First quarter, 1 May – 31 July 2024

• Net sales amounted to SEK 1,675k (3,427k).
• Operating result (EBIT) amounted to SEK -7,620k (-5,413k).
• Net result for the period amounted to SEK -7,529k (-5,000k).
• Earnings per share before dilution amounted to SEK -1.87 (-1.24). Earnings per share after dilution amounted to SEK -1.87 (-1.24).
• Cash flow from operating activities amounted to SEK 2,480k (-5,870k).
• Net cash flow amounted to SEK -209 (-12,370k).
• First payment of 11 million received from the EU supporting the development of clinical cancer diagnostics for bladder cancer and acute myeloid leukemia in adults (AML).

CEO’s statement
During the quarter, we have continued to focus on the CE marking of Qlucore Diagnostics for leukemia. At the end of the quarter, our contracted Notified Body completed the next stage of the review. The sales launch for clinical use is still estimated to be February 2025. Our solution enables, the classification of subgroups within different forms of cancer with the aim of improving diagnostics and treatment.

During the quarter, we started the EU-funded project which aims to accelerate AI-based clinical cancer diagnostics for bladder cancer as well as adult acute myeloid leukemia (AML). First payment from the EU of approximately 11 out of a total of SEK 27 million has also been received.

Net sales during the first quarter amounted to SEK 1,675 (3,427) k, which is a decrease of 51 percent. Differences between quarters occur, and this quarter the difference is largely due to the fact that during the corresponding quarter last year, an unusually large number of multi-year deals were completed, i. e. a business where the license period extends over several years. In the case of sales of multi-year licenses, these are not accrued, but the entire sales sum affects the revenue in the quarter in which they are invoiced, whereby the revenue can vary greatly between quarters. The transactions are booked on the invoicing date and thus affect the first quarter of the previous year positively and the current quarter negatively. The underlying demand has been more or less unchanged.

With the implemented cost savings, we have reduced our annual costs by approximately SEK 7 million and during the first quarter the costs are SEK 3.6 million lower than the corresponding period last year.

In April we launched the Qlucore Omics Explorer Cloud and the first customer contract is now signed.

The good technical and regulatory position we are in means that we are actively evaluating strategic options to scale up as quickly as possible.
 
Diagnostics
A new and significantly improved classification model for lung cancer is now available for Qlucore Insights. The model enables the identification of different forms of lung cancer and the determination of metastases from primary tumors. The lung model will be shown to a wider audience at the European Society for Medical Oncology (ESMO) conference in September.

According to the IVDR regulations for medical devices, the process of achieving CE marking is a requirement in order to be used for diagnostics in healthcare. For Qlucore, the next step in this process, is to carry out formal reviews together with our contracted Notified Body (BSI) and to address feedback. Estimated time for regulatory approval (CE marking) for childhood acute lymphoblastic leukemia (BCP-ALL) is February 2025. For future models, we also envision a high degree of reuse of the investments already made in Qlucore Diagnostics.

The work on the lung cancer, bladder cancer and adult acute myeloid leukemia (AML) projects is also ongoing. All forms of cancer represent strategically important therapeutic areas with great medical needs for improved diagnostics.
The two EU-funded projects in cardiovascular diseases continue to develop positively and show that our solutions are relevant for many different disease areas.
 
Global landscape
Global uncertainty with the deteriorating geopolitical situation and the weak economy, has not affected operations during the period, as far as we can judge.

The EU changed the timetable for how the IVDR[1] is to be introduced in December 2021 and there are now updated proposals for the further adjustment of the introduction.

The FDA's (Food and Drug Administration, USA) regulations for laboratory developed tests, LDTs, have changed since July 5. The starting point is that new LDTs must undergo the same approval as other IVD products. This confirms our assessments that we are moving towards stronger regulations and benefits Qlucore's ambition to develop diagnostic solutions that meet strict regulatory requirements. The Qlucore diagnostics software is one of the first of its type to receive CE marking under the new IVDR regulations. CE marking will soon be a requirement for use in diagnostics in Europe. The work undertaken by Qlucore to achieve CE marking will be able to be reused to meet the expected requirements from the FDA.
 
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Carl-Johan Ivarsson, CEO

[1]EU regulation 2017/746 on in vitro diagnostic medical devices (IVDR).