Gradientech: Interim report January–June 2024

Gradientech AB (publ) interim report for Q2 2024 is now available on the company's website www.gradientech.se.

Second quarter 2024

• Net sales amounted to SEK 1,948 thousand (1,141).
• Net profit/loss amounted to SEK -17,906 thousand (-16,837).
• Earnings per share before and after dilution were SEK -0.75 (-0.95).
• Cash flow from operating activities amounted to SEK -14,586 thousand (-14,399).
• Cash and cash equivalents amounted to SEK 6,750 thousand (39,535) as of June 30, 2024.
• Equity amounted to SEK 14,893 thousand (35,112) as of June 30, 2024.
• 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 cassette, the single-use test device in the QuickMIC® diagnostic system for ultra-rapid antibiotic susceptibility testing (AST).
• In May Gradientech announced that its distributor Biomedica Medizinprodukte GmbH has installed QuickMIC® at a university hospital in central Eastern Europe, which is now the first customer to implement the QuickMIC® system for ultra-rapid antibiotic susceptibility testing (AST) in clinical routine.
• Data from the successfully completed US pre-clinical evaluation of QuickMIC® at Medical College of Wisconsin and University of North Carolina in USA was presented at the ASM Microbe conference in Atlanta, Georgia, June 13^th-17^th 2024.

January-June 2024 period

• Net sales amounted to SEK 2,434 thousand (1,521).
• Net profit/loss amounted to SEK -33,554 thousand (-34,900).
• Earnings per share before and after dilution were SEK -1.43 (-2.03).
• Cash flow from operating activities amounted to SEK -29,399 thousand (-32,467).
• 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 (ESCMID Global) 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 July Gradientech announced the continued collaboration with Oxford-based Momentum Bioscience Ltd in the ground-breaking project to demonstrate the potential for a next-generation diagnostic workflow for patients with sepsis, together providing the fastest solution to precise phenotypic AST results directly from blood.
• The directed issue of shares to a limited number of existing shareholders, in which the subscription period ended on July 4, 2024, was registered with the Swedish Companies Registration Office in July. As a result of the issue, the number of shares increased by 3,109,849 to a total of 27,070,602 shares and the share capital increased by SEK 310,984.90 to a total of SEK 2,707,060.20. Through the Issue, Gradientech received proceeds of approximately SEK 22.1 million before deduction of issue costs.
• In August Gradientech announced that Dr Nathan A. Ledeboer, specialist within the Froedtert & Medical College of Wisconsin network, joined as new member of the company’s prominent international Scientific Advisory Board.

CEO statement

In the last quarterly report, I was able to tell you that the first hospitals in Europe had decided to implement QuickMIC® in their routine for ultra-rapid AST testing of sepsis patient samples. An important breakthrough for us. We are now systematically and purposefully working on increasing the number of routine customers in Europe to become a recognised player on the diagnostics market for infection disease. We do this through direct sales with a primary focus on Germany, or in close cooperation with our distributors in their respective markets. At the time of writing, Biomedica, distributing QuickMIC in Eastern Europe, welcomes the decision to have also won a procurement in Sarajevo in Bosnia. The procurement for this hospital includes two instruments and 200 tests per year, demonstrating the advantage of our product solution with modular instruments that suit hospital customers with both minor and major testing needs.

The US accounts for half of the world market for AST. Regulatory, the US market requires approval from the FDA, the US Food and Drug Administration, which reviews and approves diagnostic systems. In spring 2024, the FDA has approved three systems for rapid AST testing of sepsis samples. For these products, rapid means test times of 6-8 hours instead of the QuickMIC system's 2-4 hours. It will now be exciting to follow the initial development in the important US market, how reimbursement models will be put in place and how general market prices will evolve. We are currently completing installations and training of the first two US hospitals that are part of our clinical study towards an FDA clearance. This is the start our clinical study of the QuickMIC system and a gram-negative antibiotic panel adapted to the US market. We will include blood culture and isolates as sample types in the study to reach as broad a market as possible. In addition to the tests carried out at hospitals, many tests will also be run by us at Gradientech during the autumn.

As part of an increased focus on the US market, in August we welcomed Dr. Nathan A Ledeboer as new advisor to our Scientific Advisory Board. Nathan is a highly respected key opinion leader in clinical microbiology and AST, and recently assumed the role of Associated Chief Medical Laboratory Officer for Froedtert Health in Wisconsin. In addition to his expertise in clinical AST, for example, I look forward to sharing Nathan's experience and valuable insights around how US hospitals assess new diagnostics and apply reimbursement models.

In July, Gradientech carried out a directed issue to around 40 of the company's shareholders. I would like to thank you for your confidence, which meant a total of SEK 22.1 million in added capital before issue costs. We look forward to an autumn with a focus on more and more satisfied routine customers in Europe, product development of new antibiotic panels, and not least our FDA study aimed at the US market. We also have good hopes of reaching a next step in commercial partnership discussions.

Sara Thorslund, CEO Gradientech

Uppsala, August 22, 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 (ir@gradientech.se)