Preventing and treating difficult infections SoftOx Solutions AS A Norwegian MedTech Company listed on Merkur, OSE
Agenda • Highlights from Q1 • Clinical development and status • The challenge • The SoftOx technology • The solution • Product development • Commercialising • Hand disinfectant • Production facilities • Wound care products • Animal wound care market • Key financial figures 1 st Quarter 2020 • Outlook 2
Highlights 1 st Quarter 2020 • Established production of SoftOx Hand disinfectant • SoftOx hand disinfectant shows full viricidal effects • Antibac - alcohol free hand disinfection – “powered by SafeDes ” launched • Presafe - Notified Body, approved for MDR • Animal study started to explore potential effects on infections in the respiratory tract • Awarded 2.4 million from NRS for establishing a doctoral scholarship for development of SoftOx second generation • Awarded SoftOx NOK 6 million from Innovation Norway as a loan for an additional production line for hand disinfectant 3
Challenges Antibiotic resistance The ability of bacteria and other microorganisms to resist the effects of an antibiotic to which they were once sensitive Biofilm resistance Aggregated bacteria often covered by slime (biofilm matrix), acting as a fortress and protect bacteria from attacks such as antibiotic treatment and the immune system Virus epidemics / pandemics Spread of virus outbreaks leads to increased awareness of personal (hand) hygiene regimens SoftOx reinforces nature’s ability to fight antimicrobial resistance (AMR) 4
A unique combination Acetic acid Hypochlorous acid • Long history of use as an antiseptic • The body’s own antimicrobial agent • Potentially effective deep within the wound bed • Instantaneous microbial killing effect • Good stability • Superior safety profile in efficient concentrations • Retains antimicrobial activity despite contact with organic • Widely used in drinking water = safe material (e.g. blood, tissue) • Moderate antiseptic effect alone • Widely used as food additive • Moderate antiseptic effect alone The SoftOx Technology – the combination effect • The combination works synergistically, and shows superior effect on microbes • Shows no resistance or cross-resistance towards antibiotics • 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 at skin friendly pH 5
SoftOx’s prerequisites for effective infection removal An effective antimicrobial for treatment of The SoftOx Wound Model infections in wounds must: ➢ Penetrate and kill microbes within biofilms Prevent infections ➢ Be able to penetrate deep into the wound bed ➢ Be safe / non-toxic Penetrates deep ➢ Be able to kill antibiotic resistant bacteria and wound Host immune system bed not induce new resistance Kills bacteria inside biofilm 6
Pre-clinical experiments show outstanding results 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 Significantly more effective than competitors against P. SoftOx aeruginosa and S. aureus, the most common bacteria in ✓ Significant bacterial reduction in wounds 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
Multiple areas of use – current focus on hands and wounds Humans Animals Chronic otitis media, chronic Chronic and acute wounds; Mastitis sinusitis, chronic tonsillitis, dental leg wounds in particular plaque, pre and post operative Peripheral vascular catheters, stomi, urinary catheters and urinary tract infections Hand disinfection, eczema and wounds Orthopedic implants, prosthetic joints and chronic wounds SoftOx is effective against bacteria (also in biofilms), virus, fungus and spores 8
SoftOx disinfection solution shows excellent tolerability A comparison of SoftOx disinfection solution and alcohol disinfection on skin barrier properties on healthy skin in healthy individuals, N=20 Department of Dermatology, Bispebjerg Hospital, University of Copenhagen Healthy skin assessed by: TEWL (water loss), electrical conductance, pH and color (redness/irritation). Result: • No observed irritation after 40 repetitive applications of the SoftOx disinfectant. No discomfort reported. • 2 individuals reported burning sensation after use of alcohol • 1 individual developed transient redness (irritation) after alcohol treatment. Conclusion: “ the skin barrier function of the healthy skin is unaffected by the repetitive exposure to SoftOx disinection solution as compared to ABHR and control and that the new device is subjectively well- tolerated when applied on healthy skin.”
Medical Device: SoftOx Wound Irrigation Solution (SWIS) development plan 2018 2019 2020 2021 Wound Clinical Irrigation Clinical Biocomp/ study DD Submission / Solution studies Quality Approval Pilot Pivotal N=12 Medical device Cytotox No safety issues Healthy Volunteers, Irriation Bacterial acute wound Sensitization reduction model Wound healing =POC Confirm safety and --- Additional cytotox performance GMP, stability testing
Drug: SoftOx Infection Remover (Biofilm Eradicator) – Chronic wounds Preclinical phase Clinical phase Research and Development Human studies: phase 1, 2, 3 In vitro, analytics, animal models Formulation Repeated dose toxicity and local tolerance study finalized. Stability Package Results are pending 11
Treatment of infections in the respiratory tract Collaboration to treat infections has been initiated by the University of Copenhagen ➢ SoftOx is to explore effects on inhalation » Ability to combat viral and bacterial infections in respiratory tract and lungs. ➢ NOK 3.5 million allocated to the project ➢ Results from animal studies are expected in 2020 12
Product portfolio SoftOx platform Biocide to be ready for Medical Device Medical Drug developed market in 2020 ready for market in 2021 1 Hand disinfectant 3 Ready for Nordic market Wound Irrigation Solution • Acute wounds SoftOx (Surgical/Burns/Cuts) Technology • Eczema base 4 • Chronic wounds Infection Remover Chronic Wounds “Biofilm Eradicator” 2 Animal health Ready for Norwegian market Product development plan based on the SoftOx platform 13
Hand disinfectant – consumer market The Ipsos survey on hand disinfectant shows • Majority believe the increased disinfection trend with last • 84% report increased use of hand disinfectant. • Users in public places has increased from 25% to 83%. Asker og Bærum Budstikka 15.05.2020 • Most common side effect - dry skin. » 80% associate hand disinfection with dry hands. • 44% of women score this 6 on a scale of 1-6 Increased demand after the introduction of a skin friendly hand disinfectant 14 1) Ipsos- survey week 18/2020, 532 interviews, Chi2-level (W):5%
The consumer product Unique Combination: • Only AntiVir provides full effects on all viruses and bacteria • Does not dry out the skin • No hazard labeling, nonflammable • Not harmful to wounds or cracked skin • Not harmful to solid surfaces or textiles «AntiVir» - Effect without side-effects» 15
Go-to-market strategy: Consumer market Sales channels and target markets ▪ Sales through distribution partners ▪ Norway/Sweden and Denmark: ▪ Bonaventura Scandza – Retail (Scandinavia) ▪ Milas – Schools and Kinder gartens (Norway) ▪ VESO – Aquaculture and farming industry (Norway) ▪ Rest of Europe: In progress ▪ Premium product, aimed at consumers with sensitive skin incl. kids ▪ Available in retail stores and pharmacies ▪ Sold directly to kindergartens ▪ Web shops Under existing conditions market is estimated to 250 million homes in the EU NOK 10 - 25 bn A unique product benefit will make allow us to dominate this segment 16
The hand disinfectant for the health care market Largest segments for hand disinfectants have unique requirements: ▪ Must have clinical proof of better skin friendliness ▪ Must not cause microbial resistance ▪ Must be non-alcoholic SoftOx hand disinfectant ▪ will be a part of HINAs autumn 2020 ▪ Expected entry to healthcare market trough distributors and/or April 2020 Mai 2020 directly and challenge alcohol based disinfectants Well positioned to answer a large unmet need 17
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