SoftOx Solutions AS A Norwegian MedTech Company listed on Merkur, - - PowerPoint PPT Presentation

SoftOx Solutions AS A Norwegian MedTech Company listed on Merkur, OSE Preventing and treating difficult infections

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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 1st Quarter 2020
• Outlook

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• 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

Highlights 1st Quarter 2020

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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

Challenges

SoftOx reinforces nature’s ability to fight antimicrobial resistance (AMR)

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A unique combination

• 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

The SoftOx Technology – the combination effect

• Long history of use as an antiseptic
• Potentially effective deep within the wound bed
• Good stability
• Retains antimicrobial activity despite contact with organic

material (e.g. blood, tissue)

• Widely used as food additive
• Moderate antiseptic effect alone
• The body’s own antimicrobial agent
• Instantaneous microbial killing effect
• Superior safety profile in efficient concentrations
• Widely used in drinking water = safe
• Moderate antiseptic effect alone

Hypochlorous acid Acetic acid

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SoftOx’s prerequisites for effective infection removal

➢ Penetrate and kill microbes within biofilms ➢ Be able to penetrate deep into the wound bed ➢ Be safe / non-toxic ➢ Be able to kill antibiotic resistant bacteria and not induce new resistance

Kills bacteria inside biofilm Prevent infections

The SoftOx Wound Model An effective antimicrobial for treatment of infections in wounds must:

Host immune system

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Pre-clinical experiments show outstanding results

Effectiveness on Pseudomonas aeruginosa1 Effectiveness on Staphylococcus aureus1 In vitro in the lab ✓ A safe disinfectant with a unique ability to remove hard-to- treat microbes embedded in biofilm ✓ Significantly more effective than competitors against P. aeruginosa and S. aureus, the most common bacteria in chronic wounds ✓ Did not induce resistance or cross-resistance development towards antibiotics

Effect

• n

bacteria in biofilms SoftOx

SoftOx SoftOx

Animal models ✓ No negative influence on wound healing ✓ Well-tolerated in full-depth wounds ✓ Significant bacterial reduction in wounds

1) Company information

8 Orthopedic implants, prosthetic joints and chronic wounds Peripheral vascular catheters, stomi, urinary catheters and urinary tract infections Hand disinfection, eczema and wounds Chronic otitis media, chronic sinusitis, chronic tonsillitis, dental plaque, pre and post operative

Multiple areas of use – current focus on hands and wounds

SoftOx is effective against bacteria (also in biofilms), virus, fungus and spores

Mastitis Chronic and acute wounds; leg wounds in particular

Humans Animals

SoftOx disinfection solution shows excellent tolerability

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.

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

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

Clinical study

Pilot N=12 Wound Irrigation Solution Medical device

Biocomp/ Quality

Cytotox Irriation Sensitization Wound healing

• GMP, stability

2018 2019 2020 2021 No safety issues Bacterial reduction =POC

Additional cytotox testing

DD Submission / Approval

Clinical studies

Pivotal

Healthy Volunteers, acute wound model Confirm safety and performance

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Drug: SoftOx Infection Remover (Biofilm Eradicator) – Chronic wounds

Preclinical phase Clinical phase

Research and Development In vitro, analytics, animal models Human studies: phase 1, 2, 3 Repeated dose toxicity and local tolerance study finalized. Results are pending Formulation Stability Package

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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

Treatment of infections in the respiratory tract

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Product portfolio

SoftOx platform developed Biocide to be ready for market in 2020 Medical Device ready for market in 2021 Medical Drug SoftOx Technology base Hand disinfectant Ready for Nordic market 1 Wound Irrigation Solution

• Acute wounds

(Surgical/Burns/Cuts)

• Eczema
• Chronic wounds

3 Infection Remover Chronic Wounds “Biofilm Eradicator” 4 Animal health Ready for Norwegian market 2

Product development plan based on the SoftOx platform

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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%.
• 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

1) Ipsos- survey week 18/2020, 532 interviews, Chi2-level (W):5%

Asker og Bærum Budstikka 15.05.2020

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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»

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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 250 million homes in the EU Under existing conditions market is estimated to NOK 10 - 25 bn

A unique product benefit will make allow us to dominate this segment

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The hand disinfectant for the health care market

April 2020 Mai 2020

▪ 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 directly and challenge alcohol based disinfectants

Largest segments for hand disinfectants have unique requirements:

Well positioned to answer a large unmet need

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Go-to-market strategy: Hand disinfection for Healthcare markets

Sales channels and target markets Healthcare savings and revenue scenario

▪ Sales through distribution partners ▪ Nordics/Baltics: - Kiiltoclean (Antibac) TBD ▪ Rest of Europe: In progress ▪ Premium product, aimed at healthcare workers ▪ 25-50%5 of healthcare workers (HCW) have skin problems on their hands ▪ Does not cause dry skin with better antimicrobial effect than alcohol ▪ Available in pharmacies, distributors and sold directly to large users 18.8 million HCWs in the EU and the US12

Whereof 13.3 million have irritated skin and eczema1

USD 1,0803

Value of effective prevention of hand eczema per HCW

USD 20.2 bn3

Value of hand health market in Europe and the US

5 17 52 110 257 576 1 4 11 23 54 121 50 100 150 200 250 300 350 400 450 500 550 600 2022 2020 2021 2023 2025 2024 Revenue Savings Market share assumptions: Y1 (1%), Y2 (2%), Y3 (3%), Y4 (5%), Y5 (7%) USDm

1) ec.europa.eu/eurostat/Healthcare_personnel_statistics_-_nursing_and_caring_professionals 2015 & Presentation Prim. Univ.-prof Dr. Robert Strohal, Hospital Fledkirch 2) Center for Disease Control and Prevention (CDC) homepage https://www.cdc.gov/niosh/topics/healthcare/default.html 3) 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” 4) Company estimates 5) World Health Organization – Guidelines on Hand Hygiene in Health Care

Market size

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Production facilities

• Production facilities established

» One facility for small bottles, 5.000 bottles per day » One facility for large bottles (1 liter and 5 liters) 40.000 bottles per day

Production Capacity

• Existing capacity - 45,000 bottles per day

» Focus on bottling and better flexibility in bottle size and shape » New production line for increased flexibility delayed with 1-2 month

Production facilities

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Go-to-market strategy: Medical device (SWIS) + infection remover (drug)

Market access and sales strategy Infection prevention market size2

▪ To secure market access ▪ Clinical development plan ▪ Excite International ▪ KOL – University of Copenhagen ▪ Reimbursement ▪ Regulatory ▪ Infection prevention medical device ▪ Infection remover – drug ▪ Partnering to secure total wound care solution and distribution

Other chronic wounds 16.2 4.5 Venous leg ulcer Diabetic foot ulcers Pressure ulcers 9.7 10.0 250.0 Traumatic wounds 50.0 5.0 Burns Surgical wounds

Million acute wounds annually Million chronic wounds annually ~ USD 2 bn

Annual market size

~ USD 11 bn

Annual market size ▪

• Est. cost reduction by using SoftOx-technology on venous leg

ulcers (VLU) and diabetic foot ulcers (DFU) below1:

1) “MedValue health economic decision modelling; Decreased time to ulcer healing and prevention of clinical infections in diabetic foot and venous leg ulcers” 2) Wound Irrigation Solutions Market to 2027 - Global Analysis & Forecast by Product, End-user and Geography - ResearchAndMarkets.com 3) Wound prevalence and wound management, 2012-2020, Med Market Dilligence, 2013

External health economy assessment report Infection remover market size3

VLU – USD 4,969 DFU – USD 2,030 VLU – USD 643 DFU – USD 2,692 Treatment Prevention

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Go-to-market strategy: Animal wound care market - delayed

Sales channels and market entry Animal care revenue scenario – gross market

▪ First distribution agreement with VESO, a strong distributor to the Norwegian veterinary healthcare market ▪ Planned launch of first products in 2020 ▪ Will seek strong strategic partnerships for entry in the rest of Europe and the US ▪ Large potential for future line extensions Dairy cows: 23 million (EU) & 9.5 million (US)

20-35%1 and 47-71%2 reported prevalence of clinical mastitis across

• EU. Est. cost per case varies from USD 70-300 3. Est. cost in EU -

as high as USD 1.2-2 bn

Horses: 6,4 million (EU) & 9 million (US)

6-9 times higher spending on horse wound treatment than on cats and dogs4

Cats and dogs: 160 million (EU) & 185 million (US)

EU companion animal wound treatment market incl horses is est. at USD 221 million with a CAGR of 6.5%4

1) https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/j.efsa.2009.1143r 2) https://ec.europa.eu/eip/agriculture/en/content/mastitis-control-organic-dairy 3) https://www.independent.ie/business/farming/dairy/mastitis-cases-can-cost-up-to-300-per-cow-35338174.html 4) FIOR – Europe animal wound care market report 2019-2026

Market size

3 5 11 22 43 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 2020 2021 2022 2025 2023 2024 0.2 USDm

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Key figures 1st quarter

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• Commercialize SoftOx hand disinfectant

» In partnership with various distributors, SoftOx will penetrate Nordic markets and challenge the position of Alcohol-based disinfectants.

• The SoftOx disinfectant is superior to alcohol-based disinfectant and is more skin friendly.

» Expecting to receive approval for the hand disinfectant for the EU-area.

• Application for approval of SoftOx Wound Irrigation Solution

» Confirmatory clinical investigation of SoftOx Wound Irrigation Solution (SWIS) medical device.

• Preparation of first-in-human drug study (phase I) for BE in co-operation with US Authorities.

» Completion of the preclinical repeated dose toxicity studies on SoftOx Biofilm Eradicator (BE) drug candidates » To secure a successful market adoption of BE, the company will also continue to cooperate closely with EXCITE International on clinical development.

Outlook next 12 months

Thank you for your attention!