Oragenics to Present ONP-002 Progress at Nasal Innovation Forum

Oragenics, a clinical-stage biotechnology company, is set to present its advancements in intranasal delivery technology at the IPAC-RS 2026 Nasal Innovation Forum. The presentation, scheduled for Thursday, September 17, 2026, will highlight the development and clinical translation of ONP-002, the company’s first-in-class intranasal neurosteroid candidate for treating concussion.

James P. Kelly, MD, Chief Medical Officer of Oragenics, will present during Session 4: Successful Case Studies, beginning at 9:40 AM ET. The forum, which convenes leading pharmaceutical scientists, device developers, and regulators, is focused on nasal drug delivery. Kelly’s presentation will address the scientific rationale behind ONP-002’s proposed mechanism of action, which includes reducing neuroinflammation, oxidative stress, and cerebral edema through the simultaneous activation of multiple neuroprotective pathways.

ONP-002 is designed to be delivered via a proprietary breath-powered intranasal device, engineered to direct the drug to the superior nasal roof for direct olfactory nerve, brain delivery, thereby minimizing systemic exposure. The compound is currently being manufactured as a powder and is being tested in a Phase IIa feasibility trial in Australia. This trial is expected to provide valuable insights into the safety and efficacy of ONP-002 as a potential treatment for concussion, a condition with no currently approved pharmacological treatments.

The presentation will also cover the design of the Company’s intranasal delivery device and the clinical trial framework for anticipated U.S. development. According to Kelly, “The IPAC-RS Nasal Innovation Forum is an ideal venue to share the science underpinning our intranasal platform with the formulation, device, and regulatory community. Concussion represents a significant unmet need, and we are excited to present our progress toward potentially bringing the first pharmacological treatment for this condition to patients.”

Oragenics is advancing ONP-002 through Phase IIa clinical trials in Australia, with plans for U.S. Phase IIb trials pending the submission of an Investigational New Drug (IND) application, which is anticipated in the fourth quarter of 2026. The company’s intranasal delivery platform has potential applications across a range of acute and chronic neurological conditions, making it a significant step forward in the treatment of neurological disorders.

The forum, held at Liberty House in Jersey City, New Jersey, from September 16 to 17, 2026, will bring together experts from various fields to discuss the latest advancements in nasal drug delivery technology. Oragenics’ presentation is expected to contribute valuable insights into the development of ONP-002 and the broader application of intranasal delivery in the treatment of neurological conditions.