"The results from two additional studies with DiviTum® will be presented at San Antonio Breast Cancer Symposium, the world's largest scientific conference on breast cancer".
-
Period: May-October 2019/2020
SEK 000s Q2 Q2 May-Oct 19/20 May-Oct 18/19 May-April 18/19
19/20 18/19
Net sales 1,249 68 1,616 981 3,005
Operating profit -5,990 -5,609 -12,087 -9,566 -21,718
(loss)
Profit (loss) for -5,958 -5,563 -12,026 -9,592 -21,556
the period
Earnings per -0.25 -0.32 -0.51 -0.55 -1.23
share, before
dilution
Significant events during the second quarter
· Plan for clinical validation established following feedback from FDA
· Contract signed with leading US cancer group, SWOG, for analysis of major study where the results will be an important part of the FDA submission
· Timetable for 510(k) submission - now set for mid-2020
Significant events after the end of the period
·
· New results where DiviTum® has been validated as a dynamic biomarker for metastatic breast cancer in a collaborative study with Institut Curie in
· DiviTum® - New clinical data that it is a strong prognostic marker in operable breast cancer. The results will be presented at the San Antonio Breast Cancer Symposium in
Audiocast
When:
Where: https://tv.streamfabriken.com/biovica-international-q2-2019 or
SE: +46850558369 / DK: +4578150107 /
US: +18335268384
Broadcast language: in English
CEO's comments
A market approval from the FDA is necessary in order to launch DiviTum® in USA as a tool for monitoring metastatic breast cancer. After having received written feedback from the FDA and meeting with them over the summer, we had a clear understanding of their requirements and are happy to report that the analytical validation is now progressing as planned and also showing good results. Furthermore, clinical validation is progressing as planned and the 1,500 samples to be analyzed have now been sent from
As for our clinical studies, we obtained strong results subsequent to the end of 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 will be presented at the world's largest congress on breast cancer, SABCS, San Antonio Breast Cancer Symposium, during
Subsequent to the end of the quarter, we also announced clinical data 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 will also be presented at SABCS in December. It was based on more than 600 patient samples. Adding that to the prior published study conducted in
In total, we now have more than 10 studies encompassing more than 1,700 breast cancer patients. These studies create a unique value for DiviTum® and provide the foundation for commercialization of the product.
We appointed
In summary, we are working diligently to achieve our goal of launching DiviTum® so that patients with metastatic breast cancer will receive the best possible treatment from day one. Our work with the FDA application is progressing as planned. We are reporting good results from studies and pursuing our commercialization plan. We have a unique product that meets an important need in a large, attractive market. The pieces are now in place for taking
CEO
For more information
phone: +46 (0)18 444 48 35
email: anders.rylander@biovica.com
Cecilia Driving, EVP CFO/HR/IR
phone: +46 73 125 92 47
email: cecilia.driving@biovica.com (cecilia.driving@biovica.com )
This information is information that
In the event of contradictions or differences between the Swedish press release and this English version the Swedish text will prevail.
https://news.cision.com/biovica-international-ab/r/q2-interim-report-work-with-the-fda-application-progressing-as-planned,c2983237
https://mb.cision.com/Main/14910/2983237/1156498.pdf
https://mb.cision.com/Public/14910/2983237/9f326d21c04c183a.pdf
https://news.cision.com/biovica-international-ab/i/2p5a1912-color-shader,c2724499
https://news.cision.com/biovica-international-ab/i/2p5a0261-kvadrat-rbg,c2724515
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