Oragenics Inc. completes spray-drying drug manufacturing and

• Falls and car accidents lead to concussions in emergency rooms

• Spray-dried drug formulation allows easy administration to patients

• There is no drug treatment for concussions; the drug ONP-002 could be the first of its kind to treat concussions

SARASOTA, Fla., Aug. 21, 2024 (GLOBE NEWSWIRE) — Oragenics, Inc. (NYSE American: OGEN) (“the Company”), a company focused on developing unique, intranasal medicines to treat neurological disorders, today announced the completion of its spray-dried formulation and nasal device filling for its lead candidate, ONP-002, for the treatment of concussion. ONP-002 is a new chemical entity (NCE) that specifically targets the brain by administration into the nasal cavity. The prefilled formulation is designed to provide the required drug dosage for the planned Phase IIa clinical trial in patients with concussion.

For the study, the company produced both a placebo and the drug ONP-002 for use in the Phase IIa clinical trial to be conducted in Australia. The work involved manufacturing ONP-002 as a spray-dried nanoparticle formulation, loading the powder into Oragenics' novel breath-powered intranasal device, and initiating a stability program for both the drug formula alone and within the device. The Phase IIa clinical trial is expected to enroll 40 concussion patients who will receive either a placebo or the drug ONP-002 in a 1:1 ratio, with doses administered twice daily for five consecutive days post-injury. The goal of the study is to initiate treatment within 8 hours of injury in the emergency department. Patient-reported outcomes and blood biomarkers are expected to be included in the evaluation.

“In preparing for the Phase IIa trial, we wanted to ensure that ONP-002 could be formulated as a nanoparticle and administered intranasally as a powder to improve brain exposure. The anti-inflammatory effects of our novel neurosteroid are designed to reduce the negative consequences of concussion. We believe the combination of the spray-dried powder in our device is ideal for on-site administration and increases the chances of stopping the neuropathology of concussion early,” commented Michael Redmond, President of Oragenics.

About Concussion

Concussions are an unmet medical need. It is estimated that 69 million concussions are reported worldwide each year. Common causes of concussions include falls, motor vehicle accidents, and contact sports. Other neurological conditions, including Alzheimer's disease, Parkinson's disease, and chronic traumatic encephalopathy (CTE), are associated with concussions. Post-concussion symptoms are associated with long-term disability and occur in up to 20% of concussed patients.

About Oragenics

Oragenics is a development-stage biotechnology company focused on nasal delivery of drugs to combat infectious diseases and neurological disorders, including drug candidates for the treatment of mild traumatic brain injury (mTBI), also known as concussion, and for the treatment of Niemann-Pick disease type C (NPC), as well as a proprietary powder formulation and device for intranasal delivery. For more information, visit www.oragenics.com.

Forward-looking statements

This communication contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding the Company's ability to timely and successfully complete Phase II clinical trials of its novel drug-device combination for the treatment of mild traumatic brain injury. These forward-looking statements are based on management's beliefs and assumptions and information currently available to us. The words “believe,” “expect,” “anticipate,” “intend,” “estimate,” “project” and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should exercise caution in evaluating forward-looking statements because they are subject to a number of risks, uncertainties and other factors that could cause actual results to differ materially from those expressed in such forward-looking statements. These factors include, among others: the Company's ability to advance the development of its product candidates, including neurological assets, on the timelines and in accordance with the milestones it has projected; the Company's ability to raise capital and financing (non-dilutive or otherwise) for the development of its product candidates; the regulatory process, research and development phases and future clinical data and analyses relating to its product candidates, including any meetings, decisions of regulatory authorities such as the FDA and investigative committees, whether positive or negative; the Company's ability to obtain, maintain and enforce necessary patents and other intellectual property rights; the nature of competition and development relating to concussion treatments; the Company's expectations regarding the outcome of preclinical studies and clinical testing and the potential benefits, activity, efficacy and safety of its product candidates, including with respect to administration, transfer, manufacturing, storage and distribution; and general economic and market conditions and risks and other uncertainties described in our filings with the U.S. Securities and Exchange Commission. All information presented herein is as of the date of this publication, unless otherwise indicated. You should consider these factors in evaluating any forward-looking statements contained therein and should not place undue reliance on such statements. Except as otherwise required by law, we undertake no obligation to publicly revise or update any forward-looking statements, whether as a result of new information, future developments or otherwise, if circumstances change.

Oragenics, Inc.
Janet Huffman, Chief Financial Officer
813-286-7900
[email protected]

Investor Relations:
Rich Cockrell
CG Capital
404-736-3838
[email protected]