Infant Bacterial Therapeutics Ab Class B · OMXSTO:IBT_B
Infant Bacterial Therapeutics Ab Class B — Shareholder Meeting (May 2024)
20 slides from Infant Bacterial Therapeutics Ab Class B's shareholder meeting presentation, May 8, 2024
Slide 1: Annual General Meeting 2024
Infant Bacterial Therapeutics Annual General Meeting 2024 May 8, 2024
Slide 2: Translation of the 2024 AGM held in Swedish
Please note that this is a translation of the 2024 AGM held in Swedish
Slide 3: Nutrition via the gut is the key to an infant's survival and growth
Nutrition via the gut is the key to an infant’s survival and growth
Slide 4: IBP-9414 in Phase 3, a fully financed development program
IBP-9414 in Phase 3, a fully • IBP-9414: SEK 309M in cash, Phase 3 recruitment completed, Clinical financed development program results Q3 ‘24, Blockbuster USD 1,500M peak • IBT strengthens with staff in Regulatory, Supply and Marketing Launch Preparations • Premarketing/medical affairs- PAS 24 • Va
Slide 5: Well organized and capitalized according to plan
Cost Control Well organized and capitalized according to plan Well negotiated agreeements Currency Secured Efficient Organization 5
Slide 6: Structure and Control
Structure and Control ESG & United Nations Global Impact Systems & Processes Organisation & Infrastructure Policies & Guidelines 6
Slide 7: IBT's Journey
IBT’s Journey 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 Orphan Drug Status Clinical trial permits Secure pure and stable products LPI Phase II (dose) Results The Connection study (safety and efficacy) NASDAQ FDA Launch IBP 9414 7
Slide 8: The World's Largest Study
The World’s Largest Study Connection Study: 2158 infants, 95 centers, 10 countries Patients Country # sites randomized United States 1632 (76%) 57 Top 5 EU recruiters: Bulgaria 171 (8%) 5 Dr Slancheva, Bulgaria, 76 pats Hungary 79 (4%) 5 Dr Nagy, Hungary, 50 pats Dr Demetrian, Romania, 50 pats Roman
Slide 9: We are now preparing the application for market approval
We are now preparing the application for market approval Regional Administrative Information Quality Non-clinical Clinical Summary Overview & Overview & Summary Summary Quality Non-Clinical Clinical Reports Reports 9
Slide 10: Validation of the manufacturing process - 2024
Validation of the manufacturing process - 2024 Cultivation + Fill + lyophilization Packaging Purification ● Commercial Scale Manufacturing Cell bank ● Document Reproducibility ● Confirm Stability 10
Slide 11: Connection Study - Recruitment finished, results soon!
CONNECTION STUDY- Recruitment finished, results soon! Main success factors ● Prevent Necrotizing Enterocolitis (NEC) ○ 1st primary study endpoint ● Shorten time to Sustained Feeding Tolerance (SFT) ○ 2nd primary study endpoint ● Safety of infants 11
Slide 12: Connection Study - Necrotizing Enterocolitis (NEC)
CONNECTION STUDY- Recruitment finished, results soon! Necrotizing Enterocolitis (NEC) ● Virtually unique to the premature infant. ● Unknown cause ○ Immature intestine (mucosa, motility, defence), excess pathogenic bacteria ○ All 4 treatment actions of IBP-9414. ● Abdominal catastrophe ○ ‘10% inciden
Slide 13: Connection Study - Necrotizing Enterocolitis (NEC)
CONNECTION STUDY- Recruitment finished, results soon! Necrotizing Enterocolitis (NEC) ● No specific medical treatment/ prevention available. ● Promote gut development is key! ○ Most important is early enteral feeding ○ Preferably mother’s milk ○ Early SFT… ● Prevention of NEC requires large studies
Slide 14: NEC in Connection Study - Confirmed NEC
NEC in CONNECTION STUDY- Confirmed NEC NEC in Connection Study ● Diagnosis by independent examination of abdominal X-rays taken for clinical signs of NEC, surgery/autopsy. ● Confirmed NEC* ○ ~8% of infants ○ 16% died ● Predictors of confirmed NEC ○ low birth weight and gestational age ○ any SAE, hyp
Slide 15: SFT in Connection Study
SFT in CONNECTION STUDY SFT in Connection Study ● Enteral feeding to start early and progress as fast as possible w/o feeding intolerance ● Success depends on healthy gut development ● SFT defined in a new, strict way ● SFT in Connection Study* ○ Reached at 18 days of age ○ Highly sensitive to GI an
Slide 16: Infant Safety in Connection Study
INFANT SAFETY in CONNECTION STUDY Safety of IBP-9414, a key success factor ● Based on Investigator’s Adverse Event (AE) reports ○ 500+ event categories ● Generally fewer than expected events ○ Low mortality overall and in NEC ○ Low incidence of sepsis ○ No unexpected event types ● Unblinded evaluati
Slide 17: The market for drugs against NEC is more and more favorable
The market for drugs against NEC is more and more favorable Oct 2023 Sep 2023 Health Canada Jan 2024 FDA issues warnings follows suit and ESPHGAN “the right against unapproved issues a similar products are missing” products warning FDA BAN
Slide 18: The Wall Street Journal: FDA crackdown on probiotics
THE WALL STREET JOURNAL. Friday, November I Diseord Arises Over Treating Preemie Babies FDA crackdown on probiotics leaves fewer tools to help protect infant guts By Laz Essiey Wievre For years, hospitals around world have tried to pro permission first Abbott Laboratories and (un and pulhed other ma
Slide 19: IBP 9414 - Looking Forward
IBP 9414 - Looking Forward 2024 2025 ● Commercial Launch ▪ Commercial Production ▪ Market preparing activities ● Priority Sales Voucher 👉 Save Infants 2024 2025 👉A good return on investment Apr 2024: Phase 3 Application for Last patient in Results Market Approval 19
Slide 20: Infant Bacterial Therapeutics AB
Infant Bacterial Therapeutics AB www.ibtherapeutics.com 20
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