Theriva Biologics, Inc. · AMEX:TOVX
Theriva Biologics — Synthetic Biologics — Investor Presentation (September 2014)
25 slides from Theriva Biologics's investor presentation, Sep 9, 2014
Slide 1: Synthetic Biologics September 2014
oa ae NYSE MKT: SYN © SYNTHETIC September 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: MS: Relapsing-Remitting MS Phase II Results of Trimesta (oral estriol)
MS: Relapsing - Remitting MS Phase II Results of Trimesta TM (oral estriol) • Phase II trial: 158 women randomized in 16 - center, investigator - initiated, double - blind, placebo - controlled U.S. trial 1 ̶ $8 million+ grant funding supporting trial, predominantly from National MS Society and NIH
Slide 7: MS: Market
MS: Market • 400,000 MS patients in U.S. (~2.3 million worldwide) 2 • $17.8 billion forecasted worldwide sales in 2019 3 • Issued U.S. use patents for estriol for MS and in combination with Copaxone ®; 3 new provisional patents filed based on recent clinical results Trimesta Opportunity – Oral add -
Slide 8: MS: Cognitive Dysfunction Phase II Clinical Trial of Trimesta
MS: Cognitive Dysfunction Phase II Clinical Trial of Trimesta TM 8 NYSE MKT: SYN • Randomized, double - blind, placebo - controlled clinical trial of female MS patients at UCLA 4 − Enrollment ongoing − Trimesta TM versus matching placebo over one year with all patients remaining on st andard FDA - a
Slide 9: Clinical Success Rates by Therapeutic Area
Clinical Success Rates by Therapeutic Area 6 Phase I through Food & Drug Administration approval Aligns with SYN’s focus on the development of novel anti - infectives 9 NYSE MKT: SYN 0% 5% 10% 15% 20% 25% Nervous System Cardiovascular Respiratory Oncology Musculoskeletal Anti-Infective 8% 9% 10% 19%
Slide 10: C. difficile (C. diff) Infections
10 • 24 million patients administered IV antibiotics annually in the U.S. 7 – 1.1 million patients infected with C. diff annually 8 – Patients with C. diff hospitalized approximately 4 - 7 extra days 9 – $ 8.2 billion in costs associated with C. diff - related stays in hospital 10 – 30,000 C. diff -
Slide 11: Paradigm Shift
Paradigm Shift Decrease in C. diff infections expected with co - administration of SYN - 004 NYSE MKT: SYN 11 Antibiotics Treatments • β - lactam • Fluoroquinolone • Clindamycin • Other • Metronidazole • Vancomycin • Fidaxomicin Current Paradigm SYN - 004 Paradigm C. diff Infections β - lactam Antib
Slide 12: SYN-004: Prophylactic treatment for prevention of C. diff infections
12 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 13: SYN-004: Market Potential
SYN - 004: Market Potential Intended to target certain IV β - lactam antibiotics NYSE MKT: SYN 13 14.4M patients 14 26.5M prescriptions 13 117.6M doses of “SYN - 004 target” β - lactam antibiotics purchased by U.S. hospitals to fill patient prescriptions 12 * Based on U.S. market data in 2012 ** Est
Slide 14: Constipation-Predominant Irritable Bowel Syndrome (C-IBS)
14 • 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 15: SYN-010: Development of differentiated formulations
15 • Development of differentiated formulations of non - antibiotic FDA - approved oral drug candidate for ultimate product registration via potential expedited pathways is underway • Inhibiting methane production significantly relieves constipation and improves patients’ lives ̶ Strong association
Slide 16: SYN-010: Market Potential
16 • Up to $10 billion in direct costs to the U.S. healthcare system and up to $20 billion in indirect costs 15 • 40 million IBS patients in the U.S. 16 – ~13.2 million C - IBS patients in the U.S. 17 • ~$2.7 billion market expected by 2020 18 • Major IBS players include ‒ Salix ( rifaximin ) for D
Slide 17: Pertussis
Pertussis Millions of whooping cough cases globally per year • Despite aggressive vaccination strategies, incidence of Pertussis is increasing 20,21 ̶ Less effective vaccine introduced in the 1990s ̶ Non - compliance with standard vaccinations ̶ ~41,000 cases per year in the U.S. 22 • Unvaccinated i
Slide 18: SYN-005: Monoclonal Antibody (mAb) 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 19: 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 19 NYSE MKT: SYN n=3 Favorable decreases in white blood cell count indicates that SYN - 005 neutralized pertussis to
Slide 20: Acinetobacter Infections
Acinetobacter Infections Infections increasing due to this pandrug - resistant gram - negative bacterium • M ortality rates as high as 43% reported 24 • Billion dollar market opportunity 25 • Survives on dry surfaces for up to 36 days ̶ Survives twice as long as non - biofilm - forming pathogens 26
Slide 21: Corporate Snapshot
Corporate Snapshot • Cash balance (as of 6/30/14) : ~$7.8 million • Current Price : $2.57 (as of 9/4/14) • 52 Week Range: $0.95 - $3.64 • Average Volume (3 months): 681,953 • Shares Outstanding: ~58.5 million (as of 8/8/14) • Options Outstanding: ~5.3 million * • Warrants Outstanding: ~945,000 ** •
Slide 22: Key Milestones
1H 2015 Pertussis File IND and initiate Phase I clinical trial 2H 2014 C - IBS File IND and initiate Phase II POM clinical trial 2H 2014 C. difficile File IND and initiate Phase Ia and Ib clinical trials 9/16 2014 C - IBS M. Pimentel, M.D., keynote speaker at SYN’s IBS Investor Day in NYC 3Q 2014 Pe
Slide 23: SYN Sept Slide Deck
SYN Sept Slide Deck – 9.9.2014 – FINAL NYSE MKT: SYN September 2014
Slide 24: References
References Slide 6: 1 www.clinicaltrials.gov/ct2/show/NCT00451204 Copaxone ® is a registered trademark of Teva Pharmaceutical Industries Ltd. Slide 7 : 2 National Multiple Sclerosis Society. http:// www.nationalmssociety.org 3 Credit Suisse. Multiple Sclerosis - Evolution or Revolution Report. March
Slide 25: References
References 25 Slide 13 : 12 - 14 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
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