Theriva Biologics, Inc. · AMEX:TOVX
Theriva Biologics — Synthetic Biologics — Investor Day (June 2013)
26 slides from Theriva Biologics's investor day presentation, Jun 25, 2013
Slide 1: Multiple Sclerosis - Estriol Investor Day
June 25, 2013 NYSE MKT: SYN Multiple Sclerosis - Estriol Investor Day
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: Management Team
Management Team 3 • 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 4: Corporate Overview
Corporate Overview • Building portfolio of target - specific biologics for the prevention and treatment of serious infectious diseases ̶ Innovative, first - in - class product candidates ̶ Large markets • Clinical - stage ̶ Multiple sclerosis (MS) – Phase II (potential partnering opportunity) ̶ Prev
Slide 5: Keynote Speaker Rhonda R. Voskuhl, M.D.
5 • UCLA School of Medicine ̶ Professor , Department of Neurology ̶ Jack H. Skirball Chair in Multiple Sclerosis (MS) Research ̶ Director, Multiple Sclerosis Program • Serves on numerous grant review boards for the NIH and the National MS Society • Dr. Voskuhl’s laboratory is focused on: ̶ U ndersta
Slide 6: Carol Reed, M.D., Senior Vice President, Clinical & Regulatory Affairs
6 • Chief Medical Officer, Clinical Data, Inc. ̶ Responsible for ▪ Design and management of two successful, consecutive Phase III clinical trials for Viibryd ® ▪ Successful NDA filing for Viibryd ® ( vilazodone ) indicated for the treatment of major depressive disorder • Vice President, Medical Affa
Slide 7: MS – Estriol Investor Day Jeff Riley
7 NYSE MKT: SYN MS – Estriol Investor Day Jeff Riley
Slide 8: Trimesta (oral estriol): SYN Drug Candidate
MS – Estriol Investor Day Trimesta (oral estriol): SYN Drug Candidate • Exclusive worldwide license agreement with the Regents of the University of California for use of the drug candidate Trimesta ̶ U.S. Patent No. 6,936,599: MS and other autoimmune diseases ̶ U.S. Patent No. 8,372,826: In combinat
Slide 9: Current MS Market
Current MS Market • 400,000 MS patients in U.S. (~2.1 million worldwide) • $14.1 billion current estimated worldwide sales Trimesta – Opportunity as an oral add - on MS therapy 9 NYSE MKT: SYN Teva/Copaxone $4.178 30% Biogen Idec/Avonex $2.929 21% Merck KGaA/Rebif $2.425 17% Biogen Idec/Tysabri $1.7
Slide 10: Worldwide MS Market Growth – Key Therapies
Worldwide MS Market Growth – Key Therapies Projected to increase 36% by 2019 NYSE MKT: SYN 10 $- $2.0 $4.0 $6.0 $8.0 $10.0 $12.0 $14.0 $16.0 $18.0 $20.0 2012 2013 2014 2015 2016 2017 2018 2019 $14.1 $15.4 $16.4 $16.8 $17.6 $18.6 $19.2 $19.2 $ Billions Based on estimates included in the Credit Suisse
Slide 11: Worldwide MS Market Growth – Oral Therapies
Worldwide MS Market Growth – Oral Therapies P rojected to increase to 37% of overall worldwide market by 2019 NYSE MKT: SYN 11 $ Billions $- $1.0 $2.0 $3.0 $4.0 $5.0 $6.0 $7.0 $8.0 2012 2013 2014 2015 2016 2017 2018 2019 $1.2 $2.0 $3.3 $4.7 $5.8 $6.8 $7.6 $7.1 % of Worldwide Key Therapies 9% 13% 20%
Slide 12: MS – Estriol Investor Day Carol Reed, M.D.
12 NYSE MKT: SYN MS – Estriol Investor Day Carol Reed, M.D.
Slide 13: Multiple Sclerosis
13 • Unpredictable course with onset of symptoms at age 20 to 40 • More common in temperate climates and in females (2 – 3 times) • 80 - 90% is of the relapsing - remitting type (RRMS) • Symptoms include ̶ Ocular symptoms ̶ Muscle weakness in extremities ̶ Difficulty with coordination and balance ̶
Slide 14: Therapeutics Indicated for MS
Therapeutics Indicated for MS 14 Drug Company Mode of Delivery Dose Titration Avonex (interferon β - 1 a) Biogen Idec Intramuscular Reduce flu - like symptoms Rebif (interferon β - 1 a) EMD Serono/Pfizer Subcutaneous No Betaseron (interferon β - 1 b) Bayer Subcutaneous Reduce flu - like symptoms (re
Slide 15: MOA of Approved MS Treatments: Interferons
MOA of Approved MS Treatments: Interferons 15 NYSE MKT: SYN All labels: Exact mechanism of therapeutic effect in MS is unknown Chemical Name Brand Name MOA Interferon - β 1a Avonex Increases IL - 10 in CSF Rebif Increases expression of numerous proteins including 2 ’, 2 ’, 5 ’ - oligoadenylate synth
Slide 16: MOA of Approved MS Treatments
MOA of Approved MS Treatments 16 NYSE MKT: SYN All labels: Exact mechanism of therapeutic effect in MS is unknown Chemical Name Brand Name MOA glatiramer acetate Copaxone A synthetic myelin basic protein thought to modify immune processes fingolimod ( prodrug ) Gilenya Sphingosine 1 - phosphate rece
Slide 17: Labeled Indications for MS Treatments
Labeled Indications for MS Treatments 17 NYSE MKT: SYN All products are approved only for the relapsing - remitting type of MS Brand Name Relapsing - Remitting MS Relapsing - Remitting MS Decrease exacerbation frequency Slow disability accumulation First clinical episode Avonex x x x Rebif x x Betas
Slide 18: Warnings & Precautions for MS Treatments: Interferons
Warnings & Precautions for MS Treatments: Interferons 18 NYSE MKT: SYN Risk is tolerated due to high morbidity of MS Chemical Name Brand Name Warnings, Precautions, Contraindications Interferon - β 1a Avonex Depression, suicide, psychosis Monitor LFTs, CBC Monitor for worsening of cardiac symp
Slide 19: Warnings & Precautions for MS Treatments
Warnings & Precautions for MS Treatments 19 NYSE MKT: SYN Risk is tolerated for the benefit to patients Chemical Name Brand Name Warnings, Precautions, Contraindications glatiramer acetate Copaxone Immediate post - injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat co
Slide 20: Estriol and Multiple Sclerosis
Estriol and Multiple Sclerosis “Pregnancy Hormone” – Linked to decreased MS relapse rates • Estriol − Hormone produced by placenta with highest levels in 3 rd trimester − Approved in Europe/Asia for 40+ years for the management of post - menopausal symptoms • Landmark observational study published i
Slide 21: Estriol for Multiple Sclerosis
Estriol for Multiple Sclerosis Once daily oral therapeutic candidate • Proposed indications ̶ Decrease the frequency of clinical exacerbations in patients with RRMS ̶ Post - approval ▪ S low the accumulation of physical disability in patients with RRMS ▪ Patients with first clinical episode • Dose:
Slide 22: MS – Estriol Investor Day Rhonda R. Voskuhl, M.D.
22 NYSE MKT: SYN MS – Estriol Investor Day Rhonda R. Voskuhl , M.D.
Slide 23: MS – Estriol Investor Day Wrap-Up
23 NYSE MKT: SYN MS – Estriol Investor Day Wrap - Up
Slide 24: Wrap-Up
24 Wrap - Up NYSE MKT: SYN • Estriol is “ Pregnancy Hormone” linked to decreased MS relapse rates • Opportunity for Trimesta as an oral add - on MS therapy • Worldwide MS market projected to increase 36% by 2019 • Phase II relapsing - remitting MS clinical trial ̶ Final patient, final visit (January
Slide 25: MS – Estriol Investor Day Q&A Session
25 NYSE MKT: SYN MS – Estriol Investor Day Q&A Session
Slide 26: Multiple Sclerosis - Estriol Investor Day
MS Investor Day – 6.25.2013 – FINAL NYSE MKT: SYN June 25, 2013 Multiple Sclerosis - Estriol Investor Day