Theriva Biologics, Inc. · AMEX:TOVX
Theriva Biologics — Synthetic Biologics — Investor Presentation (May 2014)
29 slides from Theriva Biologics's investor presentation, May 27, 2014
Slide 1: Synthetic Biologics, May 2014
eae NYSE MKT: SYN >) SYNTHETIC May 2014
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 • Portfolio of anti - infective biologics and drugs targeting specific pathogens that cause serious infections and diseases ̶ Innovative, first - in - class product candidates for prevention and treatment ̶ Large markets ̶ Shorter treatment period may reduce clinical trial dur
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 • Michael Kaleko, M.D., Ph.D .
Slide 5: Product Pipeline
Product Pipeline 5 NYSE MKT: SYN C - Cedars - Sinai Medical Center collaboration I - Intrexon Corporation collaboration T - The University of Texas at Austin collaboration Completed Planned - 2014 Therapeutic Area Product Candidate Biologic Agent/ Drug Compound Discovery Preclinical Phase I Phase II
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 publish
Slide 7: MS: Relapsing-Remitting MS Phase II Results of Trimesta
MS: Relapsing - Remitting MS Phase II Results of Trimesta TM (oral estriol) • Topline results presented at 2014 AAN by Dr. Voskuhl demonstrated ̶ Statistically significant 47% decrease in annualized MS relapse rate at 12 months with Trimesta+Copaxone ® compared to placebo+Copaxone ® ( p=0.03 / power
Slide 8: MS: Market
MS: Market • 400,000 MS patients in U.S. (~2.3 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: MS: Cognitive Dysfunction Phase II Clinical Trial of Trimesta
MS: Cognitive Dysfunction Phase II Clinical Trial of Trimesta TM 9 NYSE MKT: SYN • Randomized, double - blind, placebo - controlled clinical trial of female MS patients at UCLA 6 − Enrollment ongoing − Trimesta TM versus matching placebo over one year with all patients remaining on st andard FDA - a
Slide 10: Emerging Consensus on the Microbiome
Emerging Consensus on the Microbiome 10 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 8 “ Your g
Slide 11: Rebirth of Anti-Infective Sector
Rebirth of Anti - Infective Sector SYN: Building a robust portfolio of targeted anti - infectives 11 NYSE MKT: SYN • January 2014 AstraZeneca and FOB Synthesis R&D agreement for novel antibiotics • December 2013 SYN collaborates with Cedars - Sinai to reduce the impact of methane producing organisms
Slide 12: Clinical Success Rates by Therapeutic Area
Clinical Success Rates by Therapeutic Area 10 Phase I through Food & Drug Administration approval Aligns with SYN’s focus on the development of novel anti - infectives 12 NYSE MKT: SYN 0% 5% 10% 15% 20% 25% Nervous System Cardiovascular Respiratory Oncology Musculoskeletal Anti-Infective 8% 9% 10% 1
Slide 13: C. difficile (C. diff) Infections
13 • 24 million patients administered IV antibiotics annually in the U.S. 11 – 1.1 million patients infected with C. diff annually 12 – Patients with C. diff hospitalized approximately 4 - 7 extra days 13 – $ 8.2 billion in costs associated with C. diff - related stays in hospital 14 – 30,000 C. dif
Slide 14: Paradigm Shift
Paradigm Shift Decrease in C. diff infections expected with co - administration of SYN - 004 NYSE MKT: SYN 14 Antibiotics Treatments • β - lactam • Fluoroquinolone • Clindamycin • Other • Metronidazole • Vancomycin • Fidaxomicin Current Paradigm SYN - 004 Paradigm C. diff Infections β - lactam Antib
Slide 15: SYN-004: Prophylactic treatment for prevention of C. diff infections
15 SYN - 004 Prophylactic treatment for prevention of C. diff infections • 1 st generation candidate studied in four Phase I and one Phase II clinical trials of 112 patients and 143 healthy normal subjects ̶ Preserved the normal intestinal microflora when co - administered with IV ampicillin or pipe
Slide 16: SYN-004: Market Potential
SYN - 004: Market Potential Intended to target certain IV β - lactam antibiotics NYSE MKT: SYN 16 14.4M patients 18 26.5M prescriptions 17 117.6M doses of “SYN - 004 target” β - lactam antibiotics purchased by U.S. hospitals to fill patient prescriptions 16 * Based on U.S. market data in 2012 ** Est
Slide 17: Constipation-Predominant Irritable Bowel Syndrome (C-IBS)
17 • Mark Pimentel, M.D., of Cedars - Sinai is a leading investigator in field ̶ Identified clinical significance of unique antibiotic in treating diarrhea - predominant IBS (D - IBS) in collaboration with Salix • Clear link between intestinal methane production and disease • Methane levels in C - I
Slide 18: SYN-010 for C-IBS
18 • Development of differentiated formulations of non - antibiotic FDA - approved oral drug candidates for ultimate product registration via potential expedited pathways is underway • Inhibiting methane production significantly relieves constipation and improves patients’ lives ̶ Strong association
Slide 19: SYN-010: Market Potential
19 • Up to $10 billion in direct costs to the U.S. healthcare system and up to $20 billion in indirect costs 19 • 40 million IBS patients in the U.S. 20 – ~13.2 million C - IBS patients in the U.S. 21 • ~$2.7 billion market expected by 2020 22 • Major IBS players include ‒ Salix ( rifaximin ) for D
Slide 20: Pertussis
Pertussis Millions of whooping cough cases globally per year • Despite aggressive vaccination strategies, incidence of Pertussis is increasing 24,25 ̶ Less effective vaccine introduced in the 1990s ̶ Non - compliance with standard vaccinations ̶ ~41,000 cases per year in the U.S. 26 • Unvaccinated i
Slide 21: SYN-005: Monoclonal Antibody Combination
SYN - 005: Monoclonal Antibody ( mAb ) Combination Designed to target and neutralize the pertussis toxin • Exclusive Channel Collaboration with Intrexon Corporation • Collaboration with researchers at The University of Texas at Austin • Humanized two antibodies to form SYN - 005 • In vitro studies d
Slide 22: Non-Human Primate Pertussis Study
0 5 10 15 0 10 20 30 40 50 Study Day W B C / u L ( x 1 , 0 0 0 ) Control SYN-005(1) SYN-005(2) SYN-005 therapy Normal WBC count Pertussis infection Non - Human Primate Pertussis Study Decrease in white blood cell counts within two days of SYN - 005 therapy 22 NYSE MKT: SYN n=3
Slide 23: Acinetobacter Infections
Acinetobacter Infections Infections increasing due to this pandrug - resistant gram - negative bacterium • M ortality rates as high as 43% reported 28 • Billion dollar market opportunity 29 • Survives on dry surfaces for up to 36 days ̶ Survives twice as long as non - biofilm - forming pathogens 30
Slide 24: Corporate Snapshot
Corporate Snapshot • Cash balance (as of 3/31/14) : ~$11.2 million • Current Price : $1.37 (as of 5/22/14) • 52 Week Range: $0.95 - $3.64 • Average Volume (3 months): 1,735,950 • Shares Outstanding: ~58.5 million (as of 5/12/14) • Options Outstanding: ~4.5 million * • Warrants Outstanding: ~963,000
Slide 25: Key Milestones
1H 2015 Pertussis File IND for human trials 2H 2014 C. difficile Initiate Phase Ia and Ib clinical trials 2H 2014 Multiple Sclerosis R. Voskuhl , M.D., report detailed Phase II results 2H 2014 Pertussis Request Orphan Drug designation 2H 2014 C - IBS Initiate Phase II clinical trial 2H 2014 C. diffi
Slide 26: SYN Slide Deck – 5.27.2014 – FINAL
SYN Slide Deck – 5.27.2014 – FINAL NYSE MKT: SYN May 2014
Slide 27: 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 28: References
References 28 Slide 12 : 10 Bank of America as reported in Wall Street Journal, November 6, 2013, C - 18. Slide 13 : 11 - 12 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 fu
Slide 29: References
References 29 Slide 20 : 24 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. 25 Centers for Disea
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