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SoftOx Solutions AS — Investor Presentation 2024
Jan 11, 2024
3747_rns_2024-01-11_c077aa60-7d60-479e-9da9-5c31c70b1afa.pdf
Investor Presentation
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Helping the world fighting infections
SoftOx Solutions AS
Norwegian medtech and pharmaceutical company
January 2024

Disclaimer
This Presentation has been produced by SoftOx Solutions AS (the "Company" or "SoftOx"), solely for use at the presentation to investors held 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 of the knowledge of the Company and its Board of Directors, 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. 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 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 (or any part of it) is not to be reproduced, distributed, passed on, or the contents otherwise divulged, directly or indirectly, to any other person (excluding an investment professional's advisors) without the prior written consent of the Company.
IN RELATION TO THE UNITED STATES AND U.S. PERSONS, THIS PRESENTATION IS STRICTLY CONFIDENTIAL AND IS BEING FURNISHED SOLELY IN RELIANCE ON APPLICABLE EXEMPTIONS FROM THE REGISTRATION REQUIREMENTS UNDER THE U.S. SECURITIES ACT OF 1933, AS AMENDED. THE SHARES HAVE NOT AND WILL NOT BE REGISTERED UNDER THE U.S. SECURITIES ACT OR ANY STATE SECURITIES LAWS, AND MAY NOT BE OFFERED OR SOLD WITHIN THE UNITED STATES, OR TO OR FOR THE ACCOUNT OR BENEFIT OF U.S. PERSONS, UNLESS AN EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE U.S. SECURITIES ACT IS AVAILABLE. ACCORDINGLY, ANY OFFER OR SALE OF SHARES WILL ONLY BE OFFERED OR SOLD (I) WITHIN THE UNITED STATES, OR TO OR FOR THE ACCOUNT OR BENEFIT OF U.S. PERSONS, ONLY TO QUALIFIED INSTITUTIONAL BUYERS ("QIBs") IN PRIVATE PLACEMENT TRANSACTIONS NOT INVOLVING A PUBLIC OFFERING AND (II) OUTSIDE THE UNITED STATES IN OFFSHORE TRANSACTIONS IN ACCORDANCE WITH REGULATIONS. ANY PURCHASER OF SHARES IN THE UNITED STATES, OR TO OR FOR THE ACCOUNT OF U.S. PERSONS, WILL BE DEEMED TO HAVE MADE CERTAIN REPRESENTATIONS AND ACKNOWLEDGEMENTS, INCLUDING WITHOUT LIMITATION THAT THE PURCHASER IS A QIB.
This Presentation speaks as of March 2023. 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.
SoftOx – a potentially break through fighting infections
• Virucidal and bacterial infections in the respiratory track
• A major challenge for the healthcare system (Covid 19), the yearly influenza epidemy, pneumonia, incl hospital acquired pneumonia, which is the most common cause of death among hospital acquired infections.
• Infections in chronic wounds
• Wound which does not heal within 3 months are considered to become chronic. More that 40 million people got it worldwide and considered as a hotbed for creation of superbugs.
• Periodontitis
• Periodontitis or gum disease can develop to a severe infection of gum that can destroy the bone that support the teeth and you lose the teeth. Nearly half of the adult population in the US is affected. 538 million people WW. A biofilm infection. Biofilms in plaque can contribute to cause stroke and hearth attack if it spreads to the veins.
• Antibiotic resistant infection
• Infections in wounds and in the respiratory track is the cause of more than 50% of the death from antibiotic resistance. SoftOx shall be an alternative in treatment of does infections
• Biological- and chemical warfare agents
▪ Developing an inhalation solution to counter biological warfare agents spread through the airways. There are also indications that SoftOx technology is effective against chemical warfare agents on the skin.
An important alternative to antibiotics and novel first line treatment of virucidal infections

A breakthrough fighting infections
Next Generation SoftOx
Stable solutions at higher concentrations

Results achieved:
- Developing second generation SoftOx
- Market leader on efficacy
- Unique environmental profile
- Efficient business model
- Abstract presented US Military Health System Research Symposium Aug 23
Respiratory Care
Next step: Proof of Concept in
humans

Results achieved
- Human safety proved
- Repeated studies in mice documented
- Prophylactic and curative effects towards virucidal infections
- Lead partner in EDF/Counteract*
- Partnership with University of Copenhagen
Wound Care


Results achieved
- Proof of concept (PoC) in humans
- Reduction in bacterial load
- Decreased wound size
*EDF/Counteract (European Defense Fund)

Overview development of SoftOx the next 2 – 3 years



Platform technology

Reinforcing nature's own ability to eradicate unwanted microbes
HYPOCHLOROUS ACID Documented broad antimicrobial effect


Picture of HOCl in action within human immune cells


The chemical solution: Reinforcing nature's own ability to eradicate unwanted microbes


5. Stabilized formulation
Synergistic properties give unique ability to eradicate biofilm infections in wounds

Unrivalled combination effect on bacterial biofilms

Outperforming market leading competitors
SoftOx with increased amount of Acetic Acid
SoftOx in brief SoftOx technology Wound care Commercial development Way forward
SoftOx Antimicrobial Technology
Next Generation SoftOx technology even better
- Final product is the same as todays SoftOx
- Stability, less than 5% degradation over 2 years
- Different acids to different needs
- Including possibility to remove scent of acetic acid
- Concentrations up to 1.000 ppm tested in human wounds
- Remain time for patents pending 19 years
- When double the amount of active substance
- Increase the effect with 100 times (>log 5 vs >log 3)
- Half the time required for disinfection


The Combination effect together with Second generation gives SoftOx a unique position
SoftOx in brief SoftOx technology Wound care Commercial development Way forward

Wound and Skin care

Chronic wounds, biofilms and antibiotic resistance – a major treath
- Chronic wounds impact the quality of life (QoL) of nearly 2.5% of the total population in the United States
- Diabetic foot ulcers (DFUs) (30.5%) have a comparable 5-year mortality rate to cancer (31%)
- Induces tolerant biofilms to induce new resistances
- Due to poor blood circulation, antibiotics often do not even reach the infection
- Due to dormant bacteria, the doses with antibiotics needed to be a to high to be safe

The global advanced wound care market is projected to reach \$18.7 billion by 2027

The cost drivers in wound care – infections and lack of wound healing


Cost of wound care – Medicare2
-
Effects of stabilized hypochlorous acid on re-epithelialization and bacterial bioburden in acute wounds, Ewa A Burian et al. Acta Derm Venereaol 5/2022
-
An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds, Samuel R. Nussbaum, MD et al. 2018

Results in treatment of leg ulcers (SBE-01) show >98% reduction in bacterial bioburden

Topline results
- Safe and well tolerated
- SBE formulations reduced the absolute number of bacteria (bacterial burden) in the wound compared with pre-dose (baseline)
- A dose dependent reduction in wound size was observed in multiple dose treatment groups
SoftOx answers on the unmet need for reduction in bioburden to promote wound healing*
*) SBE-01 trial pooled & multiple dosing groups. Data on file. Means ± standard deviation

Wound healing observed in several clinical studies

Observed dose dependent trend in reduction of wound size*
*) SBE-01 trial multiple dosing groups. Data on file. Means ± standard deviation

SoftOx Dental: Unique ability to remove oral biofilm and treat periodontitis

SoftOx Mouthwash
Aiding in the preventing disease development steps 2-4


A new penetrative mouthwash against sub-gingival biofilms in the fight against periodontitis
Goal: To replace/remove cosmetic competitors through dental professional market sales
- Clinical significance of periodontitis:
- Over 538 million affected globally
- 276 million afflicted with tooth loss
- Affects 46% of US adults over the age of 30
- 8 of 10 Europeans over 30 show signs of gum disease[3]
- The Oral Healthcare Market:
- Global market valued at \$30 50 billion
- Cosmetic mouthwash valued at \$1,5 bn
SoftOx Mouthwash can help ensure the complete removal of plaque*
*in conjunction with daily toothbrushing
Animal care – very similar to a human product portfolio
Pets – ~220 million household dogs and cats in US and Europe
Veterinarian pet market
Wound care, ears wash, eye cleansers and tooth wash SoftOx disinfectant will improve indoor climate
Production animals – ~31 billion animals worldwide
Surface disinfectant
Unique on decontamination of facilities, specially under disease outbreak; swine fever, mad cow decease and others
Other potential products
- Mastitis treatment and udder disinfectant with color
- Claw treatment and claw bath with color
- Disinfection of drinking- and milk systems
- Disinfectant of carcass in US


Regulatory fast track to market – large potential with the right partner
The Wound and skin care drop down 2-3 years plan
- Finance the new company with a separate funding of Euro 10 million.
- Achieve regulatory approval of Medical Device wound cleanser in Europe and US.
- Perform Phase 2 for SoftOx Biofilm Eradicator (SBE):
- The estimated probability of success is statistically over 80%.
- External valuation report estimated that the value will increase up to 100% after successful phase 2.
- Establish an outsourced production for both first- and second-generation technology.
- Through partners and distributors, bring products to market within animal health care, human wound health care, oral health care and skin disinfection.
- Within two to three years list/sell the Wound and Skin care company on a relevant international market. If successful, Wound and Skin care can finance further development of SIS or be used to pay dividends to shareholders.

Exit strategy wound care
- External fair market valuation February 2023 MUSD 200 PE 13 on yearly expected net licence fee
- Expect market value to increase significantly after successful phase 2
- Summer 2023 Coloplast acquire Kerecis for USDbn 1,3, Turnover USDM 75, EBITA <30%, only US market, PEG 36
Why haven't we sold wound care already
- International advisers, market value is too small
- Venture Capital lack of plan for commercialization
- Industry too little data
- Merger with NY listed company Board too early
- Valuation wound care fair market value estimate USD 200
- 85% ownership in the merge company
Turnover potential in the US Valuation and market trends

Assumptions Turnover Potential US
- Avg price per patient is \$2,280, which equates to 35% of est. saving per patient in MedValue model
- Distributors are responsible for sale and take 50% of end user price
- Estimated EBITA 35%/COGS 20%
Exit - Sale of applications or technology platform or separate listing

Respiratory care

Early intervention treatment: potential to impact peak viral load, time of viral peak and infection duration1
Because SS0330/1 is directly virucidal, it is delivered directly to upper respiratory tract mucosal surfaces (sites of viral replication), and has the potential to reduce further disease transmission, the target population are pre-symptomatic and early symptomatic patients

Early intervention and direct virucidal activity is expected to:
- reduce peak viral load
- reduce time of viral peak
- reduce infection duration
- improve symptoms and/or avert severe illness as a result of a reduced viral AUC 1,2
1. Epidemiologia 2020, 1(1), 5-15; https://doi.org/10.3390/epidemiologia1010003 2. BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m3862/

Respiratory care - Treatment and prevention
In vivo Proof of Concept - Post-exposure prophylaxis


Respiratory care - dose dependent treatment effect in mice infected at day 0 with Influenza A virus
Twice daily treatment resulted in lower viral titres on post-infections days 1 to 3 … and correspondingly higher qPCR cycle threshold values (day 3)



OP: Oropharyngeal swob, NF: Nasal flush Data on file. Mann-Whitney test, *(p < 0.01), ** (p < 0.0001).

SIS-01: Nebulized formulation safe and well tolerated at all dose levels Randomized, placebo controlled, first in human trial in healthy volunteers
Abstract presented to ERS 2022







SIS-01 trial (NCT05188638). Burton et al. ERS Congress 2022. Abstract #36474.

EDF/COUNTERACT project (*) Financed Phase I study (EDF/MOD) Progressing according to plan (2023-2025)
Key deliveries:
- Optimization of Next generation API (Active Pharmaceutical Ingredient)
- o Main partner: CR Competence
- Testing SIS 2.0 in vitro, in vivo and through different nebulizers and fogging systems
- o Main partners: University of Tous, University of Galway, University of Copenhagen, FFI (Forsvarets Forskningsinstitutt)
- Regulatory toxicology studies
- o Main partners: University of Tous, University of Galway, University of Copenhagen
- Phase Ib in healthy volunteers – Maximum Tolerated Dose Study (Phase I)
- o Main Partner: University of Galway
- CMO production of SIS 2.0
- o Main Partner: CMO and CR Competence
(*) European agile network for medical COUNTERmeasures Against CBRN Threats
The COUNTERACT project will also benefit the civilian development of SIS

Exit - Sale of applications or technology platform after phase 2 or separate listing



Key takeaways

Unique solution for eradicating infections and fighting antimicrobial resistance
Contact Information: [email protected]
Euronext Growth ticker: SOFTX
Appendix

Board of directors
Board of Directors SIS Project Leads

Geir H. Almås Executive Chairman
- Extensive experience from business development in Norway and Poland
- Previously PwC and KLP Asset Management
- MSc in business administration (BI) and Chartered Accountant (NHH)

Olav Jarlsby Non-Executive Director
- Former Counsel & Attorneyat-law, Elopak AS
- LL.M. law (UiO)

Henrik Nielsen Non-Executive Director
- Founder & CEO at CAP Partner
- Director of the European Wound Management Association
- Advisory Council Member for EXCITE International
- Expertise in association management, advocacy, fundraising and organization as well as many years of experience in the medical device industry

Jørgen Berggrav Non-Executive Director
- Many diverse roles in Armed Forces as submarine commanding officer, Defence attaché, Director General in the Ministry of Defence, representative to the Supreme Allied Commander Transformation and¨NATO's operational command, SHAPE.
- Royal Norwegian Naval Academy; German Command and General Staff Academy; Norwegian Defence University College

Adrian Bignami Non-Executive Director
- Early co-inventor of the SoftOx technology
- Vice President of Finance, Business Planning and Analysis at C4 Therapeutics, Inc
- Over 20 years of experience in management consulting, investment banking, entrepreneurship, business development and corporate finance across pharmaceutical and biotechnology sectors
- SM, Biomedical Enterprise Program, Harvard-MIT Health Sciences and Technology & MBA, (MIT Sloan School of Management)

Management and financial team
Organization Leadership

Johan Christian Harstad Chief Executive Officer
• Former submarine commander and deputy leader in the Norwegian Special Operation Forces with rank of Commodore
• Experience with US Special Operations Command, Norwegian Armed Forces central staff, and Ministry of Defence
• Security policy and foreign relations studies at the US Naval War College


Harald Saetvedt Chief Financial Officer
- Extensive experience as senior executive, capital market advisor and board director with more than 20 years of experience
- Previously Clarksons Platou Securities and Pareto Securities
- MSc in financial economics (BI)

Ingrid Juven Chief Operating Officer
- 25+ years of consulting and management expertise within a variety of industries
- Previously Director at EY and Partner at Frost Nordic
- MBA in management and marketing (BI)

Elin Jørgensen, DVM, PhD International Senior Project Manager
- DVM with broad clinical experience and profound research experience with infection models, especially wound models, including biofilm infected wounds
- Lead on SoftOx' commitment in the EDF project COUNTERACT (9 WPs) with development of SoftOx inhalation solution
- SoftOx R&D expert and veterinary advisor

Klaus Kirketerp Møller, MD, PhD Co-inventor/ Scientific Advisory Board Member
- Medical Doctor, PhD at Copenhagen Wound Healing Center,
- Bispebjerg Hospital Denmark
- Co-inventor of the SoftOx technology
- 15+ years' research focus on chronic wounds and bacterial biofilms

Dr Thomas Bjarnsholt Chief Scientific Officer
- Expert in the role of bacterial and fungal biofilms in chronic infections with over 245 peer-reviewed publications
- Co-inventor of the technology with financial rights
- Professor at the Costerton Biofilm Center, Department of Immunology and Microbiology (University of Copenhagen)
- Member of the Global Wound Biofilm Expert Panel