Oragenics - OGEN STOCK NEWS

Oragenics (NYSE American: OGEN) announced that its Chief Medical Officer, Dr. James Kelly, has been appointed to the Medical Board of The Leigh Steinberg Foundation for Concussion, Traumatic Brain Injury, and Brain Health. Dr. Kelly, previously the founding director of the National Intrepid Center of Excellence at Walter Reed National Military Medical Center, brings extensive experience in brain injury research and treatment.

The appointment aligns with Oragenics' development of ONP-002, their novel intranasal treatment for concussion. As a board member, Dr. Kelly will collaborate with leading researchers and medical professionals to advance brain health education, innovative research, and improved care access. The Leigh Steinberg Foundation focuses on supporting research, raising awareness, and developing solutions for those affected by concussions and traumatic brain injuries.

Oragenics (NYSE American: OGEN) has announced a strategic partnership with BRAINBox Solutions to develop the first intranasal therapy for mild traumatic brain injury (mTBI) and concussion. The collaboration combines BRAINBox's diagnostic platform, which uses biomarkers, neuropsychological assessments, and AI analytics, with Oragenics' therapeutic candidate ONP-002.

The partnership aims to create a comprehensive trigger-to-treat platform. BRAINBox's testing platform provides diagnostic and prognostic insights, while ONP-002, an intranasal neurosteroid therapeutic, has shown promise in preclinical studies for reducing brain injury effects. Phase I clinical trials demonstrated ONP-002's tolerability and ease of use.

With over 5 million concussions occurring annually in the U.S., this collaboration addresses a significant unmet medical need by potentially offering both rapid diagnosis and targeted treatment options for concussion patients.

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.