Infant Bacterial Therapeutics Ab Class B · OMXSTO:IBT_B
Infant Bacterial Therapeutics Ab Class B — Investor Presentation (June 2019)
37 slides from Infant Bacterial Therapeutics Ab Class B's investor presentation, June 2019
Slide 1: Infant Bacterial Therapeutics
Infant Bacterial Therapeutics June 2019
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: Corporate overview
Infant Bacterial Therapeutics AB Corporate overview ❏ Founded in 2013 in Stockholm, Sweden as a subsidiary of BioGaia ❏ IPO in 2016, currently listed on Nasdaq Stockholm Mid-Cap ❏ Cash end of Q1 2019 MSEK 540, sufficient to fund development to market ❏ Planned Phase III start during H1 2019 ❏ Market
Slide 4: Corporate development last 12 months
Corporate development last 12 months ❏ List change to regulated market Nasdaq Stockholm Mid-Cap in September 2018 ❏ Analyst coverage: SEB (Sweden) and Chardan (US) (non-commissioned research) 4
Slide 5: First distribution deal for IBP-9414 in place
First distribution deal for IBP-9414 in place With Megapharm for IBP-9414 for the Israeli market and the Palestinian Authority’s territories. ❏ Megapharm responsible for local registration, price negotiation and marketing ❏ IBT will receive 70% of revenue after an initial period ❏ Potential to inclu
Slide 6: The IBT concept
The IBT concept Altering the human microbiome to treat diseases related to poor gut function Newborn infant microbiome is dynamic Human bacterial strains derived from human breast milk Published proof-of-concept clinical signal 6
Slide 7: High unmet medical need
High unmet medical need
Slide 8: Our patients
Prenatal development Week 1 2 3 4 5 6 7 8 91011 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 Classification Preterm | Term A A 50% survival Childbirth on average
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Slide 10: Mortality
GI tract left untreated in preterm infants Incubator use Parenteral Mortality nutrition Surfactant prophylaxis Focus on GUT breastfeeding FUNCTION CDC/NCHS, National Vital Statistics System 10
Slide 11: Causes of death
Causes of death 1007 g 90+ Es Fy 80+ 1) & 704 < = & 60-4 a = w 505 x 3s A 404 < ‘Ss 30+ c 2 — 204 S a 104 o0- Patel 2015 Unknown Other Congenital anomalies © CNS injury © Infection @ Bronchopulmonary dysplasia @ Necrotizing enterocolitis i Respiratory distress syndrome @ Immaturity Birth to 12 hr >1
Slide 12: Necrotizing enterocolitis (NEC)
Necrotizing enterocolitis (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 availabl
Slide 13: 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 14: Causes of death
Causes of death 100- Proportion of All Deaths in Each Age Group (%) Patel 2015 Unknown Other Congenital anomalies © CNS injury © Infection @ Bronchopulmonary dysplasia @ Necrotizing enterocolitis i Respiratory distress syndrome @ Immaturity Birth to 12 hr >12 to 72 hr >72 hr to 7 days 8 to 14 days 1
Slide 15: Feeding the preterm infant
Feeding the preterm infant ❏ 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, pulmona
Slide 16: Feeding the preterm infant
Feeding the preterm infant ❏ Prolonged hospital stay of the preterm infant is associated with a high direct cost burden - $3,200 per day ❏ Long Term: Improved growth velocity improves neurodevelopmental outcomes in extremely low birth weight infants Ganapathy, 2011 and Ehrenkranz et al 2006 16
Slide 17: Mechanism of action – Lactobacillus reuteri
MECHANISM OF ACTION –Lactobacillus reuteri
Slide 18: Lactobacillus reuteri
Lactobacillus reuteri Active substance of IBP-9414 Lactobacillus reuteri present Lactobacillus reuteri (orange) on women’s breasts adhering to intestinal mucus 18
Slide 19: L. reuteri - mechanisms of action in the GI tract
L. reuteri - mechanisms of action in the GI tract Combats dysbiosis Reduces inflammation Improves gut motility Improved GI function and prevention of NEC Schaefer 2010, Walter 2011, Wu 2013 19
Slide 20: L. reuteri protects from NEC in animal models
L. reuteri protects from NEC in animal models Improved survival from NEC Reduced intestinal damage Control Control NEC NEC NEC NEC NEC+Lr NEC+Lr NEC+Lr NEC + L. reuteri Liu, 2012, 2013, 2014 20
Slide 21: Clinical efficacy signal – L. reuteri
CLINICAL EFFICACY SIGNAL – L. reuteri
Slide 22: Clinical research – first signal of L. reuteri effect on NEC
Clinical research – first signal of L. reuteri effect on NEC NEC in NEC in <1500g birth weight babies <1000g birth weight babies L. reuteri 5.4% NEC 15% NEC 2% NEC 3.4% NEC Placebo L. reuteri 08 9 07 09 04 05 06 10 11 l0 20 20 20 20 20 20 20 n Ju Ju Total NEC (%) NEC deaths (%) Rojas 2012, Pediatric
Slide 23: 9 studies show clinically significant reduction of NEC
9 studies show clinically significant reduction of NEC Study Number of patients Reduction in NEC incidence ■ 40% in the total study population Rojas et al. (2012) ■ 750 patients ■ 37% in infants ≤1,500g ■ 20% in the total study population Oncel et al. (2014) ■ 400 patients ■ 38% in infants ≤1,000g S
Slide 24: NEC clinical signals
NEC clinical signals Incidence of NEC Meta-analysis: NEC <1500g all randomized controlled trials gives an Odds Ratio of 0.51 24
Slide 25: Feeding Tolerance - clinical signals and consequences
Feeding Tolerance - clinical signals and consequences Time to full enteral feeding -1.28 days [-1.85, -0.72] Feeding intolerance events OR 0.51 [0.35, 0.75] Days on Parenteral Nutrition -1.67 days [-2.94, -0.41] Days in hospital -5.25 days [-8.46, -2.05] Favors L. reuteri Favors placebo 25
Slide 26: Plan endorsed by stakeholders – Regulatory agencies and KOLs
PLAN ENDORSED BY STAKEHOLDERS – Regulatory agencies and KOLs
Slide 27: Network of KOLs
Network of KOLs IBT has developed the IBP-9414 program with deep considerations of KOLs experience and clinical practice Some of the external medical experts Aideen Moore, The Hospital for Sick Children, Toronto, Canada. Alexandre Lapillonne, Necker Hospital for Sick Children, Paris, France Andreas
Slide 28: FDA meeting - November
FDA meeting - November 20 Two Primary Endpoint “NEC and/or Feeding tolerance” Additional Endpoints Additional Endpoints NEC Feeding Medical NEC Surgical Time to full feed NEC Hospital days etc etc 28
Slide 29: Phase 3: The Connection Study
Phase 3: The Connection Study A randomized, double blind, parallel-group, placebo controlled study to evaluate the efficacy and safety of IBP-9414 in premature infants 500-1500g birth weight in the prevention of necrotizing enterocolitis • Coordinating investigator: Professor Josef Neu (Univ. of Flo
Slide 30: Phase 3: The Connection Study
Phase 3: The Connection Study Selected NICUs to date 45 12 3 10 6 5 30
Slide 31: Strong interest from the market
STRONG INTEREST FROM THE MARKET
Slide 32: IBP-9414 Target Product Profile
IBP-9414 Target Product Profile For the prevention of necrotizing enterocolitis For the prevention ■ Oralof necrotizing enterocolitis suspension Product description ■ Supplied as a freeze-dried powder in a prefilled, clear, glass vial ■ To be reconstituted in sterile water and delivered in enteral s
Slide 33: A valuable pharmaceutical
A valuable pharmaceutical 33
Slide 34: A global need
A global need 15 Million Pre-term births annually ® EU5 56000 label 108 000 label 408 000 label population = 360 population population MUSD annual sales for NEC prevention 7)
Slide 35: Plan for 2019 and beyond
Plan for 2019 and beyond ● “First Patient In” Phase III - “The Connection Study” ● Finding appropriate partners, e.g. like Megapharm in Israel, for distribution of the IBP-9414 drug around the world. ● Market research to better understand the markets behavior around “poor gut function and feeding pr
Slide 36: IBP-9414 our lead Phase III program
IBP-9414 our lead Phase III 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 ✔ 36
Slide 37: Thank you
Thank you Infant Bacterial Therapeutics AB www.ibtherapeutics.com 37
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