Generex Subsidiary NuGenerex Immuno-Oncology (Formerly Antigen Express) Files Form 10 Registration Statement with the Securities and Exchange Commission

  • NuGenerex Immuno-Oncology (NGIO) is focused on modulation of the immune system to develop Ii-Key peptide vaccines for the treatment and prevention of cancer and infectious diseases
  • NGIO advancing Ii-Key peptide vaccines into development with partners in the United States and China in an effort to slow the coronavirus pandemic

MIRAMAR, Fla., March 12, 2020 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation ( (OTCQB:GNBT) ( today announced that the company's subsidiary NuGenerex Immuno-Oncology (NGIO) has filed the initial public filing of a Form 10 Registration Statement with the U.S. Securities and Exchange Commission (the "SEC"). The registration of NGIO's securities with the SEC provides investors detailed information, including an overview of business strategies and audited financial statements.

Once the Form 10 becomes effective 60 days from the filing date, NGIO will be a fully reporting company with the SEC, subject to quarterly, annual and other reporting requirements. NGIO intends to utilize an increased market presence and potential support of institutional investors to aid a growth and acquisition strategy. It is NGIO's intent to list its common stock on a national securities exchange upon meeting certain financial and regulatory requirements.

Generex President and CEO Joe Moscato said, "We are happy to announce the filing of Form 10 Registration Statement for our subsidiary. We have issued a number of NGIO shares to our shareholders through two dividend payments. Once the SEC approves the filing, and the registration becomes effective, we plan to file a Registration Statement on Form S-1 with the SEC to sell shares and apply to list NuGenerex Immuno-Oncology as a separate, publicly traded Nasdaq company. With this listing, Generex and our shareholders should be able to realize the true value of our immune system activation technology that we are developing for cancer immunotherapy. In addition to expanding our oncology clinical development program of AE37 in combination with Merck's Keytruda® for the treatment of triple negative breast cancer, we plan to initiate clinical trials of AE37 in bladder cancer and begin clinical trials in additional cancer indications with our other Ii-Key peptide vaccines."

Mr. Moscato continued, "Further, as the COVID-19 pandemic has become a true public health threat, the value of our Ii-Key technology for the treatment and prevention of infectious diseases is being recognized by government agencies around the world. In response to this global health crisis, our team at NGIO has been able to restart the pandemic virus rapid vaccine development program from a decade ago, and we are currently working with our partner EpiVax on epitope mapping and computational vaccinology, as well as with our Chinese partners at the China Technology Exchange to have a vaccine ready for human testing in the next few months. We are also initiating discussions with U.S. and Canadian health authorities to advance our Ii-Key peptide vaccine technology to the clinic here in North America. We will keep our shareholders updated as we progress in our coronavirus vaccine development program using Ii-Key peptides to activate the immune system for protection from COVID-19."

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.

NuGenerex Immuno-Oncology (formerly Antigen Express), a subsidiary of Generex Biotechnology, is a clinical stage oncology company developing immunotherapeutic peptide vaccines based on the CD4 T-Cell activation platform, Ii-Key. NuGenerex Immuno-Oncology (NGIO) is being spun out of Generex as a separate, independent public company to advance the platform Ii-Key technology, particularly in combination with the immune checkpoint inhibitors. 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.

About EpiVax
EpiVax is a 21-year old privately-held biotechnology company located in Providence, RI, with a broad portfolio of projects including vaccines and immunotherapies for infectious diseases, autoimmunity and cancer. Scientists at EpiVax, led by co-founders Annie De Groot, MD and Bill Martin, lead the field in immunogenicity risk assessment. The ISPRI and iVAX toolkits for therapeutics and vaccines are used by a global roster of companies. Visit for more information.

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

Todd Falls
1-800-391-6755 Extension 222

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