stock at $0.001 par value per share. The third filing, is to register shares of $0.001 par value per share common stock and shares of common stock issuable upon exercise of Common Stock Purchase Warrants. The number of shares to be registered and the offering price have not yet been determined.

Income taxes

Income taxes	3 Months Ended
	Oct. 31, 2020
Income Tax Disclosure [Abstract]
Income taxes	Note 5–Income taxes: Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on net deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. At October 31, 2020, the Company had a full valuation allowance against its deferred tax assets, accordingly the Company did not recognize an income tax benefit for losses incurred during the three-month period ended October 31, 2020.

Summary of Significant Accoun_2

Summary of Significant Accounting Policies (Policies)	3 Months Ended
	Oct. 31, 2020
Accounting Policies [Abstract]
Basis of Presentation	Basis of Presentation The Company’s is a wholly owned subsidiary of, Generex and the Company has been dependent on Generex to fund its operations. Generex does not have costs centralized or shared services departments serving all its subsidiaries, accordingly, no allocations of centralized or shared service are necessary or included in the financial statements, as they are de-minimis. The accompanying unaudited condensed financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments, which include only normal recurring adjustments, considered necessary for a fair presentation have been included. The Company’s fiscal year ends on July 31 of each calendar year. Operating results for the three months ended October 31, 2020 are not necessarily indicative of the results that may be expected for the fiscal year ending July 31, 2021.
Use of Estimates	Use of Estimates The preparation of financial statements in conformity with U.S. GAAP 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 dates of the financial statements and the reported amounts of revenue and expenses during the reporting periods.
Research and Development Costs	Research and Development Costs Expenditures for research and development are expensed as incurred and include, among other costs, those related to the production of experimental drugs, and amounts incurred for conducting clinical trials. Amounts expected to be received from governments under research and development tax credit arrangements are offset against current research and development expense. The Company has started Ii Key viral vaccine research in the current quarter in an effort to become revenue producing and bring vaccines to market on behalf of the parent company Generex Biotechnology. In effect, the Company has incurred increased expenses to achieve that goal with the financial support of the parent company in the current period.
Income Taxes	Income Taxes NGIO is included in the Generex consolidated federal tax return. All tax provisions and the related tax liabilities and assets have been computed using the separate return method, as if the company was the legal taxpayer. Income taxes are accounted for under the asset and liability method prescribed by FASB Accounting Standards Codification (“ASC”) Topic 740. These standards require a company to determine whether it is more likely than not that a tax position will be sustained upon examination based upon the technical merits of the position. If the more likely than not threshold is met, a company must measure the tax position to determine the amount to recognize in the financial statements. Deferred income taxes are recorded for temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities reflect the tax rates expected to be in effect for the years in which the differences are expected to reverse. A valuation allowance is provided if it is more likely than not that some or all of the deferred tax asset will not be realized.
Revenue	Revenue The Company expects to generate revenue from licenses to access its intellectual property. If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues attributed to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgement to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time. At the inception of each arrangement that contain development milestones, the Company evaluates whether the development milestones included are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not generally considered probable of being achieved until those approvals are received.
New Accounting Standards	New Accounting Standards The Company has reviewed the FASB issued Accounting Standards Update (“ASU”) accounting pronouncements and interpretations thereof that have effective dates during the periods reported and in future periods. The Company does not believe that any new or modified standards will have a material impact on the Company’s reported financial position or operations in the near term. The applicability of any standard is subject to the formal review of our financial management and certain standards are under consideration.

Nature of Operations and Goin_2

Nature of Operations and Going Concern (Details Narrative) - USD ($)	Oct. 31, 2020	Jul. 31, 2020
Nature Of Operations And Going Concern
Accumulated deficits	$ (40,162,232)	$ (38,423,697)
Working capital deficiency	$ 6,000,000

Commitments and Contingencies (

Commitments and Contingencies (Details Narrative) - USD ($)	Jul. 07, 2020	Sep. 01, 2013	Feb. 01, 2007	Nov. 20, 2018	Oct. 31, 2020	Oct. 31, 2019	Jul. 31, 2020
Research and development expense					$ 893,644	$ 37,382
Interest payable to foundation					4,149,900		$ 3,911,141
Interest expense					238,759	199,695
Related Party expenses					1,567,143	26,586
Ajin [Member]
Payment for shipping and material	$ 243,900
Research and development expense	$ 130,450				4,500
Clinical Trial Agreement (CTO) | NSABP
Service fees				$ 2,118,461
Research and development expense					$ 0	$ 251,459
Clinical Study Agreement | Henry J. Jackson Foundation
Service fees			$ 2,700,000
Forbearance Agreement
Payment and interest obligations		$ 1,315,817

Stockholders' Deficiency (Detai

Stockholders' Deficiency (Details Narrative) - Oasis [Member] - shares	Sep. 14, 2020	Jul. 14, 2020
Purchase Agreement [Member]
Common stock purchased		50,000,000
Registration Statements description	One Registration Statement relates to the offer and sale of up to 1,700,000 shares of common stock NGIO, by the selling stockholders. The second Form S-1 for Registration statement registered 100,000 shares of Series A Cumulative Redeemable Perpetual Preferred Stock at $0.001 par value per share. The third filing, is to register shares of $0.001 par value per share common stock and shares of common stock issuable upon exercise of Common Stock Purchase Warrants. The number of shares to be registered and the offering price have not yet been determined.
Oasis Capital Agreement [Member]
Stock issued		300,000

Income taxes (Details Narrative

Income taxes (Details Narrative)	3 Months Ended
	Oct. 31, 2020USD ($)
Income Tax Disclosure [Abstract]
Income tax benefit	$ 0