Q2 Interim Report - Promising Results Published at ESMO
UPPSALA, SE / ACCESSWIRE /
SEK 000s | Q2 21/22 | Q2 20/21 | May-Oct 21/22 | May-Oct 20/21 | Full year 20/21 |
Net sales | 268 | 44 | 649 | 384 | 2,077 |
Operating profit (loss) | -14,314 | -8,285 | -26,552 | -16,950 | -40,181 |
Profit (loss) for the period | -14,388 | -8,208 | -26,613 | -16,581 | -39,482 |
Earnings per share after dilution | -0.51 | -0.29 | -0.93 | -0.59 | -1.39 |
Significant events during the second quarter
Biovica has strengthened its management team with the addition ofWarren Cresswell , President Americas, with responsibility for the launch of DiviTum®TKa in theUSA .- 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:
Where: https://tv.streamfabriken.com/biovica-international-q2-2021-2022
Phone numbers: SE: +46850558350, DK: +4578150109,
Broadcast language: in English
CEO's comments
For
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
One of
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
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,
Promising DiviTum®TKa results from the Novartis BioItaLEE study (287 patients) were also presented at the
One of the most essential cornerstones of a successful commercialization of DiviTum®TKa in the
The model was presented at the ISPOR conference, and it will now also be presented at SABCS, along with having been published in the
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
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
Contact
Phone: +46-18-444 48 35
E-mail: anders.rylander@biovica.com
Cecilia Driving, EVP CFO
Phone +46-73-125 92 47
E-mail: cecilia.driving@biovica.com
This information is information that
Attachments
Q2 2021 2022 Biovica ENG
SOURCE:
View source version on accesswire.com:
https://www.accesswire.com/675469/Q2-Interim-Report--Promising-Results-Published-at-ESMO
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