Message from CEO
During the period, work continued on building the scientific and medical positioning for bringing IBP-9414, the company's drug candidate, to market. Several scientific publications are currently being written, and IBT plans to participate in a number of medical conferences. We have been working on scientific communication through our broad network of experts. Awareness of IBP-9414's potential to save lives is spreading. Every day, more hospitals and treating physicians are realizing that IBP-9414 is a drug that can do the most important thing a drug can do: save lives. It is a fact that far too many premature infants with a birth weight below 1,500 g die. We have shown that IBP-9414 can reduce mortality by more than a quarter for these infants.
To illustrate just how important the drug IBP-9414 is, one can draw parallels to the class of drugs known as surfactants. Surfactants were introduced to the market about 25 years ago for the care of premature infants and constitute the "standard of care" worldwide. These medications help these tiny babies breathe and lead to significantly higher survival rates. A review of the literature reveals the clinical effects-that is, the extent to which the medication reduces the risk of a child's death. My estimate is that the positive effects of surfactants and IBP-9414 are of the same order of magnitude. No new drug of this significance has been introduced in neonatal care in the past 25 years. Now it is time to take the next major step towards reducing mortality among premature infants. IBT is ready to bring IBP-9414 to market as soon as the product is approved by regulatory authorities.
Preparations for a Future Launch
With regard to distribution partners, IBT currently has several options. We are in regular contact with a number of companies that have expressed interest in obtaining rights to enable distribution and sales activities in multiple geographic regions. IBT wants to ensure that two interests are respected: first, we must have an effective and global distribution network to save as many children as possible. At the same time, sales revenue should, to the greatest extent possible, accrue to IBT's shareholders. It is against this backdrop that we consider every offer IBT receives regarding potential distribution agreements.
Continued Progress in Regulatory Efforts
IBT has completed the work defined by the Pediatric Investigational Plan (PIP) agreed upon by the European Medicines Agency (EMA) and IBT prior to the start of The Connection Study in 2019. During the reporting period, the EMA announced that it considers us to have fulfilled the requirements of the PIP. This is another important step in our efforts to facilitate future registration of IBP-9414 in Europe.
In the U.S., the dialogue with the FDA continues, with a focus on the upcoming Biologics License Application (BLA). On June 12, the FDA announced that it had completed its review of the safety and efficacy data submitted by IBT from the Phase II study and the Phase III study, The Connection Study. The fact that this review is now complete is very positive. At the same time, the FDA has provided comments and questions regarding how IBT should address a number of areas ahead of the expected upcoming pre-BLA meeting. I expect that IBT will be able to provide the FDA with what it is requesting during the month of September.
Production Process Validation
Regarding the validation of the manufacturing process (PPQ - Process Performance Qualification), we had hoped to be finished by early August, but we will manufacture the last of the six required batches in September. The reason for the delay is a minor operator error. We have however continued confidence in our manufacturing process. It is also gratifying that all fermentation batches meet the predefined specifications and are now put into stability studies. Work on the final report is underway and is expected to be completed by the end of October.
All in all, we can state that we have made good progress in all areas which means that our goal remains unchanged: to submit the BLA this year.
Stockholm August 25, 2026
Staffan Strömberg, CEO
Financial overview for the period
Second quarter (April - June) 2026
? Net sales KSEK 0 (0)
? Operating income KSEK -30,109* (-20,126)
? Earnings per share before and after dilution SEK -2.21 (-1.42)
Reporting period (January- June) 2026
? Net sales KSEK 0 (0)
? Operating income KSEK -53,608* (-37,621)
? Earnings per share before and after dilution SEK -3.91 (-2.67)
*Operating profit includes exchange rate effects on currency investments intended to secure future payments. During the second quarter, these amounted to KSEK -133 (465) and during the reporting period to KSEK 206 (-3,187).
Significant events during the reporting period (January-June)
? In February 2026, the results of "The Connection Study" were published in Pediatric Research.
Summary of selected financial data
| 000's | 2026 | 2025 | 2026 | 2025 | 2025 |
| Apr-Jun | Apr-Jun | Jan-Jun | Jan-Jun | Jan-Dec | |
| Net Sales | - | - | - | - | - |
| Other income | - | - | - | - | - |
| Operating profit / loss | -30,109 | -20,126 | -53,608 | -37,621 | -68,995 |
| Result after tax | -29,729 | -19,172 | -52,664 | -35,911 | -65,166 |
| Total assets | 120,221 | 193,232 | 120,221 | 193,232 | 161,749 |
| Cash flow for the period | -23,194 | -15,906 | -35,613 | -43,885 | -72,337 |
| Cash flow per share for the period (SEK) | -1.72 | -1.18 | -2.64 | -3.26 | -5.37 |
| Cash | 108,602 | 176,317 | 108,602 | 176,317 | 144,009 |
| Earnings per share before and after dilution (SEK) | -2.21 | -1.42 | -3.91 | -2.67 | -4.84 |
| Equity per share (SEK) | 3.94 | 9.97 | 3.94 | 9.97 | 7.82 |
| Equity ratio (%) | 44% | 70% | 44% | 70% | 65% |
Contacts
Staffan Strömberg, CEO
Maria Ekdahl, CFO
info@ibtherapeutics.com
About IBT
Infant Bacterial Therapeutics AB ("IBT") is a public company domiciled in Stockholm. The company's Class B shares are listed on Nasdaq Stockholm (IBTB) since September 10, 2018.
IBT is a pharmaceutical company whose mission is to develop and commercialize drugs for diseases affecting premature babies.
IBT's main focus is the drug candidate IBP-9414, a formulated bacterial strain naturally found in human breast milk. IBP-9414, is expected to be the first product in the new class of biologics called "Live Biotherapeutic Products" for premature infants. The development of IBP-9414 is currently in its final stages.
In the recent Phase III Connection study in premature infants that was completed in July 2024, the group treated with IBP-9414 demonstrated a significant 27% reduction in all-cause mortality compared with the placebo group, meaning that widespread use of IBP-9414 could save more than 1000 patients annually in the US alone. The therapy has received both Breakthrough Therapy Designation (March 2025) for gastrointestinal related mortality and Rare Paediatric Disease Designation, reflecting its potential to address a significant unmet medical need.
The portfolio also includes additional drug candidates, IBP-1016, IBP-1118 and IBP-1122. IBP-1016, for the treatment of gastroschisis, a life-threatening and rare disorder in which children are born with externalized gastrointestinal organs. IBP-1118 to prevent retinopathy of prematurity (ROP), one of the leading causes of blindness in premature babies, and IBP-1122 to eliminate vancomycin-resistant enterococci (VRE), which cause antibiotic-resistant hospital infections.
Through the development of these drugs, IBT can address medical needs where no sufficient treatments are available.
This information is information that Infant Bacterial Therapeutics is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-08-26 07:30 CEST.
