Investor Presentation

October 2013

Engineering New

Antibiotics and

Probiotics Through

Synthetic Biology 

Exhibit 99.1

1

Certain

statements

made

in

this

presentation

include

forward-looking

actions

that

Oragenics,

Inc.

(“Oragenics,”

or

the

“Company”)

anticipates

based

on

certain

assumptions.

These

statements

are

indicated

by

words

such

as

“expect,”

“anticipate,”

“should”

and

similar

words

indicating

uncertainty

in

facts,

figures

and

outcomes.

Such

statements

are

made

pursuant

to

the

Safe

Harbor

Provisions

of

the

Private

Securities

Litigation

Reform

Act

of

1995.

While

Oragenics

believes

that

the

expectations

reflected

in

such

forward-looking

statements

are

reasonable,

it

can

give

no

assurance

that

such

statements

will

prove

to

be

correct.

The

risks

associated

with

the

Company

are

detailed

in

the

Company’s

various

reports

filed

by

the

Company

with

the

Securities

and

Exchange

Commission.

Safe Harbor Statement

2

Introduction

Oragenics

Inc.

(NYSE

MKT:

OGEN,

market

cap

$83M

1

)

is

focused

on

leveragin

g its expertise in lantibiotics and probiotics with Intrexon’s leading synthetic

biology platform via two exclusive channel collaborations (ECCs)

to develop

novel biotherapeutics, including: 

1.

Lantibiotics:

a

novel

class

of

peptide

antibacterial

compounds

produced

by

certain bacteria that display broad-spectrum activity against antibiotic-

resistant strains such as Methicillin-resistant Staphylococcus aureus

(MRSA), Vancomycin-resistant Enterococcus

(VRE), Clostridium difficile (C.

diff),

Resistant

Tuberculosis

and

other

Gram-positive

bacteria

2.

Next Generation Probiotics:

bacteria-based biotherapeutics for oral

cavity, throat, sinus, and esophagus diseases, beginning with Behçet’s

disease and aphthous stomatitis

Oragenics also markets proprietary OTC oral care probiotics (ProBiora3

®

)

1

exclusive of shares from the second Intrexon ECC announced October 1, 2013

3

A Platform for Rapidly Engineering

Bacterial Systems

Inventoried DNA Modules

Genetically Modified

Bacterial Cell

1. Lantibiotic Production

2. Next Generation Probiotics

4

Serious Need for New Antibiotics

“We Will Soon Be in a Post-Antibiotic Era”

The Sep. 2013 CDC report making headlines

highlighted the serious threats of antibiotic-

resistant infections and the need for new

antibiotics:

Over 2 million infections and 23,000

deaths each year in the U.S. are caused

by resistant microbes

Over $20 billion in direct healthcare

spending as a result of resistance

infections

Over $35 billion in additional costs due to

lost productivity

“Antibiotic

Resistance

Threats

in

the

United

States,

2013”

U.S.

Department

of

Health

and

Human

Services

Centers

for

Disease

Control

and

Prevention

5

Trends Support CDC Concerns

Resistance Increases While Approvals Decrease

Resistant Bacterial Strains Spread Rapidly

Resistant Bacterial Strains Spread Rapidly

Total Approved Bacterials -

US

6

Lantibiotics

A Promising Solution to the Growing Health

Crisis of Antibacterial Resistance

Lantibiotics are a novel class of peptide antibacterial compounds:

•

Naturally-produced by a variety of Gram-positive bacterial strains

to attack competing bacterial strains

•

There are more than 50 known lantibiotics, potentially creating a

pipeline of new compounds to target resistant infections

•

Historically, their development as commercially-viable products

has been limited by technological hurdles

Oragenics is well-positioned to bring lantibiotics to the market:

•

Collaboration with Intrexon, a leader in synthetic biology,

expected to enable the production of lantibiotics at commercial

scale

•

Collaboration has already:

Produced a significant increase in production titer yield

Enabled development of robust purification methods compared

to traditional approaches

7

Lead Lantibiotic Compound MU1140

Initial focus is on MU1140, a lantibiotic shown to be effective against:

•

Methicillin-resistant Staphylococcus aureus (MRSA)

•

Vancomycin-resistant Enterococcus (VRE)

•

Clostridium difficile (C. diff)

•

Resistant Tuberculosis

•

Other Gram positive bacteria

Preliminary preclinical data suggests:

•

Excellent therapeutic index

•

Minimal cytotoxicity in vitro using mouse and human cell lines; minimal immunogenicity

•

Maximum tolerated dose in mice and rats >50 mg/Kg

•

Plasma

concentration-time

profile

declined

bi-exponentially

with

a

half

life

1.7

hr

•

In

vivo

efficacy

observed

in

a

pilot

rat

peritonitis

model

using

S.

aureus

(60xLD50)

•

Synergy with aminoglycosides

8

Intrexon collaboration has already produced a significant increase in

fermentation titer and is developing a promising new purification

process

Matrix of early experiments planned to screen MU1140 (and several

analogs/homologs) for determining primary efficacy (e.g. MICs, MTD,

primary efficacy in animals, protein binding, etc.)

Fermentation optimization/scale-up purification in progress

IND filing expected by mid-2015*

2Q13

3Q13

4Q13

1Q14

2Q14

3Q14

4Q14

Animal studies

Animal studies

Pre-IND FDA

meeting

IND*

Plan for MU1140

First of 50+ Known Lantibiotics

* Current estimate may change depending on FDA pre-IND meeting

results

9

Synthetic Biology Enables Lantibiotics

Synthetic biology is the application of engineering principles to the

design of living organisms and their constituent parts (DNA, proteins,

and cells)

We are collaborating with Intrexon, a leading synthetic biology

company, for the development and commercialization of lantibiotics

for the treatment of infectious diseases in humans and companion

animals

Intrexon’s toolset of modular molecular and cellular parts is expected

to enable the engineering of specific functionality into cells to allow

industrial scale production of lantibiotics

10

With Intrexon Collaboration

Lantibiotics –

For Resistant Bacterial Infections

Bacteria

Cell

Extract genes

responsible for

lantibiotic

production

from native

bacteria…

…insert

genes into

modified

bacteria to

maximize

lantibiotic

production…

…and produce MU1140

and pipeline lantibiotics

via fermentation at

commercial scale.

Lantibiotics

(50+ known)

11

Rising Market Demand for Novel

Antibiotic Platforms

$

Market cap:

approx. $83M

Deal size:

approx. $775M total

approx. $10M upfront

Cubist

Market cap:

approx. $4.2B

Validated Technology

Leads to Deals

Commercial

Oragenics

Cubist

Preclinical

Rib-X and Sanofi

Significant

valuations

for

“Single

Antibiotic

Product”

companies

–

Oragenics

has

potential

to

generate

a

pipeline

of

lantibiotics

Cubist/Trius/Optimer

Acquisitions

Deal size:

approx. $818M Trius

approx. $808M Optimer

Cubist Acquisitions

(7/31/13)

Approved/Late Stage

12

Next Generation Probiotics

Potential to Revolutionize Probiotics for Oral

Diseases

We are also developing, in collaboration with Intrexon, novel probiotics

focusing on the treatment of patients with oral cavity, throat, sinus, and

esophageal diseases

Initial indications:

•

Behçet’s disease -

a chronic relapsing multi-systemic inflammatory disorder

•

Recurrent aphthous stomatitis (aka canker sores) –

painful ulcers; the most

common oral mucosal disease known

As with lantibiotics, we expect to genetically manipulate bacteria; in this

case beneficial bacteria that are naturally part of the human oral cavity

microbiome

The collaboration will focus on genetically-engineered bacterial strains

designed to deliver and release therapeutics locally at the site

of disease to

target pain management, reduce inflammation, and improve patient

outcomes

13

Lead Probiotic Programs

Behçet’s Disease and Aphthous Stomatitis

Behçet’s disease -

a chronic relapsing multi-systemic inflammatory

disorder characterized by four major symptoms (oral aphthous

ulcers, genital ulcers, skin lesions, and ocular lesions)

Patients suffering from Behçet’s disease are often in constant

pain and have difficulty eating

~20,000 patients in the U.S.; similar for Europe

Recurrent aphthous stomatitis (aka canker sores)

–

painful ulcers;

the most common oral mucosal disease known

There are currently no effective treatments for aphthous

stomatitis

~200,000 patients in the U.S.

14

Oragenics/Intrexon Solution

GM Probiotics For Oral Health

Bacteria

Cell

…insert genes

responsible for

production of 

therapeutics

agent(s)…

…and deliver new

therapeutic bacteria

into the oral cavity to

produce therapeutic

benefits and supplement

the natural oral

microbiome.

Choose the

appropriate

bacterial strain

to engineer…

15

Blend of 3 naturally-occurring, non-pathogenic bacteria –

S.oralis, S.uberis,

and

S.rattus

–

is

available

without

prescription

and

taken

daily

“Good”

probiotic bacteria in ProBiora3

®

compete for binding sites and

nutrients with “harmful”

bacteria

ProBiora3

®

bacteria also release hydrogen peroxide to reduce population of

pathogens in mouth

Poor oral health linked to serious health problems, including heart disease and

diabetes; Total consumer oral care market expected to reach $10.9 billion by

2014

1

Also marketed for companion animals

ProBiora3

®

-

OTC Product

First and Only Patented Probiotic Technology for

Oral Care

1

‘The US Market for Oral Care Products (2009)’, published by Packaged Facts

16

Significant Accomplishments in

Last Year

Novel Antibiotics (Lantibiotics)

Significantly

increased

yield

of

MU1140

making

commercialization

a realistic goal

Identified two new potentially viable purification methods for

commercially producing MU1140

Progress toward a genetically modified bacteria capable of higher

yields of MU1140 and potentially analogs

Next Generation Probiotics

Completed ECC with Intrexon –

announced October 1, 2013

Intrexon purchased $3.9M of OGEN shares, with net proceeds to

support initial efforts in this new area

17

Upcoming Milestones

Novel Antibiotics (Lantibiotics)

Production

of

new

lantibiotic

analogs

using

genetically

-

modified

bacteria

–

1H

‘14

Animal

study

results

on

MU1140/analog

–

2H

‘13

Announcement

of

results

from

pre-IND

meeting

with

FDA

-

Mid

’14

Next Generation Probiotics (Preliminary Timelines)

Generation

of

next

bacterial

prototypes

–

2H

‘14

GM

probiotics

producing

cytokine

therapeutics

–

Mid

‘15

Proof-of-concept

of

a

GM

probiotic

to

be

used

for

therapeutic

purposes

in

animals

–

2H

‘15

OTC Probiotics

Results

from

Indiana

University

clinical

trial

announced

–

1H

‘14

Publication

of

clinical

study

in

children

–

1H

‘14

18

Experienced Management Team

John N. Bonfiglio, Ph.D., President, CEO & Director

30 years of management and pharmaceutical experience

Prior CEO Argos Therapeutics, CEO Immune Response, CEO Peregrine

Pharmaceuticals, COO Cypress Bio

Senior Management positions at Allergan Pharmaceuticals and Baxter Healthcare

MS and PhD in Chemistry, University of California, MBA Pepperdine University

Mike Sullivan, CFO

Has held Senior-level financial positions for both publicly and privately held businesses

Significant experience in product licensing and IP issues

Strong background in both domestic and international retail operations

Florida Certified Public Accountant, ex Big 4. MBA from The Florida State University

Dr. Martin Handfield, VP of Research & Development

Former Tenured Associate Professor, College of Dentistry at The University of Florida

Over 14 years experience with Oragenics

Expert in biomarkers and research surrounding antimicrobials

Over 40 publications and 6 patents

19

NYSE

MKT:

OGEN

Share

price

(as

of

10/9/13)

:

$3.00

Market

cap

(as

of

10/9/13)

:

$83M*

Shares

outstanding

(as

of

6/30/13)

:

27.5M*

Cash

(as

of

6/30/13)

:

$6.4M*

Debt

(as

of

6/30/13)

:

$142,000*

Warrants

and

Options

(as

of

6/30/13)

:

2.7M

warrants

and

670,000

options

outstanding

Corporate Summary

*exclusive of shares, cash and promissory note from the second Intrexon ECC announced October 1, 2013