Renalytix
plc
("Renalytix" or the
"Company")
Renalytix and Steno Diabetes
Center Announce Precision Medicine Collaboration Marking First
Expansion for KidneyIntelX Platform Beyond US
LONDON and NEW YORK, July 11, 2024 - Renalytix plc (NASDAQ: RNLX) (LSE: RENX), an artificial
intelligence-enabled in vitro diagnostics company, focused on
optimizing clinical management of kidney disease to drive improved
patient outcomes and advance value-based care, announces a collaboration with the Steno Diabetes Center
('Steno'), Copenhagen, to advance translation of precision medicine
solutions for patients with Diabetes and Chronic Kidney Disease
(DKD). The initial focus of the collaboration will be on developing
a roadmap for implementation of KidneyIntelX at the Steno Diabetes
Center and affiliated practices.
Through this collaboration Renalytix
and Steno will investigate core elements necessary for successful
clinical translation of KidneyIntelX in a European context,
beginning with integration of the biomarker testing into laboratory
workflows, education of clinicians and patients on the role of
KidneyIntelX risk assessment in the continuum of care and,
leveraging of electronic health record systems for efficient,
risk-based care management. Importantly, this is expected to launch
the first use of Renalytix's KidneyIntelX platform outside the US
to showcase the clinical utility in the EU by utilizing advanced
technology to provide better informed care for solving chronic
kidney disease.
Professor Peter Rossing, Senior Principal Investigator at the
Steno Diabetes Center said:
"The availability of multiple
proven therapies in recent years to slow or prevent kidney function
decline in patients with diabetes presents us with an opportunity
to significantly reduce the suffering of patients. Access to
biomarker-based, precision medicine tools such as KidneyIntelX in
clinical practice will be critical in ensuring individual patients
receive the right treatment as early as possible in the disease
cycle."
Steno Diabetes Center Copenhagen,
which offers tailored diabetes treatment for people with diabetes,
has been at the forefront of innovation in diabetes care since its
inception and has been proclaimed by the World Economic Forum to be
a world-leading role model from which other countries and
healthcare systems can learn.
Dr.
Frederik Persson, Head of Clinic at Steno Diabetes Center
added: "At Steno, we recognize the importance of
bridging the translation gap for novel technologies to clinical
practice so that our patients and providers have access they need
for optimized care and outcomes. We look forward to working with
Renalytix in introducing the FDA approved KidneyIntelX test to
patients in our practices and beyond."
Additional elements to be addressed
include requirements for CE marking in the EU under the In-Vitro
Diagnostic Regulation, clinical utility data, cost effectiveness
analysis and, ultimately, clinical adoption in accordance with
national and international clinical guidelines. The outputs of the
collaboration will contribute to defining a framework for
implementation of precision medicine solutions based on novel
biomarkers in clinical practice, including helping to define
requirements for future product development of tests by Renalytix
to predict and monitor therapeutic response in DKD.
Fergus Fleming, CTO of Renalytix
commented: "We welcome the opportunity to work with such
a prestigious team at Steno Diabetes Center as we seek to expand
access to KidneyIntelX and the promise of precision medicine to
patients in Europe and other territories internationally. The
insights gained from this collaboration will be pivotal in
informing our commercialization and product development activities
in the US and abroad."
Renalytix and Steno are partners in
PRIME-CKD (https://www.prime-ckd.com/),
funded by the European Union Research and Innovation programme,
advancing personalized drug treatment in patients with
CKD.
This announcement contains inside
information under the UK Market Abuse Regulation. The person
responsible for arranging for the release of this announcement on
behalf of the Company is James McCullogh, CEO.
For further information,
please contact:
Renalytix plc
|
www.renalytix.com
|
James McCullough, CEO
|
Via Walbrook
PR
|
|
|
Stifel (Nominated Adviser, Joint Broker)
|
Tel: 020 7710
7600
|
Alex Price / Nicholas Moore / Nick
Harland / Samira Essebiyea
|
|
|
|
Investec Bank plc (Joint Broker)
|
Tel: 020 7597
4000
|
Gary Clarence / Shalin
Bhamra
|
|
|
|
Walbrook PR Limited
|
Tel: 020 7933
8780 or renalytix@walbrookpr.com
|
Paul McManus / Alice
Woodings
|
Mob: 07980
541 893 / 07407 804 654
|
|
|
CapComm Partners
|
|
Peter DeNardo
|
Tel:
415-389-6400 or investors@renalytix.com
|
About Renalytix
Renalytix (NASDAQ: RNLX) (LSE: RENX)
is an artificial intelligence enabled in-vitro diagnostics and laboratory services
company that is the global founder and leader in the field of
bioprognosis™ for kidney health. In late 2023, our kidneyintelX.dkd
test was recognized as the first and only FDA-authorized prognostic
test to enable early-stage CKD (stages 1-3b) risk assessment for
progressive decline in kidney function in T2D patients. By
understanding how disease will progress, patients and clinicians
can take action earlier to improve outcomes and reduce overall
health system costs. For more information,
visit www.renalytix.com.
Steno Diabetes Center
Steno Diabetes Center Copenhagen is
an internationally leading diabetes hospital, established in 1932.
Steno Diabetes Center Copenhagen is based in Greater Copenhagen, as
a public-private partnership between the Capital Region of Denmark
and the Novo Nordisk Foundation, which is supported by a donation
of 0,4 billion Euro from Novo Nordisk Foundation the Novo Nordisk
Foundation. Steno Diabetes Center Copenhagen's purpose is not only
to improve the quality of the diabetes treatment in the Capital
Region, but also nationally and globally to contribute to the
development of new models for a value-based healthcare system.
Steno Diabetes Center Copenhagen is Scandinavia's largest diabetes
hospital.
Forward-Looking Statements
Statements contained in this press
release regarding matters that are not historical facts are
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended. Examples of
these forward-looking statements include statements concerning: the
commercial prospects of KidneyIntelX, including whether
KidneyIntelX will be successfully adopted by physicians and
distributed and marketed, the rate of testing with KidneyIntelX in
health care systems, expectations and timing of announcement of
real-world testing evidence, the potential for KidneyIntelX to be
approved for additional indications, the Company's expectations
regarding the timing and outcome of regulatory and reimbursement
decisions, the ability of KidneyIntelX to curtail costs of chronic
and end-stage kidney disease, optimize care delivery and improve
patient outcomes, the Company's expectations and guidance related
to partnerships, testing volumes and revenue for future periods,
the Company's expectations regarding the Company's ability to
obtain and maintain intellectual property protection for its
diagnostic products and the Company's ability to operate its
business without infringing on the intellectual property rights of
others, and the forecast of the Company's cash runway and the
implementation and potential for additional financing activities
and cost-saving initiatives. Words such as "anticipates,"
"believes," "estimates," "expects," "intends," "plans," "seeks,"
"indicates" and other similar expressions are intended to identify
forward-looking statements. By their nature, forward‐looking
statements are inherently predictive, speculative and involve
risks, uncertainties and assumptions that could cause actual
results, financial condition, performance, developments, or
achievements to differ materially from those expressed or implied
by the forward‐looking statements. Accordingly, the Company may not
actually achieve the plans and objectives disclosed in the
forward-looking statements, and you should not place undue reliance
on the Company's forward-looking statements. Any forward-looking
statements are based on management's current views and assumptions
and involve risks and uncertainties that could cause actual
results, performance or events to differ materially from those
expressed or implied in such statements. These risks, uncertainties
and assumptions relate to factors that are beyond the Company's
ability to control or estimate precisely, such as changes in
taxation or fiscal policy, future market conditions, currency
fluctuations, the behaviour of other market participants, the
actions of governments or governmental regulators, or other risk
factors, such as changes in the political, social and regulatory
framework in which the Company operates or in economic or
technological trends or conditions, including inflation, recession
and consumer confidence, on a global, regional or national basis.
These risks include, among others: that KidneyIntelX is based on
novel artificial intelligence technologies that are rapidly
evolving and potential acceptance, utility and clinical practice
remains uncertain; the Company has only recently commercially
launched KidneyIntelX; and risks relating to the impact on the
Company's business of the COVID-19 pandemic or similar public
health crises. These and other risks are described more fully in
the Company's filings with the Securities and Exchange Commission
(SEC), including the "Risk Factors" section of its annual report on
Form 10-K filed with the SEC on September 28, 2023, the Company's
Quarterly Report on Form 10-Q for the quarter ended September 30,
2023 filed with the SEC on November 14, 2023, the Company's
Quarterly Report on Form 10-Q for the quarter ended December 31,
2024 filed with the SEC on February 14, 2024 and other filings the
Company makes with the SEC from time to time. All information in
this press release is as of the date of the release, and the
Company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events, or otherwise, except as required by law. In
particular, but without prejudice to the generality of the above,
no representation or warranty is given, and no responsibility or
liability is accepted, either as to the achievement or
reasonableness of any future projections, forecasts, estimates or
statements as to any prospects or future returns contained or
referred to in this press release or in relation to the basis or
assumptions underlying such projections, forecasts, estimates or
statements. Except as required by
applicable law or regulation, each of the Company and the Joint
Brokers expressly disclaim any obligation or undertaking to release
any updates or revisions to these forward-looking statements
whether as a result of new information, future events or
otherwise.