Significant events during the fourth quarter

• Positive results from Swedish study with DiviTum® on metastatic breast cancer published in prestigious journal
• Senior management team strengthened as Robert Dann joins Biovica as SVP Marketing and US Business
• Collaboration with Mayo Clinic to use DiviTum® for monitoring the treatment effect of CDK4/6 inhibitor for metastatic breast cancer
• Submission of the FDA application for DiviTum® is planned for the third quarter of 2020.

Significant events after the end of the period

• 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

CEO’s comments

Biovica has had yet another eventful quarter. We have focused our efforts on the market launch of DiviTum®, our blood-based biomarker assay, for monitoring treatment of metastatic breast cancer. Our product has been designed to help clinics make more informed decisions so that patients obtain the best possible treatment from day one.

DiviTum® is currently being sold primarily to major pharmaceutical companies for use in clinical studies. We are planning to submit our 510(k) application to the FDA during the third quarter of 2020. We expect to receive market approval at the start of 2021, which will give us access to the substantial US market for patient monitoring. Preparations for the approaching launch are already well underway.

The efforts to document DiviTum® as support for the FDA 510(k) application and approval are extensive. During the period, we completed a large portion of the analytical validation work, which we will complete, as planned, during the month of June. Simultaneously, we are preparing the clinical validation, which will occur during the summer. The FDA process is progressing as planned.

As regards our clinical studies, it was particularly satisfying to see the results from a study that was conducted by researchers at Lund University and published in Scientific Reports, a prestigious journal from the publishers of Nature. Results from a study of 142 women provide strong confirmation of prior studies showing that DiviTum® can be used to more quickly evaluate the treatment effect for metastatic breast cancer. The results also show that DiviTum® can be used as a prognostic tool to evaluate the treatment results for metastatic breast cancer. The positive results from the Lund study were an important contributing factor for being able to set up our collaboration with the prestigious cancer network, SWOG. It also provides us with good prospects for being able to repeat the results in our clinical validation study that is being carried out in collaboration with SWOG on a similar patient group.

Besides the Lund study, two editorials were published, confirming the need for this type of biomarker and summarizing the results with DiviTum®. The editorials confirm that DiviTum® can become an important clinical tool for metastatic breast cancer in general and evaluating the treatment effect of CDK4/6 inhibitors in particular. ASCO (American Society of Clinical Oncology), the world’s largest oncologist organization with nearly 45,000 members worldwide, recently released the ASCO Educational Book 2020. The latest edition contains a chapter on the unique, convincing results from using DiviTum® in the area of CDK4/6 inhibitors and its ability to identify treatment resistance.

Our important collaboration with SWOG has gone well. Results will be available during the summer, after which they will be submitted for publication and presentation. The results are expected to be presented at a conference just prior to the start of the new year. We then expect that publication will be during the first quarter next year. The collaboration creates an opportunity for Biovica to, via the SWOG 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®.

During the quarter, we further strengthened the organization when Robert Dann joined Biovica as SVP Marketing and US Business. Robert has extensive experience in cancer diagnostics and an excellent track record of successful product launches, which will of course be valuable when launching DiviTum®. I consider our recruitment of Robert to be a milestone for our commercialization of DiviTum® and an important step towards achieving a successful launch in the US market. I am very proud of the strong team we’ve built at Biovica and have tremendous respect for the vast talent that Biovica and our product, DiviTum®, have been able to attract.

Robert has already made a contribution by helping us create the plan for all of the activities that will be required for establishing DiviTum® in the market. Wide knowledge of DiviTum® at the time when it obtains market approval will facilitate quicker progress in the test reaching its full commercial potential.

I would like to also highlight our collaboration with world-renowned Mayo Clinic, which was announced during the quarter. Together, we will study the clinical benefits of using DiviTum® for the on-treatment monitoring of metastatic breast cancer patients receiving CDK 4/6 inhibitors, which complements our previous studies in this field. Mayo Clinic is a world-leading institute for cancer research and treatment. They also, however, have an extensive laboratory division, which could be an important commercial partner for us. Accordingly, the collaboration is important to us in many ways.

Subsequent to the end of the quarter, we held a Capital Market Day and a link to the recorded event has been posted on our website. During the event, we presented our strategy, and also announced our goal of achieving a 15 percent market share within three years of the launch. Long term, our goal is to claim 50 percent of the share in the markets where we launch DiviTum®. We also explained our plan for companion diagnostics (CDx) at the event.

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 USA for use of DiviTum® in treating metastatic breast cancer.

We have taken many important steps aimed at achieving a successful launch. In particular, I would like to highlight the dialog we’ve had with the FDA. It has given us a good understanding of what is needed for obtaining approval. One important part of the application is the extensive clinical validation study on American patients, which we are carrying out in collaboration with SWOG.

That, along with our other strong clinical results from ten studies comprising more than 1,800 breast cancer patients and 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), gives us a very solid foundation for our commercialization.

Add to that our collaboration with ASCO and acknowledgment in ASCO Educational Book 2020, with the coverage that gives us, and it is evident that we have established excellent channels for reaching out to future customers.

We are also pursuing efforts associated with reimbursement. For example, we have been conducting market analyses and interviews with payers, which has given us a clear understanding of the expected price levels and how DiviTum® should be both positioned and used.

All of it creates favorable conditions for a successful launch and the first step towards realizing the full potential of DiviTum®.

Our strong team has had a productive quarter, where we have 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 fulfills a significant need in a market that is both large and attractive. All the pieces in the puzzle are starting to fall into place for taking Biovica to the next phase in its journey and I look forward to reporting our next successes.

Anders Rylander
CEO