Financial overview July – September:
(Figures in parentheses refer to the corresponding period of the previous year)
- The quarterly loss amounted to -5,604 KSEK (-2,047 KSEK)
- Cash and cash equivalents amounted to 17,567 KSEK (15,232 KSEK) at the end of the period
- Cash flow during the quarter amounted to -9,467 KSEK (-3,656 KSEK)
- Equity amounted to 44,602 KSEK (30,874 KSEK) at the end of the period and total assets amounted to 53,629 KSEK (32,785 KSEK)
- Equity/Assets-ratio amounted to 83% (94%) at the end of the period
Financial overview January – September:
(Figures in parentheses refer to the corresponding period of the previous year)
- The period´s loss amounted to -14,687 KSEK (-6,575 KSEK)
- Cash and cash equivalents amounted to 17,567 KSEK (15,232 KSEK) at the end of the period
- Cash flow during the period amounted to 7,918 KSEK (-11,607 KSEK)
- Equity amounted to 44,602 KSEK (30,874 KSEK) at the end of the period and total assets amounted to 53,629 KSEK (32,785 KSEK)
- Equity/Assets-ratio amounted to 83% (94%) at the end of the period
Significant events July – September:
- Extensive preparations for a pivotal study including site selection in several countries.
- In July, the last follow-up visit with patient 18/18 in the company´s First-in-Human study was conducted with results according to plan.
- In September, results from the First-in-Human study (ATMIRe) were finalized.
Significant events after the period:
- Initiation of new pre-clinical studies in animal models for heart transplantation and open-heart surgery for the company´s new indications.
A word from the CEO
During the third quarter, the intensive work that has characterized this entire year for iCoat Medical continued, and during the period, we were able to advance the development of our prioritized clinical project in kidney transplantation, as well as continue to work with the preclinical indications of heart transplantation and open heart surgery, which together means that I look forward to the near future with great confidence.
All organs that are transplanted are at risk of ischemia-reperfusion damage due to the cells lack of oxygen, which in turn activates the immune system that attacks and further damages these cells. Our lead product candidate iCM012 protects ischemic cells against the immune system and thereby reduces the risk of inflammation and organ rejection. Its use has the potential to improve patient outcomes, increase the availability of organs that can be used for transplantation, and reduce societal costs.
In July, the last follow-up visit with the 18th and last patient (Last Patient Last Visit, LPLV) was conducted in the company’s First-in-Human study ATMIRe (phase I/IIa), where iCM012 has been studied in connection with kidney transplants. Fortunately, everything went according to plan, and the results of the study were completed in September. Later in the fall, we were able to start the work linked to publications and presentations at international scientific conferences. We are seeing a great deal of interest in our clinical and preclinical program in scientific circles, which of course gives encourages us in our continued work.
During the third quarter, extensive preparations were also made for our pivotal clinical study EMPIRe (phase IIb/III), including visits to hospitals around the US and Europe. Nearly 40 transplant centers were included in the evaluation with positive responses, and our goal is to have the study approved in H1 2024 and then start enrolling patients, which is an important milestone for us.
In addition to the development of iCM012 for kidney transplantation, preclinical research in heart transplantation and open-heart surgery is also progressing, which are intended to be the next indications to advance towards clinical development. The development of our other potential drug candidate iCM020, which aims to counteract damage from so-called warm ischemia that can occur in connection with transplantation and thromboses, such as heart attack and stroke, is also continuing.
After the period, we initiated new pig studies/animal models regarding heart transplantation and open-heart surgery, and in early October we had a meeting with the Swedish Medical Products Agency to discuss them as potential new clinical indications for iCM012. Initial results are expected in Q1 2024.
As our development program continues to take shape, the company is growing, and during the quarter we moved into larger premises in the Medicon Village research park in Lund, which creates a good foundation for expanded future clinical activities.
Earlier this year, we carried out a directed share issue that secures the financing of our ongoing costs for ATMIRe, preparations for EMPIRe and continued preclinical studies for new indications and iCM020.
I look forward to updating you on our plans going forward and to continue our efforts to ultimately offer a product that has 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 will have an important role to play in this development.
Peder Waern
CEO, iCoat Medical AB
The full report is attached as PDF and is available on the company’s website: https://www.icoatmedical.com/en/investors/financial-reports/
For more information, please contact:
Peder Waern, CEO – iCoat Medical AB
E-mail: peder.waern@icoatmedical.com
Mattias Springare, CFO and Head of Investor Relations – 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 iCM012 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.
For more information, please visit https://www.icoatmedical.com/sv/