Prolight Diagnostics

Financial overview

Fourth quarter, 1 October – 31 December, Q4 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 5,941 (2,051).
• The profit after tax amounted to kSEK -2,382 (-2,809).
• Earnings per share before and after dillution: SEK -0.01 (-0.01).
• Cash flow from current operations was kSEK -1,954 (-5,436).

Full year, 1 January – 31 December 2023 Group
(figures in the brackets refer to March-September as the Group was formed 1 March
2022)

• Net sales amounted to 0 (0).
• Other operating income amounted to kSEK 6,109 (7,760).
• The profit after tax amounted to kSEK –27,750 (-10,230).
• Earnings per share before and after dillution: SEK -0.10 (-0.04).
• Cash flow from current operations was kSEK -25,239 (-7,664).

Significant events during the fourth quarter
• Prolight established a Clinical Advisory Board.

• The board decided on a preferential issue of units for approximately SEK 98.8 million
and proposed a directed new issue of shares for a maximum of approximately SEK
20.9 million subject to approval by the extraordinary general meeting.

• Prolight showed proof of performance in whole blood, meaning that the system for detecting
individual molecules gives equivalent performance in whole blood compared to
plasma, without having to separate the cells from the sample. This reduces complexity
and paves the way for an extremely competitive price level.

• The subsidiary Psyros Diagnostics’ quality management system received ISO
13485:2016 certification, which shows that the company’s quality processes meet the
global quality requirements.

• Prolight held an extraordinary general meeting on Monday 27 November 2023, which
decided in accordance with the board’s proposal for a rights issue and a directed new
issue, which in mid-December provided Prolight with approximately SEK 75.2 million
before issue costs, of which SEK 42.7 million in cash and SEK 32.5 million was part of
the acquisition of Psyros Diagnostics. Board and management subscribed shares for
SEK 12.9 million.

Significant events after the end of 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).

CEO statement
Prolight Diagnostics (“Prolight”) activities are carried out with a clear and steadfast focus - to quickly and cost-effectively implement the development steps required to launch our proprietary, digital, single molecule counting platform Psyros™, for Point-of-Care (POC) testing on the international market. We successfully met all our goals in 2023 and I am truly grateful for the support we received from both old and new shareholders in the rights issue that was completed just before Christmas.

2023 was indeed a successful year for Prolight. An early and crucial milestone was that we showed proof-of-performance for highly sensitive troponin by quantifying individual molecules of the protein troponin down to single-digit nanograms per litre (ng/L), paving the way for early detection or rule-out of myocardial infarction. This proved that our platform has the ability to 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, the platform may lead to a paradigm shift in point-of-care testing for many other major clinical areas.

Our results led to great interest in our innovative POC technology, Psyros™, at the 2023 AACC* Annual Scientific Meeting + Clinical Lab Expo in California in July. The ability to quantify individual molecules using a compact and portable POC instrument sparked great interest during the AACC-congress. The attention was very inspiring and proved that our digital technology offers significant benefits for both healthcare providers and patients.

Following the congress, we initiated an intensified phase of business development for Psyros™, 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, whereby all conversations are bound by mutual non-disclosure agreements (NDAs). The strong industrial interest in near-patient analyses, or Point-of-Care (POC), was further highlighted late in 2023 by Roche’s acquisition of LumiraDx’s point of care technology for 295 MUSD (plus an additional 55 MUSD to fund the development going forward).

Early fall, we achieved yet another important milestone, showing 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 POC 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™.

In 2023, we also initiated our Clinical Advisory Board consisting of six prominent, internationally recognised experts in cardiology, emergency medicine and clinical pathology. It has already provided valuable insights on the most effective pathway towards clinical validation and commercialization of the Psyros™ system.

Our plans for 2024 is to develop and fine-tune our platform all the way to a commercial POC-system that is ready for clinical validation. The system will focus on quick and early detection or exclusion of myocardial infarction through the quantification of individual molecules of the protein troponin, down to single-digit nanograms per litre (ng/L). 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. We are creating a platform for POC applications that can reduce healthcare costs and improve patients’ quality of life. An expansion beyond troponin to other cardiology biomarkers, such as BNP/Nt-pro-BNP and D-Dimer, is a natural first progression followed by many more clinical areas.

We have established a dedicated R&D manufacturing line to optimise the manufacturing processes that will be used for pilot production. Our solid work developing our Quality Management System (QMS) bore fruit as we obtained ISO 13485:2016 accreditation for our QMS in the past quarter, meaning that our quality processes meet global quality requirements which is a prerequisite for market approval in the US and Europe.

We intend to develop a commercial instrument ready for clinical validation by the end of 2024, and in close cooperation with ITL (Integrated Technologies Limited we are currently fine-tuning the design on our alpha prototypes. In the near term, we estimate we will in Q1 complete and freeze the cartridge design and appoint a Contract Manufacturing Organization (CMO) partner for cartridge manufacturing. We also expect the development of the optical module design to be finalized in the first or second quarter. Our usability studies have provided valuable insights for cartridge design and system workflows to ensure that the product not only meets stringent regulatory requirements but also satisfies end-user needs in different clinical settings. Next step in the product development with ITL is to produce beta prototypes which are estimated to undergo regulatory compliance testing, evaluation, and verification in the third quarter. 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.

In summary, our achievements this far have confirmed that our POC system 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 clinical areas. The system’s ease of use and low production costs also make it perfectly adapted to the market’s needs. Furthermore, the pioneering technology behind our digital immunoassay enables multiplexing, i.e. testing multiple biomarkers at the same time, from one drop of blood, with high sensitivity and precision on a single cartridge in our portable, ultra-sensitive instrument.

We are looking forward to continuing and finalize the development of our unique and groundbreaking technology into a commercial POC product and thus create value for the healthcare, the patient and for our shareholders.

Lund, February 21th 2024
Ulf Bladin
CEO Prolight Diagnostics AB (publ)