Highlights – Q3 2020, including selected information for Q4
(figures in brackets apply to 2019)
➢ Year to date pre-tax results ended 30.9.2020 with a loss of NOK 29 million (loss of NOK 15 million). Results are characterised by high levels of activity in research and development in addition to preparatory work ahead of the launch of our disinfectants in new markets
➢ Clinical study of the SoftOx Wound Irrigation Solution (SWIS) was approved and has commenced
➢ The Danish Medicines Agency recommended further development of the SoftOx Inhalation Solution (SIS) for the treatment of respiratory infections, including COVID19
➢ The US Department of Defence (DoD) awarded SoftOx app. USD 2 million for the research and development of the SoftOx Biofilm Eradicator (SBE). SoftOx considers the 2 funding and support from one of the world’s leading research organisations as a great honour
➢ SoftOx has been awarded conditional certification of its disinfectants in the EU as of December 10th. The Swedish Chemicals Agency has processed and recommended SoftOx Solutions’ disinfectants, including AntiVir, for certification. This opens the possibility for certification in all EU member states
➢ On 16 June 2020, the Biocidal Products Committee (BPC) of ECHA recommended that the EU create a separate class for active chlorine from hypochlorous acid. In order to operate in line with the new European guidelines and after a dialogue with the Norwegian Environment Directorate, it was decided by SoftOx to withdraw and change the label on the products sold before the EU change took place. The practical consequence is that SoftOx chose to take back products for approximately NOK 1 million to ensure correct labeling. This decision will reduce revenues in the Q4. Except of this, the Q4 will end relatively similarly to the Q3.
Highlights – first half 2020, including selected information for Q3
(figures in brackets apply to 2019)
➢ Pre-tax results ended with a loss of NOK 17 million (minus NOK 9 million). Profits have been affected by costs related to increased production capacity in Norway and several parallel development projects.
➢ As a result of the COVID-19 epidemic, SoftOx has accelerated its launch of disinfection agents. In the first quarter of sales (Q2) we sold for impressive nearly NOK 5 million. Sales in Q3 have been affected by the restructuring of distribution and we experienced that a number of potential customers had already filled up their stocks in Q2. We expect lower sale in Q3, compared to Q2.
➢ Throughout the year, the company has completed additional clinical studies that document that AntiVirTM hand disinfectant is just as skin-friendly as salt water and more skin-friendly than alcohol.
➢ The company has completed accredited (EN) virus tests that have showed very strong virucidal (anti-virus) effects of AntiVirTM.
➢ The Danish Medicines Agency approved SoftOx’s clinical study for its SWIS-02 wound irrigation product.
➢ In Q1 The University of Copenhagen started inhalation studies on pigs where the animals inhaled different concentrations of SoftOx. A prerequisite for the inhalation studies was that the studies could be performed without serious side effects for the pigs. The company has previously proved that the SoftOx solution deactivates all known viruses, including enveloped coronavirus.
➢ In Q3, the company announced the results of inhalation studies on pigs. The results were very promising and SoftOx is excited about the potential for developing the company’s technology into a treatment for respiratory infections, including COVID-19 patients. The results indicate that we have found ‘safe’ concentrations that do not damage the airways, while simultaneously showing a sufficient antimicrobial effect to deactivate viruses.
➢ The company has decided to apply for accelerated development of an inhalation drug for the treatment of COVID-19. An initial meeting with the Danish Medicines Agency in Denmark has been agreed in the beginning of October.
➢ Received a tentative grant of USD 2 million from a US government institution for the development of SoftOx’s infection remover (SBE), a treatment of chronic wound infections.
➢ Completed GLP studies on the SoftOx’s infection remover (SBE). The study showed good results on tolerance and toxicity for what the company regards as sufficient doses to eradicate difficult infections in chronic wounds.
Highlights for the 1st quarter of 2020
➢ The first production line for the SoftOx disinfectant was successfully established.
➢ SoftOx hand disinfection showed full virucidal effect for all types of viruses.
➢ Presafe, SoftOx` Notified Body, received approval from EU.
➢ Research, to explore possible effects on infections in the respiratory tract, was started up March 30th at the University of Copenhagen.
➢ The Research Council of Norway awarded NOK 2.4 mill to a doctoral scholarship to develop second generation SoftOx.
➢ Innovation Norway awarded SoftOx a NOK 6 mill loan for an additional production line.
➢ SoftOx launched the brand “Antibac alcohol free hand disinfection – powered by SafeDes” together with Kiiltoclean/Antibac.
Highlights for the Annual Report 2019
➢ Completed our first clinical trial.
➢ Signed an distribution agreement with VESO, one of Norway’s largest companies for Animal Health.
➢ Signed an distribution agreement with KiiltoClean AS.
➢ Private placement completed and accepted by GA.
Highlights for the 4th quarter of 2019
➢ The first- in-human clinical trial of the wound rinsing product, SWIS, was completed and the results were reported in the final study report.
➢ Signed distribution agreement with VESO, Norway’s leading supplier of vaccines and medicines for animal health, as a part of the animal health line, in November of 2019.
➢ The company raised NOK 75 million (information regarding the placement has been published). The share issue was approved by the General Assembly on December 20, 2019.
➢ SoftOx was granted the tax incentive provision “Skattefunn” for its research projects, for the upcoming three years.
Highlights for the 3rd quarter of 2019
➣ The First- in-human clinical trial of the wound rinsing product, SWIS, has been completed and the final results have been reported (see below for further details.)
➣ Signed distribution agreement with KiiltoCleanAS (former Antibac) for our hand disinfectant in the Scandinavian market, in September 2019.
➣ Signed distribution agreement with VESO, as a part of animal health line, in November 2019.
➣ The company has raised 75 million NOK (information regarding the placement has been published) The share issue was approved by the general assembly the 20th of December 2019.
➣ The European Union’s new regulation regarding approval of medical devices (MDR= Medical Device Regulation (EU)2017/745) will take effect May 2020. This is expected to affect the speed of SoftOx development of medical devices.
➣ SoftOx was granted the tax incentive provision “Skattefunn” for research projects, for the upcoming three years.Skattefunn is under reconstruction from the Norwegian government, with rather unclear rules. However, the company finds it likely that it will fulfill the requirements for future and past payments from Skattefunn.
Highlights for the 1st half year including some relevant information from the 3rd quarter of 2019
➢ The enrollment of patients of the Firstin-human clinical trial of the wound rinsing product, SWIS, is completed. The data is under analysis and will be publicly announced in 4th quarter of 2019. The full study results ill be published in peer reviewed scientific journal.
➢ Signed distribution agreement with KiiltoClean AS (former Antibac) for our hand disinfectant in the Scandinavian market.
➢ The European Union’s new regulations for approval of medical devices (MDR= Medical Device Regulation (EU)2017/745), which shall be implemented from 1st of May 2020, require new approval of Notified Body. Our Notified Body has not yet been approved as Notified Body under the new regulations and delays may be expected in the registration process of SoftOx Wound Irrigation Solution (in Europe.)
➢ The company is planning a share issue in the 4 th quarter of 2019. The company has, with assistance from the largest shareholders, established a short-term bank credit facility to bridge this share issue.
Highlights for the 1st quarter of 2019
➢ First clinical study of SoftOx Wound Irrigation Solutions (SWIS) in humans at Bispebjerg University Hospital in Copenhagen is ongoing. The study is progressing with a slight delay, with more than 50% of the patients enrolled, and is expected to be completed in Q3-2019.
➢ Negotiations are ongoing with a potential distributor for our hand disinfectant in the Scandinavian market.
➢ The European Union is undergoing regulatory transition, regarding approval of medical devices (MDR= Medical Device Regulation (EU)2017/745), which will be implemented from 1st of May 2020. The company’s assigned Notified Body has not been accredited as of yet to evaluate new applications according to new regulations, yet simultaneously stopped accepting applications in accordance with previous (MDD= Medical Device Directive) requirements. In line with this, SoftOx may experience delays in the registration process of SoftOx Wound Irrigation Solution in Europe.
➢ The planned share issue (spring 2019) took place in late 2019, in accordance with delays in the clinical development process.
Highlights for the Annual Report 2018
➢ Documented preclinical safety and efficacy in animal models to further initiate clinical testing of the first product, SoftOx Wound Irrigation Solution (SWIS), in human surgical wounds
➢ SoftOx Solutions AS made a capital increase at the end of 2018 which was completed in January 2019 of just over NOK 18 million
➢ Public funding for R&D was NOK 4.3 million, of which NOK 4.1 million from the Research Council and NOK 200,000 from Horizon 2020
➢ SoftOx expects a delay in the approval of its first Medical Device in Europe, a clarification can unfortunately be expected in January 2020 at the earliest
Highlights for the 4th quarter 2018
➢ SoftOx successfully raised NOK 18 million in new share capital in Q4-2018. The share issue was originally NOK 15 million, however, the board decided to accept all subscriptions totaling NOK 18 million. The funds will be used to conclude the first clinical trial and for general corporate purposes.
➢ The first clinical study of SoftOx Wound Irrigation Solutions (SWIS) in humans was started at Bispebjerg Hospital/ Rigshospitalet København, and the first patient was treated in December 2018. The clinical study is progressing with more than 50% of the patients now enrolled by medio March 2019.
➢ The biocidal- registration- application for the family of SoftOx disinfectants was submitted December 2018 according to the new 2019 Biocidal Products Regulations (BPR) for market approval in the Norwegian, Swedish and Danish market.
➢ The SoftOx- hand -disinfection- patentapplication has been expanded geographically to cover Europe, North America and certain South American and Asian geographies in addition to the original US application.
➢ Negotiations with Antibac (newly sold to KiiltoClean) are ongoing.
Highlights for the 3rd quarter 2018
➢ Approval from the Danish Competent authorities to start clinical study of SoftOx Wound Irrigation Solutions (SWIS) in humans at Bispebjerg Hospital/ Rigshospitalet København.
➢ The first part of the clinical study is performed to test if SoftOx is safe to be used in humans. The first patient is enrolled.
➢ SoftOx Composition Patent approval in the U.S.
➢ Biocidal registration process initiated for SoftOx disinfection product family, for market approval in the Norwegian, Swedish and Danish market from 2019.
➢ Letter of intent signed with Antibac AS for negotiation of distribution and development agreement of SoftOx disinfection products in Norway, Sweden and Denmark.
Highlights for the 2nd quarter 2018*
➢ Finalized preclinical studies of SoftOx Wound Irrigation Solution (SWIS) according to ISO-10993-series.
➢ Successfully finalized an equine wound treatment study on horse legs, showing no harmful effects of SoftOx Wound Rinse in addition to significant reduction in bioburden and favorable results for wound improvement.
➢ Applied to the Danish Medicines Agency and Ethical committee for permission to start clinical investigation of SWIS.
➢ Established a quality assurance system ISO 13485 accordance with requirements for medical device class III, rule 13 [ref: Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices, Version 1.18 (12-2017)].
➢ Listed on the Merkur list at the Oslo Stock Exchange 1st of June.
➢ Performed a 1:50 stock split 2nd of July.
➢ Became member of the “The World Health Organization Collaborating Centre on Patient Safety Infection Control & Improving Practices”.
* Includes also relevant information from 3rd quarter.
Highlights for 1st quarter 2018*
➢ Public funding of NOK 16 million over four years from Norwegian Research Council to develop SoftOx Biofilm Eradicator.
➢ Public funding from EU – Phase I, Horizon 2020 programme to develop a business plan for SoftOx’ Wound Irrigation Solution. Grant EUR 50.000,-.
➢ Finished Biocompatibility studies on SoftOx’ Wound Irrigation Solution.
➢ Finished toxicity study for SoftOx’s technology in pigs. No delay in wound healing compared with saline water.
* Includes also some relevant information from 2nd quarter.
Financial Statements 2017
➢ The Board’s report
➢ Income statement, parent company
➢ Balance sheet, parent company
➢ Income statement, group
➢ Balance sheet, group
➢ Cash flow, parent company
➢ cash flow, group
➢ Accounting principles