Dear Generex Shareholders,
The emergence and rapid escalation of the COVID-19 pandemic has deeply impacted our lives as we never could have imagined. During these uncertain times the health and well-being of our Generex family, including our employees, shareholders, investors and partners is paramount. For the well-being of all of our stakeholders, we are committed to following the precautions of health advisors and adhering to suggestions, advice, and laws set up by local municipalities, cities, states, and the federal government to stop this pandemic that has disrupted the world. Generex Biotechnology remains dedicated to safeguarding your investment in GNBT as we continue working towards positive outcomes into the future through our strategic initiatives and development programs, including our previously announced efforts to develop a vaccine for the SARS-CoV-2 virus.
We want to take this time to update shareholders on the steps we are taking to efficiently manage the businesses of Generex and our subsidiaries through these challenging times. We are virtually fully operational with all our business management teams and their employees through video conference and are committed to following through with our short, mid and long-term goals and plans to add value for our shareholders.
As reported Generex has jumped into the vaccine race with its Ii-Key-COVID-19 Complete Vaccine, which is designed to activate both the cellular (CD4 and CD8 T cells) and humoral (antibody) immune responses. As previously reported, we have signed an agreement with a Chinese consortium to develop our Complete Vaccine for China. Since signing the agreement, Generex has developed and refined our vaccine plans and has invoiced the Chinese consortium for the upfront payment and licensing fee.
Generex has also partnered with EpiVax, a leader in computational vaccinology, that has developed algorithms to identify specific amino acid peptide sequences or "epitopes" that are predicted to activate the various cellular components of the immune system including CD4 T Cells, CD8 T Cells, and B Cells that produce antibodies. An additional advantage of their vaccinology algorithms is their ability to "dehumanize" peptide sequences to minimize autoimmune reactions. EpiVax has identified a series of epitopes of the SARS-CoV-2 viral proteins that may be used to produce a vaccine. Generex plans to manufacture laboratory scale amounts of the EpiVax peptides linked with our Ii-Key technology to screen against blood samples from patients who have recovered from COVID-19. We are in the process of identifying hospitals and research centers that can provide us with the blood samples for peptide epitope screening. We expect this screening process to yield the best 3 to 5 Ii-Key peptides that we anticipate will make the most safe and effective vaccine for human clinical trials.
To advance our vaccine development efforts, the team at Generex has been proactive in reaching out to a number of countries, and we have had productive conversations with several government officials, Ministries of Health, and other key influencers to describe our technology, our clinical strategy, potential manufacturing partners, and our rapid path to vaccination for their populations. Generex has also met and had discussions with U.S. government agencies to provide them with details of our Ii-Key peptide vaccine technology, and we are in discussions with the decision makers for federal funding and partnership. It has been a slow process, but we believe that vaccines are now getting more government attention as local, state, and federal officials recognize the severity of this pandemic and the likelihood that the virus will return next year.
Generex has identified a clinical research organization, regulatory consultants, and clinical research sites to conduct our trials, and we are working with our contract manufacturing partners for AE37 to produce our Ii-Key-SARS-CoV-2 peptide vaccine for human clinical trials and population vaccination initiatives. We are also in discussions with pharmaceutical companies to include their vaccine adjuvants as part of the clinical trial design to evaluate the potential of using adjuvant in our vaccine formulation.
Generex is highly confident in our rapid vaccine development program and in our plans to scale the manufacturing of Ii-Key- SARS-CoV-2 peptide vaccines to conduct not only the clinical trials required to meet the approval standards of global regulatory authorities, but to meet government expectations for mass population vaccination.
In conclusion, while the COVID-19 pandemic is surely a fast evolving situation with multiple layers of complexity, we believe market conditions should ultimately favor long-term minded, value oriented, and fundamental investors. Generex has many subsidiaries and many assets, from its FDA-cleared wound care product Excellegen®, to our development products in inflammatory bowel diseases, diabetes, infectious disease, and cancer, to our pending operations in Arizona, with the ultimate vision of building a HMO with, in our opinion, unprecedented benefit packages through our own products, devices, and ancillary services. Based on all these efforts and assets, it is my belief that Generex has the staying power to thrive and bring value to our shareholders. Rest assured, Generex is well equipped to navigate the current environment as we remain focused on our core competencies and businesses while positioning our high-value assets for the future.
In the immediate days ahead, we will continue working to solidify the development path and government partnerships to complete our Ii-Key-SARS-CoV-2 Complete Vaccine program so that we can make a difference not only for Generex, our employees, and our shareholders, but for the world. Finally, we thank you all for your continued support as we navigate through this difficult period together, and please everyone, stay safe, be well and take care of your families and friends.
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.
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 Biotechnology Corporation
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