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. New Risk • Jun 04
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: -kr4.8m 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 (-kr4.8m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings have declined by 2.0% per year over the past 5 years. Shareholders have been substantially diluted in the past year (74% increase in shares outstanding). Revenue is less than US$1m (kr1.7m revenue, or US$177k). Market cap is less than US$10m (kr44.8m market cap, or US$4.66m). 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. New Risk • Apr 29
New major risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Swedish stocks, typically moving 15% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 4.5% per year over the past 5 years. Shareholders have been substantially diluted in the past year (74% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (kr22.7m market cap, or US$2.36m). Minor Risk Share price has been volatile over the past 3 months (15% average weekly change). 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 Board Change • Nov 28
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. 5 experienced directors. 1 highly experienced director. No independent directors (3 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. 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 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. 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 04
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 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 (kr63.1m market cap, or US$5.80m). Minor Risks Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Share price has been volatile over the past 3 months (8.9% average weekly change). 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 Announcement • Jul 12
Respiratorius AB (publ) to Report Q2, 2023 Results on Aug 08, 2023 Respiratorius AB (publ) announced that they will report Q2, 2023 results on Aug 08, 2023 Announcement • Jul 04
Respiratorius Continues to Strengthen Val001 Respiratorius presented positive results from the pharmacokinetic study with the new formution of VAL00101. The company has now announced that it has filed a new patent application regarding the formulation, which further strengthens the protection for the candidate. At the same time, work continues to build a strong case in the partnering process that is currently underway. Announcement • Jul 01
Respiratorius Announces Filing of New Patent Application for VAL001 Respirarius a announces that a patent application for the completed formulation of VAL001 has been file The patent apapplication protects the formulation of valproate, which in a PK study has shown expected results. The patent application protects a new oral formulation of sodium valproate for the pretreatment of cancer, as well as any other use of the formulation. The application is valid for at least 20 years from the date of priority, during which time it confers exclusive rights on the market. The tailored release profile of VAL001, which combines immediate-release and delayed-release properties of sodium valproate, was evaluated as previously reported in a pharmacokinetic (PK) study in healthy subjects with expected results. The plasma concentration of valproate after twice daily administration of VAL001 was similar to that achieved with the reference formulation, dosed three times daily. Advantageously, VAL001 resulted in lower peak concentrations of valproate, as well as more constant plasma concentration over time, compared to the reference formulation. In addition to the favorable PK profile, analysis of a biomarker for histone acetylation, which predicates the effect of valproate, also showed positive results. The expression of the biomarker was higher at all measured time points and at most 40 percentage points higher at 48 hours after dosing with VAL001 compared to the reference formulation. 48 hours is the time point when the immunochemotherapy with R-CHOP is initiated, why this is an important result. In addition to enabling simplified dosing twice daily instead of three times daily, the results suggest that the effect of the new formulation may be better, even though the total exposure, and thus the likely risk of side effects, does not increase. A modified PK profile is also an important part of an improved differentiation from generic valproate and better regulatory protection. Announcement • Jan 20
Respiratorius Announces Positive Results from PK Study of VAL001 impmportant biomarker are also available. The results show that VAL001 has a favorable PK profile as well as a greater histone acetylating effect compared to the reference. The tailored release profile of VAL001, which combines immediate-release properties and extended-release sodium valproate, was evaluated in a pharmacokinetic (PK) study in healthy subjects. The total plasma concentration of valproate from VAL001, with dosing twice daily, was similar to that achieved with the reference formulation, which was dosed three times daily. Advantageously, VAL001 gave lower peaks of the maximum valproate concentration than the reference formulation, which is of importance for the occurrence of side effects, especially at these relatively high concentrations of valproate that are necessary to provide the desired inhibition of histone deacetylase. VAL001 also showed more consistent plasma concentrations over time compared to the reference formulation. In addition to the favorable PK profile, analysis of a biomarker for histone acetylation also showed positive results. Valproate potentiates the effect of chemotherapy by altering the chromatin structure of DNA via inhibition of histone deacetylase and the biomarker in question thus predicates the effect of valproate. The expression of the biomarker was higher at all measured time points and at most 40% points higher at 48 hours after dosing with VAL001 compared to the reference formulation. In addition to enabling dosing 2 times daily instead of 3 times daily, the results suggest that the effect of the new formulation may be better, even though the overall exposure, and thus the likely risk of side effects, does not increase. A modified PK profile is also an important part of a better differentiation towards generic valproate and better regulatory protection. Announcement • Jan 09
Respiratorius AB (publ) to Report Fiscal Year 2022 Results on Feb 07, 2023 Respiratorius AB (publ) announced that they will report fiscal year 2022 results on Feb 07, 2023 Board Change • Nov 16
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. Announcement • Oct 10
Respiratorius AB (publ) to Report Q2, 2022 Results on Nov 08, 2022 Respiratorius AB (publ) announced that they will report Q2, 2022 results on Nov 08, 2022 Announcement • Jul 01
Respiratorius AB (Publ) Announces Dosing of Last Subjects in PK Study of VAL001 Respiratorius announced that the last subjects in the ongoing PK study of VAL001 has been dosed. The tailored release profile of VAL001, combining immediate release and extended-release characteristics of sodium valproate, is evaluated in the pharmacokinetic (PK) study in healthy subjects. Preliminary results of the initial part of the study were evaluated during March 2022. Board Change • Apr 27
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. Announcement • Apr 04
Respiratorius AB (publ), Annual General Meeting, May 02, 2022 Respiratorius AB (publ), Annual General Meeting, May 02, 2022. Announcement • Feb 15
Respiratorius AB (Publ) Announces Dosing of First Study Subjects in PK Study of VAL001 Respiratorius announced that on February 14 the first study subjects in PK study of VAL001 were dosed. The tailored release profile of VAL001, combining immediate release and extended-release characteristics of sodium valproate, will be evaluated in the pharmacokinetic study in healthy subjects. Preliminary results of the initial part of the study are expected during quarter 1, 2022 and close out of the entire study during quarter two, 2022. Announcement • Jan 12
Respiratorius announces PK study approval for VAL001 Respiratorius announced that the PK study is now approved by the Health Authorities (HA) in the country for the PK study conduct. The study has previously been approved by the Ethics Committee (EC) but the recent minor changes requested by the HA need to be reviewed and re-approved by the EC before the study can be initiated. Thereafter the study can be initiated, and study subjects can be recruited as soon as possible. The patent pending novel formulation, VAL001, combines immediate release and extended-release characteristics of sodium valproate contained in a capsule formulation. This tailored release profile will be evaluated in a pharmacokinetic (PK) phase I study in healthy subjects. Announcement • Oct 02
Brazil Grants Patent for VAL001 The Brazilian National Institute of Industrial Property (INPI) has announced the intent to grant Respiratorius patent for VAL001. After the formal fees have been paid, the patent will be granted, which will give Respiratorius market exclusivity in Brazil until 2031. Previously, the patent has been granted in Europe, US, Japan, Canada, and Korea under equivalent conditions. The patent covers a combination of an HDAC inhibitor and a steroid for pre-treatment with standard chemotherapy (R-CHOP) in the treatment of diffuse large B-cell lymphoma (DLBCL), a lymphoma which annually affects about 60,000 people in the United States and Europe. DLBCL is the most common type of Non-Hodgkin's lymphoma, and comprises 30% of diagnosed lymphoma patients in the EU. The combination is thus superior to other treatments according to the results from the phase I/IIa study, in which valproate + R-CHOP displayed a very large reduction in risk of mortality,> 50%, compared to the 20-30% reduction in mortality considered to be clinically relevant for oncology drugs in general. As previously communicated, Orphan Drug Designation in Europe and the United States has been granted, giving market exclusivity for 10 and 7 years, respectively, from market approval. Breakeven Date Change • Jun 02
Forecast to breakeven in 2022 The analyst covering Respiratorius expects the company to break even for the first time. New forecast suggests the company will make a profit of kr40.0m in 2022. Average annual earnings growth of 158% is required to achieve expected profit on schedule. 