0001493152-21-031986.txt : 20211220 0001493152-21-031986.hdr.sgml : 20211220 20211220081938 ACCESSION NUMBER: 0001493152-21-031986 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20211215 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20211220 DATE AS OF CHANGE: 20211220 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ORAGENICS INC CENTRAL INDEX KEY: 0001174940 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 593410522 STATE OF INCORPORATION: FL FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32188 FILM NUMBER: 211503704 BUSINESS ADDRESS: STREET 1: 4902 EISENHOWER BLVD STREET 2: SUITE 125 CITY: TAMPA STATE: FL ZIP: 33634 BUSINESS PHONE: 8132867900 MAIL ADDRESS: STREET 1: 4902 EISENHOWER BLVD STREET 2: SUITE 125 CITY: TAMPA STATE: FL ZIP: 33634 8-K 1 form8-k.htm
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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: December 15, 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 1.01 Entry into a Material Definitive Agreement

 

On December 15, 2021, Oragenics, Inc. (“Oragenics” or the “Company”) entered into an amendment to its Technology License Agreement with the National Resource Council of Canada (the “NRC”) dated July 26, 2021. The purpose of the amendment was to include the trimeric spike protein Omicron variant to the NRC License. All other terms of the License, as amended and filed as Exhibit 10.0 to the Company’s Form 10-Q filed on November 15, 2021, remained the same.

 

Item 8.01 Other Information

 

On December 20, 2021, Oragenics issued a press release announcing the extension of its License Agreement with the NRC to add the Omicron variant as referenced above under Item 1.01. 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

 

(d) Exhibits

 

Exhibit No.   Description
99.1   Press Release dated December 20, 2021
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 
 

 

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 20th day of December, 2021.

 

  ORAGENICS, INC.
   
  BY: /s/ Michael Sullivan
    Michael Sullivan
    Interim Principal Executive Officer
    and Chief Financial Officer  

 

 

 

 EX-99.1 2 ex99-1.htm

 

Exhibit 99.1

 

December 20, 2021

 

 

Oragenics Extends Collaboration with the National Research Council of Canada to Develop

Vaccine against the Omicron Variant

 

Agreement extends current licensing and collaboration agreement to include rapid production of

Omicron-specific intranasal vaccine candidates

 

TAMPA, Fla. (December 20, 2021) – Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) today announced it has extended a licensing and collaboration agreement with the National Research Council of Canada (NRC) that will enable Oragenics to pursue an intranasal vaccine designed to protect against the SARS-CoV-2 Omicron variant. The NRC cell expression technologies provide Oragenics with a platform that can generate cell lines for high-yield production of spike protein antigens for existing and emerging variants of concern. This platform should allow production of cell lines within six to eight weeks of spike gene sequence availability, compared with six to nine months for traditional production of such cell lines. The NRC technologies, developed with support from the NRC’s Pandemic Response Challenge program, will expedite the evaluation of an Omicron-specific Terra-CoV-2 candidate in preclinical and clinical studies.

 

“Oragenics is well-positioned to develop an Omicron-specific intranasal vaccine thanks to our successful, on-going collaboration with the NRC.” said Frederick W. Telling, Ph.D., Oragenics’ Executive Chairman. “We had anticipated the need for rapid development of COVID-19 vaccine candidates against new variants and can leverage the NRC cell expression platform to address Omicron and future variants.”

 

Oragenics recently demonstrated the protection of hamsters against SARS-CoV-2 with the intranasal Terra-CoV-2 candidate, which strongly supports the further development into an IND-enabling GLP toxicology study and a first-in-human Phase 1 clinical study.

 

About Oragenics, Inc.

 

Oragenics, Inc. is a development-stage company dedicated to fighting infectious diseases including coronaviruses and multidrug-resistant organisms. Its lead product is Terra CoV-2, an intranasal vaccine candidate to prevent COVID-19 and variants of the SARS-CoV-2 virus. The Terra CoV-2 program leverages coronavirus spike protein research licensed from the NIH and the 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.

 

 

 

 

December 20, 2021

 

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 and lantibiotics 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 product candidate, Terra CoV-2 and our lantibiotics, 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 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 Terra CoV-2 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 administration, 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.

 

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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