NuGenerex Immuno-Oncology Secures $535 Million Valuation from World-Class Independent Valuation & Appraisal Firm

Rhea-AI Summary

NuGenerex Immuno-Oncology, a subsidiary of Generex Biotechnology (GNBT), announced a $535 million valuation from an independent appraisal firm as of November 2020. Significant advancements in their Ii-Key-SARS-CoV-2 vaccine development have been achieved, including GMP manufacturing completion and a forthcoming IND submission to the FDA. The vaccine's manufacturing process is designed for stability at room temperature, enhancing commercial viability. The first-in-human clinical trial is anticipated post-FDA clearance to assess the vaccine's safety and immune response against SARS-CoV-2.

Positive

• Received a $535 million valuation from an independent firm.
• Completion of GMP manufacturing for the Ii-Key-SARS-CoV-2 vaccine.
• Developing a stable powdered vaccine suitable for room temperature storage.

Negative

• Indication of pending FDA clearance for IND submission may cause delays.
• Clinical trial outcomes are uncertain, dependent on FDA approval.

• Ii-Key Immunotherapeutic Vaccine Technology
• Ii-Key-SARS-CoV-2 Vaccine Market Potential & International Contracts
• Market Potential for AE37 (Ii-Key-HER2) Immunotherapeutic Vaccine for breast, prostate, and bladder cancers
  

MIRAMAR, Fla., June 22, 2021 (GLOBE NEWSWIRE) -- NuGenerex Immuno-Oncology (NGIO – www.nugenerexio.com), a subsidiary of 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 today announced that the company has received a $535 million valuation from an internationally recognized, independent valuation and appraisal firm that provides valuation advisory services and fairness opinions to public and private companies. NGIO received the valuation as of November 15, 2020, and since then has made significant progress in the vaccine development programs, including completion of the GMP manufacturing of the Ii-Key-SARS-CoV-2 vaccine to potentially increase this valuation. The final lot release of the COVID-19 vaccine from the manufacturer for use in clinical trials is scheduled for July. Stability studies are ongoing to support the IND, which is currently being compiled for submission to FDA. Contingent on FDA approval and the receipt of financing the final vaccine manufacturing process is commercial ready using a lyophilization method that produces a stable, powdered Ii-Key-SARS-CoV-2 vaccine that can potentially be shipped and stored at room temperature, providing a substantial commercial advantage.

The IND submission and anticipated clearance from the FDA will allow NGIO to initiate first-in-human clinical trials of the Ii-Key-SARS-CoV-2 vaccine to evaluate the safety of the vaccine as well as the immune system responses that comprise a Complete Vaccine™ against SARS-CoV-2 with neutralizing antibody responses and T-cell responses for short-term protection and long-term immune memory.

Joseph Moscato, CEO of Generex and NGIO said, “In the last six months, we have made incredible strides in manufacturing the Ii-Key COVID vaccine. Working with our development partners at Stratum Medical and University of Iowa Pharmaceuticals, we have a commercial ready manufacturing process that is not only easily scalable, but also results in a lyophilized powdered product that we expect to be stable at room temperature for months or even years, pending the final stability results. Our manufacturing process is 100% synthetic using natural amino acids, eliminating the need for cell-based manufacturing and the problems of RNA and DNA stability that has led to the loss of millions of doses of the current vaccine products.”

Mr. Moscato continued, “Once we get the IND allowed by the FDA, our Phase I study is anticipated to provide the safety and immunology data to demonstrate that the Ii-Key-SARS-CoV-2 vaccine can generate a Complete Vaccine response. We will evaluate blood samples from Ii-Key vaccinated patients to evaluate the neutralizing antibody responses against the coronavirus and its variants in a secure, BSL-3 laboratory. We will also determine the T cell responses to the Ii-Key vaccine to demonstrate activation of the Th1 CD4+ response that promotes antibody development and long-term immune memory without an adverse Th2 response that can lead to the adverse immune reactions to the virus. The recent reports of neurologic effects of COVID-19 disease, the increased incidence of myocarditis in adolescents that have received the current vaccines, and the emergence of deadly variants like Delta highlight the need for our targeted Ii-Key vaccine approach to developing a Complete Vaccine against the SARS-CoV-2 virus.”

About NuGenerex Immuno-Oncology Inc.
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.

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 Contact:

Generex Biotechnology Corporation

Joseph Moscato
646-599-6222

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

FAQ

What is the current valuation of Generex Biotechnology (GNBT)?

Generex Biotechnology has a valuation of $535 million as reported in their recent press release.

When is the IND submission for the Ii-Key-SARS-CoV-2 vaccine expected?

The IND submission is currently being compiled for submission to the FDA, with a final lot release scheduled for July.

What are the clinical trial plans for the Ii-Key-SARS-CoV-2 vaccine?

Post-FDA clearance, the company plans to initiate first-in-human clinical trials to evaluate the vaccine's safety and immune response.

What advantages does the Ii-Key-SARS-CoV-2 vaccine offer?

The vaccine can potentially be stored at room temperature, providing a significant commercial advantage.

What challenges does the company face with its vaccine development?

The company faces potential delays pending FDA clearance and uncertainty regarding clinical trial outcomes.