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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	
  
At A Glance - Oragenics
•  Expertise in bacteria – especially related to the oral cavity
•  Lantibiotics – Capable of killing bacteria, including
antibiotic-resistant strains
•  Next Generation Probiotics – Designed to be
therapeutically useful
•  ProBiora3® - OTC probiotic used to improve overall oral
health
3	
  
At A Glance - Oragenics
•  NYSE MKT: OGEN (market cap ~$126 M)
•  Founded in 1999
•  Based in Tampa, FL
•  Experienced management team
4	
  
Overview
¤  Leverage expertise in lantibiotics and probiotics with
Intrexon’s leading synthetic biology platform via two
exclusive channel collaborations (ECCs) to develop novel
biotherapeutics:
1. Lantibiotics: novel class of peptide antibacterial compounds
produced by specific strains of bacteria
2. Next Generation Probiotics: bacteria-based biotherapeutics for
oral cavity, throat, sinus, and esophagus diseases
¤  Market proprietary OTC oral care probiotics (ProBiora3®)
Investor Presentation April 9, 2014
Engineering	
  New	
  
An/bio/cs	
  and	
  
Probio/cs	
  Through	
  
Synthe/c	
  Biology	
  	
  	
  
Lan/bio/cs	
  and	
  the	
  Need	
  for	
  New	
  
An/bio/cs	
  
6	
  
Serious Need for New Antibiotics
Sept. 2013 CDC report highlighted
serious threats of antibiotic-resistant
infections and need for new
antibiotics:
¤  >2 million infections and ~23,000 deaths
each year in U.S. caused by resistant
microbes
¤  >$20 billion in direct healthcare spending
from resistance infections
¤  >$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
7	
  
Trends Support CDC Concerns
Resistance Increases While Approvals Decrease
	
  
8	
  
Lantibiotics
A Promising Solution to the Growing Health Crisis
of Antibacterial Resistance
¤  Novel class of peptide antibacterial compounds:
•  Naturally-produced by variety of bacterial strains to attack
competing gram-positive bacterial strains
•  >50 known lantibiotics and a very large number of potential
analogs
•  Pipeline of new compounds to target resistant infections
•  Development as commercially-viable products previously limited
by technological hurdles
9	
  
Lantibiotics
A Promising Solution to the Growing Health Crisis
of Antibacterial Resistance
¤  Well-positioned to bring lantibiotics to market:
•  Intrexon collaboration expected to enable production of
lantibiotics at commercial scale
•  Progress to date through Intrexon/Oragenics ECC
!  Achieved significant increase in production titer yield
!  Developing robust purification methods compared to
traditional approaches
!  Completed POC that genetically modified bacteria can produce
MU1140 and analogs
10	
  
Lead Lantibiotic Compound MU1140
¤  Initial focus on MU1140, a lantibiotic shown to be effective against:
•  Methicillin-resistant Staphylococcus aureus (MRSA)
•  Vancomycin-resistant Enterococcus (VRE)
•  Clostridium difficile (C. diff)
•  Resistant Tuberculosis and others
¤  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
•  In vivo efficacy observed in a pilot rat peritonitis model using S. aureus (60xLD50)
•  Apparent synergy with aminoglycosides
11	
  
ECC with Intrexon
Platform for Engineering Bacterial Systems
Through Synthetic Biology
Inventoried DNA Modules
Genetically Modified
Bacterial Cell
12	
  
ECC with Intrexon
Development of lantibiotics for treatment of
infectious diseases in humans and animals
¤  Application of engineering principles to the design of
living organisms and their constituent parts (DNA,
proteins, and cells)
¤  Intrexon’s toolset of modular molecular and cellular
systems expected to enable the engineering of specific
functionality into cells to allow industrial scale production
of lantibiotics
13	
  
ECC with Intrexon
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)
14	
  
¤  Matrix of early experiments initiated 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 2H 2015*
2Q13	
   3Q13	
   4Q13	
   1Q14	
   2Q14	
   3Q14	
   4Q14	
  
Animal	
  studies	
  
Animal	
  studies	
  
Pre-­‐IND	
  FDA	
  
mee4ng	
  
IND*	
  
Plan for MU1140
First of 50+ Known Lantibiotics and Analogs
* Current estimate may change depending on FDA pre-IND meeting
results
15	
  
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/Op/mer	
  
Acquisi/ons	
  
Deal size:
approx. $818M Trius
approx. $808M Optimer
Cubist Acquisitions
(7/31/13)
Approved/Late Stage
Investor Presentation April 9, 2014
Engineering	
  New	
  
An/bio/cs	
  and	
  
Probio/cs	
  Through	
  
Synthe/c	
  Biology	
  	
  	
  
Next	
  Genera/on	
  Probio/cs	
  For	
  
Therapeu/c	
  Use	
  
17	
  
Next Generation Probiotics
Potential to Revolutionize Probiotics for Oral
Diseases
¤  Developing novel probiotics focusing on treatment of patients with
oral cavity, throat, sinus, and esophageal diseases through ECC with
Intrexon
¤  Expect to genetically manipulate bacteria similar to lantibiotics
program
•  Beneficial	
  bacteria	
  naturally	
  part	
  of	
  the	
  human	
  oral	
  cavity	
  microbiome	
  
¤  Genetically-engineered bacterial strains designed to deliver and
release therapeutics locally at disease site to target pain
management, reduce inflammation, and improve patient outcomes
¤  Initial indications:
•  Behçet’s	
  disease	
  
•  Recurrent	
  aphthous	
  stoma44s	
  (aka	
  canker	
  sores)	
  
18	
  
Behçet’s	
  disease	
  
¤  Chronic	
  relapsing	
  mul4-­‐systemic	
  inflammatory	
  disorder	
  
¤  Characterized	
  by	
  four	
  major	
  symptoms	
  (oral	
  aphthous	
  ulcers,	
  
genital	
  ulcers,	
  skin	
  lesions,	
  and	
  ocular	
  lesions)	
  
¤  Pa4ents	
  oLen	
  in	
  constant	
  pain	
  and	
  have	
  difficulty	
  ea4ng	
  
¤  ~20,000	
  pa4ents	
  in	
  the	
  U.S.;	
  similar	
  for	
  Europe	
  
19	
  
Recurrent	
  Apthous	
  Stoma44s	
  
(aka	
  canker	
  sores)	
  
¤  Painful	
  ulcers;	
  most	
  common	
  oral	
  mucosal	
  disease	
  known	
  
¤  No	
  effec4ve	
  treatments	
  
¤  ~200,000	
  pa4ents	
  in	
  the	
  U.S.	
  
¤  Characterized	
  by	
  mul4ple,	
  recurrent,	
  small,	
  round,	
  or	
  ovoid	
  ulcers	
  
¤  Usually	
  presents	
  first	
  in	
  childhood	
  or	
  adolescence	
  
20	
  
Oragenics/Intrexon Solution
GM Probiotics For Oral Health
Bacteria
Cell
…insert genes
responsible for
production of
therapeutics
agent(s)…
…deliver new
therapeutic bacteria
into oral cavity to
produce therapeutic
benefits and supplement
natural oral microbiome.
Choose the
appropriate
bacterial strain
to engineer…
Investor Presentation April 9, 2014
Engineering	
  New	
  
An/bio/cs	
  and	
  
Probio/cs	
  Through	
  
Synthe/c	
  Biology	
  	
  	
  
ProBiora3® - Only OTC Probiotic
Product Specifically Designed for
Oral Health	
  
22	
  
¤  Blend of 3 naturally occurring, non-pathogenic bacteria – S.oralis,
S.uberis, and S.rattus – available without prescription and taken daily
¤  “Good” probiotic bacteria compete for binding sites and nutrients with
“harmful” bacteria
¤  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
20141	
  
¤  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
23	
  
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
¤  Prior 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	
  
24	
  
Significant Accomplishments in
2013
Novel Antibiotics (Lantibiotics)
¤  Significantly increased yield of MU1140
¤  Identified two new potentially viable purification methods for
commercially producing MU1140
¤  Obtained proof of concept for genetically modified bacteria capable of
higher yields of MU1140 and potentially analogs
Next Generation Probiotics
¤  Established ECC with Intrexon – announced October 1, 2013
¤  Completed initial research program; commenced activity in 2014
Finance
¤  Raised $3.9M in PIPE with Intrexon to support new ECC
¤  Raised $11M in shelf-takedown
¤  Relisted on NYSE:MKT
25	
  
Upcoming Potential Milestones
Novel Antibiotics (Lantibiotics)
¤  Production of new lantibiotic analogs using genetically modified bacteria –
1H 2014
¤  Animal study results for MU1140/analog – 1H 2014
¤  Pre-IND meeting with FDA - 2H 2014
Next Generation Probiotics (Preliminary Timelines)
¤  Generation of next bacterial prototypes – 2H 2014
¤  GM probiotics producing cytokine therapeutics – Mid 2015
¤  Proof-of-concept of GM probiotic for therapeutic purposes in animals – 2H
2015

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01 ogen

  • 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. 2   At A Glance - Oragenics •  Expertise in bacteria – especially related to the oral cavity •  Lantibiotics – Capable of killing bacteria, including antibiotic-resistant strains •  Next Generation Probiotics – Designed to be therapeutically useful •  ProBiora3® - OTC probiotic used to improve overall oral health
  • 3. 3   At A Glance - Oragenics •  NYSE MKT: OGEN (market cap ~$126 M) •  Founded in 1999 •  Based in Tampa, FL •  Experienced management team
  • 4. 4   Overview ¤  Leverage expertise in lantibiotics and probiotics with Intrexon’s leading synthetic biology platform via two exclusive channel collaborations (ECCs) to develop novel biotherapeutics: 1. Lantibiotics: novel class of peptide antibacterial compounds produced by specific strains of bacteria 2. Next Generation Probiotics: bacteria-based biotherapeutics for oral cavity, throat, sinus, and esophagus diseases ¤  Market proprietary OTC oral care probiotics (ProBiora3®)
  • 5. Investor Presentation April 9, 2014 Engineering  New   An/bio/cs  and   Probio/cs  Through   Synthe/c  Biology       Lan/bio/cs  and  the  Need  for  New   An/bio/cs  
  • 6. 6   Serious Need for New Antibiotics Sept. 2013 CDC report highlighted serious threats of antibiotic-resistant infections and need for new antibiotics: ¤  >2 million infections and ~23,000 deaths each year in U.S. caused by resistant microbes ¤  >$20 billion in direct healthcare spending from resistance infections ¤  >$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
  • 7. 7   Trends Support CDC Concerns Resistance Increases While Approvals Decrease  
  • 8. 8   Lantibiotics A Promising Solution to the Growing Health Crisis of Antibacterial Resistance ¤  Novel class of peptide antibacterial compounds: •  Naturally-produced by variety of bacterial strains to attack competing gram-positive bacterial strains •  >50 known lantibiotics and a very large number of potential analogs •  Pipeline of new compounds to target resistant infections •  Development as commercially-viable products previously limited by technological hurdles
  • 9. 9   Lantibiotics A Promising Solution to the Growing Health Crisis of Antibacterial Resistance ¤  Well-positioned to bring lantibiotics to market: •  Intrexon collaboration expected to enable production of lantibiotics at commercial scale •  Progress to date through Intrexon/Oragenics ECC !  Achieved significant increase in production titer yield !  Developing robust purification methods compared to traditional approaches !  Completed POC that genetically modified bacteria can produce MU1140 and analogs
  • 10. 10   Lead Lantibiotic Compound MU1140 ¤  Initial focus on MU1140, a lantibiotic shown to be effective against: •  Methicillin-resistant Staphylococcus aureus (MRSA) •  Vancomycin-resistant Enterococcus (VRE) •  Clostridium difficile (C. diff) •  Resistant Tuberculosis and others ¤  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 •  In vivo efficacy observed in a pilot rat peritonitis model using S. aureus (60xLD50) •  Apparent synergy with aminoglycosides
  • 11. 11   ECC with Intrexon Platform for Engineering Bacterial Systems Through Synthetic Biology Inventoried DNA Modules Genetically Modified Bacterial Cell
  • 12. 12   ECC with Intrexon Development of lantibiotics for treatment of infectious diseases in humans and animals ¤  Application of engineering principles to the design of living organisms and their constituent parts (DNA, proteins, and cells) ¤  Intrexon’s toolset of modular molecular and cellular systems expected to enable the engineering of specific functionality into cells to allow industrial scale production of lantibiotics
  • 13. 13   ECC with Intrexon 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)
  • 14. 14   ¤  Matrix of early experiments initiated 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 2H 2015* 2Q13   3Q13   4Q13   1Q14   2Q14   3Q14   4Q14   Animal  studies   Animal  studies   Pre-­‐IND  FDA   mee4ng   IND*   Plan for MU1140 First of 50+ Known Lantibiotics and Analogs * Current estimate may change depending on FDA pre-IND meeting results
  • 15. 15   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/Op/mer   Acquisi/ons   Deal size: approx. $818M Trius approx. $808M Optimer Cubist Acquisitions (7/31/13) Approved/Late Stage
  • 16. Investor Presentation April 9, 2014 Engineering  New   An/bio/cs  and   Probio/cs  Through   Synthe/c  Biology       Next  Genera/on  Probio/cs  For   Therapeu/c  Use  
  • 17. 17   Next Generation Probiotics Potential to Revolutionize Probiotics for Oral Diseases ¤  Developing novel probiotics focusing on treatment of patients with oral cavity, throat, sinus, and esophageal diseases through ECC with Intrexon ¤  Expect to genetically manipulate bacteria similar to lantibiotics program •  Beneficial  bacteria  naturally  part  of  the  human  oral  cavity  microbiome   ¤  Genetically-engineered bacterial strains designed to deliver and release therapeutics locally at disease site to target pain management, reduce inflammation, and improve patient outcomes ¤  Initial indications: •  Behçet’s  disease   •  Recurrent  aphthous  stoma44s  (aka  canker  sores)  
  • 18. 18   Behçet’s  disease   ¤  Chronic  relapsing  mul4-­‐systemic  inflammatory  disorder   ¤  Characterized  by  four  major  symptoms  (oral  aphthous  ulcers,   genital  ulcers,  skin  lesions,  and  ocular  lesions)   ¤  Pa4ents  oLen  in  constant  pain  and  have  difficulty  ea4ng   ¤  ~20,000  pa4ents  in  the  U.S.;  similar  for  Europe  
  • 19. 19   Recurrent  Apthous  Stoma44s   (aka  canker  sores)   ¤  Painful  ulcers;  most  common  oral  mucosal  disease  known   ¤  No  effec4ve  treatments   ¤  ~200,000  pa4ents  in  the  U.S.   ¤  Characterized  by  mul4ple,  recurrent,  small,  round,  or  ovoid  ulcers   ¤  Usually  presents  first  in  childhood  or  adolescence  
  • 20. 20   Oragenics/Intrexon Solution GM Probiotics For Oral Health Bacteria Cell …insert genes responsible for production of therapeutics agent(s)… …deliver new therapeutic bacteria into oral cavity to produce therapeutic benefits and supplement natural oral microbiome. Choose the appropriate bacterial strain to engineer…
  • 21. Investor Presentation April 9, 2014 Engineering  New   An/bio/cs  and   Probio/cs  Through   Synthe/c  Biology       ProBiora3® - Only OTC Probiotic Product Specifically Designed for Oral Health  
  • 22. 22   ¤  Blend of 3 naturally occurring, non-pathogenic bacteria – S.oralis, S.uberis, and S.rattus – available without prescription and taken daily ¤  “Good” probiotic bacteria compete for binding sites and nutrients with “harmful” bacteria ¤  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 20141   ¤  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
  • 23. 23   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 ¤  Prior 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  
  • 24. 24   Significant Accomplishments in 2013 Novel Antibiotics (Lantibiotics) ¤  Significantly increased yield of MU1140 ¤  Identified two new potentially viable purification methods for commercially producing MU1140 ¤  Obtained proof of concept for genetically modified bacteria capable of higher yields of MU1140 and potentially analogs Next Generation Probiotics ¤  Established ECC with Intrexon – announced October 1, 2013 ¤  Completed initial research program; commenced activity in 2014 Finance ¤  Raised $3.9M in PIPE with Intrexon to support new ECC ¤  Raised $11M in shelf-takedown ¤  Relisted on NYSE:MKT
  • 25. 25   Upcoming Potential Milestones Novel Antibiotics (Lantibiotics) ¤  Production of new lantibiotic analogs using genetically modified bacteria – 1H 2014 ¤  Animal study results for MU1140/analog – 1H 2014 ¤  Pre-IND meeting with FDA - 2H 2014 Next Generation Probiotics (Preliminary Timelines) ¤  Generation of next bacterial prototypes – 2H 2014 ¤  GM probiotics producing cytokine therapeutics – Mid 2015 ¤  Proof-of-concept of GM probiotic for therapeutic purposes in animals – 2H 2015