Oragenics Inc. (NYSE American: OGEN) reported progress on its Phase IIa clinical trial of ONP-002, an intranasal neurosteroid for concussion treatment, with patient enrollment and dosing underway at sites in Australia.

The company activated Mackay Base Hospital in March 2026 and began patient enrollment immediately, with the first patient dosed within days of activation. Alfred Hospital in Melbourne was activated in April 2026, with patients being screened for enrollment. Royal Adelaide Hospital completed site initiation and staff training in May 2026, with formal activation pending final approval processes.

The randomized, placebo-controlled study targets 40 patients and evaluates safety, tolerability, and feasibility of ONP-002 administered within 12 hours of concussion. No serious adverse events have been recorded to date.

Oragenics plans to submit a Type C Meeting Request to the FDA in the second quarter of 2026 and targets full Investigational New Drug application submission by the end of 2026 for U.S. clinical trials beginning in 2027.

The company signed a Letter of Intent to pursue a licensing agreement for a CNS-related medical device. The licensing structure reserves traumatic brain injury indication rights while allowing the licensor to pursue other indications independently.

For the quarter ended March 31, 2026, Oragenics reported a cash balance of $6.1 million. Research and development expenses increased 89% to $0.6 million compared to the same period in 2025, while general and administrative expenses decreased 4% to $1.6 million.

The company's annual shareholder meeting is scheduled for June 29, 2026. Upcoming milestones include additional Australian trial site activations, FDA meeting submission, and Phase IIa data readout in 2026.