Infant Bacterial Therapeutics AB Class B · OMXSTO:IBT_B
Infant Bacterial Therapeutics AB Class B — Investor Presentation (January 2020)
45 slides from Infant Bacterial Therapeutics AB Class B's investor presentation, January 2020
Slide 1: Infant Bacterial Therapeutics
Infant Bacterial Therapeutics January 2020
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: Infant Bacterial Therapeutics AB
Infant Bacterial Therapeutics AB Founded in 2013 in Stockholm, Sweden IPO in 2016, listed on Nasdaq Stockholm - Market cap SEK 1 500 M ($160 M) - Cash position as of September 30, 2019 SEK 511 M ($53 M) sufficient to fund IBP-9414 development to market Pivotal Phase III Trial for lead development prog
Slide 4: The IBT concept
The IBT concept - Establish 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 clinical proof-of-concept signal 4
Slide 5: High unmet medical need
High unmet medical need
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Slide 7: Breakthroughs in preterm infant care
Breakthroughs in preterm infant care Incubator use Parenteral Mortality nutrition Surfactant prophylaxis IBP-9414 Focus on breastfeeding Improved gut function CDC/NCHS, National Vital Statistics System 7
Slide 8: Causes of death
Proportion of All Deaths in Each Age Group (%) Causes of death nan 1005 Unknown 90-4 @ Other Congenital anomalies 80-4 . CNS injury ® Infection 70-5 @ Bronchopulmonary dysplasia 60- @ Necroti izing enterocolitis 50+ @ Respiratory distress syndrome 40- @ Immaturity 30-5 20+ 10- 0-4 Birth to >12 to >7
Slide 9: Feeding the preterm infant
Feeding the preterm infant Establishing enteral (mouth) feeding in preterm infants is a primary clinical goal to attain normal growth, important for e.g. cognitive development. Prolonged parenteral (needle feeding) nutrition increases cost and causes complications including: cholestasis, increased r
Slide 10: Economics of NICU stay
Economics of NICU stay Overall cost of of preterm births in the USA is estimated at $26 Billion More than 65% of NICU admissions have an average LOS of about 20 days Average NICU cost per day is $3,000 Cost of average NICU admission is similar to that of patients admitted for spinal cord injury and
Slide 11: Necrotizing enterocolitis (NEC)
Necrotizing enterocolitis (NEC) - NEC is severe inflammation of the bowel in preterm infants 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 12: NEC – a devastating disease
NEC – a devastating disease The smaller the premature infant is at birth, the more likely he/she will die NEC incidence rate NEC mortality rate 501-750g 42.0% 751-1,000g 29.4% 1,001-1250g 21.3% 1,251-1,500g 15.9% 1,501-2,500g 12,7% Source: Shelley 2012, Bolisetty 2000, Llanos 2002, Fitzgibbons 2009,
Slide 13: Economic burden of NEC
Economic burden of NEC Costs continue after NICU discharge Average total treatment cost of NEC is Accumulated USD cost between 6-36 $500,000 per patient in the USA months NEC Economic Burden is estimated to be 20% of the total cost of initial care and $5 Billion spent annually on NEC in the USA Gana
Slide 14: The product
The product
Slide 15: Pharmaceutical drug candidate IBP-9414
Pharmaceutical drug candidate IBP-9414 - Rigorous pharmaceutical Chemistry- Manufacturing-Control standards in all steps with GMP according to 21 CFR Part 210 - Developed under IND - Single dose vial with dose accuracy following ICH Guidelines for Pharmaceuticals - Stringent control of bioburden and
Slide 16: Lactobacillus reuteri
Lactobacillus reuteri Active substance of IBP-9414 Lactobacillus reuteri present Lactobacillus reuteri (orange) on women’s breasts adhering to intestinal mucus 16
Slide 17: L. reuteri - mechanisms of action
L. reuteri - mechanisms of action Combats dysbiosis Reduces inflammation Improves gut motility Improved gut function including prevention of NEC Schaefer 2010, Walter 2011, Wu 2013 17
Slide 18: Clinical Signal - Dysbiosis
Clinical Signal - Dysbiosis Dysbiosis with pathogen blooms in the microbiota can contribute to necrotizing enterocolitis in preterm infants NEC Controls Days after birth Bloom of pathogen-rich gamma Microbiome optimization may provide proteobacteria prior to onset of NEC a novel strategy for prevent
Slide 19: Pre-clinical - Anti-pathogen effects
Pre-clinical - Anti-pathogen effects 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 ▪ Sh
Slide 20: Clinical data - Anti-pathogen effects
Clinical data - Anti-pathogen effects Infant fecal pathogens after 1 month L. reuteri treatment * Number of positive feces samples for identified pathogens from 30 infants * P≤0.05 * L. reuteri decreased gut pathogen colonization in infants Source Savino 2015 20
Slide 21: Impaired gut motility in NEC
Impaired gut motility in NEC Poor gastrointestinal motility is associated with NEC Term infant healthy gut motility Movement Movement Premature infant impaired gut motility Standstill Increased risk of accumulation of noxious substances which can cause intestinal damage Source Lin et al, 2008 21
Slide 22: Pre-clinical data - improved gut motility
Pre-clinical data - improved gut motility Spatiotemporal mapping of mouse gut motility Krebs alone Krebs + L. reuteri Colon motility increased within Effect is strain specific and minutes of L. reuteri addition gut region specific Source Wu 2013 22
Slide 23: Clinical data - Modulation of gut motility
Clinical data - Modulation of gut motility Fasting antral area Regurgitation * * P≤0.05 * No. of episodes of regurgitation Formula Formula Gastric emptying Stooling + L. reuteri + placebo * * No. of episodes of evacuations Formula Formula + L. reuteri + placebo Preterm infants given L. reuteri show
Slide 24: Excessive inflammation in NEC
Excessive inflammation in NEC Toll-like receptors (TLR4) ⚡ IEC ⚡ ⚡ Teff Teff cells ⚡ Treg Treg DC cells FoxP 3 Mphage Inflammatory cytokines Teff Teff Treg FoxP3 Teff Teff Anti- Teff inflammatory cytokines 24
Slide 25: Anti-inflammation in NEC
Anti-inflammation in NEC L. reuteri reduces inflammation Toll-like Receptors (TLR4) IEC ⚡ Teff Teff cells Treg Treg DC cells FoxP 3 Mphage Inflammatory Treg cytokines Teff FoxP3 Treg Treg FoxP3 Anti- FoxP3 inflammatory cytokines Source Liu 2010, Liu 2012, Liu 2014 25
Slide 26: Pre-clinical - Anti-inflammation in NEC animal model
Pre-clinical - Anti-inflammation in NEC animal model TLR4 expression reduced ⚡P-IkBreduced activation Inflammatory cytokines hil op ri reduced ute li us acid Ex vivo co re E. L. L. i ter i u r ute re L. re L. In vivo ri ute ri ute re re L. L. L. reuteri has strain specific anti-inflammatory activity thr
Slide 27: Pre-clinical - Strain specific anti-inflammation in NEC animal model
Pre-clinical - Strain specific anti-inflammation in NEC animal model Treg Teff FoxP3 Treg cell modulation Teff cell modulation L. reuteri L. L. reuteri L. acidophilus A acidophilus B L. reuteri has strain specific anti-inflammatory activity through recruitment of Treg cells and down regulation of Teff ce
Slide 28: Clinical - Anti-inflammatory
Clinical - Anti-inflammatory Treg cells increase in infant blood after L. reuteri administration Treg * P≤0.05 FoxP3 * FOXP3 mRNA levels Placebo L. reuteri L. reuteri recruitment of Treg cells now shown in infants Source Savino 2017 28
Slide 29: L. reuteri protects from NEC in animal models
L. reuteri protects from NEC in animal models Control Control NEC NEC NEC NEC NEC+Lr NEC+Lr NEC+Lr NEC + L. reuteri Improved survival from NEC Reduced intestinal damage Liu, 2012, 2013, 2014 29
Slide 30: Clinical signal
Clinical signal
Slide 31: Publications with clinical signal of NEC reduction
Publications with clinical signal of NEC reduction 31
Slide 32: NEC clinical signals
NEC clinical signals Meta-analysis of 1166 patients <1500g all randomized controlled trials gives an Odds Ratio of 0.51 32
Slide 33: Publications with clinical signal of improved feeding tolerance
Publications with clinical signal of improved feeding tolerance 33
Slide 34: 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] 34
Slide 35: Clinical Development Program
Clinical Development Program
Slide 36: IBP-9414 Phase II: Safety & Tolerability Study
IBP-9414 Phase II: Safety & Tolerability Study RCT; 120 infants 500g - 2000g; 14 days daily dosing from 48h; dose 108 or 109 CFU or placebo; follow up 1 & 6 months Dr. Neu, Gainesville FL, PI Dr. Ashley, Durham NC Dr. Bloom, Wichita KS Dr. Del Moral, Miami FL Dr. Garg, Los Angeles CA Dr. Gerstmann,
Slide 37: IBP-9414 Phase II Safety & Tolerability Study
IBP-9414 Phase II Safety & Tolerability Study • Similar AE and SAE profile in active and placebo groups • No SAE related to study drug • No evidence of cross-contamination with IBP-9414 in placebo treated infants • Executed according to timeplan Key conclusion: Safe and well-tolerated http://ibtherap
Slide 38: Endorsed Phase III Pivotal Trial
Endorsed Phase III Pivotal Trial - IBT has developed the IBP-9414 program in cooperation with the regulators and with considerations of KOLs experience and clinical practice - CTX/IND approval received in UK, Spain, Hungary, France and USA, application filed in Israel 38
Slide 39: IBP-9414 Clinical Development Plan
IBP-9414 Clinical Development Plan Phase 2 Phase 3 Safety and Tolerability Trial Efficacy and Safety Trial – Connection Study ◆ Randomized, double blind, ◆ Randomized, double blind, dose escalation, placebo-controlled placebo-controlled ◆ Multicenter study ◆ Multicenter study ◆ Safety and tolerability
Slide 40: Strong interest from the market
STRONG INTEREST FROM THE MARKET
Slide 41: A valuable pharmaceutical
A valuable pharmaceutical 41
Slide 42: A global need
A global need 15 Million Pre-term births annually 56000 label ~ 108 000 label 408 000 label population = 360 population MUSD annual sales for NEC prevention population
Slide 43: IBP-9414 Market Exclusivity
IBP-9414 Market Exclusivity Three layers of IP protection Market Approval 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 + 2
Slide 44: 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 ✔ Orphan Drug and Rare Pediatric Disease designation
Slide 45: Thank you
Thank you Infant Bacterial Therapeutics AB www.ibtherapeutics.com
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