Softox Solutions As · OSL:SOFTX
Softox Solutions As — Investor Presentation (March 2024)
23 slides from Softox Solutions As's investor presentation, March 2024
Slide 1: Helping the World Fighting Infections
Helping the World Fighting Infections SoftOx Solutions AS Investor presentation March 2024 Private & Confidential draft
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: New SoftOx Solutions – Boards recommandation
New SoftOx Solutions – Boards recommandation Splitting SoftOx Solutions AS in two separate companies » Split SoftOx Solutions AS into SoftOx Inhalation Solutions AS and SoftOx Skin and Wound Care Solutions AS, by doing a drop down of the Skin and Wound care business into a daughter company of SoftOx
Slide 4: Helping the world fighting infections
Helping the world fighting infections SoftOx Inhalation Solutions AS Norwegian Pharmaceutical Company March 2024
Slide 5: Why focus on Ventilator associated pneumonia (VAP)
Why focus on Ventilator associated pneumonia (VAP) A severe type of pneumonia occurring for intubated patients at intensive care units (ICU) • Today’s treatment options are costly (USD 6 bn/y US/EU) and have limited effects • Promising study data indicated high probability of success • Moderate admi
Slide 6: 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 7: Project Plan VAP
Project Plan VAP Technology Toxicology & Phase I Preclinical Efficacy Proof of Concept in Humans - Phase 2 Market Adoption
Slide 8: 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 9: 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 10: Complete Toxicology Package
Complete Toxicology Package Test Conformance Standards Document number Summary Status Inhalation safety study of SIS (5 mL x 50, 100, or 200 µg/mL HOCl) daily for five days in Inhalation Study - Intubated (minipigs) NA SIS_EJ_001 SIS_EJ_002 Complete Göttingen minipigs with/without recovery (2-4 week
Slide 11: 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 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 * ‡ • † † † † ‡ ¤ ¤ ¤ ¤ ¤ E-coli Enterococcus hirae Poliovirus Aspergillus brasiliensis Eschericihia coli Candida albicans Staphylococcus aureus Adenovirus
Slide 13: 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 14: Effective treatment of Influenza A in mice
Effective treatment of Influenza A in mice Twice daily SIS-treatment resulted in lower … and correspondingly higher qPCR cycle viral titers on post-infections days 1 to 3 threshold values (day 3) Infectious viral titres qPCR Infectious viral titers qPCR * ** * * * 1E+09 35 >90% reduction 1E+08 30 1E
Slide 15: 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 16: 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 17: Market adoption
Market adoption Patient Hospital Commercial Hospital Acquired Infection • Hospitals must pay the extra Mortality cost themselves – USD 6bn Pathway to market • 10%-30% risk of • No need for reimbursement • Focused Market Segment developing VAP • Easier market penetration • Up to 50% mortality Easy to
Slide 18: Financial Potential
Financial Potential > 160 000 yearly VAP cases US & EU US 93 000 cases1) Value Proposition EU 70 000 cases2) • Reduced hospital costs up to $ 6 bn • Reduced mortality $ 6 bn in extra treatment costs per year • Reduced ICU days US $ 47 000 per patient3) EU $ 30 000 per patient4) Great possibility to
Slide 19: Countermeasures against biological threats
Countermeasures against biological threats Financed by European Defense Fund and Norwegian MoD COUNTERACT* - EU research project to develop medical countermeasures against CBRN threats SoftOx/SIS is the main research target for the biological threats (budget ~90M NOK) Main partners are University of
Slide 20: COUNTERACT program benefits both civil and military SIS development
Further Potential COUNTERACT program benefits both civil and military SIS development Scientific advice input on SIS 2.0 benefits the overall ongoing development of SoftOx's 2nd generation products The COUNTERACT phase 1B trial increases dosing possibilities in future trials on both the civil and mi
Slide 21: 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 22: 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
Slide 23: Key Takeaways
Key Takeaways • Following the contemplated private placement, SoftOx will be debt free and focused on the clinical development plan for VAP ➢ Representing a market with large unmet medical need and high mortality rate ➢ Expect to significantly reduce today’s high cost of treatment (USD 6 Bn) ➢ Well
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