Significant events during the fourth quarter

• Updated timetable for supplementation of the FDA submission.
• DiviTum®TKa results from the PYTHIA study published in EJC.
• Decision to set up own CLIA laboratory in San Diego, USA.
• Positive DiviTum®TKa results published in npj Breast Cancer
• Biovica submits updated 510(k) application for DiviTum®TKa to the FDA

Significant events after the end of the period

• Biovica’s DiviTum®TKa presented at ASCO
• DiviTum®TKa predicts clinical outcome for patients in the BioItaLEE study

Audiocast:
When: 16 June 2022 at 15.00 CET
Where: https://tv.streamfabriken.com/biovica-international-q4-2021-2022
Phone numbers: SE: +46856642692, DK: +4578723252, UK: +443333009031, US: +16467224956
Broadcast language: in English

CEO’s comments

The high point of the quarter was when we submitted our 510(k) application to the US Food and Drug Administration (FDS) for market approval of DiviTum®TKa. Our updated application contained answers to all of the questions asked by the FDA during the interactive process up until February 2022.

Our team has worked meticulously to provide all of the remaining information requested by the FDA and we were able to submit our complete application prior to the end of April, approximately one month earlier than we had previously communicated. We are now awaiting the FDA’s decision, which is expected to be an approval (clearance) or request that we submit more information.

During the quarter, we also continued our preparations for the upcoming launch. We are looking forward to making DiviTum®TKa available to breast cancer patients in the USA via our own CLIA certified laboratory. We have signed an agreement for laboratory premises in San Diego and are currently working to get the lab set up. We expect to receive the CLIA certification during the third quarter of 2022. The lab will serve the entire country and there are major benefits associated with this solution. It will give us better margins and enable us to have direct contact with our customers and payers, along with better circumstances for being able to establish a price for DiviTum®TKa that reflects the significant benefits it can offer to both payers and patients.

We held a capital market day on 17 May to provide more information on how we are planning for the upcoming launch. Presentations were made by representatives from every part of the organization. To prepare for the launch, we are working with the plan for market access and reimbursement, as well as fortifying our organization and processes so that we will be able to start selling DiviTum®TKa as soon as possible once we have been granted market approval. We are in the early stages of setting up a specialized salesforce for oncology diagnostics in order to train and inform healthcare professionals about the clinical advantages of DiviTum®TKa.

The launch of new, diagnostic products requires close collaboration with public and private payers. Having our own CLIA lab will enable us to manage the reimbursement process, which is a major advantage for the launch. Running their own CLIA lab is the most common model used by successful diagnostic companies in the USA. We will be actively working with payers, providing clinical data and striving to ensure that the test gets included in guidelines. For more details on our plans, please see the recorded capital market day presentation that we have posted on our website.

One important cornerstone for a successful launch is strong scientific support. It was therefore very encouraging to see recognition that DiviTum®TKa received during the last quarter. For example, positive results from the PYTHIA study were published in the European Journal of Cancer (EJC), as well as in npj Breast Cancer, a Nature open access journal, showing that DiviTum®TKa is able to identify disease progression many months ahead of imaging. DiviTum®TKa was also highlighted in an oral presentation and as both an abstract and poster at the world’s largest cancer conference, ASCO, which took place in Chicago in early June.

As we await a decision by the FDA, there is an intense level of activity going on beneath the surface. It is wonderful to see the expertise and talent we have been able attract, along with the enormous dedication of all our employees, which includes those who have recently joined and those who have been with us much longer. Everyone in the company is working with great care and perseverance so that we are ready in the starting blocks as soon as we receive market approval. It’s something we are all anticipating with great confidence.

Anders Rylander, CEO