SoftOx Solutions AS — Investor Presentation 2024

Aug 15, 2024

Helping the world fighting infections

SoftOx Solutions AS Company Presentation

August 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.

Today's presenters

Incoming Chairman of Board (COB) Ulrik Spork

Civ Ing/MSc (Danish Technical University) Civiløkonom (Copenhagen Business School)

Extensive experience as Chairman, board member and advisor to emerging Life Science Companies

• Served on more than 30 boards internationally
• Deployed venture and PE investments into the global life-science industry for 20+ years

Previous Managing Partner in Novo Holdings and head of Corporate Business Development in Novo Nordisk

Incoming Chief Executive Officer (CEO) Prof Thomas Bjarnsholt, PhD & DMSc

MSc (Danish Technical University) PhD (Danish Technical University) Doctor of Medicine (DMSc) (University of Copenhagen) Professor of Microbiology and biofilm infections 250+ peer-reviewed publications

Chief Financial Officer (CFO) Ingrid Juven, MBA

MBA (Norwegian Business School/ Handelshøyskolen BI) Over 25 years of consulting and management expertise within a variety of industries

Restructuring Pillars

FOCUSED STRATEGY

FINANCIAL RESTRUCTURING & COST REDUCTION PROFESSIONALIZATION

Investment Case

• After completing ongoing Rights Issue
  • o No outstanding debt
  • o Secured and professionalized new Board and management and lean and project-oriented organization
  • o Runway to enable funding of the VAP Phase II project
• SoftOx Inhalation Solutions / Target Indication Ventilator Associated Pneumonia (VAP)
  • o Large unmet medical need, high costs for hospitals, and high mortality rate
  • o Well-defined clinical development plan
    • Promising data from completed studies
    • Well defined 'mode of action' relatively high probability of success
  • o Tangible value inflection point reachable with modest funding
• Targeting industrial partnership(s) or exit after completion of phase II study in VAP, expected early 2027

SoftOx Solutions Group

Why start with Ventilator associated pneumonia (VAP)

A severe type of pneumonia occurring for intubated patients at intensive care units (ICU)

• Currently limited effectful treatment options, and high mortality rate
• Considered to have favorable possibility of clinical success with low study costs

• Benefits of a VAP cohort

• o Patient group well-defined and enrolled into ICU
• o Targeted delivery of SIS through already present ventilation tubes
• o ICU staff have experience in using inhalation medicines and devices for nebulization

• Favorable pathway to market

• o VAP is a hospital acquired infection; hospitals responsible of cost of treatment limits reimbursement hurdle before commercialisation can be initiated
• o Large market potential
• o Narrow and identifiable target customers (ICU's at hospitals)

The problem –> The Solution Next Generation Respiratory Antimicrobial Solutions

Ventilator Associated Pneumonia (VAP) High risk – Difficult to Cure

Frequency

• Intubated patients at ICU (Intensive Care Unit) have 10-30% risk of developing VAP1)

Mortality

• Up to 50% mortality2)

Difficult to cure

• Often antimicrobial resistance and biofilms limits effects of using antibiotics

VAP costs \$ 4 bn per year in EU and US – Good probability of clinical success

Picture from: https://www.britishjournalofnursing.com/content/clinical/does-oral-care-with-chlorhexidinereduce-ventilator-associated-pneumonia-in-mechanically-ventilated-adults/

1) https://emedicine.medscape.com/article/304836-overview?form=fpf 2) https://www.ahrq.gov/hai/pfp/haccost2017-results.html

Project Plan VAP

Technology

Toxicology & Phase I (in humans)

Preclinical Efficacy

Proof of Concept in Humans - Phase 2

Phase 3

Market Adoption

Complete Toxicology Package

	Test	Conformance Standards	Summary	Status
Repeat-Dose Toxicity Cytotoxicity	Inhalation Study - Intubated (minipigs)	NA	Inhalation safety study of SIS (5 mL x 50, 100, or 200 µg/mL HOCl) daily for five days in Göttingen minipigs with/without recovery (2-4 weeks) using intubation.	Complete
	Inhalation Study – Masked (minipigs)	NA	Inhalation safety study of SIS (8.8 mL x50 or 100 µg/mL HOCl) daily for five days in Göttingen minipigs inhaling per mask.	Complete
	Multi-Dose Safety Study (minipigs)	NA	Inhalation 7-day repeat dose study of SIS (18 mL x 50, 100, or 200µg/mL HOCl) in Göttingen minipigs inhaling per mask.	Complete
	Multi-Dose Safety Study (minipigs)	GLP	2-week inhalation toxicology study of SIS with 2-week recovery in Göttingen minipigs inhaling per mask	Complete
	Dose range finding repeat dose study (rats)	NA	5-day (phase I, 1-6 hours exposure, 1000 µg/mL HOCl) and 14-day (phase II, 2-6 hours, 1000 µg/mL HOCl) inhalation of SIS in rats (nose only exposure)	Complete
	28-day Multi-Dose Safety Study (rats)	GLP	Inhalation toxicity +/- 2-week recovery in rats with exposure up to 4 hours and 1000 µg/mL HOCl SIS (nose only exposure)	Complete
	Cytotoxicity of SIS (100-1000 µg/mL HOCl) (in vitro)	GLP	1000, 500, 200, and 100 µg/mL showed no cytotoxic effects on cultured L929 cells	Complete
Genotoxicity Other	Bacterial Reverse Mutation Assay (in vitro)	GLP	Bacterial strains used TA98, TA100, TA1535, TA1537, E Coli WP2 uvrA. SIS test concentrations used resulting in 250, 100, 50, 25, 10, 3.162, 1.0, 0.3162 µg HOCl/plate.	Complete
	Mammalian Cell Micronucleus Assay (in vitro)	GLP	In vitro micronucleus test using mouse lymphoma L5178Y TK+/- 3.7.2 C cells. SIS concentrations tested were 10, 7, 6, 5, 2 and 1 µg/mL.	Complete
	Lung Surfactant Functionality (in vitro)	NA	In vitro lung surfactant test of 500 µg/mL HOCl SS0330.	Complete
	Ocular Irritation Test (Isolated Chicken Eye Method)	GLP	SS0330 was tested at 500, 200, 100 or 50 µg/mL HOCl in a standard test according to OECD 438.	Complete
	In vitro Epi-ocular test of SIS	GLP	100 and 200 µg/mL SIS tested and was found to be non-irritant to eyes	Complete

Phase I trial showed that SIS is safe and tolerable to inhale

Up to 4 times 5 mL 100 µg/mL SIS per day for five days is safe:

• NO SAE (Serious Adverse Events)
• Predominately mild AEs:
  • 27.9% of volunteers receiving SIS
  • 21.4% of volunteers receiving placebo
• Great tolerability profile
• Easy to use

No safety signals for inhalation of SIS in healthy volunteers

Broad spectrum effect proven in antimicrobial EU Norm tests

Pan-antimicrobial effect against bacteria, fungi and viruses

* EN-1500:2013-07; †EN-1327+A2:2015-12; ‡EN-13624:2013-12; ¤EN-14476+A2:2019; •EN-14348

Effective treatment of Influenza A in mice

Twice daily SIS-treatment resulted in lower viral titers on post-infections days 1 to 3

Post-exposure prophylaxis efficacy against Sendai virus in mice

SIS treatment prevents infection after exposure

Ventilator Associated Pneumonia (VAP) Clinical Development Plan (estimated timelines)

High probability of success

• Collected all documentation to prepare CTA (Clinical Trial Application)
• Well defined group of patients
• Safe to inhale
• Reaches both upper and lower respiratory parts of the lungs
• Eradicate or inactivate all relevant microorganisms
• Proof of concept for treatment and prevention in mice
• The study is suggested to be conducted with Incept.dk at the ICUs in the Capital Region of Denmark

(*) Total MNOK 60-80 to take the company through Phase II

Pathway to market is short and well defined

VAP Patients	Hospital	Commercial
Cases • Annually 130 000 US/EU Mortality • 10%-30% risk of developing VAP • Up to 50% mortality	Hospital Acquired Infection • Hospitals pay – USD 4bn in yearly treatment costs • No need for reimbursement Low implementation hurdle – ICU • Very experienced staff at ICU's • Standard equipment	Pathway to market • Easier market penetration • Targeted sales force • Build market share faster

Financial Potential to reduce \$ 4 bn in yearly Treatment Costs

Countermeasures against biological threats Financed by European Defense Fund and Norwegian MoD

COUNTERACT - European agile network for medical COUNTERmeasures Against CBRN Threats

SoftOx/SIS is the main research target for the Biological threats (budget ~90M NOK)

Main partners are University of Copenhagen and CR Competence

Highlights:

• Scientific advice on SIS 2.0 and phase 1B obtained
• Optimization of SIS 2.0 performed
• SIS 2.0 is tested against a diverse array of pathogens (in vitro/vivo)
• Phase 1B study planned to start 2025
• Setup of GMP production of SIS 2.0 at CMO included in budget

Soft funded program - All commercial rights belong to SoftOx

Overall Clinical Development Plan (estimated timelines)

The EDF/COUNTERACT phase 1B trial increases and optimizes dosing possibilities

* SoftOx plan to team up with relevant partner(s)

Strong synergies and large market potentials

Key take-aways

• Following recent restructuring, SoftOx is now a debt-free company with a well-defined, promising and cost-effective clinical development plan in place
• New Board and Management team with strong track record
• Target indication VAP represents a significant value potential, while study costs to complete a phase II study is unusually low. If successful, will leverage development for additional indications
• Strong synergies with the soft-funded EDF project (inhalation solutions for military use)
• Leadership approach will be to maintain 'venture style' sharp focus on use of proceeds and conducting 'mission-critical' activities only, until value-inflection points are reached
• No use of management or financial resources on Skin and Wound care business to be spun off at the right point in time
• Seeking industrial partnership(s) upon successful clinical data for VAP