REG - Argent Biopharma Ltd - Letter from the CEO

Argent BioPharmaAnnouncement

27/08/2024 07:15

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RNS Number : 7951B  Argent Biopharma Limited  27 August 2024

27 August 2024

 

Argent BioPharma Ltd.

(Argent BioPharma or the Company)

 

Letter From the CEO

 

Dear Shareholders,

We are pleased to share an update on Argent BioPharma's recent progress,
strategic direction, and key developments. Our mission remains unwavering: to
deliver an innovative approach that enhances patient outcomes by offering
effective treatments for conditions where options are currently limited or
non-existent.

Argent BioPharma will continue its journey as a specialised biopharmaceutical
company with a primary research focus on the central nervous system (CNS) and
the immune system, two pivotal and promising areas in the future of medicine.
By advancing its existing portfolio of drugs and integrating new, innovative
biological and chemical therapies, Argent BioPharma is dedicated to addressing
unmet medical needs and pioneering advancements in healthcare.

As part of the final stages of our restructuring process, which began earlier
this year, we have achieved significant milestones, including raising US$2.5m
in a non-brokered placement in July at AU$1.20 per share (US$0.80) and the
appointment of new brokers in the UK. This restructuring allows us to focus
more effectively on the UK, Europe, and the US markets.

Below, we outline our achievements and future plans to continue delivering
value to our shareholders and advancing our mission.

Company Overview

Argent BioPharma is a specialised biopharmaceutical company focused on
developing and marketing innovative drugs that are pioneering in the field and
represent the new generation of advance pharmaceutical treatments. Our
operations include independent EU-GMP manufacturing plants, and a development
centre staffed by an experienced team. With continuous research and
development efforts, we aim to bring new and innovative therapies to market,
enhancing the quality of life for patients and addressing significant gaps in
medical care. Our core research focuses on the CNS and Immune System.

The company is currently listed on the London Stock Exchange, the Australian
Stock Exchange, and the OTCQB. Our main operations and management are in the
UK and EU, and a new investor base is from the USA. In the future, we may
explore dual listing on a national exchange in the USA, such as the NASDAQ or
NYSE.

Argent BioPharma has two investigational drugs with early sales in the UK,
Ireland, and the USA under special access schemes, which can generate
real-life data on our treatments, helping us to improve our medicines as we
proceed with regulatory pathways to marketing authorisations as licensed drugs
in Europe and the USA in the coming years.

Our experienced management, medical advisory teams, and multidisciplinary
professionals can develop drugs in-house from the research stage to final
production. We have a fully automated commercial EU-GMP pharmaceutical
manufacturing site in Malta and an EU-GMP research facility in Slovenia,
equipped to develop new drugs and produce them for early sales. This hub
employs researchers, a quality team, and a medical team, ensuring high
standards in research and production.

In-House Research, Development, and Manufacturing

Argent produces and develops new drugs entirely in-house, without outsourcing
or external services. All our existing drugs now use our internal IP, and we
will move forward to establish Argent's own property in all aspects of our
drug development. Our manufacturing and R&D facilities have been operating
for five years, staffed by 40 highly experienced pharmaceutical and medical
professionals, with the capability to take drugs from concept to receiving
marketing approvals in the US FDA and EMA markets 1 , operating in accordance
with high standards, including EU GMP facilities, capable of supporting
clinical trials, commercial production, and R&D with top-tier facilities,
ensuring compliance with the highest regulatory standards.

R&D Centre in Slovenia

The R&D department operates to develop a pipeline of new original drugs.
It serves as a powerful tool for the company to expand its portfolio in the
long term, with the potential to bring value to shareholders and address
diseases currently lacking optimal solutions. This EU-GMP centre has the
capability to develop and produce products for Early Patient Access in
targeted markets.

Malta Factory

Our fully automated liquid dose form EU GMP facility was commissioned in May
2023, and is strongly supported by the Maltese government through
multi-million dollar grants 2 . Based on the company's current drug portfolio
and potential contract manufacturing services, it has the potential to produce
a future revenue stream. The company is working on providing intermediate
contract manufacturing services to other pharma companies till our internal
needs fulfill the capacity.

Argent's Flagship Drug Products:

·      CannEpil® (in early sales) for the treatment of Refractory
Epilepsy, in which approximately 30% of epilepsy patients do not respond to
medication, and we aim to address this critical area. Currently, it is not
running in clinical trials. At the same time, we started communication with
the FDA under Pre-IND to define the path forward to Marketing Authorisation,
with sales started in the UK under patient-name-based prescription in May 2023
and in the Irish market under a special access scheme fully reimbursed by the
national health insurance as an unlicensed drug 3  since June 2021.

·      Cimetra® (in early sales) is an innovative treatment for unmet
medical needs relating to acute respiratory distress syndrome (ARDS) and Acute
Lung Injury. It is currently running under Phase IIb studies as part of a
clinical programme to target the prevention of Cytokine Storm, which is the
key cause of lung failure. A US distributor has signed distribution
agreements, and sales have reached over a million dollars in the US through
the special access scheme of OTC unlicensed drugs 4 . CimetrA holds an NDC
number as part of the early patient access scheme (NDC No: 83278-001).

·      CogniCann® (in the clinical stage) has demonstrated improved
behaviour and reduced agitation in dementia patients during Phase IIa
studies 5 , which has the potential to change the lives of millions of
patients. Cognicann is currently not in clinical trials, but the company is
assessing its commercial and regulatory pathways under special access schemes.

·      RGAI02GB01 - IrniCann® (in the pre-clinical stage) is an
innovative pre-clinical stage drug targeting Glioblastoma Multiforme (GBM),
one of the deadliest forms of brain cancer, with the potential to transform
treatment outcomes for this aggressive disease. This could bring significant
relief to critically ill patients around the world.

·      RGAI03MW01 - (in the pre-clinical stage) combined biological and
chemical nano-formulations for Chronic wounds which present complex
challenges, including severe symptoms and management of topical infections
complicated by antibiotic resistance, impenetrable biofilms, and local tissue
health deterioration.

Benefits of Early Access Programmes (EAPs) for Argent BioPharma

EAPs for our investigational medicinal products (IMPs) may enable faster
market entry and the potential for early revenue streams. Moreover, they
support ongoing research and business operations. These programmes provide
valuable real-world data on therapy safety and efficacy, enhancing regulatory
submissions and treatment protocols. Additionally, EAPs build trust with
patients and healthcare providers, strengthen regulatory relationships, and
offer a competitive advantage by addressing unmet medical needs. They foster
brand recognition and loyalty, contribute to financial stability, and
demonstrate the company's commitment to social responsibility.

Leveraging Real-World Data

One of the key outcomes of the EAPs is the collection of Real-World Data (RWD)
such as safety data, adverse events, treatment protocols, dosing and efficacy.
Integrating RWD into Argent BioPharma's research provides numerous advantages,
from enhancing regulatory submissions to optimising clinical practices and
expanding market opportunities. By leveraging RWD, Argent BioPharma aims to
achieve continuous improvement of its therapies, leading to better patient
outcomes.

Summary

Argent BioPharma is on a promising path with its innovative approach and
comprehensive capabilities. Our R&D facilities give us control over each
stage of the drug life cycle, from research to production. Focusing on unmet
medical needs, we are developing potentially transformative medicines like
CannEpil® and Cimetra® to address critical health challenges. Our refreshed
management team will drive our strategic initiatives, aiming for revenue
growth, a robust drug pipeline, successful product launches, and operational
efficiency.

I strongly believe that Argent BioPharma is well-positioned for sustained
growth and there is a bright future for our company and stakeholders.

 

Yours faithfully,

 

Roby Zomer

 

 

 

Authorised for release by the board of directors, for further information
please contact:

 

 Argent BioPharma                                             Argent BioPharma

 Roby Zomer                                                   Rowan Harland

 CEO & Managing Director                                      Company Secretary

 +61 8 6555 2950                                              +61 8 6555 2950

 info@argentbiopharma.com (mailto:info@argentbiopharma.com)   info@argentbiopharma.co (mailto:info@argentbiopharma.co.uk) m

 

About Argent BioPharma

 

Argent BioPharma Limited (the Company) (ASX: RGT; LSE: RGT; OTCQB: RGTLF) an
innovative multidisciplinary drug development Company within the
biopharmaceutical sector.  The Company focuses on multidisciplinary methods
with Nanotechnology, developing multi-target therapies for comprehensive
disease management, especially concerning the Central nervous system (CNS) and
Immunology treatments.

 

Follow us through our social media channels:

LinkedIn: Argent BioPharma

Twitter: @ArgentBioPharma

Facebook: Argent BioPharma

 1  Refer to announcement dated 15 September 2021

 2  Refer to announcement dated 3 November 2021

 3  Refer to announcement dated 15 June 2021

 4  Refer to announcement dated 7 July 2023

 5  Refer to announcement dated 6 June 2022

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