INFANT BACTERIAL THERAPEUTICS AB Message from the CEO
2023 was a very eventful year for IBT, as we pushed forward with the development of our clinical program IBP-9414 and achieved several milestones. During the year, we completed the final planned safety data review from the ongoing Phase III study. The fact that we now have no further protocol-related analyses remaining, combined with the current recruitment at the time of writing being 96% of infants, means that we are truly entering the final stretch towards our goal. IBT's clinical team is doing an incredible job. IBT is conducting the largest study on premature infants ever, across ten countries during a pandemic. I want to thank everyone for their creative solutions and unwavering determination to complete the study. Now is the time to look ahead, towards the next steps in the development plan, and to prepare IBT for the launch of IBP-9414 on the market.
While the clinical team continues to drive recruitment forward, work is ongoing to 'clean' all the raw patient data from the infants who have completed the study. Additionally, efforts are underway to finalize the analysis plan that will provide us with definitive results regarding the safety and efficacy of IBP-9414 compared to placebo. I look forward with great confidence to the day we gather in a room to unveil the eagerly awaited results.
IBT is also planning its future after the results with developments in the following areas: the commercial, production-related, and regulatory aspects. The commercial team has strengthened over the past quarters with additional staff to develop Payer Access and Medical Affairs. Various activities are ongoing, including the work on naming IBP-9414 and conducting additional market research.
The production of IBP-9414 is in the process of validation, leading to the commercial product being manufactured in the summer of 2024. In the second quarter, we will also launch our logistics department to begin preparations for the commercial distribution of IBP-9414.
Furthermore, IBT will expand its internal regulatory department in Q2 of this year and has already appointed the head position. This is a necessity as there are numerous documents to be handled for IBT to obtain market approval in the
We aim to complete recruitment in Q1/Q2 to obtain clinical results from the Phase III study by the later part of the summer. The next significant step for IBT will be to apply for market approval, starting in
Finally, I want to conclude by commenting on our early-stage projects. We have appointed Professor
IBP-1016, our project on Gastroschisis, is intentionally on hold right now as we do not have the capacity to conduct two clinical studies simultaneously.
Regarding IBP-1118 for the prevention of ROP (an eye disease that causes many prematurely born infants to go blind), are the current focus on pre-clinical (TOX and DMPK) activities.
IBP-1122, which combats antibiotic-resistant bacteria in a novel way, is led by a project manager working in
Thanks again to all employees and everyone else who is committed to driving IBT forward.
Staffan Strömberg, CEO
Financial overview for the period
Fourth quarter (Oct-Dec) 2023
- Net sales KSEK 0 (0)
- Operating income KSEK -45 652* (-40 757)
- Earnings per share before and after dilution
SEK -3.04 (3.57)
Reporting period (Jan-Dec) 2023
- Net sales KSEK 0 (0)
- Operating income KSEK -134 617* (-65 808)
- Earnings per share before and after dilution
SEK -9.95 (-5.83)
* Operational income includes exchange rate effects on foreign currency deposits to secure future outflows during the fourth quarter amounting to KSEK -9 387 (-10 451) and during the reporting period amounting to KSEK -2 074 (33 000)
Significant events during the reporting period (Jan-Dec)
- On
January 12, 2023 , it was announced that IBT acquired a pharmaceutical platform that can prevent antibiotic-resistant hospital infections. - In
January 2023 , IBT published new results in theBritish Journal of Gastroenterology validating “Sustained Feeding Tolerance” (SFT) as a relevant primary endpoint in “The Connection Study”. - In
March 2023 , IBT announced the opening of the final cohort for recruitment, with 1400 patients enrolled in the study. This third cohort will include infants with birth weight between 1001 grams and 1500 grams. - On
May 16, 2023 , IBT decided on a rights issue and called for an Extraordinary General Meeting of shareholders. - On
June 9, 2023 , the Extraordinary General Meeting resolved to approve the Board's decision to increase the share capital by issuing new shares with pre-emptive rights for the company's shareholders. - On
June 15, 2023 IBT announced that theEuropean Patent Office has approved its patent application for Lactobacillus reuteri. The patent covers the drug candidate IBP-9414 - On
June 21, 2023 , it was announced that the Data Monitoring Committee (DMC) conducted a planned safety analysis, without objections. At the same time, a planned futility analysis was also conducted and was positive, which means that IBT is continuing the study as planned. - On
July 3rd, 2023 , IBT announced that the product IBP-1016 for gastroschisis has been granted Orphan Drug Designation. - On
July 4, 2023 , IBT announced the outcome of the rights issue. The issue provided IBT with approximatelySEK 101 million before deduction of transaction costs. After the rights issue, the number of shares and votes in the company changed. The new number of shares now amounts to 13,471,420, of which 453,283 A-shares and 13,018,137 B-shares.
Selected financial data
| 000´s | 2023 | 2022 | 2023 | 2022 |
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
| - | - | - | - | |
| Other income | - | 9 | 77 | 12 |
| Operating profit / loss | -45 652 | -40 757 | -134 617 | -65 808 |
| Result after tax | -40 891 | -40 116 | -123 068 | -65 451 |
| Total assets | 351 335 | 349 619 | 351 335 | 349 619 |
| Cash flow for the period | -28 757 | -22 040 | -4 704 | -83 911 |
| Cash flow per share for the period (SEK) | -2.13 | -1.96 | -0.38 | -7.47 |
| Cash | 329 064 | 335 840 | 329 064 | 335 840 |
| Earnings per share before and after dilution (SEK) | -3.04 | -3.57 | -9.95 | -5.83 |
| Equity per share (SEK) | 22.65 | 29.55 | 22.65 | 29.55 |
| Equity ratio (%) | 87% | 95% | 87% | 95% |
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