Gradientech: Interim report 1 January–30 September 2023

Gradientech AB (publ) interim report for Q3 2023 is now available on the company's website www.gradientech.se.

Third quarter 2023

• Net sales amounted to SEK 53 thousand (153).
• Net profit/loss amounted to SEK -10,968 thousand (-11,640).
• Earnings per share before and after dilution were SEK -0.62 (-0.73).
• Cash flow from operating activities amounted to SEK -13,435 thousand (-10,706).
• Cash and cash equivalents amounted to SEK 25,873 thousand (41,012) as of September 30, 2023.
• Equity amounted to SEK 40,894 thousand (49,216) as of September 30, 2023.

January–September 2023 period

• Net sales amounted to SEK 1,574 thousand (157) KSEK.
• Net profit/loss amounted to SEK -45,868 thousand (-44,553).
• Earnings per share before and after dilution were SEK -2.63 (-2.87).
• Cash flow from operating activities amounted to SEK -45,901 thousand (-47,594).

Significant events during the third quarter 2023

• In July, the QuickMIC® system received Breakthrough device designation from the US Food and Drug Administration, FDA.
• In July an issue of convertible instruments, with deviation from the pre-emption rights for existing shareholder, was completed. A total of 815,823 convertible instruments were subscribed for and through the issue the company received approximately SEK 16.7 million before deduction for transaction costs.
• Gradientech announces that it has started pre-clinical studies at two sites in the US.
• In July, Gradientech exhibited at the FEMS Congress of European Microbiologists in Hamburg, Germany.
• In August, a patent application was submitted regarding early prediction of resistance mechanism using machine learning.
• In September, Gradientech together with the Swedish distributor Triolab exhibited at the NSCMID congress arranged by the Nordic Society of Clinical Microbiology and Infectious Diseases. Presented data from a study at a European university hospital confirming the promised performance of the QuickMIC system.

Significant events after the end of the period

• QuickMIC® was in October named as one of four finalists for the "Applied Microbiology International Product of the Year" award.
• In October, Gradientech signed two new exclusive distributors for the commercialisation of the QuickMIC system: AB Scientific in Great Britain and Ireland and Iberlab in Portugal.

 
CEO statement

We are preparing for the US market in several ways at Gradientech. With the Breakthrough Device classification of the QuickMIC® system, we are now having meetings with the US Food and Drug Administration, FDA, to clear out remaining questions before the start of our regulatory clinical studies in the US in 2024. In parallel, we are completing pre-clinical studies in the US involving around a hundred patient samples.

At home, development is proceeding with a focus on software, to design freeze and release the system version that will go into the FDA studies. Also, on November 28, Gradientech is organizing an on-line webinar with a focus on the USA: "Pioneering Precision Diagnostics for Antibiotic Treatment and Sepsis Care – The Role of Rapid AST". Dr. Kevin Alby from the University of North Carolina at Chapel Hill and Dr. Matthew Faron from the Medical College of Wisconsin presents their view on how innovative antibiotic susceptibility testing will change the treatment of sepsis patients and save a significant number of lives. The webinar also presents data from the US pre-clinical studies with the QuickMIC system. If you as a shareholder would like to listen in to the webinar, please register with Select Science who is arranging the webinar. A press release with more information will be distributed within short. For some time now, we have also been working together with Stefan Willemsen as strategic advisor in the USA. Through his leading positions in the clinical diagnostics industry, previously for example as CEO of bioMérieux US, Stefan has an extraordinary network of contacts among industrial actors as well as among potential US investors.

In the European market, the QuickMIC system is being evaluated at several university hospitals in our distributors Biomedica's and ADA's markets. Both distributors are now also preparing tenders where constellations of hospitals will choose rapid AST systems for their sepsis routine diagnostics. Tenders take time and Gradientech and our distributors also work in parallel with driving direct sales towards the hospitals. The fact that tenders are now being made shows that rapid AST is starting to gain a place in the market - even if we are only at the beginning of implementation. In October, we contracted two new distributors, AB Scientific for Great Britain and Ireland, and Iberlab for Portugal. AB Scientific knows rapid-AST inside and out, having introduced and distributed Accelerate Diagnostics in the UK before Becton Dickinson took over as global distributor. That AB Scientific now chooses to invest in Gradientech and our system for the British market, which is one of the largest in Europe, is confidence inspiring.

We have been working together with a British financial advisor since last summer for a long-term financing round that is planned to take Gradientech through the FDA studies in the USA. Our aim is to successfully close this financing round latest before summer 2024. To get there, we need to strengthen our cash balance and are therefore inviting to a smaller rights issue with subscription period 22 Nov - 6 Dec. Information will be distributed both via email and via postal mail to all shareholders. We also welcome you to the investor meeting on Monday 27 November, at 5-6 pm in Stockholm (Mäster Samuelsgatan 42, Redeye's premises), which you can attend either physically or digitally. In addition to informing about our achievements in 2023 and our plans for 2024, our distributor ADA is participating and informing about their plans for the promising Italian market. In addition, Stefan Willemsen gives his view on QuickMIC® and the US market. You are warmly welcome to participate, both on 27 Nov and in the rights issue!

Uppsala, November 16, 2023, Sara Thorslund, CEO Gradientech

For further information, please contact:
Sara Thorslund, CEO
Tel: + 46 763 29 35 80
sara.thorslund@gradientech.se

Urban Adolfsson, CFO
Tel: + 46 708 20 72 09
urban.adolfsson@gradientech.se

Ann Charlotte Svensson, IR
ir@gradientech.se

About Gradientech
Gradientech is leading the field of ultra-rapid antibiotic susceptibility testing. We develop next-generation diagnostics in infectious disease medicine. Our product QuickMIC®, classified as a breakthrough device by the U.S. Food and Drug Administration, allows patients with sepsis to quickly receive specific guidance on the right antibiotic in the right dose. It saves lives, reduces healthcare costs and limits the spread of antibiotic resistance – one of the greatest global health threats of our time. Gradientech is headquartered in Uppsala, Sweden. Visit www.gradientech.se for more information.