GNBT - Generex Biotechnology
Provides Fiscal Year Overview
MIRAMAR, FL -- July 10, 2019 --
InvestorsHub NewsWire
- GNBT
Reorganization & Transformation
- Acquisitions: Olaregen Therapeutix, Regentys, Veneto
Assets, Pantheon Medical, MediSource
Partners
- Completed 100% Acquisition of HDS (now NuGenerex
Diagnostics) and Retired Associated Debt
- NuGenerex Immuno-Oncology (NGIO) Formation and Kiromic
Acquisition
- ExcellagenÒ
Wound Conforming Gel Matrix
- Product Launch & Commercial
Sales
- APMA
Seal of Approval
- Substantially Increased Shareholder
Equity
- Appointed New Independent
Directors
- Rewarded Shareholders with Dividends: GNBT 20:1, GNBT 1:1
(Pending), and NGIO 1:4
Generex
Biotechnology Corporation (www.generex.com) (OTCQB:GNBT)
(http://www.otcmarkets.com/stock/GNBT/quote)
today provided an overview of Generex’s accomplishments for the
fiscal year ending on July 31, 2019, as outlined
herein.
Since the
new management team has taken over in January 2017, 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 return value to its investors. As the foundation
for the reorganization, we are acquiring operating companies that
provide multiple and significant revenue streams through delivery
of patient-focused healthcare products and services, including
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, with significant revenues and
profits projected going forward.
Our new
management team has embarked upon a complete strategic
reorganization and transformation of the entire corporate
structure, leveraging Generex’s legacy assets which have applied
over $400 million dollars in developmental activities over the
years, providing Generex with net operating loss (“NOL”)
carryforwards from both United States and Canadian sources.
Generex has NOL carryforwards totaling $241.5 million in the United
States expiring in 2019 through 2038; and $35.6 in Canada expiring
in 2024 through 2039. On December 1, 2018, the loss
carryforwards accumulated from sources in the United States are
subject to an annual limitation of approximately $36.9 million
annually on a go forewarned basis. Under the Tax Cuts and
Jobs Acts (the “Act”), additional NOL carryovers of
approximately $4.6 million can be utilized entirely subject to the
80 percent of a taxpayer’s pre-NOL deduction taxable income. We
have also formulated an acquisition strategy and identified targets
to build a specialized healthcare platform with both scalability
and the ability to leverage across the organization in an effort to
achieve higher profit margins.
On April
3, 2019, Generex appointed two new independent Directors giving
Generex an experienced and talented Board of Directors with deep
expertise in healthcare, medical devices, drug development, sales
and marketing, investment banking, and finance, thereby meeting all
requirements for listing on a national
exchange.
On January
7, 2019 Generex acquired Regentys Corporation. Regentys is a
development stage, regenerative medicine company focused on
developing treatments for patients with gastrointestinal (GI)
disorders. Their first product, ExtraCellular Matrix Hydrogel
(ECMH), is a first-in-class, non-pharmacologic, non-surgical
treatment option for patients suffering from Ulcerative Colitis.
The FDA has provided guidance that Regentys ECMHÔ can be approved through the
510(k) de novo regulatory path, which has fewer regulatory
hurdles than the PMA approval process, and which historically
resulted in a 90% approval rate. Regentys plans to initiate
clinical trials in the fourth quarter of
2019.
On January
7, 2019 Generex acquired 51% of Olaregen Therapeutix, and
subsequently acquired an additional 10% from Olaregen Class A
shareholders for a total ownership of 61%. Olaregen’s foundational
product, ExcellagenÒ, is an FDA-510(k) cleared
aseptically-manufactured, syringe-based, ready to use 3-dimensional
wound conforming matrix that supports a favorable wound healing
environment. Excellagen is indicated for the management of wounds
including; partial and full-thickness wounds, pressure ulcers,
venous ulcers, diabetic ulcers, chronic vascular ulcers,
tunneled/undermined wounds, surgical wounds (donor sites/graft,
post-Mohs surgery, post-laser surgery, podiatric, wound
dehiscence), trauma wounds (abrasions, lacerations, second-degree
burns and skin tears) and draining wounds.
Olaregen
launched ExcellagenÒ
in April at The Symposium on Advanced Wound Care
(SAWC), the premier interdisciplinary wound care program in the
United States. Olaregen has initiated sales in the VA system, in
hospital surgical suites, and physician offices, with distribution
being managed by McKesson in the commercial market and the
Buckingston Group, a disabled American Vet owned distributor in the
VA.
Olaregen
is poised to become a significant force in regenerative medicine,
as we are providing comprehensive training to over 75 biotech sales
professionals for specialty hospital sales across the US,
strategically concentrating our efforts in key metropolitan areas.
We have had unprecedented interest from new, potential partners
proceeding and following SAWC, and we are building our sales team
and growing our distribution channels to serve the wound care
market. Recently, Excellagen garnered the seal of
approval from the American Podiatric Medical Association
(APMA).
On
November 1, 2018, Generex acquired Veneto’s management services
organization (MSO) business and two additional ancillary
services. The Veneto assets acquired by Generex
include management services operations, systems, facilities,
licenses, and infrastructure to coordinate ancillary pharmacy,
laboratory, and other services.
Since the
acquisition, Generex subsidiary NuGenerex Distribution Solutions
(NDS) has expanded the MSO from 3 to 5 states, revamped the
non-opioid surgical pain management pharmacy program through
out-sourcing with local pharmacies, and reorganized the MSO to be
more efficient and compliant with federal and state Anti-Kickback
and Stark laws. Additionally, NDS hired Lance Goudzwaard as Chief
Commercial Officer. A nationally recognized speaker, author and
thought leader in his field, Mr. Goudzwaard is one of
less than a thousand fellows in the American College of Medical
Practice Executives. Mr. Goudzwaard is responsible for
the delivery and operation of the management services organization
(MSO) platform with an aggressive growth strategy designed to
expand the model to 27 states in the next several months. Mr.
Goudzwaard will also focus on building and developing our durable
medical equipment (DME) service offering called
DME-IQÔ a
software system being introduced to the orthopedic market with
turnkey services to support the development and management of
compliant and profitable in-office DME
programs.
On January
17, 2017, Generex acquired an initial 51% interest in Hema
Diagnostic Systems, LLC (“Hema” or “HDS”), and on December 1, 2018,
we acquired the remaining equity of HDS, and HDS became a wholly
owned subsidiary, renamed NuGenerex Diagnostics (NGDx). The
NGDx EXPRESS diagnostic technology has been expanded with the new,
patent-pending EXPRESS II technology and a new product pipeline. We
filled our first international commercial
order for 40,000 units of its NGDx -Malaria PF/PV
Cassette Test Kit to Imres, BV, a Netherlands-based
medical distribution company, and was recently granted a
CE Mark Certification under the European Medical Devices
Directive (MDD) for its The Express II Syphilis Treponemal
Assay, a rapid point-of-care diagnostic assay for
the detection of syphilis antibodies in primary and secondary
syphilis.
This year, Generex renamed its wholly-owned subsidiary
Antigen Express as NuGenerex Immuno-Oncology (NGIO) and announced
plans to build a multi-platform cancer immunotherapy company.
Generex completed a research partnership agreement with Merck to
study the combination of AE37 in combination with Merck’s
checkpoint inhibitor, KetrudaÒ (pembrolizumab) for the
treatment of triple negative breast cancer; the trial is currently
screening patients for enrollment. Additionally, Antigen Express
signed a licensing agreement with Shenzhen Bioscien, a Chinese
biopharmaceutical company, to develop AE37 for the treatment of
prostate cancer. Under terms of the agreement, Shenzhen is to pay
for the commercial development of AE37, conducting clinical trials
in the EU under ICH guidelines. Shenzhen holds the exclusive
license for the use of AE37 for the treatment of prostate cancer in
China; Generex retains rights to the clinical data as well as
global market rights for AE37 in the prostate cancer market outside
of China.
On
February 25, 2019 Generex paid a dividend in our new
cancer company, whereby Generex shareholders received 1 share of
NGIO for every 4 shares of GNBT. Those
shares are now book-shared with Generex’s transfer agent, which is
holding them in GNBT shareholders accounts; the shares will have
value once we take NGIO public.
To advance
the NGIO strategy, we recently announced that Generex has signed a
Letter of Intent to acquire Kiromic, a clinical-stage
immuno-oncology company with multiple, patented proprietary
platforms, including CAR-T, CAR NK, an oral vaccine delivery
system, and DIAMOND AI, an artificial intelligence system with a
multifaceted predictive algorithm. Kiromic has used the DIAMOND AI
technology to identify and validate several cancer biomarkers,
including SP17, which was granted the last orphan indication for
ovarian cancer by FDA. In addition to advancing the ovarian cancer
program, NGIO plans to advance Kiromic’s proprietary CAR-T and CAR
NK technologies into proof of concept clinical
trials.
NGIO will
house both Kiromic and Antigen Express, Inc., which is
developing AE37 in combination with Merck’s Keytruda for the
treatment of triple negative breast cancer. Together, the broad
technology portfolio and deep pipeline opportunities provided in
the merger position NuGenerex Immuno-Oncology on the forefront of
cancer immunotherapy. Generex has identified a vehicle to
accomplish the public spin-out of NGIO, and will provide updates as
the Kiromic acquisition and spin-out plans are
finalized.
On November 30, 2018 Generex rewarded shareholders with a 20
to 1 share dividend to thank investors for allowing the new
management team the time to clean up and reorganize the capital
structure of Generex, and recently announced a new 1 to 1 share
dividend for GNBT shareholders to be paid the day after the planned
up-listing to Nasdaq.
Joe
Moscato, President & Chief Executive Officer of Generex said,
“Since taking over Generex, my management team and I have
implemented a three-stage plan to bring Generex back to a national
exchange. Stage 1 included the complete restructuring of Generex’s
capital structure with a 1:1000 reverse split of GNBT shares and
the elimination of derivative liabilities. With that accomplished,
we initiated Stage 2 of our reorganization in September 2018 when
GNBT shares were trading in the $1.60 to $1.80 range. With the
acquisition of an MSO and the foundation of NuGenerex Distribution
Solutions to manage our proprietary MSO distribution channel, we
paid the promised 20:1 share dividend as a reward to shareholders
for their loyalty is allowing the reorganization. On the dividend
pay date, GNBT shares traded at $18.99 per share. FINRA
auto-adjusted our share price on December 3, 2018 to $0.83 per
share, and since then, our share price is up an additional 300%.
Additionally, we have substantially increased shareholder equity
from negative $43.6 million to positive $10.5 million, which is
projected to increase further upon closing our target
acquisitions.”
Mr.
Moscato continued, “We are still executing on our Stage 2
acquisition strategy as we expand our MSO network and close the
previously announced acquisitions of Pantheon Medical and
MediSource Partners to provide orthopedic implants, surgical kits,
and biologics to our MSO physicians. Additionally, the synergies
among our NuGenerex family of subsidiary companies are being
demonstrated through a contract between Olaregen and NDS for
distribution of Excellagen through the MSO network. Plus, we are
building the last piece of our end-to-end solution by establishing
NuGenerex Chronic Care Solutions and NuGenerex Health
HMO/MSO.
We are now
prepared to execute on Stage 3 of the plan, which is focused on the
up-listing of GNBT on the Nasdaq stock exchange. To that end, we
have engaged Donohoe and Associates to help in the
Nasdaq listing process, and we expect to file the application
shortly, followed by our final 1:1 share dividend, an S-1 filing,
and equity financing to support the future growth of the
transformed Generex.
I’d like
to thank our noteholders for giving us the courtesy of extending
our payments, thereby enabling us to continue executing on
our plan, as detailed in our quarterly filings. I would also like
to give my sincere thanks to the 3 individual investors who joined
me in contributing 34.5 million shares into the Generex share pool
that I have previously described for the benefit of Generex. We
have utilized those pool shares to pay for cashless acquisitions
and payment of notes without impacting the Generex capital
structure, because those shares are already factored into the
market, making up part of the 60.3 million outstanding shares. I
have announced that 20.4 million of the remaining pool shares will
be retired to the Generex corporate treasury following the Nasdaq
listing and the payment of the 1:1 dividend, thereby minimizing
investor dilution, as outlined in prior a press
release.
Finally,
many thanks to our shareholders and investors for their support.
Our dedicated management team and I pledge to continue executing on
our plans to build revenue, profitability, and value for GNBT
shareholders, and I will present the result of our efforts at the
H.C. Wainwright conference in September in New York
city.”
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 immuno-oncology assets,
medical devices, and diagnostics, Generex 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.
Our newly
formed, wholly-owned subsidiary, NuGenerex Distribution Solutions
(NDS), integrates our MSO network with a pharmacy network, clinical
diagnostic lab, durable medical equipment company (DME-IQ) and
dedicated call center.
About Olaregen
Therapeutics
Olaregen
Therapeutix, Inc. is a regenerative medicine company focused on the
development, manufacturing and commercialization of products that
fill unmet needs in the current wound care market. Generex aims to
provide advanced healing solutions that substantially improve
medical outcomes while lowering the overall cost of
care. Olaregen's first product introduction,
Excellagen (flowable dermal matrix) is a topically applied
product for dermal wounds and other
indications. Excellagen is a FDA 510K cleared device
for a broad array of dermal wounds, including partial and full
thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers,
chronic vascular ulcers, tunneled/undermined wounds, surgical
wounds (donor sites/ grafts, post-Mohs surgery, post-laser surgery,
podiatric, wound dehiscence), trauma wounds (abrasions,
lacerations, second-degree burns and skin tears) and draining
wounds, enabling Olaregen to market Excellagen in multiple
vertical markets. Additionally, Excellagen can serve as an
Enabling Delivery Platform for pluripotent stem cells,
antimicrobial agents, small molecule drugs, DNA-Based Biologics,
conditioned cell media and peptides. Olaregen's initial focus will
be in advanced wound care including diabetic foot ulcers (DFU),
venous leg ulcers and pressure ulcers. Future products focusing on
innovative therapies in bone and joint regeneration comprise the
current pipeline. Generex's mission is to become a significant
force in regenerative medicine and advance the science of
healing.
About our Service-Disabled Veteran-Owned Small Business
(SDVOSB)
This a
Service-Disabled Veteran-Owned Small
Business (SDVOSB) that specializes in the sale, marketing, and
distribution of innovative medical products through a nationwide
network of veteran owned distribution
services.
About MediSource
Partners
MediSource
Partners is a 10-year-old private company, currently contracted
with over 25 vendors (including Pantheon Medical) for nationwide
distribution of implants and devices for spine, hips, knees, foot,
ankle, hand, and wrist surgeries. Additional product lines include
biologics (blood, bone, tissue, stem cells), durable medical
equipment, and soft goods. Generex also supplies kits to process
bone marrow aspirates and platelet rich plasma biologics at the
time of surgery.
About Pantheon
Medical
Pantheon
Medical is a manufacturer of a physician friendly, “all-in-one”,
integrated kit that includes plates, screws, and tools required for
orthopedic surgeons and podiatrists conducting foot and ankle
surgeries. Generex is developing and submitting
several new product lines to the FDA which will include cannulated
surgical screws, plates, and implants.
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
800-391-6755 Extension 222
investor@generex.com
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