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Newly Published Preclinical Data on Oragenics, Inc.’s Lantibiotic Compound Demonstrates Tolerability and Compartmentalization to the GI Tract

May 13, 2019

TAMPA, Fla.--(BUSINESS WIRE)--May 13, 2019--Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis (“OM”), today announced the publication of preclinical data of the company’s lantibiotic compound OG253, a predecessor to its current lead lantibiotics compound OG716, when administered in animal models in the July 2019 peer review journal, Toxicology and Applied Pharmacology ( https://doi.org/10.1016/j.taap.2019.04.019 ).

“The global incidence and severity of CDAD, a leading infectious cause of antibiotic-associated diarrhea and colitis, is on the rise, with very few viable solutions to meet the increased need. We have developed the lantibiotics platform to address this and other unmet needs as we face the inevitable increase in treatment-resistant infections,” commented Alan Joslyn, Ph.D., president and CEO of Oragenics, Inc. “These data published in TAAP further validate the lantibiotic platform as a potential treatment approach against C. diff., most likely via our lead compound, OG716. In the meantime, other outcomes from the study may provide a pathway toward subsequent development of OG253 in other indications in the future.”

The published study evaluated the tolerability of three doses of OG253 in healthy rats in a one-dose escalation study, followed by a seven-day repeated dose toxicokinetics study. All three doses (6.75, 27 and 108 mg./day) of the compound were well-tolerated with no treatment-related clinical signs. Even at the highest dose, there were no significant toxic effects, and the compound remained compartmentalized to the gastrointestinal tract, as intended. The study authors recommended that the well tolerated dose of 425.7 mg/kg/day might best serve as the maximum tolerated dose for future safety and efficacy studies with encapsulated OG253.

In the meantime, the company has not advanced work with OG253 in this indication, while further developing its lead compound OG716, and will provide updates on this molecule as they emerge.

About Oragenics, Inc.

Oragenics is focused on becoming a leader in novel antibiotics against infectious disease and on developing effective treatments for oral mucositis. The company has established two exclusive worldwide channel collaborations with Intrexon Corporation and its subsidiaries. The collaborations allow Oragenics to accelerate the development of much needed new antibiotics that can work against resistant strains of bacteria and the development of biotherapeutics for oral mucositis and other diseases and conditions of the oral cavity, throat, and esophagus.

For more information about Oragenics, please visit www.oragenics.com .

Safe Harbor Statement: Under the Private Securities Litigation Reform Act of 1995: This release includes forward-looking statements that reflect management’s current views with respect to future events and performance. 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, risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission. Oragenics assumes no responsibility to update any forward-looking statements contained in this press release or with respect to the matters described herein.

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CONTACT: Oragenics, Inc.

Corporate:

Michael Sullivan, 813-286-7900

Chief Financial Officer

msullivan@oragenics.com

or

Investors:

John Marco

Managing Director

CORE IR

310-819-2948

johnm@coreir.com

Media:

Jules Abraham

CORE IR

917-885-7378

julesa@coreir.com

KEYWORD: UNITED STATES NORTH AMERICA FLORIDA

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS INFECTIOUS DISEASES PHARMACEUTICAL RESEARCH SCIENCE

SOURCE: Oragenics, Inc.

Copyright Business Wire 2019.

PUB: 05/13/2019 09:07 AM/DISC: 05/13/2019 09:07 AM

http://www.businesswire.com/news/home/20190513005463/en