Theriva Biologics, Inc. · AMEX:TOVX
Theriva Biologics — Synthetic Biologics — Investor Presentation (May 2013)
21 slides from Theriva Biologics's investor presentation, May 14, 2013
Slide 1: oo PY NTMETC
oo PY NTMETC NYSE MKT: SYN May 14, 2013 SYNTHETIC
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 biologics for the prevention and treatment of serious infectious diseases ̶ Innovative, first - in - class product candidates ̶ Large markets ̶ Proof - of - concept portfolio • Clinical - stage ̶ Multiple sclerosis (MS) – Phase II (potential partnering
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 Clinic
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: MS: Market
MS: Market • 400,000 MS patients in U.S. (~2.1 million worldwide) 1 • $14.1 billion current estimated worldwide sales 2 Trimesta TM opportunity – Oral add - on MS therapy 6 NYSE MKT: SYN Teva/Copaxone $4.178 30% Biogen Idec/Avonex $2.929 21% Merck KGaA/Rebif $2.425 17% Biogen Idec/Tysabri $1.703 12%
Slide 7: 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 with highest level in 3 rd trimester − Solid safety profile (approved in Europe/Asia for 40+ years) • Landmark study published in New England Journa
Slide 8: 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 4 ̶ Comparing relapse rates over 2 years of oral Trimesta TM vs. placebo ̶ All patients treated with Copaxone ® as sta
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 3.6 - 7 extra days 8 , costing more than $8.2 billion annually 9 – 30,000 C. diff - related deaths annually 10 • IV antibiotics may
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 product to be co - administered with IV β - lactam antibiotics ̶ Remain within the intestine to degrade certain IV β - lactam antibiotics ̶ Preventative treatment expected to pr
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: Market
Pertussis Infections : Market Millions of whooping cough cases globally per year • Increasing incidence at a 60 - year high in U.S. 13,14 ̶ ~41,000 cases per year in the U.S. 15 • Current vaccination protocols are not effective due to: ̶ Delayed infant vaccination ̶ Non - compliance ̶ 1990s vaccine
Slide 15: Acinetobacter Infections: Market
Acinetobacter Infections : Market Multidrug - resistant gram - negative bacteria • M ortality rates as high as 43% reported 17 • Billion dollar market opportunity 18 • Survives on dry surfaces for up to 36 days ̶ Survives twice as long as non - biofilm - forming pathogens 19 • Acinetobacter infectio
Slide 16: Corporate Snapshot
Corporate Snapshot • Current Price : $1.42 (as of 5/10/13) • 52 Week Range: $1.34 - $ 2.55 • Average Volume (3 months): 66,202 • Shares Outstanding: ~44.7 million (as of 3/27/13) • Market Capitalization: ~$63 million • Cap Structure: Common, no debt, no preferred • Cash: ~$8.7 million (as of 3/27/13
Slide 17: Recent IPOs in the Infectious Disease Space
Recent IPOs in the Infectious Disease Space 17 Company Name IPO Date Lead Candidate Market Cap* Tetraphase Pharmaceuticals, Inc. March 2013 Phase II: eravacycline - intra - abdominal infections (IV) $158M Cempra, Inc. February 2012 Phase III: respiratory tract infections; bacterial urethritis compri
Slide 18: Upcoming Milestones
18 Upcoming Milestones NYSE MKT: SYN • Phase II relapsing - remitting MS clinical trial ̶ Final patient, final visit (end of January 2014) ̶ Topline results ( 1H 2014) • SYN - 004 oral enzyme preventative treatment for C. diff ̶ Initiate cGMP manufacturing (3Q 2013) ̶ Initiate clinical trials (2H 20
Slide 19: May 2013 – 5.14.2013 – FINAL May 14, 2013
May 2013 – 5.14.2013 – FINAL May 14, 2013 NYSE MKT: SYN
Slide 20: References
References Slide 6: 1 National Multiple Sclerosis Society. http://www.nationalmssociety.org 2 Credit Suisse. Multiple Sclerosis - Evolution or Revolution Report. March 18, 2013. Slide 7 : 3 Pr egnancy I n M ultiple S clerosis (PRIMS) Study; Confavreux , C., Hutchinson, M., Hours, M.M., Cortinvis - T
Slide 21: References
References 21 Slide 14 : 13 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. 14 Centers for Dise
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