Message from the CEO
IBT has successfully completed the recruitment of infants for our Phase III study (The Connection Study), which is the final clinical trial planned according to the IBP-9414 development program. It all began with defining the clinical development plan for IBP-9414 with the FDA and the European equivalent, EMA, over 10 years ago. Once the plan was established, we built a small and highly efficient organization tasked with converting this plan into action. It is fantastic to note that we have succeeded. From a small office in the heart of Stockholm, we have managed to conduct the largest study ever in premature infants. Some companies choose to out-license their development projects in early stages to avoid responsibility for implementation or funding of the laborious development work and to reduce project risk. IBT has chosen to perform this work and decline early out-licensing opportunities, as we believe we will create greater long-term value for shareholders. We retain control and decide how and what should be done while maintaining good cost control. That is why reaching this milestone is truly extraordinary; 100% recruitment of 2158 infants. I also want to take this opportunity to thank the individuals behind this achievement, our team in Stockholm as well as those in the USA and Europe.
The last patient participating in "The Connection Study" will leave the study no later than July 2024. We expect to receive the results sometime during Q3 2024. IBT has initiated the demanding work to compile regulatory documentation and validation of the production process in order to submit the application for market approval (BLA) to the FDA as soon as possible. During the first quarter, we have also started preparing for the next stage. We have conducted several expert panel meetings with Key Opinion Leaders in the USA as well as in the EU. It is very stimulating to discuss IBP-9414, and there is no doubt that we will meet a clear medical need where treatments are currently lacking. We are convinced that if our study results show the expected effect, our product will contribute to less suffering and death. The medical experts share the same expectations.
During this quarter, the Canadian regulatory authority warned against using probiotic supplements as a treatment for premature infants. Therefore, Canada is choosing to follow the FDA's stance on the issue. The warning concerns several infants who have died after treatment with non-regulated products. IBT expects that EU regulatory authorities will act similarly and warn or prohibit the inappropriate use of available supplements when an approved medication is available.
Finally, I want to mention that we are now conducting something called PPQ (Product Process Qualification), which means we are documenting our manufacturing of IBP-9414 in a way that authorities can obtain the necessary documentation for approval of a medicinal product. IBT has also strengthened during the quarter by expanding our staff with more talented individuals, including a Head of Regulatory and a Supply Chain Director based in our Stockholm office to tackle the future challenges awaiting IBT.
We have entered a new stage at IBT, and we look forward to an exciting near future.
Stockholm May 7, 2024
Staffan Strömberg, CEO
| Financial overview for the period First quarter (Jan-Mar) 2024 Net sales KSEK 0 (0) Operating income KSEK -29 798* (-24 296) Earnings per share before and after dilution SEK -2.06 (-2.00) |
* Operational income includes exchange rate effects on foreign currency deposits to secure future outflows during the first quarter amounting to KSEK 5 323 (-652).
Significant events during the reporting period (Jan-Mar)
- No significant events during the first quarter
Significant events after the reporting period
- On April 4th 2024, IBT announced that the last patient of a total of 2 158 premature babies has been enrolled in the global phase 3 clinical program ("The Connection Study" for the development of IBP-9414. The results from the study are anticipated during Q3 2024.
Selected financial data
| 000's | 2024 | 2023 | 2023 |
| Jan-Mar | Jan-Mar | Jan-Dec | |
| Net Sales | - | - | - |
| Other income | 5 | 13 | 77 |
| Operating profit / loss | -29 798 | -24 296 | -134 617 |
| Result after tax | -27 815 | -22 468 | -123 068 |
| Total assets | 348 878 | 333 694 | 351 334 |
| Cash flow for the period | -24 768 | -28 509 | -4 704 |
| Cash flow per share for the period (SEK) | -1.84 | -2.54 | -0.38 |
| Cash | 309 618 | 306 680 | 329 064 |
| Earnings per share before and after dilution (SEK) | -2.06 | -2.00 | -9.95 |
| Equity per share (SEK) | 20.59 | 27.55 | 22.65 |
| Equity ratio (%) | 79% | 93% | 87% |
Contacts
Staffan Strömberg, CEO
Maria Ekdahl, CFO
info@ibtherapeutics.com
+46 76 219 37 38
About Us
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 (IBTB).
IBT is a pharmaceutical company whose purpose is to develop and commercialize drugs for diseases affecting premature babies. During the 12 years of drug development IBT has gained unique expertise in the field of drugs using live bacteria as active substances, this is a key competitive factor for our development programs.
IBT's main focus is the drug candidate IBP-9414, a formulated bacterial strain naturally found in human breast milk. The development program is designed to show a reduced incidence of necrotizing enterocolitis ("NEC") and improved gastrointestinal function ("SFT"). IBP-9414, is expected to be the first product in the new class of biologics called "Live Biotherapeutic Products" for premature infants. Upon approval, it would be the first product to prevent NEC and improve Sustained Feeding Tolerance ("SFT") in newborns. The drug development of IBP-9414 is currently in its final stages and IBT expects to receive regulatory approval in 2025 for this important product for premature babies.
The portfolio also includes additional drug candidates, IBP-1016, IBP-1118 and IBP-1122. IBP-1016, for the treatment of gastroschisis, a life-threatening and rare disorder in which children are born with externalized gastrointestinal organs. IBP-1118 to prevent retinopathy of prematurity (ROP), one of the leading causes of blindness in premature babies, and IBP-1122 to eliminate vancomycin-resistant enterococci (VRE), which cause antibiotic-resistant hospital infections.
Through the development of these drugs, IBT can address medical needs where no sufficient treatments are available.
