Gradientech: Interim report January–September 2025

Gradientech AB (publ) interim report for Q3 2025 is now available on the company's website www.gradientech.se.

Third quarter 2025

• Net sales amounted to SEK 1,517 thousand (829). Please note that quarterly sales may vary as Gradientech’s sales to distributors vary throughout the year.
• Net profit/loss amounted to SEK -14,990 thousand (-13,399).
• Earnings per share before and after dilution were SEK -0.46 (-0.51).
• Cash flow from operating activities amounted to SEK -14,640 thousand (-13,906).
• Cash and cash equivalents amounted to SEK 24,667 thousand (13,142) as of September 30, 2025.
• Equity amounted to SEK 40,879 thousand (21,699) as of September 30, 2025.
• In the beginning of July, Gradientech announced a significant order from its North American distributor, Hardy Diagnostics. The order making an important milestone in Gradientech´s U.S. market expansion strategy.
• In July Gradientech completed its clinical sample testing in ongoing FDA 510(k) clinical study of the QuickMIC® system.
• In the beginning of August, Gradientech announced that the company was awarded the Clinical Diagnostics Campaign of the Year at the prestigious Scientists’ Choice Awards® 2025, presented by SelectScience®.
• At the end of August Gradientech today announced the publication of a new peer-reviewed scientific study led by the renowned Italian research group of Professor Gian Maria Rossolini. The study confirms that QuickMIC® is fast and accurate targeting multidrug-resistant bacteria.
• At the end of September Gradientech announced the collaboration with Vienna-based Cellectric on a new proof-of-concept study of a direct-from-blood application to speed up sepsis diagnostic workflows. Cellectric is developing a direct-from-blood application for sepsis samples, selectively destroying human cells in the patient sample with the aim to bypass the need for culturing of the bacteria.

January-September 2025 period

• Net sales amounted to SEK 3,341 thousand (3,263).
• Net profit/loss amounted to SEK -54,211 thousand (-46,954).
• Earnings per share before and after dilution were SEK -1.72 (-1.92).
• Cash flow from operating activities amounted to SEK -55,640 thousand (-43,305).
• Gradientech announced in January to have started its third FDA 510(k) clinical study site in the US for the QuickMIC® system to ensure comprehensive clinical data collection for the regulatory FDA submission of the QuickMIC system and its gram-negative CSLI panel.
• In the beginning of February Gradientech announced the outcome of the new issue of shares with preferential rights for existing shareholders, resolved by the board on 17 December, 2024. The rights issue was fully subscribed, which meant that Gradientech received approximately SEK 60.6 million before deduction of issue costs. Part of the issue was registered on 11 February and affects the first quarter’s cash flow by SEK 31.7 million before deduction of issue costs. The registration increased the number of shares by 1,813,908 shares and the share capital by SEK 181,390.80. The registration meant that the share capital as of 31 March 2025 amounted to a total of SEK 3,068,108.10 and the number of shares to 30,681,081. On 7 April, 2025, the second of two registrations was carried out with the Swedish Companies Registration Office regarding the rights Issue decided by the board on December 17, 2024. After the second registration, the cash flow of which affects the second quarter of 2025, the share capital amounts to SEK 3,233,123.20 and the number of shares to 32,331,232.
• Gradientech announced at the end of February that a.d.a. SRL, its exclusive distributor for the Italian market, is starting a multicenter study in the Milan area of Italy for the QuickMIC® system. The multicenter study will be performed at four hospitals in collaboration with the Italian Society for Clinical Microbiology (AMCLI) and aims at developing new recommendations for rapid AST for Italian healthcare.
• Gradientech announced in March that the company will present new study data from clinical, real-world evaluations with its QuickMIC® system for ultra-rapid antibiotic susceptibility testing (AST) at ESCMID Global 2025 in Vienna, Austria, April 11th-15th.
• During March Gradientech announced that Mark Lischeid was appointed as the company’s new Sales Manager for Central Europe. Mark has extensive knowledge from strategic sales and commercial organisations, with over 25 years of experience in the diagnostic sector.
• In the beginning of April Gradientech announced that its new CU product that comes with its already award-winning QuickMIC® system has received the prestigious Red Dot Design Award: Product Design 2025.
• Gradientech announced at the end of April that Prof. Gian Maria Rossolini, Professor of Microbiology and Clinical Microbiology at the University of Florence, joins as a new member of the company’s prominent international Scientific Advisory Board.
• At the AGM on May 21, Veronica Byfield Sköld was elected as new member of Gradientech´s Board of Directors. Laura Chirica did not stand for re-election.
• Gradientech announced at the end of May that their distributor Biomedica installed the QuickMIC® system for routine use at the Clinical Center University of Sarajevo, one of the largest hospitals in Bosnia and Herzegovina.
• In June Gradientech announced that its distributor a.d.a. SRL, the company´s exclusive distributor at the Italian market was awarded direct tenders at two Italian hospitals.

Significant events after the end of the period

• In the middle of October Gradientech announced that the results from a new scientific study were published in the high-ranked European Journal of Clinical Microbiology & Infectious Diseases. The study confirms the QuickMIC® system to deliver accurate antibiotic susceptibility testing (AST) results up to 75% faster than current gold-standards automated solutions, enabling faster treatment decision for sepsis and blood stream infections.
• At the end of October Gradientech announced that its QuickMIC® diagnostic test for ultra-rapid antibiotic susceptibility testing (AST) of sepsis samples, has been officially certified under the European Union’s In Vitro Diagnostic Medical Device Regulation (IVDR) – the new stringent regulatory framework for diagnostic devices.

CEO statement

As we close this quarter, I am proud to share that Gradientech has achieved several key milestones that further strengthen our position as an emerging leader in rapid antimicrobial susceptibility testing.

One important accomplishment this period is the successful IVDR certification of our QuickMIC® system, marking full compliance with the European Union’s new and stringent In Vitro Diagnostic Regulation. This is a major regulatory achievement confirming that QuickMIC meets the highest standards of safety, quality, and clinical performance. With IVDR certification now complete, we are fully positioned for continued clinical adoption and expansion across Europe.

In the United States, our FDA clinical study for isolates has been successfully completed. All testing and technical documentation are finalised, and we are ready to submit our first 510(k) application to the FDA. This represents a key step toward introducing QuickMIC to the U.S. clinical diagnostics market together with our partner Hardy Diagnostics.

During early autumn, Hardy Diagnostics installed the first QuickMIC systems at U.S. hospitals under Investigational Use Only labeling. These hospitals are conducting both clinical outcome studies and workflow evaluations to assess, for example, performance and total turnaround time of QuickMIC and its U.S. antibiotic panel, generating valuable proofs to support the coming market introduction of QuickMIC for diagnostic use in the U.S following FDA clearance. As part of this early market introduction, Hardy Diagnostics showcased the QuickMIC system at the ID Week conference in October in Atlanta, a leading event that brings together infectious disease healthcare professionals from across the country.

In Europe, we continue to broaden our customer base with new clinical routine implementations now underway at hospitals in for example both Austria and Serbia, as well as additional installations in Italy. Several hospitals in Italy have also chosen to replace existing Accelerate Pheno systems with QuickMIC, reflecting the growing trust in our technology. We see a particularly promising year ahead in the Italian market, with numerous direct tender processes ongoing and strong momentum for adoption.

Finally, we continue to engage in active discussions with both existing and new investors as part of our ongoing financing round, conducted in collaboration with SEB as our financial advisor. These discussions aim to secure the resources needed to sustain our growth and advance our regulatory and commercial milestones in both Europe and the United States.

With IVDR certification achieved, our first FDA study ready for submission, and expanding clinical use across multiple regions, I see Gradientech entering an exciting phase of growth as we move closer to establishing QuickMIC as a preferred solution for rapid antimicrobial susceptibility testing.

Sara Thorslund, CEO Gradientech

For further information, please contact:
Sara Thorslund, PhD, CEO         
Tel: +46 736 29 35 80                 

Urban Adolfsson, CFO
Tel: +46 708 20 72 09

About Gradientech
Gradientech is a leader in ultra-rapid antibiotic susceptibility testing, developing next-generation diagnostics for infectious disease medicine. Our innovative diagnostic solutions aim to save lives, reduce healthcare costs, and combat the spread of antibiotic resistance – one of our greatest global health threats. Gradientech is headquartered in Uppsala, Sweden. Visit www.gradientech.se for more information.