SARASOTA, Fla., Aug. 16, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN) ("the Company"), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced recent and key 2024 business progress. The Company continues to execute its business strategy to develop and advance its lead candidate, ONP-002, for the treatment of concussion. Phase 2 human trials are being planned with anticipation of starting in the fourth quarter of this year.
Achievements:
“We are pleased with the significant progress this year, particularly in advancing ONP-002 toward Phase 2 clinical trials,” commented Michael Redmond, President of Oragenics. “Our team’s efforts in enhancing drug safety, completing key FDA tests, and improving our delivery technology and formulation demonstrate our commitment to addressing the urgent need for concussion treatments. These advancements, along with the strategic leadership appointments, position Oragenics as a leader in the development of medical solutions for acute neurological trauma, bringing us closer to meeting this critical unmet need.”
Continued Non-Compliance and NYSE Approved Plan to Gain Compliance
As previously disclosed, the Company is not in compliance with subsections (ii) and (iii) of Section 1003(a) of the NYSE American’s continued listing standards. On August 13, 2024, the Company received a notice from the NYSE American LLC informing the Company that it also is not in compliance with subsection (i) Section 1003(a), which requires stockholders’ equity of no less than $2,000,000 if the Company has sustained losses from continuing operations and/or net losses in two of its three most recent fiscal years. The Company previously submitted a Plan of Compliance (the “Plan”) to the NYSE American. The NYSE American approved the Plan. The Company has until October 18, 2025 to regain compliance under the approved Plan. The NYSE non-compliance notices do not affect the listing or trading of Oragenics’ stock, which will continue under the symbol “OGEN” with a “.BC” designation to indicate the status of the Common Stock as “below compliance”. The Company remains committed to addressing this issue while advancing its business and clinical operations.
About Concussion
Concussion is an unmet medical need. There are an estimated 69 million concussions annually reported worldwide. Common causes of concussion include falls, motor vehicle accidents, and contact sports. Other neurological disorders, including Alzheimer’s Disease, Parkinson’s Disease, and Chronic Traumatic Encephalopathy (CTE), have been linked to concussion. Post-concussion symptomology is linked to long-term disability and occurs in as high as 20% of concussed patients.
About Oragenics
Oragenics is a development-stage biotechnology company focused on nasal delivery of pharmaceutical medications in neurology and fighting infectious diseases, including drug candidates for treating mild traumatic brain injury, also known as concussion, and for treating Niemann Pick Disease Type C, as well as proprietary powder formulation and an intranasal delivery device. For more information, please 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 ability of the Company to timely and successfully undertake Phase II clinical trial using 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. 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 be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to: the Company’s ability to advance the development of its product candidates, including the neurology assets, under the timelines and in accord with the milestones it projects; the Company’s ability to raise capital and obtain funding, non-dilutive or otherwise, for the development of its product candidates; the regulatory application process, research and development stages, and future clinical data and analysis relating to its product candidates, including any meetings, decisions by regulatory authorities, such as the FDA and investigational review boards, whether favorable or unfavorable; the Company’s ability to obtain, maintain and enforce necessary patent and other intellectual property protection; the nature of competition and development relating to concussion treatments; the Company’s expectations as to the outcome of preclinical studies and clinical trials and the potential benefits, activity, effectiveness and safety of its product candidates including as to administration, transmission, manufacturing, storage and distribution; and general economic and market conditions and risks, as well as other uncertainties described in our filings with the U.S. Securities and Exchange Commission. All information set forth is as of the date hereof unless otherwise indicated. You should consider these factors in evaluating the forward-looking statements included and not place undue reliance on such statements. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by law.
Oragenics, Inc.
Janet Huffman, Chief Financial Officer
813-286-7900
This email address is being protected from spambots. You need JavaScript enabled to view it.
Investor Relations:
Rich Cockrell
CG Capital
404-736-3838
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Last Trade: | US$0.37 |
Daily Change: | 0.0025 0.68 |
Daily Volume: | 383,198 |
Market Cap: | US$4.500M |
September 05, 2024 August 21, 2024 August 14, 2024 |
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