Infant Bacterial Therapeutics AB (publ) Interim report January 1 - June 30, 2023
25 Aug 2023
Phase 3Orphan DrugClinical Result
Infant Bacterial Therapeutics AB (publ) Interim report January 1 - June 30, 2023
Message from the CEO
Our Phase-III study, the largest of its kind ever conducted, is progressing across 88 hospitals in ten countries. We have now recruited 85% of the patients (1824 out of the planned 2158), and with the current rate of approximately 75 patients per month, we anticipate completing the recruitment by the end of the year.
In June, the Data Monitoring Committee (DMC) concluded its scheduled safety analysis of data from the first 1400 recruited patients. The DMC's conclusion is that the study can proceed as planned without any reservations. The DMC also conducted a futility analysis to determine if the trial has the potential to achieve statistically significant results, and once again, the conclusion was that the clinical work can continue as scheduled. No further DMC reviews are planned, and we are now approaching the conclusion of our extensive study.
In the study, children are divided into two groups. In one group, the children receive a placebo, a treatment intended to have no effect on the patient. In the other group, the children receive IBP-9414. Both the effectiveness and safety-related observations are then compared between the two groups. IBT has, as is customary in pharmaceutical studies, reached agreements with both the FDA (the U.S. pharmaceutical authority) and the EMA (its European counterpart) that no comparisons should be made before the study is concluded. Therefore, the study has been intentionally designed so that, at this point, observations from the study cannot be attributed to a specific treatment group. However, what we can do in the present time is analyze data from a "total" perspective. During the spring, we have analyzed the amount of food the children receive. We have been able to identify several clinical factors that influence the amount of food the children receive. Our findings have been accepted for publication in the American Journal of Perinatology. One of the efficacy endpoints (one of two primary endpoints) examines how IBP-9414 improves Sustained Feeding Tolerance (SFT). The amount of food administered by the doctors to the children is one of three factors included in the SFT endpoint. The other two factors are whether the children receive intravenous feeding and how the children gain weight. The publication in the American Journal of Perinatology serves as confirmation that we have appropriately designed our Phase III study.
We are pleased that the European Patent Office has approved IBT's application covering Lactobacillus reuteri. This patent enhances IBT's exclusivity in the critical European market until 2036.
Our product portfolio initiatives continue to progress. IBT has been granted orphan drug status for our Gastroschisis program, IBT-1016. This marks the first instance in which a developmental program has received orphan drug designation for the treatment of Gastroschisis in the United States.
IBT decided at an extraordinary general meeting to conduct a rights issue to prepare for the launch of IBP-9414 and to initiate the development work of one or more of the other IBT portfolio projects. In July, IBT announced that the issuance was oversubscribed, raising approximately 100 million SEK before issuance costs, which is certainly gratifying.
Finally, I want to express my deep gratitude to IBT's colleagues for all contributions during the first half of the year. It is truly remarkable what you have achieved. Now, we have the goal within reach.
Stockholm, August 24th, 2023
Staffan Strömberg, CEO
Financial overview for the period
Second quarter (Apr-Jun) 2023
Net sales KSEK 0 (0)
Operating income KSEK -30 952* (1 758)
Earnings per share before and after dilution SEK -2.57 (0.15)
Reporting period (Jan-Jun) 2023
Net sales KSEK 0 (0)
Operating income KSEK -55 247* (-17 305)
Earnings per share before and after dilution SEK -4.57 (-1.56)
* Operational income includes exchange rate effects on foreign currency deposits for the purpose of securing future outflows during the second quarter amounting to KSEK 8 412 (19 979) and during the reporting period amounting to KSEK 7 760 (26 231)
Significant events during the second quarter (Apr-Jun)
On May 16, 2023, IBT decided on a rights issue and called for an extraordinary general meeting of shareholders.
On June 9, 2023, the Extraordinary General Meeting resolved to approve the Board's decision to increase the share capital by issuing new shares with pre-emptive rights for the company's shareholders.
On June 15, 2023 IBT announced that the European Patent Office has approved its patent application for Lactobacillus reuteri. The patent covers the drug candidate IBP-9414
On June 21, 2023, it was announced that the Data Monitoring Committee (DMC) conducted a planned safety analysis, without objections. At the same time, a planned futility analysis was also conducted and was positive, which means that IBT is continuing the study as planned.
Significant events during the reporting period (Jan-Jun)
On January 12, 2023, it was announced that IBT acquired a probiotic pharmaceutical platform 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 last cohort would open for recruitment. This third cohort will include infants with a birth weight between 1001 grams and 1500 grams.
Significant events after the reporting period
On July 3, 2023, IBT announced that the product IBP-1016 for gastroschisis had been granted orphan drug status.
On July 4, 2023, IBT announced the outcome of the rights issue. The issue provided IBT with approximately SEK 101 million before deduction of transaction costs. After the rights issue, the number of shares and votes in the company changed. The new number of shares now amounts to 13,471,420, of which 453,283 A-shares and 13,018,137 B-shares.
Selected financial data
000´s20232022202320222022 Apr-JunApr-JunJan-JunJan-JunJan-DecNet Sales-----Other income--13312Operating profit / loss-30 9521 758-55 247-17 305-65 808Result after tax-28 8201 648-51 288-17 553-65 451Total assets317 390400 007317 390400 007349 619Cash flow for the period-14 138-28 182-42 647-39 007-83 911Cash flow per share for the period (SEK)-1.26-2.51-3.80-3.47-7.47Cash 300 953373 976300 953373 976335 840Earnings per share before and after dilution (SEK)-2.570.15-4.57-1.56-5.83Equity per share (SEK)25.0233.8125.0233.8129.55Equity ratio (%)89%95%89%95%95%
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).
IBT is a pharmaceutical company whose purpose is to develop and market drugs targeting
diseases affecting prematurely born infants or caused by antibiotic-resistant bacteria.
IBT’s main focus is on its drug candidate IBP-9414, whose development program is designed
to demonstrate a reduced incidence of necrotizing enterocolitis (NEC) and whether
prematurely born infants achieve improved sustained feeding tolerance (SFT) when treated
with the active substance Lactobacillus reuteri, a bacterial strain naturally found in human
breast milk. IBP-9414 is currently in an ongoing registration-enabling the pivotal Phase III study
and is the company’s most advanced development project.
for the treatment of gastroschisis, a life-threatening and rare condition where the child is born
eliminate vancomycin-resistant enterococci (VRE), which cause antibiotic-resistant hospital
acquired infections.
By developing these drugs, IBT has the opportunity to address medical needs where no
available treatments currently exist.
Publication
The Report was submitted for publication, by the CEO, at 08.30 on August 25, 2023.
Contact person
Staffan Strömberg, 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
Attachment
IBTQ2 2023 ENG
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