View Future GrowthSoftOx Solutions 過去の業績過去 基準チェック /06SoftOx Solutionsは19.2%の年平均成長率で業績を伸ばしているが、Pharmaceuticals業界はgrowingで8.8%毎年増加している。売上は成長しており、年平均4.3%の割合である。主要情報19.16%収益成長率30.59%EPS成長率Pharmaceuticals 業界の成長7.33%収益成長率4.31%株主資本利益率-47.11%ネット・マージン-69.39%次回の業績アップデート27 May 2026最近の業績更新お知らせ • May 27+ 1 more updateSoftOx Solutions AS to Report Fiscal Year 2025 Results on May 27, 2026SoftOx Solutions AS announced that they will report fiscal year 2025 results on May 27, 2026お知らせ • Dec 18+ 4 more updatesSoftOx Solutions AS to Report Fiscal Year 2025 Results on Jun 10, 2026SoftOx Solutions AS announced that they will report fiscal year 2025 results on Jun 10, 2026お知らせ • Jan 25+ 5 more updatesSoftOx Solutions AS to Report Fiscal Year 2024 Final Results on Jun 18, 2025SoftOx Solutions AS announced that they will report fiscal year 2024 final results on Jun 18, 2025お知らせ • Nov 02SoftOx Solutions AS to Report Q3, 2023 Results on Nov 01, 2023SoftOx Solutions AS announced that they will report Q3, 2023 results on Nov 01, 2023すべての更新を表示Recent updatesBoard Change • May 20No independent directorsFollowing the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 4 non-independent directors. Non-Executive Director Tore Duvold was the last director to join the board, commencing their role in 2025. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model.お知らせ • Dec 19+ 5 more updatesSoftOx Solutions AS, Annual General Meeting, Jun 23, 2027SoftOx Solutions AS, Annual General Meeting, Jun 23, 2027.お知らせ • Sep 27SoftOx Solutions AS announced that it has received NOK 6 million in funding from Long State Investments LimitedOn September 26, 2025, SoftOx Solutions AS closed the transaction.お知らせ • Jun 30SoftOx Solutions AS Appoints Tore Duvold as New Board MemberSoftOx Solutions AS at its Annual General Meeting, announced the election of Dr. Tore Duvold as a new member of the Board of Directors. Dr. Duvold brings over 25 years of experience in the life science sector, including leadership roles in biotech, pharma, and public innovation funding. He currently serves as CEO of the Swedish diagnostics company Spermosens AB and has held senior positions at LEO Pharma, Aker Biopharma AS, Innovation Fund Denmark, Edvince AB, and Coegin Pharma. In addition, he has served on the board of Medicon Valley Alliance and been involved in several board roles.お知らせ • May 27+ 1 more updateSoftOx Solutions AS to Report Fiscal Year 2025 Results on May 27, 2026SoftOx Solutions AS announced that they will report fiscal year 2025 results on May 27, 2026お知らせ • Dec 19SoftOx Solutions AS, Annual General Meeting, Jun 24, 2026SoftOx Solutions AS, Annual General Meeting, Jun 24, 2026.お知らせ • Dec 18+ 4 more updatesSoftOx Solutions AS to Report Fiscal Year 2025 Results on Jun 10, 2026SoftOx Solutions AS announced that they will report fiscal year 2025 results on Jun 10, 2026お知らせ • Sep 13SoftOx Solutions AS to Appeal Court Ruling in Consultant Bonus DisputeThe District Court of Ringerike, Asker, and Bærum has made its ruling in a dispute between SoftOx Solutions AS and a former consultant claiming to have a bonus claim for services rendered in 2022. The district court ruled in favor of the consultant and awarded the consultant approx. NOK 2.5 million plus interest, and NOK 484,000 in compensation including legal costs. The Company believes that the claim has no merits, and the ruling will be appealed.お知らせ • Sep 12SoftOx Solutions AS Elects Additional Board MembersSoftOx Solutions AS at its ExtraOrdinary General Meeting held on 12 September 2024, elected as additional board member: Christian Vinding Thomsen, Vice Chairman of the Board and Eskil Zapffe, board member with an election term until the annual general meeting in 2025.お知らせ • Jul 03+ 1 more updateSoftox Solutions as Announces CFO ChangesSoftOx Solutions AS announced that in this process the former CFO Harald Sætvedt has stepped down and will be replaced by CFO Ingrid Juven. Ingrid Juven has over 25+ years of consulting and management expertise within a variety of industries. Juven holds an MBA from BI Norwegian Business School.New Risk • Jun 30New minor risk - Negative shareholders equityThe company has negative equity. Total equity: -kr19m This is considered a minor risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. It should be noted that some of the negative equity could be due to large buybacks of stock, which is not as much of a risk as a company with overwhelming debt, but likewise is not sustainable in the long-term. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (37% average weekly change). Earnings have declined by 18% per year over the past 5 years. Shareholders have been substantially diluted in the past year (over 48x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (€6.91m market cap, or US$7.41m). Minor Risk Negative equity (-kr19m).お知らせ • May 01SoftOx Solutions AS has completed a Follow-on Equity Offering in the amount of NOK 2.66919 million.SoftOx Solutions AS has completed a Follow-on Equity Offering in the amount of NOK 2.66919 million. Security Name: Shares Security Type: Common Stock Securities Offered: 13,345,951 Price\Range: NOK 0.2 Transaction Features: Rights OfferingNew Risk • Apr 11New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Over 47x increase in shares outstanding. This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (47% average weekly change). Earnings have declined by 21% per year over the past 5 years. Shareholders have been substantially diluted in the past year (over 47x increase in shares outstanding). Revenue is less than US$1m (kr7.0m revenue, or US$645k). Minor Risks Negative equity (-kr268k). Market cap is less than US$100m (€13.4m market cap, or US$14.4m).New Risk • Apr 05New minor risk - Negative shareholders equityThe company has negative equity. Total equity: -kr268k This is considered a minor risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. It should be noted that some of the negative equity could be due to large buybacks of stock, which is not as much of a risk as a company with overwhelming debt, but likewise is not sustainable in the long-term. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (46% average weekly change). Earnings have declined by 21% per year over the past 5 years. Revenue is less than US$1m (kr7.0m revenue, or US$650k). Market cap is less than US$10m (€368.6k market cap, or US$399.5k). Minor Risks Negative equity (-kr268k). Shareholders have been diluted in the past year (3.7% increase in shares outstanding).お知らせ • Mar 28SoftOx Solutions AS has filed a Follow-on Equity Offering in the amount of NOK 25 million.SoftOx Solutions AS has filed a Follow-on Equity Offering in the amount of NOK 25 million. Security Name: Shares Security Type: Common Stock Securities Offered: 125,000,000 Price\Range: NOK 0.2 Transaction Features: Rights OfferingNew Risk • Mar 26New major risk - Revenue sizeThe company makes less than US$1m in revenue. Total revenue: kr7.0m (US$649k) This is considered a major risk. Companies with a small amount of revenue are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (32% average weekly change). Earnings have declined by 21% per year over the past 5 years. Revenue is less than US$1m (kr7.0m revenue, or US$649k). Market cap is less than US$10m (€758.7k market cap, or US$821.8k). Minor Risks Negative equity (-kr268k). Shareholders have been diluted in the past year (3.7% increase in shares outstanding).お知らせ • Jan 25+ 5 more updatesSoftOx Solutions AS to Report Fiscal Year 2024 Final Results on Jun 18, 2025SoftOx Solutions AS announced that they will report fiscal year 2024 final results on Jun 18, 2025お知らせ • Nov 02SoftOx Solutions AS to Report Q3, 2023 Results on Nov 01, 2023SoftOx Solutions AS announced that they will report Q3, 2023 results on Nov 01, 2023New Risk • Sep 27New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr41m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr41m free cash flow). Share price has been highly volatile over the past 3 months (13% average weekly change). Earnings have declined by 33% per year over the past 5 years. Market cap is less than US$10m (€4.58m market cap, or US$4.81m). Minor Risk Revenue is less than US$5m (kr15m revenue, or US$1.4m).Board Change • Mar 10Less than half of directors are independentFollowing the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 4 non-independent directors. Independent Non-Executive Director Kari Myren was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.お知らせ • Dec 30+ 5 more updatesSoftOx Solutions AS, Annual General Meeting, Mar 28, 2024SoftOx Solutions AS, Annual General Meeting, Mar 28, 2024.お知らせ • Dec 21+ 1 more updateSoftOx Solutions AS Appoints Christian Harstad as the Interim Chief Executive OfficerThe Board of Directors of SoftOx Solutions AS announced that Christian Harstad has been appointed as the Interim Chief Executive Officer. Christian Harstad has a long military career including serving as a submarine commanding officer and roles in the Norwegian special forces, US Joint Forces Command, US Naval War College, Norwegian Defence Staff, and the Norwegian Ministry of Defence. He retired from the Military as Flag Officer and second-in-command for Norwegian Special Operations Forces. In September 2022, Harstad joined SoftOx as the Project Director for SoftOx Defense Solutions AS. Christian Harstad will commence as interim CEO on January 1, 2023.お知らせ • Dec 16Softox Solutions AS Announces Final Report Reaffirms Positive Top Line Phase 1 Results for Softox Biofilm EradicatorSoftOx Solutions AS announces that the Company has received the final report and analysis of its Phase 1 study evaluating the safety and tolerability of SoftOx Biofilm Eradicator (SBE-01) (EudraCT no. 2021-000314-42), SoftOx’s antimicrobial solution for the treatment of chronic wounds. SBE-01 is a first-in-human study investigating the safety, tolerability, and antimicrobial efficacy of single and multiple doses of SBE in patients with chronic leg wounds. The Phase 1 study was divided into two parts: a randomized, blinded, Single Ascending Dose (SAD) phase, followed by an open label, Multiple Ascending Dose (MAD) phase, where patients were treated once-daily or twice-daily over five days. Key findings The final report reaffirms previous findings that SBE is safe and well-tolerated by patients suffering from chronic leg wounds. There were no statistically significant differences in the evaluation of pain during and after the wound cleaning procedure comparing SBE with placebo. The study found that formulations of SBE consistently reduced the bacterial burden in the wound compared with pre-treatment. There was also evidence of wound healing with a reduction in wound area of between 24 to 36% after just 5 days’ treatment.お知らせ • Oct 20Softox Solutions AS Announces Approval from the Swedish Chemicals Agency on Disinfection ProductsSoftox Solutions AS received the final approval on its application for the SoftOx biocidal product family for hand- and surface disinfection from the Swedish Chemicals Agency (KemI). This approval allows SoftOx to sell its disinfection products in Sweden. SoftOx can use this approval as a basis for new applications — mutual recognition in sequence — in any European market. As the Swedish authorities have diligently evaluated and approved the application, the mutual recognition process, described in the Biocidal Products Regulation (BPR), is considered a less complex and less expensive process. A safe and effective alternative to alcohol-based disinfectants In addition, this approval may provide opportunities in markets outside Europe that normally rely on either EU or US regulatory decisions.お知らせ • Oct 13SoftOx Solutions AS announced that it expects to receive NOK 40 million in funding from Aubert Invest AS, Pro AS, Almhaug Bolig AS and other investorsSoftOx Solutions AS announced a private placement of convertible loan for gross proceeds of NOK 40,000,000 on October 11, 2022. The transaction will include participation from certain existing shareholders including GH Holding AS for NOK 5,000,000, Aubert Invest AS for NOK 2,500,000, Pro AS for NOK 10,000,000, Østlandske Pensjonsforsikring for NOK 5,300,000, Almhaug Bolig AS for NOK 15,000,000 and Geir Almås for NOK 2,200,000. The transaction has been approved by the board of directors of the company. The transaction is epected to close on October 24, 2022. The loan shall carry interest at a rate of 10% per annum. The subscription price per share on conversion of the loan shall be equal NOK 22.50.お知らせ • Sep 07SoftOx Solutions AS Announces the End of the SBE Phase 1 Clinical Study for Treatment of Chronic WoundsSoftOx Solutions AS announced the end of the Phase 1 clinical study of the SoftOx Biofilm Eradicator (SBE-01) (EudraCT no. 2021-000314-42), SoftOx’s antimicrobial solution for treatment of chronic wounds. SBE-01 is a first-in-human study investigating the safety, tolerability, and antimicrobial efficacy of single and multiple doses of the SoftOx Biofilm Eradicator (SBE) in patients with venous leg ulcers. In Phase 1b the company treated the wounds once and twice daily over 5 days. The original study design included three times daily administration for five days; however, the company expects that data from the two first groups are sufficient to document safety, tolerability, and antimicrobial efficacy in clinically relevant treatment schedules in chronic wounds. SBE is in clinical development as an anti-infective treatment for chronic wounds, designed specifically to penetrate and kill pathogens within biofilms. Due to the broad spectrum and multi-targeted antimicrobial effects, SBE has been shown to kill antibiotic resistant bacteria in biofilms without inducing new antimicrobial resistance in vitro. SoftOx has previously published clinical data supporting the association between reduced bacterial burden and improved wound healing. These associations will be further investigated in the planned SBE Phase 2 (SBE-02) study. As previously reported, SBE-01 recruitment was delayed in the early stages of the trial due to the Danish nursing strike in 2021. To maintain overall clinical development timelines, SoftOx has taken the decision to omit the three times daily treatment, stop further patient recruitment and to end the trial.お知らせ • Sep 02SoftOx Solutions AS Announces Executive Changes in its Subsidiary, SoftOx Defense Solutions ASSoftOx Solutions AS strengthened its leadership team in SoftOx Defense Solutions AS (SDS), a subsidiary of SoftOx, with the appointment of Jørgen Berggrav as Senior Advisor and Johan Christian Harstad as the Project Director. The appointments will take effect, as of September 1, 2022. In addition, Chief Executive Officer of SoftOx Solutions AS, Geir Almås, will act as interim CEO of SDS, succeeding Rune Jomaas, until a suitable successor has been identified. Jørgen Berggrav graduated from the Royal Norwegian Naval Academy (Sjøkrigsskolen) and has served in the submarine force as a ship's officer, ship's commander and operations and training officer. Berggrav has held many diverse roles in the Armed Forces including as Director General in the Ministry of Defence, representative of Europe to the Supreme Allied Commander Transformation and representative of the Chief of Defence at NATO's operational command, SHAPE, commander of the Landsdelskommando Nord-Norge, and staff training at the Bundeswehr Command and Staff College (die Führungsakademie der Bundeswehr) in Germany, the Armed Forces Academy, and Defence Attaché in Finland. In addition, Berggrav has been Chief Principal for HM the King and was appointed rear admiral in 2003. Following his retirement, Berggrav was the Secretary General of the Norwegian Reserve Officers’ Federation for nearly eight years. Johan Christian Harstad is a former submarine commander, and his last position was as deputy leader in the Norwegian Special Operation Forces with the rank of Commodore. Harstad has international experience with the United States Special Operations Command in experimentation and restructuring of military capabilities. He also studied security policy and foreign relations at the US Naval War College. Harstad has served in the Norwegian Armed Forces’ central staff in Oslo and worked for four years in the Ministry of Defence. Berggrav and Harstad’s focus will be to further develop the SoftOx applications to strengthen the military and civilian preparedness against future epidemics, chemical and biological warfare, complex wound infections and challenging conditions in the respiratory tract.お知らせ • Jun 30SoftOx Solutions AS Announces Clinical Trial Data Published in Acta Dermato-VenereologicaSoftOx Solutions AS announced the publication of data from a randomized control trial (RTC) evaluating the wound-healing effect of SoftOx's stabilized hypochlorous acid solution (HOCl) on acute wounds. The results were published in Acta Dermato-Venereologica, a peer-reviewed journal focused on clinical and experimental research in dermatology and venerology. The randomized trial applied a suction blister wound model and randomized 20 healthy volunteers whereby stabilized hypochlorous acid or control (saline) solutions were assigned. The study's primary objective was to evaluate the wound healing properties of HOCI, and the secondary objective was microbiological control, pain levels and safety with stabilized HOCl compared to the control treatment. Wounds were treated and rinsed on days 0, 2 and 4. Wound healing was assessed blindly, and bacterial growth was evaluated as the number of colony-forming units cultured from surface swabs. Stabilized HOCI was found to accelerate early re-epithelialization (wound healing) significantly on day 4 compared with the control group (p=0.00051) and was not inferior to the control solution on day 10 (p<0.0001). In addition, the median bacterial counts in the wounds were significantly lower after treatment with stabilized HOCI compared with the control group directly after treatment, which also lasted over time. Overall, the study demonstrates the immediate and durable antimicrobial action and beneficial effect of stabilized HOCI on acute wounds and suggests that hypochlorous acid is a promising antimicrobial wound rinsing agent.お知らせ • May 20SoftOx Solutions AS Announces Positive Phase 1 Results for SoftOx Inhalation SolutionSoftOx Solutions AS announced top line results from its Phase 1 study evaluating SoftOx Inhalation Solution (SIS). SIS is a novel aqueous formulation of hypochlorous acid (HOCl), a biological oxidant with broad spectrum antimicrobial (antiviral and antibacterial) properties. In this Phase 1, first-in-human study, nebulised SIS achieved the primary objective of safety and tolerability in healthy subjects. There were no observed local tolerability issues, no adverse effects on pulmonary function, and no serious adverse events. SIS-01 is a first-in-human study investigating the safety and tolerability of single and multiple ascending doses of nebulised SIS to healthy subjects. The randomized, double-blind trial was the first systematic, placebo-controlled study investigating the safety and tolerability of inhaled HOCl in humans. A total of 57 healthy volunteers were randomised to receive SIS formulations of up to 100 µg/ml HOCl, four times daily for five days, or a matching placebo regimen. Data from the study demonstrates that an aqueous formulation of HOCl can be administered to the respiratory tract as an aerosol, as evidenced by dose-response effects on safety parameters, which were predominantly mild, even in the most intensive dosing regimen. With these positive results from the Phase 1 study, SoftOx will continue Phase 2 clinical development of SIS. The company is already in the process of preparing Phase 2 documentation and is engaged in dialogue with the European Medical Association.お知らせ • May 12SoftOx Solutions AS Announces the Last Patient Completes the Last Single-Dose Cohort of the SBE-01 Clinical StudySoftOx Solutions AS (SoftOx) announced that the last patient has completed the last single-dose cohort of the SBE-01 clinical study. This marks the end of the first part (SAD phase 1a) of SBE-01 (EudraCT no. 2021-000314-42). The Safety Monitoring Committee (SMC) has now recommended the study to continue to enter the last phase (MAD phase 1b) based on encouraging safety and antimicrobial effect measures. In this part of the SBE-01 study company will test the recommended SBE-product once or multiple times daily over 5 days. This will further document the safety, tolerability, and antimicrobial efficacy when SBE is administered on a more intense and clinically relevant treatment schedule. The phase 1b will establish a tolerable dose and treatment schedule for SBE to be able to develop it into an effective infection-treatment solution in problematic, non-healing wounds. SBE-01 is the first-in-human (phase 1) study with the SoftOx’s lead wound care product, SBE (SoftOx Biofilm Eradicator), designed to treat infected chronic wounds. Chronic wounds represent a silent epidemic with an estimated 40 million chronic wounds worldwide and two million related amputations annually. As these wounds last on average 12/13 months and recur in up to 70% of patients, they can lead to loss of function and decreased quality of life as well as are a significant cause of morbidity. SoftOx is currently exploring different indications such as venous leg ulcers and diabetic foot ulcers with the aim to improve the treatment and quality of life for these patients.Board Change • Apr 27No independent directorsFollowing the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 4 non-independent directors. Chairman Melvin Teigen was the last director to join the board, commencing their role in 2020. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model.お知らせ • Jan 25SoftOx Solutions AS Announces Changes Regarding Application for National Approval of Disinfection ProductsSoftOx Solutions AS has chosen to temporarily withdraw the application. The biocidal products covered by the transitional arrangement will not be affected, and a new application will be submitted by the deadline of 1 July 2022. The transitional arrangement ensures the company's presence in the market. The reason why the company chooses to withdraw the application is a desire to rework and optimize the new application so that it better suits the changed conditions that now apply. When the application was first prepared, it was based on the Norwegian Environment Agency's recommendations and guidelines, which have subsequently proved to be unclear and not applicable, as well as the later lack of coincidence between the Norwegian Environment Agency and the EU Commission's interpretations in significant areas. A new application will be submitted in accordance with the EU Biocidal Regulations by 1 July 2022. The transitional arrangement is therefore valid if a new application is submitted by this date.お知らせ • Jul 20SoftOx Solutions AS Provides Project Update on SoftOx Biofilm EradicatorSoftOx Solutions AS provided project update on SoftOx Biofilm Eradicator. The first in human study of SoftOx Biofilm Eradicator started as planned at the end of May, but due to the ongoing nurses' strike in Denmark, the company do not expect to be able to admit patients to the study until the strike is over. The strike is expected to last for approximately 10 weeks. The study is therefore expected to be somewhat delayed; however, the company will strive to make up for lost time.お知らせ • Jun 24SoftOx Solutions' SWIS-02 Study Results Shows Superior Wound HealingSoftOx Solutions AS (SoftOx) announced that the results of the clinical investigation SoftOx Wound Irrigation Solution for acute wounds (SWIS) have been completed. The study, which has been conducted at Bispebjerg University Hospital in Copenhagen, is a confirmatory clinical investigation to document safety and performance of SoftOx Wound Irrigation Solution (SWIS) compared to Normal Saline (NS) in a human wound model. The study showed both significant improvement in wound healing and reduction in bacterial burden compared to Normal Saline (NS), positioning the product as superior towards today’s market leaders. Finishing the clinical development program strengthens the SoftOx platform for further product development. The results from the study “SWIS-02” confirm the excellent safety profile of the SoftOx technology platform, also strengthening the documentation of SoftOx hand disinfectant technology with regards to skin friendliness being superior to today’s alcohol-based hand disinfectant. The company now prepares to file their wound irrigation SWIS for final approval as a Medical Device in Europe. SoftOx Wound Irrigation Solution (SWIS) will become a Medical Device intended for wound rinsing and moistening to prevent infections in all types of acute wounds, such as abrasions, cuts, burns and surgical wounds. SWIS has the potential to become a favoured alternative to the current wound irrigation solutions on the market which have challenges related to safety (side effects, resistance development) and effect. According to market reports from The Insight Partners, the global market size for wound irrigation solutions was estimated at USD 1.6 billion in 2018, and yearly 190 million wounds is treated in hospitals. Finalization of the SWIS-02 study concludes the clinical evaluation part of the SWIS documentation package. SWIS is expected to be the company’s first CE-marked product for the European market. Regarding the wound healing capabilities, the study meets its primary endpoint of re-epithelialization (non-inferior to NS) by day 10 with high significance (p<0.0001). Furthermore, early re-epithelialization at day 4 was significantly better than normal saline (mean 57% versus 43%, p<0.0001). Also, overall usability aspects of SWIS handling were reported to be satisfactory. Once again SWIS demonstrates and confirms previous findings (from SWIS-01) to be safe and well tolerated as a wound irrigation solution for acute wounds and not associated with any major risks. Performance outcomes demonstrate antimicrobial properties with excellent wound healing (re-epithelialization) observations.お知らせ • Jun 09Softox Solutions AS Announces that the Danish Medicines Agency Has Given Conditional Approval for the First Study in Humans for Softox Inhalation SolutionSoftOx Solutions AS announced that the Danish Medicines Agency has given a conditional approval for the first study in humans for SoftOx Inhalation Solution (SIS) for the treatment of respiratory infections. SoftOx Solutions AS (SoftOx) aims to develop an inhalation solution (SIS) for the treatment of respiratory tract infections. This has the potential to be a breakthrough in the future treatment of respiratory infections, including viruses, bacteria and fungal infections.収支内訳SoftOx Solutions の稼ぎ方とお金の使い方。LTMベースの直近の報告された収益に基づく。収益と収入の歴史DB:6FV 収益、費用、利益 ( )NOK Millions日付収益収益G+A経費研究開発費31 Dec 2516-116030 Sep 2514-36030 Jun 2511-156031 Mar 259-205031 Dec 248-435030 Sep 242-735030 Jun 242-615031 Mar 24-1-584031 Dec 237-398030 Sep 2314-1714030 Jun 2315-3420031 Mar 2316-5024031 Dec 227-7126030 Sep 227-6825030 Jun 226-6624031 Mar 227-6722031 Dec 218-6521030 Sep 216-7423030 Jun 216-6422031 Mar 2110-5321031 Dec 2010-3719030 Sep 209-3014030 Jun 209-2413031 Mar 204-1912031 Dec 194-1611030 Sep 195-1712030 Jun 197-1312031 Mar 196-1310031 Dec 184-139030 Sep 183-107030 Jun 180-125031 Mar 180-115031 Dec 170-94031 Dec 160-630質の高い収益: 6FVは現在利益が出ていません。利益率の向上: 6FVは現在利益が出ていません。フリー・キャッシュフローと収益の比較過去の収益成長分析収益動向: 6FVは利益を出していないが、過去 5 年間で年間19.2%の割合で損失を削減してきた。成長の加速: 6FVの過去 1 年間の収益成長を 5 年間の平均と比較することはできません。現在は利益が出ていないためです。収益対業界: 6FVは利益が出ていないため、過去 1 年間の収益成長をPharmaceuticals業界 ( 16.1% ) と比較することは困難です。株主資本利益率高いROE: 6FVは現在利益が出ていないため、自己資本利益率 ( -47.11% ) はマイナスです。総資産利益率使用総資本利益率過去の好業績企業の発掘7D1Y7D1Y7D1YPharmaceuticals-biotech 、過去の業績が好調な企業。View Financial Health企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/22 09:12終値2026/05/22 00:00収益2025/12/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋SoftOx Solutions AS 0 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。0
お知らせ • May 27+ 1 more updateSoftOx Solutions AS to Report Fiscal Year 2025 Results on May 27, 2026SoftOx Solutions AS announced that they will report fiscal year 2025 results on May 27, 2026
お知らせ • Dec 18+ 4 more updatesSoftOx Solutions AS to Report Fiscal Year 2025 Results on Jun 10, 2026SoftOx Solutions AS announced that they will report fiscal year 2025 results on Jun 10, 2026
お知らせ • Jan 25+ 5 more updatesSoftOx Solutions AS to Report Fiscal Year 2024 Final Results on Jun 18, 2025SoftOx Solutions AS announced that they will report fiscal year 2024 final results on Jun 18, 2025
お知らせ • Nov 02SoftOx Solutions AS to Report Q3, 2023 Results on Nov 01, 2023SoftOx Solutions AS announced that they will report Q3, 2023 results on Nov 01, 2023
Board Change • May 20No independent directorsFollowing the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 4 non-independent directors. Non-Executive Director Tore Duvold was the last director to join the board, commencing their role in 2025. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model.
お知らせ • Dec 19+ 5 more updatesSoftOx Solutions AS, Annual General Meeting, Jun 23, 2027SoftOx Solutions AS, Annual General Meeting, Jun 23, 2027.
お知らせ • Sep 27SoftOx Solutions AS announced that it has received NOK 6 million in funding from Long State Investments LimitedOn September 26, 2025, SoftOx Solutions AS closed the transaction.
お知らせ • Jun 30SoftOx Solutions AS Appoints Tore Duvold as New Board MemberSoftOx Solutions AS at its Annual General Meeting, announced the election of Dr. Tore Duvold as a new member of the Board of Directors. Dr. Duvold brings over 25 years of experience in the life science sector, including leadership roles in biotech, pharma, and public innovation funding. He currently serves as CEO of the Swedish diagnostics company Spermosens AB and has held senior positions at LEO Pharma, Aker Biopharma AS, Innovation Fund Denmark, Edvince AB, and Coegin Pharma. In addition, he has served on the board of Medicon Valley Alliance and been involved in several board roles.
お知らせ • May 27+ 1 more updateSoftOx Solutions AS to Report Fiscal Year 2025 Results on May 27, 2026SoftOx Solutions AS announced that they will report fiscal year 2025 results on May 27, 2026
お知らせ • Dec 19SoftOx Solutions AS, Annual General Meeting, Jun 24, 2026SoftOx Solutions AS, Annual General Meeting, Jun 24, 2026.
お知らせ • Dec 18+ 4 more updatesSoftOx Solutions AS to Report Fiscal Year 2025 Results on Jun 10, 2026SoftOx Solutions AS announced that they will report fiscal year 2025 results on Jun 10, 2026
お知らせ • Sep 13SoftOx Solutions AS to Appeal Court Ruling in Consultant Bonus DisputeThe District Court of Ringerike, Asker, and Bærum has made its ruling in a dispute between SoftOx Solutions AS and a former consultant claiming to have a bonus claim for services rendered in 2022. The district court ruled in favor of the consultant and awarded the consultant approx. NOK 2.5 million plus interest, and NOK 484,000 in compensation including legal costs. The Company believes that the claim has no merits, and the ruling will be appealed.
お知らせ • Sep 12SoftOx Solutions AS Elects Additional Board MembersSoftOx Solutions AS at its ExtraOrdinary General Meeting held on 12 September 2024, elected as additional board member: Christian Vinding Thomsen, Vice Chairman of the Board and Eskil Zapffe, board member with an election term until the annual general meeting in 2025.
お知らせ • Jul 03+ 1 more updateSoftox Solutions as Announces CFO ChangesSoftOx Solutions AS announced that in this process the former CFO Harald Sætvedt has stepped down and will be replaced by CFO Ingrid Juven. Ingrid Juven has over 25+ years of consulting and management expertise within a variety of industries. Juven holds an MBA from BI Norwegian Business School.
New Risk • Jun 30New minor risk - Negative shareholders equityThe company has negative equity. Total equity: -kr19m This is considered a minor risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. It should be noted that some of the negative equity could be due to large buybacks of stock, which is not as much of a risk as a company with overwhelming debt, but likewise is not sustainable in the long-term. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (37% average weekly change). Earnings have declined by 18% per year over the past 5 years. Shareholders have been substantially diluted in the past year (over 48x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (€6.91m market cap, or US$7.41m). Minor Risk Negative equity (-kr19m).
お知らせ • May 01SoftOx Solutions AS has completed a Follow-on Equity Offering in the amount of NOK 2.66919 million.SoftOx Solutions AS has completed a Follow-on Equity Offering in the amount of NOK 2.66919 million. Security Name: Shares Security Type: Common Stock Securities Offered: 13,345,951 Price\Range: NOK 0.2 Transaction Features: Rights Offering
New Risk • Apr 11New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Over 47x increase in shares outstanding. This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (47% average weekly change). Earnings have declined by 21% per year over the past 5 years. Shareholders have been substantially diluted in the past year (over 47x increase in shares outstanding). Revenue is less than US$1m (kr7.0m revenue, or US$645k). Minor Risks Negative equity (-kr268k). Market cap is less than US$100m (€13.4m market cap, or US$14.4m).
New Risk • Apr 05New minor risk - Negative shareholders equityThe company has negative equity. Total equity: -kr268k This is considered a minor risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. It should be noted that some of the negative equity could be due to large buybacks of stock, which is not as much of a risk as a company with overwhelming debt, but likewise is not sustainable in the long-term. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (46% average weekly change). Earnings have declined by 21% per year over the past 5 years. Revenue is less than US$1m (kr7.0m revenue, or US$650k). Market cap is less than US$10m (€368.6k market cap, or US$399.5k). Minor Risks Negative equity (-kr268k). Shareholders have been diluted in the past year (3.7% increase in shares outstanding).
お知らせ • Mar 28SoftOx Solutions AS has filed a Follow-on Equity Offering in the amount of NOK 25 million.SoftOx Solutions AS has filed a Follow-on Equity Offering in the amount of NOK 25 million. Security Name: Shares Security Type: Common Stock Securities Offered: 125,000,000 Price\Range: NOK 0.2 Transaction Features: Rights Offering
New Risk • Mar 26New major risk - Revenue sizeThe company makes less than US$1m in revenue. Total revenue: kr7.0m (US$649k) This is considered a major risk. Companies with a small amount of revenue are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (32% average weekly change). Earnings have declined by 21% per year over the past 5 years. Revenue is less than US$1m (kr7.0m revenue, or US$649k). Market cap is less than US$10m (€758.7k market cap, or US$821.8k). Minor Risks Negative equity (-kr268k). Shareholders have been diluted in the past year (3.7% increase in shares outstanding).
お知らせ • Jan 25+ 5 more updatesSoftOx Solutions AS to Report Fiscal Year 2024 Final Results on Jun 18, 2025SoftOx Solutions AS announced that they will report fiscal year 2024 final results on Jun 18, 2025
お知らせ • Nov 02SoftOx Solutions AS to Report Q3, 2023 Results on Nov 01, 2023SoftOx Solutions AS announced that they will report Q3, 2023 results on Nov 01, 2023
New Risk • Sep 27New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr41m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr41m free cash flow). Share price has been highly volatile over the past 3 months (13% average weekly change). Earnings have declined by 33% per year over the past 5 years. Market cap is less than US$10m (€4.58m market cap, or US$4.81m). Minor Risk Revenue is less than US$5m (kr15m revenue, or US$1.4m).
Board Change • Mar 10Less than half of directors are independentFollowing the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 4 non-independent directors. Independent Non-Executive Director Kari Myren was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.
お知らせ • Dec 30+ 5 more updatesSoftOx Solutions AS, Annual General Meeting, Mar 28, 2024SoftOx Solutions AS, Annual General Meeting, Mar 28, 2024.
お知らせ • Dec 21+ 1 more updateSoftOx Solutions AS Appoints Christian Harstad as the Interim Chief Executive OfficerThe Board of Directors of SoftOx Solutions AS announced that Christian Harstad has been appointed as the Interim Chief Executive Officer. Christian Harstad has a long military career including serving as a submarine commanding officer and roles in the Norwegian special forces, US Joint Forces Command, US Naval War College, Norwegian Defence Staff, and the Norwegian Ministry of Defence. He retired from the Military as Flag Officer and second-in-command for Norwegian Special Operations Forces. In September 2022, Harstad joined SoftOx as the Project Director for SoftOx Defense Solutions AS. Christian Harstad will commence as interim CEO on January 1, 2023.
お知らせ • Dec 16Softox Solutions AS Announces Final Report Reaffirms Positive Top Line Phase 1 Results for Softox Biofilm EradicatorSoftOx Solutions AS announces that the Company has received the final report and analysis of its Phase 1 study evaluating the safety and tolerability of SoftOx Biofilm Eradicator (SBE-01) (EudraCT no. 2021-000314-42), SoftOx’s antimicrobial solution for the treatment of chronic wounds. SBE-01 is a first-in-human study investigating the safety, tolerability, and antimicrobial efficacy of single and multiple doses of SBE in patients with chronic leg wounds. The Phase 1 study was divided into two parts: a randomized, blinded, Single Ascending Dose (SAD) phase, followed by an open label, Multiple Ascending Dose (MAD) phase, where patients were treated once-daily or twice-daily over five days. Key findings The final report reaffirms previous findings that SBE is safe and well-tolerated by patients suffering from chronic leg wounds. There were no statistically significant differences in the evaluation of pain during and after the wound cleaning procedure comparing SBE with placebo. The study found that formulations of SBE consistently reduced the bacterial burden in the wound compared with pre-treatment. There was also evidence of wound healing with a reduction in wound area of between 24 to 36% after just 5 days’ treatment.
お知らせ • Oct 20Softox Solutions AS Announces Approval from the Swedish Chemicals Agency on Disinfection ProductsSoftox Solutions AS received the final approval on its application for the SoftOx biocidal product family for hand- and surface disinfection from the Swedish Chemicals Agency (KemI). This approval allows SoftOx to sell its disinfection products in Sweden. SoftOx can use this approval as a basis for new applications — mutual recognition in sequence — in any European market. As the Swedish authorities have diligently evaluated and approved the application, the mutual recognition process, described in the Biocidal Products Regulation (BPR), is considered a less complex and less expensive process. A safe and effective alternative to alcohol-based disinfectants In addition, this approval may provide opportunities in markets outside Europe that normally rely on either EU or US regulatory decisions.
お知らせ • Oct 13SoftOx Solutions AS announced that it expects to receive NOK 40 million in funding from Aubert Invest AS, Pro AS, Almhaug Bolig AS and other investorsSoftOx Solutions AS announced a private placement of convertible loan for gross proceeds of NOK 40,000,000 on October 11, 2022. The transaction will include participation from certain existing shareholders including GH Holding AS for NOK 5,000,000, Aubert Invest AS for NOK 2,500,000, Pro AS for NOK 10,000,000, Østlandske Pensjonsforsikring for NOK 5,300,000, Almhaug Bolig AS for NOK 15,000,000 and Geir Almås for NOK 2,200,000. The transaction has been approved by the board of directors of the company. The transaction is epected to close on October 24, 2022. The loan shall carry interest at a rate of 10% per annum. The subscription price per share on conversion of the loan shall be equal NOK 22.50.
お知らせ • Sep 07SoftOx Solutions AS Announces the End of the SBE Phase 1 Clinical Study for Treatment of Chronic WoundsSoftOx Solutions AS announced the end of the Phase 1 clinical study of the SoftOx Biofilm Eradicator (SBE-01) (EudraCT no. 2021-000314-42), SoftOx’s antimicrobial solution for treatment of chronic wounds. SBE-01 is a first-in-human study investigating the safety, tolerability, and antimicrobial efficacy of single and multiple doses of the SoftOx Biofilm Eradicator (SBE) in patients with venous leg ulcers. In Phase 1b the company treated the wounds once and twice daily over 5 days. The original study design included three times daily administration for five days; however, the company expects that data from the two first groups are sufficient to document safety, tolerability, and antimicrobial efficacy in clinically relevant treatment schedules in chronic wounds. SBE is in clinical development as an anti-infective treatment for chronic wounds, designed specifically to penetrate and kill pathogens within biofilms. Due to the broad spectrum and multi-targeted antimicrobial effects, SBE has been shown to kill antibiotic resistant bacteria in biofilms without inducing new antimicrobial resistance in vitro. SoftOx has previously published clinical data supporting the association between reduced bacterial burden and improved wound healing. These associations will be further investigated in the planned SBE Phase 2 (SBE-02) study. As previously reported, SBE-01 recruitment was delayed in the early stages of the trial due to the Danish nursing strike in 2021. To maintain overall clinical development timelines, SoftOx has taken the decision to omit the three times daily treatment, stop further patient recruitment and to end the trial.
お知らせ • Sep 02SoftOx Solutions AS Announces Executive Changes in its Subsidiary, SoftOx Defense Solutions ASSoftOx Solutions AS strengthened its leadership team in SoftOx Defense Solutions AS (SDS), a subsidiary of SoftOx, with the appointment of Jørgen Berggrav as Senior Advisor and Johan Christian Harstad as the Project Director. The appointments will take effect, as of September 1, 2022. In addition, Chief Executive Officer of SoftOx Solutions AS, Geir Almås, will act as interim CEO of SDS, succeeding Rune Jomaas, until a suitable successor has been identified. Jørgen Berggrav graduated from the Royal Norwegian Naval Academy (Sjøkrigsskolen) and has served in the submarine force as a ship's officer, ship's commander and operations and training officer. Berggrav has held many diverse roles in the Armed Forces including as Director General in the Ministry of Defence, representative of Europe to the Supreme Allied Commander Transformation and representative of the Chief of Defence at NATO's operational command, SHAPE, commander of the Landsdelskommando Nord-Norge, and staff training at the Bundeswehr Command and Staff College (die Führungsakademie der Bundeswehr) in Germany, the Armed Forces Academy, and Defence Attaché in Finland. In addition, Berggrav has been Chief Principal for HM the King and was appointed rear admiral in 2003. Following his retirement, Berggrav was the Secretary General of the Norwegian Reserve Officers’ Federation for nearly eight years. Johan Christian Harstad is a former submarine commander, and his last position was as deputy leader in the Norwegian Special Operation Forces with the rank of Commodore. Harstad has international experience with the United States Special Operations Command in experimentation and restructuring of military capabilities. He also studied security policy and foreign relations at the US Naval War College. Harstad has served in the Norwegian Armed Forces’ central staff in Oslo and worked for four years in the Ministry of Defence. Berggrav and Harstad’s focus will be to further develop the SoftOx applications to strengthen the military and civilian preparedness against future epidemics, chemical and biological warfare, complex wound infections and challenging conditions in the respiratory tract.
お知らせ • Jun 30SoftOx Solutions AS Announces Clinical Trial Data Published in Acta Dermato-VenereologicaSoftOx Solutions AS announced the publication of data from a randomized control trial (RTC) evaluating the wound-healing effect of SoftOx's stabilized hypochlorous acid solution (HOCl) on acute wounds. The results were published in Acta Dermato-Venereologica, a peer-reviewed journal focused on clinical and experimental research in dermatology and venerology. The randomized trial applied a suction blister wound model and randomized 20 healthy volunteers whereby stabilized hypochlorous acid or control (saline) solutions were assigned. The study's primary objective was to evaluate the wound healing properties of HOCI, and the secondary objective was microbiological control, pain levels and safety with stabilized HOCl compared to the control treatment. Wounds were treated and rinsed on days 0, 2 and 4. Wound healing was assessed blindly, and bacterial growth was evaluated as the number of colony-forming units cultured from surface swabs. Stabilized HOCI was found to accelerate early re-epithelialization (wound healing) significantly on day 4 compared with the control group (p=0.00051) and was not inferior to the control solution on day 10 (p<0.0001). In addition, the median bacterial counts in the wounds were significantly lower after treatment with stabilized HOCI compared with the control group directly after treatment, which also lasted over time. Overall, the study demonstrates the immediate and durable antimicrobial action and beneficial effect of stabilized HOCI on acute wounds and suggests that hypochlorous acid is a promising antimicrobial wound rinsing agent.
お知らせ • May 20SoftOx Solutions AS Announces Positive Phase 1 Results for SoftOx Inhalation SolutionSoftOx Solutions AS announced top line results from its Phase 1 study evaluating SoftOx Inhalation Solution (SIS). SIS is a novel aqueous formulation of hypochlorous acid (HOCl), a biological oxidant with broad spectrum antimicrobial (antiviral and antibacterial) properties. In this Phase 1, first-in-human study, nebulised SIS achieved the primary objective of safety and tolerability in healthy subjects. There were no observed local tolerability issues, no adverse effects on pulmonary function, and no serious adverse events. SIS-01 is a first-in-human study investigating the safety and tolerability of single and multiple ascending doses of nebulised SIS to healthy subjects. The randomized, double-blind trial was the first systematic, placebo-controlled study investigating the safety and tolerability of inhaled HOCl in humans. A total of 57 healthy volunteers were randomised to receive SIS formulations of up to 100 µg/ml HOCl, four times daily for five days, or a matching placebo regimen. Data from the study demonstrates that an aqueous formulation of HOCl can be administered to the respiratory tract as an aerosol, as evidenced by dose-response effects on safety parameters, which were predominantly mild, even in the most intensive dosing regimen. With these positive results from the Phase 1 study, SoftOx will continue Phase 2 clinical development of SIS. The company is already in the process of preparing Phase 2 documentation and is engaged in dialogue with the European Medical Association.
お知らせ • May 12SoftOx Solutions AS Announces the Last Patient Completes the Last Single-Dose Cohort of the SBE-01 Clinical StudySoftOx Solutions AS (SoftOx) announced that the last patient has completed the last single-dose cohort of the SBE-01 clinical study. This marks the end of the first part (SAD phase 1a) of SBE-01 (EudraCT no. 2021-000314-42). The Safety Monitoring Committee (SMC) has now recommended the study to continue to enter the last phase (MAD phase 1b) based on encouraging safety and antimicrobial effect measures. In this part of the SBE-01 study company will test the recommended SBE-product once or multiple times daily over 5 days. This will further document the safety, tolerability, and antimicrobial efficacy when SBE is administered on a more intense and clinically relevant treatment schedule. The phase 1b will establish a tolerable dose and treatment schedule for SBE to be able to develop it into an effective infection-treatment solution in problematic, non-healing wounds. SBE-01 is the first-in-human (phase 1) study with the SoftOx’s lead wound care product, SBE (SoftOx Biofilm Eradicator), designed to treat infected chronic wounds. Chronic wounds represent a silent epidemic with an estimated 40 million chronic wounds worldwide and two million related amputations annually. As these wounds last on average 12/13 months and recur in up to 70% of patients, they can lead to loss of function and decreased quality of life as well as are a significant cause of morbidity. SoftOx is currently exploring different indications such as venous leg ulcers and diabetic foot ulcers with the aim to improve the treatment and quality of life for these patients.
Board Change • Apr 27No independent directorsFollowing the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 4 non-independent directors. Chairman Melvin Teigen was the last director to join the board, commencing their role in 2020. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model.
お知らせ • Jan 25SoftOx Solutions AS Announces Changes Regarding Application for National Approval of Disinfection ProductsSoftOx Solutions AS has chosen to temporarily withdraw the application. The biocidal products covered by the transitional arrangement will not be affected, and a new application will be submitted by the deadline of 1 July 2022. The transitional arrangement ensures the company's presence in the market. The reason why the company chooses to withdraw the application is a desire to rework and optimize the new application so that it better suits the changed conditions that now apply. When the application was first prepared, it was based on the Norwegian Environment Agency's recommendations and guidelines, which have subsequently proved to be unclear and not applicable, as well as the later lack of coincidence between the Norwegian Environment Agency and the EU Commission's interpretations in significant areas. A new application will be submitted in accordance with the EU Biocidal Regulations by 1 July 2022. The transitional arrangement is therefore valid if a new application is submitted by this date.
お知らせ • Jul 20SoftOx Solutions AS Provides Project Update on SoftOx Biofilm EradicatorSoftOx Solutions AS provided project update on SoftOx Biofilm Eradicator. The first in human study of SoftOx Biofilm Eradicator started as planned at the end of May, but due to the ongoing nurses' strike in Denmark, the company do not expect to be able to admit patients to the study until the strike is over. The strike is expected to last for approximately 10 weeks. The study is therefore expected to be somewhat delayed; however, the company will strive to make up for lost time.
お知らせ • Jun 24SoftOx Solutions' SWIS-02 Study Results Shows Superior Wound HealingSoftOx Solutions AS (SoftOx) announced that the results of the clinical investigation SoftOx Wound Irrigation Solution for acute wounds (SWIS) have been completed. The study, which has been conducted at Bispebjerg University Hospital in Copenhagen, is a confirmatory clinical investigation to document safety and performance of SoftOx Wound Irrigation Solution (SWIS) compared to Normal Saline (NS) in a human wound model. The study showed both significant improvement in wound healing and reduction in bacterial burden compared to Normal Saline (NS), positioning the product as superior towards today’s market leaders. Finishing the clinical development program strengthens the SoftOx platform for further product development. The results from the study “SWIS-02” confirm the excellent safety profile of the SoftOx technology platform, also strengthening the documentation of SoftOx hand disinfectant technology with regards to skin friendliness being superior to today’s alcohol-based hand disinfectant. The company now prepares to file their wound irrigation SWIS for final approval as a Medical Device in Europe. SoftOx Wound Irrigation Solution (SWIS) will become a Medical Device intended for wound rinsing and moistening to prevent infections in all types of acute wounds, such as abrasions, cuts, burns and surgical wounds. SWIS has the potential to become a favoured alternative to the current wound irrigation solutions on the market which have challenges related to safety (side effects, resistance development) and effect. According to market reports from The Insight Partners, the global market size for wound irrigation solutions was estimated at USD 1.6 billion in 2018, and yearly 190 million wounds is treated in hospitals. Finalization of the SWIS-02 study concludes the clinical evaluation part of the SWIS documentation package. SWIS is expected to be the company’s first CE-marked product for the European market. Regarding the wound healing capabilities, the study meets its primary endpoint of re-epithelialization (non-inferior to NS) by day 10 with high significance (p<0.0001). Furthermore, early re-epithelialization at day 4 was significantly better than normal saline (mean 57% versus 43%, p<0.0001). Also, overall usability aspects of SWIS handling were reported to be satisfactory. Once again SWIS demonstrates and confirms previous findings (from SWIS-01) to be safe and well tolerated as a wound irrigation solution for acute wounds and not associated with any major risks. Performance outcomes demonstrate antimicrobial properties with excellent wound healing (re-epithelialization) observations.
お知らせ • Jun 09Softox Solutions AS Announces that the Danish Medicines Agency Has Given Conditional Approval for the First Study in Humans for Softox Inhalation SolutionSoftOx Solutions AS announced that the Danish Medicines Agency has given a conditional approval for the first study in humans for SoftOx Inhalation Solution (SIS) for the treatment of respiratory infections. SoftOx Solutions AS (SoftOx) aims to develop an inhalation solution (SIS) for the treatment of respiratory tract infections. This has the potential to be a breakthrough in the future treatment of respiratory infections, including viruses, bacteria and fungal infections.