UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the date of December 13, 2023
Commission File Number 001-39124
Centogene N.V.
(Translation of registrant's name into English)
Am Strande
7
18055 Rostock
Germany
(Address of principal executive offices)
Indicate by check mark whether the registrant files
or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F..X.. Form 40-F.....
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ___
Indicate by check mark if the registrant is submitting
the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
Centogene N.V.
On December 13, 2023, Centogene N.V. issued a press release titled
“CENTOGENE’s Frontotemporal Dementia (FTD) Genetic Study, EFRONT, Reaches Initial Patient Enrollment Milestone”.
A copy of the press release is attached hereto as Exhibit 99.1.
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: December 13, 2023
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CENTOGENE N.V.
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By: |
/s/ Jose Miguel Coego Rios |
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Name: |
Jose Miguel Coego Rios |
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Title: |
Chief Financial Officer |
Exhibit Index
Exhibit |
Description of Exhibit |
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99.1 |
Press Release dated December 13, 2023 |
Exhibit
99.1
Press Release
CENTOGENE’s
Frontotemporal Dementia (FTD) Genetic Study, EFRONT, Reaches Initial Patient Enrollment Milestone
CAMBRIDGE,
Mass. And ROSTOCK, Germany, and BERLIN, December 13, 2023 (GLOBE NEWSWIRE) –
Centogene N.V. (Nasdaq: CNTG), the essential
life science partner for data-driven answers in rare and neurodegenerative diseases, today announced the Company reached its initial
recruitment and genetic testing milestone in the observational EFRONT Study, being
conducted to advance the genetic understanding of frontotemporal dementia (FTD).
The EFRONT Study has been conducted with
support from Alector, a clinical-stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment
of neurodegenerative diseases, including FTD.
“Screening potential trial participants
for genetic variants of FTD presents significant challenges. CENTOGENE has facilitated important genetic screening of FTD patients, and
we are pleased to have supported their EFRONT Study,” said Gary Romano, M.D., Ph.D., Chief Medical Officer of Alector. “Frontotemporal
dementia is a devastating disease for which new treatment options are urgently needed. Genetic screening is critical to the successful
execution of clinical trials in genetically defined populations like FTD-GRN.”
Having met this milestone, CENTOGENE
will continue to work with its extensive network of 30,000 physicians and enroll patients in the EFRONT Study under its Cento-FTD Program
to provide timely diagnosis and further unlock insights into this neurodegenerative disorder. Advocacy groups and potential partners
are invited to learn more about this program by contacting efront@centogene.com. Patients enrolled in
the EFRONT Study and identified with disease-causing mutations may be eligible for participation in ongoing interventional clinical studies.
“Frontotemporal dementia is a rapidly
progressing neurodegenerative disease, and over recent years, we have made immense progress in establishing the best diagnostic approaches,”
said Kim Stratton, Chief Executive Officer at CENTOGENE. “In reaching such a pivotal milestone in our frontotemporal dementia study,
we have been able to unlock significant insights into the genetic factors – which may enable the development of potentially life-changing
therapeutics for patients around the world.”
"Not only is this milestone a tremendous
achievement, but it also signifies potential that lies ahead,” added Ombretta Palucci, SVP Real-World Solutions Operations at CENTOGENE.
“It forms the basis of one of the world’s largest FTD registries, which will enable current and future partners within the
Cento-FTD Program to generate real-world evidence to potentially accelerate treatment access.”
About Frontotemporal Dementia (FTD)
FTD is a rare neurodegenerative disease
and the most common form of dementia for people under the age of 60. It affects an estimated 50,000 to 60,000 people in the United States
and roughly 110,000 in the European Union. There are multiple heritable forms of FTD, including FTD-GRN, which is caused by genetic mutations
in the progranulin (GRN) gene. Patients with FTD frequently develop symptoms such
as behavioral changes, lapses in judgment,
and diminished language skills when they are in their 40’s and 50’s, with the disease running its course in 7-10 years. There
are no FDA-approved treatment options available for any form of FTD.
About the EFRONT Study
The EFRONT
Study is a single visit, multi-center, non-interventional study that investigates the prevalence of genetic etiologies in
frontotemporal dementia (FTD) by genotyping patients diagnosed with or suspected of FTD.
FTD is a genetically and pathologically
heterogeneous neurodegenerative disease caused by the loss or damage of nerve cells in the brain’s frontal and temporal lobes.
As a result, there are abnormalities in behavior, personality, and language comprehension problems, like lack of interest, judgment,
loss of empathy, and apathy.
To learn more about how you can enroll
in the EFRONT Study, visit ClinicalTrials.gov.
About CENTOGENE
CENTOGENE’s mission is to provide
data-driven, life-changing answers to patients, physicians, and pharma companies for rare and neurodegenerative diseases. We integrate
multiomic technologies with the CENTOGENE Biodatabank – providing dimensional analysis to guide the next generation of precision
medicine. Our unique approach enables rapid and reliable diagnosis for patients, supports a more precise physician understanding of disease
states, and accelerates and de-risks targeted pharma drug discovery, development, and commercialization.
Since our founding in 2006, CENTOGENE
has been offering rapid and reliable diagnosis – building a network of approximately 30,000 active physicians. Our ISO, CAP, and
CLIA certified multiomic reference laboratories in Germany utilize Phenomic, Genomic, Transcriptomic, Epigenomic, Proteomic, and Metabolomic
datasets. This data is captured in our CENTOGENE Biodatabank, with over 800,000 patients represented from over 120 highly diverse countries,
over 70% of whom are of non-European descent. To date, the CENTOGENE Biodatabank has contributed to generating novel insights for more
than 285 peer-reviewed publications.
By translating our data and expertise
into tangible insights, we have supported over 50 collaborations with pharma partners. Together, we accelerate and de-risk drug discovery,
development, and commercialization in target and drug screening, clinical development, market access and expansion, as well as offering
CENTOGENE Biodata Licenses and Insight Reports to enable a world healed of all rare and neurodegenerative diseases.
To discover more about our products,
pipeline, and patient-driven purpose, visit www.centogene.com and follow us on LinkedIn.
Forward-Looking Statements
This press release contains “forward-looking
statements” within the meaning of the U.S. federal securities laws. Statements contained herein that are not clearly historical
in nature are forward-looking, and the words “anticipate,” “believe,” “continues,” “expect,”
“estimate,” “intend,” “project,” “plan,” “is designed to,” “potential,”
“predict,” “objective” and similar expressions and future or conditional verbs such as “will,” “would,”
“should,” “could,” “might,” “can,” and “may,” or the negative of these are
generally intended to identify forward-looking
statements. Such forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause
CENTOGENE’s actual results, performance, or achievements to be materially different from any future results, performance, or achievements
expressed or implied by the forward- looking statements. Such risks and uncertainties include, among others, negative economic and geopolitical
conditions and instability and volatility in the worldwide financial markets, possible changes in current and proposed legislation, regulations
and governmental policies, pressures from increasing competition and consolidation in our industry, the expense and uncertainty of regulatory
approval, including from the U.S. Food and Drug Administration, our reliance on third parties and collaboration partners, including our
ability to manage growth, execute our business strategy and enter into new client relationships, our dependency on the rare disease industry,
our ability to manage international expansion, our reliance on key personnel, our reliance on intellectual property protection, fluctuations
of our operating results due to the effect of exchange rates, our ability to streamline cash usage, our continued ongoing compliance
with covenants linked to financial instruments, our requirement for additional financing, and our ability to continue as a going concern,
or other factors. For further information on the risks and uncertainties that could cause actual results to differ from those expressed
in these forward-looking statements, as well as risks relating to CENTOGENE’s business in general, see CENTOGENE’s risk factors
set forth in CENTOGENE’s Form 20-F filed on May 16, 2023, with the Securities and Exchange Commission (the “SEC”) and
subsequent filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and
CENTOGENE specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future
events, or otherwise.
CONTACT
CENTOGENE
Melissa Hall
Corporate Communications
Press@centogene.com
Lennart Streibel
Investor Relations
IR@centogene.com
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