During the second quarter, we continued to advance our unique digital POC platform, Psyros, towards market approval quickly and cost-effectively.

Our plan is to further develop and refine our plat- form into a commercial POC system, with readiness for a clinical performance study scheduled for 2025. Our POC system will focus on the rapid rule-in or rule-out of myocardial infarction by quantifying individual molecules of the protein troponin, down to single-digit nanograms per liter (ng/L).

In close collaboration with ITL (Integrated Tech- nologies Limited) and G&H Group, we have been working during the second quarter to produce the final components needed to begin the production of beta prototypes for the instrument. These prototypes are scheduled for testing, evaluation, and verification of regulatory compliance in the autumn. Additionally, in partnership with Flex Medical Solutions, our supplier for the disposable cartridge, we have finalized the design of the cartridge intended for commercial use. The design’s simplicity not only ensures a highly competitive cost but also facilitates the outsourcing of manufacturing.

The cartridge is composed of only a few components, optimized for large-scale manufacturing to achieve a competitively low production cost. A key competitive advantage is that it includes all necessary reagents for the test, eliminating the need for complex and expensive liquid reagents and blister packs. Additionally, the cartridge is ergonomically designed for ease of use and is compatible with venous and capillary blood as well as plasma samples. Another significant advantage is its multiplex capability, allowing for the measurement of multiple biomarkers on a single cartridge using just a drop of blood.

In collaboration with renowned institutions, including St. Thomas’ Hospital in London, we were awarded a prestigious SEK 17 million grant from the British i4i (Invention for Innovation) program during the quarter. This grant will enable us to initiate a study using whole blood samples from patients presenting at St. Thomas’ Hospital with chest pain and suspected heart attacks. Additionally, a substantial number of blood samples will be tested on our platform, utilizing a biobank of blood from patients with chest pain, confirmed myocardial infarctions, and healthy individuals, to validate the test and prototype performance of the Psyros system. Initial data from patient samples will be generated in the fall, with the first results expected in the fourth quarter of 2024. The insights gained from this study will be instrumental in the final optimization of both the test and the platform, ensuring high confidence beforethe clinical validation study. We expect that these results will further increase the interest of potential industrial partners.

Our latest whole blood troponin data confirm that we are ready to begin testing with patient samples. The data generated using the final commercial cartridge design meets the stringent requirements for single-point rule-out and the measurement of delta values for risk stratification in patients presenting with symptoms of myocardial infarction. With these promising results, we are now prepared to initiate the pre-validation study on both stored and fresh clinical samples, as we gear up for the clinical validation study. This study, to be conducted by the MDx CRO, is scheduled to begin as a multicenter trial in early 2025. The outcomes will provide the basis for a regulatory application, paving the way for our planned commercial launch in early 2026.

I would like to take this opportunity to thank both our long-standing and new shareholders for the trust they placed in us through the warrant program completed in May. The exercise of warrants from series TO6 has brought approximately SEK 9.8 million to the company before issuance costs.

Both the board and management exercised their options in full, and I am pleased to report that the total shareholding of the management and board also increased during the first half of 2024. Our achievements to date have demonstrated that our system has the potential to become the first digital, ultra-sensitive, portable platform for near-patient testing of high-sensitivity troponin. The system’s ease of use and low production costs align perfectly with market needs. This was validated at the recent international ADLM (American Association for Clinical Chemistry) congress in Chicago, which attracted over 20,000 participants from around the globe. Prolight showcased its latest instrument prototype and commercial disposable cartridge at our own stand. Images of these can be found in this report and on our website.

Additionally, our digital platform Psyros was prominently featured at the stands of our partners ITL/G&H-group and Flex Medical, resulting in significant exposure throughout the congress. The MicroFlex platform was also presented at TTP’s stand, where it generated considerable interest. The interest in Psyros at this year’s congress surpassed previous years due to the rapid and suc- cessful development of the system. As a result, we had significantly more individual meetings with leading global diagnostic companies than ever before. Our list of high-potential partners is now longer than it has been in the past, and we will be scheduling follow-up meetings with several of these prospects. A key aspect of these discussions will be the results of the pre-validation study, which we anticipate receiving by the end of this year. We expect that these results will further boost interest in our digital platform. I look forward to updating you on our progress.

Lund August 28th 2024
Ulf bladin

CEO Prolight Diagnostics (publ)