REG - ReNeuron Group plc - Fosun Tech Transfer and Supply Agreement update

ReNeuronAnnouncement

01/07/2022 07:00

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RNS Number : 9270Q  ReNeuron Group plc  01 July 2022

ReNeuron Group plc

("ReNeuron" or the "Company")

 

Update on the Technology Transfer and Supply Agreement with Fosun Pharma

 

ReNeuron has negotiated a Supplemental Terms Agreement with potential to
generate revenue of up to £6m

 

 

ReNeuron Group plc (AIM: RENE), a UK-based leader in Stem Cell and Exosomes
Technologies, is pleased to announce that it has negotiated and signed a
Supplemental Terms Agreement with Shanghai Fosun Pharmaceutical (Group) Co.,
Ltd. ("Fosun Pharma"; stock code: 600196. SH, 02196. HK) which has the
potential to generate revenues of up to £6m for the Company.

 

ReNeuron out-licensed its stroke disability programme to Fosun Pharma in April
2019 and following this, in January 2022 announced it had signed an additional
technology transfer and supply agreement contingent upon supplemental terms
being negotiated.

 

The signing of this Supplemental Terms Agreement underscores Fosun Pharma's
continued commitment to the CTX stroke disability programme. As a result the
Company expects to receive approximately £1m over the next 24 months
(including the £320k upfront payment already received in January 2022) in
relation to the initial supply of CTX cell bank vials and services provided to
undertake the technology transfer, with up to a further £5m receivable by the
Company over the medium to longer term for the continued provision of CTX cell
bank vials to enable manufacture by Fosun Pharma.

 

Fosun Pharma is expanding its cell therapy portfolio to stem cell platforms
and ReNeuron CTX is one of the starting programmes. A dedicated Fosun Pharma
team is being established for the technology transfer into China and the
construction of a 20,000 square foot GMP facility in the Pudong District of
Shanghai to manufacture CTX is underway, with the aim of completing
construction by Q1 2023.

 

Ningshu Liu, co-CSO of Fosun Pharma, commented: "We are excited about the
technical transfer and supply agreement with ReNeuron, which will not only
enable later stage clinical and commercial use of CTX in Greater China, but
also facilitate further exploration of additional clinical utilities of CTX to
address some of the greatest gaps in neurological disease treatments using our
translational framework."

 

Catherine Isted, Chief Financial Officer of ReNeuron, commented: "The extent
of the resources Fosun Pharma are putting behind this project highlights their
commitment to progressing the CTX stoke disability programme in Greater China.
We are delighted to have secured this agreement and look forward to working
together with Fosun Pharma to take this programme forward over the longer
term."

 

Iain Ross, Chairman of ReNeuron, added: "This is an important milestone for
ReNeuron as we not only look to build our Exosome and iPSC technology
platforms, but also, by negotiating agreements such as this, the team has
demonstrated that we can monetise the assets and expert capabilities built up
over a number of years."

 

 

ENDS

 

 

This announcement contains inside information. The person responsible for
arranging for the release of this announcement on behalf of the Company is
Catherine Isted, Chief Financial Officer.

 

 

 

 

Contacts:

 

 ReNeuron                                          www.reneuron.com/investors (http://www.reneuron.com/investors)
 Iain Ross, Chairman                               Via Walbrook PR
 Catherine Isted, Chief Financial Officer

 Liberum Capital Limited (NOMAD and Joint Broker)  +44 (0)20 3100 2000

 Phil Walker (Investment Banking)

 Richard Lindley (Investment Banking)

 Ben Cryer (Investment Banking)

 Allenby Capital Limited (Joint Broker)            +44 (0)20 3328 5656
 James Reeve/George Payne (Corporate Finance)
 Stefano Aquilino (Sales & Corporate Broking)

 Walbrook PR (Media & Investor Relations)          +44 (0)20 7933 8780 or reneuron@walbrookpr.com
                                                   (mailto:reneuron@walbrookpr.com)
 Paul McManus / Alice Woodings                     +44 (0)7980 541 893 / +44(0)7407 804 654

 

 

 

About ReNeuron

ReNeuron is a UK based Proprietary Stem Cell based Exosome Technologies
company, harnessing its unique stem cell technologies to develop 'off the
shelf' treatments for diseases with significant unmet needs.

 

ReNeuron's stem cell derived proprietary Exosome Technology platform offers a
delivery mechanism for a variety of payloads such as siRNA, mRNA, proteins,
small molecules and genes. The Company has a growing number of partner
collaborations with Global Pharma, Biotech and academic partners in this
fast-expanding area of scientific and commercial interest. ReNeuron also has
the ability, through its conditionally immortalised induced pluripotent stem
cell (iPSC) platform, to make allogeneic tissue cells of choice and has the
potential to produce exosomes with tissue specific targeting ability.

 

The Company has out-licenced its CTX Programme for stroke disability and hRPC
programme in retinitis pigmentosa to Fosun Pharma in China and is looking to
out-licence both these programmes in other territories.

 

ReNeuron's shares are traded on the London AIM market under the symbol RENE.L.
For further information visit www.reneuron.com (http://www.reneuron.com/)

 

About Fosun Pharma

Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun
Pharma"; stock code: 600196. SH, 02196. HK) is a global innovation-driven
pharmaceutical and healthcare industry group deep-rooted in China. Fosun
Pharma directly operates businesses including pharmaceutical manufacturing,
medical devices, medical diagnosis, and healthcare services. As a shareholder
of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical
distribution and retail business.

 

Fosun Pharma is patient-centred and clinical needs-oriented. The company
enriches its innovative product pipeline through diversified and multi-level
cooperation models such as independent research and development, cooperative
development, license-in, and in-depth incubation. Fosun Pharma has formed
technological platforms for innovative small molecule drugs, antibody drugs,
and cell therapy with a focus on key disease areas including oncology and
immunomodulation, metabolism and the digestive system, and the central nervous
system. Fosun Pharma also vigorously explores cutting-edge technologies, such
as RNA, oncolytic viruses, gene therapy and PROTAC, to enhance its innovation
capabilities.

 

Guided by the 4IN strategy (Innovation, Internationalization, Integration, and
Intelligentization), Fosun Pharma will uphold the development model of
"innovation transformation, integrated operation, and steady growth", with the
mission of creating shareholder value as well as promoting the global networks
through strengthening its innovative R&D and in-licensing ability and
enriching its product pipelines. Fosun Pharma will actively promote the
digital and physical business layout in the pharmaceutical and healthcare
industry and is committed to becoming a first-class enterprise in the global
mainstream medical and health market.

 

For more information, please visit our official website: www.fosunpharma.com
(http://www.fosunpharma.com)

 

About ReNeuron's CTX cell therapy candidate for stroke disability

ReNeuron's CTX stem cell therapy candidate for stroke disability consists of
neural stem cells which have been generated using the Company's proprietary
cell expansion and cell selection technologies and then scaled up and
manufactured under Good Manufacturing Practice (GMP) conditions. As such, CTX
is a cryopreserved, clinical and commercial-grade cell therapy product capable
of being provided at the time of use to patients at geographically diverse
trial sites.

 

CTX has been shown to be safe and well-tolerated in an initial UK clinical
trial (PISCES I) in eleven disabled stroke patients who were followed up for
at least two years post-treatment. The data from this study were published in
The Lancet(1). A subsequent single arm UK Phase II study (PISCES II) showed
clinically relevant improvements on key measures of disability and dependency
out to 12 months post-treatment against a stable baseline level of disability
in the 23 patients treated.

 

A larger, randomised, placebo controlled clinical trial (PISCES III) commenced
in the US but was put on hold due to COVID-19 and then subsequently closed to
enrolment. PISCES III was designed to show a significant difference in the
proportion of patients with at least a one-point improvement on mRS in a group
receiving CTX stem cells compared to a group receiving a sham-surgery
procedure.

 

If ultimately shown to be safe and effective in larger, controlled clinical
studies, CTX would therefore offer a ground-breaking new treatment option for
stroke survivors. The therapy offers the potential for a degree of recovery of
function in disabled stroke patients, resulting in greater independence and
quality of life for these patients and reduced reliance on health and social
care systems.

 

(1.)D.Kalladka, J.D.Sinden, K.Pollock, C.Haig, J.McLean, W.Smith,
A.McConnachie, C.Santosh, P.M.Bath, L.Dunn, K.W.Muir. 2016. Human neural stem
cells in patients with chronic ischaemic stroke (PISCES): a phase 1,
first-in-man study. Lancet. 2016 Aug 20;388(10046):787-96

 

 

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