Infant Bacterial Therapeutics AB Class B · OMXSTO:IBT_B
Infant Bacterial Therapeutics AB Class B — Investor Presentation (September 2022)
21 slides from Infant Bacterial Therapeutics AB Class B's investor presentation, September 2022
Slide 1: Staffan Strömberg - CEO September 2022
Staffan Strömberg - CEO September 2022
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: IBT Corporate Milestones
IBT Corporate Milestones Founded 2013 Sweden - in licensed technology platform from Biogaia. Orphan Designation IPO 2016 Phase II Completed Lactobacillus reuteri – a GI First North followed by Safety and tolerability bacteria improving gut function NASDAQ main markets in demonstrated. and Sustained
Slide 4: IBT has established strong core competences
IBT has established strong core competences Gastroenterology • Enabling a healthy microbiome extends to multiple treatment options especially in combination with advanced gene modification possibilities Preterm Babies • The need for preterm treatment solutions is enormous, where IBT has established
Slide 5: Introducing IBP-9414: First Pharmaceutical Grade Probiotic
Introducing IBP-9414: First Pharmaceutical Grade Probiotic IBP-9414 on a mission (since 2013) to become the first pharma grade probiotic to prevent life threatening infant diseases including NEC and sepsis by promoting Sustained Feeding Tolerance 5
Slide 6: IBP-9414 / Lactobacillus Reuteri enables good GI function
IBP-9414 / Lactobacillus Reuteri enables good GI function First naturally derived pharmaceutical grade probiotic 6
Slide 7: IBP-9414 is addressing a major unresolved medical need
IBP-9414 is addressing a major unresolved medical need Preventive treatments are Despite all current efforts with neonatal needed intensive care - a 24 week GA baby stand a 50% chance of survival… 7
Slide 8: IBP-9414 is targeting leading causes of mortality among preterm babies
IBP-9414 is targeting leading causes of mortality among preterm babies Sepsis BPD NEC Patel 2015 8
Slide 9: IBP-9414 will resolve the clinical practice void that is a reality today
IBP-9414 will resolve the clinical practice void that is a reality today Unproven dietary Costly surgical supplements lack intervention with CMC quality long term controls consequences Prevention needed No pharmaceutical due to rapid treatment available today Pharma grade disease probiotic to progre
Slide 10: IBP-9414 is anticipated as the first regulated pharma grade probiotic for preterm infants
IBP-9414 is anticipated as the first and much needed regulated pharma grade probiotic for preterm infants ● “Probiotic products in the United States are available for use in the general category of dietary supplements, bypassing the rigor of the US Food and Drug Administration (FDA) approval process
Slide 11: Phase III – Two Primary Endpoints
IBP-9414’s development is targeting two independent endpoints Phase III – Two Primary Endpoints Shortening of time to NEC prevention SFT SFT = Sustained Feeding Tolerance 11
Slide 12: IBP-9414 active ingredient has demonstrated a favorable effect on NEC
IBP-9414 active ingredient has demonstrated a favorable effect on NEC Randomized Control Trials 50% reduction in NEC with L.reuteri Historical Control Trials 70% reduction in NEC with L.reuteri 12
Slide 13: Time to Sustained Feeding Tolerance correlates to important clinical events
Time to Sustained Feeding Tolerance (SFT) correlates to a multitude of important clinical events A shortening of this time should reflect increased growth and well-being of the VLBW infant. Result of regression analysis for the 248 infants reaching the 1-day shortening of time to SFT 10-day SFT defi
Slide 14: Connection Study is progressing
IBP-9414 Connection Study is progressing • Current recruitment to Phase III is on track with >50 patients per month • Projected to accelerate the momentum and also open Cohort C (babies 1000-1500 Recruited Patients grams) at 1400 recruited patients • There is sufficient cash on hand, as planned, to
Slide 15: HCPs respond that IBP-9414 will receive broad utilization
HCPs respond that IBP-9414 will receive broad utilization ~90% ~70% ~100% ~40 K ~36 K ~25 K ~25 K Addressable US Physician Formulary Protocol Patients Preference Inclusion Access P&T committee members indicate inclusion across most large institutions and mid-sized institutions Source: Stakeholder In
Slide 16: 25K Treated US Patients Expected to Generate $630M Peak Sales
25K Treated US Patients Expected to Generate $630M Peak Sales Key Considerations IBP9414 Commercial Opportunity Patients Treated with IBP-9414 ~10 K (<1,000 g infants) 1 25K patients treated with full access in two weight 1 cohorts ~15 K (1,000-1,500 g infants) Average Treatment Duration 2 Treatment
Slide 17: Overall EU Revenue Potential Similar to the US
Overall EU Revenue Potential Similar to the US EU label broader than US; <34Weeks babies in EU vs. <1500g in the USA Key Considerations Projected EU Revenue Potential Anticipated U.S. Sales ~$630 M EU preterm prevalence of 2.8% of 4.7M births = 130K U.S. to EU Prevalence Multiplier 1 treatable patie
Slide 18: IBP-9414 has megabrand potential: >$1.5B Peak Sales
IBP-9414 has megabrand potential >$1.5B Peak Sales* → Triple layer IP protection 1) data exclusivity 2) patent protection 3) orphan drug status $M → >12 years exclusivity across EU, US, Japan and China * New market research conducted 2021. ROW estimated at 50% of EU 18
Slide 19: IBP-9414 our lead Phase III program
IBP-9414 our lead Phase III program Clinical Data Mechanism of Action Medical Highest Aligned Need GMPs Regulatory Agencies Phase III >12 Years Safe Market Clinical Exclusivity Orphan & Rare Pediatric Disease Aligned Payers 19
Slide 20: New Opportunity: Gastroschisis IBP-1016
New Opportunity: Gastroschisis IBP-1016 Significant unmet need Synergies with IBP-9414 • 2,000 diagnosed US infants per year • Same API (Lactobacillus reuteri) • Both conditions in need of gut moving and • Post surgery: gut motility is absent, and functioning more quickly oral feeding not tolerated
Slide 21: Thank you
Thank you Infant Bacterial Therapeutics AB www.ibtherapeutics.com 21
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