Oragenics Stock Price, News & Analysis

Oragenics (NYSE: OGEN) has received approval from Australia's Human Research Ethics Committee (HREC) to begin a Phase II clinical trial for ONP-002, its intranasal neuroprotective therapy for treating concussions (mild traumatic brain injury). Patient enrollment could start as early as Q2 2025, with trials conducted in level 1 trauma emergency departments across Australia and New Zealand.

ONP-002 is administered intranasally and has shown promising results in preclinical models, demonstrating ability to reduce inflammation, oxidative stress, and brain swelling associated with concussion. The drug has already completed Phase I trials, proving to be safe and well-tolerated.

Oragenics (NYSE: OGEN) has announced a management update webinar scheduled for May 20, 2025, at 4:00 PM ET. The webinar will focus on the company's lead program ONP-002, a proprietary intranasal neuroprotective therapy for treating mild traumatic brain injury (mTBI) or concussion. The event will feature presentations from CEO Janet Huffman, Chief Clinical Officer Dr. Frank Peacock, and Dr. James Kelly.

ONP-002 is currently advancing in its Phase IIa clinical program. The drug is administered intranasally for direct brain delivery while minimizing systemic exposure. Preclinical studies have shown ONP-002's ability to reduce inflammation, oxidative stress, and brain swelling post-head injury, while Phase I trials demonstrated safety and tolerability.

Oragenics (NYSE American: OGEN) announced its participation in the 15th Annual Traumatic Brain Injury Conference in Boston, MA on May 5-6, 2025. The company's Chief Clinical Officer, Dr. W. Frank Peacock, will present updates on the HeadSMART II trial, one of the largest U.S. emergency department biomarker discovery studies for mild traumatic brain injury (mTBI).

The study, expected to enroll over 2,000 patients within the next year, is conducted in collaboration with BrainBox Solutions. This partnership aims to develop a comprehensive test-to-treat platform combining BrainBox's diagnostics with Oragenics' intranasal therapeutic candidate, ONP-002.

The conference brings together leaders from academia, industry, government, and military to discuss advances in TBI research and clinical care, focusing on diagnosis, treatment, and long-term outcomes for TBI survivors.

Oragenics (NYSE American: OGEN) has submitted a clinical trial protocol to New Zealand's Health and Disability Ethics Committee (HDEC) for its Phase IIa concussion trial. The study will evaluate ONP-002, the company's proprietary neurosteroid therapy for mild traumatic brain injury (mTBI).

The trial is set to be conducted at Christchurch Hospital, New Zealand's largest tertiary teaching and research hospital on the South Island, which treats over 83,000 emergency patients annually. Upon approval, Oragenics plans to expand patient enrollment across Australia and New Zealand.

ONP-002 is administered intranasally and has shown promising results in preclinical models, reducing inflammation, oxidative stress, and brain swelling associated with concussion. The therapy has already demonstrated safety and tolerability in Phase I trials with healthy volunteers. Notably, this represents the first novel chemical drug entity tested for efficacy in concussion treatment, addressing an unmet medical need with no current pharmaceutical options available.

Oragenics (NYSE American: OGEN) announced its participation in the 3rd Nasal Formulation & Delivery Summit held April 1-3, 2025, in Boston. Chief Medical Officer Dr. James Kelly joined a panel discussion, sharing insights on intranasal drug delivery optimization and neurological treatment approaches.

The company is developing ONP-002, a novel neurosteroid designed to treat mild traumatic brain injury (mTBI) or concussion through intranasal administration, which enables rapid absorption and targeted brain delivery. The summit gathered industry leaders to discuss innovations in intranasal drug delivery, focusing on CNS therapeutics, emergency-use treatments, and infectious disease applications.

Oragenics (NYSE American: OGEN) provided a Q1 2025 shareholder update highlighting progress on ONP-002, its intranasal therapy for concussion treatment. The company raised approximately $5 million through combined financing, including $2.6 million via ATM equity and $2.25 million in non-dilutive debt funding.

Key Q1 achievements include: submission of Investigator's Brochure for Phase IIa clinical trial in Australia, partnership with BRAINBox Solutions for diagnostic biomarkers integration, and participation in the Brain Health Summit. The company completed Phase I human study showing ONP-002 was well-tolerated with no serious adverse events.

Financial updates include conversion of all Series A and B preferred shares to common stock in Q4 2024, and implementation of executive leadership changes to reduce overhead costs. The 2025 Annual Shareholder Meeting is scheduled for May 2, 2025.

Oragenics (NYSE American: OGEN), a biotechnology company focused on innovative treatments for concussion and brain-related health conditions, has filed its Annual Report on Form 10-K for the year ended December 31, 2024. The filing, submitted to the SEC on March 14, 2025, received an unqualified audit opinion from its independent registered public accounting firm.

However, the audit included an explanatory paragraph regarding the company's ability to continue as a going concern. The company states its commitment to advancing its pipeline, exploring strategic opportunities, and securing resources for long-term growth. Further details are available in Footnote 1 of the consolidated financial statements.

Oragenics (NYSE American: OGEN) has submitted an Investigator's Brochure (IB) application for its Phase II clinical trial of ONP-002 in Australia. The trial will evaluate this novel intranasal neurosteroid as a potential treatment for mild traumatic brain injury (mTBI), or concussion.

ONP-002 has shown promising preclinical results in reducing inflammation, oxidative stress, and brain swelling. A previous Phase I study confirmed safety and tolerability at multiple intranasal doses. The Phase II study will assess acute intranasal administration in mTBI patients through cognitive testing, visual motor testing, and biomarker analysis.

The IB submission provides investigators with comprehensive clinical and non-clinical data, including safety, pharmacokinetics, and pharmacodynamics information. Currently, there are no FDA-approved drug therapies for concussions, representing a significant unmet medical need. The company expects to receive final regulatory approvals and initiate the clinical trial in the coming weeks.

Oragenics (NYSE American: OGEN) announced its participation at the Emergencies in Medicine Conference in Park City, Utah from February 23-28, 2025. Dr. James Kelly, Chief Medical Officer, will present on the company's concussion treatment advancements, specifically focusing on their "Trigger-to-Treat" program.

Dr. Kelly's presentation will highlight ONP-002, a novel intranasal neurosteroid for acute concussion treatment. The clinical trials incorporate BRAINBox Solutions' multi-marker, multimodality test that combines blood biomarker technology and neurocognitive testing to improve concussion detection and patient stratification.

Dr. Frank Peacock, Meeting Director and Principal Investigator for both BRAINBox and Oragenics' clinical trials, emphasized that early identification of high-risk patients could accelerate recovery and reduce long-term neurological complications.