Infant Bacterial Therapeutics April 2019
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Factors that could cause these differences include, but are not limited to, 84 implementation of the Company’s strategy and its ability to further grow, risks associated with the development and/or approval of the Company’s products candidates, ongoing clinical trials and expected trial results, the ability to commercialise IBP-9414 or IBP-1016, technology changes and new products in the Company’s potential market 13 and industry, the ability to develop new products, the impact of competition, changes in general economy and industry conditions and legislative, regulatory and political 13 factors. While the Company always intends to express its best judgment when making statements about what it believes will occur in the future, and although the Company 13 bases these statements on assumptions that it believe to be reasonable when made, these forward-looking statements are not a guarantee of its performance, and you should not place undue reliance on such statements. 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Infant Bacterial Therapeutics Overview 142 180 227 ❏ Pharmaceutical microbiome ❏ Orphan Drug Designation from ❏ Financial resources sufficient company focused on areas of FDA and EMA finance development to 23 unmet medical need application for market 55 ❏ Rare Pediatric Disease approval 94 ❏ Lead drug candidate IBP-9414, Designation granted to prophylactically prevent ❏ Listed on Nasdaq Stockholm 89 ❏ Exclusive royalty free worldwide necrotizing enterocolitis Mid-Cap IBTB:SS, 89 license to patents (“NEC”), a fatal, rare disease 89 ❏ Third party assessed ❏ Market Approval for IBP-9414 that afflicts premature infants opportunity - USD 360m in US 191 target 2021 and reduce feeding intolerance market for IBP-9414 191 in the same patient group 191 ❏ Priority Review Voucher ❏ Opportunity for second rare eligible 148 disease program IBP-1016 for 138 the treatment of an unmet 84 medical need in gastroschisis, a 13 severe disease in infants 13 13 3
Infant Bacterial Therapeutics AB Corporate overview 142 180 227 Founded in 2013 in Stockholm, Sweden as a subsidiary of BioGaia ❏ 23 IPO in 2016, currently listed on Nasdaq Stockholm Mid-Cap ❏ 55 94 ❏ Cash end of Q4 2018: 59 MUSD, sufficient to fund development to market 89 89 Planned Phase III start during H1 2019 ❏ 89 191 Market cap: USD 220m ❏ 191 191 148 138 84 13 13 13 Stock price development since IPO 4
The IBT concept 142 Altering the human microbiome to prevent or treat diseases 180 227 23 55 94 Newborn infant microbiome is dynamic 89 89 89 191 191 Human bacterial strains derived from human breast milk 191 148 138 84 13 Published proof-of-concept clinical signal 13 13 5
Our patients 142 180 227 23 55 94 89 89 89 191 191 191 148 138 84 13 13 13 6
IBP-9414 for the prevention of necrotizing enterocolitis 1 High unmet medical need 142 180 227 2 Mechanisms of action 23 55 94 3 Efficacy Signal 89 89 4 Plan endorsed by stakeholders 89 191 5 Safety Profile 191 191 148 6 Established controlled drug production 138 84 7 Multi-Layer IP protection 13 13 13 8 Strong interest from the Market 7
142 180 227 23 55 94 89 89 89 191 191 191 148 138 84 13 13 1. A high unmet medical need 13
GI tract left untreated in preterm infants 142 Incubator use 180 227 23 55 94 89 Parenteral 89 Mortality nutrition 89 191 191 Surfactant 191 prophylaxis 148 138 Microbial 84 Focus on intervention breastfeeding 13 13 13 CDC/NCHS, National Vital Statistics System 9
Causes of death 142 180 227 23 55 94 89 89 89 191 191 191 148 138 84 13 13 13 Patel 2015 10
Necrotizing enterocolitis (NEC) 142 NEC is severe inflammation of the bowel in ❏ 180 preterm infant where 20-40% need complicated 227 and costly surgery 23 55 94 Survivors have long-term consequences such ❏ 89 as short-bowel syndrome, abnormal growth, 89 cognitive, visual and hearing impairments 89 191 191 There is no therapy available today ❏ 191 148 NEC is one of the leading causes of death in ❏ 138 84 the Neonatal intensive care unit (NICU) with 13 up to 40% morbidity rate killing 1500 US and 13 3700 EU infants each year 13 Simpson 2010, Clark 2012 11
NEC – a devastating disease The smaller the premature infant is at birth, the more likely he/she will die 142 180 227 NEC incidence rate NEC mortality rate 23 55 94 501-750g 42.0% 89 89 751-1,000g 29.4% 89 1,001-1250g 21.3% 191 191 191 1,251-1,500g 15.9% 148 138 1,501-2,500g 12,7% 84 13 13 13 Shelley 2012, Bolisetty 2000, Llanos 2002, Fitzgibbons 2009, Abdullah 2010, Christensen 2010 12
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