ORAGENICS INC
For the period ended Jun 30, 2025. Filed Aug 8, 2025.
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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, 2025 · Filed Aug 8, 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 2025-03-31; filed 2025-05-09.
0001641172-25-009464
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 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 68 previous paragraphs and 80 current paragraphs.
35 unchanged; 15 reworded; 30 added; 18 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 8 previous and 8 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 (30)
Current 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.
Current report
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 report
We expect to incur substantial expenditures to further develop out neurology assets, including increased cost related to research, nonclinical testing, clinical trials, regulatory submissions, and the ongoing requirements of being a public company. Subject to our ability to raise additional capital, we plan to continue advancing the ONP-002 toward Phase II clinical trials and further IND-enabling work.
Current report
To support these activities, we may seek additional equity and debt financings, as well as strategic alliances, joint ventures, licensing agreements, or other business arrangements that could generate sufficient capital to sustain our operations.
Current report
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 report
Additional capital will still be required to complete planned clinical trials, regulatory filings, and any future commercialization efforts. There can be no assurance that such funding will be available on favorable terms, or at all. If we are unable to secure sufficient capital, we may be forced to delay, scale back, or eliminate certain development programs, which would adversely impact our business and strategic objectives.
Current report
Due to uncertainties associated with clinical development, regulatory approval timelines, and partnership negotiations, we cannot precisely estimate our future capital requirements. However, our needs will depend on many factors, including but not limited to:
Current report
We have based these forward-looking statements on assumptions we believe are reasonable; however, actual results and funding needs may differ materially from our current expectations.
Current report
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 report
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 report
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 report
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 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%.
Current 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.
Current report
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 report
We expect general and administrative expenses to increase in future periods as we:
Current report
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 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%.
Current 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.
Current 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.
Current 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.
Current 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.
Current report
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 report
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 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.
Current 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.
Current report
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 report
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 report
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 report
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.
Removed paragraphs (18)
Previous report
Subject to our ability to raise additional capital including through possible joint ventures and/or partnerships, we expect to incur substantial expenditures to further commercialize or develop our Neurology Assets, including continued increases in costs related to research, nonclinical testing and clinical trials, as well as costs associated with our capital raising efforts and being a public company.
Previous report
Our plans include seeking both equity and debt financing, alliances or other partnership agreements with entities interested in our technologies, or other business transactions that would generate sufficient resources to ensure continuation of our operations and research and development programs.
Previous report
Our available cash and cash equivalents of $3.4 million at March 31, 2025 provide us with limited liquidity. We believe our existing cash and cash equivalents will allow us to fund our operating plan through the third quarter of 2025. Required additional capital may not be available on reasonable terms, if at all. If we were unable to obtain additional financing, we may be required to reduce the scope of, delay or eliminate some or all of our planned clinical testing, research and development and commercialization activities, which would harm our business.
Previous report
Because of the numerous risks and uncertainties associated with research, development, and commercialization of our product candidates, we are unable to estimate the exact amounts of our working capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:
Previous report
We have based our estimates on assumptions that may prove to be wrong. We may need to obtain additional funds sooner or in greater amounts than we currently anticipate.
Previous report
We operate in one reportable segment, which includes all activities related to advancing the development of our concussion drug, ONP-002. The determination of a single reportable segment is consistent with the consolidated financial information regularly provided to our chief operating decision maker (CODM). Our CODM is presently our Chief Financial Officer and Interim Chief Executive Officer, who reviews and evaluates consolidated net loss for purposes of assessing performance, making operating decisions, allocating resources and planning and forecasting for future periods. The measure of segment assets is reported on the balance sheet as total assets. During the three-month periods ended March 31, 2025 and 2024 there was no segment revenue.
Previous report
Research and development consist of expenses incurred in connection with the discovery and development of our product candidates and are divided into clinical research and nonclinical research and development activities.
Previous report
Clinical research activities consist of clinical trials, manufacturing services and regulatory activities, all of which are largely provided by third parties.
Previous report
Nonclinical research and development activities consist of our own research activities, research activities provided by third parties, our own nonclinical studies, nonclinical studies provided by third parties and the acquisition of in process research and development.
Previous report
The decrease in research and development in the three months ended March 31, 2025 compared to the same period of 2024 was due to decreased expense related to our research and development for ONP-002 during the comparable periods.
Previous report
General and administrative expense consists principally of salaries and related costs for personnel in executive, finance, business development, marketing, information technology, legal and human resources functions, facility costs not otherwise included in Research and development expenses, patent filing fees and professional fees for legal, consulting, auditing, and tax services.
Previous report
We anticipate that our general and administrative expenses will increase for the following reasons:
Previous report
The decrease in general and administrative expense was due to the following:
Previous report
The increase in legal and professional fees of $65,588 is the result of a $143,735 decrease in accounting expense, $77,260 in legal expense and $147,640 in consulting expenses offset by an increase in patent related expense in the amount of $434,222 as compared to the three months ending March 31, 2024. Salaries and benefits decreased due to lower headcount in the three months ending March 31, 2025 compared to the first quarter ending March 31, 2024. Investor relations expense was increased by $126,677 due to expenses related to our annual shareholder meeting in the three months ending March 31, 2025 as compared to the same period in 2024.
Previous report
The increase in interest expense of $192,042 for the three months ending March 31, 2025, relates to the amortization of the debt discount and closing costs incurred for the $3 million debt financing entered into in March 2025.
Previous report
Cash used in operating activities in both periods resulted from our net loss adjusted for non-cash expenses and changes in operating assets and liabilities.
Previous report
Significant items affecting net cash used in operating activities in the three months ended March 31, 2025 included a non-cash charge of $0.2 million of amortization of debt discount and closing costs, a $0.1 million increase in Prepaid expense and other current assets and a $0.2 million decrease in Accounts payable and accrued expenses.
Previous report
Inflation affects the cost of raw materials, goods, and services that we use. Fluctuations in energy costs and commodity prices can affect the cost of raw materials and components. Except with respect to payroll-related costs and costs arising from, or related to, government-imposed regulations, we do not believe that inflation has had a material impact on our results of operations for the periods presented.
Reworded paragraphs (15)
Previous wording
We are a development-stage company dedicated to the research and development of nasal delivery pharmaceutical medications in neurology and fighting infectious diseases. 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 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
Our lead product and focus is on the development and commercialization of ONP-002 for the treatment of mild traumatic brain injury (“mTBI” or “Concussion”).
Current wording
Our lead product and focus are on the development and commercialization of ONP-002 for the treatment of mild traumatic brain injury (“mTBI” or “Concussion”).
Previous wording
In February 2025, we sold 7.8 million shares pursuant to our ATM Agreement with Dawson James for net proceeds of $2.6 million. See Note 7 of Notes to Consolidated Financial Statements.
Current wording
In February 2025, we sold 260,000 shares pursuant to our ATM Agreement with Dawson James for net proceeds of $2.6 million. See Note 7 of Notes to Consolidated Financial Statements.
Previous wording
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. See Note 5 of Notes to Consolidated Financial Statements.
Current wording
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 wording
During the three months ended March 31, 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 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.
Previous wording
Our capital requirements for 2025 will depend on numerous factors, including the success of our commercialization efforts and of our research and development, the resources we devote to develop and support our technologies and our success in pursuing strategic licensing and funded product development relationships with external partners.
Current wording
Our capital requirements for 2025 and beyond will depend on numerous factors, including the success of our research and development efforts, the progress of our ONP-002 program, and our ability to secure strategic partnerships or licensing arrangements to support our pipeline.
Previous wording
The sale of additional equity or debt securities may result in dilution to our shareholders. If we raise additional funds through the issuance of debt securities or preferred stock, these securities could have rights senior to those of our common stock and could contain covenants that would restrict our operations.
Current wording
The sale of additional equity or convertible securities could result in significant dilution to our existing shareholders. If we raise funds through debt or preferred stock, these instruments may have rights senior to our common stock and could impose restrictive covenants on our operations.
Previous wording
We do not currently sell or market any products and we did not have any revenue in the three-month periods ended March 31, 2025 or 2024.
Current 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.
Previous wording
Other income (expense) includes local business taxes, interest income, interest expense and realized gains and losses related to foreign currency exchange rates with our vendors. Interest income consists of interest earned on our cash and cash equivalents. The primary objective of our investment policy is capital preservation. Interest expense consists primarily of interest and costs associated with our short-term note payable.
Current wording
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 wording
See Recent Funding above for a discussion of our recent financings.
Current wording
See “Recent Funding” above for our discussion of our July 2025 public offering of Series H Preferred Stock and warrants.
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 exercises of stock-based securities. As of March 31, 2025, we had an accumulated deficit of $219 million and we have yet to achieve profitability. We incurred net losses of $2.2 million for the three months ended March 31, 2025 and $10.5 million for the year ended December 31, 2024. We expect to incur significant and increasing operating losses for the foreseeable future as we seek to advance our Neurology Assets through nonclinical testing and clinical trials to ultimately obtain regulatory approval and eventual 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 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.
Previous wording
Significant items affecting net cash used in operating activities in the three months ended March 31 2024 included a non-cash charge of $0.1 million for stock-based compensation, a $0.1 million decrease in Prepaid expenses and other current assets and a $0.7 million increase in Accounts payable and accrued expenses.
Current 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.
Previous wording
Significant financing activities in the three months ended March 31, 2025 included $2.6 million net proceeds from the issuance of common stock, and $2.2 million in borrowings on short-term notes payable, offset by $0.2 million used for payments on our short-term note payable.
Current wording
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 wording
Significant financing activities in the three months ended March 31, 2024 included $1.8 million net proceeds from the issuance of common stock, partially offset by $0.2 million used for payments on our short-term note payable.
Current wording
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 wording
Our Short-term notes payable consisted of the following:
Current wording
Short-term note payable consisted of the following