Results from Groundbreaking Study with Prostatype® Additionally Strengthens the Clinical Benefits

Prostatype Genomics continues to deliver on the overall strategy of the Company and the previously communicated milestones. One of two main focus areas is the continued strengthening of the scientific footprint through scientific studies performed by internationally recognized clinics and research institutions. An additional milestone in the development of the Company has now been achieved through the groundbreaking clinical study with Prostatype® that has been performed at the Uppsala University Hospital (“Akademiska”), under the leadership of associate professor Michael Häggman at the Urology Clinic. A study has been performed with the purpose to show whether the result from the deployment of Prostatype® before making treatment decision for patients with prostate cancer corresponds to the actual level of aggressiveness of the tumour.

CEO Fredrik Persson comments:

”We are very happy and proud with the preliminary results for Prostatype® and our associated algorithm P-score in the now finalized study at the Urology Clinic at the Uppsala University Hospital, led by associate professor Michael Häggman. We are very well aware of the performance of Prostatype®, but these results exceed even our own very high expectations. To the best of our knowledge, this is the first time that this kind of study has been performed within the field of prostate cancer, which not only demonstrates how far advanced the Company is in regards to the performance of Prostatype® as a product, which has also been shown in previous studies, but also that Prostatype Genomics through cooperations with leading urologists is constantly trying to find new approaches to scientific challenges in order to advance the field of prostate cancer research.

Uppsala University Hospital is one of the leading urology clinics in the country and is very advanced in many fields of urology with international standards. The results, and the added clinical value that Prostatype® in the recently finalized study demonstrates, are significant and powerful which once again shows the clinical power of the product and the benefits that Prostatype® provides to health care, physicians, and individual patients suffering from prostate cancer. In total, 71 patients have been analyzed, with the purpose of comparing the P-score results from tissue samples obtained during the diagnostic phase with the P-score results in the same prostates that have been surgically removed. The purpose of the study was therefore to determine whether Prostatype® and the associated P-score that we utilize can predict the “final facts”, as represented by the values that we observe in the cancer cell of surgically removed prostates. In addition, it is of significant interest from a clinical point of view to see whether the P-score in the primary tumour corresponds with the P-score in other cancer areas since that could lead to a need for fewer tissue samples during the diagnostic phase. That would in turn lead to less pain and discomfort for patients, but also to more efficient diagnostics and testing, thus less costs for the health care systems. The type of study that we are now presenting has been requested by many urologists both in Sweden and internationally, which makes the power of the results and the demonstration of the clinical value of Prostatype® and our associated algorithm P-score all the more satisfying.

Associate Professor Michael Häggman, urologist at the Uppsala University Hospital and lead responsible for the study, comments on the results as follows:

“It is difficult to make a prognosis for patients diagnosed with prostate cancer, and we are in need of better and more specific biomarkers than the ones currently available, since they have clear limitations.  This fact creates uncertainty in the treatment decisions for the individual patient. Over-treatment of prostate cancer is a common phenomenon, where urologists are in need of better tools that also safeguard that we do find the more aggressive forms of cancer where aggressive treatment really is necessary. In this study we focused on two main clinical aims that both are important. The first aim was whether the gene test Prostatype® and its associated algorithm P-score are correlated in fusion led biopsies in relation to surgically removed prostates, so called prostatectomies. The second aim relates to the correlation between the P-score in the index tumour itself relative to that of other cancer areas in the prostate. It is of course very satisfying that the preliminary results show a high degree of correlation in P-score values (0.83-0.84) for both aims, which is further underlined by the strong statistical significance shown in both cases (p<0.0001). This means that the test results from the tissue samples using Prostatype® provide the indication that is requested in order for making the decision on next step in treatment with greater certainty.

It seems that no similar study has ever been performed regarding prostate cancer, but when we compare with similar studies of genetic biomarkers that are used for breast cancer the results are very interesting since both diseases are hormone dependent tumours in accessory sexual glands, and where the correlation is higher for Prostatype® when compared with the studies performed on similar products for breast cancer. The study indicates that Prostatype® in a clear and valuable way can aid health care to identify patients in need of radical treatment and patients who are not in need of radical treatment, e.g., surgery, with greater ease and higher certainty.

We have already started working on further statistical analysis and preparing a manuscript for publication in a relevant scientific journal as soon as possible. The results will be presented at international conferences as soon as there is opportunity.”

This disclosure contains information that Prostatype Genomics AB is obliged to make public pursuant to the Swedish Securities Markets Act (2007:528). The information was submitted for publication, through the agency of the contact person, on 09-08-2021 09:00 CET.

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fredrik.persson@prostatypegenomics.com

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