Oragenics Q2 2025 Shareholder Update
Oragenics (NYSE American: OGEN) provided a Q2 2025 shareholder update highlighting progress in developing ONP-002, its lead candidate for concussion treatment. The company secured a $16.5 million capital raise through Series H Convertible Preferred Stock and Warrants, with net proceeds of $15.2 million.
Key operational achievements include HREC approval in Australia, appointment of Southern Star Research as CRO, and a cGMP manufacturing agreement with Sterling Pharma Solutions. The company demonstrated financial discipline with a 50% reduction in R&D expenses and 8% decrease in administrative costs.
Oragenics plans to initiate Phase IIa trials in Q3 2025, followed by IND submission to FDA for Phase IIb trials in Q3-Q4 2025. The company targets the $8.9 billion global concussion market by 2027, aiming to become the first FDA-approved pharmacological treatment for concussion.
Oragenics (NYSE American: OGEN) ha fornito un aggiornamento agli azionisti relativo al secondo trimestre 2025, evidenziando i progressi nello sviluppo di ONP-002, il candidato principale per il trattamento della commozione cerebrale. La societ脿 ha ottenuto un finanziamento di 16,5 milioni di dollari tramite azioni privilegiate convertibili di Serie H e warrant, con proventi netti di 15,2 milioni di dollari.
Tra i principali traguardi operativi figurano l'approvazione dell'HREC in Australia, la nomina di Southern Star Research come CRO e un accordo di produzione cGMP con Sterling Pharma Solutions. L'azienda ha dimostrato disciplina finanziaria con una riduzione del 50% delle spese di R&S e un calo dell'8% dei costi amministrativi.
Oragenics prevede di avviare le prove di Fase IIa nel terzo trimestre 2025, seguite dalla presentazione di un IND alla FDA per le prove di Fase IIb nel terzo-quarto trimestre 2025. La societ脿 punta al mercato globale delle commozioni cerebrali da 8,9 miliardi di dollari entro il 2027, con l'obiettivo di diventare il primo trattamento farmacologico approvato dalla FDA per la commozione cerebrale.
Oragenics (NYSE American: OGEN) public贸 una actualizaci贸n para accionistas del segundo trimestre de 2025, destacando avances en el desarrollo de ONP-002, su candidato principal para el tratamiento de las conmociones cerebrales. La compa帽铆a asegur贸 una captaci贸n de capital de 16,5 millones de d贸lares mediante acciones preferentes convertibles Serie H y warrants, con ingresos netos de 15,2 millones de d贸lares.
Entre los logros operativos clave se encuentran la aprobaci贸n del HREC en Australia, el nombramiento de Southern Star Research como CRO y un acuerdo de fabricaci贸n cGMP con Sterling Pharma Solutions. La compa帽铆a mostr贸 disciplina financiera con una reducci贸n del 50% en gastos de I+D y una disminuci贸n del 8% en costos administrativos.
Oragenics planea iniciar los ensayos de Fase IIa en el tercer trimestre de 2025, seguidos por la presentaci贸n de un IND a la FDA para los ensayos de Fase IIb en el tercer-cuarto trimestre de 2025. La compa帽铆a apunta al mercado mundial de conmociones cerebrales de 8,9 mil millones de d贸lares para 2027, con la meta de convertirse en el primer tratamiento farmacol贸gico aprobado por la FDA para la conmoci贸n cerebral.
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Oragenics (NYSE American: OGEN) a publi茅 une mise 脿 jour aux actionnaires du deuxi猫me trimestre 2025, soulignant les progr猫s du d茅veloppement de ONP-002, son candidat principal pour le traitement des commotions c茅r茅brales. La soci茅t茅 a obtenu une lev茅e de fonds de 16,5 millions de dollars via des actions pr茅f茅rentielles convertibles S茅rie H et des bons de souscription, avec des produits nets de 15,2 millions de dollars.
Les principaux accomplissements op茅rationnels incluent l'approbation du HREC en Australie, la nomination de Southern Star Research en tant que CRO et un accord de fabrication cGMP avec Sterling Pharma Solutions. La soci茅t茅 a fait preuve de discipline financi猫re avec une r茅duction de 50% des d茅penses R&D et une baisse de 8% des frais administratifs.
Oragenics pr茅voit de lancer les essais de phase IIa au T3 2025, suivis du d茅p么t d'un IND aupr猫s de la FDA pour les essais de phase IIb au T3鈥揟4 2025. La soci茅t茅 vise le march茅 mondial des commotions c茅r茅brales de 8,9 milliards de dollars d'ici 2027, dans l'optique de devenir le premier traitement pharmacologique approuv茅 par la FDA pour la commotion c茅r茅brale.
Oragenics (NYSE American: OGEN) ver枚ffentlichte ein Aktion盲rs-Update f眉r Q2 2025 und hob Fortschritte bei der Entwicklung von ONP-002, dem f眉hrenden Kandidaten zur Behandlung von Gehirnersch眉tterungen, hervor. Das Unternehmen sicherte sich eine Kapitalerh枚hung in H枚he von 16,5 Millionen US-Dollar durch Serie-H wandelbare Vorzugsaktien und Warrants, mit Nettoerl枚sen von 15,2 Millionen US-Dollar.
Wesentliche operative Erfolge umfassen die HREC-Zulassung in Australien, die Ernennung von Southern Star Research als CRO und eine cGMP-Fertigungsvereinbarung mit Sterling Pharma Solutions. Das Unternehmen zeigte finanzielle Disziplin durch eine Reduzierung der F&E-Ausgaben um 50% und eine Verringerung der Verwaltungskosten um 8%.
Oragenics plant, Phase-IIa-Studien im 3. Quartal 2025 zu starten, gefolgt von der Einreichung eines IND bei der FDA f眉r Phase-IIb-Studien im 3.鈥�4. Quartal 2025. Das Unternehmen zielt bis 2027 auf den 8,9 Milliarden US-Dollar schweren globalen Markt f眉r Gehirnersch眉tterungen und strebt an, die erste von der FDA zugelassene pharmakologische Behandlung daf眉r zu werden.
- Secured $16.5 million capital raise through Series H Convertible Preferred Stock and Warrants
- Obtained HREC approval in Australia for clinical trials
- 50% reduction in R&D expenses and 8% decrease in administrative costs
- Established strategic partnerships with Sterling Pharma Solutions for manufacturing and Southern Star Research as CRO
- Targeting $8.9 billion global concussion market with first-mover advantage
- Clear development timeline with Phase IIa trials starting Q3 2025
- No FDA approval yet for lead candidate ONP-002
- Significant future capital requirements expected for clinical trials
- Potential dilution from Series H Convertible Preferred Stock
- No revenue-generating products in the market
Insights
Oragenics secures $16.5M funding and prepares for Phase IIa trials of its pioneering concussion treatment in Q3 2025.
Oragenics has strategically positioned itself at the intersection of two substantial market opportunities: the $8.9 billion global concussion market and the $40+ billion nasal delivery technology market. The company's recent
The company has achieved several critical operational milestones that substantially de-risk its near-term execution. These include securing Human Research Ethics Committee approval in Australia, appointing Southern Star Research as their CRO, and finalizing a cGMP manufacturing agreement with Sterling Pharma Solutions. These infrastructure components are essential prerequisites for the anticipated Phase IIa trial initiation in Q3 2025.
Financially, Oragenics has demonstrated improved operational efficiency with a
The concussion treatment landscape represents a completely untapped opportunity with no FDA-approved pharmacological treatments. Oragenics' ONP-002 aims to be first-to-market, potentially creating substantial barriers to entry for competitors. The upcoming clinical milestones鈥擯hase IIa initiation in Q3 2025, IND submission in Q3-Q4 2025, and data readout in Q3 2026鈥攔epresent critical value-creating events that could validate their proprietary intranasal delivery platform.
The company's strategic pivot following its 2024 acquisition of ONP-002 demonstrates a focused approach to value creation in neurology, targeting high-impact indications with clear regulatory and commercial pathways.
Advancing Brain-First Recovery Platform Toward Clinical Milestones
Pioneering Intranasal Therapeutics for Concussion
SARASOTA, Fla., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a pioneering biotechnology company striving to develop brain-targeted therapeutics through proprietary intranasal delivery technology, today shared key strategic and financial milestones achieved during the second quarter of 2025 and shortly thereafter. These successes underscore the company's momentum as it strives to transform neurotrauma care and advance its lead candidate, ONP-002, toward becoming the first FDA-approved pharmacological treatment for concussion.
"We're not just developing another drug, we're striving to pioneer a new era of brain-first recovery that could transform how we treat neurological trauma," said Janet Huffman, Chief Executive Officer of Oragenics. "We believe that our proprietary nasal delivery platform and our lead candidate ONP-002 for concussion, the Company鈥檚 current cash position, combined with strategic partnerships, position us to lead a paradigm shift in neurotrauma care. We believe that early treatment could prevent chronic brain disorders as a result of mTBI."
CLINICAL LEADERSHIP AND COMPETITIVE ADVANTAGE
Strategic Evolution and Focus
Oragenics鈥� acquisition of ONP-002 in 2024 represents a strategic transformation, focusing the company's extensive R&D capabilities on high-impact neurological therapeutics with clear commercial pathways. We anticipate this focused approach may position Oragenics to achieve a successful drug development milestone.
We anticipate Phase IIa trials will launch in Q3 2025, which we believe will allow Oragenics to maintain a significant clinical advantage in the intranasal neurotrauma space, potentially advancing toward becoming the first company to bring an FDA-approved pharmacological treatment for concussion to market.
Key Clinical Milestones Achieved in Q2:
- Human Research Ethics Committee (HREC) approval secured in Australia
- Southern Star Research appointed as Clinical Research Organization (CRO)
- US based cGMP manufacturing agreement finalized with Sterling Pharma Solutions
TRANSFORMATIONAL PLATFORM OPPORTUNITY
We believe Oragenics' proprietary intranasal delivery system positions the company at the forefront of the rapidly expanding nasal drug delivery market, projected to exceed
Our Anticipated Technology Advantages:
- Rapid onset and targeted brain biodistribution
- Bypasses systemic circulation, reducing side effects
- Non-invasive, patient and caretaker-friendly administration
- Scalable manufacturing and delivery system
- Potentially broad therapeutic applications across CNS conditions
BUILDING THE CONCUSSION CARE ECOSYSTEM
Industry Engagement and Strategic Partnerships
Oragenics' increased industry presence reflects our commitment to building comprehensive partnerships across the concussion care continuum. Our strategic engagements position us to participate in an integrated treatment ecosystem that aspires to address the full spectrum of brain injury care.
Q2 Industry Leadership:
- 2025 BIO International Convention (Boston, MA) -- Delivered corporate presentation on transforming concussion treatment paradigms
- 42nd Annual National Neurotrauma Society Symposium (Philadelphia, PA) -- Strengthened relationships with leading researchers and clinicians
- 3rd Nasal Formulation & Delivery Summit (Boston, MA) -- CMO shared insights on ONP-002's potentially revolutionary mechanism
- NATO Blast Meeting (Canadian Forces College - Toronto, Canada) 鈥� CMO attended NATO Blast meeting and strengthened relationships with leading international researchers and clinicians
- The 15th Annual Traumatic Brain Injury Conference (Boston, MA) 鈥� CMO and CCO attended and delivered corporate presentation on ONP-002, clinical blood biomarkers and the need for a trigger to treat model
STRATEGIC CAPITAL POSITION
Strengthened Financial Foundation
Our recent
Strategic Capital Deployment -- We anticipate our recent capital raise may allow us to:
- Accelerate ONP-002 clinical development and Phase IIa and Phase IIb clinical trial execution
- Advance platform technology for future therapeutic applications
- Strengthen manufacturing and regulatory capabilities
- Support operational excellence and working capital needs
"We continue to explore non-dilutive funding opportunities, including government grants and strategic partnerships, to maximize shareholder value while maintaining our focus on therapeutic development," added Huffman.
ANTICIPATED UPCOMING CATALYSTS AND MILESTONES
- Phase IIa clinical trial initiation (Q3 2025)
- IND submission to FDA for Phase IIb clinical trial (Q3-Q4 2025)
Anticipated Future Value Drivers (2026):
- Phase IIa data readout (Q3 2026)
- Phase IIb trial initiation in US (Q4 2026)
OPERATIONAL EXCELLENCE AND MARKET READINESS
Manufacturing and Regulatory Progress
Oragenics has secured critical infrastructure to support successful clinical execution and future commercial readiness:
- Manufacturing Partnership: Agreement with Sterling Pharma Solutions, a leading CDMO, should provide reliable, scalable cGMP production at their Cary, North Carolina facility
- Clinical Operations: Southern Star Research provides globally recognized CRO expertise with proven track record in Australia and Asia-Pacific region
- Regulatory Strategy: HREC approval achieved; IND submission preparations underway for U.S. Phase IIb trials
FINANCIAL STRENGTH AND OPERATIONAL EFFICIENCY
Key Financial Highlights for Six Months Ended June 30, 2025:
Operational Discipline: Year-over-year improvements demonstrate our commitment to efficient capital deployment:
50% reduction in research and development expenses8% decrease in general and administrative costs6% decline in net losses for the six-month period
Post-Capital Raise Strength:
- Gross proceeds:
$16.5 million from Series H Preferred Stock and Warrants - Net proceeds: ~
$15.2 million after fees and expenses
As we advance toward Phase IIa initiation, we anticipate strategic increases in R&D investment to support clinical excellence and accelerated development timelines.
MARKET OPPORTUNITY AND COMPETITIVE LANDSCAPE
Massive Unmet Medical Need
With no current FDA-approved treatments for concussion or mild traumatic brain injury (mTBI), the market for effective therapies represents a substantial and completely unmet opportunity. Our proprietary intranasal delivery platform we believe has the potential to offer significant advantages that have the potential to transform concussion management and recovery.
Market Dynamics:
- No FDA-approved pharmacological treatments for concussion currently exist
- Millions of cases annually across sports, military, and civilian sectors
- Growing recognition of long-term effects and need for acute intervention
$8.9 billion global concussion market opportunity by 2027$40 + billion nasal delivery technology market opportunity by 2030
Strategic Positioning: We believe that our first-mover advantage in intranasal neurotrauma therapeutics, combined with our platform technology's potential for broader applications, may position Oragenics as the category leader in brain-first recovery solutions.
A MESSAGE FROM OUR CEO
Our mission extends beyond developing treatments鈥攚e're attempting to revolutionize how the world approaches brain injury and neurological trauma. With a steadfast commitment to improving patient outcomes through breakthrough science, Oragenics is making strategic strides that position us to lead the transformation of neurotrauma care. Oragenics is positioning itself as more than a pharmaceutical company鈥攚e're building a movement around brain-first recovery; we're working to shift the conversation from symptom management to true neurological healing.
Our Strategic Focus:
- Clinical Excellence: Advancing ONP-002 toward becoming the first FDA-approved concussion treatment
- Platform Leadership: Exploring expanding our proprietary nasal delivery technology across multiple therapeutic areas
- Movement Building: Working towards creating comprehensive partnerships and advocacy programs that could shift the standard of care
- Operational Discipline: Maintaining efficient capital deployment while accelerating development timelines
The convergence of our clinical leadership, platform technology, strategic partnerships, and strengthened financial position we believe is poised to seize an unprecedented opportunity to transform brain injury treatment while delivering exceptional value to our shareholders.
We're not just treating concussions鈥攚e're pioneering the future of brain-first recovery.
Janet Huffman
Chief Executive Officer
ABOUT ONP-002
ONP-002 is a revolutionary neuroprotective, anti-inflammatory intranasal drug candidate targeting mild traumatic brain injury (mTBI) or concussion. Designed to interrupt biological pathways involved in inflammation, oxidative stress, and swelling post-head trauma, ONP-002 has the potential, we believe, to represent a paradigm shift from symptom management to true neurological healing.
Key Anticipated Differentiators:
- First-in-class approach to concussion treatment
- Rapid brain delivery through proprietary nasal delivery system
- Strong preclinical efficacy and Phase I safety data
- Precision medicine approach using biomarker guidance
- Potential to prevent long-term neurological effects
ABOUT ORAGENICS, INC.
Oragenics is striving to revolutionize neurological care through proprietary intranasal delivery technology that has the potential to enable targeted, non-invasive therapeutics for brain-related conditions. Our lead candidate, ONP-002, is advancing with the goal of becoming the first FDA-approved treatment for concussion, while our platform technology has the potential, we believe, to open pathways to address neurodegenerative diseases, CNS disorders, and other neurological conditions.
We're building more than a pharmaceutical company鈥攚e're creating a movement around brain-first recovery that transforms how patients, clinicians, and healthcare systems approach neurological trauma.
This press release does not constitute an offer to sell, or a solicitation of an offer to purchase, any securities and shall not form the basis of any contract.
FORWARD-LOOKING STATEMENTS
This communication contains 鈥渇orward-looking statements鈥� within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management鈥檚 beliefs and assumptions and information currently available. The words 鈥渂elieve,鈥� 鈥渆xpect,鈥� 鈥渁nticipate,鈥� 鈥渋ntend,鈥� 鈥渆stimate,鈥� 鈥減roject鈥� 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, those described in our Form 10-K, Forms 10-Q and other filings we make with the U.S. Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included in this press release and not place undue reliance on such statements. All information we set forth in this press release is as of the date hereof. 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, circumstances should change, except as otherwise required by law.
CONTACTS
Oragenics, Inc.
Janet Huffman
Chief Executive Officer
813-286-7900
Investor Relations:
Rich Cockrell
CG Capital
866.889.1972
FAQ
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