Softox Solutions As · OSL:SOFTX
Softox Solutions As — Investor Presentation (August 2024)
19 slides from Softox Solutions As's investor presentation, August 2024
Slide 1: Helping the world fighting infections
Helping the world fighting infections SoftOx Solutions AS Company Presentation August 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: Today's presenters
Today's presenters Incoming Chairman of Board (COB) Incoming Chief Executive Officer (CEO) Ulrik Spork Prof Thomas Bjarnsholt, PhD & DMSc Civ Ing/MSc (Danish Technical University) MSc (Danish Technical University) Civiløkonom (Copenhagen Business School) PhD (Danish Technical University) Doctor of M
Slide 4: Restructuring Pillars
Restructuring Pillars FINANCIAL RESTRUCTURING & COST FOCUSED STRATEGY PROFESSIONALIZATION REDUCTION
Slide 5: Investment Case
Investment Case • After completing ongoing Rights Issue o No outstanding debt o Secured and professionalized new Board and management and lean and project-oriented organization o Runway to enable funding of the VAP Phase II project • SoftOx Inhalation Solutions / Target Indication Ventilator Associa
Slide 6: SoftOx Solutions Group
SoftOx Solutions Group SoftOx Solutions AS Norway (public) WIAB AB Sweden IP rights SoftOx Skin & Wound Care SoftOx inhalation Solutions SoftOx Defence Solutions No current activities VAP opportunity Medical Counter Measurements To be spun out upon attracting Seeking funding to reach Currently plann
Slide 7: Why start with Ventilator associated pneumonia (VAP)
Why start with Ventilator associated pneumonia (VAP) A severe type of pneumonia occurring for intubated patients at intensive care units (ICU) • Currently limited effectful treatment options, and high mortality rate • Considered to have favorable possibility of clinical success with low study costs
Slide 8: Next Generation Respiratory Antimicrobial Solutions
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) Inhalation ensures deposition where Inhalation of SIS t
Slide 9: Project Plan VAP
Project Plan VAP Technology Toxicology & Phase I (in humans) Preclinical Efficacy Proof of Concept in Humans - Phase 2 Phase 3 Market Adoption
Slide 10: Complete Toxicology Package
Complete Toxicology Package Test Conformance Standards Summary Status Inhalation safety study of SIS (5 mL x 50, 100, or 200 µg/mL HOCl) daily for five days in Göttingen Inhalation Study - Intubated (minipigs) NA Complete minipigs with/without recovery (2-4 weeks) using intubation. Inhalation safety
Slide 11: Phase I trial showed that SIS is safe and tolerable to inhale
Phase I 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
Slide 12: Broad spectrum effect proven in antimicrobial EU Norm tests
Broad spectrum effect proven in antimicrobial EU Norm tests IN VITRO Log reduction achieved EN requirement 6 5 Log reduction (CFU/mL) 4 3 2 1 0 * • ‡ † † † † ‡ ¤ ¤ ¤ ¤ ¤ Enterococcus hirae All enveloped viruses Poliovirus E-coli Aspergillus brasiliensis Eschericihia coli Candida albicans Staphylococ
Slide 13: Effective treatment of Influenza A in mice
Effective treatment of Influenza A in mice Twice daily SIS-treatment resulted in lower viral titers on post-infections days 1 to 3 Infectious viral titres Infectious viral titers * ** * 1E+09 >90% reduction 1E+08 1E+07 1E+06 PFU/g lungs 1E+05 PBS 1E+04 SS0330 1E+03 1E+02 1E+01 1E+00 1 2 3 Day post i
Slide 14: Post-exposure prophylaxis efficacy against Sendai virus in mice
Post-exposure prophylaxis efficacy against Sendai virus in mice Saline Treatment Group Co-housing with infected mice & post- exposure prophylaxis with saline or SIS Infected mouse (determined by IVIS DAY 3 [average radiance ≥ 103 SIS Treatment Group p/s/cm2/sr]) Index (infected) mouse removed from c
Slide 15: Clinical Development Plan (estimated timelines)
Ventilator Associated Pneumonia (VAP) Clinical Development Plan (estimated timelines) 2024 2025 2026 2027 2028 Scenari o Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Phase II Phase II Phase III VAP Preparation VAP Treatment Adaptive run into VAP Regulatory Market treatment Approval Ap
Slide 16: Pathway to market is short and well defined
Pathway to market is short and well defined VAP Patients Hospital Commercial Cases • Annually 130 000 Hospital Acquired Infection US/EU • Hospitals pay – USD 4bn in Pathway to market yearly treatment costs • Easier market penetration Mortality • No need for reimbursement • Targeted sales force • 10%
Slide 17: Countermeasures against biological threats
Countermeasures against biological threats Financed by European Defense Fund and Norwegian MoD COUNTERACT - European agile network for medical COUNTERmeasures Against CBRN Threats SoftOx/SIS is the main research target for the Biological threats (budget ~90M NOK) Main partners are University of Cope
Slide 18: Overall Clinical Development Plan (estimated timelines)
Overall Clinical Development Plan (estimated timelines) 2024 2025 2026 2027 Scenario Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Phase 3* Phase 2 Phase 2 VAP Preparation VAP Treatment Adaptive run into VAP treatment GMP production Phase 2/3* Phase 1B EDF Pre-clinical work & Optimization SIS 2.0
Slide 19: Key take-aways
Key take-aways • Following recent restructuring, SoftOx is now a debt-free company with a well-defined, promising and cost-effective clinical development plan in place • New Board and Management team with strong track record • Target indication VAP represents a significant value potential, while stu
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