Press release Biocartis Holdings Inc.: Recapitalization completed and product portfolio expansion
22 Novembre 2023 - 10:00AM
Press release Biocartis Holdings Inc.: Recapitalization completed
and product portfolio expansion
PRESS RELEASE - 22 November 2023, 10:00 CET
BIOCARTIS HOLDINGS INC.
RECAPITALIZATION COMPLETED AND PRODUCT
PORTFOLIO EXPANSION
- The recapitalization of Biocartis was completed last week,
strengthening the balance sheet with a new investment of €40
million and a €132 million conversion of debt to equity.
- Product portfolio expansion with
the launch of three breast cancer products: the Idylla™ PIK3CA-AKT1
Mutation Assay and, in collaboration with our partner APIS, the
APIS Breast Cancer Subtyping Kit and the APIS ESR1 Mutations
Kit.
- Upcoming launches of thyroid and
melanoma partner assays planned in Q4 2023.
Mechelen, Belgium, and Itasca (IL) United
States 22 November 2023 – Biocartis Holdings Inc., the
entity that now owns Biocartis NV and Biocartis US Inc., announces
that its balance sheet recapitalization is complete. As part of
this recapitalization plan, the balance sheet is substantially
strengthened with the prior secured creditors of Biocartis Group
NV, converting a significant proportion of debt into equity in
Biocartis Holdings Inc.
In connection with the restructuring, approximately
€132 million of debt was converted into equity, with the new lead
shareholders of Biocartis Holdings Inc. also investing an
additional €40 million of new cash. As previously announced,
customers, suppliers, partners, employees and trade creditors of
Biocartis NV and Biocartis US Inc. have not been impacted by the
change in ownership of the Biocartis business.
Biocartis has also expanded its product portfolio
with the launch of the Idylla™ PIK3CA-AKT1 Mutation
Assay (RUO1). PIK3CA is an important biomarker in the
treatment of advanced breast cancer and research shows that it
plays a key role in other cancer indications as well.2 Through
Biocartis’ partnership with APIS Assay Technologies, it
simultaneously co-launched the APIS Breast Cancer Subtyping
Kit (RUO) and the APIS ESR1 Mutations Kit
(RUO). The APIS Breast Cancer Subtyping Kit is an advanced assay
for characterizing3 early stage breast cancer in less than five
hours, while the APIS ESR1 Mutations Kit supports detection of
mutations in the estrogen receptor gene (ESR1) that are associated
with resistance to endocrine therapy4.
Biocartis is planning more product launches with
its partners this year: Idylla™ CP-GEP (RUO) and
the Idylla™ ThyroidPrint®
Assay (RUO). Idylla™ CP-GEP is developed in
partnership with SkylineDx and is based on a powerful proprietary
algorithm that combines clinicopathological (CP) factors with gene
expression profiling (GEP) information obtained from cutaneous
melanoma FFPE5 samples. This product enables laboratories to
conduct further research in cutaneous melanoma. The Idylla™
ThyroidPrint® Assay is an advanced genomic signature Assay that is
developed in collaboration with GeneproDX. This product measures a
gene expression signature from FNA6 samples and enables
laboratories to conduct further research on risk stratification of
indeterminate thyroid nodules.
Roger Moody, Chief Executive Officer of
Biocartis, commented: “We are very pleased to have the
recapitalization behind us. The new funding will, in combination
with the significantly lowered cost structure and debt structure,
allow Biocartis to invest in expanding its business instead of
servicing its debt. Having completed the recapitalization, we have
the foundation for a bright future. We are also very excited about
our expanding product portfolio. The new oncology tests that we
have recently launched should help our growth in 2024 and beyond,
as we continue to deliver faster testing solutions to our
customers. In addition, we look forward to continuing to expand our
product portfolio with tests in the field of cutaneous melanoma and
thyroid cancer. Oncologists are looking for faster results to get
cancer patients on the right treatment, and our Idylla™ Platform is
the ideal solution to these market needs. We continue to work hard
towards the goal for our products to make a difference for cancer
patients around the world.”
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More information:
Website: www.biocartis.com
e-mail: ir@biocartis.com
About Biocartis
With its revolutionary and proprietary Idylla™
Platform, Biocartis aspires to enable personalized medicine for
patients around the world through universal access to molecular
testing, by making molecular testing actionable, convenient, fast
and suitable for any lab. The Idylla™ Platform is a fully automated
sample-to-result, real-time PCR (Polymerase Chain Reaction) based
system designed to offer in-house access to accurate molecular
information in a minimum amount of time for faster, informed
treatment decisions. Idylla™'s continuously expanding menu of
molecular diagnostic tests addresses key unmet clinical needs, with
a focus in oncology. This is the fastest growing segment of the
molecular diagnostics market worldwide. Today, Biocartis offers
tests supporting melanoma, colorectal, lung, breast and liver
cancer, as well as for sepsis. More
information: www.biocartis.com. Follow us on X (Twitter):
@Biocartis_.
This press release is not for distribution,
directly or indirectly, in any jurisdiction where to do so would be
unlawful. Any persons reading this press release should inform
themselves of and observe any such restrictions. The Company takes
no responsibility for any violation of any such restrictions by any
person. This press release does not constitute an offer to sell or
buy, nor the solicitation of an offer to sell or buy, any
securities referred to herein in any jurisdiction. Any solicitation
or offer will only be made pursuant to a confidential offering
memorandum and only to such persons and in such jurisdictions as is
permitted under applicable law.
1 For Research Use Only (RUO), not for use in
diagnostic procedures.2 Miricescu et al. PI3K/AKT/mTOR Signaling
Pathway in Breast Cancer: From Molecular Landscape to Clinical
Aspects. Int J Mol Sci (2020) 22: 1733 13th St. Gallen
International Breast Cancer Conference 2013, Expert panel consensus
opinion.4 Brett et al. ESR1 mutation as an emerging clinical
biomarker in metastatic hormone receptor-positive breast cancer.
Breast Cancer Res. (2021) 23: 855 Formalin-Fixed Paraffin-Embedded6
Fine Needle Aspirate
Grafico Azioni Biocartis Group NV (EU:BCART)
Storico
Da Mar 2024 a Apr 2024
Grafico Azioni Biocartis Group NV (EU:BCART)
Storico
Da Apr 2023 a Apr 2024
