REG - Renalytix PLC - Steno Diabetes Center (Copenhagen) Collaboration

RenalytixAnnouncement

11/07/2024 07:00

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RNS Number : 9992V  Renalytix PLC  11 July 2024

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/
(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 (http://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
                                                                (http://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 (http://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
(https://urldefense.proofpoint.com/v2/url?u=https-3A__www.globenewswire.com_Tracker-3Fdata-3DHIcvSOKWTkn1vxawrrirM1gUgFYu32VbuCH1n-2Ds4WSmIV9AKgsskrk7LVTiLtBKzh0EgMAYcMou7YzjZkrjEa0-5FXaGhXhObIdjIqNwD5nw0-3D&d=DwMGaQ&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=fSst1AtlXyuqcs3cHJXcCRilbI1Qm1WfjNYkVgQfiLE&m=CAFXC1VvASft89JL__vJ-Qy6Kr2WQDGgWUKHPBjNZDincvxkGZS93xVnNARw1RlW&s=AJTGqLN2jCYrU6NVg5tcOnsxQm6Jmv__egTZPqToZRg&e=)
.

 

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.

 

 

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