Oragenics, Inc. Provides Development Update of AG013 for Oral Mucositis

Phase 2 Clinical Trial Enrollment Progresses While World Health
Organization Provides Generic Name of AG013 Compound

TAMPA, Fla.–(BUSINESS WIRE)–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 development updates regarding the
Company’s lead compound for OM, AG013. These developments include the
enrollment of over 80 patients in the Company’s Phase 2 clinical of
AG013 and, in addition, the World Health Organization has provided the
Company with the generic name of dapatifagene navolactibac for
the AG013 compound.

“We continue to increase the number of clinical sites across the globe
with 48 of the 61 identified clinical sites actively enrolling patients
for our Phase 2 clinical trial of AG013,” stated Alan Joslyn, Ph.D.,
President and Chief Executive Officer of Oragenics, Inc. “In the
meantime, we are pleased to have an agreed upon generic designation for
AG013, which will now also be referred to as dapatifagene
navolactibac, to allow us a more specific way of referring to the
compound moving forward. We anticipate providing further updates as
developments warrant.”

The ongoing Phase 2 trial is a double-blind, placebo-controlled,
two-arm, multi-center trial, in which approximately 200 patients will be
randomized in a 1:1 ratio to receive either dapatifagene navolactibac
or placebo. The purpose of the study (NCT03234465) is to evaluate the
safety, tolerability and efficacy of topically administered dapatifagene
navolactibac compared to placebo for reducing the incidence and
severity of OM in patients undergoing traditional chemoradiation for the
treatment of head and neck cancer. Key measures include duration, time
to development, and overall incidence of OM (using a World Health
Organization scale) during the active treatment phase, which begins from
the start of chemoradiation therapy and ends two weeks following its
completion.

Dapatifagene navolactibac, which has been granted Fast Track
designation with the U.S. Food and Drug Administration and orphan drug
status in Europe, is an Intrexon Actobiotics therapeutic candidate
formulated to deliver the therapeutic molecule, human Trefoil Factor 1,
to the mucosal tissues in the oral cavity in a convenient oral rinsing
solution. Trefoil Factors are a class of peptides involved in the
protection of gastrointestinal tissues against mucosal damage and play
an important role in these tissues’ subsequent regeneration. The
compound was designed by the Company’s strategic partner, Intrexon
Actobiotics NV, a wholly-owned subsidiary of Intrexon Corporation (NYSE:
XON) whereby Oragenics, Inc. holds an exclusive world-wide license.

About Oragenics, Inc.

We are focused on becoming a leader in novel antibiotics against
infectious disease and on developing effective treatments for oral
mucositis. Oragenics, Inc. 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.

Contacts

Oragenics, Inc.
Corporate:
Michael Sullivan,
813-286-7900
Chief Financial Officer
[email protected]
or
Investors:
John
Marco
Managing Director
CORE IR
310-819-2948
[email protected]
Media:
Jules
Abraham
CORE IR
917-885-7378
[email protected]