A platform for growth

2024 was a significant year for Q-linea following a general theme of transition from a development-oriented company to one focused on commercialising our flagship ASTar® platform.
Opening the key US market
Our most important development during the year was the commercial launch in the US market which represents over 50% of the global opportunity by value. Following FDA clearance in April we rapidly engaged with the top 300 hospitals and labs in the country to introduce ASTar. This targeted approach has yielded a sizeable pipeline of interested customers with a calendar of planned evaluations through early 2025. Confirmation of NTAP funding (USD 97.50 per patient, available for Medicare patients in US hospitals) from the federal agency CMS, which is unique to ASTar, bolsters the economic proposition for ASTar which is already the leading technical solution for rapid antibiotic susceptibility test (AST) on the market. Early demand has been strong and Q-linea has steadily built up our commercial team in the US to meet the market. Contracting timelines can be unpredictable, but we welcomed our first US commercial sale in early January, just nine months after FDA clearance.
Supporting evidence of clinical benefits
In our field, clinical impact is the ultimate determinant of value, and we were pleased to see a steady cadence of clinical evidence emerging from our co-sponsored trials in Italy, Belgium and the US which all mutually reinforced the core insight that ASTar can reduce time-to-result by 30 hours or more. In particular, our investment in the four-site LIFETIMES health economics and outcomes research (HEOR) study is a pioneer in our field. We look forward to complementing the initial findings presented at AMCLI and ESCMID in 2024 with further insights on the economic benefits of ASTar emerging from the second phase in 2025. Q-linea has been an active thought leader in the rapid AST space with poster and podium presentations across the major global and regional conferences.
First clinical patients treated in Europe
The first commercial installation of ASTar was completed in Q1 2024 and has been generating clinical results for patients in Rome ever since. Two additional sites have since been added in Italy with more anticipated soon. Italy is the fastest-moving country in Europe owing to the high clinical burden of AMR and we anticipate other major European markets to follow as rapid AST demonstrates its clinical and economic impact.
Establishing the next avenues for growth
Our new agreements with partners in the Middle East and Eastern Europe have moved quickly and are already building up customer interest with expected results in 2025. We also streamlined our development pipeline, concentrating resources into several high-impact projects for delivery in 2024 and early 2025. Q-linea will continue to be at the forefront of innovation in AST with new drugs and sample types under development and are informing our priorities based on the surge of customer input received on the back of our in-market engagements. The field remains highly dynamic, and we are pleased to see the positive response from customers to our current platform and planned innovation funnel.
Strengthening the organisation
Following the theme of transition, we conducted a successful cost-cutting program during the first part of the year which reduced development and overhead costs. A portion of the savings were reinvested into commercial capacity for a net cost reduction of approx. 40 MSEK annually. Our leadership team has evolved considerably during the year, with Jonas Jarvius (CEO), Mats Gullberg (dep. CEO), Thomas Fritz (CCO), Tiziana di Martino (CMO) and Per Svahn (HR) leaving the executive group, Anders Ljunggren, Franco Pellegrini and Karl Sköld taking on expanded roles and myself joining the team.
Financing
We concluded the year with a well-subscribed rights issue which in combination with a directed issue raised approximately 216 MSEK in new equity before transaction costs. This provides us with resources needed to continue pressing our commercial advantage in the market. I would like to especially thank all the employees who left during 2024 who have made major contributions to Q-linea over the years. We have likewise welcomed new members of the team who join with fresh ideas and a shared yearning to bring ASTar to patients during 2025.
Uppsala, 27 February 2025
Stuart Gander, CEO