ORAGENICS INC
For the period ended Dec 31, 2025. Filed Mar 16, 2026.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 16, 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-K
Period ended 2024-12-31; filed 2025-03-14.
0001493152-25-010389
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-16.
0001493152-26-010282
Item 7. 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 86 previous paragraphs and 105 current paragraphs.
38 unchanged; 19 reworded; 47 added; 29 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 15 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 (47)
Current report
Stock Sale
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 million. See Note 7 of Notes to Consolidated Financial Statements.
Current report
Promissory Note
Current 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.
Current 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 6 of Notes to Consolidated Financial Statements.
Current report
Our operating plan requires significant expenditures related to research and development activities, including nonclinical studies and planned Phase 2 clinical trials for ONP-002, as well as general and administrative costs necessary to support our operations. In addition, certain of our license agreements require the payment of ongoing and milestone-based royalties, which may further impact our liquidity.
Current report
These conditions raised substantial doubt about our ability to continue as a going concern within one year after the date that the consolidated financial statements included in this Annual report are issued.
Current report
Management’s plans to address these conditions include pursuing additional sources of capital, which may consist of equity or debt financings, strategic collaborations, licensing agreements, or other funding alternatives. However, there can be no assurance that such financing will be available on acceptable terms, or at all.
Current report
If we are unable to obtain sufficient additional funding when needed, we may be required to delay, reduce, or eliminate certain research and development programs or curtail operations. The consolidated financial statements do not include any adjustments that might result from outcome of this uncertainty.
Current report
We expect to incur substantial expenditures to further develop our 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 December 31, 2025, we had $8.4 million in cash and cash equivalents. We believe this capital will allow us to fund our current operating plan through the third quarter 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
In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all the deferred income tax assets will not be realized. The ultimate realization of deferred income tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred income tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. Based on consideration of these items, management has determined that a full valuation allowance is required as of December 31, 2025, and 2024.
Current report
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the U.S. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provision of the Tax Cuts and Jobs Act, modification to the international tax framework and the restoration of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective in 2025 and other implemented through 2027. The bill does not materially impact the Company’s 2025 income tax provision.
Current report
For the years ended December 31, 2025, and 2024, the Company incurred $0 and $0, respectively, of additional unrecognized tax benefits that related to research and development credits. The entire amount of this unrecognized tax benefit, if recognized, would result in an increase to the deferred tax asset valuation allowance, and would not have an impact on the effective tax rate.
Current report
We define critical accounting estimates as those estimates that require the use of assumptions or judgements that are inherently uncertain and that could have a material impact on our financial condition or results of operations if actual results differ from those estimates.
Current report
While our significant accounting policies are described in the notes to the consolidated financial statements, we believe the following accounting estimates involve a higher degree of judgment and complexity and are therefore considered critical to the preparation of our financial statements:
Current report
Actual results could differ from management’s estimates, and such differences could be material to our consolidated financial statement. Management evaluates its estimates and assumptions on an ongoing basis and adjusts them when facts and circumstances change.
Current report
We account for stock-based compensation in accordance with U.S. Generally Accepted Accounting Principles (“U.S. GAAP”), which require share-based payment transactions with employees and non-employees to be recognized in the financial statements based on the grant-date fair value of the equity awards. The fair value of stock options is typically estimated using the Black-Scholes option-pricing model.
Current report
Stock-based compensation expense is recognized over the requisite service period during which the employee or non-employee is required to provide service, unless the award vests immediately. Compensation expense related to stock-based awards is classified within research and development expense or general and administrative expense in the consolidated statements of operations, based on the nature of services provided.
Current report
For stock options and other equity awards that include service-based vesting conditions, compensation expense is recognized on a straight-line basis over the vesting period. For performance-based awards that do not include market-based conditions, we recognize compensation expense only when achievement of the applicable performance condition is considered probable. Management uses both quantitative and qualitative factors to assess the probability of achieving such performance conditions.
Current report
We account for forfeitures of stock-based awards as they occur and record forfeitures as a reduction of stock-based compensation expense.
Current report
Research and development expenses were $2.4 million for the year ended December 31, 2025, compared to $4.1 million for the year ended December 31, 2024, representing a decrease of $1.7 million or 41.8%.
Current report
The decrease was primarily attributable to reduced nonclinical and contract research activity compared to 2024, which included higher levels of external development work and program wind-down costs associated with discontinued vaccine and antibiotic programs. During 2025, the Company focused on its research and development efforts on advancing ONP-002, which expenditures primarily related to regulatory preparation, manufacturing readiness, and consulting services. While ONP-002 activities continued during 2025, overall laboratory, formulation, and preclinical spending was lower than the prior year. The Company expects research and development expenses to increase in future periods as clinical trial activities advance, and manufacturing of additional ONP-002 clinical material expands.
Current report
General and administrative expenses were $7 million for the year ended December 31, 2025, compared to $6.4 million for the year ended December 31, 2024, representing an increase of $525,464 or 8.1%.
Current report
The increase was primarily attributable to a $616,580 increase in patent expenses, as patent-related costs in 2025 were classified within general and administrative expenses whereas a significant portion of such costs had been recorded within research and development in 2024. Investor relations expense increased by $265,004 due to expanded shareholder engagement and capital market activities. Legal and professional fees increased by $146,279 reflecting higher corporate, regulatory, and financing-related costs. These increases were partially offset by a $443,664 decrease in salaries and benefits due to lower headcount, a $38,206 decrease in board compensation, and a $33,285 decrease in public company expenses. Other expenses decreased by $72,711 primarily due to the reclassification of certain costs to travel expense. Insurance and software expenses increased modestly, while travel expense increased by $61,389 reflecting increased business development and investor-related activity.
Current report
For the year ended December 31, 2025, total other expenses, net was $616,894, compared to total other expenses, net of $9,103 for the year ended December 31, 2024. The increase in net other expenses was primarily attributable to higher interest expense related to the $3.0 million short-term promissory note issued in March 2025, including amortization of debt discount and associated financing costs. This increase was partially offset by higher interest income earned on cash balances during 2025 following capital raises completed during the year.
Current report
Interest income increased to $182,229 for the year ended December 31, 2025, compared to $45,897 in 2024, reflecting higher average cash balances and prevailing interest rates. Interest expense increased to $785,930 in 2025 from $29,828 in 2024, primarily due to debt-related costs associated with the March 2025 note, which was repaid in July 2025. Foreign currency exchange losses were $13,193 in 2025 compared to $25,172 in 2024, reflecting normal fluctuations in exchange rates related to vendor activity denominated in foreign currencies.
Current report
The Company conducts research and development activities in Australia through its wholly owned subsidiary Oragenics Australia Pty Ltd. Under Australian tax law, the Company is eligible to receive refundable research and development tax incentives. For the year ended December 31, 2025, the Company recorded $274,200 Australian income tax expense related to transfer pricing markup of 6% and $411,110 of refundable Australian R&D tax incentive benefit resulting in a net income tax benefit of $136,910.
Current report
See “Recent Funding” above for our discussion of our July 2025 public offering of Series H Preferred Stock and warrants.
Current report
Based on our lack of revenues, anticipated uses of cash and historical recurring cash losses from operating activity, and cash and cash equivalents as of December 31, 2025, we anticipate that we will be able to fund our operating expenses and capital expenditure requirements through the third quarter of 2026, depending on the timing and scope of our development activities and other strategic decisions. These factors raise substantial doubt regarding our ability to continue as a going concern.
Current report
Cash used in operating activities for the years ended December 31, 2025, and 2024, was $9.2 million and $8.6 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.
Current report
For the year ended December 31, 2025, significant non-cash items affecting the operating cash flows included in $771,437 of amortization of debt discount and closing costs associated with the March 2025 short-term promissory note, $642,364 of stock-based compensation expense, $86,617 stock-based compensation recapture adjustment, and $126,140 of common stock issued for services. Changes in operating assets and liabilities also contributed to the net cash outflow, including a $1,007,286 decrease in prepaid expenses and other current assets, $53,082 decrease in interest receivable from a 6-month certificate of deposit, and a $203,144 increase in accounts payable and accrued expenses, primarily reflecting the timing of vendor payments and ongoing ONP-002 program activities.
Current report
For the year ended December 31, 2024, non-cash adjustments included $516,049 of stock-based compensation expense. Working capital changes included a $1.5 million increase in prepaid expenses and other current assets and a $119,800 decrease in accounts payable and accrued expenses.
Current report
The increase in operating cash used year-over-year primarily reflects higher working capital utilization and debt-related non-cash charges in 2025, partially offset by lower overall expenses compared to 2024.
Current report
Net cash provided by financial activities was $16.8 million for the year ended December 31, 2025, compared to $6 million for the year ended December 31, 2024.
Current report
Financing activities in 2025 were primarily driven by $15.0 million in net proceeds from the July 2025 issuance of Series H Preferred Stock and warrants, $2.6 million in net proceeds from issuance of common stock, and $2.5 million in borrowings under short-term notes payable. These inflows were partially offset by $3.3 million in repayment of short-term notes payable.
Showing the first 40 of 47 passages. Open the source sections for the rest.
Removed paragraphs (29)
Previous report
On March 13, 2025, the Company entered into and consummated a note securities purchase agreement (the “Purchase Agreement”) with a single investor (the “Purchaser”) pursuant to which the Company sold, in a private placement (the “Offering”), to the Purchaser a promissory note with an aggregate principal amount of $3,000,000 (the “Note”) and 1,000,000 shares of Series G Mirroring Preferred Stock of the Company (the “Series G Preferred Stock”). The aggregate gross proceeds to the Company are expected to be $2,500,000 million, before deducting placement agent fees and expenses. The Company intends to use the net proceeds from the Offering for working capital and other general corporate purposes. Dawson James Securities, Inc. served as the placement agent in the Offering, pursuant to the terms of a placement agent agreement dated February 26, 2024 and received 6% of the gross proceeds of the Offering and reimbursement of the legal fees of its counsel. The Note and Series G Preferred Stock sold in the Offering were issued in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), and Regulation D promulgated thereunder and, have not been registered under the Act, or applicable state securities laws. Accordingly, the Note and Series G Preferred Stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.
Previous report
We have devoted a significant amount of our financial resources to research and development, including our nonclinical development activities and clinical trials. We expect that the costs associated with our plans to begin Phase 2 work on ONP-002 will be significant. Additionally, our License Agreements also require the payment of certain recurring and performance-based royalties that may negatively impact our financial capabilities.
Previous report
In addition, Ladenburg Thalmann has sent us an invoice and demand letter claiming we owe them $2.5 million in connection with our purchase of the Neurology Assets (the “Ladenburg Claim”). See Item 3. Legal Proceedings for additional information.
Previous report
We expect to continue to incur substantial net losses and negative cash flows for the foreseeable future. These losses and negative cash flows have had, and will continue to have, an adverse effect on our shareholders’ equity and working capital. Because of the numerous risks and uncertainties associated with product development and commercialization, we may not be able to continue as a going concern and are unable to accurately predict the timing or amount of substantial expenses or when, or if, we will be able to generate the revenue necessary to achieve or maintain profitability.
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 current available cash and cash equivalents provide us with limited liquidity. We believe our existing cash and cash equivalents of $0.8 million at December 31, 2024 will allow us to fund our operating plan through the first quarter of 2025. Subsequent to December 31, 2024, in February 2025, we sold 7.8 million shares of common stock from our ATM program. The gross proceeds before commission and expenses from the February 2025 ATM sales were $2.75 million. Additionally, on March 13, 2025, the Company entered into and consummated a note securities purchase agreement (the “Purchase Agreement”) with a single investor (the “Purchaser”) pursuant to which the Company sold, in a private placement (the “Offering”), to the Purchaser a promissory note with an aggregate principal amount of $3,000,000 (the “Note”) and 1,000,000 shares of Series G Mirroring Preferred Stock of the Company (the “Series G Preferred Stock”). The aggregate gross proceeds to the Company were $2,500,000 million, before deducting placement agent fees and expenses. The Company intends to use the net proceeds from the Offering for working capital and other general corporate purposes. We believe that these additional cash resources will allow us to fund our operating plan through the third quarter of 2025.
Previous report
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 could 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
At December 31, 2024 and 2023, we included a full valuation allowance against our deferred tax assets of approximately $46,958,449 and $41,166,891, respectively, as our management believes it is uncertain that they will be fully realized. If we determine in the future that we will be able to realize all or a portion of our net operating loss carryforwards, an adjustment to our net operating loss carryforwards would increase net income in the period in which we make such a determination.
Previous report
Stock-Based Payment Arrangements
Previous report
Generally, all forms of stock-based payments, including stock option grants and warrants are measured at their fair value on the awards’ grant date typically using a Black-Scholes Pricing Option Pricing Model. Stock-based compensation awards issued to non-employees for services rendered are recorded at the fair value of the stock-based payment. The expense resulting from stock-based payments are recorded in research and development expense or general and administrative expense in the statement of operations, depending on the nature of the services provided. Stock-based payment expense is recorded over the requisite service period in which the grantee provides services to us. To the extent the stock option grants or warrants do not vest at the grant date they are subject to forfeiture.
Previous report
Effective January 1, 2023, repurchases are subject to a non-deductible excise tax under the Inflation Reduction Act of 2022 equal to 1.0% of the fair market value of the shares repurchased, subject to certain limitations. The Company did not have an impact to the financial condition or results of operations in 2023 as a result of the excise tax.
Previous report
Grant revenue
Previous report
The decrease in Grant revenue in 2024 compared to 2023 was attributable to awards received for a small business innovation research grant that expired September 30, 2023.
Previous report
The decrease in research and development in 2024 compared to 2023 was mainly attributed to In process research and development expensed in connection with the acquisition of our concussion asset in 2023 of $10.3 million and decreased development costs. Development costs associated with the development of our ONP-002 concussion drug in 2024 were $2.8 million compared to development costs associated with our vaccine product and our lantibiotics program of $1.3 million. Research and development expense in 2024 related to our vaccine product and lantibiotics program are associated with contract terminations.
Previous report
The increase in General and administrative in 2024 compared to 2023 was primarily due to the following:
Previous report
The decrease in other income (expense) in 2024 compared to 2023 was attributed to decreased interest income generated from cash balances held in our money market account, the sale of fixed assets in 2023 related to the closing of our laboratory in Alachua Florida and foreign currency exchange in 2024 related to payments made to foreign vendors.
Previous report
Cash used in operating activities in 2024 resulted from our net loss adjusted for non-cash items and changes in operating assets and liabilities. Significant items included a non-cash charge of $0.5 million for stock-based compensation and a $1.1 million decrease in Prepaid research and development.
Previous report
Significant items affecting cash used in operations in 2023 included non-cash charges of $10.3 million for In process research and development and $1.0 million for stock-based compensation and a $2.0 million decrease in Prepaid expenses and other current assets.
Previous report
We had a working capital deficit of $211,885 at December 31, 2024 compared to a working capital surplus of $2,067,593 at December 31, 2023.
Previous report
Investing Activities
Previous report
There were no investing activities in 2024.
Previous report
Investing activities in 2023 primarily related to $1.0 million used for the purchase of In process research and development as part of the Neurology Assets purchase in December 2023.
Previous report
Cash provided by financing activities in 2024 was primarily related to $6.7 million received from sales of our common stock, this was offset by $0.7 million in payments on our short-term note payable for financed insurance premiums.
Previous report
Cash provided by financing activities in 2023 was primarily related to $0.8 million received in sales of our common stock partially offset by $0.6 million used for payments on our short-term notes payable.
Previous report
We had the following short-term notes payable outstanding:
Previous report
Inflation affects the cost of raw materials, goods, and services that we use. In recent years, inflation has been modest but has recently increased. High energy costs and fluctuations in commodity prices can affect the cost of all raw materials and components. Although we cannot precisely determine the effects of inflation on our business, it is management’s belief that the effects on operating results will not be significant. We do not believe that inflation has had a material impact on our results of operations for the periods presented, except with respect to payroll-related costs and other costs arising from or related to government-imposed regulations.
Reworded paragraphs (19)
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 is designed to can cross the blood-brain barrier with the goal of rapidly reducing 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
Following our December 2023 acquisition of the assets of Odyssey Health, Inc. (“Odyssey”) related to the segment of its business focused on developing medical products that treat brain related illnesses and diseases (the “Neurology Assets”) 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
ONP-002 to date has been shown to be stable up to 104 degrees for 18-months. The drug candidate is spray-dry manufactured into a powder and filled into the novel intranasal device. The drug is then administered through the nasal passage from the device. The novel intranasal device is lightweight and easy to use in the field.
Current wording
ONP-002, together with our other neurology assets, are referred to herein as the Neurology Assets. To date, ONP-002 has been shown to be stable up to 104 degrees for 18 months. The drug candidate is manufactured into a powder and filled into a novel intranasal device. The drug is then administered through the nasal passage from the device. The novel intranasal device is lightweight and easy to use in the field.
Previous wording
The proprietary powder formulation and intranasal administration allows for rapid and direct accessibility to the brain. The device is breath propelled and allows patients to blow into the device which closes the soft palate in the back of the nasopharynx, preventing the flow of drug to the lungs or esophagus, minimizes system exposure and side effects, and easily crosses the blood brain barrier. This mechanism is designed to trap ONP-002 in the nasal cavity allowing for more abundant and faster drug availability in the traumatized brain.
Current wording
We believe the proprietary powder formulation and intranasal administration allows for rapid and direct accessibility to the brain. The device is breath propelled and is designed to allow patients to blow into the device which closes the soft palate in the back of the nasopharynx, preventing the flow of drug to the lungs or esophagus, minimizes system exposure and side effects, and effectively crosses the blood brain barrier. This mechanism is designed to trap ONP-002 in the nasal cavity allowing for more abundant and faster drug availability in the traumatized brain.
Previous wording
In February 2025, we sold 7.8 million shares of our common stock pursuant to our ATM agreement with Dawson James for gross proceeds of $2.75 million before deducting commission and legal expenses. See Note 7 of Notes to Consolidated Financial Statements for additional information.
Current wording
In February 2025, we sold 258,849 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
We have incurred significant net losses and negative cash flow in each year since our inception, including net losses of $10.6 million and $20.7 million for the years ended December 31, 2024 and 2023 respectively. As of December 31, 2024, our accumulated deficit was $216.8 million.
Current wording
We have incurred significant net losses and negative cash flow in each year since our inception, including net losses of $9.8 million and $10.6 million for the years ended December 31, 2025, and 2024 respectively. As of December 31, 2025, our accumulated deficit was $226.6 million. We expect to continue to incur operating losses and negative cash flows for the foreseeable future as we advance the development of our product candidates.
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 manufacture or have the capacity to manufacture any of our drug candidates and have one manufacturer as our current partner in the development of synthetic chemistry and manufacturing of the ONP-002 (Molecular Formula: C20H28O2, Molecular Weight: 300.14 g/mol). Our ability to successfully develop our ONP-002 product candidates, and to ultimately supply our commercial products in quantities sufficient to meet the market demand, depends in part on our ability to obtain the drug product and drug substance for our product candidates in accordance with regulatory requirements and in sufficient quantities for commercialization and clinical testing. We do not currently have arrangements in place for a redundant or second-source supply of any products or substances in the event our current supplier ceases their operations or stops offering us sufficient quantities of these materials for any reason.
Current wording
We do not manufacture or have the capacity to manufacture any of our drug candidates and have one manufacturer as our current partner in the development of synthetic chemistry and manufacturing of the ONP-002. Our ability to successfully develop our ONP-002 product candidates, and to ultimately supply our commercial products in quantities sufficient to meet the market demand, depends in part on our ability to obtain the drug product and drug substance for our product candidates in accordance with regulatory requirements and in sufficient quantities for commercialization and clinical testing.
Previous wording
We are not certain that our single-source supplier will be able to meet our demand, either because of the nature of our agreement with the supplier, our limited experience with the supplier or our relative importance as a customer to the supplier. It may be difficult for us to assess its ability to timely meet our demand in the future based on past performance. While our supplier has generally met our demand on a timely basis in the past, they may subordinate our needs in the future to their other customers.
Current wording
We are not certain that our current source suppliers will be able to meet our demand, either because of the nature of our agreement with the suppliers, our limited experience with the suppliers or our relative importance as a customer to the suppliers. It may be difficult for us to assess their ability to timely meet our demand in the future based on past performance. While our suppliers have generally met our demand on a timely basis in the past, they may subordinate our needs in the future to their other customers.
Previous wording
Other income (expense) includes local business taxes, as well as interest income and 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 indebtedness.
Current wording
Other income (expense) consists primarily of income, interest expense, and gains and losses related to foreign currency transactions with vendors. Interest income is earned on our cash and cash equivalents, which are invested in accordance with our investment policy focused on capital preservation. Interest expense consists primarily of interest and related costs associated with our outstanding indebtedness. To a lesser extent, other income (expense) may include certain non-operating items, such as local business taxes.
Previous wording
At December 31, 2024, the Company has federal and state tax net operating loss carry forwards of $159,358,389 and $142,594,207, respectively. The State of Pennsylvania tax net operating loss carryforwards will expire through 2036. Federal and Florida tax net operating loss carryforwards generated prior to December 31, 2017 will expire through 2037 and are not subject to taxable income limitations. Federal and Florida tax net operating loss carryforwards generated subsequent to December 31, 2017, do not expire but may be subject to taxable income limitation pursuant to the Tax Cuts and Jobs Act that was enacted on December 22, 2017. The Company also has federal research and development tax credit carryforwards of $4,041,694 of which are included as an uncertain tax position. The federal tax credit carryforward will expire beginning in 2021 and continuing through 2043 unless utilized.
Current wording
Federal and Florida tax net operating loss carryforwards generated prior to December 31, 2017, will expire through 2038 and are not subject to taxable income limitations. Federal and Florida tax net operating loss carryforwards generated subsequent to December 31, 2017, do not expire but may be subject to 80% deduction limitation based upon pre-NOL deduction taxable income pursuant to the Tax Cuts and Jobs Act that was enacted on December 22, 2017. The Company also has federal research and development tax credit carryforwards of $3,959,813, of which are included as an uncertain tax position. The federal tax credit carryforward will expire beginning in 2022 and continuing through 2044 unless utilized.
Previous wording
Utilization of net operating loss carryforwards and research and development credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that may have occurred or, could occur in the future in accordance with Section 382 of the Internal Revenue Code of 1986 (“IRC Section 382”) and with Section 383 of the Internal Revenue Code of 1986, as well as similar state provisions. These ownership changes may limit the amount of net operating loss carryforwards and research and development credit carryforwards that can be utilized annually to offset future taxable income and taxes, respectively. In general, an ownership change, as defined by IRC Section 382, results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50 percentage points over a three-year period. The Company has completed several financings since its inception, which may result in a change in ownership as defined by IRC Section 382, or could result in a change in control in the future. In each period since our inception, we have recorded a 100% valuation allowance for the full amount of our deferred tax asset, as the realization of the deferred tax asset is uncertain. As a result, we have not recorded any federal tax benefit in our statements of operations.
Current wording
The utilization of the Company’s net operating loss carryforwards could be subject to annual limitations under Section 382 and 383 of the Internal Revenue Code of 1986, as amended (the “Code”), and similar state tax provisions, due to ownership change limitations that may have occurred previously or that could occur in the future. These ownership changes limit the amount of net operating loss carryforwards and other deferred tax assets that can be utilized to offset future taxable income and tax, respectively. In general, an ownership change, as defined by Section 382 and 383 of the Code, results from transactions increasing ownership of certain stockholders or public groups in the stock of the corporation by more than 50 percent points over a three-year period. The Company has not completed an analysis of an ownership change under Section 382 of the Code. To the extent that a study is completed and an ownership change is deemed to occur, the Company’s net operating losses and tax credits could be limited.
Previous wording
Our discussion and analysis of our financial condition and results of operations are based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (“US GAAP”). The preparation of financial statements in accordance with US GAAP requires us to make estimates and assumptions that affect reported amounts and related disclosures. There are certain critical estimates that we believe require significant judgment in the preparation of our financial statements. We consider an accounting estimate to be critical if:
Current wording
Our discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with the accounting principles generally accepted in the United States (“U.S. GAAP”). The preparation of these financial statements requires management to make estimates, assumptions, and judgements that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period.
Previous wording
U.S. Generally Accepted Accounting Principles (“US GAAP”) requires all share-based payments to employees, including grants of employee stock options, to be recognized in the financial statements based on their fair values as of the grant date. Stock-based compensation expense is recorded over the requisite service period in which the grantee provides services to us, to the extent the options do not vest at the grant date and are subject to forfeiture. For performance-based awards that do not include market-based conditions, we record share-based compensation expense only when the performance-based milestone is deemed probable of achievement. We utilize both quantitative and qualitative criteria to judge whether milestones are probable of achievement. For awards with market-based performance conditions, we recognize the grant-date fair value of the award over the derived service period regardless of whether the underlying performance condition is met. We account for forfeitures of stock-based awards as a component of compensation expense as the forfeitures occur.
Current wording
For awards that include market-based performance conditions, the grant-date fair value is recognized over the derived service period, regardless of whether the market-based condition is ultimately satisfied.
Previous wording
In December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures,” which requires public entities to disclose consistent categories and greater disaggregation of information in the rate reconciliation and for income taxes paid. It also includes certain other amendments to improve the effectiveness of income tax disclosures. The guidance is effective for financial statements issued for annual periods beginning after December 15, 2024, with early adoption permitted. The accounting pronouncement is not expected to have a material impact on the Company’s related disclosures.
Current wording
In December 2023, the Financial Accounting Standard Board (“FASB”) issued Accounting Standard Update (“ASU”) 2023-09, Income Taxes (Topic 740):Improvements to Income Tax Disclosures, which enhances income tax disclosure requirements by requiring greater disaggregation of information in the effective tax rate reconciliation and disclosures of income taxes paid. The guidance is effective for annual periods beginning after December 15, 2024, with early adoption permitted. The Company adopted this guidance for the year ended December 31, 2025, and the adoption did not have a material impact on the Company’s consolidated financial statements or elated disclosures.
Previous wording
Since our inception, we have funded our operations primarily through the sale of equity securities in our initial public offering, the sale of equity securities and warrants in private and public offerings, debt financing, warrant exercises and grants. As of December 31, 2024, we had an accumulated deficit of $216.8 million and we have yet to achieve profitability. We incurred net losses of $10.6 million and $20.7 million for the years ended December 31, 2024 and 2023 respectively. 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 warrants exercises. As of December 31, 2025, we had an accumulated deficit of $226.6 million and have not yet achieved profitability. We incurred a net loss of $9.8 million for the twelve-months ended December 31, 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
The following table sets forth the primary sources and uses of cash for each of the periods indicated:
Current wording
The following table sets forth our primary sources and uses of cash:
Previous wording
We have no off-balance sheet arrangements.
Current wording
We do not have any off-balance sheet arrangements.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
At December 31, 2025, the Company has federal and state tax net operating loss carry forwards of $164,834,118 and $138,451,933, respectively.