Current Report Filing (8-k)
July 23 2021 - 7:10AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington,
D.C. 20549 FORM 8-K
CURRENT REPORT
Pursuant to Section
13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of
earliest event reported): July 22, 2021
GENEREX BIOTECHNOLOGY
CORPORATION
(Exact of registrant
as specified in its charter)
DELAWARE
|
000-29169
|
98-0178636
|
State or other jurisdiction of incorporation
|
Commission File Number
|
IRS Employer Identification No.
|
10102 USA Today
Way, Miramar, Florida 33025 (Address of principal executive offices) (Zip Code)
(416) 364-2551
(Registrant’s
telephone number, including area code) (Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing
is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark
whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this
chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
☐
If an emerging growth
company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any
new or revised financial accounting standards provided pursuant to Section 13 (a) of the Exchange Act. ☐
Securities registered pursuant
to Section 12(b) of the Act:
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
N/A
|
N/A
|
N/A
|
Item 8.01 Other Events.
On
July 22, 2021, Generex Biotechnology Corporation (“Generex”) on behalf of itself and its subsidiary NuGenerex
Immuno-Oncology, Inc. (collectively “Generex”) entered into a Quality Agreement with PPD Development, L.P. (“PPD”)
regarding Generex’s efforts to develop Generex’s li- Key-SARS-CoV-2 coronavirus peptide vaccine (the “Quality
Agreement”). The Quality Agreement describes the standards, expectations, and responsibilities of Generex and PPD with respect
to managing quality, including, but not limited to, quality assurance (QA) and quality risk management (QRM) for the services and/or
deliverables.
PPD
is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle
management services. PPD’s customers include pharmaceutical, biotechnology, medical device, academic and government organizations.
With offices in 46 countries and approximately 24,000 professionals worldwide, PPD applies innovative technologies, therapeutic
expertise and a firm commitment to quality to help customers bend the cost and time curve of drug development and optimize value
in delivering life-changing therapies to improve health. For more information, visit www.ppd.com.
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.
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.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
SIGNATURE
Pursuant to the requirements of the Securities
Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Date: July 23, 2021
GENEREX BIOTECHNOLOGY CORPORATION
/s/Joseph Moscato
By: Joseph Moscato, CEO, President
Generex Biotechnology (CE) (USOTC:GNBT)
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