Infant Bacterial Therapeutics

Infant Bacterial Therapeutics AB (IBT B) -
Pharmaceuticals and Healthcare Product

Pipeline Summary
Healthcare
Healthcare
Reference Code: GDPH2363473PR

Publication Date: March 2023
Infant Bacterial Therapeutics AB (IBT B) - Pharmaceuticals and Healthcare Product Pipeline Summary
Publication Date: March 2023 Healthcare
Table of Contents
Table of Contents ............................................................................................................................................................................... 2
List of Tables.................................................................................................................................................................................. 4
List of Figures ................................................................................................................................................................................ 5
Infant Bacterial Therapeutics AB Company Overview ....................................................................................................................... 6
Infant Bacterial Therapeutics AB - Key Facts ..................................................................................................................................... 6
Infant Bacterial Therapeutics AB - Pharmaceuticals and Healthcare - Pipeline Products Summary ................................................. 7
Infant Bacterial Therapeutics AB - Number of Pipeline Products by Therapy Area ...................................................................... 7
Infant Bacterial Therapeutics AB - Number of Pipeline Products by Indication............................................................................ 9
Infant Bacterial Therapeutics AB - Number of Pipeline Products by Product Stage of Development ........................................ 11
Infant Bacterial Therapeutics AB - Major Products and Services ..................................................................................................... 12
Infant Bacterial Therapeutics AB - Key Competitors ........................................................................................................................ 13
Infant Bacterial Therapeutics AB - Key Employees .......................................................................................................................... 14
Infant Bacterial Therapeutics AB - Locations And Subsidiaries ........................................................................................................ 15
Head Office.................................................................................................................................................................................. 15
Other Locations & Subsidiaries ................................................................................................................................................... 15
Company’s Recent Developments ................................................................................................................................................... 16
Feb 10, 2023: Infant Bacterial Therapeutics AB (publ) Interim report January 1- December 31, 2022........................................... 16
Jan 27, 2023: Infant Bacterial Therapeutics publishes Annual Report for 2021 in XHTML format .................................................. 17
Jan 12, 2023: IBT secures platform for pharma grade probiotic to prevent antibiotic resistant hospital acquired infections ....... 18
Nov 04, 2022: Infant Bacterial Therapeutics announces the appointment of the Nomination Committee for the Annual General
Meeting 2023 ................................................................................................................................................................................... 19
Nov 01, 2022: Article based on Infant Bacterial Therapeutics’ (IBT) connection study published in the British Journal of
Gastroenterology demonstrates that one day shift in Sustained Feeding Tolerance (SFT)............................................................. 20
Jun 30, 2022: Infant Bacterial Therapeutics AB appoints Maria Ekdahl as CFO .............................................................................. 21
Jun 30, 2022: Infant Bacterial Therapeutics appoints Maria Ekdahl as CFO .................................................................................... 22
May 04, 2022: Annual General Meeting of Infant Bacterial Therapeutics ...................................................................................... 23
Apr 05, 2022: Notice to attend the Annual General Meeting of Infant Bacterial Therapeutics ...................................................... 24
Mar 31, 2022: Infant Bacterial Therapeutics publishes Annual Report for 2021 ............................................................................ 28
Infant Bacterial Therapeutics AB - Pharmaceuticals and Healthcare - Pipeline Products News & Press Releases .......................... 29
Jan 24, 2023: Infant Bacterial Therapeutics (IBT) publishes clinical findings in the British Journal of Gastroenterology on the
convincing association of clinical events to the feeding primary endpoint of the ‘Connection Study’ ........................................... 29
Sep 23, 2022: FDA approves Infant Bacterial Therapeutics' request for a new orphan drug designation ...................................... 30
Jan 10, 2022: Infant Bacterial Therapeutics announces that new patent protection is granted in Australia.................................. 31
Dec 27, 2021: Infant Bacterial Therapeutics announces new patent protection approvals in Brazil and in Hong Kong ................. 32
Dec 06, 2021: A blinded evaluation of the connection study – sustained feeding tolerance (SFT) correlates to clinical outcomes
......................................................................................................................................................................................................... 33
Sep 30, 2021: Next recruitment milestone reached in IBT’s phase III Study. .................................................................................. 34
Sep 22, 2021: After safety review The Connection study is now again open to recruit the smallest infants.................................. 35
Sep 10, 2021: Infant Bacterial Therapeutics announces that a new patent is granted in Mexico................................................... 36
Aug 25, 2021: Recruitment of the smallest infants in the connection study paused ...................................................................... 37
Apr 29, 2021: Infant Bacterial Therapeutics expands The Connection Study to include infants with a birth weight below 750
grams ............................................................................................................................................................................................... 38
Apr 15, 2021: Infant Bacterial Therapeutics receives additional patent protection in China .......................................................... 39
Feb 10, 2021: Infant Bacterial Therapeutics announces that the recruitment to the first stage of the phase III Connection Study
is completed - an update about the clinical development of IBP-9414 ........................................................................................... 40
Feb 09, 2021: Infant Bacterial Therapeutics announces that new patent protection is granted in Japan ...................................... 41
Nov 05, 2020: Infant Bacterial Therapeutics interim management statement, January 1 – September 30, 2020 ......................... 42
Feb 11, 2020: Infant Bacterial Therapeutics provides update on IBP-9414 drug program ............................................................. 43
Jul 05, 2019: Infant Bacterial enrols first patient in NEC study ........................................................................................................ 44
May 19, 2019: FDA and Infant Bacterial Therapeutics agree on the design of Phase III study ....................................................... 45
Mar 05, 2019: Infant Bacterial Therapeutics announces first distribution agreement ................................................................... 46
Nov 21, 2018: The Phase 3 study protocol is modified after IBT's meeting with the FDA............................................................... 47
Nov 09, 2018: IBTs Chief Scientific Officer invited to speak at NEC Society Symposium 2019 ........................................................ 48
May 15, 2018: Infant Bacterial Therapeutics: Interim Management Statement, January 1 - March 31, 2018 ............................... 49
© GlobalData 2023. This product is licensed and is not to be photocopied. Page 2

Dec 11, 2017: Infant Bacterial Therapeutics presents data from its Safety and Tolerability Study in premature infants .............. 50
Nov 23, 2017: Infant Bacterial Therapeutics Interim Management Statement, January 1 - September 29, 2017.......................... 51
Sep 28, 2017: European Medicines Agency adopts a positive opinion on the Paediatric Investigation Plan for IBT’s lead product
......................................................................................................................................................................................................... 52
Sep 11, 2017: Infant Bacterial Therapeutics announces that top line data demonstrate similar safety and tolerability profile in
the active and placebo groups ......................................................................................................................................................... 53
Jan 24, 2017: Last patient enrolled in IBT's Phase 2 study .............................................................................................................. 54
Dec 14, 2016: IBT adds new indication for Gastroschisis-Related Intestinal Dysfunction ............................................................... 55
Nov 21, 2016: Positive recommendation from the independent Data Safety Monitoring Board to continue Phase II Study ........ 56
Jun 07, 2016: Infant Bacterial Therapeutics enrolls First Patient in Phase 2 Clinical Trial ............................................................... 57
Mar 31, 2016: IBT receives Rare Pediatric Disease Designation from FDA for drug candidate ....................................................... 58
Jan 08, 2016: BioGaia’s subsidiary IBT has US IND open and Swedish CTA approved for clinical study ......................................... 59
Jun 24, 2015: BioGaia Subsidiary IBT Takes Rapid Steps in Development of a Drug for Premature Infants ................................... 60
Jun 12, 2015: BioGaia evaluates the possibility of a separate listing of Infant Bacterial Therapeutics ........................................... 61
Mar 26, 2015: Infant Bacterial Therapeutics receives additional funding from mother company BioGaia .................................... 62
Feb 23, 2015: BioGaia subsidiary Infant Bacterial Therapeutics gets Orphan Drug Designation in Europe .................................... 63
Feb 21, 2014: FDA approves orphan drug designation for IBP-9414 ............................................................................................... 64
Appendix .......................................................................................................................................................................................... 65
Methodology ............................................................................................................................................................................... 65
Glossary ....................................................................................................................................................................................... 66
About GlobalData ........................................................................................................................................................................ 66
Contact Us ................................................................................................................................................................................... 66
Disclaimer .................................................................................................................................................................................... 66

List of Tables
Infant Bacterial Therapeutics AB, Key Facts ....................................................................................................................................... 6
Infant Bacterial Therapeutics AB - Number of Pipeline Products by Therapy Area ........................................................................... 8
Infant Bacterial Therapeutics AB - Number of Pipeline Products by Indication .............................................................................. 10
Infant Bacterial Therapeutics AB - Number of Pipeline Products by Product Stage of Development ............................................. 11
Infant Bacterial Therapeutics AB, Major Products and Services ...................................................................................................... 12
Infant Bacterial Therapeutics AB, Key Employees ........................................................................................................................... 14
Infant Bacterial Therapeutics AB, Subsidiaries ................................................................................................................................ 15
Glossary............................................................................................................................................................................................ 66

List of Figures
Infant Bacterial Therapeutics AB - Number of Pipeline Products by Therapy Area ........................................................................... 7
Infant Bacterial Therapeutics AB - Number of Pipeline Products by Indication (Top 10) .................................................................. 9
Infant Bacterial Therapeutics AB - Number of Pipeline Products by Product Stage of Development ............................................. 11

Infant Bacterial Therapeutics AB Company Overview

Infant Bacterial Therapeutics AB (IBT), a subsidiary of BioGaia AB is a pharmaceutical company that develops drugs influencing the human
infant microbiome to treat rare diseases in premature infants. Its pipeline product candidates include IBP-9414, containing the active
substance Lactobacillus reuteri, co-evolved human bacterial strain derived from human breast milk, used for the prevention of Necrotizing
enterocolitis (NEC); and IBP-1016, a drug candidate used for the treatment of gastroschisis, a severe disease in infants. IBT develops
pharmaceutical drug candidates for gastrointestinal neonatal condition that causes mucosal injury, necrosis, perforation in the intestinal
tracts of infants, and death. It operates through a network of neonatologists and research groups. IBT is headquartered in Stockholm,
Sweden.
The operating loss of the company was SEK65.8 million in FY2022, compared to an operating loss of SEK44.6 million in FY2021. The net loss of
the company was SEK65.5 million in FY2022, compared to a net loss of SEK45 million in FY2021.
Infant Bacterial Therapeutics AB - Key Facts

Infant Bacterial Therapeutics AB, Key Facts
Corporate Address Bryggargatan 10, Stockholm, Ticker Symbol, Exchange IBT B [Stockholm Stock
111 21, Sweden Exchange]
Telephone +46 8 41014555 No. of Employees 8
Fax Fiscal Year End December
URL ibtherapeutics.com Revenue (in USD Million) 0.0
Industry Pharmaceuticals and Healthcare
Locations Sweden
Source: Annual Report, Company Website, Primary and Secondary Research GlobalData

Infant Bacterial Therapeutics AB - Pharmaceuticals and Healthcare - Pipeline Products

Summary
Infant Bacterial Therapeutics AB - Number of Pipeline Products by Therapy Area

Therapy Name Number of Products
Gastrointestinal 2
Infectious Disease 1
Ophthalmology 1

Infant Bacterial Therapeutics AB - Number of Pipeline Products by Indication
Infant Bacterial Therapeutics AB - Number of Pipeline Products by Indication (Top 10)

Infant Bacterial Therapeutics AB - Number of Pipeline Products by Indication
Indication Number of Products
Gastric Motility Disorder 1

Hospital-Acquired Infections 1
Necrotizing Enterocolitis 1
Retinopathy Of Prematurity 1

Infant Bacterial Therapeutics AB - Number of Pipeline Products by Product Stage of Development
Stage of Development Number of Products
Phase III 1
Phase II 1
Preclinical 2
Discovery 1

Infant Bacterial Therapeutics AB - Major Products and Services
IBT is a pharmaceutical company. The company's major products include the following:
Infant Bacterial Therapeutics AB, Major Products and Services

Products:
IBP-1016:
Gastroschisis
IBP-9414:
Necrotizing enterocolitis (NEC)

Infant Bacterial Therapeutics AB - Key Competitors
The following companies are the major competitors of Infant Bacterial Therapeutics AB:
Minervax ApS
WntResearch AB
Vicore Pharma Holding AB

Infant Bacterial Therapeutics AB - Key Employees

Infant Bacterial Therapeutics AB, Key Employees
Name Job Title Board Level Since Age
Peter Rothschild Chairman Executive Board 2011 72

Margareta Hagman Director Non Executive Board 2015 56
Anthon Jahreskog Director Non Executive Board 2017 42
Eva Iden Director Non Executive Board 2017 56
Kristina Sjoblom Nygren Director Non Executive Board 2018 61
Robert Molander Director Non Executive Board 2020 57
Staffan Stromberg Chief Executive Officer Senior Management 2013 55
Anders Kronstrom Chief Operating Officer Senior Management 2018 55
Professor Jonas Rastad Chief Medical Officer Senior Management
Maria Ekdahl Chief Financial Officer Senior Management 2022

Infant Bacterial Therapeutics AB - Locations And Subsidiaries

Head Office
Infant Bacterial Therapeutics AB
Bryggargatan 10
Stockholm
ZIP: 111 21
Sweden
Tel: +46 8 41014555
Other Locations & Subsidiaries
Infant Bacterial Therapeutics AB, Subsidiaries
IBT Baby AB
Stockholm
Sweden

Company’s Recent Developments

Feb 10, 2023: Infant Bacterial Therapeutics AB (publ) Interim report January 1- December
31, 2022
The speed of recruitment of preterm infants into our large phase 3 study significantly increased in the final three months of 2022 compared to
the corresponding period in previous years.
In the last 12 months, we succeeded in stabilizing recruitment at around 50 babies per month.In the first half of 2023, IBT will evaluate an
additional 12 neonatal intensive care clinics across the EU and the US for participation in the study to further accelerate the study
rate.According to the study protocol, aligned with medical authorities, the study is to be expanded to an additional patient group when the
recruitment has reached 1400 infants.This group includes larger premature infants with a birth weight of 1000-1500 grams.With this patient
inclusion expansion, we expect the recruitment rate in the current year to exceed the 2022 rate.As of today, we have taken in 1345 (62%) of
the planned total number of babies.If average 2023 recruitment increases to about 60 babies per month, it is reasonable to assume
recruitment to be completed towards the end of the year.We are now preparing for the conclusion of the challenging IBP-9414 development
program initiated back in 2013.IBT's focus is now and moving forward aimed at preparing us, our product and market for the paradigm shift in
the care of the premature baby that we anticipate our product will bring about.A recent example of preparing the market is that IBT already
at this stage have been able to demonstrate, via analysis of blinded data, that our second primary endpoint (SFT) is validated.These results
have been presented in the form of scientific publications in medical journals as well as presentations at several neonatal intensive care
conferences during the fall of 2022.Please refer to our website for further details including the medical value proposition that these
publications highlight which is at the core of our large phase 3 study.The published results also summarize clinical complications among the
infants, which we continuously review via adverse events reporting, and that both the frequency and type of complications are in line with the
expected outcome.We today consider it established that the time to SFT (sustained feeding tolerance, a primary endpoint in the study) is a
measure of how sick a child is.In summary, we see a statically established connection between this time and several serious disease states, of
which sepsis, the need for antibiotics and growth are some examples.We will continue to publish and communicate scientific observations
from the ongoing study in 2023.In addition, IBT is preparing for a commercial launch, which concretely means that IBT develops strategies
across several commercial areas, including Market Access and Reimbursement, concurrently as market research will be carried out so that the
product IBP-9414 can be launched in harmony with the dynamics of the market.In terms of pre-launch preparations, negotiations are ongoing
to ensure large-scale product availability of IBP-9414.I'm pleased to announce that we have secured, in late 2022, access to scaled up
production sufficient in terms of capacity for several years after launch.In 2023, we expect to produce IBP-9414 across multiple locations,
which is always preferable from a supply-chain perspective.Discussions are also ongoing with potential distribution partners, which I will get
back to once finalized.We are considering what is best for IBT in the long term.While we maintain our focus on IBP-9414, it is our intention to
build on the unique knowledge that the development of this product has given us.IBP-1118, our project to prevent ROP (retinopathy of
prematurity in prematurely born babies), has started.The aim is to generate a development plan to enable discussions with relevant
pharmaceutical authorities, following the previously completed and successful IBP-9414 process.First, we must understand what the
regulatory requirements look like to obtain a market approval and establish early on that the product that the authorities want us to develop
meets a medical and market need.IBP-1118 has thus not been allocated any significant resources because IBT's assets are earmarked to finish
the drug development of IBP-9414.IBT has secured a license agreement, IBP-1122 for the prevention of antibiotic resistant bacteria.Work on
the projects IBP-1122 (treatment against antibiotic-resistant bacteria) and IBP-1016 (gastroschisis) has also begun, with a similar focus on
primarily developing a development plan.In conclusion, I would like to take the opportunity to thank all the employees and experts around
the world who with great commitment help us get closer to our vision through the development of probiotic drugs, especially with IBP-9414
which can play a very big role for the premature babies.Stockholm, February 10, 2023

Jan 27, 2023: Infant Bacterial Therapeutics publishes Annual Report for 2021 in XHTML
format
On March 31 2022 IBT published the 2021 annual report in the format of a PDF file.
Today, IBT publish the same report in the XHTML format.The content of the report has not been changed.see link,

Jan 12, 2023: IBT secures platform for pharma grade probiotic to prevent antibiotic
resistant hospital acquired infections
Building upon the company's unique expertise in developing pharma grade probiotics, Infant Bacterial Therapeutics AB (IBT) has secured an
exclusive global license from the Medical College of Wisconsin (MCW) to a technology platform consisting of genetically modified bacteria.
IBT will investigate how to develop a pharma grade probiotic based on this platform that addresses the growing problem of hospital acquired
infections, which are responsible for high morbidity and mortality rates.
Antibiotic resistance is rising to dangerous levels across the world, including hospital acquired infections caused by vancomycin-resistant
enterococci (VRE). VRE infections have become a serious public health challenge linked with the complexities of antibiotic resistance, resulting
in 54,000 cases and 5,000 deaths among hospitalized patients in the United States alone. VRE infections are estimated to cause direct annual
U.S. healthcare costs of $539M.
"We are now investigating if, and if so how, we can contribute to the care of these patients in alternate pathways to avoid adding further
antibiotic resistance. This new opportunity builds on our current focus on IBP-9414, which remains the same, and leverages the pharma grade
probiotic leadership and expertise we have established over the last 10 years. We expect to complete IBP-9414 recruitment with existing
capital, and are concurrently exploring this new platform with minimum financial exposure, says Staffan Strömberg, Chief Executive Officer,
IBT.
"Combining MCW's technology with IBT's expertise in developing bacterial-based therapies presents a significant opportunity to develop new
options for combating hospital acquired infections. This opportunity exemplifies MCW's commitment to translating our knowledge into
innovative patient care and pursuing a healthier world. We are eager to see IBT's further development of this bacterial technology that was
invented by Drs. Nita Salzman, Chris Kristich, and Sushma Kommineni in the departments of Pediatrics and Microbiology & Immunology here
at MCW, says Ann Nattinger, MD, MPH, MACP, Associate for Research at MCW.

Nov 04, 2022: Infant Bacterial Therapeutics announces the appointment of the Nomination
Committee for the Annual General Meeting 2023
The 2022 Annual General Meeting resolved that the Chairman of the Board shall convene the three largest shareholders in the company in
terms of voting rights, who may each appoint a member who, together with the Chairman of the Board, shall form the Nomination
Committee.
For the composition of the Nomination Committee, the ownership structure as of 30 June 2022 shall determine who are the largest
shareholders in terms of voting rights. The member appointed by the largest shareholder in terms of voting rights on the Nomination
Committee at that date shall be the Chairman of the Nomination Committee. If any of the three largest shareholders waives its right to
appoint a member to the Nomination Committee, the next largest shareholder shall be given the opportunity to appoint a member to the
Nomination Committee.
The Nomination Committee for the Annual General Meeting 2023 has been formed in accordance with the decision of the Annual General
Meeting. The Nomination Committee consists of Per-Erik Andersson (Chairman of the Nomination Committee), appointed by the largest
shareholder Annwall & Rothschild Investments AB, Sebastian Jahreskog, who through direct and indirect ownership is the company's second
largest shareholder, and Jannis Kitsakis, appointed by the third largest shareholder, Fjrde AP-fonden. In addition, Peter Rothschild is a
member of the Nomination Committee in his capacity as Chairman of the Board.

Nov 01, 2022: Article based on Infant Bacterial Therapeutics’ (IBT) connection study
published in the British Journal of Gastroenterology demonstrates that one day shift in
Sustained Feeding Tolerance (SFT)
The two independent primary endpoints of the ‘Connection Study’ are the incidence of NEC and the time to SFT.
SFT a composite endpoint defined as the first day of tolerating daily enteral feeds of at least 120 ml/kg body weight with no use of parenteral
nutrition and with at least 10g/kg in average daily body weight increase, all of which should be maintained for a sustained period of time.
A blinded evaluation of IBT's Connection Study data shows that even a one day reduction in time to SFT correlates to several clinically
meaningful outcomes including a
7.65% reduction in confirmed Necrotizing Colitis (NEC) events
6.71% reduction in late onset sepsis
2.75% reduction in bronchopulmonary dysplasia (BPD)
5.85 reduction in days with antibiotic use
This blinded evaluation of extremely low birth weight infants introduces a strict definition of SFT and underlines the clinical relevance of a
one-day change in the time to SFT in premature infants.
"IBT is pioneering pharma grade probiotic development with the aim to prevent life threatening infant diseases. We are very pleased to see
that data from our study correlates to benefits in serious and sometimes deadly infant conditions.I like to emphasize that this is really
interesting and promising data that validates our study design. Given that this is a blinded evaluation it is not intended to and can not provide
any information on the efficacy of our study drug. says Staffan Strömberg, CEO of IBT.

Jun 30, 2022: Infant Bacterial Therapeutics AB appoints Maria Ekdahl as CFO
Infant Bacterial Therapeutics AB (publ) announced today that Maria Ekdahl has been appointed Chief Financial Officer (CFO) effective
September 19, 2022.
She will be part of the Management Team and report to Staffan Stromberg, CEO of IBT.Maria, who has a Master's degree in economics from
Linnaeus University, comes to IBT from the Swedish Film Institute where she served as CFO.She brings with her an extensive financial
background from organizations including Telenor, Karolinska and Coca-Cola."I am very much looking forward to starting at IBT.The company is
in an exciting growth phase and I look forward to being involved and contributing to its continued development."says Maria Ekdahl.

Jun 30, 2022: Infant Bacterial Therapeutics appoints Maria Ekdahl as CFO
Infant Bacterial Therapeutics AB (publ) announced that Maria Ekdahl has been appointed Chief Financial Officer (CFO) effective September 19,
2022.
She will be part of the Management Team and report to Staffan Strömberg, CEO of IBT.
Maria, who has a Master's degree in economics from Linnaeus University, comes to IBT from the Swedish Film Institute where she served as
CFO. She brings with her an extensive financial background from organizations including Telenor, Karolinska and Coca-Cola.
"I am very much looking forward to starting at IBT. The company is in an exciting growth phase and I look forward to being involved and
contributing to its continued development.says Maria Ekdahl.

May 04, 2022: Annual General Meeting of Infant Bacterial Therapeutics

that remuneration shall be paid to the Chairman of the Board of SEK 300,000 and an unchanged additional remuneration for the work as
Chairman of the Board of SEK 400,000 and to other Board members not employed by the company of SEK 150,000 each; that remuneration
shall be paid to the members of the Audit Committee of SEK 40,000 to the Chairman and SEK 20,000 to each of the other members of the
Audit Committee, and that a fee of SEK 40,000 shall be paid to the Chairman and SEK 20,000 to each other member of the Audit Committee
regarding the period May 4, 2021 to May 4, 2022; that the audit fee be paid according to approved invoice; re-election of Margareta Hagman,
Eva Iden, Anthon Jahreskog, Kristina Sjoblom Nygren and Peter Rothschild as Board members; re-election of Peter Rothschild as Chairman of
the Board; re-election of the registered accounting firm Deloitte AB; on appointment of the Nominating Committee in accordance with the
Nominating Committee's proposal; approval of the Board's remuneration report; principles for remuneration to senior executives in
accordance with the Board's proposal; authorization for a new issuance of B shares in accordance with the Board's proposal; and
implementation of an incentive program for the company's employees and key persons engaged as consultants through the issuance of a
maximum of 304,500 warrants in accordance with the Board's proposal.
The warrants shall entitle to subscription for a maximum of 304,500 B-shares in the company during the period June 1, 2025 up to and
including September 30, 2025 at a subscription price corresponding to 200 percent of the volume-weighted average price of the company's
share according to Nasdaq Stockholm's official price list during ten trading days before May 4, 2022.

Apr 05, 2022: Notice to attend the Annual General Meeting of Infant Bacterial Therapeutics
Shareholders of Infant Bacterial Therapeutics AB (publ) are summoned to the Annual General Meeting on Wednesday, May 4, 2022.
In light of the coronavirus, the Annual General Meeting is conducted through advance voting pursuant to temporary regulations.Therefore, it
will not be possible to attend this year's Meeting in person or by proxy.Right to participate In order to participate in the Annual General
Meeting shareholders must be recorded in the shareholder register maintained by Euroclear Sweden AB no later than Tuesday April 26, 2022
and register for the meeting no later than on Tuesday May 3 2022 by submitting an advance voting form in accordance with the instructions
set forth in the section "Advance voting" below.In order to participate in the Annual General Meeting, shareholders whose shares are
registered in the name of a trustee must, in addition to registering for the meeting, register the shares into their own name by April 26,
2022.Such registration may be temporary and is requested from the nominee in accordance with the nominee's routines at a time in advance
as the nominee determines.Voting right registration made no later than the second banking day after 26 April 2022 are taken into account in
the production of the share register.Advance voting The shareholders may exercise their voting rights at the Annual General Meeting only by
voting in advance, so called postal voting in accordance with section 22 of the Act (2022:121) on temporary exceptions to facilitate the
execution of general meetings in companies and other associations.A special form shall be used for advance voting.The form is available on
www.ibtherapeutics.com.The advance voting form is considered as the notification of participation at the general meeting.The completed
voting form must be received by company no later than Tuesday May 3, 2022.The completed form, in original, shall be sent to Infant Bacterial
Therapeutics AB (publ), Bryggargatan 10, SE-111 21 Stockholm, Sweden.The completed form may alternatively be submitted electronically to
ibt@ibtherapeutics.com.If the shareholder votes in advance by proxy, a power of attorney shall be enclosed with the form.If the shareholder
is a legal entity, a certificate of incorporation or a corresponding document shall be enclosed with the form.The shareholder may not provide
special instructions or conditions in the voting form.If so, the vote (i.e.the advance vote in its entirety) is invalid.Further instructions and
conditions are included in the form for advance voting.Proposed agenda Election of Chairman of the Meeting Election of one or two persons
to approve the minutes of the Meeting Establishment and approval of the voting list Approval of agenda Resolution as to whether the
Meeting has been duly convened Presentation of the annual report and the audit report, the consolidated accounts and the consolidated
audit report Decision: a) to determine the income statement and balance sheet and the consolidated income statement and consolidated
balance sheetb) on disposals of the company's income according to the established balance sheet, c) discharge from liability for the Board
members and the managing director Resolution regarding the number of Board members and Auditors Determinations of fees to the Board of
Directors and Auditor Election of Board members a) Re-election of Margareta Hagman b) Re-election of Eva Iden c) Re-election of Anthon
Jahreskog d) Re-election of Kristina Sjoblom Nygren e) Re-election of Peter Rothschild Election of the Chairman of the Board Election of
Auditor Resolution regarding the Nominating Committee Presentation of the Board's remuneration report for approval The Board's proposal
for a resolution regarding principles for remuneration to senior executives The Board's proposal for resolution regarding authorization for
new issuance of shares The Board's proposal for a resolution regarding implementation of an incentive program Proposed resolutions,
etc.Item 1 - Chairman of the Meeting The Nominating Committee, which consists of the Chairman of the Board, Peter Rothschild, of Per-Erik
Andersson (Annwall & Rothschild Investments AB), Sebastian Jahreskog and Jannis Kitsakis (the Fourth Swedish National Pension Fund),
proposes that lawyer Erik Sjoman or, in his absence, the person appointed by the Board, be instead elected chairman of the Annual General
Meeting.Item 2 - Persons to approve the minutes Jannis Kitsakis och Sten Irwe or, to the extent both or any of them are prevented, the
person or persons assigned by the Nomination Committee, are proposed as persons to approve the minutes.The assignment for the persons
to approve the minutes includes verifying the voting list and confirming that advance votes received are correctly reflected in the minutes of
the Meeting.Item 3 - Voting list The voting list proposed for approval under item 3 on the agenda is the voting list prepared by the company,
based on the shareholders' register and advance votes received, and verified by the persons elected to approve the mintues.The Nominating
Committee's proposals regarding items 8 - 13 on the agenda Item 8 - Resolution regarding the number of Board members and Auditors Five
members without deputies.One auditor without deputies.Item 9 - Determination of fees to be paid to the Board of Directors and Auditors The
Nominating Committee proposes the following fees for the Board of Directors and auditors: The Chairman of the Board shall receive SEK
300,000 (previously SEK 250,000) annually and an unchanged extra remuneration of SEK 400,000 annually for the duties as working Chairman
of the Board.Other members who are not employed by the company shall receive SEK 150,000 (previously SEK 125,000) annually per
member.For work in the Audit Committee, it is proposed that a fee of SEK 40,000 shall be paid to the Chairman of the Audit Committee and
SEK 20,000 to each other member of the Audit Committee.Furthermore, it is proposed that a fee of SEK 40,000 shall be paid to the Chairman
of the Audit Committee and SEK 20,000 to each other member of the Audit Committee regarding the period May 4, 2021 to May 4, 2022, in
accordance with the Nominating Committee's proposal to the Annual General Meeting 2021.Auditing fees shall be paid in accordance with
approved invoice.Item 10 - Election of Board members Re-election of Board members Margareta Hagman, Eva Iden, Anthon Jahreskog,
Kristina Sjoblom Nygren and Peter Rothschild.Robert Molander has declined re-election.Information about the members proposed for re-
election can be found at the company's website, www.ibtherapeutics.com.Item 11 - Election of Chairman of the Board Re-election of Peter
Rothschild.Item 12 - Election of auditor Re-election of Deloitte AB.The proposal is in accordance with the Board of Directors'
recommendation.Item 13 - Resolution regarding the Nominating Committee The Chairman of the Board shall convene the three, in terms of
voting rights, largest shareholders in the company, each of which shall appoint a representative to be a member of the Nominating
Committee together with the Chairman of the Board.Composing the Nominating Committee, the ownership structure as per June 30, 2022
will determine who are the largest shareholders in terms of voting rights.The Nominating Committee shall be chaired by the member
representing the largest shareholder as determined by voting rights on this date.If any of the three largest shareholders waives their right to
appoint a member of the Nominating Committee, this right shall be vested in the shareholder that, after these shareholders, has the largest
shareholding.The names of the three owner's representatives shall be published as soon as they have been appointed, but no later than six
months before the Annual General Meeting 2023.The Nominating Committee's term of office extends until the new Nominating Committee is
appointed.In the event that the shareholder the Nominating Committee member represents no longer constitutes one of the three largest

shareholders in terms of voting rights, the Nominating Committee, if it finds it appropriate, may dismiss that member and give a
representative of the shareholder that is next in terms or voting power the opportunity to be elected.In the event that a nominated member
of the Nominating Committee for other reason resigns from the Nominating Committee, the shareholder who appointed the member in
question shall be entitled to appoint a new representative in the Nominating Committee.If such shareholder declines to appoint a new
representative, the Nominating Committee shall, if it considers it appropriate with regard to the remaining term of office, request that the
shareholder that is next in terms of voting power determine, if it wishes to appoint a representative to the Nominating Committee.The
Nominating Committee shall prepare proposals in the following questions to be submitted to the Annual General Meeting 2023 for decision:
a) proposal for election of the Chairman of the AGM b) proposal for election of Board members c) proposal for election of the Chairman of the
Board d) proposal for determination of Board fees e) proposal for election of Auditor f) proposal for determination of Auditor fees g) proposal
for reasonable costs for the Nominating Committee h) proposal for a resolution regarding the Nominating Committee prior to the 2024 AGM
The Board's proposals for resolution regarding items 7b, 14-17 on the agenda Item 7b - Appropriation regarding the company's earnings The
Board of Directors proposes that no dividend be paid and that the result for the period be carried forward.Item 14 - The remuneration report
Board of Directors proposes that the Annual General Meeting resolves to approve the Board's report on remuneration prepared in
accordance with the Swedish Companies Act, Chapter 8.53 a SS.Item 15 - The Board's proposal for resolution regarding principles for
remuneration to senior executives The Board proposes that the Annual General Meeting resolves to adopt the following guidelines for
remuneration to senior executives in IBT.The guidelines shall be applied to remuneration agreed and changes to previously agreed
remuneration, after the guidelines have been adopted by the Annual General Meeting.The guidelines do not apply to remuneration resolved
by the Annual General Meeting.The guidelines' promotion of IBT's business strategy, long-term interests and sustainability IBT develops, and
intends to market and sell, safe and efficacious therapies that affect infants' microbiome and thereby prevent or treat rare diseases that
affects premature infants.For more information on IBT's business strategy, see the annual report.Successful implementation of the business
strategy and safeguarding IBT's long-term interests, including its sustainability, require IBT to be able to recruit, motivate and retain
competent employees who work to achieve maximum shareholder and customer value.This requires IBT to be able to offer competitive
remuneration.These guidelines enable senior executives to be offered competitive total remuneration.Forms of remuneration,
etc.Remuneration shall be market-based and may consist of the following components: fixed cash salary, variable cash remuneration, pension
benefits and other benefits.The Annual General Meeting may in addition - and independent of these guidelines - resolve on for example
share-related and share-price based remuneration.The total remuneration package to senior executives should include a well-balanced mix of
the above-named components as well as terms of notice and severance pay.The Board should annually evaluate the extent to which share-
based or share-price based long-term incentive programmes should be proposed to the Annual General Meeting.The fixed cash salary shall be
individual and based on the senior executive's responsibilities and role as well as the individual's competence and experience in the relevant
position.The variable cash remuneration may amount to a maximum of 40 percent of fixed annual cash salary.Senior executives who are
entitled to pensions shall have pension benefits that are defined contribution.Variable cash remuneration shall not qualify for pension
benefits.Pension premiums for defined contribution pensions shall amount to a maximum of 33 percent of fixed annual cash salary.Other
benefits may include life insurance, health insurance (Sw: sjukvardsforsakring) and a company car benefit.Such benefits shall be of limited
value in relation to other compensation and be consistent with what is customary in the respective geographical market.Other benefits may
amount to a maximum of 5 percent of fixed annual cash salary.Termination of employment In the event of termination of employment by the
company the maximum notice period is six months.Fixed cash salary during the notice period plus any severance pay may not together
exceed an amount equivalent to the individual's fixed cash salary for a one-year period.In case of termination by the senior executive, the
notice period may not be less than three months and no severance pay will be paid.Criteria for distribution of variable cash remuneration,
etc.Variable cash remuneration shall be linked to pre-determined and measurable criteria which may be financial or non-financial.It can also
comprise individually adapted quantitative or qualitative targets.The criteria shall be designed so that they promote the Group's business
strategy and long-term interests, including its sustainability, through for example having a clear link to IBT's business strategy or promoting
the senior executive's long-term development.Fulfilment of the criteria for payment of variable cash remuneration shall be measured during a
period of one year.When the measurement period for fulfilment of the criteria for payment of variable cash remuneration has ended, the
extent to which the criteria have been met shall be determined.The Remuneration Committee is responsible for assessment with regard to
variable cash remuneration to the CEO.As regards variable cash remuneration to other senior executives, the CEO is responsible for the
assessment.Salary and terms of employment for employees In preparation of the Board's proposal for these remuneration guidelines, salaries
and terms of employment for the company's employees have been taken into account through information on employees' total
remuneration, remuneration components as well as remuneration increases and rate of increase over time comprising a part of the
Remuneration Committee's and the Board's basis for decision when evaluating the reasonableness of these guidelines and the limitations that
are a consequence of them.Decision-making process to establish, review and implement the guidelines The Board has established a
Remuneration Committee.The tasks of the committee include preparation of the Board's proposal for decision on guidelines for remuneration
to senior executives.The Board shall prepare proposals for new guidelines at least every fourth year and present the proposal for decision to
the Annual General Meeting.The guidelines shall apply until new guidelines are adopted by the Annual General Meeting.The Remuneration
Committee shall also monitor and evaluate programmes for variable remuneration to senior executives, application of the guidelines for
remuneration to senior executives as well as applicable remuneration structures and remuneration levels in the Group.When the Board
considers and makes decisions on remuneration-related matters, the CEO or other senior executives are not present insofar as they are
affected by the issues.Departure from the guidelines The Board may decide temporarily to depart from the guidelines wholly or partly if in an
individual case there is reason for this and such departure is necessary in order to meet IBT's long-term interests, including its sustainability,
or in order to ensure IBT's financial viability.As stated above, the tasks of the Remuneration Committee include preparing the Board's decision
on remuneration matters, which includes decisions to depart from the guidelines.Description of material changes to the guidelines and how
the views of shareholders' have been taken into consideration In the proposal for guidelines submitted at the 2022 Annual General Meeting,
the maximum amount for variable cash remuneration has been raised from 30 percent to 40 percent of the fixed annual cash salary.IBT has

not received any views from shareholders to take into consideration in the preparation of this proposal.Item 16 - The Board's proposal for a
resolution regarding authorization for new issuance of shares The Board of Directors proposes that the Annual General Meeting approve that
the Board of Directors have a mandate to, on one or more occasion until the next Annual General Meeting, issue new B-class shares.The
Board of Directors will be able to decide on a new issuance of shares with deviation from the shareholders' pre-emption rights.This
authorisation is to include the right to issue shares with cash payment, payment by contribution in kind or payment by way of set-off, and
otherwise subject to conditions as set out in Chapter 13, Section 5, first paragraph 6 of the Swedish Companies Act.The decision by the Board
of Directors in relation to a new share issue that deviates from shareholders' pre-emption rights (directed issue) shall not exceed a twenty
percent increase in share capital in relation to the share capital when the mandate for new issue is first utilised by the Board of Directors.The
share issue under this authorization shall be on market terms.The Board shall have the right to determine the conditions of the issue under
this authorization as well as mandate to determine who has the right to subscribe for shares.The purpose of the authorization is to provide
the Board with flexibility in efforts to ensure that the company in an appropriate manner, has additional capital to finance the company's
ongoing clinical activities, and to enable a broadening of the owner base of the company.Item 17 - The Board's proposal for a resolution
regarding implementation of an incentive program The Board of Directors proposes that the Annual General Meeting resolves to adopt an
incentive program for the company's employees and key persons engaged as consultants via i) a directed issue of warrants to the company or
its wholly owned subsidiary IBT Baby AB, Reg.No 559110-7353 (the "Subsidiary"), and ii) approval of transfer of warrants to participants in the
incentive program.Each warrant entitles to subscription of one (1) new B-share in the company.The Board of Directors believes that it is
important and in the interest of all shareholders that the employees and other key persons, who are deemed to be important for the
company's further development, have a long-term interest in a good value increase of the company's shares.A personal long-term ownership
commitment can be expected to contribute to an increased interest in the company's operations and earnings and raise the participants'
motivation and connection with the company and its shareholders.Based on the existing number of shares in the company, the dilution
resulting from the proposed incentive program, assuming that all warrants are exercised for subscription of new B-shares, will be
approximately 2.64 percent of the shares and approximately 2.04 percent of the votes.The percentage dilution in respect of the shares has
been calculated according to the following formula: 1-(existing number of shares/new number of shares), and in respect of the votes
according to the following formula: 1-(existing number of votes/new number of votes).This calculation does not consider already outstanding
warrants in the incentive programs that were implemented in 2017 and 2020, respectively.The dilution is expected to have a limited effect on
the company's key performance indicators.This proposal has been prepared by the remuneration committee and thereafter by the Board of
Directors in consultation with external advisors.The resigning board member Robert Molander is a part of the executive management and has
not participated in the Board's handling of or decision in the matter.Directed issue of warrants to the company or the Subsidiary The Board of
Directors proposes that the Annual General Meeting resolves on a directed issue of a maximum of 304,500 warrants on the following terms:
The right to subscribe for the warrants shall, with deviation from the shareholders' preferential rights, belong to the company or the
Subsidiary.Over-subscription can not occur.The reason for the deviation from shareholders' preferential rights is that the issue is a part of the
implementation of the incentive program, with which the company's employees and other key persons are given the opportunity to take part
in a positive development in the company.The existence of such a program is expected to increase the company's ability to attract and retain
qualified employees.Subscription of the warrants shall be made through subscription on a subscription list no later than May 13, 2022.The
Board of Directors shall be entitled to extend the subscription period.The warrants are issued free of charge.Each warrant will entitle the
holder to subscribe for one (1) new B-share in the company at a subscription price corresponding to 200 percent of the volume-weighted
average price of the company's share according to Nasdaq Stockholm's official price list during the period ten (10) trading days before May 4,
2022.Any share premium shall be transferred to the unrestricted premium reserve.Subscription of B-shares by exercise of warrants shall be
made in accordance with the terms of the warrants from June 1, 2025 up to and including September 30, 2025.If all warrants are exercised for
subscription of B-shares, the company's registered share capital will increase by 82,990.560062 SEK (given current quota value and provided
that no recalculation is carried out pursuant to the warrant terms).B-shares issued as a result of subscription shall entitle to dividends on the
dividend record date occurring after the share capital is registered with the Swedish Companies Registration Office (Sw. Bolagsverket) and B-
shares have been recorded in the share register kept by Euroclear Sweden AB.The warrants will otherwise be subject to customary terms
regarding inter alia recalculation, which are included in the board's complete proposal.Approval of transfer of warrants from the Subsidiary to
participants in the incentive program The Board of Directors proposes that the Annual General Meeting resolves to approve that the company
or the Subsidiary transfers a maximum of 304,500 warrants to the company's CEO, senior executives and other employees and key persons
engaged as consultants, or to companies wholly owned by such persons, according to the following principles.Category A - CEO: the CEO may
be allotted a maximum of 120,000 warrants.Category B - other senior executives: participants in this category may be allotted a maximum of
115,000 warrants collectively and each participant in the category may be allotted a maximum of 75,000 warrants individually.Category C -
other employees: participants in this category may be allotted a maximum of 69,500 warrants collectively and each participant may be
allotted a maximum of 20,000 warrants individually.The warrants shall be transferred on market terms at a price established on the basis of
an estimated market value of the warrants at the time of the transfer by applying the Black & Scholes valuation model (option
premium).Calculation of the option premium shall be performed by an independent valuation expert.In order to enable the participants
acquisition of the warrants, the board may decide on an extra bonus payment which net after deduction for taxes and social security
contributions is equivalent to 100% of the option premium.In addition, a so-called pre-emption agreement shall be entered into, pursuant to
which the warrant holder shall be obliged to offer the company or the Subsidiary to acquire the warrants, or a portion of them, under certain
conditions.Transfer of warrants to participants in the incentive program requires that such transfer may be lawfully made and that it,
according to the Board of Directors' assessment, may be made to reasonable administrative costs.The employees who are entitled to acquire
warrants must notify their intention to acquire warrants during the period from May 16, 2022 up to and including May 31, 2022.However, the
Board of Directors shall have the right to extend the time for such notification and to resolve on a new notification period for employees
whose acquisitions occur after the initial acquisition period has ended.Costs for the incentive program The incentive program has been
prepared in consultation with external legal and financial advisers and the costs for this guidance is estimated to amount to a maximum of SEK

80,000.The company's costs for bonus payments to cover the option premium is expected to amount to approximately SEK 4,800,000.In
addition to the costs stated above, the Board of Directors deems that the incentive program will cause certain administrative costs in
connection with registration, transfer and share subscription by exercise of warrants.Other outstanding share-related incentive programs in
the company Warrant program 2017/2022 On May 4, 2017, the Annual General Meeting decided on an incentive program by a directed issue
of warrants to the Subsidiary.The number of issued warrants is 280,000.In total 260,000 warrants have been transferred to employees.The
transfers have been carried out on market terms at a price determined at the time of the transfers by applying the Black & Scholes method of
valuation.The holder of warrants may, during the period from April 3, 2022 up to and including May 3, 2022, for each warrant subscribe for
one and one tenth (1.1) new B-share in the company at a subscription price per share amounting to SEK 272.41 (a recalculation of the terms
has taken place due to share issues in November 2017 and January 2018).Warrant program 2020/2024 On June 16, 2020, the Annual General
Meeting decided on an incentive program by a directed issue of warrants to the Subsidiary.The number of issued warrants is 375,000.In total
244,073 warrants have been transferred to employees.The transfers have been carried out on market terms at a price determined at the time
of the transfers by applying the Black & Scholes method of valuation.The holder of warrants may, during the period from July 1, 2024 up to
and including September 30, 2024, for each warrant subscribe for one (1) new B-share in the company at a subscription price per share
amounting to SEK 400.There are no other share-based incentive programs in the company.Majority requirements The resolutions above are
conditional on each other and are therefore to be adopted jointly.A valid resolution requires approval of shareholders representing at least
nine tenths (9/10) of both the votes cast and the shares represented at the meeting.Other The CEO, or any other person appointed by the
Board of Directors, shall have the right to take those smaller measures that may be required in order to register and implement the
resolution.Further information Available documentation and proxy forms The annual report and other complete documentation will be made
available at the company and on www.ibtherapeutics.com no later than three weeks before the Meeting and will be sent free of charge to all
shareholders who so request and provide their postal address.The shareholders' register for the Meeting is also made available at the
company.Proxy form for shareholders who wish to vote in advance by proxy is available on the company's website, and will be sent free of
charge to all shareholders who so request and provide their postal address.Questions and shareholders' right to request information At the
Annual General Meeting, if any shareholder should so request and the Board assesses that this can be done without significant damage to the
company, the Board of Directors and the CEO shall provide information about conditions that could affect the assessment of items on the
agenda and conditions that could affect the assessment of the company's or a subsidiary's financial situation and the company's relationship
to other group companies.The request for such information shall be made by e-mail to ibt@ibtherapeutics.com or by mail to Infant Bacterial
Therapeutics AB (publ), Bryggargatan 10, SE-111 21 Stockholm, Sweden no later than April 24, 2022.The information is provided by being
made available at the company and the company's website, no later than April 29, 2022.Furthermore, the information will be sent within the
same time period to the shareholder who so request and provide its postal address.Shares and votes The total number of shares in the
company amounts to 11,226,184, consisting of 377,736 Class A shares and 10,848,448 Class B shares, carrying a total number of 14,625,808
votes.Personal data For information on how your personal data is processed, see the integrity policy available on Euroclear's website,
www.euroclear.com/dam/ESw/Legal/Privacy-notice-bolagsstammor-engelska.pdf.Infant Bacterial Therapeutics AB (publ) corporate
registration number is 556873-8586 and its registered office is in Stockholm, Sweden.This notice is a translation of a Swedish notice and in
case of any deviations between the both language versions, the Swedish version shall prevail.Stockholm in April 2022 The Board of Directors
of Infant Bacterial Therapeutics AB (publ) Attachment

Mar 31, 2022: Infant Bacterial Therapeutics publishes Annual Report for 2021
Infant Bacterial Therapeutics AB (publ) publishes the Annual Report for 2021.
The report is available on IBT's website ibtherapeutics.com under the section "Investors & Media – Financial Reportsand is available in printed
form for those that have requested. A copy can be requested by contacting IBT's office via info@ibtherapeutics.com.

Infant Bacterial Therapeutics AB - Pharmaceuticals and Healthcare - Pipeline Products

News & Press Releases
Jan 24, 2023: Infant Bacterial Therapeutics (IBT) publishes clinical findings in the British
Journal of Gastroenterology on the convincing association of clinical events to the feeding
primary endpoint of the ‘Connection Study’
The ‘Connection Study’ on the pharmaceutical grade probiotic IBP-9414 has two independent primary endpoints- the incidence of Necrotizing
Enterocolitis (NEC) and the time to a strict definition of Sustained Feeding Tolerance (SFT). SFT is important to reach as early as possible and a
critical goal in the neonatal intensive care (NICU) treatment of premature infants.
Treatment- blind evaluation of the first 641 infants completing the study with use of quantitative statistics revealed significant delays in the
time to reach SFT for 23 examined clinical events characteristic of the NICU treatment of premature infants. The greatest delay occurred in
infants with gastrointestinal perforation, hypotension, serious cardiac events and pneumonia (mean delays of 10.1-20.0 days). The time to SFT
also strongly influenced the duration of NICU stay and was associated with events like NEC, retinopathy of prematurity, late onset sepsis and
days on antibiotics for systemic use.
This further builds on the previously published data showing that even a one-day reduction in time to SFT correlates to several clinically
meaningful outcomes including reductions in NEC, late onset sepsis, bronchopulmonary dysplasia and antibiotic use.
“IBT is pioneering pharma grade probiotic development with the aim to prevent life threatening infant diseases. We are very pleased to see
that data from our study unveils in hitherto unknown detail the importance of reaching a full enteral feeding, being vital to the short and long
term development of the premature infant. I like to emphasize that this is really promising data that further validates our study design. Given
that this is a blinded evaluation it is not intended to and can not provide any information on the efficacy of our study drug”. says Staffan
Strömberg, CEO of IBT.

Sep 23, 2022: FDA approves Infant Bacterial Therapeutics' request for a new orphan drug
designation
Building upon Infant Bacterial Therapeutics AB’s (IBT) unique expertise in developing treatment solutions for preterm infants, IBT is at an early
stage of investigating the possibilities of developing a drug to prevent retinopathy of prematurity, a growing and serious condition that often
leads to blindness among prematurely born babies. The FDA granted orphan drug designation for IBT’s product on Sep 20th .
Retinopathy of prematurity affects 50-70% of preterm infants weighing less than 1,500 grams at birth, in several cases leading to patients
becoming legally blind. Current treatments do not sufficiently address the medical need with severe cases growing significantly from 1.7 to
14.8 per 1,000 preterm infants between the years 1990 and 2011.
Orphan drugs are either drugs or biologics intended for the treatment, diagnosis or prevention of rare diseases or disorders affecting less than
200,000 patients in the US per year. An orphan drug designation qualifies the company applying for it to receive certain benefits from the US
government, such as tax reductions and long term market exclusivity, in exchange for developing the drug.
The approval does not change the standard regulatory requirements and processes for obtaining marketing approval for a product.
Consequently, all aspects of the development must be investigated, including the clinical safety and efficacy documentation required for a
market authorisation.
The drug candidate is a dipeptide developed under the leadership of Dr. Josef Neu, Professor at University of Florida Health, Department of
Pediatrics, Division of Neonatology and Dr. Maria Grant, Professor at University of Florida Health, Department of Endocrinology, Diabetes and
Metabolism.
“Advances in neonatal intensive care include survival of extremely preterm infants that are highly susceptible to retinopathy of prematurity
(ROP), a major cause of blindness in children. Current treatment strategies are based on prevention of progression once an early stage of the
disease is diagnosed. These are invasive and involve interventions that are often difficult for these infants to tolerate. Studies in animal
models of retinopathy support the preventative potential of arginyl-glutamine dipeptide. Our goal is to determine whether this agent can be
provided at a stage that will prevent even the early onset of this disease, thereby eliminating or decreasing the need for future invasive
procedures and most importantly, progression to blindness”, says Professor Josef Neu.
“We are honored to be working with Professor Josef Neu on this initiative and pleased that the FDA has granted the product orphan drug
designation. We are now investigating if, and how, we can contribute to the care of these patients. IBT has established unique competencies
by pursuing treatment solutions for preterm infants, new pathways through pharma grade probiotics as well as enabling a healthy
microbiome across the gastroenterology field. These competencies allow us to assess potential portfolio expansion opportunities.
Retinopathy of prematurity aligns with our core focus in developing the drug candidate IBP-9414, for the prevention of necrotizing
enterocolitis (“NEC”) and improvement of feeding tolerance in premature infants. We continue to expect to complete IBP-9414 recruitment
with existing capital and are concurrently investigating this new opportunity with minimum financial exposure”, says Staffan Strömberg, Chief
Executive Officer, IBT.

Jan 10, 2022: Infant Bacterial Therapeutics announces that new patent protection is
granted in Australia
Infant Bacterial Therapeutics AB announces that the Australian Patent Office has granted a patent entitled: A method of activating lactic acid
bacteria, which protects the formulation of Lactobacillus reuteri including IBP-9414. IBP-9414 is currently in Phase III development for the
prevention of necrotizing enterocolitis (NEC) and improvement of feeding tolerance in preterm infants.
The ambition for IBP-9414 is to become the world’s first approved pharmaceutical grade probiotic drug to prevent life threatening infant
diseases including NEC, by promoting healthy stomach- and bowel development in premature infants.
The invention covers a novel way to activate the freeze-dried bacteria and corresponding patent applications are pending in additional
important future markets including the US and Europe. This patent further increases the existing protection of IBT’s drug candidate IBP-9414
for which both Orphan Drug Exclusivity and biological data protection have been granted in the USA and EU.
The patent provides coverage until 2036. IBP-9414 is intended to be marketed in Australia once market approval has been obtained.
“We are very pleased that IBT has succeeded in expanding our intellectual property protection for IBP-9414 through the approved patent in
an important additional market” says Staffan Strömberg, Chief Executive Officer of IBT.

Dec 27, 2021: Infant Bacterial Therapeutics announces new patent protection approvals in
Brazil and in Hong Kong
Infant Bacterial Therapeutics AB today announces that the Patent Offices of Brazil and Hong Kong have approved a patent of Lactobacillus
reuteri covering IBP-9414. IBT is currently developing its drug candidate IBP-9414 in Phase III for the prevention of necrotizing colitis and
improvement of feeding tolerance in preterm infants.
The patent covers a novel way to activate the bacteria. Corresponding patent applications are currently pending across several important
future markets. This patent reinforces the existing protection of IBT’s drug candidate IBP-9414. Additional market protection, beyond patent
exclusivity, is also anticipated in the form of Orphan Drug Exclusivity and biological data protection in the US and EU.
The patent provides coverage until 2036. IBP-9414 is intended to be marketed in Brazil and Hong Kong upon marketing authorization.
“We are pleased to have strengthened our intellectual property protection for IBP-9414 through the approved patents in Brazil and Hong
Kong. Brazil is in particular a substantial market with about 215 million inhabitants, which makes it a very interesting commercial opportunity
for our future product", states CEO Staffan Strömberg, IBT.

Dec 06, 2021: A blinded evaluation of the connection study – sustained feeding tolerance
(SFT) correlates to clinical outcomes
A blinded evaluation of IBT’s Connection Study will be presented by Professor Josef Neu, University of Florida, at the 2021 Hot Topics in
Neonatology on December 6, 2021. The evaluation reveals that even a modest reduction in time to Sustained Feeding Tolerance (SFT)
correlates positively to several clinically meaningful outcomes including Sepsis and Bronchopulmonary Dysplasia, a chronic lung disease that
affects premature newborns.
Given that IBT’s product IBP-9414 is first in class, there were no validated endpoints established for SFT, the Connection Study’s second
primary endpoint. Prior to initiating the study, IBT and the FDA therefore agreed on an appropriate validation procedure, the result of which
has now been presented by Professor Josef Neu.
IBT’s Clinical Phase III study of the drug candidate IBP-9414 for the prevention of necrotizing enterocolitis (NEC) and improvement of SFT in
premature infants, started in July 2019 (NTC02472769 ClinicalTrials.gov). The evaluation presented by Dr. Neu assessed the impact on clinical
outcomes related to a 1-day reduction in time to SFT. Data was consolidated from 439 randomized preterm newborns at 32 weeks gestation.
Of these, 248 (78%) reported time to SFT defined as the combination of:
Enteral feeding at =120 ml/kg/day for 10 consecutive days.No use of parenteral nutrition for 10 consecutive days.Average body weight gain is
=10g/kg/day during these days.The evaluation confirmed that several clinically adverse outcomes correlate positively to a reduction in time to
SFT. This infers that SFT may be used as a predictor for adverse outcomes in very low birthweight preterm infants.
“IBT is pioneering pharma grade probiotic development in our aim to prevent life threatening infant disease and promote healthy
gastrointestinal development. We are very pleased to see the results of the validation as presented by Professor Neu, giving us two validated
primary endpoints in our study.” says Staffan Strömberg, CEO of IBT.

Sep 30, 2021: Next recruitment milestone reached in IBT’s phase III Study.
Infant Bacterial Therapeutics (IBT) announces that the company has reached the next important milestone after recruiting 600 premature
infants in the ongoing Clinical Phase III study of IBP-9414. According to the study protocol, a safety and futility analysis will now be performed
during which the recruitment will continue. On September 22nd the company announced the reopening of stratum A (weights 500 to 749
grams) after the independent Data Monitoring Committee (DMC) completed an additional safety review. The DMC had no objections for the
continuation of the study.
IBT’s Clinical Phase III study of the drug candidate IBP-9414 for the prevention of necrotizing enterocolitis (NEC) and improvement of feeding
tolerance in premature infants, the Connection Study, started in July 2019. There are currently 79 neonatal intensive care units (NICUs) open
for recruitment in the study. These NICUs are located across 10 countries: Bulgaria, France, Hungary, Israel, Poland, Spain, the UK, the US, as
well as in the recently approved Romania and Serbia.
“Currently, we do not expect any safety signals to occur at the 600 patient review, as the DMC recently looked at 571 patients corresponding
to approximately 25,000 patient days. In addition, it is good to see that recruitment is many times greater than observed during the spring of
2021. We also see that centers are motivated to accelerate recruitment in order to develop a pharmaceutical-grade-probiotic for the
prevention of NEC and improving feeding tolerance in preterm infants.” says Staffan CEO, IBT.

Sep 22, 2021: After safety review The Connection study is now again open to recruit the
smallest infants.
Following the completion of the DMC (Data Monitoring Committee) safety review, IBT is pleased to announce the continuation of the
recruitment of patients between 500 – 1000g (Strata A and B) in the Connection study.
“Given the vulnerability of the Stratum A population, infants with a birth weight less than 750 gram, we have agreed with the FDA to carefully
monitor the safety of these infants. Therefore, the independent DMC has completed an additional safety review, and there are no objections
to continue the study. We expect recruitment to increase as we now again recruit in two strata. ” Says Staffan Strömberg, Chief Executive
Officer of IBT.
IBT is currently developing the drug candidate IBP-9414. The ambition for IBP-9414 is to become the world’s first approved probiotical drug
with the goal to prevent life threatening diseases in premature infants including NEC and sepsis by promoting healthy stomach-and bowel
development in premature infants. IBP-9414 contains the active compound 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.

Sep 10, 2021: Infant Bacterial Therapeutics announces that a new patent is granted in
Mexico
Infant Bacterial Therapeutics AB announces that the Mexican Patent Office has granted a patent entitled: A method of activating lactic acid
bacteria, which protects the formulation of Lactobacillus reuteri including IBP-9414. IBT is currently developing its drug candidate IBP-9414 in
Phase III. The ambition for IBP-9414 is to become the world’s first approved probiotical drug with the goal to prevent life threatening diseases
in premature infants including NEC and sepsis by promoting healthy stomach-and bowel development in premature infants.
The invention covers a novel way to activate the freeze-dried bacteria and corresponding patent applications are currently pending in
additional future key markets including the US and Europe. This patent increases the existing protection of IBTs drug candidate IBP-9414 in
addition to Orphan Drug Exclusivity and biological data protection already established in the US and EU.
The Mexican patent provides coverage until 2036. IBP-9414 is intended to be marketed in Mexico once marketing authorization has been
obtained.
“It is a great pleasure that IBT has succeeded in expanding our intellectual property protection for IBP-9414” says Staffan Strömberg, Chief
Executive Officer of IBT.

Aug 25, 2021: Recruitment of the smallest infants in the connection study paused
IBT started to recruit infants in Strata A (weight of 500g-749g) in The Connection Study on April 29 2021. Today, 68 infants have been
recruited to the group.
In accordance with the study protocol and clinical observations, enrolment of infants to Strata A has been paused awaiting a safety review by
the Data Monitoring Committee (DMC). Subjects already randomized will continue treatment as per protocol, and enrolment of subjects into
Strata B (750g-1000g) will continue. IBT is awaiting advice from the DMC before taking any decision regarding further recruitment of infants in
Strata A. The DMC is expected to give their opinion in September this year.

Apr 29, 2021: Infant Bacterial Therapeutics expands The Connection Study to include
infants with a birth weight below 750 grams
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.

Apr 15, 2021: Infant Bacterial Therapeutics receives additional patent protection in China
Infant Bacterial Therapeutics AB announces that the Chinese patent office has issued a decision to grant approval of IBTs patent application
entitled: A method of activating lactic acid bacteria, which protects formulations of Lactobacillus reuteri including IBP-9414. IBT is currently
developing its drug candidate IBP-9414 in Phase III for the prevention of NEC and improvement of feeding tolerance in preterm infants.
The invention covers a novel way to activate the freeze-dried bacteria and corresponding patent applications for the invention are currently
pending in additional important future markets including the US and Europe. IBT recently received similar patent protection in Japan. This
patent increases the existing protection of IBTs drug candidate IBP-9414 in addition to Orphan Drug Exclusivity and biological data protection
already established in the USA and EU.
The Chinese patent expires in 2036 and the IBP-9414 product covered by this patent is intended to be marketed in China after future
marketing authorization.
“We are very pleased that IBT has succeeded in expanding our intellectual property protection for IBP-9414 through the approved patent in
an important additional market” says Staffan Strömberg, Chief Executive Officer of IBT.

Feb 10, 2021: Infant Bacterial Therapeutics announces that the recruitment to the first
stage of the phase III Connection Study is completed - an update about the clinical
development of IBP-9414
Infant Bacterial Therapeutics (IBT) announces that the company has reached an important milestone after recruiting 300 premature infants to
the ongoing clinical Phase III study of IBP-9414. This in part 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.
IBTs clinical Phase III study of its drug candidate IBP-9414 for the prevention of necrotizing enterocolitis and improvement of feeding
tolerance in premature infants, the Connection Study, started in July 2019. There are currently 68 neonatal intensive care units (NICUs) open
for recruitment in the study. These NICUs are located in France, Hungary, Israel, Spain, the UK and the USA. The clinical trial application has
further recently been approved in Bulgaria and Poland and submitted in Romania and Serbia. IBT expects that approximately 20 NICUs will
open for recruitment in the coming months in these newly added countries.
The majority of the infants intended to be recruited to the Connection Study will be extremely low birth weight (ELBW) premature infants, i.e
they have birth weights of 1000 grams or below. These are the most vulnerable preterm infants and as a precautionary measure the study
was designed to include 300 infants with birth weights between 750 and 1000 g in the first stage of the study. After the ongoing safety
analysis of these infants the recruitment is intended to be broadened to include infants with a birthweight down to 500 g. This is expected to
double the number of infants available for inclusion in the study and we anticipate a significant increase the speed of recruitment in the
study.
Prior to commencing the Connection Study, IBT agreed with the FDA to perform a pilot analysis of the first 300 patients with the purpose of
qualitatively and quantitatively assessing the clinical meaning of the premature infants ability to, as soon as possible, receive enteral feeding
without complication. Together with the external neonatology expert group we will analyze the correlation between sustained feeding
tolerance and, for example, the incidence of sepsis in the infants. In accordance with the agreement with the FDA, the purpose of the pilot
analysis is to validate the second primary endpoint of the study and if necessary redefine it.
At the beginning of 2020 and prior to the COVID 19 pandemic, recruitment rates were close to those expected and IBT predicted reaching 300
patients during 2020. However, due to the effects of the pandemic, reaching this milestone has been delayed by a number of months. As
previously communicated, IBT now anticipates to complete the study in 2022.
Through extensive cooperation with the investigating NICUs, IBT has been able to mitigate the pandemics effects on recruitment, and patients
have been recruited during the duration of the pandemic. All patients included in the Connection Study are in-hospital patients and therefore
no formal outpatient visits are required. Due to this, hospital restrictions on visiting have not affected the Connection Study. Through for
example the use of virtual study monitoring, it has also been possible to maintain study quality in relation to patient data capture.
The pandemic has however affected recruitment to the study in several ways. Firstly, certain hospitals stopped recruitment to all clinical
research studies and new studies were not allowed to start as the relevant research staff were allocated other responsibilities. Further, the
staff on duty in the NICUs have in some cases been transferred to COVID-related intensive care departments. In addition, neonatologists in
the study as well as scientific journals are reporting a dramatic drop in the numbers of premature infants born into their NICUs during the
pandemic. Recruitment rates are expected to significantly increase once the pandemic is under control.
Clinical trial supply is functioning well and the IBP-9414 product is well-accepted by hospital pharmacies involved in the Phase III study. IBT is
also pleased that the ongoing stability program for the physical product IBP-9414 is going according to plan.
The cost estimates for the Connection Study performed prior study start correspond to the actual incurred expenses. As previously
communicated, IBT estimates that it has sufficient capital to complete the Phase III Study.
The pandemic has in various ways affected the possibility to recruit patients to the study, not least when a limited weight group interval range
was chosen as a precautionary measure for the first 300 patients in the study. The first phase of the study is being evaluated at the same time
that we can conclude that the study quality is sufficient and that the study can be completed with IBTs current capital. IBT expects that the
recruitment rate will increase during 2021 due to the combination of lower impact from the COVID pandemic, continued opening and
activation of new hospitals and the fact that the study is expected to include infants with a birth weight down to 500 grams. The medical need
for preventive treatment for necrotising enterocolitis and to improve feeding tolerance in preterm infants remains very high.

Feb 09, 2021: Infant Bacterial Therapeutics announces that new patent protection is
granted in Japan
Infant Bacterial Therapeutics AB announces 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. IBT is currently developing its drug
candidate IBP-9414 in Phase III for the prevention of NEC and improvement of feeding tolerance in preterm infants.
The invention covers a novel way to activate the freeze-dried bacteria and corresponding patent applications for the invention are currently
pending in additional important future markets including the US and Europe. This patent further increases the existing protection of IBTs drug
candidate IBP-9414 for which both Orphan Drug Exclusivity and biological data protection have been granted in the USA and EU.
The Japanese patent expires in 2036 and the IBP-9414 product covered by this patent is intended to be marketed in Japan after future
marketing authorization.
“We are very pleased to strengthen and extend our intellectual property protection for the IBP-9414 product through the approved patent in
Japan” says Staffan Strömberg, Chief Executive Officer of IBT.

Nov 05, 2020: Infant Bacterial Therapeutics interim management statement, January 1 –
September 30, 2020
Message from the CEOIBT 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 testing material 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 Stromberg
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

Feb 11, 2020: Infant Bacterial Therapeutics provides update on IBP-9414 drug program
Message from the CEO
IBT’s ongoing clinical phase III study with IBP-9414 has, as of the date of this year-end report, conducted patient recruitment for more than
seven months. We have, as previously communicated, the approval to conduct the study in France, Spain, the U.K., Hungary and the U.S. At
the end of January 2020 our phase III study with IBP-9414 was also approved in Israel. This means that the regulatory process regarding trial
approval may be concluded as we have received approval in every country we plan to conduct the study.
IBT expected the recruitment rate in the phase III study to approximate the rate noted during our concluded phase II study, and as previously
communicated in the most recent financial report, we were not satisfied with the rate of recruitment. There have been a number of practical
reasons, including misunderstandings regarding interpretation of an exclusion criteria, which precluded doctors from including patients in the
study. This was addressed during the autumn.
We have focused our work on improving the recruitment rate in the study and IBT has visited nearly all open centers. We are now able to
conclude that we can achieve similar recruitment rate as we achieved during the phase II study at centers which have initiated recruitment.
As of the date of this report 51 of a total of 100 planned centers have been contracted and we are working intensively to initiate more. Since
the previous interim report we have further strengthened our clinical department at IBT in order to ensure that the “best practice” is spread
from the top recruiting centers to others.
During January 2020, IBT strengthened its organization by recruiting a senior clinical project manager and a senior CMC (“Chemistry,
Manufacturing and Controls”) specialist in order to satisfy the long-term supply for the market as well as the study material for the ongoing
study.
The study is double blinded which means that we are not able to make observations regarding efficacy in our pharmaceutical candidate yet.
However, we can observe important factors relevant for conducting the study. Firstly, we note that the relevant infants are recruited to the
study which means that the infants meet the specific inclusion criteria. Secondly, we note that systems managing side effects, patient
allocation and independent assessment of X-rays of NEC are conducted as planned. This means that the study is operationally progressing as
expected.
Our ongoing study is randomized, double blinded and placebo controlled to assess safety and efficacy of IBP-9414 for prevention of of
necrotizing enterocolitis (“NEC”), and also includes other important clinical effect parameters in feeding premature infants comprising so
called feeding tolerance, thus comprising multiple endpoints. Hopefully the results from the study will show that our product will both reduce
the risk that infants develop NEC, and additionally, that infants will be able to absorb nutrition better.
I also wish to state that IBT’s liquidity is adequate to conduct the ongoing clinical phase III study in spite of the fact that the initial recruitment
rate of the study did not meet our expectation. IBT’s qualified team is working in a dedicated and focused manner with all vital details which
are so important in order to reach our recruitment goals.
Staffan Stromberg, Chief Executive Officer

Jul 05, 2019: Infant Bacterial enrols first patient in NEC study
Infant Bacterial Therapeutics (IBT) has started enrolling premature infants in the Phase III Connection clinical trial to evaluate its
investigational drug IBP-9414 for the prevention of necrotising enterocolitis (NEC).
IBP-9414 contains a human bacterial strain that occurs naturally in breast milk called Lactobacillus reuteri. It is intended to improve feeding
tolerance in premature babies.
The randomised, double-blind and placebo-controlled Phase III trial is designed to assess the safety and efficacy of IBP-9414 in around 2,158
premature infants with a birth weight of 500g to 1,500g.
To be performed at approximately 100 hospitals across the US, Europe and Israel, the trial secured approvals in the UK, France, Hungary and
Spain.
An investigational new drug (IND) application is currently open in the US.
Primary outcome measures of the study, which is expected to be completed in December next year, are confirmed necrotising enterocolitis
and time to sustained feeding tolerance.
In addition, the trial’s secondary outcomes include at least one clinical sign of necrotising enterocolitis, the number of hospitalisation days,
surgery with confirmation of necrotising enterocolitis, weight gain, and days with clinical signs of feeding intolerance.
Infant Bacterial Therapeutics CEO Staffan Strömberg said: “We are pleased to announce ‘first patient in’ in this important Phase III study. It is
a milestone for IBT and the study we are now starting marks a significant step in the development of therapies to address major medical
needs facing the prematurely born babies.”
The Phase III Connection study is the final trial under IBP-9414’s development programme, which also includes a completed randomised,
double-blind, dose-escalation safety and tolerability study.

May 19, 2019: FDA and Infant Bacterial Therapeutics agree on the design of Phase III study
IBT has for an extended time consulted with the US Food and Drug Administration (FDA) on how the company's planned Phase III study should
be designed. The FDA has now informed IBT in writing that IBT has responded satisfactorily to the comments that the FDA had regarding the
study design and that there are currently no additions from the FDA's side. As a consequence of the FDA's comments, an evaluation of the
effects of IBP-9414 on the digestive system of premature infants in the forthcoming Phase III study is now planned, as a serious medical
problem for premature infants is that they cannot take up nourishment in an adequate way.
As previously announced, IBT has discussed the clinical development plan PIP (pediatric investigation plan) with the EMA (European Medicines
Agency), which resulted in IBT's PIP being approved in 2017.
The coming days at IBT's office will be intensive in order for the company to as soon as possible, before the first half of the year, receive the
formal clinical trials approval required before the first patient can be dosed in the study. As previously announced, IBT plans to start the study
in hospitals in France, Hungary, Israel, Spain, the United Kingdom, and the United States.
“Receiving the FDA's comments took longer than we expected, but now we have a greatly improved protocol compared to what we had 6
months ago. Previously, our only focus was on preventing NEC (necrotizing enterocolitis), that in itself is a terrible intestinal disease which
impacts premature infants and too often leads to fatal outcomes. During the spring of 2019, through consultation with the FDA, we have
broadened the disease indications on which our drug candidate can hopefully demonstrate an effect,” says CEO Staffan Strömberg.

Mar 05, 2019: Infant Bacterial Therapeutics announces first distribution agreement
Infant Bacterial Therapeutics AB has signed the first distribution agreement for IBP-9414 with Megapharm Ltd. for the Israeli market and the
Palestinian Authority’s territories. The agreement gives MegaPharm exclusive rights to market and sell the product, if and when the product
receives market approval, after the pivotal clinical phase III trial that is expected to start during the current half year. MegaPharm will handle
the registration, price negotiations as well as manage marketing and all of the practicalities that distribution of a pharmaceutical entails.
IBT has chosen to establish a distribution agreement, and not a license agreement with significant up-front payments, in order to obtain a
larger share of future sales revenue. IBT’s share will, after an initial shorter period, account for 70% of revenues.As the Israeli health service
offers advanced medical care for premature babies, IBT plans to open clinical trial centers for the pivotal phase III trial in the country.
Megapharm is already participating in this work as it is essential to engage “key opinion leaders” in the marketing of the product.
“We are very pleased to have made this first distribution agreement with MegaPharm. A successful company with more than 25 years of
experience in distributing and selling imported drugs. In addition, the agreement gives us a significant share of sales revenue from this
market, instead of traditional low royalties and substantial advance payments. This type of agreement should be able to give the shareholders
a substantially higher return on the invested capital,” says IBT’s CEO Staffan Strömberg.
“We have great optimism for this product which we believe will satisfy a significant unmet medical need for premature infants. There is a
clear need for an approved drug for this extremely sensitive patient group and we therefore believe that, even if the Israeli market is limited
in size, we can generate significant value through our capable sales organization” says Megapharm CEO, Miron Drucker.

Nov 21, 2018: The Phase 3 study protocol is modified after IBT's meeting with the FDA
Infant Bacterial Therapeutics had a meeting with the US Food and Drug Administration (FDA) in Washington DC to discuss the design of the
company’s clinical development program. As a consequence of these discussions, IBT has chosen to modify its Phase III study for the
prevention of necrotizing enterocolitis (NEC) in premature infants.
Following the guidance from the FDA, IBT will improve the protocol which may allow additional claims such as reduction in “feeding
intolerance”, that could increase the market potential of the product and the chances of success in the company’s Phase III study.
The process to modify the study protocol has already been started. Because of these changes, the Phase III study protocol will not start in
2018 as previously communicated but is expected to start during the first half of 2019. Preparations for this study, including the production of
clinical trial material and the initiation of clinical sites in Europe and the US, continue and are unaffected by this FDA meeting.
“We do not want delays to our development program, especially with the unmet medical need that necrotizing enterocolitis represents, but
we feel that the FDA guidance will have a positive effect on our program by improving our Phase III study, allowing us ultimately to bring
significant benefits to premature babies. The company’s current financial position is sufficient to finance the IBTs continued operations and
finalize the development program ” says Staffan Strömberg, CEO of IBT.
About IBP-9414
IBP-9414 is a drug candidate being developed to prevent necrotizing enterocolitis (NEC), a devastating and often fatal disease in premature
infants. IBP-9414 contains the active substance Lactobacillus reuteri, which is a human bacterial strain naturally present in breast milk.

Nov 09, 2018: IBTs Chief Scientific Officer invited to speak at NEC Society Symposium 2019
Infant Bacterial Therapeutics (IBT) Chief Scientific Officer, Eamonn Connolly, PhD has been invited to speak and be a facilitator at the 2019
NEC Symposium in the session “Promising Novel Therapies for NEC in Preclinical and Clinical Trials”. Dr. Connolly will speak about IBT´s
pharmaceutical development program for the prevention of necrotizing enterocolitis in preterm infants, under the title “Drug development
for the prevention of NEC”.
As the only company presenting at the symposium, IBT has a unique opportunity to share its experience with the development of IBP-9414
and maintain the continuing dialogue with key stakeholders.
The NEC Symposium takes place during June 2019. The event is organised by the NEC Society, and serves as a forum to establish a
collaboration of stakeholders in NEC to accelerate the implementation and standardization of established evidence based practices that can
help to reduce the incidence and morbidity of NEC. The NEC Symposium audience ranges from family members of infants who died from or
survived NEC, to expert neonatologists, key opinion leaders, neonatal care practitioners and the US Food and Drug Administration.
The NEC Society, a non-profit organization, was launched in 2014 and is spearheaded by two mothers who lost their own babies to NEC. The
NEC Society is a clinician-family collaborative organization in the United States who seek to improve outcomes for infants at risk of necrotizing
enterocolitis.

May 15, 2018: Infant Bacterial Therapeutics: Interim Management Statement, January 1 -
March 31, 2018
Infant Bacterial Therapeutics AB., provides update on company's drug candidate, IBP-9414.
Message from the CEO
During the past year, IBT passed the most important milestones in the company's history. The company's drug candidate, IBP-9414, which we
believe will prevent necrotizing enterocolitis, has demonstrated similar safety and tolerability profile in a Phase II study focused on safety and
tolerability when IBP-9414 was administered in comparison with placebo.
During the spring of 2018 we ensured that we now have the resources needed to complete the Pivotal Phase III study, that we chose to call
"The Connection Study". We expect to be able to announce "first patient in" to this pivotal trial in the near term. The last pieces of the puzzle
in relation to our Clinical Research Organization (CRO) and Clinical Trial Material (CTM) vendors are also soon in place.
As previously communicated, IBT has applied for listing on Nasdaq's main list. We will meet all requirements for IBT to be approved for the
main list. If nothing unanticipated occurs, I expect IBT to be approved on the main list during the third quarter of 2018.
We have also established an Advisory Board to aid in evaluating other new development projects.
Here, IBT will be restrictive with focus on projects that can be taken to market and which satisfy an unmet medical need on parity with IBP-
9414. I will return with more information about and when we identify additional valuable projects.
In summary, everything is progressing according to plan and we are looking forward to getting the study started and listing change approved
in the near future.

Dec 11, 2017: Infant Bacterial Therapeutics presents data from its Safety and Tolerability
Study in premature infants
Infant Bacterial Therapeutics and the principal investigator Dr. Josef Neu presented data from its Safety and Tolerability study in premature
infants at the ongoing Hot Topics in Neonatology Conference in Washington, D.C., USA.
In summary, the Safety and Tolerability study showed that live bacterial therapy with IBP-9414 demonstrated similar safety and tolerability to
placebo in preterm infants with birth weights 500g – 2000g, that there was exposure to the study drug demonstrated by presence of the
bacterium in the feces on the last day of treatment, and that there was no evidence of cross-contamination with IBP-9414 in placebo treated
infants.
The study, “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” is part of the pharmaceutical development of IBP-9414 as a preventive therapy for
necrotizing enterocolitis in preterm infants.
The study included 120 preterm infants with birth weights between 500 – 2,000g, who were randomized to receive either IBP-9414 (low dose
or high dose) or placebo for 14 days, enterally administered daily, after which they were evaluated under 6 months follow up after the end of
treatment. The study was performed at 15 neonatal centers in the US.
With these results in hand, the IBP-9414 clinical development program is now moving into the planned Pivotal Phase III trial for the
prevention of NEC.

Nov 23, 2017: Infant Bacterial Therapeutics Interim Management Statement, January 1 -
September 29, 2017
IBT announced results from the safety and tolerability study of IBP-9414 on September 11th. The data demonstrate a similar safety and
tolerability profile in the active and placebo groups. The study included 120 preterm infants, dosed during two weeks and evaluated at time
points up to 6 months after administration of the study drug at 15 neonatal centers in the United States. We can conclude that the
recruitment rate was higher than expected without any variance between large or small infants and that the demographics of the study
population was representative of the target population. IBT was able to complete the study according to plan in terms of recruitment,
timelines and budget. We are continuing our preparations for the next and final part of the IBP-9414 development program, the planned
pivotal efficacy study for the prevention of NEC.
In September, The Paediatric Committee (PDCO) at the European Medicines Agency (EMA) adopted a positive opinion on the "Paediatric
Investigation Plan" proposed by IBT for the development of IBP-9414 for the prevention of necrotizing enterocolitis (NEC). Adoption of the
"Paediatric Investigation Plan" is a prerequisite for continuing our clinical development program. I am very happy that the IBT team again has
shown its capability to reach a significant milestone in the global development program.
IBT has the financial resources to prepare the following pivotal study of IBP-9414 which is planned to be initiated in the beginning of 2018.
The ongoing planning and preparations for the pivotal study include CMC (Chemical, manufacturing and control) activities for the production
of clinical trial material.
As previously announced, the pivotal study will require additional capital. IBT is working very actively on several different financing
possibilities. In addition, IBT is progressing in its preparation for the application to admittance for trading on the main marketplace, Nasdaq
Stockholm as previously communicated.
Significant events during the third quarter 2017
•Infant Bacterial Therapeutics ("IBT") reported results from the safety and tolerability study for IBP-9414 on September 11. The results show a
similar safety and tolerability profile in the active group as in the placebo group in IBT's clinical safety and tolerability study on IBP-9414
(NCT02472769)•IBT reported on September 28 that The European Medicines Agency's (EMA) paediatric committee (PDCO) approved IBT's
proposed "paediatric investigation plan (PIP) for IBP-9414 in prevention of necrotizing enterocolitis (NEC)"Significant events during the
reporting period January - September 2017
•In January 2017, all 120 patients were included in the Company's clinical safety and tolerability study in IBP-9414 (NCT02472769)•IBT's series
B shares were listed on Nasdaq First North Premier on March 14•Eva Idén and Anthon Jahreskog were elected new board members at the
AGM on May 4•The subsidiary IBT Baby AB was established in May for administration of a new share based incentive program•All personnel
subscribed for their respective allotments in a new share based incentive programSignificant events after the reporting period
No significant events have occurred after the reporting period

Sep 28, 2017: European Medicines Agency adopts a positive opinion on the Paediatric
Investigation Plan for IBT’s lead product
The Paediatric Committee (PDCO) at the European Medicines Agency (EMA) has adopted a positive opinion on the Paediatric Investigation
Plan (PIP) proposed by IBT for the development of IBP-9414 for the prevention of necrotizing enterocolitis (NEC).As part of European
regulations, pharmaceutical companies must submit a Paediatric Investigation Plan (PIP) outlining the strategy for investigation of new
medicines in the paediatric population. An agreed PIP is a prerequisite for filing for marketing authorization for any new medicines in
Europe.Compliance to an agreed PIP adds a two-year extension to the 10-year market exclusivity awarded to an orphan designated product
(such as IBP-9414) at market approval in the European Union.Staffan Strömberg, CEO said “We are now preparing for the Phase 3 study and
the adoption by PDCO of the PIP is necessary to allow us to move forward with our clinical development plan. I am very happy that the IBT
team again has shown its capability to reach a significant milestone.”

Sep 11, 2017: Infant Bacterial Therapeutics announces that top line data demonstrate
similar safety and tolerability profile in the active and placebo groups
Infant Bacterial Therapeutics and the principal investigator Dr. Josef Neu have made an initial evaluation of the top line data of the Phase II
“Randomized, double blind, parallel-group, dose escalation placebo-controlled multicentre study to investigate the safety and tolerability of
IBP-9414 administered in preterm infants”. The study included 120 preterm infants, evaluated at time points up to 6 months after
administration of the study drug at 15 neonatal centers in the US. Top line data demonstrate similar safety and tolerability profile in the active
and placebo groups.
The data will be further studied during the coming months and the plan is to submit results of the study for presentation at Hot Topics in
Neonatology, Washington DC on 10/11 December 2017.
“We are encouraged by the data from this study and the planning for the pivotal Phase III study is continuing. I am also happy that we have
been able to run the study according to plan in terms of recruitment, timelines and budget”, says CEO Staffan Strömberg.

Jan 24, 2017: Last patient enrolled in IBT's Phase 2 study

Infant Bacterial Therapeutics AB (“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.”

Dec 14, 2016: IBT adds new indication for Gastroschisis-Related Intestinal Dysfunction
Infant Bacterial Therapeutics AB (“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.

Nov 21, 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.

Jun 07, 2016: Infant Bacterial Therapeutics enrolls First Patient in Phase 2 Clinical Trial
Infant Bacterial Therapeutics AB 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.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.”

Mar 31, 2016: IBT receives Rare Pediatric Disease Designation from FDA for drug candidate
Infant Bacterial Therapeutics AB 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.”

Jan 08, 2016: BioGaia’s subsidiary IBT has US IND open and Swedish CTA approved for
clinical study
Infant Bacterial Therapeutics (IBT), a subsidiary of BioGaia, announced 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.IBT now has an open IND accepted by the FDA, which is an
important step in allowing IBT to start clinical studies in the US.
Furthermore, the Swedish MPA has given approval to IBT to conduct its clinical trial in Sweden. In addition to the approval by MPA, IBT has
also received approval from the Ethical Committee.
In November 2013 BioGaia founded the subsidiary IBT to manage the development of a pharmaceutical for the prevention of NEC, as this was
not within BioGaia’s core business activities. IBT will now commence clinical development of its drug to prevent necrotizing enterocolitis (NEC)
in Sweden and the US. NEC is a bowel disease, which affects premature infants and often is fatal.
“We are very happy to see that IBT has reached these important milestones. This confirms that IBT:s drug development to date meets the
requirements of both agencies to begin clinical trials in premature infants, the most vulnerable of all humans”, says Peter Rothschild,
President, BioGaia and Chairman of the IBT board.
“We are now able to conduct clinical trials both in the US and in an EU country and we are naturally excited to move on with our drug
development with the aim of satisfying the global need to find a preventive therapy for NEC”, says Staffan Strömberg, President, Infant
Bacterial Therapeutics.

Jun 24, 2015: BioGaia Subsidiary IBT Takes Rapid Steps in Development of a Drug for
Premature Infants
Infant Bacterial Therapeutics (IBT) aims to develop a unique orphan drug to prevent the fatal disease necrotising enterocolitis (NEC). The
project has proceeded faster than previously scheduled and according to the updated development plan IBT expects to run two clinical trials
within the next three years.
As announced earlier the IBT drug candidate IBP-9414 has been granted Orphan Drug Designation for the prevention of NEC by the FDA
(August 2013) and the European Commission (February 2015)
First clinical trial to start already this yearThe clinical development plan is designed with input from the FDA, EMA and US/EU key opinion
leaders

Jun 12, 2015: BioGaia evaluates the possibility of a separate listing of Infant Bacterial
Therapeutics
BioGaia’s board of directors has instructed the management team to evaluate the possibility of a separate listing of its subsidiary Infant
Bacterial Therapeutics AB (IBT).
In November 2013, BioGaia’s board of directors resolved to invest in a first phase of a project which aims at developing a prophylactic drug
against necrotizing enterocolitis (NEC), which affects premature babies. BioGaia has, until 31 May 2015, provided financing of SEK 24 million
to the project, of the total resolved amount of approximately SEK 47 million.
The project is managed by BioGaia’s subsidiary Infant Bacterial Therapeutics (IBT), where Staffan Strömberg is the CEO. IBT’s board is
composed of Peter Rothschild, Jan Annwall, Anders Ekblom¹ and IBT’s Head of R&D Eamonn Connolly.
The development of the drug has progressed more rapidly than planned and IBT is now planning to begin its first clinical trials in 2015. To
finance the first clinical trials, IBT has an estimated capital need of approximately SEK 130 million. To enable BioGaia’s shareholders to invest
directly in this project, the board of directors has instructed the management team to evaluate the possibility of a separate listing of IBT
during the second half of 2015.
It is the opinion of the board that a separate listing would be beneficial for BioGaia’s shareholders, as it would highlight the value of the
pharmaceutical project managed by IBT and also result in a streamlining of the respective businesses.
Carnegie Investment Bank and Advokatfirman Vinge have been engaged as advisers to BioGaia and IBT.

Mar 26, 2015: Infant Bacterial Therapeutics receives additional funding from mother
company BioGaia
Infant Bacterial Therapeutics continues its efforts to develop a drug to prevent necrotizing enterocolitis which is a rare and fatal disease that
affects premature infants. IBT 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.
In November 2013, the Board of BioGaia invested 42 million SEK in IBT to conduct the early stages of the pharmaceutical development of a
preventive therapy for NEC following pharmaceutical regulations.
During 16 months of activity, IBT has achieved meaningful milestones including, receipt of Orphan Drug Designation for the prevention of NEC
in both US and Europe and has consulted both FDA and EMA on a harmonized drug development program including clinical trial designs and
manufacturing process.
To conduct the upcoming clinical trials, IBT is currently seeking external financing and investigating partnership opportunities.
“At IBT we will pursue our efforts towards providing a therapeutic solution to prevent such a devastating disease as NEC. We are pleased to
see that BioGaia is providing this additional funding to IBT,” says Staffan Strömberg, CEO, Infant Bacterial Therapeutics.

Feb 23, 2015: BioGaia subsidiary Infant Bacterial Therapeutics gets Orphan Drug
Designation in Europe
Infant Bacterial Therapeutics, subsidiary of BioGaia, is in the early stages of developing a drug to prevent necrotizing enterocolitis (NEC) which
is a rare and fatal disease that affects premature infants. IBT has now obtained the Orphan Drug Designation for the prevention of NEC in
Europe, which complements the corresponding designation in the US from FDA, granted in August 2013.
Orphan drugs are either drugs or biologics intended for the treatment, diagnosis or prevention of rare diseases which are defined as life-
threatening or chronically debilitating conditions affecting less than five in 10,000 people in the European Union per year. The Orphan Drug
Designation allows IBT to obtain assistance with development of the drug, fee reductions and marketing incentives.
In 2013 BioGaia founded the subsidiary IBT to manage all business related to the development of a pharmaceutical for the prevention of NEC,
as this was not within BioGaia’s normal business activities.
“We are pleased that the European Commission have granted the Orphan Drug Designation. We are confident that our subsidiary IBT can
significantly contribute in the care of premature infants in the future”, says Peter Rothschild, CEO, BioGaia.
“The US and European approvals of the Orphan Drug Designations are important steps in our efforts to develop this preventive therapy to
save the lives of premature infants from one of the most deadly diseases occurring in the most vulnerable human population”, says Staffan
Strömberg, CEO, Infant Bacterial Therapeutics.

Feb 21, 2014: FDA approves orphan drug designation for IBP-9414
Infant Bacterial Therapeutics AB announces that the U.S. Food and Drug Administration (FDA), has approved orphan drug designation for
Necrotizing enterocolitis (NEC) is a rare and extremely severe disease that affects premature infants.
About IBP-9414:
IBP-9414 is under development for the prevention of necrotising enterocolitis (NCE) in premature infants. The drug candidate is administered
orally. It constitiues co-evolved human bacterial strain lactobacillus reuteri derived from human breast milk.

Appendix
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Glossary
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where the product is used
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Pharmaceuticals and Healthcare Product

Reference Code: GDPH2363473PR

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Infant Bacterial Therapeutics AB Company Overview

Infant Bacterial Therapeutics AB - Key Facts

Telephone +46 8 41014555 No. of Employees 8

Fax Fiscal Year End December

URL ibtherapeutics.com Revenue (in USD Million) 0.0

Industry Pharmaceuticals and Healthcare

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Infant Bacterial Therapeutics AB - Pharmaceuticals and Healthcare - Pipeline Products

Infant Bacterial Therapeutics AB - Number of Pipeline Products by Therapy Area

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Infant Bacterial Therapeutics AB - Number of Pipeline Products by Therapy Area

Therapy Name Number of Products

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Infant Bacterial Therapeutics AB - Number of Pipeline Products by Indication

Infant Bacterial Therapeutics AB - Number of Pipeline Products by Indication (Top 10)

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Infant Bacterial Therapeutics AB - Number of Pipeline Products by Indication

Indication Number of Products

Gastric Motility Disorder 1

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Infant Bacterial Therapeutics AB - Number of Pipeline Products by Product Stage of Development

Infant Bacterial Therapeutics AB - Number of Pipeline Products by Product Stage of Development

Infant Bacterial Therapeutics AB - Number of Pipeline Products by Product Stage of Development

Stage of Development Number of Products

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Infant Bacterial Therapeutics AB - Major Products and Services

Infant Bacterial Therapeutics AB, Major Products and Services

Necrotizing enterocolitis (NEC)

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Infant Bacterial Therapeutics AB - Key Competitors

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Infant Bacterial Therapeutics AB - Key Employees

Name Job Title Board Level Since Age

Peter Rothschild Chairman Executive Board 2011 72

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Infant Bacterial Therapeutics AB - Locations And Subsidiaries

Other Locations & Subsidiaries

Infant Bacterial Therapeutics AB, Subsidiaries

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Company’s Recent Developments

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7.65% reduction in confirmed Necrotizing Colitis (NEC) events

6.71% reduction in late onset sepsis

2.75% reduction in bronchopulmonary dysplasia (BPD)

5.85 reduction in days with antibiotic use

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May 04, 2022: Annual General Meeting of Infant Bacterial Therapeutics

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