GlobeNewswire

Infant Bacterial Therapeutics AB (publ) Interim Management Statement, January 1 – September 30, 2019

Share

Message from the CEO

In our previous quarterly report we were able to announce that the first patient had been recruited in our clinical phase III-study. This study is operationally the most significant in IBT’s operations and therefore I choose to provide some detailed information regarding the study. The study is randomized, double blind and placebo controlled to evaluate the safety and efficacy of IBP-9414 with respect to the prevention of necrotizing enterocolitis and other clinically important aspects of feeding preterm babies. 

Our assumptions regarding patient recruitment are based on experience from the concluded phase II study which IBT conducted at 15 clinics in the U.S. during 2017. We currently have approval for conducting the phase III study in France, Spain, The U.K., Hungary and the U.S. and have recruited patients in both Europe and in the U.S. As of the date of this report 37 centers of the 100 planned have been contracted and work is ongoing to contract more. We have not yet initiated recruitment in the UK, while in e.g. Spain recruitment is progressing above expectations at centers which have initiated recruitment.

Meetings held with study doctors during recent weeks have provided awareness of the difficulties of interpreting the inclusion and exclusion criteria described in the study protocol. Therefore, we revised and clarified these criteria during October rendering them more aligned with those used in our phase II study.

We are not satisfied that the study has had a slow start at certain clinical centers, but we also note that other centers are recruiting well, i.e. above expectations. We shall therefore further strengthen the clinical department at IBT in order to ensure that “best practice” is relayed from the centers with superior recruitment to those hospitals which have not initiated as planned. I expect the study to be concluded during 2021 based on the experience we gained from the phase II study. We will therefore further intensify our work with patient recruitment.

Stockholm
November 7, 2019

Staffan Strömberg,
Chief Executive Officer

Selected financial data          
ooo's 2019
Jul-Sep
2018
Jul-Sep
2019
Jan-Sep
2018
Jan-Sep
2018
Jan-Dec
Net sales - - - - -
Operating profit/loss -11 007 -7 683 -19 774 -15 541 -39 417
Result after tax, SEK -10 538 -7 985 -18 786 -16 464 -40 607
Total assets 545 348 589 820 545 348 589 820 563 371
Cash flow for the period (SEK) -34 064 -9 809 -42 755 406 210 381 544
Cash flow per share for the period (SEK) -3.03 -0.87 -3.81 38.17 35.36
Cash 511 888 566 786 511 888 566 786 542 170
Earnings per share before and after dilution (SEK) -0.94 -0.71 -1.67 -1.55 -3.76
Equity per share (SEK) 47.92 51.74 47.92 51.74 49.59
Equity ratio (%) 99% 98% 99% 98% 99%

Significant events during the third quarter (Jul-Sep) 2019
•  IBT announced on July 4 that the first patient had been recruited in the company’s pivotal clinical phase III-study, The Connection Study

Significant events during the reporting period (Jan-Sep) 2019

  • IBT signed its first distribution agreement on March 5, 2019, for its product 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. IBT’s share will, after an initial shorter period, account for 70% of revenues. 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
     
  • On May 19, 2019, we announced that IBT had responded satisfactorily to the comments that the FDA had regarding the study design. 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. The prior focus was solely prevention of NEC (necrotizing enterocolitis) that, in itself, is a terrible intestinal disease affecting premature infants and too often leads to fatal outcomes. Including another indication means having multiple independent endpoints which may increase the chances of success in the study and thus the market potential
     
  • IBT’s IND-Application (Investigational New Drug) was approved in the USA and the clinical study has also been approved in the UK, France, Hungary and Spain

Significant events after the reporting period
•  Lilian Wikström Ph.D. has requested to resign from the Board of Directors of IBT with immediate effect due to the risk of conflict of interest that has arisen in her role as CEO of KI Innovations AB

About Infant Bacterial Therapeutics AB
Infant Bacterial Therapeutics AB (publ) is a pharmaceutical company with a product in clinical stage with a vision to develop drugs influencing the infant microbiome, and thereby prevent or treat rare diseases affecting infants.

IBT is currently developing the drug candidate IBP-9414, for the prevention of necrotizing enterocolitis (“NEC”) and improvement of so called feeding tolerance 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 fulfil unmet needs for diseases where there are currently no prevention or treatment therapies available.

Infant Bacterial Therapeutics AB (“IBT”) is a public company domiciled in Stockholm. The company’s class B-shares shares are listed on Nasdaq Stockholm, Mid-cap (IBT B).

For additional information please contact
Staffan Strömberg, CEO
Daniel Mackey, CFO
Infant Bacterial Therapeutics AB
Bryggargatan 10
111 21 Stockholm
Phone: +46 70 670 1226
info@ibtherapeutics.com
www.ibtherapeutics.com

Publication
This information is information that Infant Bacterial Therapeutics AB is obliged to make public pursuant to the EU Market Abuse Regulation and which is to be made public according to the Nasdaq regulations for companies listed on Nasdaq Stockholm. The information was submitted for publication, through the agency of the contact person set out above, at 8.00 CET on November 7, 2019.


Attachment

About GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

Novo Nordisk reports weight loss of 14.9% (16.9% if taken as intended) in STEP 1 trial4.6.2020 19:10:28 CESTPress release

Bagsværd, Denmark, 4 June 2020 – Novo Nordisk today announced headline results from STEP 1, a phase 3a trial in the STEP programme. STEP 1 is a 68-week randomised, double-blind, multicentre, placebo-controlled weight management trial. The trial investigated the efficacy and safety of once-weekly subcutaneous (sc) semaglutide 2.4 mg on body weight over 68 weeks compared to placebo in 1,961 adults with obesity or overweight with comorbidities, both in conjunction with lifestyle intervention. The STEP 1 trial met both primary endpoints. In all people randomised1, a statistically significant and superior reduction in body weight was achieved with sc semaglutide 2.4 mg compared to placebo after 68 weeks. People treated with sc semaglutide 2.4 mg achieved a weight loss of 14.9%, from a mean baseline body weight of 105.3 kg, compared to a 2.4% weight loss with placebo. In addition, 86.4% of those who received sc semaglutide 2.4 mg reached a weight loss of 5% or more after 68 weeks, compared t

Scandinavian Tobacco Group A/S: Notification and Public Disclosure of Transactions by Person Discharging Managerial Responsibilities4.6.2020 18:00:00 CESTPress release

Company Announcement No. 15/2020 Copenhagen, 4 June 2020 Notification and Public Disclosure of Transactions by Person Discharging Managerial Responsibilities 1. Information on the person discharging managerial responsibilities/person closely associated a) Name Claus Gregersen 2. Reason for the notification a) Position/title Member of the Board of Directors b) Initial notification/amendment Initial notification 3. Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor a) Name Scandinavian Tobacco Group A/S b) LEI code 5299003KG4JS99TRML67 4. Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted a) Description of the financial instrument, type of instrument Identification code Shares DK0060696300 – STG b) Nature of the transaction Purchase of shares c) Price(s) and volume(s) Price(s)Volume(s)98.8

Scandinavian Tobacco Group A/S: Indberetning og offentliggørelse af transaktioner udført af person med ledelsesansvar4.6.2020 18:00:00 CESTpressemeddelelse

Selskabsmeddelelse Nr. 15/2020 København, den 4. juni 2020 Indberetning og offentliggørelse af transaktioner udført af person med ledelsesansvar 1. Nærmere oplysninger om personen med ledelsesansvar/personen med nær tilknytning til denne a) Navn Claus Gregersen 2. Årsag til indberetningen a) Stilling/titel Medlem af bestyrelsen b) Første indberetning/ændring Første indberetning 3. Nærmere oplysninger om udstederen, deltageren på markedet for emissionskvoter, auktionsplatformen, auktionsholderen eller den auktionstilsynsførende a) Navn Scandinavian Tobacco Group A/S b) LEI-kode 5299003KG4JS99TRML67 4. Nærmere oplysninger om transaktionen/transaktionerne: gentages for (i) hver type instrument, (ii) hver type transaktion, (iii) hver dato og (iv) hvert sted, hvor der er udført transaktioner a) Beskrivelse af det finansielle instrument, instrumenttypen Identifikationskode Aktier DK0060696300 – STG b) Transaktionens art Køb af aktier c) Pris(er) og mængde(r) Pris(er)Mængde(r)98,8849 aktier98

Maha Energy AB (publ) Announce May Production Volumes4.6.2020 17:00:00 CESTPress release

­­­Maha Energy AB (publ) Strandvägen 5A SE-114 51 Stockholm www.mahaenergy.ca Press release Stockholm June 4, 2020 Maha Energy AB (publ) Announce May Production Volumes Production Volumes The Company's aggregate sales production for the month of May totaled 106,2481 barrels of oil and 52.765 million scf of gas for a combined average production of approximately 3,711 BOE/day2, before royalties and taxes. The month of May saw increasing gas sales at Tie as a new gas end-user started taking deliveries allowing for higher oil production. Further at both Tie and Tartaruga stations, oil production was somewhat affected due to temporary surface jet pump maintenance issues which were resolved during the month. Despite the pump issues and continuing Covid-19 movement restrictions, production and off-take volumes in Brazil remain stable. 1 Subject to minor standard industry adjustments at the time of custody transfer. 2 Barrels of oil equivalent ("BOE") conversion ratio of 6,000 scf: 1 bbl is us

Cyber Security 1 AB: CYBER1 Confirms Publication Date for the 2019 Annual Report4.6.2020 16:45:00 CESTPress release

CYBER1 Confirms Publication Date for the 2019 Annual Report London United Kingdom – 04 June 2020, Cyber Security 1 AB (Publ) (“CYBER1”), (Nasdaq:CYB1, OTCQX:CYBNY), has announced a revised publication date of the 9th of June, for the 2019 Annual Report. The change in date brings the 2019 Annual Report publication in line with the Cyber Security 1 AB 2020 AGM, scheduled for Tuesday, 30 June 2020. Shareholders and key stakeholders in the interim may refer to the full year unaudited accounts, through the Q4 2019 report available on our website: www.cyber1.com The annual report once published will be available to view on the CYBER1 website. Certified Adviser Mangold Fondkommission AB is the Company’s Certified Adviser. Telephone: +46 (0)8 5030 1550 E-mail: ca@mangold.se FOR FURTHER INFORMATION, PLEASE CONTACT: Investor Relations Contact: Tim Metcalfe / Zach Cohen CYBER1 Email: cyber1@investor-focus.co.uk ABOUT CYBER1 CYBER1 is engaged in providing cyber resilience solutions and conducts it