Infant Bacterial Therapeutics Ab Class B · OMXSTO:IBT_B
Infant Bacterial Therapeutics Ab Class B — Shareholder Meeting (May 2024)
19 slides from Infant Bacterial Therapeutics Ab Class B's shareholder meeting presentation, May 8, 2024
Slide 1: Infant Bacterial Therapeutics Årsstämma 2024
Infant Bacterial Therapeutics Årsstämma 2024 8 maj 2024
Slide 2: Näring via magen är nyckeln till barnets överlevnad och tillväxt
Näring via magen är nyckeln till barnets överlevnad och tillväxt
Slide 3: IBP-9414 i Fas 3, ett fullt finansierat utvecklingsprogram
IBP-9414 i Fas 3, ett fullt • IBP-9414: 309 MSEK i kassan, Fas 3 rekryteringen avslutad, Kliniska finansierat utvecklingsprogram resultat Q3 24, Blockbuster 1 500 MUSD peak • IBT stärker med personer inom Regulatory, Supply och Marknad Förberedelser inför lanseringen • Premarketing/medical affairs-
Slide 4: Välorganiserat och kapitaliserat enligt plan
Kostnads kontroll Välorganiserat och kapitaliserat enligt plan Bra förhandlade avtal Valuta säkrat Liten organisation 4
Slide 5: Struktur och kontroll
Struktur och kontroll ESG & United Nations Global Impact System & Processer Organisation & Infrastrukur Policys & Riktlinjer 5
Slide 6: IBTs resa
IBTs resa 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 6
Slide 7: Världens största studie Connection Study: 2158 barn, 95 center, 10 länder
Världens största studie Connection Study: 2158 barn, 95 center, 10 länder Patients Country # sites randomized United States 1632 (76%) 57 Top 5 EU rekryterare: Bulgaria 171 (8%) 5 Dr Slancheva, Bulgaria, 76 pats Hungary 79 (4%) 5 Dr Nagy, Hungary, 50 pats Dr Demetrian, Romania, 50 pats Romania 100 (
Slide 8: Nu förbereder vi ansökan för marknadsgodkännande
Nu förbereder vi ansökan för marknadsgodkännande Regional Administrative Information Quality Non-clinical Clinical Summary Overview & Overview & Summary Summary Quality Non-Clinical Clinical Reports Reports 8
Slide 9: Validering av tillverkningsmetoden under 2024
Validering av tillverkningsmetoden under 2024 Odling + rening Fyllning + frystorkning Packning ● Tillverkning i kommersiell skala Cell bank ● Dokumentera reproducerbarheten ● Bekräfta stabiliteten 9
Slide 10: 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 10
Slide 11: 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 12: 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 13: 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 14: 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 15: 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 16: Marknaden för läkemedel mot NEC blir mer och mer gynnsam
Marknaden för läkemedel mot NEC blir mer och mer gynnsam Oct 2023 Sep 2023 Health Canada Jan 2024 FDA Varnar för icke utfärdar en ESPHGAN “det saknas godkända produkter liknande varning rätt produkter” FDA BAN
Slide 17: 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 18: IBP 9414 - Framtiden
IBP 9414 - Framtiden 2024 2025 ▪ Kommersiell produktion ● Kommersiell lansering ▪ Marknads förberedande ● Priority Sales Voucher aktiviteter 👉Rädda spädbarn 2024 2025 👉En bra avkastning på investerat kapital Ansökan om Apr 2024: Fas 3 marknadsgodkänn Last patient in Resultat ande 18
Slide 19: Infant Bacterial Therapeutics AB www.ibtherapeutics.com
Infant Bacterial Therapeutics AB www.ibtherapeutics.com 19
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