Financial overview

Third quarter, 1 July – 30 September, Q3 2023 Group
(figures in the brackets refer to the corresponding period in previous year)

• Net sales amounted to 0 (0).
• Other operating income amounted to kSEK 28 (2,100).
• The profit after tax amounted to kSEK -9,755 (-5,178).
• Earnings per share before and after dillution: SEK -0.03 (-0.02).
• Cash flow from current operations was kSEK -9,313 (-7,675).

Nine months period, 1 January – 30 September 2023 Group
(figures in the brackets refer to March-September as the Group was formed on 1 March) 

• Net sales amounted to 0 (0).
• Other operating income amounted to kSEK 168 (5,709).
• The profit after tax amounted to kSEK –25,368 (-15,909).
• Earnings per share before and after dillution: SEK -0.09 (-0.07).
• Cash flow from current operations was kSEK -23,286 (-14,626).

Significant events during the third quarter 

• Prolight participated in the international congress 2023 AACC* Annual Scientific Meeting + Clinical Lab Expo in California and showed a concept of the company’s POC platform Psyros™ for the first time. 

Significant events after the end of the quarter

• Prolight Diagnostics established a Clinical Advisory Board.
• The Board of Directors resolved on a rights issue of units of approximately MSEK 98.8 and proposed a directed share issue of a maximum of approximately MSEK 20.9, subject to approval by the Extraordinary General Meeting.
• Proof of performance in whole blood. The company has demonstrated that its single molecule detection system gives equivalent performance in whole blood compared to plasma, without having to separate the cells from the sample. This reduces complexity, paving the way for an extremely competitive price level.
• The subsidiary Psyros Diagnostics has gained accreditation to the industry standard
  ISO 13485 which shows that the company´s quality processes meet global quality
  requirements.
• The company held an Extraordinary General Meeting on Monday, 27 November 2023, which resolved on a rights issue and a directed share issue following the Board’s
  proposal.

CEO comment
We are now focused on quickly and cost-effectively implementing the development steps required to launch our digital platform PsyrosTM for near-patient analyses, also known as Point-of-Care (POC), on the international market. To secure the funds needed for the value-creating development that lies ahead, the Board decided after the end of the quarter to carry out a rights issue approved today by an Extraordinary General Meeting.

After receiving great interest in our innovative POC technology, PsyrosTM, at the 2023 AACC* Annual Scientific Meeting + Clinical Lab Expo in California in July, we were able to seriously begin the next phase of our business development and start
discussions with potential business partners. The system concept is based on the ongoing instrument development with our development partner ITL (Integrated Technologies Limited).

Our initial focus is on the technology’s groundbreaking ability to quantify individual molecules of the protein troponin for quick and early detection or exclusion of myocardial infarction, which can save lives, improve the quality of life for millions of patients, and create significant health economic benefits for the overburdened healthcare system. In the longer term, our platform may lead to a paradigm shift in point-of-care testing for many other major clinical areas.

After the end of the quarter, it was therefore very satisfying to be able to communicate that we had achieved proof of performance in whole blood for our innovative system. Without having to separate the cells from the sample the system may detect single molecules with equivalent performance in whole blood compared to plasma. We are not
aware of any other single molecule counting platform that can function with whole blood. The ability to measure in whole blood, without a cell-separation step, reduces complexity, paving the way for an extremely competitive price level for our POC platform Psyros™.

The extensive interest during the AACC-congress confirmed that our new digital technology for near-patient analyses is both innovative and unique. The ability to quantify individual molecules using a compact and portable instrument sparked great interest among visitors worldwide. The attention was very inspiring and made it clear that our digital technology offers significant benefits for both healthcare providers and patients.

Following the congress, we have initiated an intensified phase of business development for PsyrosTM, including meetings with representatives from leading global diagnostics companies with whom we are now exploring collaboration opportunities. These activities involve the commitment of many stakeholders in each company, making the process time-consuming, and all conversations are bound by mutual non-disclosure agreements (NDAs).

Our pioneering technology enables the quantification of individual molecules of, for example, the protein troponin, down to single-digit nanograms per litre (ng/L), opening up the possibility of quick and early detection or exclusion of myocardial
infarction. In addition, our innovative technology opens up the development of new point-of-care tests in various clinical areas currently only possible in specialised laboratories. With our unique technology, we are creating a platform for POC applications that can reduce healthcare costs and improve patients’ quality of life. The expansion beyond troponin to other cardiology biomarkers, such as BNP/Nt-pro-BNP and D-Dimer, is a natural progression.

We have also established a dedicated R&D manufacturing line to optimise the manufacturing processes that will be used for pilot production. Currently, we have many important activities in different workflows: firstly, the development of our Quality Management System (QMS). After the end of the quarter, we were able to announce that our solid work bore fruit by obtaining ISO 13485:2016 accreditation for our QMS. The accreditation shows that our quality processes meet global quality requirements which is a prerequisite for market approval in the US and Europe. Secondly, the optimisation of our antibody combinations continues. Thirdly, we will complete usability studies for cartridge design and system workflows in an emergency department. These studies will provide valuable insights to ensure that the product not only meets stringent regulatory requirements but also satisfies end-user needs in different clinical settings.

To swiftly and cost-effectively develop a commercial instrument ready for clinical validation by the end of next year, we are working with ITL on producing a number of alpha prototypes to fine-tune the design. After that, we will produce beta prototypes for regulatory compliance testing, evaluation and verification. Once these processes are complete, we will shift towards the pilot production line to produce the first commercial instruments ready for validation and clinical performance studies. We have strong in-house competence and experience in managing these steps, and I am confident that we will complete them successfully and efficiently together with ITL in 2024.

Furthermore, the pioneering technology behind our digital immunoassay enables multiplexing, i.e. multiple biomarker testing at the same time, from one drop of blood, with high sensitivity and precision on a single cartridge in our portable, ultra-sensitive instrument.

Soon after the end of the quarter, we announced the formation of a Clinical Advisory Board consisting of six prominent, internationally recognised experts in cardiology, emergency medicine and clinical pathology. We are delighted and honoured by this. Their interest in our proprietary, digital POC system is encouraging, and we hope to gain useful insights from them as we move towards clinical validation and commercialisation of the PsyrosTM system.

In summary, our activities during the period have confirmed that our platform can become the first digital, ultra-sensitive, portable platform for near-patient high-sensitivity troponin testing and, in the long term, for many other clinical tests in various significant areas. The system’s ease of use and low production costs also make it perfectly adapted to the market’s needs. We hope that as many shareholders as possible want to participate in the upcoming share issue, which will enable the continued development of this promising technology into a commercial product and thus create value for the healthcare, the patient and our shareholders.

Lund, 27 November 2023
Ulf Bladin
CEO, Prolight Diagnostics AB (publ)