Financial Performance - The company reported net losses of $9.8 million and $10.6 million for the years ended December 31, 2025, and 2024, respectively, with an accumulated deficit of $226.6 million as of December 31, 2025[344]. - The company has incurred substantial losses and negative cash flow since inception, raising doubts about its ability to continue as a going concern[346]. - The company had an accumulated deficit of $226.6 million as of December 31, 2025, and has not yet achieved profitability[396]. - The company anticipates being able to fund its operating expenses through the third quarter of 2026, raising substantial doubt about its ability to continue as a going concern[397]. Research and Development - The expected timeline for the ONP-002 clinical trials includes starting Phase 2a in Q1 2026 and Phase 3 in Q1 2028[338]. - The company plans to increase research and development expenses as it advances the ONP-002 program while pausing other product candidates pending additional financing[363]. - The company anticipates significant expenditures related to research and development activities, including clinical trials and regulatory submissions[345]. - Research and development expenses decreased to $2.4 million in 2025 from $4.1 million in 2024, a reduction of $1.7 million or 41.8%[388]. Cash and Financing Activities - As of December 31, 2025, the company had $8.4 million in cash and cash equivalents, expected to fund operations through Q3 2026[352]. - The company raised approximately $15 million from a public offering of 660,000 shares of Series H Convertible Preferred Stock on July 2, 2025[342]. - Net cash provided by financing activities was $16.8 million in 2025, up from $6 million in 2024[402]. - Financing activities in 2025 included $15.0 million in net proceeds from the issuance of Series H Preferred Stock and warrants, $2.6 million from common stock issuance, and $2.5 million from short-term borrowings, offset by $3.3 million in repayments of short-term notes payable[403]. - In 2024, financing activities consisted of $6.7 million in net proceeds from common stock issuance, partially offset by $0.7 million in repayments of short-term notes payable[404]. Debt and Interest - The company issued a $3.0 million promissory note in March 2025, which was repaid in full on July 2, 2025, using proceeds from the public offering[343]. - A $3.0 million promissory note was issued on March 13, 2025, with net proceeds of approximately $2.2 million after fees[405]. - The promissory note was non-interest bearing unless a default occurred, at which point interest would accrue at 20% per annum[406]. - Interest income rose to $182,229 in 2025, a significant increase of 297.04% from $45,897 in 2024[393]. - Interest expense surged to $785,930 in 2025 from $29,828 in 2024, an increase of 2,534.87% due to debt-related costs[393]. - Total short-term notes payable as of December 31, 2025, was $227,348, compared to $328,528 in 2024[410]. Operating Expenses - General and administrative expenses increased to $7 million in 2025 from $6.4 million in 2024, an increase of $525,464 or 8.1%[390]. - Total operating expenses were $9.4 million in 2025, down from $10.6 million in 2024, reflecting a decrease of $1.2 million or 11.3%[385]. - Cash used in operating activities was $9.2 million in 2025, compared to $8.6 million in 2024, reflecting higher working capital utilization[399]. Tax and Regulatory - The company has federal and state tax net operating loss carryforwards of $164.8 million and $138.5 million, respectively, as of December 31, 2025[368]. - The company does not have any off-balance sheet arrangements[412]. - As a smaller reporting company, the company is not required to provide information on market risk[413]. Inflation Impact - Inflation has not had a material impact on the company's operating results for the fiscal years ended December 31, 2025, and 2024[411].
Oragenics(OGEN) - 2025 Q4 - Annual Report