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Infant Bacterial Therapeutics AB (publ) (IBT-B.ST)

Stockholm - Stockholm Real-time price. Currency in SEK
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93.00+0.70 (+0.76%)
At close: 5:29PM CEST
Full screen
Previous close92.30
Open92.00
Bid91.60 x 0
Ask92.80 x 0
Day's range91.60 - 93.50
52-week range91.00 - 225.00
Volume17,720
Avg. volume20,928
Market cap1.044B
Beta (5Y monthly)1.70
PE ratio (TTM)N/A
EPS (TTM)-6.41
Earnings dateN/A
Forward dividend & yieldN/A (N/A)
Ex-dividend dateN/A
1y target est300.00
  • Globe Newswire

    Annual General Meeting of Infant Bacterial Therapeutics

    At the Annual General Meeting of Infant Bacterial Therapeutics AB (publ) on May 4, 2021, among other things, the following was resolved: adoption of the annual reportthat no dividend is givendischarge from liability granted to board members and the Chief Executive Officerthat the board shall consist of six members without deputiesthat remuneration should be paid to the Chairman of the Board of SEK 250,000 and an additional remuneration for the work as Chairman of the Board of SEK 400,000 and to other members of the company not employed by SEK 125,000 each. For members of the Remuneration Committee, a fee of forty thousand 40,000 is proposed to the Chairman and twenty thousand SEK 20,000 to each of the other members of the Committeethat the audit fee be paid according to approved invoicere-election of Margareta Hagman, Eva Idén, Anthon Jahreskog, Kristina Sjöblom Nygren, Robert Molander and Peter Rothschild as board membersre-election of Peter Rothschild as Chairman of the Boardre-election of the registered accounting firm Deloitte ABon the nomination committee in accordance with the nomination committee's proposalguidelines for remuneration to senior executives in accordance with the Board's proposal, andThe Board’s proposal for a resolution regarding mandate for a new issuance of B shares About Infant Bacterial Therapeutics ABInfant Bacterial Therapeutics AB (publ) is a pharmaceutical company with a product in 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, 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, CEODaniel Mackey, CFOInfant Bacterial Therapeutics ABBryggargatan 10111 21 StockholmPhone: +46 70 670 1226info@ibtherapeutics.comwww.ibtherapeutics.com PublicationThe information was submitted for publication, through the agency of the contact persons set out above, at 16:30 CET on May 4, 2021. Attachment PR 20210504 AGM ENG

  • Globe Newswire

    Infant Bacterial Therapeutics AB (publ) Interim Management Statement, January 1 – March 31, 2021

    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 USA during 2016 through to 2017. During the latter part of the first quarter in 2021 we have, however, in the recruiting hospitals, achieved the recruitment levels expected prior to the initiation of the phase III-study in July of 2019. The recruitment level of infants in the USA has increased, and it is a fair assumption that the increased levels result from the fact that USA has begun to “open up” following a comprehensive vaccination program in the country. We now hope to see a similar effect during the latter part of 2021 in other parts of the world where our study is being conducted. Considerable efforts by our staff have led to increased recruitment since the USA “opened up”. However, the pandemic is not over, and we can ascertain that currently we have many hospitals where the administrative preparation is completed, i.e. study approval and study medicine are in place, but that recruitment has not commenced due to resources having been diverted elsewhere within the hospitals. Considering the fact that the pandemic is ongoing, it is naturally difficult to estimate with any certainty when we may be able complete the study. We do however still expect to be able to complete the study in 2022. In February 2021 we announced that we have concluded the initial phase in our phase III-trial upon recruitment of 300 patients. During the first quarter, the data from these 300 patients have been reviewed by the independent group of experts called the Data Monitoring Committee (DMC). The DMC has reported its conclusions to IBT, and just days ago, IBT was able to increase the inclusion criteria in the study as planned, based on the recommendations by the DMC. This means that we now are able to recruit infants with birthweights from 500 grams to 1000 grams instead of previously only recruiting infants with birthweights from 750 grams to 1000 grams. As this amendment nearly doubles the theoretically possible number of infants eligible for recruitment in our study, our expectation is that the new recruitment criteria will further increase our recruitment levels. It is satisfying to report that within just a few days after opening the new weight group, we have already recruited infants in this weight group. During the first quarter of 2021 we also recruited our first patient in Bulgaria, and we currently have 75 active hospitals able to recruit patients versus 68 during the previous quarter. 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 China and Japan. This may provide considerably improved protection for potentially exclusive sales of our product. IBT has Orphan Drug status for the IBP-9414 project in both the US and the EU, but lacks the corresponding possibilities in both China and Japan. It is therefore positive that the patents have been granted in particular in China and Japan as they are expected to provide protection until 2036 in these two important markets. 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. Stockholm May 4, 2021 Staffan Strömberg Chief executive officer Interim report January 1-March 31, 2021 First quarter (Jan-Mar) 2021 Net sales 0 KSEK (0 Operating income 452 KSEK* (1 206)Earnings per share before and after dilution 0.04 (SEK) 0.10 * 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 in Japan 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 in China 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's2021Jan-Mar2020Jan-Mar2020Jan-Dec Net sales--- Other income, KSEK6475- Operating profit/loss, KSEK4521 206-71 918 Result after tax, KSEK4511 178-72 007 Total assets, KSEK451 138523 168450 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, KSEK425 758500 995423 438 Earnings per share before and after dilution (SEK)0.04-0.10-6.41 Equity per share (SEK)39.2645.5739.21 Equity ratio (%)98%98%98% About Infant Bacterial Therapeutics ABInfant Bacterial Therapeutics AB (publ) is a pharmaceutical company with a product in 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, 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, CEODaniel Mackey, CFOInfant Bacterial Therapeutics ABBryggargatan 10111 21 StockholmPhone: +46 70 670 1226info@ibtherapeutics.comwww.ibtherapeutics.com Publication The information was submitted for publication on May 4, 2021 at 08:00 (CET). Attachments PR 20210504 Q1 ENG IBTQ1Report2021ENG

  • Globe Newswire

    Infant Bacterial Therapeutics expands The Connection Study to include infants with a birth weight below 750 grams

    After the Data Monitoring Committees’ review Infant Bacterial Therapeutics expands the enrollment criteria of The Connection Study to include 500 - 1000 gram birth weight premature infants. The Data Monitoring Committee (DMC) has performed a per protocol predefined safety and tolerability assessment of the first 300 patients included in the study. The review is now complete and the DMC has no objections to the continuation of the Connection Study and expansion of the enrolment criteria from 750 to 1000 grams to include 500 to 1000 gram birth weight premature infants. All participating hospitals will be informed immediately of this change. The possibility to recruit infants in the 500 to 749 gram interval adds a significant number of patients eligible for inclusion into the Connection Study. The DMC is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing. “The medical need for preventive treatment for necrotizing enterocolitis and to improve feeding tolerance in preterm infants remains very high. IBT anticipates the completion of the study during 2022 and we expect that the opening up of the US society after their successful vaccination campaign against COVID together with the expansion of the birth weight window will increase the recruitment pace of our important study” says Staffan Strömberg, Chief Executive Officer of IBT. About Infant Bacterial Therapeutics ABInfant Bacterial Therapeutics AB (publ) is a pharmaceutical company with a product in 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, 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, CEODaniel Mackey, CFOInfant Bacterial Therapeutics ABBryggargatan 10111 21 StockholmPhone: +46 70 670 1226info@ibtherapeutics.comwww.ibtherapeutics.com Publication 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 22:00 CET on April 29, 2021. Attachment PR 20210429 DMC300 ENG