Slide 1: SoftOx Solutions AS Presentation Q2 2022
SoftOx Solutions AS Norwegian medtech and biotech company listed on Euronext Growth Presentation Q2 2022 15 August 2022
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 in connection with Q2 2022 held by the Company. This presentation is strictly confidential and may not be reproduced or redistributed, in whole or i
Slide 3: Presenters
Presenters Highlights, SoftOx in brief & Commercial and military development CEO Geir Almås SoftOx technology development CMO Dr Christopher Burton Financial update CFO Kristine Rød 3 | 2nd quarter results 2022
Slide 4: First half-year highlights and SoftOx in brief
01 First half-year highlights and SoftOx in brief 4 | 2nd quarter results 2022
Slide 5: First half-year highlights and subsequent events
First half-year highlights and subsequent events RESEARCH & DEVELOPMENT& DEVELOPMENT Completed SIS-01 in April and the study achieved the primary objective of safety and tolerability in healthy subjects Completed first phase of SBE-01 (single ascending dose) and progressed to the last phase (multipl
Slide 6: Reinforcing nature's own ability to eradicate unwanted microbes
Reinforcing nature’s own ability to eradicate unwanted microbes HYPOCHLOROUS ORGANIC ACID ACID Documented broad antimicrobial effect Antimicrobial stabilizer SOFTOX TECHNOLOGY Replicating millions of years of evolution A base technology tailored for different indications and uses 6 | 2nd quarter res
Slide 7: Helping the world fighting infections
Helping the world fighting infections VIRUS BIOFILM RESISTANCE ANTIMICROBIAL RESISTANCE Respiratory infectious diseases are 1-2% of the population are projected AMR is regarded as one of the among the leading causes of death [1 to experience a chronic wound during biggest threats to global health [3
Slide 8: Product development strategy
Product development strategy PARTNERS Preclinical Proof Clinical Proof Concept development PARTNERING of Concept of Concept DE-RISKING Commercial, Industry & Financial Partners Clinical Partners Academic Research Partners Key Opinion Leaders (KOLs) Network 8 | 2nd quarter results 2022
Slide 9: Product pipeline
Product pipeline Pending regulatory Project Indication Pre-clinical Phase I Phase II approval Collaborations Surface BIOCIDE Disinfection disinfectant Hand disinfectant PARTNERING MEDICAL Wound irrigation Wounds DEVICE solution Infection Chronic leg treatment wounds DRUG Inhalation Respiratory tract
Slide 10: Business segments
Business segments Wounds Respiratory Disinfection Infection prevention and Infection treatment for Infection prevention treatment for acute and viral infections solutions for hands and chronic wounds surfaces 10 | 2nd quarter results 2022
Slide 11: SoftOx technology development
02 SoftOx technology development 11 | 2nd quarter results 2022
Slide 12: Competitive advantage
Competitive advantage 1. Pan-spectrum antimicrobial (virucidal/bactericidal) effects 2. Not shown to induce antimicrobial resistance 3. Good safety and tolerability profile – no systemic side effects 4. Versatile technology platform 12 | 2nd quarter results 2022
Slide 13: Mechanism of Action
Mechanism of Action Source: Solodovnikov, A, & Arkhipova, V. (2021). SARS-CoV-2. 13 | 2nd quarter results 2022 https://commons.wikimedia.org/wiki/File:Coronavirus._SARS-CoV-2.png#file
Slide 14: Direct and indirect antimicrobial MoA
Direct and indirect antimicrobial MoA, independent of biological processes and unreliant on a metabolic target or receptor Oxidation of microbial surface glycoproteins disrupt viral replication, budding and cell Nucleic acid oxidation leads entry to proteome-wide unfolding and oxidation of proteins
Slide 15: Respiratory
2.1 Respiratory 15 | 2nd quarter results 2022
Slide 16: Respiratory: unmet need in flu-like symptoms
12% of the EU/US population experiences flu-like Respiratory symptoms annually Influenza Waterfall Chart OTC products focused on reducing symptoms, 30% 100% but not: Unmet Need • curing disease, 25% • shortening the duration of disease, Percentage of patients with • altering the course of the diseas
Slide 17: Majority of influenza-like illness caused by viruses other than Influenza A/B
The majority of influenza-like illness is caused by Respiratory viruses other than Influenza A/B Viral causes of Influenza-like illness Viral causes of Influenza-like illness Multiple geographies (2012-2018) [1 Denmark (2021-2022) [2 Influenza Rhinovirus Or Enterovirus Influenza Rhinovirus Or Entero
Slide 18: In vitro virucidal and bactericidal effects of SIS
In vitro virucidal and bactericidal effects of SIS Respiratory SIS intracellular viral inactivation and cell viability following treatment with SIS in vitro* 120% P. aeruginosa (Gram negative) S. aureus (Gram positive) Normalized to non-treated controls (%) 100% 80% 60% 40% * ** 20% 0% MOI 0.002 Cyt
Slide 19: SIS-01: Randomized, placebo controlled, first in human trial
SIS-01: Randomized, placebo controlled, first in human Respiratory trial in healthy volunteers Single dose of nebulised SIS @ 25 ppm/placebo Subjects (N=56) will be enrolled and randomised to receive SIS or placebo in a 3:1 ratio (42 will receive SIS; 14 Primary Endpoints Single dose of nebulised SI
Slide 20: SIS-01: Results & Conclusions
SIS-01: Results & Conclusions Respiratory • No SAEs • Mild, self-limiting AEs related/unrelated to drug administration SIS at concentrations of up • Acceptable local tolerability to 100 ppm (100 ug/ml) • No effect on spirometry administered four times daily • No effect on vital signs via a nebuliser
Slide 21: Wound care
2.2 Wound care 22 | 2nd quarter results 2022
Slide 22: Venous leg ulcers colonized by multiple bacterial species
40-70% of venous leg ulcers are colonized by multiple (~5 to 6) Wound bacterial species1 at variable distance to the wound surface2 VLU Bacteriology 1 100% Percentage of wounds colonised (%) 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 1. Gødsbøl et al, Copenhagen Wound Healing Center; 2. Fazli et al. J C
Slide 23: In vitro antibacterial efficacy in biofilms
In vitro antibacterial efficacy in biofilms Wound Data on file. 24 | 2nd quarter results 2022
Slide 24: SWIS-02 findings demonstrate relative improvement in wound healing
SWIS-02 findings demonstrate relative improvement Wound in wound healing of 32.6%† on day 4 Mean Difference in degree of re-epithelialization: SWIS vs. sterile saline Bacterial load on Day 4 35% 6 SWIS Sterile saline 30% 5 * ** Log10 Colony Forming Units (CFU) Degree of Re-epithelialization (%) 25%
Slide 25: SBE clinical studies (phase 1a & 1b) in chronic wounds
SBE clinical studies (phase 1a & 1b) in chronic wounds: Wound Blinded, randomized safety study of single & multiple ascending dose Phase 1a Phase 1b z % HOCl + t % AA 26 | 2nd quarter results 2022
Slide 26: SBE Positioning: First line treatment of locally infected wounds
SBE Positioning: First line treatment of locally infected wounds Wound (i.e. no evidence of systemic infection) TREATMENT PREVENTION Figure. The typical evolution of a superficial wound infection. A Proposed New Classification of Skin and Soft Tissue Infections Modeled on the Subset of 27 | 2nd quar
Slide 27: Commercial and military development
03 Commercial and military development 28 | 2nd quarter results 2022
Slide 28: Unmet need in wound care
Unmet need in wound care Wound ACUTE WOUNDS CHRONIC WOUNDS 180 million 40 million 1-2% of population are projected to have a Individuals have skin wounds worldwide each year[1 Chronic wounds worldwide[1 chronic wound in developed countries[2 Venous leg ulcers (VLUs) Today’s wound rinse market is dom
Slide 29: European Defence funds military inhalation solution
European Defence funds military inhalation solution Respiratory Granted approx. NOK 97 million to develop a military medical countermeasure for the EU and allies • Supported by the Norwegian Ministry of Defence (FD) joint financing International consortium involving: • 20 R&D and industry partners •
Slide 30: The main objective for European Defence Fund (EDF)
The main objective for European Defence Fund (EDF) • Identifying technologies critical for EU security and defence, boosting them through European (RTD&I) programs[1 • Foster transborder cooperation in defence research and development in the EU[2 • The Defence package strives to complement the Europ
Slide 31: EU Action plan on synergies between civil, defence and space industries
EU Action plan on synergies between civil, defence and space industries • Spin-offs: Promoting that EU funding for research and development, including on defence and space, has economic and technological dividends for EU citizens • Spin-ins: Facilitating the use of civil industry research achievemen
Slide 32: Expected value as a preventative preparedness tool
Expected value as a preventative preparedness tool for soldiers and the civilian population Estimated Unmet Need • 10-20 pcs for each soldier • 3.5 million soldiers (NATO & EU) • 2 million soldiers (partner countries) • Stockpiling for 15-20% of civilian population The company estimates that this co
Slide 33: Financial update
04 Financial update 34 | 2nd quarter results 2022
Slide 34: Financial highlights
Financial highlights Profit and loss statement Accounts for Q2 and FY 2021 SoftOx Solutions Group NOK 1,000 Q1 2022 Q2 2022 Q2 2021 Change FY 2021 Operating revenue Operating revenue 50 53 703 1 752 Low operating income due to low sales Grants 999 1 297 1 895 6 150 Total operating revenues 1 049 1 3
Slide 35: Financial highlights
Financial highlights Cash flow statement Q1 2022 Q2 2022 Q2 2021 FY 2021 Net change in cash and cash SoftOx Solutions Group NOK 1,000 equivalents -21 141 -25 603 -22 820 -72 561 Cash flow from operating activities • Strong focus on the product Net result before taxes -24 276 -20 566 -21 273 -86 291
Slide 36: Summary
05 Summary 37 | 2nd quarter results 2022
Slide 37: Multiple opportunities for development of products based on SoftOx technology
Multiple opportunities for development of products based on SoftOx technology OPPORTUNITY X Wound Irrigation Biofilm Eradicator Solution (SWIS) (SBE) Hand disinfectant Inhalation Solution (SIS) Wound Surface disinfectant/ Steam Defence Disinfection Respiratory countermeasure FOCUS SEGMENTS SoftOx wi
Slide 38: Expected news flow 2022
Expected news flow 2022 Wound care • Talks with major distributors and partners • GMP production line • Achieve a 510(k) clearance for the US market • Complete phase 1 of SBE • Initiation of phase 2 Respiratory • Initiation of phase 2 will be aligned with EDF process • Financial and strategic partne
Slide 39: Key takeaways
Key takeaways Solid progress on Highly Endogeneous Strong platform the projects targeting skilled team large global 12 PhDs & 3 ingredients with great potential for professors/researchers Well known & many products/segments markets well tolerated by human body 58 granted Co-funded Significant unmet
Slide 40: Contact Information
New ways of eradicating infections and fighting antimicrobial resistance Contact Information: ir@soft-ox.com Geir Hermod Almås Kristine Mundal Rød Chief Executive Officer Chief Financial Officer