(NYSE American: OGEN) Grabs The Spotlight With An Early Green Move (Breaking News!)

Oragenics, Inc. (NYSE American: OGEN) is off to a solid start

Any content you receive is for information purposes only. Always conduct your own research. *Sponsored (NYSE American: OGEN) Grabs The Spotlight With An Early Green Move (Breaking News!) *Get Our Updates Faster—Tap Here To Receive SMS Alerts* March 12th Greetings, Friend! Oragenics, Inc. (NYSE American: OGEN) is off to a solid start early Thursday morning while making green moves out of the bell. That comes on the heels of the company dropping breaking news today. Check it out: Ogragenics Initiates Phase IIA Clinical Trial Site Activation SARASOTA, Fla., March 12, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a clinical-stage biotechnology company pioneering brain-targeted therapeutics through proprietary intranasal delivery technology, today announced it has completed the first site initiation visit (SIV) for its Phase IIa clinical trial of ONP-002 in Australia. The visit marks the formal launch of clinical trial operations at the first of three planned trial sites in Australia, including completion of site staff training, protocol orientation, and site regulatory documentation. The remaining two clinical trial sites are currently completing their Research Governance Office (RGO) reviews — the final administrative step required following Human Research Ethics Committee (HREC) approval before each site can activate to begin patient enrollment and dosing. The Company expects these reviews to be completed in the near term, at which point all three sites will be positioned to enroll patients. The Phase IIa trial initiation follows the Company's receipt of HREC approval earlier this year, which represented the final regulatory clearance required to commence clinical site contract finalization, activation, and onboarding. ... "We said we would advance ONP-002 into patients in Australia — and that process is now underway. Our first site is trained, operational, and ready to enroll. The remaining sites are completing their final governance reviews, and we expect them to follow shortly. This is the kind of measured, disciplined execution that clinical development demands, and our team is delivering. Patient dosing is the next step, and we are ready." — Chief Executive Officer, Janet Huffman. "Site initiation marks the transition from regulatory preparation to active clinical operations. Our investigators are trained on the protocol, safety procedures are in place, and our CRO is coordinating operations across all three sites. The RGO review process at the remaining sites is proceeding as expected. We anticipate completing site activation across all three locations in the near term and beginning patient enrollment shortly thereafter." — Chief Medical Officer, Dr James Kelly M.D. Read the full article here. Don't forget. OGEN is a low float profile. With fewer than 5Mn shares in its float, the potential for heightened volatility may be significant on a daily basis. Review my initial (NYSE American: OGEN) report below and consider this idea for your radar. ----- A quiet breakthrough is underway in the world of neurological care, where one emerging biotech is reimagining how therapies reach the brain. Instead of relying on traditional methods that can take hours or even days to act, this team is harnessing an advanced nasal delivery approach designed to bring treatments directly to their target — fast, safely, and effectively. The scale of this market is remarkable, expected to surge from $95Bn in 2026 to more than $179Bn by 2035. It’s an innovation that could be worth watching very closely. And with a low float of fewer than 5Mn shares, and a string of positive news developments THIS WEEK, this little-known NYSE American profile may be ready to step into the spotlight: Oragenics, Inc. (NYSE American: OGEN) Oragenics, Inc. is a clinical-stage biotechnology company pioneering brain-targeted therapeutics through proprietary intranasal drug delivery technology. The Company's lead candidate, ONP-002, is a first-in-class intranasal neurosteroid in Phase IIa clinical development for the treatment of concussion and mild traumatic brain injury (mTBI) — conditions affecting an estimated 69 million people globally each year with no approved pharmacological treatment. Oragenics is Pioneering a New Standard of Care for Concussion: First-in-class neurosteroid for concussion (mTBI) Intranasal direct-to-brain delivery Entering Phase 2 trials; clear FDA pathway Massive TAM in target markets Expert leaders; renowned scientists Massive Markets, Zero Competition Unmet Medical Need for Concussion & Mild TBI What is a Concussion? Mild traumatic brain injury (mTBI) affecting 69Mn annually worldwide Symptoms: Headache, confusion, dizziness, memory problems, nausea Risk: 30-80% develop post-concussion syndrome; increased dementia risk Current Standard of Care "Rest, observe, wait" = symptom management only No approved pharmacological intervention Patients risk chronic complications Current treatment: Rest and hope ONP-002: A Breakthrough Neurosteroid for Concussion Treatment ONP-002 is a first-in-class neurosteroid designed to revolutionize the treatment of moderate to severe concussions. Engineered for rapid action and unparalleled brain penetration, ONP-002 aims to address the urgent unmet medical need in traumatic brain injuries. How ONP-002 Works ONP-002 penetrates cells to activate the ONP-002 receptor, found in neurons, glial cells, and the blood-brain barrier. This triggers a cascade of beneficial effects: Reduces inflammation, oxidative stress, and swelling Clears extracellular and intracellular debris to prevent long-term damage Maintains cognitive function without sedation, as it is non-GABAergic Clinical Development ONP-002 has successfully completed a Phase I Single and Multiple Ascending Dose (SAD/MAD) safety study, with ONP-002 demonstrating excellent tolerability and no severe adverse events. Oragenics is now advancing preparations for a Phase II clinical trial. Grab Source And More Here: OGEN Website. OGEN Presentation. ----- 5 Potential Catalysts Put (NYSE American: OGEN) In The Spotlight Thursday 1.) OGEN Has A Really Low Float (Volatility Potential May Be Substantial). Sporting a float of roughly 4.07Mn shares, according to Yahoo Finance, the potential for heightened volatility appearing quickly should not be dismissed. 2.) Oragenics Explores Expansion Of Cns Platform Pursuing Acquisition Of Assets In Brain Health, Recovery, And Neuroprotection. Oragenics, Inc. is advancing its strategy to expand in central nervous system (CNS) therapeutics by exploring acquisitions of assets aligned with its innovative intranasal delivery platform and lead drug, ONP-002. The company targets opp's in brain health, recovery, and neuroprotection, seeking candidates that complement its ongoing Phase IIa trial in Australia. This move underscores Oragenics’ vision of building a diversified, AI-enhanced CNS portfolio. Supported by ONP-002’s safety and promising potential in concussion therapy, Oragenics positions itself as a leader in next-generation brain-targeting biotechnology. 3.) Oragenics Receives HREC Approval for Phase IIa Clinical Trial of ONP-002 as a Treatment for Concussion and Mild Traumatic Brain Injury in Australia. Oragenics received final Human Research Ethics Committee (HREC) approval in Australia to initiate its Phase IIa clinical trial of ONP-002 for concussion and mild traumatic brain injury (mTBI). With all regulatory clearances secured, clinical site onboarding and patient enrollment will soon begin at three locations. The company expects first patient dosing by March and data before year-end 2026, moving closer to offering the world’s first pharmacological treatment for this large, unmet neurological condition. 4.) Oragenics Targets Projected $9Bn Market by Advancing First and Only Clinical-Stage Concussion and Mild Traumatic Brain Injury Therapy. Oragenics outlined 2026 milestones highlighting ONP-002’s advancement as the first and only potential pharmacological therapy for concussion and mild traumatic brain injury (mTBI). Backed by strong preclinical and safety data, the intranasal neurosteroid targets rapid brain recovery via direct delivery. The company finalized preparations for its Phase 2 trial in Australia, enhanced manufacturing with FDA-compliant U.S. partners, and partnered with AI-driven Receptor.AI for discovery expansion. With an addressable market exceeding $9Bn, Oragenics demonstrates strong operational and clinical readiness to lead innovation in brain-targeted therapeutic solutions. 5.) Oragenics Partners with DUCK FLATS Pharma to Support FDA IND Readiness and Clinical Trial Design for Concussion Program. Oragenics partnered with DUCK FLATS Pharma to advance its FDA Investigational New Drug (IND) readiness and clinical strategy for ONP-002, its novel intranasal therapy for concussion and mTBI. This collaboration bolsters regulatory rigor and clinical design as the company aligns its Australian trial with U.S. approval pathways. The partnership ensures regulatory excellence and strategic alignment as Oragenics progresses toward U.S. clinical development, reinforcing its leadership in addressing a vast, underserved brain injury market. ----- Coverage is officially kicked-off on Oragenics, Inc. (NYSE American: OGEN). Keep your eyes peeled for updates coming out shortly. Talk soon. All the best, Dane James Editor Market Pulse Today (Remember: St-ock Prices Could Be Significantly Lower Now From The Original Dates I Provided.)

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