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 USA and other key markets. For example, IBT's TMF (trial master file) must be complete, which in turn means collecting a large amount of information, including approximately a couple of thousand CVs from individuals involved in the IBP-9414 study.
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 the United States with an expected application submission in Q4 2024 or no later than Q1 2025. Soon thereafter, we plan to apply in other important parts of the world, such as Europe.
Finally, I want to conclude by commenting on our early-stage projects. We have appointed Professor Thomas Schnitzer as Chief Scientific Officer, focusing on leading the three other projects in IBT's development portfolio. We are very pleased that Professor Schnitzer has joined. His expertise is a brilliant addition to IBT. Thomas is a professor at Northwestern University in Chicago and will start in his new role at IBT part-time.
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 Chicago together with Professor Schnitzer. In February 2024, the European Patent Office announced that the patent for IBP-1122 has also been approved in the EU. This means that IBT now has good exclusivity protection for a future product in both the USA and Europe.
Thanks again to all employees and everyone else who is committed to driving IBT forward.
Stockholm, February 7th, 2023
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 the British 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 the European 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 approximately SEK 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 | |
| Net Sales | - | - | - | - |
| 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% |
Contacts
Staffan Strömberg, CEO
Maria Ekdahl, CFO
info@ibtherapeutics.com
+46 76 219 37 38
About Us
Infant Bacterial Therapeutics AB ("IBT") is a public company domiciled in Stockholm. The company's Class B shares are since September 10, 2018, listed on Nasdaq Stockholm (IBTB).
IBT is a pharmaceutical company whose purpose is to develop and market drugs targeting diseases affecting prematurely born infants or caused by antibiotic-resistant bacteria.
IBT's main focus is on its drug candidate IBP-9414, whose development program is designed to demonstrate a reduced incidence of necrotizing enterocolitis (NEC) and whether prematurely born infants achieve improved sustained feeding tolerance (SFT) when treated with the active substance Lactobacillus reuteri, a bacterial strain naturally found in human breast milk. IBP-9414 is currently in an ongoing registration-enabling the pivotal Phase III study and is the company's most advanced development project.
The portfolio also includes drug candidates, IBP-1016, IBP-1118, and IBP-1122. IBP-1016 is for the treatment of gastroschisis, a life-threatening and rare condition where the child is born with externalized abdominal organs. IBP-1118 aims to prevent ROP (retinopathy of prematurity), a leading cause of blindness in premature infants, while IBP-1122 aims to eliminate vancomycin-resistant enterococci (VRE), which cause antibiotic-resistant hospital acquired infections.
By developing these drugs, IBT has the opportunity to address medical needs where no available treatments currently exist.
