Significant events during the second quarter

• Biovica has strengthened its management team with the addition of Warren Cresswell, President Americas, with responsibility for the launch of DiviTum®TKa in the USA.
• Update on delay in the FDA process.
• Promising DiviTum®TKa results from the Novartis BioItaLEE study presented at ESMO.
• DiviTum®TKa results from the SWOG study published at Clinical Cancer Research.

Significant events after the end of the period

• Article on the DiviTum®TKa Budget Impact Model published in the Journal of Medical Economics.
• Three studies with DiviTum®TKa presented at SABCS 2021.
• Start of TK IMPACT study at Washington University in St. Louis.

Audiocast:
When: 1 December 2021 at 3 PM CET
Where: https://tv.streamfabriken.com/biovica-international-q2-2021-2022
Phone numbers: SE: +46850558350, DK: +4578150109, UK: +443333009031, US: +16467224904
Broadcast language: in English

CEO’s comments

For Biovica, there was much focus during the second quarter on the dialog with the US Food and Drug Administration (FDA). Communication with them has been positive, but the FDA is still struggling to cope with its high workload stemming from the COVID-19 pandemic, which has made it difficult for them to stick to their regular processing time.

In mid-September we announced that we are still waiting for feedback from the FDA in order to be able to submit our updated 510(k) application. The status as of the end of November is that we are still waiting for feedback from the FDA.

It will be possible to launch DiviTum®TKa in the USA once 510(k) approval has been obtained, which we are not expecting before the end of the year. In parallel with that, we are working with the launch in Europe, which is expected to occur after approval and launch in the USA.

One of Biovica’s strengths is all of the positive results from clinical trials using the assay. At the world-leading San Antonio Breast Cancer Symposium (SABCS), which will take place during 7–10 December, positive results from studies with DiviTum®TKa will once again be presented. This year, the results from two studies will be presented. One is the clinical study, PROMISE (NCT03281902) performed at the Mayo Clinic and the other is from a collaboration with Carrick Therapeutics.

Researchers involved in the PROMISE study have concluded that TK activity (TKa) prior to treatment with CDK4/6 inhibitor for patients with hormone receptor positive metastatic breast cancer is associated with progression free survival. Concluding that DiviTum®TKa has prognostic value when treating breast cancer patients is an important validation of our test as a potential standard tool for evaluation of the treatment effect on metastatic breast cancer.

Carrick Therapeutics is a pharmaceutical company which, among other things, develops a next generation CDK7 inhibitor, samuraciclib. It is a very interesting pharmaceutical candidate, which has also received Fast Track status from the FDA. Carrick has reached out to Biovica in order to investigate whether DiviTum®TKa could complement their own drug development efforts. Carrick presented the first results of our collaboration at SABCS 2021, showing that, for patients with triple negative breast cancer (TNBC), DiviTum®TKa is able to monitor samuraciclib treatment and is thus useful for monitoring of next generation CDK inhibitors.

It is truly satisfying that more and more pharmaceutical companies are recognizing the value of DiviTum®TKa as they pursue their drug development efforts. Of late, we have noticed an increasing demand for DiviTum®TKa from pharmaceutical companies that develop next generation CDK inhibitors. The next step is to establish more in-depth companion diagnostic (CDx) collaborations, which involves using a diagnostic test as a companion to a therapeutic drug in order to determine its suitability for specific patients.

During the quarter, we also announced that DiviTum®TKa results from an analysis of samples from the large SWOG S0226 study were published in the highly ranked scientific journal, Clinical Cancer Research, which is issued by the American Association for Cancer Research (AACR). The strong results support use of DiviTum®TKa as a tool for monitoring disease progression with endocrine therapy in women with hormone receptor positive metastatic breast cancer and publication in this journal represents important validation of DiviTum®TKa’s importance and value.

Promising DiviTum®TKa results from the Novartis BioItaLEE study (287 patients) were also presented at the European Society for Medical Oncology (ESMO) conference during 16-21 September. The results strengthen the potential of DiviTum®TKa as a prognostic, predictive and monitoring biomarker for treatment with the CDK4/6 inhibitor ribociclib from Novartis. It is very promising to see that the results are consistent with prior DiviTum®TKa results with CDK4/6 inhibitor palbociclib from Pfizer.

Washington University in St. Louis has initiated a prospective clinical study aimed at evaluating the clinical utility of DiviTum®TKa for monitoring patients with metastatic breast cancer. It is expected that this study will provide important information on the advantages that DiviTum®TKa offers compared to monitoring using imaging diagnostics and we are looking forward to those results.

One of the most essential cornerstones of a successful commercialization of DiviTum®TKa in the USA is reimbursement from payers. With this in mind, we have created a budget impact model based on DiviTum®TKa’s positive clinical results in order to clarify the health economic benefits associated with its use.

The model was presented at the ISPOR conference, and it will now also be presented at SABCS, along with having been published in the Journal of Medical Economics.
The results from this study show that adding DiviTum®TKa to the care regime could offer a net reduction in costs of up to three times its price.

In conjunction with that, we have grown the organization in both Sweden and the USA. During the quarter, we recruited Warren Cresswell as President of the Americas.
He has 25 years of experience in the diagnostics industry, bringing with him an extensive network and valuable knowledge of the US reimbursement system. With Warren at the helm in the USA, I am convinced that we will succeed with our launch.