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SoftOx Solutions AS — Investor Presentation 2022
Oct 26, 2022
3747_rns_2022-10-26_d6f42773-fee3-40d3-aa30-da06baeb6a8f.pdf
Investor Presentation
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SoftOx Solutions AS
Medtech and pharmaceutical company listed on Euronext Growth
Presentation Q3 2022 26 October 2022
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 Q3 2022. 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 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
Company. 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 October 2022. 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. 2 | 3rd quarter results 2022
Presenters
CEO Geir Almås SoftOx technology development Financial review
CMO Dr Christopher Burton
CFO Kristine Rød
Helping the world fighting infections
Respiratory infectious diseases are among the leading causes of death [1
1-2% of the population are projected to experience a chronic wound during their lifetime in developed countries [2
VIRUSES ANTIMICROBIAL RESISTANCE BIOFILM RESISTANCE
Our vision is to become a world-leading developer of antimicrobial technology
- 1) Forum of International Respiratory Societies (2019). The Global Impact of Respiratory Disease Second Edition. SheffIeld, European Respiratory Society.
- 2) Sen, C.K. et al. (2009) Human Skin Wounds, Wound Repair Regen, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2810192/
- 3) IACG (2019). No Time to Wait, WHO. https://www.who.int/antimicrobial-resistance/interagency-coordination-group/IACG_final_report_EN.pdf?ua=1
Third quarter highlights and subsequent events Early completion of SBE-01 study evaluating the SoftOx Biofilm Eradicator (SBE) in treating chronic wounds
RESEARCH & DEVELOPMENT
Positive top line results of SBE-01 showed SBE was safe and well tolerated
Selected as one of three main technologies that form the basis for the European Defence Fund (EDF) grant
COMMERCIAL DEVELOPMENT
Received final approval on SoftOx disinfectant family in Sweden (KemI) which allows SoftOx to sell disinfection products in Sweden and proceed with partner opportunities to bring products to market
FINANCE
Q3 result of NOK -23.7 million (LY: NOK -22 million)
Secured a convertible loan from existing shareholders for NOK 25 million and refinanced NOK 15 million convertible loan reported in June 2022 6 | 3rd quarter results 2022
| Product pipeline – | Good progress in clinical | development | programs | |||
|---|---|---|---|---|---|---|
| Phase II/ |
||||||
| Product classification Project |
Indication | Pre-clinical/ EN studies |
Phase I/ Pilot studies |
Confirmative studies |
Pending regulatory approval |
|
| BIOCIDE (SafeDes |
Disinfection & |
Surface disinfectant | ||||
| EffectDes) | Hand disinfectant | PARTNERING | KemI (Sweden) granted 10-2022 |
|||
| MEDICAL Wound solution DEVICE |
irrigation (SWIS) |
Wounds | ||||
| Infection treatment |
(SBE) | Chronic leg wounds |
||||
| Inhalation DRUG (SIS) |
solution | Respiratory tract infections |
||||
| Military | medical countermeasure |
CBRN threats |
| SoftOx in brief |
SoftOx technology |
Markets/ Commercial development | Financial review |
|---|---|---|---|
SoftOx technology – successfully developed a stable and long-lasting product with unique combination effects
1. SOFTOX TECHNOLOGY
-
Strong pan-spectrum antimicrobial (virucidal/bactericidal) effects
-
Not shown to induce antimicrobial resistance
-
Good safety and tolerability profile – no systemic side effects
-
Stabilized molecule
A base technology tailored for different indications and uses
Business segments
Wounds
Respiratory infections
Disinfection
surfaces
Infection is one of the most frequent factors associated with delayed wound healing1
Representative CLSM images of S. aureus (A and B), P. aeruginosa (C and D). Arrows point to the wound surfaces.
variable distance to the wound surface
- EWMA (2022). Antimicrobials and Non-healing Wounds: An Update. Journal of Wound Management. https://viewer.ipaper.io/jowm/1035279jowm20222303/sup01/ 2. Gødsbøl et al, Copenhagen Wound Healing Center; 2. Fazli et al. J Clin Microbiol 2009 Dec;47(12):4084-9
TREATMENT First line prevention and treatment of locally infected wounds (i.e. no evidence of systemic infection)
Dose dependent response answers on different wound needs, depending on colonization
SoftOx in brief SoftOx technology Markets/ Commercial development Financial review
Wound
Positive results from Phase 1 in treatment of chronic wounds (SBE-01) investigating single- and multiple ascending doses SBE
Topline results
- Safe and well tolerated
- SBE formulations reduced the absolute number of bacteria (bacterial burden) in the wound compared with pre-treatment (baseline).
- A dose dependent reduction in wound size was observed in multiple dose treatment groups.
Safe and well tolerated
SoftOx in brief SoftOx technology Markets/ Commercial development Financial review
Wound
Positive results from Phase 1 in treatment of chronic wounds (SBE-01) investigating single- and multiple ascending doses SBE
Pre-dose After IMP
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.
Observed reductions in bioburden*
*) SBE-01 trial pooled & multiple dosing groups.
Data on file. Means ± standard deviation
Positive results from Phase 1 in treatment of chronic wounds Wound
(SBE-01) investigating single- and multiple ascending doses SBE 15 | 3rd quarter results 2022 -70% -60% -50% -40% -30% -20% -10% 0% SBE (QD) SBE (BID) Relative change in wound area from baseline (%) Relative Change from pre-dose wound area after 5 days treatment*
Topline results
- Safe and well tolerated
- SBE formulations reduced the absolute number of bacteria (bacterial burden) in the wound compared with pre-treatment (baseline).
- A dose dependent reduction in wound size was observed in multiple dose treatment groups.
Observed dose dependent trend in reduction of wound size*
SoftOx in brief SoftOx technology Markets/ Commercial development Financial review
*) SBE-01 trial multiple dosing groups.
Data on file. Means ± standard deviation
Clinical effect of re-epithelialization in acute wounds supports finding in chronic wounds
Evidence of faster re-epithelization in acute wounds
DOI: 10.2340/actadv.v102.1624.
SBE-02 - US Phase 2 follow up study
- Blinded, randomised, PC, 2 arm: SBE vs. Normal Sterile Saline (NSS)
- Patients with chronic ulcers of lower extremities (VLU)
- Treatment regimen: Once daily, 3 times per week for 4 weeks
• End points:
- Clinical evaluation of wound
- Microbial determination, reduction of bacterial burden
- Percentage wound closure
- Re-epithelialisation
- Safety (AEs)
Co-funded by US Medical Technology Enterprise Consortium (MTEC) 17 | 3rd quarter results 2022
Business segments
Wounds
Respiratory infections
Disinfection
surfaces
SoftOx Inhaled Solution (SIS): Summary of development within civilian indication
SoftOx Inhaled Solution (SIS): Exploring potential military applications as a countermeasure to biologic threats
SoftOx in brief SoftOx technology Markets/ Commercial development Financial review
SoftOx Inhaled Solution (SIS): Exploring potential military applications as a countermeasure to biologic threats
SIS-01 trial (NCT05188638). Burton et al. ERS Congress 2022. Abstract #36474.
SoftOx Inhaled Solution (SIS): Exploring potential military applications as a countermeasure to biologic threats
Business segments
Wounds
Respiratory infections
Disinfection
surfaces
Regulatory approval in Sweden
-
Approval allows SoftOx to sell its disinfection products in Sweden Major milestone achieved: SoftOx's first regulatory approval https://newsweb.oslobors.no/message/573380 24 | 3rd quarter results 2022
-
1) Based on winning tenders in Norway and Sweden
- 2) Approval from KemI and Norwegian Environment Agency
Market potential in disinfection
Cost-saving and life-improving
75%
25-55%
of HCWs with hand eczema have Staphylococcus aureus biofilm infection [1
of health care workers (HCWs) have irritated skin and eczema [1
Major cost driver of HAIs
Direct relationship between hand hygiene compliance and HAIs[2
31 million HCWs in the EU & the US [3 [4 Whereof 10 million have irritated skin and eczema[5 26 | 3rd quarter results 2022
Clinically proven skin friendliness
"The skin barrier function of the healthy skin is unaffected by the repetitive exposure to SafeDes solution as compared to alcohol-based hand rubs. SoftOx's hand disinfectant is subjectively well-tolerated when applied on both healthy and irritated skin." [6 Department of Dermatology, Bispebjerg Hospital,
University of Copenhagen
- 1) Tomczak, H. et al. (2019). The role of Staph aureus in atopic dermatitis. Adv Dermatol Allergol; XXXVI (4): 485–491
- 2) MedValue+, Radboud 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"
- 3) Eurostat- Majority of Health Jobs Held by Women (2020)
- 4) Kaiser Family Foundation Total Health Care Employment (2020)
- 5) National Eczema Association Hand Eczema Common Among Health Care Workers
- 6) Yasemin Topal Yüksel, Mie Sonne, Line Brok Nørreslet, Glenn Gundersen, Magnus Mustafa Fazli, Tove Agner. Skin Research and Technology 2021; DOI: 10.1111/srt.13096
Market potential in wound care
ACUTE WOUNDS
180 million
Individuals have skin wounds worldwide each year[1
Replacing today's wound rinse products with a better or equal risk profile and profound antimicrobial effect
Target US patient population (2018) Venous leg ulcers (VLUs) Wound
CHRONIC WOUNDS
40 million
Prevention of infections (costs) / patient
Chronic wounds worldwide[1 of population are projected to have a chronic wound in developed countries[2
2,323,804
-\$643
Estimated \$1.5 billion potential cost savings in prevention of
Improving today's chronic wound treatment with more effective removal of infections protected by biofilm infections in VLUs [3
1) MedMarket Diligence (2011). Wound prevalence and wound management: 2012-2020 2) Sen, C.K. et al. (2009) Human Skin Wounds, Wound Repair Regen, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2810192/ 3) MedValue & Radboud University (2019). Decision Modeling Assessment.
Approved Influenza drugs (on/off-label) market
Financial review
Financial review
| Financial review | |||||
|---|---|---|---|---|---|
| Profit and loss statement Accounts for Q3 and FY 2021 |
|||||
| SoftOx Solutions Group |
Operating revenue | ||||
| NOK 1,000 | Q3 2022 | Q3 2021 | Change | FY 2021 | |
| Operating revenue | 0 | -382 | 1 752 | Low operating income due to low sales |
|
| Grants | 2 037 | 1 895 | 6 150 | ||
| Total operating revenues | 2 037 | 1 513 | 35% | 7 901 | |
| Personnel expenses | 6 931 | 5 959 | 16% | 21 113 | Operating expenses |
| Other operating expenses | 17 437 | 16 748 | 69 107 | R&D expenses accounted for | |
| Depreciation | 928 | 721 | 3 784 | approx. 64% of operating | |
| Total operating expenses | 25 296 | 23 428 | 8 % | 94 004 | expenses year to date 2022. |
| Operating result | -23 259 | -21 915 | 6 % | -86 102 | |
| Net financial items | -461 | -121 | -189 | ||
| Net result before taxes | -23 720 | -22 036 | 8 % | -86 291 | |
| Tax | 20 888 | ||||
| Net result after tax | -65 403 | ||||
| 3rd 30 quarter results 2022 |
|||||
| SoftOx in brief |
SoftOx | technology | Markets/ Commercial development Financial review |
Operating revenue
Low operating income due to low sales
Operating expenses
R&D expenses accounted for approx. 64% of operating expenses year to date 2022.
Financial review
| Financial review | |||||
|---|---|---|---|---|---|
| Cash flow statement | Q3 2022 | Q3 2021 | FY 2021 | ||
| SoftOx Solutions Group NOK 1,000 |
equivalents | ||||
| Cash flow from operating activities | -2 603 | -13 713 | -72 561 | ||
| Net result before taxes | -23 720 | -22 036 | -86 291 | development and | |
| Depreciation | 928 | 721 | 3 784 | ||
| Change in current assets | 12 772 | 4 287 | 3 061 | ||
| Change in current liabilities | 7 418 |
3 315 | 6 886 | ||
| Cash flow from investment activities | -1 934 | -814 | -4 596 | ||
| Investments in non-current assets | -1 934 | -814 | -4 596 | ||
| Cash flow from financing activities | 701 | -5 | 99 339 | ||
| Proceeds from equity issues | 0 | 0 | 89 018 | ||
| Other financing activities | 0 | 0 | 10 355 | ||
| Translation differences | 701 | -5 | -34 | ||
| Net change in cash and cash equivalents |
-3 836 | -14 535 | 22 182 | ||
| Cash and cash equivalents at end of period |
3 278 | 16 596 | 56 984 | ||
| 3rd quarter results 2022 |
|||||
| SoftOx in brief |
SoftOx | technology | Markets/ Commercial development Financial review |
Net change in cash and cash equivalents
- Strong focus on the product development and commercialisation processes while managing cash situation carefully
- Raised convertible loan from existing shareholders for NOK 25 million and refinanced the NOK 15 million convertible loan reported in
- June. Initiated a cost improvement plan to defer noncritical R&D activities, reduce future overhead and infrastructure expenditures
Platform products under development Hand disinfection Topical infection prevention for non-compromised skin Wound care for chronic and acute wounds Topical infection prevention Topical infection remover Respiratory Topical infection remover in the respiratory track Military medical countermeasure Inhalation treatment against CBRN threats Future SoftOx technology platform opportunities Respiratory virucidal infections* Hand eczema* Venous leg ulcers* Acute surgical wounds* * Development projects already started 33 | 3rd quarter results 2022
Euronext Growth ticker: SOFTX
Unique solution for eradicating infections and fighting antimicrobial resistance
Contact Information: [email protected]