SoftOx Solutions AS

Climate Impact & Sustainability Data (2022, 2023)

Reduced chemical and chlorine use by 99% in disinfection products while maintaining antimicrobial effects.
Promoting the use of online meetings to reduce CO2 footprint

Maintained a positive work environment with no work-related injuries.
Employs 56% women and 44% men, representing 7 different nationalities.
Promotes equal opportunities and prevents discrimination.
SoftOx Disinfection (hand and surface disinfection): Delivered disinfection products to Hospital Purchasing (HINAS) in Norway and other companies within and outside the health sector.
Final approval received on biocidal products application for hand and surface disinfection from the Swedish Chemicals Agency (KemI) which allows SoftOx to sell disinfection products in Sweden outside the healthcare segment.
SoftOx Biofilm Eradicator (SBE): The SBE-01 Phase 1 study confirmed safety and tolerability in patients with chronic leg wounds and provided indications of clinical efficacy with dose dependent reductions in bacterial burden and wound size (NCT05710094).
SoftOx Inhalation Solution (SIS): Phase 1 study, SIS-01, which evaluated the safety and tolerability of the SoftOx Inhalation Solution, met its primary objective in healthy subjects (NCT05188638).

Compliance with Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP), Good Clinical Practice (GCP), Good Clinical Laboratory Practices (GCLP), and Good Manufacturing Practice (GMP).
Compliance with relevant regulations from Norwegian Medicines Agency (NoMA), European Medicines Agency (EMA), and US Food and Drug Administration (FDA).
Adherence to ethical and scientific principles in preclinical and clinical trials.
Regular site monitoring visits to ensure compliance with study protocols.
Reporting of adverse events to regulatory authorities and ethics committees.
Publication of trial results in peer-reviewed journals and clinical trial registries.

Short-term Goals:

High risk inherent in medtech and pharmaceutical product development (clinical trial outcomes, timelines, program changes).
Commercial risks (development time and costs, market competition, regulatory approvals, patent protection, partner attraction).
Market risk (marketing approvals, manufacturing and supply, commercial infrastructure, product acceptance).
Collaboration and partnership risks (sustaining successful partnerships with suppliers, CROs, distributors, marketing partners, customers, licensees).
Intellectual property rights protection.
Attracting, training, and retaining talent.
Liquidity risk (postponement of EDF payment, Silicon Valley Bank collapse, difficulty raising funds).

Appropriate measures to mitigate risks in clinical studies (best practices, international regulations, CROs, world-class partners).
Ensuring sufficient patent protection (external patent counsels).
Forming partnerships with leading companies (financial and R&D expertise).
Evaluating unmet market needs and willingness to pay (collaboration with KOLs).
Partner strategy (finding the right partner at different development levels).
Compensation scheme and flexible work environment to attract and retain talent.
Cost cutting, raising cash, closing SoftOx Solutions AS Denmark, and signing an agreement with creditors to extend runway.

Outsourcing production and distribution to selected vendors fulfilling internal and external requirements.

SoftOx aims to be a workplace whose policy is to promote equal rights and opportunities and prevent any kind of discrimination based on gender, ethnicity, nationality, sexual orientation, ancestry, or religion. SoftOx is working actively to promote the Anti-Discrimination Act.
No accidents or injuries resulting in absence were registered in 2023.

SoftOx is committed to Good Corporate Governance
The board of directors has established a set of governance principles to ensure a clear division of roles between the board of directors, the executive management, and the shareholders.

SoftOx experienced serious financial challenges in 2023.
In Q2/2023 the Company was forced to temporarily lay off employees and start reducing the workforce.
During 2023 the Company has prepared for a financial restructuring.

A new strategy to change the company was developed.
The running costs were minimized, and the research and development programs were paused/narrowed down.
The R&D and production facilities at Fornebu closed, and the activities were outsourced to partners in Sweden.
The financial restructuring is expected to be completed in the first half year of 2024.
In March/April 2024 the company strengthened its solidity by converting approximately NOK 90 million in debt to owners’ capital and raising a total of NOK 25 million in fresh capital.

Frameworks Used: NGAAP