Item
8.01 Other Events.
On
February 8, 2021, Generex Biotechnology Corporation and its majority owned public entity NuGenerex Immuno-Oncology, Inc., (collectively
“Generex”) received a wire transfer of Two Million Dollars USD ($2,000,000.00) towards its COVID-19 vaccine development
initiatives from its China Partners (as defined below) pursuant to the Ii-Key Innovative Vaccine Development Agreement signed
November 13, 2020, as amended by the extension terms signed December 15, 2020 (collectively the “Agreement”), with
Beijing Youfeng International Consulting Co., Ltd (“BYIC”), National Institute for Viral Disease Control and Prevention,
Chinese Centre for Disease Control and Prevention (“NIVDC”) and Beijing Guoxin Haixiang Equity Investment Partnership
(“BGHEIP” and together with BYIC and NIVDC, the “China Partners”).
To
date Generex has received a total of Three Million One Hundred Thousand Dollars USD ($3,100,000.00) from the China Partners, broken
down as follows:
|
1.
|
One
Hundred Thousand Dollar USD ($100,000.00) “Performance Guarantee Fee” payment.
|
|
2.
|
Three
Million Dollars USD ($3,000,000.00) towards its COVID-19 vaccine development initiatives.
|
Generex
filed a FORM 8K for the signed November 13, 2020, Ii-Key Innovative Vaccine Development Agreement on November 18, 2020. Also,
Generex filed a FORM 8K/A for the signed December 15, 2020, Extension Agreement on December 17, 2020. Lastly, Generex filed a
FORM 8K for the signed January 6, 2021, Performance Guarantee Fee Agreement on January 8, 2021.
Ii-Key
Platform Overview
The
Ii-Key-SARS-CoV-2 vaccine is designed as a “Complete Vaccine” that has the potential to induce the T-Cell and antibody
immune responses that can provide protective immunity with long-lasting immunologic memory against SARS-CoV-2 in a highly specific
manner to ensure safety. Ii-Key is a platform technology enabled by the amino acid key sequence “LRMK” that is shared
across the platform. The LRMK key sequence works by its ability to deliver any desired peptide epitope of interest directly to
the MHC Class 2 complex on the surface of antigen presenting cells. Once a suitable target epitope is identified, an Ii-Key vaccine
candidate is created by means of synthetic peptide synthesis, which produces a single linear amino acid chain that includes the
Ii-Key sequence, a short inert linker sequence, and the target epitope of interest. In this way, the target epitope is delivered
by the Ii-Key sequence directly to antigen presenting cells, resulting in an immune system stimulation.
About
the China Partners
Beijing
Youfeng International Consulting Co., Ltd. is the "China High-tech Industrialization Research Society Public Health Working
Committee" to provide development strategy consulting and design, projects implementation and management.
National
Institute for Viral Disease Control and Prevention of Chinese Centre for Disease Control (CDC) and Prevention is an independent
legal entity under the CDC. It is also the only national-level research institution for the prevention and control of viral diseases
and medical virology in China.
Beijing
Guoxin Haixiang Equity Investment Partnership (Limited Partnership) is a limited partnership established by Beijing Guoxin Zhongshu
Management Co., Ltd. as an executive partner and Zhejiang Haixiang Pharmaceutical Co., Ltd. and is effectively existing. Beijing
Guoxin Zhongshu Management Co., Ltd. is an equity investment institution which has completed the registration of private fund
manager in China Securities Investment Fund Industry Association. Zhejiang Haixiang Pharmaceutical Co., Ltd. is a public company
that mainly produces specialty APIs, preparations and fine chemicals, and has large-scale production capabilities for peptide
preparations.
Forward-Looking
Statements
Statements
in this report may contain certain forward-looking statements. All statements included concerning activities, events or developments
that the Generex expects, believes or anticipates will or may occur in the future are forward-looking statements. Actual results
could differ materially from the results discussed in the forward-looking statements. Forward-looking statements are based on
current expectations and projections about future events and involve known and unknown risks, uncertainties and other factors
that may cause actual results and performance to be materially different from any future results or performance expressed or implied
by forward-looking statements. Known risks and uncertainties also include those identified from time to time in the reports filed
by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement.
No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements.
Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future
events or otherwise. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical
trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical
trials or ultimate regulatory approval cannot be regarded as actual predictions of when Generex will obtain regulatory approval
for any “phase” of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory
agency. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities
Litigation Reform Act. Additional information on these and other risks, uncertainties and factors is included in the Company’s
Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8- K and other documents filed with the SEC.