1.
Leaders in patented
HOCl Formulations &
Technologies
www.spectrumx.com
2.1
1
1
Disclaimer
The content of this document has not been approved by an authorised person within the meaning of the Financial Services and Markets Act 2000. Reliance on this document for the
purpose of engaging in any investment activity may expose an individual to a significant risk of losing all assets invested.
If you are in any doubt as to the action you should take, you are recommended to seek your own personal financial advice immediately from your stockbroker, bank manager, solicitor,
accountant or other independent financial adviser authorised under the Financial Services and Markets Act 2000 who specialises in advising on the acquisition of Ordinary Shares and
other securities.
IMPORTANT NOTICE
1. This document is exempt from the general restriction on the communication of invitations or inducements to enter into investment activity and has not been approved by an
authorised person, as would otherwise be required under section 21 of FSMA.
2. This document is sent to you by SpectrumX Holdings UK Limited on a confidential basis on the understanding that you are a person who is permitted to receive this
communication pursuant to one or more of Articles 19, 43, 48, 49, 50 or 50(A) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (“the FPO”), and
the Company will only enter into engagements with such persons. Onward transmission of this document may constitute an offence under the Financial Services and Markets Act
2000.
3. Those persons who are not legally entitled to receive this document without breaching section 21 of the Financial Services and Markets Act 2000 because they do not fall
within Articles 19, 43, 48, 49, 50 or 50(A) of the FPO and do not otherwise fall outside the provisions of the FPO should not rely or act on this document.
4. If you are in any doubt about the investment to which this communication relates you should consult an authorised person specialising in advising on investments of the kind in
question.
We would draw expressly to your attention that the value of Loan Notes and securities can fluctuate in value, and accordingly that, if you subscribe for Loan Notes under this
document, there is a significant risk that you may lose the entire amount originally invested.
Lack of trading facility
It is emphasised that no application will be made for admission of the Loan Notes to the Official List of the UK Listing Authority, or for trading on AIM, a market operated by the
London Stock Exchange, or to AQIS Exchange Markets for trading as AQIS Exchange quoted Loan Notes or on any other stock exchange. An investment in the Company involves a
significant degree of risk and may not be suitable for all recipients of this document. Prospective investors should consider carefully whether an investment in the Company is suitable
for them in the light of their circumstances and the financial resources available to them.
3.
What is it?
A highly oxidised, mildly acidic
antimicrobial solution. HOCl is
produced in our own bodies when
white blood cells attack pathogens.
Is it safe?
HOCl is non-carcinogenic and at
appropriate concentrations is well
tolerated when in contact with the
skin, lungs and eyes. It is food safe
and non-flammable.
Global Hypochlorous Acid Market
Value by 2026
Source: Maximize Market Research
Hypochlorous Acid
First discovered by Antoine Jérôme Ballard in 1834, Hypochlorous Acid (HOCl)
is biocompatible yet 300 times stronger than bleach. It has multiple FDA
approvals. Spectricept™ is a truly efficacious formulation of HOCl for real world
conditions.
Broad spectrum antiviral, antifungal, and antimicrobial
Topical anti-inflammatory properties
Alleviates topical pain
Effective at killing antibiotic resistant 'Super Bugs' which were responsible
for 700,000 deaths in 2016, predicted to rise to 10,000,000 by 2050
Dr Jerry Stonemetz, Medical Director, Johns Hopkins University Hospital
“HOCl has been well researched, published and later cleared by FDA in different therapeutic areas
including reduction of topical inflammation and topical pain as well as disinfection of food and food
preparation areas. However, none of the above mentioned products have been able to provide stability
at lower concentrations for safe use of the product on people. Spectrum Antimicrobials’ unique and
patented formulations provide rapid disinfection in the presence of soil and other organic matter, at
concentrations of 0.032% where other HOCl based products have been shown to certainly fail in
stability and performance.”
4.
Table of Contents
1. Cover
2. Disclaimer
3. Hypochlorous Acid
4. Table of Contents
5. Pre IPO Raise Overview
6. Key Team Members
7. Key Team Members
8. Capital Raise
9. Capital Raise
10. Execution Strategy
11. Spectrum Partnership
12. Production Facility
13. Production Facility
14. ILS Collaboration
15. Market Overview
16. Hand Sanitiser Market Size
17. Spectricept™
18. Support for Spectricept™
19. Trend Away From Alcohol
20. The Future of Hand Sanitisers
21. C Diff
22. Spectricept™ vs Generic HOCl
23. Spectricept™ vs Generic HOCl
24. EU Pharmaceutical Market
25. Antimicrobial Resistance
26. Deaths Due to AMR
27. SpectrumX Medical
28. Existing Validation of SXH Technology
29. Existing Validation of SXH Technology
30. Existing Validation of SXH Technology
31. Clinical Trials
32. Clinical Trials
33. Clinical Trails Outcomes
34. Prospects of trial success
35. Green Initiatives
36. Contact
5.
Pre-IPO Round
Overview
This Pre-IPO offering outlines the opportunities for the commercialisation of
novel formulations of HOCl in the healthcare and pharmaceutical markets.
Specifically, how SpectrumX can positively impact these sectors, through a
diversified portfolio of offerings, by exploiting licenses from Spectrum
Antimicrobials Inc., of the world’s first and only patent-protectable formulations
of HOCl (Hypochlorous Acid).
The company is focused on bringing to market a groundbreaking respiratory
therapy (SPC-069) and the roll out one of the most powerful hand sanitiser in
the world (Spectricept™). Both products utilise unique patent pending HOCl
formulations.
HOCl is naturally occurring in human white blood cells and is a key contributor
to mankind’s evolution and protection over millions of years. It is human safe
whilst also being the most effective disinfectant known to mankind.
6.
Key Team Members Bios
Damien Hancox - CEO
Damien Hancox is an experienced entrepreneur who specialises in identifying opportunities in emerging trends and builds businesses around the opportunities they represent. He believes strongly in a
blend between transformational and strategic leadership style. Implementing this methodology he has successfully introduced brands to bricks and mortar retail in emerging markets and fast tracked
their exposure for his customers and partners. He is also a member of the Institute of Directors.
Barry Saint - CFO
Barry has over 20 years’ experience as a FTSE-250 global finance and strategy leader and as a senior investment banker. Highly experienced raising capital for emerging companies, including at IPO
and from venture/private equity sources, he has also worked extensively with company boards and backers to source and secure value-accretive collaborations and M&A, often cross-border. He has
served as CFO of an early stage biotechnology company, and as Group Treasurer of $1 billion revenue, specialty pharma. group Indivior, where he built and led high performing finance and multidisciplinary teams servicing operations in over 40 countries worldwide. Based in the US, he acquired substantial, current, US healthcare industry experience, oversaw the upgrading of financial
reporting processes and controls, and led major collaboration, M&A and capital markets projects to enable growth. A Cambridge University Engineering graduate, Barry commenced his advisory career
as a strategy consultant KPMG, before moving into investment banking, with Dresdner Kleinwort.
Aziz McMahon - Executive Chairman
Aziz McMahon is a former Goldman Sachs managing director and head of emerging-market sales. He is a cornerstone investor in SXH. He has over 20 years experience in both investment banking and
macro advisory. He holds a masters degree in applied econometrics from Trinity College Dublin and has previously worked with ABN Amro and Ulster Bank.
Debra Leeves - Non-Executive Director, Audit Committee Chair
Debra has worked in technology companies and the pharmaceutical industry for the past 25 years, leading companies in the US, Asia-Pac, and Europe. During her career she has held various senior and
C-level positions both in start-ups and large multinationals, including Pfizer, GSK, and GE. Her experience spans both business and clinical roles including sales, marketing, finance, quality, and medical
affairs. She is currently CEO for Vertual Ltd, a leading global supplier of virtual reality (VR) training systems, and prior to that was CEO for Physeon GmbH, and Managing Director for Avita Medical Ltd.
She has held public and listed company board roles and is currently Chair of Atelerix, Chair of the Institute of Directors (East Yorkshire), Non-Executive Director of Cambridge Cognition, and is the
commercial champion and mentor for several university spinouts. She has a degree in Pharmacy, an MBA from Warwick Business school and is a part qualified Management Accountant (CIMA).
David Jones - Non-Executive Director - In-House Counsel
David is a lawyer and entrepreneur who had acquired and grown three law firms with the international professional services group, ETL Global. He is also the Executive Partner of the lead UK legal
business, Glaisyers ETL. David is consistently ranked in the Legal 500 for his problem solving and business acumen. Having been called to the Bar in 2006 and following a stint as an in-house lawyer in
London David cross-qualified as a Solicitor in 2009. David acts in complex, high value matters for entrepreneurs and corporates, particularly in the cosmetics, financial services and Biocides sectors.
Whilst primarily a litigator, David’s loyal clients rely upon him for advice on a wide range of contentious and non-contentious matters affecting their business interests and wealth.
7.
Key Team Members Bios
Dr. Donna Lockhart - Head of Clinical Program
Dr. Donna Lockhart is a senior executive with more than 30 years’ experience in the pharmaceutical industry. She joined the pharmaceutical industry in 1990 and is experienced in pharmaceutical and medical device
product development, medical affairs, clinical development, regulatory affairs, manufacturing, and quality assurance and has managed these functions on a global basis. Prior to embarking on a portfolio consultancy
career, Donna held positions at Lederle Laboratories, Allergy Therapeutics, Wyeth, Pfizer, Reckitt Benckiser and Norgine. Donna obtained her medical degree at St. Mary’s Hospital, London, and spent 7 years in clinical
practice, specialising in Obstetrics and Gynaecology and completing a year in General Practice. She is a GMC registered physician with a B.Sc. in Clinical Pharmacology, and a Master of Business Administration.
Derek Brown - Head of Commercial Development
A highly professional and entrepreneurial pharmaceutical consultant with over 30 years of UK and EU Pharmaceutical Market experience. Former Hospital Director at the UK’s largest Generics company with broad
experience across Biosimilars, Proprietary and Generic products. Former Board member of the British Generics Manufacturers Association (BGMA), current member of the BGMA Secondary Care Group, and member
of the NHS Partnership Group. Member of the British Biosimilars Association. Extensive knowledge of the pharmaceutical supply chain with focussed expertise in executing product launch strategies. A strategic
thinker with excellent interpersonal skills who has managed several very successful Key Account Management teams. Specialist expertise in tendering/contracting with the NHS in all four home nations and was
intrinsic in transforming his former company’s underperforming hospital business unit to be one of the top suppliers to the NHS.
Temi Giwa - Senior Clinical Project Manager
Temi is an experienced clinical research professional consultant with over 20 years in operational trial management, working within diverse business models such as start-ups, academia, biotech, pharmaceuticals, and
clinical research organisations. With an extensive experience of managing multi-therapeutic and multi-phase (first-in-man to post marketing) projects across multi-regions, speciality areas include clinical trial
compliance leading on regulatory inspections (European EMEA and US FDA) and rescue project management. Temi has previously held senior clinical positions at Roche, Actelion, UCL, Parexel and Novartis.
Leah Heathman - Head of Regulatory Affairs
A senior Regulatory Affairs professional with 15 years’ experience across a broad range of therapeutic areas within leading pharmaceutical companies. Extensive knowledge of regulatory procedures ensuring
successful registration and maintenance within the EU and RoW. A strong leader competent in line-management, ensuring productive and happy teams and experienced in setting up Regulatory systems/processes,
writing SOPs and training. An effective communicator delivering regulatory strategy and engaging with cross-functional teams and global Health Authorities. A Green Belt in Lean Six Sigma with proven project
management skills and a drive for achieving project objectives with a clear focus on compliance and commercial timelines. Recently appointed as a member of the MHRA Review Panel.
Gordon Buchanan - Medical Advisory Board
Gordon Buchanan is a Consultant Surgeon, specialising in Colorectal and General surgery, with particular interests in minimally invasive cancer surgery, hernias as well as proctological disorders. Gordon began studying
medicine at St Thomas’ Hospital, London over 30 years ago and has been in Consultant practice for almost 15 years. His MSc and MD research at St Mark’s Hospital, awarded by Imperial College and University of
London assessed many areas of Complex anorectal fistula – he gained several prizes to visit other centres in USA (Lahey, Mayo and Cleveland clinics) and Hong Kong and undertook training fellowships at St Mark’s
Hospital, Mount Sinai in Toronto as well as Laparoscopic Colorectal fellowships in UK. Gordon has continued to work throughout the pandemic across the NHS and private sectors, and is an advocate for minimally
invasive techniques, particularly in methods that hasten wound healing and minimise infection.
8.
Capital Raise
To date in excess of £10 million has been invested by existing shareholders and
Convertible Loan Note Holders.
Team Expansion
15%
Non-Pharma Manufacturing Line
20%
Clinic Program
15%
Support Space
10%
Pre-IPO capital is currency being raised at a discount to an initial listing price on the
London Stock Exchange, target listing date is 2023.
SpectrumX have appointed Alfred Henry, a leading corporate advisory firm for
companies listing on the London Stock Exchange. They are the 7th largest advisory
firm for companies looking to list in the biotech sector.
Share Registrars Limited has been appointed as both registrars and receiving agent to
Professional Fees
15%
3rd Party Testing
15%
Milestone Payments
10%
the Company and will hold application monies until loan note certificates are issued
on the register of loan note holders. Share Registrars was founded as a registrar and
CAPITAL ALLOCATION - BASED ON £10M RAISE
receiving agent in 2003 and is registered with the Financial Conduct Authority under
the Anti Money Laundering Regulations.
• Construction of Non-Pharma Manufacturing Line - 20%
Capital raised will be deployed to support the following key areas:
• Construction of microbiology, quality control and ancillary support space - 10%
• Development of Clinical Program - 15%
They have been selected by SpectrumX due to their good standing in the financial
services market as well as their experience in the sector.
• 3rd Party Testing and Validation of Technology -15%
• Milestone payments under licensing agreements - 10%
• Expansion of Professional Team - 15%
• Professional fees re IPO preparation - 15%
9.
Capital Raise
SpectrumX now intends to come to market fully funded with human data in
2023.
Product Launches
10%
Clinical Trial Support
20%
Clinical Trail
50%
We will therefore be completing the balance of our fund raising as pre-IPO.
We believe that this will significantly de-risk the IPO for our investors given
current market conditions.
All existing investors will still convert (with discount where applicable) at the
original proposed valuation (carried out by Alfred Henry) of £58m.
The management team are confident that with positive human trial data a
valuation of more than £200m can be achieved by the time of floatation.
Corporate Purposes
20%
Capital raised will be deployed to support the following key areas:
Proceeds from the final round of Pre-IPO funding will be utilised for the
• Execution of Clinical Trial 50%
following:
• General Corporate Purposes 20%
• Clinical Trial Support Services 20%
• Further product launches 10%
10.
Upon receipt of successful data from the trials SpectrumX will be
submitting a marketing authorisation application to both the European
Execution Strategy
Medicines Agency (EMA) and the Medicines & Healthcare products
Regulatory Agency (MHRA). SpectrumX are confident that results from the
trials will be positive, and that the product can be brought expeditiously to
the market.
SpectrumX will also be working with the health supportive Government
SpectrumX have significant plans to improve the quality of treatment for patients in
Agencies including the Department of Health and Social Care and NHS
many therapeutic areas in the coming years. The first product to reach the market is
England to demonstrate the benefits of SPC-069 for patients and to ensure
the Spectricept™ hand sanitiser (NHS approved) to be rapidly followed by the
funding is available for its use.
nebuliser product SPC-069.
Once approval has been received, the Hospital Key Account Management
A number of significant milestones are expected in 2022. SPC-069 has been
team will be using the clinical evidence produced from the clinical trial to
delineated as a pharmaceutical product by the HRPA, Ireland in 2021. In 2022,
provide Health Care Professionals in the UK with empirical reasons to use
SpectrumX will begin preparations for a Phase Ib clinical trial using a viral challenge
SPC-069 in patients with respiratory challenges (including COVID-19). The
model to establish the efficacy of SPC-069 in preventing viral infection and reducing
plan is to work with Key Opinion Leaders (KOLs) in UK teaching hospital
symptom duration and severity in healthy volunteers. This will be followed by a multi-
hospitals to demonstrate efficacy and utilise these KOLs to provide
centre Phase II trial in the UK treating upper respiratory tract infections in vulnerable
positive opinion for the roll out of SPC-069 in other hospital sectors. The
adults to prevent hospitalisation.
contracting agencies in each of the home nations will also be
communicated with to ensure their understanding of the product and to
SpectrumX has secured a 16,000 sq ft industrial unit in Cheshire in the North West of
ensure that the product is listed for use in any required catalogue.
England to serve as the production site for UK and EU distribution. Phase 1 (nonpharma) fit out is now complete with Phase 2 (pharma) fit out to begin in 2023. There
The distribution model is currently being defined and it is anticipated that
is also commitment from the Management Board to a robust and beneficial ESG
the existing wholesaler distribution network will be utilised for movement
(Environmental, Social and Governance) programme. As part of this programme, the
and receipt of the product in the correct locations to ensure patient care is
company aims to be a carbon positive biotechnology company.
achieved. Commercial price points are being modelled to ensure maximum
uptake and value gain for the NHS and similarly for SpectrumX.
11.
Spectrum Antimicrobials &
SpectrumX Partnership
Founded in 2016 by Hoji Alimi, Spectrum Antimicrobials Inc. is an infection control solutions company.
Spectrum Antimicrobials and SpectrumX formed a mutually beneficial partnership in July of 2020. SpectrumX
holds licenses for commercialisation of various applications of the unique HOCl formulations developed by
Spectrum Antimicrobials.
Hoji Alimi has been investigating and developing HOCl for over 25 years. He has previously served as
Founder, Chairman and CEO of Micromed Labs, Oculus Innovative Sciences and Ruthigen Inc. He holds more
than 36 patents in areas of anti-infectives, surgical, wound care and manufacturing of specific drugs and
devices and has raised more than $170m for previous ventures.
Historically HOCl has been overlooked by “Big Pharma” due to the fact that it has never previously been
patent protectable. This all changed with the creation of Spectrum Antimicrobials’ development of their HOCl
shielding technology - Spectricept™.
It is the only company in the world to have registered a patent on a finished HOCl product. They have created
a formulation that not only has excellent shelf life but additionally maintains efficacy in the presence of serum
(blood, saliva, dirt etc). This is key because the product works in “real world” conditions where all other HOCL
products and manufacturers have failed which therefore increases the application potential.
12.
Production Facility
A key element of the business is that SpectrumX holds a manufacturing license
for the various products, making us and Spectrum Antimicrobials the only two
companies in the world with the technical know-how to produce the unique
formulations.
We have worked with specialists in the facility and process design to identify
significant process savings allowing the company to achieve a lower unit cost and
compete on price point with traditional alcohol based sanitisers.
Manufacturing in the UK provides SpectrumX with supply chain and production
efficiencies not currently available when shipping product from California.
To execute these licenses SpectrumX has a 10 year lease on a 16,000 sq ft
manufacturing unit in Cheshire in the North West of England. This area has
excellent road, air, sea and rail links making it easy for the distribution of our
products to the UK and beyond and as such this facility serves as the production
site for UK and EU distribution. The fit out is being undertaken on a phased basis
to align with our overall delivery strategy as follows:
Phase 1 – non-pharma manufacturing – complete
Phase 1A - Microbiology and manufacturing support infrastructure
Phase 2 – pharmaceutical drug substance manufacturing – Q3 2022
13.
Production Facility Includes:
Security
Regulatory compliant restricted zoned access control
24/7 external monitored CCTV and alarm systems
SR4 secure storage provision for critical raw materials
Full perimeter secure fencing
Purified Water System:
Pharmaceutical grade reverse osmosis water purifying system including
integrated data logging and sanitisation system and 10,000L pharmaceutical
grade storage tank
Piped purified water throughout manufacturing for production and cleaning.
Clean Room / Production Area:
3,000sqft of Class 5 and 8 clean rooms for manufacturing including walk on
suspended ceiling, HEPA fan filter units, HVAC system to manage environment
Parallel production lines to maximise capacity.
Pressure cascade in place throughout to maintain cleanliness and air locks on all
doors
Automated gas injection system with HSE compliant storage and controls,
integrated monitoring and shutdown systems and automated gas extraction.
Microbiology Laboratory Facility:
Class 8 clean room for microbiology and Quality Control Equipment including:
Colorimeters, Incubators, Refrigerators, Vortexes, Light pads, PH meters,
Viscometers and Autoclaves
General:
Raw material and finished product storage areas
ISO9001 approved QC process
Halal approved facility
Secure storage for ingredients and finished products
Allowance for future expansion to provide for new product lines and in house
bottling facilities
Sustainability:
EPC Energy rating A
Increased % of rooflights to reduce need for warehouse lighting use
High level of insulation
Proposals for PV array to be installed to contribute towards power requirements
Process water used for toilet flushing
EV charging
14.
ILS Collaboration
SpectrumX has engaged Integrated Life Sciences Group (ILS) as a consultancy
partner to plan and execute the commercialisation of its various products.
ILS is a specialist consultancy company that has a proven track record within
the highly regulated medical industries. Their senior management team have a
combined industry experience of more than 90 years, and have been supplying
services to the sector since 2006, progressing numerous products through various complex
compliance arenas.
Having supplied business solutions for the likes of Varian Medical Systems,
AstraZeneca, Norgine, Optimum Medical, GlaxoSmithKline, and Convatec. ILS is
perfectly positioned to handle the requirements of SpectrumX.
ILS has identified a number of structured pathways that will see the compliant
implementation of HOCl into the associated markets. These pathways are aligned with
roadmaps to ensure that each available route is maximised to its potential.
They will provide consultancy services to SpectrumX covering compliance and
product launches across HSE, BSI and MHRA standards. Key people include:
Derek Brown
Temi Giwa
Leah Heathman
15.
Market Overview
The almost endless applications of both Spectricept™ and SPC-069, as the only
effective HOCl formulations in “Real World” conditions, opens a huge
opportunity to SpectrumX. The various industries targeted are large, profitable
and well established. Our aim is to penetrate markets, disrupt historical
technology and replace outdated products.
EU Hand Sanitiser Market
2020
€611.5 million
2026
€1.43 billion
EU Respiratory Treatment Market
2019
€3.93 billion
2026
€6.18 billion
Sources: Hand Sanitiser: Graphical Research, Respiratory: Market Data Forest, Cosmetics: Statista
16.
Hand Sanitiser Market Size
The hand sanitiser sector is a huge market with vast opportunity
for growth as the COVID-19 pandemic has heightened consumers’
awareness of the importance of hygiene.
Non alcohol-based hand sanitiser alternatives are becoming more
appealing to consumers as they can provide the same sanitising
€611.5m
€1.43bn
2020
2026
effects without harming the skin.
Understanding of HOCl is increasing at a rapid pace but still not
fully understood. Standard HOCl has an extremely weak bond
chemical formulation which is easily deactivated by contact with
serum ( blood, sweat, dirt etc) and it is the fact that Spectricept™
has overcome this challenge which unlocks its full potential.
Source: Graphic Research
17.
Spectricept™
Spectricept™ is a line of effective, non-alcohol hand sanitisers for hospitals, businesses, healthcare facilities, retailers and schools.
Converting hospital
sanitisation from
alcohol to Spectricept™
Positive feedback
resulting in imminent
rollout to additional
NHS Trusts when
production capacity
allows
Currently supplying
Chelsea & Westminster
& West Middlesex
Hospitals
Healthcare
professionals are
amongst the highest
consumers of hand
sanitisers
NHS approved supplier
for Spectricept™
Halal Certified - Plans
for expansion to
Middle East and
Malaysia
18.
Support for Spectricept™
SpectrumX have already begun providing Spectricept™ to two leading NHS hospitals, Chelsea and Westminster Hospital and West Middlesex
Hospital. Medical Director, Gary Davies, had the following to say about the commencement of use of Spectricept™:
“At the start of the pandemic, hand washing and hand sanitisers suddenly became
even more important in the drive of preventing and limiting infection, but I don’t
think we necessarily imagined we would be using sanitisers so intensively and for
such a long period. Over time we have seen a really significant increase in skin
conditions suffered by our staff from high usage of alcohol-based sanitisers. We
proactively looked for a safe and effective solution to try to prevent this from
happening and have now started utilising an HOCl based product produced by
SpectrumX. Feedback from staff members has been overwhelmingly positive.”
Gary Davies, Medical Director
19.
97%
prevalence of general skin
damage in healthcare workers
caused by excessive hygienic
measures
90%
prevalence of acute hand
dermatitis among healthcare
Trend Away From Alcohol
The global outbreak of COVID-19, has led the consumers to take more
preventive measures regarding the maintenance of personal hygiene which
will be long lasting. The use of hand sanitising solutions or other similar
germicidal agents is one of the most common precautions observed among
consumers and healthcare professionals.
Currently the global hand sanitiser market is dominated by alcohol based
products.
Continued exposure to alcohol based sanitisers has been shown to cause
dryness, irritation, itching, and even cracking and bleeding to skin. In some
cases more severe reactions occur including dermatitis, eczema and psoriasis.
workers
This potentially increases the whole life costing model to all sectors using
alcohol based sanitisers which need an alcohol free alternative such as
15%
prevalence of hand eczema
among healthcare workers
Spectricept™. This is evident from a recent study of healthcare professionals as
illustrated.
Source: The Prevalence and Dterminants of Hand and Face Dermatitis during
COVID-19 Pandemic: A Population-Based Survey
20.
The Future of Hand Sanitisers
HOCl vs Alcohol Comparison Chart
Characteristics
Spectricept™ - The most powerful hand sanitiser in the world. Soothing and
formulated for daily use. Antiviral, antibacterial, and capable of eradicating antibiotic
resistant bacteria.
HOCl
ALCOHOL
Antibiotic Resistance
Wound Healing
The “technology” of alcohol based hand sanitisers hasn’t materially changed since it
was first used in the 1890’s. SpectrumX’s product offerings utilise 21st century
technology to protect the public.
Historically the problem has been finding an alternative substance to use which
works as well as alcohol at killing bacteria and viruses (efficacy). Spectricept™ is that
substance, a safe sanitising product with efficacy which exceeds that of alcohol
based products. The product also has healing properties which mean not only does it
Topical Anti-inflammatory
Broad Spectrum Anti-viral,
Anti-fungal, Anti-bacterial
Sporicidal
Bacterial Resistance
Toxicity - Dermal
not damage skin, it actually soothes and protects it.
Efficacy & Safety Data
Our target markets include high use settings where alcohol has the most likely
prospects of causing health problems. These include:
Hospitals:
Care Homes:
Schools:
Potential for skin
Potential for skin damage due
Reported cases of ingestion and
damage due to
to natural degradation of skin
eye exposure to alcohol based
high use
tissue in older individuals
sanitisers make them unsuitable
Reduction of Topical Pain
In independent ISO laboratory testing of the product it has been
shown to provide >LOG 6 reduction across a wide range of viruses and
bacteria (including COVID-19). Additionally HOCl has proven effective
at eradicating bacterial spores which alcohol does not.
21.
23.
C Diff
C. diff (also known as Clostridioides difficile or C. difficile) is a germ (bacterium) that causes severe
diarrhea and colitis (an inflammation of the colon). C. difficile is the biggest cause of infectious
diarrhoea in hospitalised patients. SpectrumX’s Spectricept - Hand Sanitiser has recently been
shown in independent laboratory tests to be the first product in world able to claim a 2 minute kill
against C Diff whilst also safe for use on skin.
This is an extremely significant data point as there are no other products on the market, including
the currently dominant alcohol based sanitisers, which can assist with this ever growing problem.
SpectrumX believe that this is the single biggest differentiating piece of data which will lead to rapid
disruption and penetration of the multi billion hand sanitiser market.
Additionally having worked with industry experts the company has decided to launch a second
product specifically to address the C Diff problem in hospitals and care homes.
Spectricept – Body Wash
Hospitalised patients and care home residents are routinely washed by nursing staff and carers.
Currently the products being used in the sector are simply detergents with no claims against
bacterial spores (C Diff). Given the fantastic data generated on our Spectricept technology platform
we are confident that the product will rapidly become the industry leader.
Management believe that this will add £5m plus in revenues per year within 24 months.
22.
Spectricept™ vs Generic HOCl
SpectrumX and Spectrum Antimicrobials are the only 2 companies in the world
able to produce Spectricept™ due to its status as a patent pending end product
formulation. All other companies produce generic HOCl (without the shielding
technology to stop it becoming deactivated) and because HOCl in its basic form
is a naturally occurring substance it cannot be patented in the same way water
cannot be patented (H2O).
Spectrum Antimicrobials’ CEO, Hoji Alimi, was the first scientist in history to
stabilise HOCl to provide shelf life in 2004. All other companies producing basic
HOCl are using this historical methodology. No other company has been able
to achieve what Spectrum Antimicrobials have been able to, which is to create a
shielded form of HOCl.
Some manufacturers have production method patents which are of little
commercial value as they result in an unpatented basic form of HOCl with
significant efficacy problems. As well as the formulations Spectrum
Antimicrobials have also patented the production methodology which is
completely unique and differs from the standard electrolysis method all other
HOCl potent
against serum
and organic load
companies use.
The result of this unique production methodology is the creation of
Spectricept™, an HOCl effective in real world conditions.
23.
Spectricept™ vs Generic HOCl
In the presence of serum (dirt, blood, sweat etc) basic HOCl fails to even reach disinfection
levels (LOG 4) whilst Spectricept™ not only achieves disinfection against all bacteria tested
but in many cases achieves sterilisation (LOG 6). This is absolutely critical as the product
is utilised in “real world” conditions not laboratory conditions which is how other companies
test their product and display their testing results.
LOG reduction based on 1 million bacteria
24.
EU Pharmaceutical Market Size
SpectrumX holds licenses for both the UK and EU pharmaceutical application of their novel technologies.
Collectively these are the largest pharmaceutical markets in the world..
10%
Percentage of
GDP Spend
740m
Population of
Europe*
Source: Integrated Life Science Group, 2021. SpectrumX Commercial Report.
€944bn
Annual
Pharmaceutical Spend
*including Russia & Turkey
25.
Antibiotic Resistance A Global Crisis
All of SpectrumX’s current product lines have non-selective mechanisms of
actions. This allows them the status of being effective against antimicrobial
resistant pathogens.
Antimicrobial resistance (AMR) occurs naturally, but misuse of antibiotics in
humans and animals is accelerating the process. It leads to longer hospital stays,
higher medical costs and increased mortality.
In January 2022, it was reported that in 2019, AMR killed more people than
malaria or AIDS. Mortalities from antimicrobial resistant infections will rise to 10
million per year by 2050, by comparison cancer currently causes 8.2 million
deaths a year.
Societal and economical costs of antibiotic-resistant infections are currently
estimated to be €1.5 billion per year in EU.
"Just as important and deadly as climate change and international
terrorsim!" - Chief Medical Officer of England, Dame Sally Davies
26.
Deaths Due to AMR
Current Global Death Rates
Death Attributed to AMR by 2050
Sources: Review on Antimicrobial Resistance. The infographic is licensed under
the Creative Commons Attribution 4.0 International Public License and shows
comparative, annual number of deaths, including annual deaths attributable to
antimicrobial resistance. & Review on Antimicrobial Resistance 2014
27.
SpectrumX Medical
As a leader in HOCl formulations, SpectrumX is at the forefront of research and
development into its ongoing potential applications.
Globally there is an immediate need for an efficacious, safe and cost effective
treatment for respiratory infections, including COVID-19, Influenza and those caused by
antimicrobial resistant bacteria.
Our partner Spectrum Antimicrobials announced in November 2020 that they had
finished development of SPC-069. SPC-069 is a new class of HOCl-based therapy
designed to treat viral, bacterial, and fungal infections in the lung and respiratory tract
(administered via a nebuliser). This promising therapy was developed to eradicate not only
COVID-19 but also infections caused by antibiotic resistant bacteria known as
“Superbugs.” There is currently no competing product in the market which has been
shown to be effective in this field.
28.
Existing Validation of SpectrumX Technology
In preparation for the start of human trials, SpectrumX has contracted with
the Medical University Hospital Innsbruck to perform validation testing.
They were specifically engaged to test the in-vitro effectiveness of SPC069 against a range of target viruses and bacteria including COVID-19
(multiple variants).
COVID-19:
A neutralisation assay is a serological test to detect the ability to
“kill/deactivate” (in this case) viruses. Once deactivated the ability of
viruses to spread is severely diminished.
A virus neutralisation assay assesses the inhibiting of replication (or in
other words, any substance that can neutralise viral infection)
SPC-069 has demonstrated extremely encouraging results thus far.
We believe that it will continue to provide similar results against all
types of viral infections.
29.
Existing Validation of SpectrumX Technology
Influenza:
Flu is a well known seasonal contagious respiratory illness
which is caused by influenza viruses. They infect the nose,
throat, and sometimes the lungs. It can cause mild to severe
illness, and can lead to death
Whilst additional testing is necessary, it is well known that a
virus cannot replicate alone. Viruses must infect cells and use
components of the host cell to make copies of themselves.
Assuming the host cell (human lung tissues) remains healthy
then a virus attempting to infect these cells and use the
components of the host cell to replicate should, in theory,
lead to the expectation that SPC-069 will have similar activity
against all viruses.
30.
Existing Validation of SpectrumX Technology
Superbugs:
Superbugs are strains of bacteria that are resistant to most of
the antibiotics and other medications commonly used to treat
the infections they cause. A few examples of superbugs
include resistant bacteria that can cause pneumonia. The four
most common superbugs are Carbapenem-resistant
Enterobacteriaceae (CRE), Methicillin-resistant
Staphylococcus aureus (MRSA), ESBL-producing
Enterobacteriaceae (extended-spectrum β-lactamases),
Vancomycin-resistant Enterococcus (VRE).
Antimicrobial resistance (AMR) occurs when microbes –
bacteria, viruses, fungi and parasites – no longer respond to
the drugs designed to kill them. It is vital that we only use
antibiotics only when necessary, that way they are more likely
to work when we need them. Without effective antibiotics,
most medical practices, including routine surgery, emergency
operations, transplants, and chemotherapy will be less safe
and in a post-antibiotic era even minor infections could prove
fatal
31.
Clinical Trials
In early 2022, SpectrumX reached an agreement on improved terms to its SPC-069 licensing
arrangement. These included the acceleration of transfer of trade secret and manufacturing
techniques required to produce SPC-069. These transfers have now taken place and the first test
batches of SPC-069 have been produced at our Knutsford facility ahead of Drug Substance
manufacturing for the human trials. This key improvement in terms allows for complete autonomy
from Spectrum Antimicrobials with Dr Donna Lockhart in full control of the clinical evaluation
program.
SpectrumX believes in building relationships with established industry players and in keeping with
that have engaged with Boots Contract Manufacturers (part of Fareva) and will be engaging hvivo
(part of Open Orphan plc).
SpectrumX plans to conduct the following clinical trials:
Phase Ib: Viral challenge model in healthy volunteers to establish the safety and efficacy of
nebulised SPC-069 vs placebo in preventing viral infection, attenuating symptoms and reducing
duration of infection in those who become infected.
Phase II: A multicentre study of nebulised SPC-069 vs placebo to treat viral, upper respiratory
tract infections in vulnerable adult populations such as those with chronic lung disease or heart
disease. A secondary endpoint will be to examine the potential of nebulised SPC-069 to reduce
hospitalisation rates compared to placebo.
Note: Nebulisers are medical devices that enable deposition (the dispersion of vapour of nebulised medication)
into the deeper areas of the respiratory system, such as the lung tissue. This is a key treatment pathway for
COVID-19 and other respiratory infections.
32.
Clinical Trials
IBCM are one of the world's leading subcontractors in the Industrial and Household, Cosmetics and Pharmaceuticals
fields.
With over 80 years experience of manufacturing pharma and beauty products, BCM employs around 800 people and
produces products that are sold around the world from their MHRA and FDA approved factory in Nottingham in the
UK.
BCM operates out of the famous D10 building and manufactures consumer pharma and beauty products for many
famous brands, as well as special prescription medicines through BCM Specials.
BCM are contracted to manufacture the drug product which is the final product which will be released via a qualified
person to the clinical trial site.
Hvivo are world leaders in challenge trials and laboratory services. They will be conducting a Phase Ib influenza
challenge trial on behalf of SpectrumX. hVIVO has been studying influenza for over 20 years, conducting influenza
human challenge studies with their flu disease models for more than 15 years.
They have delivered numerous flu challenge studies for a range of industry, governmental and academic partners,
making their tool the most well-used commercial flu disease model available on the market.
As the industry leader in conducting human viral challenge studies, hVIVO team has developed a large Virobase, of
clinical data paired with virological, host genetics and immunology data, combined with an extensive biorepository of
blood and respiratory samples. This “Virometrics” resource, in conjunction with thei unique insight into the host
response to viral disease, allows hVIVO to tailor study designs to each Investigational Medicinal Product (IMP).
33.
Clinical Trials Outcomes
We anticipate what will be proven in these studies is that, by nebulising
SPC-069 into the nasopharynx and lung three to four times daily for up to
10 days symptoms dissipate more quickly than in placebo-treated patients.
It is predicted that the active agent will deactivate the virus in the
respiratory tract and temporarily block the viruses ability to infect new
cells.
Upon receipt of successful data from the trial SpectrumX will be submitting a
marketing authorisation application to both the European Medicines
Agency (EMA) and the Medicines & Healthcare products Regulatory Agency
(MHRA). SpectrumX are confident that results from the trial will be positive
and that the product can be brought to the market expeditiously.
The focus of the trial is to establish that the use of the product can reduce
symptom severity and duration and also reduce the need for patients to be
hospitalised.
treatment possibilities will open up to the company for investigation. It is
expected that this will be a huge potential growth market for SpectrumX and its
SPC-069 treatment.
Other measurable benefits may include reduction of the viral load in the
respiratory system, making it harder to transmit it to others. Many
vulnerable patients who contract viral respiratory infections also develop
secondary bacterial pneumonia. We believe that it may be possible to
prevent secondary infections by nebulising SPC-069.
With the benefit of successful trial data, several other potential infection
34.
Prospects of Trial Success
SpectrumX’s confidence of a successful trial outcome is based on multiple factors including our in-vitro data as well as validated positive human trial data
of generic HOCl. The active ingredient in SPC-069 is HOCl, HOCl in its generic form has shown efficacy in a nebulised form against viruses, specifically
COVID-19, in human trials conducted by Dr Ivan Delgado-Enciso in Mexico in 2021.
An academic study (i.e. not for commercial purposes) was conducted using generic HOCl and was shown to reduce hospitalisation by 89% and risk of
death by 96% in COVID-19 patients.
The full findings of the above mentioned trial can be viewed here.
Uniqueness of SPC-069
SpectrumX not only have the only patent protectable formulation of HOCl globally, but in addition have a unique evolutionary chemistry which is
specifically formulated for inhalation into lung tissue which was developed over a 5 year period by Spectrum Antimicrobials.Given this we have strong
belief that the product will exceed the efficacy of the generic formulation used in the previously mentioned human trial.
Patent protection of drug formulations is the only commercially viable route to market (20 year patent protection). Generic drugs are free to be
copied/reproduced by any company, this is the single largest differentiator between SPC-069 and generic HOCl and what will provide long term revenues
to the business.
As one of only 2 companies (with Spectrum Antimicrobials) with a patent protected formulation of HOCl we anticipate being able to dominate the market
as the only drug product with our unique claims as well as its IP protection.
35.
Green Initiatives
At SpectrumX we are committed to a robust and beneficial ESG (Environmental, Social and Governance) programme. As
part of this programme, the company aims to be a carbon positive bio technology company. Planned initiatives include:
Installation of roof
mounted solar panels
for power generation
Advanced water
recapture and
recycling system
Utilisation of natural
waterway (located
behind the unit) for
the purposes of
cooling systems
Leveraging technology
to reduce
manufacturing waste
Optimising supply
chains with electric
vehicles
36.
Contact
www.spectrumx.com
invest@spectrumx.com