INTERIM REPORT 1 JANUARY – 30 JUNE 2019
INTERIM REPORT 1 JANUARY – 30 JUNE 2019
Launch preparations continue
in the second quarter of 2019
after the end of the period
Intensified partner discussions
The second quarter of 2019 was characterised by feedback from potential customers following our participation in various conferences, preparations for regulatory studies and, last but not least, intensified discussions with several possible partners for the upcoming launch of ASTar.
The European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) is the most important annual conference for Q-linea. This year it was held in Amsterdam on 13–16 April. I am proud of the fantastic feedback we received at ECCMID on ASTar. The same can be said for our participation in the American Society for Microbiology (ASM) Microbe in San Francisco on 20–24 June.
We have received overwhelmingly positive feedback on our broad antibiotics panel, ASTar’s flexible but simple workflow and how easy it is to start using. Potential customers in Europe and the US are equally positive, but in the US we are encountering a somewhat different customer group. Customers in the US have more automated operations and more 24-hour labs. They are especially appreciative of the simplicity and the fully automated workflow, and it is particularly gratifying to be receiving positive feedback on our development process from future customers. Since customers are already starting to plan their budgets in order to purchase the system next year, it has been important for us to be able to present the final design of our ASTar system.
When it comes to our regulatory studies, we achieved an important milestone in June when we submitted a pre-submission supplement to the US Food and Drug Administration (FDA), as planned. The supplement contained a detailed description of how we plan to design the US study and the specifics of the trial protocol and the ASTar system. We will have a meeting with the FDA in September to hear their views on the design of the study and we will thereafter adapt the study to meet their requirements. If everything goes according to plan, we should be able to start the study at the beginning of next year. Our goal is to obtain FDA approval to market and sell the system next year.
I am happy to be leading the company and following its progress. We are methodically working through our goals and the impressive work that has been carried out throughout the company is now being reflected in our discussions with potential sales partners. These discussions intensified during the quarter and are now being conducted with some of the most attractive companies in the market. I look forward to our future partnership agreements with a sense of anticipation and optimism.
To sum up, the feedback we are receiving both from potential customers and in discussions with possible partners is incredibly motivating in our continued work to prepare ASTar for approval and market launch next year. I hope and believe that Q-linea’s shareholders share our enthusiasm.
Jonas Jarvius, President
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.
This interim report has not been reviewed by the company’s auditor.
Q-linea invites investors, analysts and the media to an audiocast and teleconference (in English) today, 18 July, at 1:00 to 2:00 p.m. (CET). President Jonas Jarvius and CFO Anders Lundin will present Q-linea, com-ment on the interim report for the January to June 2019 period and respond to questions.
Telephone number for the teleconference: SE: +46851999383 UK: +443333009262 US: +16467224956
Q-linea AB (publ)
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This information is information that Q-linea AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, on 18 July 2019 at 7:30 a.m. CET.
Q-linea is an innovative research, development and manufacturing company that primarily develops instruments and disposables for rapid and reliable infection diagnostics. Q-linea’s vision is to help save lives by ensuring antibiotics continue to be an effective treatment for future generations. Q-linea develops and delivers preferred solutions for healthcare providers, enabling them to accurately diagnose and treat infectious disease in the shortest possible time. The company’s lead product ASTar™ is a fully automated instrument for antibiotic susceptibility testing (AST), giving a susceptibility profile within six hours directly from a positive blood culture. For more information, please visit www.qlinea.com.