Regulatory press release

Prostatype Genomics presents Quarterly- & Year End Report

Prostatype Genomics AB has today published its quarterly report for the fourth quarter comprising the period from 1 October 2022 to 31 December 2022, and the year end report for the financial year 2022. The report is available on the company website.

Quarter 4 (1 October – 31 December 2022) summarized

Full year (1 January 2022–31 December 2022) summarized

CEO comments

2022 was a turbulent year with Russia's invasion of Ukraine, sharply increasing inflation and in the wake of this, rising interest rates and troubled stock markets. Despite this, 2022 was the year when Prostatype Genomics could seriously reach out to customers and partners after the long-term the pandemic. 2022 was also the year we took the first steps into the American market.

 Thus, Prostatype Genomics has taken several important steps forward and it is gratifying to note the concrete successes we see in our priority markets.

The building blocks that make Prostatype Genomics an attractive company and build future value are several:

1) To be able to demonstrate continued sales development in the markets where we are present,

2) Continuously growing scientific footprint through published studies

3) Presence and progress in the United States

4) In collaboration with leading partners continue to develop the business

For a relatively small company like Prostatype Genomics, it means several challenges and having the target picture clear to oneself every day, which requires important priorities. Focus and resources must always be allocated in favor of the activities that really build value and external interest for the company.

We have implemented several important and necessary changes in our organization during the second half of the year. In our home market, Albin Bremer took over as responsible for sales within the Nordics after summer. We are already seeing the concrete result of Albin's work in an increased influx of orders of Prostatype® from urologists and patients. Another concrete proof of an increased interest from urologists is that more and more clinics choose to cooperate with us and market this through our patient website, Currently, there are about 10 clinics that, after validation, have chosen to actively offer Prostatype to patients. This is of course gratifying for us and proof of the added value Prostatype® offers to healthcare as well as patents and relatives.

Increased focus

During the autumn, we initiated a collaboration regarding the laboratory handling of Prostatype® with the company Life Genomics, a laboratory that provides genetic tests to both private clinics and public healthcare. This business model is about to be launched in other prioritized target markets. The collaboration means that Life Genomics will manage all steps in the laboratory process required to analyze the aggressiveness of cancer using Prostatype®. There is no added value for Prostatype Genomics to manage these processes internally. We can and must instead continue to focus entirely on our two main goals: strengthening our scientific footprint through additional validation studies as well as continuing and accelerating the commercialization of Prostatype® in Europe and the United States.

Exciting developments in Europe

In addition to a strong tailwind in our Nordic home market, we also see a positive development in several of our priority markets in Europe. The company identified Spain as an important market several years ago, and in line with that, we have strengthened the organization during the autumn with a full-time resource on site. In December, Enrique Manglano started with us, and here too, development has gone faster than we dared to hope for. Several interesting collaborations with leading Spanish clinics and laboratories are expected to start shortly, both in the public and as in private care. It will result in a further strengthened scientific footprint as well as concrete sales – completely in line with our strategy.

At the moment, around 30 hospitals/medical units are evaluating Prostatype®. In addition to these ongoing tests, around 20 units have already evaluated the product with good clinical results and are preparing to introduce Prostatype® into clinical routine. In the next step, we have a pipeline comprising another 50 or so urological units that are about to initiate their own evaluation of Prostatype®. We can therefore look back on 2022 and state that during the year we succeeded very well in reaching out to our customers.

Go West…

In parallel with a very exciting development in the Nordics and Europe, the launch in the US continues fully in accordance with the company's offensive plans made possible by the rights issue that was carried out during the year. We have a very ambitious plan for the launch in the US where we have focused on enabling a fast commercial process, while ensuring long-term sustainable development.

The American market is different and far ahead of us in Europe in several areas. Prognostic biomarkers in prostate cancer have been routinely used for more than 10 years and are reimbursed by both Medicare and private insurance companies. In order to gain quick access to the market, a local organization with experience in US urologists, clinics and payment systems is necessary. After an extensive and thorough process, Steven Gaal was recruited as President of Prostatype Genomics Inc., the company's wholly owned US subsidiary. Steven has over 18 years of experience from leading positions in the sales of cancer diagnostic tools and services and has experience and a network of contacts that enable a short starting period.

Also in the US, it is about establishing ourselves scientifically as quickly as possible with the validation studies required to be reimbursed in accordance with the guidelines for prognostic biomarkers applied by Medicare and large private insurance companies. We have good contacts and already initiated collaborations with several leading American urologists, which is of course very important to ensure that we continue to carry out the right activities as cost-effectively and quickly as possible.

To accelerate the commercialization in the USA, the company made the early decision to launch Prostatype® in the USA as an LDT (Laboratory Developed Test) test and to initiate collaboration with a suitable, established laboratory partner, which is one of Steven's main tasks initially. This launch strategy gives the company opportunity to initiate marketing efforts and sales directly to consumers and urologists as soon as possible.

For those of you who have invested in Prostatype Genomics, it is of course encouraging to hear that we continue development in a positive direction and that more and more urologists and patients see the advantages of Prostatype® and also that sales have now started to start after the validations carried out locally. With the interesting development we see in all markets, we are convinced that sales for the year 2023 will increase significantly in relation to 2022. It is also worth remembering that our business model with very high margins means that we quickly reach break-even when sales are taking off in earnest. It is enough for approx. 150 urologists, globally, to start using Prostatype® in clinical routine for us to reach break-even. In other words, it is a highly achievable goal that demonstrates the economic potential that exists in Prostatype Genomics.

We therefore envision a 2023 where we achieve commercial breakthroughs in our key markets and not only publish the results of already completed validation studies but also initiate new ones, all to continue strengthening our scientific footprint not least in the US. We also expect continued positive sales development. The result of this will result in us positioning the company as an attractive partner for large established players in the market. The opportunities it would open up are very promising for shareholders as well as for patients and healthcare.

Fredrik Persson, CEO Prostatype Genomics AB

Solna, February 16 2023

This disclosure contains information that Prostatype Genomics AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 16-02-2023 08:00 CET.