Press release February 4, 2022
Message from the CEO
IBT’s ongoing pivotal phase lll clinical trial aims to generate data to improve survival possibilities of premature infants. This is accomplished by documenting the effects of IBP-9414 regarding two specific goals: prevention of NEC and reduction of time to Sustained Feeding Tolerance (SFT). The goal in SFT is dual. We know that proper digestion enables normal development in infants, however, we have also shown that reducing the period until the infants have achieved SFT reduces the risk of severe complications, e.g. Sepsis.
Therefore, our study measures how IBP-9414 affects the period from birth until SFT is reached and how the incidence of NEC is affected. SFT is thus the second primary “endpoint“, which was validated in 2021 by an agreed procedure with the FDA in which SFT correlates with fewer serious complications. This enables the study to evaluate two primary endpoints instead of one.
In this CEO commentary covering the fourth quarter 2021, I’m expanding on how Covid has affected us recently.
IBT included its initial patient in the comprehensive phase lll trial (“The Connection Study”) in July 2019. The study was well received and patient recruitment initiated right away at the hospitals which were open for participation in the study. The first 15 hospitals were quickly integrated as the infrastructure was in place as the majority of these had participated in our successfully concluded phase ll clinical trial during 2016 and 2017.
Following this promising start, we encountered recruitment challenges which we took action on. We learned that our CRO (Clinical Research Organization, i.e. the company assisting IBT to conduct the study) required assistance to increase the recruitment of infants. Furthermore, we improved and simplified procedures while simultaneously deciding to expand the study to five more countries. One of the decisions taken in early 2020 was for the IBT staff to visit and assist hospitals to initiate patient recruitment. We soon concluded that our efforts generated results and we were again happily recruiting as expected.
We had resumed control over recruitment in our study as we received news of a virus spreading in China. Shortly thereafter, Covid was a fact, and visiting hospitals, which we knew would expedite recruitment, became impossible. Additional challenges needed to be addressed, such as ensuring GCP (Good Clinical Practice). Practical issues such as fathers not being allowed to visit hospitals hampered recruitment as the written consent by both parents is required for inclusion in our clinical trial. To effectively resolve this IBT integrated “e-consenting”, or electronic consent. This was no trivial matter, as the hospital staff needed to conduct several process amendments during a period when they were stretched due to the increased burden at hospitals as a consequence of Covid. In particular, staff responsible for managing respirators took a heavy load which are the very same staff required to conduct our study. In addition, all non-critical staff, like IT-technicians not involved in direct care were sent home, increasing the difficulties in amending procedures. These are examples of the several challenges we encountered and solutions deployed by IBT, and I hereby wish to express my sincere gratitude to the staff for all they have accomplished since the spring of 2020, which has allowed us to continue our study during the pandemic.
The pace of recruitment during late fall in 2021 was progressing well, until Omicron struck. As of today, February 4, 2022 a total of 788 patients have been recruited in our study. The average pace of recruitment during Omicron amounts to approximately 50 patients per month. The decisive factor is how Omicron develops going forward, which nobody knows. The health authority is therefore assuming several scenarios. Given that approach, I provide three possible scenarios: Low; Omicron remains at current levels and consequently we continue to recruit 50 infants per month, which would result in recruitment concluding in 2024. Medium; the effects of Covid diminishes during the spring and the pace of recruitment increases, however, a new virus strain strikes during the fall, negatively affecting recruitment. I then expect us to conclude recruitment during 2023. High; Covid diminishes rapidly with the effects on society returning to a normal, pre-Covid situation, increasing our level of recruitment to above 100 infants per month in which case we conclude recruitment during the current year.
IBT continuously ”monitors” the hospitals’ work and reporting of patient data. Assessment of our work to ensure quality in the study is ongoing, and our evaluation of noted deviations is that they are not of any decisive consequence for the outcome of results in the study. In addition, we have passed several important milestones in the clinical development program:
In addition, we have an automatic control system adopting an algorithm performing predetermined calculations, which may trigger a safety analysis by the DMC. The DMC conducted such an analysis which was concluded on September 22, 2021. We have conducted 11 such analyses of which two after September 22, 2021, without any requirement of additional analysis.
We are also pleased that IBTs own patents providing exclusivity for IBP-9414 continuously are approved by more countries. The patent was approved in Brazil and Hong Kong during the fourth quarter, and in Australia during the first quarter of 2022.
IBT has restructured and improved its efficiency in its financial reporting responsibilities, and as part thereof we are pleased that Michael Owens has resumed his role as CFO. Michael has a background as an authorized accountant and has been active since many years as CFO in several life science companies. He has had the role of Controller of IBT since 2015.
We now enter into a stage of commercialization for IBP-9414, and I hereby wish to welcome Mr. Robert Molander as global Chief Commercial Officer. Robert has many years of experience commercializing pharmaceuticals in the US. His office location is in New Jersey, USA.
In closing, I wish to thank all our staff and experts who with great devotion progress our unique product which may be of major significance for the premature infants.
Stockholm, February 4, 2022
Financial overview for the period
Fourth quarter (Oct-Dec) 2021 Reporting period (Jan-Dec) 2021
* Operational income includes exchange rate effects on foreign currency deposits for the purpose of securing future outflows during the fourth quarter amounting to KSEK 5,296 (-11,741) and during the reporting period (Jan-Dec) to KSEK 18 846 (-15 125).
Significant events during the fourth quarter (Oct-Dec)
Significant events previously during the year
Significant events after the reporting period
|Selected financial data|
|Operating profit/loss||-16 093||-26 702||-44 578||-71 918|
|Result after tax||-16 218||-26 726||-44 991||-72 007|
|Total assets||408 478||450 318||408 478||450 318|
|Cash flow for the period||-8 904||-27 864||-55 532||-56 625|
|Cash flow per share for the period (SEK)||-0.79||-2.48||-4.95||-5.04|
|Cash||386 752||423 438||386 752||423 438|
|Earnings per share before and after dilution (SEK)||-1.44||-2.38||-1.44||-6.41|
|Equity per share (SEK)||35.21||39.21||35.21||39.21|
|Equity ratio (%)||97%||98%||97%||98%|
About Infant Bacterial Therapeutics AB
Infant Bacterial Therapeutics AB (“IBT”) is a public company domiciled in Stockholm. The company’s Class B shares are listed on Nasdaq Stockholm, Small-cap (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 NEC and sepsis by promoting 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. By developing these drugs, IBT has the potential to fulfill unmet needs for diseases where there are currently no prevention or treatment therapies available.
For additional information, please contact
Staffan Strömberg, VD
Michael Owens, CFO
Infant Bacterial Therapeutics AB
111 21 Stockholm
Telefon: +46 76 219 37 38
This information is information that Infant Bacterial Therapeutics AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 20:00 CET on February 4, 2022.