SoftOx : Open and Download Complete First Quarter 2022 Report

Quarterly Report

Q1 2022

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 Oslo. The SoftOx Solutions Group includes the holding company SoftOx Solutions AS, the Malmö and Copenhagen subsidiaries, and subsidiaries SoftOx Defense Solutions AS and SoftOx Disinfection AS. SoftOx has developed a highly effective antimicrobial solution which eradicates and prevents 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 quarter 2022 and subsequent events

(Figures in brackets are comparable figures for 2021)

•  The first-in-human clinical study for the SoftOx Inhalation Solution (SIS) for the treatment of respiratory tract infections is progressing as planned and the last subject last visit was completed in April.

•  The first-in-human clinical study for the SoftOx Biofilm Eradicator (SBE) for infections in chronic wounds has improved its enrolment of patients and has completed the three first dose-level cohorts and advanced to the fourth dose-level.

•  The Company has finalised and submitted the Premarket Notification (510(k)) application to obtain clearance by the US Food and Drug Administration (FDA) for SoftOx Wound Irrigation Solution (SWIS) as a medical device class II in the US market.

•  Q1 pre-tax results ended with a loss of NOK 24,3 million (loss of 22,5 million). Results are characterized by high levels of activity in research and development.

•  The Company has started to deliver disinfection products to Hospital Purchasing (HINAS) in Norway and other companies within and outside the health sector.

Key figures for the SoftOx Solutions Group (SoftOx) as of 31.03.2022

A statement from CEO Geir Almås

(Further details are also given later in the report)

Geir Almås, Chief Executive Officer of SoftOx Solutions, commented:

"It has been a productive first quarter of 2022 as we await the results of our two phase I trials, and at the same time, the commercial team is holding ongoing talks with international players for potentially entering partnerships for both our disinfection and wound care products.

SoftOx has achieved a major milestone with the completed enrolment of the SIS phase 1 trial (SIS-01) and the SBE phase 1a single ascending dose study (SBE-01a) is soon to follow. This accomplishment may mark SoftOx's transition from a medtech company to a biotech company. The objective of the SIS-01 study is to determine the safety and tolerability of inhaled nebulised SIS in healthy subjects, and the results of the study will determine the optimal dose. The SBE-01 study aims to determine the optimal concentration and dosing schedule for treating patients with chronic wounds with SBE. Positive results from these studies will allow the clinical development to proceed to phase 2 studies which will determine the therapeutic efficacy.

We have also made a big step forward in the regulatory process with the submission of the 510(k) application for US FDA clearance of SoftOx Wound Irrigation Solution (SWIS). The clearance of this application would allow for SWIS to be marketed and sold in the US as a medical device. The clinical development of our medical device and pharmaceutical drug products is off to a promising start in 2022.

When the COVID-19 pandemic began, SoftOx entered the disinfection market to satisfy an unmet need for an alternative to alcohol-based disinfectants. In 2021, we achieved proof of sales with the Norwegian and Swedish tender wins. In Q1, we are working to fulfil the conditions of the purchasing tenders and sell to customers in Sweden and Norway. Our long-term strategy is to find suitable partners for selling our disinfection line internationally. We are optimistic in the ongoing conversations with international partners for both our wound care line and our disinfection line, where 5 to 10 prospective international partners have signed NDAs or are in progress of doing so. We look forward to the new possibilities and achievements of this exciting year".

Geir Hermod Almås, Chief Executive Officer

Product development methodology

Figure 1. SoftOx product pipeline

Platform technology

In collaboration with leading scientific teams, SoftOx has discovered a unique synergetic effect of two natural components, proven to be well tolerated by both humans and animals. The SoftOx technology reinforces nature's ability to eradicate unwanted microbes through the combination of hypochlorous acid, which has a well-documented antimicrobial effect, and acetic acid, acting as the antimicrobial stabiliser. This unique technology is protected by a robust patent portfolio which provides multiple degrees of freedom to expand into new therapeutic applications. SoftOx has filed 84 patents worldwide, of which 58 are granted addressing formulations, uses, methods of making and devices.

The SoftOx technology has proven strong antimicrobial effects on various bacterial species (including multidrug-resistant bacteria and those embedded in biofilms), fungi, spores and viruses. Importantly, the Company's research has also determined that this novel solution does not induce microbial resistance.

The safety profile and the antimicrobial efficiency of the technology make it acceptable for multiple applications with the aim of preventing and removing infections. After thorough and successful laboratory and animal experiments, SoftOx has now entered the clinical phase with several product leads, including i.e., topical wound and inhalation treatments. There are currently four base products under development - wound irrigation solution, chronic wound treatment, inhalation treatment and hand and surface disinfectant - yet the platform technology lends itself to possibilities of numerous applications and uses.

Business development

SoftOx Solutions is a medtech and biotech company that is exploring opportunities for its patented technology in various segments. As a research and development company, SoftOx is currently developing biocides, medical devices and pharmaceutical drugs, and the Company is responsible for progressing projects to achieve the proof of concept or proof of sales stage where it is suitable to be taken over by partners. For biocides and medical devices, SoftOx will develop its products until proof of sales is achieved. Pharmaceutical drugs, including SBE and SIS, are developed by SoftOx until proof of concept is achieved.

Operational update in first quarter 2022

Research and product development

WOUND CARE

SoftOx Wound Irrigation Solution (SWIS):

SWIS is a medical device intended for acute wounds, developed to rinse wounds to prevent infections and biofilm formation. Based on the clinical evidence generated on safety and effect, the goal of the Company is to replace today's wound rinsing products with SWIS as a low-risk product with added beneficial properties.

The final confirmatory clinical investigation (SWIS-02 trial) was completed in 2021. The SWIS-02 study showed both significant improvement in wound healing and reduction in bacterial burden compared to Normal Saline (NS), positioning the product as superior to today's market leaders. The results of SWIS-02 have been summarized into a manuscript which recently has been accepted for publication later this year in the international medical journal, Acta Dermato-Venereologica. The study has also been reviewed by the European Wound Management Association (EWMA) Scientific Committee and accepted for oral presentation at the EWMA-CICA 2022 Conference in Paris, 23-25 May.

Furthermore, the Company is working diligently on establishing a Good Manufacturing Practice (GMP) pilot facility at Fornebu, setting up a quality management system (QMS) and developing the final design dossier to be sent to a Notified Body and Competent Authority for approval of SWIS as a medical device in Europe. Establishing a high-quality GMP production facility at SoftOx will add value for all future research projects within the medical device and pharmaceutical development areas.

SWIS is expected to be SoftOx's first CE-marked product for the European market. For the US market, SoftOx has finalised and submitted the Premarket Notification (510(k)) application to the US FDA to obtain clearance for SWIS as a medical device class II. A 510(k) clearance is an important step towards market access and would confirm that SWIS is as safe and effective as an equivalent device already on the US market. Getting closer to a US approval leads to possibilities in relation to current discussions with distribution partners.

SoftOx Biofilm Eradicator (SBE):

SBE functions as an infection treatment primarily in chronic wounds and is designed to have a therapeutic effect by penetrating and killing microbes within biofilms. The formula penetrates deep into the wound bed, yet it is non-toxic and safe to use, based on animal studies. SBE's strong, broad-spectrum antimicrobial effect also kills antibiotic resistant bacteria and does not induce new resistance which ultimately may lead to reduced use of antibiotics and fewer antimicrobial-resistant microbes. Studies have shown that antimicrobial resistant bacteria are found in more than 50% of chronic wounds.1

SoftOx hypothesizes that SBE can prevent and eradicate biofilms both on the wound surface and deep in the wound bed to reduce the probability of recurrence and pave the way to faster wound healing. As reported previously, the initial recruitment of patients for the first-in-human phase 1

1 Trivedi, U., Parameswaran, S., Armstrong, A., Burgueno-Vega, D., Griswold, J., Dissanaike, S., & Rumbaugh, K. gP. (2014). Prevalence of Multiple Antibiotic Resistant Infections in Diabetic versus Nondiabetic Wounds. Journal of pathogens, 2014, 173053.https://doi.org/10.1155/2014/173053 4