SecProbe.io

Eckert Seamans Cher in & Mellott,
LLC
Two Liberty Place
50 South 16th Street, 22nd Floor
Philadelphia, PA 19102TEL: 215 851 8400
FAX: 215 851 8383
Gary M. Miller
215.851.8472
gmiller@eckertseamans.com
April 30, 2020Securities and Exchange Commission
Division of Corporation FinanceOffice of Life Sciences
Mary Mast
Dan Gordon
100 S Street, NE
Washington, DC 20549-0213
VIA EDGARRe: Generex Biotechnology Corp. (the “Company”)
Form 10-K for the Fiscal Year Ended July 31, 2019Filed November 12, 2019
File No. 000-25169
Ms. Nast and Mr. Gordon:
The Company is in receipt of your correspondence dated March 25, 2020, posing comments and requesting information
regarding the Form 10-K referenced above.
Please find the issuer’s respective responses below, restating th e Staff’s comments in bold, a nd the Company’s response in
plain text. In some cases, the Staff’s comments were in mul tiple parts, and we have resp onded to individual parts
separately.
Form 10-K for the Fiscal Year Ended July 31, 2019
Management's Discussion and Analysis
Financial Condition, Liquidity  and Resources Sources of
Liquidity, page 70
1. You state that your July 31, 2019 cash position was not sufficient for 12 months of operations and that
anticipated revenues associated with the Veneto acquisition are expected to dramatically alter the cash
flow landscape. Given the litigation with Veneto and the uncertainty relating to the assets acquired, tell us
the basis for the company's assertions.
Response : On July 31, 2019, the end of  the fiscal year, the Comp any continued to believe that it could reorganize and
rehabilitate the Veneto business so that it would provide positive cash flow . Although the acquisition included pharmacy
assets and operations which ceased and reported during the measurement period as part of the amended purchase and debt restructuring, the MSO operation and anticipated cashflows are expected to be realized and increase within Generex and benefit from subsequent acquisitions and services integrated in the MSO model.
Management's Discussion and Analysis Results of Operations, page 70
2. For each significant key research and development project, provide the following to be included in future
filings:
•Page 1 of 3 3

the costs incurred durin g each period presented, reconciled to your research an d
development on your Statements of Operations
Response :
Please see the following table of research and deve lopment costs summarized by quarter and annually:
3 Months
Ending3 Months
Ending3 Months
Ending3 Months
Ending12 Months
Ending
RECONCILIATION of RESEARCH AND DEVELOPMENT COSTS 10/31/2018 1/31/2019 4/30 /2019 7/31/2019 7/31/2019
NGIO (Antigen) $ 39,000 $ 342,000 $ —  $ 30 $ 381,030
Regentys —  306,800 331,711 131,486 769,997
NGDx (HDS) 141,067 162,138 140,299 154,351 597,855
TOTAL $ 180,067 $ 810,938 $ 472,010 $ 285,867 $ 1,748,882
The Company undertakes to provide additional information in its future filings, beginning with its quarterly report on
Form 10-Q for the quarter endi ng April 30, 2020 that will summarize and reflect the information below.
NGIO
• the nature of efforts and steps necessary to complete the project,
Our most advanced immunotherapy vaccine is AE37, an Ii-Key-Hybrid molecule that contains the HER2/neu
antigenic peptide linked to the Ii-Key to enhance immune stimulation against HER2, which is expressed in numerous cancers, including breast, prostate, and bladde r cancers. We have completed a Phase I clinical trial of
AE37 in breast cancer: A phase Ib safety and immunology study of AE37 and GM-CSF in 16 breast cancer
patients who had completed all first-li ne therapies and who were disease-fr ee at the time of enrollment to the
study (Holmes et al. Results of the first phase I clinical trial of the novel Ii-Key hybrid preventive HER-2/neu
peptide (AE37) vaccine. J Clin Oncol 2008;26:3426-33). Furthermore, we completed a Phase IIb trial of AE37 in the prevention of cancer recurrence in women who were at high risk of recurrence after undergoing successful primary standard of care breast cancer therapies and were disease free at time of enrollment.
NGIO is also sponsoring the NSABP FB-14 clinical tr ial protocol. Merck is contributing pembrolizumab
(Keytruda) for use in combinatio n with AE37 for the treatment of triple negative breast cancer.
Based on the results from this trial, NGIO has entered into a collaborative agreement with Merck Sharpe &
Dohme B.V. (Merck) and the National Surgical Adjuvant  Breast and Prostate Progr am (NSABP) to conduct a
Phase II trial to evaluate the safety and efficacy of AE37 in combination with the anti-PD-1 therapy,
KEYTRUDA (pembrolizumab) in patients with metastatic triple-negative breast cancer. The trial began enrolling patients in September during 2019.
In addition to the breast cancer program, NGIO has conducted a Phase I clinical trial in prostate cancer,
enrolling thirty-two HER-2/neu+, cas trate-sensitive, and castrate-resistant prostate cancer patients to
demonstrate safety and strong im munological response to AE37. We are advancing AE37 for the treatment of
prostate cancer through a licensing and research agreement with Shenzhen BioScien Pharmaceuticals Co., Ltd.
• reasons for significant increases or decreases in research and development from period to
period,
The primary increase incurred by NGIO during the year e nding July 31, 2019 was related the initial payment of
$340,000 to NSABP Foundation Inc. (“NSABP”) for the Clinical Trial Agreement for the start-up activities of
the Phase II Study, paid during the quarter ending January 31, 2020.Page 2 of 3 3

• expected future increases or decreases in research and development,
As the clinical trial continues, NGIO will be obliga ted to pay NSABP, pursuant to the Clinical Trial
Agreement, additional amounts during each completed phase in the increments and at the times set forth in the
agreement in four primary phases: Start-Up Activities, Acc rual and Treatment Period, Follow-up Period and
Primary Endpoint.
In addition, Generex and through NGIO have been working to develop a peptide vaccine against the new
coronavirus SARS-CoV-2 using the company’s pr oprietary and patented Ii-K ey immune system activation
technology. We have built our technology to assist third party groups and gove rnment agencies in their
evaluation of potential vaccines against this pandemic SARS-CoV-2 virus.
The patented NuGenerex Immuno-Oncology (Formerly An tigen Express) Ii-Key technology uses synthetic
peptides that mimic essential protein regions from a virus that are chemically linked to the 4-amino acid Ii-Key to ensure robust immune system activ ation. In particular, the Ii-Key en sures potent activation of CD4+ T cells,
which in turn facilitates antibody produc tion to ward off infection. This Ii-Key modification can be applied to
any protein fragment of any pathogen to increase the potency of immune stimulation.
Generex is working with our partners at EpiVax who have identified such protein fragments or epitopes to
generate Ii-Key-SARS 2 peptide vaccines in collaboration with our peptide manufacturing partners. The
peptides and Ii-Key are made from naturally occurring amino acids, ensuring an excel lent safety profile for Ii-
Key peptide vaccines.
• the risks and uncertainties associated with completing development,
There is always uncertainty and risk associated with the development of any vaccine, medical treatment or
therapy, but the continued develop ment depends upon the completing the trials under various collaboration
agreements and associated potential commercialization of the product, FDA approval and/or licensing
agreements. Any collaborator with whom we may enter in to such collaboration ag reements may not support
fully our research and commercial interests since our program may compete for time, attention and resources
with such collaborator's internal programs. Therefore, thes e collaborators may not comm it sufficient resources
to our program to move it forward ef fectively, or that the program will advance as rapidly as it might if we had
retained complete control of all research, development,  regulatory and commercializatio n decisions. During the
pandemic COVID-19, it is anticipated that delays will occur, but the full impact of any slow down due to
COVID-19 has not been determined.
• the extent and nature of additional resources that need to be obtained if current liquidity
is not expected to be sufficient to complete the project, and
With respect to the NSABP FB-14 clinical trial, Merck is not contributing financial support; NGIO is funding
the conduct of the trial thr ough NSABP and a collabora tion and licensing agreement with Shenzhen Bioscien
Pharmaceuticals Co. Ltd. (“Shenzhen”) for the rights to China. This trial is expected to continue without further funding by Generex. All the funding for trial is being contributed by Shenzhen. All Clinical Data shall be jointly owned by NGIO and Merck.
In exchange for exclusive rights to AE37 for prostate canc er in China, Shenzen is financing and conducting the
Phase II trials in the European Union and Phase III trials globally under In ternational Commission on
Harmonisation (“ICH”) guidelines, with NGIO retain ing the rights to all clinical data for regulatory
submissions and commercialization in the rest of the world outside China. This trial co ntinue for the duration of
the Phase II combination trial of AE37 plus pembrolizumab in patients  with triple negative breast cancer.
NGIO has also sign a Pharmacovigilance Agreement am ong Merck, NSABP and NGIO to ensure the clinical
monitoring of the trial.Page 3 of 3 3

The funding for the development of a vaccine of SARS-CoV-2 virus is in advanced discussions and currently
expected that the development costs will be borne by the U.S. and foreign governmen t agencies and without
additional external funding, Gene rex will not pursue these projects.
• your estimate of the date of completion of any future milestone such as completion of a
development phase, date of filing an NDA with  a regulatory agency, or approval from a
regulatory agency.
Except for the development of a vaccine of SARS-CoV-2 virus, the other trials being conducted with NSABP
and Merck with Shenzhen are multi-year studies. The FDA approved our Ii-Key peptide vaccine, AE37 (Ii-
Key-HER2/neu) for Phase 1 and Phase II clinical trials  without requiring add itional animal studies.
With respect to the SARS-CoV-2 vaccine, our plan to make a targeted vaccine that produces a complete
immune response that neutralizes th e virus. We will work with the FDA to approve an IND for the Ii-Key-
SARS-COV-2 vaccine candidate to quickly enter clinical  trials with a rapid assessment of safety and
immunogenicity with the first trial starting as early as Ju ly 2020. Based on the results of this initial safety and
immunogenicity study, we propo se a pivotal healthcare worker clinical trial in the fall of 2020 as well as trials
in special populations to continue assessing the safety and efficacy data required for licensure. Manufacturing is major advantage for the Ii-Key-SARS-CoV-2 vaccine, because is a synthetic peptide that can be readily scaled. Generex and our commercial manufacturing partners will be positioned to begin delivery of up to 100
million doses (100 Kg) of vaccine starting in the fall of 2020.
Regentys
• the nature of efforts and steps necessary to complete the project,
Regentys is developing ECMH™ Rectal Solution, an extracellular matrix (“ECM”) hydrogel, to facilitate tissue
healing in patients with inflammatory bowel diseases. Initially, the company is targeting patients with Ulcerative Colitis and thereafter, it plans to modify its pr oducts and delivery system to address patients with
Crohn’s Disease, Rectal Mucositis an d other similar indications.
The company’s product is categorized by the US Food and Drug Administration (“FDA”) as a medical device.
This requires approval by the FDA prior to marketing or  sale in the United States and by other governmental
regulatory authorities in different foreign jurisdictions . Most simplistically, the process to obtain approval for
similar products in the US is as follows: undertake preclinical and animal studies; assess and validate study
results; draft regulatory filings to prepare for clin ical trials; make manufacturing batches of the product;
validate the effectiveness of the manufacturing process; scal e up manufacturing for clinical trial batches, file
clinical trial documentation, solicit patients, undertake a fi rst-in-man (FIM) pilot stu dy, adjust the product/study
and protocol if required, an d undertake additional pivotal studies, g ather and present data and submit final
regulatory applications with all the required product, manufacturing and clinical data. Thereafter, once all
elements are met, permission to market and sell is gran ted by the regulatory aut hority. For FDA medical device
applications that are 510( k) de novo, there is a great likelihood of approval.
In 2016 and 2017, Regentys comp leted promising pre-clinical and animal studies under a research and
development agreement with the University of Pitts burgh. In 2018, Regentys engaged HPA, a Boston, MA-
based consulting firm, to provide the company with gu idance in its US FDA filing activities. In 2018, Regentys
received guidance from the FDA regarding its need to file a 510(k) de novo application to position its product for clinical evaluation, commercialization and market approva l the US. The clinical program Regentys is
undertaking is being designed to  meet FDA standards which are recognized by major industrialized countries
globally with statutory regulatory clinical trial and fili ng adjustments to be made to  account for the distinctions
imposed by each country. The company expects to conduct a 20-person study and a 50-person study prior to filing its application with the US FDA.
In 2018, Regentys entered into a development agreement with Cook Biotech, Inc. (“CookBio”) a recognized
global leader in the development and manufacture of extracellular matrix products. CookBio is helping
Regentys to fa cilitate a final production version of the ECMH  product, and upon completion, CookBio has
agreed to manufacture the product in North America. As well, CookBio is collectin g relevant product data and Page 4 of 3 3

building the product and manufacturing data portfolio required for submission to the FDA and other
governmental entities. In 2018, the Company also entered in to an agreement with Natureplex, a finished goods
maker is the second largest enema manufacturer behind Fleet. The Natureplex diluent and bottles along with the Cook Bio ECM biomaterial is expected to comprise the final product kit.
During 2019, Regentys’ development acti vities focused on scaling-up batc h sizes of the pr oduct and evaluating
key indicators to demonstr ate conformity with the ori ginal formulae plus certain enhancements. The company
achieved an almost identical version of the original form ula in a scaled-up production run, but it seeks to
improve on two commercial specifications . To facilitate this process, Regentys engaged Dr. Steven Badylak,
DVD, MD and the McGowan Institute at the University of Pittsburgh to help with this work. Should improvements not meet all the desired commercialization par ameters, Regentys has an established back-up
version of its formula that will meet all indicators without the commercial enhancements.
• reasons for significant increases or decreases in research and development from period to
period,
In 2019, Regentys contracted with Brandwood CKC, a Sydney, Australia-based global regulatory firm to assist
the company with all necessary regu latory filings to condu ct clinical trials and gain  product approvals in
jurisdictions outside of the US. The company intends to undertake a clinical trial in Australia within months of
the completion of the final product. Brandwood representatives will help Regentys e