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SoftOx Solutions AS Investor Presentation 2024

Mar 20, 2024

3747_rns_2024-03-20_54468acb-3258-45ad-bd2d-19f3221819d9.pdf

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HelpingtheWorldFighting Infections

SoftOx Solutions AS

Investor presentation

March 2024

Private & Confidential draft

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.

New SoftOx Solutions – Boards recommandation

Splitting SoftOx Solutions AS in two separate companies

  • » Split SoftOx Solutions AS into SoftOx Inhalation Solutions AS and SoftOx Skin and Wound Care Solutions AS, by doing a drop down of the Skin and Wound care business into a daughter company of SoftOx Solutions AS
  • » Shareholders in SoftOx Solutions AS will afterwards receive the shares in the daughter company SoftOx Skin and Wound Care Solutions AS as extra ordinary dividend.
  • » SoftOx Solutions AS will afterwards change name to SoftOx Inhalation Solutions AS
  • » SoftOx Inhalation Solutions AS will continue to be listed at Euronext Growth, while SoftOx Skin and Wound Care Solutions AS will become a non-listed company

The listed company SoftOx Inhalation Solutions AS will

  • » Focus on Proof of Concept in Ventilator Associated Pneumonia (VAP)
  • » Control 100% of SoftOx Defense Solutions AS Focus on Medical Counter Measurements for Respiratory Biological Treats
  • » After the split has taken place, a new board and management to be established and headquarter moved to Copenhagen
  • » Company will seek separate funding for a VAP phase 2 trial discussions already initiated with strategic investors

The non-listed company SoftOx Skin and Wound Care

  • » Focus on Wound Care management
  • » No planned changes in board and management
  • » The company will seek separate funding from new investors

Helping the world fighting infections

SoftOx Inhalation Solutions AS Norwegian Pharmaceutical Company

March 2024

Why focus on Ventilator associated pneumonia (VAP)

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

  • Today's treatment options are costly (USD 6 bn/y US/EU) and have limited effects
  • Promising study data indicated high probability of success
  • Moderate administrative risk and short time to market
  • » The patient group is well-defined and enrolled into ICU
  • » Targeted delivery of SIS through already present tubus (inhalator)
  • » ICU personal are experienced in using inhalation medicine and devices for nebulization

Clear pathway to market

  • » A hospital acquired infection; hospitals pay for treatment no reimbursement process
  • » Large market, estimated to be USD 2 bn per year, with a cost reduction potential of USD 6 bn per year
  • » Few and easily reachable costumers (only ICU 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 \$ 6 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

Preclinical Efficacy

Proof of Concept in Humans - Phase 2

Market Adoption

Reinforcing nature's own ability to eradicate unwanted microbes

HYPOCHLOROUS ACID Documented broad antimicrobial effect

HOCl (red) in action produced by immune cells

SoftOx = Stabilized HOCl

Managed to solve Medical Grade Stabilized HOCl

Complete Toxicology Package

Test Conformance Standards Document number Summary Status
Repeat-Dose Toxicity
Cytotoxicit
y
Inhalation Study -
Intubated
(minipigs)
NA SIS_EJ_001
SIS_EJ_002
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 SIS_EJ_008 SIS_EJ_007 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 8458986 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 8458991 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 20/291-103PE 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 20/291-103P 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 20/291-030C 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 20-291-007M 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 20-291-013C micronucleus test using mouse lymphoma L5178Y TK+/- 3.7.2 C cells.
In vitro
SIS concentrations tested were 10, 7, 6, 5, 2 and 1 µg/mL.
Complete
Lung Surfactant Functionality
(in vitro)
NA SIS_EJ_004 In vitro lung surfactant test
of 500
µg/mL
HOCl
SS0330.
Complete
Ocular Irritation Test (Isolated Chicken Eye Method) GLP 20-291-038CS 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 20/291-038SZ 100 and 200 µg/mL SIS tested and was found to be non-irritant to eyes Complete

Phase 1 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

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

Strong antibiofilm activity of SIS against pulmonary pathogens

Data on file. SIS at various concentration tested against bacterial biofilms grown for 24 hours with one hour contact time. *Acetic acid tested against planktonic bacteria with 15 minutes of contact time.

Biofilm (red) in sputum from pneumonia patient. P. aeruginosa and S. aureus are among the most common pathogens in VAP and often present as biofilms

Picture from: M. Kolpen et al., Bacterial biofilms predominate in both acute and chronic human lung infections. Thorax, (2022).

Effective treatment of Influenza A in mice

Twice daily SIS-treatment resulted in lower viral titers 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).

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 inactive 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 50 to take the company through Phase II

Market adoption

Patient Hospital Commercial
Mortality

10%-30% risk of
developing VAP

Up to 50% mortality
Hospital Acquired Infection

Hospitals must pay the extra
cost themselves –
USD 6bn

No need for reimbursement
Easy to implement use

Handled
by Health Care
Personnel

Need only standard equipment
Pathway to market

Focused Market Segment

Easier market penetration
(smaller sales force, higher
market share faster)

Pathway to market is short and well defined

Financial Potential

> 160 000 yearly VAP cases US & EU

US 93 000 cases1)

EU 70 000 cases2)

\$ 6 bn in extra treatment costs per year

US \$ 47 000 per patient3)

EU \$ 30 000 per patient4)

Value Proposition

  • Reduced hospital costs up to \$ 6 bn
  • Reduced mortality
  • Reduced ICU days

Great possibility to reduce \$ 6 bn in Extra Treatment Costs

1) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9051358/ 2) https://www.sundhed.dk/content/cms/12/4712\_did\_aarsrapport2022.pdf 3) https://www.ahrq.gov/hai/pfp/haccost2017-results.html 4)

Technology Toxicology & Phase 1 Proof of concept and Phase 2 Preclinical Efficacy Market adoption

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

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

(*) European agile network for medical COUNTERmeasures Against CBRN Threats

Fully funded program / All commercial rights belong to SoftOx

Further Potential COUNTERACT program benefits both civil and military SIS development

Scientific advice input on SIS 2.0 benefits the overall ongoing development of SoftOx's 2 nd generation products

The COUNTERACT phase 1B trial increases dosing possibilities in future trials on both the civil and military program of SIS

  • Open for use of Second-generation SIS for VAP
  • Optimize dose for a virucidal Influenza challenge Phase 2 trial, planned in 2026

Both military counter measurement and civilian application will benefit from a virucidal challenge study

Summary of risk factors 1:2

  • The Company relies on various partnerships for development, production, and distribution, and any failure to maintain these could hinder product development, increase costs, or prevent product commercialization.
  • The Company's success relies on retaining and attracting skilled personnel, and competition for such individuals is high. Failure to maintain or protect against competitive actions from former employees could adversely affect operations.
  • There is a risk that the Company's obtained patents is insufficient to prevent other competitors to commercialize competing products incorporating the Company's methods.
  • The Company faces intense competition from established and new entities, and any inability to compete effectively could necessitate changes in clinical programs, increase costs, or impede product commercialization
  • The biopharmaceutical market's rapid evolution requires the Company to innovate and adapt continuously; failure to do so could materially affect its business and financial success.
  • The Company's competitive position and revenue depend on protecting its intellectual property, and failure to do so could allow competitors to erode its market share or lead to costly legal disputes.

Specific to the market in which SoftOx operates Specific to the industries in which SoftOx operates

  • Pharmaceutical investments are speculative, with substantial risks due to high initial costs and the possibility that product candidates may not be effective, obtain regulatory approval, or become commercially viable.
  • Completing clinical trials is critical for the Company and is subject to various internal and external factors that could cause delays or failures, impacting the ability to obtain regulatory approval and commercialize products.
  • Clinical programs may need changes due to technological advances, shifts in medical science, or regulatory demands, potentially affecting the Company's capital requirements and revenue flow.
  • Early positive results in product development may not predict later success, and most product candidates may never receive approval or reach the market, which could significantly impact the Company's finances and operations.
  • Side effects in product candidates can hinder clinical development, prevent regulatory approval, and limit commercial potential, leading to significant negative consequences including legal disputes.
  • Late-emerging side effects of approved products could lead to withdrawal of approvals, additional warnings, or reduced acceptance, potentially resulting in legal disputes and reputational damage.

Summary of risk factors 2:2

  • The Company's success hinges on its ability to commercialize product candidates, which involves numerous challenges including funding, clinical trials, regulatory approval, and acceptance within the medical community.
  • Existing or future debt arrangements could limit the Group's liquidity and flexibility in obtaining additional financing and/or pursuing other business opportunities.
  • Dependence on third-party manufacturers and suppliers exposes the Company to risks that could increase costs and delay or limit product supply, affecting the development process and time to market.
  • The Company may require more funds to cover operational and development costs, and there is no guarantee that additional financing will be available on acceptable terms, if at all.
  • Public grants and reimbursements play a significant role in funding the Company's projects, and the inability to secure such funding could have a material adverse effect on its operations.
  • The Company cannot make any assurances that the Company will be able to continue to obtain public grants or reimbursements or to have grant applications approved in the future, on the same terms or at all.

Key risks specific to financial risks Key risks related to laws and regulations etc.

  • The Company may become subject to new or increased burdensome government regulations affecting the industry
  • Legal disputes and liability claims related to clinical trials or product use could result in significant costs, distract management, damage reputation, and adversely affect the Company's finances and operations.
  • The Company may not be able to obtain the required approvals or marketing authorization from health authorities (domestic or multi-national (EU, etc.) for its products, which is required in order to enter the commercial phase
  • Compliance with extensive regulations is crucial for the Company, and failure to comply or adapt to new regulations could lead to increased costs, fines, or operational shutdowns.
  • Expansion into international markets involves regulatory challenges and compliance with various laws, which could lead to litigations, penalties, and other sanctions, adversely affecting the Company's business and reputation.
  • The Group may be subject to legal disputes in the future.

Key Takeaways

  • Following the contemplated private placement, SoftOx will be debt free and focused on the clinical development plan for VAP
    • ➢ Representing a market with large unmet medical need and high mortality rate
    • ➢ Expect to significantly reduce today's high cost of treatment (USD 6 Bn)
    • ➢ Well defined user group with infrastructure in place
    • ➢ Promising study data indicated high probability of success
    • ➢ Relatively low clinical study costs and short time to market
  • A successful phase 2 study will open up for exit alternatives in 2026
  • Continue to develop medical counter measurement towards biological treats and next pandemic in cooperation with University of Copenhagen – A world leading University within the field – and funded by EDF