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Oragenics Provides Q1 2025 Update Highlighting Strategic Progress In Concussion Treatment, Advancements In ONP-002, Partnership With BRAINBox Solutions, $5M Fundraising, And Key Regulatory And Clinical Milestones

Benzinga·03/27/2025 12:38:04
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Oragenics, Inc. (NYSE:OGEN), a biotechnology company focused on developing novel intranasal therapies for brain-related conditions, today provided shareholders with an update on its strategic and financial progress for the first quarter of 2025. The Company has made meaningful advancements across regulatory, clinical, financial, and partnership initiatives, further positioning its lead therapeutic candidate, ONP-002, as a first-in-class solution for treating concussion.

"We believe ONP-002 is one of the most undervalued clinical assets in biotechnology today," said Janet Huffman, Interim CEO of Oragenics. "With strong preclinical validation and clinical safety data, a scalable ONP-002 intranasal delivery system, and no current FDA-approved treatments for concussion, ONP-002 could redefine the standard of concussion care. Our Q1 progress — from regulatory submissions to our landmark partnership with BRAINBox — reflects a sharpened strategic focus and operational momentum. We're energized by what's ahead and remain committed to delivering long-term value for our shareholders."

Key Accomplishments in Q1 2025

In the first quarter of 2025, Oragenics achieved several strategic and operational milestones:

  • Industry Engagement & Awareness: Participated in the 12th Annual Brain Health Summit at Leigh Steinberg's Super Bowl Party 2025, helping raise visibility for traumatic brain injury (TBI) and ONP-002's potential therapeutic impact.
  • Strategic Partnership: Established a collaboration with BRAINBox Solutions to combine diagnostic biomarkers with ONP-002's intranasal delivery system, aiming to transform concussion treatment by enabling faster, more targeted care.
  • Clinical Trial Advancements: Submitted the Investigator's Brochure (IB) for the Phase IIa clinical trial in Australia, marking a key regulatory step. The trial is now publicly listed on ClinicalTrials.gov.
  • Strengthened Financial Position: Raised approximately $5 million through a combination of dilutive and non-dilutive capital, including approximately $2.6 million via At-the-Market (ATM) equity financing and approximately $2.25 million through non-dilutive debt funding.
  • Shareholder Communications: Announced that the 2025 Annual Shareholder Meeting will be held on May 2, 2025, with the preliminary proxy filed with the SEC on March 19, 2025.