Oragenics Stock Price, News & Analysis

Oragenics (NYSE American: OGEN) announced that Chief Medical Officer Dr. James P. Kelly will participate as a featured panelist at the 12th Annual Brain Health Summit during Super Bowl celebrations in New Orleans on February 8, 2025.

The summit, hosted by sports agent Leigh Steinberg, focuses on advancing awareness, prevention, and care for athletic concussions and exploring innovative approaches to traumatic brain injury (TBI) treatment. Dr. Kelly will join other thought leaders to discuss long-term TBI impacts and treatment advances.

Dr. Kelly highlighted Oragenics' innovative ONP-002, an intranasal neurosteroid designed for concussion treatment. The summit will be moderated by Dr. Nicole Roberts, founder and President of Health & Human Rights Strategies, bringing together medical experts, former professional athletes, and industry leaders to drive improvements in brain health care.

Oragenics (NYSE American: OGEN) provided updates on its strategic progress since its $4 million capital raise in September 2024 and announced Janet Huffman as interim CEO. Key developments include improvements to ONP-002's formulation and intranasal delivery device, advancement of Phase II trial preparations in Australia, and completion of spray-dry campaign for drug-device units.

The company aims to dose the first patient in Australian Phase II trials by end of Q1 2025 or early Q2. Regulatory milestones, including Phase I trial closure and IND submission, remain on track. Ms. Huffman, previously CFO at TRxADE HEALTH, brings experience in capital raising and M&A. The company plans to submit the IB package by Q1 2025, formalize Australian partnerships, and submit the IND package for US phase IIb trials in Q3 2025.

Oragenics (NYSE: OGEN) announced the conversion of its remaining Series A and Series B Preferred Shares into common stock. The conversion eliminates approximately $2.35 million in liquidation preference and simplifies the company's capital structure. Specifically, 5,417,000 Series A and 4,050,000 Series B Preferred Shares were converted into approximately 22,000 common shares. The Series A and B Preferred Shares, which carried no voting rights, have been fully retired. The company views this as a strategic move to strengthen its foundation for future growth and focus on advancing its pipeline of treatments for neurological and rare diseases.

Oragenics Inc. (NYSE American: OGEN), a company focused on developing new treatments for brain-related health conditions, has announced its participation in the Centurion One Capital 2nd Annual Bahamas Summit. The event will take place at the Rosewood Baha Mar Hotel in Nassau, Bahamas on October 22-23, 2024.

Michael Redmond, President of Oragenics, is scheduled to deliver a corporate presentation and participate in a Q&A session on October 22, 2024, at 1:20 pm ET. This presentation offers an opportunity for investors and interested parties to gain insights into Oragenics' current projects and future plans in the field of brain health treatments.

Attendees can register for the event through a provided link, allowing them to participate in this significant gathering of industry professionals and potential investors in the pharmaceutical and biotechnology sectors.

Oragenics, Inc. (NYSE American: OGEN) has provided a corporate update on its progress in developing ONP-002, a first-in-class neurosteroid for treating moderate to severe concussions. Key milestones in 2024 include:

1. Appointment of renowned experts as Chief Medical Officer and Chief Clinical Officer
2. Preparation for Phase II clinical trials
3. Successful completion of cardiotoxicity and genotoxicity tests
4. Partnership with Avance Clinical for trial execution
5. Achievement of temperature stability for ONP-002
6. Completion of spray-dry formulation and intranasal delivery devices
7. Development of a novel nanoparticle formulation increasing drug percentage by 4-fold
8. Successful intranasal casting studies for FDA approval

Oragenics raised over $6 million in 2024 to support ONP-002 development. The company plans to initiate Phase II trials later this year, starting in Australia followed by the U.S., to evaluate safety and efficacy in concussion patients.

Oragenics Inc. (NYSE American: OGEN) has successfully completed a key FDA-recognized study for its concussion drug, ONP-002. The study demonstrated that the intranasal delivery of ONP-002 effectively targets areas in the nose connected to the brain, increasing the likelihood of rapid brain treatment post-concussion. This achievement paves the way for Oragenics to proceed with Phase II human testing in emergency room patients, aiming to administer the first dose within 8 hours of injury.

The study utilized a special nasal spray device and an FDA-accepted anatomical model of the interior nose. Results showed promising drug distribution in areas where it can be quickly absorbed into the brain. With approximately 69 million people affected by concussions annually and no current pharmaceutical treatment available, ONP-002 represents a significant potential breakthrough in concussion treatment.

Oragenics, Inc. (NYSE American: OGEN), a company developing intranasal pharmaceuticals for neurological disorders, has closed its public offering of 3,078,378 common stock shares and 5,028,206 pre-funded warrants. The offering price was $0.55 per share and $0.549 per pre-funded warrant, with a $0.001 exercise price for each warrant. The company raised approximately $4.45 million in gross proceeds before deducting fees and expenses. Oragenics plans to use the funds for the continued development of its ONP-002 product candidate and general corporate purposes. Post-offering, Oragenics has 8,659,071 outstanding common stock shares and 5,028,206 outstanding pre-funded warrants. Dawson James Securities, Inc. acted as the sole placement agent for this offering.

Oragenics, Inc. (NYSE American: OGEN), a company developing intranasal pharmaceuticals for neurological disorders, has announced the pricing of a public offering. The company plans to sell 8,106,584 shares of common stock (or pre-funded warrants) at $0.55 per share. The offering is expected to close around September 5, 2024, with anticipated gross proceeds of $4.45 million. Oragenics intends to use the net proceeds to fund the development of its ONP-002 product candidate and for general corporate purposes. Dawson James Securities, Inc. is acting as the sole placement agent for this offering, which is being made pursuant to an effective registration statement filed with the SEC.

Oragenics Inc. (NYSE American: OGEN) has completed the spray-dried formulation and nasal device filling for its lead candidate, ONP-002, in preparation for a Phase IIa clinical trial targeting concussion treatment. The trial, set to enroll 40 concussed patients in Australia, will evaluate the efficacy of ONP-002 administered intranasally within 8 hours of injury. This novel neurosteroid aims to reduce negative outcomes post-concussion through its anti-inflammatory effects.

Key developments include:

• Production of placebo and ONP-002 as spray-dried nanoparticle formulations
• Loading of the powder into Oragenics' proprietary breath-propelled intranasal device
• Initiation of a stability program for both the drug formula and device

The trial design involves twice-daily dosing for five consecutive days, with patient-reported outcomes and blood biomarkers expected to be part of the evaluation process.