Oragenics Stock Price, News & Analysis

Oragenics (NASDAQ: OGEN) announced a strategic collaboration with Receptor.AI to apply AI-driven receptor profiling to Oragenics' molecules acquired in 2023, aiming to accelerate preclinical candidate identification for neurological and psychiatric indications. The work intends to guide laboratory validation and prioritize targets across Alzheimer’s, Parkinson’s, PTSD, opioid addiction, and anxiety. Oragenics remains focused on advancing its lead candidate, ONP-002, with a Phase IIa concussion trial initiation expected in Q4 2025. The company frames the partnership as a step from a single-asset model toward a diversified intranasal neurology platform while emphasizing capital-efficient discovery.

Oragenics (NYSE American: OGEN) provided a Q2 2025 shareholder update highlighting progress in developing ONP-002, its lead candidate for concussion treatment. The company secured a $16.5 million capital raise through Series H Convertible Preferred Stock and Warrants, with net proceeds of $15.2 million.

Key operational achievements include HREC approval in Australia, appointment of Southern Star Research as CRO, and a cGMP manufacturing agreement with Sterling Pharma Solutions. The company demonstrated financial discipline with a 50% reduction in R&D expenses and 8% decrease in administrative costs.

Oragenics plans to initiate Phase IIa trials in Q3 2025, followed by IND submission to FDA for Phase IIb trials in Q3-Q4 2025. The company targets the $8.9 billion global concussion market by 2027, aiming to become the first FDA-approved pharmacological treatment for concussion.

Oragenics (NYSE American: OGEN) has selected Southern Star Research as its Clinical Research Organization (CRO) for the upcoming Phase IIa clinical trial of ONP-002, a drug candidate for concussion treatment. The trial will be a randomized, double-blind, placebo-controlled study evaluating ONP-002 in adults with mild traumatic brain injury (mTBI).

The company has already secured Human Research Ethics Committee (HREC) approval and chosen Australia for the trial due to its streamlined regulatory process, experienced trial sites, and R&D tax incentive benefits. ONP-002 is a proprietary intranasal neurosteroid that has shown promising results in preclinical models, including reduced brain inflammation and improved cognitive function.

Oragenics (NYSE American: OGEN) has secured a manufacturing agreement with Sterling Pharma Solutions for the GMP production of ONP-002, its lead drug candidate for concussion treatment. The U.S.-based manufacturing partnership will support Oragenics' planned Phase IIb clinical trials expected to begin in 2026.

The collaboration with Sterling's facility in Cary, North Carolina, represents a crucial milestone in Oragenics' development strategy, ensuring domestic production capabilities for their upcoming clinical and regulatory efforts. The trials will evaluate ONP-002's early efficacy in patients with mild traumatic brain injury (mTBI), addressing a condition that currently lacks FDA-approved pharmacological treatments.

Oragenics (NYSE American: OGEN) has successfully closed a public offering, raising $16.5 million through the issuance of 660,000 shares of Series H Convertible Preferred Stock and Warrants. Each unit, comprising one preferred share and one warrant, was priced at $25.00. The warrants could potentially generate an additional $16.5 million if fully exercised.

The preferred stock is convertible at $2.50 per common share, and the warrants expire in five years. The proceeds will primarily fund the development of ONP-002, an intranasal drug candidate for treating concussion, along with repaying a $3 million bridge note and supporting general corporate purposes.

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.