Infant Bacterial Therapeutics Ab Class B · OMXSTO:IBT_B
Infant Bacterial Therapeutics Ab Class B — Investor Presentation (September 2018)
27 slides from Infant Bacterial Therapeutics Ab Class B's investor presentation, Sep 3, 2018
Slide 1: Infant Bacterial Therapeutics Corporate Presentation
Infant Bacterial Therapeutics Corporate Presentation September 2018
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: Prenatal development
— =m Prenatal development 3] 4]5 [6] 7] 8] 9] 10] 11[12]13]14 [15] 16] 17] 18]19] 20] 21[22] 23] 24] 25] 26] 27] 28] 29] 30] 31] 32] 3334] 35 4 |] 5 | 4,6 | 7 J] 8 classification 50% survival TT thi winester TTT 36] 37] 38] 39] 40] 41] 42] 43] 44] 45] 4e | ft Lf Preterm) Term) | EEN
Slide 4: Corporate Overview
Infant Bacterial Therapeutics Corporate Overview n Founded in 2013 in Stockholm, Sweden as subsidiary of BioGaia n IPO in 2016 on Nasdaq First North, listing on Nasdaq Mid-Cap from September 10, 2018 n Among top 10 institutional shareholders and specialist investors: AP4, AP3, AMF, Swedbank Robur, S
Slide 5: The IBT concept
The IBT concept § IBT focuses on concepts of altering the human microbiome to prevent or treat diseases § Microbiome of the newborn infant is more dynamic than that of the mature human § Utilize co-evolved human bacterial strains derived from human breast milk § Published proof-of-concept clinical s
Slide 6: Necrotizing Enterocolitis
Necrotizing Enterocolitis NEC is a deadly disease impacting the preterm infant 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 the NICU (neonatal intensive care unit) § Up to 40% death rate, 1500 US an
Slide 7: NEC – a devastating disease
NEC – a devastating disease NEC incidence rate NEC mortality rate 14% 12% 501-750g 42.0% 10% 8% 751-1,000g 29.4% 6% 1,001-1250g 21.3% 4% 2% 1,251-1,500g 15.9% 0% The smaller the premature infant is at birth, the more likely he/she will get NEC and die. Source Shelley 2012, Bolisetty 2000, Llanos 200
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: n US: 56,000 premature infants (≤1500 gram) 9
Slide 9: Lactobacillus reuteri
Lactobacillus reuteri Active pharmaceutical ingredient of IBP-9414 Lactobacillus reuteri present Lactobacillus reuteri (orange) on women’s breasts adhering to intestinal mucus Picture with the permission Versalovic 9
Slide 10: 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 L. reuteri strain-specific NEC benefits Dysbiosis Anti-pathogen effects Improvement of gut Impaired gut motility motility Unregulated Anti-inflammatory Inflam
Slide 11: 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 12: L. Reuteri demonstrates clear signal on improved feeding tolerance
L. Reuteri demonstrates clear signal on improved feeding tolerance Premature infants are extremely difficult to feed. In most cases intravenous fluid solutions are used on these infants for nutrition supply. However, intravenous nutrition is inadequate, and IV nutrition (TPN) can also be toxic to th
Slide 13: Network of KOLs
Network of KOLs IBT has developed IBP-9414 program with deep considerations of KOLs experience and clinical practice Some of the external participants Aideen Moore, The Hospital for Sick Children, Toronto, Canada. Alexandre Lapillonne, Necker Hospital for Sick Children, Paris, France Andreas Repa, M
Slide 14: IBP-9414 Development Plan
IBP-9414 Development Plan Safety and tolerability Pivotal phase III study – The Connection Study study Timeline 2016-2017 2018-2020 Status Completed Planned Clinical trial • A randomized, double blind, • A randomized, double blind, parallel-group, placebo- details parallel-group, dose controlled mul
Slide 15: Manufacturing Process of IBP-9414
Manufacturing Process of IBP-9414 Stringent control of manufacturing environment Cell Bank Filling and Freeze-drying Fermentation IBP-9414 powder for oral suspension 15
Slide 16: Need for pharmaceutical grade product
Need for pharmaceutical grade product FDA concerned about use of dietary suppliments October 2014 November 2014 December 2014 Consequences n A premature infant n Solgar issued a n FDA/CDC warning n Pressure to conform to given a Solgar product voluntary recall of letter issued FDA’s rigorous (ABC Do
Slide 17: IBP-9414 Market Exclusivity
IBP-9414 Market Exclusivity Three layers of IP protection MA* 2013 2016 2020 2030 2035 Patent Protection EU Granted Patent SPC 5y + .5y pedia US Granted Patent PTE 3y + 0.5y pedia Bill A2041 Patent Application Pending Orphan Drug EU Orphan Drug Designation Orphan Drug Exclusivity 10y + 2y pedia US O
Slide 18: 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, which means that IBT should be awarded a priority review voucher at the time of approval § A voucher is transferrable and does not expire. 23 vouchers have been awarded as of
Slide 19: Economic burden of NEC
Economic burden of NEC NEC Economic Burden is estimated to be 20% of the total cost of initial care and USD 5 Billion spent annually on NEC in the US And long term costs associated with sequelae such as impaired growth, short bowel syndrome, poor neurodevelopment Source Ganapathy 2011, 2013 19
Slide 20: IBP-9414 Target Product Profile
IBP-9414 Target Product Profile For the prevention of necrotizing enterocolitis n Oral suspension Product description n Supplied as a freeze-dried powder in a prefilled, clear, glass vial n To be reconstituted in sterile water and delivered in enteral syringe n Once daily until gestational age week
Slide 21: 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 22: 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 22
Slide 23: 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 24: Market potential for IBP-9414 assessment
Market potential for IBP-9414 assessment IBT has mandated consultants to assess the market opportunity… n Including 60 Neonatology Key Opinion Leaders interviews …who have interviewed the relevant key stakeholders n 15 Pharmacy and Therapeutics neonatologists and pharmacists (P&T members) across US
Slide 25: A globally valuable pharmaceutical
A globally valuable pharmaceutical Rest of the World China: 438 000 label population EU5: 108 000 US: label population 360 MUSD 56,000 label population 25
Slide 26: IBP-9414 for the prevention of necrotizing enterocolitis
IBP-9414 for the prevention of necrotizing enterocolitis IBP-9414 is based on all relevant pillars for the development of a successful drug n Medical need ✔ n Mechanism of action ✔ n Clinical data ✔ n Safe ✔ n Aligned regulatory agencies ✔ n GMP manufacture ✔ n Market exclusivity ✔ n Aligned payers
Slide 27: 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 27
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