Regulatory press release

Prostatype Genomics presents Quarterly Report

Prostatype Genomics AB has today published its quarterly report for the second quarter comprising the period from 1 April 2023 to 30 June 2023. The Company also projects that revenue growth will return to positive trend in the Third Quarter. The report is available on the company website (

Quarter 2 (1 April – 30 June 2023) summarized

Period 1 Jan – 30 June 2023 summarized

CEO comments

The second quarter of the year saw continued strong investment in a rapid US launch in parallel with several important steps being taken towards a broader commercial presence in several of our prioritized European markets. After sales growth for several quarters in a row, Q2 fell out a little lower, which is explained by timing factors as several buy orders came in right at the beginning of Q3. Consequently, we already know that Q3 will perform significantly better and be more in line with the sales growth we have seen over the past year. Although we are not yet quite where we want to be, the trend in sales growth remains positive, which of course is pleasing.

With the recruitment of Steve Gaal as President and responsible for our US subsidiary, we have established the necessary conditions for the communication with authorities required for our entry into the US market to be as fast, cost-effective, and affordable as possible. This work has accelerated during the quarter where we had initial meetings with Medicare, which is the part of the US healthcare market that determines whether a product should be included in the public US reimbursement system or not. There have been very rewarding meetings with quick and concrete feedback on how Prostatype Genomics should best act to be covered by Medicare's reimbursement system. Unlike in Europe, we have the advantage of not being the first on the US market as other companies that provide similar tests as Prostatype® have made the journey before us. Our strategy is not to do anything different or special in relation to our competitors, but to follow the practices and arrangements that have proven to work historically to ensure that Prostatype® will replace the patients who use the product as soon as possible.

The discussions have initially been conducted at a high scientific level and it has been crucial to have the support of Professor Gerald Andriole, who last spring was appointed Chief Medical Officer of Prostatype Genomics both in the US and globally. The respect that Professor Andriole enjoys in the US as both a clinician and a researcher means a lot for the future growth of Prostatype Genomics in that market. With over 35 years of experience from leading US institutions in urology, and with over 450 peer-reviewed publications, Professor Andreoli gives some weight when discussing with US authorities, to say the least.

In summary, it is full steam ahead in the United States, with ongoing discussions with both authorities and commercial partners, while we participate in the important urological congresses that are regularly held around the country. As I write these lines, I have just returned to Sweden after representing Prostatype Genomics at a urology congress in the United States. We continue to build up our network of leading American urologists, including the first American advisory board meeting regarding Prostatype® with several of America's leading urologists present. Their feedback is and will be invaluable to us in the future, as the urologists who participated in the meeting have extensive experience of using biomarkers similar to Prostatype®.

The next concrete step in Prostatype Genomics' US establishment will be to conclude already initiated negotiations with a suitable laboratory partner in the US (so-called CLIA partner), which is a piece of the puzzle that needs to be in place from Medicare's point of view. We are still in several interesting discussions and hope to be able to reach an agreement with the right partner in the coming quarters. As I previously mentioned, the decision regarding the selection of CLIA partners is a crucial milestone for the company, which is why the board and management need to carefully evaluate the options available from both a short- and long-term perspective.

In our prioritized markets in Europe, we are beginning to see that the great interest many hospitals and laboratories have shown in Prostatype® has turned into concrete measures. During the spring, we initiated studies with leading players in several markets, including Italy and Spain, while deepening our collaborations with major laboratory partners. One example of this is that Emilie Berglund, Chief Technology Officer at Prostatype Genomics, recently carried out certifications on site at several laboratories around Europe, which can now perform the entire process of sampling and analysis in a quality-assured manner. This is fully in line with our strategy to work with leading partners in prioritized markets, thus enabling rapid expansion as cost-effectively as possible.

Finally, we continue to work tirelessly to continue to strengthen our scientific footprint in the form of several ongoing validation studies with Prostatype® both in the US and Europe. We eagerly await the outcome of these studies and even though validation studies can be described more as marketing activities and are not conducted to investigate whether the product works or not, it was both gratifying and interesting that one of America's leading urologists at the conclusion of the recently held congress stood up in front of his colleagues and stated that "The Prostatype® data is very impressive"!

Thank you for joining us on the journey, and please keep an eye on our website, and take part of our exciting news in the future!

Fredrik Persson

CEO Prostatype Genomics AB

Solna 17 August 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 17-08-2023 08:00 CET.