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Oragenics, Inc. (NYSE: OGEN) is a clinical-stage biotechnology company pioneering the intranasal delivery of pharmaceutical medications for neurological disorders. Its lead candidate, ONP-002, is a first-in-class, novel neurosteroid administered via an innovative intranasal device for the treatment of mild traumatic brain injury (mTBI), commonly known as concussion. With concussions representing a significant market opportunity with no FDA-approved treatments currently available, ONP-002 is uniquely positioned to become the first FDA-approved pharmaceutical therapy for this critical unmet medical need.

$8.9B

Global Concussion Market Potential Projected to Grow by 2027

3.8M

Approximate Concussions Reported in the United States Annually

$40B

Nasal Drug Delivery Platform Market  Value Projected to Grow by 2040

Investor Resources:

Investment Considerations
First-in-Class Opportunity: With no FDA-approved treatments for concussions, Oragenics' lead candidate, ONP-002, is poised to become the first-in-class therapy. It addresses a significant unmet medical need in a global market valued at $8.9 billion, offering a groundbreaking solution where none currently exists.
Strong Intellectual Property: Oragenics has robust IP protection, with pending USPTO and PCT filings for both ONP-002 and its delivery device, ensuring long-term market exclusivity through 2040.
Large Market Opportunity: With the concussion treatment market projected to reach $8.9 billion by 2027 and no approved therapies, ONP-002 is uniquely positioned to capture a significant share of this market. The company’s innovative approach also aligns with the rapidly growing $40 billion nasal drug delivery market.
Innovative Drug Delivery System: The company’s intranasal delivery technology offers rapid and targeted brain access, bypassing traditional systemic pathways. This approach minimizes side effects and enhances therapeutic outcomes, setting ONP-002 apart from conventional treatment methods.
A Differentiated Treatment Method and Innovative Platform: ONP-002 + Intranasal Delivery
 
Oragenics' intranasal delivery system features a double-tube airflow design that optimizes drug dispersion to the nasal roof, ensuring efficient and precise delivery. By directly targeting the olfactory nerve, this advanced approach enhances brain access, potentially improving therapeutic outcomes for patients with neurological conditions like concussions.
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Intranasal Delivery Advantages: Provides rapid and direct access to the brain, enabling swift therapeutic effects. With a quicker onset compared to oral medications, this approach offers an efficient and effective solution for treating neurological conditions like concussions

Innovative Design: Device allows patients to blow into it, elevating the soft palate to enhance drug delivery directly to the brain. This design minimizes systemic exposure, reducing the risk of side effects for a safer and more targeted treatment. 

User-Friendly and Portable: Compact and lightweight design ensures ease of use, making it accessible for patients in acute brain injury scenarios.

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