Press release Stockholm, 15 February 2023
THE PERIOD IN BRIEF
FINANCIAL OVERVIEW OCTOBER-DECEMBER (COMPARED TO CORRESPONDING PERIOD THE PREVIOUS YEAR)
- The quarterly loss amounted to -3,899 KSEK (-1,290)
- Cash and cash equivalents amounted to 9,648 KSEK (26,838) at the end of the period
- Cash flow during the quarter amounted to -5,584 KSEK (4,473)
- Equity amounted to 27,057 KSEK (36,832) at the end of the period and total assets amounted to 31,901 KSEK (39,052)
- Equity/Assets-ratio amounted to 85% (94%) at the end of the period
FINANCIAL OVERVIEW JANUARY-DECEMBER (COMPARED TO CORRESPONDING PERIOD THE PREVIOUS YEAR)
- The period’s loss amounted to -10,474 KSEK (-2,593)
- Cash and cash equivalents amounted to 9,648 KSEK (26,838) at the end of the period
- Cashflow during the period amounted to -17,191 KSEK (22,566)
- Equity amounted to 27,057 KSEK (36,832) at the end of the period and total assets amounted to 31,901 KSEK (39,052)
- Equity/Assets-ratio amounted to 94% (97%) at the end of the period
SIGNIFICANT EVENTS OCTOBER-DECEMBER
- Interim data was published for the ongoing First-in-Human study on TUM012. More than 50 percent of patients that will participate in the study have now been treated with TUM012 in connection to transplantation and no negative side effects connected to the medication have been observed. The study is expected to be completed during the first half of 2023.
- FDA has approved the company’s application for orphan drug designation for TUM012 in connection to organ transplants.
SIGNIFICANT EVENT AFTER THE PERIOD
No significant events have been announced after the period.
CEO LETTER
Dear shareholder,
iCoat Medical was able to finish the year in the best possible way – with continued progress and positive results from the ongoing clinical studies. During the period, we’ve taken important steps in clinical development of our product candidate TUM012 which aims to protect organs in connection to transplants. At the same time we’ve initiated pre-clinical development of TUM012 for new indications, heart transplants and open heart surgery. Pre-clinical development also continues for TUM020 which aims to prevent damage from warm ischemia.
All organs that are transplanted run the risk of Ischemia Reperfusion Injury since cells suffer from a lack of oxygen and thereby the immune system is activated and it attacks and damages these cells. TUM012 protects ischemic cells from the immune system and thereby reduces the risk of inflammation and organ rejection. Its use improves patient outcome, increases availability of marginalized organs for transplantation and reduces societal costs associated with kidney failure.
Our ongoing First-in-Human study (phase I) ATMIRe reported updated interims data when more than 50 percent of the patients that will participate in the study had been treated. Data clearly shows that none of the patients that had been treated with TUM012 in connection to a transplant had experienced any negative side effects. Our preliminary conclusion is therefor that we have created a safe product. In parallel we continue to make preparations ahead of the next clinical phase for TUM012 for use in kidney transplants, an international phase II study. We have, among other things, recruited an experienced project manager who will be responsible for carrying out the phase II study and we will shortly have completed the study design.
Since we see great potential in that TUM012 will also be able to create significant medical benefits also in connection to other treatments, we have initiated pre-clinical studies for TUM012 in connection to heart transplants and open heart surgery which are expected to take approximately two years. Ischemia reperfusion damage poses serious problems also in these treatments.
We continue to see that specialist care is facing a shortage of personnel but thankfully transplant operations at Skåne’s university hospital in Malmö have proceeded without significant disruptions.
Preparations ahead of a market listing continues and we plan to complete a listing on Nasdaq First North Growth Market during the second half of 2023. In order to finance the business until then, the business is now completing a bridge financing arrangement which we expect to finalize shortly and this financing enables us to maintain momentum in the business and complete the First-in-Human study, planning of a future phase II study as well as continued pre-clinical studies for new indications and TUM020.
iCoat Medical continues to make steady progress and I look forward to presenting final results from our clinical study ATMIRe when the study is completed in the first half of 2023.
Peder Waern
CEO, iCoat Medical AB
Interim Report Q4 2022
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
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, 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.