Tillkännagivande • May 06
Oxurion NV, Annual General Meeting, Jun 01, 2026 Oxurion NV, Annual General Meeting, Jun 01, 2026, at 14:00 Romance Standard Time. New Risk • Apr 19
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2025. 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 Debt is not well covered by operating cash flow (currently running at an operating cash loss). Share price has been highly volatile over the past 3 months (13% average weekly change). Negative equity (-€12m). Shareholders have been substantially diluted in the past year (over 18x increase in shares outstanding). Revenue is less than US$1m (€2.0k revenue, or US$2.4k). Market cap is less than US$10m (€354.8k market cap, or US$417.5k). Minor Risk Latest financial reports are more than 6 months old (reported June 2025 fiscal period end). Tillkännagivande • Nov 10
Oxurion NV to Report Fiscal Year 2025 Results on Apr 03, 2026 Oxurion NV announced that they will report fiscal year 2025 results on Apr 03, 2026 Reported Earnings • Oct 06
First half 2025 earnings released First half 2025 results: €0.24 loss per share. Net loss: €1.19m (loss narrowed 61% from 1H 2024). Tillkännagivande • Jul 23
Oxurion NV announced that it expects to receive €10 million in funding from Atlas Special Opportunities LLC Oxurion NV entered into a term sheet agreement for a private placement to issue 6% convertible bonds for the proceeds of €10 million on July 22, 2025. The transaction involves participation of Atlas Special Opportunities LLC as returning investor. The bonds matures on 12 months from issuance and bears 6% interest. The expected closing of transaction is end of August 2025 and transaction will happen in 10 tranches. Reported Earnings • Apr 14
Full year 2024 earnings released: EPS: €0.094 (vs €115 loss in FY 2023) Full year 2024 results: EPS: €0.094 (up from €115 loss in FY 2023). Net income: €119.0k (up €19.1m from FY 2023). Products in clinical trials Phase II: 1 Tillkännagivande • Apr 07
Oxurion NV, Annual General Meeting, May 13, 2025 Oxurion NV, Annual General Meeting, May 13, 2025. Reported Earnings • Oct 03
First half 2024 earnings released First half 2024 results: Net loss: €3.03m (loss narrowed 72% from 1H 2023). Tillkännagivande • Jul 09
Oxurion NV (ENXTBR:OXUR) signed a letter of intent to acquire 80% stake in Contract Research Organisation for €9.8 million. Oxurion NV (ENXTBR:OXUR) signed a letter of intent to acquire 80% stake in Contract Research Organisation for €9.8 million on July 8, 2024. Payment would be made in three steps: an initial payment of €4.39 million at closing , an earn-out of up to €4.39 million conditional on achieving an EBITDA of €860,000 in 2024 and a payment of €1 million payable in June 2025. Funding for the transaction will be secured at the level of an Oxurion's subsidiary, through a mix of debt financing (non dilutive) and funding on Oxurion level (than can be either a shareholder loan or equity/quasi equity financing). The transaction is subject to the completion of due diligence work, which is due to start in July, with completion scheduled for the end of September 2024. Signature of the definitive documentation is scheduled for October 2024 at the latest. Reported Earnings • Apr 17
Full year 2023 earnings released: €0.01 loss per share (vs €0.37 loss in FY 2022) Full year 2023 results: €0.01 loss per share (improved from €0.37 loss in FY 2022). Net loss: €19.0m (loss narrowed 40% from FY 2022). New Risk • Apr 16
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2023. 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 (83% average weekly change). Negative equity (-€8.6m). Earnings have declined by 1.5% per year over the past 5 years. Shareholders have been substantially diluted in the past year (over 7x increase in shares outstanding). Revenue is less than US$1m (€515k revenue, or US$547k). Market cap is less than US$10m (€575.4k market cap, or US$611.5k). Minor Risk Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Tillkännagivande • Apr 06
Oxurion NV to Report Fiscal Year 2023 Results on Apr 15, 2024 Oxurion NV announced that they will report fiscal year 2023 results on Apr 15, 2024 Tillkännagivande • Jan 25
Oxurion NV, Annual General Meeting, May 07, 2024 Oxurion NV, Annual General Meeting, May 07, 2024, at 14:00 Central European Standard Time. Tillkännagivande • Nov 20
Oxurion NV Discloses Topline Data from Kalahari Phase 2, Part B Trial of Novel PKal Inhibitor THR-149 in Diabetic Macular Edema Oxurion NV announced that topline data in its KALAHARI Phase 2, Part B clinical trial for Diabetic macular edema (DME) (KALAHARI trial) did not demonstrate that its novel PKal Inhibitor, THR-149, improved vision as much as the comparator, the anti-VEGF therapy aflibercept, at Month 3 (the primary endpoint). The mean change in best corrected visual acuity (BCVA) from baseline at Month 3 was -0.2 letters for theTHR-149 arm and +3.5 letters for the aflibercept arm. The results confirmed that THR-149 was safe and well tolerated. The KALAHARI trial is the only ongoing trial sponsored by Oxurion. In light of these results and the Company's low cash position, the Company has therefore decided to take the necessary steps to file for bankruptcy. Oxurion's investigators over-enrolled the trial with a total of 112 patients, for whom the current standard of care is suboptimal in treating their DME, reflecting the strong interest of both investigators and patients. The KALAHari trial evaluated Oxurion's novel plasma kallikrein (PKal) inhibitor THR-149 as a potential treatment for DME patients who respond suboptimally to anti-VEGF therapy. The continuation of the trial followed the recommendation from an Independent Data Monitoring Committee (IDMC) in December 2022 that it would not be futile for the KALAHARI trial to continue based on the outcome of a pre-specified futility analysis that included an evaluation of interim efficacy and safety data from 31 patients at Month 3 and followed encouraging data from the Part A dose- selection part of the KALAHARI trial. Reported Earnings • Oct 05
First half 2023 earnings released: €0.02 loss per share (vs €0.32 loss in 1H 2022) First half 2023 results: €0.02 loss per share (improved from €0.32 loss in 1H 2022). Net loss: €10.6m (loss narrowed 27% from 1H 2022). Tillkännagivande • Aug 24
Oxurion NV to Report First Half, 2023 Results on Sep 29, 2023 Oxurion NV announced that they will report first half, 2023 results on Sep 29, 2023 Tillkännagivande • May 26
Oxurion NV Reaches Enrollment Target in Kalahari Phase 2, Part B Trial of Novel Pkal Inhibitor Thr-149 in Diabetic Macular Edema Oxurion NV announced that it has reached its enrollment target of 108 patients randomized in its KALAHARI Phase 2, Part B clinical trial for diabetic macular edema (DME) (KALAHARI trial). As of Oxurion’s investigators have successfully enrolled the 108 patients planned for this trial. Given the high level of interest from both investigators and patients, additional patients are still likely to be included in the trial, which would mean the trial will be over-enrolled. As it has now reached its enrollment target, Oxurion confirms its previous guidance that it anticipates reporting top-line data from the KALAHARI trial in the fourth quarter of 2023. The KALAHARI trial is evaluating Oxurion’s novel plasma kallikrein (PKal) inhibitor THR-149 as a potential treatment for DME patients who respond suboptimally to anti-VEGF therapy, the current standard of care. This milestone follows the recommendation from an Independent Data Monitoring Committee (IDMC) in December 2022 that the KALAHARI trial should continue based on the outcome of a pre-specified futility analysis that included an evaluation of interim efficacy and safety data from 31 patients at the three-month time point. Approximately 22 million people worldwide have DME currently, with prevalence increasing due to the growing global diabetic epidemic. DME is the leading cause of vision loss in working-age people, and the market for treatments is currently estimated at +$5 billion. People who suffer from DME have leaking vessels in the back of the eye, leading to a thickening of the retina that causes vision problems such as blurriness in the center of vision, the appearance of dark spots or patches in the field of vision, and colors to look dull. These symptoms may affect the ability to read, write, drive, and recognize faces – presenting a significant patient and caregiver burden. Board Change • May 19
High number of new and inexperienced directors There are 4 new directors who have joined the board in the last 3 years. The company's board is composed of: 4 new directors. No experienced directors. 1 highly experienced director. Independent Non-Executive Director Thomas Clay is the most experienced director on the board, commencing their role in 2011. The company’s lack of experienced directors is considered a risk according to the Simply Wall St Risk Model. Board Change • Mar 16
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Non-Executive Independent Director Philippe Vlerick was the last independent director to join the board, commencing their role in 2015. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Tillkännagivande • Dec 16
Oxurion NV Announces the Continuation of KALAHARI Phase 2, Part B Study in Diabetic Macular Edema Following Interim Analysis Oxurion NV that an Independent Data Monitoring Committee (IDMC) completed its planned interim analysis of the KALAHARI Phase 2, Part B clinical trial evaluating Oxurion’s novel plasma kallikrein (PKal) candidate, THR-149, as a potential treatment for patients who respond suboptimally to anti-VEGF standard of care for treatment of diabetic macular edema (DME). The IDMC recommended continuation of the study based upon the outcome of the futility analysis. The IDMC assessment included an evaluation of interim efficacy and safety data from three-month data, with a total of 31 patients. Top-line data from the study is anticipated in the second half of 2023. Tillkännagivande • Nov 19
Oxurion NV Announces Interim Analysis for KALAHARI Trial Oxurion NV announced it is planning an interim analysis of at least 25% of the patients for the KALAHARI Phase 2, Part B clinical trial. Results of the interim analysis are expected by year-end 2022 and full top-line data from the trial is now expected in the second half of 2023. The KALAHARI trial is evaluating Oxurion’s novel plasma kallikrein (PKal) candidate, THR-149, as a potential treatment for patients who respond suboptimally to anti-VEGF standard of care for treatment of diabetic macular edema (DME). The Phase 2 KALAHARI study is a two-part, randomized, prospective, multi-center study assessing multiple injections of THR-149 in DME patients who have previously shown a suboptimal response to anti-VEGF therapy. Part B follows Part A of the study, in which three dose levels of THR-149 (0.005mg, 0.022mg and 0.13mg), were each administered in three monthly IVT injections, were evaluated in order to select the best dose for Part B of the study. High-level Month 3 data from Part A of the KALAHARI trial was first presented in October 2021 and demonstrated that in the eight patients who received the high dose of THR-149, a mean BCVA gain of 6.1 letters at Month 3, the primary endpoint, was observed. A post-hoc analysis of an OCT (Optical Coherence Tomography) biomarker assessment, was performed by the masked central reading center in February 2022. The masked reading center identified two subjects with abnormalities at baseline, which could impact responsiveness to any medical treatment. Excluding these two subjects resulted in an improvement in mean BCVA of 9.3 letters at Month 3 that was sustained until Month 6, the end of the trial. The six-month data also demonstrated THR-149’s attractive safety profile and its ability to stabilize the Central Subfield Thickness (CST). The learnings from the Part A data were incorporated into Part B through an amended study design. Price Target Changed • Nov 16
Price target decreased to €1.25 Down from €7.67, the current price target is an average from 2 analysts. New target price is 544% above last closing price of €0.19. Stock is down 91% over the past year. The company is forecast to post a net loss per share of €0.47 next year compared to a net loss per share of €0.76 last year. Tillkännagivande • Jun 09
Oxurion NV Announces Preclinical Presentation on THR-149 at KININ2022 Oxurion NV delivered a preclinical presentation evaluating the pharmacokinetic properties of THR-149 at KININ2022, held in Annecy, France, June 5-8, 2022. Overview: THR-149, a bicyclic peptide identified by a combination of phage-based selections and directed medicinal chemistry, is a potent and specific inhibitor of plasma kallikrein. In preclinical studies, THR-149 effectively blocked the release of bradykinin in the vitreous and reduced the level of edema and retinal vascular leakage in rodent models. Results: IVT-PK and IV-PK data were analyzed based on a mono-compartmental pharmacokinetic model, leading to ocular and systemic half-lives of 36 h and 1.1 h, respectively. The model indicates IVT administration of THR-149 reduces the four DME disease hallmarks: retinal vascular leakage, retinal edema, retinal inflammation and reactive gliosis. THR-149 is being developed as a potential new standard of care for the up to 50% of diabetic macular edema (DME) patients showing suboptimal response to anti-VEGF therapy. Oxurion is currently evaluating THR-149 for the treatment of DME in Part B, the second part of its two-part Phase 2 KALAHARI trial. Tillkännagivande • May 10
Oxurion Announces Top-Line Results from Part A of Phase 2 INTEGRAL Trial Evaluating THR-687 for Treatment of Diabetic Macular Edema (DME) Oxurion NV announced top-line results from Part A of its Phase 2 trial (“INTEGRAL”) of THR-687, an integrin antagonist, for the treatment of diabetic macular edema (DME). The Part A data showed THR-687 to be safe and well tolerated with no serious adverse events and none of the patients required rescue medication through Month 3, however, there was insufficient evidence of efficacy on the key endpoints (Best-Corrected Visual Acuity and Central Subfield Thickness). As a result, Oxurion has decided not to advance THR-687 to Part B of the INTEGRAL trial. The company is therefore fully focused on THR-149 which recently demonstrated a compelling safety and efficacy profile in patients with DME in the first part of the two-part Phase 2 KALAHARI trial. Part B of that trial is currently enrolling patients in the US and Europe. The INTEGRAL trial is a two-part, randomized, prospective, multicenter trial assessing multiple injections of THR-687 in treatment naïve DME patients. The Part A endpoints were safety (n = 16) and efficacy (n = 14), with two dose levels of THR-687 (1.2mg and 2.0mg) each administered in three monthly IVT injections. Patients are being followed-up until month six of Part A of the trial, and it looks forward to presenting the full data set at an upcoming medical conference. Price Target Changed • May 09
Price target increased to €10.00 Up from €7.50, the current price target is an average from 2 analysts. New target price is 1,567% above last closing price of €0.60. Stock is down 76% over the past year. The company is forecast to post a net loss per share of €0.78 next year compared to a net loss per share of €0.76 last year. Tillkännagivande • Apr 21
Oxurion NV, Annual General Meeting, May 02, 2023 Oxurion NV, Annual General Meeting, May 02, 2023. Tillkännagivande • Apr 13
Oxurion Announces Upcoming Pre-Clinical Data Presentation on THR-687 for the Treatment of Diabetic Macular Edema at the 2022 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting Oxurion NV announced it will be presenting pre-clinical data from a study evaluating THR-687 for treatment of diabetic macular edema (DME) at the upcoming Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting being held in Denver, Colorado on May 1-4th and virtually on May 11-12th. The presentation will review pre-clinical data supporting THR-687 providing protection against retinal vascular permeability, inflammation and reactive gliosis in the diabetic rat.THR-687 is a highly selective pan-RGD integrin antagonist that is initially being developed as a potential first line therapy for DME patients and may have the potential to deliver improved treatment outcomes for patients with wet macular degeneration (wet AMD) and macular edema following retinal vein occlusion (ME-RVO). Oxurion is currently evaluating THR-687 in a two-part Phase 2 clinical trial (“INTEGRAL”) in patients with DME. Part A dose optimization data from the INTEGRAL trial is anticipated in the first half of 2022. If successful, the efficacy and safety of THR-687 versus aflibercept (the current standard of care) will be evaluated in Part B of the INTEGRAL Phase 2 clinical trial in both treatment-naïve and treatment-experienced patients with DME. The pre-clinical data supports the view that THR-687 provides protection in the diabetic rat against retinal vascular permeability, inflammation and reactive gliosis. Reported Earnings • Mar 29
Full year 2021 earnings: Revenues exceed analyst expectations Full year 2021 results: Net loss: €29.2m (loss widened 4.1% from FY 2020). Revenue exceeded analyst estimates by 147%. Over the next year, revenue is expected to shrink by 71% compared to a 155% growth forecast for the pharmaceuticals industry in Belgium. Reported Earnings • Feb 24
Full year 2021 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2021 results: €0.77 loss per share (down from €0.73 loss in FY 2020). Net loss: €29.2m (loss widened 4.1% from FY 2020). Products in clinical trials Phase I: 1 Phase II: 1 Revenue exceeded analyst estimates by 147%. Earnings per share (EPS) missed analyst estimates by 3.7%. Over the next year, revenue is expected to shrink by 100% compared to a 87% growth forecast for the pharmaceuticals industry in Belgium. Over the last 3 years on average, earnings per share has increased by 22% per year but the company’s share price has fallen by 29% per year, which means it is significantly lagging earnings. Tillkännagivande • Feb 15
Oxurion NV Announces New Data on THR-149 Phase 2 Clinical Trial in DME At the Angiogenesis, Exudation, and Degeneration 2022 Conference Oxurion NV presented new data from Part A of its two-part Phase 2 Clinical Trial assessing THR-149 for treatment of diabetic macular edema at the Angiogenesis, Exudations, and Degeneration 2022 Meeting on February 11-12th. THR-149 is a potent plasma kallikrein inhibitor being developed as a potential new standard of care for the 40-50% of DME patients showing suboptimal response to anti-VEGF therapy. High-level Month 3 data from Part A of the KALAHARI trial was first presented in October 2021 and demonstrated that in the 8 patients who received the highest dose of THR-149, a mean BCVA gain of 6.1 letters at Month 3, the primary endpoint, was observed. The new data reviewed is a post-hoc analysis of an OCT biomarker assessment, which was performed by the masked central reading center. The masked reading center identified two subjects with abnormalities at baseline, which could impact responsiveness to treatment. Excluding these two subjects resulted in an improvement in mean BCVA of 9.3 letters at Month 3 that was sustained until Month 6, the end of the trial. The six-month data also demonstrated THR-149’s attractive safety profile and its ability to stabilize the Central Subfield Thickness. Tillkännagivande • Jan 07
Oxurion Provides Update on Clinical Pipeline Progress Oxurion NV announced updates on its two clinical programs, THR-687, initially being developed for first line treatment of DME, and THR-149 being developed for second line treatment of DME.THR-687 is a potential best-in-class small molecule pan-RGD integrin antagonist being developed for the treatment of DME and holding promise for the treatment of wet Age-related Macular Degeneration (wAMD) and macular edema following Retinal Vein Occlusion (RVO). The INTEGRAL trial is a two-part Phase 2, randomized, multi-center clinical trial and is the first trial in which multiple intravitreal injections of THR-687 will be administered in humans. Part A of the trial will assess two dose levels of multiple THR-687 injections and, if successful, the trial’s results will be used to select the appropriate dose for Part B of the INTEGRAL trial that will evaluate the efficacy and safety of THR-687 versus aflibercept (the current standard of care) for the treatment of DME. Part B of the trial will include both treatment experienced and treatment naïve subjects. The dose selection decision, following Part A, is anticipated in the first half of 2022 with top line data from Part B expected in the second half of 2023. The post-hoc analysis of the Part A results identified opportunities to optimize the inclusion and exclusion criteria for Part B for both probability of success and speed. Part B of the KALAHARI trial is ongoing, assessing three monthly injections of THR-149, compared to three monthly injections of aflibercept, up to Month 3. As from Month 3, the safety and efficacy of a switched fourth injection (THR-149 to aflibercept or aflibercept to THR-149) will be evaluated in about half of the subjects whereas in the other half of the subjects the durability of three monthly injections (THR-149 or aflibercept) will be evaluated through a single sham injection. The trial is planned to randomize approximately 108 subjects in Part B and the primary endpoint remains the mean change in BCVA letter score from baseline, at Month 3. Tillkännagivande • Nov 24
Oxurion NV announced that it has received €10 million in funding from Pontifax Ltd., Kreos Capital Management (UK) Limited Oxurion NV announced that it has entered into loan agreement with new investors Pontifax Ltd., Kreos Capital Management (UK) Limited for the issue of convertible bonds for the gross proceeds of €10 million on November 22, 2021. The bonds will have a 38-month term, consisting of at least eight months of interest only payments followed by 30 monthly payments of principal and interest. The bonds will accrue interest at a rate of 7.95% per annum. The loan agreement provides for a €125,000 transaction fee and €350,000 end of loan fee. The bonds will be convertible into new ordinary shares at 140% of the 30 day VWAP on the third trading day immediately preceding the date of the notarial deed relating to the issuance of the bonds. The transaction is subject to customary closing conditions. Tillkännagivande • Oct 02
OXURION Announces Positive Results from Part A of Phase 2 Study Evaluating THR-149 for Treatment of Diabetic Macular Edema (DME) Oxurion NV announced positive data from Part A of its Phase 2 study (“KALAHARI”) of THR-149, a plasma kallikrein inhibitor, for the treatment of DME. Based on these data the Company has decided to move the dose of THR-149 (0.13mg) into Part B of the study, which is expected to begin shortly. THR-149, is being developed as a potential new standard of care intravitreal (IVT) therapy for the 40-50% of DME patients showing suboptimal response to anti-VEGF therapy. THR-149 acts through inhibition of the plasma kallikrein-kinin (PKaI-Kinin) system, a validated VEGF-independent target for DME. The Phase 2 KALAHARI study is a two-part, randomized, prospective, multi-center study assessing multiple injections of THR-149 in DME patients who have previously shown a suboptimal response to anti-VEGF therapy. The endpoints of Part A of the study were safety (n= 23) and efficacy (n = 20). In Part A of the study, three dose levels of THR-149 (0.005mg, 0.022mg and 0.13mg), each administered in three monthly IVT injections, were evaluated in order to select the best dose for Part B of the study. Results from Part A showed that all dose levels of THR-149 had a favorable safety profile, with no serious adverse events being observed. All adverse events in the study eye were mild to moderate in intensity and no severe ocular adverse events were reported. Finally, no inflammation was seen in the study eye of any patient at any dose evaluated in Part A of the study. When assessing efficacy, three IVT injections of THR-149 (0.13mg) delivered the most promising results in terms of Best Corrected Visual Accuity (BCVA), the primary endpoint for registration in DME, and also delivered a stable Central Subfield Thickness (CST), a promising result in a population were if left untreated CST would be expected to deteriorate. No patients in the high dose group (n = 8) required rescue medication. In terms of BCVA, the dose delivered a mean 6.1 letter improvement at Month 3. The range of BCVA changes with the dose was -0.4 to 12.6 letters at Month 3. In terms of CST, the dose showed a stable CST (mean change of 13 µm) at Month 3. The range of CST changes with the dose was -37.1 to 63.6 µm at Month 3. Tillkännagivande • Jun 10
OXURION Confirms Institutional Review Board Approval and Submission of the Investigational New Drug Application to the FDA to Start Phase 2 Study Evaluating THR-687 for Diabetic Macular Edema (DME) Oxurion NV announced that it has received Institutional Review Board (IRB) approval to initiate a Phase 2 clinical study of THR-687 in patients with Diabetic Macular Edema (study name “INTEGRAL”). Together with its earlier submission to the U.S. Food and Drug Administration (FDA) of the final protocol to the Investigational New Drug (IND) Application, this is an important step forward for the Phase 2 INTEGRAL study. Today’s announcement follows the positive data reported from a Phase 1, open-label, multi-center (US), single dose escalation study (n=12) evaluating the safety of a single intravitreal injection of 3 increasing doses (0.4 mg, 1.0 mg, 2.5 mg) of THR-687 for the treatment of DME. A single injection of THR-687 was reported safe and well-tolerated, showing a very encouraging efficacy signal. Across all doses, a rapid onset of action in mean BCVA was observed from Day 1 with an increase of 3.1 letters, which further improved to 9.2 letters at Month 1. This activity was maintained with a mean BCVA improvement of 8.3 letters at Month 3 following a single injection of THR-687. A clear dose response was seen with the positive effect on BCVA and Central Subfield Thickness (CST) with the dose of THR-687. For this dose, a mean BCVA Improvement of 11 letters was noted at Day 14, with a peak improvement of 12.5 letters at Month 3. Similarly, a peak mean CST decrease of 106 µm was observed at Day 14 with the dose of THR-687. Beyond DME, THR-687 also has development possibilities in additional vascular retinal disorders including for wet Age-related Macular Degeneration (wet AMD) and retinal vein occlusion (RVO), thereby potentially allowing the Company to tap into a broader therapeutic market with a current combined estimated annual value of $12+ billion. Tillkännagivande • Jun 08
OXURION Completes Patient Enrollment for Part A of Phase 2 Study Evaluating THR-149 for Treatment of Diabetic Macular Edema (DME) Oxurion NV announced the completion of patient enrollment into Part A of its two part Phase 2 study evaluating multiple injections of THR-149 for the treatment of DME. Dose selection data from Part A of the study is expected in the second half of 2021. THR-149, Oxurion’s most advanced drug candidate, is being developed to potentially become the treatment of choice for the up to 40% of DME patients, who respond suboptimally to anti-VEGF therapy. THR-149 acts through inhibition of the plasma kallikrein-kinin (PKaI-Kinin) system, a validated VEGF-independent target for DME. A single dose Phase 1 study showed that THR-149 was well-tolerated, safe and delivered promising efficacy results, particularly improvements in patients’ Best Corrected Visual Acuity (BCVA) the primary endpoint for registration in DME. A rapid onset of action was observed from Day 1, across all doses, with an increasing average improvement in BCVA of up to 7.5 letters at Day 14. Importantly, this visual gain was maintained with an average improvement in BCVA of 6.4 letters at Day 90. The Phase 2 KALAHARI study is a two part, randomized, prospective, multi-center study assessing multiple (3) injections of THR-149 in DME patients who suboptimally respond to anti-VEGF therapy. In Part A of the study, three dose levels of THR-149, each administered in 3 monthly intravitreal injections, are being tested in at least 18 patients to select the optimal dose for Part B. Reported Earnings • Apr 08
Full year 2020 earnings released Full year 2020 results: Net loss: €28.0m (loss narrowed 46% from FY 2019). Products in clinical trials Phase I: 1 Phase II: 1 Tillkännagivande • Apr 07
Oxurion NV announced that it expects to receive €30 million in funding from Negma Group Ltd. Oxurion NV (ENXTBR:OXUR) announced a private placement of mandatory convertible bonds for gross proceeds of €30 million on April 6, 2021. The transaction will include participation from new investor Negma Group Ltd. The bonds are convertible for common shares of the company. The company will receive the funding in multiple tranches over a 12-month period Reported Earnings • Mar 20
Full year 2020 earnings released: €0.75 loss per share (vs €1.35 loss in FY 2019) Full year 2020 results: Net loss: €28.0m (loss narrowed 46% from FY 2019). Products in clinical trials Phase I: 1 Phase II: 1 Over the last 3 years on average, earnings per share has fallen by 58% per year but the company’s share price has only fallen by 14% per year, which means it has not declined as severely as earnings. Tillkännagivande • Mar 18
Oxurion NV to Report Fiscal Year 2020 Final Results on Apr 05, 2021 Oxurion NV announced that they will report fiscal year 2020 final results on Apr 05, 2021 Tillkännagivande • Jan 21
Oxurion Nv Appoints Prof Alan Stitt as Chief Scientific Officer Oxurion NV announced the appointment of Professor Alan Stitt, Ph.D. as the company’s Chief Scientific Officer, effective January 19, 2021. This appointment follows the retirement of current CSO Jean Feyen, PhD, who has served in this position since joining the company in 2013. Dr. Feyen will remain available to the company during a transition period to support Professor Stitt and the rest of the pre-clinical development team. Is New 90 Day High Low • Nov 26
New 90-day high: €2.90 The company is up 17% from its price of €2.47 on 28 August 2020. The Belgian market is up 10.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is flat over the same period. Tillkännagivande • Nov 09
OXURION NV Confirms New Patents for THR-687 Issued by European and US Patent Offices Oxurion NV announced a further strengthening of its intellectual property (IP) portfolio governing THR-687, an integrin antagonist being developed for the treatment of DME. The European Patent Office (EPO) and the United States Patent and Trademark Office (USPTO) have both issued new composition-of-matter patents covering THR-687. Patents EP3613739 and US10703752 were issued in November 2020 and July 2020 respectively, and expire in 2039, with possible patent extensions of up to 5 additional years (2044). An international application is still pending. THR-687 is a potential best-in-class small molecule pan-RGD integrin antagonist being developed to treat DME holding potential of becoming the standard of care for DME patients. Data from a Phase 1 trial showed that THR-687 is well-tolerated and safe with no dose-limiting toxicities and no serious adverse events reported at any of the doses evaluated in the study. Early signs of efficacy were also observed across all doses, with a rapid onset of action in mean Best Corrected Visual Acuity (BCVA) from Day 1. Following a single injection of the highest dose of THR-687, this activity was maintained at Month 3 with a mean BCVA improvement of 12.5 letters. Oxurion pre-clinical data show that THR-687 has the potential to be developed for additional significant indications, including wet Age-related Macular Degeneration (wAMD) and Retinal Vein Occlusion (RVO). Tillkännagivande • Oct 14
Oxurion NV Announces Executive Changes Oxurion NV announced the appointment of Tom Graney as its Chief Financial Officer. Mr. Graney will begin his role on 14th October and will be based in Boston, MA, US. He will succeed Dominique Vanfleteren who, according to plan, is leaving Oxurion to pursue other interests. Mr. Graney will be responsible for the extension and execution of the financial strategy to support Oxurion's ambitious global growth plans, including the important US market. Tom has over 25 years’ experience in senior finance, strategy and operational roles including capital raising, accounting, and audit. He most recently served as CFO at Generation Bio, a non-viral gene therapy company based in Cambridge, MA, where he led all of the company’s financial operations. Tillkännagivande • Sep 22
Baron Philippe Vlerick, Non-Executive member of the Board of ThromboGenics NV acquired 3.6% stake in ThromboGenics NV (ENXTBR:THR). Baron Philippe Vlerick, Non-Executive member of the Board of ThromboGenics NV acquired 3.6% stake in ThromboGenics NV (ENXTBR:THR) on May 19, 2015.
Baron Philippe Vlerick, Non-Executive member of the Board of ThromboGenics NV completed the acquisition of 3.6% stake in ThromboGenics NV (ENXTBR:THR) on May 19, 2015. Is New 90 Day High Low • Sep 22
New 90-day low: €2.45 The company is down 24% from its price of €3.22 on 24 June 2020. The Belgian market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is flat over the same period. Tillkännagivande • Sep 21
Oxurion NV(ENXTBR:OXUR) dropped from S&P Global BMI Index Oxurion NV(ENXTBR:OXUR) dropped from S&P Global BMI Index Reported Earnings • Sep 18
First half earnings released Over the last 12 months the company has reported total losses of €31.6m, with losses narrowing by 44% from the prior year.