Infant Bacterial Therapeutics Ab Class B · OMXSTO:IBT_B
Infant Bacterial Therapeutics Ab Class B — Investor Presentation (March 2018)
29 slides from Infant Bacterial Therapeutics Ab Class B's investor presentation, March 2018
Slide 1: Infant Bacterial Therapeutics Corporate Presentation
Infant Bacterial Therapeutics Corporate Presentation March 2018 1
Slide 2: Disclaimer
Disclaimer You must read the following before continuing. The following applies to this document and the information provided in this presentation by Infant Bacterial Therapeutics AB (publ) (the “Company”) or any person on behalf of the Company and any other material distributed or statements made i
Slide 3: Periods
Periods Week nr. Month nv. Birth classification Antepartum or 3f4[s[el7[a[9 Tro] 11] 12] 13]14]15]16[17]18]19| 20] 21]22] 23] 24] 25] 26 [27] 28] 29] 30] 31] 32] 33[ 34] 35 50% survival,
Slide 4: Lead drug candidate IBP-9414 to prevent necrotizing enterocolitis
Lead drug candidate IBP-9414, to prophylactically prevent necrotizing enterocolitis (“NEC”), a fatal, rare disease that afflicts premature infants Label Patient Population 56,000 children in US estimated up to USD 350m per year in US market for IBP-9414 Market Approval for IBP-9414 target 2020 / 202
Slide 5: The IBT concept
The IBT concept n IBT focuses on concepts of altering the human microbiome to prevent or treat diseases n Microbiome of the newborn infant is more dynamic than that of the mature human n Utilize co-evolved human bacterial strains derived from human breast milk n Clinical proof-of-concept signal publ
Slide 6: Necrotizing Enterocolitis
Necrotizing Enterocolitis NEC is a severe inflammation and necrosis of the preterm infant bowel True unmet medical need • There is no therapy available today • 20-40% need complicated and costly surgery • One of the leading causes of death in NICU • Up to 40% death rate, 1500 US and 3700 EU infants
Slide 7: Who gets NEC?
Who gets NEC? Infants birth NEC incidence NEC mortality Mortality (% of weight rate (%) rate (%) weight cohort) 501-750g 12.0% 42.0% 5.0% High incidence 751-1,000g 9.2% 29.4% 2.7% and mortality 1,001-1250g 5.7% 21.3% 1.2% 1,251-1,500g 3.3% 15.9% 0.5% 1,501-2,500g 0.4% 8.2-17% 0.03-0.06% >2,500g 0.1%
Slide 8: Target population
Target population A preventive therapy for all preterm infants at risk of NEC Current clinical NEC progression Target label population 100 premature infants (751-1,000g) Based on the expected IBP-9414 drug label, the targeted annual label population is: 9 NEC cases n US: 56,000 premature infants (≤1
Slide 9: Lactobacillus reuteri
Lactobacillus reuteri Active substance of IBP-9414 Lactobacillus reuteri (orange) Lactobacillus reuteri present adhering to intestinal mucus on women’s breasts Picture with the permission Versalovic 9
Slide 10: Evolutionary adaptation of L. reuteri to the human gut
Evolutionary adaptation of L. reuteri to the human gut Figure 1 AFLP analysis of a global collection of Lactobacillus reuteri strains from humans, Host Poultry Human Porcine Rodents Genetic relatedness of global L. reuteri genomes 0.02 Evolution of the gut symbiont L. reuteri PL Oh et al C ii B D E
Slide 11: L. reuteri an ideal candidate for NEC
L. reuteri an ideal candidate for NEC L. reuteri has strain-specific attributes which affect the NEC pathogenesis Major processes involved in NEC L. reuteri strain-specific benefits Dysbiosis Anti-pathogen effects Improvement of gut Impaired gut motility motility Unregulated Anti-inflammatory Inflam
Slide 12: Clear efficacy signal from L. reuteri
Clear efficacy signal from L. reuteri All studies show clinically significant reduction of NEC Study Number of patients Reduction in NEC incidence n 40% in the total study population Rojas et al. (2012) n 750 patients n 37% in infants ≤1,500g n 20% in the total study population Oncel et al. (2014) n
Slide 13: Potential benefit to all premature infants
Potential benefit to all premature infants Premature infants are extremely difficult to feed Infants require intravenous fluids solution for brain and body Intravenous nutrition is inadequate IV nutrition (TPN) can also be toxic to the liver L. Reuteri demonstrates clear signal on improved feeding t
Slide 14: Economic burden of NEC
Economic burden of NEC Major surgery required in 20-40% of NEC Survivors have long-term consequences: cases at cost of 300 kUSD or more short-bowel syndrome, abnormal growth, cognitive, visual and hearing impairments The economic cost of NEC is estimated to be USD 5 Billion for hospitalization in th
Slide 15: Economic burden of NEC
Economic burden of NEC Prolonged days of Initial hospitalization hospital stay* costs in USD* 107 405 000 76 281 000 64 207 000 NO NEC MEDICAL SURGICAL NO NEC MEDICAL SURGICAL NEC NEC NEC NEC *Ganapathy et al, 2011; For infants ≤ 28 weeks of gestational age 15
Slide 16: Extended economic burden of NEC
Extended economic burden of NEC 6-36 month health care costs in USD * No NEC Medical NEC Surgical NEC 45 213 46 378 26 055 13 610 8 726 9 856 5 598 6 279 5 809 6 -1 2 M O N TH S 1 2 -2 4 M O N TH S 2 4 -3 6 M O N TH S And long term costs associated with sequelae such as impaired growth, short bowel
Slide 17: Neonatologists show high willingness to prescribe IBP-9414
Neonatologists show high willingness to prescribe IBP-9414 Clearview US market research indicates an overall 78% physician preference share reflecting a high unmet medical need <1,000 g Infants 1,000 – 1,500 g Infants Physician Preference Share Physician Preference Share ~40% ~90% ~70% (%) ~60% (%)
Slide 18: Treatment up to 34 weeks
Treatment up to 34 weeks 1000 – 1,500 g ~3.4 Infants Weeks <1,000 g ~7.8 Infants Weeks 22 23 24 25 26 27 28 29 30 31 32 33 34 35 Gestational Age (Weeks) Physicians expected to halt IBP-9414 treatment once infants had reached 32 to 34 weeks postmenstrual age 18
Slide 19: Expected Formulary Inclusion by Institution Type
Expected Formulary Inclusion by Institution Type In the United States, high adoption in hospitals is anticipated in institutions which have the biggest share of premature infants Small Community Institution Type Major Medical Centers Medium Hospitals Hospitals Share of Premature ~60% ~30% ~10% Infan
Slide 20: Commercial Opportunity
Commercial Opportunity Assuming a price of $3 K per week of treatment, IBP-9414 is expected to achieve sales of ~$360 M IBP-9414 Commercial Opportunity Key Considerations Opportunity Calculation 1 • Average treatment durations of ~7.7 and ~3.3 weeks are expected, based on physician Patients Treated
Slide 21: Global preterm births
Global preterm births 15 Million preterm births annually US 3,5% Preterm birth rates are increasing in almost all countries with reliable data Rest of the World 96,5% Source H. Blencowe et al. 2012 21
Slide 22: A globally valuable pharmaceutical
A globally valuable pharmaceutical 100 preterms per NICU bed China: 438 000 label population Rest of the World EU5: 108 000 label population 22 preterms per NICU bed US: 360 MUSD 56 000 label population 22
Slide 23: IBP-9414's eligibility for a Priority Review Voucher
IBP-9414’s eligibility for a Priority Review Voucher § FDA granted Rare Pediatric Disease product status to IBT for IBP-9414, this means that IBT should be awarded a priority review voucher at the time of approval § This voucher is transferrable and cannot expire. 18 vouchers were awarded by year en
Slide 24: IBP-9414 – Roadmap
IBP-9414 – Roadmap Development program in accordance with advice from regulators and KOLs Roadmap to Biologics License Application 2017 2018 2019 2020 Safety and tolerability trial PIP Adopted by EMA Capital Raise of 545 MSEK to fund development program The Connection Study - Pivotal trial n CRO sel
Slide 25: IBP-9414 Safety and Tolerability study
IBP-9414 Safety and Tolerability study Conclusions § Recruitment rate was higher than estimated without a difference between big and small babies § Demographics of the study was representative of the target population § Similar Adverse Event and Serious Adverse Event profile between active and place
Slide 26: IBP-9414 Safety and Tolerability study
IBP-9414 Safety and Tolerability study Conclusions cont. § No evidence of cross-contamination with IBP-9414 in placebo treated infants § Treatment with IBP-9414 leads to presence of bacterium in the feces on day of last dose § Smaller infants needed the higher dose to display IBP-9414 in the feces §
Slide 27: Manufacturing Process of IBP-9414
Manufacturing Process of IBP-9414 Stringent control of manufacturing environment Cell Bank Filling Pre-culture Freeze-drying Fermentation Packaging & Labelling Filtration IBP-9414 powder for oral suspension Mixing Formulated Cell Suspension 27
Slide 28: IBP-9414 for the prevention of necrotizing enterocolitis
IBP-9414 for the prevention of necrotizing enterocolitis IBP-9414 is based on all relevant pillars 2. MECHANISM OF for the development of a successful drug ACTION L. reuteri for the prevention of NEC 1. NEC: HIGH UNMET MEDICAL NEED 3. EFFICACY SIGNAL n Medical need ✔ 8 independent clinical No curren
Slide 29: Thank you!
Thank you! Visit us in Stockholm, Sweden Infant Bacterial Therapeutics AB Bryggargatan 10 www.ibtherapeutics.com ☏: +46 (0) 8 410 145 55 info@ibtherapeutics.com 29
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