Theriva Biologics, Inc. · AMEX:TOVX
Theriva Biologics — Synthetic Biologics — Investor Presentation (February 2013)
23 slides from Theriva Biologics's investor presentation, Feb 11, 2013
Slide 1: NYSE MKT: SYN February 11, 2013
NYSE MKT: SYN February 11, 2013
Slide 2: Forward-Looking Statements
Forward - Looking Statements This presentation includes forward - looking statements on Synthetic Biologics’ current expectations and projections about future events . In some cases forward - looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expec
Slide 3: Corporate Snapshot
Corporate Snapshot • Current Price : $2.00 (as of 2/8/13) • 52 Week Range: $1.46 - $ 2.95 • Average Volume (3 months): 63,337 • Shares Outstanding: ~44.3 million (as of 12/7/12 ) • Warrants Outstanding: ~2.0 million * • Vested Options Outstanding: ~2.6 million ** • Market Capitalization: ~$88.6 mill
Slide 4: Corporate Overview
Corporate Overview • Clinical - stage programs ̶ Relapsing - remitting multiple sclerosis (MS) – Phase II ̶ Cognitive dysfunction in MS – Phase II ̶ Prevention of Clostridium difficile ( C. diff ) – Phase II* • Discovery/preclinical stage programs ̶ Pertussis (whooping cough) ̶ Prevention of C. diff
Slide 5: Management Team
Management Team 5 • Jeffrey Riley, CEO Pfizer, Nichols Institute (Quest), SmithKline Beecham, QIC • C. Evan Ballantyne , CFO Clinical Data, Inc., Avedro , ZymeQuest , ACNielsen, IMS • John Monahan, Ph.D., EVP R&D Avigen , Somatix , Triton Biosciences, Hoffman - LaRoche • Carol Reed, M.D., SVP Clinic
Slide 6: Product Pipeline
Product Pipeline Therapeutic Area | (pronyct picleete esti Discovery | Preclinical | Phase! | Phase! | Phase it! eee Trimesta™ SOLS Sa aee Trimesta™ ee es infect Soneatanen SME Clery IEPs eee wwncssing coueny | smo" |e — > Aaeropecter | sin-cox | Monederal fama Puree | ww | — ¥ Suite of oral enzyme
Slide 7: MS: Market Opportunity
MS: Market Opportunity • MS market − 400,000 MS patients in U.S. (2.5 million worldwide) − 200 people diagnosed per week in the U.S. − 1.75 million patients worldwide are women • ~60% relapsing - remitting MS patients are women • Oral therapies like Trimesta TM , expected to overtake injectables for
Slide 8: MS: Historical Efficacy of Estriol
MS: Historical Efficacy of Estriol “Pregnancy Hormone” – Linked to decreased MS relapse rates • Estriol − Hormone produced by placenta during pregnancy − Solid safety profile (approved in Europe/Asia for 40+ years) • Landmark study published in New England Journal of Medicine 2 − Study of 254 women
Slide 9: MS: Relapsing-Remitting MS Phase II Clinical Trial of Trimesta
MS: Relapsing - Remitting MS Phase II Clinical Trial of Trimesta TM (oral estriol) • Multi - center, investigator - initiated, randomized, double - blind, placebo - controlled trial ̶ Comparing relapse rates over 2 years between 8 mg of oral Trimesta TM taken daily versus matching placebo ̶ All pati
Slide 10: Emerging Worldwide Crisis: Multidrug-resistant infectious diseases
Emerging Worldwide Crisis 10 Multidrug - resistant infectious diseases “Infections were the second leading cause of death worldwide in 2002, killing nearly 15 million people – almost 1 in 3 deaths across the globe ” “Multidrug - resistant (MDR) microbes infect more than 2 million Americans each year
Slide 11: Revolutionize Infectious Disease Treatment
Revolutionize Infectious Disease Treatment • Infectious disease outbreaks increasing while intervention options decline 5 ̶ Widespread MDR pathogens ̶ Increasing numbers of immuno - compromised patients • Utilize targeted biologics approach – similar to cancer drugs • Large and growing markets – sig
Slide 12: C. difficile: Market Overview
12 • Infections caused by C. diff in the U.S. (2009) resulted in: ̶ 337,000+ hospitalizations 6 ̶ Cost per patient $24,000 ̶ 30,000 deaths 6 ̶ $8.2 billion in costs associated with C. diff - related stays in the hospital 7 ̶ Increasing incidence and often multidrug - resistant • C . diff toxins caus
Slide 13: Infectious Disease: Clostridium difficile (C. diff)
13 Infectious Disease: Clostridium difficile (C. diff) Acquired clinical - stage program November 2012 • Prophylactic treatment for prevention of C. diff infection • First generation candidate (formerly known as P1A), a proprietary oral enzyme co - administered with certain penicillins , eliminated
Slide 14: SYN-004: Oral Enzyme for Prevention of C. diff
SYN - 004: Oral Enzyme for Prevention of C. diff Intended to neutralize effects of β - lactam antibiotics in GI tract 14 Patient hospitalized with PRIMARY infection ( eg . pneumonia) Administer IV β - lactam antibiotic for primary infection SYN - 004 to eliminate the antibiotic from the GI tract, pr
Slide 15: Pertussis: Market Overview
Pertussis : Market Overview Serious threat from steady increase in whooping cough outbreaks • 294,000 deaths worldwide 9 ̶ Primarily young, unvaccinated children • Increased incidence associated with ̶ Infants not yet fully vaccinated ̶ Unvaccinated individuals ̶ Individuals with diminished immunity
Slide 16: Pertussis: Monoclonal Antibody Approach
Pertussis: Monoclonal Antibody Approach 16 mAb development • I nfectious disease collaboration with Intrexon • Licensed rights related to certain pertussis antibodies from The University of Texas at Austin ̶ Antibody research conducted by Jennifer A. Maynard, Ph.D. ̶ Pending patents • Develop SYN -
Slide 17: Acinetobacter Infection: Market Overview
Acinetobacter Infection : Market Overview Deadly gram - negative bacteria • M ortality rates as high as 43% reported 12 • Multi - billion dollar market opportunity 13 • Multidrug - resistant due to pathogen’s ability to rapidly mutate 14 • Survives on dry surfaces for up to 36 days ̶ Survives twice
Slide 18: Acinetobacter: Monoclonal Antibody Approach
Acinetobacter : Monoclonal Antibody Approach 18 Intrexon collaboration for mAb development Intrexon’s proprietary technologies/processes produce mAbs to detect and destroy viruses, bacteria and toxins • mAbLogix ™ – fully human antibody discovery platform • LEAP ™ – rapid identification and selectio
Slide 19: mAb Therapies for Infectious Diseases
mAb Therapies for Infectious Diseases Infectious disease pathogen (bacteria, viruses & toxins) mAb injection “tags” pathogen Immune system attacks “tagged” pathogen For the treatment of pertussis and Acinetobacter 19
Slide 20: Anticipated Milestones
20 Anticipated Milestones • MS (oral estriol ) ̶ Continued patient enrollment in Phase II cognitive dysfunction in MS trial (ongoing) ̶ Topline results from Phase II relapsing - remitting MS trial (1H 2014) ̶ Results from cognitive dysfunction trial (2H 2014) • C. diff (oral enzyme) ‒ Generate maste
Slide 21: NYSE MKT: SYN February 11, 2013
NYSE MKT: SYN February 11, 2013 Feb 2013 – FINAL – 2.11.2013
Slide 22: References
References Slide 7 : 1 Current estimated sales of injectable disease - modifying MS therapies. Research and Markets: Multiple Sclerosis Therapeutics – Pi peline Assessment and Market Forecasts to 2019. Novartis 2011 Financial Report. Slide 8 : 2 Pr egnancy I n M ultiple S clerosis (PRIMS) Study; Con
Slide 23: References
References 23 Slide 15 : 9 World Health Organization. Pertussis: immunization surveillance, assessment and monitoring. http://www.who.int/immunization_monitoring/diseases/pertussis/en/index.html . 10 Misegades LK, Winter K, Harriman K, Talarico J, Messonnier NE, Clark TA, Martin SW, Association of c
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