Fourth quarter: 1 October–31 December 2021

• Net sales amounted to SEK 3.9 million (0.0).
• The operating result totalled SEK -51.6 million (-57.1).
• The result for the period amounted to SEK -51.0 million (-56.6).
• Earnings per share before and after dilution amounted to SEK -1.75 (-2.10).
• Cash flow from operating activities totalled SEK -90.9 million (-76.7).

Period: 1 January–31 December 2021

• Net sales amounted to SEK 9.3 million (0.2).
• The operating result totalled SEK -233.6 million (-221.5).
• The result for the year amounted to SEK -231.2 million (-218.7).
• Earnings per share before and after dilution amounted to SEK -8.19 (-8.64).
• Cash flow from operating activities totalled SEK -255.0 million (-237.3).
• As of 31 December 2021, the Company had access to cash and cash equivalents of SEK 15.1 million (10.1), short-term investments including short-term components of other securities held as non-current assets of SEK 150.9 million (296.7) and long-term listed corporate bonds of SEK 181.8 million (24.4), totalling SEK 347.8 million (331.3) in available funds.

Significant events
In the fourth quarter of 2021

• The Company signed the first commercial evaluation contract for ASTar.
• The first patients were enrolled in the US clinical study for ASTar.
• Thermo Fisher Scientific, the Company’s global partner, has presented ASTar at two different industry fairs.

after the end of the period

• The antibiotic panel in ASTar was expanded to offer even broader results.
• The clinical study has progressed well and the Company has begun compiling a 510(k) application to the FDA for approval of ASTar for the US market.
• Q-linea announced that Thermo Fisher Scientific’s evaluation study of ASTar showed very strong results.

Comments by the CEO
The fourth quarter of 2021 caps off a year of successes for Q-linea. During the quarter, we achieved several important milestones: we signed the first commercial evaluation contract for ASTar, enabling us to demonstrate the patient benefit of rapid AST during the evaluation, and the first patient was enrolled in our pivotal US study. In addition, we made major progress with our portable blood culture technology, which has been trademarked under the trademark Podler©.

Thermo Fisher Scientific continued its launch of ASTar in Europe. Thermo Fisher Scientific has in-depth knowledge of our potential customers and can meet them at exactly the right level. After many years of hard work, it’s fantastic to finally see ASTar being launched and to receive such a positive response. Next comes a period of procurement administration before the Company’s sales and revenue increase. In recent years, there has been a global trend in the healthcare system towards stricter procurement rules, which has led to prolonged sales processes. This trend is essentially positive but has resulted in sales cycles that are longer than in the past.

In Sweden, we sell ASTar ourselves, and during the fourth quarter our first potential customer performed an evaluation with extremely good results. During the evaluation, we could clearly see that ASTar made a difference in healthcare so that patients received correct care faster, which is exactly what we want the system to accomplish. In addition, after the end of the quarter we announced that we have broadened the panel to further increase the benefit to patients and physicians.
In December, the pivotal clinical study for the US entered the final prospective stage when the first patient was enrolled. A total of approximately 450 patient samples will be analysed at three US hospitals where ASTar has been
installed. We expect to be able to conclude the study at the beginning of 2022, enabling us to prepare the submission of our marketing application to the US Food and Drug Administration (FDA).

During the first quarter of 2022, after the end of the reporting period, we hired our first employees in the US whose job duties will include supporting the clinical studies. These hires mark the beginning of a process of building a small team that will also support Thermo Fisher Scientific and potential customers as well as being responsible for various pre-market activities. It’s important for us to be able to hold training in the US time zone as we proceed towards US market approval.

We are working to be able to initiate patient studies with Podler in the US in late 2022. In parallel with the development of the technology, we had several extremely positive discussions with a number of major commercial firms that would be able to launch Podler successfully. Interest in the technology has proven to be strong since a diagnosis immediately after sampling would be incredibly valuable compared with today’s procedure where time is lost in transport. Our objective is to sign an agreement with one or more partners with the best prospects of commercialising our technology on favourable terms.

We are now closing the books on an eventful year and look forward with confidence to a continued busy and interesting 2022 where ASTar could contribute to improved patient outcomes for as many patients as possible around the world.

Uppsala, 16 February 2022, Jonas Jarvius, President

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, 17 February 2022 at 1:00 to 2:00 p.m. (CET). President Jonas Jarvius and CFO Anders Lundin will present Q-linea, comment on the interim report for the January to December 2021 period and respond to questions.

Webcast: https://tv.streamfabriken.com/q-linea-q4-2021

Telephone numbers for the teleconference:
SE: +46 850 558 357
UK: +44 333 300 9261
US: +1 646 722 4903