Significant events during the third quarter

• Otti Bengtsson Gref joined the company as Biovica’s new R&D Director and Henrik Winther joined as SVP Business Development in January 2020
• Additional results validating DiviTum® as a dynamic biomarker in monitoring metastatic breast cancer were presented by Institut Curie, Paris at the San Antonio Breast Cancer Symposium in December 2019
• New clinical data demonstrating that DiviTum® is a strong prognostic marker in operable breast cancer were presented at the San Antonio Breast Cancer Symposium in December 2019
• Clinical Cancer Research published data from the TREnd study on the benefits of using DiviTum®.   The new results show that a change in TK levels one month after the start of treatment can be used to evaluate treatment effect.

Significant events after the end of the period

• Submission of our 510(k) application for DiviTum® to the FDA is expected to occur during the third quarter of 2020, rather than in mid-2020, as earlier announced.

Audiocast

When: 12 March 2020 at 10.00 CET

Where:            https://tv.streamfabriken.com/biovica-international-q3-2019-2020 or

SE: +46850558352 / DK: +4578150110 / UK: +443333009263 /

US: +18335268398 

Broadcast language:  in English

CEO’s comments

During the quarter, we made significant progress in our prioritized areas: regulatory preparations, clinical studies and commercial activities.

We have a clear understanding of the FDA’s requirements for granting market approval for DiviTum® to be launched in USA as a tool for monitoring treatments in metastatic breast cancer patients.

I am very proud to announce that, thus far, the results from the analytical validation meet our established requirements.  Simultaneous to that, all of the patient samples from SWOG have been analyzed and the results will soon be published.

Production has been delayed due to late deliveries of one of the product’s components. These problems have now been solved, which means that the analytical validations will be completed during the second quarter. Our goal is to submit the 510(k) application for market approval to the FDA during the third quarter of 2020.

Clinical results confirmed and strengthened with new studies
As for our clinical studies, we presented new results during the quarter in line with prior results, namely, that DiviTum® could be a valuable tool for ensuring that patients get the best possible results from their treatment. I would also like to highlight one of the studies that was presented at the world’s largest congress on breast cancer, SABCS, San Antonio Breast Cancer Symposium, during 10-14 December 2019. The study is based on more than 100 patient samples and it was carried by the internationally renowned research center, Institut Curie. Results of the study show that DiviTum® can be used to monitor the treatment response of women with metastatic breast cancer. It supports the results from the TREnd study presented early in 2019 and it gives us confidence in our plans for making DiviTum® a clinically useful cell proliferation biomarker for monitoring metastatic breast cancer.

During the quarter, clinical data was presented demonstrating that DiviTum® is a strong prognostic marker in operable breast cancer. In particular, I would like to highlight a study that shows the prognostic effect of DiviTum®, making it possible to assess the risk of recurrence. That study was also presented at SABCS in December. It was based on more than 600 patients. Adding that to Nisman’s earlier groundbreaking study, it means that we now have data on more than 800 patients Subsequent to the end of the quarter, results were also published from a study by researchers at Lund University in the prestigious journal, Scientific Report. The results support prior evidence showing that DiviTum® can be used to more quickly evaluate treatment effect and as a prognostic tool. The results of this study give us confidence that with time, we should be able to expand the use of DiviTum® to other application areas.

New additions to the senior management team
During the quarter, Otti Bengtsson Gref joined the company as our new R&D Director and Henrik Winther joined as SVP Business Development. They have extensive expertise and experience in development, production, regulatory approval and commercialization of diagnostic products. They will be valuable assets to Biovica and important pieces in the puzzle for our continued market expansion. At Biovica, we now possess quite a unique combination of scientific expertise and commercial experience.

We are reporting favorable results from studies and moving towards launch of the product in the US market early in 2021 and in selected European markets shortly thereafter. Wide knowledge of DiviTum® at the time when it obtains market approval will facilitate quicker progress in the test reaching its full commercial potential.

We have a unique product that meets an important need in a large, attractive market. The pieces are now in place for taking Biovica to the next level. I would like to end by taking this opportunity to thank our shareholders for the continued confidence they have in us and all our dedicated employees for the excellent work they’ve done. I’m very much looking forward to the journey ahead with all of you.

Anders Rylander, CEO