New Risk • May 27
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr8.1m 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 (-kr8.1m free cash flow). Share price has been highly volatile over the past 3 months (31% average weekly change). Shareholders have been substantially diluted in the past year (55% increase in shares outstanding). Revenue is less than US$1m (kr11k revenue, or US$1.2k). Minor Risk Market cap is less than US$100m (€17.3m market cap, or US$20.1m). Board Change • May 20
No independent directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. No highly experienced directors. No independent directors (3 non-independent directors). was the last director to join the board, commencing their role in . The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Insufficient board refreshment. Announcement • Apr 27
Respiratorius AB (publ) to Report Q1, 2026 Results on May 26, 2026 Respiratorius AB (publ) announced that they will report Q1, 2026 results on May 26, 2026 Announcement • Jan 13
Respiratorius AB (publ) to Report Fiscal Year 2025 Results on Feb 10, 2026 Respiratorius AB (publ) announced that they will report fiscal year 2025 results on Feb 10, 2026 Announcement • Oct 13
Respiratorius AB (publ) to Report Q3, 2025 Results on Nov 11, 2025 Respiratorius AB (publ) announced that they will report Q3, 2025 results on Nov 11, 2025 Announcement • Sep 01
Respiratorius AB (Publ) Receives Meeting Minutes from FDA Pre-IND Meeting Respiratorius AB (publ) announced that the company has received the official meeting minutes from the pre-IND (Investigational New Drug) meeting recently held with the US Food and Drug Administration (FDA). The purpose of the meeting was to discuss strategic considerations ahead of the forthcoming clinical development of the company's drug candidate VAL001. The candidate is intended for the treatment of previously untreated difficult large B-cell lymphoma (DLBCL). The minutes provide a clear summary of the key topics discussed, including study design and the conduct of the planned Phase III trial. Overall, the content is consistent with the company's own interpretation of the FDA's recommendations. Respiratorius therefore considers that the outcome of the pre-IND meeting further strengthens the attractiveness of VAL001 and improves the company's opportunities to secure a development partner. The documentation will thus form an important part of the company's data room. Announcement • Aug 13
Respiratorius AB (publ) Conducts Pre-IND Meeting with the FDA Respiratorius AB (publ) announced that the company has held an advisory pre-IND (Investigational New Drug) meeting with the US Food and Drug Administration (FDA). The purpose of the meeting was to discuss strategic considerations ahead of the upcoming clinical development of the drug candidate VAL001, intended for the treatment of previously untreated diffuse large B-cell lymphoma (DLBCL). Prior to the meeting, Respiratorius submitted comprehensive background material to the FDA, including data from previous studies as well as specific questions regarding the planning and design of a future phase III trial. The meeting with the FDA primarily focused on two key areas: the study design and the implementation of the phase III trial, with the aim of obtaining marketing authorisation in the United States. The FDA recommended that supplementary data for dose levels lower than the maximum tolerated dose - established in previous phase I/IIa studies - should be incorporated into the phase III study design. Respiratorius views the constructive dialogue with the FDA and the guidance received as highly valuable inaping the study design and subsequent execution of the phase III trial together with a partner. The company now plans to maintain continued engagement with the agency in order to follow the FDA's recommendations and optimize the study design. Announcement • Jul 13
Respiratorius AB (publ) to Report First Half, 2025 Results on Aug 12, 2025 Respiratorius AB (publ) announced that they will report first half, 2025 results on Aug 12, 2025 Announcement • Jun 19
Respiratorius AB (publ) Grants Pre-IND Meeting with FDA for VAL001 Respiratorius AB (publ) announced that the company has been granted a pre-IND meeting with the U.S. Food and Drug Administration (FDA) ahead of a planned Investigational New Drug (IND) application for its drug candidate VAL001. The purpose of the meeting is to obtain regulatory guidance for the next steps in the clinical development of VAL001 in the strategically important U.S. market. The granted meeting request reflects interest from multiple stakeholders and forms a key part of the company's ongoing efforts to strengthen the positioning of the candidate. In collaboration with an international partner, Respiratorius has conducted a large number of interviews (N=135) with treating physicians and key opinion leaders (KOLs) in the U.S., Europe, and Japan. The results indicate that VAL001 is perceived as an attractive treatment option, demonstrating favorable clinical efficacy, with a well-known and established safety profile. A significant proportion, more than 70%, of the physicians and KOLs stated they would be willing to prescribe the drug. The findings have formed the basis for a comprehensive commercial analysis indicating that VAL001 is expected to achieve strong profitability shortly after a potential marketing authorization. A base-case scenario projects annual sales of USD 190 million at estimated market penetration, with cumulative revenue of USD 2.3 billion over the period of market exclusivity. A European patent for the formulation of VAL001 was recently granted. Similar patents have already been approved in the U.S., Japan, and Canada, ensuring protection of the formulation and its intended use across all key markets--particularly in the U.S. VAL001 is an innovative oral formulation of sodium valproate, developed to enhance efficacy with a low risk of side effects when used as pre-treatment prior to standard cancer therapy, primarily Diffuse Large B-cell Lymphoma (DLBC). Preclinical data suggest that VAL001 sensitize tumor cells to chemotherapy, potentially improving treatment outcomes across several cancer indications. The formulation has been evaluated in a pharmacokinetic study showing that VAL001, administered twice daily, achieves systemic exposure levels of valproate equivalent to those seen with the reference product used in the company's completed Phase I/IIa study--which requires dosing three times daily. The pre-IND meeting with the FDA represents a natural next step following the positive results previously communicated. The company looks forward to continuing development in line with its established strategy to enable broader clinical access to the drug candidate. Announcement • May 28
Respiratorius AB (Publ) Announces Notice of Allowance for European Patent on VAL001 Formulation Respiratorius AB (publ) announced that the European Patent Office (EPO) has issued a formal Notice of Allowance for its patent application covering the novel oral formulation of sodium valproate that supports VAL001. This milestone marks Respiratorius' first granted formulation patent, protecting a unique method for administering valproate as a pre-treatment in oncology. The patent carries a priority date of April 21, 2016, and once formally granted, will confer market exclusivity for at least 20 years from that date. Corresponding patents have already been approved in Japan, Canada and the United States. Announcement • Apr 22
Respiratorius AB (publ) to Report Q1, 2025 Results on May 21, 2025 Respiratorius AB (publ) announced that they will report Q1, 2025 results on May 21, 2025 Announcement • Apr 17
Respiratorius Research Accepted for Publication in Clinical Pharmacology in Drug Development Respiratorius AB (publ) announced that its scientific manuscript titled "Combined immediate-release and extended release formulation of sodium valproate provides stable plasma levels for inhibition of histone deacetylation" has been accepted for publication in the peer-reviewed journal Clinical Pharmacology in Drug Development. The study demonstrates that a novel formulation of sodium valproate - incorporating both immediate-release and sustained-release components - achieves stable plasma concentrations that are crucial for effective inhibition of histone deacetalases (HDAC). These results further support an improved dosing regimen for VAL00, Respiratorius' lead candidate being developed for first-line treatment of diffuse large B-cell lymphoma (DLBCL) in combination with R-CHOP. The acceptance of this manuscript underscores Respiratorius' commitment to high-quality research and strengthens its scientific presence in the field of clinical pharmacology and oncology drug development. Announcement • Dec 11
Respiratorius AB (publ) to Report Fiscal Year 2024 Results on Feb 11, 2025 Respiratorius AB (publ) announced that they will report fiscal year 2024 results on Feb 11, 2025 Announcement • Oct 14
Respiratorius AB (publ) to Report Q3, 2024 Results on Nov 12, 2024 Respiratorius AB (publ) announced that they will report Q3, 2024 results on Nov 12, 2024 Announcement • Jul 08
Respiratorius AB (publ) to Report Q2, 2024 Results on Aug 06, 2024 Respiratorius AB (publ) announced that they will report Q2, 2024 results on Aug 06, 2024 New Risk • Jul 07
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 70% 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 Less than 1 year of cash runway based on free cash flow trend (-kr6.6m free cash flow). Share price has been highly volatile over the past 3 months (68% average weekly change). Earnings have declined by 13% per year over the past 5 years. Shareholders have been substantially diluted in the past year (70% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (€10.5m market cap, or US$11.3m). New Risk • Jul 01
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr6.6m 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 (-kr6.6m free cash flow). Share price has been highly volatile over the past 3 months (66% average weekly change). Earnings have declined by 13% per year over the past 5 years. Revenue is less than US$1m. Market cap is less than US$10m (€6.15m market cap, or US$6.59m). Announcement • Apr 24
Respiratorius AB (publ), Annual General Meeting, May 21, 2024 Respiratorius AB (publ), Annual General Meeting, May 21, 2024. Announcement • Apr 23
Respiratorius AB (publ) to Report Q1, 2024 Results on May 21, 2024 Respiratorius AB (publ) announced that they will report Q1, 2024 results on May 21, 2024 Announcement • Apr 09
Respiratorius Announces Decision from the Patent Trial and Appeal Board at the American Patent Office Regarding the Patent Application for the Formulation of VAL001 Respiratorius announced decision from the Patent Trial and Appeal Board (PTAB) at the American Patent Office (USPTO) regarding the patent application for the formulation of VAL001. The PTBA has reversed all rejections of the examiner to both individual claims and the decision to reject the patent application, which means that the examiner must reopen the application. In addition to reversing the examiner's decision, the Patent Trial and Appeal Board does not point out any new rejections, which is considered as the examiner's ability to raise new rejections to the patent application is limited. The patent application is Respiratorius' first concerning formulation and claims a new oral formulation of sodium valproate for the pre-treatment of cancer. The priority date for the patent application is April 21, 2016, and is valid for at least 20 years from the priority date, which if approved provides market exclusivity during this period. The corresponding application was approved in Japan in 2022 and in Canada in 2023. New Risk • Feb 15
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -kr6.6m This is considered a minor 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 Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings have declined by 19% per year over the past 5 years. Revenue is less than US$1m. Market cap is less than US$10m (€6.21m market cap, or US$6.68m). Minor Risk Less than 1 year of cash runway based on current free cash flow (-kr6.6m). Announcement • Jan 15
Respiratorius AB (publ) to Report Fiscal Year 2023 Results on Feb 13, 2024 Respiratorius AB (publ) announced that they will report fiscal year 2023 results on Feb 13, 2024 New Risk • Nov 05
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2022. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (16% average weekly change). Earnings have declined by 22% per year over the past 5 years. Revenue is less than US$1m. Market cap is less than US$10m (€5.41m market cap, or US$5.80m). Minor Risk Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Announcement • Oct 16
Respiratorius AB (publ) to Report Q3, 2023 Results on Nov 14, 2023 Respiratorius AB (publ) announced that they will report Q3, 2023 results on Nov 14, 2023 Board Change • Aug 29
No independent directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 7 experienced directors. 2 highly experienced directors. No independent directors (6 non-independent directors). Director Kristina Drott was the last director to join the board, commencing their role in 2012. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Insufficient board refreshment. 