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United States securities and exchange commission logo
August 7, 2020
Joseph Moscato
Chief Executive Officer
NuGenerex Immuno-Oncology, Inc.
10102 USA Today Way
Miramar, FL 33025
Re:NuGenerex Immuno-Oncology, Inc.
Amendment No. 2 to Registration Statement on Form 10-12G
Filed July 23, 2020
File No. 000-56153
Dear Mr. Moscato:
            We have reviewed your filing and have the following comments.  In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
            Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond.  If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
            After reviewing your response and any amendment you may file in response to these
comments, we may have additional comments.
Amendment No. 2 to Registration Statement on Form 10-12G
AE37 – Ii-Key/HER2/neu Hybrid Immunotherapeutic Vaccine, page 4
1.We note your revisions in response to prior comment 2 that the company is licensing
patents related to AE37 for the development of effective treatments for prostate cancer.
Please revise your disclosure to clarify, if true, that you are referring to an agreement to
out-license your technology to Shenzhen BioScien Pharmaceuticals Co., Ltd.
2.We note your revisions in response to prior comment 4. Please reconcile your disclosure
that the Phase IIb Trial did not achieve the primary endpoint in the entire intent to treat
study population with your disclosure in the same paragraph that both the primary and
secondary endpoints of the trial were met.  Please also revise your disclosure to indicate
what you mean by "intent to treat."

 FirstName LastNameJoseph Moscato
 Comapany NameNuGenerex Immuno-Oncology, Inc.
 August 7, 2020 Page 2
 FirstName LastName
Joseph Moscato
NuGenerex Immuno-Oncology, Inc.
August 7, 2020
Page 2
3.We note your response to prior comment 5 and reissue.  Please disclose in this section the
data that supports your statement that the primary and secondary endpoints were met in
the 2006 and 2007 trials for AE37. We also note your statement that the Phase IIb trial
provided evidence of a "positive effect" in the triple negative and low HER2 populations.
Please revise to disclose the evidence and clarify whether the findings were statistically
significant.
4.Please explain what you mean and provide the basis for your statement on page
4 that developing AE37 in combination with newly approved immune checkpoint
inhibitors enables you to move earlier in the treatment paradigm to evaluate the effect of
AE37 on tumors rather than wait another 10 years for the completion of a Phase III
registration trial.
5.We note your disclosure on page 5 that if you are unable to identify a large
pharmaceutical company as a partner, you will have to raise the funds necessary for NGIO
to commercialize AE37 in cancer.  We also note your disclosure on page 6 that you are
focused on bringing your product candidates through Phase II clinical trials and that you
do not plan to bring the products to market.  Please reconcile these disclosures and clarify
what your next steps are for AE37 in cancer and your proposed timeline based on your
current level of funding.
Note 3 - Commitments and Contingencies
Payable to Foundation, page F-10
6.We note from your response to comment 12 that you accrued interest related to the
outstanding payable balance.  However your disclosure indicating that you capitalized
interest may be confusing to investors given the meaning of capitalization of interest in
ASC 835-20.  Please confirm you will revise your disclosures in future periodic reports.
            We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
            You may contact Eric Atallah at 202-551-3663 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Ada D. Sarmento at 202-551-3798 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Jeffrey Wofford, Esq.