Vivoryon Therapeutics N.V. Presents Phase 2 Kidney Function and Biomarker Data at the American Society of Nephrology Kidney Week 2025

Vivoryon Therapeutics N.V. Presents Phase 2 Kidney Function and Biomarker Data at the American Society of Nephrology Kidney Week 2025

• Compelling kidney function data from VIVIAD Phase 2b study presented in late-breaking poster at ASN kidney week, the world’s premier nephrology meeting
• VIVIAD analyses continue to support varoglutamstat’s potential in kidney disease, and consistently provide further evidence for a beneficial impact on kidney function based on its proposed mechanism of action
  

Halle (Saale) / Munich, Germany, November 6, 2025 - 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 the presentation of clinical study data from the Company’s lead investigational medicine in development, varoglutamstat, in a late-breaking poster today, November 6, 2025, at the American Society of Nephrology (ASN) Kidney Week 2025 in Houston, Texas.

The poster titled “Correlation of eGFR and pE-CCL2 in Older Adult Patients Treated with Varoglutamstat: Data from VIVIAD, a Phase 2B Randomized Clinical Trial” featured Phase 2 clinical study data underscoring varoglutamstat’s unique ability to stabilize and even improve kidney function, as measured by eGFR values.

Results from Vivoryon’s VIVIAD Phase 2b study previously showed that reduction of the anti-inflammatory biomarker pE-CCL2 was associated with an improvement of kidney function as measured by eGFR in study participants with and without diabetes at a dose group level. In line with these results, the poster highlights further analyses of total population data from the VIVIAD study evaluating the correlation of pE-CCL2 levels and eGFR slope on an individual participant level, which revealed a statistically significant correlation between the change from baseline in pE-CCL2 serum levels at week 48 and the eGFR slope over time. Specifically, a decrease in pE-CCL2 was significantly correlated with a positive (improved) eGFR slope.

“We are truly grateful for the opportunity to share our consistently compelling results with world leading scientific and medical experts in the kidney field at ASN Kidney week, considered to be the world’s premier nephrology congress,” said Frank Weber, MD, CEO of Vivoryon. “Inflammation is known to be a key driver in diabetic kidney disease and our data to date show clearly that inhibition of glutaminyl-cyclases with varoglutamstat is a promising new approach to treat diabetic kidney disease and other chronic diseases of the kidney. Every step forward strengthens our belief that, with varoglutamstat, we have a unique opportunity to develop a game-changing medicine with the potential to go beyond current standard of care and meaningfully improve kidney function in people with kidney disease.”

Vivoryon is planning to confirm the previously reported compelling data from its two independent Phase 2 studies, VIVIAD and VIVA-MIND, by conducting a dedicated Phase 2b clinical study in patients with advanced diabetic kidney disease (DKD) stage 3b/4. Initiation of the Phase 2b and all future studies is subject to additional funding and/or partnership, which Vivoryon continues to actively explore.

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About VIVIAD / Methods

VIVIAD (NCT04498650) is a randomized clinical trial (Phase 2b) in 259 patients with early Alzheimer’s disease treated with 300 or 600 mg varoglutamstat, or placebo, BID for 48-96 weeks. Measurement of eGFR and biomarkers of inflammation were prospectively defined. pE-CCL2 serum levels were measured at baseline and at week 48 with an ELISA. Individual patient slopes of eGFR (MDRD formula) were calculated using random-coefficient analysis. Spearman correlations were calculated with R.

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. www.vivoryon.com

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:

Investor 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

Media Contact
Trophic Communications
Valeria Fisher or Verena Schossmann
Tel: +49 175 8041816 / +49 151 219 412 77
Email: vivoryon@trophic.eu

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