Softox Solutions As · OSL:SOFTX
Softox Solutions As — Investor Presentation (January 2024)
31 slides from Softox Solutions As's investor presentation, Jan 8, 2024
Slide 1: Helping the world fighting infections
Helping the world fighting infections SoftOx Solutions AS Norwegian medtech and pharmaceutical company January 2024
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: A breakthrough fighting infections
A breakthrough fighting infections Results achieved Next Generation SoftOx • Human safety proved • Repeated studies in Respiratory mice documented Care • Prophylactic and curative effects towards Stable solutions virucidal infections at higher • Lead partner concentrations Next step: in EDF/Countera
Slide 4: Overview development of SoftOx the next 2–3 years
Overview development of SoftOx the next 2 – 3 years Wound and skin care 2024-25 Approval Medical device EU/US Today 2026 Phase 2 SBE Infection remover Proof of concept on both Distribution of SoftOx wound treatment and prophylactic Outsource production First- and cleanser in EU and US use in human N
Slide 5: Platform technology
01 Platform technology
Slide 6: Reinforcing nature's own ability to eradicate unwanted microbes
Reinforcing nature’s own ability to eradicate unwanted microbes Disrupts microbial replication, budding & host cell entry HYPOCHLOROUS ACID Disrupts microbial integrity Documented broad & repair antimicrobial effect Disrupts nucleic acid synthesis & metabolism Picture of HOCl in action within human
Slide 7: 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 ORGANIC ACID ACID 3. Not shown to induce antimicrobial Documented broad Antimicrobial stabilizer antimicrobia
Slide 8: Unrivalled combination effect on bacterial biofilms
Unrivalled combination effect on bacterial biofilms 9 8 7 LOG10 REDUCTION - CFU/ML 6 5 4 SoftOx with 3 increased 2 amount of Acetic Acid 1 0 3 hours (1 application) (3+3) hours (2 applications) Outperforming market leading competitors SoftOx in brief SoftOx technology Wound care Commercial developme
Slide 9: SoftOx Antimicrobial Technology
SoftOx Antimicrobial Technology Next Generation SoftOx technology even better • Final product is the same as todays SoftOx • Stability, less than 5% degradation over 2 years • Different acids to different needs • Including possibility to remove scent of acetic acid • Concentrations up to 1.000 ppm t
Slide 10: Wound and Skin care
O02 Wound and Skin care
Slide 11: Chronic wounds, biofilms and antibiotic resistance – a major threat
Chronic wounds, biofilms and antibiotic resistance – a major treath • Chronic wounds impact the quality of life (QoL) of nearly 2.5% of the total population in the United States • Diabetic foot ulcers (DFUs) (30.5%) have a comparable 5-year mortality rate to cancer (31%) • Induces tolerant biofilms
Slide 12: The cost drivers in wound care – infections and lack of wound healing
The cost drivers in wound care – infections and lack of wound healing SoftOx’s synergistic antimicrobial effect Cost of wound care – Medicare2 Creates opportunities to treat different wounds Others Amount of organic material presemt High 8% Diabetic Ulcers infections 37% 15% Medium Total cost ~100 b
Slide 13: Results in treatment of leg ulcers (SBE-01) show >98% reduction in bacterial bioburden
Results in treatment of leg ulcers (SBE-01) show >98% reduction in bacterial bioburden 1.E+08 >98% reduction 1.E+07 1.E+06 Topline results Bacterial burden (CFU/mL) 1.E+05 • Safe and well tolerated 1.E+04 • SBE formulations reduced the absolute 1.E+03 number of bacteria (bacterial burden) in the 1.E
Slide 14: Wound healing observed in several clinical studies
Wound healing observed in several clinical studies Wound Healing SBE Phase 1b) Wound Healing SWIS Confirmative Study 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 i
Slide 15: SoftOx Dental: Unique ability to remove oral biofilm and treat periodontitis
SoftOx Dental: Unique ability to remove oral biofilm and treat periodontitis A new penetrative mouthwash against SoftOx Mouthwash sub-gingival biofilms in the fight Aiding in the preventing disease against periodontitis development steps 2-4 Goal: To replace/remove cosmetic competitors through denta
Slide 16: Animal care – very similar to a human product portfolio
Animal care – very similar to a human product portfolio Pets – ~220 million household dogs and cats in US and Europe Veterinarian pet market Wound care, ears wash, eye cleansers and tooth wash SoftOx disinfectant will improve indoor climate Production animals – ~31 billion animals worldwide Surface
Slide 17: The Wound and skin care drop down 2-3 years plan
The Wound and skin care drop down 2-3 years plan • Finance the new company with a separate funding of Euro 10 million. • Achieve regulatory approval of Medical Device wound cleanser in Europe and US. • Perform Phase 2 for SoftOx Biofilm Eradicator (SBE): • The estimated probability of success is sta
Slide 18: Exit strategy wound care
Exit strategy wound care Valuation and market trends Turnover potential in the US • KWC, fair market value Wound Care MUSD 200 1 200 1 060 Potential profit yearly profit PE 13 on yearly expected net licence fee 1 000 927 795 800 662 • KWC, fair market value will increase up to approx. NOK 4 530 in M
Slide 19: Respiratory care
03 Respiratory care
Slide 20: Early intervention treatment: potential to impact peak viral load and infection duration
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 21: Respiratory care - Treatment and prevention
Respiratory care - Treatment and prevention In vivo Proof of Concept - Post-exposure prophylaxis Co-housing with infected mice & post-exposure Saline Treatment Group prophylaxis with saline or SoftOx DAY 3 SoftOx Treatment Group Index (infected) mouse removed from cohousing on day 3 Uninfected mouse
Slide 22: Respiratory care - dose dependent treatment effect in mice infected with Influenza A
Respiratory care - dose dependent treatment effect in mice infected at day 0 with Influenza A virus Twice daily treatment resulted in lower … and correspondingly higher qPCR viral titres on post-infections days 1 to 3 cycle threshold values (day 3) Infectious viral titres qPCR * ** * * * 1E+09 35 >9
Slide 23: 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 Wound and
Slide 24: EDF/COUNTERACT project
EDF/COUNTERACT project (*) Financed Phase I study (EDF/MOD) Progressing according to plan (2023-2025) Key deliveries: • Optimization of Next generation API (Active Pharmaceutical Ingredient) o Main partner: CR Competence • Testing SIS 2.0 in vitro, in vivo and through different nebulizers and foggin
Slide 25: Pathway to exit
Pathway to exit Acute Exacerbation of COPD prevention Volume: Price: Influenza like-illness** treatment +/- prevention Price erosion compensated by larger Volume: increase in volumes – MNOK 80 - Expected total cost of Proof of Concept in phase 2 opportunity to go OTC Price: Hospital acquired,* venti
Slide 26: Summary
04 Summary
Slide 27: Key takeaways
Key takeaways Targeting a High Proven effect Strong platform $40bn+ profitability Successful clinical trial in humans with great potential for many products/segments market Strong Huge unmet Commercial Collaboration medical need patents Phase outsourced product and no antimicrobial protecting IP dev
Slide 28: Unique solution for eradicating infections and fighting antimicrobial resistance
Unique solution for eradicating infections and fighting antimicrobial resistance Contact Information: [email protected] Euronext Growth ticker: SOFTX
Slide 29: Appendix
Appendix
Slide 30: 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 • Former Counsel & Attorney- • Founder & CEO at CAP Partner business development in Norway at-law, Elopak AS
Slide 31: 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
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