Infant Bacterial Therapeutics Ab Class B · OMXSTO:IBT_B
Infant Bacterial Therapeutics Ab Class B — Investor Presentation (January 2020)
41 slides from Infant Bacterial Therapeutics Ab Class B's investor presentation, Jan 22, 2020
Slide 1: Infant Bacterial Therapeutics
Infant Bacterial Therapeutics Staffan Strémberg January 22, 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: Infant Bacterial Therapeutics AB
Infant Bacterial Therapeutics AB 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
Slide 6: 6
6
Slide 7: Mortality
Mortality CDC/NCHS, National Vital Statistics System 7
Slide 8: Proportion of All Deaths in Each Age Group (%)
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: 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 availab
Slide 11: NEC mortality by birth weight
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% 11
Slide 12: NEC Economic Burden
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 Ganapathy 2011, Niño 2016 12
Slide 13: Strong interest from the market
Slide 14: A valuable pharmaceutical
A valuable pharmaceutical = Results of NEC market analysis by ClearView Healthcare Partners Number of infants born under 1,500 grams in the United States annually Physician preference share demonstrates neonatologists show high willingness to prescribe IBP-9414 Of addressable patients are anticipate
Slide 15: 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 6®
Slide 16: The product
Slide 17: 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 18: IBP-9414 timeline
2013 2016 2020 2030 2035 + 2y pedia 18
Slide 19: Lactobacillus reuteri
Lactobacillus reuteri Active substance of IBP-9414 Lactobacillus reuteri present Lactobacillus reuteri (orange) on women’s breasts adhering to intestinal mucus "@
Slide 20: Control NEC vs 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 20
Slide 21: Schaefer 2010, Walter 2011, Wu 2013, West 2020
Schaefer 2010, Walter 2011, Wu 2013, West 2020 21
Slide 22: NEC Controls
NEC Controls Days after birth Source Warner et al, 2016, Pammi et al. 2017 22
Slide 23: Positive feces samples for identified pathogens
Number of positive feces samples for identified pathogens from 30 infants * * * P≤0.05 23
Slide 24: L. reuteri inhibits pathogens
Bacteria ▪ Bacillus subtilis ▪ Escherichia coli (patogena) ▪ Listeria monocytogenes ▪ Salmonella typhimurium ▪ Campylobacter jejuni ▪ Enterobacter sakazakii ▪ Porphyromonas gingivalis ▪ Shigella spp ▪ Clostridium perfringens ▪ Fusobacterium nucleatum ▪ Prevotella intermedia ▪ Staphylococcus aureus ▪
Slide 25: Treg response, placebo vs L. reuteri
Treg * P≤0.05 FoxP3 * Placebo L. reuteri 25
Slide 26: Treg and Teff cell modulation
Treg Teff FoxP3 Treg cell modulation Teff cell modulation L. reuteri L. L. reuteri L. acidophilus A acidophilus B 26
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: Pre-clinical data - improved gut motility
Pre-clinical data - improved gut motility Microvesicles from L. reuteri completely reproduce gut motility modulation of the intact bacteria in mouse Control OQO g——__evm Cytoplasmic: \ i i membrane DNA; RNA- Bacterial membrane vesicles Propagating contractile clusters produced by L. reuteri in the c
Slide 29: Clinical signal
Slide 30: Reduction in feeding intolerance episodes
* reduction in episodes of feeding intolerance ** reduction in time to full enteral feeding 30
Slide 31: NEC clinical signals
NEC clinical signals L reuteri Placebo Odds Ratio Odds Ratio Study or Subgroup Events Total Events Total Weight M-H, Fixed, 95% CI M-H, Fixed, 95% CI Hernandez-Enriquez 2016 1 24 5 25 110% 0.17[0.02, 162) +—————.————7—_ Oncel 2014 8 200 10 200 22.5% 0.79[0.31, 2.05] a, ae Oncel 2015 7 150 9 150 20.1
Slide 32: Favors L. reuteri Favors placebo
Favors L. reuteri Favors placebo 32
Slide 33: 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 34: Clinical Development Program
Slide 35: IBP-9414 Phase II: Safety & Tolerability Study
IBP-9414 Phase Il: Safety & Tolerability Study RCT; 120 infants 500g - 2000g; 14 days daily dosing from 48h; dose 108 or 10° CFU or placebo; follow up 1 & 6 months Dr. Neu, Gainesville FL, Pl Dr. Ashley, Durham NC Dr. Bloom, Wichita KS Dr. Del Moral, Miami FL Dr. Garg, Los Angeles CA Dr. Gerstmann,
Slide 36: http://ibtherapeutics.com/wp-content/uploads/2016/03/Hot-topics-poster-1128.pdf
http://ibtherapeutics.com/wp-content/uploads/2016/03/Hot-topics-poster-1128.pdf 36
Slide 37: IBP-9414 Clinical Development Plan
IBP-9414 Clinical Development Plan Phase 2 Safety and Tolerability Trial Sd Sd Randomized, double blind, dose escalation, placebo-controlled Multicenter study Safety and tolerability of IBP-9414 in premature infants <2,000g birth weight 120 infants 15 sites in the USA Phase 3 Efficacy and Safety Tri
Slide 38: Phase III Pivotal Trial
Phase III Pivotal Trial 1 IBT has developed the IBP-9414 program in cooperation with the regulators and with considerations of KOLs experience and clinical practice “1 CTX/IND approval received in UK, Spain, Hungary, France and USA, application filed in Israel J During the autumn focus has been on i
Slide 39: 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 CNN NNN888 Orphan Drug and Rare Pediatric Disease designations =
Slide 40: Slide 40
Slide 41: Thank you
Thank you
Infant Bacterial Therapeutics — Investor Presentation (January 2020) on 6ix