Gradientech: Interim report January–March 2024

Gradientech AB (publ) interim report for Q1 2024 is now available on the company's website www.gradientech.se.

First quarter 2024

• Net sales amounted to SEK 485 thousand (380).
• Net profit/loss amounted to SEK -15,648 thousand (-18,063).
• Earnings per share before and after dilution were SEK -0.68 (-1.08).
• Cash flow from operating activities amounted to SEK -14,813 thousand (-18,068).
• Cash and cash equivalents amounted to SEK 21,336 thousand (25,993) as of March 31, 2024.
• Equity amounted to SEK 32,800 thousand (40,731) as of March 31, 2024.
• In January 2024 Gradientech successfully completeed its pre-clinical testing of the QuickMIC® system in the US. The pre-clinical testing of the QuickMIC system has included about a hundred clinical patient samples and was performed at two reputable US clinical laboratories.
• The rights issue, whose subscription period ended on December 6, 2023, was registered together with the shares from the conversion of the convertible instruments issued in July 2023, with the Swedish Companies Registration Office on three occasions: 3 January 2024, 12 February 2024 and 15 February 2024. As a result of the two issues, the number of shares increased by 6,165,503 to a total of 23,960,753 shares and the share capital increased by SEK 616,550.30 to a total of SEK 2,396,075.30.
• Gradientech announced in the beginning of February that six QuickMIC® abstracts will be presented at the 34th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Barcelona, Spain 27-30 April 2024.
• In March 2024 Gradientech announced that its assigned distributor for Sweden, Triolab AB, will start its first commercial evaluation of the QuickMIC® system at the Kalmar County Hospital. Further, Gradientech has started a new prospective and observational QuickMIC® study that will investigate the clinical utility of a new rapid workflow for prediction of optimal antibiotic treatment for patients with urosepsis. The study is conducted in collaboration with Assoc. Prof. Martin Sundqvist at Örebro University Hospital.

Significant events after the end of the period

• In April 2024 Gradientech announced that AnnaLotta Schiller Vestergren has been appointed as the company’s Chief Commercial Officer and part of the management team. AnnaLotta has extensive experience with international commercial organisations, with nearly 30 years of leading positions in life science and diagnostics.
• In May Gradientech reports having received a Notification to Grant Patent Rights in China for its QuickMIC® cassette, the single-use test device in the QuickMIC® diagnostic system for ultra-rapid antibiotic susceptibility testing (AST).

CEO statement

The largest world congress in infectious medicine and clinical microbiology, this year with the new name ESCMID Global, has just finished in Barcelona. We and our strategic advisors from the USA were there when we exhibited in the well-attended industry exhibition. This year, more than 17,000 visitors active in clinic, research and industry gathered, and study results with the QuickMIC system were presented both by ourselves and by four additional European hospitals. We also took the opportunity to gather all Gradientech's distributors during the congress, where the distributors themselves talked about ongoing commercial evaluations in their respective markets while being able to share experiences with each other. This year's ESCMID Global Congress provided a record number of leads, productive meetings with our users, distributors, study partners in the USA, and contract manufacturers and, above all, valuable contacts with strategic partners. Now we are working focused on follow-up from everything created at this year's congress and are already looking forward to ESCMID Global 2025, then in Vienna.

Since the QuickMIC system was CE marked in mid-2022, the stated goal has been for the system to be included in routine diagnostics in Europe, where it is currently market approved. Decision-making processes are now underway at hospitals in Europe, where the system has been evaluated on site. We know that countries in southern Europe, such as Italy, are the markets that have shown perhaps the greatest market maturity to introduce rapid AST of sepsis samples. But it is interesting to note that we also see a lot of activity in Eastern Europe, where the time for individual hospitals to make decisions about routine implementation seems to be shorter. Many countries in Eastern Europe have major problems with antibiotic resistance and seem determined to be at the forefront of implementing (ultra)rapid AST in routine diagnostics. For each hospital that starts using QuickMIC in routine, the step for the next routine customer should be a little shorter. I look forward with confidence to future announcements from hospitals in Europe soon.

The new system release that is released in June is the one with the greatest functional growth since CE marking of QuickMIC. Primarily it applies to software and also includes the American version that will be used in the FDA study starting this summer. In recent months, we have been in close contact with the US FDA for detailed planning of the regulatory clinical studies in the US, which have the ultimate goal of reaching approval for the US market. Together with the FDA, we have agreed on both the number of tests and the layout of individual test packages in the clinical study. Installation and the start of studies at the first American hospital will take place at the beginning of the summer, which is currently the plan.

Now in May, our new colleague AnnaLotta Schiller takes up the position as Chief Commercial Officer, CCO at Gradientech. AnnaLotta will thus take responsibility for the commercial activities with a strong focus on gaining an increasing number of regular customers in Europe. I take the opportunity to wish AnnaLotta a warm welcome to us!

Sara Thorslund, CEO Gradientech

Uppsala, May 17, 2024

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.