Theriva Biologics, Inc. · AMEX:TOVX
Theriva Biologics — Synthetic Biologics — Investor Presentation (September 2017)
46 slides from Theriva Biologics's investor presentation, Sep 7, 2017
Slide 1: Investor Presentation
September 07, 2017 Investor Presentation
Slide 2: Forward-Looking Statements
Forward - Looking Statements This presentation includes forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 , as amended, on Synthetic Biologics’ current expectations and projections about future events . In some cases forward - looking statements
Slide 3: Our Mission
“Pioneering elegant solutions that leverage the microbiome to improve global health” Our Mission 3
Slide 4: Our Strategy
Our Strategy Core Future Developing simple therapeutics that have the potential to influence the microbiome to protect the health of patients A robust pipeline of new programs designed to improve global health Growth Advancing innovative microbiome drugs with billion - dollar market potential that a
Slide 5: Solving Critical Problems
Solving Critical Problems 5
Slide 6: The Gut Microbiome: A Community of Microbes
The Gut Microbiome: A Community of Microbes The microbiome affects our health 4,5,6 • Immune system • Metabolism • Obesity • Inflammatory diseases • Central nervous system disorders gut bacterial species have now been characterized 3 Containing bacteria, archaea, protists, fungi and viruses in the d
Slide 7: Antibiotics Cause Dysbiosis to the Gut Microbiome
Antibiotics Cause Dysbiosis to the Gut Microbiome A healthy microbiome protects the body from infection Antibiotics wipe out good and bad bacteria Resistant bacteria (bad bacteria) multiply and take over Body primed for infection resistant bacteria spreads to others Dysbiosis — disruption to the bal
Slide 8: CDI: An Urgent Threat in the U.S. and Growing Global Concern
CDI: An Urgent Threat in the U. S. and Growing Global Concern patients experience at least one recurrence of CDI 9 patients in U.S. affected annually 9 453,000 1 in 5 extra days spent in the hospital by a CDI patient 10 ~7 annual added cost to hospitals and society from CDI 11 $5.4B annual CDI - ass
Slide 9: Antimicrobial Resistance is a Serious Global Threat
Antimicrobial Resistance is a Serious Global Threat AMR (antimicrobial resistance): the ability of a microbe to resist the effects of medication (previously) used to treat them Can cause antibiotics to become ineffective Sometimes referred to as super bugs infections persist and increase risk of spr
Slide 10: How Do CDI and AMR Spread?
Other patients are exposed to CDI & resistant bacteria John seeks medical attention and could receive more antibiotics John spreads resistant bacteria in his community Patients spread CDI & resistant bacteria in their community How Does AMR Spread? Patients go home John receives antibiotics which ca
Slide 11: Antimicrobial Resistance: Public Policy Tailwind
Antimicrobial Resistance: Public Policy Tailwind • AMR is a serious threat — world leaders are taking action • Government recognizes need to expedite drug review timelines • Recruiting leaders in industry and academia to develop action plans • Synthetic Biologics is pioneering microbiome science: De
Slide 12: Innovating Great Solutions
Section Title Innovating Great Solutions
Slide 13: Building a Deep Pipeline Focused on the Microbiome
Building a Deep Pipeline Focused on the Microbiome Therapeutic Area Product Candidate Preclinical Phase 1 Phase 2 Phase 3 Phase 4 Prevention of CDI and AMR [Degrade IV β - lactam Antibiotics] ribaxamase SYN - 004 Prevention of CDI and AMR [Degrade IV Carbapenem Antibiotics] Oral enzyme SYN - 006 Pre
Slide 14: SYN-004 (ribaxamase)
SYN - 004 (ribaxamase)
Slide 15: Building a Deep Pipeline Focused on the Microbiome
Building a Deep Pipeline Focused on the Microbiome Therapeutic Area Product Candidate Preclinical Phase 1 Phase 2 Phase 3 Phase 4 Prevention of CDI and AMR [Degrade IV β - lactam Antibiotics] ribaxamase SYN - 004 Prevention of CDI and AMR [Degrade IV Carbapenem Antibiotics] Oral enzyme SYN - 006 Pre
Slide 16: What is Ribaxamase?
• Oral 75mg capsule (custom designed oral β - lactamase) • Designed to protect the natural balance of microbes in the gut microbiome during antibiotic use • Did not interfere with the efficacy of IV antibiotics in Phase 2 studies What is Ribaxamase? 16
Slide 17: How Does Ribaxamase Work?
How Does Ribaxamase Work? • be co - administered with certain IV antibiotics • b reak down excess IV antibiotic excreted into the GI tract • h elp prevent CDI, pathogen overgrowth and AMR Designed to: 17
Slide 18: Delivering Clinical Outcomes: Ribaxamase Phase 2b Data
Delivering Clinical Outcomes: Ribaxamase Phase 2b Data • Achieved primary endpoint of significant (P=0.045) reduction of CDI • 71.4% relative risk reduction in CDI rates vs placebo • Significant (p=0.002) reduction in new VRE colonization vs placebo • Significant reduction of ceftriaxone - mediated
Slide 19: Ribaxamase Protected Microbial Diversity
Prevented Ceftriaxone(CRO) - mediated loss of α - diversity and enhanced microbiome recovery Ribaxamase Protected Microbial Diversity Note: Shannon Index and Chao1 represent α - diversity, a measure of the microbial community composition within a sample Size of each ball is relative to the standard
Slide 20: Goal of Impacting Global Health
Goal of Impacting Global Health ~500k cases of CDI per year 13 2M illnesses and 23k deaths caused by AMR 13 US, Canada & Mexico 49% increase in antibiotic use in NZ between 2006 - 2014 18 25% of Australian CDI cases come from community settings 16 Australia & New Zealand Japan High use of Cephalospo
Slide 21: A Potential Transformation in Anti-Infective Standard of Care
A Potential Transformation in Anti - Infective Standard of Care The dominoes begin to fall… Preventing C. difficile infection Inhibiting the emergence of AMR Preserving use of existing antibiotics Avoiding downstream problems • Prevention of secondary infections • Shortened hospital stays • Reduced
Slide 22: Valuing Ribaxamase
Valuing Ribaxamase Value Story The total economic cost of antibiotic resistance to the U.S. is estimated to be $20 billion in excess direct healthcare costs, with additional costs to society for lost productivity as high as $35 billion a year (2008 dollars) 13 C. difficile costs up to up to $5.4 bil
Slide 23: Patient Access is Priority
Patient Access is Priority Improved patient access delivers value to patients and stakeholders Define and Communicate Value Price Effectively Unite Focus of Stakeholders in Healthcare System • Establish common goals with KPI’s • Map the patient journey • Understand payer, PBM, and provider pathways
Slide 24: °o = SS 7)
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Slide 25: Building a Deep Pipeline Focused on the Microbiome
Building a Deep Pipeline Focused on the Microbiome Therapeutic Area Product Candidate Preclinical Phase 1 Phase 2 Phase 3 Phase 4 Prevention of CDI and AMR [Degrade IV β - lactam Antibiotics] ribaxamase SYN - 004 Prevention of CDI and AMR [Degrade IV Carbapenem Antibiotics] Oral enzyme SYN - 006 Pre
Slide 26: Pain, Constipation and Bloating in the Gut
Pain, Constipation and Bloating in the Gut • The archaeon, Methanobrevibacter smithii ( M. smithii ), produces methane in the human intestine during digestion • Clinical evidence has established that elevated intestinal methane production is a cause of constipation in Irritable Bowel Syndrome with C
Slide 27: IBS-C and CIC: Large Economic Burden and Huge Opportunity
IBS - C and CIC: Large Economic Burden and Huge Opportunity adults in U.S. suffer from IBS - C 23 people suffer from chronic constipation 22 1 in 7 16M satisfaction of current treatment across the globe 24 average additional expense per person, per year with IBS - C 25 $3.9k current drugs treat the
Slide 28: What is SYN-010?
What is SYN - 010? Modified - release formulation of lovastatin lactone optimal for reducing methane - production by certain gut microorganisms ( M. smithii ) 28
Slide 29: How Does SYN-010 Work?
How Does SYN - 010 Work? • Methane produced by M. smithii may cause constipation, pain and bloating • SYN - 010 acts in the intestinal lumen to inhibit methane production with few systemic effects • Proactively targets a cause of constipation, pain and bloating rather than reactively treating the sy
Slide 30: SYN-010 Appears to Improve Symptoms
SYN - 010 had no SAEs, few TEAEs and no incidences of drug - related diarrhea reported in clinical trials SYN - 010 was not microbicidal indicating minimal disruption to the gut microbiome 29 SYN - 010 showed compelling improvements in CSBM frequency, abdominal pain and bloating SYN - 010 Appears to
Slide 31: SYN-010: Competitive Overview
SYN - 010: Competitive Overview Product Candidate SYN - 010 Linzess Amitiza Trulance OTC Laxatives Company Synthetic Allergan Takeda Synergy Various Phase/Status Planned pivotal 2b/3 Marketed Marketed Marketed Marketed Designed to treat underlying cause of IBS - C Designed to treat symptoms w/o caus
Slide 32: Goal of Enhancing Global Health
Goal of Enhancing Global Health Maximize reach to save lives, improve global health, reduce burden 71M addressable patients US, Canada & Mexico 4M addressable patients Australia & New Zealand Japan 18M addressable patients China, Korea & India 406M addressable patients EU 105M addressable patients W
Slide 33: IBS and Constipation Markets are Growing
IBS and Constipation Markets are Growing More than 2x growth in 4 years! US IBS and Constipation Market 1 • Digital and DTC campaigns are enhancing awareness of both IBS and gut health • New entrants are growing the market , not cannibalizing it 27 • Only 26% of patients are “very satisfied” with cu
Slide 34: Synthetic Biologics Building Capabilities
Synthetic Biologics Building Capabilities
Slide 35: Executive Leadership Team
Raymond Stapleton, PhD, SVP Manufacturing Merck & Co., Inc. Jeffrey Riley CEO Pfizer, Nichols Institute (Quest), SmithKline Beecham, QIC Steven Shallcross CFO Vanda Pharmaceuticals, Inc., Empire Petroleum Partners, LLC, Innocoll AG Joseph Sliman, MD, MPH, CMO Vanda Pharmaceuticals, Inc., MedImmune,
Slide 36: Building Capabilities
Building Capabilities Financial Stewardship Clinical/ Regulatory and Med Affairs Manufacturing Innovation R&D Capabilities Marketing and Commercial • Developing innovative solutions and platforms • Manufacturing process development, tech transfer and scale up • Completed two phase 2 clinical trials
Slide 37: Synthetic Biologics Strong Patent Position
2023 SYN - 010: Patented Methods of Treatment (Broadest Indication) SYN - 010: Patented and Pending Methods of Treating Constipation with SYN - 010 ribaxamase : Patented Composition of Matter & Uses ribaxamase : Patented other β - lactamase Composition of Matter & Uses ribaxamase : Pending Patent Ap
Slide 38: Building a Deep Pipeline Focused on the Microbiome
Building a Deep Pipeline Focused on the Microbiome C - License and collaboration with Cedars - Sinai Medical Center I - License and collaboration with Intrexon Corporat ion collaboration T - License and collaboration with The University of Texas at Austin M - Scientific collaboration with Massachuse
Slide 39: Thank You
Thank You
Slide 40: Sources
1. Ursell LK, Metcalf JL, Parfrey LW, Knight R. Defining the Human Microbiome. Nutrition reviews . 2012;70(Suppl 1):S38 - S44. doi:10.1111/j.1753 - 4887.2012.00493.x. 2. Rodríguez JM, Murphy K, Stanton C, et al. The composition of the gut microbiota throughout life, with an emphasis on early li fe.
Slide 41: Sources (continued)
Sources (continued) 13. Centers for Disease Control and Prevention (CDC). Antibiotic Resistance Threats in the United States, 2013. (Page last up dat ed April 10, 2017) Retrieved from https://www.cdc.gov/drugresistance/threat - report - 2013/index.html (Last accessed September 2017) 14. IMS Health A
Slide 42: Sources (continued 2)
Sources (continued 2) 24. IBS Patients: Their Illness Experience and Unmet Needs – US Study – International Foundation for Functional Gastrointestina l Disorders (IFFGD) (Last accessed: August 2017) 25. Doshi JA, Cai Q, Buono JL, et al. Economic burden of irritable bowel syndrome with constipation:
Slide 43: Appendix
Appendix
Slide 44: Resistome Analysis of Longitudinal Fecal Samples
Resistome Analysis of Longitudinal Fecal Samples • DNA extracted from 350 fecal samples sequenced by whole genome shotgun sequencing (Diversigen, Houston, TX) • Interrogated against the CARD database • 21,000,000 DNA matches • 1300 AMR genes identified with ~60,000 matches per sample • Including man
Slide 45: Analysis of the Change in Relative Abundance of AMR Genes
Analysis of the Change in Relative Abundance of AMR Genes Collection point T0 to T1, Placebo vs. Ribaxamase - treated patients Placebo Ribaxamase Decreased Increased T0 T1 Vancomycin resistance genes Β - lactamase genes Tet and erm resistance genes LefSe Analysis 45
Slide 46: Comparison of Ribaxamase vs. Placebo-Treated
Comparison of Ribaxamase vs. Placebo - Treated Gene of Interest P value gb|AY082011|0-699|ARO:3002923|vanRD 0.00533347 gb|EU999036|688-1390|ARO:3002934|vanSD 0.01298036 gb|AY769934|27-993|ARO:3003096|CfxA5 0.015348147 gb|U38243|149-1115|ARO:3003001|CfxA 0.020131869 gb|AY769933|0-966|ARO:3003005|CfxA
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