REG - Celadon Pharma. PLC - Business Update

Celadon PharmaceuticalsAnnouncement

22/06/2022 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20220622:nRSV7100Pa&default-theme=true

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

 Ibrahim Khalil                                            celadon@powerscourt-group.com (mailto:celadon@powerscourt-group.com)

 

 

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
(http://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, this information is now considered to be in the public
domain.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  UPDFLFLTRAILFIF