Softox Solutions As · OSL:SOFTX
Softox Solutions As — Investor Day (November 2021)
77 slides from Softox Solutions As's investor day presentation, Nov 17, 2021
Slide 1: Helping the World Fighting Infections
Helping the World Fighting Infections New ways of eradicating infections and fighting antimicrobial resistance Strategy and Capital Markets Day, including Q3 2021 results November 17, 2021
Slide 2: Agenda
Agenda 01 | SoftOx Solutions in Brief 02 | Proof of Concept 03 | Program Areas for Development SoftOx Wound SoftOx Disinfection SoftOx Respiratory Tract 04 | Summary 2 | Capital Markets Day 2021
Slide 3: Presenters
Presenters SoftOx in Brief & SoftOx Disinfection CEO Geir Almås Today’s Host & Finance CFO Kristine Rød Proof of Concept & SoftOx Wound CMO Dr Glenn Gundersen SoftOx Wound - Commercial CSO Finn Ketler SoftOx Respiratory Tract CMO-SIS Dr Christopher Burton 3 | Capital Markets Day 2021
Slide 4: Disclaimer
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 Capital Markets Day held by the Company. This presentation is strictly confidential and may not be reproduced or redistributed, i
Slide 5: SoftOx Solutions in Brief
01 SoftOx Solutions in Brief 5 | Capital Markets Day 2021
Slide 6: Our purpose
Our purpose MISSION Helping the world fighting infections VISION To become a world-leading developer of antimicrobial technology 6 | Capital Markets Day 2021
Slide 7: SoftOx is addressing major global issues
SoftOx is addressing major global issues VIRUS BIOFILM RESISTANCE ANTIMICROBIAL RESISTANCE Respiratory infectious diseases are 1-2% of the population are projected to Drug-resistant diseases could cause the third leading cause of death with experience a chronic wound during their 10 million deaths e
Slide 8: Reinforcing nature's own ability to eradicate unwanted microbes
Reinforcing nature’s own ability to eradicate unwanted microbes HYPOCHLOROUS ACETIC ACID ACID Documented broad Antimicrobial SOFTOX TECHNOLOGY antimicrobial effect stabilizer Replicating millions of years of evolution 8 | Capital Markets Day 2021
Slide 9: Competitive advantage
Competitive advantage 1. Unique chemical stability and quality 2. Strong antimicrobial effects 3. Non-toxic, excellent tolerability 4. Does not induce microbial resistance 5. Technology protected with extensive patent portfolio 6. Technology platform suitable for several needs 9 | Capital Markets Da
Slide 10: Team in brief
Team in brief Leadership Team Executive management team with a wealth of experience in business development, finance and medical strategy Scientific & Research Team 8 3 Highly skilled scientific team with 8 PhDs and 3 world-leading university professors professors & researchers on board PhDs & resea
Slide 11: Business model
Business model PARTNERS Preclinical Proof Clinical Proof Concept development PARTNERING of Concept of Concept DE-RISKING Investment phase Cash flow 11 | Capital Markets Day 2021
Slide 12: Partner strategy
Partner strategy PARTNERS Preclinical Proof Clinical Proof Concept development PARTNERING of Concept of Concept DE-RISKING Commercial, Industry & Financial Partners Clinical Partners Academic Research Partners Key Opinion Leaders (KOLs) Network 12 | Capital Markets Day 2021
Slide 13: Business model
Business model PARTNERS Preclinical Proof Clinical Proof Concept development PARTNERING of Concept of Concept DE-RISKING Investment phase Cash flow SOFTOX DISINFECTION SOFTOX WOUND IRRIGATION SOLUTION SOFTOX BIOFILM ERADICATOR SOFTOX INHALATION SOLUTION 13 | Capital Markets Day 2021
Slide 14: Project plan
Project plan Project Entering Partner type Market opportunity commercial partnership talks Disinfection 2021 Industrial 25-55 % of health care workers Hand disinfectant for eczematous (HCWs) have irritated skin and skin eczema & 70% of HCWs experience problems with alcohol SWIS 2022 Distributors 180
Slide 15: Financials
Financials CASH FLOW CONSIDERATIONS Medical Devices & Biocides 01 • Short- to medium-term • Long-term investment investments • License and milestones • Royalties and cash flow payments margins • Institutional/financial • Industrial partners and investors distributors 02 Drugs 15 | Capital Markets Da
Slide 16: Professionalization through spin-offs
Professionalization through spin-offs Key personnel Lung Project- Respiratory Tract Review of funding alternatives, including potential spin-off/partner tracks ✓ DNB Markets engaged to assist SoftOx in the process ✓ Find partners to finance Clinical Phase 2 Christopher Burton Thomas Bjarnsholt ✓ Sep
Slide 17: Financials
Financials Q3 FINANCIALS SoftOx Solutions Group Third quarter First three quarters NOK 1,000 2021 2020 2021 2020 Total operating revenue 1 513 1 738 5 594 9 243 Total operating expenses 23 428 13 962 71 357 38 614 Profit before tax -22 036 -12 199 -65 810 -29 244 Net change in cash and cash equivale
Slide 18: Proof of Concept
02 Proof of Concept 18 | Capital Markets Day 2021
Slide 19: Well proven technology
Well proven technology PRECLINICAL AND CLINICAL DOCUMENTATION 19 | Capital Markets Day 2021
Slide 20: Mechanism of action: Hypochlorous acid
Mechanism of action: Hypochlorous acid Hypochlorous acid (HOCl) is a natural biological compound produced by mammalian cells, mainly neutrophils. Endogenous production of HOCl plays a pivotal role in the ability of these cells to kill a wide range of pathogens. [1] The antimicrobial mode-of-action (
Slide 21: Antimicrobial European Norm (EN) tests
Antimicrobial European Norm (EN) tests Proven broad spectrum effect against bacteria, fungi and viruses 21 | Capital Markets Day 2021
Slide 22: Strong antimicrobial effects in biofilms
Strong antimicrobial effects in biofilms IN VITRO Biofilm eradication efficacy measured as reduction in the number of viable bacterial cells in mature deep-tissue embedded biofilms of S. aureus after treatment with lead candidates adjusted Biofilm eradication efficacy measured as reduction in the nu
Slide 23: Unrivalled combination effect on bacteria in biofilms
Unrivalled combination effect on bacteria in biofilms 9 8 7 LOG10 REDUCTION CFU/ML 6 5 4 3 2 1 0 3 hours (1 application) (3+3) hours (2 applications) Outperforming market leading competitors 23 | Capital Markets Day 2021
Slide 24: Visualization of profound anti-biofilm effect
Visualization of profound«anti-biofilm» effect Live cells Dead cells 400 um 400 um 400 um Static biofilm formation Static biofilm formation Static biofilm formation Added agent at time 0: LB medium Added agent at time 0: LB medium Added agent at time 0: 5% SoftOx 4 hours incubation 4 hours incubatio
Slide 25: Gentle to mammalian cells (limited cytotoxicity)
Gentle to mammalian cells (limited cytotoxicity) L-929: Exposure to SOFT-OX L-929: Exposure to SOF 003/53, L-929: Exposure to SOF 003/51, Wound Irrigation Solution 448 ppm, 1% eddiksyre 200 ppm HOCl, 1% eddiksyre 120 120 120 100 100 100 Viability (%) Viability (%) Viability (%) 80 80 80 60 60 60 40
Slide 26: Animal tests, GLP standard
Animal tests, GLP standard Sensitization tests → passed on all test samples Irritation tests → subcutaneous injection contraindicated Wound healing → Excellent results, does not impede normal wound healing, even at high concentrations Control SoftOx Proof of Concept on in vivo safety / tolerability
Slide 27: Clinical documentation
Clinical documentation PROOF OF CONCEPT Completed studies: Ongoing studies: SafeDes disinfectant 1a SBE-01 (Chronic leg wounds) SafeDes disinfectant 1b 1. No effect on skin barrier, no SIS-01 (Safety in healthy drying of skin, no irritation volunteers) SWIS-01 pilot study SWIS-02 pivotal study Proof
Slide 28: Patented and well protected technology
Patented and well protected technology SoftOx Competitors Broad and extensive patent portfolio covering: • formulation • production • storage • route of administration • antimicrobial indications A unique and protected technology for achieving an acceptable regulatory profile • Two years shelf life
Slide 29: Robust patent portfolio
Robust patent portfolio Rolling patent strategy Australia Austria Belgium SoftOx Solutions’ patent portfolio consists of U.S. and Brazil Canada Chile international patents and applications directed to China Denmark hypochlorous acid (HOCl)-based antimicrobial Eurasia Europe (EU) solutions and variou
Slide 30: Product portfolio opportunities
Product portfolio opportunities Opportunity Opportunity X Opportunity X X Opportunity X Opportunity Animal infection Defense X treatment multiproduct Opportunity X Opportunity SoftOx Biofilm X Defense Eradicator (SBE) countermeasure Opportunity Opportunity X X SoftOx Wound Hand Irrigation Solution d
Slide 31: Program Areas of Development
03 Program Areas of Development 31 | Capital Markets Day 2021
Slide 32: Business segments
Business segments Wounds Disinfection Respiratory Infection prevention and Infection prevention Infection treatment for treatment for acute and solutions for hands and viral infections chronic wounds surfaces 32 | Capital Markets Day 2021
Slide 33: SoftOx Wounds
3.1.a SoftOx Wounds 33 | Capital Markets Day 2021
Slide 34: Same technology – tailored concentrations
Same technology – tailored concentrations Preventive Treatment Antimicrobials Skin and Biofilm Wound Challenges Immune Wound bed Wound bed defenses SoftOx Wound Irrigation Solution SoftOx Biofilm Remover (SWIS) (SBE) SoftOx Solutions 34 | Capital Markets Day 2021
Slide 35: SWIS development plan
SWIS development plan 2018 2019 2020 2021 2022 Wound Biocomp/ Irrigation Clinical study DD development, Quality/ Clinical studies Submission / Solution Design Pilot Pivotal Approval, N=12 Medical device Control Partnering Formulation Cytotox No safety Healthy Volunteers, MDR, GMP Antimicrobial Irria
Slide 36: SWIS: Well documented safety profile
SWIS: Well documented safety profile Day 0 Day 14 SWIS-01 study1, Pilot study: Irrigation of acute wounds (Split Skin Graft Donor sites) n=12 → Well-tolerated in acute wounds, excellent wound healing, bacterial reduction SWIS-02 study, Pivotal (confirmatory) study: Safety and performance of SoftOx W
Slide 37: SWIS-01 published
SWIS-01 published Publication in The International Journal of Lower Extremity Wounds 37 | Capital Markets Day 2021
Slide 38: SWIS-02 study to be presented at EWMA Conference
SWIS-02 study will be presented at European Wound Management Association (EWMA) Conference Your abstract entitled: HYPOCHLOROUS ACID IN ACETIC ACID INCREASES EARLY REEPTHELIALZATION OF SUPERFICIAL ACUTE WOUNDS – A RANDOMIZED CONTROLLED TRIAL Abstract ID no.: 112 has been reviewed by the EWMA Scienti
Slide 39: SWIS – an optimal wound rinse solution
SWIS – an optimal wound rinse solution Features ▪ Well tolerated in wounds ▪ Skin friendly ▪ Excellent wound healing ▪ Documented to be just as safe as NS with significant better effect on early re-epithelialization (wound healing) ▪ Bacterial reduction ▪ Does not induce microbial resistance 39 | Ca
Slide 40: SoftOx infection remover (SBE)
SoftOx infection remover (SBE) Features ▪ SBE is a stronger antimicrobial solution than SWIS that aims to treat established (biofilm) infections ▪ Penetrates deep into the wound bed ▪ Animal data indicates excellent local safety and tolerability with no systemic exposure ▪ Kills antibiotic resistant
Slide 41: SoftOx Wounds - Commercial
3.1.b SoftOx Wounds - Commercial 41 | Capital Markets Day 2021
Slide 42: Unmet need in wound care
Unmet need in wound care ACUTE WOUNDS CHRONIC WOUNDS 180 million 40 million 1-2% of population are projected to have a Individuals have skin wounds worldwide each year1 Chronic wounds worldwide1 chronic wound in developed countries2 Today’s wound rinse market is dominated by saline Biofilm resistanc
Slide 43: Wound care
Wound care MARKET SIZE CONSIDERATIONS - WORLD North America Surgical Wounds Europe Ulcers Asia Pacific Traumatic Wounds RoW Burns 11.9% 23.3% 30.2% 34.5% 32.3% 28.3% 16.3% 10.3% by Region by Wound Type $10.43 bn market1 1. Research and Markets (2017). Advanced Wound Care Market. 43 | Capital Markets
Slide 44: Focus on US, EU and Middle East markets
Focus on US, EU and Middle East markets • Industry • Various players • Distributors 5m • Country specific 100m 330m Targeting larger international markets for our wound care products 44 | Capital Markets Day 2021
Slide 45: Perspectives on the wound care market
Perspectives on the wound care market HEALING WOUNDS TAKES MORE THAN ONE PRODUCT Based on a thorough diagnose a treatment is initiated including indication-specific essential treatment options like: • Offloading for Diabetic Foot Ulcers (pressure sores) • Compression for Venous Leg Ulcers not to men
Slide 46: Wound care product plan
Wound care product plan Project Regulatory class Entering Partner type First delivery commercial to partner partnership talks SWIS US: 510K 2022 Distributors/ 2023 Industry Wound rinse product EU: MDR cl. III SBE US: Drug 2023 Distributors/ 2025 Industry Infection remover claim EU: Drug US Europe FD
Slide 47: Commercial strategies – medical devices
Commercial strategies – medical devices Our aims: NORWAY • partnering with industry players or major Technology HQ & Test set-up distributors • offering a branded portfolio for proof-of-sales via distributors, to stay cash-flow independent from EUROPE fluctuations in industry interest (dual strategy
Slide 48: SoftOx Disinfection
3.2 SoftOx Disinfection 48 | Capital Markets Day 2021
Slide 49: Unmet need in hand disinfection
Unmet need in hand disinfection Cost-saving and life-improving Economic impact 31 million HCWs in the EU & the US [3 [4 Whereof 10 million have irritated skin and eczema[5 75% CAD 1.38 USD 1,080 [2 per HCW of HCWs with hand eczema have Value of effective prevention of hand eczema Value of effective
Slide 50: Health care workers demand new solutions
Health care workers demand new solutions Distribution of hand eczema among 59 million health care worker worldwide (31 million in Europe and US) 5% of HCWs risk losing job due to hand health issues 25-55% 70% of health care workers (HCWs) of HCWs experience problems have irritated skin and eczema[1
Slide 51: A paradigm shift in disinfection
A paradigm shift in disinfection CHALLENGES ANSWERED BY SOFTOX Skin Friendly • Clinically documented skin friendly for healthy skin, irritated skin and eczematous skin Effective • Full effect on all viruses incl. 15 sec effect on enveloped viruses • Effective towards biofilm (hand eczema) No health
Slide 52: Two clinical studies documenting skin friendliness
Two clinical studies documenting skin friendliness A comparison of SoftOx disinfection solution and alcohol disinfection on skin barrier function on intact and compromised skin in healthy subjects “The skin barrier function of the healthy skin is unaffected by the repetitive exposure to SafeDes solu
Slide 53: Opinion leaders emphasise need for new solutions
Opinion leaders emphasise need for new solutions Recommendation from WHO EXCITE International Norwegian Hospital Tender Expert panel (Kaiser Permanente, Established a separate class for «Provide alternative hand hygiene Mayo Clinic, NICE) acknowledged a alcohol-free hand disinfectant. products for H
Slide 54: Relevance of alcohol-free disinfection products
Relevance of alcohol-free disinfection products Main Benefits Safe usage in critical areas Airplanes/ Airports Skin Friendly Avoid skin irritation and eczema Military Effective Stadiums/ Full effect on all viruses and Arenas effective towards biofilm Schools and No health concerns kindergartens » Sa
Slide 55: Biocidal product approval status Europe
Biocidal product approval status Europe Regulatory process – BPR approval • The Swedish Chemicals Agency (KemI), forwarded the application to Norway and Denmark with the recommendation for final approval • Later KemI raised concerns regarding the lack of data on impurities • SoftOx’s answer: • Re-co
Slide 56: Unique chemical stability & quality
Unique chemical stability & quality Formation of impurities in SoftOx hand disinfection 44 44 40 Maximum safe dose of long-term exposure to 36 chlorates estimated by toxicologists 32 Ppm impurities Projection of formation of chlorates for ALS Global 28 measured as ppm where T0 is the time 24 of prod
Slide 57: Commercialization (US)
Commercialization (US) 2021 2022 2023-24 Proof of Sales from Supplement clinical Norwegian Hospital documentation for Tender (HINAS) FDA approval Enter the US market as a drug with medical claims added to our disinfectant products Response from FDA on Start talks for establishing classification as d
Slide 58: Market opportunity hand eczema
Market opportunity hand eczema Potential customer share: Unique value proposition towards 25% of the market Estimated global number of HCWs with hand eczema: 15 million healthcare workers (8 million in the US and Europe) Gross profit margin: 80-90% (achieved in Norwegian hospital tender) Customer sa
Slide 59: SoftOx Respiratory Tract
3.3 SoftOx Respiratory Tract 59 | Capital Markets Day 2021
Slide 60: Unmet need in prevention and treatment of respiratory infectious diseases
Unmet need in prevention and treatment of respiratory infectious diseases Limitation of vaccines Need for scalable, broad spectrum, antiviral treatments that either prevent disease progression or spread, and/or facilitate disease recovery Morbidity & mortality Microbial airway infections remain a pr
Slide 61: COVID-19 continues to pose a significant global threat
COVID-19 continues to pose a significant global economic and health threat $$$$ $$$ $$ $ Countries appear to be more focused on Large sums spent on vaccine roll-out rather Healthcare test-track-trace More limited use of test- than a test-track-trace infrastructure in these strategy. track-trace stra
Slide 62: COVID-19 and the evolution from pandemic to seasonal epidemic or endemic
COVID-19 and the evolution from pandemic to seasonal epidemic or endemic 3 Scenarios of COVID-19 transition Key gaps in an effective global response 1. Failure to gain rapid control of this pandemic Epidemiology • Effects of geographical and socioeconomic variations in vaccine coverage • Contributio
Slide 63: Percentage of patients with flu-like symptoms
12% of the EU/US population experiences flu-like symptoms annually Influenza Waterfall Chart 30% OTC products focused on reducing symptoms, but not: 100% • curing disease, Percentage of patients with flu-like symptoms • shortening the duration of disease, 25% • altering the course of the disease, •
Slide 64: SIS removes intracellular enveloped virus within 15 min in vitro
SIS removes intracellular enveloped virus without effecting host cell viability within 15 min in vitro SIS intracellular viral inactivation and cell viability following treatment with SIS in vitro* 120% Normalized to non-treated controls (%) 100% 80% 60% 40% 20% 0% MOI 0.002 Cytotoxicity Virus antig
Slide 65: SIS-01: Randomized, placebo controlled, first in human trial
SIS-01: Randomized, placebo controlled, first in human trial in healthy volunteers Single dose of nebulised SIS @ 25 ppm/placebo Subjects (N=56) will be enrolled and randomised to receive SIS or placebo in a 3:1 ratio (42 will receive SIS; 14 Primary Endpoints Single dose of nebulised SIS @ 50 ppm/p
Slide 66: SIS development
SIS development SUITABLE FOR MULTIPLE INFECTIOUS DISEASE INDICATIONS Pre-Clinical Phase 1 Phase 2 Phase 3 Regulatory Market Approval Approval Viral URTI Indications: • Acute viral upper respiratory tract infection (rhinovirus, adenovirus, Bacterial/Fungal URTI parainfluenza virus, respiratory SIS sy
Slide 67: Commercialization
Commercialization 2021 2022 2023… Phase I completion Phase II completion (first indication) Pre-clinical phase Phase II start Seek industrial partnership Separate entity Phase I start (all indications) Phase II start Financial partners (second indication) In 2022, a spin-off company will manage the
Slide 68: Summary
04 Summary 68 | Capital Markets Day 2021
Slide 69: Key takeaways
Key takeaways Solid progress on all R&D projects High Proven effect Strong platform targeting Successful clinical trial with great potential for $40bn+ profitability in humans many products/segments market 57+ patent Commercial Huge unmet Collaboration filings Phase with medical need 2 products in 2
Slide 70: Contact Information: ir@soft-ox.com
New ways of eradicating infections and fighting antimicrobial resistance Contact Information: ir@soft-ox.com Geir Hermod Almås Kristine Mundal Rød Chief Executive Officer Chief Financial Officer 70 | Capital Markets Day 2021
Slide 71: Appendix
05 Appendix 71 | Capital Markets Day 2021
Slide 72: Q3 financial highlights
Q3 financial highlights Income Statement Operating revenue • Increased, despite regulatory issues • Grants reduced due to low activity in SBE project (nurses strike) Operating expenses increase driven by • Research and development, approx. 47 % – SIS 60 % 72 | Capital Markets Day 2021
Slide 73: Q3 financial highlights
Q3 financial highlights Cash Flow Statement Negative cash flow from operating activities • Negative net result • Reduced accounts receivables due to payment of Skattefunn Negative cash flow from investment activities • Investments in IPR The Board is monitoring the Company's liquidity position and f
Slide 74: Board of directors & scientific advisory board
Board of directors & scientific advisory board Board of Directors Scientific Advisory Board SIS Project Leads Melvin Teigen Olav Jarlsby Dr Pål Rongved Chairman Non-Executive Director Professor, UiO • Listing Department • General Counsel & • Professor at School of Pharmacy, UiO Leader, Oslo Stock At
Slide 75: Management and financial team
Management and financial team Organization leadership Geir H. Almås Kristine Mundal Rød Trine Hasselknipe Olsby Chief Executive Officer & Founder Chief Financial Officer HR & Office Manager • 14+ years of experience in financial and • 14+ years of experience with personnel • Extensive experience fro
Slide 76: CMC, quality & commercialization teams
CMC, quality & commercialization teams Chemistry, Manufacturing and Controls (CMC) and Quality Management Hanne Grøgaard Kent Ghose Elisabeth A. Ohlsen CMC Scientist Quality Manager QA & Regulatory Affairs Manager • Broad startup experience and strong • Nearly 20 years’ experience in GMP • Several y
Slide 77: Scientific and research team
Scientific and research team Science and Medical Research SIS Project Leads Dr Glenn Gundersen Dr Julia Robertson Aina Kristin Pham Dr Christopher Burton Chief Medical Officer Medical Research Industrial PhD Candidate Chief Medical Officer - SIS Manager • 25+ years of experience • Formulation scient