Dear Shareholder,
During the third quarter, we continued to work purposefully to finalize preparations for our upcoming Phase IIb study EMPIRe with our lead product candidate, iCM012, in kidney transplantation as cost-effectively as possible. We initiated a collaboration with a financial advisor, Back Bay Life Science Advisors—specialists in the pharmaceutical industry—to secure financing for our upcoming activities.
The Company is now approaching the time when the application for the EMPIRe study can be submitted to the EMA. The study will be conducted with 200 patients at selected high-quality clinics in Europe. The aim is for the results to form the basis for an accelerated approval of the drug in Europe. Once the application is submitted and approved, and future financing is secured, the study can be initiated immediately—hopefully as early as the beginning of 2025.
Earlier this summer, we received positive feedback from the EMA’s Committee for Medicinal Products for Human Use (CHMP) regarding both the EMPIRe study and our completed preclinical program. The feedback from CHMP confirms our own belief in iCM012 and our clinical development plan.
We are seeing continued strong scientific interest in our projects. At the prestigious American Society of Nephrology (ASN) Kidney Week conference, held in October in San Diego, our Chief Medical Officer, Dr. Alireza Biglarnia, gave a presentation on our completed first-in-human study ATMIRe.
This double-blind, placebo-controlled, randomized, single-center study evaluated the safety and tolerability of iCM012 for ex vivo treatment of retrieved kidneys to minimize ischemia-reperfusion injury and thereby improve both the short- and long-term outcomes of kidney transplantation. Presenting these results from the successfully completed Phase 1/2a study at such a renowned conference is a major recognition of our clinical data and of iCM012.
In early November, iCoat Medical was one of the exhibitors in the Sweden BIO pavilion at the well-attended BIO Europe event, which this year took place in Stockholm. We had the opportunity to present our projects and interact with various stakeholders. Here too, we observed a great deal of interest in our unique technology platform and projects.
In parallel with our clinical preparations, we are systematically continuing to build our platform based on our unique coating technology. We currently have 14 granted patents worldwide and 39 ongoing patent applications. Taken together, we have an increasingly attractive patent portfolio with IP protection extending until 2039–2045. Additional patent applications, which will be filed this year and in 2025, will give iCoat Medical a very comprehensive IP protection in our area of focus—ischemia-reperfusion injury—together with our existing patent portfolio.
iCoat Medical has developed rapidly since the company was founded in 2018, and we are now on the verge of a major and significant step as we prepare to launch our international EMPIRe study. To successfully carry out the study and continue building our technology platform from 2025 to 2026, we need a capital injection of about USD 25 million.
Given the uncertain market environment for pharmaceutical companies and our substantial future capital requirements, the Board has decided to pursue a so-called dual-track strategy. This means that we may either complete a strategic deal with a larger pharmaceutical company or raise capital from investors for continued development on our own. The process has begun together with Back Bay and is expected to be completed at the beginning of 2025.
In summary, I would like to emphasize that our collaboration with our U.S. advisor has reinforced our belief that iCoat is on track to build a very strong product platform, and that there is a potentially significant market for iCoat to capture.
I look forward to updating you on our upcoming plans and our continued efforts to ultimately provide a product that has the potential to transform the entire large and non-cyclical transplantation market. Likely more than 200,000 transplants will be performed in 2026, meaning that research and new technologies will be crucial to ensuring that patients receive the best possible treatment. I am convinced that iCoat Medical will play a central role in this development.
Peder Waern
CEO, iCoat Medical AB