Infant Bacterial Therapeutics AB (publ) Interim Management Statement, January 1 – September 30, 2019

Message from the CEO

In our previous quarterly report we were able to announce that the first patient had been recruited in our clinical phase III-study. This study is operationally the most significant in IBT’s operations and therefore I choose to provide some detailed information regarding the study. The study is randomized, double blind and placebo controlled to evaluate the safety and efficacy of IBP-9414 with respect to the prevention of necrotizing enterocolitis and other clinically important aspects of feeding preterm babies. 

Our assumptions regarding patient recruitment are based on experience from the concluded phase II study which IBT conducted at 15 clinics in the U.S. during 2017. We currently have approval for conducting the phase III study in France, Spain, The U.K., Hungary and the U.S. and have recruited patients in both Europe and in the U.S. As of the date of this report 37 centers of the 100 planned have been contracted and work is ongoing to contract more. We have not yet initiated recruitment in the UK, while in e.g. Spain recruitment is progressing above expectations at centers which have initiated recruitment.

Meetings held with study doctors during recent weeks have provided awareness of the difficulties of interpreting the inclusion and exclusion criteria described in the study protocol. Therefore, we revised and clarified these criteria during October rendering them more aligned with those used in our phase II study.

We are not satisfied that the study has had a slow start at certain clinical centers, but we also note that other centers are recruiting well, i.e. above expectations. We shall therefore further strengthen the clinical department at IBT in order to ensure that "best practice” is relayed from the centers with superior recruitment to those hospitals which have not initiated as planned. I expect the study to be concluded during 2021 based on the experience we gained from the phase II study. We will therefore further intensify our work with patient recruitment.

Stockholm
November 7, 2019

Staffan Stro¨mberg,
Chief Executive Officer

Significant events during the third quarter (Jul-Sep) 2019
•  IBT announced on July 4 that the first patient had been recruited in the company’s pivotal clinical phase III-study, The Connection Study

Significant events during the reporting period (Jan-Sep) 2019

• 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. The agreement gives MegaPharm exclusive rights to market and sell the product, if and when the product receives market approval. IBT’s share will, after an initial shorter period, account for 70% of revenues. IBT plans to open clinical trial centers for the pivotal phase III trial in the country. MegaPharm is already participating in this work as it is essential to engage "key opinion leaders” in the marketing of the product
   
• On May 19, 2019, we announced that IBT had responded satisfactorily to the comments that the FDA had regarding the study design. As a consequence of the FDA’s comments, an evaluation of the effects of IBP-9414 on the digestive system of premature infants in the forthcoming phase III study is now planned, as a serious medical problem for premature infants is that they cannot take up nourishment in an adequate way. The prior focus was solely prevention of NEC (necrotizing enterocolitis) that, in itself, is a terrible intestinal disease affecting premature infants and too often leads to fatal outcomes. Including another indication means having multiple independent endpoints which may increase the chances of success in the study and thus the market potential
   
• IBT’s IND-Application (Investigational New Drug) was approved in the USA and the clinical study has also been approved in the UK, France, Hungary and Spain

Significant events after the reporting period
•  Lilian Wikström Ph.D. has requested to resign from the Board of Directors of IBT with immediate effect due to the risk of conflict of interest that has arisen in her role as CEO of KI Innovations AB

About Infant Bacterial Therapeutics AB
Infant Bacterial Therapeutics AB (publ) is a pharmaceutical company with a product in clinical stage with a vision to develop drugs influencing the infant microbiome, and thereby prevent or treat rare diseases affecting infants.

IBT is currently developing the drug candidate IBP-9414, for the prevention of necrotizing enterocolitis ("NEC”) and improvement of so called feeding tolerance in premature infants. IBP-9414 contains the active compound Lactobacillus reuteri, which is a human bacterial strain naturally present in breast milk. The product portfolio also includes another project, IBP-1016, for the treatment of gastroschisis, a severe and rare disease affecting infants. By developing these drugs, IBT has the potential to fulfil unmet needs for diseases where there are currently no prevention or treatment therapies available.

Infant Bacterial Therapeutics AB ("IBT”) is a public company domiciled in Stockholm. The company’s class B-shares shares are listed on Nasdaq Stockholm, Mid-cap (IBT B).

For additional information please contact
Staffan Strömberg, CEO
Daniel Mackey, CFO
Infant Bacterial Therapeutics AB
Bryggargatan 10
111 21 Stockholm
Phone: +46 70 670 1226
info@ibtherapeutics.com
www.ibtherapeutics.com

Publication
This information is information that Infant Bacterial Therapeutics AB is obliged to make public pursuant to the EU Market Abuse Regulation and which is to be made public according to the Nasdaq regulations for companies listed on Nasdaq Stockholm. The information was submitted for publication, through the agency of the contact person set out above, at 8.00 CET on November 7, 2019.

Attachment

• PR Q32019 ENG