OGEN Oragenics Inc

 

 

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: August 14, 2024

(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)

 

1990 Main Street Suite 750 Sarasota, FL		34236
(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 8.01. OTHER INFORMATION.

 

On August 14, 2024, the Company issued a press release announcing its lead candidate, ONP-002, an innovative neurosteroid designed to treat mild Traumatic Brain Injury (mTBI), commonly referred to as concussion, is stable across a wide temperature range, eliminating the need for cumbersome cold storage for the drug device combination during transport and storage. A copy of the Press Release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.

 

ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.

 

(d) Exhibits

 

Exhibit No.		Description
99.1		Press Release Dated, August 14, 2024.
104		Cover page Interactive Data File (embedded in the cover page formatted in Inline XBRL)

 

 

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 14^th day of August, 2024.

 

	ORAGENICS, INC. (Registrant)
	BY:	/s/ Janet Huffman
		Janet Huffman Chief Financial Officer

 

 

 

Exhibit 99.1

 

Oragenics Inc. Shows Concussion Drug, ONP-002, Designed for Acute Field-Delivery Stable Across a Wide Temperature Range

 

 

● ONP-002 stability suggest no need for cumbersome cold storage

● No FDA-approved pharmaceutical treatment available for concussion

 

 

SARASOTA, Fla., August 14, 2024 (GLOBE NEWSWIRE) Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced its lead candidate for treating concussion, ONP-002, is stable across a wide temperature range, eliminating the need for cumbersome cold storage for the drug device combination. ONP-002 is a new chemical entity (NCE) designed to target the brain through a breath propelled delivery system into the nasal cavity to treat concussions.

 

Oragenics recently completed the synthesis of its ONP-002 drug batch for the planned Phase II clinical trial. The company reports 3-month stability with over 99% purity at temperatures ranging from -20°C to 104°C. Oragenics is confident in its belief that ONP-002 will not require cumbersome cold chain protocols during transport and storage, maintaining its chemical structure and function even in extreme temperatures.

 

Field conditions for contact sports and military operations involve a wide range of temperatures that may affect the stability and effectiveness of drugs intended for acute concussion treatment. ONP-002 has been formulated as a spray-dried powder to improve stability in extreme temperatures. In contrast, narrow temperature storage protocols can be cumbersome and pose greater risk for non-compliance during shipping and field operations.

 

“We understand the importance of getting ONP-002 into the brain quickly after concussive injury to squelch the pathological cascade of inflammation and oxidative stress. As an emergency medicine physician, I am especially excited to find out that Oragenics’ drug is expected to maintain its function out in the field where we plan to administer the initial dose. While there is currently no drug treatment for concussion, we believe strongly that targeting the brain intranasally during the acute field-phase will improve treatment efficacy,” commented Frank Peacock, MD and Chief Clinical Officer for Oragenics.

 

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

jhuffman@oragenics.com

 

Investor Relations :

 

Rich Cockrell

CG Capital

404-736-3838
ogen@cg.capital

 

 

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Cover	Aug. 14, 2024
Cover [Abstract]
Document Type	8-K
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Document Period End Date	Aug. 14, 2024
Entity File Number	001-32188
Entity Registrant Name	Oragenics, Inc.
Entity Central Index Key	0001174940
Entity Tax Identification Number	59-3410522
Entity Incorporation, State or Country Code	FL
Entity Address, Address Line One	1990 Main Street
Entity Address, Address Line Two	Suite 750
Entity Address, City or Town	Sarasota
Entity Address, State or Province	FL
Entity Address, Postal Zip Code	34236
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Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock
Trading Symbol	OGEN
Security Exchange Name	NYSEAMER
Entity Emerging Growth Company	false

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