Infant Bacterial Therapeutics AB (publ) Interim report January 1- December 31, 2022

Message from the CEO

The speed of recruitment of preterm infants into our large phase 3 study significantly increased in the final three months of 2022 compared to the corresponding period in previous years. In the last 12 months, we succeeded in stabilizing recruitment at around 50 babies per month. In the first half of 2023, IBT will evaluate an additional 12 neonatal intensive care clinics across the EU and the US for participation in the study to further accelerate the study rate. According to the study protocol, aligned with medical authorities, the study is to be expanded to an additional patient group when the recruitment has reached 1400 infants. This group includes larger premature infants with a birth weight of 1000-1500 grams. With this patient inclusion expansion, we expect the recruitment rate in the current year to exceed the 2022 rate. As of today, we have taken in 1345 (62%) of the planned total number of babies. If average 2023 recruitment increases to about 60 babies per month, it is reasonable to assume recruitment to be completed towards the end of the year.

We are now preparing for the conclusion of the challenging IBP-9414 development program initiated back in 2013. IBT's focus is now and moving forward aimed at preparing us, our product and market for the paradigm shift in the care of the premature baby that we anticipate our product will bring about. A recent example of preparing the market is that IBT already at this stage have been able to demonstrate, via analysis of blinded data, that our second primary endpoint (SFT) is validated. These results have been presented in the form of scientific publications in medical journals as well as presentations at several neonatal intensive care conferences during the fall of 2022. Please refer to our website for further details including the medical value proposition that these publications highlight which is at the core of our large phase 3 study. The published results also summarize clinical complications among the infants, which we continuously review via adverse events reporting, and that both the frequency and type of complications are in line with the expected outcome.

We today consider it established that the time to SFT (sustained feeding tolerance, a primary endpoint in the study) is a measure of how sick a child is. In summary, we see a statically established connection between this time and several serious disease states, of which sepsis, the need for antibiotics and growth are some examples. We will continue to publish and communicate scientific observations from the ongoing study in 2023. In addition, IBT is preparing for a commercial launch, which concretely means that IBT develops strategies across several commercial areas, including Market Access and Reimbursement, concurrently as market research will be carried out so that the product IBP-9414 can be launched in harmony with the dynamics of the market.

In terms of pre-launch preparations, negotiations are ongoing to ensure large-scale product availability of IBP-9414. I’m pleased to announce that we have secured, in late 2022, access to scaled up production sufficient in terms of capacity for several years after launch. In 2023, we expect to produce IBP-9414 across multiple locations, which is always preferable from a supply-chain perspective. Discussions are also ongoing with potential distribution partners, which I will get back to once finalized. We are considering what is best for IBT in the long term.

While we maintain our focus on IBP-9414, it is our intention to build on the unique knowledge that the development of this product has given us. IBP-1118, our project to prevent ROP (retinopathy of prematurity in prematurely born babies), has started. The aim is to generate a development plan to enable discussions with relevant pharmaceutical authorities, following the previously completed and successful IBP-9414 process.

First, we must understand what the regulatory requirements look like to obtain a market approval and establish early on that the product that the authorities want us to develop meets a medical and market need. IBP-1118 has thus not been allocated any significant resources because IBT's assets are earmarked to finish the drug development of IBP-9414. IBT has secured a license agreement, IBP-1122 for the prevention of antibiotic resistant bacteria. Work on the projects IBP-1122 (treatment against antibiotic-resistant bacteria) and IBP-1016 (gastroschisis) has also begun, with a similar focus on primarily developing a development plan.

In conclusion, I would like to take the opportunity to thank all the employees and experts around the world who with great commitment help us get closer to our vision through the development of probiotic drugs, especially with IBP-9414 which can play a very big role for the premature babies.

Stockholm, February 10, 2023

Staffan Strömberg
CEO

   * Operational income includes exchange rate effects on foreign currency deposits for the purpose of securing future outflows during the third quarter amounting to KSEK -10 451 (-5 296) and during the reporting period amounting to KSEK 33 000 (18 846)

Significant events during the fourth quarter (Oct-Dec)

• The British Journal of Gastroenterology published in October an article based on IBT's "Connection Study” demonstrating that SFT is linked to serious disease progression including sepsis and bronchopulmonary dysplasia.

Significant events during the reporting period (Jan-Dec)

• On January 10, IBT announced that the Australian Patent Office has granted a patent entitled: "A method of activating lactic acid bacteria”.
• On January 19, IBT announced that The Connection Study continues after the Data Monitoring Committee (DMC) had completed its pre-scheduled safety analysis without any concerns. At the same time a futility analysis was performed. Based on DMC recommendations and futility outcome, IBT is continuing the recruitment to the study as planned.
• On September 23, the FDA approved IBT’s request for a new orphan drug designation for ROP (retinopathy of prematurity).

Significant events after the reporting period

• The British Journal of Gastroenterology published in January new results that validate "Sustained Feeding Tolerance" (SFT) as a relevant primary endpoint in "The Connection Study".
• On January 12, IBT announced it secured a probiotic drug platform that can prevent antibiotic-resistant hospital acquired infections.

Selected financial data

IBT in brief

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 (IBT B).

Infant Bacterial Therapeutics AB (publ) ("IBT”) is a pharmaceutical company with a product in clinical phase III with a vision to develop drugs influencing the infant microbiome, and thereby prevent or treat rare diseases affecting infants.

IBT is currently developing the drug candidate IBP-9414. The ambition for IBP-9414 is to become the world’s first approved probiotical drug with the goal to prevent life threatening diseases in premature infants including NEC and sepsis by conducting sound stomach-and bowel development in premature infants. IBP-9414 contains the active compound Lactobacillus reuteri, which is a human bacterial strain naturally present in breast milk.

The product portfolio also includes another project, IBP-1016, for the treatment of gastroschisis, a severe and rare disease affecting infants, IBP-1118 to prevent ROP (retinopathy of prematurity), a growing and serious condition that often leads to blindness among prematurely born babies and IBP-1122 for the prevention of antibiotic resistant hospital acquired infections. By developing these drugs, IBT has the potential to fulfill unmet needs for diseases where there are currently no prevention or treatment therapies available.

Contact persons

Staffan Stro¨mberg, CEO

Maria Ekdahl, CFO

Contact information

Infant Bacterial Therapeutics AB (Reg. no. 556873-8586)
Bryggargatan 10
111 21 Stockholm, Sweden
Telephone: +46 76 219 37 38
info@ibtherapeutics.com 
www.ibtherapeutics.com

Publication

The Report was submitted for publication, by the CEO, at 08.00 on February 10, 2023.

Attachment

• IBTQ42022ENG