Message from CEO
IBT's plan to apply for marketing approval in the US through a so-called accelerated application remains unchanged. The development program for IBP-9414 is "Breakthrough Designated," which gives us the opportunity to submit the marketing authorization application in several parts, rather than all at once. IBT has made use of this opportunity, and so the FDA reviewed the clinical documentation already in the summer of 2025. During the fall, we held meetings with the FDA where IBT answered clinical questions about the results of our Phase III study, "The Connection Study." We are therefore very pleased that the FDA is encouraging IBT to work towards market approval.
What remains can be summarized in two parts:
The first is to ensure continued documentation of the clinical effects of IBP-9414, with a focus on its ability to reduce mortality in premature babies. At a meeting on 19th December 2025, IBT and the FDA agreed that IBT would develop a proposal for a study intended to be conducted after the launch of IBP-9414. The study proposal is being developed with clinical and statistical experts. The study design is based on the following four principles:
Feasibility - To ensure that the study is feasible.
Equipoise - To ensure that healthcare professionals do not withhold a treatment that is believed to help the patient.
Ethics: To ensure that good morals are upheld.
Meeting "CBER Standards": To ensure that legal requirements are met in the manner deemed appropriate by the FDA
The second part we are working on is the validation of production at the companies that will manufacture the commercial volumes of IBP-9414. The plan is for our German manufacturer of the drug substance to be ready in April 2026. The product will then be further processed into a drug by filling vials and freeze-drying them at our manufacturer in the Netherlands.
Despite a somewhat tight schedule, I consider our timetable to be realistic, based on the cooperation with suppliers and working methods we have today.
Shortly after the drug is manufactured, IBT intends to submit an application for marketing approval in the US. Most of the documents required for the application have been completed, and the remainder are expected to be ready once we have completed the two steps above.
Discussions are continuing with several partners regarding sales partnerships and distribution of IBP-9414. For the US market, IBT intends to register IBP-9414 with the FDA itself and handle distribution and sales. At the same time, we are working with potential partners in other parts of the world, with the request that the partner convert the US/EU-adapted registration to local requirements.
In January 2026, IBT received the welcome news that the clinical results from "The Connection Study" will be published in the scientific journal Pediatric Research shortly. This is the first publication of study results from "The Connection Study," which showed that IBP-9414 is safe and reduces mortality by 27% in premature infants.
IBP-9414 has Rare Pediatric Disease Designation, which means that IBT can be awarded a Priority Review Voucher ("PRV") upon market approval. The program, that previously had an end date of 30th September 2026, has now been extended to 30th September 2029. The last known sale value for a PRV was 200MUSD.
At the end of Q4 2025, IBT had cash reserves of SEK 144 million. The company has very low fixed costs and is therefore a sustainable company.
Stockholm February 5, 2026
Staffan Strömberg, CEO
| Fourth quarter (October - December) 2025 Net sales KSEK 0 (0) Operating income KSEK -20,538* (-37,445) Earnings per share before and after dilution SEK -1.43 (-2.51) Reporting period (January - December) 2025 Net sales KSEK 0 (0) Operating income KSEK -68,995* (-145,353) Earnings per share before and after dilution SEK -4.84 (-10.16) |
*Operating profit includes exchange rate effects on currency investments intended to secure future payments. During the fourth quarter, these amounted to KSEK -1,162 (5,552) and during the reporting period to KSEK -7,043 (5,445).
Significant events during the fourth quarter (October - December)
- On November 20, 2025, IBT announced that it had entered into a partnership with Recipharm Advanced Bio for the production of drug substance.
- On November 25, 2025, IBT announced that it had decided to proceed with an accelerated approval process for IBP-9414.
- On December 11, 2025, IBT announced that it had entered into a partnership with BioConnection for the production of drugs.
Significant events during the reporting period (January - December)
- On March 28, 2025, IBT announced that the FDA had granted IBP-9414 "Breakthrough Therapy Designation" for its potential to reduce gastrointestinal-related mortality.
- On May 8, IBT announced that the Clinical Study Report (CSR) for "The Connections Study" had been submitted to the FDA. The report contains data from the Phase 3 clinical trial that was completed in 2024.
Summary of selected financial data
| 000's | 2025 | 2024 | 2025 | 2024 |
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
| Net Sales | - | - | - | - |
| Other income | - | - | - | 4 |
| Operating profit / loss | -20,538 | -37,445 | -68,995 | -145,343 |
| Result after tax | -19,203 | -33,765 | -65,166 | -136,905 |
| Total assets | 161,749 | 239,566 | 161,749 | 239,566 |
| Cash flow for the period | -20,087 | -8,360 | -72,337 | -111,120 |
| Cash flow per share for the period (SEK) | -1.49 | -0.62 | -5.37 | -8.25 |
| Cash | 144,009 | 223,388 | 144,009 | 223,388 |
| Earnings per share before and after dilution (SEK) | -1.43 | -2.51 | -4.84 | -10.16 |
| Equity per share (SEK) | 7.82 | 12.64 | 7.82 | 12.64 |
| Equity ratio (%) | 65% | 71% | 65% | 71% |
