Theriva Biologics, Inc. · AMEX:TOVX
Theriva Biologics — Synthetic Biologics — Investor Presentation (June 2013)
20 slides from Theriva Biologics's investor presentation, Jun 27, 2013
Slide 1: June 2013
NYSE MKT: SYN June 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: Investment Proposition
Investment Proposition • Building portfolio of target - specific biologics for the prevention and treatment of serious infectious diseases ̶ Innovative, first - in - class product candidates ̶ Large markets • Clinical - stage ̶ Multiple sclerosis (MS) – Phase II (potential partnering opportunity) ̶
Slide 4: Management Team
Management Team 4 • 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 Clini
Slide 5: Product Pipeline
Product Pipeline 5 NYSE MKT: SYN * - SYN - 004, 2 nd generation oral enzyme candidate under development based on 1 st generation candidate (P1A) Phase II results I - Intrexon collaboration – design, engineering and optimization of lead candidates T - The University of Texas at Austin – antibody rese
Slide 6: Estriol "Pregnancy Hormone" – Linked to decreased MS relapse rates
Estriol “Pregnancy Hormone” – Linked to decreased MS relapse rates • Estriol − Hormone produced by placenta during pregnancy with highest level in 3 rd trimester − Large safety database exists from prior foreign approvals for treatment of post - menopausal symptoms • Landmark observational study pub
Slide 7: 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 2 ̶ Relapse rates at 2 years of oral Trimesta / Copaxone ® vs. placebo/ Copaxone ® • Trial status ̶ Enrollment complet
Slide 8: MS: Market
MS: Market • 400,000 MS patients in U.S. (~2.1 million worldwide) 3 • $14.1 billion current estimated worldwide sales 4 • Issued U.S. patent includes claims for use of Trimesta in combination with Copaxone ® Trimesta Opportunity – Oral add - on MS therapy 8 NYSE MKT: SYN Teva/Copaxone $4.178 30% Bio
Slide 9: Emerging Worldwide Crisis
Emerging Worldwide Crisis 9 SYN building portfolio of biologics for serious 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 microbes infect more than 2 million
Slide 10: SYN Infectious Disease Strategy
Current Market Limited Solutions Significant Unmet Medical Needs Limited Big Pharma Investment SYN Products Targeted Biologics Novel Antibacterial R&D GAIN Act Revolutionize Infectious Disease Treatment 10 NYSE MKT: SYN SYN infectious disease strategy • Large and growing markets • Infectious disease
Slide 11: C. difficile Infections: Market
11 • 24 million patients administered IV antibiotics annually in the U.S. 6 – 1.1 million patients infected with C. diff annually 7 – Patients with C. diff hospitalized approximately 4 - 7 extra days 8 – $ 8.2 billion in costs associated with C. diff - related stays in hospital 9 – 30,000 C. diff -
Slide 12: SYN-004: Co-Administered with Antibiotics
12 SYN - 004: Co - Administered with Antibiotics Prophylactic treatment for prevention of C. diff infections • Oral enzyme to be co - administered with penicillins or most cephalosporins ( β - lactam antibiotics) ̶ Remain within the intestine to degrade certain IV β - lactam antibiotics ̶ Preventati
Slide 13: SYN-004: Co-Administered with Antibiotics
SYN - 004: Co - Administered with Antibiotics Intended to neutralize effects of β - lactam antibiotics in GI tract 13 Patient hospitalized with PRIMARY infection ( eg . pneumonia) Administer IV β - lactam antibiotic for primary infection SYN - 004 eliminates the antibiotic, protecting native microfl
Slide 14: Pertussis Infections
Pertussis Infections Millions of whooping cough cases globally per year • Despite aggressive vaccination strategies, incidence of Pertussis is increasing 12,13 ̶ Less effective vaccine introduced in the 1990s ̶ Non - compliance with standard vaccinations ̶ ~41,000 cases per year in the U.S. 14 • Unv
Slide 15: Acinetobacter Infections
Acinetobacter Infections Increasingly pandrug - resistant gram - negative bacteria • M ortality rates as high as 43% reported 16 • Billion dollar market opportunity 17 • Survives on dry surfaces for up to 36 days ̶ Survives twice as long as non - biofilm - forming pathogens 18 • Acinetobacter infect
Slide 16: Corporate Snapshot
Corporate Snapshot • Current Price : $1.74 (as of 6/18/13) • 52 Week Range: $1.34 - $ 2.55 • Average Volume (3 months): 62,441 • Shares Outstanding: ~44.7 million (as of 5/14/13) • Market Capitalization: ~$78 million • Cap Structure: Common, no debt, no preferred • Cash: ~$8.5 million (as of 3/31/13
Slide 17: Upcoming Milestones
17 Upcoming Milestones NYSE MKT: SYN • Phase II relapsing - remitting MS clinical trial ̶ Final patient, final visit (January 2014) ̶ Topline results ( 1H 2014) • SYN - 004 oral enzyme preventative treatment for C. diff ̶ Initiate cGMP manufacturing (3Q 2013) ̶ Initiate clinical trials (2H 2014) • m
Slide 18: June 2013
June 2013 – 6.27.2013 – FINAL NYSE MKT: SYN June 2013
Slide 19: References
References Slide 6: 1 Pr egnancy I n M ultiple S clerosis (PRIMS) Study; Confavreux , C., Hutchinson, M., Hours, M.M., Cortinvis - Tourniaire , P., Moreau, T., and the Pregnancy in MS Group (1998). Rate of Pregnancy - Related Relapse in Multiple Sclerosis. New England Journal of Medicine , 339, 285
Slide 20: References
References 20 Slide 14 : 12 Misegades LK, Winter K, Harriman K, Talarico J, Messonnier NE, Clark TA, Martin SW, Association of childhood pertussis with receipt of 5 doses of pertussis vaccine by time since last vaccine dose, California, 2010. JAMA, 2012 Nov 28;308(20): 2126 - 32. 13 Centers for Dise
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