Odyssey Health Closes Asset Sale of its Neurological Drug Technology Pipeline Including Concussion Drug Candidate with Oragenics, Inc.

January 02, 2024 at 03:30 AM EST

LAS VEGAS, NV / ACCESSWIRE / January 2, 2024 / Odyssey Health, Inc. (OTCQB:ODYY) ("Odyssey" or the "Company") today announces the closing of the definitive Asset Purchase Agreement, that was entered into on October 4, 2023, with Oragenics, Inc., (OGEN:NYSE American) under which Oragenics acquired Odyssey's proprietary assets related to its neurological drug therapy platform under dvelopment. 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 retains its other assets and operations.

The Company received cash in two installments: $500,000 upon the execution of the Asset Purchase Agreement on October 4, 2023 and $500,000 on December 11, 2023, after Odyssey obtained its stockholders' approval for the asset sale at its special stockholder meeting held on December 7, 2023. At the Closing on December 28, 2023, Oragenics issued eight million (8,000,000) shares of Oragenics' Series F Preferred Stock to Odyssey. On the day of the closing Oragenics' common stock last traded at $5.37 valuing the preferred stock at approximately $43 million dollars..

Certain members of Odyssey management joined Oragenics to lead the continued development of the 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.

The lead drug candidate, ONP-002 has the potential to be a first-in-class intranasal drug to treat moderate-to-severe concussion in the acute through subacute phases. In preclinical animal studies, the drug showed 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 1human clinical trial showing it is safe and well tolerated in healthy human subjects. 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 the novel drug platform," said Michael Redmond, President and Chief Executive Officer of Odyssey. "Our lead drug candidate for treating concussion has performed well in preclinical studies, generating promising 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 affects 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 in hopes of 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.

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 timing and future distribution of the Oragenics shares to Odyssey stockholders; the ability of the Oragenics to timely and successfully achieve the anticipated benefits of acquiring the Odyssey assets; Oragenic'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, 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.

Contacts

Odyssey Health, Inc.
info@odysseyhealthinc.com

SOURCE: Odyssey Health, Inc.

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Odyssey Health Closes Asset Sale of its Neurological Drug Technology Pipeline Including Concussion Drug Candidate with Oragenics, Inc.

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