Generex Provides Clarification on Its Ii-Key COVID-19 Complete Vaccine China Partnership Agreement

Rhea-AI Summary

Generex Biotechnology Corporation (OTCQB:GNBT) announced a $2 million agreement with Beijing Youfeng Biological Technology for the development of its Ii-Key SARS-CoV-2 vaccine. Under the agreement, Youfeng will conduct clinical trials and provide data for US and international approvals. Youfeng gains exclusive sales rights outside of the US and certain Latin American countries upon successful trial execution. Additionally, Youfeng will supply Generex with a comprehensive development plan and regulatory documents. CEO Joseph Moscato expressed optimism regarding the collaboration.

Positive

• Agreement with Youfeng includes $2 million payment for vaccine development, supporting R&D costs.
• If clinical trials are successful, Youfeng will provide valuable data for US FDA approval.
• Youfeng to obtain exclusive sales rights in specified regions, potentially enhancing revenue streams.

Negative

• The agreement's success is dependent on Youfeng's ability to conduct effective clinical trials, introducing execution risk.

MIRAMAR, Fla., May 05, 2021 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (“Generex” or the “Company”), an innovative and integrated healthcare holding company with end-to-end solutions for patient centric care including the development of its innovative “Complete Vaccine” to fight SARS-CoV-2, today provided guidance on the terms of its agreement with Beijing Youfeng Biological Technology, Ltd (Youfeng-BI) in connection with the $2,000,000 payment made by Youfeng-BI to GNBT and its subsidiary NuGenerex Immuno-Oncology, Inc. (NGIO) on or about April 27, 2021. Under the terms of this agreement:

	If YouFeng-BI conducts phase I, phase II, phase III clinical trials in accordance with ICH guidelines to support commercial approval of the Ii-Key SARS-Cov-2 vaccine by the NMPA (the Chinese FDA), then:
	(1) YouFeng will provide the clinical data to Generex for its US FDA and the international approvals in its current contracts as available; and
	(2) YouFeng shall have the exclusive sales rights in any country other than US, Canada and the countries, territories under GNBT’s current licensed out contracts, and Mexico, Ecuador, Peru and Colombia with respects to li-key SARS-Cov-2 vaccine (provided that YouFeng complies with clauses (1) and makes a commitment to execute clause (3) of this paragraph); and
	(3) Upon the technology is recognized by NMPA through this li-key SARS-Cov-2 vaccine, YouFeng will execute the payment terms of license fee for the entire Ii-key platform referred to in a contract previously executed by GNBT.

Although YouFeng will obtain the exclusive sales rights mentioned above upon the satisfaction of the conditions mentioned above, Generex and NGIO will maintain worldwide patent rights to the Ii-Key SARS-Cov-2 vaccine, except for China.

Additionally, Youfeng has agreed to provide GNBT with (i) a complete development plan outlining the regulatory path, data requirements, pre-clinical and clinical studies planned, and regulatory filing timeline and (ii) copies of all NMPA filings to date and in the future.

Generex CEO, Joseph Moscato said, “We are pleased that our Chinese partners have paid Generex $2 million dollars for our vaccine development expertise which will subsidize the costs of research, development, and technology transfer in support of their NMPA submission, and we look forward to the approval of the Ii-Key Complete Vaccine.”

About Generex Biotechnology Corp.
Generex Biotechnology is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care.

About NuGenerex Immuno-Oncology
NuGenerex Immuno-Oncology, a subsidiary of Generex Biotechnology, is a clinical stage oncology company developing immunotherapeutic peptide vaccines for cancer and infectious disease based on the CD4 T-Cell activation platform, Ii-Key. NuGenerex Immuno-Oncology (NGIO) has been spun out of Generex as a separate public company to advance the platform Ii-Key technology, particularly in combination with the immune checkpoint inhibitors for the treatment of cancer. NGIO is currently engaged in a Phase II clinical trial of its lead cancer immunotherapeutic vaccine AE37 in combination with pembrolizumab (Merck’s Keytruda®) for the treatment of triple negative breast cancer. The company has also turned its Ii-Key technology on infectious disease, responding to the coronavirus pandemic with a SARS-CoV-2 vaccine development program.

Cautionary Note Regarding Forward-Looking Statements
This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties 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 claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Generex Contact:

Generex Biotechnology Corporation

Joseph Moscato
646-599-6222

Todd Falls
1-800-391-6755 Extension 222
investor@generex.com

FAQ

What is the agreement between Generex and Youfeng regarding the Ii-Key SARS-CoV-2 vaccine?

Generex has entered into a $2 million agreement with Youfeng for the development of the Ii-Key SARS-CoV-2 vaccine, which includes conducting clinical trials and providing necessary data for regulatory approvals.

What are the financial terms of the Generex and Youfeng partnership?

Youfeng has made a $2 million payment to Generex as part of their agreement, with potential additional payments tied to the execution of the contract.

What exclusive rights does Youfeng gain under the agreement with Generex?

Youfeng will have exclusive sales rights for the Ii-Key SARS-CoV-2 vaccine in countries outside the US and specific Latin American nations upon successful completion of clinical trials.

What responsibilities does Youfeng have in the Generex agreement?

Youfeng is required to conduct clinical trials, provide clinical data to Generex, and deliver a complete development plan and all relevant regulatory filings.

What is Generex's CEO's opinion on the agreement with Youfeng?

CEO Joseph Moscato expressed optimism about the collaboration, indicating that the agreement will subsidize costs for research and development.