NuGenerex Family of Companies

NuGenerex Family of Companies

Since January 2017, a new management team took over Generex Biotechnology Corporation. Generex has been reorganized as a strategic, diversified life science holding company that is actively involved in building a modern organizational platform for the financing, development, commercialization, and distribution of promising devices, biologics, therapeutic, and diagnostic products to improve human health and the method of patient care.

Our foundation and reorganized corporate directive is to acquire operating companies that provide multiple and significant revenue streams through delivery of patient-focused healthcare products and services.

This includes but is not limited to, specialty pharmacy, orthopedic implants, surgical supplies, biologics, medical devices, and regenerative medicines. These foundational acquisitions service unique market channels that provide end-to-end healthcare solutions in partnerships with patients, physicians, health systems, and payors. The synergistic business models of the combined organization offer cross channel sales opportunities for rapid growth.

This new kind of healthcare company, “The NuGenerex Family of Companies”, extends beyond traditional models positioning to provide support to physicians, fostering ongoing relationships with patients, and to improve overall patient experience and access to optimal care.

NuGenerex

Immuno Oncology

IMMUNO-ONCOLOGY

AE37 immunotherapeutic vaccine for Breast, Prostate, Bladder

NuGenerex

NuGenerex Health

HEALTH

Ancillary health management services for chronic conditions

NuGenerex

Immuno Oncology

REGENERATIVE

Olaregen Therapeutix, Regentys

NuGenerex

Immuno Oncology

DIAGNOSTICS

NGDx Express II rapid diagnostic tests for infectious disease

NuGenerex

Immuno Oncology

THERAPEUTICS

Oral-lyn (Buccal Insulin) and RapidMist Buccal delivery technology

NuGenerex Immuno-Oncology
Immuno Oncology

NuGenerex Immuno-Oncology is a platform biotechnology company focused on harnessing the power of the innate immune system to treat and prevent cancer and infectious disease with a pipeline of immunotherapy indications based on our proprietary, patented platform technology, Ii-Key. NGIO was created not only to advance the Ii-Key core technology, but also to expand our portfolio in the field of immunotherapy, infectious disease, and personalized medicine through partnerships and acquisitions.

The Company’s lead cancer immunotherapy product candidate is AE37, an Ii-Key-HER2 peptide vaccine for breast, prostate, and bladder cancer which links our li-Key to a designated tumor antigen like HER-2 to activates the immune system to target specific cancer cells.

Clinical trials with AE37 have demonstrated a statistically significant improvement in disease free survival (DFS) for patients with advanced, low HER-2 breast cancer; this benefit has lasted for 10 years. In a prostate cancer trial, AE37 generated long-term immune memory responses 3 years after vaccination, with improvement in DFS. AE37 clinical development is being advanced in breast, prostate, and soon, bladder cancer.

Our Complete Vaccine™

Our Complete Vaccine™ is designed to regulate the immune system the ii-Key technology to provide a targeted, neutralizing antibody response as well as activated T cell responses to generate long-term immune memory against infectious diseases. Our proprietary vaccine development process enables us to select Complete Vaccine candidates that activate specific and targeted T helper (Th1) responses without generating detrimental Th2 responses or off-target, non-neutralizing antibodies that have been associated with antibody dependent disease enhancement (ADE) and the immune-related complications of COVID-19 disease.

The Ii-Key technology and our proprietary vaccine discovery platform enables us to rapidly respond to emerging infectious disease threats. Our 20-year history of creating new vaccines against potentially pandemic viruses (SARS-1, Avian Influenza, Swine Flu) has positioned us to be a leader in the fight against COVID-19 with an Ii-Key-SARS-CoV-2 vaccine.

Human clinical trials of the Ii-Key COVID Vaccine are expected to begin by Summer 2021.  NGIO has applied to the NASDAQ and plans to spin out of Generex Biotechnology and simultaneously list on the NASDAQ.

Key Differentiators of our “Complete Vaccine”:

  • Artificial Intelligence (AI) Platform for biomarker discovery
  • Targeted immune system modulation
  • T-Cell activation for long-term immunity
  • Cellular and humoral (antibody) activation for a Complete Vaccine™
  • Neo-antigen approaches to personalized vaccines
  • Synthetic peptide manufacturing; produce mass quantities quickly with no incubation time (100 Kg = 100 million vaccines)
  • Eliminate peptides that can produce ADE antibodies (no cytokine storm)

To learn more about our science and collaborations, please visit our NuGenerex Immuno-Oncology website at: www.nugenerexio.com

NuGenerex Health
NuGenerex Health

NuGenerex Health is the final link to our corporate mission…to provide physicians, hospitals, and all healthcare providers with an end-to-end solution for patient centric care from rapid diagnosis through delivery of personalized therapies, streamlining care processes, minimizing expenses, and delivering transparency for payers.

NuGenerex Health provides ancillary health services in partnership with Arizona Endocrinology Center and Paradise Valley Family Medicine, two major physician practices that care for a population of ~65,000 patients, approximately 25,000 of whom are insulin dependent diabetics with chronic care needs. Our focus will be in the areas of eyecare, podiatry and chronic care management (CCM). NuGenerex also plans a Health Maintenance Organization (HMO) providing healthcare services and disease management solutions.

We plan to generate significant membership growth by developing patient centric engagement programs and building on our strong provider relationships. Generex has partnered with an experienced HMO developer led by Dr. Kiran Patel who has built several of the most successful HMO companies over the last decade. The (HMO) infrastructure will be managed by an industry-leading back office management company, which has provided back-end services for HMOs since 2009.

By bringing the specialty ancillary care directly to the patients who regularly visit the clinic, we anticipate that NuGenerex Health will provide an integrated, collaborative care model to enhance patient well-being.

Partnerships

NuGenerex Health LLC entered into a strategic 50/50 partnership with Worldwide Digitech, LLC (“WWDT”). WWDT will provide the software powered by the HealthKOS framework and back-end support for the NuGenHealth SaaS system, while NuGenerex Health LLC shall be responsible for the day-to-day management and oversight of business operations.

NuGenHealth, also signed a services agreement with Paradise Valley Family Medicine, P.C. an Arizona professional corporation (“PVFM”) to provide a software and services solution for patient engagement, Remote Patient Monitoring (RPM) and Chronic Care Management (CCM) services that are recommended and reimbursed by the Centers of Medicare and Medicaid Services (CMS).

Once the inaugural system is implemented at PVFM, we plan to expand the NuGenHealth SaaS system to other practices and chronic care patient populations to rapidly grow revenues for the company. These practices and patient populations will serve as the foundation that enables NuGenerex Health to establish a new HMO with our ophthalmology, podiatry, neurology, and cardiovascular services.

Areas of Focus

Ophthalmology

Regular eye exams for persons diagnosed with diabetes mellitus are important for detecting potentially treatable vision loss. Monitoring, surveillance, and evaluation of visual health are widely recognized as prerequisites for effective, accessible, and high-quality individual and population-based health services.

Medicare Part B (Medical Insurance) covers preventive and diagnostic eye exams as part of a comprehensive diabetes care plan, with reimbursements averaging $215 per patient for standard eye exam with accompanying tests for glaucoma and macular degeneration.

Podiatry

According to an article that was published in Therapeutics Advances Endocrinology & Metabolism, Financial burden of diabetic foot ulcers to world: a progressive topic to discuss always(2018 Jan; 9(1): 29–31.), as diabetic foot ulcers (DFUs) are the leading cause of non-traumatic lower extremity amputation costing an estimated $13 billion annually, CMS promotes preventive and diagnostic foot exams by a podiatrist, with reimbursement rates averaging $175 for a new patient evaluation, and $150 for follow up. Under the CMS guidelines, patients are eligible for diabetic foot exams every six months.

Chronic Care Management (CCM)

According to the CDC an estimated 117 million adults have one or more chronic health conditions, and 2/3 of Medicare patients have 2 or more chronic conditions. The Centers for Medicare & Medicaid Services (CMS) made benefit payments of $583 billion in 2018, with chronic care patients accounting for 99% of expenditures. Recognizing chronic care management (CCM) as a critical component of health care, CMS has established reimbursement codes to promote adoption in the marketplace, including significant improvements in 2017 that increased payment amounts and introduced new billing codes.

NuGenerex Regenerative Medicine

NuGenerex Regenerative Medicine (NRM) is focused on developing novel high-value drugs, medical devices, and innovative therapeutics that will improve treatment outcomes and patient’s quality of care.

The acquisitions of companies to date such as Olaregen Therapeutix Incorporated, and Regentys Corporation. Highlights our focus to develop, manufacturing, and commercialize products for the advancement of comfort and patient care.

NuGenerex Regenerative Medicine acquired Olaregen, a regenerative medicine company focused on the development, manufacturing, and commercialization of products in the wound-healing space. Olaregen’s owns Excellagen, a 3-dimensional flowable dermal matrix, which is FDA-approved for 17 indications of wound care management representing over 92 million potential cases. Excellagen reduces wound size by 362% over the standard of care and has been shown to require fewer visits from a healthcare professional, which reduces the burden of care for care-givers.

Olaregen Therapeutics’ wound conforming matrix, Excellagen, has been awarded a Blanket Purchase Agreement (BPA) contract from the National Strategic Acquisition Center (SAC). The VA’s National Contract and National BPA programs are used by VA medical centers, related facilities, specific State Veterans Homes, and other Federal facilities to procure select products based on clinical evidence, patient outcomes, and economic cost to the VA hospitals.

This will expedite the purchasing of Excellagen at over 165 VA medical centers across the U.S. and Puerto Rico that treat veterans who suffer from diabetic foot ulcers, venous leg ulcers, and other difficult to manage wounds that disproportionately impact the veteran population. The VA system represents the two largest wound care networks in the United States.

Regentys Corporation is a regenerative medicine company developing therapies for the treatment of ulcerative colitis and other inflammatory bowel diseases.

Regentys’ initial product, ECMH™ Rectal Solution, is a first-in-class, non-pharmacologic, non-surgical treatment option for millions of patients suffering from mild to moderate ulcerative colitis.

The projected drug costs for ulcerative colitis (UC) alone are expected to exceed $7.5B globally by 2023, according to a 2017 report by Allied Market Research; including other inflammatory bowel disease indications, the global market is expected to double. Based upon the nature of Inflammatory Bowel Disease, and the characteristics of Regentys’ technology, management believes variations of Regentys’ core technology will also be effective in treating IBD diseases such as Crohn’s, rectal mucositis, proctitis, and anal fissures.

NuGenerex Diagnostics
Immuno Oncology

NuGenerex Diagnostics (NGD) is a manufacturer of in-vitro medical diagnostic devices commonly referred to as rapid diagnostic tests for both point of care and laboratory-based tests, primarily for infectious diseases.

Strategically, the Company’s mission has been to develop, manufacture and market a series of diagnostic tests that yield repeatable and reliable test results for an antibody or antigenic response to a specific disease in such samples as whole blood, plasma, or serum. Currently, our product line includes such tests for infectious diseases such as HIV ½, Syphilis, Tuberculosis, Malaria, Hepatitis-B, and Hepatitis-C.

HDS has developed rapid diagnostic assays capable of delivering test results within 10-15 minutes, and requires a small amount of whole blood usually taken from a finger stick; serum or plasma samples are approved for use when performing the test in a laboratory. HDS has produced and validated multiple diagnostic test strips, each developed for a particular disease and carefully produced following strict ISO 13485, and ISO 9001 standards. Our test strips are assembled into any of the two available delivery devices, the RAPID 1-2-3® HEMA EXPRESS®, and the RAPID 1-2-3® HEMA CASSETTE. Any of these two formats facilitate the rapid and easy use of the diagnostic in the field, clinic, or office.

The particular design characteristics of the RAPID 1-2-3® HEMA EXPRESS® sets it apart from all other rapid testing devices currently available.

The key and outstanding characteristics that surround the EXPRESS device design permits HDS to bring into the market a medical device that is discernibly different from other diagnostics and which is simple to use and available for use with a number of different analytes. The RAPID 1-2-3® HEMA EXPRESS® is a perfect choice.

NuGenerex Therapeutics
Immuno Oncology

NuGenerex Therapeutics houses the legacy diabetes assets, Oral-lyn (Buccal Insulin) and RapidMist Buccal delivery technology is a safe, effective, fast, flexible, pain-free and simple alternative to needle administered medications. We believe that our Buccal Delivery Technology is a platform technology that has application for many large molecule drugs and is designed to provide a convenient, non-invasive, accurate, and cost-effective alternative to injectable biologics.

Development of new and innovative therapeutics is crucial to improving treatment outcomes and patient’s quality of life, it is at the heart of what we do at NuGenerex Therapeutics (NGT). NGT is a wholly-owned subsidiary developing novel, high-value drugs and medical devices with an initial focus on diabetes.

The Rapid-Mist® buccal delivery technology that is used for our Oral-Lyn (oral insulin) spray for type II diabetes is a key focal point for the development of new drug formulations in a variety of therapeutic areas.  The technology enables alternative delivery of both small and large molecules through an oral spray, providing convenience, metered dosing, and the elimination of injections.

Our strategy is to partner with drug developers to out-license the Rapid-Mist® technology for formulation of new drugs and supplements. Our focus will be to generate both near and long-term revenues through licensing fees and royalties on future products of small and large molecule drugs which will benefit from an alternative route of administration

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