Infant Bacterial Therapeutics AB (publ), Interim report January 1-March 31, 2023

 Message from the CEO

Significant advancements have been made in the development of microbiome-based pharmaceuticals in the past few months. Ferring/Rebiotics' product REBYOTA™ was approved by the FDA at the end of last year, and now in April 2023, Seres/Nestlé Health Science's product VOWST™ also received approval. First and foremost, I would like to congratulate the respective development teams on these approvals.

I’d like to summarize the implications of these approvals from an IBT perspective. For starters, it means that pharmaceuticals based on bacteria can be approved in the US. Although the products differ, they share the characteristic of having an active substance belonging to a new class. Previously, small molecules or proteins have been the active substances in many drugs on the market. Now, drugs containing bacteria have been approved by regulatory authorities. A new "class" has accordingly been created, and Pharma Grade Probiotics is an attainable target. At IBT we have always believed that this would be possible, and in 2012, we began our drug development with the goal of obtaining approval with a bacteria as the active substance. The approvals by Ferring and Seres further reassures that it is possible to achieve this goal.

As both REBYOTA™ and VOWST™ target the same patient population, namely those suffering from recurrent C. difficile infections (CDI), they will need to compete against each other to gain and defend market share. In contrast, IBP-9414 targets a population with a significant medical need where there are no competing therapies. Against this background, IBP-9414 has a unique potential to fill a market gap and address the needs of premature infants who currently lack suitable treatment.



The validation of bacterial therapies provides additional inspiration and impetus for us at IBT to finalize the development of IBD-9414 and meet the challenges in the development of our other new projects: IBP-1016, IBP-1118, and IBP-1122.

As of the time of writing, we have enrolled over 70% of the targeted 2158 children in the study, corresponding to 1542 number of children. We expect to further accelerate recruitment by increasing IBT’s presence in the US with new study centers. Previously, we spoke of a recruitment rate of 50 children per month, but I can now report that in the last 30 days, we have enrolled 86 children. This is encouraging, and we expect to complete recruitment for the study in 2023. In March, we surpassed 1400 patients, which means that the Data Monitoring Committee (DMC) will analyze study data for safety during the summer.

IBT has been able to produce IBP-9414 fermented on a commercial scale starting from the first batches produced in 2013/2013, eliminating the need for fermentation upscaling. Scaling up is usually risky because it is difficult to predict problems that may arise. Therefore, IBT does not need to take these risks as we will produce at the scale that we have previously documented. We have a very stable commercial fermentation and are now working to increase capacity for the less critical steps such as vial filling and lyophilization. The work to increase capacity is progressing according to plan.

The preparations for the launch of IBP-9414 is proceeding according to plan. The cash balance of 307 million SEK is sufficient to complete the drug development.



It is essential we take the time to thank everyone who has worked hard to keep the world's largest study in premature infants running in 10 different countries, especially considering the difficult challenges we have faced. We are deeply grateful for the efforts of our colleagues, who enable us to continue driving this vital development forward.

Stockholm, May 8, 2023

Staffan Strömberg

CEO

First quarter (Jan-Mar) 2023

• Net sales KSEK 0 (0)                                     
• Operating income KSEK -24 296* (-19 063)

Earnings per share before and after dilution SEK -2.00 (-1.71)

Significant events during the first quarter (Jan-Mar)

• On January 12, 2023, IBT announced the acquisition of a probiotic drug platform with a drug candidate 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 that the final cohort was opened for recruitment, with 1400 patients enrolled in the study. This third cohort includes infants with a birth weight between 1001 grams and 1500 grams.

Significant events after the reporting period

• No significant events after the reporting period.

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 Strömberg, CEO

Maria Ekdahl, CFO

Contact information

Infant Bacterial Therapeutics AB (Reg. no. 556873-8586)

Bryggargatan 10

111 21 Stockholm, Sweden

Telephone: 8

 

Publication

The Report was submitted for publication, by the CEO, at 13.00 on May 8, 2023.

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