Infant Bacterial Therapeutics (IBT) Q3 2024 earnings summary

Executive summary

• Completed global Phase 3 clinical trial for IBP-9414; last patient treated in July 2024 and topline data reported in August 2024.

• Phase 3 study did not meet primary endpoints but showed a significant 27% reduction in all-cause mortality as a secondary endpoint.

• IBP-9414 demonstrated a strong safety profile, with lower cardiopulmonary and gastrointestinal deaths compared to placebo.

• IBT is preparing for regulatory meetings and expects to produce first commercial batches in 2025.

Financial highlights

• Net sales were SEK 0 for both Q3 and the nine-month period, unchanged from the previous year.

• Operating loss for Q3 was SEK -33,821k (vs. -33,718k last year); nine-month operating loss was SEK -107,897k (vs. -88,965k).

• Result after tax for Q3 was SEK -32,650k (vs. -30,888k); for the nine months, SEK -103,140k (vs. -82,176k).

• Cash flow for Q3 was SEK -50,595k (vs. 66,701k); for the nine months, SEK -102,975k (vs. -24,053k).

• Cash position at September 30, 2024, was SEK 226,196k, down from SEK 329,064k at year-end 2023.

Outlook and guidance

• IBT plans to meet with the FDA in December 2024 to discuss regulatory pathways for IBP-9414.

• First commercial production batches of IBP-9414 are planned for 2025.

• IBT expects regulatory approval for IBP-9414 in 2025.