OTC BB: SNGX

Forward-Looking Statements

This presentation contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as "anticipates," "believes," "intends," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop or commercialize products based on its technology, including orBec®, SGX201, RiVax™, and LPMTM, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that its cash expenditures will not exceed projected levels, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program, that it will be able to patent, register or protect its technology from challenge and products from competition or maintain or expand its license agreements with its current licensors, or that its business strategy will be successful. Important factors which may affect the future use of orBec® for gastrointestinal GVHD include the risks that: the FDA's requirement that Soligenix conduct additional clinical trials to demonstrate the safety and efficacy of orBec® will take a significant amount of time and money to complete and positive results leading to regulatory approval cannot be assumed; Soligenix is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacturing, marketing, sales and distribution of its products; orBec® may not gain market acceptance if it is eventually approved by the FDA; and others may develop technologies or products superior to orBec®. Factors affecting the development and use of SGX201, RiVax™, and LPMTM are similar to those affecting orBec®. These and other factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

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Soligenix, Inc. is a late-stage, biopharmaceutical

company developing products to treat life-threatening

side effects of cancer treatments and serious

gastrointestinal diseases, and vaccines for certain

bioterrorism agents

Soligenix

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Value Proposition

1. Low current valuation of approximately $60 million • Potential for exponential growth with the achievement of a single milestone – A positive

confirmatory Phase 3 clinical trial of orBec®

• Relatively low risk and late stage drug development proposition due to existing orBec® Phase 3 data

2. Four active clinical trials

3. Clean capital structure with no debt or preferred stock outstanding

4. FDA SPA and EMEA agreement on Phase 3 protocol supports regulatory path to approval in US and EU

5. 35% royalty generating North American partnership with Sigma-Tau on orBec®

6. orBec® addresses a potential $400 million global GVHD market, where there is an unmet medical need with poor therapeutic options

7. Oral BDP application in other GI areas - Radiation Enteritis and Crohn’s Disease; markets in excess of $500 million worldwide 

8. LPM™ - novel oral delivery system for drugs such as leuprolide

9. Diversified portfolio: BioTherapeutics and BioDefense• BioDefense - Grant funded and revenue generating – New $9.4 million NIH grant

− Soligenix is world leader in ricin toxin vaccine research

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Pipeline

Biotherapeutics  Preclinical Phase 1 Phase 2 Phase 3orBec®  Treatment of GVHD         orBec®Prevention of GVHD        orBec®Treatment of Chronic GVHD         SGX201 Radiation Enteritis        SGX203Crohn’s Disease        LPM™ LeuprolideProstate Cancer/Endometriosis        Biodefense  Proof of Concept Animal Phase 1 Phase 2/3

RiVax™ - VaccineRicin Toxin Exposure        SGX202 - Therapeutic Radiation Injury        

FAST TRACK and ORPHAN DESIGNATION

ORPHAN DESIGNATION

ORPHAN DESIGNATION

FAST TRACK DESIGNATION

ORPHAN DESIGNATION

Programs highlighted in green are supported in whole or in part by NIH funding .

FDA ANIMAL RULE

FDA ANIMAL RULE

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Management Team

Executive Yrs. Exp Industry Experience

Christopher J. Schaber, PhD 21 Discovery Laboratories, Inc. (COO)

President and CEO Acute Therapeutics, Inc. (Co-Founder)Ohmeda PPD, Inc.The Liposome Company, Inc.Wyeth Ayerst

Evan Myrianthopoulos 15 CVL Advisors Group, Inc., - Life science Chief Financial Officer financial consulting firm

Discovery Laboratories (CFO, VP Finance)Paramount Capital Investments, LLC

Brian Hamilton, MD, PhD 30 Astra, USA Chief Medical Officer Wyeth Research

Alkermes, Inc.University of Washington

Robert Brey, PhD 27 Lederle-Praxis, division of American Chief Scientific Officer Cyanamid

Vaxcel, Inc.

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orBec®

Gastrointestinal Graft-versus-Host Disease (GI GVHD)

An Unmet Medical Need

BioTherapeutics – Lead Program

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Gastrointestinal GVHD

Normal Upper GI Mucosa Acute GvHD

• Unmet medical need – orphan disease• Occurs in leukemia and other blood cancer patients who undergo bone

marrow or stem cell transplantation• Patients’ tissue attacked by lymphocytes of donor marrow/stem cells• Most debilitating symptoms occur in stomach and small intestine• Symptoms include anorexia, nausea, vomiting, bloody stool, necrosis and

exfoliation of endothelial cells• Treated with high dose systemic prednisone – for lack of better treatment

Normal Upper GI Mucosa Acute GvHD

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orBec® (oral beclomethasone dipropionate or BDP)

• Beclomethasone – Potent, topically active, anti-inflammatory steroid− Designed to treat inflammation within lining of GI tract

• orBec® strategy is to decrease need for prolonged use of high dose systemic prednisone

• Treatment with prednisone: effective, but highly toxic− Increases susceptibility to opportunistic infection− Inhibits positive Graft-versus-Leukemia (GvL) effect

• orBec® clinical advantage gained by:− Fewer opportunistic infections− Enhanced GvL effect - fewer relapses, improved survival− Shortening of prednisone course− Sustained remission of GI GVHD

• Fast Track and Orphan Drug Designations for treatment of acute GI GVHD

orBec®

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orBec® - A Targeted Approach to GI GVHD

A Two-Pill System• Each tablet contains 1 mg BDP

• 1 Immediate Release (IR) tablet designed to release in the upper GI tract and 1 Enteric Coated (EC) tablet designed to release in the lower GI tract

• Total of only 8 mgs BDP per day

Diagram showing dispersion of IR tablet in the stomach

Diagram showing dispersion of IR and EC tablets in small intestine

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orBec® - Risk/Benefit Analysis

Clinical Significance:• Statistically significant reductions in GVHD treatment failures

• Statistically significant increase in daily caloric intake ability

• Statistically significant reductions in mortality

Safety:• Well established – beclomethasone known to FDA

• No major side effects seen in orBec® trials

• Superior safety profile compared to high dose prednisone

• Beclomethasone use previously approved by FDA:

− Becloforte® – inhalant marketed by Glaxo and used to treat asthma

− Beconase® – nasal spray marketed by Glaxo for rhinitis

− Propaderm® – topical cream for psoriasis

Positive Phase 2 and 3 clinical trial data provide strong support for Confirmatory, Pivotal Phase 3 Study

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McDonald et al. 1998. Gastroenterology

Primary endpoint achieved – Positive response to orBec® therapy at Day 30• Positive response defined as the ability to consume > 70% of expected daily caloric

requirements• Rapid control of GI GVHD not requiring additional prednisone

Secondary endpoint achieved• Positive treatment response through Study Day 40

orBec® - Phase 2 Study Results

60-patient randomized, double-blind, placebo-controlled, single center trial

Endpoints orBec®

n=31Placebo

n=29p-value

Treatment Responders at Day 30 (Primary endpoint)

22 (71%) 12 (41%) 0.021

Treatment Responders at Day 40 16 (52%) 5 (17%) 0.005

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orBec® - Previous Phase 3 Study Results

Endpoints orBec®

n=62Placebo

n=67p-value

Time to Treatment Failure through Day 50 (primary endpoint)

0.118

Treatment Failure Rate at Day 50

18 (31%)

30 (48%)

0.051

Time to Treatment Failure through Day 80

0.023

Treatment Failure Rate at Day 80

22 (39%)

39 (65%)

0.005

Mortality Rate at 200 Days Post-Transplant

5 (8%)

16 (24%)

0.014

Placebo

BDP

0.00

0.25

0.50

0.75

1.00

Days since randomization

0 10 20 30 40 50 60 70 80 90

Time to Treatment Failure through Day 80

p = 0.0226

129-patient randomized, double-blind, placebo-controlled, multicenter trial

Hockenbery et al. 2007. Blood

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orBec® - Comprehensive Mortality Data

Long-Term SurvivalOutcomes orBec® Placebo

p-value orBec® vs.

placebo

Percentagereduction

in mortality

Mortality Rate at 200 days posttransplant - Pivotal Phase 3 study

5 (8%) 16 (24%) .013 66%

Mortality Rate at 200 days posttransplant - Prior Phase 2 study

3 (10%) 6 (21%) 0.18 55%

Mortality Rate among mismatcheddonors at 200 days post transplant Pivotal Phase 3 study

1 (4%) 10 (42%) 0.02 94%

Mortality Rate at 1 year postrandomization - Pivotal Phase 3 study

18 (29%) 28 (42%) 0.04 46%

Mortality Rate at 1 year postrandomization - Prior Phase 2 study

6 (19%) 9 (31%) 0.26 45%

Mortality Rate at median time periods at 3.5 years – Both studies combined

37 (40%) 49 (51%) 0.03 37%

Hockenbery et al. 2007. Blood

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orBec® Clinical Development Path Forward

• Special Protocol Assessment (SPA) for confirmatory, pivotal Phase 3 clinical trial cleared by FDA− Highly powered clinical trial of similar design to previous Phase 3

study is acceptable to support a regulatory submission seeking new drug approval

− Enrollment sample size – approximately166 patients

− New Primary Endpoint – Treatment failure rate at Study Day 80 – highly statistically significant in previous Phase 3 trial with p-value of 0.005

• EMEA Agreement on Phase 3 protocol for potential EU approval

• With 2 positive trials completed – strong basis for confidence in efficacy of confirmatory trial

• Trial initiated; completion targeted for 1H 2011

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Prior Phase 3 Confirmatory Phase 3

Number of sites Multicenter Multicenter

Number of patients

129 166

Patient population

Allogeneic transplant patients with

Grade 2 GI GVHDSame

Powering80% at a two-sided significance level of

0.0590% at a two-sided significance level of

0.05

Primary endpointTime to Treatment Failure Through Day

50Treatment Failure Rate at Day 80

(p-value of 0.005 in prior Phase 3)

Dosing regimen8 mg BDP per day / 1 mg BDP per

tablet

/ dosing duration 50 daysSame

Design

2 Randomized groups: High dose prednisone for 10 days followed by

rapid taper with 50 days on placebo or drug

Same

Confirmatory Phase 3 Replicates Prior Study

Improvements in design including change of primary endpoint increase likelihood of success The key factors - drug, dose, patient population and expected control group outcomes - have

remained constant since the prior Phase 3

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Sigma-Tau Partnership and Commercialization

• Marketing partnership with Sigma-Tau aimed at launching orBec® in North America− 35% royalty on net sales back to Soligenix− $10 million in milestones with $1 million milestone received upon enrollment of first patient in

confirmatory trial− Soligenix to lead all R&D and regulatory

• Certain inherent market factors suggest quick launch and significant penetration− No competition – Nothing approved by FDA for GI GVHD − Rapid dissemination of information− Focused market – 15 transplant centers do 60% of all transplants

• Soligenix seeking marketing partners in Europe and ROW

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Lifecycle Management – New BDP Trials

Program Purpose# of Available

PatientsStatus

Prevention of GVHD Decrease incidence or severity of acute GVHD 10,000+ US

Phase 2 – 140 patientsenrollment completed 1H 2010

Radiation Enteritis

Block inflammatory component of acute radiation enteritis in GI tract in rectal cancer patients receiving radiation therapy

50,000+ US

Initiated. Supported by $500,000 NIH grantFast Track granted Completion targeted 1H 2011

Chronic GI GVHDDecrease need for systemic immunosuppressive therapy in chronic GI GVHD

6,000+ USPhase 2 protocol Initiation targeted for 2H 2010

Crohn’s Disease Minimize inflammation in chronic GI conditions

500,000 US100,000 Pediatric US

TBD

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Worldwide Potential Oral BDP Market

$300

$100

0

50

100

150

200$ M

illi

on

s

250

300

$200

orBec®

GVHDTreatment

$120

400

450

350

orBec®

GVHDPrevention

orBec®

GVHD Chronic

Oral BDPRadiationEnteritis

Assumptions~ 20,000 allogeneic transplants annually

~ 7% annual market growth

Acute GI GVHD Treatment 5,000 Patients US 5,000 Patients Europe

Acute GVHD Prevention10,000 Patients US

10,000 Patients Europe

Chronic GI GVHD Treatment6,000 Patients US

6,000 Patients Europe

Radiation Enteritis50,000 Patients US

50,000 Patients Europe

Crohn’s Disease500,000 Patients US

500,000 Patients EuropeOral BDPCrohn’sDisease

>$500500

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Lipid Polymer Micelle (LPMTM)

Delivery System

for Improving Oral Drug/Peptide Absorption

BioTherapeutics – Pipeline Expansion

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Lipid Polymer Micelles (LPM)

• Drug delivery system potentially applicable to a wide variety of poorly absorbable water-soluble drugs/peptides (500 - 5,000 daltons)

• Stable reverse micelle composed of GRAS lipids and polymers

• Transiently opens tight junctions in intestinal mucosa

• High relative bioavailability

• First candidate selected: − GnRH analog: Leuprolide (1200 daltons)

• Pre-clinical proof-of-concept: Reproducible and consistent absorption in rats and dogs− LPM achieved 20-40% bioavailability with leuprolide versus <5% with

straight oral delivery

• Next steps: Complete preclinical work and conduct Phase 1 human PK study to confirm preclinical findings

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Paracellular Transport

Peptides and small proteins do not normally penetrate intestinal epithelial barriers

Tight junctions (TJ) are inter-cellular contact points that regulate intestinal absorption of solutes and nutrients

TJ consist of a belt of protein strands and lipids that surround the lateral membrane of epithelial cells and seals the outermost end of the intercellular space.

In the presence of LPM (polymer stabilized reverse micelles) tight junctions transiently open and allow the penetration of small proteins and peptides with a hydrodynamic radius in the range of small molecules, proteins and cells across these barriers in the range of 8–20 degrees.

Apical surface

Intestinal epithelial cells

Basal surface

surface

Paracellular transport of peptides

Tight Junction

Reverse Micelles and Paracellular Transport

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Leuprolide Market

• Annual US sales of Leuprolide approx. $1.7 billion

• Other approved/marketed LHRH agonists:

− Lupron (Lupron Depot, TAP)

− Goserelin (Zoladex, Astra/Zeneca), 1-3 month s.c. implant

− Nafarelin (Synarel, Pharmacia), intranasal solution

− Histrelin (Supprelin, Roberts), s.c. daily injection

• Indications:

− Prostate cancer

− Endometriosis and puberty in children

• Other depot formulations available (1,3,4 & 6 months)

• No oral product on the market

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RiVaxTM

Ricin Toxin Vaccine (Phase 1)

BioDefense – Lead Program

Castor Bean

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Ricin - Evolution Of A Threat

from “Ricin: Technical Background and potential Role in Terrorism,” Dana Shea and Frank Gottron, CRS Report for Congress; February 4, 2004

1940s – weaponized by UK military“Compound W”

1978 – Umbrella Assassination in London of Bulgarian dissident Georgi Markov

1991 – Minnesota Patriots Council found with 0.7 g ricin; arrested and convicted

1995 – Thomas Lewis Lavy arrested for possession of 130 g ricin while crossing into Canada from Alaska

2002 – Kenneth Olson arrested and sentenced 13 years for producing ricin

2003 – Secret Service intercepted a letter contaminated with ricin addressed to the White House

2004 – US Senate closed - Ricin detected in mail sent to Senate Majority Leader Bill Frist

2004 - Reports of ricin in Afghanistan/Al Qaeda

2005 - Reports of ricin possession in Florida and Arizona

2007- Ricin highlighted in FBI terrorism report as top bioterror threat along with Anthrax

2008 - Roger Bergendorff put himself in coma after ricin exposure in Las Vegas Motel

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2007 FBI Terrorism Report

“Ricin and the bacterial

agent anthrax are

emerging as the most

prevalent agents involved

in WMD investigations”

FBI Terrorism Report,

November 2007

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RiVax™

Profile:• Soligenix is world leader in ricin toxin vaccine research• Vaccine is derived from a non toxic recombinant ricin A chain• Retains immunogenic properties: induces production of serum antibodies capable of neutralizing native ricin toxin

Funding:• Recent $9.4 million NIH grant to develop heat stable vaccines• Received >$20 million NIAID grant funding to date• Partner UT Southwestern received $3.6 million grant funding

Status:• Phase 1 clinical trial complete: Demonstrated safety and immunogenicity in humans• Non-human primate study initiated• Phase 1b clinical trial underway at UTSW: adjuvant formulation• Scale-up GMP process optimization and development completed

Next Milestones:• Complete Phase 1B clinical trial• Manufacture large scale commercial grade batches for future clinical

trials and potential procurement contracts• Continue development under new $9.4 million heat stabilization grant

Castor beans

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Milestone Events - Past & Future

Event 22009 1H 2010

2H 2010

1H 2011

SPA cleared by FDA and EMEA for orBec® confirmatory Phase 3 trial √

Fast Track granted for SGX201 for Radiation Enteritis √ Completed $30 million partnership with Sigma-Tau for orBec® in NA √ Received $9.4 million NIH grant award for heat stable vaccine development

√

Initiated confirmatory orBec® Phase 3 study in acute GI GVHD √ Initiated Phase 1/2 Radiation Enteritis study with SGX201 √ Patents granted in US for treatment of IBS and in EU for treatment of inflammatory GI disorders

√

Complete enrollment of orBec® Phase 2 study in prevention of acute GVHD

√

Announce results of orBec® Phase 2 study in prevention of acute GVHD

+

Complete Phase 1B clinical trial for RiVax™ + Initiate Phase 2 study of orBec® in chronic GI GVHD + Complete European partnership for orBec® + Initiate Phase 1 PK study of LPMTM leuprolide + Complete confirmatory Phase 3 clinical trial of orBec® in GI GVHD + Complete Phase 1/2 study with SGX201 in radiation enteritis +

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Investment Highlights

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1. Low current valuation of approximately $60 million • Potential for exponential growth with the achievement of a single milestone – A positive

confirmatory Phase 3 clinical trial of orBec®

• Relatively low risk and late stage drug development proposition due to existing orBec® Phase 3 data

2. Four active clinical trials

3. Clean capital structure with no debt or preferred stock outstanding

4. FDA SPA and EMEA agreement on Phase 3 protocol supports regulatory path to approval in US and EU

5. 35% royalty generating North American partnership with Sigma-Tau on orBec®

6. orBec® addresses a potential $400 million global GVHD market, where there is an unmet medical need with poor therapeutic options

7. Oral BDP application in other GI areas - Radiation Enteritis and Crohn’s Disease; markets in excess of $500 million worldwide 

8. LPM™ - novel oral delivery system for drugs such as leuprolide

9. Diversified portfolio: BioTherapeutics and BioDefense• BioDefense - Grant funded and revenue generating – New $9.4 million NIH grant

− Soligenix is world leader in ricin toxin vaccine research

THANK YOU www.soligenix.com

BioTherapeutics | BioDefense