Significant events during the fourth quarter

• Biovica announced its goal to achieve 15 percent share of the total market potential in each market within three years of the launch.
• Importance of DiviTum® and TK activity acknowledged in two scientific journals.
• ASCO Educational Book 2020 highlights DiviTum® results and TK activity.

Significant events after the end of the period

• Clinical validation, which is the last step required for the FDA validation, has been completed with positive results and the stated criteria have been met.
• Directed share issue for SEK 148 million a number of Swedish and international investors, including Andra AP-fonden, Coeli Asset Management and Lancelot Asset Management.

CEO’s comments

During the quarter, we took important steps towards achieving our goals. Preparations for the market launch of DiviTum® have intensified and we are working in accordance with our timetable to submit the application for market approval to the US Food and Drug Administration (FDA) during the third quarter of 2020.

After having submitted the 510(k) application to the FDA, we expect to receive market approval at the start of 2021, which will give us access to the substantial US market for patient monitoring. Efforts to document the assay prior to approval have been extensive and during the quarter, we took several important steps in this process. One important part of the application is the extensive clinical validation study on American patients, which we are carrying out in collaboration with SWOG Cancer Research Network.

The clinical validation was completed during the summer, where we analyzed more than 1,700 samples with good results. Just as with the analytical validation, we met the criteria we had defined. The clinical validation has thus been completed with positive results. What now remains is to compile and submit the application, which we are planning to do during the month of September.

Also during the summer, we submitted the results from the SWOG study for publication and presentation. We expect that they will be presented at a conference just prior to year-end, along with publication of the results during the first quarter of next year.

Our important collaboration with SWOG also lays the foundation for Biovica to, via the organization’s network of more than 12,000 oncologists and 1,000 cancer hospitals, widely reach the right target group and in doing so, quickly gain clinical acceptance for DiviTum®. In addition to the clinical validation study with SWOG, we have strong clinical results from eleven studies comprising more than 1,800 breast cancer patients, which were carried out in collaboration with world-leading oncologists at some of the most prestigious institutions in the world (e.g. Johns Hopkins, Mayo Clinic and Dana Farber Cancer Institute). Furthermore, there are currently five published studies underway comprising a total of 670 breast cancer patients, in addition to the SWOG study. These collaborations with the laboratory divisions of major cancer institutes are very important, in that they could later become important commercial partners for us.

During the quarter, results from a study with DiviTum® were published in Scientific Reports, a prestigious journal from the publishers of Nature. Furthermore, the ASCO Educational Book 2020 highlighted DiviTum® and the unique, strong results achieved when using it for monitoring the treatment effect of CDK4/6 inhibitors. This type of recognition is extremely important because it gives us extensive coverage and thereby creates excellent channels for reaching future customers. Wide knowledge of DiviTum® at the time when it obtains market approval will facilitate quicker progress in the test reaching its full commercial potential.

Besides that, we have made progress in creating a plan for reimbursement. Specifically, our efforts during the quarter have resulted in a clear plan for coding, coverage and payment of DiviTum®. We also initiated studies on the social benefits via cost savings of using the DiviTum® assay to treat metastatic breast cancer and thereby convince payers in USA of its value.

The market potential in the initial markets for DiviTum® is substantial, at USD 400-700 million per year for metastatic breast cancer. It is important to keep in mind, however, that initially, we are only addressing about 1 percent of all the 43 million people who are living with cancer and could potentially benefit from DiviTum®. The first step towards realizing the enormous potential is a successful launch in the USA for use of DiviTum® in treating metastatic breast cancer.

In May, we held a Capital Market Day, where we presented our strategy and announced our goal of achieving a 15 percent market share in each market within three years of the launch of DiviTum®. Long term, our goal is to claim 50 percent of the market share in each market. We also explained our plan for companion diagnostics (CDx) at the event.

To finance the commercialization plan, we carried out a directed share issue for a total of SEK 148 million.

In recent years, Biovica has attracted unique expertise and built a strong organization that is prepared for our important launch in the USA. At today’s AGM, two individuals will be proposed as new Board members: Annika Carlsson Berg and Marie-Louise Fjällskog. Annika Carlsson Berg has 34 years of experience in the pharmaceutical, biotech and diagnostics industry, of which, 23 years have been in executive positions. She is currently employed as the Director of Quality and Regulatory Affairs at the ImmunoDiagnostic Division of Thermo Fisher Scientific. Marie-Louise Fjällskog is an oncologist with more than 25 years of experience in clinical oncology, transnational research and pharmaceutical development. She is currently employed as the Chief Medical Officer at Sensei Biotherapeutics in Boston, USA. Their expertise and talent will be a great asset to Biovica and I am very much looking forward to the contribution each will make by participating on the Board.

Biovica has had an intensive quarter, where we’ve taken further steps towards achieving our goal: that patients with metastatic breast cancer will receive the best possible treatment from day one. We have a unique product that meets an important need in a large, attractive market, which gives us a very solid foundation for our commercialization. A successful launch in the USA for use of DiviTum® in treating metastatic breast cancer is the first step towards realizing the product’s full potential. I’m looking forward to what lies ahead and reporting our next successes.