OneMedForum New York Company Presentation: Soligenix, Inc., a late-stage biopharmaceutical company, focuses on the development of products to treat life-threatening side effects of cancer treatments. Learn More at: http://www.onemedplace.com/database/list/cid/14016
3. 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
4.
5. Pipeline 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 . Biotherapeutics Preclinical Phase 1 Phase 2 Phase 3 orBec® Treatment of GVHD orBec® Prevention of GVHD orBec® Treatment of Chronic GVHD SGX201 Radiation Enteritis SGX203 Crohn’s Disease LPM™ Leuprolide Prostate Cancer/Endometriosis Biodefense Proof of Concept Animal Phase 1 Phase 2/3 RiVax™ - Vaccine Ricin Toxin Exposure SGX202 - Therapeutic Radiation Injury FDA ANIMAL RULE FDA ANIMAL RULE
6. 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.
7. orBec ® Gastrointestinal Graft-versus-Host Disease (GI GVHD) An Unmet Medical Need BioTherapeutics – Lead Program
8.
9.
10.
11.
12.
13. orBec ® - Previous Phase 3 Study Results Time to Treatment Failure through Day 80 p = 0.0226 129-patient randomized, double-blind, placebo-controlled, multicenter trial Hockenbery et al. 2007. Blood Endpoints orBec ® n=62 Placebo n=67 p-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
14. orBec ® - Comprehensive Mortality Data Hockenbery et al. 2007. Blood Long-Term Survival Outcomes orBec ® Placebo p-value orBec ® vs. placebo Percentage reduction in mortality Mortality Rate at 200 days post transplant - Pivotal Phase 3 study 5 (8%) 16 (24%) .013 66% Mortality Rate at 200 days post transplant - Prior Phase 2 study 3 (10%) 6 (21%) 0.18 55% Mortality Rate among mismatched donors at 200 days post transplant Pivotal Phase 3 study 1 (4%) 10 (42%) 0.02 94% Mortality Rate at 1 year post randomization - Pivotal Phase 3 study 18 (29%) 28 (42%) 0.04 46% Mortality Rate at 1 year post randomization - 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%
15.
16.
17.
18. Lifecycle Management – New BDP Trials Program Purpose # of Available Patients Status Prevention of GVHD Decrease incidence or severity of acute GVHD 10,000+ US Phase 2 – 140 patients enrollment 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 grant Fast Track granted Completion targeted 1H 2011 Chronic GI GVHD Decrease need for systemic immunosuppressive therapy in chronic GI GVHD 6,000+ US Phase 2 protocol Initiation targeted for 2H 2010 Crohn’s Disease Minimize inflammation in chronic GI conditions 500,000 US 100,000 Pediatric US TBD
19.
20. Lipid Polymer Micelle (LPM TM ) Delivery System for Improving Oral Drug/Peptide Absorption BioTherapeutics – Pipeline Expansion
21.
22.
23.
24. RiVax TM Ricin Toxin Vaccine (Phase 1) BioDefense – Lead Program Castor Bean
25. 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
26. 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
07/12/10 Contains forward looking statements that reflect Soligenix’s current expectations about its future results, performance, prospects and opportunities. I would encourage everyone to consult our most recent annual report to familiarize yourself with the risks associated with the type of work we do.
07/12/10
07/12/10
07/12/10
07/12/10 Thank you Dina. Again, that was Dina Lyaskowitz of Ibis Consulting, who does investor relations work for Soligenix, Inc. My name is Geoff Green, I am the President and Acting CEO of Soligenix. Before I get into the presentation I’d like to remind everyone (next slide) that this presentation contains
07/12/10 Thank you Dina. Again, that was Dina Lyaskowitz of Ibis Consulting, who does investor relations work for Soligenix, Inc. My name is Geoff Green, I am the President and Acting CEO of Soligenix. Before I get into the presentation I’d like to remind everyone (next slide) that this presentation contains
07/12/10
07/12/10
07/12/10
07/12/10
07/12/10
07/12/10
07/12/10
07/12/10
07/12/10
07/12/10
07/12/10 Thank you Dina. Again, that was Dina Lyaskowitz of Ibis Consulting, who does investor relations work for Soligenix, Inc. My name is Geoff Green, I am the President and Acting CEO of Soligenix. Before I get into the presentation I’d like to remind everyone (next slide) that this presentation contains
07/12/10
07/12/10
07/12/10 Thank you Dina. Again, that was Dina Lyaskowitz of Ibis Consulting, who does investor relations work for Soligenix, Inc. My name is Geoff Green, I am the President and Acting CEO of Soligenix. Before I get into the presentation I’d like to remind everyone (next slide) that this presentation contains
07/12/10
07/12/10 Thank you Dina. Again, that was Dina Lyaskowitz of Ibis Consulting, who does investor relations work for Soligenix, Inc. My name is Geoff Green, I am the President and Acting CEO of Soligenix. Before I get into the presentation I’d like to remind everyone (next slide) that this presentation contains
![Forward-Looking Statements ,[object Object]](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)