Exhibit 99.1
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934.
Date of Report: March 9, 2021
(Date of earliest event reported)
Oragenics, Inc.
(Exact name of registrant as specified in its charter)
| FL | 001-32188 | 59-3410522 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification Number) |
4902 Eisenhower Boulevard, Suite 125 Tampa, FL |
33634 | |
| (Address of principal executive offices) | (Zip Code) |
813-286-7900
(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 7.01 Regulation FD Disclosure.
Oragenics, Inc. (“Oragenics” or the “Company”) will be making an electronic investor presentation (the “Investor Presentation”) on March 9, 2021. The Company also expects to use the Investor Presentation from time to time thereafter in connection with presentations to potential investors, industry analysts and others. A copy of the Investor Presentation is attached hereto as Exhibit 99.1 and is incorporated herein by reference. Additionally, the Investor Presentation will be available under the “Presentations” tab in the “News and Media” section of the Company’s website, located at www.oragenics.com.
By filing this Current Report on Form 8-K and furnishing the information contained herein, the Company makes no admission as to the materiality of any information in this report that is required to be disclosed solely by reason of Regulation FD.
The information contained in the Investor Presentation is summary information that is intended to be considered in the context of the Company’s Securities and Exchange Commission (“SEC”) filings and other public announcements that the Company may make, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in this report, although it may do so from time to time as its management believes is warranted. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure.
The information presented in Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, unless the Company specifically states that the information is to be considered “filed” under the Exchange Act or specifically incorporates it by reference into a filing under the Securities Act of 1933, as amended, or the Exchange Act.
Item 8.01. Other Information.
On March 9, 2021, the Company issued a press release announcing that it had entered into material transfer agreement with Biodextris Inc. for mucosal adjuvant for intranasal COVID-19 vaccine.
A copy of the press release is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
| (d) | Exhibits. |
Exhibit No. |
Description | |
| 99.1 | Investor Presentation. | |
| 99.2 | Press Release dated March 9, 2021. | |
SIGNATURES
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 9th day of March, 2021.
ORAGENICS, INC. (Registrant) | ||
| BY: | /s/ Michael Sullivan | |
| Michael Sullivan | ||
| Chief Financial Officer | ||
Exhibit 99.1
Exhibit 99.2
Oragenics Enters into Material Transfer Agreement with Biodextris for Mucosal Adjuvant for Intranasal COVID-19 Vaccine
TAMPA, Fla. (March 9, 2021) – Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) announced it has entered into a material transfer agreement with Biodextris Inc. for the use of three intranasal mucosal adjuvants in the Company’s Terra CoV-2 vaccine against COVID-19. Adjuvants are added to vaccines to enhance their immunogenicity. BDX100, BDX300 and BDX301 are proteosome-based adjuvants comprised of proteins and lipopolysaccharides with improved attributes including enhanced immune response, manufacturing efficiency and the benefits of intranasal vaccine administration.
The initial agreement calls for the three intranasal adjuvants to be used in combination with the Oragenics’ antigen vaccine candidate as part of the preclinical immunological evaluation of Terra CoV-2, for the prevention of coronavirus disease caused by infection with SARS-CoV-2 virus. The information generated from the studies employing the new intranasal vaccine candidate would potentially support the U.S. Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) application and an application to Health Canada to initiate clinical trials. The agreement allows for the future collaboration regarding the intranasal delivery of vaccine during clinical development with the opportunity to enter into a commercial agreement upon regulatory approval of the intranasal vaccine.
The Terra CoV-2 vaccine plus Biodextris’ intranasal mucosal adjuvants will be studied in the preclinical animal studies, including hamster viral challenge studies, mouse immunogenicity studies and the rodent toxicology study required for regulatory approval prior to the initiation human testing.
“This material transfer agreement both expands and advances the development of our Terra CoV-2 vaccine with a novel delivery option,” said Alan Joslyn, Ph.D., President and Chief Executive Officer of Oragenics. “The Biodextris intranasal mucosal adjuvants in combination with the Oragenics antigen open up new possibilities for a vaccine that could potentially be a more effective and convenient option than those currently available. Given the benefits of intranasal administration along with Terra CoV-2’s other advantages, including the potential to be stored and distributed at refrigerated temperatures, we believe there is significant opportunity to help address the worldwide COVID-19 pandemic, particularly in the post-near term immunization phase where booster shots and potential effectiveness against a variety of Covid-19 variant strains may continue to be required.”
Joseph Zimmermann, President of Biodextris, added, “We are delighted to partner with Oragenics on exploring the potential of their Terra CoV-2 vaccine. Our proteosome-based compounds can be powerful adjuvants and offer several advantages, including the ability to elicit both mucosal and serum antibodies while offering innate and adaptive immunity.”
About Terra CoV-2
In March 2020, Oragenics acquired a non-exclusive license from the National Institutes of Health (“NIH”) for its stabilized prefusion Terra CoV-2 spike protein. Oragenics announced that its spike protein had been successfully inserted into Chinese Hamster Ovary (“CHO”) cells production and analytical development are underway. CHO cells are used to produce a number of FDA-approved recombinant proteins.
About Biodextris Inc.
Based in Laval, Québec, Biodextris is a contract research organization providing a suite of analytical, process development and CMC consulting services for vaccines and biologics in the clinical stages of development. The company’s expertise, facilities and quality systems support clients to confidently navigate a path from R&D to early-phase clinical trials. For more information, visit: www.biodextris.com.
About Oragenics, Inc.
Oragenics, Inc. is focused on the creation of the Terra CoV-2 vaccine candidate to combat the novel coronavirus pandemic and the further development of effective treatments for novel antibiotics against infectious diseases. The Company is dedicated to the development and commercialization of a vaccine candidate providing specific immunity from novel coronavirus. The Terra CoV-2 immunization leverages coronavirus spike protein research conducted by the National Institutes of Health. In addition, Oragenics has an exclusive worldwide channel collaboration with Eleszto Genetika, Inc. relating to the development of novel lantibiotics.
For more information about Oragenics, 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, the following: the Company’s ability to advance the development of Terra CoV-2 under the timelines and in accord with the milestones it projects including in potential combination with a nasal mucosal adjuvant; the Company’s ability to obtain funding, non-dilutive or otherwise, for the development of Noachis Terra’s Terra CoV-2 vaccine and adjuvant products, 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 Terra CoV-2, including any meetings, decisions by regulatory authorities, such as the FDA and investigational review boards, whether favorable or unfavorable; the potential application of Terra CoV-2 to 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 including adjuvants; the Company’s expectations as to storage, administration and distribution, potential market and impact of other vaccines being administered; 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 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.
Contacts:
Oragenics, Inc.
Michael Sullivan, Chief Financial Officer
813-286-7900
msullivan@oragenics.com
or
LHA Investor Relations
Kim Golodetz
212-838-3777
kgolodetz@lhai.com
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