Theriva Biologics, Inc. · AMEX:TOVX
Theriva Biologics — Synthetic Biologics — Investor Presentation (December 2012)
26 slides from Theriva Biologics's investor presentation, Dec 6, 2012
Slide 1: Synthetic Biologics December 2012
oo PY NTE NYSE MKT: SYN SYNTHETIC December 2012
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: Emerging Worldwide Crisis
Emerging Worldwide Crisis 3 Antibiotic - resistant infectious diseases Brad Spellberg , M.D., author of the book, Rising Plague 1 : Infections were the second leading cause of death worldwide in 2002, killing nearly 15 million people – almost 1 in 3 deaths across the globe Antibiotic - resistant mic
Slide 4: Targeting Infectious Diseases
Targeting Infectious Diseases 4 Synthetic Biologics is utilizing monoclonal antibodies, proteins, peptides and enzymes to execute a “ sniper” approach to address infectious disease indications vs. a broad spectrum “shotgun” approach Strategically, this has been successfully validated over the past 1
Slide 5: Management Team
Management Team 5 • 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 6: Corporate Overview
Corporate Overview • Build out pipeline with later clinical - stage opportunities • Targeting multidrug - resistant infectious diseases using biologics approach ̶ Clostridium difficile infections ̶ Acinetobacter baumanni – gram - negative ̶ Additional undisclosed infectious disease - specific progra
Slide 7: Corporate Focus
Corporate Focus • Infectious disease outbreaks increasing while intervention options decline 2 ̶ Widespread multidrug - resistant pathogens ̶ Increasing numbers of immuno - compromised patients ̶ New pathogens • Utilize targeted biologics approach – similar to cancer drugs 15 years ago • Large and g
Slide 8: Product Pipeline
Product Pipeline Therapeutic Area pe Epes Discovery | Preclinical | Phase! | Phasetl | Phase ll Retapsing-remiting | timesta™ | ora estriol Geri dvtuncton] imesta™ | oral esto c.digcte | simone | _ oral enayme Paper ecet [emcee | Smgencoe PL “cifecion” | SMO" | Mtttoay = **intrexon — design, enginee
Slide 9: Infectious Diseases: Clostridium difficile (C. diff)
9 • Prophylactic treatment for prevention of C. diff infection ̶ Develop SYN - 004, a proprietary oral β - lactamase enzyme, to be co - administered with β - lactam antibiotics, such as penicillins and cephalosporins ▪ ~8.7 million Americans administered IV β - lactam antibiotics during 2011 3 ̶ Act
Slide 10: SYN-004: Prevention of C. difficile
10 SYN - 004: Prevention of C. difficile Protects against damaging/harmful effects of β - lactam antibiotics N O N N S O O O H H N O N N H S O H H O O H Active β-lactam Inactive Ampicilloic acid P3A Orally adminstered P3A i.v. administered ß-lactams P3A degrades active ß-lactam antibiotics in GI tra
Slide 11: SYN-004: Acting Locally in the GI Tract
SYN - 004: Acting locally in the GI Tract without Affecting Systemic Action of Antibiotics PIPERACILLIN-TAZOBACTAM + IPSAT P1A 28 mg (N=12) PIPERACILLIN-TAZOBACTAM + IPSAT P1A 56 mg (N=12) PIPERACILLIN-TAZOBACTAM + Placebo (N=12) FAECAL PIPERACILLIN CONCENTRATIONS (µg/g) 0 25 50 75 100 125 150 175 2
Slide 12: C. difficile: Market Overview
12 • Increasing incidence and often drug resistant • Toxins produced by C. diff bacteria result in diarrhea, and in serious cases lead to pseudomembranous colitis and possibly death • In the U.S. during 2009, infections caused by C. diff resulted in: – More than 337,000 hospitalizations 4 – 30,000 d
Slide 13: Acinetobacter Infection: Market Overview
Acinetobacter Infection : Market Overview Deadly gram - negative bacteria • M ortality rates as high as 43% reported 6 • Multi - billion dollar market opportunity 7 • Multidrug - resistant due to pathogen’s ability to rapidly mutate 8 • Survives on dry surfaces for up to 36 days ̶ Survives twice as
Slide 14: Acinetobacter: Monoclonal Antibody Approach
Acinetobacter : Monoclonal Antibody Approach 14 Intrexon collaboration for mAb development Intrexon’s proprietary technologies/processes produce mAbs to detect and destroy viruses, bacteria and toxins • mAbLogix ™ – fully human antibody discovery platform • LEAP ™ – rapid identification and selectio
Slide 15: mAbLogix Platform for mAb Development
15 mAbLogix TM Platform for mAb Development Infection disease pathogen (bacteria, viruses & toxins) mAb injection “tags” pathogen Immune system attacks “tagged” pathogen Rapid production of fully human mAbs begins with human tonsil tissue mAbLogix ™ is a registered trademark of Intrexon Corporation.
Slide 16: SYN-PAH: Synthetic DNA Therapy
SYN - PAH: Synthetic DNA Therapy Intrexon’s proprietary technologies/processes deliver synthetic DNA to the pulmonary arteries generating high levels of prostacyclin to treat PAH • UltraVector® Platform – scalable, rapid development and customization of transgenes • Cellular modeling – cell system i
Slide 17: PAH: Market Overview
PAH: Market Overview 17 • Global PAH market expected to reach $3.6 billion 12 by 2015 • High morbidity and mortality • Currently three classes of approved therapeutics − Prostacyclin analogs: well - established efficacy but significant systemic side effects that inhibit utility and long - term benef
Slide 18: MS: Market Opportunity
MS: Market Opportunity • According to the National Multiple Sclerosis Society − 400,000 MS patients in U.S. (2.5 million worldwide) − 200 people diagnosed per week in the U.S. − 1.75 million patients worldwide are women • ~60% of patients are women originally diagnosed with relapsing - remitting MS
Slide 19: MS: Historical Efficacy of Estriol
MS: Historical Efficacy of Estriol The “Pregnancy Hormone”: Linked to decreased MS relapse rates • Estriol − Hormone produced by placenta during pregnancy − Solid safety profile (approved in Europe/Asia for 40+ years) • Landmark study published in New England Journal of Medicine 14 − Study of 254 wo
Slide 20: 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, randomized, double - blind, placebo - controlled trial − Comparing relapse rates over 2 years between 8 mg of oral Trimesta TM taken daily versus matching placebo − All patients treated with Copaxone
Slide 21: MS: Cognitive Dysfunction
MS: Cognitive Dysfunction • Randomized, double - blind, placebo - controlled clinical trial of female MS patients at UCLA 16 − Enrollment initiated January 2012 − Trimesta TM versus matching placebo over one year with all patients remaining on st andard FDA - approved MS treatment − Results expected
Slide 22: Corporate Snapshot
Corporate Snapshot • Current Price : $2.00 (as of 11/30/12) • 52 Week Range: $1.04 - $ 2.95 • Average Volume (3 months): 48,087 • Shares Outstanding: ~43.7 million (as of 10/31/12 ) • Warrants Outstanding: ~2.0 million * • Vested Options Outstanding: ~2.6 million ** • Market Capitalization: ~$87 mil
Slide 23: Upcoming Milestones
23 Upcoming Milestones • Initiate development of recently acquired C. difficile clinical program (4Q 2012) • Fully human mAbs for Acinetobacter − Design, engineer and optimize lead candidates to confirm in vivo activity (1Q 2013) − Generate panel of recombinant fully human antibodies (1Q 2013) − Dev
Slide 24: NYSE MKT: SYN December 2012
NYSE MKT: SYN December 2012 Dec 2012 – v6 – FINAL
Slide 25: References
References Slide 3 : 1 Spellberg , B. Rising Plague: The Global Threat from Deadly Bacteria and Our Dwindling Arsenal to Fight Them. Copyright 2009. Slide 7 : 2 Saylor, C, Dadachova , E, Casadevall , A, Monoclonal antibody - based therapies for microbial diseases. Vaccine. 2009 December 30; 27 ( Sup
Slide 26: References
References Slide 12 : 12 GlobalData , Pulmonary Arterial Hypertension (PAH) – Drug Pipeline Analysis and Market Forecasts to 2016. Slide 13 : 13 Current estimated sales of injectable disease - modifying MS therapies. Research and Markets: Multiple Sclerosis Therapeutics – Pi peline Assessment and Ma
Synthetic Biologics — Investor Presentation (December 2012) on 6ix