Oragenics Stock Price, News & Analysis

Oragenics (NYSE American: OGEN), a company developing intranasal pharmaceuticals for neurological disorders, has announced the pricing of a public offering of up to 800,000 shares of Series H Convertible Preferred Stock and Warrants. The combined offering price is set at $25.00 per unit, with the potential to raise up to $20 million in gross proceeds.

The Preferred Stock is convertible into common stock at $2.50 per share, and the Warrants allow purchase of additional Preferred Stock at $25.00 per share. The offering is expected to close around July 2, 2025. Dawson James Securities is serving as the sole placement agent.

The company plans to use the proceeds to fund its ONP-2 concussion clinical trials, related R&D activities, repay a $3 million bridge note, and for working capital and general corporate purposes.

Oragenics (NYSE American: OGEN), a biotech company focused on intranasal therapeutics for brain-related conditions, announces its participation in two major industry events in June 2025. Greg Gironda, Head of Business Development, will present at the 2025 BIO International Convention in Boston (June 16-19), where he will discuss ONP-002, the company's lead intranasal neurosteroid candidate for treating concussion. Additionally, Oragenics will attend the 42nd Annual National Neurotrauma Society Symposium in Philadelphia (June 15-18), co-hosted by the National Neurotrauma Society and AANS/CNS Joint Section on Neurotrauma & Critical Care. These events provide platforms for Oragenics to showcase its development pipeline and engage with industry leaders in neuroscience, neurology, biotech, and pharma.

Oragenics (NYSE: OGEN) has announced a 1-for-30 reverse stock split of its common stock, effective June 3, 2025. Following the split, every 30 pre-split shares will automatically combine into one new share, with fractional shares rounded up to the nearest whole share. The reverse split was approved by the Board on May 27, 2025, after receiving shareholder authorization for a split ratio between 1-for-5 and 1-for-50.

The company's stock will continue trading under the symbol "OGEN" with a new CUSIP number (684023 609). The split will not affect the par value of common stock or authorized but unissued shares. CEO Janet Huffman stated that this move aims to strengthen their capital markets presence and attract long-term, quality-focused investors.

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.