
Infant Bacterial Therapeutics AB (publ) Interim Management Statement, January 1 – June 30, 2019
Infant Bacterial Therapeutics AB (publ) Interim Management Statement, January 1 – June 30, 2019
Message from the CEO
On July 4 we were able to announce that the first patient had been recruited and dosed in the company’s clinical phase III-study. Our work is now to focused to ensure that contracted clinics become operational for recruitment of patients and that we may be able to maintain a rapid recruitment rate of premature infants in the study. This work is conducted in part by our CRO, and the IBT staff are deeply involved in the various phases of this work, such as negotiating contracts with hospitals, motivating participating doctors, as well as other health care personnel, to give our study priority and to ensure that clinical trial material is at hand at the right time.
The ongoing pivotal phase III-study, which we have named “The Connection Study” is a randomized, double blind and placebo-controlled study to investigate the safety and efficacy of IBP-9414 for the prevention of necrotizing enterocolitis (NEC), and includes other significant clinical aspects in feeding preterm infants.
Comments on our development program from the FDA and other authorities in Europe improved the clinical program as we now also include the primary endpoint in the phase III-study of so called “feeding tolerance”. The study will include 2 158 infants with birthweight of 500-1 500 grams and will be conducted at approximately 100 hospitals in the USA, Europe and Israel.
The amendments to the clinical program do not render significant impact on costs or otherwise affect conducting the planned phase III-study.
The ongoing clinical phase III-study is historical as it is the most comprehensive clinical study to ever be conducted regarding necrotizing enterocolitis, and to IBT’s knowledge the most comprehensive clinical study ever on premature infants.
In parallel to the development project, IBT is also continuously evaluating potential marketing and distribution partners. We entered into an agreement in March regarding distribution of IBP-9414 in Israel. The agreement provides IBT with the possibility to long-term receive of the majority of future income from sales of IBP-9414 in Israel.
Stockholm
August 21, 2019
Staffan Strömberg,
Chief Executive Officer
Selected financial data | |||||
ooo's | 2019 Apr-Jun | 2018 Apr-Jun | 2019 Jan-Jun | 2018 Jan-Jun | 2018 Jan-Dec |
Net sales | - | - | - | - | - |
Operating profit/loss | -7 973 | 1 286 | -8 766 | -7 858 | -39 417 |
Result after tax, SEK | -7 561 | 665 | -8 247 | -8 479 | -40 607 |
Total assets | 554 977 | 600 420 | 554 977 | 600 420 | 563 371 |
Cash flow for the period (SEK) | -1 114 | -6 788 | -8 691 | 416 019 | 381 544 |
Cash flow per share for the period (SEK) | -0.10 | -0.60 | -0.82 | 40.19 | 35.36 |
Cash | 539 453 | 576 800 | 539 453 | 576 800 | 542 170 |
Earnings per share before and after dilution (SEK) | -0.67 | 0.06 | -0.73 | -0.82 | -3.76 |
Equity per share (SEK) | 48.86 | 52.54 | 48.86 | 52.54 | 49.59 |
Equity ratio (%) | 99% | 98% | 99% | 98% | 99% |
* Operational costs for the second quarter include exchange rate gains on forward currency contracts and currency deposits amounting to 53 (10 739) KSEK. Operational costs amounted to 7 976 (9 453) KSEK prior to exchange rate gains (Note 2)
Significant events during the second quarter (Apr-Jun) 2019
- 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 during the reporting period (Jan-Jun) 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
Significant events after the reporting period
- IBT announced on July 4 that the first patient had been recruited in the company’s pivotal clinical phase III-study, The Connection Study
- No other significant events have occurred after the reporting period
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
Attachments
To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.About GlobeNewswire by notified
GlobeNewswire by notified 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 by notified
Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire by notified
Iveco Group signs a 150 million euro term loan facility with Cassa Depositi e Prestiti to support investments in research, development and innovation11.6.2024 12:00:00 CEST | Press release
Turin, 11th June 2024. Iveco Group N.V. (EXM: IVG), a global automotive leader active in the Commercial & Specialty Vehicles, Powertrain and related Financial Services arenas, has successfully signed a term loan facility of 150 million euros with Cassa Depositi e Prestiti (CDP), for the creation of new projects in Italy dedicated to research, development and innovation. In detail, through the resources made available by CDP, Iveco Group will develop innovative technologies and architectures in the field of electric propulsion and further develop solutions for autonomous driving, digitalisation and vehicle connectivity aimed at increasing efficiency, safety, driving comfort and productivity. The financed investments, which will have a 5-year amortising profile, will be made by Iveco Group in Italy by the end of 2025. Iveco Group N.V. (EXM: IVG) is the home of unique people and brands that power your business and mission to advance a more sustainable society. The eight brands are each a
DSV, 1115 - SHARE BUYBACK IN DSV A/S11.6.2024 11:22:17 CEST | Press release
Company Announcement No. 1115 On 24 April 2024, we initiated a share buyback programme, as described in Company Announcement No. 1104. According to the programme, the company will in the period from 24 April 2024 until 23 July 2024 purchase own shares up to a maximum value of DKK 1,000 million, and no more than 1,700,000 shares, corresponding to 0.79% of the share capital at commencement of the programme. The programme has been implemented in accordance with Regulation No. 596/2014 of the European Parliament and Council of 16 April 2014 (“MAR”) (save for the rules on share buyback programmes set out in MAR article 5) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the Safe Harbour rules. Trading dayNumber of shares bought backAverage transaction priceAmount DKKAccumulated trading for days 1-25478,1001,023.01489,100,86026:3 June 20247,0001,050.597,354,13027:4 June 20245,0001,055.705,278,50028:6 June20243,0001,096.273,288,81029:7 June 20244,0001,106.174,424,68
Landsbankinn hf.: Offering of covered bonds11.6.2024 11:16:36 CEST | Press release
Landsbankinn will offer covered bonds for sale via auction held on Thursday 13 June at 15:00. An inflation-linked series, LBANK CBI 30, will be offered for sale. In connection with the auction, a covered bond exchange offering will take place, where holders of the inflation-linked series LBANK CBI 24 can sell the covered bonds in the series against covered bonds bought in the above-mentioned auction. The clean price of the bonds is predefined at 99,594. Expected settlement date is 20 June 2024. Covered bonds issued by Landsbankinn are rated A+ with stable outlook by S&P Global Ratings. Landsbankinn Capital Markets will manage the auction. For further information, please call +354 410 7330 or email verdbrefamidlun@landsbankinn.is.
Relay42 unlocks customer intelligence with a new insights and reporting module, powered by Amazon QuickSight11.6.2024 11:00:00 CEST | Press release
AMSTERDAM, June 11, 2024 (GLOBE NEWSWIRE) -- Relay42, a leading European Customer Data Platform (CDP), is leveraging Amazon QuickSight to power its new real-time customer intelligence, reporting, and dashboard module. Harnessing the breadth and quality of customer data, the new Insights module empowers marketing teams to dive deep into customer behaviors and gain invaluable insights into the performance of their marketing programs across all online, offline, paid, and owned marketing channels. Preview of the Relay42 Insights module, in pre-beta version Key capabilities of the Relay42 Insights module include: Deep insights into customer behaviors: With the Relay42 Insights module, marketers can ask unlimited questions about their data and gain a deeper understanding of how to serve their customers more effectively. Simplicity with AI-powered querying: Marketers can use artificial intelligence to query their data using natural language search, reducing the reliance on data scientists. Us
Metasphere Labs Announces X Spaces Event on the Topic of Green Bitcoin Mining and Sound Money for Sustainability11.6.2024 10:30:00 CEST | Press release
VANCOUVER, British Columbia, June 11, 2024 (GLOBE NEWSWIRE) -- Metasphere Labs Inc. (formerly Looking Glass Labs Ltd., "Metasphere Labs" or the "Company") (Cboe Canada: LABZ) (OTC: LABZF) (FRA: H1N) is thrilled to announce an engaging Twitter Spaces event on Green Bitcoin mining, energy markets, and sustainability on July 3, 2024 at 2 p.m. ET. Follow us on X at MetasphereLabs for updates and to join the event. What We'll Discuss Bitcoin Mining Basics: Understand the fundamentals of Bitcoin mining.Energy Market Dynamics: Explore how Bitcoin mining interacts with energy markets.Sustainable Innovations: Learn about our efforts to promote sustainability in Bitcoin mining.Sound Money: Discover how tamper-proof currency can enhance stability.Efficient Payment Rails: See how fast, neutral payment systems support humanitarian projects.Carbon Footprint: Compare Bitcoin's environmental impact with traditional banking. "We're excited to host this event and dive into the critical topics of Bitcoin