Quarterly report [Sections 13 or 15(d)]

Basis of Presentation and Nature of Operations

v3.25.2
Basis of Presentation and Nature of Operations
6 Months Ended
Jun. 30, 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. are 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”) applicable to interim financial reporting. All intercompany balances and transactions have been eliminated in consolidation.

 

In the opinion of management, all adjustments (consisting solely of normal recurring adjustments) considered necessary for a fair presentation of the Companby’s consolidated financial position, results of operations, and cash flows for the interim period presented have been included. The condensed consolidated balance sheet as of December 31, 2024, has been derived from the audited financial statements included in the Company’s annual report on the Form 10-K for the year ended December 31, 2024, filed with the SEC on March 14, 2025.

 

These interim financial statements should be read in conjunction with the audited consolidated financial statements and accompanying notes thereto included in the Company’s Annual Report on the Form 10-K for the year ended December 31, 2024. The results of operations for the three and six months ended June 30, 2025, are not necessarily indicative of the results that may be expected for the full fiscal year ending December 31, 2025.

 

On June 3, 2025, the Company effected a 1-for-30 reverse stock split of its outstanding common stock. All share and per share amounts in these consolidated financial statements and related footnotes have been retroactively adjusted to reflect the reverse stock split for all periods presented, unless otherwise indicated.

 

Significant Accounting Policies

 

There have been no material changes to the Company’s significant accounting policies during the six-month ended June 30, 2025, as compared to those disclosed in the consolidated financial statements included in the Company’s Annual Report on the Form 10-K for the year ended December 31, 2024.

 

Nature of Operations

 

Organics, Inc. (the “Company”) is development-stage biopharmaceutical company dedicated to the research and development of nasally delivered pharmaceutical therapies targeting neurological conditions and infectious diseases. The Company is currently focused on advancing the development and commercialization of its lead product candidate, ONP-002, novel formulation intended for the treatment of mild traumatic brain injury (“mTBI” or “concussion”). ONP-002 is being developed as a potential first-in-class therapeutic targeting the unmet medical need for effective concussion treatment.

 

Going Concern

 

Considering our recurring losses, accumulated deficit, and negative cash flows, the report of our independent registered public accounting firm on our consolidated financial statements for the year ended December 31, 2024, included an explanatory paragraph raising substantial doubt about our ability to continue as a going concern.

 

We have incurred operating losses and negative cash flow from operations since inception. To date, we have not generated significant revenues from our operations. We incurred a net loss of $4.5 million and used $3.4 million cash resources in operating activities during the six months ending June 30, 2025. As of June 30, 2025, we had an accumulated deficit of $221 million and cash and cash equivalents of $2 million.

 

Historically, our primary sources of liquidity have included proceeds from public and private offerings of our common and preferred stock, warrant exercises, debt financings, grant income, and interest income. During the six months ending June 30, 2025, we raised approximately $2.6 million in net proceeds from private placements and sales of our common stock and received approximately $2.2 million in net proceeds from the issuance of debt.

 

We expect to continue to incur substantial expenses as we advance the development of ONP-002, our lead product candidate for the treatment of mild traumatic brain injury. Based on our available cash of June 30, 2025, we previously concluded that our working capital would only be sufficient to fund operations through the third quarter of 2025.

 

Subsequent to quarter-end, on July 2, 2025, we completed a public offering of Series H Preferred Stock and warrants to purchase additional shares of Series H Preferred Stock, resulting in net proceeds of approximately $15.2 million. We believe that this financing meaningfully extends our cash runway and extends our ability to execute on our near-term operating objectives.

 

While this subsequent financing mitigates some of the liquidity risk, substantial doubt about our ability to continue as a going concern continues to exist unless and until we obtain additional capital to fund operations beyond the current planning horizon. There can be no assurance that we will be able to obtain such financing on acceptable terms, or at all. If we are unable to raise sufficient capital in the future, we may be forced to delay, reduce, or eliminate our research and development programs or future commercialization efforts, which would adversely affect our business prospects and ability to continue as a going concern.