Oragenics Partners with Duck Flats Pharma to Advance New Drug Development
Oragenics announced it has engaged Duck Flats Pharma as its U.S. Investigational New Drug, IND, readiness and regulatory execution partner to support FDA-facing preparation and clinical trial design as the Company advances its novel intranasal concussion therapy toward U.S.-based development. The engagement is intended to align the Company's upcoming Phase 2a clinical trial in Australia with its U.S regulatory strategy. "We highly value our collaboration with DUCK FLATS Pharma as we advance our IND strategy for ONP-002 and prepare for future U.S. clinical development," said Janet Huffman, Chief Executive Officer of Oragenics.
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Oragenics Partners with DUCK FLATS Pharma to Advance Novel Concussion Therapy
- Collaboration Enhances Regulatory Readiness: Oragenics partners with DUCK FLATS Pharma to support FDA application and clinical trial design for its novel intranasal concussion therapy, aiming to reduce risks and ensure trial integrity in the U.S. development pathway.
- Significant Market Potential: The global concussion market is projected to exceed $9 billion by 2027, and if approved, ONP-002 will enter a nasal drug delivery market expected to surpass $125 billion, highlighting substantial commercial opportunities.
- Clinical Trial Progress: Oragenics is advancing ONP-002 through Phase 2a clinical trials in Australia, with plans for subsequent Phase 2b trials in the U.S., marking a strategic move in the treatment of neurological disorders.
- Rich Industry Experience: DUCK FLATS Pharma brings approximately 38 years of regulatory and drug development experience, having managed over 400 regulatory documents, which is expected to provide Oragenics with valuable insights to excel in a competitive market.
Oragenics Engages with Global Clinical Research Leaders at SCOPE Summit
- Clinical Trial Progress: Oragenics is advancing its first-in-class concussion treatment candidate ONP-002, with plans to initiate Phase 2a clinical trials in Australia, aiming to address significant unmet medical needs in this area, particularly as there are currently no FDA-approved therapies.
- Global Conference Participation: The company will engage with experts from over 1,200 companies across 30 countries at the 2026 SCOPE Summit, leveraging this opportunity to gain insights into cutting-edge technological innovations and best practices in clinical operations.
- Technological Platform Advantage: Oragenics' proprietary intranasal delivery platform enables targeted, non-invasive delivery of therapeutics directly to the brain, which is expected to positively impact various neurological conditions, including Parkinson's disease and Alzheimer's disease.
- Future Development Plans: In addition to the Phase 2a trials in Australia, Oragenics plans to conduct Phase 2b trials in the U.S., further advancing the development of ONP-002 and demonstrating the company's long-term commitment to neurological care.
High Roller Technologies Inc Closes Direct Offering, Raises $25 Million
- Successful Financing: High Roller Technologies Inc announced the completion of a registered direct offering of 1.89 million common shares at $13.21 per share, raising approximately $25 million in gross proceeds, significantly enhancing the company's liquidity to support future business expansion.
- Stock Surge: Following this announcement, High Roller’s shares jumped 29.6% to $10.21 in pre-market trading, reflecting strong market confidence in the company's growth potential and likely attracting more investor interest.
- Positive Market Reaction: The successful financing not only improves High Roller’s capital structure but also positions the company to gain a stronger competitive edge in the fiercely competitive online gaming market, aiding in further market share expansion.
- Strategic Growth Outlook: With this financing, High Roller Technologies can accelerate its strategic plans, including technological innovation and market expansion, which is expected to bring long-term growth opportunities and enhance shareholder value.
Oragenics (OGEN) to Present Novel Therapy at Sequire Investor Summit 2026
- Investor Summit Presentation: Oragenics will showcase its innovative therapy for concussions at the Sequire Investor Summit from January 20-22, 2026, in Puerto Rico, aiming to attract potential investors and enhance company visibility.
- Clinical Advancement: The company is advancing its lead candidate ONP-002 into Phase 2a clinical trials in Australia, addressing the significant unmet medical need in concussion and mild traumatic brain injury, which is expected to positively impact future market demand.
- Market Potential: Puerto Rico's favorable tax benefits attract numerous family offices and wealthy investors, and Oragenics' presentation will help secure funding support in this affluent investment environment, facilitating its research and development progress.
- Technology Platform Applications: Oragenics' intranasal delivery platform not only targets concussions but also shows potential for treating various neurological conditions such as Parkinson's and Alzheimer's diseases, indicating a broad application outlook in the neuroscience field.
Oragenics Q3 2025 Update for Shareholders
Operational Achievements: Oragenics regained compliance with NYSE American listing standards and established the necessary infrastructure for its Phase IIa clinical trial of ONP-002 in Australia, marking a significant step towards its first drug entering clinical trials.
Strategic Partnerships: The company formed a collaboration with Receptor.AI to enhance its drug development pipeline, aiming to leverage AI for identifying promising therapeutic candidates beyond its lead drug, ONP-002.
Financial Discipline: Oragenics strengthened its balance sheet through a $16.5 million capital raise, eliminating debt and restoring stockholder equity, while also demonstrating operational efficiency with reduced R&D and operating expenses.
Future Milestones: Upcoming catalysts include finalizing HREC amendments for clinical site onboarding, initiating the Phase IIa trial, and preparing for U.S. Phase IIb trials, alongside continued research for expanding its therapeutic portfolio.
Oragenics Collaborates with Receptor.AI on Brain Health Product Line
Strategic Collaboration: Oragenics has partnered with Receptor.AI to accelerate the development of new pharmaceutical candidates for brain health, utilizing AI modeling to optimize receptor binding profiles for compounds added to its portfolio in 2023.
Clinical Trials and Broader Scope: The company is advancing its clinical studies for ONP-002, currently in Phase IIa trials in Australia, with plans for Phase IIb trials in the US, while aiming to discover treatments for various neurological and psychiatric disorders through AI-guided laboratory testing.
Oragenics Partners with DUCK FLATS Pharma to Advance Novel Concussion Therapy
- Collaboration Enhances Regulatory Readiness: Oragenics partners with DUCK FLATS Pharma to support FDA application and clinical trial design for its novel intranasal concussion therapy, aiming to reduce risks and ensure trial integrity in the U.S. development pathway.
- Significant Market Potential: The global concussion market is projected to exceed $9 billion by 2027, and if approved, ONP-002 will enter a nasal drug delivery market expected to surpass $125 billion, highlighting substantial commercial opportunities.
- Clinical Trial Progress: Oragenics is advancing ONP-002 through Phase 2a clinical trials in Australia, with plans for subsequent Phase 2b trials in the U.S., marking a strategic move in the treatment of neurological disorders.
- Rich Industry Experience: DUCK FLATS Pharma brings approximately 38 years of regulatory and drug development experience, having managed over 400 regulatory documents, which is expected to provide Oragenics with valuable insights to excel in a competitive market.
Oragenics Engages with Global Clinical Research Leaders at SCOPE Summit
- Clinical Trial Progress: Oragenics is advancing its first-in-class concussion treatment candidate ONP-002, with plans to initiate Phase 2a clinical trials in Australia, aiming to address significant unmet medical needs in this area, particularly as there are currently no FDA-approved therapies.
- Global Conference Participation: The company will engage with experts from over 1,200 companies across 30 countries at the 2026 SCOPE Summit, leveraging this opportunity to gain insights into cutting-edge technological innovations and best practices in clinical operations.
- Technological Platform Advantage: Oragenics' proprietary intranasal delivery platform enables targeted, non-invasive delivery of therapeutics directly to the brain, which is expected to positively impact various neurological conditions, including Parkinson's disease and Alzheimer's disease.
- Future Development Plans: In addition to the Phase 2a trials in Australia, Oragenics plans to conduct Phase 2b trials in the U.S., further advancing the development of ONP-002 and demonstrating the company's long-term commitment to neurological care.
High Roller Technologies Inc Closes Direct Offering, Raises $25 Million
- Successful Financing: High Roller Technologies Inc announced the completion of a registered direct offering of 1.89 million common shares at $13.21 per share, raising approximately $25 million in gross proceeds, significantly enhancing the company's liquidity to support future business expansion.
- Stock Surge: Following this announcement, High Roller’s shares jumped 29.6% to $10.21 in pre-market trading, reflecting strong market confidence in the company's growth potential and likely attracting more investor interest.
- Positive Market Reaction: The successful financing not only improves High Roller’s capital structure but also positions the company to gain a stronger competitive edge in the fiercely competitive online gaming market, aiding in further market share expansion.
- Strategic Growth Outlook: With this financing, High Roller Technologies can accelerate its strategic plans, including technological innovation and market expansion, which is expected to bring long-term growth opportunities and enhance shareholder value.
Oragenics (OGEN) to Present Novel Therapy at Sequire Investor Summit 2026
- Investor Summit Presentation: Oragenics will showcase its innovative therapy for concussions at the Sequire Investor Summit from January 20-22, 2026, in Puerto Rico, aiming to attract potential investors and enhance company visibility.
- Clinical Advancement: The company is advancing its lead candidate ONP-002 into Phase 2a clinical trials in Australia, addressing the significant unmet medical need in concussion and mild traumatic brain injury, which is expected to positively impact future market demand.
- Market Potential: Puerto Rico's favorable tax benefits attract numerous family offices and wealthy investors, and Oragenics' presentation will help secure funding support in this affluent investment environment, facilitating its research and development progress.
- Technology Platform Applications: Oragenics' intranasal delivery platform not only targets concussions but also shows potential for treating various neurological conditions such as Parkinson's and Alzheimer's diseases, indicating a broad application outlook in the neuroscience field.
Oragenics Q3 2025 Update for Shareholders
Operational Achievements: Oragenics regained compliance with NYSE American listing standards and established the necessary infrastructure for its Phase IIa clinical trial of ONP-002 in Australia, marking a significant step towards its first drug entering clinical trials.
Strategic Partnerships: The company formed a collaboration with Receptor.AI to enhance its drug development pipeline, aiming to leverage AI for identifying promising therapeutic candidates beyond its lead drug, ONP-002.
Financial Discipline: Oragenics strengthened its balance sheet through a $16.5 million capital raise, eliminating debt and restoring stockholder equity, while also demonstrating operational efficiency with reduced R&D and operating expenses.
Future Milestones: Upcoming catalysts include finalizing HREC amendments for clinical site onboarding, initiating the Phase IIa trial, and preparing for U.S. Phase IIb trials, alongside continued research for expanding its therapeutic portfolio.
Oragenics Collaborates with Receptor.AI on Brain Health Product Line
Strategic Collaboration: Oragenics has partnered with Receptor.AI to accelerate the development of new pharmaceutical candidates for brain health, utilizing AI modeling to optimize receptor binding profiles for compounds added to its portfolio in 2023.
Clinical Trials and Broader Scope: The company is advancing its clinical studies for ONP-002, currently in Phase IIa trials in Australia, with plans for Phase IIb trials in the US, while aiming to discover treatments for various neurological and psychiatric disorders through AI-guided laboratory testing.
