Oragenics(OGEN) - 2024 Q4 - Annual Report

Financial Performance - The company reported net losses of $20.7 million and$10.6 million for the years ended December 31, 2023 and 2024, respectively, with an accumulated deficit of $216.8 million as of December 31, 2024[346]. - For the year ended December 31, 2024, the company reported a net loss of$10.6 million, a decrease of 49% compared to a net loss of $20.7 million in 2023[381]. - Total operating expenses decreased by 50$10.6 million in 2024 from $20.9 million in 2023, primarily due to a significant reduction in research and development expenses[381]. - Cash used in operating activities was$8.6 million in 2024, compared to $7.3 million in 2023, reflecting the net loss adjusted for non-cash items[388]. - The company recorded a working capital deficit of$211,885 at December 31, 2024, compared to a surplus of $2.1 million at December 31, 2023[390]. - The company has a full valuation allowance against deferred tax assets of approximately$46.96 million as of December 31, 2024, indicating uncertainty in realizing these assets[373]. - The company expects to incur substantial net losses and negative cash flows for the foreseeable future, impacting shareholder equity and working capital[349]. Research and Development - The company has completed pre-clinical animal studies and Phase 1 trials for its lead product ONP-002, with Phase 2a expected to start in Q1/Q2 2025 and Phase 3 anticipated to begin in Q1 2027[341]. - Research and development expenses are anticipated to increase as the company advances its ONP-002 product development program, while costs related to other product candidates have been paused pending additional financing[364]. - Research and development expenses were $4.1 million in 2024, down 73$15.5 million in 2023, largely due to the expensing of $10.3 million related to the acquisition of a concussion asset in 2023[383]. Funding and Capital - In February 2025, the company raised$2.75 million from the sale of 7.8 million shares of common stock under its ATM agreement[344]. - A private placement on March 13, 2025, generated gross proceeds of $2.5 million from the sale of a$3 million promissory note and 1 million shares of Series G Preferred Stock[345]. - The company plans to seek additional capital through equity and debt financing, strategic alliances, and partnerships to support its operations and research initiatives[353]. Revenue and Grants - Grant revenue was $0 in 2024, a 100$37,653 in 2023, attributed to the expiration of a small business innovation research grant[382]. - The company has incurred significant expenses related to its licensing agreements, which may negatively impact its financial capabilities[347]. Product Development - The proprietary formulation of ONP-002 allows for rapid brain accessibility, with a novel intranasal device designed to minimize systemic exposure and side effects[340]. - The company expects to incur significant and increasing operating losses as it advances its Neurology Assets through nonclinical testing and clinical trials[386].