Financial overview
First quarter, January 1 – March 31, Q1 2025 Group
(figures in parentheses refer to the corresponding period in the previous year)
- Net sales amounted to 0 (0).
- Other operating income amounted to 1,662 (68) thousand SEK.
- Profit after tax amounted to -10,937 (-8,929) thousand SEK.
- Earnings per share before and after dilution: -0.02 (-0.02) SEK
- Cash flow from operating activities was -9,176 (-8,800) thousand SEK.
Significant events during the quarter
Prolight received a positive patent decision for core Psyros patent
A Notice of Intention to Grant from the European Patent Office (EPO) protects the company’s point-of-care analysis technology for single molecule counting.
Prolight received its second positive patent decision for the Psyros technology
The Notice of Intention to Grant from the EPO is an extension of the main application.
Prolight received notice of allowance for the MicroFlex patent
Prolight received a Notice of Allowance from the US Patent and Trademark Office (USPTO) for a patent application concerning the analytical unit and reaction chamber of the company’s point-of-care analysis system, MicroFlex, which is being developed by Prolight’s partner TTP (The Technology Partnership plc).
Prolight announced positive preclinical data
The results show that Prolight is well on track to deliver a high-sensitivity troponin test on the company’s Psyros platform for single molecule counting.
Significant events after the end of the period
Study demonstrates how quickly biomarkers can be integrated into the Psyros POC platform
A joint research project between Prolight and cardiologist Dr. Sam McGrath at St Thomas’ Hospital demonstrated how rapidly a test for the cardiac biomarker cMyC can be transferred to the Psyros POC system. The study highlights the platform’s potential and broader diagnostic applications beyond high-sensitivity troponin.
Prolight was granted its first two European patents for the Psyros technology
The company’s first two European patents for the Psyros technology for single molecule counting have been officially granted by the European Patent Office (EPO).
Prolight received new MicroFlex patent approval in the US
The US Patent and Trademark Office granted Prolight a patent for the analytical unit and reaction chamber of the company’s POC system MicroFlex.
Prolight resolved on a rights issue
The proceeds are intended to be used to complete the development of the Psyros system and achieve commercialization, subject to approval at the upcoming extraordinary general meeting.
Notice of extraordinary general meeting in Prolight Diagnostics AB (publ)
The meeting will be held at Prolight’s premises at Gasverksgatan 3 A, 222 29 Lund, on Tuesday, June 10, 2025, at 10:00 am CET.
New chairman of the board
The nomination committee has nominated Fredrik Alpsten as new board member and chairman of the board for the AGM on June 30, 2025.
CEO statement
During the quarter, we made significant progress towards establishing Psyros™ as the next-generation point-of-care (POC) solution. We delivered the first commercial prototypes of our POC system to the preclinical validation study at St Thomas’ Hospital in London. This marks a technical milestone that shows we are well on our way to initiating the full clinical performance study later this year. Preclinical data from biobank samples has also provided strong support: the Psyros platform demonstrated very high clinical sensitivity and specificity, with an AUC of 0.97–0.98 (1.00 being perfect). These results confirm that our small, portable commercial instrument prototypes perform on par with large laboratory instruments.
Our pilot production line at FlexMedical Solutions reached new levels during the quarter. With the delivery of additional automated equipment, we are now ready to scale up production for launch – from hundreds to hundreds of thousands of cartridges per year. The production cost of our disposable cartridge remains one of our key competitive advantages.
It is also encouraging to see how quickly new biomarkers can be integrated into the Psyros platform. This was demonstrated in a research collaboration with cardiologist Dr. Sam McGrath at St Thomas’ Hospital, London, where a new test for the biomarker cMyC (cardiac myosin-binding protein C) was transferred to the Psyros system in just a few weeks. “This clearly demonstrates the power of single-molecule counting and its potential to revolutionize POC diagnostics. The transfer of the test was simple and quick thanks to the userfriendliness of the Psyros technology,” summarized Dr. Sam McGrath. This confirms that our strategy — initially focusing on troponin and then expanding to other biomarkers — is fully feasible on our Psyros product platform.
After the end of the quarter, the European Patent Office (EPO) announced its intention to grant not one, but two patents related to the Psyros technology, offering protection in 17 countries until 2040 and 2041, respectively. The first – the core patent EP 3987287 – protects the central measurement system in our platform, where individual binding events are detected through the bleaching of fluorescent spots, enabling extremely sensitive assays. The second, EP 4264266, builds on this foundation and covers methods for extending the lifespan of reactive oxygen species – a technological improvement that further enhances the system’s precision and simplifies optical readout. These protections strengthen our competitiveness and make us an even more attractive partner in point-of-care testing and diagnostics.
The granting of these patents is a clear acknowledgment of the level of innovation and technical sophistication that Psyros represents. They reinforce our position in a globally growing market for advanced point-of-care solutions, where the need for fast and reliable results has never been greater. We are particularly proud to have created a platform capable of counting individual molecules – something that until now has only been possible in large laboratories, but which we are now bringing to the point of care.
Market dynamics also support our strategic focus. bioMérieux’s acquisition of SpinChip Diagnostics shows that major players are now actively seeking next-generation point-of-care solutions. We are uniquely positioned as the first and only digital, portable POC system capable of single-molecule counting with multiplex capabilities and low manufacturing costs. We are engaged in discussions with numerous potential partners who are highly impressed by the rapid development of the POC system, Psyros – particularly by the fact that we have already succeeded in delivering strong analytical and clinical performance using plasma from biobanks in the pre-clinical validation study.
However, both we and our potential partners are aware that fresh whole blood samples can behave significantly differently compared to plasma. It is therefore critical to demonstrate equivalence between plasma and whole blood within the target population. This is the primary objective of the study being conducted at St Thomas’ Hospital in London. When equivalence is demonstrated, both we and future partners can infer that we will achieve the desired clinical performance in whole blood during the final clinical performance study – a requirement for regulatory approval.
The results from the ongoing whole blood study at St Thomas’ Hospital, expected during the second quarter of this year, will therefore be pivotal for potential partners seeking to minimize risk ahead of a strategic partnership or commercial agreement.
To secure the best possible deal with potential partners, we want to avoid being under financial pressure or in a stressed position. For this reason, the Board has recommended that we raise capital now. In the broader perspective, we are confident that this is the right course of action – a view also reflected in the strong participation in the share issue by the board of directors, management, employees, and our instrument contract manufacturing partner ITL.
With our groundbreaking technology, a top-tier team delivering on ambitious goals, solid preclinical data, a strengthened IP portfolio, and growing partner interest, we are now ready to optimize and finalize the development of the Psyros POC system ahead of the clinical performance study starting in 2025. Our goal is clear: we are creating value for our investors by providing healthcare with rapid, accurate, and point-of-care testing that enables faster diagnosis and appropriate treatment – ultimately saving lives.
Lund May 30, 2025
Ulf Bladin
VD Prolight Diagnostics (publ)
