TIDMCEL
RNS Number : 7100P
Celadon Pharmaceuticals PLC
22 June 2022
Celadon Pharmaceuticals Plc
("Celadon" or the "Company")
Business Update
Progress against IPO milestones
London, UK, 22 June 2022 : Celadon Pharmaceuticals Plc (AIM:
CEL), a UK-based pharmaceutical company focused on the development
and supply of natural, cannabis-based medicines, is pleased to
announce an update on its business and operations following the
Company's Admission to AIM on 28 March 2022.
Highlights
-- Successfully completed sixth harvest from its Phase 1 grow
facility, with initial results from the selected test batches
showing high quality, consistent growing of pharmaceutical grade,
high THC medical cannabis
-- Nearing completion of all preparatory work ahead of GMP
inspection by MHRA, having undertaken extensive internal audits and
independent third-party testing
-- High level of new patient enquiries to LVL clinic for
participation in the chronic pain study, with feedback from initial
patients reporting improvements in quality of life
-- Phase 2 grow facility build on track and expected to become
operational in Q1 2023, following which the Company will aim to
expand its high THC medical cannabis grow capacity to three tonnes
per year
James Short, CEO of Celadon, commented:
" We are pleased to report on our significant progress since
Admission, which has seen Celadon advance all the necessary
preparatory work to be in position for an MHRA inspection and
continue the preliminary works for the build-out of its Phase 2
grow facilities. Alongside our grow activity, I am delighted to
report that LVL has been experiencing significant levels of new
enquiries from those looking to participate in the chronic pain
study. The LVL team is working hard to keep pace with patient
onboarding as we continue to advance towards our objective of
conducting what we believe would be the UK's only MHRA approved
clinical trial exploring the use of medical cannabis for the
treatment of chronic pain.
"We believe that our highly regulated, pharmaceutical approach
is the most effective route to ensuring that patient needs are met.
With our focus on evidence-based data, facilitated by our medical
cannabis study and MHRA conditionally approved medical cannabis
trial, we hope to demonstrate the safety and efficacy of
cannabis-based medicines, underpinning the case for regulatory
approval and, in turn, reimbursement by the NHS."
Business update
Phase 1 grow
In May 2022, the Company completed its sixth harvest of test
batches of high THC medical cannabis from the Phase 1 grow rooms
for the purpose of supporting its application for MHRA registration
as a manufacturer of medicinal product Active Pharmaceutical
Ingredients ( " APIs " ). The harvested product has since undergone
rigorous internal and initial independent testing of certain of the
cannabis flower to assess its consistency, quality, purity and
cannabinoid profile. The results of the independent third party
testing confirmed that the cannabis flower tested has consistently
met Good Agricultural and Collection Practice ( " GACP " ) /
pharmaceutical grade standards for medical cannabis, demonstrating
a consistent and high level of THC, well within all testing
tolerances. Ahead of an MHRA inspection, independent third party
testing will also be undertaken on Celadon's processed cannabis
oil.
The harvested high THC cannabis is currently being stored and
processed by the Company for the purposes of its MHRA inspection,
which is noted in more detail below, as part of its Good
Manufacturing Practice ( " GMP ") certified medical grade cannabis
application.
GACP & MHRA preparatory work and grow facility fit out
The Company is in the final stages of completing all necessary
preparatory work to be in a position for an MHRA inspection of the
Celadon facility. This has included successfully running internal
audits conducted via third party professional advisers and the
independent third party testing of its batches from its analytical
testing partner, in order to ensure the business is in a prime
position to receive its MHRA registration. The Company continues to
engage with the MHRA on its progress and potential timings for the
inspection, which it expects will now be during H2 2022.
On the basis of a successful MHRA inspection and subsequent
receipt of MHRA registration and the grant of a further licence
from the Home Office permitting supply for manufacture into
finished medicinal products, the Directors believe that the Company
will become one of the first organisations in the UK to be licensed
to sell GMP standard API, high THC medical cannabis from its
Midlands facility, and one of a limited number of GMP approved
medical cannabis facilities in the world.
Celadon has made significant progress in the development of its
cannabis cultivation and processing capacity. The Company is on
track for its Phase 2 facility to become operational by Q1 2023,
which will see the fit out of the facility's second grow space for
the cultivation of high THC medical cannabis. Following completion
of the Phase 2 fit out, the Directors believe that the Company has
the potential to achieve an annualised yield of approximately three
tonnes of dry flower. Although the Company has not been immune to
inflationary cost pressures across the economy attaching to the
vast majority of building materials and labour, Celadon is aiming
to mitigate certain rising cost pressures where it can, to ensure
the build programme remains on track by bringing inhouse the
project management activity and rephasing certain aspects of the
build.
The Company has been working closely with the Home Office and
has been successful in its application to expand its Home Office
licence, which now allows for increased permitted storage of
cannabis products at its Midlands based facility, and has received
the necessary approvals to export its cannabis products for the
purposes of analytical testing.
Commencement of feasibility study in chronic pain by LVL Health
( " LVL " )
As set out in the Company's admission document, LVL, the
Company's private pain clinic subsidiary, received approval from
Research Ethics Committee ( " REC " ) allowing for a 100-patient
feasibility study of medical cannabis in patients with non-cancer
chronic pain. The feasibility study is designed to demonstrate the
ability to engage and retain patients and will allow LVL to carry
out an in-depth evaluation of the patient pathway.
The Company has commenced the enrolment of patients on to the
feasibility study. Enquiries from patients interested in
participating in the feasibility study have surpassed the Company's
expectations with approximately 1,500 potential leads currently
being screened for eligibility. There have been some delays in
onboarding certain patients due to the volume of enquiries being
processed, however the Company is working to resolve this. This
initial patient onboarding data will be used in the feasibility
study, and in due course the MHRA conditionally approved patient
trial, for presentation to the National Institute for Clinical
Excellence ( " NICE " ). Initial feedback from patients who have
received treatment has been positive, with improvements in quality
of life being noted.
LVL also received Care Quality Commission approval for its
physical clinic on Harley Street in London in order to operate that
clinic, and the physical clinic is now able to see patients face to
face.
Commercialisation
Whilst the Company is required to obtain both MHRA registration
and a subsequent Home Office licence before it can sell cultivated
medical cannabis commercially, Celadon is pleased to report that
there have been a number of positive preliminary discussions
regarding sales of bulk cannabis flower both in the UK and
internationally.
Enquiries:
Celadon Pharmaceuticals Plc
James Short Via Powerscourt
Arthur Wakeley
Canaccord Genuity Limited (Nominated
Adviser and Broker)
Andrew Potts / Patrick Dolaghan +44 (0) 20 7523 8000
Powerscourt Group
Sarah MacLeod / Nick Johnson / Sam Austrums +44 (0) 20 7250 1446
/ celadon@powerscourt-group.com
Ibrahim Khalil
About Celadon Pharmaceuticals Plc
Celadon Pharmaceuticals Plc is a UK based pharmaceutical company
focused on the research, cultivation, manufacturing, and supply of
natural cannabis-based medicines. Its primary focus is on improving
quality of life for chronic pain sufferers, as well as exploring
the potential of cannabis-based medicines for other conditions such
as autism. Its 100,000 sq ft UK facility comprises a laboratory
designed to meet GMP standards, and capacity for a large indoor
hydroponic growing facility that has received a Home Office Licence
for the legal cultivation of high-THC medicinal cannabis for the
purpose of producing test batches of cannabis oil to support its
application to the MHRA. The Company's subsidiary, LVL, owns an
MHRA conditionally approved cannabis trial using cannabis based
medicinal products to treat chronic pain in the UK.
For further information please visit our website
www.celadonpharma.com
This announcement contains inside information for the purposes
of article 7 of the Market Abuse Regulation (EU) 596/2014 as
amended by regulation 11 of the Market Abuse (Amendment) (EU Exit)
Regulations 2019/310. With the publication of this announcement,
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