Message from CEO

During the quarter, IBT successfully completed its commercial-scale manufacturing validation with positive results at our two contract manufacturers: Recipharm in Germany, which manufactures the active substance, and BioConnection in the Netherlands, which manufactures the finished product administered to infants. Reaching this milestone has taken longer than anticipated, as we changed manufacturers and had to execute a technology transfer to the new partners, revalidate our analytical methods, and ensure that both Recipharm and BioConnection could produce a high-quality product. We raised capital for this validation back in 2023, and it is with great satisfaction that we have now successfully concluded this work within our available financial resources.

The second major development during the quarter involved our interactions with regulatory authorities to prepare for the submission of our drug marketing applications. IBT has been working centrally with the EMA, as IBP-9414 holds Orphan Drug Designation in the EU. IBT plans to submit a Marketing Authorization Application (MAA) for IBP-9414 to the EMA in the near future.

IBT has also maintained an intensive dialogue with the FDA. On October 29, 2026, we addressed whether the FDA had any objections to IBT’s plan to submit a Biologics License Application (BLA). During this so-called “Pre-BLA” meeting, nothing was identified that would prevent IBT from submitting an application. While I did not anticipate any issues, we can never know with certainty how the agency views matters until IBT and the agency have formally interacted. Consequently, we do not plan to conduct any additional tests, or clinical studies prior to our intended submission of the marketing approval application for IBP-9414. We expect to receive written minutes from the FDA 30 days after the meeting, as is customary, and we will provide an update should we unexpectedly receive different information. In my assessment, on October 29, 2026, IBT cleared yet another milestone toward our goal of bringing IBP-9414 to market.

We have long been actively working on the scientific and medical positioning of IBP-9414. As one example, IBT will present at “Hot Topics in Neonatology” in Washington D.C., on December 6–9, with the titles “A Proposed Gut-to-Systemic Mechanism of Gastrointestinal-Related Mortality in Very Low Birth Weight Infants” and “What Every Clinician Should Know About Bringing Newborn Therapeutics to Market.”

Looking ahead, we intend to intensify preparations for our anticipated launch of IBP-9414. With the Pre-BLA meeting behind us, we plan to resume commercial activities that had been put on hold pending FDA feedback. Among other initiatives, we aim to further develop our commercial strategy, including establishing the basis for justified pricing. We also plan to procure raw materials so that we can supply and launch IBP-9414 shortly after receiving marketing approval. IBT requires additional capital to commercialize IBP-9414. Accordingly, the Board of Directors and management are continuously evaluating various financing alternatives and considering whether a capital raise should be conducted prior to marketing approval. These financing alternatives include the possibility of IBT entering into early licensing and/or distribution agreements with partners across different geographic markets.

Finally, I would like to take this opportunity to extend my gratitude to our manufacturing partners, who have successfully resolved the technical challenges that arose and delivered a robust product. 

Stockholm November 13, 2026
Staffan Strömberg, CEO

Financial overview for the period

Third quarter (July – September) 2026

• Net sales KSEK 0 (0) 
• Operating income KSEK -20,726* (-10,836)
• Earnings per share before and after dilution SEK -1.52 (-0.75)

Reporting period (January- September) 2026

• Net sales KSEK 0 (0) 
• Operating income KSEK -64,334* (-48,457)
• Earnings per share before and after dilution SEK -5.43 (-341)

*Operating profit includes exchange rate effects on currency investments intended to secure future payments. During the second quarter, these amounted to KSEK -1,359 (-2,694) and during the reporting period to KSEK 1,565 (-5,881). 

Significant events during the reporting period (January-September) 2026

• In February 2026, the results of “The Connection Study” were published in Pediatric Research.
• In September 2026, it was published that FDA Grants Infant Bacterial Therapeutics AB’s Request for a Type B Pre-BLA Meeting

Summary of selected financial data

IBT requires additional capital to commercialize IBP-9414. The Board of Directors and management continuously evaluate various financing alternatives, and a capital raise may be carried out even prior to market approval. If the company’s planning assumptions are not met, capital may need to be raised earlier and to a greater extent than planned. See further the section "Risks and uncertainties”.