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

Preventing and treating chronic infections SoftOx Solutions AS A … · 2020-04-02 · Preventing and treating chronic infections . 2 Agenda • Introduction • Key highlights •

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Page 1: Preventing and treating chronic infections SoftOx Solutions AS A … · 2020-04-02 · Preventing and treating chronic infections . 2 Agenda • Introduction • Key highlights •

SoftOx Solutions AS

A Norwegian MedTech Company listed on Merkur, OSE

Preventing and treating chronic infections

Page 2: Preventing and treating chronic infections SoftOx Solutions AS A … · 2020-04-02 · Preventing and treating chronic infections . 2 Agenda • Introduction • Key highlights •

2

Agenda

• Introduction• Key highlights• The challenge• The SoftOx technology• The solution• Pre clinical and clinical studies• Virus and bacteria• Product portfolio• Commercialization

4th Quarter 2019• Key Figures• Highlights• Product development

1st Quarter 2020• Highlights• Product development

Investment proposition

Page 3: Preventing and treating chronic infections SoftOx Solutions AS A … · 2020-04-02 · Preventing and treating chronic infections . 2 Agenda • Introduction • Key highlights •

3

• First clinical trial in humans completed successfully

• Secured distribution agreements for hand disinfection (Kiiltoclean/Antibac) andanimal health (VESO)

• Cooperation with globally leading universities, and research teams

• Entered the market with the company’s hand disinfectant

Highlights

SoftOx has discovered a unique combination of natural chemicals proven to

have superior antimicrobial effect when compared to today’s solutions*

*Company information; Filter grown Pseudomonas aeruginosa and Staphylococcus aureus embedded in biofilm

Removing and preventing infections

Page 4: Preventing and treating chronic infections SoftOx Solutions AS A … · 2020-04-02 · Preventing and treating chronic infections . 2 Agenda • Introduction • Key highlights •

4

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

The challenge

Nature’s ability to fight antimicrobial resistance (AMR) is reinforced

Page 5: Preventing and treating chronic infections SoftOx Solutions AS A … · 2020-04-02 · Preventing and treating chronic infections . 2 Agenda • Introduction • Key highlights •

5

A unique combination

• 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

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 natural antimicrobial agent

• Widely used but inherently unstable

• Instantaneous microbial killing effect

• Superior safety profile in efficient concentrations

• Moderate antiseptic effect alone

• Well tolerated, e.g. drinking water

Hypochlorous acid Acetic acid

Page 6: Preventing and treating chronic infections SoftOx Solutions AS A … · 2020-04-02 · Preventing and treating chronic infections . 2 Agenda • Introduction • Key highlights •

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Penetrates wound

bed

Works on wound surfaces AND beneath the wound bed

▪ Penetrate and kill microbes within the biofilm

▪ Penetrate and eradicate biofilm within the wound bed

▪ Microbial resistance must not develop

▪ Well tolerated

Kills bacteria inside biofilm

Prevent infections

Infection remover

The SoftOx Wound Model Success criteria for removal of infections

Removal of infections → critical for wound healing

Page 7: Preventing and treating chronic infections SoftOx Solutions AS A … · 2020-04-02 · Preventing and treating chronic infections . 2 Agenda • Introduction • Key highlights •

7

Pre-clinical experiments show promising effects

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

✓ Appears to be 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

on

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

Page 8: Preventing and treating chronic infections SoftOx Solutions AS A … · 2020-04-02 · Preventing and treating chronic infections . 2 Agenda • Introduction • Key highlights •

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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

Page 9: Preventing and treating chronic infections SoftOx Solutions AS A … · 2020-04-02 · Preventing and treating chronic infections . 2 Agenda • Introduction • Key highlights •

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Product portfolio

SoftOx platform

developed

Biocide expected to be

ready for

market in 2020

Medical Device

Expected 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)

• 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

Page 10: Preventing and treating chronic infections SoftOx Solutions AS A … · 2020-04-02 · Preventing and treating chronic infections . 2 Agenda • Introduction • Key highlights •

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Go-to-market strategy: Hand disinfection

Sales channels and target market Healthcare savings and revenue scenario

▪ Sales through distribution partners

▪ Nordics/Baltics: Kiiltoclean (Antibac), market leader in the

region (est. >50% market share)

▪ Rest of Europe: In progress

▪ Premium product, aimed at healthcare workers

▪ 25-50%4 of healthcare workers (HCW) have skin problems on their

hands

▪ Does not cause dry skin with same antimicrobial effect as alcohol

▪ Planned to be made available in pharmacies, sold directly to large

clients and through consumer channels

18.8 million HCWs in the EU and the US 1,2

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

517

52

110

257

576

1 4 1123

54

121

0

50

100

150

200

250

300

350

400

450

500

550

600

20222020 2021 2023 20252024

RevenueSavings

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) World Health Organization – Guidelines on Hand Hygiene in Health Care

Market size

1

Page 11: Preventing and treating chronic infections SoftOx Solutions AS A … · 2020-04-02 · Preventing and treating chronic infections . 2 Agenda • Introduction • Key highlights •

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Commercialization strategy Europe

Strategy Roll-out 2020 2021 2022 2023 2024

Push - distribution partner• Local presence• Leading brand

SafeDes

Local partners

NSDK

FINLVLTEST

DACH

GBIRL

FNLB

Continued evaluation of other markets

Page 12: Preventing and treating chronic infections SoftOx Solutions AS A … · 2020-04-02 · Preventing and treating chronic infections . 2 Agenda • Introduction • Key highlights •

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Product lines

Revenue from sale of hand

disinfectant and wound-solution

for animals is intended to

finance further clinical

development

Clinical trials are intended to be

conducted to achieve status as

medical device and drug

▪ 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

➢ Expected market entry in 1H 2020.

Hand hygiene - Antibac1

▪ 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.

Animal health - VESO2

Wounds - medical device & drug

▪ Clear plan to conduct further clinical trials to achieve classification as medical device and medical drug,

such as toxicity tests and RCT-studies

➢ Expected market entry in 2021 (US) as a medical device.

3

Page 13: Preventing and treating chronic infections SoftOx Solutions AS A … · 2020-04-02 · Preventing and treating chronic infections . 2 Agenda • Introduction • Key highlights •

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Key Figures

Key figures (NOK 1,000)

2019 2018

SoftOx Solutions GroupTotal 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

Page 14: Preventing and treating chronic infections SoftOx Solutions AS A … · 2020-04-02 · Preventing and treating chronic infections . 2 Agenda • Introduction • Key highlights •

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• 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

Highlights 4th Quarter 2019

Page 15: Preventing and treating chronic infections SoftOx Solutions AS A … · 2020-04-02 · Preventing and treating chronic infections . 2 Agenda • Introduction • Key highlights •

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SWIS & BE wound care products

• Product development according to plan

» First clinical study completed successfully

• Notified body approved

SafeDesTM - alcohol-free hand disinfectant

• Tests show fully viricidal effects

• Delays in post market studies in Copenhagen

» not expected to influence sales

Effect Vet - animal products

• Wound Irrigation for small pets

• Wound Irrigation in infected wounds.

Highlights 4th Quarter 2019 – Product Development

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

Page 16: Preventing and treating chronic infections SoftOx Solutions AS A … · 2020-04-02 · Preventing and treating chronic infections . 2 Agenda • Introduction • Key highlights •

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Production facilities

• Production facilities established

» First delivery made

• First sale completed

» Antibac Alcohol-free Hand Disinfection "Powered by SafeDes".

Production Capacity

• Existing capacity - 5,000 bottles per day

• Scaling up to - 15,000 bottles per day .

• May 2020, expected increase to - 45,000 bottles per day.

Highlights 1st Quarter 2019

Page 17: Preventing and treating chronic infections SoftOx Solutions AS A … · 2020-04-02 · Preventing and treating chronic infections . 2 Agenda • Introduction • Key highlights •

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Treatment of infections in the respiratory tract.

• Collaboration initiated by the University of Copenhagen

• SoftOx effects on inhalation

» Combat viral and bacterial infections in respiratory tract and lungs.

• NOK 3.5 million allocated to the project.

• Animal studies are expected to take 6 months.

Highlights 1st Quarter 2019 – Product Development

Page 18: Preventing and treating chronic infections SoftOx Solutions AS A … · 2020-04-02 · Preventing and treating chronic infections . 2 Agenda • Introduction • Key highlights •

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Investment proposition

2021Objective; cash

positive operations

$33B+Large market

opportunity1

+80%Gross margin

target2

No antimicrobial

resistance

Collaboration with

world leading scientists

Strong patent

family protecting IP

Leading distribution

partners

Proven effectSuccessful clinical trial

Full viricidal effect

1) Calculated by adding the potential hand health, infection prevention and the infection remover market

2) Company estimate

Page 19: Preventing and treating chronic infections SoftOx Solutions AS A … · 2020-04-02 · Preventing and treating chronic infections . 2 Agenda • Introduction • Key highlights •

Thank you for your attention!