Plan for 510(k) submission specified – Q1 Interim Report: May-July 2019/2020

2019-08-29 08:00

SEK thousands  Q1 19/20  Q1 18/19  May-April 18/19 
Net sales  367  914  3,005 
Operating profit (loss)  -6,097  -3,956  -21,718 
Profit (loss) for the period  -6,068  -4,028  -21,556 
Earnings per share, after dilution  -0.33  -0.23  -1.18 

Significant events during the first quarter

  •  Targeted new share issue for SEK 60 million to European and Swedish institutional investors and family offices
  •  Positive study results from the EFECT study with DiviTum® published in the prestigious European Journal of Cancer

Significant events after the end of the period

  •  Plan for clinical validation established following feedback from FDA
  •  Contract signed with leading US cancer group for analysis of major study where the results will be an important part of the FDA submission
  •  Timetable for 510(k) submission adjusted – now set for mid-2020

CEO’s comments

Commercialization of DiviTum® for breast cancer
During the first quarter of the new financial year, we achieved several important milestones in our efforts to launch DiviTum® in the US and European market for monitoring of treatment for metastatic breast cancer. Significant milestones during the period:

  • We carried out a targeted new share issue to broaden the scope of ownership and fund our ongoing commercialization efforts

Significant events after the end of the period:

  • We signed an agreement with a leading US network for cancer research aimed at analyzing the clinical value of DiviTum® based on data from their major study. It will serve as the basis for our FDA application
  • Based on feedback from the FDA, Biovica set the timetable for its 510(k) application
  • The timetable for submitting the application has been adjusted from end of 2019 (previously communicated) to mid-2020

Broader ownership and equity injection of SEK 60 million
Biovica boosted its equity by SEK 60 million during the fourth quarter via a targeted new share issue. The new share issue was targeted at professional investors like European funds, institutional investors and family offices. In total, 29 professional investors subscribed for shares. The financing provides Biovica with resources for pursuing its business plan.

Contract signed for analysis of a major study that will be used as the basis for the FDA application
Biovica signed a contract with a US cancer research network consisting of leading oncologists who are analyzing a major study on metastatic breast cancer. The study involves several hundred patients and this comprehensive material has great potential for serving as the foundation for Biovica's FDA 510(k) application and creating the conditions for gaining clinical acceptance.

Timetable set for Biovica's 510(k) application based on feedback from the FDA
Supplement II contained Biovica's questions to the FDA on the company's clinical validation plan. During the summer, Biovica received written feedback from the FDA and had meetings with its contacts there, which has given us a clear understanding of how to meet the FDA requirements in our clinical validation plan. This has enabled us to move forward towards our next milestone, which is clinical validation. The feedback gives us assurance that our plan will meet the stated requirements for approval. As previously communicated, we will submit our application for approval for one area of application on monitoring treatments of metastatic breast cancer.

We decided to move the date for submitting the application until the middle of 2020 so that we can, in it, include the major US breast cancer study we now have access to and, to improve the likelihood of covering all areas we’ve established in consultation with the FDA.

Launch of DiviTum®
Other work is being done simultaneous to the 510(k) application efforts. We are striving to introduce DiviTum® for routine clinical use by getting it included in treatment guidelines, payment systems and by setting up commercial partnerships for sales in networks that will serve as a channel for reaching Biovica’s market.

The product is already being sold for research purposes, primarily by major pharmaceutical companies that are using DiviTum® in clinical studies for taking new drugs to market.

I can proudly conclude that we are getting very close to the day when we will launch DiviTum® for clinical use and thereby offer patients with metastatic breast cancer a diagnostic tool ensuring that they get the best possible treatment from day one. In doing so, we will also generate value to our shareholders.

Anders Rylander



Numbers of patients in studies




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