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SoftOx Solutions AS — Investor Presentation 2019
Dec 2, 2019
3747_rns_2019-12-02_81695ee6-f999-455b-99f5-e540858fdc2d.pdf
Investor Presentation
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Preventing and treating chronic infections

SoftOx Solutions AS A Norwegian MedTech Company listed on Merkur, OSE
Disclaimer
This Presentation has been produced by SoftOx Solutions AS (the "Company" or "SoftOx"), solely for use at the presentation to investors held in connection with the proposed private placement of shares by the Company. This presentation is strictly confidential and may not be reproduced or redistributed, in whole or in part, to any other person. To the best knowledge of the Company, the information contained in this Presentation is in all material respect in accordance with the facts as of the date hereof, and contains no material omissions likely to affect its import. However, no representation or warranty (express or implied) is made as to, and no reliance should be placed on, any information, including projections, estimates, targets and opinions, contained herein, and no liability whatsoever is accepted as to any errors, omissions or misstatements contained herein, arising directly or indirectly from the use of this Presentation. This Presentation contains information obtained from third parties. Such information has been accurately reproduced and no facts have been omitted that would render the reproduced information to be inaccurate or misleading, as far as the Company is aware and able to ascertain from the information published by these third parties.
Information in the following Presentation relating to the price at which relevant investments have been bought or sold in the past or the yield on such investments cannot be relied upon as a guide to the future performance of such investments. This Presentation does not constitute an offering of securities or otherwise constitute an invitation or inducement to any person to underwrite, subscribe for or otherwise acquire securities in the Company or any affiliated company thereof.
This document contains certain forward-looking statements relating to the business, financial performance and results of the Company and/or the industry in which it operates. Forward-looking statements concern future circumstances and results and other statements that are not historical facts, sometimes identified by the words "believes", "expects", "predicts", "intends", "projects", "plans", "estimates", "aims", "foresees", "anticipates", "targets", and similar expressions. The forward-looking statements contained in this Presentation, including assumptions, opinions and views of the Company or cited from third party sources, are solely opinions and forecasts which are subject to risks, uncertainties and other factors that may cause actual events to differ materially from any anticipated development. The Company does not provide any assurance that the assumptions underlying such forward-looking statements are free from errors, nor does the Company accept any responsibility for the future accuracy of the opinions expressed in this Presentation or the actual occurrence of the forecasted developments. The Company does not assume any obligation, except as required by law, to update any forward-looking statements or to conform these forward-looking statements to our actual results.
AN INVESTMENT IN THE COMPANY INVOLVES RISK, AND SEVERAL FACTORS COULD CAUSE THE ACTUAL RESULTS, PERFORMANCE OR ACHIEVEMENTS OF THE COMPANY TO BE MATERIALLY DIFFERENT FROM ANY FUTURE RESULTS, PERFORMANCE OR ACHIEVEMENTS THAT MAY BE EXPRESSED OR IMPLIED BY STATEMENTS AND INFORMATION IN THIS PRESENTATION. THESE FACTORS INCLUDE, E.G., RISKS OR UNCERTAINTIES ASSOCIATED WITH THE COMPANY'S BUSINESS, SEGMENTS, DEVELOPMENT, GROWTH MANAGEMENT, FINANCING, MARKET ACCEPTANCE AND RELATIONS WITH CUSTOMERS, AND, MORE GENERALLY, GENERAL ECONOMIC AND BUSINESS CONDITIONS, CHANGES IN DOMESTIC AND FOREIGN LAWS AND REGULATIONS, TAXES, CHANGES IN COMPETITION AND PRICING ENVIRONMENTS, FLUCTUATIONS IN CURRENCY EXCHANGE RATES AND INTEREST RATES, AND OTHER FACTORS. SHOULD ONE OR MORE OF THESE RISKS OR UNCERTAINTIES MATERIALIZE, OR SHOULD UNDERLYING ASSUMPTIONS PROVE INCORRECT, ACTUAL RESULTS MAY VARY MATERIALLY FROM THOSE DESCRIBED IN THIS PRESENTATION. THE COMPANY DOES NOT INTEND, AND DOES NOT ASSUME ANY OBLIGATION, TO UPDATE OR CORRECT THE INFORMATION INCLUDED IN THIS PRESENTATION.
No representation or warranty (express or implied) is made as to, and no reliance should be placed on, any information, including projections, estimates, targets and opinions, contained herein, and no liability whatsoever is accepted as to any errors, omissions or misstatements contained herein arising directly or indirectly from the use of this document. By attending or receiving this Presentation you acknowledge that you will be solely responsible for your own assessment of the market and the market position of the Company and that you will conduct your own analysis and be solely responsible for forming your own view of the potential future performance of the Company's business. This presentation is incomplete without reference to, and should be viewed solely in conjunction with, the oral briefing provided by the Company and/or its Managers. This Presentation is confidential and is being communicated in the United Kingdom to persons who have professional experience, knowledge and expertise in matters relating to investments and are "investment professionals" for the purposes of article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 and only in circumstances where, in accordance with section 86(1) of the Financial and Services Markets Act 2000 ("FSMA") the requirement to provide an approved prospectus in accordance with the requirement under section 85 FSMA does not apply. Consequently, the Investor understands that the Private Placement may be offered only to "qualified investors" for the purposes of sections 86(1) and 86(7) FSMA, or to limited numbers of UK investors, or only where minima are placed on the consideration or denomination of securities that can be made available (all such persons being referred to as "relevant persons"). This presentation is only directed at qualified investors and investment professionals and other persons should not rely on or act upon this presentation or any of its contents. Any investment or investment activity to which this communication relates is only available to and will only be engaged in with investment professionals. This presentation and the information contained herein do not constitute an offer of securities for sale in the United States and are not for publication or distribution to U.S. persons (within the meaning of Regulation Sunder the U.S. Securities Act of 1933, as amended (the "Securities Act")). The securities proposed to be offered in the Company have not been and will not be registered under the Securities Act and may not be offered or sold in the United States or to U.S. persons except pursuant to an exemption from the registration requirements of the Securities Act.
This Presentation speaks as of the date on the cover page. Neither the delivery of this Presentation nor any further discussions of the Company with any of the recipients shall, under any circumstances, create any implication that there has been no change in the affairs of the Company since such date.


Investments in shares always entail a high degree of risk. Potential investors should give careful consideration to the specific factors listed below, which is a non-exhaustive list of certain risks and uncertainties inherent in any investment in securities issued by SoftOx. Each of the risks listed below and other risks and uncertainties described could, if they are realized, have a material negative effect on SoftOx's business, results of operations, financial position, or future operations, or result in a reduction in the value of SoftOx' shares. The risks described below are not listed in order of significance and are not the only risks faced by the Group. Before making an investment decision with respect to the shares, investors should, among other things, carefully consider the risk factors described herein and all information contained in this Presentation. An investment in the shares is suitable only for investors who understand the risks associated with this type of investment and who can afford to lose all or part of their investment.
The materialization of any of the risk factors listed below or other risk factors could have a material adverse effect on the Company's business, operating results or financial condition
- SoftOx's business is difficult to evaluate because the Company has a limited history and has generated limited sales revenue/profit since its incorporation. Its past performance does not necessarily give a basis for its likely future results.
- SoftOx's success for the foreseeable future is highly dependent upon the commercialization of its product candidates. No assurance can be given as to whether or when these will be successfully developed or commercialized or will generate revenues or whether the Company will be able to develop additional product candidates
- In the event the product candidates are commercialized, SoftOx is dependent on developing relationships with business partners, distributors and key customers or licensees, including attaining sufficient market acceptance of its product candidates among physicians, patients, healthcare payers or the medical community.
- SoftOx's results of operations may be adversely affected by changes in the pricing environment and/or regulations for medical products
- SoftOx is dependent on its key personnel and employees and its ability to recruit skilled personnel for future operations
- Product development may not deliver expected results and may not be indicative of results in later stage trials, or may not result in the Company's pursuit of further clinical trials
- Any failure or delay in completing clinical trials for any of the Company's product candidates may prevent SoftOx from obtaining regulatory approval or commercializing product candidates on a timely basis, or at all, which would require the Company to incur additional costs which may in turn delay receipt of any product revenue
- SoftOx may need to change the clinical programme to meet various health authorities' requirements, as well as to adapt to results from on-going clinical trials and other product improvement metrics. Such change is likely to influence the overall capital requirement and revenue flow of the Company, including the costs and time required to complete the clinical programme
- SoftOx may become subject to burdensome government regulations affecting the industry, which could directly affect the Company's products and product development, which will in turn affect the Company's overall capital requirement, revenue flows and time to commercialization.
- SoftOx may not obtain required marketing authorization from health authorities (domestic og multi-national (EU, etc.) for its products, which is required in order to enter the commercial phase.


- SoftOx may face competition from new as well as from known competing products. If the Company is unable to compete effectively, in terms of its products or prices, it may have to alter the design of its clinical programmes, its overall costs may increase and the Company may be unable to successfully commercialize its products or achieve the expected margins.
- The Company could become subject to liability claims in connection with clinical trials or otherwise in connection with the use or misuse of the Company's products after commercialization
- SoftOx expects to continue to incur substantial expenses related to further research and development of its product candidates, personnel costs, commercializing, support of patent rights, as well as administrative functions. It is expected that the currently available funds will not be sufficient to meet the Company's needs or unexpected factors could arise that could increase the Company's need for capital, and the Company expects that it will need to seek additional funding bay way of debt or equity capital. The Company may not be able to obtain the required funding or may not be able to do so at acceptable cost. A future equity raising will dilute the ownership interest of existing shareholders.
- As of today, SoftOx has several projects that are partially funded by public grants. There is no assurance that SoftOx will continue to have grant applications approved in the future, on the same terms or at all.
- SoftOx's markets are undergoing rapid technological change, and the Company's future success will depend on its ability to meet the changing needs of the industry
- SoftOx faces risks inherent to international expansion and operating in multiple jurisdictions
- SoftOx is dependent on its intellectual property rights and the Company's methods of protecting its intellectual property rights may not be adequate
- SoftOx faces risks of claims for intellectual property rights infringement from third parties
- SoftOx depends in large part on its ability to protects its exiting patents and to obtain new patents, maintain trade secret protection, protect its trademarks and operate without infringing on the proprietary rights of third parties. Third parties may have filed patent applications, or hold issues patents, relating to products or processes competitive with those that have been developed by the Company, and this may impair the Company's ability to do business in a particular area. There can be no assurance that the Company's pending patent applications will be approved, either in a timely manner or at all, that the Company will develop additional products that are patentable, that any patents issued by to the Company will provide the Company with competitive advantages or will not be challenged by any third parties, that the patents or others will not prevent the commercialization of products incorporating the Company's methods, or that existing or former employees, consultants or partners of the Company will not allege that they have rights to the Company's intellectual property. Furthermore, there can be no assurance that other companies will not independently develop similar products, duplicate or reverse engineer any of the Company's products or, if patents are issued to the Company, design around the Company's patents. Filed patents that are not granted may cause the development program can be terminated because of lack of market protection
- In the ordinary course of business, SoftOx is subject to credit risk in its contractual relationships with various parties
- SoftOx may not be able to earn the planned revenue or to raise sufficient working capital to fund its operations until its business generates positive cash flow
- SoftOx may face challenges in production of the products which may delay timelines, increase costs or stop the development of the product(s)


SoftOx has discovered a unique combination of natural chemicals proven to have superior antimicrobial effect 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
- Intends to raise NOK 40-75m in equity to finance studies and corporate development
Removing infections – critical for wound healing
*Company information; Filter grown Pseudomonas aeruginosa and Staphylococcus aureus embedded in biofilm

Company background
| • | Extensive experience from animal husbandry in the European agricultural sphere | |||||||
|---|---|---|---|---|---|---|---|---|
| --- | -- | -- | -------------------------------------------------------------------------------- | -- | -- | -- | -- | -- |
• Key observations:
Background
Research
1
2
- » 20% of cows suffer from chronic bacterial infections1
- » Antibiotic treatments are mostly ineffective in biofilm infections and cause bacterial resistance
- » Hypochlorous acid are also used, but are generally unstable and with limited effect
- Hypochlorous and acetic acid have long histories of use as antiseptics2
- In collaboration with leading researchers in Lund, SoftOx started its research in 2008
- The concept was further developed in 2016, supported by world leading professors at the Copenhagen University
- By combining hypochlorous acid with acetic acid, SoftOx has created a best-in-class non-toxic and clinically proven topical antiseptic
Patents 3
- Intellectual property is protected by a large and strong patent family; first patent granted in 2012
- 20 patent filings; Important patents like composition method and product, NPWT acetic acid and sodium diacetate are granted, others like the biofilm removal still pending.

Key personnel

Geir H. Almås, CPA – Chief Executive Officer & Founder
- Extensive experience from business development
- Previously PwC and KLP Asset Management
- MSc Business Administration (BI) and Chartered Accountant (NHH)

Glenn Gundersen, PhD – Director Medical Affairs
- Over 25 years of experience from the pharmaceutical industry, immunology/inflammation and oncology
- Previously Bristol-Myers Squibb Norway, Biotec Pharmacon, Biogen Norway, Roche
- PhD Molecular and Cellular Biology (University of Oslo)

Magnus M. Fazli, PhD – Head of Research
- More than ten years of experience in biofilm research
- Specializing in chronic wound biofilms, biofilm formation and antibiotic tolerance
- PhD Medical Microbiology (University of Copenhagen), and MSc Bio-entrepreneurship (Copenhagen Business School)

Hans Petter Grette – Sales and Marketing Director
- 20 years marketing and executive management background from Lilleborg (Orkla)
- MSc Business Administration (BI) and AGSIM International Management (Arizona, U.S.)

Hans Jørgen Holum - CEO SoftOx Denmark & Head of Animal Health
- Over 20 years' experience with international sales and management positions
- MSc in Business Administration from Copenhagen Business School
Advisory Board
Thomas Bjarnsholt, PhD
- Professor of bacterial and fungal biofilms in chronic infections,
- Ranked as the world leading scientist on biofilms
- Co-inventor of the technology with financial rights, see Patent and IP
- Works for the company as a consultant
- Member of the Global Wound Biofilm expert panel
Klaus Kirketerp-Møller, MD
- Since 2007, mainly focused on research on chronic wounds and bacterial biofilms
- Co-inventor of the technology with financial rights, see Patent and IP
- Works for the company as a consultant
- MD at Copenhagen University and specialist in orthopedic surgery, and chair of Nordic Diabetic Foot Task Force
Pål Rongved, PhD,
- Professor Pharmaceutical institute, University of Oslo
- Member of The Norwegian Board of Appeals for Industrial Property Rights
- Works as consultant for the company




Strong international support from key opinion leaders and institutions


Antimicrobial resistance
The ability of bacteria and other microorganisms to resist the effects of an antibiotic/antiseptic 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

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

SoftOx works both on wound surface and beneath wound bed

The SoftOx Wound Model Success criteria for removal of infections
- Penetrate and kill microbes within the biofilm
- Penetrate and eradicate biofilm also within the wound bed
- Not cause development of microbial resistance to the products
- Well tolerated
Removal of infections → critical for wound healing

Pre-clinical experiments show promising effects
In vitro in the lab
✓ A safe disinfectant with a unique ability to remove hard-totreat 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
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

Effect on bacteria in biofilms
SoftOx

Multiple areas of use – current focus on hands and wounds

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

Human pilot study on safety in 12 patients with acute wounds
Primary Objective
The primary objective of this clinical investigation is to document safety of the SoftOx Wound Irrigation Solution when used on split skin graft donor sites1 in an adult population
Secondary Objectives
The secondary objectives are to document the SoftOx Wound Irrigation Solution capability to provide clean wounds for optimal reepithelization (including microbiological control), and subject/user satisfaction when used on split skin graft donor sites in an adult population
Results: No serious adverse events | Well tolerated | Bacterial reduction confirmed | Excellent wound healing

Study confirms safety and bacterial reduction

Product development plan
| 1 | Hand Disinfection | In vitro/EN studies | Preclinical/EN studies |
PoC/Pilot | Confirmative studies |
Application market approval |
Post market studies |
|---|---|---|---|---|---|---|---|
| SafeDes | N/A | N/A | 2020 |
| 2 Animals |
|||||
|---|---|---|---|---|---|
| Infection prevention |
1H2020 | N/A | |||
| Infection treatment |
1H2020 | N/A | 2H2020 |
| Device & Drug | |||||
|---|---|---|---|---|---|
| 3 | SWIS | 2020 | |||
| 4 | Infection treatment |
1H2020 | 2020/2021 | TBD |


Product development plan based on the SoftOx platform

Product portfolio
Go-to-market strategy: Hand disinfection 1
- 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
Market size
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

16
USD 20.2 bn3 Value of hand health market in Europe and the US
Sales channels and target market 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) World Health Organization – Guidelines on Hand Hygiene in Health Care
Go-to-market strategy: Animal wound- and disinfection market 2
- 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
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 -
as high as USD 1.2-2 bn 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

17
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
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

Go-to-market strategy: Medical device (SWIS) Infection remover (drug) 3 4
- To secure market access
- Clinical development plan
- Excite International
- KOL University of Copenhagen
- Reimbursement
- Regulatory
- Infection prevention medical device
- Infection remover drug
- Clinical development plan
- 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
Existing products shall cover overheads and indirect costs
Hand hygiene - Antibac 1
- Distribution agreement with Kiiltoclean the market leader in disinfection for healthcare industry
- Antibac-brand strong brand recognition
- 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.
Animal health - VESO 2
- Market leader on pharmaceutical products for animal and veterinarian industry in Norway
- Sale 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.

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.
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

Intended use of proceeds – cash positive on operations
| 1 | Enter the hand disinfectant market – NOK 10 mill |
|---|---|
| 2 | Enter the animal health market – NOK 8 mill |
| 3 | Increase production capacity – NOK 2 mill |
| 4 | Infection remover – NOK 25 mill ▪ Conduct phase 1 and phase 2 trials (PoC) on infection remover wounds (medical drug) |
| 5 | Finish clinical development SWIS – NOK 10 mill • Conduct confirmative study (medical device) |
| 6 | General corporate purposes – NOK 20 mill • including repayment of NOK 3 in debt to shareholders and transaction fees |

Key assumptions for market penetration – first two products*
| Targets | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| Hand disinfection | ||||||||||
| No. of users | 3,500 | 14,000 | 37,000 | 75,000 | 180,000 | 360,000 | ||||
| Target market share | 0.5% | 2% | 1.3% | 1.2% | 2.1% | 4.2% | ||||
| Markets | N, S, DK, IS | N, S, DK, IS | N, S, DK, G | N, S, DK, G, UK, F |
N, S, DK, G, UK, F, I, SP |
EU |
| Animal | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Target market share | 4% | 0.6% | 0.7% | 3.1% | 3.1% | 6.2% | |||
| Markets | N, DK | Europe | US, Europe |
US, Europe | US, Europe | US, Europe |
Revenue target scenario
Revenue scenario based on following key assumptions Preliminary sales projections
- First two years' budget income are independent of costs
- Profit sharing with pilot partners assumed initially, later 60/40
- Price estimated to be 10% of target costumers cost savings
- Market approval according to company's aspirations
- For hand disinfection, we target the 25% with the most severe hand eczema
- Revenue from acute and chronic wounds products not included in this scenario

Potential for solid gross- and EBITDA margins

Investment proposition

23


Thank you for your attention!