CORPORATE OVERVIEW

JANUARY 2009

This presentation does not constitute an offering of any securities for sale or a solicitation
of offers to purchase securities. The Company's securities may not be offered or sold
absent registration under applicable securities laws or an exemption from registration. Any
public offering of the securities of the Company will be made by means of a prospectus
that will contain detailed information about the offering and the Company.

 

Safe Harbor

Under the Private Securities Litigation Reform Act of 1995: This release includes
forward-looking statements that reflect ONI BioPharma's current views with respect to
future events and financial 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: future costs associated with any potential
listing sponsor, those factors set forth in our most recently filed annual report on Form
10-KSB and quarterly report on Form 10-Q, and other factors detailed from time to time
in filings with the Securities and Exchange Commission. We expressly disclaim any
responsibility to update forward-looking statements
.

2

 

ONI BioPharma is a multi-faceted biopharmaceutical

company with operations in four divisions:

  Consumer Healthcare

  Diagnostics

  Replacement Therapy

  Antibiotics

ONI is commercializing its first consumer products:

-  Probiora3TM , the first full-care oral probiotic that promotes healthy teeth and gums and whitens teeth
   and freshens breath.

-  LPT3-04TM for weight loss is in clinical trials and, if successful, should be ready for marketing in 2009.

ONI expects to generate revenue from consumer products in 2009 both in the US and internationally.
Proceeds will support the Company’s diagnostic, replacement therapy, and antibiotic divisions.

Patents, strategic sales channels, and international partners will support ONI’s growth. ONI is developing
commercial and research facilities in Mexico and France to support its global strategy. ONI was founded
in 1996 by Dr. Jeffrey Hillman, a recognized expert in molecular genetics. The Company is based in
Alachua, Florida.

Corporate Mission

3

 

Financial Highlights

4

OTCBB:                                                                         ORNI

NYSE Alternext Paris:
        ALONI

Industry:                                                                    Biopharmaceutical

Equity Cap:                                                       $13.03M (US)
                                                                          As of 1/2/09

                  

Volume:                                                                        33,843

Shares Outstanding:            38.3M

Float:                                                                                     21.6M

Long-term debt:                                    0

Founded:                                                                1996

 

Four Product Divisions

Consumer Healthcare

DPOLT/Antibiotics Platform

Diagnostics

Replacement Therapy

ONI’s science has developed into four distinct categories.
Technologies complement one another. ONI intends to use revenue
generated by initial consumer products to support research and
development of longer-term therapies.

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Technology Overview

 

Mixture of 3 natural beneficial oral bacteria for          

Maintaining dental (tooth) health

Maintaining periodontal (gum) health

Whitening teeth

Promoting fresh breath

Probiora3™

 

 

Safety and activity established in animals

Novel MOA - selectively kills white fat cells

Strong evidence for safety in humans

Clinical trial in Q2

LPT3-04™ : Weight Loss Agent

 

Our lead antibiotic

Novel mechanism of action

Safe and very active in pilot studies

MRSA

Most other gram positive infections

Mtb, both growing and dormant

No evidence for development of resistance

Hard to make by conventional fermentation
methods

DPOLT

MU1140™ - A Focus Techno

 

Platform for organic synthesis of MU1140

Proof of principle completed

Cost effective GMP production

Can make analogues of MU1140 and the other 50 known
lantibiotics

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DPOLT™ - A Focus

 

Fast, sensitive, superior method for identification of targets for
new diagnostics, vaccines and drugs

Human infections

Plant infections

Cancers

Also applicable to various other problems such as
bioscavenging and biofouling

IVIAT / CMAT – A Focus

 

Genetically modified Streptococcus mutans

One-time treatment for lifelong protection against most tooth
decay

SMaRT

 


Strategy and Forecasted
Calendar of Development

 

Revenue Model

15

$

$

* Consumer Health revenue is expected to support the growth of other business units.

 

Consumer

Healthcare

2010

Diagnostic

Replacement

Therapy

15 projects completed

Second Phase I  clinical trial

DPOLT/

Antibiotic

Platform

Pro Biora3™

LPT3-04™

Commercially Available:
EvoraPet
,
EvoraKids
,
EvoraPLUS

Regulatory approval &
marketing Evora & LPT3-04

in Europe, Asia, South America

2009

2012

5 molecules made

MU1140 IND filed

Market first
antibiotic,

MU1140

15 proj.
completed

Three 510(k)s
filed

Commercially

Available

2011

2013

Market

SMaRT

16

Phase II/III clinical trial

5 molecules
made

1 IND filed

5 molecules
made

1 IND filed

5 molecules
made

1 IND filed

15 proj.
completed

Three 510(k)s
filed

15 proj.
completed

Three 510(k)s
filed

15 proj.
completed

Three 510(k)s
filed

Projected Summary Timeline
2009-2013

 

Consumer Healthcare

Benefits/Characteristics:

GRAS – Generally Recognized as Safe status (vs FDA approval)

Significantly reduces regulatory costs

Fast to market

Faster generation of gross and net revenues

Lower capital requirements

Marketed in US and internationally (Mexico in early 2009)

Sales and marketing arrangements in place

Human and companion animal applications

2009

2010

Oral Health

ProBiora3™– Finish identity  work & mass
market companion pet product

Commence marketing upon granting of
regulatory exemption status – non-US

Weight Loss

  Finish all clinical trials

  Begin selling LPT3-04™

  Begin seeking regulatory exemptions in   
  non-US markets (Europe, Asia & South
  America)

Begin global marketing

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ProBiora3™ - Probiotic mint to promote gum and dental health.

LPT3-04™     - Natural weight loss compound to kill white fat cells.

 

Consumer Product Manufacturers

Direct Selling Companies

Dental Product Companies

Contract Private Label Companies

Natural Product Companies

Pet Product Companies

Mass Retail

Internet

Independent Health Food Stores

Independent Pharmacies

Dental Offices

Direct Response

Direct Mail

Government

Media and Distribution Strategy

 

EvoraPlus Activity

19

Existing Internet & Dental

Meetings With 50+ Mass Retailers

 

Confidential

Probiotics Market

20

Probiotics: live microorganisms, which when administered in adequate
amounts, confer a health benefit on the host.

Generally associated with the gut health, though they have been
promoted for urogenital health, irritable bowel syndrome, bladder
cancer and to boost the immune system.

Only 40 probiotic products in the US market in 2005.  In last three years
more than 250 new products were launched.

Yakult (Japan) is credited with beginning the probiotics revolution and
sales of its lead product  in 2007 were estimated at $2.5 billion.

In addition to Yakult, major players in this market include Danone,
Nestle, Danisco, DSM and Proctor & Gamble.

Americans spent close to $80 billion on oral healthcare in 2007, with over
$5 billion in OTC products.

      ONI BioPharma has the FIRST probiotics product that represents an
entry into the total oral health care market.

 

DPOLT/Antibiotics Platform

Benefits/Characteristics:

Overcomes 80+ years of previous failures

Predicted to lead to new antibiotics with novel mechanisms of action

Potential substantial antibiotic pipeline

Replaces current antibiotic treatments that are failing

  

2009*

2010*

2011*

2012-2013*

MU1140 IND filed and 5
new molecules made

5 new molecules made
and 1 new IND filed

5 new molecules made
and 1 new IND filed

Market MU1140, 5 new
molecules made and 1
new IND filed

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DPOLT™ - Novel organic chemistry synthesis platform enabling large-scale,
cost-effective production of clinical grade MU1140 and 50 other known lantibiotics.

* EXPECTED MILESTONES

 

Diagnostics

2009*

2010*

2011*

2012*

2013*

15 proj. completed

15 proj. completed

Three 510(k)s filed

15 proj. completed

Three 510(k)s filed

15 proj. completed

Three 510(k)s filed

15 proj. completed

Three 510(k)s filed

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PIVIAT™ - Rapid and sensitive identification of novel targets for use in diagnosis and treatment
of human infectious diseases.

PCMAT™ - Rapid and sensitive identification of novel targets for diagnostics and therapeutic
strategies that address an extraordinary range of medical, agricultural, and industrial applications.

* EXPECTED MILESTONES

 

Replacement Therapy

2009*

2010*

2012*

Second Phase I clinical trial

Phase II/III FDA clinical trials

Market SMaRT™

Benefits/Characteristics:

Efficiency

Mexico trials = 50% cost savings (vs. US)

Regulatory Speed

ONI Mexico (subsidiary) should attain faster regulatory access within Mexican government

Reduced “red-tape” associated with government clearance to clinical trials

Preventative medicines/treatments typically receive faster acceptance and clearance by
governments worldwide

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SMaRT™ - a single, painless application of a genetically modified bacterial strain for
tooth surfaces to protect against tooth decay.

* EXPECTED MILESTONES

 

Timeline

Oragenics

(ONI BioPharma)
Founded by
Jeffrey Hillman

2008

1996

Completes Initial
public offering (IPO)

2005

2009

2003

2004

Obtains $9M
financing

Initiates Phase I studies for
tooth decay-replacement
therapy

Seeks patent to
treat obesity-
LPT3-04™

2006

Acquires iviGene
Corporation and
gene/biomarker
assets

Patent issued
for

MU 1140™

SMaRT Phase I
trials begin

2007

Receives European
patent for IVIAT™
biomarker
technology

Begin test
marketing
ProBiora3 tablets

Starts to do
business as ONI
BioPharma

David Hirsch joins

as COO & CFO

Launch of
ProBiora3™
Website

Successful
synthesis using
DPOLT
technology

Alternext
Paris listing

ONI Mexico
established

2010

ProBiora3™
approval &
marketing
globally

Replacement
therapy SMaRT
phase II

2011

2012

Diagnostic
projects &
licensing
continues

Market SMaRT

Market MU
1140

24

Projected

 

Confidential

Management

Stanley B. Stein, Chief Executive Officer, President and Director

25 years in securities in biotech & healthcare industry

Managing Director at Drexel Burnham Lambert, Inc.

Founded SRS Capital - boutique investment firm; specializing in healthcare

Principal investment banker in the creation of Fresenius Medical Care AG, the
largest renal care business in the world

Jeffry Hillman, DMD, PhD, Chief Scientific Officer and Director

Founded ONI to commercialize the fruits of 25 years of research at the Harvard-affiliated
Forsyth Institute in Boston and the University of Florida

Author of 125+ publications

Undergraduate training at the University of Chicago; DMD degree from Harvard School of
Dental Medicine; PhD from Harvard Medical School

 David B. Hirsch, Chief Financial Officer and Chief Operating Officer

Manager in the Restructuring Group at Deloitte and Touche

Associate at The Cottonwood Group, a venture capital firm in San Mateo, California

MBA from the Tepper School of Business at Carnegie Mellon University and a JD from
Drake University Law School

Licensed attorney in Florida and Indiana

Corporate
Structuring

Science

Legal/

Accounting

25

 

Confidential

Outside Directors –

Expertise in: Management , International Business, Academic Science & Media

Rick Welch, Chairman

   President of Welch Business Solutions and Consulting, LLC in Tampa, Florida

   Director and CFO for the following: Orthopedic Development Corporation, Albiorex, LLC, Medi-Spa's of
   America, Inc, and Vision Twenty-One

  Previously CFO/Executive Vice-President of Finance and Administration, for Sports and Recreation, Inc.

Derek Hennecke, Director

  Independent Board member and expert in drug development

   Founder and CEO of Xcelience, a formulation and clinical manufacturing contract research company in  Tampa,
    Florida

   25+ years in the international biotechnology; MDS Pharma Sciences, DSM (contract manufacturing company) (NBD)
    Boehringer Mannheim in NBD

  Work experience in Europe, Egypt, Mexico, Canada, and USA

Kevin Sills, Director

   Independent director Vice President of Pharmaceutical Development of King Pharmaceuticals Research & Development

  25+ years related experience, novel chemical formulations, clinical supplies management

   Faculty experience at University of North Carolina: Center for Professional Advancent; President of NC
  Pharmaceutical Discussion Group

  Active member of the Licensing Executives Society and the American Assoc of Pharmaceutical Scientists

Dr. Marc Siegel, Director

  Clinical Associate Professor of Medicine at NYU School of Medicine

  Medical Director of Doctor Radio with NYU and Sirius Satellite Radio

  Fox News Medical Contributor

  Columnist for the Los Angeles Times, a member of the Board of Contributors at USA Today, regular contributor to the
 NY Post, and frequent contributor to the Washington Post, the Wall Street Journal, and Newsday

26

 

Confidential

Global Expansion

27

Mexico

Subsidiary (ONI Biotec, Mexico)

launch - Q1 2009

France

Alternext Paris Listing –

Planned operations in European Union

USA – Alachua, FL

ONI Corporate Offices

est. 1996

 

An anchor point for the commercial conquest of Europe

Significant market : popularity of probiotics among European consumers

Central location

Strong scientific and industrial network

Attractive political environment

“Fast Path” to Listing

Direct listing (use of SEC filings for Information Document)

Tailored market place

Listing sponsor

Exposure as a listed company

Qualified investors (Small & Mid Caps / health care and biotech)

Inclusion in the NYSE Euronext Next Biotech index

       Supporting growth in Europe

Why a Listing in Paris?

 


Summary

 

Confidential

Summary

Sales & near-term revenue generated from consumer product,  
Probiora3™.

Facilities & business relations in the United States, Mexico,
South America and Europe.

Multiple strategies for getting consumer and biotech products to
market.

Targeting global healthcare segments where there is distinct
need and growing population.

Undiscovered by Wall Street.

30

 

Confidential

31

In the News

Probiotics - Topic Overview

What are Probiotics?

Why Probiotics?

Probiotics May Help People Taking Antibiotics

What health benefits do they offer?

What is important to know about Probiotics?

 

Confidential

Investor Contacts

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Global Headquarters:

Stanley B. Stein

Chief Executive Officer

ONI BioPharma, Inc.

13700 Progress Blvd

Alachua, FL 32615

Ph: (386) 418-4018

sstein@onibiopharma.com

www.onibiopharma.com

Investor Contact:

Axelle Vuillermet

Pierre Laurent

8 place de la Madeleine

75008 Paris

Tél. : 01 44 71 94 94

avuillermet@newcap.fr

plaurent@newcap.fr