{"url_path":"/sec/ogen/10-q/2026/item-1a","section_key":"item-1a","section_title":"Item 1A **","topic":"sec","document":{"doc_type":"10-Q","doc_date":"2026-05-08","source_url":"https://www.sec.gov/Archives/edgar/data/1174940/0001493152-26-021967-index.html","accession_number":"0001493152-26-021967","cik":"0001174940","ticker":"OGEN","issuer_name":"ORAGENICS INC","edgar_url":"https://www.sec.gov/Archives/edgar/data/1174940/0001493152-26-021967-index.html","primary_entity_key":"0001174940","primary_entity_name":"ORAGENICS INC"},"word_count":3417,"has_tables":true,"body_markdown":"**ITEM\n1A.**\n**RISK\nFACTORS**\n\n \n\nIn\naddition to the other information set forth in this Form 10-Q, you should carefully consider the factors discussed in Part I, Item 1A,\nsubsection “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, which could materially\naffect our business, financial condition or future results of operations. The risks described in our Annual Report on Form 10-K for the\nfiscal year ended December 31, 2025, are not the only risks that we face. If any of the identified risks occur, our business, financial\ncondition and results of operations could suffer. The trading price of our common stock could decline, and you may lose all or part of\nyour investment in our common stock. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial\nmay also materially adversely affect our business, financial condition and future results of operations. The following information updates,\nand should be read in conjunction with, the risk factors previously disclosed in Item 1A, subsection “Risk Factors” to Part\nI of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed on March 16, 2026. Except as set forth below,\nthere have been no material changes to the risk factors previously disclosed under the caption “Risk Factors” in our Annual\nReport on Form 10-K.\n\n \n\n**The\nCertificate of Designation for our Series H Convertible Preferred Stock (the “Series H Preferred Stock”) contains anti-dilution\nprovisions that may result in the reduction of the Conversion Price for the Series H Preferred Stock in the future. This feature may\nresult in an indeterminate number of shares of Common Stock being issued upon conversion.**\n\n \n\nThe Certificate of Designation for our Series H Preferred Stock contains\nanti-dilution provisions, which provisions require the lowering of the initial $2.50 Conversion Price on any unconverted Series H Preferred\nStock to the purchase price of future offerings by us (subject to certain exclusions). If in the future we issue securities for less than\nthe Conversion Price of our Series H Preferred Stock, we will be required to reduce the relevant Conversion Price of any unconverted Series\nH Preferred Stock, which will result in a greater number of shares of Common Stock being issuable upon conversion, which in turn will\nhave a greater dilutive effect on our shareholders. In addition, as there is no floor price on the Conversion Price, we cannot determine\nthe total number of shares issuable upon conversion. As such, it is possible that we will not have sufficient available shares to satisfy\nthe conversion of the Series H Preferred Stock if we enter into a future transaction that results in the further reduction of the Conversion\nPrice. If we do not have sufficient available shares for any Series H Preferred Stock conversions, we will be required to increase our\nauthorized shares, which may not be possible and will be time-consuming and expensive. The potential for such Conversion Price adjustments\nmay depress the price of our Common Stock regardless of our business performance, and, as a result, we may find it more difficult to raise\nadditional equity capital while our Series H Preferred Stock is outstanding.\n\n \n\nOn March 14, 2026, the Company issued shares of its\ncommon stock at a price below the then-current conversion price of the Series H Preferred Stock. As a result, pursuant to the anti-dilution\nprovisions contained in the Certificate of Designation, the conversion price of the Series H Preferred Stock was adjusted to $1.00 per\nshare.\n\n \n\n**We\nwill need to raise additional capital in the future to complete the development and commercialization of our product candidates and operate\nour business.**\n\n \n\nDeveloping and commercializing biopharmaceutical\nproducts, including Phase 2 work for our ONP-002 product candidate and conducting nonclinical studies and clinical trials and establishing\nmanufacturing capabilities, and the progress of our efforts to develop and commercialize our product candidates, is expensive, and can\ncause us to use our limited, available capital resources faster than we currently anticipate. Our current cash, cash equivalents and\nshort-term investments are not sufficient to fully implement our business strategy and sustain our operations. Our auditor has expressed\nsubstantial doubt about our ability to continue as a going concern. We anticipate we will need to raise additional capital in the future\nto complete the development and commercialization of our product candidates and operate our business. Until we can generate a sufficient\namount of product revenue, if ever, we expect to finance future cash needs through public or private equity offerings, debt financings\nor corporate or government collaboration and licensing arrangements. However, our recently completed Series H Preferred Stock offering\nand the anti-dilution protection contained in the Series H Preferred Stock’s Certificate of Designation, as well as our auditor’s\nsubstantial doubt about our ability to continue as a going concern, may depress the price of our Common Stock regardless of our business\nperformance and may make it more difficult for us to raise or obtain additional financing. Furthermore, even if we are able to obtain\nadditional financing, it may not be on favorable terms and, if such financing is undertaken at a price below the Conversion Price of\nour Series H Preferred Stock, it will trigger the anti-dilution protection in our Series H Preferred Stock’s Certificate of Designation,\nas discussed above, which in turn may result in a greater number of shares of Common Stock being issued upon conversion of our Series\nH Preferred Stock, which in turn will have a greater dilutive effect on our shareholders and may make it more difficult to raise additional\ncapital. If we do not succeed in raising additional funds on acceptable terms, we may be unable to complete existing nonclinical and\nplanned clinical trials, undertake acquisitions or licensing or joint venture arrangements, or obtain approval of our product candidates\nfrom the FDA and other regulatory authorities, and, absent sufficient additional financing, we may be unable to remain a going concern.\n\n \n\n**The\nmarket price of our Common Stock may never exceed the Conversion Price of the Series H Preferred Stock.**\n\n \n\nThe warrants we issued in connection with the Series H Preferred Stock\noffering (the “Series H Warrants”) become exercisable upon issuance and will expire five years from the date of issuance.\nThe exercise price of the Series H Warrants is $25 per share of Series H Preferred Stock. Upon exercise, a holder will be required to\npay us the exercise price per share in cash and in exchange will receive shares of our Series H Preferred Stock with a stated value of\n$25. Such shares of Preferred Stock are currently convertible into shares of Common Stock at the Conversion Price of $1.00. The number\nof shares of Common Stock into which each share of Preferred Stock is convertible into is determined by dividing the stated value by the\nConversion Price. Thus, if the Conversion Price is $1.00, each share of Series H Preferred Stock, exclusive of dividends, is convertible\ninto approximately 25 shares of Common Stock. If the market price of our Common Stock is below the Conversion Price, the holder of the\nWarrant may elect not to exercise the Warrant until the market price of our Common Stock increases. However, the market price of our Common\nStock may never exceed the Conversion Price prior to the expiration of the Warrants. As a result, the holders of our Warrants may elect\nnot to ever exercise their Warrants. We will not receive any additional proceeds in connection with unexercised Warrants, which likely\nwill result in our needing to raise additional capital sooner than if some or all of the Warrants are exercised, of which there can be\nno assurances. Any Warrants not exercised by their date of expiration will expire worthless and we will be under no further obligation\nto the Warrant holder.\n\n \n\n**The\nissuance of additional equity securities by us in the future would result in dilution to our existing common shareholders.**\n\n \n\nOur\nBoard of Directors has authority, without action or vote of our shareholders, to issue all or a part of our authorized but unissued shares,\nexcept where shareholder approval is required by law or the rules of any exchange on which our shares are listed. Any issuance of additional\nequity securities by us in the future could result in dilution to our existing common shareholders. Such issuances could be made at a\nprice that reflects a discount or a premium to the then-current trading price of our Common Stock. In addition, our business strategy\nmay include expansion through internal growth by acquiring complementary businesses, acquiring or licensing additional products or brands,\nor establishing strategic relationships with targeted customers and suppliers. In order to do so, or to finance the cost of our other\nactivities, we may issue additional equity securities that could result in further dilution to our existing common shareholders. These\nissuances would dilute the percentage ownership interest of our existing common shareholders, which would have the effect of reducing\ntheir influence on matters on which our shareholders vote and might dilute the book value of our Common Stock.\n\n \n\n20\n\n \n\n \n\n**Future\nsales of our Common Stock in the public market could cause our stock price to fall.**\n\n \n\nSales\nof a substantial number of shares of our Common Stock, or the perception by the market that those sales could occur, could cause the\nmarket price of our Common Stock to decline or could make it more difficult for us to raise funds through the sale of equity in the future.\nFuture issuances of Common Stock could further depress the market for our Common Stock. We expect to continue to incur drug development\nand selling, general and administrative costs, and to satisfy our funding requirements, we will need to sell additional equity securities,\nwhich may include sales of significant amounts of Common Stock to investors, and which Common Stock may be subject to registration rights\nand warrants with anti-dilutive protective provisions. The sale or the proposed sale of substantial amounts of our Common Stock or other\nequity securities in the public markets or in private transactions may adversely affect the market price of our Common Stock and our\nstock price may decline substantially. Our shareholders may experience substantial dilution and a reduction in the price that they are\nable to obtain upon sale of their shares. Also, new equity securities issued may have greater rights, preferences or privileges than\nour existing Common Stock. In addition, we have a significant number of shares of restricted stock, stock options and warrants outstanding.\nThe exercise and conversion of such securities will cause additional dilution. Additionally, if we make one or more significant acquisitions\nin which the consideration includes stock or other securities, our shareholders’ holdings may be significantly diluted. In addition,\nshareholders’ holdings may also be diluted if we enter into arrangements with third parties permitting us to issue shares of Common\nStock in lieu of certain cash payments upon the achievement of milestones.\n\n \n\n**We might not be successful\nat acquiring, investing in or integrating businesses, entering into joint ventures or divesting businesses.**\n\n \n\nWe have undertaken, and expect to continue\npursuing, strategic acquisitions, investments and joint ventures to enhance or add to our skills and capabilities or offerings of services\nand solutions, or to enable us to expand in certain geographic and other markets, such as our acquisition of our neurology assets. Depending\non the opportunities available, we may increase the amount of capital invested in such opportunities. We may not succeed in completing\ntargeted transactions, including as a result of the market becoming increasingly competitive, or achieve desired results of operations.\nFurthermore, we face risks in successfully integrating any businesses we might acquire or create through a joint venture. Ongoing business\nmay be disrupted, and our management’s attention may be diverted by acquisition, investment, transition or integration activities.\nIn addition, we might need to dedicate additional management and other resources, and our organizational structure could make it difficult\nfor us to efficiently integrate acquired businesses into our ongoing operations and assimilate and retain employees of those businesses\ninto our culture and operations. The loss of key executives, employees, customers, suppliers, vendors and other business partners of\nbusinesses we acquire may adversely impact the value of the assets, operations or businesses. Furthermore, acquisitions or joint ventures\nmay result in significant costs and expenses, including those related to retention payments, equity compensation, severance pay, early\nretirement costs, intangible asset amortization and asset impairment charges, assumed litigation and other liabilities, and legal, accounting\nand financial advisory fees, which could negatively affect our profitability. We may have difficulties as a result of entering into new\nmarkets where we have limited or no direct prior experience or where competitors may have stronger market positions. We might fail to\nrealize the expected benefits or strategic objectives of any acquisition, investment or joint venture we undertake. We might not achieve\nour expected return on investment or may lose money. We may be adversely impacted by liabilities that we assume from a company we acquire\nor in which we invest, including from that company’s known and unknown obligations, intellectual property or other assets, terminated\nemployees, current or former clients or other third parties. In addition, we may fail to identify or adequately assess the magnitude\nof certain liabilities, shortcomings or other circumstances prior to acquiring, investing in or partnering with a company, including\npotential exposure to regulatory sanctions or liabilities resulting from an acquisition target’s previous activities, internal\ncontrols and security environment. If any of these circumstances occurs, they could result in unexpected legal or regulatory exposure,\nunfavorable accounting treatment, unexpected increases in taxes or other adverse effects on our business. In addition, we have a lesser\ndegree of control over the business operations of the joint ventures and businesses in which we have made minority investments or in\nwhich we have acquired less than 100% of the equity. This lesser degree of control may expose us to additional reputational, financial,\nlegal, compliance or operational risks. Litigation, indemnification claims, and other unforeseen claims and liabilities may arise from\nthe acquisition or operation of acquired businesses. For example, we may face litigation or other claims as a result of certain terms\nand conditions of the acquisition agreement, such as earnout payments or closing net asset adjustments. For example, the Company was\nrecently served with a complaint for a pure bill of discovery in a state court in Tallahassee, Florida. The Complaint was initiated by\nthe inventor of the Company’s technology and former consultant. The Complaint seeks access to certain company documents relating\nto the Company’s purchase of the technology from Odyssey, among other information. While no claims are being made in the Complaint\nthe Company expects to vigorously contest the matter and there can be no assurances that the company will prevail on preventing such\ndiscovery and if not whether or not further actions could be commenced against the company. Alternatively, shareholder litigation may\narise as a result of proposed acquisitions. If we are unable to complete the number and kind of investments for which we plan, or if\nwe are inefficient or unsuccessful at integrating any acquired businesses into our operations, we may not be able to achieve our planned\nrates of growth or improve our market share, profitability or competitive position in specific markets or services. We also periodically\nevaluate, and have engaged in, the disposition of assets and businesses. Divestitures could involve difficulties in the separation of\noperations, services, products and personnel, the diversion of management’s attention, the disruption of our business and the potential\nloss of key employees. After reaching an agreement with a buyer for the disposition of a business, the transaction may be subject to\nthe satisfaction of pre-closing conditions, including obtaining necessary regulatory and government approvals, which, if not satisfied\nor obtained, may prevent us from completing the transaction. Divestitures may also involve continued financial involvement in or liability\nwith respect to the divested assets and businesses, such as indemnities or other financial obligations, in which the performance of the\ndivested assets or businesses could impact our results of operations. Any divestiture we undertake could adversely affect our results\nof operations.\n\n \n\n**We\nmay not be able to successfully consummate the transaction contemplated by the Sigyn Letter of Intent.**\n\n \n\nOn\nMay 7, 2026, we announced that we had entered into a Letter of Intent (“LOI”) under which we expect to license from Sigyn\nTherapeutics, Inc. (“Sigyn”) certain disease indications of CardioDialysis™, a blood purification technology that enables\nthe broad-spectrum clearance of inflammatory and pathogenic molecules from the bloodstream.  Under the terms of the proposed license\nagreement, we would receive an exclusive license from Sigyn to develop and commercialize CardioDialysis™ for the treatment of Traumatic\nBrain Injury (TBI) and other chronic neurodegenerative diseases.  The proposed transaction terms set forth in the  LOI include\nthat: (i) ** **we expect to issue 3,250,000 shares of a new class of restricted preferred stock to Sigyn, convertible, (ii) we\nexpect to pay a three percent (3%) royalty on revenue from sales of the licensed technology following FDA market clearance, for a period\nof six years from the date of first commercial sale per approved indication and country, (iii)  the closing is expected to occur\nwithin 90 days from the effective date of the LOI, subject to completion of due diligence, board approvals, an independent third-party\nvaluation, and other customary closing conditions, and (iv) Sigyn has agreed not to license the CardioDialysis™ technology to third\nparties for the proposed Target Markets during the exclusivity period. The LOI is non-binding except for certain provisions including\nexclusivity, confidentiality, and governing law. The completion of a definitive agreement remains subject to due diligence satisfactory\nto us, board approvals by both companies, NYSE American continued listing compliance, and other customary closing conditions.  Although\nthe LOI provides that certain provisions are binding on the parties, it does not obligate the parties to consummate the proposed transaction.\nThe consummation of the proposed transaction remains subject to due diligence and the negotiation, execution and delivery of a definitive\nlicense agreement and the satisfaction or waiver of applicable closing conditions. There can be no assurance that any definitive agreements\nwill be entered into or that the proposed transaction will be consummated on the terms described therein or at all.  The closing\nof the transaction is subject to various closing conditions, including without limitation the following: (1) due diligence satisfactory\nto the Company, (2) both companies shall have obtained its shareholders’ approval; (3) NYSE American continued listing compliance;\nand (4) other customary closing conditions. There can be no assurances that the conditions to consummate the transaction contemplated\nby the Sigyn LOI will be satisfied or that we will be able to successfully consummate a transaction.\n\n \n\n**The\nissuance of additional equity securities by us in the future associated with the transaction contemplated by the Sigyn LOI would result\nin dilution to our existing common shareholders.**\n\n \n\nIn\nconnection with the transaction contemplated by the Sigyn LOI, we may issue 3,250,000 shares of a new series of our Preferred Stock,\nconvertible into 3,250,000 shares of Common Stock. Our Board of Directors has authority, without action or vote of our shareholders,\nto issue all or a part of our authorized but unissued shares, except where shareholder approval is required by law or the rules of any\nexchange on which our shares are listed. Any issuance of additional equity securities by us in the future in connection with the LOI\ncould result in dilution to our existing common shareholders. Such issuances could be made at a price that reflects a discount or a premium\nto the then-current trading price of our common stock. These issuances would dilute the percentage ownership interest of our existing\ncommon shareholders, which would have the effect of reducing their influence on matters on which our shareholders vote and might dilute\nthe book value of our common stock. The terms of the new series of our preferred stock are subject to further negotiation and may be\nissued without action or vote of our shareholders, except where shareholder approval may be required by law or the rules of any exchange\non which our shares are listed. To the extent we are able to conclude the transaction contemplated by the LOI, the issuance of such new\nseries of Preferred Stock convertible into common stock would result in significant dilution to our existing common shareholders. \nSuch issuance could adversely affect the market price of our common stock and impair our ability to raise additional capital through\nfuture equity financings.\n\n \n\n21"}