Infant Bacterial Therapeutics AB
Annual Report 2022
1!
Infant Bacterial Therapeutics AB
(publ)
Annual Report 2022
We aim to satisfy unmet medical needs in the
premature infant
SIGNIFICANT EVENTS 2022
On January 19, IBT announced that The Connection Study continues after the Data
Monitoring Committee (DMC) had completed its pre-scheduled safety analysis without
any concerns. At the same time a futility analysis was performed. Based on DMC
recommendations and futility outcome, IBT is continuing the recruitment to the study as
planned.
On September 23, the FDA approved IBT’s request for a new Orphan Drug Designation
for retinopathy of prematurity (ROP).
IBT published in the British Journal of Gastroenterology in October an article based on
IBT's “Connection Study” which demonstrates that sustained feeding tolerance (SFT)
is linked to serious disease progression including sepsis and bronchopulmonary
dysplasia, validating the study design. It also highlights the potential to reduce
healthcare costs with fewer treatment days in the hospital.
The company negotiated during 2022 the acquisition of a drug platform that can
prevent antibiotic-resistant hospital infections.
2!
Infant Bacterial Therapeutics AB
(publ)
Annual Report 2022
Infant Bacterial Therapeutics AB (publ)
Annual Report January 1 – December 31, 2022
Table of Contents
IBT IN BRIEF 3
IBT’S HISTORY 5
MESSAGE FROM THE CEO 8
IBT’S PIPELINE 10
DIRECTORS REPORT 19
OPERATIONS 19
SIGNIFICANT EVENTS DURING 2022 19
SIGNIFICANT EVENTS AFTER THE FISCAL YEAR 20
SELECTED FINANCIAL DATA 21
FINANCIAL DEVELOPMENT 21
RISKS AND UNCERTAINTIES 23
ENVIRONMENTAL RESPONSIBILITIES 26
SUSTAINABILITY 26
LEGAL PROCEEDINGS 26
CORPORATE GOVERNANCE 26
PUBLICATION 26
CALENDAR 26
ANNUAL GENERAL MEETING 27
BOARD OF DIRECTORS RECOMMENDATION OF APPROPRIATION OF PROFITS 27
INCOME STATEMENT 28
BALANCE SHEET 29
STATEMENT OF CHANGES IN EQUITY 30
STATEMENT OF CASH FLOWS 31
NOTES 32
AUDITOR´R REPORT 52
CORPORATES GOVERNANCE REPORT IBT AB 56
DEDUCTION OF CERTAIN KEY FIGURES 67
SHARES 67
MANAGEMENT 69
BOARD OF DIRECTORS 70
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The annual report is published on the company’s homepage, www.ibtherapeutics.com
and is distributed in printed form when ordered. Orders may be placed via
info@ibtherapeutics.com. The annual report is also published in Swedish.
3!
Infant Bacterial Therapeutics AB
(publ)
Annual Report 2022
IBT IN BRIEF
Infant Bacterial Therapeutics AB (“IBT”) is a public company domiciled in Stockholm. The
company’s Class B shares are since September 10, 2018, listed on Nasdaq Stockholm (IBT B).
Infant Bacterial Therapeutics AB (publ) (“IBT”) is a pharmaceutical company with a product in
clinical phase III 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. The ambition for IBP-9414 is to
become the world’s first approved probiotical drug with the goal to prevent life threatening
diseases in premature infants including Necrotizing Enterocolitis (NEC) and sepsis by conducting
sound stomach-and bowel development 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, IBP-1118 to prevent ROP (retinopathy of prematurity),
a growing and serious condition that often leads to blindness among prematurely born babies
and IBP-1122 for the prevention of antibiotic resistant hospital acquired infections. By
developing these drugs, IBT has the potential to fulfill unmet needs for diseases where there are
currently no prevention or treatment therapies available.
Vision
Premature infants are the most vulnerable beings on the planet and for them to survive, grow
and thrive they need intensive and specialized care. Although advances in medical care and
handling over the last 30 years have improved survival and well-being of these sensitive infants,
both in the immediate post-natal period and in their subsequent lives, current drugs and
therapies are mostly designed for adults and are not adapted to this specific and vulnerable
patient population. Specific treatment and prophylactic therapy are thus underdeveloped and
there is an urgent demand for drugs designed for the unique needs of the premature baby. IBT:s
vision is to become an internationally recognized and leading company in the development of
pharmaceuticals in the areas of premature babies, gastrointestinal diseases and probiotics.
Mission
IBT develops, and intends to market and sell, effective, safe and effective medicines that can
prevent or treat rare diseases. The company is focused around three areas of developed
competence:
● Gastroenterology - Enabling a healthy gut microbiome extends to multiple treatment
options, especially in combination with advanced gene modification possibilities.
● Premature babies - The need for premature treatment solutions is substantial, where IBT
has established a comprehensive global network of KOLs and institutions.