Q2 and

half year report

H1 2022

SOFT-OX.COM/FINANCIAL-CALENDAR-REPORTS/

FIRST HALF YEAR 2022 REPORT

SoftOx Solutions AS is a medtech and biotech company listed on Euronext Growth Oslo with ticker 'SOFTX'. SoftOx Solutions AS was founded in 2012 and is headquartered in Fornebu. The SoftOx Solutions Group includes the holding company SoftOx Solutions AS, the Malmö and Copenhagen subsidiaries, and the subsidiaries SoftOx Defense Solutions AS and SoftOx Disinfection AS. SoftOx is developing a highly effective antimicrobial solution which will eradicate and prevent biofilm, viral and antimicrobial resistant infections. The technology is based on years of research and development in partnership with leading Nordic research institutes and is protected by patents.

Highlights for the first half of 2022 and subsequent events

(Figures in brackets are comparable figures for corresponding periods in 2021)

  • Through its subsidiary SoftOx Defense Solutions (SDS), SoftOx was granted approx. NOK 97 million from the European Defence Fund to develop an inhalation solution for the armed forces within the EU and its allies. SDS is a part of a pan-European consortium of 20 international R&D and industry partners from 10 nations, which will develop military medical countermeasures (MCMs) against chemical, biological, radiological and nuclear threats.
  • In May, SoftOx announced that the Phase 1 study, SIS-01, which evaluated the safety and tolerability of the SoftOx Inhalation Solution, had met its primary objective in healthy subjects (NCT05188638).
  • The positive results of the SWIS-02 study demonstrating improvement in wound healing and reduction in bacterial burden compared to Normal Saline was published in the peer- reviewed journal Acta Dermato-Venereologica (DOI: 10.2340/actadv.v102.1624).
  • The Norwegian Defence Research Establishment (FFI)'s field experiment in Hemsedal evaluating non-alcohol disinfectants, including SafeDes+, SoftOx's alcohol-free hand disinfectant, showed that alcohol-free disinfectants reduced the level of volatile organic compounds (VOCs) in the air when compared with alcohol disinfectants.
  • In May, SoftOx presented the results of the SWIS-02 study and hosted a symposium entitled "Future practical solutions for fighting antimicrobial resistance in wound care" at the European Wound Management Association conference in Paris.
  • SoftOx submitted a Premarket Notification (a 510(k) application) to obtain clearance by the US Food and Drug Administration (FDA) for the SoftOx Wound Irrigation Solution (SWIS) to be used as a Class II medical device in the US.
  • For the second quarter, pre-tax results amounted to a loss of NOK 20.6 million (loss of 22.2 million). The financial results are characterised by high levels of research and development activity in the period.
  • SoftOx entered into a loan agreement of NOK 15 million with Almhaug Bolig AS, where the main shareholder is one of the shareholders in SoftOx.

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FIRST HALF YEAR 2022 REPORT

Key figures for the SoftOx Solutions Group (SoftOx)

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FIRST HALF YEAR 2022 REPORT

CEO statement

During our Capital Markets Day in November last year, we delivered some bold and ambitious statements on what the company is aiming to achieve in the coming years. Over halfway into 2022, I am proud to report on the significant progress made in our clinical and commercial development to achieve these goals, such as demonstrating proof of concept and identifying the best partners to advance our pipeline. In the past six months, the SoftOx team and technology platform have proven their uniqueness.

In a period characterised by increased clinical trial and regulatory activities, we completed the SIS- 01 study, which reached its primary objective of safety and tolerability in healthy subjects. We also completed the single-ascending dose phase of the SBE-01 study, which is nearing completion of the final half of the study.

In May, the European Wound Management Association (EWMA) conference in Paris provided an international platform and audience for the SoftOx team to present our technology and exchange ideas with global wound care experts. As part of the conference, we hosted a symposium entitled "Future Practical Solutions for Fighting Antimicrobial Resistance in Wound Care", which breaks down the significant potential of our technology in the fight against antimicrobial resistance.

Our presence at the EWMA conference has brought attention to our technology from several prominent market players and sparked exciting discussions amongst peers. As for the wound segment, SWIS and SBE, we are discussing potential partnerships and have signed non-disclosure agreements with several large international players.

The SBE product targets the unmet need to remove infections in venous leg ulcers, a problem estimated by EXCITE International and MedValue to cost the healthcare system in the United States USD 1.5 billion per year, which is an amount assumed to be in the same range in Europe. As a result of the interest from international players, the commercialisation process for SBE was initiated ahead of schedule. Though these processes tend to be time-consuming, especially in the early stages, the interest shown from relevant potential parties is intriguing and worthwhile for allocating internal resources to pursue.

Following this eventful second quarter and half year, we were delighted to announce in July the positive feedback on our European Defence Fund (EDF) application and the award of approximately NOK 97 million to develop a military inhalation solution for the European Union and its allies. The Norwegian Ministry of Defence (FD) and SoftOx will jointly cover approximately 10 percent of the awarded funding, and the FD has guaranteed to co-finance an additional 40 percent of the Norwegian contribution. The project is in the grant agreement negotiation phase, and the final grant agreement is expected to be signed by the end of the year.

The EU Commission stated the following in the publication of the grant decision:

"The project "European agile network for medical COUNTER measures Against CBRN Threats" (COUNTERACT) aims to establish a robust and agile network within the EU to be capable to develop and deploy medical countermeasures (MCMs) against major Chemical-Biological-Radiological and Nuclear (CBRN) threats such as terror plots, nuclear accidents, weapon developments and epidemics caused by emerging or re-emerginghigh-consequence pathogens. COUNTERACT will increase EU preparedness for immediate response to such threats."1

  • European Union (2022). COUNTERACT.https://defence-industry-space.ec.europa.eu/system/files/2022-07/Factsheet_EDF21_COUNTERACT.pdf

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FIRST HALF YEAR 2022 REPORT

Knowing that our SoftOx technology and team have been carefully selected by the EU commission to develop medical countermeasures to CBRN threats is a testament to our cutting-edge expertise. It confirms the innovativeness and robustness of our platform technology and, importantly, provides a significant partner to further the development of SoftOx's inhalation solution.

By participating in an international consortium of 20 R&D and industry partners, we are part of a network and scientific partnership that can help advance our clinical trial efforts.

Moving forward, we will work hard to achieve future EU grants for later stages of our product development to elevate the subsequent phases to commercialisation. These efforts are pursued with the clear goal of being the solution the EU and its military partners need to ensure readiness for future pandemics and CBRN threats.

Based on this achievement, the company is looking into aligning the civil development of its Inhalation Solution with the military development to maximize the synergies between the two projects. Through this strategic change, SoftOx estimates that this development cooperation can double the potential sale of SoftOx inhalation solution, together with establishing a centralised distribution model for the military solution.

Moving into the second half of 2022, our priority remains focused on delivering on our ambitious goals, advancing the clinical development and finding the right partners for our projects."

Geir Hermod Almås, Chief Executive Officer

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SoftOx Solutions AS published this content on 15 August 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 15 August 2022 05:42:03 UTC.