{"id":830564,"date":"2025-03-27T08:43:41","date_gmt":"2025-03-27T12:43:41","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/oragenics-inc-provides-q1-2025-shareholder-update-on-strategic-and-financial-progress\/"},"modified":"2025-03-27T08:43:41","modified_gmt":"2025-03-27T12:43:41","slug":"oragenics-inc-provides-q1-2025-shareholder-update-on-strategic-and-financial-progress","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/oragenics-inc-provides-q1-2025-shareholder-update-on-strategic-and-financial-progress\/","title":{"rendered":"Oragenics, Inc. Provides Q1 2025 Shareholder Update on Strategic and Financial Progress"},"content":{"rendered":"<h2>\nONP-002 Advances Toward Phase IIa Concussion Trial with Strengthened Financial Foundation and Industry Momentum<br \/>\n<\/h2>\n<div class=\"mw_release\">\n<p align=\"justify\">SARASOTA, Fla., March  27, 2025  (GLOBE NEWSWIRE) &#8212; Oragenics, Inc. (NYSE American: OGEN), a biotechnology company focused on developing novel intranasal therapies for brain-related conditions, today provided shareholders with an update on its strategic and financial progress for the first quarter of 2025. The Company has made meaningful advancements across regulatory, clinical, financial, and partnership initiatives, further positioning its lead therapeutic candidate, ONP-002, as a first-in-class solution for treating concussion.<\/p>\n<p align=\"justify\">\u201cWe believe ONP-002 is one of the most undervalued clinical assets in biotechnology today,\u201d said Janet Huffman, Interim CEO of Oragenics. \u201cWith strong preclinical validation and clinical safety data, a scalable ONP-002 intranasal delivery system, and no current FDA-approved treatments for concussion, ONP-002 could redefine the standard of concussion care. Our Q1 progress \u2014 from regulatory submissions to our landmark partnership with BRAINBox \u2014 reflects a sharpened strategic focus and operational momentum. We\u2019re energized by what\u2019s ahead and remain committed to delivering long-term value for our shareholders.\u201d<\/p>\n<p>\n        <strong>Key Accomplishments in Q1 2025<\/strong>\n      <\/p>\n<p>In the first quarter of 2025, Oragenics achieved several strategic and operational milestones:<\/p>\n<ul type=\"disc\">\n<li style=\"margin-top:12pt\">\n          <strong>Industry Engagement &amp; Awareness<\/strong>: Participated in the 12th Annual Brain Health Summit at Leigh Steinberg\u2019s Super Bowl Party 2025, helping raise visibility for traumatic brain injury (TBI) and ONP-002\u2019s potential therapeutic impact.<\/li>\n<li>\n          <strong>Strategic Partnership<\/strong>: Established a collaboration with BRAINBox Solutions to combine diagnostic biomarkers with ONP-002\u2019s intranasal delivery system, aiming to transform concussion treatment by enabling faster, more targeted care.<\/li>\n<li>\n          <strong>Clinical Trial Advancements<\/strong>: Submitted the Investigator\u2019s Brochure (IB) for the Phase IIa clinical trial in Australia, marking a key regulatory step. The trial is now publicly listed on ClinicalTrials.gov.<\/li>\n<li>\n          <strong>Strengthened Financial Position<\/strong>: Raised approximately $5 million through a combination of dilutive and non-dilutive capital, including approximately $2.6 million via At-the-Market (ATM) equity financing and approximately $2.25 million through non-dilutive debt funding.<\/li>\n<li style=\"margin-bottom:12pt\">\n          <strong>Shareholder Communications<\/strong>: Announced that the 2025 Annual Shareholder Meeting will be held on May 2, 2025, with the preliminary proxy filed with the SEC on March 19, 2025.<\/li>\n<\/ul>\n<p align=\"justify\">\n        <strong>ONP-002: An Undervalued Asset with First-Mover Advantage<\/strong>\n      <\/p>\n<p align=\"justify\">Oragenics\u2019 lead drug candidate, ONP-002, is a neuroprotective, anti-inflammatory compound administered intranasally for the treatment of concussion, classified as a mild traumatic brain injury (mTBI). ONP-002 is an intranasal therapeutic being developed for concussion and is designed to interrupt key biological pathways involved in inflammation, oxidative stress, and swelling following head trauma.<\/p>\n<p align=\"justify\">Although still in clinical development, ONP-002 represents a \u201csilent asset\u201d that has been significantly de-risked through extensive preclinical studies. These include cardiotoxicity, genotoxicity, and dose-ranging evaluations. In addition ONP-002 successfully completed a Phase I human study that was well-tolerated with no serious adverse events. With a novel formulation and scalable ONP-002 intranasal delivery system already in place, ONP-002 is ready for rapid and cost-effective progression through clinical phases.<\/p>\n<p align=\"justify\">\n        <strong>Clinical and Regulatory Milestones Build Momentum<\/strong>\n      <\/p>\n<p align=\"justify\">In late 2024 and early 2025, Oragenics finalized drug production for the Phase IIa clinical trial and submitted the Investigator\u2019s Brochure to regulatory authorities in Australia. The trial has been officially listed on ClinicalTrials.gov, and the Company is now awaiting approval from the Human Research Ethics Committee (HREC), with first patient enrollment expected shortly thereafter.<\/p>\n<p align=\"justify\">\n        <em>\u201cReaching this stage of clinical preparation\u2014especially with a commercial-ready delivery device and finalized drug product\u2014positions us for rapid execution once regulatory clearance is received,\u201d<\/em> added Huffman.<\/p>\n<p align=\"justify\">\n        <strong>Strategic Partnership with BRAINBox Solutions<\/strong>\n      <\/p>\n<p align=\"justify\">In February, Oragenics formed a pivotal collaboration with BRAINBox Solutions, a diagnostics company pioneering biomarker-based concussion testing. This partnership pairs Oragenics\u2019 intranasal therapeutic with BRAINBox\u2019s diagnostic tools to create a smarter, faster, and more personalized approach to concussion care.<\/p>\n<p align=\"justify\">\n        <em>\u201cThis collaboration unites two emerging leaders in brain health\u2014Oragenics in therapeutic innovation and BRAINBox in diagnostic excellence,\u201d<\/em> said Huffman. <em>\u201cTogether, we are designing a smarter, faster approach to treating concussion that could set a new benchmark for the field.\u201d<\/em><\/p>\n<p align=\"justify\">\n        <strong>Increased Visibility and Market Awareness<\/strong><br \/>\n        <br \/>Beyond industry events, Oragenics has made a concerted effort in recent months to engage investors, clinicians, and thought leaders through media, podcasts, and speaking opportunities. The Company\u2019s outreach has focused on raising awareness around the scale of untreated concussion, the science behind ONP-002, and the lack of approved pharmacological options.<\/p>\n<p align=\"justify\">\n        <em>\u201cWe\u2019ve worked diligently to educate the market\u2014both the investment community and clinical stakeholders\u2014about the game-changing potential of ONP-002,\u201d<\/em> said Huffman. <em>\u201cThe response has been highly encouraging. It\u2019s clear there is an unmet need, and the concept of a fast-acting, intranasal treatment resonates with physicians, patients, and investors alike.\u201d<\/em><\/p>\n<hr \/>\n<p align=\"justify\">\n        <strong>Financial Foundation and Capital Structure Improvements<\/strong>\n      <\/p>\n<p align=\"justify\">In Q1 2025, Oragenics raised approximately $5 million in new funding through a balanced mix of equity and debt capital. This included approximately $2.6 million via ATM equity sales and approximately $2.25 million in non-dilutive debt financing. In addition, the Company submitted a grant request to the Department of Defense to secure non-dilutive capital in support of its concussion program. In Q4 2024, Oragenics also converted all outstanding Series A and B preferred shares to common stock, simplifying its capital structure and enhancing transparency for shareholders.<\/p>\n<p align=\"justify\">\n        <em>\u201cThis funding underscores our ability to secure capital through multiple channels and at critical moments,\u201d<\/em> Huffman stated. <em>\u201cIt reflects growing confidence in our strategy and allows us to continue executing with discipline and focus.\u201d<\/em><\/p>\n<hr \/>\n<p align=\"justify\">\n        <strong>Operational Efficiencies and Governance Updates<\/strong>\n      <\/p>\n<p align=\"justify\">As part of its disciplined approach to resource management, Oragenics implemented executive leadership changes in late 2024 that have meaningfully reduced fixed overhead costs. These moves ensure that capital is directed toward value-driving programs like ONP-002. The Company also confirmed that its 2025 Annual Shareholder Meeting will be held on May 2, 2025, with preliminary proxy materials filed in March.<\/p>\n<p align=\"justify\">\n        <strong>Key Milestones Ahead<\/strong>\n      <\/p>\n<p align=\"justify\">With strong positioning across clinical, operational, and financial fronts, Oragenics is preparing to advance ONP-002 through the next stage of development. The Company\u2019s upcoming projected milestones include:<\/p>\n<table style=\"border-collapse: collapse;width:100%;border-collapse:collapse\">\n<tr>\n<td style=\"border-top: solid black 1pt;border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px\">\n            <strong>Milestone<\/strong>\n          <\/td>\n<td style=\"border-top: solid black 1pt;border-right: solid black 1pt;border-bottom: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px\">\n            <strong>Expected Timing<\/strong>\n          <\/td>\n<\/tr>\n<tr>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px\">HREC approval in Australia<\/td>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px\">Q2 2025<\/td>\n<\/tr>\n<tr>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px\">First patient enrolled in Phase IIa trial<\/td>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px\">Q2 2025<\/td>\n<\/tr>\n<tr>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px\">Completion of Phase IIa enrollment<\/td>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px\">Q4 2025<\/td>\n<\/tr>\n<tr>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px\">Interim safety and biomarker readout<\/td>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px\">Q4 2025 \u2013 Q1 2026<\/td>\n<\/tr>\n<tr>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px\">Initiation of Phase IIb (Part B)<\/td>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px\">Q1 2026<\/td>\n<\/tr>\n<tr>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px\">Topline Phase IIb results<\/td>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px\">Q2 2026<\/td>\n<\/tr>\n<tr>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px\">FDA End-of-Phase 2 Meeting<\/td>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px\">Q3 2026<\/td>\n<\/tr>\n<tr>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px\">FDA Accelerated Approval Filing (if eligible)<\/td>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px\">Q3 2026<\/td>\n<\/tr>\n<tr>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px\">First revenues from licensing or early access<\/td>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px\">2027 (projected)<\/td>\n<\/tr>\n<\/table>\n<p align=\"justify\">\n        <strong><br \/>\n          <br \/>Our Commitment to Long-Term Value Creation<\/strong>\n      <\/p>\n<p align=\"justify\">As Oragenics enters a pivotal execution phase, the Company remains committed to advancing ONP-002 with urgency and precision. Its goal is to deliver a meaningful clinical breakthrough in concussion care and to generate long-term value for its shareholders.<\/p>\n<p align=\"justify\">\n        <em>\u201cWe are committed to seeing ONP-002 through to its full potential,\u201d<\/em> said Huffman. <em>\u201cWith each milestone we reach, our conviction only grows stronger. This is more than a drug program\u2014it\u2019s an opportunity to change the standard of care for millions of patients. Our team is fully aligned, fully engaged, and determined to deliver results that matter for shareholders and society alike.\u201d<\/em><\/p>\n<p align=\"justify\">\n        <strong>Investor Contact<\/strong>\n      <\/p>\n<p align=\"justify\">Rich Cockrell<br \/>866.889.1972<br \/>ogen@cg.capital<\/p>\n<p align=\"justify\">\n        <strong>About Oragenics, Inc.<\/strong>\n      <\/p>\n<p align=\"justify\">Oragenics is a biotechnology company focused on developing intranasal therapeutics for neurological disorders, including its lead candidate, ONP-002, for the treatment of mild traumatic brain injury (mTBI) or concussion. The Company is also advancing proprietary powder formulations and intranasal delivery technology to enhance drug administration. For more information, visit<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=wowauox9bdRjYYHThbPDK-GK-5S6DYEUeKKhYJtQf4pGt-Wtb2-X2I5iNKsRlGUBT7ax-Wwb0qbHSMmFs36v1SJFQdAWQymQZgJbjCEA5OU=\" rel=\"nofollow\" target=\"_blank\"><u>www.oragenics.com<\/u><\/a>.<\/p>\n<p align=\"justify\">\n        <strong>Forward-Looking Statements<\/strong><br \/>\n        \n      <\/p>\n<p align=\"justify\">This communication contains \u201cforward-looking statements\u201d within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management\u2019s beliefs and assumptions and information currently available. The words \u201cbelieve,\u201d \u201cexpect,\u201d \u201canticipate,\u201d \u201cintend,\u201d \u201cestimate,\u201d \u201cproject\u201d and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to, those described in our Form 10-K and other filings with the U.S. Securities and Exchange Commission. All information set forth in this press release is as of the date hereof. You should consider these factors in evaluating the forward-looking statements included in this press release and not place undue reliance on such statements. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, circumstances should change, except as otherwise required by law.<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQxMTgxMiM2ODM2NjczIzIyMDE3Mzc=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/ZTA2YzEzMzEtMmI1Mi00ZTVjLWE4NTItMTVjYjlkMmExZmVkLTEyMTMyOTAtMjAyNS0wMy0yNy1lbg==\/tiny\/Oragenics.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>ONP-002 Advances Toward Phase IIa Concussion Trial with Strengthened Financial Foundation and Industry Momentum SARASOTA, Fla., March 27, 2025 (GLOBE NEWSWIRE) &#8212; Oragenics, Inc. (NYSE American: OGEN), a biotechnology company focused on developing novel intranasal therapies for brain-related conditions, today provided shareholders with an update on its strategic and financial progress for the first quarter of 2025. The Company has made meaningful advancements across regulatory, clinical, financial, and partnership initiatives, further positioning its lead therapeutic candidate, ONP-002, as a first-in-class solution for treating concussion. \u201cWe believe ONP-002 is one of the most undervalued clinical assets in biotechnology today,\u201d said Janet Huffman, Interim CEO of Oragenics. \u201cWith strong preclinical validation and clinical safety data, a scalable ONP-002 intranasal delivery system, and &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/oragenics-inc-provides-q1-2025-shareholder-update-on-strategic-and-financial-progress\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Oragenics, Inc. Provides Q1 2025 Shareholder Update on Strategic and Financial Progress&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-830564","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Oragenics, Inc. 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(NYSE American: OGEN), a biotechnology company focused on developing novel intranasal therapies for brain-related conditions, today provided shareholders with an update on its strategic and financial progress for the first quarter of 2025. The Company has made meaningful advancements across regulatory, clinical, financial, and partnership initiatives, further positioning its lead therapeutic candidate, ONP-002, as a first-in-class solution for treating concussion. \u201cWe believe ONP-002 is one of the most undervalued clinical assets in biotechnology today,\u201d said Janet Huffman, Interim CEO of Oragenics. \u201cWith strong preclinical validation and clinical safety data, a scalable ONP-002 intranasal delivery system, and &hellip; Continue reading &quot;Oragenics, Inc. 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(NYSE American: OGEN), a biotechnology company focused on developing novel intranasal therapies for brain-related conditions, today provided shareholders with an update on its strategic and financial progress for the first quarter of 2025. The Company has made meaningful advancements across regulatory, clinical, financial, and partnership initiatives, further positioning its lead therapeutic candidate, ONP-002, as a first-in-class solution for treating concussion. \u201cWe believe ONP-002 is one of the most undervalued clinical assets in biotechnology today,\u201d said Janet Huffman, Interim CEO of Oragenics. \u201cWith strong preclinical validation and clinical safety data, a scalable ONP-002 intranasal delivery system, and &hellip; Continue reading \"Oragenics, Inc. 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