UPPSALA, SWEDEN / ACCESSWIRE / March 16, 2023 / Biovica International (STO:BIOVIC-B)(STO:BIOVIC.B)(FRA:9II) DiviTum® TKa ready for clinical use in the US
|May-Jan 22/23||May-Jan 21/22||Full year|
|Operating profit (loss)||-29,277||-14,417||-73,250||-40,970||-60,101|
|Profit (loss) for the period||-28,538||-14,334||-72,793||-40,947||-60,003|
|Earnings per share, after dilution||-0.64||-0.50||-2.33||-1.44||-2.11|
Significant events during the third quarter
- Resolution on rights issue passed at the extraordinary general meeting on 7 November 2022
- Abstract and poster at SABCS on TK IMPACT study
- Abstract and poster at SABCS on results from MA38 study
- Sales team in place for launch in the USA from December.
- Successful outcome for the rights issue. SEK 148 million in capital raised, prior to issue costs.
- Anders Morén took over as the CFO on 1st of January 2023
- Clinical validation data on DiviTum® TKa published in Biomarkers.
Significant events after the end of the period
- Biovica obtained CLIA Certification for its laboratory in San Diego.
When: 16 March 2023, 3:00 pm to 4:00 pm CET
Broadcast language: in English
During the quarter, we focused our efforts on completing the CLIA certification of our laboratory in San Diego. We achieved that milestone early in February, just after the end of the quarter. The CLIA certification means that we now have all of the regulatory approvals required for being able to offer DiviTum® TKa to patients for clinical use in the US market.
In December 2022, we set up a sales team in the USA by hiring eight employees, which will ensure a quick launch of DiviTum® TKa. I was in the USA at the beginning of the year and met with the entire team, which impressed me with their overall knowledge and enthusiasm. Already prior to obtaining the certification, they had made progress meeting customers and informing them of the major benefits associated with DiviTum® TKa. The feedback from customers that our sales team has met over the last few months has been very positive. They understand the value of measuring cell proliferation for metastatic breast cancer, as well as in other areas.
We are focusing on customers with the greatest potential. One of those categories is the NCI Designated Cancer Centers, of which 63 meet patients for clinical treatment. The NCI Designated Cancer Centers are funded by the National Cancer Institute (NCI) and they are considered to be the leading cancer clinics in the USA. We have interacted with 89% of these clinics and have already had initial meetings with 51% of them.
Our Research Use Only category of sales is also making progress. Our strategy is to offer DiviTum® TKa to pharmaceutical companies that are developing new drugs in the cancer area in order to streamline ongoing clinical studies and simultaneously generate opportunities for long-term and joint development projects. Our ambition is for these projects to result in new companion diagnostic (CDx) collaborations for Biovica.
During the period, we got involved in six new projects run by pharmaceutical companies that include DiviTum® TKa. Here, too, we see the value of having our own CLIA laboratory in San Diego, since a large portion of the analyses from these projects will be performed there. This guarantees Biovica revenue already now. However, the greatest potential exists in our partners developing new cancer drugs that obtain market approval together with DiviTum® TKa.
Strong scientific support is crucial to generating demand. With that in mind, it is very encouraging that DiviTum® TKa, once again, was represented at the world's largest cancer symposium, an Antonio Breast Cancer Symposium (SABCS). It took place in December of last year and the results from two studies with DiviTum® TKa were presented there. One was the MA38 study together with Canadian Cancer Trial Group and the other was the TK IMPACT study together with Washington University, St Louis.
In addition to the publications at SABCS, the clinical validation data for DiviTum® TKa was published in the scientific journal, Biomarkers, in January. The results from the clinical validation support the use of DiviTum® TKa for monitoring patients with metastatic breast cancer, which served as the foundation for our FDA approval. These studies further strengthen the already strong documentation on the clinical value of DiviTum® TKa.
CLIA certification was the final regulatory milestone that we needed to pass prior to launch in the US market and making serious progress with sales of the product there. We are now fervently working to establish DiviTum® TKa in the USA as quickly as possible so that it may benefit patients, health care providers and payers!
Anders Rylander, CEO
Anders Rylander, CEO
Phone: +46-18-444 48 35
E-mail: [email protected]
Biovica - Treatment decisions with greater confidence
Biovica develops and commercializes blood-based biomarker assays that help oncologists monitor cancer progression. Biovica's assay, DiviTum® TKa, measures cell proliferation by detecting the TKa biomarker in the bloodstream. The assay has demonstrated its ability to provide insight to therapy effectiveness in several clinical trials. The first application for the DiviTum® TKa test is treatment monitoring of patients with metastatic breast cancer. Biovica's vision is: "Improved care for cancer patients." Biovica collaborates with world-leading cancer institutes and pharmaceutical companies. DiviTum® TKa has received FDA 510(k) clearance in the US and is CE-marked in the EU. Biovica's shares are traded on the Nasdaq First North Premier Growth Market (BIOVIC B). FNCA Sweden AB is the company's Certified Adviser. For more information, please visit: www.biovica.com
SOURCE: Biovica International