ORAGENICS INC
For the period ended Sep 30, 2025. Filed Nov 7, 2025.
View on SEC.govAbout this filing
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.
Sep 30, 2025 · Filed Nov 7, 2025
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 2025-06-30; filed 2025-08-08.
0001641172-25-022766
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-07.
0001493152-25-021257
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 80 previous paragraphs and 81 current paragraphs.
49 unchanged; 19 reworded; 13 added; 12 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 8 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 (13)
Current report
The increase was primarily attributable to higher external research and consulting costs related to regulatory documentation, clinical-site preparation, and pre-trial activities associated with the Company’s ONP-002 concussion program. These increases were partially offset by lower formulation and laboratory costs compared to the prior-year period, which included wind-down activities for the company’s discontinued vaccine and antibiotic programs.
Current 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%.
Current 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.
Current 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.
Current 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.
Current 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.
Current 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.
Current 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.
Current 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.
Current report
Net cash provided by financing activities was $16.9 million for the nine months ended September 30, 2025, compared to $6.2 million for the same period in 2024.
Current 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.
Current 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.
Current 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.
Removed paragraphs (12)
Previous report
For the six months ended June 30, 2025, research and development expenses totaled $791,221, compared to $1.6 million for the same period in 2024, representing a decrease of $778,972 or 49.6%.
Previous report
In the 2025 periods, the decrease in research and development expenses, was primarily driven by a shift in program activity compared to the prior year. In the 2024 periods, research and development spending included costs related to our vaccine and antibiotics programs, in addition to ONP-002. In contrast, research and development activity in 2025 periods was solely focused on our lead candidate, ONP-002, specifically related to regulatory submissions and approvals required to initiate our Phase IIa clinical trial in Australia and New Zealand. By comparison, ONP-002-related activities in the 2024 periods included formulation work, IND-enabling studies, and broader Phase IIa development efforts.
Previous report
For the six months ended June 30, 2025, general and administrative expenses totaled $3.0 million compared to $3.2 million in the prior period, a decrease of $246,702, or 7.7%.
Previous report
For the quarter, the decrease was primarily driven by a $424,132 decrease in legal and professional fees and a $111,606 decrease in salaries and benefits, attributable to lower external legal support and reduced headcount, respectively. These decreases were partially offset by higher public company expenses of $64,256, reflecting increased audit and regulatory filing costs, and a $45,890 increase in insurance costs due to higher premiums.
Previous report
On a year-to-date basis, legal and professional fees declined $792,766 due to lower advisory and legal spend compared to the first half of 2024, which included transaction-related activity. Salaries and benefits were also down $382,783. Offsetting these declines were a $754,511 increase in patent expense, which was reclassified from research and development beginning in Q1 2025, as well as a $49,795 increase in public company expenses and $142,897 increase in investor relations driven by annual meeting and shareholder engagement costs.
Previous report
We expect general and administrative expenses may increase in future periods as we continue to meet our public company compliance obligations, support investor communications, and build operational infrastructure aligned with our development pipeline.
Previous report
Other income (expense) includes interest income, 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, including the amortization of the related debt discount and closing costs.
Previous report
For the three months ended June 30, 2025, total other expense was $557,833, compared to $910 of income in the prior year period. The change was primarily driven by an increase in interest expense of $570,507, related to the amortization of debt discount and financing costs associated with the $3.0 million note issued in March 2025. The note carries no stated interest unless in default, and the related expense reflects the accounting treatment of the original issue discount and issuance fees.
Previous report
The reduction in operating cash outflows year-over-year reflects a lower net loss and fewer R&D expenditures during the current period, consistent with our efforts to preserve capital while pursuing additional financing and partnership opportunities.
Previous report
Significant financing activities for the six months ended June 30, 2025, included $2.6 million in net proceeds from the issuance of common stock and $2.2 million in borrowing under short-term notes payable, primarily related to the $3.0 million promissory note issued in March 2025. These inflows were partially offset by $328,528 in repayments on short-term notes during the period.
Previous report
In comparison, financial activities for the six months ended June 30, 2024, included $2.8 million in net proceeds from the issuance of common stock, partially offset by $313,000 in payments on short-term notes payable.
Previous report
The increase in net financing activity year-over-year reflects the addition of debt financing in 2025, whereas the 2024 period relied solely on equity proceeds to support operations.
Reworded paragraphs (19)
Previous wording
We are a development-stage biopharmaceutical company dedicated to the research and development of nasal delivery 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. Our lead product, ONP-002, is a fully synthetic, non-naturally occurring neurosteroid, is lipophilic, and we believe 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 nasal delivery 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. 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
Subsequent to quarter end, 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.
Current wording
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 wording
During the three- and six-months ending June 30, 2025, there were no significant changes to our significant accounting policies and estimates as described in Note 2.Significant Accounting Policies included in Part II, Item 8. of our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 14, 2025.
Current wording
During the three- and nine-months ending September 30, 2025, there were no significant changes to our significant accounting policies and estimates as described in Note 2.Significant Accounting Policies included in Part II, Item 8. of our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 14, 2025.
Previous wording
As of June 30, 2025, we had $1.9 million in cash and cash equivalent. Subsequent to quarter end, on July 2, 2025, we completed a public offering of Series H Convertible Preferred Stock and warrants, resulting in net proceeds of approximately $15.2 million. We believe this capital will allow us to fund our current operating plan through the first half of 2026, depending on the timing and scope of our development activities and other strategic decisions.
Current wording
As of September 30, 2025, we had $11.4 million in cash and cash equivalents. We believe this capital will allow us to fund our current operating plan through the first half of 2026, depending on the timing and scope of our development activities and other strategic decisions.
Previous wording
For the three and six months ended June 30, 2025, and 2024, we did not generate any revenue. Our segment asset measure is reported on the consolidated balance sheet and total assets.
Current wording
For the three and nine months ended September 30, 2025, and 2024, 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 and six months ended June 30, 2025, and 2024.
Current wording
We do not currently sell or market any products and did not generate any revenue for the three and nine months ended September 30, 2025, and 2024.
Previous wording
For the three months ended June 30, 2025, research and development expenses were $449,679, compared to $906,779 for the same period in 2024, representing a decrease of $457,100 or 50.4%.
Current wording
For the three months ended September 30, 2025, research and development (“R&D”) expenses were $930,894, compared to $879,041 for the same period in 2024, representing an increase of $51,853, or 5.9%.
Previous wording
We anticipate that research and development expenses will increase in future periods as we initiate the Phase IIa trial in Australia, begin IND-enabling work to support a Phase IIb trial in the United States, and commence manufacturing of additional ONP-002 clinical trial material.
Current wording
We anticipate that research and development expenses will increase in future periods as we initiate the phase IIa clinical trial in Australia, begin IND-enabling work to support a Phase IIb trial in the United States, and commence manufacturing of additional ONP-002 clinical material.
Previous wording
For the three months ended June 30, 2025, general and administrative expenses were $1.3 million compared to $1.4 million in the same period in 2024, representing a decrease of $134,698, or 9.6%.
Current wording
For the three months ended September 30, 2025, general and administrative (“G&A”) expenses were $2.2 million, compared to $1.6 million for the same period in 2024, representing an increase of $634,640, or 40.7%
Previous wording
We expect general and administrative expenses to increase in future periods as we:
Current wording
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 wording
Since our inception, we have funded our operations primarily through the sale of equity securities in public and private offerings, debt financing, and the exercise of stock-based awards. As of June 30, 2025, we had an accumulated deficit of $221 million and have not yet achieved profitability. We incurred a net loss of $4.4 million for the six-months ended June 30, 2025, and $10.5 million for the year ended December 31, 2024. 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 warrants exercises. As of September 30, 2025, we had an accumulated deficit of $224.3 million and have not yet achieved profitability. We incurred a net loss of $7.6 million for the nine-months ended September 30, 2025, and $10.5 million for the year ended December 31, 2024. 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 six months ended June 30, 2025, and 2024 was $3.4 million and $4.6 million, respectively. In both periods, cash used in operations resulted primarily from our net losses adjusted for non-cash charges and changes in working capital.
Current wording
Cash used in operating activities for the nine months ended September 30, 2025, and 2024 was $6.4 million and $6.6 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 six months ending June 30, 2025, significant items affecting cash used in operating activities included a non-cash charge of $771,437 related to amortization of debt discount and an closing costs associated with our March 2025 financing, and stock-based compensation expense of $24,485, partially offset by a stock-based compensation recapture adjustment of $86,617. Changes in operating assets and liabilities also contributed to the net cash outflows, including a $441,707 increase in prepaid expenses and other current assets, and a $88,444 decrease in accounts payable and accrued expense, reflecting timing of payments and reduced research and development activity during the period.
Current wording
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 wording
For the six months ended June 30, 2024, non-cash adjustments included $127,564 of stock-based compensation, while working capital changes included a $111,939 increase in prepaid expenses and other current assets, and a $92,358 decrease in accounts payable and accrued expenses.
Current wording
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 wording
On March 13, 2025, the company issued a $3.0 million promissory note (the “Note”) to a single investor at an original issue discount. Net proceeds were approximately $2.2 million, net of placement fees and legal expenses.
Current wording
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 wording
The note is non-interest bearing, unless an event of default occurs, in which case interest accrues at a rate of 20% per annum. The note matures upon the earlier of (i) July 14, 2025, or (ii) the closing of any subsequent offering with net proceeds equal to or greater than the outstanding balance.
Current wording
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 wording
Subsequent to quarter-end, 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.
Current wording
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.
Previous wording
Short-term note payable consisted of the following
Current wording
Short-term notes payable consisted of the following:
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 six-month period ending June 30, 2025, and 2024, 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 nine-month period ending September 30, 2025, and 2024, inflation has not had a material impact on our results of operations.