CEO’s comments

Continued focus on commercialization of DiviTum®

The focus of Biovica’s business plan is commercialization of DiviTum®, which will provide cancer patients with more personalized treatments leading to better outcomes while ensuring that society uses it resources in the most efficient way. We have targeted the US and European market, where Biovica’s market potential for DiviTum® is estimated at SEK 6 billion.

We took significant steps towards that goal in the third quarter:

• Progress in the efforts aimed at FDA approval in accordance with plan
• Additional positive study results that provide the foundation for commercialization of DiviTum®
• New employees fortify the organization for the pending commercialization

Progress in our efforts to obtain FDA approval

Biovica has concluded the development project for the product to meet the requirements for FDA approval. These improvements are currently being verified in accordance with the agreed specification with the FDA in the supplement 1 stage.

Additional positive study results

Our clinical development program documents the benefits of DiviTum® to both patients and society. It also provides the foundation for successful commercialization of the product. The study results are a necessary component of the regulatory process and for obtaining reimbursement. They are also very important in generating demand and for establishing commercial partnerships for sales.

We are thus very pleased with the study results we received in February 2019 showing that DiviTum®, as the first blood-based biomarker, can be used to evaluate the effects on metastatic breast cancer following treatment with Palbociclib (a CDK4/6 inhibitor).  The results will be presented at the AACR Annual Congress in April 2019.

Fortified organization as we prepare for commercialization

Biovica held an extraordinary general meeting on 20 March 2019 to elect Lars Holmqvist as the company’s new Chairman of the Board. Lars Holmqvist will contribute his unique expertise of the commercialization process. He also has an extensive international network that will be of great value to Biovica during the ongoing commercialization process for DiviTum®. Lars replaces Göran Brorson, who has made a valuable contribution to Biovica and was a driving force in its development.

Biovica also established an office and staff in Boston, USA. It is another important part of the ongoing commercialization process, bringing us closer to both partners and customers.

New customers and sales of SEK 1.5 million

The great potential for the product exists in the market for clinical use, which requires regulatory approval. Additional potential for DiviTum® exists in the research market, where the test is used to help develop new cancer drugs. Two new customers, a pharmaceutical company and a CRO, haves been added and they've also placed their first orders. Their orders for the DiviTum® kit total approximately SEK 1.5 million. Two global pharmaceutical companies that develop new cancer drugs and see the benefits of DiviTum® are behind these orders.

Future

Biovica has a unique product that fulfills a great need in the market. We are following our plan for product launch. We have obtained good results from our studies with DiviTum® and our interaction with the FDA has been positive. On the whole, I am optimistic about the future and confident that the day is approaching when we can feel proud of having contributed the best possible treatment from day one to cancer patients all over the world, while creating great significant value to our shareholders.

Anders Rylander

CEO