ORAGENICS INC
For the period ended Jun 30, 2026. Filed Aug 13, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 13, 2026
OGEN$0.35+0.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-08.
0001493152-26-021967
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-13.
0001493152-26-037749
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 81 previous paragraphs and 88 current paragraphs.
52 unchanged; 27 reworded; 9 added; 2 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 6 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
As of June 30, 2026, we have enrolled 9 participants and have administered 34 study drug doses in our ongoing Phase IIa clinical trial evaluating ONP-002 in concussed patients in Australia. Enrollment is progressing at three sites in Australia; Mackay Base Hospital, Alfred Health, and Royal Adelaide Hospital. Zero serious adverse events have been reported across all treated participants to date.
Current report
In July of 2026 we submitted our Type B Meeting request to the U.S. Food and Drug Administration (FDA) and followed that with submission of our full briefing dossier. The meeting with the FDA is intended to facilitate FDA guidance on our planned U.S. clinical development program for ONP-002, in support of our Investigational New Drug (IND) application, which remains targeted for submission by the end of 2026.
Current report
Effective July 1, 2026, the Board of Directors appointed John Spencer, the Company’s Senior Controller, to serve as the Company’s Chief Financial Officer, and, in connection therewith, effective July 1, 2026, the Company entered into an Executive Employment Agreement with Mr. Spencer (the “Employment Agreement”). The Employment Agreement provides for base compensation of $200,000.
Current report
For the six months ended June 30, 2026, R&D expenses were $1.8 million compared to $791,221 for the same period in 2025, representing an increase of $1,030,876, or 130.3%.
Current report
The increase was primarily driven by higher patent-related expenses of approximately $405,000. This increase was partially offset by lower salaries and benefits of approximately $135,000 due to reduced headcounts, lower public company expenses of approximately $76,000, and lower investor relations expenses of approximately $21,000.
Current report
For the six months ended June 30, 2026, G&A expenses were $3 million, compared to $2.9 million for the same period in 2025, representing an increase of $77,150, or 2.6%.
Current report
The increase was primarily driven by higher legal and professional fees of approximately $390,000, reflecting greater use of external advisors and consultants. This increase was substantially offset by lower salaries and benefits of approximately $219,000 due to reduced headcount, lower public company expenses of approximately $74,000, lower insurance expense of approximately $22,000, lower travel expense of approximately $23,000, and lower patent-related expenses of approximately $17,000.
Current report
Other income (expense) includes interest expense, and realized gains or losses related to foreign currency exchange rates with our vendors. Interest income reflects earnings on our cash and cash equivalents, which are invested with a primary objective of capital preservation. Interest expense consists of costs associated with our short-term note payable for financing insurance premiums.
Current report
Subsequent to June 30, 2026, the Company renewed its annual commercial insurance program and entered into a premium financing agreement in the ordinary course of business. Under the agreement, approximately $504,664 of insurance premiums were financed and are payable in monthly installments through April 2027.
Removed paragraphs (2)
Previous 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.
Previous 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.
Reworded paragraphs (27)
Previous wording
These statements are often, but not always, made through the use of word or phrases such as “believe,” “will,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” and “would. “These forward-looking statements are not guarantees of future performance and concern matters that could subsequently differ materially from those described in the forward-looking statements. Actual events or results may differ materially from those discussed in this Quarterly Report on Form 10-Q. Except as may be required by applicable law, we undertake no obligation to update any forward-looking statements or to reflect events or circumstances arising after the date of this Report.
Current wording
These statements are often, but not always, made through the use of word or phrases such as “believe,” “will,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “would,” and “These,” forward-looking statements are not guarantees of future performance and concern matters that could subsequently differ materially from those described in the forward-looking statements. Actual events or results may differ materially from those discussed in this Quarterly Report on Form 10-Q. Except as may be required by applicable law, we undertake no obligation to update any forward-looking statements or to reflect events or circumstances arising after the date of this Report.
Previous wording
We are a development-stage biopharmaceutical company dedicated to the research and development of nasal delivery pharmaceutical therapies targeting neurological conditions; delivered with our novel and proprietary intranasal drug delivery device. The Company is currently focused on advancing the development and commercialization of its lead product candidate, ONP-002. Our lead product, ONP-002, is a fully synthetic, non-naturally occurring neurosteroid, is lipophilic, and we believe it can cross the blood-brain barrier with the goal of rapidly eliminating swelling, oxidative stress and inflammation while restoring proper blood flow through gene amplification.
Current wording
We are a development-stage biopharmaceutical company dedicated to the research and development of nasally delivered pharmaceutical therapies targeting neurological conditions; delivered with our novel and proprietary intranasal drug delivery device. The Company is currently focused on advancing the development and commercialization of its lead product candidate, ONP-002. Our lead product, ONP-002, is a fully synthetic, non-naturally occurring neurosteroid, is lipophilic, and we believe it can cross the blood-brain barrier with the goal of rapidly eliminating swelling, oxidative stress and inflammation while restoring proper blood flow through gene amplification.
Previous wording
This product development plan is an estimate and is subject to change based on funding, technical risks and regulatory approvals.
Current wording
This product development plan is an estimate and is subject to change based on additional funding (of which there can be no assurances), technical risks and regulatory approvals.
Previous wording
Success in the biopharmaceutical and product development industry relies on the continuous development of novel product candidates. Most product candidates do not make it past the clinical development stage, which forces companies to look externally for innovation. Accordingly, we expect, from time to time, to seek strategic opportunities through various forms of business development, which can include strategic alliances, licensing deals, joint ventures, collaborations, equity or debt-based investments, dispositions, mergers, and acquisitions. We view these business development activities as a necessary component of our strategies, and we seek to enhance shareholder value by evaluating business development opportunities both within and complementary to our current business, as well as opportunities that may be new and separate from the development of our existing product candidates.
Current wording
Success in the biopharmaceutical and product development industry relies on the continuous development of novel product candidates. Most product candidates do not make it past the clinical development stage, as a result of which companies frequently look externally for innovation. Accordingly, we expect, from time to time, to seek strategic opportunities through various forms of business development, which can include strategic alliances, licensing deals, joint ventures, collaborations, equity or debt-based investments, dispositions, mergers, and acquisitions. We view these business development activities as a necessary component of our strategies, and we seek to enhance shareholder value by evaluating business development opportunities both within and complementary to our current business, as well as opportunities that may be new and separate from the development of our existing product candidates.
Previous wording
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 wording
On May 7, 2026, we announced that we had entered into a Letter of Intent (“LOI”) under which we expected to negotiate a license with Sigyn Therapeutics, Inc. (“Sigyn”) pursuant to which we would license 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, it was anticipated that 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 included that: (i) we would expect to issue 3,250,000 shares of a new class of restricted preferred stock to Sigyn, convertible into common shares, (ii) we would 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 was 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 would agree not to license the CardioDialysis™ technology to third parties for the proposed Target Markets during the exclusivity period.
Previous wording
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 wording
The LOI is non-binding except for certain provisions including exclusivity, confidentiality, and governing law. The completion of a definitive agreement was 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. As of the date hereof, we are not actively negotiating such license agreement or undertaking any further due diligence regarding CardioDialysis and have paused discussions with Sigyn, choosing instead to continue to focus on ONP-002 and our capital raising efforts. There can be no assurances that we will resume our negotiations with Sigyn or that we will ever enter into any definitive agreements with Sigyn.
Previous wording
As of March 31, 2026, we had $6.1 million in cash and cash equivalents. We believe this capital will allow us to fund our current operating plan through the end of 2026, depending on the timing and scope of our development activities and other strategic decisions.
Current wording
As of June 30, 2026, we had $3.9 million in cash and cash equivalents. We believe this capital will allow us to fund our current operating plan through the end of 2026, depending on the timing and scope of our development activities and other strategic decisions.
Previous wording
We operate in a single reportable segment, which includes all activities related to the development of our lead product candidate, ONP-002, for the treatment of mild traumatic brain injury (concussion). This determination is consistent with how financial information is reviewed and evaluated by our Chief Operation Decision Maker (“CODM”) for purposes of performance assessment, resource allocation, and planning.
Current wording
We operate in a single reportable segment, which includes all activities related to the development of our lead product candidate, ONP-002, for the treatment of mild traumatic brain injury (concussion). This determination is consistent with how financial information is reviewed and evaluated by our Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”) for purposes of performance assessment, resource allocation, and planning.
Previous wording
Our CODM is currently our Chief Executive Officer and Chief Financial Officer, who regularly reviews consolidated net loss and total assets as key measures in operating decision-making. We do not separately evaluate results by geographic region or product line.
Current wording
Our CEO and CFO regularly review consolidated net loss and total assets as key measures in operating decision-making. We do not separately evaluate results by geographic region or product line.
Previous wording
For the three months ended March 31, 2026, and 2025, we did not generate any revenue. Our segment asset measure is reported on the consolidated balance sheet and total assets.
Current wording
For the six months ended June 30, 2026, and 2025, we did not generate any revenue. Our segment asset measure is reported on the consolidated balance sheet and total assets.
Previous wording
We do not currently sell or market any products and did not generate any revenue for the three months ended March 31, 2026, and 2025.
Current wording
We do not currently sell or market any products and did not generate any revenue for the six months ended June 30, 2026, and 2025.
Previous wording
For the three months ended March 31, 2026, research and development (“R&D”) expenses were $645,470, compared to $341,542 for the same period in 2025, representing an increase of $303,928, or 88.9%.
Current wording
For the three months ended June 30, 2026, research and development (“R&D”) expenses were $1.2 million compared to $449,679 for the same period in 2025, representing an increase of $726,948, or 161.7%.
Previous wording
Subject to our ability to raise additional capital, the Company expects R&D expenses to increase in future periods as it advances the ONP-002 program, including initiating a Phase IIa clinical trial in Australia, conducting IND-enabling activities to support a Phase IIb trial in the United States, and scaling manufacturing of clinical trial material.
Current wording
Subject to our ability to raise additional capital, the Company expects R&D expenses to increase in future periods as it advances the ONP-002 program, including the ongoing Phase IIa clinical trial in Australia, conducting IND-enabling activities to support U.S. based clinical trials, and scaling manufacturing of clinical trial material.
Previous wording
For the three months ended March 31, 2026, general and administrative (“G&A”) expenses were $1,610,457, compared to $1,684,685 for the same period in 2025, representing a decrease of $74,228, or 4.4%.
Current wording
For the three months ended June 30, 2026, general and administrative (“G&A”) expenses were $1.4 million, compared to $1.3 million for the same period in 2025, representing an increase of $151,378, or 12.0%.
Previous wording
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 wording
For the three months ended June 30, 2026, total other income, net was $17,444, compared to total other expense, net of $557,833 for the same period in 2025. The change was primarily attributable to a significant decrease in interest expense of approximately $571,896 resulting from the repayment of the Company’s short-term financing obligations outstanding during the prior-year period, as well as an increase in interest income of approximately $13,233 due to higher average cash and investment balances. These favorable changes were partially offset by higher foreign currency exchange losses of approximately $9,852 compared to the prior-year period.
Previous wording
Since our inception, we have funded our operations primarily through the sale of equity securities in public and private offerings, debt financing, and warrants exercises. As of March 31, 2026, we had an accumulated deficit of $228.8 million and have not yet achieved profitability. We incurred a net loss of $2.2 million for the three months ended March 31, 2026, and $9.8 million for the year ended December 31, 2025. We expect to continue incurring significant operating losses as we advance the development of our Neurology Assets, including ONP-002, through regulatory and clinical stages toward potential commercialization.
Current wording
Since our inception, we have funded our operations primarily through the sale of equity securities in public and private offerings, debt financing, and warrant exercises. As of June 30, 2026, we had an accumulated deficit of $231.4 million and have not yet achieved profitability. We incurred a net loss of $4.7 million for the six months ended June 30, 2026, and $9.8 million for the year ended December 31, 2025. We expect to continue incurring significant operating losses as we advance the development of our Neurology Assets, including ONP-002, through regulatory and clinical stages toward potential commercialization.
Previous wording
Cash used in operating activities for the three months ended March 31, 2026, and 2025 was $2.2 million and $2.1 million, respectively. In both periods, cash used in operations primarily reflected the Company’s net losses adjusted for non-cash charges and changes in working capital accounts.
Current wording
Cash used in operating activities for the six months ended June 30, 2026, and 2025 was $4.4 million and $3.4 million, respectively. In both periods, cash used in operations primarily reflected the Company’s net losses adjusted for non-cash charges and changes in working capital accounts.
Previous wording
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 wording
For the six months ended June 30, 2026, non-cash adjustments primarily consisted of $34,969 of stock-based compensation expense and $5,000 of common stock issued for services. In contrast, the prior-year period included $771,437 of amortization of debt discount and closing costs, partially offset by an $86,617 stock-based compensation recapture, neither of which recurred in 2026.
Previous wording
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 wording
Changes in operating assets and liabilities also impacted operating cash flows during the current period, including a $53,082 decrease in interest receivable, a $13,361 increase in prepaid expenses and other current assets, and a $262,856 increase in accounts payable and accrued expenses, primarily reflecting the timing of vendor payments.
Previous wording
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 wording
The increase in cash used in operating activities year over year was primarily attributable to higher working capital requirements and the absence of significant prior-year non-cash financing-related adjustments, partially offset by lower net cash outflows from prepaid expenses.
Previous wording
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 wording
Net cash provided by investing activities for the six months ended June 30, 2026, primarily consisted of proceeds from the maturity of a short-term certificate of deposit totaling $4 million. The Company also recognized $40,876 of interest income associated with this investment.
Previous wording
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 wording
There were no comparable investment activities during the six months ended June 30, 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.
Previous wording
Net cash used in financing activities was $92,004 for the three months ended March 31, 2026, compared to net cash provided by financing activities of $4,668,328 for the same period in 2025.
Current wording
Net cash used in financing activities was $148,138 for the six months ended June 30, 2026, compared to net cash provided by financing activities of $4.5 million for the same period in 2025.
Previous wording
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 wording
Financing activities during the six months ended June 30, 2026, consisted of $227,348 in repayments of short-term notes payable and proceeds from issuance of common stock of $79,210.
Previous wording
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 wording
In contrast, financing activities during the six months ended June 30, 2025, were primarily 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 $328,528 in repayments of short-term notes payable.
Previous wording
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.
Current wording
The year-over-year decrease in financing cash inflows primarily reflects the absence of equity financing and borrowings during the current period, compared to the prior-year period.
Previous wording
Inflation may impact the cost of services and supplies used in our operations, including professional services, insurance premiums, and research-related vendor agreements. Increases in wages, employee benefits, and regulatory compliance costs may continue to exert upward pressure on operating expenses. However, because we are currently in the development stage and do not maintain significant manufacturing operations or large-scale procurement of raw materials, we have not experienced material inflationary effect on our operating results. For the three-month period ending March 31, 2026, and 2025, inflation has not had a material impact on our results of operations.
Current wording
Inflation may impact the cost of services and supplies used in our operations, including professional services, insurance premiums, and research-related vendor agreements. Increases in wages, employee benefits, and regulatory compliance costs may continue to exert upward pressure on operating expenses. However, because we are currently in the development stage and do not maintain significant manufacturing operations or large-scale procurement of raw materials, we have not experienced material inflationary effect on our operating results. For the six months ended June 30, 2026, and 2025, inflation has not had a material impact on our results of operations.