NYSE American: OGEN
ONP-002, a groundbreaking fully synthetic neurosteroid, is at the forefront of mTBI (concussion) treatment innovation. Its preclinical trials have revealed remarkable neuroprotective capabilities, surpassing even its natural neurosteroid counterparts. In animal studies, ONP-002 exhibited the potential to alleviate the distressing behavioral manifestations of brain injuries, including memory impairment, anxiety, and motor/sensory function impairment. Furthermore, this remarkable compound's lipophilic nature enables it to seamlessly traverse the blood-brain barrier, swiftly addressing concerns like swelling, oxidative stress, and inflammation while restoring healthy blood flow. It's a game-changer in the world of neurological medicine.
Concussions, a global healthcare gap, affect millions, often leading to Chronic Traumatic Encephalopathy (CTE) and other neuropsychiatric issues. In the U.S., 5 million cases go largely unreported, while 69 million occur worldwide. The market for concussion treatment was $6.9 billion in 2020, with a projected growth to $8.9 billion by 2027.
ONP-002, a synthetic neurosteroid for mTBI treatment, demonstrates superior neuroprotection in preclinical studies, rivaling related compounds. Animal models confirm its efficacy in alleviating memory problems, anxiety, and motor/sensory impairments. Its lipophilic nature enables efficient blood-brain barrier penetration, addressing swelling, oxidative stress, and inflammation.
Niemann-Pick Type C (NPC) disease is a rare genetic neurodegenerative disorder. It hinders cells from metabolizing and transporting cholesterol and lipids, causing their abnormal buildup in various body tissues, including the brain. The NPC market is anticipated to expand from $128 million in 2022 to $188 million by 2031, spanning the U.S., Germany, and the U.K.
Oragenics, Inc. (NYSE American: OGEN) is poised for success under the seasoned leadership of CEO Kim Murphy, a veteran in the vaccine industry with a track record of successful commercial launches
The company's groundbreaking intranasal COVID-19 vaccine, NT-CoV2-1, offers a needle-free, patient-friendly administration and has the potential to reduce virus transmission at the source of infection. With a small competitive landscape, this innovative platform allows for rapid production of cell lines to address emerging variants.
Oragenics presents a compelling investment opportunity in a multibillion-dollar market, addressing an unmet need for intranasal vaccine delivery and transmission reduction. With a combination of technologies and strong immunogenicity, Oragenics is at the forefront of the future of vaccines.
Strategic Partnership: Oragenics, Inc. (NYSE American: OGEN) and Odyssey Health, Inc. (OTCQB: ODYY) have entered a definitive agreement. Oragenics is set to acquire Odyssey's assets related to cutting-edge neurological drug therapies and technologies, including ONP-002, a promising treatment for mTBI (concussion) and Niemann-Pick Type C Disease.
Market Potential: This collaboration harnesses the immense potential in the field of neurological therapeutics. With mTBI affecting millions and no FDA-approved treatment, the partnership aims to address this pressing health challenge. Additionally, the growing NPC market offers opportunities for innovative solutions, aligning with Oragenics and Odyssey's mission to enhance lives through meaningful medical solutions.
We are thrilled to present to you an exciting investment opportunity that demands your attention: NT-CoV2-1, a groundbreaking intranasal COVID-19 vaccine.
Innovative Vaccine: NT-CoV2-1 is not just another COVID vaccine. It stands out as a non-viral platform with an adjuvant, allowing for rapid production to address emerging variants.
Large Market Opportunity: The potential market for this intranasal vaccine is enormous, with a multibillion-dollar valuation. It addresses the unmet need for intranasal vaccine delivery, potentially reducing virus transmission.
Intranasal Advantage: This vaccine's intranasal administration is patient-friendly and has the potential to reduce virus transmission at the source of infection. It's a protein subunit-based intranasal vaccine, with a competitive edge in a small intranasal landscape.
Collaboration: The collaboration with the National Research Council of Canada adds credibility to this venture.
Reduced Viral Loads: The intranasal formulation led to undetectable viral loads, suggesting it may reduce transmission more effectively than current mRNA vaccines.
Patient-Friendly: Intranasal vaccines offer a needle-free option, addressing the concerns of those with strong needle fears, which could potentially reduce vaccine hesitancy.
The opportunistic business model includes capital markets, business development, and clinical development pathways. It emphasizes execution, building visibility and credibility, and securing capitalization for future development milestones.
NT-CoV2-1 is not just a vaccine; it's a game-changer. With a strong leadership team, impressive efficacy, and a significant market opportunity, this investment opportunity is one you should have on your radar. We encourage you to explore this exciting venture further and consider adding it to your investment portfolio.
Promising Concussion Drug: ONP-002 Oragenics acquires Odyssey Health's innovative ONP-002 for concussions—potential breakthrough in treating this common yet unmet medical need.
Oragenics, Inc. is a pioneering venture committed to the battle against infectious diseases, with a particular focus on combating coronaviruses and multi-drug resistant pathogens. Our flagship innovation is an intranasal vaccine prospect designed to provide enduring protection against SARS-CoV-2 and its ever-evolving variants, the culprits behind the COVID-19 pandemic. The NT-CoV-2 initiative harnesses cutting-edge coronavirus spike protein research, which we've obtained through licensing agreements with renowned institutions such as the National Institutes of Health (NIH) and the National Research Council of Canada (NRC). Our primary aim is to not only curtail viral transmission but also enhance patient convenience with an easily administered intranasal solution. Furthermore, our lantibiotics program introduces a groundbreaking class of antibiotics tailored to combat bacteria that have developed insurmountable resistance to conventional antibiotic treatments.
Our mission revolves around the development of vaccines and groundbreaking antibiotics, aimed at averting and addressing the infectious challenges of both the present and the future.
Oragenics, Inc. is dedicated to addressing the growing concern of antibiotic-resistant infections. According to the CDC, the United States witnesses over 2.8 million antibiotic-resistant infections annually, resulting in more than 35,000 deaths. Oragenics recognizes the pressing need to combat this issue, given that the national cost of treating infections exceeds $4.6 billion each year, with overuse and misuse of antibiotics exacerbating the problem.
Oragenics focuses on lantibiotics, a novel class of antibiotics with a unique mechanism of action engineered to limit the development of antibiotic resistance. Their lantibiotics, originating from Gram-positive bacterial species, effectively target bacteria responsible for healthcare-acquired infections, sequestering their molecular target, Lipid II. This approach addresses bacterial strains inherently resistant to conventional treatments.
The company has made significant strides in large-scale lantibiotic production, overcoming previous limitations. Their research includes Mutacin 1140 (MU1140), a groundbreaking lantibiotic, and over 700 analogs engineered, manufactured, and tested for safety, toxicity, stability, manufacturability, and drug activity. Animal studies have confirmed their efficacy against significant human pathogens.
Oragenics collaborates with Florida International University, exploring novel compounds and mechanisms of action. Their research extends to ESKAPE pathogens, a group of antibiotic-resistant pathogens, with the potential to provide innovative solutions to the ongoing challenge of antimicrobial resistance. Oragenics' work represents a promising avenue in the fight against infectious diseases and antibiotic resistance.
Oragenics, Inc. is at the forefront of addressing the global challenge posed by COVID-19 and its variants. The COVID-19 pandemic, caused by the SARS-CoV-2 virus, has created a pressing need for effective vaccines. Oragenics' lead product, NT-CoV-2, represents a novel and promising approach to combatting the disease and its evolving strains.
NT-CoV-2 is designed to induce mucosal immunity, a crucial aspect often lacking in conventional injectable vaccines. Intranasal administration of NT-CoV-2 offers a needle-free alternative, enhancing ease of use, particularly for children and those with a fear of needles. This approach also reduces the logistical complexities associated with stringent storage and transport requirements of traditional mRNA-based vaccines, making it more accessible in remote or underserved areas.
The durability of NT-CoV-2 is a notable advantage, potentially providing longer-lasting immunity compared to existing mRNA vaccines. Its hybrid NIH/NRC construct allows for quicker development of spike proteins, offering a more rapid response to emerging COVID-19 variants.
Oragenics' proof-of-concept research has shown robust immune responses and significant reduction in viral loads in preclinical models, highlighting the vaccine candidate's effectiveness. Collaborations with organizations like Inspirevax, the National Research Council of Canada, and the National Institutes of Health have enriched the research and development process.
Oragenics is well-positioned to make a significant impact in the fight against COVID-19 and its variants, offering innovative solutions that encompass mucosal immunity, ease of administration, improved durability, and rapid response to emerging threats.
Oragenics is pioneering a next-generation COVID-19 vaccine, NT-CoV2-1, with a focus on mucosal immunity. Administered intranasally, this vaccine generates an immune response at the respiratory mucosa, producing immunoglobulin A and resident memory B and T cells that provide effective protection at the site of viral entry. This approach enhances early immune response even against viral variants. The company has harnessed the expertise of the U.S. National Institutes of Health (NIH) to obtain a DNA sequence license for making a stabilized spike protein, a critical component of their vaccine candidate. Additionally, they've partnered with the Canadian National Research Council (NRC) to use CHO-based protein technology, enabling the rapid development of cell lines for recombinant spike protein antigens. Collaborating with Inspirevax, they are exploring intranasal adjuvant BDX301 to enhance the vaccine's efficacy. Oragenics also delves into lantibiotics, a unique class of antibiotics with a novel mechanism of action, aimed at combating antibiotic-resistant infections. Their innovative methods address key limitations in large-scale production of these compounds.
Oragenics, Inc. (NYSE American: OGEN) and Odyssey Health, Inc. have officially entered into a definitive agreement, which details the acquisition of Odyssey's assets related to neurological drug therapies and technologies by Oragenics. These assets encompass drug candidates designed to treat mild traumatic brain injury (mTBI) or concussions, as well as Niemann-Pick Disease Type C (NPC). Additionally, Oragenics will acquire Odyssey's proprietary powder formulation and nasal delivery device.
The transaction involves an exchange of assets, with Oragenics making cash payments totaling $1.0 million to Odyssey and offering eight million shares of Oragenics' Series F Convertible Preferred Stock. The agreement is set to close in the fourth quarter of 2023, contingent on various closing conditions, including approval from Odyssey's shareholders and Oragenics' shareholders for the conversion of Series F Preferred Stock.
Following the transaction, key members of Odyssey's management are anticipated to join Oragenics to lead the continued development of Odyssey's pipeline of neurological drug therapies and technologies. Odyssey's assets are expected to enable easy nasal administration, rapid drug uptake to the brain, and enhanced patient safety, thus potentially improving patient outcomes.
Odyssey's lead asset, ONP-002, is a first-in-class intranasal drug aimed at treating moderate-to-severe concussion in the acute through subacute phases. It has demonstrated promise in preclinical studies by reducing swelling, inflammation, oxidative stress, and enhancing safety. In a Phase 1 clinical trial, ONP-002 exhibited safety and tolerability in healthy human subjects. Phase 2 clinical trials to assess its safety and efficacy are in the planning stages.
Concussions are a global health concern, affecting millions annually, and currently lack FDA-approved treatments. ONP-002 shows potential in addressing this unmet medical need. Additionally, Oragenics' acquisition provides them an entry into the NPC market, a rare genetic disorder.
This strategic move offers Oragenics an opportunity to expand its scope into neurological therapeutics and address pressing health challenges, benefiting countless individuals.
Oragenics, Inc. is set to acquire Odyssey Health's pioneering neurological drug technologies, including a groundbreaking concussion drug candidate, ONP-002. This strategic move aims to address a pressing medical need, as concussions have become increasingly prevalent across sports, military, and the elderly, affecting over five million Americans each year, yet lacking FDA-approved treatments. ONP-002, administered intranasally, has demonstrated remarkable potential in preclinical studies, rapidly distributing throughout the brain, reducing inflammation and oxidative stress, and exhibiting excellent safety in animal models. Human trials have confirmed its safety and tolerability in Phase 1.
Upon completion of the transaction, Oragenics plans to further develop Odyssey's neurological assets, with certain members of Odyssey management joining to lead the effort. The collaboration aims to advance the treatment of concussions and expand the company's reach in the neurological therapeutics market.
Concussions pose serious health risks, including the development of Chronic Traumatic Encephalopathy (CTE) and neuropsychiatric disorders. The global market for concussion treatment is substantial, forecasted to reach $8.9 billion by 2027. ONP-002's innovative approach holds promise in providing a much-needed solution to improve the lives of individuals affected by concussions, addressing a significant medical challenge.
| Organization | Organization Type | Vaccine Type | Stage | Comments |
|---|---|---|---|---|
| Astra Zeneca | Global pharma | Live chimpanzee adenovirus vector | Phase 1 | Known AEs (blood clots) may hinder approval & acceptance in US/EU |
| Codagenix | US private biotech | Live attenuated SARS-CoV-2 virus | Phase 1 | Hard to establish safety of live, attenuated SARS-CoV-2 vaccine |
| Meissa Vaccines | US private biotech | Live respiratory syncytial virus vector | Phase 1 | Need to establish safety of new viral vector |
| CyanVac | US private biotech | Live parainfluenza-5 virus vector | Phase 1 | Need to establish safety of new viral vector |
| CastleVax | US private biotech | Live Newcastle disease viral vector | Phase 1 | Need to establish safety of new viral vector |
| ACM Biolabs | Singapore & Swiss private biotech | Protein subunit + polymer vesicles | Phase 1 | Non-viral vaccine candidate |
| Oragenics | US public biotech | Protein subunit + BDX-301 adjuvant | Late preclinical | Non-viral vaccine candidate |
| Xanadu Bio | US public biotech | Protein subunit + polymer vesicles | Late preclinical | Non-viral vaccine candidate |
| Intravacc | Netherlands private CDMO | Protein subunit + OMV adjuvant | Late preclinical | Non-viral vaccine candidate |
In partnership with Odyssey Health, Inc. (OTCQB: ODYY), Oragenics expands its portfolio to encompass neurological drug therapies and technologies. This strategic move positions Oragenics at the forefront of healthcare innovation, making it an attractive prospect for healthcare investors.
Oragenics, Inc. (NYSE American: OGEN) emerges as a compelling investment opportunity with its forward-thinking leadership under CEO Kim Murphy, a distinguished figure in the vaccine industry. Backed by her experience in successful vaccine launches at top pharmaceutical companies, Oragenics is set to make waves in the market.
The company's standout offering is its innovative intranasal COVID-19 vaccine, NT-CoV2-1. This game-changer promises a needle-free, patient-friendly approach that could potentially reduce virus transmission at the mucosal nasopharyngeal surfaces. With a small competitive landscape, this vaccine platform stands out, providing the agility to address emerging variants with rapid cell line production in just 6-8 weeks.
Investors will find Oragenics well-positioned to tap into a multibillion-dollar market opportunity, addressing the unmet need for intranasal vaccine delivery and transmission reduction. The combination of cutting-edge technologies and remarkable immunogenicity places Oragenics at the forefront of the future of vaccines, making it an appealing prospect for those seeking to invest in the healthcare sector.
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