• Closing Scheduled for December 2019
  • Patented AltuCaps® for Microencapsulation of stem cells for autoimmune and inflammatory diseases: Partnering opportunities available
  • Altsulin® implantable Sertoli Cells for Type I Diabetes
  • New technology: Patented, next generation, permeable microcapsules for implantable protein production
  • Broad Range of Medical Applications for Cell & Gene Therapy

MIRAMAR, Fla., Nov. 25, 2019 (GLOBE NEWSWIRE) — Generex Biotechnology Corporation (OTCQB: GNBT) is excited to announce that the Company has signed a Stock Purchase Agreement to acquire a 51% controlling interest in ALTuCELL, a privately held biotechnology company, in a stock and cash transaction. With this agreement, Generex gains a broad patent portfolio for cell encapsulation technology and cellular therapy. The transaction is expected to close by the end of the year.

The ALTuCELL patent portfolio includes global patents for the AltuCaps® cell encapsulation platform, together with patents for the chemistry, manufacturing, and ultra-purification of capsules. ALTuCELL has also been granted a wide-ranging patent, Microencapsulation of Myofibroblasts (Stem cells) Isolated from Wharton Jelly for Prevention and Treatment of Autoimmune and Inflammatory Diseases. Generex is pleased to offer this patent for partnering and licensing to generate new cell therapy products, and to enable stem cell companies to patent their cellular therapy products with global market protection.

Generex is also very excited to announce ALTuCELL’s recently filed patent, Alginate Microcapsules for Cell and Molecular Therapy that Secrete Bioactive Immune Molecules, which will pave the way for implanted cells that can secrete therapeutic antibodies to treat innumerable diseases including cancer, arthritis, psoriasis, and inflammatory bowel disease. “The implications for this new patent are amazing”, said Gary Harlem, ALTuCELL’s President & Chief Executive Officer. “I have been working for a decade with my partners at the University of Perugia in Italy, who are global leaders in cell encapsulation technology, to make cellular implantation for the treatment of diabetes a reality. This new, patent-pending technology opens up a whole new world for cell and gene therapy, and our partnership with Generex will help us to reach our goal to cure Type I diabetes and other autoimmune and inflammatory diseases. Now that we have finalized the deal, we will advance discussions with biopharmaceutical company partners that are developing proprietary stem cell products to co-develop cellular and regenerative medicine products. With our new patent for next generation capsules that secrete bioactive molecules, Generex is positioned to lead the way to a new era in molecular medicine, where we can essentially implant a mini bioreactor directly in the patient to treat genetic disease with enzyme replacement therapy, and autoimmune disease with antibody therapy. We are looking forward to accelerating the clinical development of ALTuCell’s product line and working with Generex to build a deep pipeline of cellular therapies.” 

Joe Moscato, President  & Chief Executive Officer of Generex stated, “We can’t be more excited about this partnership with ALTuCELL. With this acquisition, we are not only reigniting our diabetes franchise with Altsulin microencapsulated Sertoli Cells for the potential cure of Type I diabetes, but we also get the best-in-class, globally patented cellular microencapsulation technology with broad utility in cellular and regenerative medicine therapy.”

Mr. Moscato continued, “Let me be more specific when I state “best-in-class” as it pertains to ALTuCELL’s IP portfolio. First, our proprietary and patented purification processes yield ultra-pure, pharmaceutical grade capsules that are completely inert, with no toxicity nor immune system rejection problems in any preclinical models or clinical studies to date. Further, and most importantly in comparison to competitive encapsulation technologies, our capsules have been implanted in people with diabetes for 5 years, demonstrating clear, long-term safety, with no toxicity or tissue necrosis, and no rejection in any of the patients treated. Also, as part of our due diligence process, we pinpointed specific, comparable deals that validate the huge value of the ALTuCELL acquisition, as evidenced by the recently announced purchase of Semma Therapeutics by Vertex Pharmaceuticals for close to a billion dollars. The industry at large is advancing cellular therapy, immune modulation, and gene therapy at a rapid pace, and with ALTuCell and our other regenerative medicine platforms, ExcellagenÒ and Regentys ECMHÔ, Generex is positioned to be an integral part of this revolution in cellular and molecular medicine. It is not often that you get a chance to acquire an industry leader in a hot and emerging field like stem cell therapy, and based on our research, we are way ahead of any and all competition with the 5-year human data. As we move forward with a third-party evaluation of ALTuCELL by a leading pharmaceutical appraisal consulting firm, we are building a roadmap for the future to realize the massive market opportunity for the ALTuCELL IP portfolio, and we sincerely hope that the market will recognize the huge value that we are building in the NuGenerex Family of companies.”

For additional information, please visit the ALTuCELL web site (https://altucell.com/home).

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.

In addition to advancing a legacy portfolio of immune-oncology assets, medical devices, and diagnostics, the Company is focused on an acquisition strategy of strategic businesses that complement existing assets and provide immediate sources of revenue and working capital. Recent acquisitions include a management services organization, a network of pharmacies, clinical laboratory, and medical device companies with new and approved products. 

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 Source: Generex Biotechnology Corporation

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