Message from the CEO
IBT is conducting a phase III-study (“The Connection Study”) which is the last phase of the clinical development program with the pharmaceutical candidate IBP-9414 containing Lactobacillus reuteri as active substance. The active substance is a human bacterial strain found naturally in breast milk. The objective of the study is to show that the active substance can prevent necrotizing enterocolitis (NEC) and improve sustained feeding tolerance.
The medical need of a well-functioning digestion system is very high in premature infants and it is our expectation that IBT’s pharmaceutical candidate IBP-9414 may improve gut motility in nutritional uptake, and simultaneously also reduce the risk for several complications such as NEC.
The COVID-19 pandemic has now lasted more than one year. I have in previous quarterly statements described how IBT is affected by the pandemic. The pandemic has affected the recruitment level in the phase III-study, and at the same time the quality in the generated data is high, in spite of COVID-19. We have noted a lower recruitment level than we observed in our phase II-study conducted at 15 hospitals in the
In
During the first quarter of 2021 we also recruited our first patient in
It is worth reiterating that the bulk of the costs for conducting the study are incurred at the time of recruitment. IBT’s liquidity is expected to be sufficient to complete the study.
During the first quarter, our own first patents were approved both in
Finally, I wish to extend my gratitude to all our staff and consultants who with great dedication drive the work forward with a product which can have an important role for the premature infants.
Staffan Strömberg
Chief executive officer
Interim report
First quarter (Jan-Mar) 2021
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* Operational income includes exchange rate gains on foreign currency deposits for the purpose of securing future outflows amounting to 12 114 (13 857) KSEK.
Significant events during the first quarter (Jan-Mar) 2021
- On
February 9 , we announced that the Japan Patent Office has issued a decision to grant a patent entitled: “A method of activating lactic acid bacteria”, which protects the formulation of Lactobacillus reuteri including IBP-9414. The Japanese patent is valid until 2036 and IBP-9414 is intended for marketing inJapan upon market approval.. - On
February 10 , we announced that the company has reached an important milestone after recruiting 300 premature infants to the ongoing clinical Phase III study of IBP-9414. This also means that a safety analysis of these infants will take place in order to also recruit infants with a very low birth weight, which in turn is expected to significantly increase the recruitment rate. Furthermore it means that IBT has an opportunity to validate the study’s second primary endpoint, “feeding tolerance”, and redefine this if necessary. - In response to the COVID-19 pandemic and the coronavirus, IBT is closely monitoring developments and is actively taking measures to minimize or limit affects thereof on the company’s operations. IBT adheres to directives issued by Folkhälsomyndigheten, the WHO and ECDC (European center for prevention and control of disease). The pandemic affects the recruitment level in IBT’s pivotal study, “The Connection study”. The bulk of the costs for conducting the study are generated in connection with recruitment of patients, and thus the assessment is that IBT has sufficient funds to conclude the study even if this occurs at a later point in time than originally planned.
Significant events after the reporting period
- On
April 15 , we announced that the Chinese Patent Office has issued a decision to grant a patent entitled: “A method of activating lactic acid bacteria”, which protects the formulation of Lactobacillus reuteri. The Chinese patent is valid until 2036 and IBP-9414 is intended for marketing inChina upon market approval. - On Aprll 29, we announced that inclusion criteria of The Connection Study has been expanded to include 500 - 1000 gram birth weight premature infants (from earlier 750 -1000 grams) after the Data Monitoring Committees’ planned review of study data. Since
April 29 , infants in this weight group have been recruited.
Selected financial data | ||||
ooo's | 2021 Jan-Mar | 2020 Jan-Mar | 2020 Jan-Dec | |
Net sales | - | - | - | |
Other income, KSEK | 64 | 75 | - | |
Operating profit/loss, KSEK | 452 | 1 206 | -71 918 | |
Result after tax, KSEK | 451 | 1 178 | -72 007 | |
Total assets, KSEK | 451 138 | 523 168 | 450 318 | |
Cash flow for the period, KSEK | -9 794 | -8 050 | -56 625 | |
Cash flow per share for the period (SEK) | -0.87 | -0.72 | -5.04 | |
Cash, KSEK | 425 758 | 500 995 | 423 438 | |
Earnings per share before and after dilution (SEK) | 0.04 | -0.10 | -6.41 | |
Equity per share (SEK) | 39.26 | 45.57 | 39.21 | |
Equity ratio (%) | 98% | 98% | 98% |
About
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.
For additional information please contact
Staffan Strömberg, CEO
Bryggargatan 10
111 21 Stockholm
Phone: +46 70 670 1226
info@ibtherapeutics.com
www.ibtherapeutics.com
Publication
The information was submitted for publication on
Attachments
- PR 20210504 Q1 ENG
- IBTQ1Report2021ENG
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