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IBT B - Infant Bacterial Therapeutics AB News Story

SEK104.6 -2.4  -2.2%

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Sector
Healthcare
Size
Small Cap
Market Cap £102.0m
Enterprise Value £65.9m
Revenue £n/a
Position in Universe 888th / 1828

Infant Bacterial Therapeutics AB (publ) Interim Management Statement, January 1 – September 30, 2020

Thu 5th November, 2020 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 has been ongoing for almost nine months. The pandemic not only affects
our work at IBT but of course also the staff at the hospitals where our study
is ongoing. Right now, in November 2020, it seems as if the hospitals now
again have to care for more COVID-19 patients compared to just a couple of
months ago. As the development of the pandemic is difficult to assess, it is
equally difficult to predict how it will affect IBT's timelines. I would like
to mention again that our study is not dependent on “normal” hospital or
doctor visits, as the infants we recruit are already in the intensive care
units independent of our study. This is important as many hospitals have now
introduced restrictions for non-essential visitors.

As I mentioned earlier, we have managed to change our way of working in order
to ensure the quality of our study by, amongst other things, carrying out
so-called virtual monitoring and providing the study drug to all recruiting
hospitals despite the ongoing COVID pandemic. We have previously communicated
that in order to increase the recruitment rate, we have applied to start our
clinical study in four more European countries, Poland, Serbia, Bulgaria and
Romania. During the third quarter, we have received trial permits in Poland
while we are still working on Serbia, Bulgaria and Romania. At the time of
writing, we have 101 contracted hospitals, of which 62 are activated and may
include patients. During the third quarter, we have managed to open more
hospitals compared to the previous quarter when we had 76 contracted and 55
activated. Our goal of completing the ongoing Phase III study in 2021 will
most likely not be achieved in the face of the continuing pandemic and its
effects on patient recruitment. However, it is important to emphasize that
IBT's cash is sufficient for the completion of the ongoing phase III study,
even if it takes longer than we would like.

We monitor our study on a regular basis and we can today confirm that the
study generates data in the way we predicted. Specifically, we see, among
other things, good compliance with the protocol, e.g. administration of the
study drug and that the reporting system for clinical observations works well
and as expected. We have also carried out two pre-planned safety-oriented
interim analyses. The outcome of these analyses is that we continue the study
as planned. We also have a planned pilot sub-study regarding "feeding
tolerance" which includes data from 300 infants in the current study.
Preparations for the analysis in this sub-study are ongoing.

IBT has strengthened its organization by hiring a clinical project manager and
a CMC (Chemistry, Manufacturing and Controls) manager. Both of these recruits
add significant competence to the organization, which ensures that we can
better meet future challenges.

IBT's qualified team continues to work in a dedicated and focused manner to
deliver study results which in turn hopefully means that a product, which
could play a vital role for the well-being of premature infants, can reach the
market as soon as possible. Today, no drug against NEC exists on the market,
and as far as is known to IBT, no other company has any ongoing clinical study
for a potential pharmaceutical to prevent, alleviate or cure NEC. IBT thus has
a substantial edge over other possible future players in the market.

Stockholm, November 5, 2020

Staffan Strömberg

Chief Executive Officer

Significant events during the third quarter (Jul-Sep) 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, approximately 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-Sep) 2020

 •  IBT’s clinical study application was approved in Israel at the end
of January 2020

Significant events after the reporting period

 •  No significant events have occurred after the reporting period

 Selected financial data                                                                               
 ooo's                                               2020      2019      2020      2019      2019      
                                                     Jul-Sep   Jul-Sep   Jan-Sep   Jan-Sep   Jan-Dec   
 Net sales                                           -         -         -         -         -         
 Operating profit/loss                               -18 586   -11 007   -45 294   -19 774   -47 200   
 Result after tax, SEK                               -18 600   -10 538   -45 359   -18 786   -46 320   
 Total assets                                        480 304   545 348   480 304   545 348   518 273   
 Cash flow for the period (SEK)                      -6 693    -34 064   -28 761   -42 755   -51 301   
 Cash flow per share for the period (SEK)            -0.60     -3.03     -2.56     -3.81     -4.57     
 Cash                                                463 043   511 888   463 043   511 888   495 188   
 Earnings per share before and after dilution (SEK)  -1.66     -0.94     -4.04     -1.67     -4.13     
 Equity per share (SEK)                              41.43     47.92     41.43     47.92     45.46     
 Equity ratio (%)                                    97%       99%       97%       99%       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

 

 

Attachments
*     IBTQ3Report2020ENG
(https://ml-eu.globenewswire.com/Resource/Download/c9f0fb59-296f-459e-a763-985bbca0e688)
  
*     PR 20201105 Q3 ENG
(https://ml-eu.globenewswire.com/Resource/Download/49eabe0c-80fd-4962-bf74-68e366bdef56)
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