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IBT B - Infant Bacterial Therapeutics AB News Story

SEK111.6 2.6  2.4%

Last Trade - 12/05/21

Sector
Healthcare
Size
Small Cap
Market Cap £105.8m
Enterprise Value £69.9m
Revenue £n/a
Position in Universe 880th / 1830

Infant Bacterial Therapeutics AB (publ) Interim Management Statement, January 1 – December 31, 2020

Fri 5th February, 2021 7:00am
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Message from the CEO

IBT is currently developing its lead drug candidate IBP-9414 to prevent
necrotizing enterocolitis (NEC), and to improve so-called "feeding tolerance"
in premature infants. IBP-9414 contains Lactobacillus reuteri as an active
ingredient, which is a human bacterial strain found naturally in breast
milk. 

This message from the CEO is written during the continuing COVID-19 pandemic
which now has been ongoing for one year. The pandemic appeared to be under
control during the fall, however the outbreak of COVID worsened during
November and December in many parts of the world. I have in previous quarterly
reports described the impact of the pandemic on IBT. Simply put, our
recruitment rate is affected, but the quality of data generated in the study
is not. The bulk of the costs for conducting the study are incurred at the
time of recruitment. This means that IBT’s liquidity is expected to be
sufficient to complete the study even if the study is concluded at a later
point in time.

Scientific articles published during the final quarter of 2020 stated that the
birth rates of premature infants were lower than in previous years. The
authors mention for example the fact of reduced shift-labor being performed
along with improved diets, and also limited social contacts as possible
factors affecting observations of reduced numbers of premature births.
Regardless of the cause, we have received similar signals from our direct
contact with neonatologists in our study that have also indicated reduced
numbers in premature births. We expect the number of births to return to
normal when the COVID pandemic decreases in intensity.

IBT’s study design includes infants with birthweights from 500 to 1 500
grams, however, thus far in the study we only included infants with
birthweights from 750 to 1 000 grams, i.e. a range of 250 grams. IBT always
applies the rule of caution, which is a regulatory key for us as the sole
company worldwide with FDA approval of dosing premature infants with live
bacteria. We have in addition to trial permits in the USA been granted
approval for our study also in France, Hungary, Israel, Spain, and the UK, and
in the fourth quarter also received approvals in Poland and Bulgaria. We
currently have 68 active hospitals which are able to include patients compared
to 62 in the previous quarterly report. It is against this background that we
have chosen to open up for inclusion of patients under 750 grams only after
reviewing the data from the initial 300 patients. We expect to have included
300 patients in the study within the month.

The fact that we during the initial phase of the study recruit patients in a
narrow range of 250 grams, during an ongoing pandemic, has resulted in
relatively few patient inclusions to date. IBT hopes that diminishing effects
of the pandemic in combination with opening up the study to include infants
born below 750 grams will significantly increase the recruitment rate during
2021.

We have during the fourth quarter aimed for a better understanding of the
value of our second primary endpoint in the phase III-study, “sustained
feeding tolerance”.  After consultations with the FDA, an expert group has
been established by IBT comprised of neonatologists, nurses, and patient
organizations. Our goal with this expert group is to better understand as well
as to demonstrate how malnutrition negatively affects premature infants both
in the short and long term. These experts have already made clear that poor
nutrition reduces growth of infants resulting in severe suffering in
combination with high costs for healthcare payers. We seek to quantify the
market value of improved “feeding tolerance” by our product IBP-9414 and I
shall revisit the issue in due course.

We at IBT look forward to continuing our development work as our efforts can
have great impact for all premature infants. Motivation will be even higher
after the initial phase of this study, comprised of 300 patients, is
concluded.

Stockholm, February 5, 2021

Staffan Strömberg 
Chief Executive Officer

Financial overview for the period                      

 Fourth quarter (Oct-Dec) 2020                                     Reporting period (Jan-Dec) 2020                                   
 * Net sales 0 KSEK (0)                                            * Net sales 0 KSEK (0)                                            
 * Operating income -26 702 KSEK* (-27 428)                        * Operating income -71 918** KSEK (-47 200)                       
 * Earnings per share before and after dilution -2.38 SEK (-2.45)  * Earnings per share before and after dilution -6.41 SEK (-4.13)  

 

Significant events during the fourth quarter (Oct-Dec) 2020
•  The COVID-19 pandemic affects our development work, for example,
activation of hospitals, which has not occurred at the desired rate. As of the
date of this interim report, more than half of the planned hospitals have been
activated. IBT's cash position is sufficient to carry out the ongoing Phase
III study, even if recruitment in the study currently does not take place at
the desired rate

Significant events during the reporting period (Jan-Dec) 2020
•  IBT’s clinical study application was approved in Israel in January, in
Poland in October and in Bulgaria in November

Significant events after the reporting period
•  No significant events have occurred after the reporting period

 Selected financial data                                                                     
 ooo's                                               2020      2019      2020      2019      
                                                     Oct-Dec   Oct-Dec   Jan-Dec   Jan-Dec   
 Net sales                                           -         -         -         -         
 Operating profit/loss                               -26 702   -27 428   -71 918   -47 200   
 Result after tax, SEK                               -26 726   -27 535   -72 007   -46 320   
 Total assets                                        450 318   518 273   450 318   518 273   
 Cash flow for the period (SEK)                      -27 864   -8 546    -56 625   -51 301   
 Cash flow per share for the period (SEK)            -2.48     -0.76     -5.04     -4.57     
 Cash                                                423 438   495 188   423 438   495 188   
 Earnings per share before and after dilution (SEK)  -2.38     -2.45     -6.41     -4.13     
 Equity per share (SEK)                              39.21     45.46     39.21     45.46     
 Equity ratio (%)                                    98%       98%       98%       98%       

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 feeding tolerance in
premature infants. IBP-9414 contains the active substance 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.

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

The information was submitted for publication on February 5, 2021 at 08:00
(CET).



 

 

Attachments
*     PR 20210205 Q4 ENG
(https://ml-eu.globenewswire.com/Resource/Download/b01928df-6f2a-4bd0-8fa5-ebfc2ba6df87)
  
*     IBTQ4Report2020ENG
(https://ml-eu.globenewswire.com/Resource/Download/55691c68-54b0-40a9-9f09-ba335c99eaaf)
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