Softox Solutions As · OSL:SOFTX
Softox Solutions As — Investor Presentation (March 2023)
39 slides from Softox Solutions As's investor presentation, March 2023
Slide 1: Helping the world fighting infections
Helping the world fighting infections SoftOx Solutions AS Norwegian medtech and pharmaceutical company March 2023
Slide 2: Disclaimer
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
Slide 3: Helping the world fighting infections
Helping the world fighting infections VIRUSES BIOFILM RESISTANCE ANTIMICROBIAL RESISTANCE Respiratory infectious diseases are 1-2% of the population are projected AMR is regarded as one of the largest among the leading causes of death [1 to experience a chronic wound during threats to global health
Slide 4: New ways of eradicating infections and fighting antimicrobial resistance
New ways of eradicating infections and fighting antimicrobial resistance Team of top scientists and supported by an international KOL network • Experienced R&D team with the top biofilm researchers and several medical professionals • Support from US Naval Medical Research Center, European Defence Fu
Slide 5: SoftOx overview
SoftOx overview Public company dedicated to developing a new class of antimicrobials restructuring into two companies to secure focus and answer on different investor needs SoftOx Solutions AS Non-toxic and highly effective anti-infective technology TBD TBD Wound Care Respiratory Care Anti- infectiv
Slide 6: Technology co-developed with key players in wound care
Technology co-developed with key players in wound care SCIENTIFIC & RESEARCH TEAM COLLABORATION PARTNERS Chief Medical Officer EDF funds research and development of state-of-the-art defence technology Dr Christopher Burton, MD , PhD December 2022 – Granted approx. €4.1 million to SoftOx and €4.2 mil
Slide 7: Patented and well protected technology
Patented and well protected technology SoftOx Competitors Broad and extensive patent portfolio covering: • formulation • production • storage • route of administration • antimicrobial indications A unique and protected technology for achieving an acceptable regulatory profile • Two years shelf life
Slide 8: Platform technology
eM. eo _ apy y -@ \ “@ df. & \ ad A” Wa » a ee O1 as Platform technology
Slide 9: The chemical solution: Reinforcing nature's own ability to eradicate unwanted microbes
The chemical solution: Reinforcing nature’s own ability to eradicate unwanted microbes 1. SOFTOX TECHNOLOGY 2. Strong pan-spectrum antimicrobial (virucidal/bactericidal) effects HYPOCHLOROUS ACETIC ACID ACID 3. Not shown to induce antimicrobial Documented broad Antimicrobial stabilizer antimicrobial
Slide 10: HOCl has direct and indirect antimicrobial MoA
HOCl has direct and indirect antimicrobial MoA: independent of biological processes and unreliant on a metabolic target or receptor Disrupts microbial replication, budding & host cell entry Disrupts microbial integrity & repair Disrupts nucleic acid synthesis & metabolism Increases microbial immunog
Slide 11: Stabilised formulations of hypochlorous acid (HOCl)
Stabilised formulations of hypochlorous acid (HOCl) are pre-requisite for developing HOCl based pharmacotherapeutics and enhancing commercial viability Illustration of the effect of stability and achieving optimal treatments in different indications Increasing the starting concentration is Wound Car
Slide 12: Wound care
02 Wound care
Slide 13: Targeting the chronic wound market in the US
Targeting the chronic wound market in the US UNMET NEED1: $25 billion Patient population drivers: 6.5 million • Obesity chronic wound patients • Diabetes Annual treatment costs of chronic in the US annually1 • Population over 65 years of age wounds in US1 WANTED PRODUCT PROFILE According to FDA Woun
Slide 14: The unmet need for treatment of chronic wounds
The unmet need for treatment of chronic wounds Broad spectrum also inside biofilm Reaching microbes where they are VLU Bacteriology2 Percentage of wounds 100% 90% colonised (%) 80% 70% 60% 50% 40% Surface 30% 20% 10% 0% Within 40-70% of venous leg ulcers are colonized by multiple (~5 to 6) wound bed
Slide 15: SoftOx target positioning fits well with current consensus guidelines
SoftOx target positioning fits well with current consensus guidelines SoftOx’s position in standard of care Topical antiseptics are recommended as first-line therapy in wounds Consensus guidelines f or the identif ication and treatment of biof ilms in chronic nonhealing wounds. Schultz G, Bjarnsholt
Slide 16: Phase results in treatment of leg ulcers show >99% reduction in bacterial bioburden
Phase 1 results in treatment of leg ulcers (SBE-01) show >99% reduction in bacterial bioburden 1,E+08 >99% reduction 1,E+07 Topline results 1,E+06 Bacterial burden (CFU/mL) 1,E+05 - Safe and well tolerated 1,E+04 - SBE formulations reduced the absolute number 1,E+03 of bacteria (bacterial burden) in
Slide 17: Wound healing observed in three clinical studies
Wound healing observed in three clinical studies Relative Change from pre-dose Mean Difference in degree of re-epithelialization: wound area after 5 days treatment* SWIS vs. sterile saline SBE (QD) SBE (BID) 35% 0% Relative change in wound area Degree of Re-epithelialization (%) 30% -10% from baseli
Slide 18: Technology platform: different concentrations for different indications and wounds
Technology platform: Different concentrations offers possibility to designing products for different indications and wounds SoftOx’s synergistic antimicrobial effect Cost of wound care – Medicare2 Creates opportunities to treat different wounds Others Amount of organic material presemt High 8% Diabe
Slide 19: Target market selection in advanced wound care
Target market selection in advanced wound care US 35% of total Geographic market global market Ulcers Targeted type of wounds Venous and arterial leg Clinical indication ulcers and initial market Hospitals and wound care End-user segment centres SoftOx in brief SoftOx technology Chronic wounds Respi
Slide 20: High cost-saving potential for leg ulcer treatment
High cost-saving potential for leg ulcer treatment Independent health market analyses Excite International Assumed wound healing rate in third party valuation model and University of Radboud • Cost of care based on literature and interview with KOL/Payers Estimated wound healing rate in US 100% • Me
Slide 21: Potential profit in US given assumptions
Potential profit in US – given assumptions1) Assumptions • Number of patients in the US: 2,323,804 POTENTIAL PROFIT SBE 900 USD 837 • Avg price per patient is $2,280, which equates to 50% Potential profit yearly profit in Mill USD 800 USD 732 of est. saving per patient in MedValue model 700 USD 627
Slide 22: SBE-02 - US Phase 2 follow-up study
SBE-02 - US Phase 2 follow-up study Blinded, randomised, placebo-controlled, study comparing SBE vs. Normal Sterile Saline (NSS) in patients with venous leg ulcers (VLU) End points: • Change in bacterial burden • Percentage wound closure • Clinical evaluation of wound • Safety and tolerability Co-fu
Slide 23: Timeline development of SoftOx wound care technology
Timeline development of SoftOx wound care technology 2026/27 2018 2019 2020 2023/24 2025/26 2021 2022 Market Pre-clinical Phase 1a/1b Phase 2 Phase 3 approval Preclinical Pilot study Pivotal study study Wound SBE drug Wound Wound Wound Wound Early PoC antimicrobial Wound antimicrobial Irrigation Irr
Slide 24: Respiratory infections
O04 Respiratory infections
Slide 25: SARS-CoV-2 pandemic and preparedness for Disease X
SARS-CoV-2 pandemic & preparedness for Disease X: Consequences of exceeding healthcare system capacity US observed vs. expected weekly deaths 1 Vaccines are virus species/strain specific during the SARS-CoV-2 pandemic and require repeated inoculation 100 000 Large proportion of excess SARS-CoV-2 Vac
Slide 26: US and EU military priority: medical readiness for emerging infectious diseases
US and EU military priority: Medical readiness for emerging infectious diseases and bioterrorism Military Inf ectious Diseases Research Program Portf olio Ov erv iew and Strategy . COL Stuart D. Ty ner, PhD. 07 Nov ember 2022 SoftOx in brief SoftOx technology Chronic wounds Respiratory infections
Slide 27: 12% of the EU/US population experiences flu-like symptoms annually
12% of the EU/US population experiences flu-like symptoms annually Influenza Waterfall Chart OTC products focused on reducing 30% 100% symptoms but: Unmet Need • does not alter the course of disease 25% • does not shorten disease duration Percentage of patients with • does not reduce disease transmi
Slide 28: Early intervention treatment: potential to impact peak viral load
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 tra
Slide 29: Pre-clinical proof of concept in infectious disease
Pre-clinical proof of concept in infectious disease: Mice exposed to index mouse infected with Sendai virus at day 0 Cohousing with infected mice & exposure prophylaxis Saline Treatment Group with Saline or SoftOx DAY 5 SoftOx Treatment Group Index (infected) mouse removed from cohousing on day 3 Un
Slide 30: SIS-01: Nebulized formulation safe and well tolerated at all dose levels
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. SoftOx in brief SoftOx technology Chronic w
Slide 31: Ongoing clinical development plans address regulatory feedback
Ongoing clinical development plans (CDP) addresses feedback received from European and US Regulatory Authorities EMA FDA In context of clinical ILI indication In context of SARS-CoV-2 indication Feedback addressed in CDPs SoftOx in brief SoftOx technology Chronic wounds Respiratory infections
Slide 32: Protecting the soldier and the population from respiratory infectious disease
Protecting the soldier and the population from respiratory infectious disease & biological threats European Defence Fund (EDF) COUNTERACT aims to develop and deploy medical countermeasures against major Chemical, Biological, Radiological, and Nuclear (CBRN) threats such as terror plots, nuclear acci
Slide 33: Summary
Summary
Slide 34: SoftOx summary
SoftOx summary SoftOx Solutions AS Non-toxic and highly effective anti-infective technology Wound Care Respiratory Care Anti- infective Technology Anti-infective Technology Opportunity: Opportunity: - Aim to cover a large unmet need - Aim to cover a large unmet need - Well tolerated in humans - Achi
Slide 35: Unique solution for eradicating infections and fighting antimicrobial resistance
Unique solution for eradicating infections and fighting antimicrobial resistance Contact Information: ir@soft-ox.com Euronext Growth ticker: SOFTX
Slide 36: Appendix
Appendix
Slide 37: Board of directors
Board of directors Board of Directors SIS Project Leads Geir H. Almås Olav Jarlsby Henrik Nielsen Executive Chairman Non-Executive Director Non-Executive Director • Extensive experience from • General Counsel & Attorney- • Founder & CEO at CAP Partner business development in Norway at-law, Elopak AS
Slide 38: Management and financial team
Management and financial team Organization leadership Johan Christian Harstad Harald Saetvedt Ingrid Juven Chief Executive Officer Chief Financial Officer Chief Operating Officer • Former submarine commander and deputy • Extensive experience as senior executive, • 25+ years of consulting and managem
Slide 39: SoftOx Biofilm Eradicator background calculations
SoftOx Biofilm Eradicator background calculations SoftOx Biofilm Eradiactor backrground calculations Leg Ulcer Treatment (Annual US Revenues & Profitability) Comments Total Pts/Yr 2 323 804 Market insight on which patients more likely to use -> According to standard of care it shall Peak Market Shar
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