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Generex Biotechnology Expands Medical Device & Wound Care Portfolio with Acquisition of Regentys Corporation

Thursday, November 29th 2018 at 1:30pm UTC

Acquisition of Clinical Stage Developer of A Novel Hydrogel for the
Treatment of Ulcerative Colitis and Other Inflammatory Bowel Diseases

MIRAMAR, Fla.–(BUSINESS WIRE)– Generex Biotechnology Corporation (OTCMKTS:GNBT) is pleased to announce
that the company has signed a Binding Letter of Intent to acquire 51% of
Regentys Corporation, a regenerative medicine company focused on
developing treatments for patients with gastrointestinal (GI) disorders.
The company’s first product, Regentys Extra-Cellular Matrix Hydrogel, is
a first-in-class, non-pharmacologic, non-surgical treatment option for
patients suffering from Ulcerative Colitis. Regentys has received
guidance from FDA that the treatment can be approved through the FDA
Office of Device Evaluation as a 510K de novo application, and
the company will initiate the clinical studies necessary to obtain that
approval by Q4 2019. Generex made an initial payment of $400,000 on
November 28, 2018, to secure the agreement and the company is in the
process of completing the legal documents with a plan to close the
transaction in the coming weeks.

Ulcerative Colitis (“UC”), a disease that affects approximately 750,000
patients in the United States and 1.9 million patients worldwide, is a
chronic, inflammatory disease that causes sores or ulcers in the lining
of the large intestine (the colon). There are currently four biologics
approved by FDA, including the top-selling antibody medicines Humira
(adalimumab), Simponi (golimumab), Remicade (infliximab) and Entyvio
(vedolizumab), all of which target the pro-inflammatory protein, TNF-?
(Tumor Necrosis Factor Alpha). Even with the introduction of expensive
biologics, more than half of all patients with ulcerative colitis (UC)
do not achieve long-term remission. Many, because of the disease, also
require colectomy surgery. Future indications for the drug include
inflammatory bowel disorder and irritable bowel syndrome, conditions
that affect millions of patients.

The Regentys™ Extracellular Matrix Hydrogel (“RECMH”) is a proprietary,
patented UC treatment that protects damaged tissue from waste flow and
promotes tissue regeneration and healing rather than suppressing the
immune system as other treatments currently do. The product has been
developed with polymeric characteristics that transform ECMH from a
liquid to gel form upon adherence to the mucosal lining of the diseased
colon, providing a “Bio-Scaffold Bandage” to the affected area. The
RECMH Bio-scaffold facilitates healing and functional repair of the
colon lining, first by covering the ulcer to limit the inflammatory
response, then by providing a framework to mobilize endogenous (the
body’s own) stem cells.

Jason Terrell, MD, Chief Medical and Scientific Officer of Generex,
stated, “The acquisition of Regentys and their patented Extracellular
Matrix Hydrogel technology for tissue regeneration provides Generex with
a high-value clinical stage asset. With the FDA guidance to a 510K de
novo
application for the treatment of Ulcerative Colitis, together
with data from an extensive pre-clinical program, we have a clear
regulatory path to approval. The RECMH product is well positioned as
first line therapy for UC. The clinical trial process is rapidly
advancing, and we will keep our investors apprised of results as they
become available.”

Joe Moscato, CEO of Generex, commented on the acquisition, “Our
acquisition of and investment in Regentys will provide Generex with
significant upside potential. We have worked closely with CEO Rick
Bulman and his team to define the clinical and commercialization
strategy, and we look forward to executing on our plan.”

Rick Bulman, CEO of Regentys, continued, “Generex provides our company
with an exceptional opportunity for the continued development of a
remarkable clinical asset that has the potential to improve patient
outcomes, reduce medical costs and better the quality of life of many UC
patients. The Regentys family is very excited to collaborate with Joe
and his team as they help transform the landscape of health care.”

About Generex Biotechnology

Generex is a strategic, diversified healthcare holdings company with
offerings in a variety of services, diagnostics, medical devices, and
pharmaceutical development. The Company’s direct-to-patient services
support its strategy of all-inclusive access to doctors, diagnostics,
therapeutics, and additional health-related services to greatly improve
the patient experience in receiving care. On the provider side,
Generex’s management services remove administrative burdens in multiple
provider settings, including private practice and hospital, allowing
doctors to devote more time to patient care. Revenue from the Company’s
subsidiaries will support clinical advancement of its wholly owned
therapeutic products with a focus in immunotherapeutics based on
stimulating critical members of the immune response, known as T helper
cells, and its proprietary buccal administration of insulin.

About Regentys

REGENTYS™ is a development stage, regenerative medicine company focused
on developing treatments for patients with gastrointestinal (GI)
disorders.

Our first product, ExtraCellular Matrix Hydrogel (ECMH), is a
first-in-class, non-pharmacologic, non-surgical treatment option for
patients suffering from Ulcerative Colitis.

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.

Contacts

Generex Biotechnology Corporation
Joseph Moscato
646-599-6222

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

Regentys
Corporation

Rick Bulman CEO
844-432-7262
rbulman@regentys.com

Russo
Partners

Investor / Media Contacts:
Alex Fudukidis
646-942-5632
alex.fudukidis@russopartnersllc.com

Caroline
Cunningham
212-845-4292
Caroline.Cunningham@russopartnersllc.com

Source: Generex Biotechnology Corporation and Regentys Corporation


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