Infant Bacterial Therapeutics AB Class B · OMXSTO:IBT_B
Infant Bacterial Therapeutics AB Class B — Investor Presentation (September 2020)
52 slides from Infant Bacterial Therapeutics AB Class B's investor presentation, September 2020
Slide 1: Infant Bacterial Therapeutics
Infant Bacterial Therapeutics September 2020
Slide 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 connectio
Slide 3: Corporate and financial information
Corporate and financial information 3
Slide 4: The IBT concept
The IBT concept - Establish the human microbiome to treat diseases related to poor gut function - Newborn infant microbiome © A is dynamic © G) - Human bacterial strains derived from human breast milk - Published clinical proof-of-concept signal PEDIATRICS
Slide 5: High unmet medical need
High unmet medical need
Slide 6: 6
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Slide 7: Causes of death
Causes of death Source: Patel 2015 7
Slide 8: Mortality
GI tract left untreated in preterm infants Incubator use Parenteral Mortality nutrition Surfactant prophylaxis Focus on GUT breastfeeding FUNCTION Source: CDC/NCHS, National Vital Statistics System 8
Slide 9: Necrotizing enterocolitis (NEC)
Necrotizing nterocoliti (NEC) ❏ NEC is severe inflammation of the bowel in preterm infant where 20-40% need complicated and costly surgery ❏ Survivors have long-term consequences such as short-bowel syndrome, abnormal growth, cognitive, visual and hearing impairments ❏ There is no therapy available
Slide 10: Establishing enteral feeding in preterm infants
❏ Establishing enteral (mouth) feeding in preterm infants to establish “catch up growth” that is important for e.g. cognitive development. ❏ Prolonged parenteral (needle feeding) nutrition increases cost and causes complications: cholestasis, increased risk of BPD, pulmonary vascular resistance, inf
Slide 11: Economic burden of NEC
Economic burden of NEC Costs continue after NICU discharge Accumulated cost USD between 6-36 months 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. Long term costs associated with sequelae such as impaired growth, short
Slide 12: Growth around week 30 is critical
Growth around week 30 is critical ❏ Prolonged hospital stay of the preterm infant is associated with a high direct cost burden ❏ Improved growth velocity improves neurodevelopmental outcomes in extremely low birth weight infants Source: Lee 2016 12
Slide 13: The product
The product
Slide 14: Lactobacillus reuteri
Lactobacillus reuteri Active substance of IBP-9414 Lactobacillus reuteri present Lactobacillus reuteri (orange) on women’s breasts adhering to intestinal mucus «@
Slide 15: Limosilactobacillus reuteri
Limosilactobacillus reuteri Lifestyle BB vertebrate nost {9 Insect host BB Environmental I Nomadic is - Sirens — ‘ mecoooeecceeee Source: Zheng 2020
Slide 16: Microvesicles from L. reuteri
Microvesicles from L. reuteri Bacterial membrane vesicles produced by L. reuteri Source: Wu 2013, West 2020 16
Slide 17: Source: Schaefer 2010, Walter 2011, Wu 2013, West 2020
Source: Schaefer 2010, Walter 2011, Wu 2013, West 2020 17
Slide 18: Bloom of pathogen-rich gamma proteobacteria prior to onset of NEC
NEC Controls Days after birth Bloom of pathogen-rich gamma proteobacteria prior to onset of NEC Source: Warner et al, 2016, Pammi et al. 2017 18
Slide 19: L. reuteri produces antimicrobial substance reuterin
L. reuteri produces species-specific antimicrobial substance called Bacteria reuterin ▪ Bacillus subtilis ▪ Escherichia coli (patogena) ▪ Listeria monocytogenes ▪ Salmonella typhimurium ▪ Campylobacter jejuni ▪ Enterobacter sakazakii ▪ Porphyromonas gingivalis ▪ Shigella spp ▪ Clostridium perfringen
Slide 20: Positive feces samples for identified pathogens
Number of positive feces samples for identified pathogens from 30 infants * * * P≤0.05 20
Slide 21: T DC Mphage
⚡ ⚡ ⚡ ⚡ T DC FoxP 3 Mphage Teff Teff Treg FoxP3 Teff Teff Teff 21
Slide 22: L. reuteri reduces inflammation
L. reuteri reduces inflammation IEC ⚡ Teff Treg DC FoxP 3 Mphage Treg Teff FoxP3 Treg Treg FoxP3 FoxP3 22
Slide 23: ute cid L.a
L. re ute In vivo ri Ex vivo ⚡ L. re ute ri L. re ute ri L.a cid op hil E. us co li L. L. re re ute ri u ter i 23
Slide 24: Treg and Teff cell modulation
Treg Teff FoxP3 Treg cell modulation Teff cell modulation L. reuteri L. acidophilus L. reuteri L. acidophilus A B 24
Slide 25: Treg FoxP3 placebo vs L. reuteri
Treg * P≤0.05 FoxP3 * Placebo L. reuteri 25
Slide 26: Pre-clinical data - improved gut motility
Pre-clinical data - improved gut motility jee Microvesicles from L. reuteri completely reproduce gut motility modulation of the intact bacteria in mouse © €& ® >———_______ Control Cytoplasmic: \ i i membrane DNA; RNA- Bacterial membrane vesicles Propagating contractile clusters produced by L. reuter
Slide 27: Regurgitation and evacuations
* * P≤0.05 * No. of episodes of regurgitation Formula Formula + L. reuteri + placebo * * No. of episodes of evacuations Formula Formula + L. reuteri + placebo 27
Slide 28: NEC + L. reuteri
Control Control NEC NEC NEC NEC NEC+Lr NEC+Lr NEC+Lr NEC + L. reuteri Improved survival from NEC Reduced intestinal damage 28
Slide 29: Developed under IND and CTX in contrast to food supplements
Developed under IND and CTX in contrast to food supplements 29
Slide 30: Clinical efficacy signal – L. reuteri
Clinical efficacy signal – L. reuteri
Slide 31: Clear clinical signal (1/5)
Clear clinical signal (1/5) Randomised double-blind placebo-controlled clinical studies indicate reduction of NEC Rojas et al. (2012) Oncel et al. (2014) ■ Determine whether prophylactic administration ■ Evaluate the effect of administration of L. of L. reuteri to pre-term infants reduces the Aim of
Slide 32: Clear clinical signal (2/5)
Clear clinical signal (2/5) Randomised double-blind placebo-controlled clinical studies indicate reduction of NEC Spreckels et al. (2018) Kaban et al. (2019) ■ Measure the colonization rate of L. reuteri and ■ Evaluate whether preterm infants receiving L. Aim of the study relate the colonization rat
Slide 33: Clear clinical signal (3/5)
Clear clinical signal (3/5) Retrospective cohort clinical studies indicate reduction of NEC Hunter et al. (2012) & Dimaguila et al. (2013) Jerkovic Raguz et al. (2016) ■ Examine the potential benefit of administering L. ■ Analyse the treatment, course and outcome of premature Aim of the study reuter
Slide 34: Clear clinical signal (4/5)
Clear clinical signal (4/5) Retrospective cohort clinical studies indicate reduction of NEC Sanchez Alvarado (2017) Rolnitsky et al. (2019) ■ Demonstrate that the use of Lactobacillus reuteri ■ Quality improvement study to reduce NEC rates in infants Aim of the study prevents NEC in premature infant
Slide 35: Clear clinical signal (5/5)
Clear clinical signal (5/5) Other studies indicating reduction of NEC Shadkam et al. (2015) Hernandez-Enriquez et al. (2016) ■ Evaluate the effects of Lactobacillus reuteri on the ■ Evaluate the effectiveness of the use of Aim of the study gastrointestinal complications and feeding Lactobacillus reu
Slide 36: Clinical signal
Reduction in episodes of NICU Study es a os ee feeding intolerance or reduction in time to full enteral feeding Rojas et al. 2012 750 37 % 43 % Oncel et al. 2014 400 20 % 33 % Oncel et al. 2015 300 22 % 36 % Shadkam et al. 2015 60 82% 24 % Hernandez-Enriquez et al. 2016 44 83 % 17% Indrio et al. 201
Slide 37: NEC clinical signals
NEC clinical signals Incidence of NEC Meta-analysis: NEC <1500g all randomized controlled trials gives an Odds Ratio of 0.51 37
Slide 38: Feeding tolerance – clinical signals
Feeding tolerance – clinical signals Reported feeding intolerance events Time to full enteral feeding 38
Slide 39: Hospital stay – clinical signal
Hospital stay – clinical signal Days in hospital Favors L. reuteri Favors placebo 39
Slide 40: Strong interest from the market
Strong interest from the market
Slide 41: 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 41
Slide 42: Treatment up to 34 weeks
Treatment up to 34 weeks 1000 - 1,500 g Infants 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 CLEARVIEW Healthcare Partners e@
Slide 43: 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 largest share of premature infants 43
Slide 44: A valuable pharmaceutical
A valuable pharmaceutical 44
Slide 45: A globally valuable pharmaceutical
A globally valuable pharmaceutical China: 438 000 label population EU5: US: 108 000 label population 360 MUSD for NEC 56 000 label population 45
Slide 46: Clinical development program
Clinical development program
Slide 47: The Connection Study - COVID-19
The Connection Study - COVID-19 _) No study-induced hospital visits are required “1 Life and death study. Urgent medical need to prevent NEC ‘J Monitoring is now virtual with no face to face visits needed NICUs have been able to continue recruiting but since the pandemic continues to affect patient
Slide 48: Phase III Pivotal Trial - The Connection Study
Phase III Pivotal Trial - The Connection Study a a Connection Study started July 2019 Regulatory approvals to start Phase III in Hungary, France, Spain, Israel, UK and USA Additional Regulatory filings during summer in Poland, Serbia, Bulgaria and Romania 55 (45) sites are activated 76 (62) sites th
Slide 49: First distribution deal for IBP-9414 in place
First distribution deal for IBP-9414 in place ❏ ❏ ❏ 49
Slide 50: + 2y pedia
2013 2016 2020 2030 2035 + 2y pedia 50
Slide 51: IBP-9414 our lead Phase III program
IBP-9414 our lead Phase Ill program Ticks all relevant pillars for the development of a successful drug Medical need Mechanism of action Clinical data Safe Aligned regulatory agencies GMP manufacture Market exclusivity Aligned payers Orphan Drug and Rare Pediatric Disease designations Cash position
Slide 52: Thank you
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