Prolight Diagnostics

Financial overview

Second quarter, 1 April – 30 June, Q2 2023 Group

• Net sales amounted to 0 (0).

• Other operating income amounted to kSEK 101 (2,311).

• The profit after tax amounted to kSEK -8,033 (-7,055).

• Earnings per share before and after dillution: SEK -0.03 (-0.03).

• Cash flow from current operations was kSEK -8,571 (-10,210).

First half-year, 1 January – 30 June 2023 Group
(figures in brackets refer to March–June 2022 as the Group was formed on 1 March 2022)

• Net sales amounted to 0 (0).

• Other operating income amounted to kSEK 140 (3,609).

• The profit after tax amounted to kSEK -15,613 (-10,730).

• Earnings per share before and after dillution: SEK -0.06 (-0.04).

• Cash flow from current operations was kSEK -13,972 (-6,951).

Significant events during the second quarter

• Prolight demonstrated 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.

• Prolight’s subsidiary Psyros filed two more priority patent applications with the Intellectual Property Office in the UK. One application covers different aspects of multiplexing, and the other uses a similar method to simultaneously allow the measurement of the same biomarker at both very low and very high concentrations.

• Prolight’s Annual General Meeting was held on 11 May 2023. Masoud Khayyami,
  Maria Holmlund, Ulf Bladin, Steve Ross, Aileen McGettrick, and Tobias Volker were re-elected as board members. Masoud Khayyami was elected as Chairman of the Board.

Significant events after the end of the quarter

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

 
*AACC has been renamed the Association for Diagnostic & Laboratory Medicine (ADLM).
 
CEO comment
During the quarter, we reached our most important milestone so far when we showed proof-of-performance for high-sensitive troponin. Quantifying individual molecules of the protein troponin down to single-digit nanograms per litre (ng/L) paves the way for early detection or rule-out of myocardial infarction.
 
Our new pioneering technology opens up the possibility of developing new tests for Point-of-Care (POC) testing in a wide range of clinical areas that were previously only possible to carry out in specialised laboratories. Based on our unique technology, we are developing a platform for point-of-care testing that can reduce healthcare costs and improve patients’ quality of life. After troponin, it would be natural to expand to other biomarkers, for example, in the cardiac field such as BNP/NT-pro-BNP and D-Dimer.
 
At the international congress 2023 AACC* Annual Scientific Meeting + Clinical Lab Expo in California in July, one of the most highly regarded IVD congresses in the world, we were able to show the concept of our digital POC platform for the first time. The system concept is based on the ongoing instrument development with our development partner ITL (Integrated Technologies Limited). The pioneering ability to count individual molecules on a small portable POC instrument attracted strong interest, and we welcomed around a hundred interested visitors from all over the world to our exhibition. It was most inspiring to repeatedly receive confirmation of how innovative and unique our new digital POC technology is and how it can be extremely beneficial to healthcare and patients. The high level of interest Prolight received during this congress has greatly encouraged us and confirms that the company is on the right track.

As a result of the congress, an intensification of our business development began with, among other things, individual meetings with representatives from major global diagnostics companies, which we will follow up on. In connection with the congress, we also developed a new graphic profile, logo, and a brand-new website, www.prolightdx.com. The company is still called Prolight and our digital POC system is called Psyros™, named after the company we acquired that originally developed the pioneering technology. 
 
At the international congress 2023 AACC* Annual Scientific Meeting + Clinical Lab Expo, TTP (The Technology Partnership) also showcased a model of the working prototype of our second POC system, MicroFlex, with the innovative cartridge, where the vacuum tube can be directly integrated and with the on-board centrifuge, which offers a fully automated POC platform for immunodiagnostics. In addition, the new sustainable cartridge, ecoflex, was showcased for the very first time together with a new, smaller MicroFlex instrument concept to perform ELISA assays, for example for distributed testing. According to TTP, MicroFlex generated significant interest during the congress, and they are now planning for various market activities and follow-up meetings under our existing commercialisation agreement.
 
The innovative technology behind Psyros™ digital immunoassays makes it possible to test completely different biomarkers with high sensitivity and accuracy on a single instrument. At the beginning of the quarter, we filed two priority patent applications with the Intellectual Property Office in the UK. They cover different aspects of multiplexing, i.e., the detection of several different biomarkers simultaneously on a single sample. By using Prolight’s unique technology for single molecule counting, a multiplex can be performed in just one drop of blood without having to divide the sample.
 
A potential application for multiplex is the development of panels that measure biomarkers corresponding to pathologies with similar symptoms. The technology may lead to a paradigm shift in point-of-care testing that can ultimately lead to major health economic benefits. Another application is the combined use of several biomarkers related to the same disease, but whereby the combination provides for better sensitivity and specificity, i.e. for better accuracy of the diagnosis.
 
Our platform could become the first digital, ultra-sensitive, portable POC platform for testing troponin with high-sensitivity and eventually for performing an array of other clinical tests for a wide range of indication. The system is also very simple to operate and has low production costs making it incredibly cost-effective, just what the market demands. I look forward to reporting back to you.
 
Lund in August 2023

Ulf Bladin
CEO, Prolight Diagnostics AB (publ)
 
*AACC har bytt namn till Association for Diagnostic & Laboratory Medicine (ADLM)