Infant Bacterial Therapeutics AB (publ), (IBT) has been approved for listing on Nasdaq First North’s Premier segment.

Infant Bacterial Therapeutics AB (publ) (“IBT”), today traded on Nasdaq First North, has applied and been approved for listing on Nasdaq First North’s Premier segment. Companies which are listed on the Premier segment generally apply the same rules as the Nasdaq Stockholm main list, which means that going forward IBT will follow the more extensive requirements. In addition, the Premier segment rules include a recommendation to follow the Swedish Code for Corporate Governance, which IBT intends to implement as of the month of March 2017.

 

The first day for trading on Nasdaq First North Premier is March 14, 2017.  IBTs shares will continue to trade under the same ticker and ISIN code.

 

Staffan Strömberg, Chief Executive Officer at IBT, commented “The listing on Nasdaq First North Premier is a natural step towards the main market of Nasdaq Stockholm.”

 

For additional information please contact

Staffan Strömberg, CEO, phone: +46 8 410 145 55

 

Infant Bacterial Therapeutics AB

Bryggargatan 10

111 21 Stockholm

Phone: +46 8 410 145 55

info@ibtherapeutics.com

 

About IBT:

Infant Bacterial Therapeutics AB (publ) (“IBT”) is a pharmaceutical company with a vision to develop drugs influencing the human infant microbiome, and thereby prevent or treat rare diseases affecting premature infants. Using its extensive experience in live bacterial therapeutics and its well-developed knowledge of the action of Lactobacillus reuteri, IBT is developing its lead drug candidate IBP-9414, to prevent necrotizing enterocolitis (“NEC”), a fatal, rare disease that afflicts premature infants. IBT is further pursuing a second rare disease programme IBP-1016 for the treatment of an unmet medical need in gastroschisis, a severe disease in infants. By developing these drugs, IBT has the potential to fulfil unmet needs for diseases where there are currently no prevention or treatment therapies available.

The FDA and the European Commission have granted IBT Orphan Drug Designation, and the FDA have granted Rare Pediatric Disease Designation for IBP-9414 for the prevention of NEC.

IBT is listed on Nasdaq First North with Erik Penser Bank as Certified Adviser.

www.ibtherapeutics.com

 

Publication

This information is information that Infant Bacterial Therapeutics AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 13.00 CET on March 10, 2017.

 

See Press Release in both English and Swedish

IBT Press Release 20170310 (English)

IBT Press Release 20170310 (English)

March 10, 2017

IBT to present at Bio-Europe Spring 2017

Infant Bacterial Therapeutics AB (publ) (“IBT”), a pharmaceutical company that develops drugs that meet the medical needs of premature infants, will present the company on Tuesday March 21, 2017 at Bio-Europe Spring Conference, Rare and Orphan Diseases track, at CCIB Convention Centre, Barcelona, Spain. The conference takes place between March 20-22, 2017.

 

Staffan Strömberg, President and Chief Executive Officer will represent the company in the presentation scheduled to begin at 11:30 local time.

 

About IBT:

Infant Bacterial Therapeutics AB (publ) (“IBT”) is a pharmaceutical company with a vision to develop drugs influencing the human infant microbiome, and thereby prevent or treat rare diseases affecting premature infants. Using its extensive experience in live bacterial therapeutics and its well-developed knowledge of the action of Lactobacillus reuteri, IBT is developing its lead drug candidate IBP-9414, to prevent necrotizing enterocolitis (“NEC”), a fatal, rare disease that afflicts premature infants. IBT is further pursuing a second rare disease programme IBP-1016 for the treatment of an unmet medical need in gastroschisis, a severe disease in infants. By developing these drugs, IBT has the potential to fulfil unmet needs for diseases where there are currently no prevention or treatment therapies available.

 

The FDA and the European Commission have granted IBT Orphan Drug Designation, and the FDA have granted Rare Pediatric Disease Designation for IBP-9414 for the prevention of NEC.

 

IBT is listed on Nasdaq First North with Erik Penser Bank as Certified Adviser.

www.ibtherapeutics.com

 

 

For additional information please contact

Staffan Strömberg, CEO

Infant Bacterial Therapeutics AB

Bryggargatan 10

111 21 Stockholm

Phone: +46 8 410 145 55

info@ibtherapeutics.com

 

See Press Release in both English and Swedish

IBT Press Release 20170301 (English)

IBT Press Release 20170301 (Swedish)

 

 

March 1, 2017

Infant Bacterial Therapeutics AB (publ), (IBT) Interim report January 1 – December 31 2016

Message from the CEO

“During the month of June, the first patients were recruited and dosed in IBTs clinical study, IBP-9414, in the USA.  The last patient was recruited on January 23, 2017 and the results of the study are expected during the autumn of 2017.  During the month of December, IBT presented a further development project, IBP-1016, which is aimed to address the medical issues that arise in infants that are affected by gastroschisis, a rare and serious disease.

 

2017 is going to be an important year for IBT.  We will continue to build our organization so that we are well prepared for future challenges.  We expect to understand how agencies and experts view our new project IBP-1016 and we also expect to receive our Phase II (NCT02472769) results.

 

It is our long-term hope and ambition to offer the market pharmaceuticals that can save the lives of premature infants and I am optimistic about the future of IBT and our projects.”

 

Staffan Strömberg,

Chief Executive Officer

  

Financial summary 2016 

Significant events during the second half year 2016

July – December

-   In November, the independent safety monitoring committee (DSMB) reviewed the ongoing phase ll clinical trial in IBP-9414 (NCT02472769). Following the recommendation by the DSMB it was decided to continue the trial with the higher dose of IBT’s drug candidate IBP-9414 in the final group of patients

-   In December, IBT announced that it is in the early planning stages of another project, IBP-1016, to develop a drug to treat the consequences of gastroschisis, a rare life threatening and debilitating birth abnormality in infants

 

Significant events during the reporting period

January-December

-   The Annual General Meeting decided on repayment of conditional shareholder contributions by offsetting previously received group contributions by SEK 20.6m

-   BioGaia AB (publ) distributed its entire holding (94.5 % of shares and 96 % of votes) in IBT to BioGaia’s shareholders

-   IBT’s shares were listed on Nasdaq First North

-   IBT completed a guaranteed share issue which generated approximately SEK 89m after deduction of issue costs

-   In June, the first premature infants were enrolled and dosed in the Company’s phase ll clinical trial in IBP-9414 (NCT02472769)

 

Significant events after the reporting period

 

-   In January 2017, all 120 patients were included in the Company’s phase ll clinical trial in IBP-9414 (NCT02472769)

 

For additional information please contact

Staffan Strömberg, CEO, phone: +46 8 410 145 55

 

Infant Bacterial Therapeutics AB

Bryggargatan 10

111 21 Stockholm

Phone: +46 8 410 145 55

info@ibtherapeutics.com

 

Publication

The information in this Interim Report is such which IBT is obliged to make public pursuant to the EU Market Abuse Regulation and which is to be made public according to the Nasdaq regulations for companies listed on Nasdaq First North.

The information was submitted for publication, by the CEO, at 08.00 a.m. CET on February 14, 2017.

 

About IBT:

Infant Bacterial Therapeutics AB (publ) (“IBT”) is a pharmaceutical company with a vision to develop drugs influencing the human infant microbiome, and thereby prevent or treat rare diseases affecting premature infants. Using its extensive experience in live bacterial therapeutics and its well-developed knowledge of the action of Lactobacillus reuteri, IBT is developing its lead drug candidate IBP-9414, to prevent necrotizing enterocolitis (“NEC”), a fatal, rare disease that afflicts premature infants. IBT is further pursuing a second rare disease programme IBP-1016 for the treatment of an unmet medical need in gastroschisis, a severe disease in infants. By developing these drugs, IBT has the potential to fulfil unmet needs for diseases where there are currently no prevention or treatment therapies available.

 

The FDA and the European Commission have granted IBT Orphan Drug Designation, and the FDA have granted Rare Pediatric Disease Designation for IBP-9414 for the prevention of NEC.

 

IBT is listed on Nasdaq First North with Erik Penser Bank as Certified Adviser.

www.ibtherapeutics.com

 

See Press release in both English and Swedish

IBT Press Release 20170214 (English)

IBT Press Release 20170214 (Swedish)

 

See the Year-End Report 2016 in both English and Swedish

IBT Year-End Report 2016 (English)

IBT Year-End Report 2016 (Swedish)

February 14, 2017

Last patient enrolled in IBT’s Phase 2 study

Infant Bacterial Therapeutics AB (publ) (“IBT”) announces that the last premature infant has now been enrolled and recruitment to the Phase 2 study is now closed.

 

The Phase 2 study (ClinicalTrial.gov identifier: NCT02472769), which is part of IBT´s NEC prevention development program, is a randomized, double blind, parallel-group, dose escalation placebo-controlled multicenter study performed at neonatal intensive care units in the USA. The aim of the study is to investigate the safety and tolerability of two doses of the drug candidate (IBP-9414) administered to preterm infants. One-hundred and twenty (120) premature infants with birth weights ranging from 500g to 2,000g are included in the study. All patients in the study are treated with IBP-9414 or placebo for 14 days. The study ends after the last infant has been followed up for 6 months after the last dose administered.

 

Staffan Strömberg, Chief Executive Officer of IBT, commented "Reaching this milestone within the expected time frame is the result of diligent work by the study investigators and our own staff. We are pleased to have reached this goal considering the urgent need for a preventive therapy against this fatal disease NEC.”

 

About Infant Bacterial Therapeutics AB

Infant Bacterial Therapeutics AB (publ) (“IBT”) is a pharmaceutical company with a vision to develop drugs influencing the human infant microbiome, and thereby prevent or treat rare diseases affecting premature infants. Using its extensive experience in live bacterial therapeutics and its well-developed knowledge of the action of Lactobacillus reuteri, IBT is developing its lead drug candidate IBP-9414, to prevent necrotizing enterocolitis (“NEC”), a fatal, rare disease that afflicts premature infants. IBT is further pursuing a second rare disease program for the unmet medical need gastroschisis, a severe disease in infants. By developing these drugs, IBT has the potential to fulfil unmet needs for diseases where there are currently no prevention or treatment therapies available.

The FDA and the European Commission have granted IBT Orphan Drug Designation, and the FDA have granted Rare Pediatric Disease Designation for IBP-9414 for the prevention of NEC.

 

IBT is listed on Nasdaq First North with Erik Penser Bank as Certified Adviser.

 

For additional information please contact

Staffan Strömberg, CEO

Infant Bacterial Therapeutics AB

Bryggargatan 10

111 21 Stockholm

Phone: +46 8 410 145 55

info@ibtherapeutics.com

 

This information is information that Infant Bacterial Therapeutics AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 16.50 CET on 24 January 2017.

 

See Press Release in both English and Swedish

IBT Press Release 20170124 (English)

IBT Press Release 20170124 (Swedish)

January 24, 2017

IBT to present at 9th Annual Biotech Showcase 2017

 

Infant Bacterial Therapeutics AB (publ) (“IBT”), a pharmaceutical company that develops drugs that meet the medical needs of premature infants, will present the company on Wednesday January 11, 2017 at the Biotech Showcase 9th Annual Conference at the Hilton San Francisco Union Square, 333 O'Farrell St, San Francisco. The conference takes place between Jan. 9-11, 2017.

 

Staffan Strömberg, President and Chief Executive Officer will represent the company in the presentation scheduled to begin at 11:30 am Pacific Time.

 

About Infant Bacterial Therapeutics AB

Infant Bacterial Therapeutics AB (publ) (“IBT”) is a pharmaceutical company with a vision to develop drugs influencing the human infant microbiome, and thereby prevent or treat rare diseases affecting premature infants. Using its extensive experience in live bacterial therapeutics and its well-developed knowledge of the action of Lactobacillus reuteri, IBT is developing its lead drug candidate IBP-9414, to prevent necrotizing enterocolitis (“NEC”), a fatal, rare disease that afflicts premature infants. IBT is further pursuing a second rare disease programme for the unmet medical need Gastroschisis-Related Intestinal Dysfunction (“GRID”), a severe disease in infants. By developing these drugs, IBT has the potential to fulfil unmet needs for diseases where there are currently no prevention or treatment therapies available.

The FDA and the European Commission have granted IBT Orphan Drug Designation, and the FDA have granted Rare Pediatric Disease Designation for IBP-9414 for the prevention of NEC.

 

IBT is listed on Nasdaq First North with Erik Penser Bank as Certified Adviser.

 

 

 

For additional information please contact

Staffan Strömberg, CEO

Infant Bacterial Therapeutics AB

Bryggargatan 10

111 21 Stockholm

Phone: +46 8 410 145 55

info@ibtherapeutics.com

www.ibtherapeutics.com

 

See Press Release in both English and Swedish

IBT Press Release 20161215 (English)

IBT Press Release 20161215 (Swedish)

 

December 15, 2016

IBT adds new indication for Gastroschisis-Related Intestinal Dysfunction

Infant Bacterial Therapeutics AB (publ) (“IBT”), a pharmaceutical company that develops drugs that meet the medical needs of premature infants, is in the early planning stages of developing a drug to treat gastroschisis-related intestinal dysfunction (“GRID”) using its live bacterial technology based on Lactobacillus reuteri.

 

GRID is a direct consequence of gastroschisis, a rare, life-threatening and debilitating birth abnormality in late preterm infants where the infant is born with externalized intestines. Infants suffering from GRID have a greatly increased risk of sepsis and liver cholestasis. GRID represents an area of significant unmet medical need with no definitive treatment available. Therefore, post-operative management of gastroschisis is largely aimed at overcoming the significant morbidity related to the reduction in gut motility and consequent feeding intolerance necessitating the prolonged requirement for parenteral nutrition. It is common for neonates born with gastroschisis to have typically an extended hospital stay of 1-5 months thereby causing significant burden to the healthcare system.

 

Based on Lactobacillus reuteri's known anti-pathogen and anti-inflammatory effects as well as effects on gut motility, and building on its knowledge from necrotizing enterocolitis (“NEC”), IBT believes Lactobacillus reuteri will have significant benefits in the treatment of GRID.

 

About Infant Bacterial Therapeutics AB

Infant Bacterial Therapeutics AB (publ) (“IBT”) is a pharmaceutical company with a vision to develop drugs influencing the infant microbiome, and thereby prevent or treat rare diseases affecting premature infants. Currently, IBT’s lead clinical programme is focused on developing the drug candidate, IBP-9414, using Lactobacillus reuteri to prevent necrotizing enterocolitis (“NEC”), a fatal disease that afflicts premature infants. IBT is listed on Nasdaq First North with Erik Penser Bank as Certified Adviser.

 

For additional information please contact

Staffan Strömberg, CEO

Infant Bacterial Therapeutics AB

Bryggargatan 10

111 21 Stockholm

Phone: +46 8 410 145 55

info@ibtherapeutics.com

www.ibtherapeutics.com

 

See Press Release in both English and Swedish

IBT Press Release 20161214 (English)

IBT Press Release 20161214 (Swedish)

December 14, 2016

Positive recommendation from the independent Data Safety Monitoring Board to continue Phase II Study

 

IBT announces that the second and last planned evaluation of safety data by the independent Data Safety Monitoring Board (DSMB), in the ongoing Phase II clinical study, was performed on November 18th. The DSMB concluded that there were no objections to dose escalation into the final cohort of the smallest  premature babies, who will be dosed with the highest dose of IBT´s drug candidate IBP-9414.

 

"We are very pleased that we now have 90 of the 120 premature babies recruited and that the study is progressing according to plan. This is another major milestone in the development of a new pharmaceutical for this very sensitive group of patients”, says Staffan Strömberg, CEO IBT.

 

The Phase ll trial is a randomized, double blind, parallel group, dose escalation, placebo-controlled multicenter study to investigate the safety and tolerability of IBP-9414 administered in preterm infants. The multicenter trial is being conducted in a number of neonatal intensive care units in the US and will enroll 120 premature infants in total.

 

 

For additional information please contact

Staffan Strömberg, CEO, phone: +46 8 410 145 55

 

Infant Bacterial Therapeutics AB

Bryggargatan 10

111 21 Stockholm

Phone: +46 8 410 145 55

info@ibtherapeutics.com

 

 

See Press Release in both English and Swedish

IBT Press Release 20161121 (English)

IBT Press Release 20161121 (Swedish)

November 21, 2016

Infant Bacterial Therapeutics AB appoints new CFO

Infant Bacterial Therapeutics AB (publ.) (“IBT”) is pleased to announce the appointment of Daniel Mackey as Chief Financial Officer (CFO) from January 2017 replacing Michael Owens in this role. Michael Owens will continue as financial controller of the company.

 

Daniel has 20 years experience from diverse U.S. and international management positions in finance and accounting with Investors Bank & Trust Co., Nordea Investment Management AB and Nordea Bank AB.  In his role as CFO, Daniel will be responsible for overseeing capital and financing strategies, accounting and investor relations.

 

- We welcome Daniel to IBT. Our current operational focus is on the on-going US phase-II clinical trial. Next year will hold important new challenges and we are therefore very pleased to have Daniel on board to contribute to the development of IBT, says Staffan Strömberg CEO.

 

More information about the IBT Team is available here

 

 

For additional information please contact

Staffan Strömberg, CEO, phone: +46 8 410 145 55

 

Infant Bacterial Therapeutics AB

Bryggargatan 10

111 21 Stockholm

Phone: +46 8 410 145 55

info@ibtherapeutics.com

 

 

See Press Release in both English and Swedish

IBT Press Release 20161012 (English)

IBT Press Release 20161012 (Swedish)

October 12, 2016

Infant Bacterial Therapeutics AB (publ), (IBT) Interim report January 1 – June 30 2016

 

Message from the CEO

“In June we announced that the first premature infant had been enrolled and dosed in the Company´s Phase ll clinical trial. This Phase ll trial is a randomized, double blind, parallel group, dose escalation, placebo-controlled multicenter study to investigate the safety and tolerability of IBP-9414 administered in preterm infants. The multicenter trial is being conducted in a number of neonatal intensive care units in the US and will enroll 120 premature infants in total. The first planned independent Data Safety Monitoring Board (DSMB) evaluation of safety data was performed on August 12th. The DSMB concluded that there were no objections to dose escalation based on the information provided to the DSMB.

We are very pleased that the trial has begun and is progressing according to plan. This is another major milestone in the development of a new pharmaceutical for this very sensitive group of patients.”

 

Staffan Strömberg,

Chief Executive Officer

 

Financial summary

Financial Summary

Significant events during the first six months

  • ●   Annual General Meeting decided on 8 February on repayment of conditional shareholder contributions by offsetting previously received group contributions by SEK 20.6m
  • ●   BioGaia AB (publ) distributed its entire holding (94.5 % of shares and 96 % of votes) in IBT to BioGaia’s shareholders
  • ●   IBT’s shares were listed on Nasdaq First North
  • ●   IBT completed a guaranteed share issue which generated approximately SEK 89m after deduction of issue costs
  • ●   The first premature infant has been enrolled and dosed in the Company’s Phase ll clinical trial

 

 

Significant events after the reporting period 

  • ●   There were no significant events after the reporting period prior to the date of publication of this interim report

 

For additional information please contact

Staffan Strömberg, CEO, phone: +46 8 410 145 55

Peter Rothschild, Chairman of the Board, phone: +46 8 410 145 55

 

Infant Bacterial Therapeutics AB

Bryggargatan 10

111 21 Stockholm

Phone: +46 8 410 145 55

info@ibtherapeutics.com

 

Publication

The information in this Interim Report is such which IBT is obliged to make public pursuant to the EU Market Abuse Regulation and which is to be made public according to the Nasdaq regulations for companies listed on Nasdaq First North.

The information was submitted for publication, by the CEO stated above, at 08.00 a.m. CET on 19 August, 2016.

 

2016

Interim report January 1 - June 30 2016

Press Release + Interim report English version

Press release + Interim report Swedish version

 

August 19, 2016

Infant Bacterial Therapeutics enrolls First Patient in Phase 2 Clinical Trial

 

Infant Bacterial Therapeutics AB (publ) (“IBT”) announces that the first premature infant has been enrolled and dosed in the Company´s Phase 2 clinical trial. This Phase 2 trial is a randomized, double blind, parallel group, dose escalation, placebo-controlled multicenter study to investigate the safety and tolerability of IBP-9414 administered in preterm infants.

 

This is the first trial in the clinical development of IBP-9414 for the prevention of the often fatal disease necrotizing enterocolitis which affects premature infants. The multicenter trial is being conducted in a number of neonatal intensive care units in the US and will enroll 120 premature infants.

 

More information about the clinical trial can be found on ClinicalTrials.gov (ClinicalTrials.gov identifier: NCT02472769).

 

Staffan Strömberg, Chief Executive Officer of IBT, comments, "We are very excited to have started the study and to now have the first baby included. This is an important milestone in our development of this potentially life-saving new drug.”

 

For additional information please contact

Staffan Strömberg, CEO, phone: +46 8 410 145 55

Peter Rothschild, Chairman of the Board, phone: +46 8 410 145 55

 

Infant Bacterial Therapeutics AB

Bryggargatan 10

111 21 Stockholm, Sweden

Phone: +46 8 410 145 55

info@ibtherapeutics.com

 

See Press Release in both English and Swedish

IBT Press Release 20160607 (English)

IBT Press Release 20160607 (Swedish)

June 7, 2016

IBT’s rights issue fully subscribed

 

The result of Infant Bacterial Therapeutics AB’s (“IBT” or the “Company”) rights issue, for which the subscription period ended on 23 May 2016, indicates that 3,575,583 shares, corresponding to approximately 97.5 percent of the offered shares, were subscribed for by exercise of subscription rights. Additionally, applications for subscription without subscription rights of 2,215,458 shares, corresponding to approximately 60.4 percent of the offered shares, have been received. Thus, the rights issue is fully subscribed. Through the rights issue, IBT will receive proceeds amounting to approximately SEK 100 million before transaction costs.

 

Those who have subscribed for shares without subscription rights will be allotted shares according to the principles outlined in the prospectus. Such subscribers who have been allotted shares without subscription rights are expected to be notified on 26 May 2016. Only those who are allotted shares will be notified.

 

Through the rights issue IBT’s  share capital increases by approximately SEK 1,000,000 from SEK 500,000 to approximately SEK 1,500,000 and the total number of shares increases by 3,669,092 from 1,834,546 to 5,503,638 when the rights issue is registered by the Swedish Companies Registration Office.

 

The final day for trading in paid subscribed shares (BTAs) was 25 May 2016. The new shares subscribed for with subscription rights are expected to start trading on Nasdaq First North on 29 May 2016, and the shares subscribed for without subscription rights on 31 May 2016.

 

Financial and legal advisors

Carnegie Investment Bank is financial advisor and Advokatfirman Vinge is legal advisor to IBT.

 

For additional information please contact

Staffan Strömberg, CEO, phone: +46 8 410 145 55

Peter Rothschild, chairman, phone: +46 8 410 145 55

 

 

Infant Bacterial Therapeutics AB (publ)

Bryggargatan 10

111 21 Stockholm

Phone: +46 8 410 145 55

info@ibtherapeutics.com

 

IBT discloses this information in accordance with Swedish Securities Market Act. The information was provided for publication at 8.00 AM on 26 May 2016.

 

 

IMPORTANT INFORMATION

This press release is not a prospectus or an offer to subscribe for shares in IBT and an investor shall not subscribe for or purchase any securities, except on the basis of information provided in the prospectus.

This press release may not be made public, released or distributed, directly or indirectly, in or into the United States, Australia, Hong Kong, Japan, Canada, Singapore, South Africa or New Zealand or in any other jurisdiction in which the distribution of this press release would be unlawful. Further, this press release does not constitute an offer to sell new shares, paid subscribed for shares ("BTA") or subscription rights to any person in any jurisdiction in which it is unlawful to make such offer to such person or where such action would require additional prospectuses, registration or other measures other than those pursuant to Swedish law. The prospectus, application forms and other documents associated with the rights issue may not be distributed in or to any country where such distribution or the rights issue would require such measures set forth in the preceding sentence or be in violation of the regulations of such country.

The new shares, BTAs and subscription rights have not been recommended by a United States federal or state securities commission or regulatory authority. No new shares, BTAs, subscription rights or other securities issued by IBT have been or will be registered under the U.S. Securities Act of 1933, as amended, or under the securities legislation in any state of the United States or any province in Canada. Accordingly, no new shares, BTAs, subscription rights or other securities issued by IBT may be transferred or offered for sale in the United States or Canada, other than in such exceptional cases that do not require registration. The securities issued in the rights issue will not be offered to the public in the United States.

IBT has not authorized any offer of securities to the public in any country in the European Economic Area ("EEA") other than Sweden. In other member states in the EEA which have implemented the Directive 2003/71/EC (the "Prospectus Directive") (each, a "Relevant Member State"), no action has been undertaken and will not be undertaken to make an offer of securities to the public requiring publication of a prospectus in any Relevant Member State. As a result, the securities may only be offered in Relevant Member States to (a) any legal entity which is a qualified investor as defined in the Prospectus Directive; or (b) any person falling within Article 3(2) of the Prospectus Directive.

The rights issue is only directed at (i) persons who are outside the United Kingdom or (ii) persons who have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order") and (iii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2) of the Order (all such persons together being referred to as "relevant persons"). The securities issued in the rights issue will only be available to and will only be engaged with, relevant persons. Any person who is not a relevant person should not act or rely on this document or any of its contents.

 

 

See Press Release in both English and Swedish

IBT Press Release 20160526 (English)

IBT Press Release 20160526 (Swedish)

May 26, 2016

Prospectus relating to IBT’s rights issue published

To access the press release, please read the following disclaimer here.

April 27, 2016

IBT announces fully underwritten SEK 100 million rights issue

To access the press release, please read the following disclaimer here.

April 27, 2016

IBT receives Rare Pediatric Disease Designation from FDA for drug candidate

Infant Bacterial Therapeutics AB (publ) (“IBT”) announces that the U.S. Food and Drug Administration (FDA) has awarded IBT Rare Pediatric Disease Designation for its drug candidate IBP-9414, intended for the prevention necrotizing enterocolitis in premature infants.

 

Rare Pediatric Disease Designation is intended to encourage development of new drug and biological products for the prevention and treatment of certain rare pediatric diseases. Having obtained the Rare Pediatric Disease Designation, FDA may award IBT a priority review voucher. A priority review voucher means that FDA ought to handle a drug application faster than normal.

 

Staffan Strömberg, Chief Executive Officer of IBT, commented, “The fact that FDA has given IBP-9414 Rare Pediatric Disease Designation, confirms how important it is to reach our goal that fewer premature babies shall be affected by the deadly disease necrotizing entercolitis, whilst at the same time this can reduce the time for this product to reach the market.”

 

For additional information please contact

Staffan Strömberg, CEO, phone: +46 8 410 145 55

Peter Rothschild, Chairman of the Board, phone: +46 8 410 145 55

 

Infant Bacterial Therapeutics AB

Bryggargatan 10

111 21 Stockholm

Phone: +46 8 410 145 55

info@ibtherapeutics.com

 

See Press Release in both Swedish and English:

 

IBT Press Release 20160331 (English)

IBT Press Release 20160331 (Swedish)

March 31, 2016

Infant Bacterial Therapeutics is listed on Nasdaq First North and publishes company description

Infant Bacterial Therapeutics AB (publ) (“IBT”) has been approved for listing and the company’s series B shares will be traded on Nasdaq First North as from 29 March 2016 with Erik Penser Bankaktiebolag as Certified Adviser. The listing is part of the distribution of all of BioGaia AB’s (publ) shares in IBT to BioGaia’s shareholders, which was resolved at the extraordinary general meeting of BioGaia on 18 March 2016.

 

A company description has been prepared in connection with the listing and is available on IBT’s website, www.ibtherapeutics.com

 

 

For additional information please contact

Staffan Strömberg, CEO, phone: +46 8 410 145 55

 

Infant Bacterial Therapeutics AB

Bryggargatan 10

111 21 Stockholm

Phone: +46 8 410 145 55

info@ibtherapeutics.com

 

See Press Release in both Swedish and English:

IBT Press Release 20160321 (Swedish)

IBT Press Release 20160321 (English)

March 21, 2016

Proposal for distribution and separate listing of Infant Bacterial Therapeutics from BioGaia

The board of directors of parent company BioGaia AB (publ) has resolved to propose to an Extraordinary General Meeting in BioGaia on 18 March 2016 to distribute the shares in the subsidiary Infant Bacterial Therapeutics AB (publ) ("IBT") to the shareholders of BioGaia. In connection with the execution of the dividend, IBT will apply for a listing of its series B shares on Nasdaq First North. To finance IBT’s first clinical trial, the company has, as previously communicated, a capital need of approximately SEK 100 million, which is planned to be raised through a rights issue with preferential rights for IBT’s shareholders during the second quarter 2016.

 

Read more the official BioGaia press release here

February 19, 2016

IBT has U.S. IND open and Swedish CTA approved for clinical study

IBT announces today that the IND (Investigational New Drug) for the prevention of necrotizing enterocolitis (NEC), has been accepted by the FDA (U.S. Food and Drug Administration). Furthermore, IBT has received approval from the MPA (Medical Product Agency) to conduct its clinical trial in Sweden.

Read the official IBT press release here Read the official BioGaia press release here

January 8, 2016

IBT receives additional funding from BioGaia

Infant Bacterial Therapeutics plans to start a study on the safety and tolerability of the product in 2015. To allow for the study start, BioGaia will support IBT with an additional investment of 520 000 US dollars.

Read the official IBT press release here Read the official BioGaia press release here

March 26, 2015

Orphan Drug Designation in Europe

Infant Bacterial Therapeutics has now obtained the Orphan Drug Designation for Lactobacillus reuteri for the prevention of necrotizing enterocolitis in Europe.
Read the official press release here

February 23, 2015

FDA approves orphan drug designation

Necrotizing enterocolitis (NEC) is a rare and extremely severe disease that affects premature infants. The FDA Office of Orphan Product Development has approved the request.
Read the official press release here

February 21, 2014

BioGaia invests in a drug against NEC

The board of BioGaia has decided to invest in the first phase of a long-term project aimed at developing a drug with rigorous hygiene, analysis and documentation requirements, to treat the highly fatal disease Necrotising Enterocolitis (NEC), which affects premature infants. BioGaia will invest SEK 42 million in the project over a two-year period. The project will be driven by BioGaia’s subsidiary Infant Bacterial Therapeutics (IBT), of which 9% is owned by the company’s President, Staffan Strömberg, and its Research Director, Eamonn Connolly. The remaining 91% is owned by BioGaia.
Read the official press release here

February 21, 2014