July 15, 2019 -- InvestorsHub NewsWire -- BioResearch Alert's Blog
- Generex A37 Immunotherapy Vaccine demonstrates high efficacy
with low adverse side effects against many common cancers and
diseases.
- Combination Phase II
trial with MRK Keytruda and GNBT A37 for Breast Cancer
enrolling 2019.
- Upfront license payments for AE37 by Shenzhen BioScien
Pharmaceuticals for Prostate Cancer in China, Taiwan, Hong Kong and
Macau.
- Proprietary buccal oral insulin delivery for $27 billion insulin
market.
- Aggressive acquisition strategy of diagnostics, therapeutics,
orthopedic surgical implants and patient care in play with recent
closes and signed LOI’s.
- Plans to launch million bottles of CBD water and health
products beginning 2019.
- Share price is low but in strong uptrend with near-term Nasdaq
up-listing in sight.
Summary
Shares of Generex Biotechnology Corporation (OTC: GNBT)
have been rising and continue in a strong uptrend for several
reasons. Unlike many biotech companies that are developing just one
technology and have only one drug or very few drugs in their
pipeline, Generex is successfully executing an aggressive
acquisition strategy to own a broad spectrum of diagnostic
products, therapeutic products, orthopedic implants, surgical kits,
biologic products, and care delivery solutions through their
MSO.
Joseph Moscoto, CEO, has thoroughly restructured Generex
Biotechnology and has assembled an experienced and effective
management team that has successfully architected several
acquisitions that have either been closed, or that are under LOI.
Each individual acquisition has the potential to generate
blockbuster revenues, and each new company is either already in
commercial stages or is developing attractive solutions for the
$400 billion biotechnology market and the $4 trillion healthcare
market.
Biotech companies are known for wild share price swings on drug
development news and can see their shares either rocket on good
news or crash on bad news. Biotech valuations tend to be
substantially higher than most industries because the leverage of
one single drug can create several billions of dollars in new
wealth. A37 is a broad-spectrum, Immunotherapy drug of great
interest because it has the potential to deliver therapeutic
solutions for so many cancers and disease conditions. If
successful, its value can be enormous. The demonstrated efficacy
against breast cancer and the belief it works against a host of
cancers and illnesses with minimal adverse side effects has
motivated the drug giant, Merck to enter into a clinical trial with
Generex. MRK is conducting a Combination Trial for breast cancer
with Generex A37 and their giant blockbuster PD1 Checkpoint
Inhibitor Keytruda. As A37 moves forward with MRK, dramatically
higher share prices appear to be in Generex future if positive
outcomes are published. Generex current market cap of well under
$200 million is very small by industry standards and subject to
very large overnight revaluations on expected news runway.
Additionally, Generex has the potential to deliver large and
fast-growing revenues from the several products and services
currently offered and about to be offered. Further increases in
Generex share valuations are likely and expected as the company
begins enrollment for their combination trial and as the company
gets closer to reporting revenues from several profit centers.
Generex Biotechnology Provides Fiscal Year
Overview
The following press release, “Generex
Biotechnology Provides Fiscal Year Overview”, published July 10,
2019 best explains why shares are quickly becoming the new
Cinderella of Biotech:
- 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
- Excellagen® 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
MIRAMAR, Fla., July 10, 2019 -- Generex Biotechnology
Corporation (www.generex.com) (GNBT) 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
(OTCPK: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 ECMH™ 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, Excellagen®, 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 Excellagen® 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-IQ™, 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 Kitto 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, Ketruda® (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 TherapeuticsOlaregen
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 PartnersMediSource 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 MedicalPantheon 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.
Conclusion
Generex Biotechnology appears strongly positioned to enjoy
substantially higher price multiples of today’s $2.83 per share.
GNBT share price has been continually rising as the company is
positioning for several major achievements in 2019 and beyond.
There are risks associated with all drug development, but
navigating any drug through the challenging FDA approval, can
create remarkably high valuations and share prices. Generex offers
the additional advantage of diversification of potentially large
revenues from several different profit centers other than drug
development. Generex Biotechnology is showing early signs of being
the new rising star of biotech and warrants a close look and early
positioning.
Legal Disclaimer:
Except for the historical information presented herein, matters
discussed in this release contain forward-looking statements that
are subject to certain risks and uncertainties that could cause
actual results to differ materially from any future results,
performance or achievements expressed or implied by such
statements. Emerging MicroCaps or BioResearchAlert or its
principals may have been compensated for its services in the form
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forward-looking statements, i.e. statements or discussions that
constitute predictions, expectations, beliefs, plans, estimates, or
projections as indicated by such words as ''expects,'' ''will,''
''anticipates,'' and ''estimates''; therefore, you should proceed
with extreme caution in relying upon such statements and conduct a
full investigation of the Information and the Profiled Issuer as
well as any such forward-looking statements.
Disclosure: I/we have no positions in any
stocks mentioned, and no plans to initiate any positions within the
next 72 hours.
Source: BioResearch Alert's Blog
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