Press release Stockholm, 16 May 2023
THE PERIOD IN BRIEF
FINANCIAL OVERVIEW JANUARY-MARCH (COMPARED TO CORRESPONDING PERIOD THE PREVIOUS YEAR)
· The quarterly loss amounted to –3,850 KSEK (–1,553)
· Cash and cash equivalents amounted to 2,877 KSEK (23,735) at the end of the period
· Cash flow during the quarter amounted to –6,771 KSEK (3,104)
· Equity amounted to 23,647 KSEK (35,897) at the end of the period and total assets amounted to 27,991 KSEK (37,602)
· Equity/Assets-ratio amounted to 84% (95%) at the end of the period
SIGNIFICANT EVENTS JANUARY-MARCH
· The company filed an international patent application for a new indication for PEG-phospholipid molecules. The molecule is connected to iCoat Medical’s focus area ischemic reperfusion injury and is expected to contribute to a strengthening of the company’s product portfolio.
SIGNIFICANT EVENT AFTER THE PERIOD
· In the beginning of May, the 18th and final patient was included in the company’s First-In-Human study, ATMIRe, at Skåne’s University Hospital in Malmö.
· A directed issue was completed in May and provided proceeds of 33 MSEK.
· Carl Bjartmar was appointed the company’s Chief Commercial Officer and is thereby a member in the executive management. Carl is also a Board member in iCoat Medical. Carl has extensive experience of pharma development and IPOs and has been part of management in Wilson Therapeutics and Ascelia Pharma, among other companies.
During the quarter, iCoat Medical continued to make progress in the ongoing clinical trial ATMIRe, which evaluates the safety and tolerability of ex vivo allograft treatment with TUM012 to mitigate ischemia-reperfusion injury in kidney transplantation. In parallel, pre-clinical development of TUM012 continues for the indications heart transplants and open heart surgery, as well as of TUM020 which aims to prevent damage from warm ischemia.
Ischemia-reperfusion injury is a detrimental event that inevitably occurs during organ or cell transplantation. This condition can lead to early inflammation and inferior short and long-term transplant outcome. TUM012 has shown promise in reducing the severity of ischemia-reperfusion injury by providing protection against injurious immune attacks. This novel intervention holds the potential to improve patient outcome, increases the availability of organs for transplantation, and reduces costs associated with premature transplant failure.
In our ongoing First-in-Human study (phase I) ATMIRe, the enrollment of all intended 18 patients has recently been completed. As the study progresses, we eagerly await the completion of the 3-month follow-up period for all patients, after which a comprehensive data analysis will be conducted. Subsequently, we will present the final results of the study.
We also continue to work on the study design for the upcoming efficacy trial, known as EMPIRe. EMPIRe is a multicenter phase II trial that aims to evaluate the efficacy and safety of TUM012 in kidney transplantation. The study is planned to include between 100-150 patients across several transplant centers. We have recruited a project manager for EMPIRe and are negotiating with a Clinical Research Organization (CRO) which will be responsible for carrying out the study. Our team is working on preparing the necessary documentation and data required for the study’s application to regulatory authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). We anticipate submitting the application for the study in the third quarter of 2023, and based on our current projections, we expect the application to be approved during the second half of 2023.
Preparations ahead of a market listing on Nasdaq First North Growth Market continue even though its timing has become more uncertain due to a more uncertain market environment. After the period, we completed a directed issue of 33 MSEK that ensures financing of the business’s ongoing costs for ATMIRe, preparations for EMPIRe and continued pre-clinical studies for new indications and TUM020 during the coming 12 months. iCoat Medical continues to make steady clinical progress and I look forward to soon present final results from our clinical study ATMIRe.
CEO, iCoat Medical AB
Interim Report Q1 2023
In addition to the English version of the Interim Report, a Swedish version is also attached to this press release.
For additional information, please contact:
Peder Waern, CEO – iCoat Medical AB
Mattias Springare, CFO – iCoat Medical AB
About iCoat Medical
iCoat Medical is a clinical stage, pharmaceutical company focusing on reducing and preventing ischemia reperfusion injuries by developing novel pharmaceutical products. The company is one of the world’s leading R&D-centered organizations within innate immunology and is systematically expanding its pipeline using its proprietary coating-technology platform. iCoat Medical’s lead candidate TUM012 is developed to improve the outcome of organ transplantations. The company’s unique ex-vivo coating of the grafts has the ambition of being an integral part in the transplant procedures of tomorrow. iCoat Medical has operations in Uppsala, Lund and Malmö, and is headquartered in Stockholm.