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Word from CEO

Dear shareholder,

peder wearn word from ceo icoat medical

We can now put an intense and eventful year behind us, and it is with joy and pride I can say that iCoat Medical made great progress in 2023. Strengthened by a successful issue of SEK 32 million, we were able to relentlessly continue the development of our project portfolio, with special focus on the leading product candidate iCM012 in kidney transplantation. During the fourth quarter, work also continued with the preclinical indications of heart transplantation and open heart surgery, which all in all means that I view the immediate future with great confidence.

The progress with our clinical project portfolio is important for value creation of the company and our assets, and this applies not the least to the work with iCM012 in kidney transplantation. In November, we therefore announced the decision to proceed to a clinical efficacy study based on valuable dialogue with the Swedish Medicines Agency.

Earlier in the year, we completed our First-in-Human study ATMIRe (phase 1/2a) with convincing safety and preliminary efficacy results where iCM012 was studied in connection with kidney transplants. We are now preparing the global phase 2b clinical study EMPIRe, which is expected to start in 2024.

We also see a great deal of interest in our clinical and preclinical program within the scientific community, both via publications and presentations at scientific conferences, which of course gives us extra strength in our continued work with iCM012.

The discussions with the Swedish Medicines Agency also included our preclinical research in transplantation of other solid organs, as well as in open heart surgery, which we see as the next indication in clinical development. The Agency also supports continued preclinical work, which, together with the promising results from the ATMIRe study, should be able to form the basis for future phase 1/2a studies for the transplantation of other organs, as well as in open heart surgery.

As our development program takes shape, the company continues to grow, and during the third quarter, the operations for our clinical studies moved into larger premises in the research and development campus Medicon Village in Lund, Sweden, with the aim of creating a good foundation for expanded future clinical operations.

We also continue to strengthen the scientific competence in and around the company. We have created a strong Scientific Board, where Dr. Stefan Tullis, Dr. Stefan Schneeberger, and Dr. Gabriel Oniscu are the latest additions. Earlier in 2023, Carl Bjartmar, MD, PhD, also joined the company as Chief Commercial Officer and is part of iCoat Medical’s management team; a clear proof that we can attract people with great expertise and a broad scientific network.

During the year, we carried out a directed issue of SEK 32 million which secures the financing of our running costs for the phase 1/2a study ATMIRe, the preparations with EMPIRe and continued preclinical studies with new indications, as well as the work with our second product candidate iCM020. The focus is primarily the EMPIRe study, which is expected to start in 2024, but it will also be exciting to continue the development of the preclinical portfolio where we see significant potential.

I look forward to updating you on our upcoming plans and continued efforts to finally offer a product with the potential to transform the entire large and non-cyclical transplant market, where it is estimated that more than 200,000 transplants will be performed in 2026 alone. I am convinced that iCoat Medical and our exciting project portfolio will have an important role to play in this development.

Peder Waern

CEO, iCoat Medical AB