Oragenics raises $16.5 million, plans phase IIa trial for concussion drug

Oragenics Inc. (NYSE American: OGEN) announced it raised $16.5 million in gross proceeds through Series H Convertible Preferred Stock and Warrants during the second quarter of 2025. The biotechnology company reported net proceeds of approximately $15.2 million after fees and expenses.

The company said it plans to initiate Phase IIa clinical trials for its lead candidate ONP-002 in the third quarter of 2025. ONP-002 is an intranasal drug candidate designed to treat mild traumatic brain injury or concussion. The company reported securing Human Research Ethics Committee approval in Australia and appointing Southern Star Research as its Clinical Research Organization.

Oragenics also finalized a manufacturing agreement with Sterling Pharma Solutions for cGMP production at their North Carolina facility. The company stated it plans to submit an Investigational New Drug application to the FDA for Phase IIb clinical trials between the third and fourth quarters of 2025.

For the six months ended June 30, 2025, Oragenics reported a 50% reduction in research and development expenses, an 8% decrease in general and administrative costs, and a 6% decline in net losses compared to the prior year period.

"We're 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.

The company stated there are currently no FDA-approved pharmacological treatments for concussion. Oragenics anticipates Phase IIa data readout in the third quarter of 2026 and Phase IIb trial initiation in the fourth quarter of 2026.

The information is based on a company press release statement.

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