Preventing and treating chronic infections SoftOx Solutions AS A Norwegian MedTech Company listed on Merkur, OSE
Agenda • Introduction 4th Quarter 2019 • Key highlights • Key Figures • The challenge • Highlights • The SoftOx technology • Product development • The solution • Pre clinical and clinical studies 1st Quarter 2020 • • Highlights Virus and bacteria • Product portfolio • Product development • Commercialization Investment proposition 2
Highlights SoftOx has discovered a unique combination of natural chemicals proven to have superior antimicrobial effect when compared to today’s solutions* • First clinical trial in humans completed successfully • Secured distribution agreements for hand disinfection (Kiiltoclean/Antibac) and animal health (VESO) • Cooperation with globally leading universities, and research teams • Entered the market with the company’s hand disinfectant Removing and preventing infections *Company information; Filter grown Pseudomonas aeruginosa and Staphylococcus aureus embedded in biofilm 3
The challenge Viral epidemics • No known cure. • Vaccines serve as the only solution for viral infections requiring 1-2 years of development. Antimicrobial resistance • The ability of bacteria and other microorganisms to resist the effects of an antibiotic/antiseptic. Biofilm resistance • Aggregated bacteria often covered by slime (biofilm matrix), acting as a fortress and protecting bacteria from attacks Nature’s ability to fight antimicrobial resistance (AMR) is reinforced 4
A unique combination Acetic acid Hypochlorous acid • Long history of use as an antiseptic • The body’s natural antimicrobial agent • Potentially effective deep within the wound bed • Widely used but inherently unstable • Good stability • Instantaneous microbial killing effect • Retains antimicrobial activity despite contact with organic • Superior safety profile in efficient concentrations material (e.g. blood, tissue) • Moderate antiseptic effect alone • Widely used as food additive • Well tolerated, e.g. drinking water • Moderate antiseptic effect alone The SoftOx Technology – the combination effect • The combination works synergistically, and shows superior effect on microbes • Does not induce resistance in bacteria. Effective in antibiotic-resistant bacteria (e.g. MRSA) • Can be customized for specific purposes; » Higher concentration of acetic acid increases the formula’s antimicrobial potency (biofilm eradication) » Lower concentration of acetic acid yields a softer sting when applied to wounds (disinfectant, wound irrigation) • Effectively stabilizes hypochlorous acid 5
Works on wound surfaces AND beneath the wound bed Success criteria for removal of infections The SoftOx Wound Model ▪ Penetrate and kill microbes within the biofilm Prevent infections ▪ Penetrate and eradicate biofilm within the wound bed ▪ Microbial resistance must not develop ▪ Well tolerated Penetrates wound bed Infection remover Kills bacteria inside biofilm Removal of infections → critical for wound healing 6
Pre-clinical experiments show promising effects In vitro in the lab Animal models ✓ A safe disinfectant with a unique ability to remove hard-to- ✓ No negative influence on wound healing treat microbes embedded in biofilm ✓ ✓ Well-tolerated in full-depth wounds Appears to be significantly more effective than competitors SoftOx against P. aeruginosa and S. aureus, the most common ✓ Significant bacterial reduction in wounds bacteria in chronic wounds ✓ Did not induce resistance or cross-resistance development towards antibiotics Effectiveness on Staphylococcus aureus 1 Effectiveness on Pseudomonas aeruginosa 1 Effect on bacteria in biofilms 7 1) Company information SoftOx SoftOx
VirusProtect A hand disinfectant - fully effective on all types of viruses and bacteria, including the novel Corona virus Benefits • Improved skin health • Prevention of hand eczema • Reduced Hospital Acquired Infections • Reduced spread of Antimicrobial Resistance. Fully viricidal & skin friendly hand disinfectant 8
Product portfolio Biocide expected to be Medical Device SoftOx platform ready for Expected ready for Medical Drug developed market in 2020 market in 2021 1 Hand disinfectant 3 Ready for Nordic market Wound Irrigation Solution SoftOx • Acute wounds Technology (Surgical/Burns/Cuts) base • Chronic wounds 4 Infection Remover Chronic Wounds “Biofilm Eradicator” 2 Animal health Ready for Norwegian market Product development plan based on the SoftOx platform 9
Go-to-market strategy: Hand disinfection 1 Sales channels and target market Healthcare savings and revenue scenario USDm ▪ Sales through distribution partners 600 ▪ Nordics/Baltics: Kiiltoclean (Antibac), market leader in the 576 region (est. >50% market share) 550 ▪ Rest of Europe: In progress 500 ▪ Premium product, aimed at healthcare workers 25-50% 4 of healthcare workers (HCW) have skin problems on their ▪ 450 hands 400 ▪ Does not cause dry skin with same antimicrobial effect as alcohol ▪ Planned to be made available in pharmacies, sold directly to large 350 clients and through consumer channels 300 Market size 257 250 200 18.8 million HCWs in the EU and the US 1,2 Whereof 13.3 million have irritated skin and eczema 1 150 121 110 100 USD 1,080 3 54 52 Value of effective prevention of hand eczema per HCW 50 23 17 11 5 4 1 0 2020 2021 2022 2023 2024 2025 USD 20.2 bn 3 Savings Revenue Value of hand health market in Europe and the US Market share assumptions: Y1 (1%), Y2 (2%), Y3 (3%), Y4 (5%), Y5 (7%) 1) ec.europa.eu/eurostat/Healthcare_personnel_statistics_-_nursing_and_caring_professionals 2015 & Presentation Prim. Univ.-prof Dr. Robert Strohal, Hospital Fledkirch 10 2) Center for Disease Control and Prevention (CDC) homepage https://www.cdc.gov/niosh/topics/healthcare/default.html 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” 3) World Health Organization – Guidelines on Hand Hygiene in Health Care 4)
Commercialization strategy Europe Strategy Roll-out 2020 2021 2022 2023 2024 Push - distribution partner SafeDes FIN GB F N D LV IRL NL • Local presence S A LT B DK CH • Leading brand EST Local partners Continued evaluation of other markets 11
Product lines 1 Hand hygiene - Antibac ▪ Distribution agreement with Kiiltoclean – the market leader in disinfection for healthcare industry ▪ Antibac-brand ▪ Premium non-alcoholic antimicrobial hand disinfection ▪ Provides access to pharmacies and whole stores ▪ Targeted sales channels: online stores, direct sales to large corporates and non-medical chain stores Revenue from sale of hand disinfectant and wound-solution ➢ Expected market entry in 1H 2020. for animals is intended to finance further clinical development 2 Animal health - VESO ▪ Market leader on pharmaceutical products for animal and veterinarian industry in Norway ▪ Sales and distribution of SoftOx through VESO’s platform incl. veterinarians, webshop and pharmacies ▪ Intentional agreement for future JV on further product development for aqua culture and farming industry ➢ Expected market entry in 2H 2020. 3 Wounds - medical device & drug Clinical trials are intended to be ▪ Clear plan to conduct further clinical trials to achieve classification as medical device and medical drug, conducted to achieve status as such as toxicity tests and RCT-studies medical device and drug ➢ Expected market entry in 2021 (US) as a medical device. 12
Key Figures Key figures (NOK 1,000) 2019 2018 SoftOx Solutions Group Total revenue and other income 4 216 4 323 Total operating expenses 24 387 21 609 Operating result -20 171 -17 286 Net result before taxes -20 279 -17 466 Net proceeds from equity issues 88 194 600 Net cash flow 70 246 -15 862 Cash and cash equivalents at end of period 71 483 1 237 Outstanding shares, beginning of the period 3 778 650 2 488 500 Outstanding shares, end of the period 7 751 000 3 778 650 Employees, end of the period 11 11 13
Highlights 4th Quarter 2019 • First- in-human clinical trial of the wound rinsing product, SWIS, completed • Signed distribution agreement with VESO • Raised NOK 75 million • Share issue approved by General Assembly • SoftOx granted the tax incentive provision “ Skattefunn ” for 3 years 14
Highlights 4th Quarter 2019 – Product Development SWIS & BE wound care products • Product development according to plan Chronic otitis media, chronic » First clinical study completed successfully sinusitis, chronic tonsillitis, dental plaque, pre and post operative • Notified body approved Peripheral vascular catheters, SafeDes TM - alcohol-free hand disinfectant stomi, urinary catheters and urinary tract infections • Tests show fully viricidal effects Hand disinfection, eczema and • Delays in post market studies in Copenhagen wounds » not expected to influence sales Orthopedic implants, prosthetic joints and chronic wounds Effect Vet - animal products • Wound Irrigation for small pets • Wound Irrigation in infected wounds. 15
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