Oragenics reported Q2 EPS of -$3.10, compared to -$15.27 last year. CEO Janet Huffman stated that the company is developing a new era of brain-first recovery for neurological trauma and is positioning itself to lead a paradigm shift in neurotrauma care through its proprietary nasal delivery platform and lead candidate ONP-002 for concussion.
Sarasota, FL — Oragenics, Inc. (NYSE American: OGEN), a biotechnology company focused on developing brain-targeted therapeutics via proprietary intranasal delivery technology, reported its second-quarter earnings per share (EPS) of -$3.10, compared to -$15.27 in the same period last year. CEO Janet Huffman highlighted the company's strategic progress in advancing its lead candidate, ONP-002, toward becoming the first FDA-approved treatment for concussion.
The company secured several key milestones in Q2 2025, including Human Research Ethics Committee (HREC) approval in Australia, appointment of Southern Star Research as Clinical Research Organization (CRO), and finalization of a U.S.-based cGMP manufacturing agreement with Sterling Pharma Solutions. These achievements position Oragenics to launch Phase IIa trials in Q3 2025, furthering its clinical momentum.
Oragenics' intranasal delivery platform is designed to enable rapid, targeted drug delivery to the brain, bypassing systemic circulation and reducing side effects. The company believes this technology has the potential to revolutionize neurological care, addressing not only concussion but also acute neurological emergencies and chronic neurodegenerative diseases.
The global nasal drug delivery market is projected to exceed $40 billion by 2030, presenting a significant growth opportunity for Oragenics. The company's strategic capital raise of $16.5 million through Series H Convertible Preferred Stock and Warrants reflects growing investor confidence in its transformational approach to neurotrauma treatment.
Oragenics continues to build industry partnerships and strengthen its financial foundation. The company anticipates launching Phase IIa clinical trials in Q3 2025, followed by an IND submission to the FDA for Phase IIb trials later in the year. These developments underscore Oragenics' commitment to advancing its intranasal delivery platform and lead candidate ONP-002.
References:
[1] https://www.streetinsider.com/Investor+Brand+Network/InvestorNewsBreaks+%E2%80%93+Oragenics+Inc.+%28NYSE+American%3A+OGEN%29+Highlights+Q2+2025+Progress+and+Prepares+for+Phase+IIa+Concussion+Trial/25179488.html
[2] https://www.biospace.com/press-releases/oragenics-q2-2025-shareholder-update
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