Biovica International
Biovica - Q2 ’19/’20: FDA application in the works (ABG Sundal Collier)

2019-12-06 16:36
510(k) application set for mid-2020
Clinical data
Financial update and key milestones ahead
Progress made in the FDA process
During Q2, Biovica established its plan for clinical validation of DiviTum following feedback from the FDA, setting the timetable for the 510(k) submission to mid-2020. A contract was also signed with a US cancer group (SWOG) for analysis of a large study (approximately 400 patients) where the results will be fundamental for the FDA submission. More than 1,500 samples to be analyzed for the SWOG study (a study on metastatic breast cancer conducted by a US network of oncologists) have now been sent from the US. Results from the study are expected to create favourable conditions for subsequent clinical acceptance. The next steps will be to perform analytical validation (end of Q1’20e) and finally clinical validation.

Clinical data to be presented at the SABCS conference
Biovica also reported new clinical data from two studies after the end of the quarter. The ALCINA study (n=103) was carried out in collaboration with Institut Curie. Results of the study show that low DiviTum values at four weeks were associated with longer progression free survival and overall survival compared with high values (10.4 vs. 4.7 months, and not reached vs. 20 months, respectively). We also received prognostic data in operable breast cancer (n=644). The studies will be presented at the world’s largest congress on breast cancer, SABCS, San Antonio Breast Cancer Symposium, during 10-14 December 2019.

Financial update and key milestones
Q2 sales amounted to SEK 1.2m, stemming from a customer in the research market. Biovica closed the quarter with a cash position of SEK 59m, implying a burn rate of SEK -9m during Q2 ’19/’20 (vs. SEK -6m in Q2 ’18/’19). Management guides for a gradual pickup in operating expenditures as Biovica approaches commercialization in the US. We note the following upcoming milestones: FDA 510(k) submission (mid-2020); 510(k) approval (end 2020); 1st US Re
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