Biovica - Take-aways from Capital Markets Day

Paving the road towards commercialisation US lab partner expected within 12 months Looking at the potential beyond breast cancer DiviTum looking to fill a gap in current treatment guidelines Biovica hosted a virtual CMD and gave an update on the pathway to commercialisation. It revealed its reimbursement strategy and plans to go for a value-based code. It expects to get payment support on its pricing (USD 400), supported by the published health economic model (ISPOR 2021) that show DiviTum can achieve savings if it reduces futile treatment. It also showed the landscape for guidelines for diagnostic tools, which will be important for adoption and reimbursement.

Currently, no explicit guidance is given for the use of tumor markers (or PET/CT), which leaves room for tools that can prove a strong clinical benefit. Commercial partner will be an important milestone Currently, there are ongoing signing discussions with lab partners in the US and Europe. These late-stage discussions relate to a research-only setting, but there are also ongoing talks with labs for commercial IVD use.

The rationale behind focusing on research-only initially is that it allows for establishing a partnership before it achieves 510(k). These lab partners may become familiar with DiviTum and it provides an opportunity for expansion to a commercial IVD agreement later. In the Q&A, Biovica highlighted a lab partnership agreement as a milestone it expects to reach within the next 12 months.

The company expects an FDA 510(k) clearance in Q3’21 and first US reimbursement at the end of 2021. Exploring potential in new indications beyond breast cancer It also discussed the potential in other indications and focused on metastatic malignant melanoma (mMM) as a natural next step. mMM is a highly aggressive cancer that benefits from treatment monitoring and it is primarily not treated with chemotherapy (similar to MBC).

It also highlighted castrate-resistant prostate cancer (CRPC) and non-small c.