Today iCoat Medical releases the company´s first public interim report for the period january-june 2022.
THE PERIOD IN BRIEF
Financial overview April-June (compared to corresponding period the previous year)
- The quarterly loss amounted to -2,975 KSEK (-277 KSEK)
- Cash and cash equivalents amounted to 18,888 KSEK (126 KSEK) at the end of the period
- Cashflow during the quarter amounted to -4,848 KSEK (-2,330 KSEK)
- Equity amounted to 32,922 KSEK (3,968 KSEK) at the end of the period and total assets amounted to 34,585 KSEK ( 6,075 KSEK)
- Equity/Assets-ratio amounted to 95% (65%) at the end of the period
Financial overview January-June (compared to corresponding period the previous year)
- The period’s loss amounted to -4,527 KSEK (-472 KSEK)
- Cashflow during the period amounted to -7,952 KSEK (-4 147 KSEK)
Significant events January-June
- EMA (European Medicines Agency) approved the company’s application for Orphan Drug status for TUM012 in connection to kidney transplants. The EU commission provides Orphan Drug status to treatments that can be used for life threatening or serious diseases that are unusual and lack available treatment. Orphan Drug status gives advantages such as 10 years’ market exclusivity for TUM012, support during clinical studies and reduced regulatory fees.
- The first patients in the First in Human study ATMIRe have begun treatment. In total, 18 patients will participate in the study and the patients will be treated at Skåne University Hospital in Malmö, Sweden. The study is expected be finished in 2023.
- Mattias Springare was appointed CFO and Head of Investor Relations. The purpose of the recruitment is to expand iCoat Medical’s financial and accounting function and make necessary preparations ahead of a potential IPO.
- Jacob Westman was appointed Head of Chemistry, Manufacturing and Control (CMC). The purpose of the recruitment is to support ongoing and coming clinical studies, and lead
product development. - Göran Lerenius was appointed iCoat Medical’s General Counsel & Contract Manager. The recruitment will strengthen the company’s judicial capacity to prepare the company ahead of coming clinical studies.
Significant event after the period
- On August 10, iCoat Medical reported interim data from the ongoing First-In-Human study ATMIRe which showed that the first patients had successfully been treated without any serious or significant side effects
CEO LETTER
Dear Shareholder,
I am glad to present iCoat Medical’s first quarterly report, something we will continue to do during coming quarters to keep investors informed on our clinical and financial progress.
During the first half of 2022 we have continued to take important steps in the development of our product candidate TUM012 which aims to protect organs in connection to transplant. All organs that are transplanted run the risk of Ischemia Reperfusion Injury due to cells lacking oxygen, since the patient’s immune system is activated and attacks the damaged cells. TUM012 protects ischemic cells against attacks from the immune system and reduces the risk of inflammation and organ rejection. Its use improves patient outcome, increases availability of organs for transplantation and reduces societal costs associated with kidney failure.
The number of organ transplants have increased during the past 20 years. Serious kidney diseases continue to be one of our most common diseases and those who are affected face a tough reality. A kidney transplant makes it possible for these patients to return to a more normal life again. However, there is currently a significant shortage in available organs for transplantation across the whole world and currently only 10% of the transplantation needs can be met. With iCoat Medical’s products we hope to make more organs available for transplant.
First patients have been treated with no side effects
Sweden’s Medical Products Agency and Ethics Review Authority approved our application in December 2021 to initiate our First in Human study ATMIRe. The purpose of the study is to show that TUM012 is a safe product and will be the basis for the planned multicenter study afterwards. The first patients have now been transplanted and treated with TUM012 at the kidney transplant unit at Skåne University Hospital in Malmö with positive results. The study will include in total 18 patients and is expected to be completed in 2023.
In parallel, our organization has been strengthened to support clinical studies and make necessary preparations ahead of a potential IPO. During the first half of the year we have welcomed Göran Lerenius as General Counsel, Jacob Westman as Head of CMC and Mattias Springare as CFO and Head of Investor Relations. These recruitments strengthen the company’s judicial competence required ahead of the company’s future clinical studies, allow for necessary preparations in production ahead of market approval and strengthen our financial competence ahead of future capital raisings and a potential IPO.
The market environment continues to be challenging which also affects iCoat Medical. As the pandemic has softened its grip on society, the war in Ukraine and rising inflation and interest rates coupled with turbulence on global stock markets has resulted in a more unsecure environment. So far, iCoat Medical has not seen any negative consequences but we see rising prices and increasing wages in our business. iCoat Medical’s business does however remain stable and progresses according to plan. The capital raising in 2021 which raised 40 MSEK together with our strengthened organization ensures that we can complete our First In Human study according to plan.
iCoat Medical consists of world-class scientists and doctors that carry out groundbreaking research in innate immunity, and people with commercial expertise that together build a stronger iCoat Medical. I look forward to updating you on the company’s development and clinical studies in coming quarterly reports. We have an exciting time ahead of us!
Peder Waern
CEO, iCoat Medical AB
Interim Report Q2 2022
In addition to the English version of the Interim Report which is attached to this press release, a Swedish version is available on the company’s website (www.icoatmedical.com)
For additional information, please contact:
Peder Waern, CEO – iCoat Medical AB
E-mail: peder.waern@icoatmedical.com
Mattias Springare, CFO – iCoat Medical AB
E-mail: mattias.springare@icoatmedical.com
About iCoat Medical
iCoat Medical is a clinical stage, immunotherapy 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.