Vivoryon Therapeutics N.V. Reports Q3 2026 Financial Results
and Provides Business Update
- Ongoing negotiations with different parties towards securing a partnership or financing for the development of varoglutamstat in kidney disease
- Agreement with partner Simcere Pharmaceutical Group Ltd. to regain development and commercial rights for lead asset varoglutamstat in Greater China, consolidating global rights and supporting Vivoryon’s strategic focus on kidney disease
- New analysis performed by Lucera GmbH, a biomedical intelligence company, links preclinical treatment responses to human disease processes, further strengthening the dataset supporting varoglutamstat’s MoA in kidney disease
- Updated financial guidance: additional cost-saving measures extend expected cash runway into the second half of December 2026
Halle (Saale) / Munich, Germany, November 5, 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 nine-month period ended September 30, 2026, and provided a corporate update.
“We remain engaged in negotiations with different parties regarding a partnership or financing for the development of varoglutamstat in kidney disease,” said Frank Weber, MD, CEO of Vivoryon. “The agreement with Simcere consolidates worldwide rights to varoglutamstat, simplifying the rights structure for potential partners, while additional cost-saving measures extend our operating runway into the second half of December 2026. Our priority is to secure funding for the planned Phase 2b study. In parallel, we are evaluating alternative strategic and financing options, taking into account the available cash runway and the potential of each option to preserve and realize shareholder value.”
Q3 2026 and Post-Period Updates
Strategic Priorities
Vivoryon's key strategic priority remains securing the funding necessary to advance varoglutamstat into a Phase 2b clinical study in patients with advanced diabetic kidney disease (DKD), with the aim of confirming the compelling data observed in the VIVIAD and VIVA-MIND studies. The Company continues negotiations with different parties towards securing a partnership or financing for the development of varoglutamstat in kidney disease. In parallel, Vivoryon is assessing alternative strategic and financing options, including a potential sale of the Company or a sale of assets.
Corporate Updates
- In September 2026, Vivoryon held its 2026 Annual General Meeting (AGM) in Amsterdam, the Netherlands. The shareholders approved all items on the agenda of the meeting.
- Vivoryon has recently signed an agreement with partner Simcere Pharmaceutical Group Ltd. to regain development and commercial rights for lead asset varoglutamstat in Greater China, consolidating global rights and supporting the Company’s strategic focus on kidney disease. The Termination Agreement covers the existing regional licensing partnership for the development and commercialization of medicines targeting the neurotoxic amyloid species N3pE (pGlu-Abeta) to treat Alzheimer's disease (AD) in Greater China, resulting in the return of all development and commercialization rights for varoglutamstat as well as Vivoryon's pre-clinical stage monoclonal N3pE-antibody PBD-C06 in this territory to Vivoryon. Under the terms of the Termination Agreement, no cash payment is due by Vivoryon upon termination. Simcere will be eligible to receive certain payments upon the achievement of specified future regulatory milestones in Greater China for varoglutamstat.
Varoglutamstat Program Overview and Updates
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.
Vivoryon has continued to actively expand and strengthen pre-clinical and clinical data sets for varoglutamstat, as well as present updates on the growing body of evidence validating glutaminyl cyclases (QPCT/L) as promising targets in DKD at the World Congress of Nephrology, Japan.
A new computational analysis by Lucera GmbH, a biomedical intelligence company, provides further mechanistic support for the development of varoglutamstat in kidney disease. By integrating preclinical gene-expression data for varoglutamstat and one of Vivoryon’s second-generation QPCT/L inhibitors with human kidney disease datasets, the analysis identified molecular networks connecting treatment responses with inflammatory and fibrotic processes implicated in kidney disease progression. These findings extend the mechanistic rationale beyond individual inflammatory pathways and support investigation of a broader role for QPCT/L inhibition in kidney disease. The analysis also prioritized potential mechanisms for additional experimental validation.
Financial Results for the Nine Months Ended September 30, 2026
Revenues were zero in the nine months ended September 30, 2026, as well as in the nine months ended September 30, 2025.
Research and development expenses decreased by EUR 1.4 million to EUR 2.3 million in the nine months ended September 30, 2026, compared to EUR 3.7 million in the nine months ended September 30, 2025. This reduction was largely attributable to a decrease in clinical development and analysis costs of EUR 1.0 million related to kidney research.
General and administrative expenses were EUR 2.7 million in the nine months ended September 30, 2026, compared to EUR 4.0 million in the nine months ended September 30, 2025. The decrease was largely attributable to lower non-cash-effective share-based personnel costs of EUR 0.6 million and the implementation of cost-saving measures.
Net loss for the nine months ended September 30, 2026, was EUR 4.8 million, compared to EUR 7.6 million for the nine months ended September 30, 2025.
The Company held EUR 1.7 million in cash and cash equivalents as of September 30, 2026, compared to EUR 5.6 million as of December 31, 2025.
Outlook & Financial Guidance
The Company expects, based on its most recent financial and business plan, that its existing cash and cash equivalents will now be sufficient to fund its operating plans into the second half of December 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 will require additional funding to continue operations beyond the current financial guidance. The Company has concluded that the ability to continue as a going concern, depends on the ability to generate additional funding. For further information please refer to the Company’s Annual Report 2025 published on April 23, 2026.
All ongoing negotiations and potential partnerships remain subject to the customary risks and uncertainties associated with such processes, and there can be no assurance that any transaction or investment will materialize.
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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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