Gains Nasal Delivery Technologies and
Expands Product Pipeline
Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the
“Company”) and Odyssey Health, Inc. (OTCQB: ODYY) (“Odyssey”)
announce the signing of a definitive agreement under which
Oragenics will acquire Odyssey’s assets related to its proprietary
neurological drug therapies and technologies. The assets include
drug candidates for treating mild traumatic brain injury (mTBI),
also known as concussion, and for treating Niemann Pick Disease
Type C (NPC), as well as Odyssey’s proprietary powder formulation
and its nasal delivery device. Odyssey will retain its other assets
and operations.
The asset purchase includes cash payments to Odyssey totaling
$1.0 million and eight (8) million shares of Oragenics’ Series F
Convertible Preferred Stock. The transaction is expected to close
in the fourth quarter of 2023, subject to the satisfaction of
various closing conditions, including approval of the transaction
by Odyssey’s shareholders and approval of the conversion of the
Series F Preferred Stock by Oragenics’ shareholders, of which there
can be no assurances.
After closing this transaction, certain members of Odyssey
management intend to join Oragenics and lead the continued
development of Odyssey’s pipeline of neurological drug therapies
and technologies. Odyssey’s technologies are expected to allow for
easy nasal administration, rapid drug uptake to the brain, no
cumbersome cold-chain protocols, and a strong safety profile, which
hold potential to improve patient outcomes.
“We believe this strategic transaction could place Oragenics in
a prime position to harness our expertise in intranasal
administration, propelling us forward in neurological therapeutics.
Our rigorous analysis of the underlying science and technologies
has illuminated the immense potential of Odyssey’s neurological
assets, which could significantly expand our potential reach into a
broader market. Concussions have reached epidemic proportions
across sports, the military and among the elderly, with more than
five million Americans affected annually. Shockingly, there remains
no FDA-approved treatment for this condition,” said Kim Murphy,
President and Chief Executive Officer of Oragenics. “We are excited
by the prospect of addressing some of the world’s most pressing
health challenges and evolving our company to enhance the lives of
countless individuals.”
Odyssey’s lead concussion asset (ONP-002) is believed to be a
first-in-class intranasal drug under development for the treatment
of moderate-to-severe concussion in the acute through subacute
phases. In preclinical animal studies, the asset demonstrated rapid
and broad biodistribution throughout the brain while simultaneously
reducing swelling, inflammation, and oxidative stress along with an
excellent safety profile. Results from animals treated with the
drug post-concussion showed positive behavioral outcomes using
various testing platforms including improved memory and
sensory-motor performance, and reduced anxiety. ONP-002 has
completed a Phase 1 clinical trial showing it is safe and well
tolerated in healthy human subjects. Odyssey and Oragenics are now
preparing for Phase 2 clinical trials to further evaluate ONP-002’s
safety and efficacy.
“I look forward to working with Oragenics on further developing
our assets,” said Michael Redmond, President and Chief Executive
Officer of Odyssey Health. “Our lead drug candidate for treating
concussion has performed well in preclinical studies, generating
promising efficacy and safety data in animal models. In addition,
ONP-002 has completed a Phase 1 clinical study that concluded the
drug is safe and well tolerated in humans. A pre-IND package has
been submitted to the FDA for a Phase 2 trial and the collaboration
with Oragenics allows for the advancement of these important
neurological drug candidates.”
About Mild Traumatic Brain Injury (mTBI)
Concussions are an unmet medical need that affect millions
worldwide. Repetitive concussions can increase the risk of
developing Chronic Traumatic Encephalopathy (CTE) and other
neuropsychiatric disorders. It is estimated that 5 million
concussions occur in the U.S. annually and that as many as 50% go
unreported. The worldwide incidence of concussion is estimated at
69 million. The global market for concussion treatment was valued
at $6.9 billion in 2020 and is forecast to reach $8.9 billion by
2027, according to Grandview Research. Common settings for
concussion include contact sports, military training and
operations, motor vehicle accidents, children at play and elderly
assistive-living facilities due to falls.
About ONP-002
ONP-002 is a fully synthetic, non-naturally occurring
neurosteroid being developed to treat mTBI (concussion). In
preclinical studies, the drug demonstrated equivalent or better
neuroprotective effects compared with related neurosteroids. Animal
models of concussion showed the drug reduces the behavioral
pathology associated with brain injury symptoms such as memory
impairment, anxiety and motor/sensory performance. Additionally,
ONP-002 is lipophilic and can easily cross the blood-brain barrier
to rapidly eliminate swelling, oxidative stress and inflammation
while restoring proper blood flow.
About Niemann-Pick Type C Disease
Niemann-Pick Type C (NPC) disease is a rare neurodegenerative
genetic disorder characterized by the inability of cells to
metabolize and properly transport cholesterol and other lipids,
leading to the abnormal accumulation in various bodily tissues,
including brain tissue. The NPC market is expected to grow from
$128 million in 2022 to $188 million in 2031 across the U.S.,
Germany and U.K.
About Odyssey Health Inc.
Odyssey Health Inc., formerly Odyssey Group International, Inc.,
is a medical company with a focus on life-enhancing medical
solutions. Odyssey's corporate mission is to create, acquire and
develop distinct assets, intellectual property and exceptional
technologies that provide meaningful medical solutions. The company
is focused on areas that have an identified technological
advantage, provide superior clinical utility and have a substantial
market opportunity. For more information, please visit
www.odysseyhealthinc.com.
Visit Odyssey' corporate social media accounts for updates:
https://twitter.com/OdysseyHealth1
https://www.facebook.com/odysseyhealthinc
https://www.linkedin.com/company/odysseyhealthinc
https://www.youtube.com/channel/UCsS--v0od_fYIBu2tvqmj9Q
About Oragenics
Oragenics, Inc. is a development-stage company focused on nasal
delivery of pharmaceutical medications including in neurology and
fighting infectious diseases including coronaviruses and
multidrug-resistant organisms. Its lead product is NT-CoV2-1, an
intranasal vaccine candidate to prevent COVID-19 and variants of
the SARS-CoV-2 virus. The NT-CoV2-1 program leverages coronavirus
spike protein research licensed from the National Institutes of
Health (NIH) and the National Research Council of Canada (NRC) with
a focus on reducing viral transmission and offering a more
patient-friendly intranasal administration. Its lantibiotics
program features a novel class of antibiotics against bacteria that
have developed resistance to commercial antibiotics. For more
information, please visit www.oragenics.com.
Not a Solicitation
This communication does not constitute an offer to sell or the
solicitation of an offer to buy the securities of either Oragenics
or Odyssey or the solicitation of any vote or approval. This
communication relates to the proposed acquisition of certain assets
from Odyssey by Oragenics.
Forward-Looking Statements
This communication contains “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995, including, but not
limited to, statements regarding: the ability of Odyssey and
Oragenics to successfully close their asset purchase agreement; the
ability of the Oragenics to timely and successfully achieve the
anticipated benefits of acquiring the Odyssey assets; Oragenics’
future performance, business prospects, events and product
development plans. These forward-looking statements are based on
management’s beliefs and assumptions and information currently
available. The words “believe,” “expect,” “anticipate,” “intend,”
“estimate,” “project” and similar expressions that do not relate
solely to historical matters identify forward-looking statements.
Investors should be cautious in relying on forward-looking
statements because they are subject to a variety of risks,
uncertainties, and other factors that could cause actual results to
differ materially from those expressed in any such forward-looking
statements. These factors include, but are not limited to, the
following: Oragenics’ ability increase its authorized shares of
Common Stock; Oragenics’ ability to obtain a quorum at future
shareholders meetings; Oragenics’ ability to obtain its
shareholders’ approval for the (a) the increase in Oragenics’
authorized Common Stock from 4,166,666 to 350,000,000 and (b) the
conversion of the Series F Preferred Stock into Common Stock;
whether or not all of the closing conditions to the Odyssey
transaction will be satisfied and otherwise whether Oragenics will
be able to successfully close the Odyssey transaction; Oragenics’
ability to obtain necessary funding, non-dilutive or otherwise, for
the development of its product candidates, including its vaccine
and lantibiotic assets and, if the Odyssey transaction successfully
closes, the concussion asset; Oragenics’ ability to advance the
development of its vaccine candidate and lantibiotics candidate
(and, if the Odyssey transaction successfully closes, the
concussion asset) under the timelines and in accord with the
milestones it projects; the regulatory application process,
research and development stages, and future clinical data and
analysis relating to vaccines and lantibiotics, including any
meetings, decisions by regulatory authorities, such as the FDA and
Canadian regulatory authorities and investigational review boards,
whether favorable or unfavorable; the potential application of
Oragenics’ vaccine candidate to variants and other coronaviruses;
Oragenics’ ability to obtain, maintain and enforce necessary patent
and other intellectual property protection and license agreements;
the nature of competition and development relating to COVID-19
immunization and therapeutic treatments and demand for vaccines and
antibiotics; Oragenics’ and/or Odyssey’s expectations as to the
outcome of preclinical studies, nasal administration, transmission,
manufacturing, storage and distribution; other potential adverse
impacts such as delays in regulatory review, manufacturing delays
and supply chain issues, adverse impacts on healthcare systems and
disruption of the global economy; the ability to sustain compliance
with Oragenics’ exchange listing requirements; and general economic
and market conditions and risks, as well as other uncertainties
described in our filings with the U.S. Securities and Exchange
Commission. All information set forth in this press release is as
of the date hereof. You should consider these factors in evaluating
the forward-looking statements included in this press release and
not place undue reliance on such statements. We do not assume any
obligation to publicly provide revisions or updates to any
forward-looking statements, whether as a result of new information,
future developments or otherwise, should circumstances change,
except as otherwise required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20231004015689/en/
Oragenics, Inc. Janet Huffman, Chief Financial Officer
813-286-7900 jhuffman@oragenics.com
Odyssey Health, Inc. info@odysseyhealthinc.com
LHA Investor Relations Tirth T. Patel 212-201-6614
tpatel@lhai.com
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