Softox Solutions As · OSL:SOFTX
Softox Solutions As — Investor Presentation (April 2024)
26 slides from Softox Solutions As's investor presentation, Apr 18, 2024
Slide 1: Helping the World Fighting Infections
Helping the World Fighting Infections SoftOx Solutions AS Norwegian Pharmaceutical Company Presentation of “New SoftOx” 18 April 2024
Slide 2: Today's Speakers
Today’s Speakers Executive Chairman of Board, Co-inventor Geir H. Almås MSc in business administration (BI) and State authorized public accountant (NHH) Extensive experience from business development Previously PwC and KLP Asset Management Chief Scientific Officer, Co-inventor Prof Thomas Bjarnsholt
Slide 3: 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 4: The "New SoftOx" restructuring after refinancing of company
The “New SoftOx” restructuring after refinancing of company The Board suggest to split SoftOx Solutions AS in two separate companies » SoftOx Solutions AS is separated into SoftOx Inhalation Solutions AS and SoftOx Skin and Wound Care Solutions AS by doing a drop down of the Skin and Wound care busi
Slide 5: Investment Highlights – SoftOx Inhalation Solutions AS
Investment Highlights – SoftOx Inhalation Solutions AS Following the recent private placement and conversion of debt, listed SoftOx will be a debt free project- oriented company with a slim organization and a well-defined clinical development plan ✓ Target indication Ventilator Associated Pneumonia
Slide 6: Helping the world fighting infections
Helping the world fighting infections SoftOx Inhalation Solutions AS Norwegian Pharmaceutical Company April 2024
Slide 7: 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 8: 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 9: Project Plan VAP
Project Plan VAP Technology Toxicology & Phase I (in humans) Preclinical Efficacy Proof of Concept in Humans - Phase 2 Market Adoption
Slide 10: Reinforcing nature's own ability to eradicate unwanted microbes
SoftOx technology Reinforcing nature’s own ability Strong pan-spectrum to eradicate unwanted microbes antimicrobial (virucidal/bactericidal) effects Not shown to induce antimicrobial resistance HYPOCHLOROUS ACID Documented broad Good safety and antimicrobial effect tolerability profile – no systemic
Slide 11: Medical Grade Stabilized HOCl
Managed to solve Medical Grade Stabilized HOCl Competitors' product profile Unacceptable toxicity SoftOx product profile gives • Dose optimization within designated therapeutic HOCl SoftOx window therapeutic window • Stability - less than 5% degradation over 2 years • Robust Patent Protection > 90 g
Slide 12: 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 13: Phase 1 trial showed that SIS is safe and tolerable to inhale
Phase 1 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 14: 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 * ‡ • † † ‡ † † ¤ ¤ ¤ ¤ ¤ Staphylococcus aureus Murine norovirus E-coli Enterococcus hirae Poliovirus Aspergillus brasiliensis Eschericihia coli Candida alb
Slide 15: Strong antibiofilm activity of SIS against pulmonary pathogens
Strong antibiofilm activity of SIS against pulmonary pathogens P. aeruginosa (Gram negative) S. aureus (Gram positive) * ** Biofilm (red) in sputum from pneumonia patient. P. aeruginosa and S. aureus are among the most common pathogens in VAP and often present as biofilms Data on file. SIS at variou
Slide 16: Effective treatment of Influenza A in mice
Effective treatment of Influenza A in mice Infectious viral titers 1E+09 * ** * 1E+08 >90% reduction 1E+07 1E+06 PFU/g lungs Placebo 1E+05 SIS 1E+04 1E+03 1E+02 1E+01 1E+00 1 2 3 Day post infection Twice daily SIS treatment resulted in lower viral lung titers on post-infection days 1-3
Slide 17: 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 18: Clinical Development Plan (estimated timelines)
Ventilator Associated Pneumonia (VAP) 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 Regulatory Market Study Costs MNOK 25 (*) Approval
Slide 19: Market adoption
Market adoption Patient Hospital Commercial Hospital Acquired Infection Mortality • Hospital costs – USD 4bn Pathway to market • 10-30% risk of • No reimbursement • Easier market penetration developing VAP • Smaller sales force Easy to implement – ICU • Build market share • Up to 50% mortality • Hea
Slide 20: Financial Potential
Financial Potential > 130,000 yearly VAP cases US & EU US: 60,000 cases1) Value Proposition EU: 70,000 cases2) Reduced hospital costs up to USD 4 bn Reduced mortality USD 4 bn in extra treatment costs per year Reduced ICU days US: USD 47,000 per patient3) EU: USD 30,000 per patient4) Significant pot
Slide 21: 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 22: EDF project market potentials
EDF project market potentials We expect 3-years stockpiling within NATO + partner countries ~1 M soldiers Military (NATO + partners) stockpiling ~1 Bn civilians Civil (NATO + partners) stockpiling If successfully developed, the product is expected to be directly purchased by the military forces EDF
Slide 23: 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 Regulatory Market Approval Approval Study Costs MNOK 25 GMP** production Phase 1
Slide 24: Key Takeaways
Key Takeaways • Following the recent refinancing, SoftOx is a debt free company with a well-defined clinical development plan and a clear market pathway ✓ SIS for treatment of VAP answers to a large unmet medical need with high mortality rate ✓ Modest clinical development costs due to well defined u
Slide 25: Summary of risk factors 1:2
Summary of risk factors 1:2 Specific to the market in which SoftOx operates Specific to the industries in which SoftOx operates • The Company relies on various partnerships for • Pharmaceutical investments are speculative, with development, production, and distribution, and any failure to substantia
Slide 26: Summary of risk factors 2:2
Summary of risk factors 2:2 Key risks specific to financial risks Key risks related to laws and regulations etc. • The Company's success hinges on its ability to commercialize • The Company may become subject to new or product candidates, which involves numerous challenges increased burdensome gover
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