SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934.
Date of Report: December 22, 2022
(Date of earliest event reported)
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
4902 Eisenhower Boulevard, Suite 125
|(Address of principal executive offices)||(Zip Code)|
(Registrant’s telephone number, including area code)
(Former Name or Former Address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
|☐||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|☐||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|☐||Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|☐||Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class||Trading Symbol(s)||Name of each exchange on which registered|
|Common Stock||OGEN||NYSE American|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 OTHER EVENTS.
On December 22, 2022, Oragenics, Inc. issued a press release announcing favorable results from its ongoing Good Laboratory Practice toxicology study to evaluate the safety and immunogenicity of its NT-CoV2-1 intranasal vaccine candidate. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 FINANCIAL STATEMENTS AND EXHIBITS.
|99.1||Press Release dated December 22, 2022.|
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document)|
In accordance with the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized on this 22nd day of December, 2022.
|BY:||/s/ Kimberly Murphy|
President and Chief Executive Officer
December 22, 2022
Oragenics Reports Favorable Toxicology Results for its COVID-19 Intranasal Vaccine Candidate
No toxicity found in NT-CoV2-1, supports regulatory filing for Phase 1 study
TAMPA, Fla. (December 22, 2022) Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a biotechnology company dedicated to fighting infectious diseases including COVID-19, today announced results indicating no toxicity signals or adverse events from its Good Laboratory Practices (GLP) toxicology study in rabbits evaluating the safety and immunogenicity of its NT-CoV2-1 intranasal vaccine candidate. Oragenics believes the findings of the final toxicology report, including a full histopathology evaluation, confirm a safety and immunogenicity profile that further support its plan to submit regulatory filings required to progress to a Phase 1 clinical study.
“There is an unmet medical need for an intranasally administered COVID-19 vaccine. We are encouraged by these favorable toxicology study results, which advance the preclinical work required for pursuing regulatory permission to begin human testing. This marks an important milestone in the progress of bringing an intranasal COVID-19 vaccine to the market,” said Kim Murphy, President and Chief Executive Officer of Oragenics. “Signals of adequate immune responses have been demonstrated in prior preclinical studies with NT-CoV2-1 against multiple SARS-CoV-2 variants of interest. We expect to provide an update on our regulatory pathway in the first quarter of 2023.”
The objectives of the toxicology study were to evaluate the potential toxicity of NT-CoV2-1 following repeated intranasal administration at the maximal dose anticipated to be used in humans, and to confirm the immunogenicity of the vaccine.
Oragenics previously published positive preclinical data in Scientific Reports, a Nature journal, demonstrating that intranasal administration of NT-CoV2-1 induced robust antigen-specific IgG and IgA titers in the blood and lungs of mice, and reduced viral load below the limit of detection in a hamster SARS-CoV-2 challenge model. In both mice and hamsters, the antibodies had strong neutralizing activity, preventing the cellular binding of the viral spike protein based on the ancestral reference strain and variants of concern.
About Oragenics, Inc.
Oragenics, Inc. is a development-stage company dedicated to fighting infectious diseases, including those caused by coronaviruses and multidrug-resistant organisms. Its lead product is NT-CoV2-1, an intranasal vaccine candidate to prevent COVID-19 and variants of the SARS-CoV-2 virus. The NT-CoV2-1 program leverages coronavirus spike protein research licensed from the National Institutes of Health (NIH) and the National Research Council of Canada (NRC) with a focus on reducing viral transmission and offering a more patient-friendly intranasal administration. Its lantibiotics program features a novel class of antibiotics against bacteria that have developed resistance to commercial antibiotics. For more information about Oragenics, please visit www.oragenics.com.
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, the following: the Company’s ability to advance the development of its vaccine candidate and lantibiotics candidate under the timelines and in accord with the milestones it projects; the Company’s ability to obtain funding, non-dilutive or otherwise, for the development of the vaccine and lantibiotic product candidates, whether through its own cash on hand, or another alternative source; the regulatory application process, research and development stages, and future clinical data and analysis relating to vaccines and lantibiotics, including any meetings, decisions by regulatory authorities, such as the FDA and investigational review boards, whether favorable or unfavorable; the potential application of our vaccine candidate to variants and other coronaviruses; the Company’s ability to obtain, maintain and enforce necessary patent and other intellectual property protection; the nature of competition and development relating to COVID-19 immunization and therapeutic treatments and demand for vaccines and antibiotics; the Company’s expectations as to the outcome of preclinical studies, nasal administration, transmission, manufacturing, storage and distribution; other potential adverse impacts due to the global COVID-19 pandemic, such as delays in regulatory review, interruptions to manufacturers and supply chains, adverse impacts on healthcare systems and disruption of the global economy; 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 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.
LHA Investor Relations
Tirth T. Patel
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