Oragenics, Inc. Files 10K and Provides Company Update

Rhea-AI Summary

Oragenics, Inc. (OGEN) announces filing of annual report, focusing on developing intranasal pharmaceuticals for neurological disorders. Key highlights include new technology acquisition, successful Phase I trial, fundraising of $2.1 million, hiring of Chief Medical Officer, addition of two Board members, establishment of Australian subsidiary, and preparation for Phase II clinical trial.

Insights

Financial Analyst

Oragenics, Inc.'s recent annual report highlights several strategic moves that could influence investor sentiment. The acquisition of a platform technology with a completed Phase I trial for treating neurological disorders like concussion represents an expansion of the company's pipeline. This diversification could mitigate risk and potentially enhance shareholder value if the technology proves successful in subsequent trials.

The capital raised through a public and private offering totaling nearly $3 million strengthens the company's financial position, enabling further research and development. This infusion of capital is essential for biotech firms, which often face cash-burn issues due to high R&D costs before achieving profitability.

The appointment of Dr. James Kelly as Chief Medical Officer could bring valuable expertise to the company's clinical development, given his background in brain injury. Strategic board appointments and the creation of an Australian subsidiary to leverage R&D rebates also suggest a proactive approach to governance and fiscal optimization.

However, investors should be aware of the inherent risks in biotech investment, especially in companies focused on early-stage clinical trials. The long-term value creation mentioned relies heavily on the successful progression of their technology through rigorous clinical trials and eventual market approval, which is never guaranteed.

Medical Research Analyst

The progression of Oragenics, Inc.'s intranasal pharmaceutical technology through a successful Phase I trial is a significant milestone. Phase I trials primarily assess safety and moving on to Phase II indicates a positive safety profile. Phase II will delve deeper into efficacy, which is critical for regulatory approval and commercial viability.

The choice to focus on concussion is strategic, given the increasing awareness and concern around sports-related brain injuries and the lack of definitive treatments. If successful, the technology could address a substantial unmet medical need.

Dr. James Kelly's expertise could be pivotal in guiding the clinical development process for brain injury treatments. His reputation in the field might also lend credibility to the company's research endeavors, potentially attracting further investment and partnerships.

Manufacturing drug preparations for Phase II trials denotes a commitment to advancing the clinical program. However, the success of the Phase II trial will be important for the company's future, as it will determine the efficacy of the product and its potential impact on the market.

Market Research Analyst

The neurological disorder treatment market is rapidly growing, driven by a rising prevalence of conditions and an aging population. Oragenics, Inc.'s entry into this space with a novel intranasal delivery system could set them apart from competitors if the technology is proven effective.

Establishing a subsidiary in Australia is a savvy move, considering the country's generous R&D tax incentives, which could reduce overall development costs. This strategic decision may also provide access to a broader talent pool and potential new markets.

Engaging a leading Contract Research Organization (CRO) to oversee the Phase II clinical trial is a testament to the company's commitment to maintaining high standards in its clinical research. This could enhance the credibility of the trial results, which is vital for regulatory approval and market acceptance.

Investors should monitor the company's progress closely, as the outcomes of the Phase II trial will likely have a significant impact on Oragenics' stock performance. Positive results could lead to an uptick in investor confidence and stock value, while negative outcomes could have the opposite effect.

SARASOTA, Fla.--(BUSINESS WIRE)-- Oragenics, Inc. (the “Company”) (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced that it has filed its annual report on March 29, 2024. The Company is pleased to report it has executed on its strategy to diversify its product development portfolio and makes progress in transforming the Company to create long term value. Some key items that have helped to improve the Company moving forward are:

• The Company acquired a platform technology intended to treat multiple neurological disorders. The first target indication is for concussion and the technology has successfully completed a Phase I trial.
• Raised approximately $ 2.1 million in a public offering and $890,000 in a private transaction.
• Hired a Chief Medical Officer: Dr James Kelly MD, is a thought leader in brain injury including concussion.
• Added two new Board members: John Gandolfo and Bruce Cassidy.
• Created a subsidiary in Australia to take advantage of R&D rebates offered by the Australian government.
• Contracted with a leading Contract Research Organization to oversee our Phase II clinical trial.
• Manufacturing drug in preparation for our Phase II trial.

We are excited about the progress the Company has made in the past several months. We are creating a team with the experience and drive to further our neurological drug candidates through clinical trials during 2024,” commented Michael Redmond, President of Oragenics.

As previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2023, which was filed on March 29, 2024 with the Securities and Exchange Commission, the audited consolidated financial statements contained an unqualified audit opinion from its independent registered public accounting firm that included an explanatory paragraph related to the Company’s ability to continue as a going concern. See further discussion in footnote 1 of the Company’s consolidated financial statements included in the Company’s Annual Report on Form 10-K.

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 (mTBI), also known as concussion, and for treating Niemann Pick Disease Type C (NPC), 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. 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 those described in our Form 10-K and other filings with the U.S. Securities and Exchange Commission. All information set forth in this press release is as of the date hereof. You should consider these factors in evaluating the forward-looking statements included in this press release 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240328369604/en/

Oragenics, Inc.

Janet Huffman, Chief Financial Officer

813-286-7900

jhuffman@oragenics.com

LHA Investor Relations

Tirth T. Patel

212-201-6614

tpatel@lhai.com

Source: Oragenics, Inc.

FAQ

What did Oragenics, Inc. (OGEN) announce in the press release?

Oragenics, Inc. announced the filing of its annual report, highlighting its focus on developing intranasal pharmaceuticals for neurological disorders.

What are some key highlights mentioned in the press release?

Key highlights include the acquisition of a platform technology for treating neurological disorders, successful completion of a Phase I trial for concussion treatment, fundraising of $2.1 million, hiring of Chief Medical Officer Dr. James Kelly MD, addition of two new Board members, establishment of an Australian subsidiary, and preparation for a Phase II clinical trial.

How much did Oragenics, Inc. (OGEN) raise in a public offering and a private transaction?

Oragenics, Inc. raised approximately $2.1 million in a public offering and $890,000 in a private transaction.

Who is the newly hired Chief Medical Officer of Oragenics, Inc. (OGEN)?

The newly hired Chief Medical Officer of Oragenics, Inc. is Dr. James Kelly MD, a thought leader in brain injury including concussion.

What is the purpose of Oragenics, Inc. (OGEN) creating a subsidiary in Australia?

Oragenics, Inc. created a subsidiary in Australia to take advantage of R&D rebates offered by the Australian government.

What is Oragenics, Inc. (OGEN) preparing for in terms of clinical trials?

Oragenics, Inc. is preparing for its Phase II clinical trial by manufacturing the drug.