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IBT Corporate Facts

IBT is founded as a subsidiary to BioGaia and commences the development of a preventive therapy (IBP-9414) against NEC using Lactobacillus reuteri
IBT is granted Orphan Drug Designation by the FDA for Lactobacillus reuteri for the prevention of NEC in premature infants
FDA provides scientific input to IBT development plans

IBT is granted Orphan Drug Designation by the European Commission for IBP-9414 including Lactobacillus reuteri for the prevention of NEC in premature infants
Production of drug candidate IBP-9414 according to all applicable pharmaceutical chemistry-manufacture-control regulations for the safety and tolerability study
Active IND obtained from FDA for start of Safety and Tolerability clinical trial in 2016
IBT received approval from the MPA to conduct a clinical trial in Sweden

IBT’s share of series B is traded on First North Premier
IBT completes IBP-9414 safety and tolerability trial and announces that top line data demonstrate similar safety and tolerability profile in the active and placebo groups
EMA adopts a positive opinion on the Pediatric Investigational Plan proposed by IBT for the development of IBP-9414 for the prevention of NEC

The EGM on January 8 decided on a new share issue amounting to SEK 439.1m and as of January 31the share issue was fully subscribed. The share issue in combination with the directed share issue in November of 2017 generated approximately SEK 543.6m prior to transaction costs
In June 2018, IBT contracted Premier Research International LLC, the company’s CRO during the Phase II clinical trial, to also conduct the company’s Phase III clinical trial
IBT series B shares are traded on Nasdaq Stockholm, Mid Cap
IBT has, resulting from discussions with the FDA chosen to modify its Phase III study for the prevention of necrotizing enterocolitis (NEC) in premature infants. Following the guidance from the FDA, IBT will improve the protocol which may allow additional claims such as improvement of “feeding tolerance”, that could increase the chance of success in the Company’s Phase III study and the market potential of the product

IBT signed its first distribution agreement on March 5, 2019, for its product IBP-9414, with MegaPharm Ltd. for the Israeli market and the Palestinian Authority’s territories
On May 19, 2019, it was announced that IBT had responded satisfactorily to the comments that the FDA had regarding the study design to the companies planned Phase III Study which led to the approval of IBTs IND (Investigational New Drug) application. As a consequence of the FDA’s comments, an evaluation of the effects of IBP-9414 on the digestive system, or so called “feeding tolerance” of premature infants in the ongoing Phase III study is now included
During 2019 IBT’s application for clinical trial was also approved in the UK, France, Hungary and Spain
IBT announced on July 4, 2019 that the first patient had been recruited in the company’s pivotal clinical Phase III study, The Connection Study

IBT’s clinical study application was approved in Israel in January, in Poland in October and in Bulgaria in November

IBT’s clinical study application was approved in Serbia in July and in Romania in August