Fourth quarter Q4 2022 Group
Formed March 1, 2022
- Other operating income amounted to kSEK 2,050.
- The profit after tax amounted to kSEK -2,809.
- Earnings per share before and after dilution: SEK -0.01.
- Cash flow from current operations was kSEK -5,436.
- Cash and cash equivalents amounted to kSEK 54,111 as of December 31, 2022.
Fourth quarter Q4 2022 Parent company
- Other operating income amounted to kSEK 3,429 (29).
- The profit after tax amounted to kSEK -21,242 (-1,315).
- Earnings per share before and after dilution: -0.09 (-0.01) SEK.
- Cash flow from current operations was kSEK -13,627 (-1,534).
- Cash and cash equivalents amounted to kSEK 45,551 (43,886) as of December 31, 2022.
- The Board proposes that no dividend will be paid for the financial year 2022.
Significant events during 2022
- Prolight signed an agreement to acquire the UK company Psyros Diagnostics Ltd at a value of MSEK 65 (about MGBP 5.25). Psyros has developed a POC technology for digital immunoassay, where individual molecules can be counted digitally from a drop of blood.
- Prolight decided on a rights issue of units for approximately MSEK 77, subject to approval by an Extraordinary General Meeting. The issue was secured up to approximately 80 percent by a guarantee consortium syndicated by G&W Fondkommission.
- Prolight acquired the shares of Psyros on 1 March 2022, through an issue in kind.
- Prolight carried out a rights issue that provided the Company with approximately MSEK 62 before issue costs.
- Prolight’s subsidiary, Psyros, filed a further patent application regarding the Company’s unique POC technology to digitally count individual molecules. The patent application involves a refined measurement of individual molecules and was filed with the Intellectual Property Office in the UK.
- Tobias Volker assumed the role of acting subsidiary manager at Psyros. Henrik Ljung became CFO of the Group. Both will be part of the management team and report to CEO Ulf Bladin.
- Prolight’s Annual General Meeting was held on 20 May 2022. Masoud Khayyami, Maria Holmlund, and Ulf Bladin were re-elected as board members. Steve Ross, Aileen McGettrick, and Tobias Volker were elected as new board members. Masoud Khayyami was elected as new Chairman of the Board.
- Prolight strengthened the organisation by making important new recruitments, partly for the development of the platform and partly by appointing a Head of QA/RA, Andrew Goodenough, who will lead the implementation of the safety and quality management system and the regulatory work. In addition, Karl Bullen was hired as Head of Manufacturing to ensure Psyros’ internal manufacturing competence. Karl Bullen took office on 31 October.
- An Extraordinary General Meeting for Prolight was held on 4 August 2022 and resolved to implement long-term incentive schemes for senior executives and board member Maria Holmlund.
- Prolight Diagnostics (Prolight) announced that Psyros Diagnostics’ (Psyros) highly sensitive digital immunoassay platform can detect extremely low levels of specific proteins. These reproducible proof-of-performance results with Thyroid Stimulating Hormone (TSH) are a crucial step towards developing a highly sensitive assay for the detection of the cardiospecific protein troponin to rule in or rule out myocardial infarction.
- Prolight signed a commercialisation agreement for the PLD MicroFlex POC platform with The Technology Partnership (TTP), in Cambridge, UK, to continue the development and pursue ongoing external initiatives and discussions. Under this agreement, remuneration to Prolight will be paid as future revenues are generated.
- Prolight issued new shares in a set-off issue to its UK partner, The Technology Partnership (TTP). The issue was made as payment for TTP’s claim on Prolight for the development project in distributed testing that was announced on 16 December 2021.
- Prolight hired Karl Bullen as Head of Manufacturing in the subsidiary Psyros to ensure its internal manufacturing competence.
Significant events after the end of the quarter
- Prolight’s subsidiary Psyros achieved all milestones for the second phase of the SBRI Healthcare grant, primarily by producing functional prototypes for the company’s unique digital immunoassay.
- Prolight’s subsidiary Psyros chose Integrated Technologies Limited (ITL) to design and develop the commercial instrument for the digital immunoassay, which will be based on the existing functional prototypes. This next step in product development is based on the prototypes internally developed at the subsidiary Psyros.
- Prolight announced that the development project in distributed testing reached a positive milestone with the transfer of two laboratory-based diagnostic tests to the platform. The test results from the project indicate that commercially available laboratory tests can be transferred to the PLD MicroFlex POC platform.
Our digital immunoassay POC system is currently being developed at a very fast pace in our UK subsidiary Psyros. The patent-pending digital immunoassay, where every molecule is counted, enables biomarkers to be detected at extremely low concentrations with high sensitivity and precision. We now have a highly motivated and competent team that has developed six functional instrument prototypes in a very short time. The team strongly believes that this new, ground-breaking POC platform will significantly benefit patients and the rapidly growing market for near-patient testing.
During the quarter, we received reproducible results from a proof-of-performance study confirming that our highly sensitive, digital immunoassay can detect exceedingly low levels of a specific protein, Thyroid Stimulating Hormone (TSH), in human plasma. These low measured concentration levels are, in turn, within the range required to detect and rule out a myocardial infarction with high-sensitivity troponin under current guidelines. These results are an important milestone and bode well for the further development of a high-sensitivity assay for digital detection of troponin, but also for the development of further clinical tests in other major indication areas. The next important milestone is proof-of-performance, specifically for troponin, which we are working intensively to demonstrate before summer 2023.
After the end of the quarter, we were pleased to announce that we had met or exceeded all milestones for the second phase of the SBRI Healthcare grant, primarily by producing functional prototypes of the instrument. Psyros received the grant of around £1 million last year, conditional on achieving certain milestones this year. The grant has accelerated the development of our unique digital immunoassay.
To further accelerate the development, we have signed an agreement with a subcontractor for the industrialisation of the device. In parallel, our ambition is to set up the first parts of a development production line for cartridge manufacturing on our own premises.
Development work is proceeding according to plan, and we focus on further developing the unique digital technology, including additional data generation and advancement of our prototype system for instruments and cartridge. To raise awareness of our digital immunoassay concept, we aim to showcase it in July 2023 at the American Association for Clinical Chemistry (AACC) international congress, which is considered one of the largest among industry experts.
After the end of the quarter, we were pleased to announce that our technology and development partner, The Technology Partnership (TTP), reached a positive milestone in the development project in distributed testing for the PLD MicroFlex POC platform, with the transfer of two laboratory-based diagnostic tests to the platform. The development project is the first step in demonstrating that the platform can be adapted for existing tests currently implemented in central laboratories without making significant chemical changes. TTP is now working on identifying a suitable commercial partner to take the technology to market. During the quarter, we signed a commercialisation agreement with TTP for the PLD MicroFlex POC platform to continue development and pursue ongoing external initiatives and discussions. Under this agreement, remuneration to Prolight will be paid as future revenues are generated. We still believe strongly in the MicroFlex technology but prioritise our resources on our unique product platform for digital immunoassay.
Overall, our ground-breaking product platform for digital immunoassay has enormous potential. The platform may become the first digital, ultra-sensitive, portable POC platform for testing high-sensitivity troponin and eventually for performing many other clinical tests in large indication areas. The system is also very easily operated and has low production costs making it incredibly cost-effective, just what the market demands. Our strong team is highly motivated to do its utmost to deliver the best POC systems to healthcare providers and patients in the rapidly growing point-of-care testing market.
Lund in February 2023
Ulf Bladin, CEO Prolight Diagnostics AB (publ)
 European Cardiology Society´s Guidelines on Fourth Universal Definition of Myocardial infarction.
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