ASTar has been tested at the Uppsala University Hospital before the start of studies

Third quarter, 1 July – 30 September 2020

• Net sales amounted to SEK 0.0 million (0.0).
• The operating result totalled SEK -50.0 million (-35.8).
• The result for the period amounted to SEK -48.7 million (-35.1).
• Earnings per share before and after dilution amounted to SEK -1.80 (-1.53).
• Cash flow from operating activities totalled SEK -46.7 million (-35.8).

Period: 1 January – 30 September 2020

• Net sales amounted to SEK 0.2 million (1.0).
• The operating result totalled SEK -164.5 million (-117.1).
• The result for the period amounted to SEK -162.1 million (-115.4).
• Earnings per share before and after dilution amounted to SEK -6.55 (-5.04).
• Cash flow from operating activities totalled SEK -160.6 million (-117.7).
• At 30 September 2020, cash and cash equivalents totalled SEK 17.8 million (26.0). Short-term investments in fixed-income funds amounted to SEK 205.5 million (150.4), short-term components of listed corporate bonds to SEK 151.4 million (30.1) and long-term investments in listed corporate bonds to SEK 34.5 million (121.0).

Significant events
in the third quarter of 2020

• The company signed an agreement with Hvidovre Hospital in Denmark as a participant in the
• clinical study and thus both Hvidovre and the Uppsala University Hospital will participate in the Company’s pivotal study in Europe
• Q-linea installed the first ASTar system for testing at Uppsala University Hospital before the start of the studies

after the end of the period

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

Comments by the CEO
Intense quarter lays the foundation for imminent clinical study

Q-linea’s third quarter has been full of intense preparations ahead of our European pivotal clinical study with our key product, ASTar®, which is scheduled to start in the fourth quarter. Most of the quarter’s activities have focused on the study and most of our preparations have now been finished. Our verification batches have been completed and have soon completed the analytical verification and are preparing the start of the clinical validation.

During the quarter we announced that the clinical microbiology laboratory at Uppsala University Hospital and Hvidovre Hospital in Denmark will participate in the study. Together with Q-linea, Uppsala University Hospital completed a prospective patient study that yielded excellent results, which met the regulatory limits for the EU and the US. The upcoming study is a prospective performance study with 80 to 100 patients. Its results will be an important part of the documentation in the ongoing process for CE-IVD approval prior of the market launch of ASTar in Europe. The study will also be conducted internally at Q-linea.

We installed an ASTar instrument at Uppsala University Hospital during the quarter for beta testing and evaluation, which was an important part of preparing for the study and launch. We have numerous ASTar units in operation at our laboratory but the feedback from external users could not be overestimated. Being evaluated in a real laboratory environment by a potential customer will provide us with valuable insights on ASTar. It is an important milestone that marks further progress on the road towards bringing ASTar on the market.

The feedback we have received so far is that the system is easy to use. Those who have tested the system at Uppsala University Hospital note that tests can be started easily and that anyone in the lab can use the system. This is the best feedback we could have received. User friendliness and time to result have been a central part of our development. To have it confirmed that the system functions works as well as expected is enormously satisfying and bodes well for the future. Additionally, Uppsala University Hospital is exactly the type of large hospital ASTar was designed for.

During the quarter we intensified discussions with Thermo Fisher Scientific ahead of the launch and we feel ready for commercialisation as soon as the study, which is self-certified, is complete. The partnership with Thermo Fisher Scientific is working very well and we are moving forward in everything from webinars to marketing material to supply chain issues, where we are now starting to establish procedures for the processes. We have also started visiting potential customers.

As soon as ASTar receives its CE label, we will also be ready to start detailed planning for our first health economics study, which we plan to start in 2021. We have plans to carry it out in Italy and we will be able to use it around the world. What we learn in the Italian study will be of great use when planning future health economics studies, which are all planned to support our sales process.

The ongoing pandemic has had an effect on the atmosphere and work on Q-linea as well, and the effects we have seen have been primarily based on more stringent internal and external guidelines. At present, with the large increases we see around us, there is of course an increased risk that the situation may affect the time frame for the emerging clinical studies. However, we continue to see that the clinical studies will begin in accordance with previous communication, which feels positive.

Preparations for the American study have gone well despite a difficult COVID situation in the US. As in Europe, several large hospitals have been interested in testing ASTar. We will choose at least two to partner with.

In summary, I am proud of what we achieved during the quarter. After the private placement in the second quarter, which raised SEK 270 million for the company before costs, we are well equipped for the forthcoming commercialisation of ASTar. I look forward towards the journey ahead with you all, and especially to 2021.

Uppsala, November 2020,
Jonas Jarvius, President

This report has been subject to auditors’ review. This 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, 5 November, 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 September 2020 period and respond to questions.

Webcast: https://tv.streamfabriken.com/q-linea-q3-2020

Telephone numbers for the teleconference:
SE: +46856642704
UK: +443333009268
US: +18332498403