SoftOx Solutions AS
A Norwegian MedTech Company listed on Euronext Growth,
Presentation Q3 2020
Disclaimer
This Presentation has been produced by SoftOx Solutions AS (the "Company" or "SoftOx"), solely for use at the presentation to investors held in connection with the proposed private placement of shares by the Company. This presentation is strictly confidential and may not be reproduced or redistributed, in whole or in part, to any other person. To the best of the knowledge of the Company and its Board of Directors, the information contained in this Presentation is in all material respect in accordance with the facts as of the date hereof, and contains no material omissions likely to affect its import. However, no representation or warranty (express or implied) is made as to, and no reliance should be placed on, any information, including projections, estimates, targets and opinions, contained herein, and no liability whatsoever is accepted as to any errors, omissions or misstatements contained herein, arising directly or indirectly from the use of this Presentation. This Presentation contains information obtained from third parties. Such information has been accurately reproduced and no facts have been omitted that would render the reproduced information to be inaccurate or misleading, as far as the Company is aware and able to ascertain from the information published by these third parties. This document contains certain forward-looking statements relating to the business, financial performance and results of the Company and/or the industry in which it operates. Forward-looking statements concern future circumstances and results and other statements that are not historical facts, sometimes identified by the words "believes", "expects", "predicts", "intends", "projects", "plans", "estimates", "aims", "foresees", "anticipates", "targets", and similar expressions. The forward-looking statements contained in this Presentation, including assumptions, opinions and views of the Company or cited from third party sources, are solely opinions and forecasts which are subject to risks, uncertainties and other factors that may cause actual events to differ materially from any anticipated development. The Company does not provide any assurance that the assumptions underlying such forward-looking statements are free from errors, nor does the Company accept any responsibility for the future accuracy of the opinions expressed in this Presentation or the actual occurrence of the forecasted developments. The Company does not assume any obligation, except as required by law, to update any forward-looking statements or to conform these forward-looking statements to our actual results.
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2
Highlights Q3 2020, including selected information for Q4
Finance
RnD
Awards
- Year to date pre-tax results ended 30.9.2020 with a loss of NOK 29 million (loss of NOK 15 million). Results are characterised by high levels of activity in research and development in addition to preparatory work ahead of the launch of our disinfectants in new markets
- Clinical study of the SoftOx Wound Irrigation Solution (SWIS) was approved and has commenced
- The Danish Medicines Agency recommended further development of the SoftOx Inhalation Solution (SIS) for the treatment of respiratory infections, including COVID-19
- The US Department of Defence (DoD) awarded SoftOx app. USD 2 million for the research and development of the SoftOx Biofilm Eradicator (SBE)
- SoftOx has been awarded conditional certification of its disinfectants in the EU. The Swedish Chemicals Agency has processed and recommended SoftOx Solutions' disinfectants, including AntiVir, for certification.
3
Financial highlights
Operating revenue, increase driven by sale of disinfection products and public grants
Operating expenses, increase
driven by
- Increased production capacity - Research and development
- Cost of goods sold
4
Financial highlights
Net change in cash and cash equivalents
- Approx. NOK 11 mill due to repayment of short-term loans
- Approx. NOK 8 mill in increased production facilities
5
SoftOx at a Glance
Eradicating
infections and
fighting
resistance
Strong
patented product portfolio
Strong
international research and market support
Targeting large
markets
- A strong medical technology platform developed over 10+ years
- The medical products being developed on this platform will effectively eradicate bacteria and viruses without creating resistance unlike existing antibiotics
- A non-alcoholic, exceptionally efficient hand disinfectant
- Biofilm Eradicator (SBE) and Wound Irrigation Solution (SWIS)
- Inhalation solution for respiratory tract infections (SIS)
- Strong development and research support from Bispebjerg Hospital and Copenhagen University
- US Navy Medical Research Centre sponsoring the development of the SBE
- Blue Cross/Blue Shield recommendation of the SBE product
- The largest market opportunities for SoftOx are in the professional health sectors worldwide
- All markets targeted by SoftOx are billion $ opportunities
- Currently in dialogue with leading players in some of the world´s largest markets
6
Contents
- New Ways of Eradicating Infections
- Product Portfolio
- Hand Disinfectant
- Wound Care Products
- Respiratory Tract Solutions
- Summary
7
Global Challenges Targeted by SoftOx
Antibiotic resistance
- The ability of bacteria and other microorganisms to resist the effects of an antibiotic to which they were once sensitive
- WHO estimates that drug-resistant diseases could cause 10 million deaths each year by 2050 [1
- The world needs a new antibiotic preventing and removing resistant infections without inducing new resistance
Biofilm resistance
- Aggregated bacteria often covered by slime (biofilm matrix), which acts as a fortress and protects bacteria
- 1 to 2 percent of the total population are projected to experience a chronic wound during their lifetime in developed countries [2
- The world needs a new antibiotic preventing and removing infections protected by a biofilm
Virus
- A submicroscopic infectious agent that replicates only inside the living cells of an organism [3
- The COVID-19 pandemic will likely end up costing between $8.1 and $15.8 trillion globally [4
- The world needs a broad spectrum, first-line alternative to vaccines
- https://www.who.int/antimicrobial-resistance/interagency-coordination-group/IACG_final_report_EN.pdf?ua=1
- Chandan K. Sen, PhD, Wound Repair Regen, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2810192/
- 3)Wu, Katherine J. National Geographic Society. April 2020 4) Schwab, World Economic Forum, August 2020
SoftOx - A Technology Product Platform Eradicating Infections
Over the past 10 years, SoftOx has developed and | Unrivalled Effect on Bacteria in Biofilms |
demonstrated our competitive advantage by: | |
9 | |
- Securing a unique chemical stability between two of the body's own antimicrobial agents
- Generating unique antimicrobial effects against all known groups of microbes
- Tweaking the concentrations between the two antimicrobials to develop a broad range of products, satisfying different medical needs
- Does not induce antimicrobial resistance
- Developing a solution that is non-toxic at effective concentrations
- Creating an easily scalable production method
LOG10 REDUCTION CFU/ML
8
7
6
5
4
3
2
1
0
Effect on
Staphylococcus aureus Biofilm
3 hours (1 application) (3+3) hours (2 applications)
New ways of eradicating infections and fighting antimicrobial resistance
9
Antibiotics are Struggling with Resistant Microbes
Platform products under development
- Wound irrigation solutions for acute wounds (SWIS)
- Topical infection prevention
- Infections remover in chronic wounds (SBE)
- Topical infection remover
- Inhalation solution (SIS)
- Topical infection remover in the respiratory tract
- Hand disinfection
- Topical infection prevention for non-compromised skin
Respiratory virucidal infections*
Acute surgical wounds*
Hand eczema*
Venous leg ulcers*
SoftOx is replacing today's antibiotics to become the first line of treatment
* Development projects already started
10
Contents
- New Ways of Eradicating Infections
- The Product Portfolio
- Wound Care Products
- Respiratory Tract Solutions
- Production and Distribution
- Summary
11
SoftOx Product Development Methodology*
Concept development | Preclinical PoC | PoC in humans | Regulatory approval and market adoption | |||
In vitro and | Pilot and | Post market or | |||
Excite International | confirmative or | Partners for | Full market | ||
Randomized | |||||
University of Copenhagen | Animal studies | Clinical trial | market adoption | ||
clinical trial | adoption | ||||
phase I/II | |||||
Early Technology review | Dose finding | Proof of concept | Partnerships | Confirmative study |
SoftOx Disinfection Program (Antivir)
SWIS (SoftOx Wound Irrigation)
SBE (SoftOx Biofilm Eradicator)
SIS (SoftOx Inhalation Solution)
12
* There are minor differences in the development stages between the products, for details, see each product description later in the presentation
Actual clinical development progress versus estimates Dec-2019
StudyObjectives
Animal (minipigs); MAX | RTC: Local tolerance, systemic effects and pathology in minipigs after |
repeated dosing (continuously for 28 days) with increasing SOX-strengths. | |
dose; wound healing | |
Aiming to achieve maximal tolerable dose. | |
Cost | Expectations December 2019 | Status 2020 |
(NOK) | ||
4m | Q2-3 2020 | Completed |
Biocide (SafeDes) Skin | Clinical testing of SafeDes hand disinfectant on healthy and experimentally | Completed | ||
induced eczema with respect to skin barrier functions. Comparison with | 1.5m | Q3-2020 | ||
Tolerability | ||||
alcohol-based products. | ||||
Clinical Study Medical | Pivotal, confirmatory, comparative trial in subjects with superficial (blister) and | On schedule | ||
full depth (biopsy) wounds to demonstrate safety and performance, with focus | 10m | Late 2020 | ||
Device (SWIS-02) | ||||
on wound healing. n = est. 40 (tbd). | ||||
To test drug candidates in relevant patient population (infected chronic | Slightly delayed | |||
Phase I drug study | wounds), dose escalation, safety and efficacy measures. n = est. 30 (tbd). | 25m | TBD, 2021 | |
Clinical Study (phase I) under development.
13 | SOX: SoftOx test solutions |
On track on most projects
1 | |||||||||
Hand Disinfection | In vitro/EN studies | Preclinical/EN | PoC/Pilot | Confirmative | Application market | Post market | |||
studies | studies | approval | studies | ||||||
SafeDes | N/A | TBD | |||||||
2 | Animals | ||||||||
Infection prevention | 1H2020 | N/A | |||||||
Infection treatment | 1H2020 | N/A | 2H2020 | ||||||
Device & Drug | |||||
3 | SWIS | 2020 | |||
4 | SBE | 1H2020 | 2020/2021 | TBD |
5 sis
14
• Blue arrow represent expectations 2019
• Green arrow represent actual 2020
Probability of Success for Developing Medical Drugs
Key points in SoftOx development | Probabilities by disease | |||||
• Topical usage moderate the risk factors | 30% | |||||
• Active substances are well known in the human body | ||||||
25% | ||||||
• Solid clinical experience for each of the active substances | 20% | |||||
15% | ||||||
• In vitro studies show clear combination effect | ||||||
• Clinical trial showed antimicrobial effect on low dose | 10% | |||||
5% | ||||||
• Preclinical and clinical trials showed no safety concerns | ||||||
0% | ||||||
SoftOx is developing products within an area that has one of the highest probabilities
of success from Phase I to Approval
15 *Clinical Development Success Rates, 2006-2015, June 2016. Biotechnology Innovation Organization, Biomedtracker & Amplion
Collaboration with World-Leading Scientists and Research Organisations
Key research development partners
US Department of Defense (DoD) awarded SoftOx $1.977 million (USD) for research and development of the SoftOx Infection remover (Biofilm Eradicator). NMRC and SoftOx have weekly meetings, monthly reporting, and are active partners in the clinical development
Bispebjerg Hospital - a development site and a major contributor to the SoftOx advisory board.
SoftOx has a close cooperation with University of Copenhagen, University of Oslo and Malmö University. Professor Bjarnsholt from University of Copenhagen is also a member of SoftOx advisory board
Key support partners
EXCITE International is a
global collaboration of key stakeholders. EXCITE and Blue Cross/ Blue Shield recommended SoftOx to MTEC and US Navy
Key financial partners
16
A Strong and Experienced Management and Financial Team
Geir H. Almås - Chief Executive Officer & Founder
- Extensive experience from business development in Norway and Poland
- Previously PwC and KLP Asset Management
- MSc in Business Administration (BI) and Chartered Accountant (NHH)
Dag Abrahamsen - Director Communication
- 20+ years' experience working with Pharma-, Bio Tech- and health sector-related companies and organizations
- Specialist in Market Access, Reimbursement and Business Development within this industry
- Law studies at the University of Bergen, as well as International Business Management and International Business Strategy at the Norwegian Business School
Kristine Mundal Rød - Finance Manager
- 14+ years of experience in financial and non- financial reporting, auditing, forecasting, and strategy
- Previously EY and Fretex Miljø/Salvation Army
- State Authorized Public Accountant and Master of Business Administration in Economics (NHH)
Hans Petter Grette - Director Marketing Sales Norway
- 20+ years' top management experience working with market-leading branded consumer goods companies and within professional B2B industry
- MSc Business Administration (BI), AGSIM (American Graduate School of International Management - Thunderbird), Arizona, USA
Finn Ketler - Director Marketing Sales EU
- 20+ years' experience in Medtech, former SVP at Coloplast (DK, DE), CEO at Vigmed AB (SE), VP at Biotech Pharmacon (NO) and Selection Committee Member at BII a Novo Nordisk Foundation initiative
- Managing Partner and Founder of Coopmed where mission is to ensure more MedTech innovations reach market and help patients by supporting startups commercializing innovations
Elisabeth A. Ohlsen - QA & Regulatory Affairs Manager
- Several years of experience working with pharmaceutical companies and the health care sector
- Expertise of how to operate a Quality Management System, Good Manufacturing Practice, and regulatory standards
- Civil Engineer in Pharmaceutical Design and Engineering from the Technical University of Denmark
17
A Strong and Experienced Research and Development Management Team
Management and research team
Glenn Gundersen - Director of Medical Affairs
- Over 25 years of experience from the pharmaceutical industry with focus on immunology/inflammation and oncology
- Previously Bristol-Myers Squibb Norway, Biotec Pharmacon, Biogen Norway
- PhD in Molecular and Cellular Biology, University of Oslo
Magnus M. Fazli - Director of Science &
Research
- 15 years of experience in biofilm research
- Specializing in chronic wound biofilms, biofilm formation, and antibiotic resistance
- PhD in Medical Microbiology, University of Copenhagen; MSc in Bio-Business and Innovation, Copenhagen Business School
Julia Robertson - Medical Research Manager
- More than 8 years of experience in Pharma- and health sector related companies
- MSc in Medical Biotechnology from the Technical University of Berlin; PhD in Molecular Biology from the University of Oslo
Geir Utigard - Director of CMC
- 20 years of experience in product and production process development, upscaling, operational optimization, analysis of production data, and technology transfer
- Previously Lilleborg AS, Orkla, Axis-Shield AS
- MSc in Chemical Engineering, NTNU
Aina Kristin Pham - Industrial Ph.D Candidate
- The company's formulation scientist and industrial PhD researcher
- Experience from the pharmaceutical field, previously working at the Norwegian Medicinal Agency and as a pharmacist for Apotek1 Gruppen AS
- Master of Pharmacy from the University of Oslo
Hanne Grøgaard - Scientist, CMC
- Several years of experience in research, marketing documentation, analytical chemistry, product and process development for supplements and drugs
- Worked in start-ups and contributed to build laboratories, systems, routines, methods and production processes.
- MSc in Biotechnology, NTNU
Scientific advisory board
Klaus Kirketerp-Møller - Principal Investigator
- Since 2007, mainly focused on research on chronic wounds and bacterial biofilms
- Co-inventorof the technology with financial rights
- Works for the company as a consultant
- Medical Doctor, PhD at Copenhagen Wound Healing Center, Bispebjerg Hospital, Denmark
Thomas Bjarnsholt - Scientific Advisor
- Expert in the role of bacterial and fungal biofilms in chronic infections with over 135 peer reviewed publications
- Co-inventorof the technology with financial rights
- Member of the Global Wound Biofilm Expert Panel
- Professor at the Costerton Biofilm Center, Department of Immunology and Microbiology, University of Copenhagen
Pål Rongved - Professor at the University of Oslo
- Professor at School of Pharmacy, UiO and Senior Consultant in Board of Appeal Industrial Intellectual Property Rights (KFIR)
- Specialties: Medicinal chemistry, contrast agents, chelating agents, innovation, IPR, patent technology.
- Cand.scient. in organic chemistry and PhD in medicinal chemistry, UiO
18
Strong Intellectual Property rights
Advisors regarding patent and IP rights
- Attorney Thomas Meyers, Head of Intellectual Property, Brown Rudnick LLP
- Main architect behind IP strategy and has worked with SoftOx since 2012
- Pål Rongved, Professor of Pharmaceutical Chemistry and Advisor for The Norwegian Industrial Property Office
- Senior Advisor on chemical formulation and IP protection
More than 20 fillings where key patents granted, some key applications regarding matter of use:
- SoftOx hand disinfectant (Allowed U.S. App. 15/167,076, and corresponding applications across the world)
- SoftOx as a treatment for biofilms and wound care (U.S. App.15/612,571)
- SoftOx treatment of biofilms without inducing antimicrobial resistance (U.S. App. 16/672,393 and PCT/IB2019/001231);
- SoftOx treatment of transient biofilms (U.S. App. 16/672,395 and PCT/IB2019/001177); and mastitis treatment (U.S. App. 14/618,820).
- SoftOx has a license with co-inventors at the University of Copenhagen to patents related to wound treatment using SoftOx technology: Wound Care Products: U.S. 9,655,840 and EP 2515869; and Improved Wound Care Products: U.S. App. No. 14/112,518 and EP Pat. No. 2699232.
Ongoing patent application process to secure new inventions
Key patents filed in US, Europe, Asia and several South American countries
19
Contents
- New Ways of Eradicating Infections
- The Product Portfolio
- Hand Disinfectant
- Wound Care Products
- Respiratory Tract Solutions
- Summary
20
SoftOx Product Development Methodology*
How to enter the market
Concept development | Preclinical | Proof of Concept | Regulatory approval and market adoption | |||
Excite International | In vitro efficiency | Safety study MD | Partners for | Post market studies | Full market |
University of | Animal studies | EN 1500 | EU approval | ||
Copenhagen | market adoption | adoption | |||
Early Technology review | Dose finding | Proof of concept | Partnerships | Confirmative study |
SoftOx Hand Disinfection Program (Antivir)
21 | * There are minor differences in the development stages between the products, for details, see each product description later in the |
presentation |
Leading Players Emphasise Need for an Alternative to Alcohol
The World Health Organization recommendation to healthcare facilities [1
- «Provide alternative hand hygiene products for HCWs with confirmed allergies or adverse reactions to standard products used in the health-care setting»
The Norwegian Hospitals (Helseforetakenes Innkjøpsservice AS (HINAS))
- Established a separate class for alcohol-free hand disinfectant
EXCITE International
- The expert panel which includes some of the largest customers in the US and UK (Kaiser Permanente, Mayo Clinic, NICE) acknowledges a great need for more skin friendly solutions and recommends SoftOx as a strategy for replacing Alcohol-Based Hand Rub
SoftOx is answering an unmet need in a $6 bn market in US and EU[2
- World Health Organization - Guidelines on Hand Hygiene in Health Care
- Company own estimates
22
SoftOx - a Paradigm Shift in Disinfection
Challenges answered by SoftOx
- Skin friendly alternative to 25-55% of healthcare workers (HCW) have skin problems on their hands [1
- Alternative to for 70% of HCW experience problems with alcohol
- Full effect on all viruses incl. 15sec effect on enveloped viruses
- Effective towards biofilm (hand eczema)
- No health concerns
- No burning sensation
- Not toxic for eyes and drinking
- Non-flammable
Economic impact
31.5 million HCWs in the EU and the US [2 [3
Whereof 10 million have irritated skin and eczema[4
USD 1,080 [5
Value of effective prevention of hand eczema per HCW
1 mill HCWs in EU and US at risk of losing their job
If so, 2/3 of them risk ending up on disability benefits
- 20 bn in estimated cost for US and European Hospitals
- World Health Organization - Guidelines on Hand Hygiene in Health Care
- Eurostat- Majority of Health Jobs Held by Women (2020)
- Kaiser Family Foundation - Total Health Care Employment (2018)
- National Eczema Association - Hand Eczema Common Among Health Care Workers
- MedValue+, Radbound University Medical Center and Exite International's Panel of 11 KOL/experts - "2019 Health Technology Assessment; SoftOx Hand-wash for Health Care Workers with Eczema"
Relevance of Alcohol-Free Disinfection Products
Main Benefits
Avoid skin irritation and eczema
Safe and non-flammable formula
Prevents alcohol consumption/poisoning
Safe transportation
24
Safe usage in critical areas
Airplanes/
MilitaryAirports
Health care
sector
Stadiums/
Schools andArenas kindergartens
Offshore
Hand Disinfectant - Market Roll Out
Norway
Nordic | |||
Healthcare | Europe+ | ||
- User requirements | |||
Healthcare | |||
- Point of use | |||
- Sweden | |||
Healthcare | |||
- Price elasticity | |||
- Denmark | |||
- Germany | |||
Other segments | - Benelux | ||
- Retail | - Middle East | ||
- B to B | - Asia | ||
- USA and Canada | |||
Nordic market pre corona
Retail
Business to 5 % Business
16 %
Other
healthcare
6 %
Hospitals and
nursing
homes 73 %
Norway serves as a pilot market to better understand the post-Covid-19 consumer
25
SoftOx Disinfection Norway
Hospitals | Pharmacies & B2C | |||||
Other B2B
Segment distributors
- Cover the whole market
- Signal customers
Rationale
- Category for non-alcohol hand sanitizer
- Well documented efficiency
- Clinically proven skin friendly
- Safe
Business model
- HINAS Tender expected Des20/Jan21
- Direct of via distribution partners
Rationale
- Norway's largest brand distributor
- Own marketing, KAM and sales force towards pharmaceuticals
- Category for "Infection prevention" partnering with Aeris facemasks
- Innovation Window Feb 1st
- Consumer activities:
- XXL launched in NO/SV/DK
- Now being used in EM Denmark
- Product of the month jan 21 Br. Dahls
Doctors office
Home Care
Public & Private sector
The defense sector
International transport
Sports
Offshore
26
Production and Distribution - Hand Disinfection
Production
- Production facilities established in Norway
- Three facilities for small bottles (up to 1 litre)
- One facility for large bottles (1 litre and 5 litre)
- Established QA system
- Existing capacity up to 2,5 million liters per month
- Focus on bottling and flexibility in bottle size and shape
- New inhouse production line gives increased flexibility
Distribution and roll out strategy
- Sales through distribution partners
- Premium product, aimed at healthcare workers
- Planned to be made available in pharmacies, sold directly to large clients and through consumer channels
Highly efficient production capacity for a turnover of up to $ 70 million per year
27
Contents
-
New Ways of Eradicating Infections
2 Product Portfolio
3 Hand Disinfectant
4 Wound Care Products
5 Respiratory Tract Solutions
6 Summary
28
Same Technology - Tailored Concentrations for Different Use
Intact skinAcute woundChronic wound
Skin and | ||||
Wound | Antimicrobials | |||
Skin and environmental microbes | ||||
Challenges | Wound bed | Biofilm | ||
Wound bed | immune | |||
defence | ||||
s |
AntiVir | SoftOx Wound | SoftOx Infection |
Hand disinfection | Irrigation Solution | Remover |
SoftOx
Solutions
29
SoftOx Product Development Wound Irrigation Solutions (SWIS)
Market segmentation
Concept development | Preclinical PoC | PoC in humans | Regulatory approval and market adoption | |||
In vitro and | Pilot and | Partners for | Post market or | Full market | |
University of Copenhagen | confirmative | Randomized | |||
Animal studies | market adoption | ||||
clinical trial | clinical trial | adoption | |||
Early Technology review | Dose finding | Proof of concept | Partnerships | Confirmative study |
SWIS (SoftOx Wound Irrigation Solutions)
30
SoftOx Wound Irrigation Solution (SWIS)
Features
- Safe to use (user friendly)
- Non-toxicto host cells/tissue
- Profound antimicrobial effect
- Effectively kills antibiotic resistant bacteria and does not induce new resistance
Infection prevention market size of USD 1.6 bn [1
Million acute wounds annually | ||||
~ USD 465 mn | ||||
Annual market size | Traumatic wounds | |||
in Europe [2 | 50.0 | Burns | ||
5.0 | ||||
~ USD 668 mn | ||||
Annual market size | ||||
in North America[3 | Surgical wounds 250.0 |
Market opportunity
• Skin wounds affect 120 million individuals worldwide [4
• Replacing today's wound wash products with a better or equal risk profile and profound antimicrobial effect
» Saline - 80% market share
» Other wound wash products - 20% market share
1) | Wound Irrigation Solutions to Market 2027 - ResearchandMarkets.com | |
2) | Europe Wound Irrigation Solution Market Forecast to 2027 - Reportlinker (2019) | |
31 | 3) | North America Wound Irrigation Solutions Market - Reportlinker (2019) |
4) | European Union - HEXKIN - Delivering Healing EXosomes for sKIN (2019) |
SoftOx Product Development Infection Remover (SBE)
Concept development | Preclinical PoC | PoC in humans | Regulatory approval and market adoption | |||
Excite InternationalUniversity of Copenhagen
Early Technology review
- Scientific evaluation
- Unmet need
- Input from KOLs and early adopters
- Financial profitability
In vitro and | Pilot and | Post market or | ||
confirmative or | Partners for market | Full market | ||
Randomized clinical | ||||
Animal studies | Clinical trial | adoption | ||
trial | adoption | |||
phase I/II | ||||
Dose finding | Proof of concept | Partnerships | Confirmative study | Secured adoption |
• Repeated dose | • Safety | • Customer | • Significant results | |
toxicity (GLP) | • Effectiveness | • Salesforce | • User feedback and | |
• Lab experiments | recommendation | |||
• Stability | • Regulatory approval |
SBE (SoftOx Biofilm Eradicator)
32
SoftOx Infection Remover (SBE)
Features
- Penetrates and kill microbes within biofilms
- Penetrates deep into the wound bed
- Non-toxicand safe to use
- Kills antibiotic resistant bacteria and does not induce new resistance
Development and market opportunity
- 40 million chronic wounds to heal [2
- Before healing, infections must be removed
- Today's recommended solution removes only 90% of the bacteria and includes surgical removal of wound bed
External market support
US Navy Research Center - 2 million USD
EXCITE International incl. Blue Cross/Blue Shield European Wound Management Association
1) | Advanced Wound Care Market Size, Share & Industry Analysis - Fortune Business Insights (2020) | |
33 | 2) | European Union - HEXKIN - Delivering Healing EXosomes for sKIN (2019) |
3) | Europe Advanced Wound Care Market Analysis Report - MarketDataForecast.com (2020) | |
4) | North America Advanced Wound Care Market Research Report- MarketDataForecast.com (2020) |
Global infection remover market size of 11 bn [1
Million chronic wounds annually | ||
~ USD 2.8 bn | ||
Annual market size | ||
in Europe [3 | ||
Venous leg ulcer | 9.7 | |
16.2 Other chronic wounds | ||
~ USD 3.0 bn | ||
250.0 | ||
Annual market size | ||
in North America | Diabetic foot ulcers | 10.0 |
4.5 | ||
Pressure ulcers |
Contents
-
New Ways of Eradicating Infections
2 Product Portfolio
3 Hand Disinfectant
4 Wound Care Products
5 Respiratory Tract Solutions
6 Summary
34
SoftOx Product Development Inhalation Solution
Concept development | Preclinical | PoC in humans | Regulatory approval and market adoption | |||
Danish Medical Agency | In vitro and | Clinical trial | Partners for | Randomized | Full market |
University of Copenhagen | Animal studies | phase I/II | market adoption | clinical trial | adoption |
Early Technology review | Dose finding | Proof of concept | Partnerships | Confirmative study |
SIS (SoftOx Inhalation Solution)
* The arrow shows Soft-Ox product progress
35
Treatment of Infections in the Respiratory Tract
Unmet need
- Combat viral and bacterial infections in respiratory tract and lungs
- Treatment of Covid-19
- Pneumonia, Cystic Fibrosis, other
Results from preclinical studies with SoftOx Inhalation Solution (SIS)
- Antiviral and antibacterial effects demonstrated in vitro
- Tolerable & safe concentration range established in minipig model
Latest news
- A Scientific Advice meeting has been performed with Danish Medicines Agency obtaining clarity and input to an accelerated drug development process aiming for first-in-human (FIH) study Q2 2021.
- Intensive research activity is currently ongoing to secure safety & tolerability aspects prior to FIH study. On schedule.
Answering the unmet medical need of treating respiratory tract infections
36
SoftOx Inhalation Solution (SIS)
Features
- Antimicrobial inhalation solution for respiratory tract infections
- Broad spectrum including virus and resistance bacteria
Market opportunity
- Huge unmet need for infectious treatment in respiratory tract
- Supplement for vaccine development
- Replacing antibiotics to treat resistant infections
Project leader Professor Thomas Bjarnsholt
Market Inhalation Solutions in Europe and the US ¹
Acute
bronchitis;
32,5
Covid 19; | Influenza; |
75 | |
12,3 | |
Bacterial | |
~ USD 12 bn | |
pneumonia; | |
Annual market | |
8,4 | |
size |
- European Lung White-book, European Respiratory Society. Chapter 18. Available from: https://www.erswhitebook.org/chapters/acute-lower-respiratory-infections/
Number of cases from 31 Dec 2019 to 10 Aug 2020. Source: European Centre for Disease Control and Prevention. Available from: https://www.ecdc.europa.eu/en/geographical-distribution-2019-ncov-cases
Singh A, Avula A, Zahn E. Acute Bronchitis. [Updated 2020 Jun 24]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK448067/
37 Disease burden of influenza. Source: Centers for Disease Control and Prevention. Available from: https://www.cdc.gov/flu/about/burden/index.html
Sattar SBA, Sharma S. Bacterial Pneumonia. [Updated 2020 Mar 6]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK513321/
Contents
-
New Ways of Eradicating Infections
2 Product Portfolio
3 Hand Disinfectant
4 Wound Care Products
5 Respiratory Tract Solutions
6 Summary
38
Investment highlights
$20bn+
Large market opportunity1
Strong patent family protecting IP
+80%
Gross margin target2
+35%
EBITDA2
AntiVir ™
Distribution through partners
Proven effect | 2021 |
Successful clinical trial | Ambition of cash |
in humans | positive operations |
Collaboration with | No antimicrobial |
world-leading scientists | resistance |
- Calculated by adding the potential markets
39 2) Company estimate
New ways of eradicating infections and
fighting antimicrobial resistance
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Disclaimer
SoftOx Solutions AS published this content on 15 December 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 16 December 2020 08:50:00 UTC