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."
Joseph Moscato
FirstName
NuGenerexLastNameJoseph Moscato
Immuno-Oncology, Inc.
Comapany
August NameNuGenerex Immuno-Oncology, Inc.
7, 2020
August
Page 2 7, 2020 Page 2
FirstName LastName
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.