Theriva Biologics, Inc. · AMEX:TOVX
Theriva Biologics — Synthetic Biologics — Investor Presentation (January 2014)
31 slides from Theriva Biologics's investor presentation, Jan 13, 2014
Slide 1: Synthetic Biologics
See NYSE MKT: SYN ©) 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 targeted, pathogen - specific anti - infectives for the prevention and treatment of serious infectious diseases ̶ Innovative, first - in - class product candidates ̶ Large markets ̶ Shorter treatment period may reduce clinical trial duration • Clinical
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 * - Cedars - Sinai clinical trials in Phase I/II for various indications ** - 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 optimizatio
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) 4 • $14.1 billion current estimated worldwide sales 5 • 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 Consensus on the Microbiome
Emerging Consensus on the Microbiome 9 SYN building portfolio of targeted, pathogen - specific novel drugs “Infections were the second leading cause of death worldwide in 2002, killing nearly 15 million people – almost 1 in 3 deaths across the globe ” Brad Spellberg, M.D., Rising Plague 6 100 trilli
Slide 10: Rebirth of Anti-Infective Sector
Rebirth of Anti - Infective Sector SYN: Building a robust portfolio of targeted anti - infectives 10 NYSE MKT: SYN • December 2013 The Medicines Company acquires Rempex Pharmaceuticals for $474M • November 2013 Shire acquires ViroPharma for $4.2B • November 2013 Roche returns to antibiotics field wi
Slide 11: Clinical Success Rates by Therapeutic Area
Clinical Success Rates by Therapeutic Area 8 Phase I through Food & Drug Administration approval Aligns with SYN’s focus on the development of novel anti - infectives 11 NYSE MKT: SYN 0% 5% 10% 15% 20% 25% Nervous System Cardiovascular Respiratory Oncology Musculoskeletal Anti-Infective 8% 9% 10% 19
Slide 12: Methanobrevibacter smithii and the Archaea Kingdom
12 • M. smithii is the predominant human methanogen ‒ Unique position within the micro biome ‒ Critically important in health and disease ‒ During it’s energy life cycle it creates methane gas in the gut • Research shows link to irritable bowel syndrome (IBS), obesity and diabetes • Excessive methan
Slide 13: Constipation-Predominant IBS: Role of methanogens
13 • Dr. Pimentel of Cedars - Sinai is the leading investigator in this field • Clear link between Small Intestinal Bacterial Overgrowth (SIBO) and disease • Methane levels in C - IBS are significantly higher • Methane slows intestinal transit causing constipation, bloating and abdominal pain • Micr
Slide 14: C-IBS: How are we going to help patients?
14 • Use a Rx/ Dx approach with SYN - 010 – Have both a diagnostic biomarker in the form of a methane breath test as well as a compound – Multiple clinical studies show reduction in methane gas in the small intestine improves patients’ lives • Treat the cause and not just the symptoms – Current ther
Slide 15: C-IBS and Tertiary Markets
15 • Up to $10 billion in direct costs to the U.S. healthcare system and up to $20 billion in indirect costs 9 • 40% of all IBS patients have C - IBS • ~$2.7 billion market expected by 2020 10 • Major IBS players include ‒ Salix ( rifaximin ) for diarrhea - predominant IBS (D - IBS) ‒ Ironwood/ Almi
Slide 16: Anti-Archaea Timeline
16 Anti - Archaea Timeline SYN - 010 targeted at C - IBS, obesity and diabetes NYSE MKT: SYN 2014 2015 2016 / 2017 2013 License Constipation Program Metabolic Syndrome Study Phase II Study OMICS 2 Phase II Clinical Trial Phase II: Top Line Results Phase III Program OMICS 3a Phase III Clinical Trial
Slide 17: Paradigm Shift: Decrease in C. diff infections with SYN-004
Paradigm Shift Decrease in C. diff infections expected with co - administration of SYN - 004 NYSE MKT: SYN 17 Antibiotics Treatments • β - lactam • Fluoroquinolone • Clindamycin • Other • Metronidazole • Vancomycin • Fidaxomicin Current Paradigm SYN - 004 Paradigm C. diff Infections β - lactam Antib
Slide 18: C. difficile (C. diff) Infections
18 • 24 million patients administered IV antibiotics annually in the U.S. 15 – 1.1 million patients infected with C. diff annually 16 – Patients with C. diff hospitalized approximately 4 - 7 extra days 17 – $ 8.2 billion in costs associated with C. diff - related stays in hospital 18 – 30,000 C. dif
Slide 19: SYN-004: Co-Administered with IV Antibiotics
19 SYN - 004: Co - Administered with IV Antibiotics Prophylactic treatment for prevention of C. diff infections • Oral enzyme to be co - administered with penicillins or cephalosporins ( β - lactam antibiotics) ̶ Remain within the intestine to degrade certain IV β - lactam antibiotics ̶ Preventative
Slide 20: SYN-004: Neutralizes effects of β-lactam antibiotics in GI tract
SYN - 004: Co - Administered with IV Antibiotics Intended to neutralize effects of β - lactam antibiotics in GI tract 20 NYSE MKT: SYN SYN - 004 Antibiotic 1. SYN - 004 is being developed as an oral enzyme tablet ( blue) to be co - administered with IV antibiotics (yellow ). 3. SYN - 004 is intended
Slide 21: SYN-004: Market Potential
SYN - 004: Market Potential Intended to target certain IV β - lactam antibiotics NYSE MKT: SYN 21 14.4M patients 22 26.5M prescriptions 21 117.6M doses of “SYN - 004 target” β - lactam antibiotics purchased by U.S. hospitals to fill patient prescriptions 20 * Based on U.S. market data in 2012 ** Est
Slide 22: Pertussis Infections
Pertussis Infections Millions of whooping cough cases globally per year • Despite aggressive vaccination strategies, incidence of Pertussis is increasing 23,24 ̶ Less effective vaccine introduced in the 1990s ̶ Non - compliance with standard vaccinations ̶ ~41,000 cases per year in the U.S. 25 • Unv
Slide 23: Acinetobacter Infections
Acinetobacter Infections Infections increasing due to this pandrug - resistant gram - negative bacterium • M ortality rates as high as 43% reported 27 • Billion dollar market opportunity 28 • Survives on dry surfaces for up to 36 days ̶ Survives twice as long as non - biofilm - forming pathogens 29
Slide 24: SYN-007: Biologics for Specific Subset of IBS Patients
SYN - 007: Biologics for Specific Subset of IBS Patients Intrexon Collaboration 24 NYSE MKT: SYN • Discovered by Dr. Pimentel to be a form of small intestinal bacterial overgrowth (SIBO) • Under Dr. Pimentel’s patents, D - IBS now treated with antibiotics as standard of care ‒ Rifaximin approved for
Slide 25: Corporate Snapshot
Corporate Snapshot • Cash balance (as of 9/30/13 ) : ~$5.1 million • Capital raise (12/17/13 close) : ~$12.1 million net proceeds • Current Price : $1.89 (as of 1/6/14) • 52 Week Range: $0.95 - $ 2.10 • Average Volume (3 months): 332,005 • Shares Outstanding: ~58 million (as of 12/17/13) • Options O
Slide 26: Key Milestones
26 Key Milestones NYSE MKT: SYN • Trimesta TM (oral estriol) in Phase II relapsing - remitting MS clinical trial ‒ Final patient, final visit (January 2014) ‒ Topline results ( 1H 2014 ) • SYN - 010 compound for C - IBS ‒ Multiple Phase I and II clinical trials planned for C - IBS, obesity and diabe
Slide 27: Jan 2014 – 1.10.2014 – FINAL January 2014
Jan 2014 – 1.10.2014 – FINAL NYSE MKT: SYN January 2014
Slide 28: 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 29: References
References 29 Slide 18 : 15 - 16 This information is an estimate derived from the use of information under license from the following IMS Health Incorporated inf ormation service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution a
Slide 30: References
References 30 Slide 23 : 27 Falagas , ME, Bliziotis , LA, and Siempos , II. Attributable mortality of Acinetobacter baumannii infections in critically ill patients: a systematic review of matched cohort and case - control studies. Critical Care 2006, 10:R48. 28 Barrett, L. Former VP of US Marketing
Slide 31: P1A - 1st Generation Oral β-lactamase: Results of Phase I/II Clinical Trials
P1A - 1 st Generation Oral β - lactamase • P1A was studied in four (4) Phase I and one (1) Phase II clinical trials ‒ 112 patients and 143 healthy normal subjects exposed, generally: ▪ P reserved the normal intestinal microflora when co - administered with IV ampicillin or piperacillin ▪ Prevented e
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