ORAGENICS INC

Current report

On April 20, 2026, we announced that 2 patients and 8 study drug doses have been administered in our ongoing Phase IIa clinical trial evaluating ONP-002. Enrollment is progressing at Mackay Base Hospital in Queensland, Australia, the first activated site in the trial, with additional sites completing final activation steps.

Current report

Traumatic brain injury represents a significant neurological condition without an FDA-approved pharmacological treatment. According to the CDC, an estimated 1.7 to 3.8 million people in the U.S. experience traumatic brain injuries annually, with sports and recreational activities among the leading causes.1 Globally, an estimated 69 million individuals sustain traumatic brain injuries each year. Despite this scale, no pharmacological treatments have been approved — leaving patients, military personnel, athletes, and families without FDA-approved effective options beyond rest and symptom management. If approved by the FDA, ONP-002 would be the first and only pharmacological standard of care for a global concussion market projected to reach over $9 billion by 2030.2

Current report

Our Phase IIa trial is designed to enroll 40 patients who meet enrollment criteria based on CT scan findings, presenting symptoms, and emergency room or hospital admission. Patients receive first dosing within 12 hours of concussion, followed by continued treatment for up to 30 days. We believe early enrollment activity reflects both strong site readiness and the significant unmet clinical need in this patient population.

Current report

Recent Developments

Current report

On May 7, 2026, we announced that we had entered into a Letter of Intent (“LOI”) under which we expect to license from Sigyn Therapeutics, Inc. (“Sigyn”) certain disease indications of CardioDialysis™, a blood purification technology that enables the broad-spectrum clearance of inflammatory and pathogenic molecules from the bloodstream. Under the terms of the proposed license agreement, we would receive an exclusive license from Sigyn to develop and commercialize CardioDialysis™ for the treatment of Traumatic Brain Injury (TBI) and other chronic neurodegenerative diseases. The proposed transaction terms set forth in the LOI include that: (i) we expect to issue 3,250,000 shares of a new class of restricted preferred stock to Sigyn, convertible into common shares, (ii) we expect to pay a three percent (3%) royalty on revenue from sales of the licensed technology following FDA market clearance, for a period of six years from the date of first commercial sale per approved indication and country, (iii) the closing is expected to occur within 90 days from the effective date of the LOI, subject to completion of due diligence, board approvals, an independent third-party valuation, and other customary closing conditions, and (iv) Sigyn has agreed not to license the CardioDialysis™ technology to third parties for the proposed Target Markets during the exclusivity period.

Current report

The LOI is non-binding except for certain provisions including exclusivity, confidentiality, and governing law. The completion of a definitive agreement remains subject to due diligence satisfactory to us, board approvals by both companies, NYSE American continued listing compliance, and other customary closing conditions. Although the LOI provides that certain provisions are binding on the parties, it does not obligate the parties to consummate the proposed transaction. The consummation of the proposed transaction remains subject to due diligence and the negotiation, execution and delivery of a definitive license agreement and the satisfaction or waiver of applicable closing conditions. There can be no assurance that any definitive agreements will be entered into or that the proposed transaction will be consummated on the terms described therein or at all.

Current report

As of March 31, 2026, the Company had no outstanding promissory notes during the quarter.

Current report

1 American Association of Neurological Surgeons; Sports Related Head Injury / CDC TBI Data

Current report

2 Grand Market Research; Concussion Market (2025–2030)

Current report

The decrease was primarily driven by lower patent-related expenses, which declined by approximately $422,266 compared to the prior-year period. Salaries and benefits also decreased by approximately $83,289 due to reduced headcount. These decreases were partially offset by higher legal and professional fees, which increased by approximately $52,621, reflecting greater use of external advisors and consultants, as well as increased investor-relations expenses of approximately $26,351 related to ongoing shareholder communications and public-company activities.

Current report

We expect general and administrative expenses to remain relatively consistent, with potential increases driven by legal, regulatory, and public-company compliance requirements, as well as continued investor-relations activities supporting the Company’s strategic initiatives.

Current report

For the three months ended March 31, 2026, total other income was $32,059, compared to total other expense of $190,766 for the same period in 2025. The change was primarily driven by a significant decrease in interest expense of approximately $195,400 related to prior-year financing activities, as well as an increase in interest income of approximately $30,673 due to higher average cash balances. These favorable changes were partially offset by higher foreign currency exchange losses compared to the prior-year period.

Current report

For the three months ended March 31, 2026, non-cash adjustments were minimal and included stock-based compensation expense of $17,386 and $5,000 of common stock issued for services. In contrast, the prior-year period included $192,859 of amortization of debt discount and closing costs and a stock-based compensation recapture of $86,470, which did not recur in 2026.

Current report

Changes in operating assets and liabilities were a primary driver of operating cash flows in the current period, including a $232,398 increase in prepaid expenses and other current assets and a $53,082 increase in income receivables, partially offset by a $307,267 decrease in accounts payable and accrued expenses, reflecting the timing of vendor payments.

Current report

The increase in cash used in operating activities year over year was primarily attributable to these working capital changes and the absence of prior-year non-cash financing-related adjustments.

Current report

Investing Activities

Current report

Net cash provided by investing activities for the three months ended March 31, 2026, primarily consisted of proceeds from the maturity of a short-term certificate of deposit totaling $4,000,000. The Company also recognized $40,876 of interest income associated with this investment.

Current report

There were no comparable investment activities during the three-month ended March 31, 2025. The increase in cash inflows reflects the liquidation of short-term investments in the current period as the Company redeployed cash into operating activities.

Current report

Financing activities during the three months ended March 31, 2026, primarily consisted of $79,210 in net proceeds from the issuance of common stock, offset by $171,214 in repayments of short-term notes payable.

Current report

In contrast, financing activities for the three months ended March 31, 2025, were driven by $2.6 million in net proceeds from the issuance of common stock and $2.2 million in borrowings under short-term notes payable, partially offset by $195,565 in repayments of such borrowings.

Current report

The year-over-year decrease in financing cash inflows reflects the absence of significant equity raises and borrowing activity in the current period compared to the prior-year period.

Previous report

On July 2, 2025, we completed a public offering of 660,000 shares of Series H Convertible Preferred Stock and 660,000 common stock warrants to purchase additional shares of Series H Convertible Preferred Stock, resulting in net proceeds of approximately $15.2 million. See Note 7 of Notes to Consolidated Financial Statements.

Previous report

In March 2025, we issued a $3.0 million promissory note at a 17% original issue discount. After expenses, we received net proceeds of $2.2 million.

Previous report

On July 2, 2025, the Company repaid in full the $3.0 million promissory note. The repayment was made using a portion of the net proceeds from the Company’s July 2, 2025, public offering of Series H Preferred Shares and warrants. See Note 5 of Notes to Consolidated Financial Statements.

Previous report

For the nine months ended September 30, 2025, R&D expenses totaled $1.7 million compared to $2.4 million for the same period in 2024, representing a decrease of $727,119, or 29.7%.

Previous report

The year-to-date decrease was primarily due to the completion of non-core program work in 2024 and a shift in focus toward ONP-002 regulatory submissions and manufacturing readiness, resulting in lower laboratory and preclinical costs. The decrease also reflects lower use of external consultants and reduced contract research activity outside of the ONP-002 program.

Previous report

The increase was primarily driven by higher legal and professional fees, which rose $1.1 million year over year and included a $700,000 accrual related to the Ladenburg Thalmann legal settlement recorded as of September 30, 2025. Excluding this accrual, legal and professional fees increased approximately $375,000, reflecting higher legal, audit, and regulatory compliance costs associated with maintaining public-company status and supporting the Company’s Series H Preferred Shares financing.

Previous report

Investor-relations expense increased by $63,325, due to enhanced shareholder engagement and communication activity surrounding the July 2025 capital raise. Salaries and benefits decreased by $514,594, reflecting lower headcount. Patent-related expenses increased by $44,249 due to continued investment in intellectual property protection following the reclassification of patent costs from R&D to G&A in Q1 2025. Insurance expense was relatively consistent, increasing modestly by $421, while board compensation decreased by $13,126 as a result of changes in board membership. Other variances included a $33,664 decrease in public company expenses, a $12,654 increase in travel, and $3,312 increase in miscellaneous items.

Previous report

For the nine months ended September 30, 2025, G&A expenses totaled $5.1 million, compared to $4.8 million for the same period in 2024, representing an increase of $387,938, or 8.2%. The year-to-date increase was driven primarily by a $798,760 rise in patent-related legal expenses, a $206,222 increase in investor-relations costs, and a $26,101 increase in insurance expenses. These increases were partially offset by a $897,377 decrease in salaries and benefits, reflecting the full impact of headcount reduction earlier in the year, and a $29,375 reduction in board compensation compared to the same period in 2024.

Previous report

We expect general and administrative expenses may continue to increase modestly in future periods as we maintain compliance with public-company reporting requirements, continue investor-relations efforts, and support the operational infrastructure needed to advance the ONP-002 program.

Previous report

For the three months ended September 30, 2025, total other income was $57,184, compared to an expense of $25,590 in 2024. The change was primarily due to higher interest income from invested cash following the July 2025 financing and lower foreign-exchange losses.

Previous report

For the nine months ended September 30, 2025, total other expense was $691,415, compared to $15,412 in 2024, primarily reflecting amortization of debt discount and closing costs related to the $3.0 million short-term promissory note issued in March 2025, partially offset by higher interest income on cash balances.

Previous report

See “Recent Funding” above for our discussion of our July 2025 public offering of Series H Preferred Stock and warrants.

Previous report

For the nine months ended September 30, 2025, significant non-cash items affecting operating cash flows included $771,437 of amortization of debt discount and closing costs associated with the March 2025 short-term promissory note, stock-based compensation expense of $30,525, and a stock-based compensation recapture adjustment of $86,617. Changes in operating assets and liabilities also contributed to the net cash outflow, including a $694,108 increase in prepaid expenses and other current assets and a $1.1 million increase in accounts payable and accrued expenses, primarily reflecting timing of vendor payments and ongoing ONP-002 program activities.

Previous report

For the nine months ended September 30, 2024, non-cash adjustments included $458,366 of stock-based compensation, while working capital changes included a $49,951 increase in prepaid expenses and other current assets and a $131,449 increase in accounts payable and accrued expenses.

Previous report

The slight reduction in operating cash outflows year-over-year primarily reflects lower R&D expenditures and improved working capital management, partially offset by higher general and administrative expenses associated with maintaining public-company operations, legal settlements, and financing activities in 2025.

Previous report

The increase was primarily attributable to the completion of the July 2025 Series H Preferred Stock and warrant financing, which generated net proceeds of approximately $15.2 million, as well as $2.6 million in net proceeds from sales of common stock during the period. The Company also received $2.2 million in borrowing under short-term notes payable, primarily related to the March 2025 promissory note and new insurance premium financing.

Previous report

These inflows were partially offset by $3 million in repayments of short-term notes payable. In comparison, financing activities for the nine months ended September 30, 2024, consisted primarily of $6.6 million of common stock, partially offset by $430,283 in repayment of short-term notes payable.

Previous report

On March 13, 2025, we issued a $3.0 million promissory note (the “Note”) to a single investor at an original issue discount of 17%. Net proceeds to us were approximately $2.2 million after placement agent fees of $175,000 and legal expenses of $98,437.

Previous report

The Note was a non-interesting bearing unless an event of a default occurred, at which time interest would accrue at a rate of 20% per annum. The Note was scheduled to mature on the earlier of July 14, 2025, or the closing of any subsequent offering with net proceeds equal to or exceeding all amounts due under the Note.

Previous report

In connection with the issuance of the Note, we designated and issued 1,000,000 shares of our authorized but unissued Series G Mirroring Preferred Stock. For a description of the Series G terms, see Note 8. We used the net proceeds for working capital and general corporate purposes. Subsequently, in connection with the Reverse Stock Split the shares of Series G Preferred Stock were cancelled. See Note 8.

Previous report

On July 2, 2025, the Company repaid in full the $3.0 million promissory note issued on March 13, 2025. The repayment was made using a portion of the net proceeds from the Company’s July 2, 2025, public offering of Series H Preferred Stock and warrants to purchase additional shares of Series H Preferred Stock.