Non-regulatory press release

Updated strategy and implementation of efficiency programs in Prostatype Genomics

During 2022 and 2023, Prostatype Genomics has introduced Prostatype®, the company's prognostic gene test for prostate cancer, in European pilot markets and in Taiwan in parallel with a mapping of the market in the USA. Based on these experiences, the company can now specify the strategy moving forward which means:

· That the company continues to invest in attractive entry countries within Europe
· That the company expands the business in Asia with Taiwan as a springboard
· That the company implements a quick and cost-effective establishment in the American market

This will be achieved at the same time as an efficiency program is implemented, which means that running costs are reduced by approximately 30% (approximately SEK 9 million on an annual basis) without affecting sales and continued research.

Prostatype Genomics has two main strategic areas of activity: commercial establishment and strengthening of Prostatype®'s scientific basis in the form of external studies. Over the past two years, the company has systematically worked to map and evaluate various markets and approaches from a commercial perspective on site in various countries in order to identify whether the following criteria are met or can be met in the near future:

– Clinical acceptance of genetic testing in prostate cancer and confirmed clinical benefit

– Market acceptance via clinics evaluating and starting to use Prostatype® on a smaller scale

It is today difficult to predict how a patient's prostate cancer should best be treated with conventional methods. We have been able to establish that the clinical need for accurate biomarkers in diagnosed prostate cancer is very clear regardless of European country. The company has managed to achieve a high trial rate in clinics with strong results and the doctors are positive, which has shown that Prostatype® fulfils a large and clear clinical need.

Prostatype Genomics has been the first in many countries in Europe to launch a prognostic biomarker as a basis for the treatment of diagnosed prostate cancer. Through this, we have mapped logistical obstacles and opportunities, which vary from country to country. Large parts of the European market and healthcare systems are immature to the extent that national public reimbursement systems do not yet exist for the very type of gene test Prostatype® represents, which means that patients themselves pay for the test. However, we have identified several countries in Europe where there are different compensation systems on a regional or hospital-specific basis that are paid for by the public budget or insurance companies, and based on these experiences, we have chosen to initially establish a presence in the Nordics, Spain, Switzerland, and the United Kingdom.

The path to a high sales volume in each country or market is via proving clinical value and a functioning business model through 'repeat sales'. The company has already achieved this in Sweden, Spain and Taiwan. Now that this is in place, higher sales can be achieved.

Our published larger studies show extraordinarily strong results. As a complement, the company also carries out local validation studies with partners in the countries where a commercial launch is to be carried out. We therefore currently have ongoing studies in Spain, Sweden, and the USA, with a validation in the start phase also in Switzerland. Thanks to these studies, our knowledge has also been strengthened in how we can further improve the clinical benefit through continued investments in artificial intelligence to continuously further develop our algorithms and databases. This will generate even better precision, which will be a decisive advantage for the clinical benefit and for the market to choose Prostatype®.

The American market is considerably more mature compared to Europe and Asia. Prognostic biomarkers for use in established prostate cancer have been used clinically for over 10 years and are covered by reimbursement systems, for example with Medicare, and are also included in socalled "national guidelines". The established compensation level of USD 3,874 is twice as high compared to the European market. In 2022, the company established a subsidiary in the United States and hired key personnel with the goal of cost-effectively and quickly achieving reimbursement from Medicare and private insurance companies. Progress in the US has been faster than we first assumed, and Prostatype® is currently well positioned to be approved by Medicare by the end of 2024.

Prostatype® will be launched on the American market as a so-called LDT product (Laboratory Developed Test). We thereby avoid a long, costly and uncertain FDA process. We do not differ  from  American companies that provide similar products but use the same established approach. Furthermore, we do not establish our own laboratory in the USA but work with a "lab-in-lab" solution where the company uses an already existing infrastructure of a partner who holds the necessary permits and a so-called CLIA license. This ensures high flexibility for extensive sales in the US in a cost-effective manner. The US market for our product is estimated to be worth approximately 600 MUSD annually.

With a completed study in the USA, our goal is for the product to achieve the attractiveness required to be able to switch up the business after Q4 2024 via partnerships with major players in the industry on a global or regional basis either in the form of part ownership or commercial collaboration. This work has already started.

As already mentioned, the company, based on the experiences gained during 2022 and 2023, has introduced an efficiency program . This program will lead to an annual reduction of current costs corresponding to SEK 9 million or approximately 30% of the total cost. The board's and management's joint assessment is that this can be implemented without the overall strategy or pace being affected, as resources are instead concentrated on the markets where we see immediate potential. Work on continuous product development can continue at an unchanged level. Streamlining further frees up the resources needed for the company's primary focus, which is the American market.