Bifogade filer
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | Nordic SME Sweden |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
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Financial overview
(figures in parentheses refer to the corresponding period in the previous year)
Fourth quarter, October 1 - December 31, 2025
- Net sales amounted to 0 (0).
- Other operating income amounted to 10,670 (15,317) TSEK.
- Operating profit (EBIT) amounted to -13,060 (1,492) TSEK
- Profit after tax amounted to -12,123 (2,014) TSEK.
- Earnings per share before and after dilution: -1,01 (-0.29) SEK.*
- Cash flow from operating activities was -11,546 (6,448) TSEK.
Full year, January 1 - December 31, 2025
- Net sales amounted to 0 (0).
- Other operating income amounted to 26,854 (19,133) thousand SEK.
- Operating profit (EBIT) amounted to -53,249 (-27,270) thousand SEK.
- Profit after tax amounted to -49,708 (-26,937) thousand SEK.
- Earnings per share before and after dilution: -4.13 (-0.04) SEK.*
- Cash flow from operating activities was -37,005 (-27,946) thousand SEK.
*During the year, a reverse split was carried out
Significant events during the quarter
-Assay design freeze achieved for the Psyros cartridge
The design freeze confirms the final configuration and performance characteristics, freezing the cartridge chemistry.
-The European Patent Office (EPO) granted a third patent related to the Psyros
-Extraordinary General Meeting 19 November 2025
The general meeting resolved, among other things, to carry out a reverse share split.
Significant events after the end of the period
-Completion of the instrument design and preparation for pilot manufacturing
-Cartridge manufacturing scale-up
CEO statement
During 2025, we took clear and tangible steps toward commercialisation. We presented positive patient data demonstrating that the Psyros system delivers laboratory-grade performance even in whole blood, showcased a fully functional commercial system prototype for the first time, and achieved assay design freeze for the cartridge. In addition, our IP position was further strengthened through granted patents by the Japanese and European Patent Offices.
At the international ADLM (Association for Diagnostics & Laboratory Medicine) congress, we presented a fully functional commercial prototype of Psyros for the first time. Interest from potential partners and end users was very strong. The positive response reflected a combination of the platform’s ultra-sensitive detection capabilities, compact form factor, and cost-efficient consumables.
Following delivery of the commercial prototypes, we carried out targeted design and manufacturing improvements during the autumn to optimise assembly processes and reproducibility. The year concluded with an important milestone as we achieved assay design freeze for the cartridge, confirming that assay chemistry met the requirements for verification, validation, and pilot production. This milestone also led to more structured and forward‑looking discussions with several potential partners.
In early 2026, we also announced that, together with FlexMedical Solutions, we have made significant progress to optimise the production capacity for the cartridge. The modular production line enables scalable output of more than one million cartridges per year as demand increases.
This production setup supports our ambition to achieve cost-efficient manufacturing without compromising analytical performance, thereby enabling broad adoption in point-of-care testing.
In parallel, 30 instrument prototypes underwent pre-clinical evaluation, confirming technical performance and identifying a limited number of targeted hardware improvements to ensure long-term robustness and scalable manufacturing. With these improvements the risks associated with transfer to production have been materially reduced.
As the instrument design is being finalised, preparations for the pilot manufacturing line are now underway. To mitigate the risk of potential delays in the global supply chain, we have already placed orders for components with long lead times. The first pilot instruments will be representative of the commercial product and will be used for internal verification and validation activities, to support design freeze, as well as in the forthcoming clinical performance study planned for 2026.
The technical advances underpinning this year’s milestones are further validated by our pre-clinical programmes. Results demonstrate that Psyros is well positioned for a high-sensitivity troponin test, while a joint study with a cardiologist at St Thomas’ Hospital has shown that a biomarker such as cMyC (cardiac myosin-binding protein C) can be rapidly and efficiently implemented on the platform. This confirms the system’s broad clinical potential and strengthens our long-term development and market opportunity.
From a financial perspective, we strengthened the company’s liquidity through a fully subscribed rights issue of SEK 100 million, securing funding for the completion of Psyros. With assay design freeze achieved for the cartridge, a strengthened balance sheet, and clearly defined next steps, we enter 2026 with a focus on final system verification, validation of manufacturing processes, pilot production of cartridges and instruments, followed by initiation of the European multicentre clinical performance study. These activities represent the final and decisive steps ahead of commercial launch in 2027.
I would like to extend my sincere thanks to our employees, our development and manufacturing partners, and our shareholders for your support during an important year for Prolight. We have significantly reduced the technical risk, strengthened our IP position, delivered on our commitments, and strategically positioned the company for potential partnerships and future commercialisation. With a clear and realistic timeline, we are now advancing Psyros through the final clinical performance study and onward to market, creating value for patients, healthcare, society, and our shareholders.
Lund February 26 2025
Ulf Bladin
CEO Prolight Diagnostics (publ)