Adds Clinical-Stage Product Pipeline, Expands
Intranasal Drug Delivery Technologies,
Names Michael Redmond as President of
Oragenics
Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the
“Company”) announces it has completed its previously announced
acquisition of assets related to Odyssey Health, Inc.’s (OTCQB:
ODYY) (“Odyssey”) proprietary neurological drug therapies and
technologies.
The acquired assets include ONP-002 and a unique nasal delivery
device, Odyssey’s lead concussion asset, 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 in healthy human subjects
showing it is safe and well tolerated. Oragenics anticipates
preparing for Phase 2 clinical trials to further evaluate ONP-002’s
safety and efficacy.
Also included in the acquired assets are all of Odyssey’s rights
and interest in ONP-001, believed to be a first-in-class
neurosteroid being developed for the treatment of Niemann Pick
Type-C Disease (NPC), as well as Odyssey’s proprietary powder
formulation and its intranasal delivery device. Odyssey will retain
its other assets and operations.
“We are delighted to complete this pivotal transaction following
a favorable vote of shareholders at both companies. We expect that
Odyssey’s neurological pipeline will significantly expand our
market opportunity and believe its technology complements our
expertise in intranasal drug delivery. This acquisition also
addresses a significant and growing health concern. There are an
estimated 5 million concussions annually in the U.S., with up to
half going unreported, underscoring a substantial market
opportunity for an efficacious treatment,” said Kim Murphy, Chief
Executive Officer of Oragenics.
“Our decision to invest in this innovative therapy is driven by
our commitment to pioneering solutions that build upon our
expertise in intranasal drug delivery and our dedication to
improving patient outcomes. These new pipeline candidates hold
potential to deliver innovative treatments for millions affected by
mTBI and NPC, and introduce Oragenics into a market that is
projected to grow to $8.9 billion annually by 2027,” added Ms.
Murphy.
In conjunction with the transaction, Michael Redmond, who has
served as President and CEO of Odyssey since 2018, was named
President of Oragenics. Mr. Redmond has 35 years of commercial
experience with medical device companies, having held various sales
and marketing leadership positions that helped accelerate growth at
companies to multiples of their previous revenue and valuation. Mr.
Redmond also has significant experience in raising capital and
securing licensing and distribution deals with major biotech and
pharmaceutical companies. In his new position, Mr. Redmond will
oversee the growth of Oragenics’ neurology product pipeline and
intranasal drug delivery technologies.
Additionally, the Odyssey management and development team that
led the ONP-002 clinical trial design and implementation for the
treatment of concussion, will continue to oversee research and
development of the newly acquired neurology assets at Oragenics.
The team has experience in conducting clinical trials, developing
drug formulations and commercializing pharmaceutical products
across a broad range of indications.
“I’m proud to join the executive team at Oragenics and look
forward to continuing the development of ONP-002 and ultimately
utilizing my experience in commercializing therapeutics. We intend
to leverage our joint expertise and resources to expedite the
development of this drug, with the goal of filling a critical gap
in concussion care as we prepare for a Phase 2 clinical study in
the first half of 2024. We believe this transaction also
strengthens Oragenics’ research and development capabilities,
including the integration of key members of Odyssey’s research and
development team with the Oragenics team,” said Mr. Redmond.
About ONP-002
ONP-002 is a fully synthetic neurosteroid being developed to
treat mTBI. 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 cross the blood-brain
barrier to rapidly eliminate swelling, oxidative stress and
inflammation while restoring proper blood flow.
About Mild Traumatic Brain Injury (mTBI)
Concussions are an unmet medical need that affects millions
worldwide. Repetitive concussions can increase the risk of
developing chronic traumatic encephalopathy and other
neuropsychiatric disorders. It is estimated that 5 million
concussions occur in the U.S. annually and that up to 50% go
unreported. The worldwide incidence is estimated at 69 million per
year. 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 Niemann-Pick Type C Disease
Niemann-Pick Type C 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 tissues including brain tissue.
The market for NPC therapeutics is expected to grow from $128
million in 2022 to $188 million in 2031 across the U.S., Germany
and UKi.
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, without
limitation, statements regarding the ability of the Company to
timely and successfully achieve the anticipated benefits of
acquiring the Odyssey assets and the Company’s 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: the Company’s
ability to advance the development of its product candidates under
the timelines and in accord with the milestones it projects; the
Company’s ability to obtain funding, non-dilutive or otherwise, for
the development of its product candidates, whether through its own
cash on hand, or another alternative source; the regulatory
application process, research and development stages, and future
clinical data and analysis, decisions by regulatory authorities,
such as the FDA and investigational review boards, whether
favorable or unfavorable; the potential application of our research
and development candidates; the Company’s ability to obtain,
maintain and enforce necessary patent and other intellectual
property protection; the nature of competition and development
relating to concussion treatments, treatments for NPC and COVID-19
immunization and therapeutic treatments and demand for vaccines and
antibiotics; the Company’s expectations as to the outcome of
preclinical studies, nasal administration, transmission,
manufacturing, storage and distribution; other potential adverse
impacts due to the global COVID-19 pandemic, such as delays in
regulatory review, interruptions to manufacturers and supply
chains, adverse impacts on healthcare systems and disruption of the
global economy; 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 communication is as of the date hereof. You should
consider these factors in evaluating the forward-looking statements
included in this communication 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.
i Source: GlobalData
https://www.globaldata.com/store/report/niemann-pick-type-c-market-analysis/
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version on businesswire.com: https://www.businesswire.com/news/home/20231227658588/en/
Oragenics, Inc. Janet Huffman, Chief Financial Officer
813-286-7900 jhuffman@oragenics.com
LHA Investor Relations Tirth T. Patel 212-201-6614
tpatel@lhai.com
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