Full Press Release Details
Completes Acquisition of Odyssey Health's Neurological Assets
Clinical-Stage Product Pipeline, Expands Intranasal Drug Delivery Technologies,
Michael Redmond as President of Oragenics
Fla.--(BUSINESS WIRE)-- 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.
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.
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.
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.
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,"
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.
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.
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.
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.
Mild Traumatic Brain Injury (mTBI)
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
Niemann-Pick Type C Disease
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.
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.
source version on businesswire.com: https://www.businesswire.com/news/home/20231227658588/en/
Janet Huffman, Chief Financial Officer