Quarterly report [Sections 13 or 15(d)]

Basis of Presentation and Nature of Operations

v3.25.1
Basis of Presentation and Nature of Operations
3 Months Ended
Mar. 31, 2025
Accounting Policies [Abstract]  
Basis of Presentation and Nature of Operations

Note 1. Basis of Presentation and Nature of Operations

 

Basis of Presentation

 

The accompanying condensed consolidated financial information of Oragenics, Inc. and its wholly-owned subsidiary Noachis Terra Inc. is unaudited and has been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). All intercompany balances and transactions have been eliminated. However, such information reflects all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary for a fair presentation of the consolidated financial position, results of operations and cash flows for the interim periods. The consolidated financial information as of December 31, 2024 is derived from our 2024 Annual Report on Form 10-K. The consolidated financial statements included herein should be read in conjunction with the consolidated financial statements and the notes thereto included in our 2024 Annual Report on Form 10-K filed with the SEC on March 14, 2025. The consolidated results of operations for the interim periods presented are not necessarily indicative of the results to be expected for the full year.

 

Significant Accounting Policies

 

Our significant accounting policies have not changed during the three months ended March 31, 2025 from those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024.

 

Nature of Operations

 

We are a development-stage company dedicated to the research and development of nasal delivery pharmaceutical medications in neurology and fighting infectious diseases. We currently 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”).

 

Going Concern

 

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, 2024 contained an explanatory paragraph raising substantial doubt about our ability to continue as a going concern.

 

We have incurred losses and negative cash flows from operations since inception. To date, we have not generated significant revenues from operations. We incurred a net loss of $2.2 million and used cash of $2.1 million in our operating activities during the three months ended March 31, 2025 and, as of March 31, 2025, we had an accumulated deficit of $219 million.

 

Historically, our major sources of cash have been comprised of proceeds from various public and private offerings of our common stock and preferred stock, warrant exercises, income earned on grants and interest income. During the first quarter of 2025, we raised $2.6 million in net proceeds from private placements and sales of our common stock and $2.2 million from the issuance of debt, net of issuance costs.

 

We expect to incur substantial expenditures to further develop our concussion drug. We believe the working capital at March 31, 2025 will be sufficient to meet our business objectives through the third quarter of 2025.

 

These matters, when considered in the aggregate, raise substantial doubt about our 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.

 

Additional financing will be required to continue operations after we exhaust our current cash resources and to continue our long-term plans for clinical trials and new product development. There can be no assurance that any such financing can be realized or, if realized, what the terms thereof may be, or that any amount that we are able to raise will be adequate to support our working capital requirements until we achieve profitable operations.