Generex to receive $10M in
common stock, a warrant, & $1M in
R&D funding
WORCESTER, Mass. and
TORONTO, April 23, 2015 /PRNewswire/ -- Generex
Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) today
announced that it has entered into a non-binding Letter of Intent
(LOI) to license the Generex proprietary RapidMist™ drug delivery
technologies to Smoofi, Inc. (www.smoofi.com) (OTCQB: SMFI) for the
delivery of medicinal and recreational cannabis derived products
into the bloodstream through the buccal membrane.
The Generex RapidMist™ drug delivery platform administers
medications directly into the mouth as a metered dose spray for
rapid absorption by the buccal mucosa. Generex's most advanced
product in development using RapidMist™ is Generex Oral-lyn™, an
insulin spray product for the treatment of diabetes mellitus.
SMFI is a provider of consulting and advisory services to
licensed medical and recreational marijuana operators and retail
dispensaries within the United
States. SMFI guides clients through the "seed to retail"
process, beginning with business planning, competitive strategy and
technology, regulatory compliance and local permitting, site
selection, setup and financing.
In exchange for the grant of the global license (excluding
Canada), SMFI will issue to
Generex (a) $10,000,000 worth of SMFI
common stock, and (b) a warrant to acquire up to 15,000,000 shares
of SMFI common stock. SMFI will be obliged to qualify the
common stock, including the common stock underlying the warrant,
for public distribution. The per share strike price of the
warrant will be determined based on the average closing price of
the SMFI common stock on the OTCQB for the 10 trading days
immediately preceding the effective date of the qualifying
registration statement. If that price is equal to or less
than $3.00, the strike price will be
$1.30. If that price is greater
than $3.00, the strike price will be
equal to 43.34% of that reference price.
SMFI will be solely responsible for the costs associated with
the research and development of buccal cannabis products.
SMFI will also be solely responsible for the regulatory endeavors
associated with such products in its territory as well as the
manufacturing, marketing, distribution, and sale of such products
in its territory. SMFI will pay to Generex a royalty equal to
20% of SMFI's net revenues from the sale of such products in its
territory.
The previously announced buccal cannabis co-development
arrangement between Generex and CannScience Innovations Inc. has
been revised. Under the revised arrangement, (a) Generex will
grant to CannScience a license for the commercialization of buccal
cannabis products in Canada in
exchange for royalty equal to 15% of Canadian net revenues from
product sales, (b) Generex and CannScience will undertake the
research and development of buccal cannabis products for SMFI and
CannScience, and (c) Generex will remit to CannScience 50% of any
royalty payments paid to Generex by SMFI. SMFI will provide
initial R&D funding of $1,000,000.
CannScience (www.cannsci.com) is an R&D biopharmaceutical
company established in Toronto,
Canada to conduct research and product development for
formulations and extracts related to medical cannabis and its
derivatives. CannScience is developing proprietary technologies and
owns know-how related to the chemistry and pharmacology of
cannabinoids and potentially how they integrate with various
medical devices and drug delivery technologies.
Generex, SMFI, and CannScience believe that absorption of
cannabis derived products through the buccal membrane offers
distinct advantages to alternative routes of administration –
principally, a faster onset of activity compared to oral
administration, higher level of control for dosing, and more
predictable absorption and pharmacodynamics.
The discussions between Generex, SMFI, and CannScience are at an
early stage, and the LOI does not assure that SMFI or CannScience
will enter into licenses with Generex or utilize the RapidMist™
technologies. Even if Generex, SMFI, and CannScience enter
into formal license arrangements, any benefit from those
arrangements will depend upon the abilities of Generex and
CannScience to develop products, and of SMFI and CannScience to
have such products approved by the appropriate regulators, and
successfully commercialize them.
About Generex Biotechnology Corporation
Generex is engaged in the research, development, and
commercialization of drug delivery systems and technologies.
Generex has developed a proprietary platform technology for the
delivery of drugs into the human body through the oral cavity (with
no deposit in the lungs). The Company's proprietary liquid
formulations allow drugs typically administered by injection to be
absorbed into the body by the lining of the inner mouth using the
Company's proprietary RapidMist™ device. Antigen Express, Inc. is a
wholly owned subsidiary of Generex. The core platform technologies
of Antigen Express comprise immunotherapeutic vaccines for the
treatment of malignant, infectious, allergic, and autoimmune
diseases. Antigen Express has pioneered the use of specific CD4+
T-helper stimulation technologies in immunotherapy. One focuses on
modification of peptides with Ii-Key to increase potency, while a
second relies on inhibition of expression of the Ii protein.
Antigen Express scientists, and others, have shown clearly that
suppression of expression of the Ii protein in cancer cells allows
for potent stimulation of T-helper cells and prevents the further
growth of cancer cells. For more information, visit the Generex
website at www.generex.com or the Antigen Express website at
www.antigenexpress.com.
About Smoofi, Inc.
Smoofi, Inc. is a provider of consulting and advisory services
to licensed medical and recreational marijuana operators and retail
dispensaries within the United
States. Smoofi guides clients through the "seed to retail"
process, beginning with business planning, competitive strategy and
technology, regulatory compliance and local permitting, site
selection, setup and financing. Smoofi will provide a wide variety
of industry education and training including business process
optimization and how to scale growth. The practice also includes
operational assistance with cannabis cultivation, offering
expertise in modern farming techniques, utilizing new technology
and conservation methods to improve quality and yield, waste
reduction and maximizing profit. For retail clients, the Smoofi
consulting practice assists with the design of retail locations,
staffing, loss prevention techniques, marketing and community
outreach. For more information please visit: www.smoofi.com.
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
cannot be sure when or if it will be permitted by regulatory
agencies to undertake additional clinical trials or to commence any
particular phase of clinical trials. Because of this, statements
regarding the expected timing of clinical trials or ultimate
regulatory approval cannot be regarded as actual predictions of
when Generex will obtain regulatory approval for any "phase" of
clinical trials or when it will obtain ultimate regulatory approval
by a particular regulatory agency. Generex claims the protection of
the safe harbor for forward-looking statements that is contained in
the Private Securities Litigation Reform Act.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/generex-announces-new-11-million-collaboration-on-buccal-cannabis-300070896.html
SOURCE Generex Biotechnology Corporation
