Prolight Diagnostics

Financial overview

First quarter, January 1 – March 31, Q1 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 68 (39) thousand.
• The profit after tax amounted to SEK -8,929 (-7,580) thousand.
• Earnings per share before and after dilution: -0.02 (-0.03) SEK.
• Cash flow from current operations was SEK -8,800 (-5,402) thousand.

Significant events during the quarter

• In accordance with the underwriting agreements entered into in connection with the new issues, Prolight’s board of directors decided on a targeted issue of units.
• Prolight reported last day for trading in paid subscribed units (“BTU”) (January 12, 2024) which were replaced with shares and subscription options of series TO6 and TO7 (first day of trading, January 18, 2024).
• Prolight Diagnostics selects FlexMedical Solutions as CMO partner.

Significant events after the end of the period

• In April, Prolight Diagnostics AB (publ) agreed to write down capitalized development costs regarding troponin testing with the analog POC system MicroFlex with SEK 113 million. The commercialization agreement with TTP is not affected by this decision.
• Prolight announces positive accounting adjustments for the full year 2023. The revised estimate of Prolight’s claim is approximately SEK 5.6 million higher than previously reported.
• Prolight announced the finalization of the cartridge design to be used on the Psyros commercial platform.
• Prolight selects MDx CRO for the clinical performance studies for Psyros™ with hs Troponin I assay.
• The exercise price for the warrants of series TO6 in Prolight Diagnostics has been determined to SEK 0,10 per share.
• Prolight Diagnostics awarded SEK17M UK government grant in collaboration with leading UK hospital Trust.

CEO comment

During the first quarter of 2024, we continued our set path to quickly and cost-effectively carry out the development steps required to launch our proprietary digital POC platform Psyros™ on the international market.

Our plan is to develop and finalize our platform all the way to a commercial POC system that is ready for clinical validation by the end of 2024. In close collaboration with Integrated Technologies Limited (ITL), we fine-tuned the design of our alpha prototypes during the first quarter. The next step in product development with ITL is to produce beta prototypes, which are expected to undergo testing, evaluation, and compliance verification during the third quarter of 2024.

During the quarter, we appointed the Scottish contract manufacturer FlexMedical Solutions as our CMO for the manufacturing of our disposable cartridge. This collaboration is a significant step in expanding our capabilities, as FlexMedical is a specialized medical device manufacturer with existing, fully validated facilities and extensive IVD experience.

Our usability studies have provided valuable insights into cartridge design and system workflows, not only to ensure that the product meets stringent regulatory requirements but also to satisfy the endusers’ needs in various clinical environments. The simplicity of the design of our cartridge allows for a highly competitive cost and the outsourcing of our manufacturing.

After the end of the quarter, we were pleased to announce the finalization of the cartridge design to be used on the commercial platform. The cartridge has a number of important competitive features with its simple design containing few parts, designed for large-scale manufacturing to ensure a competitively low production cost. Another key competitive advantage is that it contains all the necessary reagents required to complete the test without the need for complex and costly liquid reagents and blister packs. Additionally, it is ergonomically designed for ease of use and compatible with both venous and capillary blood as well as plasma samples. One more competitive advantage is multiplexing, meaning it can measure multiple analytes on a single cartridge.

After the end of the quarter, we also appointed MDx CRO to conduct the clinical validation studies for hs TnI assays concerning the clinical performance of the commercial POC system required for regulatory approval. MDx CRO will be responsible for the preparation and execution of the upcoming clinical multicenter study, which is scheduled to start in early 2025. The clinical evaluation will form the basis for a regulatory application ahead of the planned commercial launch in early 2026.

Our POC system will focus on the rapid and early rule-in or rule-out of heart attack through quantification of individual molecules of the protein troponin, down to single-digit nanograms per liter (ng/L). Our achievements so far have confirmed that our system could become the first digital, ultra-sensitive, portable platform for high-sensitivity troponin POC testing. The system’s ease of use and low production costs makes it ideally suited for the stringent requirement set by the market.

During the quarter, the analysis firm Emergers and the investment bank Mangold began covering Prolight, and I recommend that anyone interested in us to read their analyses, which not only provide reviews of Prolight but also give a good overview of the market.

Today we were able to announce that our wholly owned subsidiary, Psyros Diagnostics, in collaboration with King’s College London, Guy’s and St. Thomas’ NHS Trust and market access consultancy Lightning Health, has been awarded a prestigious grant of 17 million SEK from the UK’s National Institute of Health and Care Research (NIHR). The grant is an Invention for Innovation (i4i) Product Development Award (PDA) which will be invested, among other things, in the final steps of the development of the Psyros platform, including pilot manufacturing of the instruments, furthering our understanding of needs of patients and performing initial clinical studies. The i4i PDA grant is extremely competitive; it is a strong positive external validation of our proprietary Psyros digital point of care system.

From Monday, May 20, 2024, through Friday, May 31, 2024, there will be the opportunity to exercise warrants for series TO6, which grants the right to subscribe for one new share at a price of 0,10 SEK. The maximum capital that can be raised through TO6 is 21,8 MSEK before issue costs. Obviously, we hope that as many holders of the TO6 warrants as possible will participate so that we can accelerate our efforts.

We look forward to continuing to finalize the development of our innovative digital technology into a commercial POC product to create value for healthcare providers, patients, and our shareholders. I look forward to updating you again soon.

Lund May 17th 2024

Ulf bladin
CEO Prolight Diagnostics (publ)