Prostatype Genomics presents Quarterly Report

Quarter 3 (1 January – 30 June 2022 compared with 1 July – 30 September 2022) summarized

• Net sales amounted to 109 (0) TSEK.
• Net revenue amounted to 110 (426) TSEK.
• EBITDA (earnings before interest, taxes, depreciation, and amortization) amounted to -7 175 (-3 613) TSEK.
• Cash flow from current operations in the quarter amounted -8 526 (-3 831).
• Total cash flow for the period amounted to 10 627 (18 888) TSEK.
• Earnings per share amounted to -0,35 (-0,25) SEK.

Year to date (1 January – 30 September 2022 compared with prior year to date 1 January 2021 – September 2021) summarized

• Net sales amounted to 378 (10) TSEK.
• Net revenue amounted to 378 (1 787) TSEK.
• EBITDA (earnings before interest, taxes, depreciation, and amortization) amounted to -19 113 (-9 748) TSEK.
• Cash flow from current operations in the quarter amounted -19 844 (-10 697) TSEK.
• Total cash flow for the period amounted to -891 (10 697) TSEK.
• Earnings per share amounted to -0,92 (-0,65) SEK.

Significant events during the Third Quarter

Strengthened commercial organization

Prostatype Genomics continues to strengthen the European sales organization and has hired Albin Bremer as sales manager responsible for the Nordic market. Albin has over 20 years of experience from both sales and sales manager roles in several leading pharmaceutical companies such as Abbott and ALK-Abelló. Most recently, Albin comes from Ipsen where he was involved in starting up and developing the company's oncology division with a strong commercial focus. With many years of experience in prostate cancer, Albin has a great understanding of how the disease affects patients and the challenges healthcare faces when it comes to better prognosticating patients with established prostate cancer.

Improved availability for laboratories

In collaboration with Karolinska Institutet in Stockholm, Prostatype Genomics has carried out an extensive validation process with the aim of significantly increasing the commercial and technical availability of Prostatype®. By validating laboratory kits from additional suppliers as well as several instruments for RNA amplification, many more laboratories can now perform the test as the results from the validations turned out positive.

Strong results for Prostatype® in Asian pilot study

The recent study was conducted in China in collaboration with the Nanjing Drum Tower University Hospital, Jiangsu, and Prostatype Genomics’ partner GloriousMed based in Shanghai. The study indicates that the clinical performance of Prostatype® in East Asian population is in line with the results previously communicated results in several studies in Caucasian populations.

Outcome of rights issue of units

The Company’s rights issue of units was closed on July 20. The rights issue was subscribed for a total of approximately SEK 17.9 million, including pre-subscription commitments of approximately SEK 8.5 million, corresponding to a subscription ratio of 79.5 percent. In addition, guarantee commitments corresponding to approximately SEK 4.6 million have been activated, meaning that Prostatype Genomics is provided 100 percent of the issue volume. Prostatype Genomics will thus initially receive approximately SEK 22.5 million before deduction of transaction related costs of approximately SEK 3.1 million in total (including compensation to guarantors of approximately SEK 1.4 million). Through the rights issue, 7,755,895 shares and 7,755,895 warrants of series TO 2 are issued. A total of 306,315 units (corresponding to approximately SEK 16.9 million) were subscribed for with the support of unit rights, including subscription commitments of approximately SEK 8.5 million. The allocation of units has been made in accordance with the allocation principles described in the prospectus that was published by the Company on the 28 June 2022.

Events after the balance day

Changes in the sales organization and updated sales forecast

The company notes that progress has been made in the designated target markets. In collaboration with local clinics, we are now building up the routines and processes that are necessary for Prostatype® to be used routinely in each market in a simple way. Innovations such as Prostatype give healthcare completely new opportunities, while initially challenging existing routines and established processes, which is why the sales trend is slightly shifted forward at a time when healthcare needs time to adapt. To strengthen the development, Prostatype Genomics is moving the responsibility for the sales organization to Sweden to ensure that the entire process takes place as uniformly and efficiently as possible. In connection with this, Mats Bergström has been hired as Sales Director EMEA. Mats has a long and solid experience from sales and introduction of new advanced Medtech products and will significantly strengthen the Company's commercial ability. The sales forecast for the year has also been updated to SEK 700,000.

New CTO

On November 8, Emelie will take over the important role of CTO of Prostatype Genomics from Lidi Xu, who has held the position since 2019. Lidi is leaving the company to move back to China with her family but will continue to work on various projects for Prostatype Genomics. Emelie Berglund has a PhD in Biotechnology from the Royal Institute of Technology in Stockholm, and more than seven years of combined research experience within prostate cancer. After her degree, Emelie has led the R&D operations of a Swedish life science company that develops products in cancer detection and biomarker analysis.

CEO comments

Positive momentum

During the third quarter, we have taken several measures to intensify the commercialization process, and we are now experiencing positive signals in several markets, although we naturally would like to see faster decision-making processes within certain parts of the healthcare systems. The key thing, however, is that we get confirmation from our customers that Prostatype® fulfils the existing clinical need and that sales have started to come in, albeit still at low levels. The fact that the healthcare system sees the added value of Prostatype® so clearly that they want to introduce the product into clinical routine in order to more effectively stratify patients diagnosed with prostate cancer is of course crucial to further marketing.

Sales and market development

We can already state that full year sales for 2022 will not reach the expectations we had at the beginning of the year. During the quarter, the Company had a turnover of around 0.1 MSEK, which means that we have reached a turnover of around 0.4 MSEK during the three first quarters of the year. However, we are in a positive trend in terms of sales, and it is obvious that we are making concrete progress. In total, we have acceptance from more than 100 clinics/healthcare facilities that will begin their own evaluation of Prostatype®, which is very gratifying. Of these, about 20 units have already completed their validation with good results. A further 30 or so units are currently in the middle of the evaluation phase. To this must be added another 50 or so units that are about to start their evaluation of Prostatype.

Of the 20 or so healthcare facilities that have already completed their evaluation, all have expressed a wish to work with Prostatype® in clinical routine. A better rating is difficult to achieve, and it clearly shows the potential Prostatype® possesses, which will result in a continued sales growth.

It is also gratifying to note that healthcare is increasingly turning directly to Prostatype Genomics for information about Prostatype® and this is the clearest proof of all that we are on the right track to the satisfaction of shareholders, patients, and healthcare systems. We have now increased our focus on building up, in collaboration with local clinics, the routines and processes that are necessary for Prostatype® to be used routinely in a simple way. Innovative tests and therapies give healthcare completely new opportunities, while initially challenging existing routines and established processes. It is our task to find, together with the local healthcare system, the logistical and practical solutions required to make Prostatype® available to more and more patients diagnosed with prostate cancer.

To put things into perspective, there are around 23,000 urologists active in the target markets we work with within EMEA. An average urologist specializing in prostate cancer sees approximately 80 newly diagnosed patients each year. Roughly 50 of these patients have a low or intermediate risk, which is the patient group where Prostatype® provides the most benefit. Concretely, this means that globally we only need to have 150 urologists using Prostatype® routinely for us to break even. This means a penetration rate of less than 1% and shows the very interesting financial possibilities an investment in Prostatype Genomics entails. We still have some way to go before we achieve this goal, but we are clearly on the right track and with all the positive comments we are getting from our customers, it feels reassuring.

To be able to respond even better to our customers' expectations, it is a pleasure to welcome Mats Bergström and Albin Bremer to Prostatype Genomics. Mats has taken overall sales responsibility for Europe and possesses an invaluable knowledge of successfully introducing medical innovations to the European markets and we have already seen concrete results of what Mats will contribute. Albin is responsible for sales for the Nordic market and has more than 20 years of experience in the therapy area of ​​urology, which of course means very good access to our priority customers. During the quarter, Albin has done an enormous amount of work in a very short time, and we all have reason to look forward to Albin's further efforts for the company.

US

Another very interesting region is of course the USA. Not only is the US market huge in terms of value, but it is also characterized by a level of maturity and a general healthcare acceptance of prognostic markers that is more than a decade ahead of Europe. The successful rights issue we completed during the summer now gives us opportunities to increase the speed of our US establishment, and I expect to get back to you with exciting news shortly.

New opportunities to use Prostatype® locally strengthen our offering

One of the major commercial and scientific strengths of Prostatype® is the simplicity of performing the test, enabling most qualified testing laboratories to perform it locally. To open up for even more testing laboratories to be able to use Prostatype®, we have executed an extensive process to validate laboratory kits as well as instruments for RNA amplification from a number of different suppliers. The validation process was carried out together with the Karolinska Institutet in Stockholm and the results mean great logistical advantages, as the number of laboratories that can perform the test, in Sweden, Europe and globally, increases dramatically.

In summary, we are well positioned for the fourth quarter of this year and above all for the full year of 2023 when we will be able to seriously begin to reap the rewards of all the hard work that has been put in during the current year and I look forward to sharing continued progress with you.

A big thank you to all shareholders for all the interest and support you show the company. It means a lot to us who work and live with Prostatype Genomics every day!

Fredrik Persson

CEO, Prostatype Genomics AB

Solna 10 November

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 10-11-2022 08:00 CET.