AI assistant
SoftOx Solutions AS — Investor Presentation 2020
Jun 30, 2020
3747_rns_2020-06-30_ac95efed-5d7e-4032-822d-91b88f3d8838.pdf
Investor Presentation
Open in viewerOpens in your device viewer
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 1st Quarter 2020
- Outlook
Highlights 1st 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
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)
A unique combination
Hypochlorous acid Acetic acid
- 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
-
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 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
SoftOx's prerequisites for effective infection removal
The SoftOx Wound Model An effective antimicrobial for treatment of infections in wounds must:
- ➢ 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
Pre-clinical experiments show outstanding results
In vitro in the lab
- ✓ A safe disinfectant with a unique ability to remove hard-totreat 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
Animal models
- ✓ No negative influence on wound healing
- ✓ Well-tolerated in full-depth wounds
- ✓ Significant bacterial reduction in wounds
Effectiveness on Pseudomonas aeruginosa1 Effectiveness on Staphylococcus aureus1
7 1) Company information
Effect on bacteria in biofilms
SoftOx
SoftOx SoftOx
Multiple areas of use – current focus on hands and wounds
SoftOx is effective against bacteria (also in biofilms), virus, fungus and spores
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
Drug: SoftOx Infection Remover (Biofilm Eradicator) – Chronic wounds
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
Product development plan based on the SoftOx platform
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
Asker og Bærum Budstikka 15.05.2020
Increased demand after the introduction of a skin friendly hand disinfectant
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»
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
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 directly and challenge alcohol based disinfectants
Well positioned to answer a large unmet need
Go-to-market strategy: Hand disinfection for Healthcare markets
- 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
Market size
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
18
USD 20.2 bn3
Value of hand health market in Europe and the US
Sales channels and target markets Healthcare savings and revenue scenario
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
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
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
Go-to-market strategy: Medical device (SWIS) + infection remover (drug)
- 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
External health economy assessment report Infection remover market size3
▪ Est. cost reduction by using SoftOx-technology on venous leg ulcers (VLU) and diabetic foot ulcers (DFU) below1 :
| Treatment | Prevention |
|---|---|
| VLU – | VLU – |
| USD 4,969 | USD 643 |
| DFU – | DFU – |
| USD 2,030 | USD 2,692 |
Market access and sales strategy Infection prevention market size2
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
Go-to-market strategy: Animal wound care market - delayed
- 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
as high as USD 1.2-2 bn
Market size
Dairy cows: 23 million (EU) & 9.5 million (US) 20-35%1 and 47-71%2reported prevalence of clinical mastitis across EU. Est. cost per case varies from USD 70-300 3 . Est. cost in EU -
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
Horses: 6,4 million (EU) & 9 million (US) 6-9 times higher spending on horse wound treatment than on cats and dogs4
Sales channels and market entry Animal care revenue scenario – gross market
21 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
Key figures 1st quarter
| 1Q20 | 1Q19 | 2019 | |
|---|---|---|---|
| SoftOx Solutions Group | |||
| Total revenue and other income | 1 2 3 9 | 1 2 9 0 | 4 0 9 9 |
| Total operating expenses | 8494 | 5 5 6 6 | 25 969 |
| Operating result | $-7254$ | -4 277 | $-21870$ |
| Net result before taxes | $-7245$ | -4 251 | $-22178$ |
| Net proceeds from equity issues | 0 | 0 | 89 903 |
| Net cash flow | $-21630$ | $-5829$ | 70 246 |
| Cash and cash equivalents at end of period | 54 365 | 11 269 | 75 995 |
| Outstanding shares, beginning of the period (1, 2) | 7 751 000 | 2 488 500 | 2 488 500 |
| Outstanding shares, end of the period (1, 2) | 7 751 000 | 3758650 | 7 751 000 |
| Employees and of the neriod | 1 | 1Ο. | 1 ว |
Outlook next 12 months
• 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.
Thank you for your attention!