Oragenics Chases Concussion Cure and Capital in Puerto Rico

SARASOTA, Fla. – January 14, 2026 – Oragenics, Inc., a clinical-stage biotechnology company, announced today it will present its pioneering work on a potential first-in-class concussion treatment at the upcoming Sequire Investor Summit in San Juan, Puerto Rico. The presentation places the company and its lead drug candidate, ONP-002, before a concentrated audience of high-net-worth investors in a location renowned for its significant tax advantages.

The move highlights a critical duality in the biotech industry: the pursuit of life-changing scientific breakthroughs and the relentless need for capital to fund them. As Oragenics advances its intranasal therapy for mild traumatic brain injury (mTBI), an area with no currently approved drug treatments, its presence at the January 20-22 summit is a strategic play to secure the resources needed for its next phase of clinical trials.

“We appreciate the opportunity to present at the Sequire Investor Summit and discuss our novel approach to addressing the significant unmet medical need in concussion and mild traumatic brain injury,” said Janet Huffman, CEO of Oragenics, in a statement. “There are currently no approved drug therapies for concussion, underscoring the importance of advancing our ONP-002 clinical program to Phase 2a studies.”

The Urgent Hunt for a Breakthrough

Concussion, or mTBI, represents a vast and challenging public health issue, affecting an estimated 69 million people globally each year. From athletes on the field to soldiers in combat and victims of everyday accidents, the consequences can range from short-term symptoms to long-term neurological complications. Despite its prevalence, the standard of care remains limited to rest and symptom management, leaving a therapeutic void that pharmaceutical companies are racing to fill.

Oragenics is positioning ONP-002 as a front-runner in this race. The drug is a proprietary neurosteroid designed to be administered via a non-invasive intranasal spray immediately following a head injury. This delivery method is key, allowing the drug to bypass the formidable blood-brain barrier and rapidly target the site of injury. Preclinical studies have shown that ONP-002 works by reducing inflammation, swelling, and oxidative stress at the cellular level, interrupting the damaging cascade of events that follows a concussion.

After demonstrating a strong safety profile in a 40-patient Phase 1 human trial, Oragenics is now advancing ONP-002 into a crucial Phase 2a clinical study in Australia. The company selected Australia for its streamlined regulatory environment and established network of experienced concussion trial sites. This randomized, double-blind, placebo-controlled study will evaluate the drug's safety, tolerability, and effect on blood biomarkers and cognitive function in adults with recent mTBIs. Positive results from this trial would be a significant milestone, paving the way for planned Phase 2b trials in the United States.

To maximize its utility in real-world settings, the company has also developed a spray-dried nanoparticle powder formulation of ONP-002 that is stable across a wide range of temperatures, eliminating the need for cold-chain logistics. This makes it practical for use in ambulances, sports sidelines, and military field operations. Furthermore, Oragenics has developed specialized intranasal delivery devices, including a breath-propelled model and an automated prototype, to ensure effective administration even if a patient is disoriented or unconscious.

The High-Stakes World of Biotech Finance

The path from a promising molecule to an approved medicine is notoriously long and expensive. For a clinical-stage company like Oragenics, which does not yet have a product on the market, securing consistent funding is as critical as achieving positive trial data. The company's recent history reflects this reality.

In July 2025, Oragenics successfully raised $15.2 million in net proceeds through a public offering of preferred stock. This capital infusion was essential, not only to fund the ongoing ONP-002 trials but also to regain full compliance with NYSE American listing standards after facing a stockholder equity deficiency. The move shored up its balance sheet and provided the runway to pursue its clinical objectives.

Now, the presentation at the Sequire Investor Summit represents the next step in its long-term financial strategy. The summit, held at the luxurious Condado Vanderbilt Hotel, is specifically designed to connect growth-stage public companies with family offices, institutional funds, and affluent individual investors. For Oragenics, it is a prime opportunity to communicate its value proposition directly to those with the capital to fuel its ambitious development pipeline.

Investors in the biotech space are accustomed to high risk and volatility, a fact reflected in Oragenics' stock (NYSE American: OGEN), which has seen a wide 52-week trading range. The company's ability to clearly articulate the scientific merit of ONP-002, the size of the untapped market, and its strategy for navigating the regulatory landscape will be paramount to winning investor confidence.

A Strategic Play in a Caribbean Tax Haven

The choice of Puerto Rico as the summit's location is no coincidence. The U.S. territory has deliberately cultivated an environment to attract wealth and investment through its Incentives Code, commonly known as Act 60. Under these provisions, bona fide residents of Puerto Rico can benefit from a 100% tax exemption on passive income, including capital gains from securities, and pay no U.S. federal income tax on income sourced from the island.

This has turned Puerto Rico into a magnet for the very investor class Oragenics needs to reach. By presenting at the Sequire Summit, the company gains direct access to a concentrated pool of capital that is actively seeking high-growth opportunities. It is a strategic move to fish where the fish are, leveraging the island's unique economic landscape to its advantage.

Beyond Concussion: A Platform for the Brain

While ONP-002 is the company's current flagship candidate, Oragenics' long-term vision extends far beyond concussion. The core of its strategy lies in its proprietary intranasal delivery platform, a technology that holds promise for a wide array of neurological disorders that have historically been difficult to treat.

Conditions such as Alzheimer's disease, Parkinson's disease, PTSD, and anxiety disorders all present the common challenge of delivering therapeutics effectively across the blood-brain barrier. Oragenics' nose-to-brain delivery system offers a potential solution, and the company is actively exploring its application for other conditions.

To accelerate this pipeline expansion, Oragenics entered a strategic partnership in late 2025 with Receptor.AI, a firm specializing in artificial intelligence for drug discovery. By using AI modeling, Oragenics aims to more rapidly identify and validate new drug candidates for its platform, transforming itself from a single-asset company into a diversified developer of neurological therapies.

As Oragenics prepares to make its case in San Juan, it stands at the intersection of urgent medical need and immense financial opportunity. The success of its presentation could be a pivotal moment, determining its ability to carry ONP-002 across the clinical finish line and unlock the broader potential of its brain-targeted delivery technology.