Financial overview
Third quarter, July 1 - September 30, 2025
(figures in parentheses refer to the corresponding period in the previous year)

• Net sales amounted to 0 (0).
• Other operating income amounted to 577 (3,730) TSEK.
• Operating profit (EBIT) amounted to -13,908 (-8,731) TSEK.
• Profit after tax amounted to -13,909 (-8,795) TSEK.
• Earnings per share before and after dilution: -0.01 (-0.01) SEK.
• Cash flow from operating activities was -12,558 (-12,611) TSEK.

Period, January 1 – September 30, 2025
(figures in parentheses refer to the corresponding period in the previous year)

• Net sales amounted to 0 (0).
• Other operating income amounted to 3,185 (3,816) TSEK.
• Operating profit (EBIT) amounted to -37,262 (-28,760) TSEK.
• Profit after tax amounted to -37,585 (-28,948) TSEK.
• Earnings per share before and after dilution: -0.03 (-0.03) SEK.
• Cash flow from operating activities was -26,342 (-21,499) TSEK.

Significant events during the quarter

Fully Subscribed Rights Issue
Prolight’s rights issue of SEK 100.3 million was fully subscribed. Approximately 70.2 percent was subscribed for with subscription rights and around 29.8 percent without subscription rights. The new shares have been registered with the Swedish Companies Registration Office (Bolagsverket) and delivered to the respective investors.

Patent Granted in Japan for Psyros Technology
The Japan Patent Office (JPO) has granted Prolight a patent covering the Psyros single-molecule counting technology. The patent is valid until 2040.

Psyros Showcased at ADLM 2025 in Chicago
Prolight showcased a fully functional commercial prototype of the Psyros system for the first time at the Association for Diagnostics & Laboratory Medicine (ADLM) international congress held in Chicago on 27–29 July 2025.

Positive European Patent Decision for Third Psyros Patent
The European Patent Office (EPO) has issued a Notice of Intention to Grant for Prolight’s third patent application related to the Psyros technology.

Significant events after the end of the period

Preparations for Clinical Performance Study
In the October and November investor letters, the company reported ongoing design and manufacturing improvements alongside preparations for pilot production and validation of manufacturing processes. Qualification activities for study sites in Europe have also commenced in preparation for the upcoming clinical performance study.

Extraordinary General Meeting 19 November 2025
The general meeting resolved, in accordance with the board’s proposal, to carry out a reverse share split (consolidation of shares) and to implement an incentive program for the employees of the UK subsidiary.

CEO statement

Prolight is taking clear steps toward the commercialization of the Psyros platform

The third quarter was characterized by strategic progress, deepened discussions with potential partners, growing interest in Psyros™ – our groundbreaking point-of-care (POC) platform – and a fully subscribed rights issue with strong participation from the Board, management team, and our instrument manufacturing partner, Integrated Technologies Ltd (ITL).

Following the successful completion of the rights issue, our focus has been on optimizing and finalizing the development of Psyros ahead of the upcoming, pivotal clinical performance study. After the on-schedule delivery of commercial prototypes and the positive results from preclinical validation studies earlier in 2025, we are now completing a series of design and manufacturing improvements aimed at optimizing assembly processes and ensuring reproducibility.

The positive preclinical results were achieved using only a small subset of biobank and whole-blood samples from St Thomas’ Hospital. This efficient use of materials allows us to conserve significant resources, as the remaining samples can now be used for the final verification and validation phases. The final system verification is being conducted to confirm the platform’s robustness, user-friendliness, and reproducibility ahead of the clinical performance study.

Cartridge production continues to ramp up with our partner FlexMedical Solutions. Our goal is to reach assay design freeze during the current quarter, locking the design of the high-sensitivity assay. This milestone will enable the start of pilot instrument production at ITL, laying the foundation for the clinical performance study and, ultimately, for the regulatory processes leading to market launch.

To ensure that the upcoming clinical performance study can be carried out as smoothly and according to plan as possible, we have chosen to devote extra time to thorough preparatory work. Despite our efforts to follow the indicative timeline presented in June 2025, these necessary preparations mean that the initiation of the study is now planned for 2026 instead of the end of 2025. As a result, regulatory approval (IVDR) and commercialization are expected to take place in 2027. We are convinced that this strategic prioritization will reduce the risks in the study and create the best possible conditions for a successful launch.

The positive response we received from potential commercial partners and end users during the international ADLM Congress in the United States in July reaffirmed the unique value of the Psyros system – combining ultra-sensitive detection with a compact design and cost-efficient consumables. These strengths position Prolight to meet substantial demand in the global market for POC cardiac diagnostics, as well as in many other clinical areas.

Our recently granted patents in Europe and Japan further strengthen our intellectual property portfolio and underscore the inventive step of our singlemolecule counting technology. These milestones not only protect our core technology but also enhance our attractiveness in ongoing discussions with potential industrial partners.

The point-of-care diagnostics industry is evolving rapidly. Demand for decentralized and rapid testing solutions continues to grow, particularly in emergency and primary care settings. Innovations in AI, real-time data, and home-based diagnostics are reshaping the landscape – and Prolight is well positioned to take a leading role in this transformation. High-sensitivity troponin is the first assay we are developing – but it is only the beginning.

The platform’s unique, IP-protected technology enables fast and robust analysis of multiple biomarkers across various therapeutic areas – from cardiovascular disease to infections, sepsis, sexually transmitted infection, inflammation, traumatic brain injury, stroke, dementia, and other clinical conditions. Its high sensitivity and rapid turnaround time make Psyros particularly well suited for acute care situations where every minute counts, as well as for use in primary care and future home-testing solutions. Our vision is to create a platform capable of addressing a wide range of clinical needs – all within one system.

As part of our preparations for the clinical performance study, we have demonstrated that the biomarkers TSH (Thyroid Stimulating Hormone) and cMyC (Cardiac Myosin-binding Protein C) can be rapidly implemented on the Psyros platform. This highlights the system’s flexibility and its potential to expand beyond analysis of high-sensitivity troponin. It is an important indication of the platform’s commercial strength – the more biomarkers we can offer, the greater the market opportunity.

We look forward to continuing our journey toward providing healthcare professionals with the most advanced tools for rapid and accurate diagnostics at the patient’s side. With robust technology and a clear path to commercialization, we believe that the Psyros system has the potential to create significant shareholder value in the fast-growing global pointof- care diagnostics market.

I would like to extend my sincere gratitude to our shareholders, partners, and employees for your continued trust and support.

Lund November 27 2025

Ulf Bladin
CEO Prolight Diagnostics (publ)