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Infant Bacterial Therapeutics April 2019 Disclaimer You must read - PowerPoint PPT Presentation

Infant Bacterial Therapeutics April 2019 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


  1. Infant Bacterial Therapeutics April 2019

  2. 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 in connection with such presentation (the 142 “Information”), and you are therefore advised to carefully read the statements below before reading, accessing or making any other use of the Information. In accessing the 180 Information, you agree to be bound by the following terms and conditions. 227 The Information does not constitute or form part of, and should not be construed as, an offer of invitation to subscribe for, underwrite or otherwise acquire, any securities of the Company or a successor entity or any existing or future subsidiary or affiliate of the Company, nor should it or any part of it form the basis of, or be relied on in connection 23 with, any contract to purchase or subscribe for any securities of the Company or any of such subsidiaries or affiliates nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. Specifically, this presentation does not constitute a “prospectus” within the meaning of the U.S. Securities Act 55 of 1933, as amended. 94 The Information may not be reproduced, redistributed, published or passed on to any other person, directly or in directly, in whole or in part, for any purpose. The Information is not directed to, or intended for distribution to or use by, any person or entity that is a citizen or resident of, or located in, any locality, state, country or other jurisdiction 89 where such distribution or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction. The Information is not for publication, release or distribution in the United States, the United Kingdom, Australia, Canada or Japan, or any other jurisdiction in which the distribution or release would be 89 unlawful. 89 All of the Information herein has been prepared by the Company solely for use in this presentation. The Information contained in this presentation has not been independently verified. No representation, warranty or undertaking, express or implied, is made as to, and no reliance should be placed on, the fairness, accuracy, completeness or 191 correctness of the Information or the opinions contained herein. The Information contained in this presentation should be considered in the context of the circumstances 191 prevailing at that time and has not been, and will not be, updated to reflect material developments which may occur after the date of the presentation. The Company may alter, modify or otherwise change in any manner the content of this presentation, without obligation to notify any person of such revision or changes. 191 This presentation may contain certain forward-looking statements and forecasts which relate to events and depend on circumstances that will occur in the future and which, 148 by their nature, will have an impact on the Company’s operations, financial position and earnings. The terms “anticipates”, “assumes”, “believes”, “can”, “could”, “estimates”, “expects”, “forecasts”, “intends”, “may”, “might”, “plans”, “should”, “projects”, “will”, “would” or, in each case, their negative, or other variations or comparable terminology are 138 used to identify forward-looking statements. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in a forward-looking statement or affect the extent to which a particular projection is realised. 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. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the Company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this presentation are made only as of the date hereof. The Company does not undertake, and specifically decline, any obligation to update any such statements or to publicly announce the results of any revisions to any of such statements to reflect future events or developments. 2

  3. 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

  4. 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

  5. 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

  6. Our patients 142 180 227 23 55 94 89 89 89 191 191 191 148 138 84 13 13 13 6

  7. 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

  8. 142 180 227 23 55 94 89 89 89 191 191 191 148 138 84 13 13 1. A high unmet medical need 13

  9. 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

  10. Causes of death 142 180 227 23 55 94 89 89 89 191 191 191 148 138 84 13 13 13 Patel 2015 10

  11. 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

  12. 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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