Vivoryon Therapeutics N.V. Reports Q1 2026 Financial Results
and Provides Business Update
- Compelling kidney function data and meta-analysis from two Phase 2 studies with varoglutamstat presented at WCN 2026
- Pronounced treatment effect in high-risk patients, including those with diabetes and lower baseline eGFR supporting plans to advance development in stage 3b/4 diabetic kidney disease (DKD)
- Company continues to prioritize strategic partnering objectives; active due diligence processes underway with multiple parties
- Financial guidance reconfirmed: Vivoryon expects cash and cash equivalents to be sufficient for funding operations into Q4 2026
Halle (Saale) / Munich, Germany, June 11, 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 three-month period ended March 31, 2026, and provided a corporate update.
“In Q1 2026 our focus remained on strategic discussions with potential partners to support the Phase 2b development of varoglutamstat in advanced DKD. We continue to make substantial progress and remain actively engaged with multiple parties who, like us, understand the need for disease-modifying therapeutics that could improve or stabilize kidney function,” said Frank Weber, MD, CEO of Vivoryon. “We have consistently shown that varoglutamstat improves kidney function in elderly patients, in particular those with diabetes, and have established a large pre-clinical and clinical data set to de-risk the planned Phase 2b program. Taken together, these data give us further confidence that, through its differentiated mechanism of action targeting fibrotic and inflammatory pathways, varoglutamstat could have a transformative role in preventing progression of life-limiting kidney diseases.”
Q1 2026 and Post-Period Updates
Strategic Priorities
Vivoryon’s key strategic priority for 2026 is to secure the funding necessary to advance varoglutamstat into a Phase 2b clinical study in patients with advanced DKD stage 3b/4 in order to confirm the compelling data observed in the VIVIAD and VIVA-MIND studies. Throughout the reporting period and recent months, the Company has continued to engage in active discussions and due diligence under CDA with multiple potential biopharma partners and strategic investors.
Varoglutamstat Program
Vivoryon’s varoglutamstat Phase 2 program has shown highly consistent, statistically significant and clinically meaningful improvement of kidney function (eGFR) versus placebo in two independent randomized double-blind placebo-controlled studies, VIVIAD and VIVA-MIND. The Company is planning to confirm these results in a dedicated Phase 2b clinical study in patients with 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.
- On March 28, 2026, Vivoryon presented a poster at the World Congress of Nephrology (WCN) in Yokohama, Japan, providing an update on the growing body of evidence validating glutaminyl cyclases (QPCT/L) as promising targets in DKD. The analyses underscored previous reports showing that the effect of varoglutamstat on eGFR observed in VIVIAD and VIVA-MIND was greater in elderly participants with diabetes compared to elderly participants without diabetes. In participants with diabetes and lower baseline eGFR (mean 60 mL/min/1.73m2), the effect size was comparable or higher than in the total population of participants with diabetes. Additionally, analysis of data from a DKD mouse model showed significant improvements of inflammation, glomerulosclerosis and kidney function. These results further support Vivoryon’s rationale for a dedicated Phase 2b clinical study in patients with advanced DKD stage 3b/4.
- The Company has actively expanded the pre-clinical data set around varoglutamstat’s mechanism of action (MOA) and recent studies have further elucidated the molecular mechanisms underlying the substantial benefits reported from the VIVIAD and VIVA-MIND studies. On April 22, 2026, the Company published on its website a pre-recorded webcast contextualizing these new data. The webcast includes new data on the role of QPCT and QPCTL in inflammation and fibrosis, including revealing their newly discovered role in collagen maturation, the disruption of which is a key factor in fibrosis, as well as new data on the existing medical need in kidney disease and the positive effect of varoglutamstat treatment on specialized blood-filtering kidney cells (podocytes). The webcast is available here:
https://www.vivoryon.com/science-insights-understanding-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 VIVAD 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.
Financial Results for the First Quarter of 2026
No Revenues were generated in the three months ended March 31, 2026.
Research and development expenses decreased by EUR 0.3 million to EUR 0.9 million in the three months ended March 31, 2026, compared to EUR 1.2 million in the three months ended March 31, 2025. This decrease is primarily attributable to EUR 0.2 million lower third-party expenses due to the ramp-down of the Phase 2b clinical studies VIVIAD and VIVA-MIND, reflecting EUR 0.1 million lower clinical costs and EUR 0.1 million lower manufacturing costs.
General and administrative expenses were EUR 0.9 million in the three months ended March 31, 2026, compared to EUR 1.3 million in the three months ended March 31, 2025. The EUR 0.4 million decrease was primarily attributable to lower personnel expenses of EUR 0.2 million and reduced legal costs of EUR 0.2 million. The decline in personnel expenses was mainly due to a EUR 0.2 million reduction in share-based payment expenses.
The net loss for the three months ended March 31, 2026 was EUR 1.8 million compared to EUR 2.5 million for the three months ended March 31, 2025.
As of March 31, 2026, Vivoryon held cash and cash equivalents of EUR 4.0 million compared to cash and cash equivalents of 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 funds from the 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. The initiation of the Phase 2b DKD study and all future studies is 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
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.
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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:
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
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