Fourth quarter, 1 February – 30 April 2024

• Net sales amounted to SEK 3,217k (2,597k).
• Operating result (EBIT) amounted to SEK -5,001k (-4,328k).
• Net result for the period amounted to SEK -4,668k (-4,057k).
• Earnings per share amounted to SEK -1.16 (-1.01). Earnings per share after dilution amounted to SEK -1.16 (-1.01).
• Cash flow from operating activities amounted to SEK -2,194k (1,496k).
• Net cash flow amounted to SEK -6,005k (-869k).
• Qlucore Omics Explorer for cloud is launched.
• Qlucore Insights is sold to the University Hospital in Uppsala.
• After the reporting period. First payment from the EU in May.

1 May 2023 - 30 April 2024

• Net sales increased to SEK 14,369k (12,672k).
• Operating result (EBIT) amounted to SEK -16,822k (-16,305k).
• Net result for the period amounted to SEK -15,681k (-15,936k).
• Earnings per share amounted to -3.89 (-3.96) SEK. Earnings per share after dilution amounted to -3.89 (-3.96) SEK.
• Cash flow from operating activities amounted to SEK -16,949k (-8,049k).
• Net cash flow amounted to SEK -40,746k (-27,871k).
• Liquid funds amounted to SEK 28,619k on the closing day.
• The Board of Directors proposal to the general meeting is that no dividend is distributed for the financial year.

CEO’s statement
During the year, we have taken several important steps to reach our goals. Within Cancer diagnostics, the focus has been on the CE marking of Qlucore Diagnostics for leukemia. With the submission of the technical file in January 2024, we are a big step closer to commercialization. Sales launch for clinical use is estimated for February 2025. Our solution enables the classification of subgroups within different forms of cancer with the aim of improving diagnostics and treatment.

Sales of Qlucore Omics Explorer, i. e. data analysis, have been good and account for the majority of our current net sales. The customers are mainly to be found at the big universities and among the big pharmaceutical companies.
Our solution Qlucore Insights, which is already used in clinical research in leukemia, has been sold to both Sahlgrenska Hospital and Uppsala University Hospital. Together with our customer Rigshospitalet in Denmark, we have published a "case study" that points to the good results they are achieving (qlucore.com/case).

During February 2024, we were pleased to receive a prestigious EU grant of SEK 27 million. The grant aims to accelerate AI- based clinical cancer diagnostics for bladder cancer and acute myeloid leukemia in adults (AML). There were 1,083 applicant companies within the EIC Accelerator program, of which we were one of the 42 awarded grants. This demonstrates our strength in the rapidly expanding field of precision diagnostics. We will start the project in May 2024.

In total during the financial year, sales increased organically by 13 percent to SEK 14,369k. Cash and cash equivalents amount to SEK 28,619k and do not include the EU grant. The net cash flow in the fourth quarter was SEK -6,005k.

Net sales during the fourth quarter increased to SEK 3,217k (2,597k), which is an increase of 25 percent.

Through cost savings, we have succeeded in reducing our annual costs by the equivalent of approximately SEK 7 million, effective from quarter four. We also envision a high degree of reuse for future models regarding the investments that have already been made within Qlucore Diagnostics.

In April, we launched Qlucore Omics Explorer Cloud, enabling customers to choose whether they want to perform the data analysis locally or in the cloud. The solution has been developed with minimal resources through innovative use of Amazon's cloud solution.

The good technical and regulatory position we are in means that we are actively evaluating strategic options to scale up as quickly as possible.
 
Cancer diagnosis
During the year, we also made significant progress with our first solution for solid tumors – lung cancer. Lung cancer is one of the forms of cancer that leads to the most deaths annually, and improved diagnostics are therefore of great importance. A new classification model for lung cancer with significant improvements is now available for Qlucore Insights. The model enables the identification of different forms of lung cancer and the determination of whether it is a metastasis.
CE marking according to the IVDR regulations for medical devices is a requirement for use in diagnostics in healthcare. The estimated time of regulatory approval (CE marking) for childhood acute lymphoblastic leukemia (BCP-ALL) is February 2025.
The submission of the technical documentation enables us to now shift the development focus towards completing the quality system and to carry out formal reviews together with our contracted Notified Body (BSI). Work on the projects in lung cancer, bladder cancer and acute myeloid leukemia in adults (AML) is also ongoing. All forms of cancer represent strategically important therapeutic areas with a great medical need for improved diagnostics.

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. Although we have noted a continued trend for redundancies in the pharmaceutical and biotech sectors, especially in the USA, we have not yet noticed any direct effect from this.
 
In December 2021, the EU changed the timetable for how the IVDR[1] is to be introduced and there are now updated proposals for the further adjustment of the introduction. During April, the FDA (Food and Drug Administration, USA) published proposals with the implication that the relatively unregulated tests known as lab developed tests (LDTs) in the USA should undergo approval similar to CE marking according to the IVDR in Europe. This is well in line with our assessment that we are moving towards stronger regulations and that this benefits Qlucore’s ambition to develop diagnostic solutions that meet strict regulatory requirements.
We are at the forefront with Qlucore Diagnostics for CE marking and that work can be reused to meet expected FDA requirements.
 
The past business year has been a very eventful and significant year for Qlucore.
We have;
-launched several new product versions and classification models,
-sold to more hospitals,
-received a prestigious EU grant and
-passed a significant milestone in the form of the submission of the complete technical file for Qlucore Diagnostics for BCP-ALL.
 
All this has been possible thanks to our committed and competent team. We are now continuing the work with marketing and development of new models.
 
Carl-Johan Ivarsson
CEO

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