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.
August 21, 2019
Chief Executive Officer
|Selected financial data|
|ooo's||2019 Apr-Jun||2018 Apr-Jun||2019 Jan-Jun||2018 Jan-Jun||2018 Jan-Dec|
|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
111 21 Stockholm
Phone: +46 70 670 1226
One Liberty Plaza - 165 Broadway
NY 10006 New York
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
Change in Orion Group Executive Management Board as of 1 June 2020: Professor Outi Vaarala appointed as Senior Vice President for Research and Development25.5.2020 15:20:00 CEST | Press release
ORION CORPORATION STOCK EXCHANGE RELEASE 25 MAY 2020 AT 4.20 p.m. EEST Change in Orion Group Executive Management Board as of 1 June 2020: Professor Outi Vaarala appointed as Senior Vice President for Research and Development ProfessorOuti Vaarala, M.D., Ph.D. has been appointed Senior Vice President for Research and Development and member of the Executive Management Board of the Orion Group, as of 1 June 2020. Vaarala has held the position of Vice President, Oncology Research in Orion’s Research and Development as of 10 June 2019. Prior to Orion, Vaarala led drug discovery and development from target identification to clinical Phase 2 studies in Respiratory Inflammation and Autoimmunity therapy area, first at AstraZeneca, Sweden, and later at Medimmune/AstraZeneca, USA. Outi Vaarala is a medical doctor (University of Helsinki) and has a PhD in immunology. Outi Vaarala was appointed as a Professor of Pediatric Immunology, Linkoping University, Sweden, in 2000, and as a Professor of Aut
Auriant Mining:s delårsrapport för Q1 2020 och online-konferens den 29 maj 202025.5.2020 12:05:44 CEST | Pressemelding
Auriant Mining AB har nöjet att meddela att Bolagets delårsrapport för Q1 2020 kommer att publiceras på fredagen den 29 maj. Detta kommer att följas av en interaktiv webcast för analytiker och investerare med vd Sergey Ustimenko som kommer att presentera Auriant Mining:s resultat för Q1 2020 samt med en möjlighet att ställa frågor. Evenemanget börjar kl. 13:00 CET (13:00 Stockholm, 14:00 Moskva, 12:00 London). De som vill få en e-postpåminnelse en timme innan evenemanget kan registrera sig genom länken eller öppna följande länk direkt för att delta i online-konferensen fredagen den 29 maj: Link to register on Q1 2020 Interim Report Online Conference För mer information, vänligen kontakta: Sergey Ustimenko, VD Tel: +7 495 109 02 82 E-post: firstname.lastname@example.org Företagsnamn: Auriant Mining AB Kortnamn: AUR ISIN-kod: SE0001337213 Website: www.auriant.com www.facebook.com/AuriantMining/ Auriant Mining AB (AUR) är ett svenskt gruvbolag med inriktning på prospektering och guldprodukt
Auriant Mining Q1 2020 Interim Report and Online Conference, May 29th 202025.5.2020 12:05:44 CEST | Press release
Auriant Mining AB is pleased to announce that the Company’s Q1 2020 interim report will be published on Friday, May 29th. This will be followed by an interactive webcast for analysts and investors with the CEO, Sergey Ustimenko who will be presenting Auriant Mining’s Q1 2020 results as well as hosting a Q&A session. The event will begin at 13:00 CET (13:00 Stockholm, 14:00 Moscow, 12:00 London). Those who wish to receive an email reminder an hour before the event can pre-register using the link or open the link directly to participate in Online Conference on Friday, May 29th: Link to register on Q1 2020 Interim Report Online Conference For more information, please contact: Sergey Ustimenko, CEO Tel: +7 495 109 02 82 E-mail: email@example.com Company name: Auriant Mining AB Short name: AUR ISIN-code: SE0001337213 Website: www.auriant.com www.facebook.com/AuriantMining/ Auriant Mining AB (AUR) is a Swedish junior mining company focused on gold exploration and production in Rus
Result of SEK credit operation25.5.2020 11:45:00 CEST | Press release
RESULT OF SEK CREDIT OPERATION 2020-05-25 Auction date:2020-05-25Payment date:2020-05-25 (at 3 pm)Maturity date:2020-08-25Term:92 daysOffered volume:UnlimitedTotal bid amount:SEK 0.00 billionNumber of bids0Allotment:SEK 0.00 billionInterest rate: Repo rate + 0,20 percentage points
Ress Life Investments AS Half-Year Report – 1 October 2019 – 31 March 202025.5.2020 11:21:09 CEST | Press release
Corporate Announcement no. 20/2020: Half-Year Report 1 October 2019 – 31 March 2020 Copenhagen, 25 May 2020 The Board of Directors and Management have today discussed and approved the Half-Year Report of Ress Life Investments A/S for the period 1 October 2019 – 31 March 2020: Ress Life Investments A/S realised a net profit before and after tax of USD 3,638,925 for the period 1 October 2019 – 31 March 2020. The net profit for the period corresponds to a net return on equity of 1.99%, earnings per share at 40.60 and an increase in net asset value of USD 42.01 per share.The increase in profit before tax mainly relates to positive fair value adjustments offset by administrative expenses and staff costs.The fair value of the Company’s investment assets increased from USD 118,791,752 at 30 September 2019 to USD 159,631,723 at 31 March 2020.Equity stands at USD 182,699,386 as of 31 March 2020, corresponding to a net asset value of USD 1,960 per share compared with a net asset value of USD 1,9
Prosafe SE: Notice of Change to financial calendar25.5.2020 10:54:58 CEST | Press release
Due to a change in the timing of the Board meeting, the Q1 2020 results will be published on 26 May 2020 at about 01.30 p.m. CEST, which is one day earlier than originally announced. The Q1 2020 report and the Q1 2020 presentation will be published on www.newsweb.no and on Prosafe’s website www.prosafe.com Jesper Kragh Andresen, CEO and Stig H. Christiansen, Deputy CEO & CFO will on 27 May 2020 at 10:00 a.m. CEST host an audio webcast. The webcast can be followed at www.prosafe.com It will be possible to ask questions during the presentation by using the Q&A tool embedded in the audio webcast. A replay of the audio webcast will be made available at www.prosafe.com shortly after. Prosafe is a leading owner and operator of semi-submersible accommodation vessels. The company is listed on the Oslo Stock Exchange with ticker code PRS. For more information, please refer to www.prosafe.com Stavanger, 25 May 2020 Prosafe SE For further information, please contact: Jesper K. Andresen, CEO Phone