Prostatype Genomics updates on significant progress in the US study with Prostatype®

Prostatype Genomics AB (”Prostatype Genomics” or ”the Company”) announces that the US study with Prostatype®, which includes approximately 1,200 patients with prostate cancer with a broad ethnicity coverage, is progressing significantly faster than expected. Approximately 40% of the entire study has already been completed. The Company will compile interim data from the study and apply to get Prostatype® approved for reimbursement in the United States by Medicare when approximately 150 African American patients have been analysed. The Company expects to submit the Medicare application in Q2-Q3 2024 and receive approval in Q4 2024.

Currently, reimbursement from Medicare for genetic testing of patients with diagnosed prostate cancer amounts to approximately 3,800 USD per test. The sales for such gene tests in the US market today amount to approximately 2 billion SEK (200 million SEK) per year, and the Company estimates that the total market potential in the United States is approximately 6 billion SEK.

“It is inspiring that the US study with Prostatype® is progressing much faster than expected, more than twice as fast as previous studies in Europe. Some parts of the study which are usually quite time consuming, such as identifying patient data and biopsies, have already been completed for all of the patients. The high pace is due to the fact that we are working with experienced partners with comprehensive clinical and personal resources, under supervision of the distinguished professor Stephen Freedland,” says Prostatype Genomics’ CEO Fredrik Rickman.

Due to the high pace in the study, the Company is getting closer and closer to applying for reimbursement from Medicare and receiving an expected approval in Q4 2024.

”Our timeline up until expected Medicare approval, a crucial milestone for the Company, looks more and more reasonable. We recently presented a collaboration with the internationally recognised urologist professor E. David Crawford, who will also become our first customer in the United States, and we expect several urologists to follow his example. This is likely as Prostatype® has potential to significantly improve the quality of life for tens of thousands of men with prostate cancer every year in the United States alone,” says Fredrik Rickman.

The US study is also connected to the ongoing laboratory validation, which constitutes the final regulatory step before the Prostatype® is commercially available in the United States. The laboratory validation is also progressing according to plan, and it is expected to be completed shortly.

About Prostatype Genomics’ increased focus on the US market

There is comprehensive scientific support for the use of Prostatype® as a supplementary basis when choosing treatment for patients with prostate cancer. Market launches have already taken place in selected markets in Europe and Asia. Based on data and experience from these markets, the Company is now focusing on the US market where the commercial conditions are best developed from a global perspective. Prostatype Genomics expects to receive Medicare reimbursement approval of approx. 3,800 USD per test in Q4 2024, a crucial milestone for the Company.

In Q1 2024, three of four important regulatory milestones prior to US market entry were achieved, and the fourth (laboratory validation) is expected to be achieved shortly. Interim data from the ongoing US study, as well as submitting the application for reimbursement to Medicare, is expected in Q2-Q3 2024, and approval from Medicare is expected in Q4 2024.

The US market for gene testing of patients with diagnosed prostate cancer is currently valued at approx. 2 billion SEK per year, and the total market potential in the United States is valued by the Company to be at least 6 billion SEK per year.

Prostatype Genomics experiences great interest from potential commercial partners, especially in the United States, and the Company continuously evaluate possible collaborations or a sale of the entire Company with regard to the interests of its shareholders and the patient group.

For further information about Prostatype Genomics, please contact:

Fredrik Rickman (previously Persson), CEO Prostatype Genomics AB

Telephone: +46 (0) 73 049 77 01

Email: [email protected]

About Prostatype Genomics AB

Prostatype® is a genetic test that is available to patients and treating urologists as a supplementary decision support tool to answer the question of radical treatment or no radical treatment of prostate cancer. The test is developed by a research group at Karolinska Institutet and is provided by Prostatype Genomics AB. The Company’s Certified Advisor is Carnegie Investmentbank AB.