Fourth quarter: 1 October – 31 December 2020

• Net sales amounted to SEK 0.0 million (0.0).
• The operating result totalled SEK -57.1 million (-62.1).
• The result for the period amounted to SEK -56.6 million (-62.0).
• Earnings per share before and after dilution amounted to SEK -2.10 (-2.71).
• Cash flow from operating activities totalled SEK -76.7 million (-52.1).

Period: 1 January – 31 December 2020

• Net sales amounted to SEK 0.2 million (1.0).
• The operating result totalled SEK -221.5 million (-179.1).
• The result for the year amounted to SEK -218.7 million (-177.4).
• Earnings per share before and after dilution amounted to SEK -8.64 (-7.74).
• Cash flow from operating activities totalled SEK -237.3 million (-169.8).
• At 31 December 2020, cash and cash equivalents totalled SEK 10.1 million (26.0). Short-term investments in fixed-income funds amounted to SEK 165.7 million (150.4), short-term components of listed corporate bonds to SEK 131.0 million (30.1) and long-term investments in listed corporate bonds to SEK 24.4 million (121.0).

Significant events
in the fourth quarter of 2020

• Q-linea initiated a pivotal clinical study for ASTar
• The Company started the development of a portable blood culture technology with the goal of shortening the time from sampling to correct antibiotic response.
• The company has built up inventories of ASTar instruments for the upcoming launch.

after the end of the period

• No significant events took place after the end of the period.

Comments by the CEO

Well prepared ahead of commercialisation
The fourth quarter of 2020 marked a key milestone for Q-linea: the start of our European pivotal clinical study for our key product, ASTar®. The quarter was also characterised by preparations ahead of the forthcoming launch of ASTar in cooperation with our partner, Thermo Fisher Scientific.

Our cooperation with the participating hospitals in our pivotal study for Europe progressed well during the quarter, and we were very pleased to be able to initiate the study in December.

The results of the study will be an important part of the documentation in the ongoing process for CE-IVD approval prior to the market launch of ASTar in Europe. During the second quarter, Uppsala University Hospital, in collaboration with Q-linea, conducted a highly successful prospective patient study comprising samples from 17 patients and an antibiotic panel consisting of 29 antibiotic preparations. In this small study, the ASTar system displayed very strong results that exceeded the regulatory requirements for the EU and the US. This bodes very well for the results of the pivotal study to be presented during the spring.

Preparations for the US study have gone well, despite a difficult situation in the wake of the COVID-19 pandemic in the US. As in Europe, several hospitals have shown considerable interest in testing ASTar, and we will choose at least two US hospitals to partner with. In addition, discussions have been held regarding the choice of reference laboratory for the study. These discussions yielded positive results, and we plan to begin this work during the first quarter of 2021.

During the quarter, we also spent a great deal of time preparing for the launch of ASTar together with Thermo Fisher Scientific. This collaboration is working very well, and we feel ready for commercialisation as soon as the study is completed and ASTar receives CE marking, which is self-certified. We have established a good routine for our shared processes, and the collaboration is moving forward in all areas, from webinars and marketing materi-al to supply chain issues. Together, we have visited potential future customers and we are happy to say that there is considerable interest in ASTar. The ASTar instrument assessed at Uppsala University Hospital for beta testing and evaluation ahead of the study provided us with a great deal of important feedback prior to the forthcoming commercialisation. The system is considered to be easy to use, provided much faster responses and was able to analyse more antibiotics than during routine testing, which is the best feedback we could receive.

As soon as ASTar receives its CE label, we will be ready to start detailed planning for our first health economics study, which we plan to conduct in Italy starting in 2021. Favourable results in health economics studies are key to the process of convincing healthcare payers of the benefits of ASTar. In the coming years, we will conduct several health economics studies in various parts of the world, and the Italian study will be of great use when dealing with healthcare payers across the world as well as giving us useful experience for the planning of future health economics studies.

During the quarter, we took the first step in the development of portable blood culture technology, with the goal of shortening the time from sampling to correct antibiotic response. In many cases today, it can take more than ten hours for a sample to get to the laboratory, depending on when and where the sample is taken, and it is only once the sample has arrived that diagnostics can begin. It would be incredibly valuable to begin diagnostics immediately after the sample is taken and to use the transport time for analysis instead of wasting it. This technology will mean hours saved in the workflow and enable improved and equivalent care regardless of when and where a sample is taken. Together, ASTar and the portable blood culture technology could enable a major improvement in diagnostics.

In summary, I am proud of what we achieved during the quarter and the commitment and positive attitude demonstrated by the entire team, despite a very difficult time in the face of COVID-19 and changed working conditions. Naturally, the ongoing pandemic has increased the risk of delays in our clinical studies, but our current assessment is that it will be possible to conduct these studies in accordance with the previously announced timelines. We have a period of intensive work ahead of us that will involve continued regulatory studies as well as the commercialisation of ASTar and health economics studies. I look forward to continuing this journey with all of you.

Jonas Jarvius, President, February 2020

This report has not been reviewed by the Company’s auditors. The report has been prepared in a Swedish original and an English translation. In the event of any discrepancies between the two, the Swedish version is to apply.

Presentation
Q-linea invites investors, analysts and the media to an audiocast and teleconference (in English) today, 18 February at 1:30 to 2:30 p.m. (CET). President Jonas Jarvius and CFO Anders Lundin will present Q-linea, comment on the Year-end report for the January to December 2020 period and respond to questions.

Webcast: https://tv.streamfabriken.com/q-linea-q4-2020

Telephone numbers for the teleconference:
SE: +46 856 642 692
UK: +44 3333 009 265
US: +1 833 526 8384