Oragenics Reports $10.6 Million Net Loss, Plans Phase 2 Trials for ONP-002

Oragenics Inc. has reported significant financial developments in its latest 10-K filing for the fiscal year ending December 31, 2024. The company, which focuses on the research and development of nasal delivery pharmaceutical medications, particularly for neurological conditions, recorded a net loss of $10.6 million, a decrease from a loss of $20.7 million in the previous year. This reduction in losses is attributed to a 73% decrease in research and development expenses, which fell to $4.1 million from $15.5 million in 2023, primarily due to the completion of in-process research and development related to the acquisition of its ONP-002 concussion asset.

In December 2023, Oragenics acquired assets from Odyssey Health, Inc., which included the development of ONP-002, a synthetic neurosteroid aimed at treating mild traumatic brain injury (mTBI). The company has made strides in its product development, with ONP-002 showing stability for up to 18 months and designed for intranasal delivery to enhance accessibility to the brain. The company plans to initiate Phase 2 clinical trials for ONP-002, with expectations of significant costs associated with this advancement.

Operationally, Oragenics has a small workforce, consisting of three full-time and two part-time employees, and has engaged various consultants to support its research and development efforts. The company has also faced challenges, including a legal dispute with Ladenburg Thalmann regarding a claimed fee of $2.5 million related to the acquisition of the Neurology Assets. The ongoing litigation could strain the company's limited resources, which are already under pressure due to its accumulated deficit of approximately $217 million as of December 31, 2024.

Looking ahead, Oragenics has raised approximately $2.8 million through the sale of common stock and an additional $2.5 million from a private placement of a promissory note and preferred stock. These funds are expected to support operations through the third quarter of 2025. However, the company acknowledges the need for additional capital to continue its development efforts and maintain compliance with NYSE American listing standards, as it reported stockholders' equity of only $3.2 million, below the required thresholds. The company’s future remains uncertain, hinging on the successful development and commercialization of ONP-002 and its ability to secure further funding.