A Phase 2A Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Varoglutamstat (PQ912) in Patients With Early Alzheimer's Disease With a Stage-Gate to Phase 2B (VIVA-MIND)

This is a Phase 2A multi-center, randomized, double blind, placebo-controlled, parallel group study of varoglutamstat, with a stage gate to Phase 2B.
In Phase 2A there will be adaptive dosing evaluation of three dose levels with exposure to varoglutamstat or placebo for a minimum of 24 weeks, with preliminary evaluation of both cognitive function and pharmacodynamic changes on EEG spectral analysis in approximately 180 participants.
In the event that the stage gate for Phase 2B is reached, then Phase 2B will assesses efficacy and longer-term safety in a larger study group, i.e., 414.

Start Date15 Nov 2021

Sponsor / Collaborator

Vivoryon Therapeutics NV

[+1]

NCT02389413

/ CompletedPhase 2

A Phase 2A Multicentre, Randomised, Double Blind, Placebo-Controlled, Parallel-Group Safety and Tolerability Study of PQ912 in Subjects With Early Alzheimer's Disease

The aim of this study is to evaluate the safety, tolerability and preliminary efficacy of PQ912 in subjects with Mild Cognitive Impairment (MCI) due to Alzheimers Disease (AD) or mild dementia due to AD.

Start Date01 Mar 2015

Sponsor / Collaborator

Vivoryon Therapeutics NV

[+1]

NCT02190708

/ CompletedPhase 1

A Phase I, Open Label Study to Assess the Effects of PQ912 on the Pharmacokinetics of Midazolam and Omeprazole in Healthy Male Subjects

Midazolam is a rapid-acting benzodiazepine, with a short half-life (approximately 1.9 hours) and is primarily metabolised by CYP3A.
Omeprazole is a selective proton pump inhibitor substrate used to reduce gastric acid secretion. Omeprazole is primarily metabolised by CYP2C19.
Midazolam and omeprazole are both used as probe drugs in clinical pharmacology studies to evaluate clinical CYP3A and CYP2C19 drug interactions, respectively. Furthermore the EMA and the FDA guidance on drug interactions recommend the use of these drugs for such evaluations.
The aim of this study is to assess the effect of PQ912 on the PK of midazolam and omeprazole. In vitro studies have demonstrated that PQ912 inhibits several CYP enzymes, including CYP3A4 and CYP2C19 and at the expected exposure levels in patients, has the potential to inhibit these enzymes in-vivo. This study is therefore planned to investigate the potential changes in the PK of midazolam and omeprazole due to the effect of PQ912 at steady-state. In clinical practice it is likely that co-administration of PQ912 with other drugs that are metabolised via the CYP3A and/or CYP2C19 enzymes will occur. This study will provide important information for the requirement of dose adjustments or contraindications in these circumstances.

Start Date01 Jun 2014

Sponsor / Collaborator

Vivoryon Therapeutics NV

[+1]

100 Clinical Results associated with Varoglutamstat

100 Translational Medicine associated with Varoglutamstat

100 Patents (Medical) associated with Varoglutamstat

Literatures (Medical) associated with Varoglutamstat

14 Apr 2026·ChemMedChem

Benzimidazole as a Versatile Scaffold for Developing Neurotherapeutics Against Neurodegenerative Diseases

Review

Author: Tiwari, Prashant ; Dubey, Sonal ; Barnwal, Nivedita

Neurodegenerative diseases (NDs) such as Alzheimer's disease (AD), Parkinson's disease (PD), Huntington's disease (HD), and amyotrophic lateral sclerosis (ALS) are characterized by progressive neuronal loss, leading to severe cognitive and motor dysfunction. Benzimidazole, a privileged heterocyclic scaffold, has emerged as a promising pharmacophore in modulating key pathological targets across these disorders. In AD, benzimidazole derivatives inhibit cholinesterases, glycogen synthase kinase‐3β (GSK‐3β), and glutaminyl cyclase (QC), thereby addressing cholinergic dysfunction, tau phosphorylation, and amyloid aggregation. In PD and HD, they act as monoamine oxidase‐B (MAO‐B) inhibitors, dopamine D1/D2 receptor modulators, and N‐methyl D‐aspartate receptor antagonists, improving dopaminergic signalling and reducing excitotoxicity. In ALS, benzimidazoles regulate acetylcholine dysfunction and inhibit receptor‐interacting protein kinase 1 (RIPK1), limiting neuroinflammation and cell death. Preclinical studies demonstrate potent enzyme inhibition, often with IC 50 values in the nanomolar to micromolar range, alongside favourable ADMET properties enabling blood‐brain barrier penetration. Clinically, the glutaminyl cyclase inhibitor Varoglutamstat has advanced to Phase II trials for AD, while Riluzole remains the only food and drug administration (FDA)‐approved benzimidazole drug for ALS. The structural versatility of benzimidazoles supports their development as multi‐target‐directed ligands, addressing overlapping mechanisms such as protein aggregation, oxidative stress, and neuroinflammation. Emerging strategies including hybrid molecules, nanocarrier delivery, and AI‐driven design may accelerate their clinical translation.

01 Dec 2025·Alzheimers & Dementia

Generalizability of digital speech and language assessments in MCI/mild AD across four non‐English languages

Article

Author: Xu, Mengdan ; Schaeffer, Michael ; Cormack, Francesca K ; Wenzkowski, Christine ; Lillo, Martina De ; Fuchs, Katharina ; Spilka, Michael J. ; Robin, Jessica

Abstract:

Background:

Neurodegenerative diseases affect speech production. Previous studies show various acoustic and linguistic changes in Mild Cognitive Impairment (MCI) and Alzheimer's disease (AD) speech patterns, such as more pauses and lower usage of nouns. However, most research has focused on English speakers. This analysis examines speech features in MCI and AD patients across four languages to determine if digital speech assessments yield comparable results across different languages.

Method:

This study included 244 patients with MCI or mild AD enrolled in the Phase 2b VIVIAD trial of varoglutamstat, in four language groups: Danish ( n =84), German ( n =59), Dutch ( n =40), and Spanish ( n =61). A picture description task was administered to all patients at baseline using instructions in their respective languages. Five speech features including number of picture objects described, number of nouns, speech rate, pronoun‐to‐noun ratio and average of word length were chosen based on previous analyses of speech patterns in MCI/AD, and a composite score was calculated combining the five measures. We tested the interrelationships among the features in each language and examined whether the speech features were related to another measure of cognitive function, the Mini‐Mental State Exam (MMSE). Associations were examined using a correlational approach.

Result:

There was variation in the magnitudes of the correlations between speech features in the different languages, but the directions of the associations were generally consistent across the four languages in the study. In all four languages, significant correlations with the MMSE were found with both the composite score (‐0.46 ≤ r ≤ ‐0.26) and the object content score (0.27 ≤ r ≤ 0.42).

Conclusion:

Together, these results indicate that there are consistent interrelationships among different speech features across languages. In addition, in the four languages examined, the speech composite score and the number of objects correctly described related to a standard measure of cognition, the MMSE. These results suggest that digital measures of speech and language in MCI/AD are generalizable across languages and relate to cognitive ability more generally. In addition, a composite score of multiple speech features may be more sensitive to cognitive impairment than individual speech metrics.

01 Dec 2025·Alzheimers & Dementia

The VIVA‐MIND study: Topline Results from Phase 2 RCT of Varoglutamstat in Early AD

Article

Author: Messer, Karen ; Lama, Nicola ; Revta, Carolyn ; Weber, Frank ; Balasubramanian, Archana ; Edland, Steven D ; Wenzkowski, Christine ; Pol, Alessandra ; Jacobs, Diane M. ; Meyer, Antje ; Wassmann, Tanja ; Duehring, Jasmin ; Schell‐Mader, Sylvia ; Leger, Gabriel C ; Lupo, Jody‐Lynn ; Zhang, Jing ; Schaeffer, Michael ; Feldman, Howard H. ; MacKelfresh, Andrew ; Quach, Natalie E

Abstract:

Background:

Varoglutamstat (PQ912) is an oral small molecule inhibitor of glutaminyl cyclases which reduces the pyroglutamate formation of Aβ and CCL2. Preclinical and Ph1 trials support this Ph2 evaluation in early AD. Our objectives included selecting the highest safe and well‐tolerated dose of varoglutamstat with futility analysis at 24 weeks (Ph2A) followed by seamless evaluation of longer‐term safety and efficacy at 72 weeks at this dose (Ph2B).

Method:

Participants with biomarker confirmed early AD were randomized to varoglutamstat or placebo. A sequential design tested 3 descending doses (600mg, 300mg, 150mg BID) using a continuous Pocock safety boundary. A Stage Gate futility analysis of the first 180 subjects at 24 weeks was designed to guide the decision from Ph2A‐B (Figure 1). The Ph2B primary endpoint was CDR‐sum‐of‐boxes (CDR‐SB), with secondary endpoints CFC2, ABC score, spectral EEG, FAQ, ADAS‐Cog‐13, and NPI.

Result:

Table 1 presents baseline characteristics of the 109 randomized and dosed participants. The first dose cohort of varoglutamstat 600mg or placebo did not cross the safety boundary in Ph2A, supporting this dose selection for all participants thereafter. An abbreviated futility analysis was conducted after the trial was terminated prematurely for administrative reasons, with the provisional result of ‘halt enrollment’(yellow) (Figure 1). There were 74% of participants who completed week 24 and 31% week 72 (Figure 2). There were no significant differences between varoglutamstat and placebo in LS mean squares from baseline to week 72 in CDR‐SB (‐0.05 [95% CI ‐1.03, 0.92]), CFC2 (0.97 [95% CI ‐3.34, 5.28]), ABC score (0.10 [95% CI ‐0.10, 0.30]), FAQ (‐0.60 [95% CI ‐4.22, 3.01]), ADAS‐Cog‐13 (2.03 [95% CI ‐2.29, 6.36]); or NPI (‐3.09 [95% CI ‐7.81, 1.62]). At least one TEAE during treatment was reported in 84.9% varoglutamstat and 76.8% placebo with treatment discontinuations due to AE 11.3% varoglutamstat and 3.4% placebo. Severe TEAEs occurred with similar frequencies across arms. Frequency of SAEs/AESIs was 18.9/1.9% varoglutamstat versus 8.9%/5.4% placebo.

Conclusion:

Varoglutamstat was safe and well‐tolerated in this VIVA‐MIND early AD RCT. Efficacy assessment did not demonstrate any significant treatment benefits however, the available sample was limited. Biomarker results and PK/PD are pending.

News (Medical) associated with Varoglutamstat

06 Aug 2026

·www.biospace.com

Vivoryon Therapeutics N.V. Reports H1 2026 Financial Results and Provides Business Update

Vivoryon Therapeutics N.V. Reports H1 2026 Financial Results and Provides Business Update Strategic partnering remains a key priority, with multiple strategic discussions progressing, including advanced term sheet negotiations for a potential licensing agreement Gained further insight into varoglutamstat’s unique mechanism of action and therapeutic potential in kidney disease Financial guidance maintained: Vivoryon expects cash and cash equivalents to be sufficient for funding operations into Q4 2026 Management to host a conference call today at 3:00 pm CEST (9:00 am EDT) Halle (Saale) / Munich, Germany, August 6 , 2026 - Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) ( Vivoryon ), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, today announced financial results for the six-month period ended June 30, 2026, and provided a corporate update. The half year report is available on the Company’s website . “Throughout the first half of this year we continued to see increased external interest in varoglutamstat in kidney disease. We have made meaningful progress in our partnering efforts and are currently in advanced term sheet negotiations for a potential licensing agreement. Separately, a specialist kidney-focused investor is conducting an independent assessment of selected aspects of the varoglutamstat program in connection with its evaluation of a potential investment,” said Frank Weber, MD, CEO of Vivoryon. “We are highly encouraged by the level of external engagement and remain focused on securing the funding and partnership required to advance the Phase 2b program for varoglutamstat, and look forward to providing you with an update in due course.” H1 2026 and Post-Period Updates ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Strategic Priorities Vivoryon's key strategic priority is to secure the funding necessary to advance varoglutamstat into a Phase 2b clinical study in patients with advanced diabetic kidney disease (DKD) stage 3b/4 in order to confirm the compelling data observed in the VIVIAD and VIVA-MIND studies. Throughout the reporting period and in recent months, multiple strategic discussions have been progressing. The Company is advancing negotiations with different parties towards securing beneficial partnerships for varoglutamstat in kidney disease and is currently in advanced term sheet negotiations for a potential licensing agreement. Separately, a specialist kidney-focused investor is conducting an independent assessment of selected aspects of the varoglutamstat program in connection with its evaluation of a potential investment. Vivoryon also continues to engage with additional strategic parties to maximize the full potential of the QPCT/L platform. Note that all ongoing negotiations and potential investments are subject to the typical risks and uncertainties associated with such processes and there can be no guarantee that any transaction or investment will materialize. Varoglutamstat Program The strong clinical and preclinical data and analyses generated to date continue to support advancement of varoglutamstat in advanced diabetic kidney disease (DKD). Vivoryon's Phase 2 clinical program with varoglutamstat has consistently demonstrated statistically significant and clinically meaningful improvements in kidney function (eGFR) versus placebo across two independent randomized, double-blind, placebo-controlled studies in elderly participants, VIVIAD and VIVA-MIND. Based on these findings, the Company is preparing to advance varoglutamstat into a dedicated Phase 2b clinical trial in patients with stage 3b/4 diabetic kidney disease (DKD), subject to securing additional funding and/or a strategic partnership. Further elucidated varoglutamstat’s MOA The Company continues to strengthen the scientific understanding of varoglutamstat‘s mechanism of action through an expanding preclinical data package. New preliminary findings from a CKD animal model show, on the molecular level, a significant beneficial effect of varoglutamstat on the endothelial cells in the kidney. These cells are a crucially important part of the kidneys’ filtration barrier, whose integrity is a key factor in maintaining kidney function. The new pathway analysis data support an improvement of endothelial cell function via activation of HIF pathways and upregulation of VEGF in response to varoglutamstat, which may lead to a reversal of capillary rarefaction, the prevention of endothelial cell death as well as vascular stabilization. Together with additional pre-clinical data on varoglutamstat’s molecular mechanisms, these findings further reinforce the therapeutic rationale for targeting QPCT/L in kidney disease. Vivoryon published a pre-recorded webcast in April 2026 which contextualizes pre-clinical data relating to the biological mechanisms of varoglutamstat’s kidney benefits observed in VIVIAD and VIVA-MIND. This included evidence of the role of QPCT and QPCTL in inflammation, fibrosis and collagen maturation, as well as data demonstrating the positive effects of varoglutamstat on podocytes, the specialized cells essential for maintaining kidney filtration function. The webcast is available here: Presented new analyses at key international medical meeting Vivoryon presented new analyses further validating QPCT/L as promising therapeutic targets in DKD at the World Congress of Nephrology (WCN) 2026 in Yokohama, Japan. The data reinforced previous findings that varoglutamstat's effect on eGFR was more pronounced in elderly participants with diabetes than in those without diabetes. Among participants with diabetes and lower baseline kidney function (mean eGFR of 60 mL/min/1.73m²), treatment effects were comparable to or greater than those observed in the overall diabetic population. Also presented at WCN were findings from a DKD mouse model showing significant improvements in inflammation, glomerulosclerosis and kidney function with varoglutamstat. Proposed clinical development plan in DKD The Company is planning to conduct a randomized, placebo-controlled Phase 2b study in patients with advanced DKD stage 3b/4 to confirm the compelling effects of varoglutamstat on kidney function observed in the VIVIAD and VIVA-MIND Phase 2 studies in elderly patients. Initiation of the Phase 2b and all future studies is subject to additional funding and/or partnership, which Vivoryon continues to actively explore. Corporate Update The Company plans to host its 2026 Annual General Meeting on September 29, 2026 in Amsterdam, The Netherlands. The convocation note and all related materials will be made available on the Company’s website in due time. Financial Results for the First Half of 2026 Revenues were zero in the six months ended June 30, 2026, as well as in the six months ended June 30, 2025. Research and development expenses decreased by EUR 1.1 million to EUR 1.7 million in the six months ended June 30, 2026, compared to EUR 2.8 million in the six months ended June 30, 2025. This reduction was largely attributable to a decrease in clinical development costs of EUR 0.6 million related to kidney research and a reduction of associated patent and consulting fees of EUR 0.2 million. General and administrative expenses were EUR 1.7 million in the six months ended June 30, 2026, compared to EUR 2.8 million in the six months ended June 30, 2025. The decrease of EUR 1.1 million was largely attributable to less non-cash-effective share-based personnel costs of EUR 0.4 million and a decrease in legal costs of EUR 0.4 million. Net loss for the six months ended June 30, 2026, was EUR 3.4 million, compared to EUR 5.5 million for the six months ended June 30, 2025. The Company held EUR 2.4 million in cash and cash equivalents as of June 30, 2026, compared to EUR 5.6 million as of December 31, 2025. Outlook & financial guidance As published on April 23, 2026, the issuance date of its annual Financial Statements 2025, the Company expects, based on its most recent financial and business plan, that its existing cash and cash equivalents will be sufficient to fund its operating plans into the fourth quarter of 2026, subject to the occurrence of unforeseen circumstances and without taking into account any potential financing through its standby equity purchase agreement (SEPA) as well as other potential additional financing transactions, if any. This cash runway guidance reflects an overall reduction in cash utilization while prudently investing in preparing to execute on the Company’s kidney disease strategy. Funding operations beyond its current guidance as well as initiation of the planned Phase 2b DKD study and all future studies are subject to further additional funding and/or partnership, which the Company continues to actively explore. The viability of the Company’s business beyond its current guidance is dependent on its ability to raise additional funds to finance its operations which also depends on the success of its research and development activities such as those focusing on exploring opportunities in kidney disease. The Company expects to have continued operating losses for the foreseeable future and the need to raise additional capital to finance its future operations. The Company has concluded that the ability to continue as a going concern in the financial year 2026, as stated in the Company’s Annual Report 2025 published on April 23, 2026, depends on the ability to generate additional funding. Please refer to the Company’s Annual Report 2025 for further information. Conference call and webcast Vivoryon will host a conference call and webcast today, August 6, 2026, at 3:00 pm CEST (9:00 am EDT). A Q&A session will follow the presentation of the half year results. A live webcast and slides will be made available at: To join the conference call via phone, participants may pre-register and will receive dedicated dial-in details to easily and quickly access the call via the following website: It is suggested participants dial into the conference call 15 minutes prior to the scheduled start time to avoid any delays in attendance. Approximately one day after the call, a slide-synchronized audio replay of the conference will be available on: ### Vivoryon Therapeutics N.V. Financial Statements Unaudited Statement of Operations and Comprehensive Loss for the Six Months Ended June 30, 2026 and 2025 For the six months ended June 30, in kEUR, except for share data 2026 (unaudited) 2025 (unaudited) Research and development expenses (1,659) (2,768) General and administrative expenses (1,732) (2,755) Operating loss (3,391) (5,523) Finance income 27 74 Finance expenses (24) (24) Finance result 3 50 Result before income taxes (3,388) (5,473) Income taxes — — Net loss for the period (3,388) (5,473) Items not to be reclassified subsequently to profit or loss Remeasurement of the net defined benefit pension liability (5) 26 Total other comprehensive profit / (loss) (5) 26 Comprehensive loss (3,393) (5,447) Loss per share in EUR (basic and diluted) (0.11) (0.21) The accompanying notes are an integral part of these condensed interim financial statements. Vivoryon Therapeutics N.V. Unaudited Condensed Statements of Financial Position as of June 30, 2026 and December 31, 2025 (audited) in kEUR June 30, 2026 (unaudited) December 31,2025 (audited) ASSETS Non-current assets Property, plant and equipment 6 13 Intangible assets 765 797 Right-of-use assets 76 108 Other non-current assets 182 173 Total non-current assets 1,029 1,091 Current assets Financial assets 98 33 Other current assets and prepayments 594 775 Cash and cash equivalents 2,446 5,619 Total current assets 3,138 6,427 TOTAL ASSETS 4,167 7,518 Equity Share capital 296 296 Share premium 166,218 166,218 Other capital reserves 16,901 16,670 Accumulated other comprehensive loss (242) (237) Accumulated deficit (181,608) (178,220) Total equity 1,565 4,727 Non-current liabilities Pension liability 1,211 1,232 Provisions long-term 692 678 Lease liability 11 44 Total non-current liabilities 1,914 1,954 Current liabilities Trade payables 388 458 Lease liabilities 65 64 Other liabilities 235 315 Total current liabilities 688 837 Total Liabilities 2,602 2,791 TOTAL EQUITY AND LIABILITIES 4,167 7,518 The accompanying notes are an integral part of these condensed interim financial statements. Vivoryon Therapeutics N.V. Unaudited Condensed Statements of Changes in Shareholders’ Equity for the six months ended June 30, 2026 and 2025 in kEUR Share capital Share premium Other capital reserves Accumulated other comprehensive loss Accumulated deficit Total equity January 1, 2026 296 166,218 16,670 (237) (178,220) 4,727 Net loss for the period — — — — (3,388) (3,388) Remeasurement of the net defined benefit pension liability — — — (5) — (5) Comprehensive loss — — — (5) (3,388) (3,393) Share-based payments — — 231 — — 231 June 30, 2026 296 166,218 16,901 (242) (181,608) 1,565 January 1, 2025 261 161,477 15,777 (268) (169,367) 7,880 Net loss for the period — — — — (5,473) (5,473) Remeasurement of the net defined benefit pension liability — — — 26 — 26 Comprehensive loss — — — 26 (5,473) (5,477) Proceeds from the issuance of common shares 1 — — — — 1 Share-based payments — — 747 — — 747 June 30, 2025 262 161,477 16,524 (242) (174,840) 3,181 The accompanying notes are an integral part of these condensed interim financial statements. Vivoryon Therapeutics N.V. Unaudited Condensed Statements of Cash Flows for the six months ended June 30, 2026 and 2025 For the six months ended June 30, in kEUR 2026 (unaudited) 2025 (unaudited) Operating activities Net loss for the period (3,388) (5,473) Adjustments for: Finance result (3) (50) Depreciation and amortization 67 73 Share based payments 231 747 Foreign currency gain (loss) from other items than cash (1) 3 Other non-cash adjustments — 1 Changing in: Financial assets (75) — Provisions long term 14 0 Other current and non-current assets and prepayments 172 262 Other long-term assets — (27) Pension liabilities (47) (47) Trade payables (70) 10 Other liabilities (79) (96) Interest received 35 103 Interest paid (1) (2) Cash flows used in operating activities (3,145) (4,496) Investing activities (Purchase) / sale of plant and equipment 4 (4) Cash flows used in investing activities 4 (4) Financing activities Payment of lease liabilities (32) (30) Proceeds from the issuance of common shares — 2 Cash flows provided by financing activities (32) (28) Net change in cash and cash equivalents (3,173) (4,528) Cash and cash equivalents at the beginning of period 5,619 9,365 Cash and cash equivalents at end of period 2,446 4,837 The accompanying notes are an integral part of these condensed interim financial statements. ### About Vivoryon Therapeutics N.V. Vivoryon is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines for the treatment of inflammatory and fibrotic disorders of the kidney. Driven by its passion for ground-breaking science and innovation, the Company strives to improve patient outcomes by changing the course of severe diseases through modulating the activity and stability of pathologically relevant proteins. Vivoryon’s most advanced program, varoglutamstat, a proprietary, first-in-class orally available QPCT/L inhibitor, is being evaluated to treat diabetic kidney disease. Vivoryon Forward Looking Statements This press release includes forward-looking statements, including, without limitation, those regarding the business strategy, management plans and objectives for future operations of Vivoryon Therapeutics N.V. (the “Company”), estimates and projections with respect to the market for the Company’s products and forecasts and statements as to when the Company’s products may be available. Words such as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “project,” “predict,” “should” and “will” and similar expressions as they relate to the Company are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance; rather they are based on the Management’s current expectations and assumptions about future events and trends, the economy and other future conditions. The forward-looking statements involve a number of known and unknown risks and uncertainties. These risks and uncertainties and other factors could materially adversely affect the outcome and financial effects of the plans and events described herein. The Company’s results of operations, cash needs, financial condition, liquidity, prospects, future transactions, strategies or events may differ materially from those expressed or implied in such forward-looking statements and from expectations. As a result, no undue reliance should be placed on such forward-looking statements. This press release does not contain risk factors. Certain risk factors that may affect the Company’s future financial results are discussed in the published annual financial statements of the Company. This press release, including any forward-looking statements, speaks only as of the date of this press release. The Company does not assume any obligation to update any information or forward-looking statements contained herein, save for any information required to be disclosed by law. For more information, please contact: Vivoryon Therapeutics N.V. Dr. Manuela Bader, Director IR & Communication Email: IR@vivoryon.com LifeSci Advisors Sandya von der Weid Tel: +41 78 680 05 38 Email: svonderweid@lifesciadvisors.com Attachment 2026-08-06_VVY_H12026_

Phase 2Financial StatementLicense out/in

22 Jul 2026

·www.biospace.com

Vivoryon Therapeutics N.V. to Report H1 2026 Financial Results and Business Updates on August 6, 2026; Annual General Meeting Planned for End of September 2026

Vivoryon Therapeutics N.V. to Report H1 2026 Financial Results and Business Updates on August 6, 2026; Annual General Meeting Planned for End of September 2026 Halle (Saale) / Munich, Germany, July 22 , 2026 - Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) ( Vivoryon ), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, today announced that it will report half year financial results and business updates for the period ended June 30, 2026, on Thursday, August 6, 2026, and that it plans to host its 2026 Annual General Meeting at the end of September 2026. The convocation note and all related materials will be made available on the Company’s website in due time. For the H1 2026 financial results, the Company will host a conference call and webcast open to the public. The report will be available for download on the Company’s website ( ). H1 2026 conference call details Date: August 6, 2026 Time: 3:00 pm CEST / 9:00 am EDT The H1 2026 conference call will be available via phone and webcast. The live audio webcast of the call will be available on Vivoryon’s website at: To join the H1 2026 conference call via phone, participants may pre-register and will receive dedicated dial-in details to easily and quickly access the call via the following website: ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); It is suggested participants dial into the conference call 15 minutes prior to the scheduled start time to avoid any delays in attendance. ### About Vivoryon Therapeutics N.V. Vivoryon is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines for the treatment of inflammatory and fibrotic disorders of the kidney. Driven by its passion for ground-breaking science and innovation, the Company strives to improve patient outcomes by changing the course of severe diseases through modulating the activity and stability of pathologically relevant proteins. Vivoryon’s most advanced program, varoglutamstat, a proprietary, first-in-class orally available QPCT/L inhibitor, is being evaluated to treat diabetic kidney disease. Vivoryon Forward Looking Statements This press release includes forward-looking statements, including, without limitation, those regarding the business strategy, management plans and objectives for future operations of Vivoryon Therapeutics N.V. (the “Company”), estimates and projections with respect to the market for the Company’s products and forecasts and statements as to when the Company’s products may be available. Words such as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “project,” “predict,” “should” and “will” and similar expressions as they relate to the Company are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance; rather they are based on the Management’s current expectations and assumptions about future events and trends, the economy and other future conditions. The forward-looking statements involve a number of known and unknown risks and uncertainties. These risks and uncertainties and other factors could materially adversely affect the outcome and financial effects of the plans and events described herein. The Company’s results of operations, cash needs, financial condition, liquidity, prospects, future transactions, strategies or events may differ materially from those expressed or implied in such forward-looking statements and from expectations. As a result, no undue reliance should be placed on such forward-looking statements. This press release does not contain risk factors. Certain risk factors that may affect the Company’s future financial results are discussed in the published annual financial statements of the Company. This press release, including any forward-looking statements, speaks only as of the date of this press release. The Company does not assume any obligation to update any information or forward-looking statements contained herein, save for any information required to be disclosed by law. For more information, please contact: Vivoryon Therapeutics N.V. Dr. Manuela Bader, Director IR & Communication Email: IR@vivoryon.com LifeSci Advisors Sandya von der Weid Tel: +41 78 680 05 38 Email: svonderweid@lifesciadvisors.com Attachment 20260722_H1 2026 NoR_

Financial Statement

11 Jun 2026

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Vivoryon Therapeutics N.V. to Report Q1 2026 Financial Results on June 11, 2026

Vivoryon Therapeutics N.V. to Report Q1 2026 Financial Results on June 11, 2026 Halle (Saale) / Munich, Germany, June 8, 2026 - Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) ( Vivoryon ), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, today announced that it will publish its first quarter financial results for the period ended March 31, 2026 on Thursday, June 11, 2026. The Company’s next financial and business update conference call / webcast will be held in conjunction with the publication of its H1 results, anticipated in August. ### About Vivoryon Therapeutics N.V. Vivoryon is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines for the treatment of inflammatory and fibrotic disorders of the kidney. Driven by its passion for ground-breaking science and innovation, the Company strives to improve patient outcomes by changing the course of severe diseases through modulating the activity and stability of pathologically relevant proteins. Vivoryon’s most advanced program, varoglutamstat, a proprietary, first-in-class orally available QPCT/L inhibitor, is being evaluated to treat diabetic kidney disease. Vivoryon Forward Looking Statements This press release includes forward-looking statements, including, without limitation, those regarding the business strategy, management plans and objectives for future operations of Vivoryon Therapeutics N.V. (the “Company”), estimates and projections with respect to the market for the Company’s products and forecasts and statements as to when the Company’s products may be available. Words such as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “project,” “predict,” “should” and “will” and similar expressions as they relate to the Company are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance; rather they are based on the Management’s current expectations and assumptions about future events and trends, the economy and other future conditions. The forward-looking statements involve a number of known and unknown risks and uncertainties. These risks and uncertainties and other factors could materially adversely affect the outcome and financial effects of the plans and events described herein. The Company’s results of operations, cash needs, financial condition, liquidity, prospects, future transactions, strategies or events may differ materially from those expressed or implied in such forward-looking statements and from expectations. As a result, no undue reliance should be placed on such forward-looking statements. This press release does not contain risk factors. Certain risk factors that may affect the Company’s future financial results are discussed in the published annual financial statements of the Company. This press release, including any forward-looking statements, speaks only as of the date of this press release. The Company does not assume any obligation to update any information or forward-looking statements contained herein, save for any information required to be disclosed by law. For more information, please contact: Vivoryon Therapeutics N.V. Dr. Manuela Bader, Director IR & Communication Email: IR@vivoryon.com LifeSci Advisors Sandya von der Weid Tel: +41 78 680 05 38 Email: svonderweid@lifesciadvisors.com Attachment 20260608_Q1 2026 NoR

Financial Statement

100 Deals associated with Varoglutamstat

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Mild dementia	Phase 2	China	Jiangsu Simcere Pharmaceutical Co., Ltd.	26 Apr 2022
Mild dementia	Phase 2	China	Haupt Pharma Wülfing GmbH	26 Apr 2022
Mild dementia	Phase 2	China	Vivoryon Therapeutics NV	26 Apr 2022
Mild cognitive disorder	Phase 2	Denmark	Nordic Bioscience A/S	06 Jul 2020
Mild cognitive disorder	Phase 2	Denmark	Vivoryon Therapeutics NV	06 Jul 2020
Mild cognitive disorder	Phase 2	Germany	Nordic Bioscience A/S	06 Jul 2020
Mild cognitive disorder	Phase 2	Germany	Vivoryon Therapeutics NV	06 Jul 2020
Mild cognitive disorder	Phase 2	Netherlands	Vivoryon Therapeutics NV	06 Jul 2020
Mild cognitive disorder	Phase 2	Netherlands	Nordic Bioscience A/S	06 Jul 2020
Mild cognitive disorder	Phase 2	Poland	Nordic Bioscience A/S	06 Jul 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03919162 (VIVA-MIND, CTgov)	Phase 2	Alzheimer Disease	112	PQ912 (PQ912)	fjveicaasf = osbcqxycay prnbrwwdnx (gikwqtmoph, nhuxhvlpgp - bensnlipaw) View more	-	12 Dec 2025
				Placebo (Placebo)	fjveicaasf = nefwenzeic prnbrwwdnx (gikwqtmoph, ruowjzqixa - hctngwcufe) View more
NCT03919162 (VIVA-MIND, GlobeNewswire) Manual	Phase 2	Alzheimer Disease	-	Varoglutamstat	izmjyvmzhk(tnaeacrmwv) = no clinically meaningful and no statistically significant differences between varoglutamstat 600mg BID and placebo derkxzeahq (tkrsqtitor ) View more	Positive	09 Dec 2024
				placebo
NCT04498650 (VIVIAD, ASN2024)	Phase 2	Alzheimer Disease \| Mild cognitive disorder	259	Varoglutamstat 300 mg	mnfqkjasxc(erzeaxjkit) = pmsmncpvov aicktnbozr (uzxigjbmjb )	Positive	25 Oct 2024
				Varoglutamstat 600 mg	apqksitldi(gbklfkmsiq) = kehdhphvrr ourmrwgnay (zvdbhizxwg ) View more
NCT04498650 (VIVIAD, GlobeNewswire \| ASN2024)	Phase 2	Alzheimer Disease \| Diabetic Nephropathies	32	Varoglutamstat	yfmmxwuqif(favusqqoch) = endosmmlzg yptnwflyws (armfgysygh )	Positive	25 Oct 2024
				placebo	yfmmxwuqif(favusqqoch) = lotqngklpy yptnwflyws (armfgysygh )
NCT04498650 (VIVIAD, GlobeNewswire) Manual	Phase 2	Kidney Diseases CCL2 Expression	-	Varoglutamstat 600mg BID	oxstliqumz(fiabozwgqb) = ojiyniwrfp yehdxmofvm (gszttlloif ) View more	Positive	12 Sep 2024
NCT04498650 (VIVIAD, Corporate Publications) Manual	Phase 2	Alzheimer Disease	250	Varoglutamstat	fxdjxvxisy(brvhkwdwpc) = kfjopjxycu nkurgzyuoc (yozsrzjuuf ) View more	Positive	31 Jul 2022
NCT02389413 (Pubmed \| Alzheimers Res Ther) Manual	Phase 2	Alzheimer Disease	120	PQ912	nvwvkyujuc(gaxosgbssn) = There was no significant difference between treatments in the number of subjects with (serious) adverse events, although there were slightly more patients with a serious adverse event in the PQ912 group compared to placebo. ntrqvoayfq (yupmbxyiwe ) View more	Positive	12 Oct 2018
				Placebo

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