1. Basis of Presentation

The Company

Oragenics, Inc. (formerly known as Oragen, Inc.) (the “Company” or “we”) was incorporated in November 1996. Commencing in December of 2023, we are focused on the development of medical products that treat brain related illnesses and diseases and our lead product candidate and focus is on the development and commercialization of ONP-002 for the treatment of mild traumatic brain injury (“mTBI” or “Concussion”).

Basis of Presentation

The accompanying consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States (“US GAAP”) including the assumption of a going concern basis which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business.

Reverse Stock Split

In December of 2022 the Board of Directors approved an amendment to the Company’s articles of incorporation to affect a reverse stock split of the Company’s common stock by a ratio of one for sixty. The Company’s common stock began trading on a split adjusted basis on January 23, 2023. All references to common stock for the comparable fiscal year ended December 31, 2022, have been adjusted to reflect the effect of the reverse split.

Going Concern Consideration

In light of our recurring losses, accumulated deficit and negative cash flow the report of our independent registered public accounting firm on our consolidated financial statements for the year ended December 31, 2023 contained an explanatory paragraph raising substantial doubt about our ability to continue as a going concern.

The Company has incurred recurring losses and negative cash flows from operations since inception. To date the Company has not generated significant revenues from operations. The Company incurred a net loss of $(20,655,737) and used cash of $(7,290,880) in its operating activities during the year ended December 31, 2023. As of December 31, 2023, the Company had an accumulated deficit of $(206,218,254).

Historically, the Company’s major sources of cash have been comprised of proceeds from various public and private offerings of its common stock and preferred stock, warrant exercises, income earned on grants and interest income. For the fiscal year ended December 2023 the Company raised approximately $0.8 million in gross proceeds from a private placement and sale of its common stock. The Company expects to incur substantial expenditures to further develop its concussion drug. The Company believes the working capital at December 31, 2023, will be sufficient to meet the business objectives through the second quarter of 2024. A subsequent financing in March of 2024 raised approximately $2.1 million in gross proceeds and approximately $1.8 million in net proceeds. The Company anticipates that these additional cash resources will continue to fund research and development activities and operating expenses through the third quarter of 2024.

These matters, when considered in the aggregate, raise substantial doubt about the Company’s ability to continue as a going concern for a reasonable period of time, which is defined as within one year after the date that our consolidated financial statements are issued.

The Company’s ability to continue operations after its current cash resources are exhausted depends on its ability to obtain additional financing or achieve profitable operations, as to which no assurances can be given. Cash requirements may vary materially from those now planned because of changes in the Company’s focus and direction of its research and development programs, competitive and technical advances, or other developments. Additional financing will be required to continue operations after the Company exhausts its current cash resources and to continue its long-term plans for clinical trials and new product development. There can be no assurance that any such financing can be realized by the Company, or if realized, what the terms thereof may be, or that any amount that the Company is able to raise will be adequate to support the Company’s working capital requirements until it achieves profitable operations.

The Company intends to seek additional funding through sublicensing arrangements, joint venturing or partnering, sales of rights to technology, government grants and public or private financings and may receive funding through the exercise of outstanding warrants. The Company’s future success depends on its ability to raise capital and ultimately generate revenue and attain profitability. The Company cannot be certain that additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to it or, if available, will be on terms acceptable to the Company. If the Company issues additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of its common stock, and the Company’s current shareholders may experience dilution. If the Company is unable to obtain funds when needed or on acceptable terms, the Company may be required to curtail its current development programs, cut operating costs and forego future development and other opportunities.