Word from CEO

During the first quarter of this year, we continued the development of our preclinical and clinical project portfolio, with a particular focus on the lead product candidate iCM012 in kidney transplantation, where we are now preparing the global clinical phase 2b study EMPIRe, with an expected start in 2024. We have also continued to strengthen our IP position and was recently able to submit two new patent applications that broaden the patent portfolio and thus the protection for future products.

In February, we announced that we have made the formal decision to proceed with the EMPIRe study as the next step in the clinical development of iCM012. We had previously had fruitful and constructive discussions with the Swedish Medicines Agency, and a phase 2b study demonstrating efficacy is deemed to be the logical next step, based on the promising data generated by the now completed phase 1/2a study ATMIRe.

The EMPIRe trial, which is scheduled to start in 2024, will include approximately 100 patients and be performed at selected high-quality clinics in Europe and the United States. The potential for conditional approval, given sufficiently convincing data generated by the phase 2b study, will later be discussed with the regulatory authorities. This progress with our clinical project portfolio is important to the value creation of the company and our assets.

In parallel with these preparations, the work on the preclinical indications CAR T-cell therapy and open-heart surgery has continued according to plan, which all in all means that I view the immediate future of iCoat Medical’s development work with great confidence.

We have a significant strength by standing firmly on these two strong legs: on the one hand the clinical development around iCM012, on the other hand the preclinical research that together creates a breadth and a depth. Our future does not stand and fall with a single product or indication, but several parallel indications are continuously developing.

We also continue to develop our unique technology platform and associated IP portfolio based on the company’s coating technology. We recently filed two new patent applications that broaden the patent portfolio and thereby the protection for future products. iCoat Medical now has a total of 40 patents and patent applications with international coverage within a total of five patent families.

It is also gratifying to see that our extremely competent employees are being noticed by the scientific community. In March, our Chief Medical Officer Dr. Alireza Biglarnia was one of five research doctors who received a grant for their research in the field of transplantation from the Transplantation Fund, a collaboration between Skåne University Hospital and Skåne’s kidney care network.

We also continue to create a solid scientific network, and in February we presented our strong Scientific Advisory Board, with three leading international experts – Dr. Gabriel Oniscu, Dr. Stefan Schneeberger and Dr. Stephen Tullius. I am very pleased and proud that we have been able to attract some of the leading global transplant experts, and their long, combined experience in research and treatment will be invaluable to us as we now continue the clinical development of iCM012 in the upcoming EMPIRe study.

To be able to continue the business, financing is of course needed, and we will therefore make a convertible loan before the summer. In common with other small and medium-sized biotech companies, we have noticed that the market has been – and to some extent still is – in a wait-and-see mode in the last two to three years, and therefore I believe that a convertible loan is the best strategic financing solution for us in the short term.

I look forward to updating you on our upcoming plans and continued efforts to finally be able to offer a product with the potential to transform the entire large and non-cyclic transplant market. It is likely that more than 200,000 transplants will be carried in 2025, making research and new techniques essential to ensure these people receive the best possible treatment. I am convinced that iCoat Medical will play a key role in this development.