Prolight Diagnostics publishes quarterly report Q3, 2024

Financial overview
Third quarter, 1 July - 30 September, Q3 2024 Group
(figures in parentheses refer to the corresponding period in the previous year)

• Net sales amounted to 0 (0).

• Other operating income amounted to SEK 3,730 (28) thousand.

• The profit after tax amounted to SEK -8,795 (-9,755) thousand.

• Earnings per share before and after dilution: -0.01 (-0.03) SEK.

• Cash flow from current operations was SEK -12,611 (-9,313) thousand.

Nine months, 1 January - 30 September, Q3 2024 Group
(figures in parentheses refer to the corresponding period in the previous year)

• Net sales amounted to 0 (0).

• Other operating income amounted to SEK 3,816 thousand (168).

• The profit after tax amounted to SEK -28,948 (-25,368) thousand.

• Earnings per share: -0.05 (-0.09) SEK.

• Cash flow from current operations was SEK -21,499 (-23,286) thousand.

Significant events during the quarter

• The Psyros system was showcased at DxPx¹ during the major international congress ADLM² in Chicago from July 28 to August 1, 2024.

• In September, Prolight conducted a business review with its contract manufacturer for cartridges, FlexMedical Solutions (FMS). The review included an inspection of the pilot line for cardridge manufacturing and associated support facilities.

• The Psyros system was presented at the 2024 Cardiac Markers Dialogue Meeting, September 26–27 in Glasgow, UK.

Significant events after the end of the period

• In October, warrants of series TO7 were exercised for new shares in Prolight. The exercise period ran from October 7 to October 18 and were exercised to approximately 96.4 percent. Prolight raised approximately SEK 12.6 million before issue costs.

• Prolight was granted a European patent for the separation of plasma from whole blood within a fluidic consumable. The patent opens new potential business opportunities by incorporating the technology into other disposable fluidic systems.

CEO statement
The list of potential partners is long, and they, like us, are eagerly awaiting the results of the pre-validation study.

During the past quarter, we have continued to make significant progress with our point of care system, Psyros™. With the support of the prestigious UK i4i grant of 17 million SEK, we are now preparing for a comprehensive pre-validation study in collaboration with St. Thomas’ Hospital in London. This study will help with the fine-tuning of our test and platform in preparation for the clinical performance study in 2025. Our ongoing focus is on ensuring a smooth transition to commercial production through partnerships.

The pre-validation study will be conducted with fresh whole blood from approximately 120 cardiac patients at St. Thomas’ Hospital in London, UK. Additionally, around 800 frozen plasma samples will be tested and analyzed from a biobank of healthy patients, as well as approximately 400 frozen plasma samples from patients with chest pain, of which approximately 200 have had a confirmed heart attack. The data generated from these studies will be used for the final fine-tuning of the high-sensitivity troponin test and platform. The results will minimize risks and help ensure an optimal outcome for the clinical performance study in 2025, which is expected to increase the already high interest from potential partners in the Psyros POC system.

In September, we conducted a business review with our partner for the disposable cartridge FlexMedical Solutions (FMS), which included an inspection of the pilot line for manufacturing. This line is being brought online to support regulatory approvals, including the clinical performance study as well as commercial volumes. We are very pleased that the technologies and processes developed by FMS have the capacity to produce hundreds of thousands of cartridges at a low, competitive cost and are designed to be scalable with a future high level of automation, enabling a swift transition to large-scale commercial production.

The prestigious meeting, the Cardiac Markers Dialogue Meeting, held on September 26–27, 2024, in Glasgow, brought together global experts in cardiology to discuss advancements in cardiac marker diagnostics and their impact on patient care. For Prolight, this was an important forum to showcase Psyros while gaining valuable insights into the progress of biomarker research and its application in the early detection of cardiac events, as well as how new technologies can be integrated into clinical practice. Participation as one of the sponsors raised awareness amongst KOLs and the cardiovascular biomarker community. The Psyros POC system was well received and recognized as fulfilling a significant need in today’s healthcare.

Shortly after the end of the quarter, we took an important step forward with the granting of a European patent for our innovative solution to separate plasma from whole blood within a fluidic consumable. This method provides high-quality plasma quickly, without requiring much space, which is crucial when designing a point of care system. The separation method, developed in conjunction with the MicroFlex system, could also be utilized in other disposable fluidic systems, meaning the patent opens new business opportunities for our partner TTP (The Technology Partnership). The patent strengthens the market position of MicroFlex and enhances its value in the commercial discussions TTP has with potential partners.

I would like to take this opportunity to thank both our existing and new shareholders for the trust placed in us during the exercise of the warrant program carried out in October. Warrants of series TO7 were exercised to approximately 96.4 percent and the company receives approximately SEK 12.6 million before issue costs. Both the board and management fully exercised their options, and I can also confirm that management and the board have increased their total shareholding over the year. The total ownership among the board, management and employees after subscription of the warrants of series TO7 amounted to approximately 22,8 percent of the outstanding shares.

Overall, we are following our plan to develop the Psyros platform all the way to a commercial POC system. The interest we are encountering for Psyros is very flattering. We frequently hear that the system has developed rapidly and successfully, while the needs are substantial. Our list of potential partners is therefore extensive, and they, like us, are eager to see the results of the pre-validation study. I look forward to keeping you updated as Prolight reaches its upcoming milestones.

Lund November 27th 2024

Ulf Bladin
CEO Prolight Diagnostics (publ)