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Building on a strong foundation of clinical impact and commercial traction

It is a great honour to be joining the Q-linea team at this key juncture for the Company. As incoming CEO as of 1 March 2024, I have had the opportunity to witness the fruits of
significant achievements made during 2023 on all fronts. Most notably, how the Company has laid the groundwork for the coming phase of commercialisation of our flagship ASTar rapid AST testing platform.

We are in a period of transition now, moving from a focus on the development and launch of a novel technology with great clinical promise to the methodical commercialisation of a solution for our laboratory and clinical users. Significant investments were made in 2023 which have opened key markets across Europe and created the basis for commercial activities in the US once we have secured FDA clearance. Offsetting this expansion of commercial capacity, the Company has implemented a cost-saving programme that recognises that the majority of its foundational R&D work has been completed. The programme is expected to reduce running costs by some SEK 4 million per month while simultaneously shifting resources closer to the market interface.

With more than a decade of development and clinical testing behind us, the ASTar platform is ready to lead the market in the next generation of antimicrobial susceptibility testing. We are proud to announce our commercial installation in Italy, at Tor Vergata Hospital. Feedback from that process, and others advanced in the commercial pipeline, has emphasised the superior engineering of ASTar, with its outstanding ease-of-use and workflow integration, breadth of menu and unparalleled fidelity of test results that enable a same-shift report to clinicians and consequent adjustment of therapy where needed.

Early indications of this impact are already being seen. I was inspired to hear the presentations from our clinical partners at the AMCLI conference in Rimini, where Dr Verroken and Dr Sanguinetti shared interim results from studies in Belgium and Italy respectively, indicating that up to 45 per cent of patients received appropriate therapeutic adjustment 20–34 hours faster than with the current standard of care, depending on the clinical workflow environment. We expect to see more evidence of this tremendous clinical impact as more results are published, with our clinical partners and other ongoing research in this emerging field. During 2024, we expect deeper findings related to the health economics to be ready, which will underscore the anticipated savings that accompany the faster treatment and discharge of sepsis patients.

In 2024, my focus will be on anchoring ASTar with our customers and accelerating our commercialisation. We are energised by the signals we are receiving from customers, including pre-market interactions with leading hospital and reference lab groups in the US who are eagerly awaiting our FDA clearance. We initiated two Early Access Programs in the US during 2023 and anticipate more placements through 2024. We also see a steady expansion in our pipeline across Europe, including a tender worth over EUR 2 million in Italy which has been submitted with results expected in the coming months. Our distribution partners in the UK, France, Benelux, and the Nordics are similarly seeing growing interest and anticipate orders for the ASTar platform through 2024.

In conclusion, I would like to extend my heartfelt gratitude to Jonas Jarvius, who has been supportive through the leadership transition and, more importantly, has imbued in Q-linea the technical vision, passion for patient impact, and creative problem-solving spirit that has built the Company to this point and established a legacy in the team I inherit now. I am excited to lead Q-linea during this next phase of our journey, and committed to delivering on our mission for patients, and thereby our value promise to customers, employees and shareholders

Uppsala, April 2024
Stuart Gander, President & CEO, Q-linea Group