Full Press Release Details
Q2 2025 Shareholder Update
Brain-First Recovery Platform Toward Clinical Milestones
Intranasal Therapeutics for Concussion
Fla., August 11, 2025 - 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
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's 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
LEADERSHIP AND COMPETITIVE ADVANTAGE
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.
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.
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 |
PLATFORM OPPORTUNITY
believe Oragenics' proprietary intranasal delivery system positions the company at the forefront of the rapidly expanding nasal
drug delivery market, projected to exceed $40 billion by 2030 . We anticipate this technology may enable targeted, non-invasive
delivery of therapeutics directly to the brain. Although the Company is focused on the treatment of concussion with its lead candidate
ONP-002, the applications for its novel intranasal device may extend beyond concussion treatment to acute neurological emergencies and
chronic neurodegenerative diseases.
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 |
THE CONCUSSION CARE ECOSYSTEM
Engagement and Strategic Partnerships
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.
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) - CMO attended NATO Blast meeting and strengthened relationships with leading international researchers and clinicians | ||
| The 15 th Annual Traumatic Brain Injury Conference (Boston, MA) - CMO and CCO attended and delivered corporate presentation on ONP-002, clinical blood biomarkers and the need for a trigger to treat model |
Financial Foundation
recent $16.5 million capital raise through Series H Convertible Preferred Stock and Warrants reflects growing investor confidence in
our transformational approach to neurotrauma treatment. These funds strategically position us to accelerate our lead program while advancing
our nasal delivery platform.
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 |
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.
UPCOMING CATALYSTS AND MILESTONES
| Phase IIa clinical trial initiation (Q3 2025) | ||
| IND submission to FDA for Phase IIb clinical trial (Q3-Q4 2025) |
Future Value Drivers (2026):
| Phase IIa data readout (Q3 2026) | ||
| Phase IIb trial initiation in US (Q4 2026) |
EXCELLENCE AND MARKET READINESS
and Regulatory Progress
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 |
STRENGTH AND OPERATIONAL EFFICIENCY
Financial Highlights for Six Months Ended June 30, 2025:
Discipline: Year-over-year improvements demonstrate our commitment to efficient capital deployment:
| 50% reduction in research and development expenses | ||
| 8% decrease in general and administrative costs | ||
| 6% decline in net losses for the six-month period |
| Gross proceeds: $16.5 million from Series H Preferred Stock and Warrants | ||
| Net proceeds: ~$15.2 million after fees and expenses |
we advance toward Phase IIa initiation, we anticipate strategic increases in R&D investment to support clinical excellence and accelerated
development timelines.
OPPORTUNITY AND COMPETITIVE LANDSCAPE
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.
| 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 |
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.
MESSAGE FROM OUR CEO
mission extends beyond developing treatments-we'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-we're building a movement around brain-first recovery; we're working to shift the conversation from symptom
management to true neurological healing.
| 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 |
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.
not just treating concussions-we're pioneering the future of brain-first recovery.
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.
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 |
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.
building more than a pharmaceutical company-we're creating a movement around brain-first recovery that transforms how patients,
clinicians, and healthcare systems approach neurological trauma.
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