Oragenics(US:OGEN)2025-11-07 21:06Financial Performance - The net loss for the three months ended September 30, 2025, was $3,066,589, representing an increase of 24.51% from a net loss of $2,462,870 in the same period in 2024[97]. - The company incurred a net loss of $7.6 million for the nine months ended September 30, 2025, compared to a net loss of $10.5 million for the year ended December 31, 2024[110]. - The company had an accumulated deficit of $224.3 million as of September 30, 2025, and has not yet achieved profitability[110]. Research and Development Expenses - For the three months ended September 30, 2025, research and development expenses were $930,894, an increase of 5.9% from $879,041 in the same period in 2024[98]. - For the nine months ended September 30, 2025, research and development expenses totaled $1.7 million, a decrease of 29.7% from $2.4 million in the same period in 2024[100]. - The company anticipates increased R&D expenses in future periods as it initiates Phase IIa clinical trials and IND-enabling work for ONP-002[102]. Operating Expenses - Total operating expenses for the three months ended September 30, 2025, were $3,123,773, an increase of 28.17% from $2,437,280 in the same period in 2024[97]. - General and administrative (G&A) expenses for Q3 2025 were $2.2 million, a 40.7% increase from $1.6 million in Q3 2024, primarily due to higher legal and professional fees[103]. - For the nine months ended September 30, 2025, G&A expenses totaled $5.1 million, an 8.2% increase from $4.8 million in the same period in 2024, driven by a $798,760 rise in patent-related legal expenses[105]. - The company expects G&A expenses to continue to increase modestly in future periods to maintain compliance with public-company reporting requirements[106]. Cash Flow and Financing Activities - As of September 30, 2025, the company had $11.4 million in cash and cash equivalents, expected to fund operations through the first half of 2026[88]. - In February 2025, the company sold 260,000 shares for net proceeds of $2.6 million[79]. - On July 2, 2025, the company completed a public offering resulting in net proceeds of approximately $15.2 million[80]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $6.4 million, slightly lower than $6.6 million in the same period in 2024[112]. - Net cash provided by financing activities was $16.9 million for the nine months ended September 30, 2025, compared to $6.2 million for the same period in 2024, primarily due to the July 2025 Series H Preferred Stock financing[116]. Other Income and Expenses - Total other income for Q3 2025 was $57,184, compared to an expense of $25,590 in Q3 2024, mainly due to higher interest income from invested cash[107]. - Significant non-cash items affecting operating cash flows included $771,437 of amortization of debt discount for the nine months ended September 30, 2025[113]. Company Operations - The company operates in a single reportable segment focused on the development of ONP-002 for mild traumatic brain injury[94]. - The company completed pre-clinical studies and is estimating to start Phase 2a trials in Q4 2025 and Phase 2b trials in Q4 2026[77]. Inflation Impact - Inflation has not had a material impact on the company's results of operations for the nine-month periods ending September 30, 2025, and 2024[124].