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:
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